CA2027591C - Pre-slit injection site and tapered cannula - Google Patents
Pre-slit injection site and tapered cannulaInfo
- Publication number
- CA2027591C CA2027591C CA 2027591 CA2027591A CA2027591C CA 2027591 C CA2027591 C CA 2027591C CA 2027591 CA2027591 CA 2027591 CA 2027591 A CA2027591 A CA 2027591A CA 2027591 C CA2027591 C CA 2027591C
- Authority
- CA
- Canada
- Prior art keywords
- blunt
- injection site
- housing
- slit
- cannula
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/04—Access sites having pierceable self-sealing members
- A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/1011—Locking means for securing connection; Additional tamper safeties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2055—Connecting means having gripping means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1033—Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1066—Tube 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/19—Constructional features of carpules, syringes or blisters
- A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
- A61M2205/195—Avoiding coring, e.g. preventing formation of particles during puncture by the needle tip shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/19—Constructional features of carpules, syringes or blisters
- A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
- A61M2205/197—Avoiding coring, e.g. preventing formation of particles during puncture by the seal material
-
- Y—GENERAL 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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S604/00—Surgery
- Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
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
~.02759 1 WO ~/11103 1 PCT/US90/01350 PR~-STTT T~J~CTION S~TE ~D TAPERED CANNV~
F~ of ~he Tnven~i on The invention pertains to coupling systems usable to tran~fer materials from one flow conduit to another.
More particularly, the invention pertains to two-part coupling members with a fir~t part including a pre-slit septum and second part including a blunt c~nntll A The pre-slit septum slidably receives the blunt cannula to effect the coupling.
R~-~L~-~ of th~ T~ven~in Injection sites usable with pointed cannulae have long been known. For example, such ites 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 in~ection 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 th~ present invention.
The pointed cannula can be forced through the ~eptum into fluid flow communic~tion with the flow path in the housing. Known injection s$tes 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 s~1h~ ent leakage.
Due to problems A~OC~ ~ted with infectious agents, perFonn~1 using such pointed r~nn~1ae do so with great care. Notwithst~ ng careful and prudent practice, from time to time, accidents do occur and individuals using such pointed cannulae jab themselves.
Injection ~ites 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 r ~ ' -20275gl ~090/11103 PCT/US90/01350 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 5 member has an opening therethrough.
A blunt rannulae 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 r~n~t~l a have the advantage that the blunt cAn~t~la 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.
~ enre, there con~int~eC to be a need for a pre-slit injection site which can be used with a variety of colutions and over a range of fluid pressures. Further, there continues to be a need for ~uch a pre-slit injection site which will reliably reseal even after many insertions of the blunt cann~ll A .
Such an injection site should be able to receive a large number of insertions of the cannula without displaying reseal failure. Such an injection cite should provide for improved alignment of the cannula on insertion. lm~ ed alignment will result in less r~Ance of damage to the injection site after repeated insertions of the c~n~ . Preferably, the injection site would also be usable with a pointed ~a~lll A . Preferably, a pre-slit injection site u~able with a blunt ~nntlla will provide a reA~o~Ahle level of insertion force ~uch that health care perro~ne~ will readily be able to insert the blunt C~nnlll A ~ yet the ~nnl~la will not easily fall from or drop out of contact with the septum.
~ 20275~ ~
Summary of the Invention Various aspects of this invention are as follows:
An injection site usable with a blunt cannula device, said in~ection site comprising:
a housing having ^ fluid p~ssag~way therein and means defining first and r~:: nA opçn i ~gs within said housing in communication with said passageway;
flexible means carried by said housing for sealing said first open;ng, said means having a re~ealable ~pen;ng therein and a curved exterior peripheral surface such that a blunt C~n~ltl A can be sealingly inserted through said re~-~lAhle op^n~nq and placed in fluid flow communication with said pa~sageway and such that the blunt c~n~lll a can be removed thQrefrom with ~aid flexible means interacting with ~aid housing so a~ to reseal fiaid rQsealablQ op^~ ng; and first and 5æ_~,1 distinct loc~ng means on the exterior of said hou~ing for cooperation with a plurality of blunt rann~la devices.
An in~ection ~ite usable with a blunt cannula devica comprising:
a housing having a fluid passageway therein and means defining first and v~o"-l op~ gs within ~aid housing in communication with ~aid passageway;
flexible mQans carr~Qd by said housing for ~Qaling said first opening, said means having a r~ Ahl Q op~ning th~rein and a curved cxt~rior peripheral ~urface such that a blunt ran~la can be ~ealingly inserted through said ~ hle opQning and placed in fluid flow communication with ~aid passageway and such that th~ blunt cannula can be removed ~, 3a 202759 1 therefrom with said flexible means interacting with said hou~ing so as to reseal said r~~ hla oren~
means defining a generally radially eXtenA i n~
shoulder on the ~xterior of said housing for lo~ing engagQmQnt with one type of blunt ~n~-ll a device;
me~ns defined on the exterior of s~id housing for thre~dQd ngagement with another type of blunt rannl~la devices 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 ~ite ag being usablQ with a blunt cannula device, ~aid identification means comprising a colored ring circumscribing said flexible means and being of a color different from said housing An in~ection site usable with a blunt c~nn~l a device comprising
F~ of ~he Tnven~i on The invention pertains to coupling systems usable to tran~fer materials from one flow conduit to another.
More particularly, the invention pertains to two-part coupling members with a fir~t part including a pre-slit septum and second part including a blunt c~nntll A The pre-slit septum slidably receives the blunt cannula to effect the coupling.
R~-~L~-~ of th~ T~ven~in Injection sites usable with pointed cannulae have long been known. For example, such ites 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 in~ection 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 th~ present invention.
The pointed cannula can be forced through the ~eptum into fluid flow communic~tion with the flow path in the housing. Known injection s$tes 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 s~1h~ ent leakage.
Due to problems A~OC~ ~ted with infectious agents, perFonn~1 using such pointed r~nn~1ae do so with great care. Notwithst~ ng careful and prudent practice, from time to time, accidents do occur and individuals using such pointed cannulae jab themselves.
Injection ~ites 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 r ~ ' -20275gl ~090/11103 PCT/US90/01350 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 5 member has an opening therethrough.
A blunt rannulae 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 r~n~t~l a have the advantage that the blunt cAn~t~la 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.
~ enre, there con~int~eC to be a need for a pre-slit injection site which can be used with a variety of colutions and over a range of fluid pressures. Further, there continues to be a need for ~uch a pre-slit injection site which will reliably reseal even after many insertions of the blunt cann~ll A .
Such an injection site should be able to receive a large number of insertions of the cannula without displaying reseal failure. Such an injection cite should provide for improved alignment of the cannula on insertion. lm~ ed alignment will result in less r~Ance of damage to the injection site after repeated insertions of the c~n~ . Preferably, the injection site would also be usable with a pointed ~a~lll A . Preferably, a pre-slit injection site u~able with a blunt ~nntlla will provide a reA~o~Ahle level of insertion force ~uch that health care perro~ne~ will readily be able to insert the blunt C~nnlll A ~ yet the ~nnl~la will not easily fall from or drop out of contact with the septum.
~ 20275~ ~
Summary of the Invention Various aspects of this invention are as follows:
An injection site usable with a blunt cannula device, said in~ection site comprising:
a housing having ^ fluid p~ssag~way therein and means defining first and r~:: nA opçn i ~gs within said housing in communication with said passageway;
flexible means carried by said housing for sealing said first open;ng, said means having a re~ealable ~pen;ng therein and a curved exterior peripheral surface such that a blunt C~n~ltl A can be sealingly inserted through said re~-~lAhle op^n~nq and placed in fluid flow communication with said pa~sageway and such that the blunt c~n~lll a can be removed thQrefrom with ~aid flexible means interacting with ~aid housing so a~ to reseal fiaid rQsealablQ op^~ ng; and first and 5æ_~,1 distinct loc~ng means on the exterior of said hou~ing for cooperation with a plurality of blunt rann~la devices.
An in~ection ~ite usable with a blunt cannula devica comprising:
a housing having a fluid passageway therein and means defining first and v~o"-l op~ gs within ~aid housing in communication with ~aid passageway;
flexible mQans carr~Qd by said housing for ~Qaling said first opening, said means having a r~ Ahl Q op~ning th~rein and a curved cxt~rior peripheral ~urface such that a blunt ran~la can be ~ealingly inserted through said ~ hle opQning and placed in fluid flow communication with ~aid passageway and such that th~ blunt cannula can be removed ~, 3a 202759 1 therefrom with said flexible means interacting with said hou~ing so as to reseal said r~~ hla oren~
means defining a generally radially eXtenA i n~
shoulder on the ~xterior of said housing for lo~ing engagQmQnt with one type of blunt ~n~-ll a device;
me~ns defined on the exterior of s~id housing for thre~dQd ngagement with another type of blunt rannl~la devices 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 ~ite ag being usablQ with a blunt cannula device, ~aid identification means comprising a colored ring circumscribing said flexible means and being of a color different from said housing An in~ection site usable with a blunt c~nn~l a device comprising
2) ~ housing having an inlet and an outlet and defining a fluid channel therebetween mQans defining an ~cce~ aperture in communication with fluid ch~nn~l; and flexible means carried by ~id housing for sealing ~aid access aperture, said means having a re~ hle open~ ng therein and a curved exterior peripheral surface such that a blunt cAnnula can be s~lingly inserted through s~id op~n~g and placed in fluid flow ' ~
3b 202759 1 communication with ~aid channel and such that the blunt ~nn-ll A can be removed therefrom with ~aid flexible means interacting with said housing 50 aB to re~eal said resealable oper~ 1 ng .
A blunt-ended cannula device for use with a pre-slit resealable 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 15 substantial portion of its length and terminating in a generally tapered distal end portion having a blunt end edge, the distal end portion including an outer circumference along its length that gradually and uniformly decreases toward the blunt end edge and the 20 distal end portion and being sufficiently tapered to allow the elongated member to penetrate the pre-slit injection site; and a substantially cylindrical sheath surrounding said elongated member and being at least coextensive with and spaced apart from said elongated member to protect said member from inadvertent touch contamination.
A blunt ~Ann-~la device for use with a pre-~ slit iniect~on ~ite comprising:
means def ining a base portion and an elongated member exten~i ng from said base portion, said elongated member having a fluid flow ch~nnel defined generally axially therQwithin, said elongat~d member being ~ssentially cylindrical for a subatantial , ~ .
i~
3c 20275q 1 portion of the length ther~of and terminating - in a tap~red nd portion having a blunt end edge;
a plurality of reta~ning fingers carried by s~id ~a~e portion, each of ~aid retaining fingers having retention means at one end and gripping means at the other end, said fingers being carried by ~aid base portion inter-mediate said ends, whereby squeezing of the gripping ends of ~aid fingers spreads of the retention ends of said fingers to allow locki~g engagement with and release from a pre-slit injection site.
In accordance with an aspect of the invention, an easily wipeable in~ection site usable with a blunt cA~n-lla is provided. The in~ection ~ite includes a hou~ing which defines a fluid flow chAn~el therethrough. The housing has a first ~nd a e~ -nA end.
a flexible sealing member i~ carried by the housing for sealing the first end. The sealing member has a r~e~lAhle op~n~ng therein. The sealing member also is formed with a curved exter~or peripheral ~urface ~uch that the blunt c~n~la can be sealingly inserted through the ~ni~g and placed in fluid flow communication with the flow path. Further, the blunt c~n~ a can be removed from the opening with a sealing member then interacting with the housing 80 a~ to l~eAl the opening.
Th~ hou~ing can al~o be formed with the fir~t end including an annular ~h~nn-l underlying the ~ealing member. The ~ealing member i~ sub~ected to radially directed force~ by a tapered ~urface of the first end of the housing. These forces tend to ~ al the opening in the ~ealing member.
~ .~
3d 2 027591 The sealing member can be a cylindrically shaped rubber member. m e first end of the housing can include an interior tapered surface for receiving the ~ealing member and for applying the radially directed forces to the ~ealing member.
A reta~n~ng member carried by the first end of the hou~ing can be used to retain the ~ealing member within the housing. The retaining mPmher can be generally U-shaped. Alternately, the retA~ing member can be formed a~ a coiled ~pring.
The r~ta~n~ng memb~r applies axially directed forces to the ~ealing member. In one emho~ent of the invention, the ret~ning member deflects the ~ealing member and forms a curved exterior peripheral surface thereon. The ~ ed exterior peripheral surface is an easily wipeable ~urface.
,_=.
3b 202759 1 communication with ~aid channel and such that the blunt ~nn-ll A can be removed therefrom with ~aid flexible means interacting with said housing 50 aB to re~eal said resealable oper~ 1 ng .
A blunt-ended cannula device for use with a pre-slit resealable 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 15 substantial portion of its length and terminating in a generally tapered distal end portion having a blunt end edge, the distal end portion including an outer circumference along its length that gradually and uniformly decreases toward the blunt end edge and the 20 distal end portion and being sufficiently tapered to allow the elongated member to penetrate the pre-slit injection site; and a substantially cylindrical sheath surrounding said elongated member and being at least coextensive with and spaced apart from said elongated member to protect said member from inadvertent touch contamination.
A blunt ~Ann-~la device for use with a pre-~ slit iniect~on ~ite comprising:
means def ining a base portion and an elongated member exten~i ng from said base portion, said elongated member having a fluid flow ch~nnel defined generally axially therQwithin, said elongat~d member being ~ssentially cylindrical for a subatantial , ~ .
i~
3c 20275q 1 portion of the length ther~of and terminating - in a tap~red nd portion having a blunt end edge;
a plurality of reta~ning fingers carried by s~id ~a~e portion, each of ~aid retaining fingers having retention means at one end and gripping means at the other end, said fingers being carried by ~aid base portion inter-mediate said ends, whereby squeezing of the gripping ends of ~aid fingers spreads of the retention ends of said fingers to allow locki~g engagement with and release from a pre-slit injection site.
