WO1990011103A2 - Pre-slit injection site and tapered cannula - Google Patents

Pre-slit injection site and tapered cannula Download PDF

Info

Publication number
WO1990011103A2
WO1990011103A2 PCT/US1990/001350 US9001350W WO9011103A2 WO 1990011103 A2 WO1990011103 A2 WO 1990011103A2 US 9001350 W US9001350 W US 9001350W WO 9011103 A2 WO9011103 A2 WO 9011103A2
Authority
WO
WIPO (PCT)
Prior art keywords
injection site
cannula
blunt
housing
blunt cannula
Prior art date
Application number
PCT/US1990/001350
Other languages
French (fr)
Other versions
WO1990011103A3 (en
Inventor
Steven C. Jepson
Thomas E. Dudar
Michael J. Finley
Vincent C. Desecki
Original Assignee
Baxter International Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc. filed Critical Baxter International Inc.
Priority to DE1990609131 priority Critical patent/DE69009131T2/en
Priority to JP50509590A priority patent/JPH07110284B2/en
Priority to EP19900905119 priority patent/EP0419620B1/en
Publication of WO1990011103A2 publication Critical patent/WO1990011103A2/en
Publication of WO1990011103A3 publication Critical patent/WO1990011103A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • A61M39/045Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/1011Locking means for securing connection; Additional tamper safeties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/14Tube connectors; Tube couplings for connecting tubes having sealed ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1406Septums, pierceable membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1033Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1066Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1072Tube connectors; Tube couplings with a septum present in the connector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/19Constructional features of carpules, syringes or blisters
    • A61M2205/192Avoiding coring, e.g. preventing formation of particles during puncture
    • A61M2205/195Avoiding coring, e.g. preventing formation of particles during puncture by the needle tip shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/19Constructional features of carpules, syringes or blisters
    • A61M2205/192Avoiding coring, e.g. preventing formation of particles during puncture
    • A61M2205/197Avoiding coring, e.g. preventing formation of particles during puncture by the seal material
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00Surgery
    • Y10S604/905Aseptic connectors or couplings, e.g. frangible, piercable