In accordance with an aspect of the invention, an easily wipeable in~ection site usable with a blunt cA~n-lla is provided. The in~ection ~ite includes a hou~ing which defines a fluid flow chAn~el therethrough. The housing has a first ~nd a e~ -nA end.
a flexible sealing member i~ carried by the housing for sealing the first end. The sealing member has a r~e~lAhle op~n~ng therein. The sealing member also is formed with a curved exter~or peripheral ~urface ~uch that the blunt c~n~la can be sealingly inserted through the ~ni~g and placed in fluid flow communication with the flow path. Further, the blunt c~n~ a can be removed from the opening with a sealing member then interacting with the housing 80 a~ to l~eAl the opening.
Th~ hou~ing can al~o be formed with the fir~t end including an annular ~h~nn-l underlying the ~ealing member. The ~ealing member i~ sub~ected to radially directed force~ by a tapered ~urface of the first end of the housing. These forces tend to ~ al the opening in the ~ealing member.
~ .~
3d 2 027591 The sealing member can be a cylindrically shaped rubber member. m e first end of the housing can include an interior tapered surface for receiving the ~ealing member and for applying the radially directed forces to the ~ealing member.
A reta~n~ng member carried by the first end of the hou~ing can be used to retain the ~ealing member within the housing. The retaining mPmher can be generally U-shaped. Alternately, the retA~ing member can be formed a~ a coiled ~pring.
The r~ta~n~ng memb~r applies axially directed forces to the ~ealing member. In one emho~ent of the invention, the ret~ning member deflects the ~ealing member and forms a curved exterior peripheral surface thereon. The ~ ed exterior peripheral surface is an easily wipeable ~urface.
,_=.
3 2 0 2 7 5 ~1 PCT/US~/01350 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 c~An~Pl.
Deformation of this annular peripheral region results in an insertion force in a range of 2.0 pounds (.7564 k~lograms) to 5.0 rollnA~ (1. 891 kilograms).
Preferably, the insertion force will have a value of the order of 2.0 pounds (.7564 kilograms).
The resaalable or~n~ng in the ~ealing member can extend entirely through that member. Alternately, the resealable opo~g can extend only partway therethrough.
In this embodiment, the end of the blunt c~nn~lla 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 ~eal the site until the blunt cann~ is inserted therethrough the fir~t time.
The intQrior surface of the first end can be formed with the taper in ~ range on the order of 5 degrees to 20 degrees. Preferably, the interior surface will have a tapér on the order of 12 d~.eQr. This tapered surface permits the use of ~ cylindrically shaped sealing member.
To provide for leak-free insertion, the length of the slit in the ~ealing member must be le58 than one-hal~
the circumference of the cannula being inserted therethrough. u~nce~ the slit length may ~Yc~A the diameter of the ~n~ 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.
3~ Further, in accordance with an aspect of the invention, a coupling system for coupling first and ~econd fluid flow members together is provided. The coupling system includes an injection sitQ which i6 affixed to the first t WO ~11103 PCT/US90/01350 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 ore~ therein.
An annular ret~i~in~ member is carried by the housing and cooperates with the housing to retain the sealinq member therein. ~aA~lly directed forces are applied to the sealing member by the housing, thereby urging the or~ into a resealed condition.
A blunt c~ , affixed to ~ronA fluid flow member, has a fluid flow path therethrough. The c~n~t~l a carries a locki~ member for loçkin~ly engaging the housing when the cAnn~la extends through the opening of the ~ ;n~ member. When so positioned, the two fluid flow members are placed into fluid flow cc ~ cation.
The lorki~g member can include a luer-type twist lock fitting. Alternately, the lo~k~ member can include slidably engageable members which are responsive to axial movement of the injection site and the r~n~ a toward one another.
In accordance with further ~p~cts of this invention, the blunt r~nn~lA may be provided with features that facilitate insertion into the injection site, enh~nce fluid flow or dispersion, increase tug resistance, and reduce ~ckhAck.
In part~c~llAr, one embodiment of the ~nnt~la includes a tube with a plurality of elongate ~ir~h~ge slots adjacent the distal end. The fluid changes direction ~8 it ~A~es later~lly through the slots and out of the tube. The flow area of the filots eYreeAc the flow area inside the tube. ~his slot structure ~nh~c~e fluid flow and in~rersion characteristlcs. In addition, the slots decrease the contact. fiurface area on the tube exterior ~o as to facilitate insertion.
In a further modification, the r~n~ll A includes a lead post on the tube distal end to guide the cannula through the slit in the injection site.
~027~9i WO90~11103 PCTJUS~/01350 In another cannula embodiment, the tube is generally cylindrical and the fluid ~icch~rges 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 egual in length. The taper facilitates insertion, and the remaining cylindrical portion r~ ne~ kick~ack.
In yet another embodiment, the ~n~ a includes an annular barb whic~ functions to reduce kickback.
Other advantages of a blunt plastic r~nn-~l a in accor~nc~ 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 ~;ch 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 ~^con~ distinct lock~ ng means are provided on the exterior of the housing for selective ~o o~eration with complementary locking means on different c~nnvl A~ The first locki~g means may be a ~olll A~ for engaging resilient fingers on a c~nnl~la and the r~ ~A lo~ng means m~y be a ~crew thread for engaging a ~crew thread on a d~fferent c~nnlll A . The in~ection site is, therefore, particularly versatile in use.
The invention may also reside in a c~nn~la device having ret~i n~ ng fingers which are resiliently biased to positions in wh~ch they can engage a ~ho~ r of an injection site to lock the c~nnt?l~ device on the site.
S~ hle gripping means is provided for spreading the O90/11103 ~ PCTrUS90/01350 fingers to permit their engagement with a disengagement from the cannula. This provide~ a particularly effective locking system which is easy to operate.
20~75g~ .
WO ~/11103 PCT/US~/013~0 Rrief DescriDtion of the Drawin~s Figure 1 is a side elevational view, partly in section, of a prior art pre-slit injection site and an associated blunt r~n~l~1 a;
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 cite, a hielded blunt c~n~1la and a syringe prior to being coupled together;
Figure 4B is an enlarged, side elevational view in section of the ~-_ -lit injection site, the shielded blunt CAnnt~l A 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 c~n~l-la carrying 2S a loc~in~ member;
Figure 5B is an enlarged side elevational view, partly broken away, illustrating the interrelationship between the pre-slit injection site and the blunt c~nnl~la of Figure 5A;
~igure 6 is an overall view of a cont~ jner, an AF-o~i Ated colution administration set and a pre-slit injection ~ite in accordance with the present invention:
2027~1 Woso/lllU3 PCT/US~/01350 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 c~nnl~la in accordance with the pre~ent invention;
Figure 9 is a side elevational view, partly in section, of a pre-slit injection site mounted on a fragment of a solution cont~i n^r;
10Figure 10 i5 a side elevational view of a fragment of a solution cont~i n~r carrying, as a single port, a p~e slit injection site;
Figure 11 is a side elevational view of the injection site and the fragmentary container of Figure lo 15prior to h~ing engaged with a shielded r~nnt~la carried by a syringe;
Figure 12 is an enlarged ~ide elevat;o~l view, partly in section, of a coupling ~ystem with a pre-slit injection site partly coupled to a blunt c~nml~a:
20Figure 13 i8 an enlarged side elevational view, partly in ~ection, of the coupling system of Figure 12 -~quent to engayement of the two coupling members;
Figure 14 is a side elevational view, partly broken away, of a spike ~o~ne~tor carrying a pre-slit 25injection site in accordance with the p~ Pt invention;
Figure 15 is an enlarged ~ide elevational view of a Y-connector in sect~on c~rrying a pre-slit injection site in accor~nce with the ~Fe~t i"~en~ion;
Figure 16 is ~n enlarged fragmentary side 30elevatio~l view in section of a coupling member carrying a pre-slit injection site where the slit extends only partway through the ~eptum;
Figure 17 is a p~D~--ctive view of a ~urette solution ~dministration fiet carrying a pre-slit in;ection 35 site in accor~"ce with the ~ e~t iveLion;
F~gure 18 is a view of part of a burette solution administration set carrying a pre-slit injection site being coupled to a shielded bluu~t r~n~ a;
2~59i WO ~/11103 PCT/US90/01350 Figure 19 is a step in the method of ~ki ~g a pre-slit injection site in accordance with the present invention;
Figure 20 is another ~tep 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 ~ite 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 accor~nc~ with the present invention:
Figure 23 is a final phase of the final ~tep 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 ~tep of making a ~e ~lit injection site in accor~n~e 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;
2S Figure 27 is an enlarged, fragmentary cross-secti~ view of another embodiment of an injection site in accordance with the ~-^~t invention;
Figure 28 is a cross-sect~on view taken generally along the plane 28-28 in Figure 27;
Figure 29 is an end ViQW of another embodiment of the ~nn~la 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 cAn~l~lA in accordance with the present invention;
Figure 32 is a cro~s-~ectional view taken generally along the plane 32-32 in Figure 31;
2027S9l WO ~/11103 PCT/US90/01350 Figure 33 is a cross-sectional view taken generally along the plane 33-33 in Figure 32;
Figure 34 i8 an end view of another emho~ir~nt of the c~nnllla in accordance with the present invention;
5Figure 35 is a fragmentary, side elevational view of the emhoAiment of the c~nnl~l a illustrated in ~igure 34;
Figure 36 is a cross-sectional view taken generally along the plane 36-36 in Figure 34;
Figure 37 i5 a cross-sectional view taken 10generally 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;
15Figure 40 is a cross-sectional view taken generally along the plane 40-40 in Figure 39;
Figure 41 is an end view of _nother embodiment of the ç~nnl-1 a according to the present invention;
~igure 42 i5 a cross-sectional view taken 20generally along the plane 42-42 in Figure 41;
Figure 43 i~ an end view of another embodiment of the cannula _ccording to the present invention;
Figure 44 is a cross-~ectional view taken generally along the plane 44-44 in Figure 43; and 25Figure 45 is a view in section of another insertion member for a blunt c~nntlla.
Figure 46 is a perspective view of another embodiment of a blunt c~nnl~la embodying the present invention.
30Figure 47 is a perspective view of a blunt cA~n~~la 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 35heparin lock of Figure 48 in joined relatio~hip with a blunt cAnnl~l~ device of altern_tive construction embodying the present invention.
, ~02759i WO ~/11103 PCr/US90/01350 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 ~ cross-sectional view of a pre-slit in-line injection site embodying the present invention in joined relationchir with a blunt cAn~ shown in side elevational view.
Figure 52 i8 a perspective view of the alternative blunt r~n~tlla 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 ~nnllla device of the present invention for injecting or removing liguid through a pre-slit in-line injection site, such as depicted in Figure 51.
Figure 54 is a per pective view of a blunt cannula shield or tip protector for attachment over the end of the blunt c~n~ 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 ~yringe as ~hown in Figure 53.
Figure 56 is a perspective view of the blunt r~nn~ device ~hown in Figure 53 in joined relationship with the pre-slit injection ~ite shown in Figure 51.
-2~27591 WO ~/11103 PCT/US~/01350 Det~iled Descr~ ion of ~he Preferred ~mbodiments While this invention is susceptible of embo~i~?nt in many different forms, there are shown in the drawing and will be described herein in detail specific embodiments thereof with the unders~A~ing that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intenA~ to limit the in~ention to the specific embodiments illustrated.
A prior art pre-slit in;ection site 10 and associated blunt c~nn-ll a 12 are illustrated in Figure 1.
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 rel~tively thin disc-~hApe~ re~ealable member 20. The member 20 has a resealable or~i ng 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 op~ 22.
The c~nnl~la 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 ~ Ahly engages the opening 22. The f~ 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 c~nn-ll a 12 will then be in fluid flow communication with the flow path 16 via the hollow piercing member 26.
In ~ollLl~distinction to the prior art pre-slit injection s~te 10 of Figure 1, Figures 2A and 2B
illustrate a ~re _lit injection site 34 being coupled to a peripheral venous catheter 36. The catheter 36 is shown in fluid flow comml~nic~tion with ~ vein in a hand H of a patient. The catheter 36 carries~at- a proximal end 38 a lue~ ~y~a female twist lock csnn?ctor 41.
20275g~ --WO ~/11103 PCT/US90/01350 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 ~econd 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 ad~acent the re~on~ end 44.
The threads 48 will engage the flange member 41 when the injection site 34 is rotated in a direction 50. When 80 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 srAç~ apart surfaces 54 and 56 respectively. The surface 54 has been forced into a dome-like ~ e by Annl-l A~ U-~h~p~ 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 cle~ni~ 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 ~eptum can be formed of a thermoplastic ela~tomer. The material used for the septum 52 ~ho~ be non-toxic and ster~ hle such A S by means of radi~tion, steam or Ethylene Q~ A~ .
R9~ the septum 52 ~ gQnerally cylindrical in shape, it can be die-cut from a sheet, cut from an extruded rod or molded. The ~eptum 52 c~n have an exemplary diameter on the order of .30 inçh~ (0.762 centimeters). The height of the ~eptum 52 can be, for example, on the order of .125 i~h~ (.317~ centimeters).
The fir~t end 42 is also formed with a t~pered interior ~urface 60 which terminates in an ~n~ ch~nnel ~ ~027~91 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 oh~nr~l 62 is on the order of 10%.
The `h~nllel 62 is ho~n~3e~ in part by a septum D~ OL Ling ridge 62a. The ch~nrl~l 62 can typically have a depth in a range of .050-.070 ;n~hes (.l27-.l778 centimeter~).
A peripheral surface 64 of the septum 52 slidably engages the tapered interior l;urface 60 as the septum 52 c into the first end 42. The annular ch~ el 62 which underlies the interior peripheral surface 56 of the ~;eptum 52 is provided to permit the septum 52 to deform when a blunt c~nn~la is inserted through an op~nin~ 66 therein.
The housing 40 is al80 formed with a fluid- flow path 68 ~iuch that fluids injected via a blunt cannula in~;erted through the reQealable orGni ng 66 can flow into the catheter 36 for delivery to hlmd H of the patient.
The ~;waged end members 58 _pply axial forces to the ~eptum S2 thereby creating the domed exterior peripheral ~;urface 54. The AYi A~ forces applied by the end members 58 slightly deform the regions 52a and 52b.
In ~u,.L~adistinction, the tapered internal surface 60 applies rA~iA1ly directed forces to the septum 52, thereby forcing the ore~ 66 into a ~ -6-1 ed condition.
In an alternate embodiment, the surface 52 could be formed as a flat, as ~ to a domed, surface.
Once the in~ection ~;ite 34 is lo~cin~ly engaged with the catheter 36, a r^- le~ system is formed through whi ch fluids can be infused into the catheter 36. The ^lAhle ~;eptum 52 closes the fluid flow path 68.
Figures 4A and 4B illustrate in combination the in~ection ~;ite 34, a blunt shielded c~nn~ 80 and a syringe of a ~-~n~,el.Lional type 82. The syringe 82, as is we~l known, can be formed with a cylindrical hollow end 84 2027591 ~
WO ~/11103 PCT/US~/01350 which carries a ~ale luer-type twist lock thread 86. A
hollow centrally located cylindrical fluid flow member 88 i~ in fluid flow com~l~ic~tion with an interior region 90 of the syringe 82.
5The chielded blunt c~n~ a 80 carries at a first end 92 a female luer twist-lock flange 94. The flange 94 will ~lidably engage the threads 86 of the end 84. Hence, the shielded blunt r~n~t~la 80 can be locked to the syringe 82 forming a closed fluid flow pathway. The shielded 10c~n~ a 80 could alternately be formed fixedly attached to the syringe 82.
The ~hielded blunt cannula 80 carries a cylindrical hollow protective shield 96 which surrounds a centrally located hollow, elongated cylindrical blunt 15piercing member 98. The cylindrical blunt piercing member 98 has a total length on the order of three times the thirknr-~ 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 2052. The shield 96 is desirable and useful for maint~ining the piercing member 98 in an aseptic con~ition by .Ling touch cont mination prior to the shielded c~ 80 engaging the pre-slit septum 52. Al~o, the shield helps to align the piercing member with the pre-25slit septum.
The cylindrical blunt piercing member 98 can slidably engage the pre-slit septum 52, best illustrated in Figure 4B, thereby exte~in~ through the preformed oren~ n7 66 therein. As illustrated in Figure 4B, when the 30piercing m~mher 98 fil~hly engageæ ~nd pierces the septum 52, the region 52a deforms by ~Y~ in~ into and filling, ~t lea~t in part, the AnnlllAr ~h-n~el 62.
The deformation f~ tates insertion of the piercing member 98 through the slit 66. Subsequent to the 35piercing member 98 slidably engaging the in~ection site 34, the $nterior region 90 of the syringe 82 is in fluid flow communication with the flow path 68 of the injection %Q~759~
.
WO ~/11103 PCT/US~/01350 .. .. . ..
~ 17 site 34 via flow paths 88a and 99 respectively of the syringe and the blunt piercing member 98.
In this engagement condition, the ~eptum 52 ~eals completely around the piercing member 98. ~ence, exterior gase~, liguids or airborne matter will be excluded from the çh~n~Pl 68.
Subsequent to infusing fluid from the syringe 82 into the fluid flow pathway 68, hP~ce into the catheter 36 and the hand H of the patient, the syringe 82 with lorkin~ly engaged shielded rann~la 80 can be slidably withdrawn from the injection site 34. Subsequent to this withdrawal, the septum 52 rD~ the ope~i~g 66 therein.
The op_~ing 66 will repeatedly lc-^-l, when the piercing member 98 is removed, provided that the pressure (in the septum 52 of the orening 66) created by interaction of the septum material properties and compres~ion ~upplied by the housing eY~-eA~ the pressure ~hallenge of the fluid con~nr~ within. Blunt cAnn~lla do not h~rh~7~rdly core, lacerate, or otherwise damage the 20 r^~l ~ng interf~ce 66 as CG~.~e~io~l n^~^~les do, thereby allowing repeatable ,~ lAhility. ~owever, septum ~aterial properties, thir~n-~c, and compression allow L ~ bility for a finite number of conventional needle insertions. The combination in;ection ~ite 34 and catheter 36 then e~u~.- to its pre-infusion, ~ealed condition.
Figures 5A and 5B illustr~te the pre-slit injection site 34 used in combination with a blunt ~nn~ 80a. The rAnn~la 80a includes a hollow body portion 92a with a luer flange 94a, a piercing member 98a, ~nd manually operable elongated lo~i ng members lOOa and lOOb. Alternately, a tubing member could be affixed to the hollow body portion 92.
C~ed end regions lOOc of the members lOOa and lOOb ~ hly engage the -E-on~ end 44 of the housing 40 when the piercing member 98a of the blunt r~nnllla 80a has been forced through the pre-formed or~i n~ 66, best illustrated i~ Figure ~B. The embodiment illustr~ted in 2027591 ~
WO ~/11103 PCT/US90/01350 Figures 5A and 5B has the advantage that the infusion c~n~ a 80a cannot accidentally ~ir~age from the pre-slit ~eptum 34 during the fluid infusion process. It will be understood that while ~pring-like deflecting members 5lOOa and lOOb are illustrated in Figures 5A and SB that other forms of locking members are within the ~pirit and scope of the present in~ention.
Figure 6 illustrates an alternate pre-slit injection site 34a. A tubing member 102 can be fixedly lOatt ched to the cylindrical hollow fluid flow member 46.
The emko~ nt 34a of Figure 6 utilizes the same structure for the septum 52 including the tapered surface 60 and the underlying annular ~n~el 62 as does the embodiment 34 in Figure 3. The shielded CA~Ul ~ 80 can be utilized with 15the in~ection site 34~ as previously described.
In the event that it is desirable to infuse solution from a con~Ajner 104 with a connectional port 106, a fluid admini~tration ~et llO of a conventional variety may be utilized. The ~et llO includes a spike 20co~n~ctor 112 at a first end. The ~pike ~o~n~ctor 112 is d~signed to pierce the port 106 of the contAi n~r 104. The ~et llO can also carry ~ slidably eng_geable ~o~neotor 114 of a known type at a recQn~ end. As illustrated in Figure 7, the connector 114 can ~lidably engage the 25hollow cylindrical member 98 of the ~hielded c~nnllla 80, thereby placing the interior fluid of the cont~; nPr 104 into fluid communication with the tubing ~ember 102.
Figure 8 illustrates yet another alternate 8Ob to the ~hi ~1 ~P~ ~n~lll A 80. The piercing member 98b carries 30a tubing member 118 fixedly attached thereto. The tubing - member 118 could be coupled at a second end to a cont~;ner such as the contAinPr l04.
The present pre-~lit injection site can be directly affixed to a contA; n~r 120 as illustrated in 3SFigure 9. The contA;n~r 120 includes a rigid hollow cylindrical Ar -c~ port 122 aff;~ thereto. The access port 122 includes a fluid flow ~h~n~l 124 in fluid flow communication with the interior of the cont~ n~r 12 0 .
~z~5~1 WO90~11103 PCT/US90/01350 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 fir~t end 130 has been swaged to form An annular U-~h~reA retAining member 136. The ret~ n~ member 136 in turn forms a domed exterior peripheral ~urface 138 on the septum 132.
~he first end 130 also includes a tapered interior force applying surface 140 and an annular rh~nnel 142 underlying the ~eptum 132. As dis~-lcF~
previously, the ~h~n~lel 142 provides a ~pace into which the septum 132 can deform when a blunt c~n~lla is forced through the r~e~l~hle 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 ~G~ Lional port 106 of the bag 120.
While the bag 120 is illustrated formed with two 20 ports, the ~o~e,.Lional pierceable port 106 and the pre-slit in~ection site 126, it will be understood that as an alternate (Figure 10), a contA~r 150 could be formed which includes only the pre-slit injection port 126. The removable cover 146 could be used in combination with the cont~ 150.
As illustrated in Figure 11, the pre-slit injection site 126 can be utilized for the purpose of n~ecting fluid from the syringe 82, coupled to the ~hielded n~nnt~l ~ 80, into the cont~in~r 150. When so ut~li 7~A, the blunt piercing member 98 is used to place the interior fluid con~n~ region 90 of the syringe into fluid flow communication with the interior of the contAin6~ 150.
Figures 12 and 13 illustrate a fluid flow coupling system 151 having as ~ first element a pre-slit iniection site 126a. The ~ite 126a is the same ~s the ~ite 126 except for a plurality of exterior threads 153 formed on an~ exterior peripheral surface 155 of the ~027~91 ~ ~
WO ~/11103 PCT/US~/013~0 housing 128a. A second element of the coupling system 151 is a shielded ~lunt c~nula 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 lS3.
The two co~no~tor elements 126a and 157 ælidably engage one another when the shielded ~nm-l~ 157 moves in ~n axial direction 167 tow~rd the injection ~ite 126a.
The blunt piercing member 165 penetrates the ~eptum 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 ~esult, the two coup~ing members 126a and 157 are loc~;ngly engaged together with the insertion member 165 eX~en~ing through the op~in~ 134a in the septum 132a.
~ce, fluids can flow from the cont~i n~ 150a via the connPctor system 126a ~nd 157 through the tubing member 159 to the recipient.
Injection ~ites of the type described above are also u able in co~nection with other fluid flow coupling com~ r.~Ls. For example, with ~__~ect to Figure 14, a pre-slit injection æite 160 of the type described above can be u~ed in combination with a spike connector 162 of a ~ v~ on~ l v~riety. Spike ~o~n~ctors such as the ~pike co~n~ctor 162 can be used to pierce ~v~.vel,~iQn~l ports such ~8 the port 106 of the con~;n~ 104 (Figure 6).
When the spike ro~nector 162 i~ 80 used, the pre-slit in~ection site 160 can then ~e utilized for the ~u.~c ~ of coupling to other fluid Administration 8et~.
The injection 8ite 160 illustrates _n alternate form of ~waging the fir~t end 42c for the ~ C of retA;n~n~ the septum 52c therein. The first end 42c can be ~waged 80 ~s to form ~n ~m~l A~ly ~h~-~ E ~, ~piral, ~ ?o275gi WOg0/11103 PCT/US~/01350 spring-like me~ber 164. The me~ber 164 has a free end 164a which engages the exterior dome-shaped peripheral surface 54c of the septum 52c. The spiral, spring-like swaged me~ber 164 will tend to uncoil, thereby continuous-ly applying axial force to the septum 52c and main~iningthe domed exterior peripheral surface 54c.
In yet another alternate, Figure 15 illustrates a pre-slit injection site 166 formed in ~ Y-junction member 168. The Y-~unction member 168 is fixedly attached to first ~nd 6econd tubing members 170 and 172 respectively.
As an alternate to forming the ~lit 66 completely through the ~eptum 52, ~s illustr~ted 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 - ~ealed.
The ~eptum 52 can be formed in two part~. One part can have a slit, such as the slit 66, exten~ing entirely therethrough. A r~co?l~ part can be formed without a ~lit. 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 ~An~nl A
alignment with the slit upon insertion, ~nd aids ~ Ahility by minimiz~ng the critical ~lit ~ealing interface area.
In accorA~n~ with the p~--ent inv6~Lion, the slit could have a length with a range on the order of .03 inches (.0762 centimeters) to .150 inches (.381 centimeters). Prefer bly, a ~lit length on the order of . 07 ~? nc~ c (.1778 centimeters) will be used in co~bination with a blunt C~nmll A having a diameter on the order of .1 inr~h~; (.254 CentimeterS)-When initially used, the blunt Ç~nmll A piercing member, such a8 the me~ber 98, will be forced through the ~lit 66a. The lower peripheral ~urface 56e will then be LULe1~ providing A~ S for the blunt rannl~lA piercing m~nher g8 into the fluid flow pathway 68e.
2~7~
WO90J11103 PCT/US~/01350 Pre-slit injection sites of the type described above can be utilized in combination with L~eLLe 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 ~urface 180 of the ~le~Le 182. A removable cover 184 can be used to maintain the injection site 178 in an aseptic condition until blunt cAnn~ 186 or 188 is inser~ed therethrough.
Figures 19 through 23 ~; FOl ose a method of making a pre-slit injection site in accordance with the present invention. In a fir~t step, a housing 200 is provided.
The housing 200 has an interior tapered sur~ace 202 at a first end 200a thereof. The interior peripheral surface terminates in an ~nnt-l Ar ~h~nn~l 204. A cylindrical septum 206 can be provided adjacent the end 200a.
In a ~Q~ ~tep, 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 AYi ~11 y moving die 210. When positioned by the die 210, the septum 206 is located ~djacent an internal ~nnular right 212 which h~ -~c the Ann~ ~ c~nnel 204.
In a third fitep, a reoQn~ die 214 can be utilized to swage the end 200a into spiral~ re~, spring-like members 200b which apply AY~Al ly directed forces against ~n exterior peripheral surface 206a of the geptum 206.
The ~Yi~lly directed forces form the flat surface 206a into a domed exterior peripheral ~urface 206b as illustra-ted in Figure 23.
Simultaneously, with ~waging the end members 200a so a~ to lock the ~eptum 206 into the housing 200 and to form the domed exterior peripheral 6urface 206b, a knife 216 can be utilized to form a slit in the septum 206.
Altern2tively, the slit may be cut ~y a ~eparate die in a separate step. If the septum 206 i~ formed as an _~L~u~ion~ the slit can be created during the extrusion . If the sep~um 206 is formed by stamping from a rubber ~heet, the slit can ~e cut during the ~tamping %~27Sgl WO ~/11103 PCT/US~/01350 process. If th~ ~eptum 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 b~h; ng can be used. A trailing ribbon may be S 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 ~lit and provide lubrication and a visible target for ç~n~lt~la insertion.
Figures 24 and 25 illustrate alternate swaging steps wherein a die 220 moving ~Yi~lly toward the housing 200 swages the end region 200a 80 as to form an annular U-ch~re~ region 200c and the exterior domed peripheral surface 206c.
The dies 214 or 220 can be formed with various alternate ~h~re~ swaging surfaces 224, as illustrated in Figure 26, deper~ q 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 in;ection site configur~tion 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 ca~Lu~ed in a chousing which provides compression to create a seal against pre~sure and a void region to accommodate deformed portions of the sealing member material only when the material is deformed or displaced by a blunt c~n~ la pierc$ng member. One ~uch 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 c~n~ a 98. The ~nn~ 250 includes a proximal end 252 with an ~nterior region 254. The region 254 is in part bounded by 2027~gi WO ~/11103 PCr/US~/013~0 an internal peripheral wall 256 which is formed with a st~Ard 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 ~i~c~csed.