Definitions

  • the invention pertains to coupling systems usable to transfer materials from one flow conduit to another. More particularly, the invention pertains to two-part coupling members with a first part including a pre-slit septum and second part including a blunt cannula. The pre-slit septum slidably receives the blunt cannula to effect the coupling.
  • Injection sites usable with pointed cannulae have long been known.
  • such sites can be formed with a housing having a fluid flow path therein.
  • a septum is positioned in the housing closing the fluid flow path.
  • One injection site usable with a piercing cannula is disclosed in U.S. Patent No. 4,412,573 to Zbed entitled "Injection Site.” The Zbed patent is assigned to the assignee of the present invention.
  • the pointed cannula can be forced through the septum into fluid flow communication with the flow path in the housing.
  • Known injection sites usable with a piercing cannula can be physically damaged by repetitive piercing caused by the sharp cannula. This damage, known as coring or laceration, can result in subsequent leakage.
  • Injection sites usable with a blunt cannula are also known.
  • U.S. Patent No. 4,197,848 issued to Garrett, et al., entitled “Closed Urinary Irrigation Site” and assigned to the assignee of the present invention discloses one such injection site. That injection site is a relatively low pressure device having a relatively thin, molded, sealing member. The sealing member has an opening therethrough.
  • a blunt cannulae can be forced through the sealing member placing the cannulae into fluid flow communication with a fluid flow pathway in the injection site.
  • Injection sites of the type noted above usable with a blunt cannula have the advantage that the blunt cannula will not pierce the skin of a user. On the other hand, it is important that the pre-slit injection site reseal with enough force that fluids do not ooze therefrom and that airborne particulate matter, bacterial or viral matter do not enter therethrough.
  • Such an injection site should be able to receive a large number of insertions of the cannula without displaying reseal failure. Such an injection site should provide for improved alignment of the cannula on insertion. Improved alignment will result in less chance of damage to the injection site after repeated insertions of the cannula.
  • the injection site would also be usable with a pointed cannula.
  • a pre-slit injection site usable with a blunt cannula will provide a reasonable level of insertion force such that health care personnel will readily be able to insert the blunt cannula, yet the cannula will not easily fall from or drop out of contact with the septum.
  • an easily wipeable injection site usable with a blunt cannula is provided.
  • the injection site includes a housing which defines a fluid flow channel therethrough.
  • the housing has a first and a second end.
  • a flexible sealing member is carried by the housing for sealing the first end.
  • the sealing member has a resealable opening therein.
  • the sealing member also is formed with a curved exterior peripheral surface such that the blunt cannula can be sealingly inserted through the opening and placed in fluid flow communication with the flow path. Further, the blunt cannula can be removed from the opening with a sealing member then interacting with the housing so as to reseal the opening.
  • the housing can also be formed with the first end including an annular channel underlying the sealing member.
  • the sealing member is subjected to radially directed forces by a tapered surface of the first end of the housing. These forces tend to reseal the opening in the sealing member.
  • the sealing member can be a cylindrically shaped rubber member.
  • the first end of the housing can include an interior tapered surface for receiving the sealing member and for applying the radially directed forces to the sealing member.
  • a retaining member carried by the first end of the housing can be used to retain the sealing member within the housing.
  • the retaining member can be generally U- shaped. Alternately, the retaining member can be formed as a coiled spring.
  • the retaining member applies axially directed forces to the sealing member.
  • the retaining member deflects the sealing member and forms a curved exterior peripheral surface thereon.
  • the curved exterior peripheral surface is an easily wipeable surface.
  • the retaining member deflects or distorts the upper and lower peripheral edges slightly as a result of applying axial forces thereto.
  • an annular interior peripheral region of the sealing member deforms further and fills, at least in part, the annular channel.
  • the insertion force will have a value of the order of 2.0 pounds (.7564 kilograms).
  • the resealable opening in the sealing member can extend entirely through that member. Alternately, the resealable opening can extend only partway therethrough. In this embodiment, the end of the blunt cannula will be used to tear through the remainder of the sealing member.
  • the sealing member can be formed in two parts.
  • An exterior cylindrical portion can be slit completely.
  • An interior cylindrical unslit portion can be provided to seal the site until the blunt cannula is inserted therethrough the first time.
  • the interior surface of the first end can be formed with the taper in a range on the order of 5 degrees to 20 degrees.
  • the interior surface will have a taper on the order of 12 degrees. This tapered surface permits the use of a cylindrically shaped sealing member.
  • a coupling system for coupling first and second fluid flow members together includes an injection site which is affixed to the first fluid flow member.
  • the injection site includes a housing.
  • the housing has a fluid flow path therethrough.
  • a sealing member is carried by the housing.
  • the sealing member has a resealable opening therein.
  • An annular retaining member is carried by the housing and cooperates with the housing to retain the sealing member therein. Radially directed forces are applied to the sealing member by the housing, thereby urging the opening into a resealed condition.
  • a blunt cannula, affixed to second fluid flow member has a fluid flow path therethrough.
  • the cannula carries a locking member for lockingly engaging the housing when the cannula extends through the opening of the sealing member. When so positioned, the two fluid flow members are placed into fluid flow communication.
  • the locking member can include a luer-type twist lock fitting.
  • the locking member can include slidably engageable members which are responsive to axial movement of the injection site and the cannula toward one another.
  • the blunt cannula may be provided with features that facilitate insertion into the injection site, enhance fluid flow or dispersion, increase tug resistance, and reduce kickback.
  • one embodiment of the cannula includes a tube with a plurality of elongate discharge slots adjacent the distal end.
  • the fluid changes direction as it passes laterally through the slots and out of the tube.
  • the flow area of the slots exceeds the flow area inside the tube.
  • This slot structure enhances fluid flow and inspersion characteristics.
  • the slots decrease the contact surface area on the tube exterior so as to facilitate insertion.
  • the cannula includes a lead post on the tube distal end to guide the cannula through the slit in the injection site.
  • the tube is generally cylindrical and the fluid discharges directly from an open end of the tube.
  • the exterior surface of the tube is provided with grooves to reduce the contact surface area.
  • the tube has a cylindrical portion and a tapered distal end portion which are each about equal in length.
  • the taper facilitates insertion, and the remaining cylindrical portion reduced kickback.
  • the cannula includes an annular barb which functions to reduce kickback.
  • blunt plastic cannula in accordance with the invention, relative to conventional steel needles include a higher fluid flow rate capacity and a simpler one-piece plastic design.
  • the invention may reside in the provision of an injection site in which first and second distinct locking means are provided on the exterior of the housing for selective co-operation with complementary locking means on different cannulas.
  • the first locking means may be a shoulder for engaging resilient fingers on a cannula and the second locking means may be a screw thread for engaging a screw thread on a different cannula.
  • the injection site is, therefore, particularly versatile in use.
  • the invention may also reside in a cannula device having retaining fingers which are resiliently biased to positions in which they can engage a shoulder of an injection site to lock the cannula device on the site.
  • Squeezable gripping means is provided for spreading the fingers to permit their engagement with a disengagement from the cannula. This provides a particularly effective locking system which is easy to operate.
  • Figure 1 is a side elevational view, partly in section, of a prior art pre-slit injection site and an associated blunt cannula
  • Figure 2A is a view in perspective of a catheter positioned in the hand of a patient with a pre-slit injection site in accordance with the present invention positioned adjacent thereto;
  • Figure 2B is a perspective view of the catheter of Figure 2A with a pre-slit injection site in accordance with the present invention rotatably affixed thereto;
  • Figure 3 is an enlarged side elevational view in a section of a pre-slit injection site in accordance with the present invention formed on a body having a luer twist-lock type connector for coupling to a catheter;
  • Figure 4A is an exploded view of a pre-slit injection site, a shielded blunt cannula and a syringe prior to being coupled together;
  • Figure 4B is an enlarged, side elevational view in section of the pre-slit injection site, the shielded blunt cannula and the syringe of Figure 4A coupled together to form a sealed fluid flow system;
  • Figure 5A is a view in perspective of a pre-slit injection site prior to engaging a blunt cannula carrying a locking member
  • Figure 5B is an enlarged side elevational view, partly broken away, illustrating the interrelationship between the pre-slit injection site and the blunt cannula of Figure 5A;
  • Figure 6 is an overall view of a container, an associated solution administration set and a pre-slit injection site in accordance with the present invention;
  • Figure 7 is an enlarged side elevational view, partly broken away illustrating the relationship between selected elements of Figure 6;
  • Figure 8 is a side elevational view, partly broken away illustrating an alternate shielded cannula in accordance with the present invention.
  • Figure 9 is a side elevational view, partly in section, of a pre-slit injection site mounted on a fragment of a solution container;
  • Figure 10 is a side elevational view of a fragment of a solution container carrying, as a single port, a pre-slit injection site;
  • Figure 11 is a side elevational view of the injection site and the fragmentary container of Figure 10 prior to being engaged with a shielded cannula carried by a syringe;
  • Figure 12 is an enlarged side elevational view, partly in section, of a coupling system with a pre-slit injection site partly coupled to a blunt cannula;
  • Figure 13 is an enlarged side elevational view, partly in section, of the coupling system of Figure 12 subsequent to engagement of the two coupling members;
  • Figure 14 is a side elevational view, partly broken away, of a spike connector carrying a pre-slit injection site in accordance with the present invention.
  • Figure 15 is an enlarged side elevational view of a Y-connector in section carrying a pre-slit injection site in accordance with the present invention
  • Figure 16 is an enlarged fragmentary side elevational view in section of a coupling member carrying a pre-slit injection site where the slit extends only partway through the septum;
  • Figure 17 is a perspective view of a burette solution administration set carrying a pre-slit injection site in accordance with the present invention.
  • Figure 18 is a view of part of a burette solution administration set carrying a pre-slit injection site being coupled to a shielded blunt cannula;
  • Figure 19 is a step in the method of making a pre- slit injection site in accordance with the present invention
  • Figure 20 is another step in the method of making a pre-slit injection site in accordance with the present invention.
  • Figure 21 is an initial phase of a final step in making a pre-slit injection site in accordance with the present invention
  • Figure 22 is an intermediate phase of the final step in a method of making a pre-slit injection site in accordance with the present invention
  • Figure 23 is a final phase of the final step in a method of making a pre-slit injection site in accordance with the present invention.
  • Figure 24 illustrates an initial phase in an alternate step of making a pre-slit injection site in accordance with the present invention
  • Figure 25 illustrates a final phase of the alternate step in a method of making an injection site in accordance with the present invention
  • Figure 26 illustrates yet another alternate step in a method of making a pre-slit injection site in accordance with the present invention
  • Figure 27 is an enlarged, fragmentary cross- sectional view of another embodiment of an injection site in accordance with the present invention.
  • Figure 28 is a cross-section view taken generally along the plane 28-28 in Figure 27;
  • Figure 29 is an end view of another embodiment of the cannula in accordance with the present invention.
  • Figure 30 is a cross-section view taken generally along the plane 30-30 in Figure 29;
  • Figure 31 is an end view of another embodiment of the cannula in accordance with the present invention.
  • Figure 32 is a cross-sectional view taken generally along the plane 32-32 in Figure 31;
  • Figure 33 is a cross-sectional view taken generally along the plane 33-33 in Figure 32;
  • Figure 34 is an end view of another embodiment of the cannula in accordance with the present invention.
  • Figure 35 is a fragmentary, side elevational view of the embodiment of the cannula illustrated in Figure 34;
  • Figure 36 is a cross-sectional view taken generally along the plane 36-36 in Figure 34;
  • Figure 37 is a cross-sectional view taken generally along the plane 37-37 in Figure 36;
  • Figure 38 is an end view of another embodiment of the cannula according to the present invention.
  • Figure 39 is a cross-sectional view taken generally along the plane 39-39 in Figure 38;
  • Figure 40 is a cross-sectional view taken generally along the plane 40-40 in Figure 39;
  • Figure 41 is an end view of another embodiment of the cannula according to the present invention.
  • Figure 42 is a cross-sectional view taken generally along the plane 42-42 in Figure 41;
  • Figure 43 is an end view of another embodiment of the cannula according to the present invention.
  • Figure 44 is a cross-sectional view taken generally along the plane 44-44 in Figure 43; and Figure 45 is a view in section of another insertion member for a blunt cannula.
  • Figure 46 is a perspective view of another embodiment of a blunt cannula embodying the present invention.
  • Figure 47 is a perspective view of a blunt cannula shield or tip protector.
  • Figure 48 is a perspective view of a heparin lock embodying the present invention.
  • Figure 49 is a side elevational view of the heparin lock of Figure 48 in joined relationship with a blunt cannula device of alternative construction embodying the present invention.
  • Figure 50 is a cross-sectional view of the heparin lock of Figure 48 in joined relationship with a blunt cannula device of further alternative construction embodying the present invention.
  • Figure 51 is a cross-sectional view of a pre-slit in-line injection site embodying the present invention in joined relationship with a blunt cannula shown in side elevational view.
  • Figure 52 is a perspective view of the alternative blunt cannula device of Figure 49 in joined and locked relationship with the pre-slit in-line injection site depicted in Figure 51.
  • Figure 53 is a perspective view, partially broken away, depicting the combination of a syringe and an alternative blunt cannula device of the present invention for injecting or removing liquid through a pre-slit in ⁇ line injection site, such as depicted in Figure 51.
  • Figure 54 is a perspective view of a blunt cannula shield or tip protector for attachment over the end of the blunt cannula device such as depicted in Figure 53.
  • Figure 55 is a cross-sectional view of an alternative blunt cannula device particularly suited for attachment to a syringe as shown in Figure 53.
  • Figure 56 is a perspective view of the blunt cannula device shown in Figure 53 in joined relationship with the pre-slit injection site shown in Figure 51.
  • a prior art pre-slit injection site 10 and associated blunt cannula 12 are illustrated in Figure l.
  • the prior art injection site 10 has a cylindrical housing 14 with a fluid flow path 16 therethrough.
  • a first end 18 of the housing 14 is closed with a relatively thin disc- shaped resealable member 20.
  • the member 20 has a resealable opening 22 therein.
  • the member 20 is a molded septum with an integrally formed skirt 20a.
  • the skirt 20a is oriented generally perpendicular to the portion of the septum with the opening 22.
  • the cannula 12 includes a body portion 24 which carries at a first end a hollow, cylindrical, blunt piercing member 26. As the cannula 12 is moved in a direction 28 toward the first end 18 of the injection site 10, the member 26 slidably engages the opening 22. The sealing member 20 is then deformed adjacent the opening 22 and the number 26 extends into the flow path 16. A fluid flow path through the cannula 12 will then be in fluid flow communication with the flow path 16 via the hollow piercing member 26.
  • FIGS 2A and 2B illustrate a pre-slit injection site 34 being coupled to a peripheral venous catheter 36.
  • the catheter 36 is shown in fluid flow communication with a vein in a hand H of a patient.
  • the catheter 36 carries at a proximal end 38 a luer-type female twist lock connector 41.
  • the pre-slit injection site 34 is formed with a cylindrical housing 40 having a first end 42 and a second end 44.
  • a hollow cylindrical fluid flow member 46 Carried by the housing 40, adjacent the second end 44 is a hollow cylindrical fluid flow member 46.
  • the member 46 slidably engages a receiving member in the housing 38 of the catheter 36, thereby providing a sterile fluid flow coupling as is well known and conventional.
  • a plurality of internal male luer-type threads 48 is carried by the housing 40 adjacent the second end 44.
  • the threads 48 will engage the flange member 41 when the injection site 34 is rotated in a direction 50.
  • the catheter 36 and the injection site 40 provide a sealed coupling through which fluids may be injected into the vein of the hand H.
  • FIG. 3 illustrates, in section, further details of the injection site 34.
  • a resealable septum 52 is carried by the first end 42 of the housing 40.
  • the septum 52 includes first and second spaced apart surfaces 54 and 56 respectively.
  • the surface 54 has been forced into a dome-like shape by annular, U-shaped, swaged end members 58 carried by the first end 42.
  • the dome-like shape of the surface 54 can extend beyond a surface 42a of the first end 42. This facilitates cleaning the surface 54.
  • the septum 52 has a generally cylindrical shape.
  • the septum 52 can be formed of a latex or synthetic rubber material. Alternately, the septum can be formed of a thermoplastic elastomer. The material used for the septum 52 should be non-toxic and sterilizable such as by means of radiation, steam or Ethylene Oxide.
  • the septum 52 is generally cylindrical in shape, it can be die-cut from a sheet, cut from an extruded rod or molded.
  • the septum 52 can have an exemplary diameter on the order of .30 inches (0.762 centimeters) .
  • the height of the septum 52 can be, for example, on the order of .125 inches (.3175 centimeters).
  • the first end 42 is also formed with a tapered interior surface 60 which terminates in an annular channel 62.
  • the tapered interior surface 60 has a taper in a range of 5 degrees to 20 degrees. Preferably, the taper will be on the order of 12 degrees. With the indicated size of the above noted exemplary septum 52 and a 12 degree taper, diametric resealing compression of the septum 52 adjacent the channel 62 is on the order of 10%.
  • the channel 62 is bounded in part by a septum supporting ridge 62a.
  • the channel 62 can typically have a depth in a range of .050-.070 inches (.127-.1778 centimeters) .
  • a peripheral surface 64 of the septum 52 slidably engages the tapered interior surface 60 as the septum 52 slides into the first end 42.
  • the annular channel 62 which underlies the interior peripheral surface 56 of the septum 52 is provided to permit the septum 52 to deform when a blunt cannula is inserted through an opening 66 therein.
  • the housing 40 is also formed with a fluid flow path 68 such that fluids injected via a blunt cannula inserted through the resealable opening 66 can flow into the catheter 36 for delivery to hand H of the patient.
  • the swaged end members 58 apply axial forces to the septum 52 thereby creating the domed exterior peripheral surface 54.
  • the axial forces applied by the end members 58 slightly deform the regions 52a and 52b.
  • the tapered internal surface 60 applies radially directed forces to the septum 52, thereby forcing the opening 66 into a resealed condition.
  • the surface 52 could be formed as a flat, as opposed to a domed, surface.
  • FIGS. 4A and 4B illustrate in combination the injection site 34, a blunt shielded cannula 80 and a syringe of a conventional type 82.
  • the syringe 82 can be formed with a cylindrical hollow end 84 which carries a male luer-type twist lock thread 86.
  • a hollow centrally located cylindrical fluid flow member 88 is in fluid flow communication with an interior region 90 of the syringe 82.
  • the shielded blunt cannula 80 carries at a first end 92 a female luer twist-lock flange 94.
  • the flange 94 will slidably engage the threads 86 of the end 84.
  • the shielded blunt cannula 80 can be locked to the syringe 82 forming a closed fluid flow pathway.
  • the shielded cannula 80 could alternately be formed fixedly attached to the syringe 82.
  • the shielded blunt cannula 80 carries a cylindrical hollow protective shield 96 which surrounds a centrally located hollow, elongated cylindrical blunt piercing member 98.
  • the cylindrical blunt piercing member 98 has a total length on the order of three times the thickness of the septum 52 in order to ensure complete penetration.
  • the cylindrical blunt piercing member 98 has a diameter on the order of 1/3 the diameter of the septum 52.
  • the shield 96 is desirable and useful for maintaining the piercing member 98 in an aseptic condition by preventing touch contamination prior to the shielded cannula 80 engaging the pre-slit septum 52. Also, the shield helps to align the piercing member with the pre- slit septum.
  • the cylindrical blunt piercing member 98 can slidably engage the pre-slit septum 52, best illustrated in Figure 4B, thereby extending through the preformed opening 66 therein. As illustrated in Figure 4B, when the piercing member 98 slidably engages and pierces the septum 52, the region 52a deforms by expanding into and filling, at least in part, the annular channel 62.
  • the deformation facilitates insertion of the piercing member 98 through the slit 66. Subsequent to the piercing member 98 slidably engaging the injection site 34, the interior region 90 of the syringe 82 is in fluid flow communication with the flow path 68 of the injection site 34 via flow paths 88a and 99 respectively of the syringe and the blunt piercing member 98.
  • the septum 52 seals completely around the piercing member 98. Hence, exterior gases, liquids or airborne matter will be excluded from the channel 68.
  • the syringe 82 with lockingly engaged shielded cannula 80 can be slidably withdrawn from the injection site 34. Subsequent to this withdrawal, the septum 52 reseals the opening 66 therein.
  • the opening 66 will repeatedly reseal, when the piercing member 98 is removed, provided that the pressure (in the septum 52 of the opening 66) created by interaction of the septum material properties and compression supplied by the housing exceeds the pressure challenge of the fluid contained within.
  • Blunt cannula do not haphazardly core, lacerate, or otherwise damage the sealing interface 66 as conventional needles do, thereby allowing repeatable resealability.
  • septum material properties, thickness, and compression allow resealability for a finite number of conventional needle insertions.
  • the combination injection site 34 and catheter 36 then return to its pre-infusion, sealed condition.
  • Figures 5A and 5B illustrate the pre-slit injection site 34 used in combination with a blunt cannula 80a.
  • the cannula 80a includes a hollow body portion 92a with a luer flange 94a, a piercing member 98a, and manually operable elongated locking members 100a and 100b.
  • a tubing member could be affixed to the hollow body portion 92.
  • Curved end regions 100c of the members 100a and 100b slidably engage the second end 44 of the housing 40 when the piercing member 98a of the blunt cannula 80a has been forced through the pre-formed opening 66, best illustrated in Figure 5B.
  • the embodiment illustrated in Figures 5A and 5B has the advantage that the infusion cannula 80a cannot accidentally disengage from the pre- slit septum 34 during the fluid infusion process. It will be understood that while spring-like deflecting members 100a and 100b are illustrated in Figures 5A and 5B that other forms of locking members are within the spirit and scope of the present invention.
  • Figure 6 illustrates an alternate pre-slit injection site 34a.
  • a tubing member 102 can be fixedly attached to the cylindrical hollow fluid flow member 46.
  • the embodiment 34a of Figure 6 utilizes the same structure for the septum 52 including the tapered surface 60 and the underlying annular channel 62 as does the embodiment 34 in Figure 3.
  • the shielded cannula 80 can be utilized with the injection site 34a as previously described.
  • a fluid administration set 110 of a conventional variety may be utilized.
  • the set 110 includes a spike connector 112 at a first end.
  • the spike connector 112 is designed to pierce the port 106 of the container 104.
  • the set 110 can also carry a slidably engageable connector 114 of a known type at a second end. As illustrated in Figure 7, the connector 114 can slidably engage the hollow cylindrical member 98 of the shielded cannula 80, thereby placing the interior fluid of the container 104 into fluid communication with the tubing member 102.
  • Figure 8 illustrates yet another alternate 80b to the shielded cannula 80.
  • the piercing member 98b carries a tubing member 118 fixedly attached thereto.
  • the tubing member 118 could be coupled at a second end to a container such as the container 104.
  • the present pre-slit injection site can be directly affixed to a container 120 as illustrated in Figure 9.
  • the container 120 includes a rigid hollow cylindrical access port 122 affixed thereto.
  • the access port 122 includes a fluid flow channel 124 in fluid flow communication with the interior of the container 120. Sealingly affixed to the port 122 is a pre-slit injection site 126.
  • the site 126 includes a cylindrical housing 128 which carries at a first end 130 a septum 132 with a slit 134 formed therein.
  • the first end 130 has been swaged to form an annular U-shaped retaining member 136.
  • the retaining member 136 in turn forms a domed exterior peripheral surface 138 on the septum 132.
  • the first end 130 also includes a tapered interior force applying surface 140 and an annular channel 142 underlying the septum 132.
  • the channel 142 provides a space into which the septum 132 can deform when a blunt cannula is forced through the resealable opening 134.
  • the injection site 126 can be covered by a removable cover 146 of a type used with the conventional port 106 of the bag 120.
  • a container 150 could be formed which includes only the pre-slit injection port 126.
  • the removable cover 146 could be used in combination with the container 150.
  • the pre-slit injection site 126 can be utilized for the purpose of injecting fluid from the syringe 82, coupled to the shielded cannula 80, into the container 150.
  • the blunt piercing member 98 is used to place the interior fluid containing region 90 of the syringe into fluid flow communication with the interior of the container 150.
  • Figures 12 and 13 illustrate a fluid flow coupling system 151 having as a first element a pre-slit injection site 126a.
  • the site 126a is the same as the site 126 except for a plurality of exterior threads 153 formed on an exterior peripheral surface 155 of the housing 128a.
  • a second element of the coupling system 151 is a shielded blunt cannula 157.
  • the shielded blunt cannula 157 is sealingly affixed to a flexible tubing member 159 by means of a proximal hollow cylindrical member 161.
  • the member 161 extends into a hollow cylindrical shield 163 to form a blunt piercing member 165.
  • the shield 163 carries, on an interior peripheral surface, a set of coupling threads 149.
  • the threads 149 match the threads 153.
  • the two connector elements 126a and 157 slidably engage one another when the shielded cannula 157 moves in an axial direction 167 toward the injection site 126a.
  • the blunt piercing member 165 penetrates the septum 132a.
  • the coupling member 157 can then be rotated in a direction 169 such the interior set of threads 149 carried thereon engages the exterior set of threads 153.
  • the two coupling members 126a and 157 are lockingly engaged together with the insertion member 165 extending through the opening 134a in the septum 132a.
  • fluids can flow from the container 150a via the connector system 126a and 157 through the tubing member 159 to the recipient.
  • a pre-slit injection site 160 of the type described above can be used in combination with a spike connector 162 of a conventional variety.
  • Spike connectors such as the spike connector 162 can be used to pierce conventional ports such as the port 106 of the container 104 ( Figure 6) .
  • the pre-slit injection site 160 can then be utilized for the purpose of coupling to other fluid administration sets.
  • the injection site 160 illustrates an alternate form of swaging the first end 42c for the purpose of retaining the septum 52c therein.
  • the first end 42c can be swaged so as to form an annularly shaped, spiral.
  • the member 164 has a free end 164a which engages the exterior dome-shaped peripheral surface 54c of the septum 52c.
  • the spiral, spring-like swaged member 164 will tend to uncoil, thereby continuous- ly applying axial force to the septum 52c and maintaining the domed exterior peripheral surface 54c.
  • Figure 15 illustrates a pre-slit injection site 166 formed in a Y-junction member
  • the Y-junction member 168 is fixedly attached to first and second tubing members 170 and 172 respectively.
  • 66e can be formed only partly through the septum 52e.
  • Such a structure has the further advantage that, until used for the first time, the septum 52e is completely sealed.
  • the septum 52 can be formed in two parts. One part can have a slit, such as the slit 66, extending entirely therethrough. A second part can be formed without a slit. These two parts can be located adjacent one another in the first end 42 of the injection site.
  • the slit 66 may be longer on the top of the septum than the bottom. This feature aids blunt cannula alignment with the slit upon insertion, and aids resealability by minimizing the critical slit sealing interface area.
  • the slit could have a length with a range on the order of .03 inches (.0762 centimeters) to .150 inches (.381 centimeters) .
  • a slit length on the order of .07 inches (.1778 centimeters) will be used in combination with a blunt cannula having a diameter on the order of .1 inches (.254 centimeters).
  • Pre-slit injection sites of the type described above can be utilized in combination with burette solution administration sets.
  • One such set 176 is illustrated in Figure 17.
  • the set 176 includes a pre-slit injection site 178 of the type described above.
  • the injection site 178 is affixed to an exterior planar surface 180 of the burette 182.
  • a removable cover 184 can be used to maintain the injection site 178 in an aseptic condition until blunt cannula 186 or 188 is inserted therethrough.
  • Figures 19 through 23 disclose a method of making a pre-slit injection site in accordance with the present invention.
  • a housing 200 is provided.
  • the housing 200 has an interior tapered surface 202 at a first end 200a thereof.
  • the interior peripheral surface terminates in an annular channel 204.
  • a cylindrical septum 206 can be provided adjacent the end 200a.
  • the septum 206 can be forced into the end 200a of the housing 200 and slightly deformed by the tapered peripheral surface 202 using an axially moving die 210.
  • the septum 206 is located adjacent an internal annular right 212 which bounds the annular channel 204.
  • a second die 214 can be utilized to swage the end 200a into spiral-shaped, spring-like members 200b which apply axially directed forces against an exterior peripheral surface 206a of the septum 206.
  • the axially directed forces form the flat surface 206a into a domed exterior peripheral surface 206b as illustra ⁇ ted in Figure 23.
  • a knife 216 can be utilized to form a slit in the septum 206.
  • the slit may be cut by a separate die in a separate step.
  • the slit can be created during the extrusion process. If the septum 206 is formed by stamping from a rubber sheet, the slit can be cut during the stamping process. If the septum 206 is formed by compression molding, the slit can be cut during the trimming process.
  • a flat pin extrusion bushing In order to extrude the slit into rod, a flat pin extrusion bushing can be used. A trailing ribbon may be attached to the bushing. The ribbon would prevent curing material across the slit. The ribbon or wire could be placed in the rod core and later stripped out leaving a slit. An inert substance, such as silicone oil, could be coextruded in the center of the rod to prevent curing across the slit and provide lubrication and a visible target for cannula insertion.
  • Figures 24 and 25 illustrate alternate swaging steps wherein a die 220 moving axially toward the housing 200 swages the end region 200a so as to form an annular U- shaped region 200c and the exterior domed peripheral surface 206c.
  • the dies 214 or 220 can be formed with various alternate shaped swaging surfaces 224, as illustrated in Figure 26, depending on the precise shape of the end swage which is desired. It will be understood that all such variations in the swaging operation are within the spirit and scope of the present invention.
  • the injection site configuration need not be limited to the configurations depicted in Figures 3 through 5B, 9, and 12 through 16. Rather, several configurations could be constructed without departing from the scope of this invention. Any such configuration would provide a flexible pre-slit sealing member captured in a chousing which provides compression to create a seal against pressure and a void region to accommodate deformed portions of the sealing member material only when the material is deformed or displaced by a blunt cannula piercing member.
  • Figures 27 and 28 Figures 29 and 30 illustrate a tapered cannula structure 250 which is an alternate to the tapered cannula 98.
  • the cannula 250 includes a proximal end 252 with an interior region 254.
  • the region 254 is in part bounded by an internal peripheral wall 256 which is formed with a standard luer taper.
  • the tapered cannula 250 can be formed with a luer-type coupling flange 257 at the proxi ⁇ mal end so as to be releasably connectable to the syringe 82 as was the tapered cannula 98 previously discussed.
  • a cylindrical tube Extending from the proximal end 252 is a cylindrical tube having a cylindrical mid-region 258 and a distal end member 260.
  • the member 260 has a generally elongated, cylindrical shape with an exterior side wall 262.
  • a centrally located, cylindrical, internal fluid flow path 264 extends through the distal end member 260 and mid-region 258 in fluid flow communication with the interior region 254.
  • the distal end of the end member 260 has a tapered exterior surface 266.
  • the tapered exterior surface 266 minimizes insertion force as the cannula 250 is being forced through a slit of a septum, such as the slit 66 in the septum 52.
  • the angle of taper of the surface 266 is preferably in a range between 1 to 15 degrees.
  • the member 260 is also provided with a plurality of elongated grooves 268.
  • the grooves 268 in the exterior wall of the member 260 decrease the surface area of contact at the cannula/septum interface during insertion of the cannula into the injection site 34. This reduced exterior contact surface area decreases the frictional component of the insertion force.
  • the tapered blunt cannula 250 may have overall insertion length, corresponding to combined axial lengths of mid-region 258 and end member 260, on the order of 0.375 inches (.9525 centimeters).
  • the cannula structure 280 includes a proximal end region 282 corresponding to the end region 252 of the cannula 250.
  • the region 282 includes a luer flange 283.
  • the cannula 280 also includes a central, elongated, cylindrical region 288.
  • the central region 288 carries at a distal end thereof an elongated cylindrical end member 290.
  • the member 290 includes an exterior, peripheral, cylindrical surface 292 ( Figure 31) .
  • the surface 292 is interrupted by a plurality of spaced-apart, elongated slots or apertures 294.
  • the slots 294 are defined by first and second spaced-apart, elongated, parallel side surfaces 294a and 294b. Each of the slots terminates in an end surface 294c at the central region 288.
  • a fluid flow path 294d extends through the cannula 280.
  • the flow path 294d is in fluid flow communication with the slots 294.
  • the exterior surface 292 terminates in tapered end regions 298 to facilitate insertion of the cannula into a pre-slit injection site.
  • the slots 294 themselves also function to decrease the surface contact area, and this further minimizes the insertion force.
  • the slots 294 are oriented substantially 90 degrees apart around a longitudinal axis 300.
  • the slots 294 increase the internal flow path cross-section. This increases the fluid flow rate.
  • the slots 294 also provide for enhanced dispersion characteristics owing to the fluid flowing radially out through the slots 294. This radial flow, effecting as change in fluid flow direction of about 90 degrees, promotes flushing and dispersion of fluid through the injection site 34.
  • FIG. 34 through 37 Another embodiment of a blunt cannula 310 is illustrated in Figures 34 through 37.
  • the cannula 310 is formed with an enlarged proximal connection region 312 corresponding to the region 252 of the cannula 250.
  • the region 312 includes a luer flange 313 and a central fluid flow region 314.
  • An intermediate, cylindrical region 318 extends from the proximal connection region 312.
  • the cylindrical intermediate region 318 includes a fluid flow path 320 in communication with the fluid flow region 314.
  • the end region 324 extends from the region 318 and includes a first cylindrical portion 326 into which the fluid flow path 320 extends.
  • the region 326 terminates in a tapered exterior surface 328.
  • the tapered exterior surface 328 merges with a centrally located lead post or guide post 330.
  • the lead post 330 terminates in a hemispherical end surface 332.
  • the lead post 330 helps locate the septum slit 66 prior to insertion and facilitates penetration of the septum slit 66 by the cannula.
  • the lead post 330 facilitates insertion by providing a very low insertion force at the beginning of the insertion step as the cannula is pushed through the slit, such as the slit 66.
  • the guide post 330 can have a length on the order of 0.060 inches (.1524 centimeters) and a diameter on the order of 0.050 inches (.127 centimeters).
  • the end region 318 includes a novel structure for increasing the flow rate and enhancing dispersion characteristics.
  • the region 318 includes three radially oriented slots 338.
  • Each slot 338 has sides 339a and 339b which each lie along a radius of the cylindrical portion 326 as best illustrated in Figure 37.
  • the fluid flowing through the cannula 310 undergoes a change in direction (of up to about 90 degrees relative to the cannula center line 337) in the slots 338. This change in direction increases fluid dispersion.
  • the slots 338 open radially, fluid flow can be maintained even if the end surface 332 of the cannula is pushed up against any material in the system in which the cannula is inserted.
  • the cannula 340 includes a proximal end 342 which can include a luer coupling flange 344 for cooperating with a suitable mating structure on a syringe.
  • the proximal end 342 also defines an interior region 346.
  • Extending from the proximal end 342 is a generally cylindrical mid-region 348. Extending from the mid-region 348 is an end member or region 350 which includes a tapered surface 352.
  • the distal end of the end region 352 terminates in a blunt, arcuate end surface 356.
  • an internal fluid flow channel 354 which communicates with the interior region 346. Fluid discharges from the flow channel 354 via grooves or apertures 358 in the end region 350.
  • the change in direction of the fluid flow as the fluid passes from the interior channel 354 through the apertures 358 improves fluid dispersion with respect to mixing or flushing in the system downstream of the cannula (e.g., the injection site, drug vial, etc.).
  • the apertures 358 may also function to increase withdrawal force or tug resistance.
  • fluid flow through the cannula 340 can be maintained even when the distal end surface 356 of the cannula is bottomed out or pushed against any material in the system in which the cannula is inserted.
  • the structure of the cannula 340 is adapted to be constructed with a minimal lead post length (i.e., the portion of the cannula distal end between the end surface 356 and the interior flow channel 354) . Further, the design accommodates the use of a minimal tip diameter, minimal taper angle, and minimal cannula diameter. The minimization of these parameters results in a decrease in the peak insertion force required to properly install the cannula in the injection site. Preferably, the total cross-sectional flow area through the three apertures 358 is about three times the cross-sectional flow area of the interior channel 354. This enhances the flow rate capability compared with a simple open ended cylindrical flow channel of equal length.
  • the design of the cannula 340 also is effective in reducing or limiting "kick back" or recoil of the cannula after insertion.
  • the resilient material of the septum in an injection site can subject the cannula to forces tending to push the cannula back out of the septum.
  • the kick back forces on the cannula 340 are minimized by the provision of the generally cylindrical mid-region 348.
  • Another embodiment of the cannula of the present invention is illustrated in Figures 41 and 42 wherein the cannula embodiment is designated generally therein by the reference numeral 360.
  • the cannula 360 includes a proximal end 362 defining an interior region 364 and having a luer flange 366 for connection to a suitable mating engaging structure.
  • a generally cylindrical mid-region 366 extends from the proximal end 362, and an end region 368 extends from the mid-region 366.
  • the embodiment of the cannula 360 minimizes kick back or recoil owing to the provision of a substantially cylindrical mid-region 366.
  • This design also increases withdrawal or tug resistance.
  • a generally cylindrical internal flow channel 370 extends through the end region 368 and mid-region 366 in communication with the interior region 364 of the proximal end region 362.
  • the end region 368 is provided with a tapered surface 372. The design permits the use of a very small taper to minimize the insertion force.
  • the design permits the cannula 360 to be constructed with a small tip diameter, small taper angle, and small cannula diameter so as to reduce the peak insertion force.
  • Another embodiment of the cannula of the present invention is illustrated in Figures 43 through 44 and is designated generally therein by reference numberal 380.
  • the cannula 380 includes a proximal end 382 with a luer flange 384.
  • An interior fluid flow region 386 is defined on the interior of the proximal end 382.
  • a mid- region 388 Extending from the proximal end 382 is a mid- region 388.
  • a distal end region 390 extends from the mid- region 388.
  • An internal fluid flow channel or path 392 extends through the end region 390 and mid-region 388, and is in communication with the interior flow region 386.
  • the end region 390 has an exterior tapered surface
  • the mid-region 388 is generally cylindrical so as to minimize kick back and increase the withdrawal force or tug resistance.
  • the mid-region 388 includes an annular barb 396.
  • the barb 396 has a sufficient radius so as to preclude damage to the septum of the injection site and so as to accommodate molding in a straight draw tool.
  • the maximum diameter of the annular barb 396 may typically be on the order of 0.02 inches (.0508 centimeters) greater than the diameter of the cylindrical mid-region 388.
  • Figure 45 includes a blunt tapered cannula insertion member 400 for insertion into a pre-slit injection site, the cannula 400 having a distal end region 402 with a tapered exterior surface which in the preferred embodiment is an approximately 8 degrees taper.
  • the defined aperture 404 for fluid flow is disposed at the end 406 of the distal end region 402.
  • the end 406 includes a radiused tip defined by a radius of approximately 0.01 inch (.025 centimeters) .
  • the radiused tip reduces insertion force, assists in locating the slit in the injection site and in addition has the practical advantage of facilitating complete filling of the cannula mold cavity.
  • the tapered surface of the distal end region 402 has an axial length of approximately 0.10 inch in the preferred embodiment. Adjacent to the tapered distal end region is a generally cylindrical region 408 for entering into the injection site behind the distal end region 402, thereby reducing kick back during insertion.
  • the generally cylindrical region 408 has a small draft angle such as about one-half degree.
  • the force required to insert any of the above- discussed embodiments of the blunt tapered cannula into the septum of the injection site depends upon a number factors: friction at the cannula/septum interface, cannula diameter, cannula taper angle, and degree of septum compression.
  • the cannula/septum interface friction is, in turn, dependent upon lubrication, if any, material properties, and surface finish. It will be understood that the friction at the cannula/septum interface can be reduced by providing a smoother surface finish on the cannula (e.g., by sand blasting the cannula exterior surface) or by molding the cannula so as to produce a matte finish. Conventional lubricants can also be used to further reduce the friction and thereby lower the insertion force required.
  • the mid-region and the tapered distal end region may be alternatively characterized as together forming at least one tube defining a fluid flow path therein with the tube having a distal end region for penetrating the injection site.
  • the exterior surface of the distal end region may have a taper angle as small as between 1 and 15 degrees.
  • a locking means such as the locking arms 100a and 100b discussed with reference to Figures 5A and 5B, may be provided on the cannula embodiments illustrated in Figures 29 through 44 to permit the cannulae to be releasably locked to the injection site.
  • FIG. 46 shows a blunt cannula member, generally at 410, for use with the pre-slit injection sites disclosed herein.
  • the blunt cannula member 410 generally has a hollow cylindrical portion 412 and a blunt cannula portion 414.
  • the blunt cannula member 410 is preferably of one-piece molded, rigid plastic, with a through bore 416 extending through the blunt cannula portion and communicating with the hollow cylindrical portion.
  • the hollow cylindrical portion has a pair of opposed raised flanges or threads 418 for threaded engagement with other devices, for example, syringes, administration sets and the like.
  • the hollow cylindrical portion 412 may also be adapted for attachment to other devices.
  • the internal surface of the cylindrical portion may define a tapered female luer surface for interfitting with the standard male luer connectors utilized in many medical devices, as is well known in the medical field.
  • the hollow cylindrical portion 412 may also include a pair of opposed flat surfaces 420 for cooperation with a tip protector or shield such as depicted in Figure 47, which is described below.
  • the blunt cannula portion 414 extends generally axially from the hollow cylindrical portion 410.
  • the cannula portion is generally cylindrical throughout the greater part of its length, with a tapered end portion 424, which narrows to the blunt end edge 426.
  • Figure 47 is an enlarged view of a hollow shield or tip protector 428 for covering and protecting a blunt cannula, such as, for example, the blunt cannula portion 414 of blunt cannula member 410 shown at Figure 46 or other blunt cannulae as disclosed herein.
  • the shield 428 has a generally elongated housing 430, which is open at one end for receiving the blunt cannula.
  • the interior surface 432 of the shield generally corresponds to the shape of the exterior surface of the blunt cannula portion 412, i.e., it is generally cylindrical, with a pair of opposed flat surfaces 434 matching the flat surfaces 420 of the blunt cannula device 410.
  • either surfaces 432 or 434 can be provided with standing ribs to control the depth of insertion of the blunt cannula portion 414 into housing 430.
  • the matching flat surfaces of the shield and the blunt cannula device allow a user to secure the blunt cannula onto a syringe or similar device, for example, without exposing the cannula portion 414 to touch contamination.
  • the shield may simply be slidably removed from the cannula.
  • the outer surface of the shield 428 can be shaped in such a manner or provided with a roughened finish to assist the user in gripping or removing shield 428 from the cannula.
  • the blunt cannula 410 or other blunt cannula device and shield 428 would be provided in a joined sterile configuration.
  • the shield 428 can be provided with channels to facilitate gas sterilization.
  • the user preferably leaves the shield on to prevent inadvertent contamination when attaching the blunt cannula to the mating product, e.g., the male luer fitting of a syringe or administration set.
  • the matching flat surfaces 432 of the shield and 420 of the blunt cannula act as a wrench to allow any twisting force applied to the shield to be transmitted to the cannula, e.g., for threading the cannula onto a luer lock device or for applying a twisting force in making a luer slip connection.
  • Figure 48 shows what is commonly referred to as a heparin lock, generally at 436, employing a pre-slit injection site 442 and other features of the present invention.
  • the heparin lock 436 may be attached, for example, to the end of a venous catheter.
  • the heparin lock 436 shown in Figure 48 is for attaching to a patient's catheter for maintaining patency of the catheter during interruption in fluid flow.
  • the heparin lock 436 also shown in Figures 49 and 50, has a first end portion 438 in the form of a male luer connector for sealingly engaging a complementary female tapered luer surface on the patient's catheter (see cross- sectional view in Figure 50) .
  • the other end of the heparin lock 436 includes a pre-slit injection site 442 of the type previously discussed in detail.
  • An axial fluid flow passageway 444 communicates between the pre-slit injection site and the end of the male luer for fluid flow therebetween.
  • the tapered exterior surface of the male luer 438 is substantially surrounded by generally cylindrical gripping collar 446.
  • Threads 448 are provided on the interior surface of the collar for threadedly engaging a standard luer lock connector, as is often found on intravenous catheter devices.
  • the exterior surface of the collar 446 is generally arcuate in cross-sectional shape (as best seen in Figures 49 and 50) , to provide a gripping surface.
  • the surface curves generally outwardly in a direction toward the pre-slit injection site 442. This allows the nurse, physician or attending staff member to grip the heparin lock and to reduce any force exerted during entry of a blunt cannula into the pre-slit injection site from being transmitted to the venous catheter.
  • the heparin lock includes features which allow attachment to various styles or types of blunt cannulae.
  • threads 452 are provided on the exterior surface of the cannula for threaded locking engagement to a blunt cannula device of the type having an interiorly threaded sleeve or shield, such as depicted in Figure 50.
  • the heparin lock 436 also includes a generally radially-extending shoulder 454 for locking retention of resilient gripping fingers on a blunt cannula device of the type shown in Figure 49.
  • a visual identifier is also provided with the heparin lock of Figure 48.
  • Such an identifier may also be provided with the other pre-slit injection site devices described ' above.
  • the identifier may take the form of any unique color or configuration which allows the staff member to determine that the heparin lock 436 embodies the present invention and is intended for use with blunt cannulae.
  • the visual identifier comprises a distinct color identifier and, more particularly, is a brightly colored ring 456 ( Figure 48) circumscribing the pre-slit injection site 442. While the color selected may vary depending on application, it should be a color which is distinct from and in contrast to the color of any plastic used in the manufacture of the heparin lock.
  • Figure 48 may be used with a variety of styles or types of blunt end cannula devices.
  • the heparin lock may be used with a bare blunt end cannula, such as that depicted in Figure 46, which does not lock onto to the heparin lock.
  • the heparin lock may be used in combination with a blunt cannula device 458 which utilizes a pair of resilient gripping fingers 460 for retaining the blunt cannula in joined relationship with the heparin lock.
  • the blunt cannula device 458 depicted in Figure 49 has a generally cylindrical, hollow base or body portion 462 and a blunt cannula portion 464 substantially as described earlier in connection with Figure 46 or with the other figures of the present inventions.
  • a fluid flow path 463 extends through the blunt cannula portion and communicates with a female luer connection 465 defined in the hollow body portion for fluid flow through the blunt cannula device.
  • Flanges or threads 467 on the body portion permit the attachment of a male luer lock connector to the blunt cannula device.
  • Each of the gripping fingers 460 is mounted to the body portion of the blunt cannula device by an intermediate radially extending wall portion 466.
  • the gripping fingers have radially inwardly directed retention means 468 at one end for engaging against radial shoulder 454, and gripping means 470 at the other end for squeezing and spreading the retention means to release the blunt cannula device from the heparin lock.
  • the gripping fingers are biased radially inwardly, toward the blunt cannula portion 464. Because of the natural resilience of the plastic, the retention end of the fingers may be spread by squeezing the gripping end of the fingers. The natural resilience will hold the retention means in the lock position (shown in Figure 49) until manually released.
  • the blunt cannula device 458 When used in combination with a heparin lock such as depicted in Figure 48, the blunt cannula device 458 may be attached by simply pushing the blunt cannula into the pre-slit injection site 442.
  • a forward facing tapered surface 472 ( Figure 49) in front of the threads engages a similar tapered surface 474 on the retention means 468 so as to naturally spread the fingers 460 apart as the blunt cannula is forced into the pre-slit injection site.
  • the gripping fingers After the blunt cannula is inserted into pre-slit injection site sufficiently far so that the retention means are beyond the radial shoulder 454, the gripping fingers will snap inwardly behind the shoulder, holding the blunt cannula in the position depicted in Figure 49.
  • the user To withdraw the blunt cannula, the user need simply squeeze the gripping end 470 of the handles, which will spread the retention means of the fingers and release the blunt cannula device from the heparin lock.
  • the heparin lock of Figure 48 is also useful with a blunt cannula device 475 having an internally threaded shield or sleeve, such as depicted in Figure 50.
  • Figure 50 illustrates the blunt cannula device 475 as it first enters the pre-slit injection site 442 of the heparin lock and prior to engagement with the heparin lock threads 452.
  • the blunt cannula device shown in Figure 50 has a generally cylindrical outer wall 476 and a transverse end wall 478.
  • a blunt cannula 480 extends through the end wall.
  • the blunt cannula may be constructed in generally the same manner as the blunt cannula portion depicted in Figure 46 or in accordance with the other embodiments of the present invention.
  • the cylindrical outer wall 476 preferably extends beyond the tip end of the blunt cannula to protect the cannula against inadvertent touch contamination.
  • the interior surface of the cylindrical wall is preferably threaded at 482 for threadedly engaging the device to which the blunt cannula is attached, such as the heparin lock depicted in Figure 48.
  • Figure 50 depicts the blunt cannula device 475 at an initial entry position. Further insertion of the blunt cannula and simultaneous turning of the blunt cannula device results in threaded locking engagement between the blunt cannula device 475 and the heparin lock.
  • the blunt cannula 480 of the blunt cannula device 475 is in fluid communication with an entry port, generally defined by wall 484, which extends in. the opposite direction of the blunt cannula, from the other side of the transverse wall.
  • the entry port is for attachment to other devices such as syringes, tubing, administration sets or the like, and may take such form as is appropriate for the particular device to which it is attached.
  • the entry port 484 preferably has a tapered inner surface for receiving a standard male luer fitting of a syringe or the like, and may include external threads or flanges 485 for attachment to a luer lock. Another embodiment provides the entry port 484 as having a tapered inner surface for receiving a tubing fit.
  • FIG. 51 shows, in cross-sectional view, a further alternative device 492 which may employ the pre- slit injection site of the present invention.
  • the pre- slit injection site device 492 depicted in Figure 51 is an in-line device, preferably for adding medication to a fluid stream, removing a sample from a fluid stream, or similar application.
  • the device depicted in Figure 51 has a fluid entry port 494 at one end, a fluid exit port 496 at the other end, and a fluid passageway 498 communicating directly between the entry and exit ports.
  • the inlet and outlet may have such additional features as are useful connecting the injection site device within a fluid flow path.
  • the inlet defines a slightly tapered female surface and the outlet defines a similarly female tapered surface which are preferably joined by solvent bonding a similar attachment to plastic tubing of an administration set, extension set or the like.
  • Standard luer fittings or surfaces could also be provided at the inlet or outlet, as desired.
  • the device For injecting liquid into the fluid stream or sampling the fluid stream, the device has a side channel 496 which communicates between a pre-slit septum 502 made and assembled in accordance with the present invention, and the fluid passageway 498.
  • the septum 502 is made as described above, and mounted and held in position by a swaged-over wall 504, as previously described, which may include a colored identifier ring around the septum.
  • a blunt cannula such as cannula 506 may be inserted through the pre-slit septum for injecting fluid into the liquid stream flowing between the inlet and outlet, or for taking samples of the fluid stream.
  • the in-line injection site device 492 shown in Figure 51 may be used in combination with a bare blunt cannula, such as that depicted in Figure 51, or may be used in combination with the blunt cannula device 458, depicted in Figure 49, when a locking relationship between the blunt cannula and injection site is desired.
  • the blunt cannula device 458 may be attached in a secure locking relationship to the in-line injection site 492.
  • the in-line injection site has a radially extending shoulder 508 on each side of the housing, for engaging against the retention means 468 on the end of the resilient gripping fingers 460.
  • the in-line injection site also includes a generally tapered surface 510 defined on the exterior surface for spreading the retention means as the blunt cannula is inserted into the injection site.
  • insertion of the blunt cannula into the injection site results in the retention means being spread by the tapered surface 510 and, as the blunt cannula is inserted farther, the retention means snap into a locking position behind the radial shoulder 508.
  • the blunt cannula is securely locked onto the injection site and inadvertent withdrawal is thus prevented.
  • the gripping ends 470 of the resilient fingers are squeezed, causing spreading of the retention means 468 and release from the injection site. The cannula may then be simply removed by withdrawing it from the injection site.
  • Figure 53 depicts yet a further embodiment of the present invention. That figure depicts a blunt cannula device 512 embodying the present invention in combination with a syringe 514.
  • the blunt cannula device 512 has a generally cylindrical outer wall 516 which encloses and substantially protects a blunt cannula portion 518.
  • the blunt cannula portion is attached to and extends from an intermediate transverse interior wall 520.
  • the blunt cannula device 512 may be attached to a syringe in various ways. As depicted, however, the syringe 514 has a glass barrel wall which is tightly press fit into one end of the cylindrical outer wall, extending therewithin to the transverse wall 520.
  • the syringe depicted in Figure 53 is of the type prefilled with a medical liquid such as heparin. Although it does not form a part of the present invention, for purposes of completeness, the syringe depicted in Figure 53 has a pair of resilient pistons 522 spaced apart, with the fluid to be dispensed contained between the pistons. A plunger rod 524 pushes the pistons forward until the forward most piston engages against an entry port 526 which extends in a direction opposite the blunt cannula 518. The forwardmost piston has a frangible portion, which is pierced by the entry port, releasing the liquid contained between the pistons for expulsion through the blunt cannula.
  • the blunt cannula portion 518 is substantially protected from inadvertent touch contamination by the outer cylindrical wall 516.
  • a pair of opposed, generally U-shaped recesses 528 are provided in the cylindrical wall for receiving the inlet and outlet portions 494, 496 of the in-line injection site when the cannula is attached to it. This arrangement is depicted in a perspective view in Figure 56.
  • the blunt cannula device 512 may be attached to the in-line injection site by inserting the blunt cannula portion into the pre-slit injection site, with the U-shaped recesses 528 receive the inlet and outlet portions 494, 496 of the in-line injection site, thus allowing the bare cannula to be inserted suffi ⁇ ciently far into the pre-slit injection site.
  • Figure 54 shows a shield or tip protector 530 for a blunt cannula device of the type shown in Figure 53.
  • the tip protector 530 has a generally cylindrical outer wall 532 with raised ribs 534 for gripping.
  • the cylindrical wall is sized to slip over the end cylindrical wall 514 of the blunt cannula device 512, and is sufficiently long to extend beyond the U-shaped recesses to completely enclose and protect the blunt cannula 518 during shipping, storing and between uses, if so desired.
  • the tip protector Concentrically disposed within the cylindrical wall 532, the tip protector has an axially extending, hollow tube 536 for slidably receiving the blunt cannula 518 therewithin.
  • the shield or tip protector 530 would typically be attached to the blunt cannula device 512 during manufacture, and removed when the syringe and blunt cannula device are used. If so desired, it may be reat- tached between uses to protect the cannula from any further contamination.
  • Figure 55 is an alternative embodiment of the blunt cannula device shown in Figure 53, and is depicted without a syringe attached to it.
  • the blunt cannula device 538 similarly has a cylindrical outer wall 540, a transverse intermediate inner wall 542, a blunt cannula 544 extending axially from the transverse intermediate wall and an entry port 546 extending in the opposite direction from the blunt cannula.
  • the essential difference between this embodiment and the one shown in Figure 53 is the absence of U-shaped recesses for use with an in-line injection site such as depicted in Figure 56.
  • the inner surface of the cylindrical wall is preferably tapered at 548.