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 ~urface 266. The tapered exterior ~urface 266 minimizes insertion force as the r~nn~ 250 is being forced through a ~lit of a septum, ~uch as the ~lit 66 in the septum S2. The angle of taper of the surface 266 is preferably in a range ~etween l to 15 degrees.
The member 260 is also provided with a plurality of elongated yLouves 268. The ~.o~es 268 in the exterior wall of the member 260 decrease the surface area of contact at the c~n~ /septum interface during insertion of the c~nnlll A into the injection site 34. This r~A~ A
exterior contact surface area decreases the frictional comr~nent of the insertion force.
In one embodiment, the tapered blunt cAnnllla 250 may have overall insertion length ~ CorresronA i nq to combined ~xial lengths of mid-region 2S8 and end member 260, on the order of 0.375 ~n~h~ (.9525 centimeters).
An alternate c~nnllla ~tructure 280 is illustrated in Figures 31, 32 and 33. The c~nnl-l A structure 280 includes a proximal end region 282 corres~onAing to the end region 252 of the cannula 250. The region 282 includes a luer flange 283. The c~nnlll A 280 ~lso includes a central, elongated, cylindrical region 288.
The ~enL~l region 288 carries at a distal end thereof an elong~ted cylindrical end member 290. The ~ 2G~591 ~ ]' 25 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 ~econd 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 c~n~l7~a 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 ~ 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 9o degrees apart around a longit~ n~l axis 300. The slots 294 increase the internal flow path cross-section. This increases the fluid flow rate.
The slots 294 also pro~ide for enhanced d~spersion characteristics ow~ng to the fluid flowing - radially out through the slots 294. This radial flow, effecting ~s change in fluid flow direction of about so degrees, promotes fltlC~i ng ~nd dispersion of fluid through the injection site 34.
Another emho~iment of a blunt c~n~ a 310 is illustrated in Figures 34 through 37. The c~n~t 1 A 310 is formed with an enlarged prnYi~l ro~n~tion region 312 corrc~ ;ng to the region 252 of the c~nm-la 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 co~ection region 312. The cylindrical interr^~i~te region 318 includes a fluid flow path 320 in communic~tion 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 ~7S9i WO ~/11103 PCT/US~/01350 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 CAnnl~ A . The lead post 330 facilitates insertion by providing a very low insertion force at the beginning of the insertion step as the ~nmlla is p-lch~ 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 ; n~h~c ( .1524 centimeters) and a diameter on the order of 0.050 inches (.127 centimeter~).
The end region 318 includes a novel structure for increasing the flow rate and erhA~cing ~i~r~sion characteristic~. 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 ae ~e~t illustrated in Figure 37.
The fluid flowing through the c~n~ a 310 undergoes a change in direction (of up to about 90 degrees relative to the cAn~ a center line 337) in the slots 338. This change in direction increases fluid di~persion. Further, since the slots 338 open radially, fluid flow can be maint~ even if the end surface 332 of the ~n~t~la is rll~A Up A~A inct any material in ~he system in which the r~nn~ is inserted.
Another embodiment of the tapered r~nnl-l A of the ~-ent invention is illustrated in Figures 38 through 40 and is designated generally therein by reference numeral 340. The c-~nnl~la 340 includes a proximal end 342 which c~n include a luer coupling flange 344 for cooperating with a suitable mating ~tructure on a syringe. The proximal end 342 also define~ an interior region 346.
Extending from the proximal end 342 is a generally cylindrical mid-region 348. Ex~enAing from the -20275gl WosO/11103 PCT/US90/01350 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 ~h~nn~l 354 which com~unicates with the interior region 346. Fluid ~ h~rges from the flow ch~nnel 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 c~Annel 354 through the apertures 358 improves fluid dispersion with respect to mixing or flushing in the system downstream of the r~nn~la (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 p~c~^c rA~iAlly out through the apertures 358, fluid flow through the r~nn~lla 340 can be maintAine~ even when the distal end surface 356 of the cannula is bottomed out or pll~h~A against any material in the system in which the c~nnnla is inserted.
The ~tructure of the rAnnt~la 340 is adapted to be constructed with a minimal lead post length (i.e., the portion of the CAnnlll 8 distal end between the end surface 356 and the interior flow rh~nnel 354). Further, the design accommodates the use of a minimal tip diameter, minimal taper angle, and minimal cannula di_meter. The minimization of these par~meteræ results in a decrease in the peak insertion force required to properly install the ~Anml~a in the injection site.
Preferably, the total cross-sectional flow area through the three apertures 358 is about three times the cross-sectio~l flow area of the interior rh~nn~l 354.
This ~nh~cec the flow rate capability compared with a simple open ~nA~ cylindrical flow ~hAnn~l of equal length.
The design of the r~n~t~la 340 also is effective in r~ ng or- limiting ~kick ~ack" or recoil of the c~nn~l a after insertion. The resilient material of the septum in ~ , WO90/11103 2~ 5~i PCT/US90/01350 an injection site can subject the r~n~ a to forces ten~ing to push the can~ 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 c~nn~la of the present invention i~ illustrated in Figures 41 and 42 wherein the cAnn~la embodiment is designated generally therein by the reference numeral 360. The c~n~ 360 includes a proximal end 362 defining an interior region 364 and having a luer flange 366 for ro~n~ction 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 ~n~l~la 340 illustrated in Figures 38 through 40, the embodiment of the canntll~ 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 ~han~Pl 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 2S small t~per to minimize the insertion force.
Further, the design permits the c~nntll~ 360 to be con~tructed with a small tip diameter, small taper angle, and ~mall c~nnl-l~ diameter so as to reduce the peak insertion force.
Another embodiment of the c~nnl~la of the present invention is illustrated in Figures 43 through 44 and is de~ignated generally therein by reference numberal 380.
The rAnn~la 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.
EXt~n~n~ from the proximal end 382 is a mid-region 388. A distal end region 390 ~xtends from th~ mid-region 388. An internal fluid ~low rhan~el or path 392 -~ 202q591 W090tl1103 PCT/US90/01350 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 c~n~la 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 lo 396 has a sufficient radius ~o 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 inC~ (.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 c~n~ 380.
Still another embodiment is illustrated in Figure 45 which includes a blunt tapered c~nm~la insertion member 400 for insertion into a pre-slit injection site, the c~nl~la 400 having a distal end region 402 with a tapered exterior ~urface which in the preferred embodiment is an approximately 8 deyLLFs taper. The defined aperture 404 for fluid flow i5 di~ at the end 406 of the distal end region 402. The end 406 includes a radiuced tip defined by a radius of approximately 0.01 inch (.025 centimeters). The radiused tip re~ eC insertion force, assists in locating the slit in the injection site and in addit~on has the practical advantage of facilitating complete f~ g of the c~nnl-l a mold cavity.
The tapered ~urface of the di~tal end region 402 3~ has an axial length of a~oximately 0.10 inch in the preferred embodiment. Ad~acent to the tapered distal end region is a generally cylindrical region 408 for entering into the injection site ~hi~d the distal end region 402, 2~7~
WO90/11103 PCT/US90/013~0 thereby reducing kick back during insertion. The generally cylindrical region 408 has a small draft anglé
such as about one-half degree.
The force required to insert any of the above-~i~c~c~ embodiments of the blunt tapered cannula into the septum of the injection site depends upon a number factors: friction at the c~n~ a/septum interface, c~nllla diameter, cannula taper angle, and degree of septum co~ ession. The c~n~l~la/septum interface friction i~, in turn, ~pen~P~t upon lubrication, if any, material properties, and surf~ce finish. It will be understood that the friction at the r~nn~la/~eptum interface can be reduced by providing a smoother surface finish on the cannula (e.g., by sand blasting the c~n~l~l a exterior surface) or by molding the c~nnll~ so as to ~o~ce a matte finish. Conventional lubricants can also be used to further reduce ~he friction and thereby lower the insertion force required.
In the embodiments of the ~Annlllae 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 w~th the tube having a distal end region for penetrating the injection site.
In preferred contemplated em~odiments, the exterior surface of the distal end region may h~ve a taper angle as small as between l and 15 degrees.
Further, a loc~ing means, such as the loc~nq arms lOOa and lOOb ~i~c~ with reference to Figures 5A and 58, may be provided on the ~An~ A embodiment~ illustrated in Figures 29 through 44 to permit the c~nn~llAe to be releasably locked to the injection site.
The above described insertion members, usable as part of a blunt rAnm~la, are preferably molded of a plastic formulation including silicone or other lubricant.
~he use of silicone or other lubricant increases the ease of insertion of that ~ember into the pre-slit in~ection site.
-~ ~ 2~275g~
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 c~nnl~la member 410 is preferably of one-piece molded, rigid plastic, with a through bore 416 exte~;ng 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 ex_mple, syringes, admini~tration sets and the like. Tnternally, 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 st~n~d male luer co~Pctors utilized in many medical devices, as is well ~nown in the medical field. The hollow cylindrical portion 412 may also include a pair of op~o~ flat surfaces 420 for cooperation with a tip protector or shield such as depicted in Figure 47, which is described below.
The blunt c~n~ portion 414 extends generally ~YiAlly from the hollow cylindrical portion 410. The cAn~--la 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 i~ an enlarged view of a hollow shield or tip protector 428 for covering and protecting a blunt rAnn~ uch as, for example, the blunt ~nnl~la portion 414 of blunt r~tnn~ member 410 shown at Figure 46 or other blunt r~n~ Ae a~ disclosed herein. The shield 428 has a generally elongated housing 430, which is open at one end for receiving the blunt c~nnt-l A At the open end, the interior surface 432 of the shield generally co~,~7l~-Jc to the ~h~p~ of the exterior-surface of the blunt~ cannula portion 412, i.e., it i~ generally cylindrical, with a pair of oprQ~^~ flat 8urfaces 434 WO90/11103 202~$91 32 PCT/U590/~1350 matching the flat surfaces 420 of the blunt ~nn1lla device 410. Further, either surfaces 432 or 434 can be provided with ~tanding ribs to co11L,ol the depth of insertion of the blunt cannula portion 414 into housing 430. The matching flat ~urfaces of the shield and the blunt ~n~11la device allow a user to secure the blunt cannula onto a syringe or similar device, for example, without exposing the ~n~ a portion 414 to touch contamination. When access to the blunt cannula is required, the shield may simply be slidably removed from the c~nn1~la. As can be appreciated, the outer surface of the shield 428 can be rh~re~ in ~uch a manner or provided with a roughened finish to assist the user in gripping or removing shield 428 from the c~nnllla.
Typically, the blunt cannula 410 or other blunt r~n~1~la 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 c~n~ a to the mating product, e.g., the male luer fitting of a syringe or administration set. The matc~ flat surfaces 432 of the ~hield and ~20 of the blunt c~nn1~la act as a wrench to allow any twisting force applied to the shield to be transmitted to the c~n~lll A ~ e.g., for threading the oAn~ onto a luer lock device or for applying a twisting force in making a luer lip cn~ction.
Figure 48 shows what is commonly referred to as a heparin lock, generally at 436, employing a pre-slit injection ~ite 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 i,-Ll~enous therapy, it is not llnllc~l~l for the admini~tration of liquid to be interrupted from time to time. Instead of performing a new catheterization pro~ e each time administration is to be restarted, it is often preferable to utilize tAe same catheter, thus reducing the number of catheterization procedures, more ~ 20275~1 WOgO/11103 --, PCT/US90/01350 colloquially referred to as the number of "sticks," and reducing the trauma and risk associated with each such proce~l~re .
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 maint~ining 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 in~ection site 442 of the type previously ~icc~lc-^~ in detail. An axial fluid flow p~ geway 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 ~ul~uu~.~ed by generally cylindrical gripping collar 446. Threads 448 are provided on the interior surface of the collar for thr~A~ y engaging a 8~ rd luer lock ç~Pctor, as is often found on i~.LLavenous catheter devices. The exterior surface of the collar 446 is generally arcuate in cross-sectional ~h~p~
(as best s~en in Figures 49 aNd 50), to provide a gripping ~urf~ce. ~he ~urface curves generally outwardly in a direction toward the pre-slit in~ection site 442. This allows the nurse, physician or att~ n~ staff member to grip the h~parin lock and to re~se any force exerted during e..L~ of a blunt- r~ a into the pre-slit injection site from being transmitted to the venous catheter. For improvement in the gripping, a ~eries of axial groove~ 450 are provided in the exterior surface of the collar 446.
W090/11103 ~0~75~ PCT/US90/01350 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 c~nn1lla for threaded lo~-k; ng engagement to a blunt cannula device of the type having an interiorly threaded ~leeve or shield, such as depicted in Figure 50. The heparin lock 436 also includes a generally radially-ext~n~;~g shoulder 454 for locking retention of resilient gripping fingers on a blunt c~nn11la device of the type ~hown 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 cite 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 in~en~ for u~e with blunt cannulae. In the preferred embodiment, however, the visual identifier comprises a distinct color identifier and, more partir~ rly, is a brightly colored ring 456 (Figure 48) circumscribing the pre-slit injection site 442. While the color ~elected may vAry ~p~1ng on application, it should be a color which is distinct from and in ~o..L~ast to the color of any plastic used in the manufacture of the heparin lock.
Aæ noted earlier, the heparin lock 436 depicted in Figure 48 may be used with a variety of styles or types of blunt end ~nn1lla devices. For example, the heparin lock may be used with a bare blunt end ~nnl~ uch 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 ~An~1~la device 458 which utilizes a pair of resilient gripping fingers 460 for retAi~ing the blunt ~nn~la in .
W090~11103 PCT/US9OtO1350 joined relationship with the heparin lock. The blunt c~n~ a de~ice 458 depicted in Figure 49 has a generally cylindrical, hollow base or body portion 462 and a blunt c~n~llla portion 464 substantially as described earlier in co~n~ction 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 co~n~ctor to the blunt c~n~t~la device.
Each of the gripping fingers 460 is mounted to the body portion of the blunt cannula device by an intermediate radially exten~ wall portion 466. The gripping fingers have rA~ y inwardly directed retention means 468 at one end for engaging against r~ l shoulder 454, and gripping means 470 at the other end for squeezing and spre~; ng the retention means to release the blunt cAn~ A device from the heparin lock. Tn the as-molded condit~on, the gripping fingers are b~e~ radially inwardly, toward the blunt c~nntlla 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 rele~
When used in combination with a h~r~rin lock such as depicted in Figure 48, the blunt c~n~ device 458 may be att~ by ~imply p--~h 1 ~g the blunt ~n~tll a into the pre-slit injection site 442. A forward facing tapered surface 472 (Figure 49) in front of the threads engages a ~imilar tapered surface 474 on the retention means 468 50 as to naturally spread the fingers 460 apart ~s the blunt ~n~llla i8 forced into the pre-slit in~ection site. After the blunt c~nnl~l~ is inserted into pre-slit injection site sufficiently far so that the retention means are beyond the radial 5houlder 454, the gripping fingers will snap -WO ~/11103 ~0~7~9~ 36 PCT/USgO/01350 inwardly behind the æhoulder, holding the blunt cannula in the position depicted in Figure 49. To withdraw the blunt c~nn~la, the user need simply sgueeze the gripping end 470 of the hAn~les~ which will ~pread the retention means of the fingers and release the blunt ~nnnl~l a device from the heparin lock.
The heparin lock of Figure 48 is also useful with a blunt c~nn~la device 475 having an internally threaded shield or ~leeve, such as depicted in Figure 50. Figure lo 50 illustrates the blunt c~nnllla device 475 as it first enters the pre-slit i~ection site 442 of the heparin lock and prior to engagement with the heparin lock threads 452. The blunt c~n~l A device shown in Figure 50 has a generally cylindrical outer wall 476 and a transverse end wall 478. A blunt ~nnl-l~ 480 extends through the end wall. The blunt rAn~ a m~y be constructed in generally the ~ame manner as the blunt r~nn~ portion depicted in ~igure 46 or in accordance with the other embodiments of the present invention.
The cylindrical outer w~ll 476 preferably extends beyond the tip end of the blunt ~nnlll A to protect the c~n~ against inadvertent touch contamination. The interior ~urf~ce of the cylindrical w~ preferably threaded at 482 for thrQ~P~ly engaging the device to which the blunt ~nml~ is attached, such as the heparin lock depicted in Figure 48. As noted above, ~igure 50 depicts the blunt c~nn~ device 475 at an initial entry position. Further insertion of the blunt ~nnllla and simul~nen?lc turning of the blunt cAn~ device results in threaded lo~in~ engagement between the blunt ~nn~
device 475 and the heparin lock.
The blunt r~n~l~la 480 of the blunt ~nn~ device 475 i~ in fluid communication with ~n entry port, generally defined by wall 484, which extends in the opposite direction of the blunt ~nnllla~ from the other side of the tr~nsveræe wall. The ~lIL-~ port is for attachment to other devices such as syringes, tubing, administration ~ets or the like, and ~ay take such form as ~ 2027591 is appropriate for the particular device to which it is attached. The entry port 484 preferably has a tapered inner surface for receiving a s~An~rd 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 c~nnl~la portion for flow therebetween.
Figure 51 shows, in cross-section~1 view, a further alternative device 492 which may employ the pre-slit injection site of the pre~ent invention. The pre-slit injection site device 492 depicted in Figure 51 is an in-line device, preferably for adding medication to a lS 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 ~on~ecting the injection site device within a fluid flow path. As depicted, the inlet defines a ælightly tapered female surface and the outlet defines 8 similarly female tapered surface which are preferably joined by solvent 25 hon~ i n~ a similar attachment to plastic tubing of an administration set, extension set or the like. S~ rd luer fittings or surfaces could also be provided at the inlet or outlet, as desired.
~or injecting liquid into the fluid stream or 8 mpling the fluid stream, the device has ~ side ~h~n~l 496 which comm~ tes between a pre-slit ~eptum 502 made and assembled in accor~A~ce with the present invention, and the fluid r~ qeway 498. The ~eptum 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 c~nnUl a, auch as ~nn~ S06, may be inserted through the -WO90~11103 2 ~ 2 ~5 ~ PCT/US90/01350 -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 u~ed in combination with a bare blunt cannula, æuch as that depicted in Figure 51, or may be used in combination with the blunt cannula device 458, depicted in Figure 4g, when a lo~i ng relationship between the blunt ~nntlla and injection site is desired.
As depicted, for example, in Figure 52, the blunt c~nnlll a device 458 may be attached in a secure locking relationship to the in-line injection ~ite 492. As shown there, the in-line injection site has a radially extending shoulder 508 on each side of the housing, for engaging ~gainst the retention means 468 on the end of the resilient gripping fingers 460. As with the heparin lock, the in-line injection site alæo includes a generally tapered surface 510 defined on the exterior surface for æpreading the retention means as the blunt cannula is inserted into the in;ection site. As was described above, insertion of the blunt c~nnl~la into the injection site results in the retention ~eans being spread by the tapered surface 510 and, as the blunt c~nnlll a is inserted farther, the retention means snap into a locking position behind the radial shoulder 508. In this arrangement, the blunt cAnn~ is securely locked onto the in~ection site and inadvertent withdrawal is thus p~ ,.Led. To remove the blunt c~nnllla from ~he in-line in~ection site, the gripping ends 470 of the resilient fingers are æqueezed, causing spreading of the retention means 468 and release from the injection site. ~he c~nnlll a ~ay then be simply removed by withdrawing it from the in~ection site.
Figure 53 depicts yet a further embodiment of the present invention. That figure depicts a blunt c~nmlla device 512 embodying the present invention in combination with a syringe 514. The ~lunt c~nn-ll A device 512 has a generally cylindrical outer wall 516 which encloses and substantially protects a blunt c~nnula portion 518. The '~ 20275gl WO 90/11103 ; ~ PCr/US90/01350 blunt c ~nnol a portion is attached to and extends from an intermediate transver~;e interior wall 520. The blunt r~rnl~la device 512 may be attached to a ~yringe 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, ext~n~ing therewithin to the transverse wall 520.
Although various syringes may be used in cor~ ction with the blunt cAnm~la device 512 without departing from the present invention, the ~yringe 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 ~uL~o-es of complete~sc, the syringe depicted in Figure 53 has a pair of resilient pistons 522 ~;paced apart, with the fluid to be disr~r~
cont~ P~ between the pistons. A plunger rod 524 pushes the pistons forward until the forward most piston engages ~g~ t an entry port 526 which extends in a direction opposite the blunt c;~nr~lll a 518. The forwardmost piston has a frangible portion, which is pierced by the entry port, rele~sing the liquid cont~in~ between the pistons for ~ ion through the blunt cAnn1ll~.
In accordance with the present invention, the blunt c;~nt~ portion 518 is ~ubstantially protected from inadvertent touch contz~mination by the outer cylindrical wall Sl6. To permit the blunt c~nl~lll a to be used, however, with the in-line injection site 492 or a similar device, a pair of ~_~r~l, generally U-~hApe~ receC-es 528 are provided in the cylindrical wall for recei~ring the inlet- and outlet portions 494, 496 of the in-line in~ection ~;ite when the c~nn~ is ~tt~he~ to it. This arrzmgement is depicted in a perspective view in Figure s6. As shown there, the blunt c~nnnla device 512 may be attAfh~ to the in-line injection site by inserting the 3S blunt rAnr~ portion into the pre-slit injection site, with the U-~hApGd r~C~^C 528 receive the inlet and outlet portions 494, 496 of the in-line injection site, -2~7~g~ .
WO90/11103 PCT/US~/01350 thus allowing the bare c~nn~lla to be inserted suffi-ciently far into the pre-slit injection site.
Figure 54 shows a shield or tip protector 530 for a blunt ~nnl~la device of the type shown in Figure ~3.
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 c~n~ a device 512, and is sufficiently long to extend ~eyond the U-~hArD~ rec~c~es to completely enclose and protect the blunt c~n~t~la 518 during shipping, storing and between uses, if so desired.
Concentrically disposed within the cylindrical wall 532, the tip protector has an ~YiAlly exten~;ng, hollow tube 536 for slidably receiving the blunt cannula 518 therewithin. The shield or tip protector 530 would - typically be attached to the blunt ~Anntll A device 512 during manufacture, and removed when the syringe and blunt c~nn-~la device ~re used. If so desired, it mày be reat-tached between uses to protect the cannula from any further contamination.
Figure 55 is an ~lternative embodiment of the blunt cAnnl~la device ~hown in Figure 53, and is depicted without a syringe at~oh~ to it. As shown in Figure 55, the blunt c~n~tlla device 538 similarly has a cylindrical outer wall 540, a transverse intermediate inner wall 542, a blunt c~n~la 544 ex*e~ing axially from the transverse intermediate wall and an entry port 546 exte~di ng in the opposite direction from ~he blunt C~nnlll A . The essential difference between this embodiment and the one shown in Figure 53 is the ~hcenre of U-~h~pe~ rec~C-es for use with an in-line injection ~ite such as depicted in Figure 56.
For ease of attachment to an injection site, the inner surface of the cylindrical wall i8 preferably tapered at 548.
~rom the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the spirit and ~cope of the novel co~cept of the invention. It is to be understood that no 2027~91 WO90~11103 PCT/US90/01350 ~ '~' 41 limitation with respect to the specific apparatus illustrated herein is inten~ 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.
Deformation of this annular peripheral region results in an insertion force in a range of 2.0 pounds (.7564 k~lograms) to 5.0 rollnA~ (1. 891 kilograms).
Preferably, the insertion force will have a value of the order of 2.0 pounds (.7564 kilograms).
The resaalable or~n~ng in the ~ealing member can extend entirely through that member. Alternately, the resealable opo~g can extend only partway therethrough.
In this embodiment, the end of the blunt c~nn~lla 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 ~eal the site until the blunt cann~ is inserted therethrough the fir~t time.
The intQrior surface of the first end can be formed with the taper in ~ range on the order of 5 degrees to 20 degrees. Preferably, the interior surface will have a tapér on the order of 12 d~.eQr. This tapered surface permits the use of ~ cylindrically shaped sealing member.
To provide for leak-free insertion, the length of the slit in the ~ealing member must be le58 than one-hal~
the circumference of the cannula being inserted therethrough. u~nce~ the slit length may ~Yc~A the diameter of the ~n~ 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.
3~ Further, in accordance with an aspect of the invention, a coupling system for coupling first and ~econd fluid flow members together is provided. The coupling system includes an injection sitQ which i6 affixed to the first t WO ~11103 PCT/US90/01350 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 ore~ therein.
An annular ret~i~in~ member is carried by the housing and cooperates with the housing to retain the sealinq member therein. ~aA~lly directed forces are applied to the sealing member by the housing, thereby urging the or~ into a resealed condition.
A blunt c~ , affixed to ~ronA fluid flow member, has a fluid flow path therethrough. The c~n~t~l a carries a locki~ member for loçkin~ly engaging the housing when the cAnn~la extends through the opening of the ~ ;n~ member. When so positioned, the two fluid flow members are placed into fluid flow cc ~ cation.
The lorki~g member can include a luer-type twist lock fitting. Alternately, the lo~k~ member can include slidably engageable members which are responsive to axial movement of the injection site and the r~n~ a toward one another.
In accordance with further ~p~cts of this invention, the blunt r~nn~lA may be provided with features that facilitate insertion into the injection site, enh~nce fluid flow or dispersion, increase tug resistance, and reduce ~ckhAck.
In part~c~llAr, one embodiment of the ~nnt~la includes a tube with a plurality of elongate ~ir~h~ge slots adjacent the distal end. The fluid changes direction ~8 it ~A~es later~lly through the slots and out of the tube. The flow area of the filots eYreeAc the flow area inside the tube. ~his slot structure ~nh~c~e fluid flow and in~rersion characteristlcs. In addition, the slots decrease the contact. fiurface area on the tube exterior ~o as to facilitate insertion.
In a further modification, the r~n~ll A includes a lead post on the tube distal end to guide the cannula through the slit in the injection site.
~027~9i WO90~11103 PCTJUS~/01350 In another cannula embodiment, the tube is generally cylindrical and the fluid ~icch~rges 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 egual in length. The taper facilitates insertion, and the remaining cylindrical portion r~ ne~ kick~ack.
In yet another embodiment, the ~n~ a includes an annular barb whic~ functions to reduce kickback.
Other advantages of a blunt plastic r~nn-~l a in accor~nc~ 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 ~;ch 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 ~^con~ distinct lock~ ng means are provided on the exterior of the housing for selective ~o o~eration with complementary locking means on different c~nnvl A~ The first locki~g means may be a ~olll A~ for engaging resilient fingers on a c~nnl~la and the r~ ~A lo~ng means m~y be a ~crew thread for engaging a ~crew thread on a d~fferent c~nnlll A . The in~ection site is, therefore, particularly versatile in use.
The invention may also reside in a c~nn~la device having ret~i n~ ng fingers which are resiliently biased to positions in wh~ch they can engage a ~ho~ r of an injection site to lock the c~nnt?l~ device on the site.
S~ hle gripping means is provided for spreading the O90/11103 ~ PCTrUS90/01350 fingers to permit their engagement with a disengagement from the cannula. This provide~ a particularly effective locking system which is easy to operate.
20~75g~ .