Abstract

A pre-slit injection site (436) includes a housing with an axial flow path (444) therethrough. A first end portion (438) has the form of a male Luer connector. The other end includes a pre-slit septum (442). The tapered exterior surface of the male Luer is substantially surrounded by a generally cylindrical gripping collar (446). The second end is provided on its outer surface with threads (452) and also with a radially-extending shoulder (454). These two distinct locking means allow connection with blunt cannula devices having either an interiorly threaded sleeve (476) or resilient gripping fingers (460).

Description

PRE-SLIT INJECTION SITE AND TAPERED CANNULA
This is a continuation-in-part of U.S. Patent Application Serial No. 217,004, filed July 8, 1988, which is a continuation-in-part of U.S. Patent Application Serial No. 147,414, filed January 25, 1988.
Field of the Invention
The invention pertains to coupling systems usable to transfer materials from one flow conduit to another. More particularly, the invention pertains to two-part coupling members with a first part including a pre-slit septum and second part including a blunt cannula. The pre-slit septum slidably receives the blunt cannula to effect the coupling.
Background of the Invention Injection sites usable with pointed cannulae have long been known. For example, such sites can be formed with a housing having a fluid flow path therein. A septum is positioned in the housing closing the fluid flow path. One injection site usable with a piercing cannula is disclosed in U.S. Patent No. 4,412,573 to Zbed entitled "Injection Site." The Zbed patent is assigned to the assignee of the present invention.
The pointed cannula can be forced through the septum into fluid flow communication with the flow path in the housing. Known injection sites usable with a piercing cannula can be physically damaged by repetitive piercing caused by the sharp cannula. This damage, known as coring or laceration, can result in subsequent leakage.
Due to problems associated with infectious agents, personnel using such pointed cannulae do so with great care. Notwithstanding careful and prudent practice, from time to time, accidents do occur and individuals using such pointed cannulae jab themselves.
Injection sites usable with a blunt cannula are also known. For example, U.S. Patent No. 4,197,848 issued to Garrett, et al., entitled "Closed Urinary Irrigation Site" and assigned to the assignee of the present invention discloses one such injection site. That injection site is a relatively low pressure device having a relatively thin, molded, sealing member. The sealing member has an opening therethrough.
A blunt cannulae can be forced through the sealing member placing the cannulae into fluid flow communication with a fluid flow pathway in the injection site.
Injection sites of the type noted above usable with a blunt cannula have the advantage that the blunt cannula will not pierce the skin of a user. On the other hand, it is important that the pre-slit injection site reseal with enough force that fluids do not ooze therefrom and that airborne particulate matter, bacterial or viral matter do not enter therethrough.
Hence, there continues to be a need for a pre-slit injection site which can be used with a variety of solutions and over a range of fluid pressures. Further, there continues to be a need for such a pre-slit injection site which will reliably reseal even after many insertions of the blunt cannula.
Such an injection site should be able to receive a large number of insertions of the cannula without displaying reseal failure. Such an injection site should provide for improved alignment of the cannula on insertion. Improved alignment will result in less chance of damage to the injection site after repeated insertions of the cannula. Preferably, the injection site would also be usable with a pointed cannula. Preferably, a pre-slit injection site usable with a blunt cannula will provide a reasonable level of insertion force such that health care personnel will readily be able to insert the blunt cannula, yet the cannula will not easily fall from or drop out of contact with the septum. sii-m-mary of the Invention
In accordance with the invention, an easily wipeable injection site usable with a blunt cannula is provided. The injection site includes a housing which defines a fluid flow channel therethrough. The housing has a first and a second end.
A flexible sealing member is carried by the housing for sealing the first end. The sealing member has a resealable opening therein. The sealing member also is formed with a curved exterior peripheral surface such that the blunt cannula can be sealingly inserted through the opening and placed in fluid flow communication with the flow path. Further, the blunt cannula can be removed from the opening with a sealing member then interacting with the housing so as to reseal the opening.
The housing can also be formed with the first end including an annular channel underlying the sealing member. The sealing member is subjected to radially directed forces by a tapered surface of the first end of the housing. These forces tend to reseal the opening in the sealing member.
The sealing member can be a cylindrically shaped rubber member. The first end of the housing can include an interior tapered surface for receiving the sealing member and for applying the radially directed forces to the sealing member.
A retaining member carried by the first end of the housing can be used to retain the sealing member within the housing. The retaining member can be generally U- shaped. Alternately, the retaining member can be formed as a coiled spring.
The retaining member applies axially directed forces to the sealing member. In one embodiment of the invention, the retaining member deflects the sealing member and forms a curved exterior peripheral surface thereon. The curved exterior peripheral surface is an easily wipeable surface. The retaining member deflects or distorts the upper and lower peripheral edges slightly as a result of applying axial forces thereto. When the blunt cannula is inserted into the slit in the sealing member, an annular interior peripheral region of the sealing member deforms further and fills, at least in part, the annular channel.
Deformation of this annular peripheral region results in an insertion force in a range of 2.0 pounds
(.7564 kilograms) to 5.0 pounds (1.891 kilograms). Preferably, the insertion force will have a value of the order of 2.0 pounds (.7564 kilograms).
The resealable opening in the sealing member can extend entirely through that member. Alternately, the resealable opening can extend only partway therethrough. In this embodiment, the end of the blunt cannula will be used to tear through the remainder of the sealing member.
The sealing member can be formed in two parts. An exterior cylindrical portion can be slit completely. An interior cylindrical unslit portion can be provided to seal the site until the blunt cannula is inserted therethrough the first time.
The interior surface of the first end can be formed with the taper in a range on the order of 5 degrees to 20 degrees. Preferably, the interior surface will have a taper on the order of 12 degrees. This tapered surface permits the use of a cylindrically shaped sealing member.
To provide for leak-free insertion, the length of the slit in the sealing member must be less than one-half the circumference of the cannula being inserted therethrough. Hence, the slit length may exceed the diameter of the cannula being inserted. In addition, the slit length must be great enough, given the elastic limit of the sealing member, to prevent tearing during inser¬ tion. Further, in accordance with the invention, a coupling system for coupling first and second fluid flow members together is provided. The coupling system includes an injection site which is affixed to the first fluid flow member. The injection site includes a housing. The housing has a fluid flow path therethrough.
A sealing member is carried by the housing. The sealing member has a resealable opening therein. An annular retaining member is carried by the housing and cooperates with the housing to retain the sealing member therein. Radially directed forces are applied to the sealing member by the housing, thereby urging the opening into a resealed condition. A blunt cannula, affixed to second fluid flow member, has a fluid flow path therethrough. The cannula carries a locking member for lockingly engaging the housing when the cannula extends through the opening of the sealing member. When so positioned, the two fluid flow members are placed into fluid flow communication.
The locking member can include a luer-type twist lock fitting. Alternately, the locking member can include slidably engageable members which are responsive to axial movement of the injection site and the cannula toward one another.
In accordance with further aspects of this invention, the blunt cannula may be provided with features that facilitate insertion into the injection site, enhance fluid flow or dispersion, increase tug resistance, and reduce kickback.
In particular, one embodiment of the cannula includes a tube with a plurality of elongate discharge slots adjacent the distal end. The fluid changes direction as it passes laterally through the slots and out of the tube. The flow area of the slots exceeds the flow area inside the tube. This slot structure enhances fluid flow and inspersion characteristics. In addition, the slots decrease the contact surface area on the tube exterior so as to facilitate insertion. In a further modification, the cannula includes a lead post on the tube distal end to guide the cannula through the slit in the injection site. In another cannula embodiment, the tube is generally cylindrical and the fluid discharges directly from an open end of the tube. The exterior surface of the tube is provided with grooves to reduce the contact surface area.
In still another cannula embodiment, the tube has a cylindrical portion and a tapered distal end portion which are each about equal in length. The taper facilitates insertion, and the remaining cylindrical portion reduced kickback.
In yet another embodiment, the cannula includes an annular barb which functions to reduce kickback.
Other advantages of a blunt plastic cannula in accordance with the invention, relative to conventional steel needles include a higher fluid flow rate capacity and a simpler one-piece plastic design.
Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention and the embodiments thereof, from the claims and from the accompanying drawings in which the details for the invention are fully and completely disclosed as a part of this specification.
The invention may reside in the provision of an injection site in which first and second distinct locking means are provided on the exterior of the housing for selective co-operation with complementary locking means on different cannulas. The first locking means may be a shoulder for engaging resilient fingers on a cannula and the second locking means may be a screw thread for engaging a screw thread on a different cannula. The injection site is, therefore, particularly versatile in use.
The invention may also reside in a cannula device having retaining fingers which are resiliently biased to positions in which they can engage a shoulder of an injection site to lock the cannula device on the site.
Squeezable gripping means is provided for spreading the fingers to permit their engagement with a disengagement from the cannula. This provides a particularly effective locking system which is easy to operate.
Brief Description of the Drawings Figure 1 is a side elevational view, partly in section, of a prior art pre-slit injection site and an associated blunt cannula; Figure 2A is a view in perspective of a catheter positioned in the hand of a patient with a pre-slit injection site in accordance with the present invention positioned adjacent thereto;
Figure 2B is a perspective view of the catheter of Figure 2A with a pre-slit injection site in accordance with the present invention rotatably affixed thereto;
Figure 3 is an enlarged side elevational view in a section of a pre-slit injection site in accordance with the present invention formed on a body having a luer twist-lock type connector for coupling to a catheter;
Figure 4A is an exploded view of a pre-slit injection site, a shielded blunt cannula and a syringe prior to being coupled together;
Figure 4B is an enlarged, side elevational view in section of the pre-slit injection site, the shielded blunt cannula and the syringe of Figure 4A coupled together to form a sealed fluid flow system;
Figure 5A is a view in perspective of a pre-slit injection site prior to engaging a blunt cannula carrying a locking member;
Figure 5B is an enlarged side elevational view, partly broken away, illustrating the interrelationship between the pre-slit injection site and the blunt cannula of Figure 5A; Figure 6 is an overall view of a container, an associated solution administration set and a pre-slit injection site in accordance with the present invention; Figure 7 is an enlarged side elevational view, partly broken away illustrating the relationship between selected elements of Figure 6;
Figure 8 is a side elevational view, partly broken away illustrating an alternate shielded cannula in accordance with the present invention;
Figure 9 is a side elevational view, partly in section, of a pre-slit injection site mounted on a fragment of a solution container; Figure 10 is a side elevational view of a fragment of a solution container carrying, as a single port, a pre-slit injection site;
Figure 11 is a side elevational view of the injection site and the fragmentary container of Figure 10 prior to being engaged with a shielded cannula carried by a syringe;
Figure 12 is an enlarged side elevational view, partly in section, of a coupling system with a pre-slit injection site partly coupled to a blunt cannula; Figure 13 is an enlarged side elevational view, partly in section, of the coupling system of Figure 12 subsequent to engagement of the two coupling members;
Figure 14 is a side elevational view, partly broken away, of a spike connector carrying a pre-slit injection site in accordance with the present invention;
Figure 15 is an enlarged side elevational view of a Y-connector in section carrying a pre-slit injection site in accordance with the present invention;
Figure 16 is an enlarged fragmentary side elevational view in section of a coupling member carrying a pre-slit injection site where the slit extends only partway through the septum;
Figure 17 is a perspective view of a burette solution administration set carrying a pre-slit injection site in accordance with the present invention;
Figure 18 is a view of part of a burette solution administration set carrying a pre-slit injection site being coupled to a shielded blunt cannula; Figure 19 is a step in the method of making a pre- slit injection site in accordance with the present invention;
Figure 20 is another step in the method of making a pre-slit injection site in accordance with the present invention;
Figure 21 is an initial phase of a final step in making a pre-slit injection site in accordance with the present invention; Figure 22 is an intermediate phase of the final step in a method of making a pre-slit injection site in accordance with the present invention;
Figure 23 is a final phase of the final step in a method of making a pre-slit injection site in accordance with the present invention;
Figure 24 illustrates an initial phase in an alternate step of making a pre-slit injection site in accordance with the present invention;
Figure 25 illustrates a final phase of the alternate step in a method of making an injection site in accordance with the present invention;
Figure 26 illustrates yet another alternate step in a method of making a pre-slit injection site in accordance with the present invention; Figure 27 is an enlarged, fragmentary cross- sectional view of another embodiment of an injection site in accordance with the present invention;
Figure 28 is a cross-section view taken generally along the plane 28-28 in Figure 27; Figure 29 is an end view of another embodiment of the cannula in accordance with the present invention;
Figure 30 is a cross-section view taken generally along the plane 30-30 in Figure 29;
Figure 31 is an end view of another embodiment of the cannula in accordance with the present invention;
Figure 32 is a cross-sectional view taken generally along the plane 32-32 in Figure 31; Figure 33 is a cross-sectional view taken generally along the plane 33-33 in Figure 32;
Figure 34 is an end view of another embodiment of the cannula in accordance with the present invention; Figure 35 is a fragmentary, side elevational view of the embodiment of the cannula illustrated in Figure 34;
Figure 36 is a cross-sectional view taken generally along the plane 36-36 in Figure 34;
Figure 37 is a cross-sectional view taken generally along the plane 37-37 in Figure 36;
Figure 38 is an end view of another embodiment of the cannula according to the present invention;
Figure 39 is a cross-sectional view taken generally along the plane 39-39 in Figure 38; Figure 40 is a cross-sectional view taken generally along the plane 40-40 in Figure 39;
Figure 41 is an end view of another embodiment of the cannula according to the present invention;
Figure 42 is a cross-sectional view taken generally along the plane 42-42 in Figure 41;
Figure 43 is an end view of another embodiment of the cannula according to the present invention;
Figure 44 is a cross-sectional view taken generally along the plane 44-44 in Figure 43; and Figure 45 is a view in section of another insertion member for a blunt cannula.
Figure 46 is a perspective view of another embodiment of a blunt cannula embodying the present invention. Figure 47 is a perspective view of a blunt cannula shield or tip protector.
Figure 48 is a perspective view of a heparin lock embodying the present invention.
Figure 49 is a side elevational view of the heparin lock of Figure 48 in joined relationship with a blunt cannula device of alternative construction embodying the present invention. Figure 50 is a cross-sectional view of the heparin lock of Figure 48 in joined relationship with a blunt cannula device of further alternative construction embodying the present invention. Figure 51 is a cross-sectional view of a pre-slit in-line injection site embodying the present invention in joined relationship with a blunt cannula shown in side elevational view.
Figure 52 is a perspective view of the alternative blunt cannula device of Figure 49 in joined and locked relationship with the pre-slit in-line injection site depicted in Figure 51.
Figure 53 is a perspective view, partially broken away, depicting the combination of a syringe and an alternative blunt cannula device of the present invention for injecting or removing liquid through a pre-slit in¬ line injection site, such as depicted in Figure 51.
Figure 54 is a perspective view of a blunt cannula shield or tip protector for attachment over the end of the blunt cannula device such as depicted in Figure 53.
Figure 55 is a cross-sectional view of an alternative blunt cannula device particularly suited for attachment to a syringe as shown in Figure 53.
Figure 56 is a perspective view of the blunt cannula device shown in Figure 53 in joined relationship with the pre-slit injection site shown in Figure 51.
Detailed Description of the Preferred τnt-*nfliments
While this invention is susceptible of embodiment in many different forms, there are shown in the drawing and will be described herein in detail specific embodiments thereof with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated. A prior art pre-slit injection site 10 and associated blunt cannula 12 are illustrated in Figure l. The prior art injection site 10 has a cylindrical housing 14 with a fluid flow path 16 therethrough. A first end 18 of the housing 14 is closed with a relatively thin disc- shaped resealable member 20. The member 20 has a resealable opening 22 therein.
The member 20 is a molded septum with an integrally formed skirt 20a. The skirt 20a is oriented generally perpendicular to the portion of the septum with the opening 22.
The cannula 12 includes a body portion 24 which carries at a first end a hollow, cylindrical, blunt piercing member 26. As the cannula 12 is moved in a direction 28 toward the first end 18 of the injection site 10, the member 26 slidably engages the opening 22. The sealing member 20 is then deformed adjacent the opening 22 and the number 26 extends into the flow path 16. A fluid flow path through the cannula 12 will then be in fluid flow communication with the flow path 16 via the hollow piercing member 26.
In contradistinction to the prior art pre-slit injection site 10 of Figure 1, Figures 2A and 2B illustrate a pre-slit injection site 34 being coupled to a peripheral venous catheter 36. The catheter 36 is shown in fluid flow communication with a vein in a hand H of a patient. The catheter 36 carries at a proximal end 38 a luer-type female twist lock connector 41. The pre-slit injection site 34 is formed with a cylindrical housing 40 having a first end 42 and a second end 44.
Carried by the housing 40, adjacent the second end 44 is a hollow cylindrical fluid flow member 46. The member 46 slidably engages a receiving member in the housing 38 of the catheter 36, thereby providing a sterile fluid flow coupling as is well known and conventional.
A plurality of internal male luer-type threads 48 is carried by the housing 40 adjacent the second end 44. The threads 48 will engage the flange member 41 when the injection site 34 is rotated in a direction 50. When so coupled together, the catheter 36 and the injection site 40 provide a sealed coupling through which fluids may be injected into the vein of the hand H.
Figure 3 illustrates, in section, further details of the injection site 34. A resealable septum 52 is carried by the first end 42 of the housing 40. The septum 52 includes first and second spaced apart surfaces 54 and 56 respectively. The surface 54 has been forced into a dome-like shape by annular, U-shaped, swaged end members 58 carried by the first end 42. The dome-like shape of the surface 54 can extend beyond a surface 42a of the first end 42. This facilitates cleaning the surface 54. The septum 52 has a generally cylindrical shape.
The septum 52 can be formed of a latex or synthetic rubber material. Alternately, the septum can be formed of a thermoplastic elastomer. The material used for the septum 52 should be non-toxic and sterilizable such as by means of radiation, steam or Ethylene Oxide.
Because the septum 52 is generally cylindrical in shape, it can be die-cut from a sheet, cut from an extruded rod or molded. The septum 52 can have an exemplary diameter on the order of .30 inches (0.762 centimeters) . The height of the septum 52 can be, for example, on the order of .125 inches (.3175 centimeters).
The first end 42 is also formed with a tapered interior surface 60 which terminates in an annular channel 62. The tapered interior surface 60 has a taper in a range of 5 degrees to 20 degrees. Preferably, the taper will be on the order of 12 degrees. With the indicated size of the above noted exemplary septum 52 and a 12 degree taper, diametric resealing compression of the septum 52 adjacent the channel 62 is on the order of 10%.
The channel 62 is bounded in part by a septum supporting ridge 62a. The channel 62 can typically have a depth in a range of .050-.070 inches (.127-.1778 centimeters) .
A peripheral surface 64 of the septum 52 slidably engages the tapered interior surface 60 as the septum 52 slides into the first end 42. The annular channel 62 which underlies the interior peripheral surface 56 of the septum 52 is provided to permit the septum 52 to deform when a blunt cannula is inserted through an opening 66 therein.
The housing 40 is also formed with a fluid flow path 68 such that fluids injected via a blunt cannula inserted through the resealable opening 66 can flow into the catheter 36 for delivery to hand H of the patient.
The swaged end members 58 apply axial forces to the septum 52 thereby creating the domed exterior peripheral surface 54. The axial forces applied by the end members 58 slightly deform the regions 52a and 52b. In contradistinction, the tapered internal surface 60 applies radially directed forces to the septum 52, thereby forcing the opening 66 into a resealed condition.
In an alternate embodiment, the surface 52 could be formed as a flat, as opposed to a domed, surface.
Once the injection site 34 is lockingly engaged with the catheter 36, a sealed system is formed through which fluids can be infused into the catheter 36. The resealable septum 52 closes the fluid flow path 68. Figures 4A and 4B illustrate in combination the injection site 34, a blunt shielded cannula 80 and a syringe of a conventional type 82. The syringe 82, as is well known, can be formed with a cylindrical hollow end 84 which carries a male luer-type twist lock thread 86. A hollow centrally located cylindrical fluid flow member 88 is in fluid flow communication with an interior region 90 of the syringe 82. The shielded blunt cannula 80 carries at a first end 92 a female luer twist-lock flange 94. The flange 94 will slidably engage the threads 86 of the end 84. Hence, the shielded blunt cannula 80 can be locked to the syringe 82 forming a closed fluid flow pathway. The shielded cannula 80 could alternately be formed fixedly attached to the syringe 82.
The shielded blunt cannula 80 carries a cylindrical hollow protective shield 96 which surrounds a centrally located hollow, elongated cylindrical blunt piercing member 98. The cylindrical blunt piercing member 98 has a total length on the order of three times the thickness of the septum 52 in order to ensure complete penetration. The cylindrical blunt piercing member 98 has a diameter on the order of 1/3 the diameter of the septum 52. The shield 96 is desirable and useful for maintaining the piercing member 98 in an aseptic condition by preventing touch contamination prior to the shielded cannula 80 engaging the pre-slit septum 52. Also, the shield helps to align the piercing member with the pre- slit septum.
The cylindrical blunt piercing member 98 can slidably engage the pre-slit septum 52, best illustrated in Figure 4B, thereby extending through the preformed opening 66 therein. As illustrated in Figure 4B, when the piercing member 98 slidably engages and pierces the septum 52, the region 52a deforms by expanding into and filling, at least in part, the annular channel 62.
The deformation facilitates insertion of the piercing member 98 through the slit 66. Subsequent to the piercing member 98 slidably engaging the injection site 34, the interior region 90 of the syringe 82 is in fluid flow communication with the flow path 68 of the injection site 34 via flow paths 88a and 99 respectively of the syringe and the blunt piercing member 98.
In this engagement condition, the septum 52 seals completely around the piercing member 98. Hence, exterior gases, liquids or airborne matter will be excluded from the channel 68.
Subsequent to infusing fluid from the syringe 82 into the fluid flow pathway 68, hence into the catheter 36 and the hand H of the patient, the syringe 82 with lockingly engaged shielded cannula 80 can be slidably withdrawn from the injection site 34. Subsequent to this withdrawal, the septum 52 reseals the opening 66 therein.
The opening 66 will repeatedly reseal, when the piercing member 98 is removed, provided that the pressure (in the septum 52 of the opening 66) created by interaction of the septum material properties and compression supplied by the housing exceeds the pressure challenge of the fluid contained within. Blunt cannula do not haphazardly core, lacerate, or otherwise damage the sealing interface 66 as conventional needles do, thereby allowing repeatable resealability. However, septum material properties, thickness, and compression allow resealability for a finite number of conventional needle insertions. The combination injection site 34 and catheter 36 then return to its pre-infusion, sealed condition.
Figures 5A and 5B illustrate the pre-slit injection site 34 used in combination with a blunt cannula 80a. The cannula 80a includes a hollow body portion 92a with a luer flange 94a, a piercing member 98a, and manually operable elongated locking members 100a and 100b. Alternately, a tubing member could be affixed to the hollow body portion 92.
Curved end regions 100c of the members 100a and 100b slidably engage the second end 44 of the housing 40 when the piercing member 98a of the blunt cannula 80a has been forced through the pre-formed opening 66, best illustrated in Figure 5B. The embodiment illustrated in Figures 5A and 5B has the advantage that the infusion cannula 80a cannot accidentally disengage from the pre- slit septum 34 during the fluid infusion process. It will be understood that while spring-like deflecting members 100a and 100b are illustrated in Figures 5A and 5B that other forms of locking members are within the spirit and scope of the present invention.
Figure 6 illustrates an alternate pre-slit injection site 34a. A tubing member 102 can be fixedly attached to the cylindrical hollow fluid flow member 46. The embodiment 34a of Figure 6 utilizes the same structure for the septum 52 including the tapered surface 60 and the underlying annular channel 62 as does the embodiment 34 in Figure 3. The shielded cannula 80 can be utilized with the injection site 34a as previously described.
In the event that it is desirable to infuse solution from a container 104 with a connectional port 106, a fluid administration set 110 of a conventional variety may be utilized. The set 110 includes a spike connector 112 at a first end. The spike connector 112 is designed to pierce the port 106 of the container 104. The set 110 can also carry a slidably engageable connector 114 of a known type at a second end. As illustrated in Figure 7, the connector 114 can slidably engage the hollow cylindrical member 98 of the shielded cannula 80, thereby placing the interior fluid of the container 104 into fluid communication with the tubing member 102.
Figure 8 illustrates yet another alternate 80b to the shielded cannula 80. The piercing member 98b carries a tubing member 118 fixedly attached thereto. The tubing member 118 could be coupled at a second end to a container such as the container 104.
The present pre-slit injection site can be directly affixed to a container 120 as illustrated in Figure 9. The container 120 includes a rigid hollow cylindrical access port 122 affixed thereto. The access port 122 includes a fluid flow channel 124 in fluid flow communication with the interior of the container 120. Sealingly affixed to the port 122 is a pre-slit injection site 126.
The site 126 includes a cylindrical housing 128 which carries at a first end 130 a septum 132 with a slit 134 formed therein. The first end 130 has been swaged to form an annular U-shaped retaining member 136. The retaining member 136 in turn forms a domed exterior peripheral surface 138 on the septum 132.
The first end 130 also includes a tapered interior force applying surface 140 and an annular channel 142 underlying the septum 132. As discussed previously, the channel 142 provides a space into which the septum 132 can deform when a blunt cannula is forced through the resealable opening 134. Further, as illustrated in Figure 9, the injection site 126 can be covered by a removable cover 146 of a type used with the conventional port 106 of the bag 120.
While the bag 120 is illustrated formed with two ports, the conventional pierceable port 106 and the pre- slit injection site 126, it will be understood that as an alternate (Figure 10) , a container 150 could be formed which includes only the pre-slit injection port 126. The removable cover 146 could be used in combination with the container 150.
As illustrated in Figure 11, the pre-slit injection site 126 can be utilized for the purpose of injecting fluid from the syringe 82, coupled to the shielded cannula 80, into the container 150. When so utilized, the blunt piercing member 98 is used to place the interior fluid containing region 90 of the syringe into fluid flow communication with the interior of the container 150.
Figures 12 and 13 illustrate a fluid flow coupling system 151 having as a first element a pre-slit injection site 126a. The site 126a is the same as the site 126 except for a plurality of exterior threads 153 formed on an exterior peripheral surface 155 of the housing 128a. A second element of the coupling system 151 is a shielded blunt cannula 157.
The shielded blunt cannula 157 is sealingly affixed to a flexible tubing member 159 by means of a proximal hollow cylindrical member 161. The member 161 extends into a hollow cylindrical shield 163 to form a blunt piercing member 165.
The shield 163 carries, on an interior peripheral surface, a set of coupling threads 149. The threads 149 match the threads 153.
The two connector elements 126a and 157 slidably engage one another when the shielded cannula 157 moves in an axial direction 167 toward the injection site 126a. The blunt piercing member 165 penetrates the septum 132a. The coupling member 157 can then be rotated in a direction 169 such the interior set of threads 149 carried thereon engages the exterior set of threads 153. As a result, the two coupling members 126a and 157 are lockingly engaged together with the insertion member 165 extending through the opening 134a in the septum 132a. Hence, fluids can flow from the container 150a via the connector system 126a and 157 through the tubing member 159 to the recipient.
Injection sites of the type described above are also usable in connection with other fluid flow coupling components. For example, with respect to Figure 14, a pre-slit injection site 160 of the type described above can be used in combination with a spike connector 162 of a conventional variety. Spike connectors such as the spike connector 162 can be used to pierce conventional ports such as the port 106 of the container 104 (Figure 6) . When the spike connector 162 is so used, the pre-slit injection site 160 can then be utilized for the purpose of coupling to other fluid administration sets. The injection site 160 illustrates an alternate form of swaging the first end 42c for the purpose of retaining the septum 52c therein. The first end 42c can be swaged so as to form an annularly shaped, spiral. spring-like member 164. The member 164 has a free end 164a which engages the exterior dome-shaped peripheral surface 54c of the septum 52c. The spiral, spring-like swaged member 164 will tend to uncoil, thereby continuous- ly applying axial force to the septum 52c and maintaining the domed exterior peripheral surface 54c.
In yet another alternate. Figure 15 illustrates a pre-slit injection site 166 formed in a Y-junction member
168. The Y-junction member 168 is fixedly attached to first and second tubing members 170 and 172 respectively.
As an alternate to forming the slit 66 completely through the septum 52, as illustrated in Figure 16, a slit
66e can be formed only partly through the septum 52e.
Such a structure has the further advantage that, until used for the first time, the septum 52e is completely sealed.
The septum 52 can be formed in two parts. One part can have a slit, such as the slit 66, extending entirely therethrough. A second part can be formed without a slit. These two parts can be located adjacent one another in the first end 42 of the injection site.
The slit 66 may be longer on the top of the septum than the bottom. this feature aids blunt cannula alignment with the slit upon insertion, and aids resealability by minimizing the critical slit sealing interface area.
In accordance with the present invention, the slit could have a length with a range on the order of .03 inches (.0762 centimeters) to .150 inches (.381 centimeters) . Preferably, a slit length on the order of .07 inches (.1778 centimeters) will be used in combination with a blunt cannula having a diameter on the order of .1 inches (.254 centimeters).
When initially used, the blunt cannula piercing member, such as the member 98, will be forced through the slit 66a. The lower peripheral surface 56e will then be punctured, providing access for the blunt cannula piercing member 98 into the fluid flow pathway 68e. Pre-slit injection sites of the type described above can be utilized in combination with burette solution administration sets. One such set 176 is illustrated in Figure 17. The set 176 includes a pre-slit injection site 178 of the type described above. The injection site 178 is affixed to an exterior planar surface 180 of the burette 182. A removable cover 184 can be used to maintain the injection site 178 in an aseptic condition until blunt cannula 186 or 188 is inserted therethrough. Figures 19 through 23 disclose a method of making a pre-slit injection site in accordance with the present invention. In a first step, a housing 200 is provided. The housing 200 has an interior tapered surface 202 at a first end 200a thereof. The interior peripheral surface terminates in an annular channel 204. A cylindrical septum 206 can be provided adjacent the end 200a.