WO ~/11103 PCT/US~/013~0 Rrief DescriDtion of the Drawin~s Figure 1 is a side elevational view, partly in section, of a prior art pre-slit injection site and an associated blunt r~n~l~1 a;
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 cite, a hielded blunt c~n~1la and a syringe prior to being coupled together;
Figure 4B is an enlarged, side elevational view in section of the ~-_ -lit injection site, the shielded blunt CAnnt~l A 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 c~n~l-la carrying 2S a loc~in~ member;
Figure 5B is an enlarged side elevational view, partly broken away, illustrating the interrelationship between the pre-slit injection site and the blunt c~nnl~la of Figure 5A;
~igure 6 is an overall view of a cont~ jner, an AF-o~i Ated colution administration set and a pre-slit injection ~ite in accordance with the present invention:
2027~1 Woso/lllU3 PCT/US~/01350 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 c~nnl~la in accordance with the pre~ent invention;
Figure 9 is a side elevational view, partly in section, of a pre-slit injection site mounted on a fragment of a solution cont~i n^r;
10Figure 10 i5 a side elevational view of a fragment of a solution cont~i n~r carrying, as a single port, a p~e slit injection site;
Figure 11 is a side elevational view of the injection site and the fragmentary container of Figure lo 15prior to h~ing engaged with a shielded r~nnt~la carried by a syringe;
Figure 12 is an enlarged ~ide elevat;o~l view, partly in section, of a coupling ~ystem with a pre-slit injection site partly coupled to a blunt c~nml~a:
20Figure 13 i8 an enlarged side elevational view, partly in ~ection, of the coupling system of Figure 12 -~quent to engayement of the two coupling members;
Figure 14 is a side elevational view, partly broken away, of a spike ~o~ne~tor carrying a pre-slit 25injection site in accordance with the p~ Pt invention;
Figure 15 is an enlarged ~ide elevational view of a Y-connector in sect~on c~rrying a pre-slit injection site in accor~nce with the ~Fe~t i"~en~ion;
Figure 16 is ~n enlarged fragmentary side 30elevatio~l view in section of a coupling member carrying a pre-slit injection site where the slit extends only partway through the ~eptum;
Figure 17 is a p~D~--ctive view of a ~urette solution ~dministration fiet carrying a pre-slit in;ection 35 site in accor~"ce with the ~ e~t iveLion;
F~gure 18 is a view of part of a burette solution administration set carrying a pre-slit injection site being coupled to a shielded bluu~t r~n~ a;
2~59i WO ~/11103 PCT/US90/01350 Figure 19 is a step in the method of ~ki ~g a pre-slit injection site in accordance with the present invention;
Figure 20 is another ~tep 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 ~ite 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 accor~nc~ with the present invention:
Figure 23 is a final phase of the final ~tep 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 ~tep of making a ~e ~lit injection site in accor~n~e 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;
2S Figure 27 is an enlarged, fragmentary cross-secti~ view of another embodiment of an injection site in accordance with the ~-^~t invention;
Figure 28 is a cross-sect~on view taken generally along the plane 28-28 in Figure 27;
Figure 29 is an end ViQW of another embodiment of the ~nn~la 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 cAn~l~lA in accordance with the present invention;
Figure 32 is a cro~s-~ectional view taken generally along the plane 32-32 in Figure 31;
2027S9l WO ~/11103 PCT/US90/01350 Figure 33 is a cross-sectional view taken generally along the plane 33-33 in Figure 32;
Figure 34 i8 an end view of another emho~ir~nt of the c~nnllla in accordance with the present invention;
5Figure 35 is a fragmentary, side elevational view of the emhoAiment of the c~nnl~l a illustrated in ~igure 34;
Figure 36 is a cross-sectional view taken generally along the plane 36-36 in Figure 34;
Figure 37 i5 a cross-sectional view taken 10generally 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;
15Figure 40 is a cross-sectional view taken generally along the plane 40-40 in Figure 39;
Figure 41 is an end view of _nother embodiment of the ç~nnl-1 a according to the present invention;
~igure 42 i5 a cross-sectional view taken 20generally along the plane 42-42 in Figure 41;
Figure 43 i~ an end view of another embodiment of the cannula _ccording to the present invention;
Figure 44 is a cross-~ectional view taken generally along the plane 44-44 in Figure 43; and 25Figure 45 is a view in section of another insertion member for a blunt c~nntlla.
Figure 46 is a perspective view of another embodiment of a blunt c~nnl~la embodying the present invention.
30Figure 47 is a perspective view of a blunt cA~n~~la 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 35heparin lock of Figure 48 in joined relatio~hip with a blunt cAnnl~l~ device of altern_tive construction embodying the present invention.
, ~02759i WO ~/11103 PCr/US90/01350 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 ~ cross-sectional view of a pre-slit in-line injection site embodying the present invention in joined relationchir with a blunt cAn~ shown in side elevational view.
Figure 52 i8 a perspective view of the alternative blunt r~n~tlla 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 ~nnllla device of the present invention for injecting or removing liguid through a pre-slit in-line injection site, such as depicted in Figure 51.
Figure 54 is a per pective view of a blunt cannula shield or tip protector for attachment over the end of the blunt c~n~ 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 ~yringe as ~hown in Figure 53.
Figure 56 is a perspective view of the blunt r~nn~ device ~hown in Figure 53 in joined relationship with the pre-slit injection ~ite shown in Figure 51.
-2~27591 WO ~/11103 PCT/US~/01350 Det~iled Descr~ ion of ~he Preferred ~mbodiments While this invention is susceptible of embo~i~?nt in many different forms, there are shown in the drawing and will be described herein in detail specific embodiments thereof with the unders~A~ing that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intenA~ to limit the in~ention to the specific embodiments illustrated.
A prior art pre-slit in;ection site 10 and associated blunt c~nn-ll a 12 are illustrated in Figure 1.
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 rel~tively thin disc-~hApe~ re~ealable member 20. The member 20 has a resealable or~i ng 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 op~ 22.
The c~nnl~la 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 ~ Ahly engages the opening 22. The f~ 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 c~nn-ll a 12 will then be in fluid flow communication with the flow path 16 via the hollow piercing member 26.
In ~ollLl~distinction to the prior art pre-slit injection s~te 10 of Figure 1, Figures 2A and 2B
illustrate a ~re _lit injection site 34 being coupled to a peripheral venous catheter 36. The catheter 36 is shown in fluid flow comml~nic~tion with ~ vein in a hand H of a patient. The catheter 36 carries~at- a proximal end 38 a lue~ ~y~a female twist lock csnn?ctor 41.
20275g~ --WO ~/11103 PCT/US90/01350 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 ~econd 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 ad~acent the re~on~ end 44.
The threads 48 will engage the flange member 41 when the injection site 34 is rotated in a direction 50. When 80 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 srAç~ apart surfaces 54 and 56 respectively. The surface 54 has been forced into a dome-like ~ e by Annl-l A~ U-~h~p~ 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 cle~ni~ 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 ~eptum can be formed of a thermoplastic ela~tomer. The material used for the septum 52 ~ho~ be non-toxic and ster~ hle such A S by means of radi~tion, steam or Ethylene Q~ A~ .
R9~ the septum 52 ~ gQnerally cylindrical in shape, it can be die-cut from a sheet, cut from an extruded rod or molded. The ~eptum 52 c~n have an exemplary diameter on the order of .30 inçh~ (0.762 centimeters). The height of the ~eptum 52 can be, for example, on the order of .125 i~h~ (.317~ centimeters).
The fir~t end 42 is also formed with a t~pered interior ~urface 60 which terminates in an ~n~ ch~nnel ~ ~027~91 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 oh~nr~l 62 is on the order of 10%.
The `h~nllel 62 is ho~n~3e~ in part by a septum D~ OL Ling ridge 62a. The ch~nrl~l 62 can typically have a depth in a range of .050-.070 ;n~hes (.l27-.l778 centimeter~).
A peripheral surface 64 of the septum 52 slidably engages the tapered interior l;urface 60 as the septum 52 c into the first end 42. The annular ch~ el 62 which underlies the interior peripheral surface 56 of the ~;eptum 52 is provided to permit the septum 52 to deform when a blunt c~nn~la is inserted through an op~nin~ 66 therein.
The housing 40 is al80 formed with a fluid- flow path 68 ~iuch that fluids injected via a blunt cannula in~;erted through the reQealable orGni ng 66 can flow into the catheter 36 for delivery to hlmd H of the patient.
The ~;waged end members 58 _pply axial forces to the ~eptum S2 thereby creating the domed exterior peripheral ~;urface 54. The AYi A~ forces applied by the end members 58 slightly deform the regions 52a and 52b.
In ~u,.L~adistinction, the tapered internal surface 60 applies rA~iA1ly directed forces to the septum 52, thereby forcing the ore~ 66 into a ~ -6-1 ed condition.
In an alternate embodiment, the surface 52 could be formed as a flat, as ~ to a domed, surface.
Once the in~ection ~;ite 34 is lo~cin~ly engaged with the catheter 36, a r^- le~ system is formed through whi ch fluids can be infused into the catheter 36. The ^lAhle ~;eptum 52 closes the fluid flow path 68.
Figures 4A and 4B illustrate in combination the in~ection ~;ite 34, a blunt shielded c~nn~ 80 and a syringe of a ~-~n~,el.Lional type 82. The syringe 82, as is we~l known, can be formed with a cylindrical hollow end 84 2027591 ~
WO ~/11103 PCT/US~/01350 which carries a ~ale luer-type twist lock thread 86. A
hollow centrally located cylindrical fluid flow member 88 i~ in fluid flow com~l~ic~tion with an interior region 90 of the syringe 82.
5The chielded blunt c~n~ a 80 carries at a first end 92 a female luer twist-lock flange 94. The flange 94 will ~lidably engage the threads 86 of the end 84. Hence, the shielded blunt r~n~t~la 80 can be locked to the syringe 82 forming a closed fluid flow pathway. The shielded 10c~n~ a 80 could alternately be formed fixedly attached to the syringe 82.
The ~hielded blunt cannula 80 carries a cylindrical hollow protective shield 96 which surrounds a centrally located hollow, elongated cylindrical blunt 15piercing member 98. The cylindrical blunt piercing member 98 has a total length on the order of three times the thirknr-~ 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 2052. The shield 96 is desirable and useful for maint~ining the piercing member 98 in an aseptic con~ition by .Ling touch cont mination prior to the shielded c~ 80 engaging the pre-slit septum 52. Al~o, the shield helps to align the piercing member with the pre-25slit septum.
The cylindrical blunt piercing member 98 can slidably engage the pre-slit septum 52, best illustrated in Figure 4B, thereby exte~in~ through the preformed oren~ n7 66 therein. As illustrated in Figure 4B, when the 30piercing m~mher 98 fil~hly engageæ ~nd pierces the septum 52, the region 52a deforms by ~Y~ in~ into and filling, ~t lea~t in part, the AnnlllAr ~h-n~el 62.
The deformation f~ tates insertion of the piercing member 98 through the slit 66. Subsequent to the 35piercing member 98 slidably engaging the in~ection site 34, the $nterior region 90 of the syringe 82 is in fluid flow communication with the flow path 68 of the injection %Q~759~
.
WO ~/11103 PCT/US~/01350 .. .. . ..
~ 17 site 34 via flow paths 88a and 99 respectively of the syringe and the blunt piercing member 98.
In this engagement condition, the ~eptum 52 ~eals completely around the piercing member 98. ~ence, exterior gase~, liguids or airborne matter will be excluded from the çh~n~Pl 68.
Subsequent to infusing fluid from the syringe 82 into the fluid flow pathway 68, hP~ce into the catheter 36 and the hand H of the patient, the syringe 82 with lorkin~ly engaged shielded rann~la 80 can be slidably withdrawn from the injection site 34. Subsequent to this withdrawal, the septum 52 rD~ the ope~i~g 66 therein.
The op_~ing 66 will repeatedly lc-^-l, when the piercing member 98 is removed, provided that the pressure (in the septum 52 of the orening 66) created by interaction of the septum material properties and compres~ion ~upplied by the housing eY~-eA~ the pressure ~hallenge of the fluid con~nr~ within. Blunt cAnn~lla do not h~rh~7~rdly core, lacerate, or otherwise damage the 20 r^~l ~ng interf~ce 66 as CG~.~e~io~l n^~^~les do, thereby allowing repeatable ,~ lAhility. ~owever, septum ~aterial properties, thir~n-~c, and compression allow L ~ bility for a finite number of conventional needle insertions. The combination in;ection ~ite 34 and catheter 36 then e~u~.- to its pre-infusion, ~ealed condition.
Figures 5A and 5B illustr~te the pre-slit injection site 34 used in combination with a blunt ~nn~ 80a. The rAnn~la 80a includes a hollow body portion 92a with a luer flange 94a, a piercing member 98a, ~nd manually operable elongated lo~i ng members lOOa and lOOb. Alternately, a tubing member could be affixed to the hollow body portion 92.
C~ed end regions lOOc of the members lOOa and lOOb ~ hly engage the -E-on~ end 44 of the housing 40 when the piercing member 98a of the blunt r~nnllla 80a has been forced through the pre-formed or~i n~ 66, best illustrated i~ Figure ~B. The embodiment illustr~ted in 2027591 ~
WO ~/11103 PCT/US90/01350 Figures 5A and 5B has the advantage that the infusion c~n~ a 80a cannot accidentally ~ir~age from the pre-slit ~eptum 34 during the fluid infusion process. It will be understood that while ~pring-like deflecting members 5lOOa and lOOb are illustrated in Figures 5A and SB that other forms of locking members are within the ~pirit and scope of the present in~ention.
Figure 6 illustrates an alternate pre-slit injection site 34a. A tubing member 102 can be fixedly lOatt ched to the cylindrical hollow fluid flow member 46.
The emko~ nt 34a of Figure 6 utilizes the same structure for the septum 52 including the tapered surface 60 and the underlying annular ~n~el 62 as does the embodiment 34 in Figure 3. The shielded CA~Ul ~ 80 can be utilized with 15the in~ection site 34~ as previously described.
In the event that it is desirable to infuse solution from a con~Ajner 104 with a connectional port 106, a fluid admini~tration ~et llO of a conventional variety may be utilized. The ~et llO includes a spike 20co~n~ctor 112 at a first end. The ~pike ~o~n~ctor 112 is d~signed to pierce the port 106 of the contAi n~r 104. The ~et llO can also carry ~ slidably eng_geable ~o~neotor 114 of a known type at a recQn~ end. As illustrated in Figure 7, the connector 114 can ~lidably engage the 25hollow cylindrical member 98 of the ~hielded c~nnllla 80, thereby placing the interior fluid of the cont~; nPr 104 into fluid communication with the tubing ~ember 102.
Figure 8 illustrates yet another alternate 8Ob to the ~hi ~1 ~P~ ~n~lll A 80. The piercing member 98b carries 30a tubing member 118 fixedly attached thereto. The tubing - member 118 could be coupled at a second end to a cont~;ner such as the contAinPr l04.
The present pre-~lit injection site can be directly affixed to a contA; n~r 120 as illustrated in 3SFigure 9. The contA;n~r 120 includes a rigid hollow cylindrical Ar -c~ port 122 aff;~ thereto. The access port 122 includes a fluid flow ~h~n~l 124 in fluid flow communication with the interior of the cont~ n~r 12 0 .
~z~5~1 WO90~11103 PCT/US90/01350 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 fir~t end 130 has been swaged to form An annular U-~h~reA retAining member 136. The ret~ n~ member 136 in turn forms a domed exterior peripheral ~urface 138 on the septum 132.
~he first end 130 also includes a tapered interior force applying surface 140 and an annular rh~nnel 142 underlying the ~eptum 132. As dis~-lcF~
previously, the ~h~n~lel 142 provides a ~pace into which the septum 132 can deform when a blunt c~n~lla is forced through the r~e~l~hle 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 ~G~ Lional port 106 of the bag 120.
While the bag 120 is illustrated formed with two 20 ports, the ~o~e,.Lional pierceable port 106 and the pre-slit in~ection site 126, it will be understood that as an alternate (Figure 10), a contA~r 150 could be formed which includes only the pre-slit injection port 126. The removable cover 146 could be used in combination with the cont~ 150.
As illustrated in Figure 11, the pre-slit injection site 126 can be utilized for the purpose of n~ecting fluid from the syringe 82, coupled to the ~hielded n~nnt~l ~ 80, into the cont~in~r 150. When so ut~li 7~A, the blunt piercing member 98 is used to place the interior fluid con~n~ region 90 of the syringe into fluid flow communication with the interior of the contAin6~ 150.
Figures 12 and 13 illustrate a fluid flow coupling system 151 having as ~ first element a pre-slit iniection site 126a. The ~ite 126a is the same ~s the ~ite 126 except for a plurality of exterior threads 153 formed on an~ exterior peripheral surface 155 of the ~027~91 ~ ~
WO ~/11103 PCT/US~/013~0 housing 128a. A second element of the coupling system 151 is a shielded ~lunt c~nula 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 lS3.
The two co~no~tor elements 126a and 157 ælidably engage one another when the shielded ~nm-l~ 157 moves in ~n axial direction 167 tow~rd the injection ~ite 126a.
The blunt piercing member 165 penetrates the ~eptum 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 ~esult, the two coup~ing members 126a and 157 are loc~;ngly engaged together with the insertion member 165 eX~en~ing through the op~in~ 134a in the septum 132a.
~ce, fluids can flow from the cont~i n~ 150a via the connPctor system 126a ~nd 157 through the tubing member 159 to the recipient.
Injection ~ites of the type described above are also u able in co~nection with other fluid flow coupling com~ r.~Ls. For example, with ~__~ect to Figure 14, a pre-slit injection æite 160 of the type described above can be u~ed in combination with a spike connector 162 of a ~ v~ on~ l v~riety. Spike ~o~n~ctors such as the ~pike co~n~ctor 162 can be used to pierce ~v~.vel,~iQn~l ports such ~8 the port 106 of the con~;n~ 104 (Figure 6).
When the spike ro~nector 162 i~ 80 used, the pre-slit in~ection site 160 can then ~e utilized for the ~u.~c ~ of coupling to other fluid Administration 8et~.
The injection 8ite 160 illustrates _n alternate form of ~waging the fir~t end 42c for the ~ C of retA;n~n~ the septum 52c therein. The first end 42c can be ~waged 80 ~s to form ~n ~m~l A~ly ~h~-~ E ~, ~piral, ~ ?o275gi WOg0/11103 PCT/US~/01350 spring-like me~ber 164. The me~ber 164 has a free end 164a which engages the exterior dome-shaped peripheral surface 54c of the septum 52c. The spiral, spring-like swaged me~ber 164 will tend to uncoil, thereby continuous-ly applying axial force to the septum 52c and main~iningthe domed exterior peripheral surface 54c.
In yet another alternate, Figure 15 illustrates a pre-slit injection site 166 formed in ~ Y-junction member 168. The Y-~unction member 168 is fixedly attached to first ~nd 6econd tubing members 170 and 172 respectively.
As an alternate to forming the ~lit 66 completely through the ~eptum 52, ~s illustr~ted 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 - ~ealed.
The ~eptum 52 can be formed in two part~. One part can have a slit, such as the slit 66, exten~ing entirely therethrough. A r~co?l~ part can be formed without a ~lit. 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 ~An~nl A
alignment with the slit upon insertion, ~nd aids ~ Ahility by minimiz~ng the critical ~lit ~ealing interface area.
In accorA~n~ with the p~--ent inv6~Lion, the slit could have a length with a range on the order of .03 inches (.0762 centimeters) to .150 inches (.381 centimeters). Prefer bly, a ~lit length on the order of . 07 ~? nc~ c (.1778 centimeters) will be used in co~bination with a blunt C~nmll A having a diameter on the order of .1 inr~h~; (.254 CentimeterS)-When initially used, the blunt Ç~nmll A piercing member, such a8 the me~ber 98, will be forced through the ~lit 66a. The lower peripheral ~urface 56e will then be LULe1~ providing A~ S for the blunt rannl~lA piercing m~nher g8 into the fluid flow pathway 68e.
2~7~
WO90J11103 PCT/US~/01350 Pre-slit injection sites of the type described above can be utilized in combination with L~eLLe 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 ~urface 180 of the ~le~Le 182. A removable cover 184 can be used to maintain the injection site 178 in an aseptic condition until blunt cAnn~ 186 or 188 is inser~ed therethrough.
Figures 19 through 23 ~; FOl ose a method of making a pre-slit injection site in accordance with the present invention. In a fir~t step, a housing 200 is provided.
The housing 200 has an interior tapered sur~ace 202 at a first end 200a thereof. The interior peripheral surface terminates in an ~nnt-l Ar ~h~nn~l 204. A cylindrical septum 206 can be provided adjacent the end 200a.
In a ~Q~ ~tep, 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 AYi ~11 y moving die 210. When positioned by the die 210, the septum 206 is located ~djacent an internal ~nnular right 212 which h~ -~c the Ann~ ~ c~nnel 204.
In a third fitep, a reoQn~ die 214 can be utilized to swage the end 200a into spiral~ re~, spring-like members 200b which apply AY~Al ly directed forces against ~n exterior peripheral surface 206a of the geptum 206.
The ~Yi~lly directed forces form the flat surface 206a into a domed exterior peripheral ~urface 206b as illustra-ted in Figure 23.
Simultaneously, with ~waging the end members 200a so a~ to lock the ~eptum 206 into the housing 200 and to form the domed exterior peripheral 6urface 206b, a knife 216 can be utilized to form a slit in the septum 206.
Altern2tively, the slit may be cut ~y a ~eparate die in a separate step. If the septum 206 i~ formed as an _~L~u~ion~ the slit can be created during the extrusion . If the sep~um 206 is formed by stamping from a rubber ~heet, the slit can ~e cut during the ~tamping %~27Sgl WO ~/11103 PCT/US~/01350 process. If th~ ~eptum 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 b~h; ng can be used. A trailing ribbon may be S 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 ~lit and provide lubrication and a visible target for ç~n~lt~la insertion.
Figures 24 and 25 illustrate alternate swaging steps wherein a die 220 moving ~Yi~lly toward the housing 200 swages the end region 200a 80 as to form an annular U-ch~re~ region 200c and the exterior domed peripheral surface 206c.
The dies 214 or 220 can be formed with various alternate ~h~re~ swaging surfaces 224, as illustrated in Figure 26, deper~ q 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 in;ection site configur~tion 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 ca~Lu~ed in a chousing which provides compression to create a seal against pre~sure and a void region to accommodate deformed portions of the sealing member material only when the material is deformed or displaced by a blunt c~n~ la pierc$ng member. One ~uch 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 c~n~ a 98. The ~nn~ 250 includes a proximal end 252 with an ~nterior region 254. The region 254 is in part bounded by 2027~gi WO ~/11103 PCr/US~/013~0 an internal peripheral wall 256 which is formed with a st~Ard 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 ~i~c~csed.
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 ~urface 266. The tapered exterior ~urface 266 minimizes insertion force as the r~nn~ 250 is being forced through a ~lit of a septum, ~uch as the ~lit 66 in the septum S2. The angle of taper of the surface 266 is preferably in a range ~etween l to 15 degrees.
The member 260 is also provided with a plurality of elongated yLouves 268. The ~.o~es 268 in the exterior wall of the member 260 decrease the surface area of contact at the c~n~ /septum interface during insertion of the c~nnlll A into the injection site 34. This r~A~ A
exterior contact surface area decreases the frictional comr~nent of the insertion force.
In one embodiment, the tapered blunt cAnnllla 250 may have overall insertion length ~ CorresronA i nq to combined ~xial lengths of mid-region 2S8 and end member 260, on the order of 0.375 ~n~h~ (.9525 centimeters).
An alternate c~nnllla ~tructure 280 is illustrated in Figures 31, 32 and 33. The c~nnl-l A structure 280 includes a proximal end region 282 corres~onAing to the end region 252 of the cannula 250. The region 282 includes a luer flange 283. The c~nnlll A 280 ~lso includes a central, elongated, cylindrical region 288.
The ~enL~l region 288 carries at a distal end thereof an elong~ted cylindrical end member 290. The ~ 2G~591 ~ ]' 25 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 ~econd 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 c~n~l7~a 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 ~ 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 9o degrees apart around a longit~ n~l axis 300. The slots 294 increase the internal flow path cross-section. This increases the fluid flow rate.
The slots 294 also pro~ide for enhanced d~spersion characteristics ow~ng to the fluid flowing - radially out through the slots 294. This radial flow, effecting ~s change in fluid flow direction of about so degrees, promotes fltlC~i ng ~nd dispersion of fluid through the injection site 34.
Another emho~iment of a blunt c~n~ a 310 is illustrated in Figures 34 through 37. The c~n~t 1 A 310 is formed with an enlarged prnYi~l ro~n~tion region 312 corrc~ ;ng to the region 252 of the c~nm-la 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 co~ection region 312. The cylindrical interr^~i~te region 318 includes a fluid flow path 320 in communic~tion 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 ~7S9i WO ~/11103 PCT/US~/01350 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 CAnnl~ A . The lead post 330 facilitates insertion by providing a very low insertion force at the beginning of the insertion step as the ~nmlla is p-lch~ 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 ; n~h~c ( .1524 centimeters) and a diameter on the order of 0.050 inches (.127 centimeter~).
The end region 318 includes a novel structure for increasing the flow rate and erhA~cing ~i~r~sion characteristic~. 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 ae ~e~t illustrated in Figure 37.
The fluid flowing through the c~n~ a 310 undergoes a change in direction (of up to about 90 degrees relative to the cAn~ a center line 337) in the slots 338. This change in direction increases fluid di~persion. Further, since the slots 338 open radially, fluid flow can be maint~ even if the end surface 332 of the ~n~t~la is rll~A Up A~A inct any material in ~he system in which the r~nn~ is inserted.
Another embodiment of the tapered r~nnl-l A of the ~-ent invention is illustrated in Figures 38 through 40 and is designated generally therein by reference numeral 340. The c-~nnl~la 340 includes a proximal end 342 which c~n include a luer coupling flange 344 for cooperating with a suitable mating ~tructure on a syringe. The proximal end 342 also define~ an interior region 346.
Extending from the proximal end 342 is a generally cylindrical mid-region 348. Ex~enAing from the -20275gl WosO/11103 PCT/US90/01350 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 ~h~nn~l 354 which com~unicates with the interior region 346. Fluid ~ h~rges from the flow ch~nnel 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 c~Annel 354 through the apertures 358 improves fluid dispersion with respect to mixing or flushing in the system downstream of the r~nn~la (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 p~c~^c rA~iAlly out through the apertures 358, fluid flow through the r~nn~lla 340 can be maintAine~ even when the distal end surface 356 of the cannula is bottomed out or pll~h~A against any material in the system in which the c~nnnla is inserted.
The ~tructure of the rAnnt~la 340 is adapted to be constructed with a minimal lead post length (i.e., the portion of the CAnnlll 8 distal end between the end surface 356 and the interior flow rh~nnel 354). Further, the design accommodates the use of a minimal tip diameter, minimal taper angle, and minimal cannula di_meter. The minimization of these par~meteræ results in a decrease in the peak insertion force required to properly install the ~Anml~a in the injection site.
Preferably, the total cross-sectional flow area through the three apertures 358 is about three times the cross-sectio~l flow area of the interior rh~nn~l 354.
This ~nh~cec the flow rate capability compared with a simple open ~nA~ cylindrical flow ~hAnn~l of equal length.
The design of the r~n~t~la 340 also is effective in r~ ng or- limiting ~kick ~ack" or recoil of the c~nn~l a after insertion. The resilient material of the septum in ~ , WO90/11103 2~ 5~i PCT/US90/01350 an injection site can subject the r~n~ a to forces ten~ing to push the can~ 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 c~nn~la of the present invention i~ illustrated in Figures 41 and 42 wherein the cAnn~la embodiment is designated generally therein by the reference numeral 360. The c~n~ 360 includes a proximal end 362 defining an interior region 364 and having a luer flange 366 for ro~n~ction 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 ~n~l~la 340 illustrated in Figures 38 through 40, the embodiment of the canntll~ 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 ~han~Pl 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 2S small t~per to minimize the insertion force.
Further, the design permits the c~nntll~ 360 to be con~tructed with a small tip diameter, small taper angle, and ~mall c~nnl-l~ diameter so as to reduce the peak insertion force.
Another embodiment of the c~nnl~la of the present invention is illustrated in Figures 43 through 44 and is de~ignated generally therein by reference numberal 380.
The rAnn~la 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.
EXt~n~n~ from the proximal end 382 is a mid-region 388. A distal end region 390 ~xtends from th~ mid-region 388. An internal fluid ~low rhan~el or path 392 -~ 202q591 W090tl1103 PCT/US90/01350 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 c~n~la 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 lo 396 has a sufficient radius ~o 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 inC~ (.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 c~n~ 380.