In a second step, the septum 206 can be forced into the end 200a of the housing 200 and slightly deformed by the tapered peripheral surface 202 using an axially moving die 210. When positioned by the die 210, the septum 206 is located adjacent an internal annular right 212 which bounds the annular channel 204.
In a third step, a second die 214 can be utilized to swage the end 200a into spiral-shaped, spring-like members 200b which apply axially directed forces against an exterior peripheral surface 206a of the septum 206. The axially directed forces form the flat surface 206a into a domed exterior peripheral surface 206b as illustra¬ ted in Figure 23. Simultaneously, with swaging the end members 200a so as to lock the septum 206 into the housing 200 and to form the domed exterior peripheral surface 206b, a knife 216 can be utilized to form a slit in the septum 206. Alternatively, the slit may be cut by a separate die in a separate step. If the septum 206 is formed as an extrusion, the slit can be created during the extrusion process. If the septum 206 is formed by stamping from a rubber sheet, the slit can be cut during the stamping process. If the septum 206 is formed by compression molding, the slit can be cut during the trimming process.
In order to extrude the slit into rod, a flat pin extrusion bushing can be used. A trailing ribbon may be attached to the bushing. The ribbon would prevent curing material across the slit. The ribbon or wire could be placed in the rod core and later stripped out leaving a slit. An inert substance, such as silicone oil, could be coextruded in the center of the rod to prevent curing across the slit and provide lubrication and a visible target for cannula insertion.
Figures 24 and 25 illustrate alternate swaging steps wherein a die 220 moving axially toward the housing 200 swages the end region 200a so as to form an annular U- shaped region 200c and the exterior domed peripheral surface 206c.
The dies 214 or 220 can be formed with various alternate shaped swaging surfaces 224, as illustrated in Figure 26, depending on the precise shape of the end swage which is desired. It will be understood that all such variations in the swaging operation are within the spirit and scope of the present invention.
The injection site configuration need not be limited to the configurations depicted in Figures 3 through 5B, 9, and 12 through 16. Rather, several configurations could be constructed without departing from the scope of this invention. Any such configuration would provide a flexible pre-slit sealing member captured in a chousing which provides compression to create a seal against pressure and a void region to accommodate deformed portions of the sealing member material only when the material is deformed or displaced by a blunt cannula piercing member. One such possible configuration is depicted in Figures 27 and 28. Figures 29 and 30 illustrate a tapered cannula structure 250 which is an alternate to the tapered cannula 98. The cannula 250 includes a proximal end 252 with an interior region 254. The region 254 is in part bounded by an internal peripheral wall 256 which is formed with a standard luer taper. The tapered cannula 250 can be formed with a luer-type coupling flange 257 at the proxi¬ mal end so as to be releasably connectable to the syringe 82 as was the tapered cannula 98 previously discussed.
Extending from the proximal end 252 is a cylindrical tube having a cylindrical mid-region 258 and a distal end member 260. The member 260 has a generally elongated, cylindrical shape with an exterior side wall 262. A centrally located, cylindrical, internal fluid flow path 264 extends through the distal end member 260 and mid-region 258 in fluid flow communication with the interior region 254.
The distal end of the end member 260 has a tapered exterior surface 266. The tapered exterior surface 266 minimizes insertion force as the cannula 250 is being forced through a slit of a septum, such as the slit 66 in the septum 52. The angle of taper of the surface 266 is preferably in a range between 1 to 15 degrees. The member 260 is also provided with a plurality of elongated grooves 268. The grooves 268 in the exterior wall of the member 260 decrease the surface area of contact at the cannula/septum interface during insertion of the cannula into the injection site 34. This reduced exterior contact surface area decreases the frictional component of the insertion force.
In one embodiment, the tapered blunt cannula 250 may have overall insertion length, corresponding to combined axial lengths of mid-region 258 and end member 260, on the order of 0.375 inches (.9525 centimeters).
An alternate cannula structure 280 is illustrated in Figures 31, 32 and 33. The cannula structure 280 includes a proximal end region 282 corresponding to the end region 252 of the cannula 250. The region 282 includes a luer flange 283. The cannula 280 also includes a central, elongated, cylindrical region 288.
The central region 288 carries at a distal end thereof an elongated cylindrical end member 290. The member 290 includes an exterior, peripheral, cylindrical surface 292 (Figure 31) . The surface 292 is interrupted by a plurality of spaced-apart, elongated slots or apertures 294. The slots 294 are defined by first and second spaced-apart, elongated, parallel side surfaces 294a and 294b. Each of the slots terminates in an end surface 294c at the central region 288.
A fluid flow path 294d extends through the cannula 280. The flow path 294d is in fluid flow communication with the slots 294.
Between the slots 294, at a distal end of the region 290, the exterior surface 292 terminates in tapered end regions 298 to facilitate insertion of the cannula into a pre-slit injection site. The slots 294 themselves also function to decrease the surface contact area, and this further minimizes the insertion force.
The slots 294 are oriented substantially 90 degrees apart around a longitudinal axis 300. The slots 294 increase the internal flow path cross-section. This increases the fluid flow rate.
The slots 294 also provide for enhanced dispersion characteristics owing to the fluid flowing radially out through the slots 294. This radial flow, effecting as change in fluid flow direction of about 90 degrees, promotes flushing and dispersion of fluid through the injection site 34.
Another embodiment of a blunt cannula 310 is illustrated in Figures 34 through 37. The cannula 310 is formed with an enlarged proximal connection region 312 corresponding to the region 252 of the cannula 250. The region 312 includes a luer flange 313 and a central fluid flow region 314.
An intermediate, cylindrical region 318 extends from the proximal connection region 312. The cylindrical intermediate region 318 includes a fluid flow path 320 in communication with the fluid flow region 314.
The end region 324 extends from the region 318 and includes a first cylindrical portion 326 into which the fluid flow path 320 extends. The region 326 terminates in a tapered exterior surface 328. The tapered exterior surface 328 merges with a centrally located lead post or guide post 330. The lead post 330 terminates in a hemispherical end surface 332.
The lead post 330 helps locate the septum slit 66 prior to insertion and facilitates penetration of the septum slit 66 by the cannula. The lead post 330 facilitates insertion by providing a very low insertion force at the beginning of the insertion step as the cannula is pushed through the slit, such as the slit 66.
In a preferred embodiment, the guide post 330 can have a length on the order of 0.060 inches (.1524 centimeters) and a diameter on the order of 0.050 inches (.127 centimeters).
The end region 318 includes a novel structure for increasing the flow rate and enhancing dispersion characteristics. In particular, the region 318 includes three radially oriented slots 338. Each slot 338 has sides 339a and 339b which each lie along a radius of the cylindrical portion 326 as best illustrated in Figure 37. The fluid flowing through the cannula 310 undergoes a change in direction (of up to about 90 degrees relative to the cannula center line 337) in the slots 338. This change in direction increases fluid dispersion. Further, since the slots 338 open radially, fluid flow can be maintained even if the end surface 332 of the cannula is pushed up against any material in the system in which the cannula is inserted. Another embodiment of the tapered cannula of the present invention is illustrated in Figures 38 through 40 and is designated generally therein by reference numeral 340. The cannula 340 includes a proximal end 342 which can include a luer coupling flange 344 for cooperating with a suitable mating structure on a syringe. The proximal end 342 also defines an interior region 346.
Extending from the proximal end 342 is a generally cylindrical mid-region 348. Extending from the mid-region 348 is an end member or region 350 which includes a tapered surface 352.
The distal end of the end region 352 terminates in a blunt, arcuate end surface 356. Defined within the mid- region 348 and end region 350 is an internal fluid flow channel 354 which communicates with the interior region 346. Fluid discharges from the flow channel 354 via grooves or apertures 358 in the end region 350. The change in direction of the fluid flow as the fluid passes from the interior channel 354 through the apertures 358 improves fluid dispersion with respect to mixing or flushing in the system downstream of the cannula (e.g., the injection site, drug vial, etc.). The apertures 358 may also function to increase withdrawal force or tug resistance.
Moreover, since the fluid passes radially out through the apertures 358, fluid flow through the cannula 340 can be maintained even when the distal end surface 356 of the cannula is bottomed out or pushed against any material in the system in which the cannula is inserted.
The structure of the cannula 340 is adapted to be constructed with a minimal lead post length (i.e., the portion of the cannula distal end between the end surface 356 and the interior flow channel 354) . Further, the design accommodates the use of a minimal tip diameter, minimal taper angle, and minimal cannula diameter. The minimization of these parameters results in a decrease in the peak insertion force required to properly install the cannula in the injection site. Preferably, the total cross-sectional flow area through the three apertures 358 is about three times the cross-sectional flow area of the interior channel 354. This enhances the flow rate capability compared with a simple open ended cylindrical flow channel of equal length.
The design of the cannula 340 also is effective in reducing or limiting "kick back" or recoil of the cannula after insertion. The resilient material of the septum in an injection site can subject the cannula to forces tending to push the cannula back out of the septum. The kick back forces on the cannula 340 are minimized by the provision of the generally cylindrical mid-region 348. Another embodiment of the cannula of the present invention is illustrated in Figures 41 and 42 wherein the cannula embodiment is designated generally therein by the reference numeral 360. The cannula 360 includes a proximal end 362 defining an interior region 364 and having a luer flange 366 for connection to a suitable mating engaging structure.
A generally cylindrical mid-region 366 extends from the proximal end 362, and an end region 368 extends from the mid-region 366. As with the previous embodiment of the cannula 340 illustrated in Figures 38 through 40, the embodiment of the cannula 360 minimizes kick back or recoil owing to the provision of a substantially cylindrical mid-region 366. This design also increases withdrawal or tug resistance. A generally cylindrical internal flow channel 370 extends through the end region 368 and mid-region 366 in communication with the interior region 364 of the proximal end region 362. The end region 368 is provided with a tapered surface 372. The design permits the use of a very small taper to minimize the insertion force.
Further, the design permits the cannula 360 to be constructed with a small tip diameter, small taper angle, and small cannula diameter so as to reduce the peak insertion force. Another embodiment of the cannula of the present invention is illustrated in Figures 43 through 44 and is designated generally therein by reference numberal 380. The cannula 380 includes a proximal end 382 with a luer flange 384. An interior fluid flow region 386 is defined on the interior of the proximal end 382.
Extending from the proximal end 382 is a mid- region 388. A distal end region 390 extends from the mid- region 388. An internal fluid flow channel or path 392 extends through the end region 390 and mid-region 388, and is in communication with the interior flow region 386.
The end region 390 has an exterior tapered surface
394. This facilitates insertion of the cannula into the injection site. In contrast, the mid-region 388 is generally cylindrical so as to minimize kick back and increase the withdrawal force or tug resistance.
Further, to provide even greater withdrawal force, the mid-region 388 includes an annular barb 396. The barb 396 has a sufficient radius so as to preclude damage to the septum of the injection site and so as to accommodate molding in a straight draw tool. The maximum diameter of the annular barb 396 may typically be on the order of 0.02 inches (.0508 centimeters) greater than the diameter of the cylindrical mid-region 388. Although the barb 396 functions to prevent inadvertent removal of the cannula 380 from the septum of the injection site, removal of the cannula 380 can still be achieved by entering a sufficiently great axially directed removal force on the cannula 380.
Still another embodiment is illustrated in Figure 45 which includes a blunt tapered cannula insertion member 400 for insertion into a pre-slit injection site, the cannula 400 having a distal end region 402 with a tapered exterior surface which in the preferred embodiment is an approximately 8 degrees taper. The defined aperture 404 for fluid flow is disposed at the end 406 of the distal end region 402. The end 406 includes a radiused tip defined by a radius of approximately 0.01 inch (.025 centimeters) . The radiused tip reduces insertion force, assists in locating the slit in the injection site and in addition has the practical advantage of facilitating complete filling of the cannula mold cavity.
The tapered surface of the distal end region 402 has an axial length of approximately 0.10 inch in the preferred embodiment. Adjacent to the tapered distal end region is a generally cylindrical region 408 for entering into the injection site behind the distal end region 402, thereby reducing kick back during insertion. The generally cylindrical region 408 has a small draft angle such as about one-half degree.
The force required to insert any of the above- discussed embodiments of the blunt tapered cannula into the septum of the injection site depends upon a number factors: friction at the cannula/septum interface, cannula diameter, cannula taper angle, and degree of septum compression. The cannula/septum interface friction is, in turn, dependent upon lubrication, if any, material properties, and surface finish. It will be understood that the friction at the cannula/septum interface can be reduced by providing a smoother surface finish on the cannula (e.g., by sand blasting the cannula exterior surface) or by molding the cannula so as to produce a matte finish. Conventional lubricants can also be used to further reduce the friction and thereby lower the insertion force required.
In the embodiments of the cannulae described herein, the mid-region and the tapered distal end region may be alternatively characterized as together forming at least one tube defining a fluid flow path therein with the tube having a distal end region for penetrating the injection site. In preferred contemplated embodiments, the exterior surface of the distal end region may have a taper angle as small as between 1 and 15 degrees.
Further, a locking means, such as the locking arms 100a and 100b discussed with reference to Figures 5A and 5B, may be provided on the cannula embodiments illustrated in Figures 29 through 44 to permit the cannulae to be releasably locked to the injection site.
The above described insertion members, usable as part of a blunt cannula, are preferably molded of a plastic formulation including silicone or other lubricant. The use of silicone or other lubricant increases the ease of insertion of that member into the pre-slit injection site. Figure 46 shows a blunt cannula member, generally at 410, for use with the pre-slit injection sites disclosed herein. The blunt cannula member 410 generally has a hollow cylindrical portion 412 and a blunt cannula portion 414. The blunt cannula member 410 is preferably of one-piece molded, rigid plastic, with a through bore 416 extending through the blunt cannula portion and communicating with the hollow cylindrical portion.
The hollow cylindrical portion has a pair of opposed raised flanges or threads 418 for threaded engagement with other devices, for example, syringes, administration sets and the like. Internally, the hollow cylindrical portion 412 may also be adapted for attachment to other devices. For example, the internal surface of the cylindrical portion may define a tapered female luer surface for interfitting with the standard male luer connectors utilized in many medical devices, as is well known in the medical field. The hollow cylindrical portion 412 may also include a pair of opposed flat surfaces 420 for cooperation with a tip protector or shield such as depicted in Figure 47, which is described below.
The blunt cannula portion 414 extends generally axially from the hollow cylindrical portion 410. The cannula portion is generally cylindrical throughout the greater part of its length, with a tapered end portion 424, which narrows to the blunt end edge 426.
Figure 47 is an enlarged view of a hollow shield or tip protector 428 for covering and protecting a blunt cannula, such as, for example, the blunt cannula portion 414 of blunt cannula member 410 shown at Figure 46 or other blunt cannulae as disclosed herein. The shield 428 has a generally elongated housing 430, which is open at one end for receiving the blunt cannula. At the open end, the interior surface 432 of the shield generally corresponds to the shape of the exterior surface of the blunt cannula portion 412, i.e., it is generally cylindrical, with a pair of opposed flat surfaces 434 matching the flat surfaces 420 of the blunt cannula device 410. Further, either surfaces 432 or 434 can be provided with standing ribs to control the depth of insertion of the blunt cannula portion 414 into housing 430. The matching flat surfaces of the shield and the blunt cannula device allow a user to secure the blunt cannula onto a syringe or similar device, for example, without exposing the cannula portion 414 to touch contamination. When access to the blunt cannula is required, the shield may simply be slidably removed from the cannula. As can be appreciated, the outer surface of the shield 428 can be shaped in such a manner or provided with a roughened finish to assist the user in gripping or removing shield 428 from the cannula. Typically, the blunt cannula 410 or other blunt cannula device and shield 428 would be provided in a joined sterile configuration. The shield 428 can be provided with channels to facilitate gas sterilization. The user preferably leaves the shield on to prevent inadvertent contamination when attaching the blunt cannula to the mating product, e.g., the male luer fitting of a syringe or administration set. The matching flat surfaces 432 of the shield and 420 of the blunt cannula act as a wrench to allow any twisting force applied to the shield to be transmitted to the cannula, e.g., for threading the cannula onto a luer lock device or for applying a twisting force in making a luer slip connection.
Figure 48 shows what is commonly referred to as a heparin lock, generally at 436, employing a pre-slit injection site 442 and other features of the present invention. The heparin lock 436 may be attached, for example, to the end of a venous catheter.
During intravenous therapy, it is not unusual for the administration of liquid to be interrupted from time to time. Instead of performing a new catheterization procedure each time administration is to be restarted, it is often preferable to utilize the same catheter, thus reducing the number of catheterization procedures, more colloquially referred to as the number of "sticks," and reducing the trauma and risk associated with each such procedure.
To maintain the patency of the catheter during interruption, and prevent blood from clotting and clogging the catheter, it is a common practice to attach an injection site over the catheter and fill the catheter with heparin or other anticoagulant. The heparin lock 436 shown in Figure 48 is for attaching to a patient's catheter for maintaining patency of the catheter during interruption in fluid flow.
The heparin lock 436, also shown in Figures 49 and 50, has a first end portion 438 in the form of a male luer connector for sealingly engaging a complementary female tapered luer surface on the patient's catheter (see cross- sectional view in Figure 50) . The other end of the heparin lock 436 includes a pre-slit injection site 442 of the type previously discussed in detail. An axial fluid flow passageway 444 communicates between the pre-slit injection site and the end of the male luer for fluid flow therebetween.
The tapered exterior surface of the male luer 438 is substantially surrounded by generally cylindrical gripping collar 446. Threads 448 are provided on the interior surface of the collar for threadedly engaging a standard luer lock connector, as is often found on intravenous catheter devices. The exterior surface of the collar 446 is generally arcuate in cross-sectional shape (as best seen in Figures 49 and 50) , to provide a gripping surface. The surface curves generally outwardly in a direction toward the pre-slit injection site 442. This allows the nurse, physician or attending staff member to grip the heparin lock and to reduce any force exerted during entry of a blunt cannula into the pre-slit injection site from being transmitted to the venous catheter. For improvement in the gripping, a series of axial grooves 450 are provided in the exterior surface of the collar 446. In accordance with other aspects of the present invention, the heparin lock includes features which allow attachment to various styles or types of blunt cannulae. For example, as best seen in Figure 48, threads 452 are provided on the exterior surface of the cannula for threaded locking engagement to a blunt cannula device of the type having an interiorly threaded sleeve or shield, such as depicted in Figure 50. The heparin lock 436 also includes a generally radially-extending shoulder 454 for locking retention of resilient gripping fingers on a blunt cannula device of the type shown in Figure 49.
As a safety measure, and to prevent staff confusion of an injection site of the present invention with other injection sites which are for use with needles, a visual identifier is also provided with the heparin lock of Figure 48. Such an identifier may also be provided with the other pre-slit injection site devices described 'above. The identifier may take the form of any unique color or configuration which allows the staff member to determine that the heparin lock 436 embodies the present invention and is intended for use with blunt cannulae. In the preferred embodiment, however, the visual identifier comprises a distinct color identifier and, more particularly, is a brightly colored ring 456 (Figure 48) circumscribing the pre-slit injection site 442. While the color selected may vary depending on application, it should be a color which is distinct from and in contrast to the color of any plastic used in the manufacture of the heparin lock. As noted earlier, the heparin lock 436 depicted in
Figure 48 may be used with a variety of styles or types of blunt end cannula devices. For example, the heparin lock may be used with a bare blunt end cannula, such as that depicted in Figure 46, which does not lock onto to the heparin lock. Alternatively, as shown in Figure 49, the heparin lock may be used in combination with a blunt cannula device 458 which utilizes a pair of resilient gripping fingers 460 for retaining the blunt cannula in joined relationship with the heparin lock. The blunt cannula device 458 depicted in Figure 49 has a generally cylindrical, hollow base or body portion 462 and a blunt cannula portion 464 substantially as described earlier in connection with Figure 46 or with the other figures of the present inventions. A fluid flow path 463 extends through the blunt cannula portion and communicates with a female luer connection 465 defined in the hollow body portion for fluid flow through the blunt cannula device. Flanges or threads 467 on the body portion permit the attachment of a male luer lock connector to the blunt cannula device.
Each of the gripping fingers 460 is mounted to the body portion of the blunt cannula device by an intermediate radially extending wall portion 466. The gripping fingers have radially inwardly directed retention means 468 at one end for engaging against radial shoulder 454, and gripping means 470 at the other end for squeezing and spreading the retention means to release the blunt cannula device from the heparin lock. In the as-molded condition, the gripping fingers are biased radially inwardly, toward the blunt cannula portion 464. Because of the natural resilience of the plastic, the retention end of the fingers may be spread by squeezing the gripping end of the fingers. The natural resilience will hold the retention means in the lock position (shown in Figure 49) until manually released.
When used in combination with a heparin lock such as depicted in Figure 48, the blunt cannula device 458 may be attached by simply pushing the blunt cannula into the pre-slit injection site 442. A forward facing tapered surface 472 (Figure 49) in front of the threads engages a similar tapered surface 474 on the retention means 468 so as to naturally spread the fingers 460 apart as the blunt cannula is forced into the pre-slit injection site. After the blunt cannula is inserted into pre-slit injection site sufficiently far so that the retention means are beyond the radial shoulder 454, the gripping fingers will snap inwardly behind the shoulder, holding the blunt cannula in the position depicted in Figure 49. To withdraw the blunt cannula, the user need simply squeeze the gripping end 470 of the handles, which will spread the retention means of the fingers and release the blunt cannula device from the heparin lock.
The heparin lock of Figure 48 is also useful with a blunt cannula device 475 having an internally threaded shield or sleeve, such as depicted in Figure 50. Figure 50 illustrates the blunt cannula device 475 as it first enters the pre-slit injection site 442 of the heparin lock and prior to engagement with the heparin lock threads 452. The blunt cannula device shown in Figure 50 has a generally cylindrical outer wall 476 and a transverse end wall 478. A blunt cannula 480 extends through the end wall. The blunt cannula may be constructed in generally the same manner as the blunt cannula portion depicted in Figure 46 or in accordance with the other embodiments of the present invention. The cylindrical outer wall 476 preferably extends beyond the tip end of the blunt cannula to protect the cannula against inadvertent touch contamination. The interior surface of the cylindrical wall is preferably threaded at 482 for threadedly engaging the device to which the blunt cannula is attached, such as the heparin lock depicted in Figure 48. As noted above. Figure 50 depicts the blunt cannula device 475 at an initial entry position. Further insertion of the blunt cannula and simultaneous turning of the blunt cannula device results in threaded locking engagement between the blunt cannula device 475 and the heparin lock.
The blunt cannula 480 of the blunt cannula device 475 is in fluid communication with an entry port, generally defined by wall 484, which extends in. the opposite direction of the blunt cannula, from the other side of the transverse wall. The entry port is for attachment to other devices such as syringes, tubing, administration sets or the like, and may take such form as is appropriate for the particular device to which it is attached. The entry port 484 preferably has a tapered inner surface for receiving a standard male luer fitting of a syringe or the like, and may include external threads or flanges 485 for attachment to a luer lock. Another embodiment provides the entry port 484 as having a tapered inner surface for receiving a tubing fit. A fluid passageway 486 extends continuously through the entry port and the cannula portion for flow therebetween. Figure 51 shows, in cross-sectional view, a further alternative device 492 which may employ the pre- slit injection site of the present invention. The pre- slit injection site device 492 depicted in Figure 51 is an in-line device, preferably for adding medication to a fluid stream, removing a sample from a fluid stream, or similar application. The device depicted in Figure 51 has a fluid entry port 494 at one end, a fluid exit port 496 at the other end, and a fluid passageway 498 communicating directly between the entry and exit ports. The inlet and outlet may have such additional features as are useful connecting the injection site device within a fluid flow path. As depicted, the inlet defines a slightly tapered female surface and the outlet defines a similarly female tapered surface which are preferably joined by solvent bonding a similar attachment to plastic tubing of an administration set, extension set or the like. Standard luer fittings or surfaces could also be provided at the inlet or outlet, as desired.
For injecting liquid into the fluid stream or sampling the fluid stream, the device has a side channel 496 which communicates between a pre-slit septum 502 made and assembled in accordance with the present invention, and the fluid passageway 498. The septum 502 is made as described above, and mounted and held in position by a swaged-over wall 504, as previously described, which may include a colored identifier ring around the septum.
In accordance with the present invention, a blunt cannula, such as cannula 506, may be inserted through the pre-slit septum for injecting fluid into the liquid stream flowing between the inlet and outlet, or for taking samples of the fluid stream.
The in-line injection site device 492 shown in Figure 51 may be used in combination with a bare blunt cannula, such as that depicted in Figure 51, or may be used in combination with the blunt cannula device 458, depicted in Figure 49, when a locking relationship between the blunt cannula and injection site is desired. As depicted, for example, in Figure 52, the blunt cannula device 458 may be attached in a secure locking relationship to the in-line injection site 492. As shown there, the in-line injection site has a radially extending shoulder 508 on each side of the housing, for engaging against the retention means 468 on the end of the resilient gripping fingers 460. As with the heparin lock, the in-line injection site also includes a generally tapered surface 510 defined on the exterior surface for spreading the retention means as the blunt cannula is inserted into the injection site. As was described above, insertion of the blunt cannula into the injection site results in the retention means being spread by the tapered surface 510 and, as the blunt cannula is inserted farther, the retention means snap into a locking position behind the radial shoulder 508. In this arrangement, the blunt cannula is securely locked onto the injection site and inadvertent withdrawal is thus prevented. To remove the blunt cannula from the in-line injection site, the gripping ends 470 of the resilient fingers are squeezed, causing spreading of the retention means 468 and release from the injection site. The cannula may then be simply removed by withdrawing it from the injection site.
Figure 53 depicts yet a further embodiment of the present invention. That figure depicts a blunt cannula device 512 embodying the present invention in combination with a syringe 514. The blunt cannula device 512 has a generally cylindrical outer wall 516 which encloses and substantially protects a blunt cannula portion 518. The blunt cannula portion is attached to and extends from an intermediate transverse interior wall 520. The blunt cannula device 512 may be attached to a syringe in various ways. As depicted, however, the syringe 514 has a glass barrel wall which is tightly press fit into one end of the cylindrical outer wall, extending therewithin to the transverse wall 520.
Although various syringes may be used in connection with the blunt cannula device 512 without departing from the present invention, the syringe depicted in Figure 53 is of the type prefilled with a medical liquid such as heparin. Although it does not form a part of the present invention, for purposes of completeness, the syringe depicted in Figure 53 has a pair of resilient pistons 522 spaced apart, with the fluid to be dispensed contained between the pistons. A plunger rod 524 pushes the pistons forward until the forward most piston engages against an entry port 526 which extends in a direction opposite the blunt cannula 518. The forwardmost piston has a frangible portion, which is pierced by the entry port, releasing the liquid contained between the pistons for expulsion through the blunt cannula.
In accordance with the present invention, the blunt cannula portion 518 is substantially protected from inadvertent touch contamination by the outer cylindrical wall 516. To permit the blunt cannula to be used, however, with the in-line injection site 492 or a similar device, a pair of opposed, generally U-shaped recesses 528 are provided in the cylindrical wall for receiving the inlet and outlet portions 494, 496 of the in-line injection site when the cannula is attached to it. This arrangement is depicted in a perspective view in Figure 56. As shown there, the blunt cannula device 512 may be attached to the in-line injection site by inserting the blunt cannula portion into the pre-slit injection site, with the U-shaped recesses 528 receive the inlet and outlet portions 494, 496 of the in-line injection site, thus allowing the bare cannula to be inserted suffi¬ ciently far into the pre-slit injection site.
Figure 54 shows a shield or tip protector 530 for a blunt cannula device of the type shown in Figure 53. The tip protector 530 has a generally cylindrical outer wall 532 with raised ribs 534 for gripping. The cylindrical wall is sized to slip over the end cylindrical wall 514 of the blunt cannula device 512, and is sufficiently long to extend beyond the U-shaped recesses to completely enclose and protect the blunt cannula 518 during shipping, storing and between uses, if so desired.
Concentrically disposed within the cylindrical wall 532, the tip protector has an axially extending, hollow tube 536 for slidably receiving the blunt cannula 518 therewithin. The shield or tip protector 530 would typically be attached to the blunt cannula device 512 during manufacture, and removed when the syringe and blunt cannula device are used. If so desired, it may be reat- tached between uses to protect the cannula from any further contamination.
Figure 55 is an alternative embodiment of the blunt cannula device shown in Figure 53, and is depicted without a syringe attached to it. As shown in Figure 55, the blunt cannula device 538 similarly has a cylindrical outer wall 540, a transverse intermediate inner wall 542, a blunt cannula 544 extending axially from the transverse intermediate wall and an entry port 546 extending in the opposite direction from the blunt cannula. The essential difference between this embodiment and the one shown in Figure 53 is the absence of U-shaped recesses for use with an in-line injection site such as depicted in Figure 56. For ease of attachment to an injection site, the inner surface of the cylindrical wall is preferably tapered at 548. From the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the spirit and scope of the novel concept of the invention. It is to be understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

WHAT IS CLAIMED IS:
1. An injection site usable with a blunt cannula device, said injection site comprising: a housing having a fluid passageway therein and means defining first and second openings within said housing in communication with said passageway; flexible means carried by said housing for sealing said first opening, said means having a resealable opening therein and a curved exterior peripheral surface such that a blunt cannula can be sealingly inserted through said resealable opening and placed in fluid flow communication with said passageway and such that the blunt cannula can be removed therefrom with said flexible means interacting with said housing so as to reseal said resealable opening; and first and second distinct locking means on the exterior of said housing for cooperation with a plurality of blunt cannula devices.
2. An injection site as recited in Claim 1 wherein said housing further includes exterior grasping means for grasping said injection site while inserting or withdrawing a cannula.
3. An injection site as recited in Claim 1 including identification means carried by said housing for identifying said injection site as being usable with a blunt cannula device.
4. An injection site as recited in Claim 3 wherein said identification means comprises visually perceptible indicia.
5. An injection site as recited in Claim 4 wherein said indicia comprises a colored ring circumscribing said flexible means.
6. An injection site as recited in Claim 1 wherein said first locking means includes a substantially radially extending shoulder defined on the exterior surface of said housing.
7. An injection site as recited in Claim 6 wherein said second locking means includes means for threadedly engaging a blunt cannula device.
8. An injection site as recited in Claim 2 wherein said grasping means is generally tapered substantially throughout its length.
9. An injection site as recited in Claim 8 wherein said grasping means tapers curvilinearly.
10. An injection site as recited in Claim 8 wherein said grasping means includes a plurality of radially projecting spline.
11. An injection site usable with a blunt cannula device comprising: a housing having a fluid passageway therein and means defining first and second openings within said housing in communication with said passageway; flexible means carried by said housing for sealing said first opening, said means having a resealable opening therein and a curved exterior peripheral surface such that a blunt cannula can be sealingly inserted through said resealable opening and placed in fluid flow communication with said passageway and such that the blunt cannula can be removed therefrom with said flexible means interacting with said housing so as to reseal said resealable opening; means defining a generally radially extending shoulder on the exterior of said housing for locking engagement with one type of blunt cannula device; means defined on the exterior of said housing for threaded engagement with another type of blunt cannula device; grasping means circumscribing said housing to aid in grasping said injection site while inserting or withdrawing a blunt cannula, said grasping means being tapered substantially throughout its length; and visually perceptible identification means carried by said housing to identify said injection site as being usable with a blunt cannula device, said identification means comprising a colored ring circumscribing said flexible means and being of a color different from said housing.
12. An injection site usable with a blunt cannula device comprising: a housing having an inlet and an outlet and defining a fluid channel therebetween; means defining an access aperture in communication with fluid channel; and flexible means carried by said housing for sealing said access aperture, said means having a resealable opening therein and a curved exterior peripheral surface such that a blunt cannula can be sealingly inserted through said opening and placed in fluid flow communication with said channel and such that the blunt cannula can be removed therefrom with said flexible means interacting with said housing so as to reseal said resealable opening.
13. A blunt-ended cannula device for use with a pre-slit injection site, said cannula device comprising: an elongated member with a fluid flow channel extending generally axially therewithin and through a distal end of said member; said elongated member being generally cylindrical along a substantial portion of its length and terminating in a generally tapered distal end portion having a blunt end edge; and a substantially cylindrical sheath sur¬ rounding said elongated member and being at least coextensive with and spaced apart from said elongated member to protect said member from inadvertent touch contamination.
14. A blunt-ended cannula device as recited in Claim 13 further including means defining at least two slots opposite one another at the distal end of said sheath.
15. A blunt-ended cannula device as recited in Claim 13 further comprising means defining threads on the interior surface of said sheath.
16. A blunt-ended cannula device in accordance with Claim 13 wherein the interior surface of said sheath is outwardly tapered.
17. A cannula device in accordance with Claim 13 further comprising a generally cylindrical wall extending in the opposite direction of said sheath for receiving the end of a syringe or the like.
18. A blunt cannula device for use with a pre- slit injection site comprising: means defining a base portion and an elongated member extending from said base portion, said elongated member having a fluid flow channel defined generally axially therewithin, said elongated member being essentially cylindrical for a substantial portion of the length thereof and terminating in a tapered end portion having a blunt end edge; a plurality of retaining fingers carried by said base portion, each of said retaining fingers having retention means at one end and gripping means at the other end, said fingers being carried by said base portion inter¬ mediate said ends, whereby squeezing of the gripping ends of said fingers spreads of the retention ends of said fingers to allow locking engagement with and release from a pre-slit injection site.
PCT/US1990/001350 1989-03-17 1990-03-16 Pre-slit injection site and tapered cannula WO1990011103A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
DE1990609131 DE69009131T2 (en) 1989-03-17 1990-03-16 PRE-SLIT INJECTION DEVICE AND CONICAL CANNULA.
JP50509590A JPH07110284B2 (en) 1989-03-17 1990-03-16 Injection site
EP19900905119 EP0419620B1 (en) 1989-03-17 1990-03-16 Pre-slit injection site and tapered cannula

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US32561789A 1989-03-17 1989-03-17
US325,617 1989-03-17

Publications (2)

Publication Number Publication Date
WO1990011103A2 true WO1990011103A2 (en) 1990-10-04
WO1990011103A3 WO1990011103A3 (en) 1991-01-10

Family

ID=23268652

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1990/001350 WO1990011103A2 (en) 1989-03-17 1990-03-16 Pre-slit injection site and tapered cannula

Country Status (10)

Country Link
US (5) US6217568B1 (en)
EP (3) EP0541515B1 (en)
JP (5) JPH07110284B2 (en)
AU (5) AU634532B2 (en)
CA (1) CA2027591C (en)
DE (4) DE69019170D1 (en)
ES (3) ES2074909T3 (en)
IE (3) IE62767B1 (en)
MX (1) MX173202B (en)
WO (1) WO1990011103A2 (en)

Cited By (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5098392A (en) * 1991-06-28 1992-03-24 Fleischhacker John J Locking dilator for peel away introducer sheath
US5203775A (en) * 1990-09-18 1993-04-20 Medex, Inc. Needleless connector sample site
US5242393A (en) * 1992-06-18 1993-09-07 Becton, Dickinson And Company Valved blunt cannula injection site
US5251873A (en) * 1992-06-04 1993-10-12 Vernay Laboratories, Inc. Medical coupling site
US5295658A (en) * 1987-04-27 1994-03-22 Vernay Laboratories, Inc. Medical coupling site including slit reinforcing members
US5324256A (en) * 1987-07-31 1994-06-28 Lawrence A. Lynn Apparatus and methods for transferring blood between aspiration assembly and an external container
WO1994022506A2 (en) * 1993-04-02 1994-10-13 Minnesota Mining And Manufacturing Company Apparatus for and method of making an injection or sampling site
US5368574A (en) * 1992-10-01 1994-11-29 Ethicon, Inc. Percutaneous catheter introducer
US5405331A (en) * 1992-07-29 1995-04-11 Minnesota Mining And Manufacturing Company IV injection site and system
US5417673A (en) * 1993-01-13 1995-05-23 Medex, Inc. Whole blood sample needleless sample site
US5441487A (en) * 1993-11-30 1995-08-15 Medex, Inc. Plastic needleless valve housing for standard male luer locks
US5474544A (en) * 1994-05-25 1995-12-12 Lynn; Lawrence A. Luer-receiving medical valve
US5501426A (en) * 1992-06-04 1996-03-26 Vernay Laboratories, Inc. Medical coupling site valve body
US5533708A (en) * 1992-06-04 1996-07-09 Vernay Laboratories, Inc. Medical coupling site valve body
US5549651A (en) * 1994-05-25 1996-08-27 Lynn; Lawrence A. Luer-receiving medical valve and fluid transfer method
US5697915A (en) * 1994-02-15 1997-12-16 Lynn; Lawrence A. Displacement-activated medical check valve
EP0880371A1 (en) * 1995-06-09 1998-12-02 Migada, Inc. Blunt cannula construction for multiple applications
US5899888A (en) * 1988-01-25 1999-05-04 Baxter International Inc. Pre-slit injection site and tapered cannula
US6171287B1 (en) 1998-05-29 2001-01-09 Lawrence A. Lynn Luer receiver and method for fluid transfer
US6394979B1 (en) 2000-06-09 2002-05-28 Inviro Medical Devices Ltd. Cannula for use with a medical syringe
WO2002047756A1 (en) 2000-12-12 2002-06-20 Gambro Dasco S.P.A. Site for access to the inside of a channel, and corresponding cannula
EP1245282A2 (en) * 2001-03-30 2002-10-02 Becton, Dickinson and Company Walled adaptor for use with point-of-care testing kit
WO2003020343A1 (en) * 2001-08-31 2003-03-13 Disetronic Licensing Ag Connecting device for a percutaneously implanted port and port system comprising the connecting device
USRE38145E1 (en) * 1994-05-25 2003-06-17 Lawrence A. Lynn Luer-receiving medical valve
WO2003090815A3 (en) * 2002-04-24 2004-02-05 Becton Dickinson Co Fluid transfer adapter for use with a syringe barrel
US6808161B1 (en) 1999-09-16 2004-10-26 Terumo Kabushiki Kaisha Connector
US6918500B2 (en) 2000-12-04 2005-07-19 Jms Co., Ltd. Plug body for medical fluid container
US6936031B2 (en) 2000-12-12 2005-08-30 Gambro Dasco S.P.A. Site for access to the inside of a channel, and corresponding cannula
USRE39334E1 (en) 1994-05-25 2006-10-10 Lynn Lawrence A Luer-receiving medical valve and fluid transfer method
GB2445437A (en) * 2007-07-06 2008-07-09 Applied Medical Technology Ltd Cannula insertion device
WO2008115244A1 (en) * 2007-03-16 2008-09-25 Smiths Medical Asd, Inc. Blunt cannula for accessing a slit septum
US7947032B2 (en) 2001-12-07 2011-05-24 Becton, Dickinson And Company Needleless luer access connector
ITTO20110481A1 (en) * 2011-06-01 2012-12-02 Borla Ind NEEDLE POINT FOR MEDICAL TUBULAR FITTINGS
US9095500B2 (en) 2007-02-03 2015-08-04 Fresenius Kabi Deutschland GmgH Closure cap for a container for receiving medical liquids, and container for receiving medical liquids
WO2015160522A1 (en) * 2014-04-15 2015-10-22 Advanced Scientifics, Inc. Aseptic connector
WO2016206804A1 (en) * 2015-06-24 2016-12-29 Fresenius Medical Care Deutschland Gmbh Adapter
US9795736B2 (en) 2012-08-01 2017-10-24 Jms Co., Ltd. Infusion set and method for using same

Families Citing this family (217)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5411499A (en) * 1988-01-25 1995-05-02 Baxter International Inc. Needleless vial access device
US5100394A (en) * 1988-01-25 1992-03-31 Baxter International Inc. Pre-slit injection site
US8753317B2 (en) * 1992-05-06 2014-06-17 Cook Medical Technologies Llc Hemostasis cannula
US6663599B2 (en) * 1992-05-06 2003-12-16 Cook Incorporated Hemostasis cannula
US6827705B2 (en) * 1993-03-19 2004-12-07 Venetec International, Inc. Catheter anchoring system
US6162206A (en) 1997-12-23 2000-12-19 Baxter International Inc. Resealable access site
WO2000035367A1 (en) * 1998-12-15 2000-06-22 Mdc Investment Holdings, Inc. Fluid collection device with captured retractable needle
DE60043734D1 (en) 1999-04-20 2010-03-11 Jms Co Ltd CONTAINER CAP FOR TANK AND LIQUID TRANSFER DEVICE
WO2000071196A1 (en) * 1999-05-21 2000-11-30 Micro Therapeutics, Inc. Interface needle and method for creating a blunt interface between delivered liquids
US6450992B1 (en) * 1999-07-02 2002-09-17 Smith & Nephew, Inc. Cannula interface
US6685667B1 (en) 2000-01-11 2004-02-03 C. R. Bard, Inc. Electrically powered surgical irrigator
US20020120231A1 (en) * 2000-01-18 2002-08-29 Douglas Joel S. Subcutaneous injection set with secondary injection septum
US6749589B1 (en) 2000-01-18 2004-06-15 Sterling Medications, Inc. Subcutaneous injection set for use with a reservoir that has a septum
AU2001289310B2 (en) * 2000-04-11 2006-07-06 Boston Scientific Limited Reinforced retention structures
US6488666B1 (en) * 2000-05-23 2002-12-03 Vital Signs, Inc. Apparatus for preventing used hypodermic needle sticks
US6638265B1 (en) * 2000-06-08 2003-10-28 Artin M. Ternamian Laparoscopy cannula adapter and assembly
US6695817B1 (en) 2000-07-11 2004-02-24 Icu Medical, Inc. Medical valve with positive flow characteristics
JP2002087968A (en) * 2000-09-14 2002-03-27 Otsuka Pharmaceut Factory Inc Heparin liquid agent
US7316679B2 (en) * 2001-01-22 2008-01-08 Venetec International, Inc. Medical device connector fitting
WO2002066100A2 (en) * 2001-02-20 2002-08-29 Medrad, Inc. Syringes, connectors, and syringe and connector systems for use in fluid delivery systems
JP4387105B2 (en) * 2001-03-04 2009-12-16 アイシーユー・メディカル・インコーポレーテッド Infusion hub assembly and fluid line cutting system
US20020138046A1 (en) * 2001-03-23 2002-09-26 Douglas Joel S. Adapter for medication cartridges
DK3210637T3 (en) 2001-04-06 2021-04-06 Hoffmann La Roche Infusion set
US6974447B2 (en) * 2001-04-17 2005-12-13 Baxter International Inc. High gas barrier receptacle and closure assembly
AU2002259265B2 (en) * 2001-07-27 2008-06-05 Becton, Dickinson And Company Luer connector assembly
US20070161970A1 (en) 2004-04-16 2007-07-12 Medrad, Inc. Fluid Delivery System, Fluid Path Set, and Pressure Isolation Mechanism with Hemodynamic Pressure Dampening Correction
US8540698B2 (en) * 2004-04-16 2013-09-24 Medrad, Inc. Fluid delivery system including a fluid path set and a check valve connector
US7611503B2 (en) * 2004-04-16 2009-11-03 Medrad, Inc. Fluid delivery system, fluid path set, sterile connector and improved drip chamber and pressure isolation mechanism
JP4568775B2 (en) * 2002-02-25 2010-10-27 株式会社ジェイ・エム・エス Connector structure with connection port member with bulkhead and communication lock connector
DE20209663U1 (en) * 2002-06-21 2003-10-23 Braun Melsungen Ag infusion pump
CA2490358A1 (en) * 2002-06-25 2003-12-31 The Government Of The United States Of America, As Represented By The Se Cretary Of The Department Of Health And Human Services, Centers For Dise Mixing vial
SE523001C2 (en) * 2002-07-09 2004-03-23 Carmel Pharma Ab Coupling component for transmitting medical substances, comprises connecting mechanism for releasable connection to second coupling component having further channel for creating coupling, where connecting mechanism is thread
US6802806B2 (en) 2002-09-23 2004-10-12 Cleveland Clinic Foundation Apparatus for use with an inflow cannula of ventricular assist device
US6851165B2 (en) 2002-09-24 2005-02-08 Siemens Vdo Automotive, Inc. Apparatus for retaining a poppet seal
US8377039B2 (en) 2002-10-04 2013-02-19 Nxstage Medical, Inc. Injection site for male luer or other tubular connector
US7025744B2 (en) * 2002-10-04 2006-04-11 Dsu Medical Corporation Injection site for male luer or other tubular connector
DE10250421A1 (en) * 2002-10-30 2004-05-13 A. Raymond & Cie connecting element
FR2852518A1 (en) * 2003-03-18 2004-09-24 Endos Pharma Connector for assembling syringe equipped with needle and transfer component has truncated conical adapter with axial channel for needle
JP2004305466A (en) * 2003-04-08 2004-11-04 Nipro Corp Medical connector set and catheter set for dwelling using the same
WO2004096113A2 (en) 2003-04-28 2004-11-11 Medical Instill Technologies, Inc. Container with valve assembly for filling and dispensing substances, and apparatus and method for filling
US20050004527A1 (en) * 2003-05-13 2005-01-06 Albert Prescott Apparatus and method for containing and dispensing medical grade sterile viscous substances
US20070073242A1 (en) * 2003-06-17 2007-03-29 Erik Andersen Closure for engaging a surface of a haemostatic valve assembly
AU2003245593B2 (en) * 2003-06-20 2010-06-03 Apollo Endosurgery, Inc. Two-way slit valve
CN1809398B (en) 2003-07-09 2010-06-16 株式会社Jms Mixed injection port
US7169128B2 (en) * 2003-08-04 2007-01-30 Bioquiddity, Inc. Multichannel fluid delivery device
US7220244B2 (en) * 2003-08-04 2007-05-22 Bioquiddity, Inc. Infusion apparatus with constant force spring energy source
US20050033232A1 (en) * 2003-08-05 2005-02-10 Kriesel Marshall S. Infusion apparatus with modulated flow control
US7198620B2 (en) * 2003-11-13 2007-04-03 The United States Of America As Represented By The Secretary Of The Army One stage saline lock and intravenous catheter set and method of use
WO2005056094A1 (en) 2003-11-20 2005-06-23 Nmt Medical, Inc. Air embolization prevention system
US7306586B2 (en) * 2003-12-30 2007-12-11 Opmi Funding Corporation Continuous drainage adaptor
US20050182384A1 (en) * 2004-02-12 2005-08-18 Medtronic Vascular, Inc. Flushing cannula with integral catheter sheath
US20050187532A1 (en) * 2004-02-24 2005-08-25 Medex, Inc. Diaphragm-based reservoir for a closed blood sampling system
US7364571B2 (en) * 2004-03-02 2008-04-29 Schinazi Robert G Flow restrictor device for a medical apparatus
AU2005228826B2 (en) 2004-03-31 2008-05-08 Fisher & Paykel Healthcare Limited A patient ventilating and aspirating system
JP4599875B2 (en) * 2004-04-07 2010-12-15 株式会社ジェイ・エム・エス Syringe with connector, connector used for syringe, and syringe
WO2005099791A1 (en) * 2004-04-07 2005-10-27 Jms Co., Ltd. Syringe with connector, connector for syringe, and syringe
US7390028B2 (en) * 2004-05-12 2008-06-24 Blazek Larry M Medical tubing quick disconnect apparatus
US7470253B2 (en) * 2004-05-26 2008-12-30 Bioquiddity, Inc. Fluid delivery apparatus with adjustable flow rate control
US20050277884A1 (en) * 2004-05-26 2005-12-15 Kriesel Marshall S Fluid delivery apparatus with bellows reservoir
US7220245B2 (en) * 2004-05-26 2007-05-22 Kriesel Marshall S Infusion apparatus
US20050277883A1 (en) * 2004-05-26 2005-12-15 Kriesel Marshall S Fluid delivery device
US20070156090A1 (en) * 2004-05-26 2007-07-05 Kriesel Marshall S Fluid delivery apparatus
US7828773B2 (en) 2005-07-11 2010-11-09 Covidien Ag Safety reset key and needle assembly
US7905857B2 (en) 2005-07-11 2011-03-15 Covidien Ag Needle assembly including obturator with safety reset
US7850650B2 (en) 2005-07-11 2010-12-14 Covidien Ag Needle safety shield with reset
WO2006052655A2 (en) 2004-11-05 2006-05-18 Icu Medical, Inc. Soft-grip medical connector
JP2006164312A (en) * 2004-12-02 2006-06-22 Hitachi Ltd Semiconductor device and magnetic recording and reproducing device using same
US7303543B1 (en) * 2004-12-03 2007-12-04 Medtronic Minimed, Inc. Medication infusion set
US7241285B1 (en) * 2004-12-06 2007-07-10 Medical Ventures, Inc. Medical site connection
DE102004059126B4 (en) * 2004-12-08 2014-01-16 Roche Diagnostics Gmbh Adapter for injection device
US8029468B2 (en) * 2005-02-15 2011-10-04 Bioquiddity, Inc. Fluid delivery and mixing apparatus with flow rate control
US7694938B2 (en) * 2005-02-17 2010-04-13 Bioquiddity, Inc. Distal rate control device
US20080009835A1 (en) * 2005-02-17 2008-01-10 Kriesel Marshall S Fluid dispensing apparatus with flow rate control
US7837653B2 (en) * 2005-02-18 2010-11-23 Bioquiddity, Inc. Fluid delivery apparatus with vial fill
US8585655B2 (en) * 2005-05-23 2013-11-19 Venetec International, Inc. Securement device for I.V. t-connector
US8152767B2 (en) 2005-05-27 2012-04-10 Cook Medical Technologies Llc Low profile introducer apparatus
US20060276747A1 (en) 2005-06-06 2006-12-07 Sherwood Services Ag Needle assembly with removable depth stop
US7731692B2 (en) 2005-07-11 2010-06-08 Covidien Ag Device for shielding a sharp tip of a cannula and method of using the same
US20070055200A1 (en) 2005-08-10 2007-03-08 Gilbert Scott J Needle-free jet injection drug delivery device
US8052649B2 (en) 2005-09-19 2011-11-08 Venetec International, Inc. Medical tubing securement assembly and methods of use
US20070068594A1 (en) * 2005-09-26 2007-03-29 Fischer Dan E Syringe locking structures
US7654735B2 (en) 2005-11-03 2010-02-02 Covidien Ag Electronic thermometer
US20070095941A1 (en) * 2005-11-03 2007-05-03 Gorres Geoffrey H Scent dispensing apparatus
US20070179454A1 (en) * 2006-01-31 2007-08-02 Smiths Medical Asd, Inc. Safety needle assembly with correct medication connection
US7993304B2 (en) * 2006-03-15 2011-08-09 Bioquiddity, Inc. Fluid dispensing apparatus
US7828772B2 (en) * 2006-03-15 2010-11-09 Bioquiddity, Inc. Fluid dispensing device
US8211089B2 (en) * 2006-03-24 2012-07-03 Nexus Medical, Llc Intravenous injection site with split septum and pressure activated flow control valve
US9717834B2 (en) 2011-05-24 2017-08-01 Deka Products Limited Partnership Blood treatment systems and methods
US7794141B2 (en) 2006-04-14 2010-09-14 Deka Products Limited Partnership Thermal and coductivity sensing systems, devices and methods
US10537671B2 (en) 2006-04-14 2020-01-21 Deka Products Limited Partnership Automated control mechanisms in a hemodialysis apparatus
ES2544556T3 (en) 2006-05-25 2015-09-01 Bayer Healthcare Llc Reconstitution device
US7862539B2 (en) * 2006-06-01 2011-01-04 Codan Us Corporation System and method for infusing toxins using safety set, connect set and cyto admin set
US8292848B2 (en) * 2006-07-31 2012-10-23 Bio Quiddity, Inc. Fluid dispensing device with additive
US8057435B2 (en) 2006-07-31 2011-11-15 Kriesel Joshua W Fluid dispenser
JP4994775B2 (en) 2006-10-12 2012-08-08 日本コヴィディエン株式会社 Needle point protector
US8221363B2 (en) 2006-10-18 2012-07-17 Baxter Healthcare S.A. Luer activated device with valve element under tension
US7771412B2 (en) * 2006-10-18 2010-08-10 Insulet Corporation Environmental seal for fluid delivery device
US7981090B2 (en) 2006-10-18 2011-07-19 Baxter International Inc. Luer activated device
US7753338B2 (en) 2006-10-23 2010-07-13 Baxter International Inc. Luer activated device with minimal fluid displacement
MX2009004380A (en) 2006-10-25 2009-05-08 Icu Medical Inc Medical connector.
ITPD20060419A1 (en) * 2006-11-13 2008-05-14 Federico Nalesso DEVICE FOR THE MAINTENANCE TREATMENT OF CENTRAL VENOUS CATHETERS
US7758082B2 (en) * 2006-12-05 2010-07-20 Nxstage Medical, Inc. Fluid line connector safety device
US8002756B2 (en) 2006-12-08 2011-08-23 Becton, Dickinson And Company Method and apparatus for delivering a therapeutic substance through an injection port
US20080200837A1 (en) * 2007-02-15 2008-08-21 Frazier John A Disposable, closed blood sampling system for use in medical conduit line
US20090107335A1 (en) 2007-02-27 2009-04-30 Deka Products Limited Partnership Air trap for a medical infusion device
US8425471B2 (en) 2007-02-27 2013-04-23 Deka Products Limited Partnership Reagent supply for a hemodialysis system
US8491184B2 (en) 2007-02-27 2013-07-23 Deka Products Limited Partnership Sensor apparatus systems, devices and methods
US8317492B2 (en) 2007-02-27 2012-11-27 Deka Products Limited Partnership Pumping cassette
US8042563B2 (en) 2007-02-27 2011-10-25 Deka Products Limited Partnership Cassette system integrated apparatus
KR101861192B1 (en) 2007-02-27 2018-05-28 데카 프로덕츠 리미티드 파트너쉽 Hemodialysis apparatus and methods
US8357298B2 (en) 2007-02-27 2013-01-22 Deka Products Limited Partnership Hemodialysis systems and methods
US8393690B2 (en) 2007-02-27 2013-03-12 Deka Products Limited Partnership Enclosure for a portable hemodialysis system
US8562834B2 (en) 2007-02-27 2013-10-22 Deka Products Limited Partnership Modular assembly for a portable hemodialysis system
US9028691B2 (en) 2007-02-27 2015-05-12 Deka Products Limited Partnership Blood circuit assembly for a hemodialysis system
US8409441B2 (en) 2007-02-27 2013-04-02 Deka Products Limited Partnership Blood treatment systems and methods
US20080243077A1 (en) * 2007-04-02 2008-10-02 Bivin Donald B Fluid dispenser with uniformly collapsible reservoir
US20080303267A1 (en) * 2007-06-05 2008-12-11 Schnell William J Fluid flow connector permitting forceful lateral separation
US8211059B2 (en) * 2007-06-25 2012-07-03 Kriesel Marshall S Fluid dispenser with additive sub-system
US20080319385A1 (en) * 2007-06-25 2008-12-25 Kriesel Marshall S Fluid dispenser with additive sub-system
US9993619B2 (en) 2007-07-17 2018-06-12 C. R. Bard, Inc. Securement system for a medical article
EP2188004A4 (en) * 2007-08-21 2015-06-17 Yukon Medical Llc Vial access and injection system
US8771508B2 (en) * 2008-08-27 2014-07-08 Deka Products Limited Partnership Dialyzer cartridge mounting arrangement for a hemodialysis system
US8357104B2 (en) 2007-11-01 2013-01-22 Coviden Lp Active stylet safety shield
US11833281B2 (en) 2008-01-23 2023-12-05 Deka Products Limited Partnership Pump cassette and methods for use in medical treatment system using a plurality of fluid lines
US10201647B2 (en) 2008-01-23 2019-02-12 Deka Products Limited Partnership Medical treatment system and methods using a plurality of fluid lines
GB0807271D0 (en) * 2008-04-22 2008-05-28 Star Syringe Ltd Syringes
CA2724339C (en) * 2008-05-14 2017-08-01 Biolyph, Llc Reagent preparation and dispensing device and methods for the same
CA2873003C (en) 2008-05-14 2017-06-13 J&J Solutions, Inc. Systems and methods for safe medicament transport
US20100016829A1 (en) * 2008-07-15 2010-01-21 Krumme John F Apparatus and methods for retaining a needle on a medical injector
US7959598B2 (en) 2008-08-20 2011-06-14 Asante Solutions, Inc. Infusion pump systems and methods
WO2010102153A1 (en) 2009-03-04 2010-09-10 C.R. Bard, Inc. Catheter securement device
US8454579B2 (en) 2009-03-25 2013-06-04 Icu Medical, Inc. Medical connector with automatic valves and volume regulator
US8057095B2 (en) * 2009-04-23 2011-11-15 Medtronic, Inc. Multiple use temperature monitor adapter, system and method of using same
US8821505B2 (en) * 2009-04-24 2014-09-02 Kyphon Sarl Minimally invasive cement delivery system retainer
US8394080B2 (en) * 2009-05-14 2013-03-12 Baxter International Inc. Needleless connector with slider
WO2010144957A1 (en) * 2009-06-17 2010-12-23 Unitract Syringe Pty Ltd Syringe adapter
US7955317B2 (en) * 2009-06-30 2011-06-07 Tyco Healthcare Group Lp Female adaptor for feeding line
WO2011044259A1 (en) 2009-10-06 2011-04-14 Venetec International, Inc. Stabilizing device having a locking collet
JP2013507186A (en) 2009-10-06 2013-03-04 ヴェネテック・インターナショナル,インコーポレーテッド Stabilization device with snap clamp
US8585096B2 (en) 2009-10-27 2013-11-19 Nxstage Medical, Inc. Fluid line safety device
MX2012005088A (en) 2009-10-30 2012-10-03 Deka Products Lp Apparatus and method for detecting disconnection of an intravascular access device.
US9205248B2 (en) 2010-02-24 2015-12-08 Becton, Dickinson And Company Safety Drug delivery connectors
US9056163B2 (en) 2010-02-24 2015-06-16 Becton, Dickinson And Company Safety drug delivery system
WO2011109542A1 (en) 2010-03-03 2011-09-09 Venetec International , Inc. Medical article with rotable wings
USD644731S1 (en) 2010-03-23 2011-09-06 Icu Medical, Inc. Medical connector
US8758306B2 (en) 2010-05-17 2014-06-24 Icu Medical, Inc. Medical connectors and methods of use
NZ714715A (en) 2010-05-27 2016-11-25 J&J Solutions Inc Closed fluid transfer system
JP5742120B2 (en) * 2010-06-23 2015-07-01 ニプロ株式会社 Connecting device
EP2588404B1 (en) 2010-06-29 2018-03-28 Biolyph, Llc Reagent preparation assembly
US8465461B2 (en) 2010-07-27 2013-06-18 Becton, Dickinson And Company Blunt needle safety drug delivery system
JP5678510B2 (en) * 2010-08-04 2015-03-04 株式会社ジェイ・エム・エス Medical connector
CN103079964B (en) * 2010-09-17 2015-11-25 美国圣戈班性能塑料公司 Pre-open annular breakseal part and preparation method thereof
JP5697138B2 (en) * 2010-09-27 2015-04-08 株式会社カネカ Stent delivery catheter system
US8919390B2 (en) 2010-11-18 2014-12-30 Biolyph, L.L.C. Reagent preparation and dispensing device
EP2469146B1 (en) * 2010-12-21 2017-08-30 CareFusion Corporation Connector part and fluid connection structure
US9962524B2 (en) 2011-03-11 2018-05-08 Venetec International, Inc. Medical article securement device
WO2012145683A1 (en) 2011-04-21 2012-10-26 Venetec International, Inc. Anchoring system
US8486024B2 (en) 2011-04-27 2013-07-16 Covidien Lp Safety IV catheter assemblies
CA3078889C (en) 2011-05-24 2022-08-30 Deka Products Limited Partnership Hemodialysis system
US9220660B2 (en) * 2011-07-15 2015-12-29 Antares Pharma, Inc. Liquid-transfer adapter beveled spike
US8628497B2 (en) 2011-09-26 2014-01-14 Covidien Lp Safety catheter
EP2760521B1 (en) 2011-09-26 2016-01-06 Covidien LP Safety iv catheter and needle assembly
US8834422B2 (en) 2011-10-14 2014-09-16 Covidien Lp Vascular access assembly and safety device
JP2013117471A (en) * 2011-12-05 2013-06-13 Nipro Corp Sampler
EP2830499B8 (en) 2012-03-30 2019-04-03 Insulet Corporation Fluid delivery device with transcutaneous access tool, insertion mechansim and blood glucose monitoring for use therewith
EP2837403B1 (en) 2012-04-13 2016-09-14 JMS Co., Ltd. Male connector equipped with lock mechanism
JP6094829B2 (en) 2012-04-13 2017-03-15 株式会社ジェイ・エム・エス Male connector with locking mechanism
ES2927466T3 (en) 2012-11-14 2022-11-07 Hollister Inc Urinary catheters that have variable flexibility
EP3603715B1 (en) 2013-03-14 2021-03-03 Fisher & Paykel Healthcare Limited Catheter mount with suction port
US10149940B2 (en) 2013-07-09 2018-12-11 Nipro Corporation Connector for fluid, and syringe
EP3027162B1 (en) 2013-08-02 2018-07-18 J&J Solutions, Inc. D.B.A Corvida Medical Compounding systems and methods for safe medicament transport
EP3079739B1 (en) 2013-12-11 2023-02-22 ICU Medical, Inc. Check valve
GB2523989B (en) 2014-01-30 2020-07-29 Insulet Netherlands B V Therapeutic product delivery system and method of pairing
US10173044B2 (en) * 2014-09-19 2019-01-08 TA Instruments—Waters L.L.C. Locking taper fluid connection interfaces
USD786427S1 (en) 2014-12-03 2017-05-09 Icu Medical, Inc. Fluid manifold
USD793551S1 (en) 2014-12-03 2017-08-01 Icu Medical, Inc. Fluid manifold
EP3258991B1 (en) 2015-02-18 2020-10-21 Insulet Corporation Fluid delivery and infusion devices, and methods of use thereof
IL237788B (en) 2015-03-16 2019-10-31 Kriheli Marino Septum holders for use in syringe connectors
JP6834120B2 (en) * 2015-09-11 2021-02-24 ニプロ株式会社 Medical connector
CA2999123C (en) 2015-09-17 2020-08-25 J&J SOLUTIONS, INC. d/b/a Corvida Medical Medicament vial assembly
EP3362114A4 (en) 2015-10-13 2019-09-25 J&J Solutions, Inc. D.B.A Corvida Medical Automated compounding equipment for closed fluid transfer system
US10413665B2 (en) 2015-11-25 2019-09-17 Insulet Corporation Wearable medication delivery device
JP6719198B2 (en) * 2015-12-11 2020-07-08 株式会社Eviジャパン Fixed structure
US10275573B2 (en) 2016-01-13 2019-04-30 Bigfoot Biomedical, Inc. User interface for diabetes management system
US10780223B2 (en) 2016-01-14 2020-09-22 Bigfoot Biomedical, Inc. Adjusting insulin delivery rates
WO2017136268A1 (en) 2016-02-04 2017-08-10 Insulet Corporation Anti-inflammatory cannula
IL261268B (en) 2016-02-22 2022-07-01 L2R Entpr Llc Microflow restrictor assembly and methods of making the same
JP6825210B2 (en) * 2016-03-02 2021-02-03 株式会社ジェイ・エム・エス Puncture needle connector and connecting tube
EP3216487B1 (en) 2016-03-07 2020-05-06 Fenwal, Inc. System and method for creating sterile connections using ultraviolet light
US11648179B2 (en) 2016-05-16 2023-05-16 Haemonetics Corporation Sealer-less plasma bottle and top for same
EP3461259B1 (en) 2016-05-16 2021-01-06 Haemonetics Corporation Sealer-less plasma bottle and top for same
BR112019003955A2 (en) 2016-08-29 2019-05-21 Allegiance Corporation medical waste fluid receptacle port connector and methods of use
EP3515535A1 (en) 2016-09-23 2019-07-31 Insulet Corporation Fluid delivery device with sensor
HUE058041T2 (en) * 2016-11-01 2022-06-28 Samsung Sdi Co Ltd A male connector for a cooling pipe and a connection system
US11045603B2 (en) 2017-02-22 2021-06-29 Insulet Corporation Needle insertion mechanisms for drug containers
WO2018173925A1 (en) * 2017-03-22 2018-09-27 テルモ株式会社 Female syringe and syringe kit
US10898656B2 (en) 2017-09-26 2021-01-26 Insulet Corporation Needle mechanism module for drug delivery device
US11147931B2 (en) 2017-11-17 2021-10-19 Insulet Corporation Drug delivery device with air and backflow elimination
US11389596B2 (en) * 2018-01-12 2022-07-19 Becton, Dickinson And Company Smart vial adapter and method
US10576211B2 (en) 2018-01-12 2020-03-03 Becton, Dickinson And Company Medication dispensing system
WO2019213493A1 (en) 2018-05-04 2019-11-07 Insulet Corporation Safety constraints for a control algorithm-based drug delivery system
EP3796884A4 (en) * 2018-05-22 2022-03-09 Haemonetics Corporation Sealer-less plasma bottle and top for same
CN112789070A (en) 2018-09-28 2021-05-11 英赛罗公司 Mode of activity of the artificial pancreas System
EP3864668A1 (en) 2018-10-11 2021-08-18 Insulet Corporation Event detection for drug delivery system
GB201907070D0 (en) 2019-05-20 2019-07-03 Metis Design Bv Connector for a gastrostomy device
US11801344B2 (en) 2019-09-13 2023-10-31 Insulet Corporation Blood glucose rate of change modulation of meal and correction insulin bolus quantity
US11833329B2 (en) 2019-12-20 2023-12-05 Insulet Corporation Techniques for improved automatic drug delivery performance using delivery tendencies from past delivery history and use patterns
US11551802B2 (en) 2020-02-11 2023-01-10 Insulet Corporation Early meal detection and calorie intake detection
US11547800B2 (en) 2020-02-12 2023-01-10 Insulet Corporation User parameter dependent cost function for personalized reduction of hypoglycemia and/or hyperglycemia in a closed loop artificial pancreas system
US11324889B2 (en) 2020-02-14 2022-05-10 Insulet Corporation Compensation for missing readings from a glucose monitor in an automated insulin delivery system
US11607493B2 (en) 2020-04-06 2023-03-21 Insulet Corporation Initial total daily insulin setting for user onboarding
US11684716B2 (en) 2020-07-31 2023-06-27 Insulet Corporation Techniques to reduce risk of occlusions in drug delivery systems
CA3198353A1 (en) 2020-10-09 2022-04-14 Icu Medical, Inc. Fluid transfer device and method of use for same
US11904140B2 (en) 2021-03-10 2024-02-20 Insulet Corporation Adaptable asymmetric medicament cost component in a control system for medicament delivery
WO2023018926A1 (en) * 2021-08-12 2023-02-16 Becton, Dickinson And Company Syringe adapter with needle hub
US11738144B2 (en) 2021-09-27 2023-08-29 Insulet Corporation Techniques enabling adaptation of parameters in aid systems by user input
US11439754B1 (en) 2021-12-01 2022-09-13 Insulet Corporation Optimizing embedded formulations for drug delivery

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3986508A (en) * 1973-08-22 1976-10-19 Abcor, Inc. Sterilizable, medical connector for blood processing
US4150673A (en) * 1977-02-03 1979-04-24 Pharmachem Corporation Coded entry system for blood bag
EP0114677A2 (en) * 1983-01-24 1984-08-01 ICU Medical, Inc. Medical connector system
DE8425197U1 (en) * 1984-08-25 1985-09-19 Magasi, Josef, 6902 Sandhausen Self-sterile coupling for fluids to be supplied to the human or animal organism, in particular for hyperosmolar peritoneal dialysis fluids
EP0169704A1 (en) * 1984-07-21 1986-01-29 H.G. Wallace Limited Intravascular device including a clip for use in preventing needle retraction
WO1986001487A1 (en) * 1984-08-21 1986-03-13 Baxter Travenol Laboratories, Inc. Reconstitution device
EP0220911A2 (en) * 1985-10-22 1987-05-06 Minntech Corporation Peritoneal device system
US4804366A (en) * 1987-10-29 1989-02-14 Baxter International Inc. Cartridge and adapter for introducing a beneficial agent into an intravenous delivery system
WO1989006553A2 (en) * 1988-01-25 1989-07-27 Baxter International Inc. Pre-slit injection site and tapered cannula

Family Cites Families (266)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1180665A (en) 1915-11-29 1916-04-25 Randall Faichney Company Inc Closure or stopper for serum-containers, &c.
DE441387C (en) 1925-03-23 1927-03-07 Achille Francois Raymond Rotary knob, especially for closing the tops of motor vehicles
US2102704A (en) 1935-06-10 1937-12-21 George N Hein Syringe cartridge
US2183900A (en) 1938-01-10 1939-12-19 William J Voit Inflation valve
US2325929A (en) 1939-06-28 1943-08-03 American Flange & Mfg Die mechanism and method
US2579724A (en) 1946-04-15 1951-12-25 Breakstone Seymour Valved closure plug for insertion in the neck of a bottle
US2436291A (en) 1946-06-25 1948-02-17 Lewis H Daniel Self-sealing closure for containers
US2577780A (en) 1950-05-09 1951-12-11 Compule Corp Crowned cupped resilient plug for cylindrical passages
US2546672A (en) 1947-07-25 1951-03-27 Tecalemit Ltd Nipple or lubricant-receiving device
US2579725A (en) 1950-02-10 1951-12-25 Bradford Novelty Co Inc Illuminated figure with reflector
US2908274A (en) 1953-06-29 1959-10-13 Abbott Lab Closure
US2989053A (en) * 1956-01-17 1961-06-20 Baxter Don Inc Hypodermic needle
US2912980A (en) 1956-06-13 1959-11-17 Cutter Lab Blood strainer
CA655407A (en) 1956-06-15 1963-01-08 Firma B. Braun Container for biological liquids
FR1171578A (en) 1957-02-08 1959-01-28 Improvements in blood transfusion and perfusion equipment
US3057350A (en) 1958-06-27 1962-10-09 Baxter Don Inc Administration set
GB894653A (en) 1958-10-13 1962-04-26 Cook Waite Lab Inc Needle assembly
US2998635A (en) 1959-01-22 1961-09-05 Oscar C Rixson Co Method of making roller bearings
US3055363A (en) * 1959-11-18 1962-09-25 Becton Dickinson Co Hypodermic syringe barrel assembly
US3064652A (en) 1960-02-11 1962-11-20 Baxter Don Inc Transfusion equipment
FR1373027A (en) 1963-05-22 1964-09-25 Improved device for opening a container or a sealed conduit, in particular for perfusion and blood transfusion
US3233727A (en) 1963-09-13 1966-02-08 Karl H Wilson Multiple use packaging container
US3245698A (en) 1963-11-04 1966-04-12 Westinghouse Electric Corp Latching means
US3313299A (en) 1964-02-05 1967-04-11 Richard G Spademan Intravascular catheter with coaxial puncturing means
US3332418A (en) 1964-05-28 1967-07-25 Baxter Don Inc Injection site for venoclysis apparatus
GB1078650A (en) 1964-09-01 1967-08-09 Eschmann Bros & Walsh Ltd Surgical or veterinary tubing containing a flow control valve
US3378008A (en) 1965-07-23 1968-04-16 Min I Jet Corp Hypodermic syringe with vial
US3394954A (en) 1966-05-06 1968-07-30 Sarns Inc Tube coupling for medical appliances
US3577992A (en) 1967-08-31 1971-05-11 Brunswick Corp Valve for use with a conduit having a lumen
US3478743A (en) 1967-09-20 1969-11-18 Elliot Lab Inc Closed urinary drainage system
US3447570A (en) 1967-11-01 1969-06-03 Robert M Collins Puncture pad and holder
US3598124A (en) 1968-02-01 1971-08-10 Andersen Prod H W Drainage control
DE1773331A1 (en) 1968-05-02 1972-01-27 Eppendorf Geraetebau Netheler Reaction vessel for small amounts of liquid
US3604420A (en) 1969-01-21 1971-09-14 Bard Inc C R Closed system drainage design
GB1277377A (en) 1969-02-03 1972-06-14 Bard Inc C R Fluid supply means for catheters
FR2049513A5 (en) * 1969-06-12 1971-03-26 Monsallier Julien Blood sampler for external circulations
BE755165A (en) 1969-08-23 1971-02-22 Philips Nv ELASTICALLY DEFORMABLE PLUG FOR INJECTION SYRINGE
US3602009A (en) 1969-09-25 1971-08-31 Stewart Warner Corp Snap on ferrule
US3848593A (en) 1970-10-09 1974-11-19 Affiliated Hospital Prod Side loading disposable carpule syringe
JPS509195Y1 (en) * 1970-12-10 1975-03-19
US3741217A (en) 1971-08-17 1973-06-26 Kendall & Co Retractable closure cap
US3770155A (en) 1971-10-19 1973-11-06 New England Nuclear Corp Dually sealable, non-leaking vial for shipping radioactive materials
BE789972A (en) 1971-10-20 1973-02-01 Baxter Laboratories Inc OPENING OF ACCESS, SUITABLE TO BE PIERCED, FOR CONTAINERS INTENDED TO SERVE FOR PARENTERAL SOLUTIONS
BE790246A (en) 1971-11-26 1973-02-15 American Hospital Supply Corp MEDICINAL LIQUID ADMINISTRATION DEVICE IN FLOW AND VOLUMETRIC REGIMES
US3729032A (en) 1971-12-06 1973-04-24 Mpl Inc Liquid dispenser and method and apparatus for filling same
US3729031A (en) 1971-12-06 1973-04-24 Mpl Inc Liquid dispenser and plunger and method and apparatus for filling same
BE794248A (en) 1972-02-22 1973-05-16 Baxter Laboratories Inc IMPROVEMENTS TO STERILE CLOSURES FOR SOLUTION BOTTLES OR VIALS
US3768473A (en) 1972-03-24 1973-10-30 W Shields Syringe diaphragm with ballooning dome
US3823840A (en) 1972-08-04 1974-07-16 Silver J Prepunctured closure
US3837381A (en) 1972-12-26 1974-09-24 Prod Adex Sa Shuttoff valve device
US3851647A (en) 1973-03-07 1974-12-03 Bard Inc C R Intravenous catheter introduction assembly
US3853127A (en) 1973-04-03 1974-12-10 R Spademan Elastic sealing member
FR2256768B1 (en) 1974-01-03 1976-11-26 Rhone Poulenc Ind
US3900028A (en) 1974-02-26 1975-08-19 American Hospital Supply Corp Injection site for sterile medical liquid container
AR205565A1 (en) 1974-04-29 1976-05-14 Abbott Lab STORAGE AND TRANSFER UNIT FOR AN ADDITIVE PARTICULARLY APPLICABLE TO TRANSFER OF MEDICINES
US3976073A (en) 1974-05-01 1976-08-24 Baxter Laboratories, Inc. Vial and syringe connector assembly
FR2269970A1 (en) 1974-05-07 1975-12-05 Crinospital Spa
US4000740A (en) 1974-05-31 1977-01-04 Baxter Travenol Laboratories, Inc. Injection site
NL173477C (en) 1974-09-12 1984-02-01 Duphar Int Res INJECTION SYRINGE WITH TELESCOPIC BODY BETWEEN CARTRIDGE AND MEDICINE BOTTLE.
US3977400A (en) 1974-11-29 1976-08-31 Deseret Pharmaceutical Co., Inc. Catheter placement unit with resilient sleeve and manual sleeve closure
US3990445A (en) 1975-01-03 1976-11-09 Valleylab, Inc. Drug injection device
JPS551628Y2 (en) * 1975-04-24 1980-01-17
US4000739A (en) 1975-07-09 1977-01-04 Cordis Corporation Hemostasis cannula
US4076285A (en) * 1975-08-01 1978-02-28 Erika, Inc. Laminar flow connector for conduits
US4048995A (en) 1975-08-15 1977-09-20 Baxter Travenol Laboratories, Inc. Injection site
US4130932A (en) 1975-11-11 1978-12-26 Arkla Industries, Inc. Method of joining a tube to a plate
US4048996A (en) 1976-06-14 1977-09-20 Baxter Travenol Laboratories, Inc. Dual injection site
US4066556A (en) 1976-10-28 1978-01-03 Johnson & Johnson Fluid filter and method of making same
SE413345B (en) * 1977-03-07 1980-05-19 Gambro Ab DEVICE INTENDED FOR INJECTION AND / OR SAMPLING THROUGH AN ELASTIC WALL
US4192919A (en) * 1977-05-17 1980-03-11 Mpl, Inc. Blood sampling and culturing kit
US4134512A (en) 1977-06-08 1979-01-16 Becton, Dickinson And Company One-way evacuated tube stopper
US4127131A (en) 1977-06-20 1978-11-28 Johnson & Johnson Hub assembly for use in the filtration of fluids and method of making the same
GB1580924A (en) 1977-06-24 1980-12-10 Smiths Industries Ltd Methods of hole-forming in plastics workpieces and products manufactured using such methods
US4143853A (en) 1977-07-14 1979-03-13 Metatech Corporation Valve for use with a catheter or the like
US4123081A (en) 1977-07-22 1978-10-31 Dee, Inc. Beet harvester hitch
GB1588362A (en) 1977-10-07 1981-04-23 Wallace Ltd H G Catheters
US4123091A (en) * 1977-11-21 1978-10-31 Renal Systems, Inc. Tube connector
US4197848A (en) 1978-01-06 1980-04-15 Baxter Travenol Laboratories, Inc. Closed urinary irrigation site
US4177814A (en) 1978-01-18 1979-12-11 KLI, Incorporated Self-sealing cannula
US4243150A (en) 1978-01-23 1981-01-06 Siemens Aktiengesellschaft Bottle seal
US4133441A (en) 1978-03-23 1979-01-09 Baxter Travenol Laboratories, Inc. Injection site
US4405316A (en) 1978-04-03 1983-09-20 Baxter Travenol Laboratories, Inc. Injection site with check valve inlet
DE2817102C2 (en) 1978-04-19 1985-01-24 Dr. Eduard Fresenius, Chemisch-pharmazeutische Industrie KG, 6380 Bad Homburg Connector for plastic cannulas or venous catheters
US4205675A (en) 1978-06-15 1980-06-03 Johnson & Johnson Catheter placement unit with needle removal provision and method of use
US4276170A (en) 1978-08-16 1981-06-30 Critikon, Inc. Vented flexible filtration device for use in administering parenteral liquids
US4219912A (en) 1978-10-10 1980-09-02 Baxter Travenol Laboratories, Inc. Injection site having thermoplastically sealed injection port
SE414272B (en) 1978-10-17 1980-07-21 Viggo Ab CANNEL OR CATETER DEVICE
US4246899A (en) 1978-10-23 1981-01-27 Loseff Herbert S Drainage system for a collection of body fluids
US4346703A (en) * 1979-01-23 1982-08-31 Baxter Travenol Laboratories, Inc. Solution container for continuous ambulatory peritoneal dialysis
US4232669A (en) 1979-02-15 1980-11-11 Bristol Myers Co. Protective sheath for syringe needle
US4277226A (en) 1979-03-09 1981-07-07 Avi, Inc. IV Pump with empty supply reservoir and occlusion detector
US4322201A (en) 1979-03-09 1982-03-30 Avi, Inc. IV Pump with back pressure control
US4236880A (en) 1979-03-09 1980-12-02 Archibald Development Labs, Inc. Nonpulsating IV pump and disposable pump chamber
US4362156A (en) 1979-04-18 1982-12-07 Riverain Corporation Intravenous infusion assembly
US4334551A (en) 1979-04-30 1982-06-15 Becton Dickinson & Company Connector
DE7918241U1 (en) * 1979-06-26 1980-12-11 B. Braun Melsungen Ag, 3508 Melsungen DRIP CHAMBER WITH IMPROVED SEAT RESISTANCE OF THE DRIP CHAMBER SPIN
US4296949A (en) * 1979-08-06 1981-10-27 Abbott Laboratories Rotatable connecting device for I.V. administration set
GB2058248B (en) 1979-09-12 1982-09-22 Butterworth System Inc Sealing arrangement
US4294249A (en) 1979-10-18 1981-10-13 Cutter Laboratories, Inc. Swage-molded injection site
FR2468400A1 (en) 1979-11-01 1981-05-08 Baxter Travenol Lab METHOD AND DEVICE FOR MIXING HYPERNUTRIENT SOLUTIONS
US4289129A (en) 1979-11-01 1981-09-15 Turner Roger S Injection site apparatus
CA1171030A (en) 1979-11-05 1984-07-17 David Bellamy Fluid transfer assembly
US4496348A (en) 1979-11-29 1985-01-29 Abbott Laboratories Venipuncture device
US4294250A (en) * 1979-12-07 1981-10-13 Baxter Travenol Laboratories, Inc. Luer lock connection device
GB2067075B (en) 1980-01-11 1983-11-23 Fresenius Chem Pharm Ind Connector for connecting cannulae catheters flexible tubes or the like
US4303067A (en) 1980-01-21 1981-12-01 American Hospital Supply Corporation Medical liquid bag having an improved additive port
US4326569A (en) 1980-02-15 1982-04-27 Critikon, Inc. Stopcock seal
AU540623B2 (en) 1980-04-08 1984-11-29 Minntech Corporation Implantable blood access tee
US4776843A (en) 1980-11-21 1988-10-11 Minntech Corporation Blood access systems
US4311137A (en) 1980-04-30 1982-01-19 Sherwood Medical Industries Inc. Infusion device
US4810241A (en) 1980-06-09 1989-03-07 Rogers Phillip P Ambulatory dialysis system and connector
US4439188A (en) 1980-09-15 1984-03-27 Baxter Travenol Laboratories, Inc. Tube connector
AU7485681A (en) * 1980-10-22 1982-04-29 Travenol European Research And Development Centre Spike connector
US4411661A (en) 1980-10-22 1983-10-25 Travenol European Research And Development Centre Spike connector
US4430081A (en) 1981-01-06 1984-02-07 Cook, Inc. Hemostasis sheath
US4436519A (en) 1981-05-28 1984-03-13 Argon Medical Corp. Removable hemostasis valve
US4624393A (en) 1981-07-02 1986-11-25 Survival Technology, Inc. Split hub assembly for a necked down cartridge tube
US4424833A (en) 1981-10-02 1984-01-10 C. R. Bard, Inc. Self sealing gasket assembly
US4417888A (en) 1982-03-15 1983-11-29 Renal Systems, Inc. Percutaneous implant
US4416661A (en) 1981-12-24 1983-11-22 Cutter Laboratories, Inc. Injection site for fluids
US4412573A (en) * 1981-12-28 1983-11-01 Baxter Travenol Laboratories, Inc. Injection site
US4405320A (en) 1982-02-22 1983-09-20 Renal Systems, Inc. Septum retaining means for percutaneous device
US4445896A (en) 1982-03-18 1984-05-01 Cook, Inc. Catheter plug
US4411662A (en) 1982-04-06 1983-10-25 Baxter Travenol Laboratories, Inc. Sterile coupling
US4475548A (en) 1982-06-01 1984-10-09 Rudolph Muto Fitting for endotracheal tube apparatus and method of making the fitting
US4823833A (en) 1982-06-24 1989-04-25 Baxter Healthcare Corporation Fluid communication device
US4545367A (en) 1982-07-16 1985-10-08 Cordis Corporation Detachable balloon catheter and method of use
US4452473A (en) * 1982-07-26 1984-06-05 Baxter Travenol Laboratories, Inc. Luer connection system
US4511359A (en) * 1982-09-29 1985-04-16 Manresa, Inc. Sterile connection device
FR2536283A1 (en) 1982-11-19 1984-05-25 Bruneau & Cie Lab FIT FOR EXTEMPORANEOUS INJECTIONS
DE8235862U1 (en) * 1982-12-21 1983-06-16 B. Braun Melsungen Ag, 3508 Melsungen INJECTION DEVICE FOR AN INFUSION OR TRANSFUSION SYSTEM
US4610665A (en) 1983-01-18 1986-09-09 Terumo Kabushiki Kaisha Medical instrument
US5344414A (en) * 1983-01-24 1994-09-06 Icu Medical Inc. Medical connector
JPS59141954A (en) * 1983-01-24 1984-08-14 ジヨージ・エイ・ロペツ Medical connector system
US4752292A (en) * 1983-01-24 1988-06-21 Icu Medical, Inc. Medical connector
US5199947A (en) 1983-01-24 1993-04-06 Icu Medical, Inc. Method of locking an influent line to a piggyback connector
NL8300386A (en) * 1983-02-02 1984-09-03 Steritech Bv STERILE DEVICE CONNECTING TWO ROOMS.
DE3303718C1 (en) * 1983-02-04 1984-10-04 B. Braun Melsungen Ag, 3508 Melsungen Injection valve for puncture implements or infusion devices
EP0165926B1 (en) 1983-05-20 1990-10-24 Bengt Gustavsson A device for transferring a substance
DE3477543D1 (en) 1983-09-02 1989-05-11 Minntech Corp Implantable parenteral hyperalimentation catheter system
US4496046A (en) 1983-09-15 1985-01-29 Baxter Travenol Laboratories, Inc. Multiple chamber container with inner diaphragm and intermediate chamber
DE3469560D1 (en) * 1983-10-05 1988-04-07 Lubrizol Corp Manganese and copper containing compositions
US4655752A (en) 1983-10-24 1987-04-07 Acufex Microsurgical, Inc. Surgical cannula
US4589879A (en) 1983-11-04 1986-05-20 Baxter Travenol Laboratories, Inc. Cannula assembly having closed, pressure-removable piercing tip
US4607868A (en) * 1983-11-30 1986-08-26 Baxter Travenol Laboratories, Inc. Universal connector
DE8402311U1 (en) 1984-01-27 1984-04-19 B. Braun Melsungen Ag, 3508 Melsungen INJECTION DEVICE FOR AN INFUSION OR TRANSFUSION SYSTEM
JPS60129941U (en) * 1984-02-09 1985-08-31 テルモ株式会社 medical equipment
US4638809A (en) 1984-03-22 1987-01-27 Kuperus John H Method of preparing radionuclide doses
DE8410069U1 (en) 1984-03-31 1984-06-28 B. Braun Melsungen Ag, 3508 Melsungen CONNECTING DEVICE
US4634424A (en) 1984-04-23 1987-01-06 Windsor Medical, Inc. Multiple re-entry implantable septum and method of using same
US4535820A (en) 1984-05-24 1985-08-20 Burron Medical Inc. Normally closed check valve
US4588403A (en) 1984-06-01 1986-05-13 American Hospital Supply Corporation Vented syringe adapter assembly
US4704177A (en) 1984-07-06 1987-11-03 Manresa, Inc. Medicator securing device
JPS6171065A (en) 1984-09-13 1986-04-11 テルモ株式会社 Catheter introducer
US4578063A (en) 1984-09-14 1986-03-25 W. L. Gore & Assoc., Inc. Central venous catheter
US4759756A (en) 1984-09-14 1988-07-26 Baxter Travenol Laboratories, Inc. Reconstitution device
US4653010A (en) 1984-10-26 1987-03-24 Baxter Travenol Laboratories, Inc. Compounding system
US4559043A (en) 1984-10-29 1985-12-17 Drs Infusion Systems, Inc. Assembly with septum fitting for connecting adaptor and fluid tube
US4610374A (en) 1984-10-29 1986-09-09 Dougherty Brothers Company Apparatus for mixing flowable materials in sealed containers
US4889256A (en) 1984-11-13 1989-12-26 Baxter International Inc. Port and elastic closure
US4673389A (en) 1984-11-29 1987-06-16 Minnesota Mining And Manufacturing Company Sequence valve for piggyback IV administration
US4705506A (en) 1984-11-29 1987-11-10 Minnesota Mining And Manufacturing Company Multiple solution IV system with setup error protection
US4673390A (en) 1984-11-29 1987-06-16 Minnesota Mining & Manufacturing Company Multiple solution IV system
US4714463A (en) 1984-11-29 1987-12-22 Minnesota Mining And Manufacturing Company Sequence valve for piggyback IV administration with tube reversal prevention
JPS61154679A (en) 1984-12-28 1986-07-14 テルモ株式会社 Medical instrument
DE3513205C1 (en) 1985-04-12 1987-01-15 Fresenius Ag Connector for peritoneal dialysis
DE3513204A1 (en) 1985-04-12 1986-10-16 Fresenius AG, 6380 Bad Homburg DOUBLE BAG SYSTEM FOR PERITONEAL DIALYSIS AND CONNECTOR HERE
US4645495A (en) 1985-06-26 1987-02-24 Vaillancourt Vincent L Vascular access implant needle patch
JPS624143A (en) * 1985-06-28 1987-01-10 Oki Electric Ind Co Ltd Cash disposing device at cage
US4650475A (en) 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
IT1185857B (en) * 1985-08-02 1987-11-18 Erba Farmitalia DEVICE FOR CONNECTING AN END OF A LIQUID DRUG DISPENSE TO A DEVICE FOR CONNECTING A SYRINGE TO A BOTTLE CONTAINING THE DRUG
CA1268917A (en) 1985-08-02 1990-05-15 Takayoshi Murakami Rubber or plastic coated roller, method and apparatus for production thereof
US4626245A (en) 1985-08-30 1986-12-02 Cordis Corporation Hemostatis valve comprising an elastomeric partition having opposed intersecting slits
US4675020A (en) 1985-10-09 1987-06-23 Kendall Mcgaw Laboratories, Inc. Connector
US4617012A (en) 1985-10-29 1986-10-14 Manresa, Inc. Sterile connector with movable connection member
US4711636A (en) 1985-11-08 1987-12-08 Bierman Steven F Catheterization system
GB8527646D0 (en) 1985-11-08 1985-12-11 Cox J A Devices for sampling drainage
US4662878A (en) 1985-11-13 1987-05-05 Patents Unlimited Ltd. Medicine vial adaptor for needleless injector
US4655750A (en) 1985-11-22 1987-04-07 Manresa, Inc. Closed system catheter with guide wire
DD243858A1 (en) 1985-12-06 1987-03-18 Medizin Labortechnik Veb K INJECTION VALVE
US4795446A (en) 1986-01-30 1989-01-03 Sherwood Medical Company Medical tube device
US4834152A (en) 1986-02-27 1989-05-30 Intelligent Medicine, Inc. Storage receptacle sealing and transfer apparatus
US4673386A (en) 1986-03-06 1987-06-16 Gordon Mark G Blood sampler device
US4834709A (en) 1986-03-26 1989-05-30 Sherwood Medical Company Preformable catheter
US4735311A (en) 1986-04-09 1988-04-05 The West Company Needle shield assembly
US4813937A (en) 1986-05-07 1989-03-21 Vaillancourt Vincent L Ambulatory disposable infusion delivery system
US4718467A (en) 1986-05-30 1988-01-12 Baxter Travenol Laboratories, Inc. Pumping module arrangement and manifold
JPS6320554A (en) * 1986-07-14 1988-01-28 Nec Corp Memory error detecting and correcting circuit
US4765588A (en) 1986-08-18 1988-08-23 Vernay Laboratories, Inc. Check valve for use with a syringe
US4760847A (en) 1986-08-18 1988-08-02 Vincent Vaillancourt Depth measuring device
US4763648A (en) * 1986-09-12 1988-08-16 Migada, Inc. Method and apparatus for arterial and venous blood sampling
US4683916A (en) 1986-09-25 1987-08-04 Burron Medical Inc. Normally closed automatic reflux valve
US4796615A (en) 1986-10-16 1989-01-10 Baxter Travenol Laboratories, Inc. Connector for esophageal probe
US4723550A (en) 1986-11-10 1988-02-09 Cordis Corporation Leakproof hemostasis valve with single valve member
US4809679A (en) 1986-11-19 1989-03-07 Olympus Optical Co., Ltd. Forceps plug for endoscopes
GB8627808D0 (en) * 1986-11-20 1986-12-17 Cox J A Sampling liquids from human/animal body
US4936832A (en) 1986-11-24 1990-06-26 Vaillancourt Vincent L Ambulatory disposable infusion delivery system
US4789014A (en) 1986-12-05 1988-12-06 Baxter International Inc. Automated system for adding multiple fluids to a single container
US4886495A (en) 1987-07-08 1989-12-12 Duoject Medical Systems Inc. Vial-based prefilled syringe system for one or two component medicaments
US4781680A (en) 1987-03-02 1988-11-01 Vir Engineering Resealable injection site
US4850970A (en) 1987-03-26 1989-07-25 American Home Products, Corp. Two part mastitis cannula cap
US4768568A (en) 1987-07-07 1988-09-06 Survival Technology, Inc. Hazardous material vial apparatus providing expansible sealed and filter vented chambers
US4842587A (en) * 1987-07-15 1989-06-27 Poncy George W No-prick hypodermic syringe
US4834716A (en) * 1987-07-17 1989-05-30 Ims, Limited Protected cannula
US4826491A (en) 1987-07-27 1989-05-02 Schramm James J Needle bearing medical device with three-position shield
US4874369A (en) 1987-07-27 1989-10-17 Baxter International Inc. Self-priming injection site with check valve
US4789281A (en) * 1987-07-30 1988-12-06 Autohaul Industries, Inc. Automobile hauling trailer
US5324256A (en) 1987-07-31 1994-06-28 Lawrence A. Lynn Apparatus and methods for transferring blood between aspiration assembly and an external container
US4838855A (en) 1987-07-31 1989-06-13 Lynn Lawrence A Blood aspiration assembly and method
US5178607A (en) 1987-07-31 1993-01-12 Lynn Lawrence A Blood aspiration assembly septum and blunt needle aspirator
US4840017A (en) 1987-08-03 1989-06-20 Baxter Healthcare Corporation Method for filling collapsible containers
US4966586A (en) 1987-09-04 1990-10-30 Vaillancourt Vincent L Closed system over-the-needle I.V. catheter
US4798594A (en) 1987-09-21 1989-01-17 Cordis Corporation Medical instrument valve
US4822343A (en) 1987-09-21 1989-04-18 Louise Beiser Blood collection device with ejectable tips
US4895565A (en) 1987-09-21 1990-01-23 Cordis Corporation Medical instrument valve
US4850978A (en) 1987-10-29 1989-07-25 Baxter International Inc. Drug delivery cartridge with protective cover
DE8714659U1 (en) 1987-11-04 1987-12-10 Clinico Infusionstechnik Gmbh & Co Medizinische Kunststoffprodukte Kg, 6430 Bad Hersfeld, De
US4909798A (en) 1987-11-12 1990-03-20 Daig Corporation Universal hemostasis cannula
EP0319764B1 (en) 1987-12-07 1995-08-30 Nissho Corporation Connector with injection site
US4842591A (en) 1988-01-21 1989-06-27 Luther Ronald B Connector with one-way septum valve, and assembly
US5100394A (en) 1988-01-25 1992-03-31 Baxter International Inc. Pre-slit injection site
CA1335167C (en) * 1988-01-25 1995-04-11 Steven C. Jepson Pre-slit injection site and associated cannula
AU649832B2 (en) * 1988-01-25 1994-06-02 Baxter International Inc. Cannula insertion member
US5211638A (en) 1988-01-25 1993-05-18 Baxter International Inc. Pre-slit injection site
US5135489A (en) 1988-01-25 1992-08-04 Baxter International Inc. Pre-slit injection site and tapered cannula
US4915690A (en) 1988-02-02 1990-04-10 C. R. Bard, Inc. Micro-injection port
US5059186A (en) 1988-03-07 1991-10-22 Vitaphore Corporation Percutaneous access device
US4857062A (en) 1988-03-09 1989-08-15 Medical Parameters, Inc. Catheter introducer valve
US4932944A (en) 1988-03-09 1990-06-12 The University Of Virginia Alumni Patents Foundation Intravenous port injection and connector system
US4981469A (en) 1988-04-18 1991-01-01 Dij Catheter Corp. Septum adapter assembly and external needle adapter fitting
SU1625650A1 (en) 1988-04-20 1991-02-07 Волжское объединение по производству легковых автомобилей Method of sealed fixing of holes of tubular end elements
US4895346A (en) 1988-05-02 1990-01-23 The Kendall Company Valve assembly
US5009391A (en) 1988-05-02 1991-04-23 The Kendall Company Valve assembly
US4874377A (en) 1988-05-26 1989-10-17 Davis Newgard Revocable Family Living Trust Self-occluding intravascular cannula assembly
US4874378A (en) 1988-06-01 1989-10-17 Cordis Corporation Catheter sheath introducer
CA1336060C (en) 1988-06-02 1995-06-27 George W. Bourne, Iv Self-sealing guidewire and catheter introducer
US4909794A (en) 1988-06-24 1990-03-20 Habley Medical Technology Corporation Combination retractable needle cannula and cannula lock for a medication carpule
US4946445A (en) 1988-09-06 1990-08-07 Lynn Lawrence A Intravenous line coupling device
CA2001732A1 (en) 1988-10-31 1990-04-30 Lawrence A. Lynn Intravenous line coupling device
US4932633A (en) 1988-11-21 1990-06-12 Schneider-Shiley (U.S.A.) Inc. Hemostasis valve
US4892222A (en) 1988-11-25 1990-01-09 Baxter International Inc. Port assembly for a container
US4961729A (en) 1988-12-13 1990-10-09 Vaillancourt Vincent L Catheter insertion assembly
US5009640A (en) 1989-01-19 1991-04-23 The Upjohn Company Slip cap for cannula use
US4915687A (en) 1989-02-17 1990-04-10 Sivert George A Needleless injection port arrangement
IE62767B1 (en) * 1989-03-17 1995-02-22 Baxter Int Pre-slit injection site and tapered cannula
US5314411A (en) * 1989-07-24 1994-05-24 Steven F. Bierman, M.D. Catheterization system with universal retention device and method of use
US5071404A (en) 1989-08-01 1991-12-10 Abbott Laboratories Injection site
US5210157A (en) 1989-08-15 1993-05-11 Akzo N.V. Interpenetrating network of ring-containing allyl polymers and epoxy resin, and a laminate prepared therefrom
US5149327A (en) 1989-09-05 1992-09-22 Terumo Kabushiki Kaisha Medical valve, catheter with valve, and catheter assembly
US4994029A (en) 1989-09-12 1991-02-19 David Bull Laboratories Pty. Ltd. Syringe mixer and injector device
US5080654A (en) 1989-09-18 1992-01-14 Applied Medical Technology, Inc. Fluid injection device for intravenous delivery system
US5017192A (en) 1989-10-20 1991-05-21 Minnesota Mining And Manufacturing Company Free flow prevention system for infusion pump
US4950260A (en) 1989-11-02 1990-08-21 Safetyject Medical connector
US4998713A (en) 1990-01-10 1991-03-12 Vaillancourt Vincent L Needle connector
US5053014A (en) 1990-02-01 1991-10-01 Critikon, Inc. Catheter with controlled valve
US5078689A (en) 1990-05-14 1992-01-07 Keller Alan M Device for removing body fluids
US5071413A (en) 1990-06-13 1991-12-10 Utterberg David S Universal connector
US5088995A (en) 1990-06-22 1992-02-18 Baxter International Inc. Port and closure assembly including a resealing injection site for a container
DE4025717A1 (en) 1990-08-14 1992-02-20 Hoechst Ag SYRINGE RACK
US5350367A (en) 1990-11-06 1994-09-27 Sterling Winthrop Inc. Snap together hypodermic syringe holder
ES1016714Y (en) 1991-01-17 1992-07-01 Instituto De Biologia Y Sueroterapia, S.A. ACCESS DEVICE FOR FLEXIBLE CONTAINERS.
JP2568950B2 (en) * 1991-07-30 1997-01-08 日本写真印刷株式会社 Decorative film for simultaneous painting
AU662203B2 (en) 1992-04-03 1995-08-24 Baxter International Inc. Improved transfer set
US5356396A (en) * 1992-09-29 1994-10-18 Medical Associates Network Inc. Infusion apparatus
US5603706A (en) * 1992-09-29 1997-02-18 Wyatt; Philip Infusion apparatus
JP6243694B2 (en) 2013-10-07 2017-12-06 株式会社Uacj Aluminum paint

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3986508A (en) * 1973-08-22 1976-10-19 Abcor, Inc. Sterilizable, medical connector for blood processing
US4150673A (en) * 1977-02-03 1979-04-24 Pharmachem Corporation Coded entry system for blood bag
EP0114677A2 (en) * 1983-01-24 1984-08-01 ICU Medical, Inc. Medical connector system
EP0169704A1 (en) * 1984-07-21 1986-01-29 H.G. Wallace Limited Intravascular device including a clip for use in preventing needle retraction
WO1986001487A1 (en) * 1984-08-21 1986-03-13 Baxter Travenol Laboratories, Inc. Reconstitution device
DE8425197U1 (en) * 1984-08-25 1985-09-19 Magasi, Josef, 6902 Sandhausen Self-sterile coupling for fluids to be supplied to the human or animal organism, in particular for hyperosmolar peritoneal dialysis fluids
EP0220911A2 (en) * 1985-10-22 1987-05-06 Minntech Corporation Peritoneal device system
US4804366A (en) * 1987-10-29 1989-02-14 Baxter International Inc. Cartridge and adapter for introducing a beneficial agent into an intravenous delivery system
WO1989006553A2 (en) * 1988-01-25 1989-07-27 Baxter International Inc. Pre-slit injection site and tapered cannula

Cited By (58)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5295658A (en) * 1987-04-27 1994-03-22 Vernay Laboratories, Inc. Medical coupling site including slit reinforcing members
US5447495A (en) * 1987-07-31 1995-09-05 Lawrence A. Lynn Apparatus and methods for transferring blood between a blood aspirator assembly and an external container
US5324256A (en) * 1987-07-31 1994-06-28 Lawrence A. Lynn Apparatus and methods for transferring blood between aspiration assembly and an external container
US5899888A (en) * 1988-01-25 1999-05-04 Baxter International Inc. Pre-slit injection site and tapered cannula
US5203775A (en) * 1990-09-18 1993-04-20 Medex, Inc. Needleless connector sample site
USRE35841E (en) * 1990-09-18 1998-07-07 Medex, Inc. Needleless connector sample site
US5098392A (en) * 1991-06-28 1992-03-24 Fleischhacker John J Locking dilator for peel away introducer sheath
US5251873A (en) * 1992-06-04 1993-10-12 Vernay Laboratories, Inc. Medical coupling site
US5295657A (en) * 1992-06-04 1994-03-22 Vernay Laboratories, Inc. Medical coupling site valve body
US5533708A (en) * 1992-06-04 1996-07-09 Vernay Laboratories, Inc. Medical coupling site valve body
US5501426A (en) * 1992-06-04 1996-03-26 Vernay Laboratories, Inc. Medical coupling site valve body
US5242393A (en) * 1992-06-18 1993-09-07 Becton, Dickinson And Company Valved blunt cannula injection site
US5405331A (en) * 1992-07-29 1995-04-11 Minnesota Mining And Manufacturing Company IV injection site and system
US5368574A (en) * 1992-10-01 1994-11-29 Ethicon, Inc. Percutaneous catheter introducer
US5417673A (en) * 1993-01-13 1995-05-23 Medex, Inc. Whole blood sample needleless sample site
WO1994022506A3 (en) * 1993-04-02 1994-11-24 Minnesota Mining & Mfg Apparatus for and method of making an injection or sampling site
WO1994022506A2 (en) * 1993-04-02 1994-10-13 Minnesota Mining And Manufacturing Company Apparatus for and method of making an injection or sampling site
US5441487A (en) * 1993-11-30 1995-08-15 Medex, Inc. Plastic needleless valve housing for standard male luer locks
US5697915A (en) * 1994-02-15 1997-12-16 Lynn; Lawrence A. Displacement-activated medical check valve
US5769825A (en) * 1994-02-15 1998-06-23 Lynn; Lawrence A. Self-contained syringe and pharmaceutical packaging system for enclosed mixing of pharmaceutical and diluent
USRE38145E1 (en) * 1994-05-25 2003-06-17 Lawrence A. Lynn Luer-receiving medical valve
US5549651A (en) * 1994-05-25 1996-08-27 Lynn; Lawrence A. Luer-receiving medical valve and fluid transfer method
USRE37357E1 (en) * 1994-05-25 2001-09-04 Lawrence A. Lynn Luer-receiving medical valve and fluid transfer method
USRE39334E1 (en) 1994-05-25 2006-10-10 Lynn Lawrence A Luer-receiving medical valve and fluid transfer method
US5474544A (en) * 1994-05-25 1995-12-12 Lynn; Lawrence A. Luer-receiving medical valve
EP1669101A1 (en) * 1995-01-26 2006-06-14 Medical Ventures LLC Medical coupling site valve body
EP0880371A1 (en) * 1995-06-09 1998-12-02 Migada, Inc. Blunt cannula construction for multiple applications
EP0880371A4 (en) * 1995-06-09 1999-04-14 Migada Inc Blunt cannula construction for multiple applications
US6171287B1 (en) 1998-05-29 2001-01-09 Lawrence A. Lynn Luer receiver and method for fluid transfer
US6808161B1 (en) 1999-09-16 2004-10-26 Terumo Kabushiki Kaisha Connector
US6616632B2 (en) 2000-06-09 2003-09-09 Inviro Medical Device Ltd. Cannula for use with a medical syringe
US6394979B1 (en) 2000-06-09 2002-05-28 Inviro Medical Devices Ltd. Cannula for use with a medical syringe
US7163114B2 (en) 2000-12-04 2007-01-16 Jms Co., Ltd. Plug body for medical fluid container
US6918500B2 (en) 2000-12-04 2005-07-19 Jms Co., Ltd. Plug body for medical fluid container
WO2002047756A1 (en) 2000-12-12 2002-06-20 Gambro Dasco S.P.A. Site for access to the inside of a channel, and corresponding cannula
US6936031B2 (en) 2000-12-12 2005-08-30 Gambro Dasco S.P.A. Site for access to the inside of a channel, and corresponding cannula
EP1245282A2 (en) * 2001-03-30 2002-10-02 Becton, Dickinson and Company Walled adaptor for use with point-of-care testing kit
EP1245282A3 (en) * 2001-03-30 2004-03-10 Becton, Dickinson and Company Walled adaptor for use with point-of-care testing kit
WO2003020343A1 (en) * 2001-08-31 2003-03-13 Disetronic Licensing Ag Connecting device for a percutaneously implanted port and port system comprising the connecting device
US7947032B2 (en) 2001-12-07 2011-05-24 Becton, Dickinson And Company Needleless luer access connector
WO2003090815A3 (en) * 2002-04-24 2004-02-05 Becton Dickinson Co Fluid transfer adapter for use with a syringe barrel
US9095500B2 (en) 2007-02-03 2015-08-04 Fresenius Kabi Deutschland GmgH Closure cap for a container for receiving medical liquids, and container for receiving medical liquids
WO2008115244A1 (en) * 2007-03-16 2008-09-25 Smiths Medical Asd, Inc. Blunt cannula for accessing a slit septum
EP2075021A1 (en) * 2007-03-16 2009-07-01 Smiths Medical ASD, Inc. Adaptator for a blunt cannula for accessing a slit septum
GB2445437A (en) * 2007-07-06 2008-07-09 Applied Medical Technology Ltd Cannula insertion device
GB2445437B (en) * 2007-07-06 2008-11-26 Applied Medical Technology Ltd Cannula insertion device
US8172803B2 (en) 2007-07-06 2012-05-08 Applied Medical Technology Ltd Cannula insertion device
WO2012164514A2 (en) 2011-06-01 2012-12-06 Industrie Borla S.P.A. Injection site for tubular medical connectors
WO2012164514A3 (en) * 2011-06-01 2013-01-17 Industrie Borla S.P.A. Injection site for tubular medical connectors
CN103648577A (en) * 2011-06-01 2014-03-19 伯尔拉工业有限公司 Injection site for tubular medical connectors
ITTO20110481A1 (en) * 2011-06-01 2012-12-02 Borla Ind NEEDLE POINT FOR MEDICAL TUBULAR FITTINGS
US9345871B2 (en) 2011-06-01 2016-05-24 Industrie Borla S.P.A. Injection site for tubular medical connectors
US9795736B2 (en) 2012-08-01 2017-10-24 Jms Co., Ltd. Infusion set and method for using same
WO2015160522A1 (en) * 2014-04-15 2015-10-22 Advanced Scientifics, Inc. Aseptic connector
US9186493B2 (en) 2014-04-15 2015-11-17 Advanced Scientific, Inc. Aseptic connector
US10111809B2 (en) 2014-04-15 2018-10-30 Advanced Scientifics, Inc. Aseptic connector and method
US11191700B2 (en) 2014-04-15 2021-12-07 Advanced Scientifics, Inc. Aseptic connector
WO2016206804A1 (en) * 2015-06-24 2016-12-29 Fresenius Medical Care Deutschland Gmbh Adapter

Also Published As

Publication number Publication date
WO1990011103A3 (en) 1991-01-10
JPH08243092A (en) 1996-09-24
DE69019170T4 (en) 1996-05-30
EP0540507B1 (en) 1995-11-29
IE940634L (en) 1990-09-17
CA2027591A1 (en) 1990-09-18
JPH03504571A (en) 1991-10-09
JP2006055670A (en) 2006-03-02
EP0541515A1 (en) 1993-05-12
IE66526B1 (en) 1996-01-24
JPH07110284B2 (en) 1995-11-29
AU5333290A (en) 1990-10-22
AU3718393A (en) 1993-07-01
US6217568B1 (en) 2001-04-17
US6569125B2 (en) 2003-05-27
US6261266B1 (en) 2001-07-17
EP0419620B1 (en) 1994-05-25
IE900938L (en) 1990-09-17
EP0540507A1 (en) 1993-05-05
DE69009131D1 (en) 1994-06-30
AU3022195A (en) 1995-11-23
DE69023926T2 (en) 1996-08-14
AU8022294A (en) 1995-03-16
EP0541515B1 (en) 1995-05-03
ES2057546T3 (en) 1994-10-16
US20010047154A1 (en) 2001-11-29
CA2027591C (en) 1996-02-27
US6213996B1 (en) 2001-04-10
ES2083247T3 (en) 1996-04-01
IE62767B1 (en) 1995-02-22
JP2002191583A (en) 2002-07-09
ES2074909T3 (en) 1995-09-16
JP2003126269A (en) 2003-05-07
EP0419620A1 (en) 1991-04-03
AU681317B2 (en) 1997-08-21
MX173202B (en) 1994-02-08
AU3796095A (en) 1996-01-25
IE72466B1 (en) 1997-04-09
US5899888A (en) 1999-05-04
AU634532B2 (en) 1993-02-25
AU678071B2 (en) 1997-05-15
IE940633L (en) 1990-09-17
DE69019170T2 (en) 1995-11-30
AU666181B2 (en) 1996-02-01
DE69019170D1 (en) 1995-06-08
DE69023926D1 (en) 1996-01-11
JP3411984B2 (en) 2003-06-03
DE69009131T2 (en) 1995-01-19

Similar Documents

Publication Publication Date Title
AU634532B2 (en) Pre-slit injection site and tapered cannula
US5135489A (en) Pre-slit injection site and tapered cannula
US6193697B1 (en) Pre-slit injection site and tapered cannula
US5797897A (en) Pre-slit injection site and tapered cannula
US5158554A (en) Pre-slit injection site and associated cannula
AU635736C (en) Pre-slit injection site and tapered cannula

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AU CA JP

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): AT BE CH DE DK ES FR GB IT LU NL SE

WWE Wipo information: entry into national phase

Ref document number: 2027591

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 1990905119

Country of ref document: EP

AK Designated states

Kind code of ref document: A3

Designated state(s): AU CA JP

AL Designated countries for regional patents

Kind code of ref document: A3

Designated state(s): AT BE CH DE DK ES FR GB IT LU NL SE

WWP Wipo information: published in national office

Ref document number: 1990905119

Country of ref document: EP

WWG Wipo information: grant in national office

Ref document number: 1990905119

Country of ref document: EP

ENP Entry into the national phase

Ref country code: CA

Ref document number: 2027591

Kind code of ref document: A

Format of ref document f/p: F