Still another embodiment is illustrated in Figure 45 which includes a blunt tapered c~nm~la insertion member 400 for insertion into a pre-slit injection site, the c~nl~la 400 having a distal end region 402 with a tapered exterior ~urface which in the preferred embodiment is an approximately 8 deyLLFs taper. The defined aperture 404 for fluid flow i5 di~ at the end 406 of the distal end region 402. The end 406 includes a radiuced tip defined by a radius of approximately 0.01 inch (.025 centimeters). The radiused tip re~ eC insertion force, assists in locating the slit in the injection site and in addit~on has the practical advantage of facilitating complete f~ g of the c~nnl-l a mold cavity.
The tapered ~urface of the di~tal end region 402 3~ has an axial length of a~oximately 0.10 inch in the preferred embodiment. Ad~acent to the tapered distal end region is a generally cylindrical region 408 for entering into the injection site ~hi~d the distal end region 402, 2~7~
WO90/11103 PCT/US90/013~0 thereby reducing kick back during insertion. The generally cylindrical region 408 has a small draft anglé
such as about one-half degree.
The force required to insert any of the above-~i~c~c~ embodiments of the blunt tapered cannula into the septum of the injection site depends upon a number factors: friction at the c~n~ a/septum interface, c~nllla diameter, cannula taper angle, and degree of septum co~ ession. The c~n~l~la/septum interface friction i~, in turn, ~pen~P~t upon lubrication, if any, material properties, and surf~ce finish. It will be understood that the friction at the r~nn~la/~eptum interface can be reduced by providing a smoother surface finish on the cannula (e.g., by sand blasting the c~n~l~l a exterior surface) or by molding the c~nnll~ so as to ~o~ce a matte finish. Conventional lubricants can also be used to further reduce ~he friction and thereby lower the insertion force required.
In the embodiments of the ~Annlllae 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 w~th the tube having a distal end region for penetrating the injection site.
In preferred contemplated em~odiments, the exterior surface of the distal end region may h~ve a taper angle as small as between l and 15 degrees.
Further, a loc~ing means, such as the loc~nq arms lOOa and lOOb ~i~c~ with reference to Figures 5A and 58, may be provided on the ~An~ A embodiment~ illustrated in Figures 29 through 44 to permit the c~nn~llAe to be releasably locked to the injection site.
The above described insertion members, usable as part of a blunt rAnm~la, are preferably molded of a plastic formulation including silicone or other lubricant.
~he use of silicone or other lubricant increases the ease of insertion of that ~ember into the pre-slit in~ection site.
-~ ~ 2~275g~
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 c~nnl~la member 410 is preferably of one-piece molded, rigid plastic, with a through bore 416 exte~;ng 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 ex_mple, syringes, admini~tration sets and the like. Tnternally, 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 st~n~d male luer co~Pctors utilized in many medical devices, as is well ~nown in the medical field. The hollow cylindrical portion 412 may also include a pair of op~o~ flat surfaces 420 for cooperation with a tip protector or shield such as depicted in Figure 47, which is described below.
The blunt c~n~ portion 414 extends generally ~YiAlly from the hollow cylindrical portion 410. The cAn~--la 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 i~ an enlarged view of a hollow shield or tip protector 428 for covering and protecting a blunt rAnn~ uch as, for example, the blunt ~nnl~la portion 414 of blunt r~tnn~ member 410 shown at Figure 46 or other blunt r~n~ Ae a~ disclosed herein. The shield 428 has a generally elongated housing 430, which is open at one end for receiving the blunt c~nnt-l A At the open end, the interior surface 432 of the shield generally co~,~7l~-Jc to the ~h~p~ of the exterior-surface of the blunt~ cannula portion 412, i.e., it i~ generally cylindrical, with a pair of oprQ~^~ flat 8urfaces 434 WO90/11103 202~$91 32 PCT/U590/~1350 matching the flat surfaces 420 of the blunt ~nn1lla device 410. Further, either surfaces 432 or 434 can be provided with ~tanding ribs to co11L,ol the depth of insertion of the blunt cannula portion 414 into housing 430. The matching flat ~urfaces of the shield and the blunt ~n~11la device allow a user to secure the blunt cannula onto a syringe or similar device, for example, without exposing the ~n~ a portion 414 to touch contamination. When access to the blunt cannula is required, the shield may simply be slidably removed from the c~nn1~la. As can be appreciated, the outer surface of the shield 428 can be rh~re~ in ~uch a manner or provided with a roughened finish to assist the user in gripping or removing shield 428 from the c~nnllla.
Typically, the blunt cannula 410 or other blunt r~n~1~la 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 c~n~ a to the mating product, e.g., the male luer fitting of a syringe or administration set. The matc~ flat surfaces 432 of the ~hield and ~20 of the blunt c~nn1~la act as a wrench to allow any twisting force applied to the shield to be transmitted to the c~n~lll A ~ e.g., for threading the oAn~ onto a luer lock device or for applying a twisting force in making a luer lip cn~ction.
Figure 48 shows what is commonly referred to as a heparin lock, generally at 436, employing a pre-slit injection ~ite 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 i,-Ll~enous therapy, it is not llnllc~l~l for the admini~tration of liquid to be interrupted from time to time. Instead of performing a new catheterization pro~ e each time administration is to be restarted, it is often preferable to utilize tAe same catheter, thus reducing the number of catheterization procedures, more ~ 20275~1 WOgO/11103 --, PCT/US90/01350 colloquially referred to as the number of "sticks," and reducing the trauma and risk associated with each such proce~l~re .
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 maint~ining 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 in~ection site 442 of the type previously ~icc~lc-^~ in detail. An axial fluid flow p~ geway 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 ~ul~uu~.~ed by generally cylindrical gripping collar 446. Threads 448 are provided on the interior surface of the collar for thr~A~ y engaging a 8~ rd luer lock ç~Pctor, as is often found on i~.LLavenous catheter devices. The exterior surface of the collar 446 is generally arcuate in cross-sectional ~h~p~
(as best s~en in Figures 49 aNd 50), to provide a gripping ~urf~ce. ~he ~urface curves generally outwardly in a direction toward the pre-slit in~ection site 442. This allows the nurse, physician or att~ n~ staff member to grip the h~parin lock and to re~se any force exerted during e..L~ of a blunt- r~ a into the pre-slit injection site from being transmitted to the venous catheter. For improvement in the gripping, a ~eries of axial groove~ 450 are provided in the exterior surface of the collar 446.
W090/11103 ~0~75~ PCT/US90/01350 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 c~nn1lla for threaded lo~-k; ng engagement to a blunt cannula device of the type having an interiorly threaded ~leeve or shield, such as depicted in Figure 50. The heparin lock 436 also includes a generally radially-ext~n~;~g shoulder 454 for locking retention of resilient gripping fingers on a blunt c~nn11la device of the type ~hown 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 cite 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 in~en~ for u~e with blunt cannulae. In the preferred embodiment, however, the visual identifier comprises a distinct color identifier and, more partir~ rly, is a brightly colored ring 456 (Figure 48) circumscribing the pre-slit injection site 442. While the color ~elected may vAry ~p~1ng on application, it should be a color which is distinct from and in ~o..L~ast to the color of any plastic used in the manufacture of the heparin lock.
Aæ noted earlier, the heparin lock 436 depicted in Figure 48 may be used with a variety of styles or types of blunt end ~nn1lla devices. For example, the heparin lock may be used with a bare blunt end ~nnl~ uch 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 ~An~1~la device 458 which utilizes a pair of resilient gripping fingers 460 for retAi~ing the blunt ~nn~la in .
W090~11103 PCT/US9OtO1350 joined relationship with the heparin lock. The blunt c~n~ a de~ice 458 depicted in Figure 49 has a generally cylindrical, hollow base or body portion 462 and a blunt c~n~llla portion 464 substantially as described earlier in co~n~ction 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 co~n~ctor to the blunt c~n~t~la device.
Each of the gripping fingers 460 is mounted to the body portion of the blunt cannula device by an intermediate radially exten~ wall portion 466. The gripping fingers have rA~ y inwardly directed retention means 468 at one end for engaging against r~ l shoulder 454, and gripping means 470 at the other end for squeezing and spre~; ng the retention means to release the blunt cAn~ A device from the heparin lock. Tn the as-molded condit~on, the gripping fingers are b~e~ radially inwardly, toward the blunt c~nntlla 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 rele~
When used in combination with a h~r~rin lock such as depicted in Figure 48, the blunt c~n~ device 458 may be att~ by ~imply p--~h 1 ~g the blunt ~n~tll a into the pre-slit injection site 442. A forward facing tapered surface 472 (Figure 49) in front of the threads engages a ~imilar tapered surface 474 on the retention means 468 50 as to naturally spread the fingers 460 apart ~s the blunt ~n~llla i8 forced into the pre-slit in~ection site. After the blunt c~nnl~l~ is inserted into pre-slit injection site sufficiently far so that the retention means are beyond the radial 5houlder 454, the gripping fingers will snap -WO ~/11103 ~0~7~9~ 36 PCT/USgO/01350 inwardly behind the æhoulder, holding the blunt cannula in the position depicted in Figure 49. To withdraw the blunt c~nn~la, the user need simply sgueeze the gripping end 470 of the hAn~les~ which will ~pread the retention means of the fingers and release the blunt ~nnnl~l a device from the heparin lock.
The heparin lock of Figure 48 is also useful with a blunt c~nn~la device 475 having an internally threaded shield or ~leeve, such as depicted in Figure 50. Figure lo 50 illustrates the blunt c~nnllla device 475 as it first enters the pre-slit i~ection site 442 of the heparin lock and prior to engagement with the heparin lock threads 452. The blunt c~n~l A device shown in Figure 50 has a generally cylindrical outer wall 476 and a transverse end wall 478. A blunt ~nnl-l~ 480 extends through the end wall. The blunt rAn~ a m~y be constructed in generally the ~ame manner as the blunt r~nn~ portion depicted in ~igure 46 or in accordance with the other embodiments of the present invention.
The cylindrical outer w~ll 476 preferably extends beyond the tip end of the blunt ~nnlll A to protect the c~n~ against inadvertent touch contamination. The interior ~urf~ce of the cylindrical w~ preferably threaded at 482 for thrQ~P~ly engaging the device to which the blunt ~nml~ is attached, such as the heparin lock depicted in Figure 48. As noted above, ~igure 50 depicts the blunt c~nn~ device 475 at an initial entry position. Further insertion of the blunt ~nnllla and simul~nen?lc turning of the blunt cAn~ device results in threaded lo~in~ engagement between the blunt ~nn~
device 475 and the heparin lock.
The blunt r~n~l~la 480 of the blunt ~nn~ device 475 i~ in fluid communication with ~n entry port, generally defined by wall 484, which extends in the opposite direction of the blunt ~nnllla~ from the other side of the tr~nsveræe wall. The ~lIL-~ port is for attachment to other devices such as syringes, tubing, administration ~ets or the like, and ~ay take such form as ~ 2027591 is appropriate for the particular device to which it is attached. The entry port 484 preferably has a tapered inner surface for receiving a s~An~rd 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 c~nnl~la portion for flow therebetween.
Figure 51 shows, in cross-section~1 view, a further alternative device 492 which may employ the pre-slit injection site of the pre~ent invention. The pre-slit injection site device 492 depicted in Figure 51 is an in-line device, preferably for adding medication to a lS 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 ~on~ecting the injection site device within a fluid flow path. As depicted, the inlet defines a ælightly tapered female surface and the outlet defines 8 similarly female tapered surface which are preferably joined by solvent 25 hon~ i n~ a similar attachment to plastic tubing of an administration set, extension set or the like. S~ rd luer fittings or surfaces could also be provided at the inlet or outlet, as desired.
~or injecting liquid into the fluid stream or 8 mpling the fluid stream, the device has ~ side ~h~n~l 496 which comm~ tes between a pre-slit ~eptum 502 made and assembled in accor~A~ce with the present invention, and the fluid r~ qeway 498. The ~eptum 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 c~nnUl a, auch as ~nn~ S06, may be inserted through the -WO90~11103 2 ~ 2 ~5 ~ PCT/US90/01350 -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 u~ed in combination with a bare blunt cannula, æuch as that depicted in Figure 51, or may be used in combination with the blunt cannula device 458, depicted in Figure 4g, when a lo~i ng relationship between the blunt ~nntlla and injection site is desired.
As depicted, for example, in Figure 52, the blunt c~nnlll a device 458 may be attached in a secure locking relationship to the in-line injection ~ite 492. As shown there, the in-line injection site has a radially extending shoulder 508 on each side of the housing, for engaging ~gainst the retention means 468 on the end of the resilient gripping fingers 460. As with the heparin lock, the in-line injection site alæo includes a generally tapered surface 510 defined on the exterior surface for æpreading the retention means as the blunt cannula is inserted into the in;ection site. As was described above, insertion of the blunt c~nnl~la into the injection site results in the retention ~eans being spread by the tapered surface 510 and, as the blunt c~nnlll a is inserted farther, the retention means snap into a locking position behind the radial shoulder 508. In this arrangement, the blunt cAnn~ is securely locked onto the in~ection site and inadvertent withdrawal is thus p~ ,.Led. To remove the blunt c~nnllla from ~he in-line in~ection site, the gripping ends 470 of the resilient fingers are æqueezed, causing spreading of the retention means 468 and release from the injection site. ~he c~nnlll a ~ay then be simply removed by withdrawing it from the in~ection site.
Figure 53 depicts yet a further embodiment of the present invention. That figure depicts a blunt c~nmlla device 512 embodying the present invention in combination with a syringe 514. The ~lunt c~nn-ll A device 512 has a generally cylindrical outer wall 516 which encloses and substantially protects a blunt c~nnula portion 518. The '~ 20275gl WO 90/11103 ; ~ PCr/US90/01350 blunt c ~nnol a portion is attached to and extends from an intermediate transver~;e interior wall 520. The blunt r~rnl~la device 512 may be attached to a ~yringe 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, ext~n~ing therewithin to the transverse wall 520.
Although various syringes may be used in cor~ ction with the blunt cAnm~la device 512 without departing from the present invention, the ~yringe 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 ~uL~o-es of complete~sc, the syringe depicted in Figure 53 has a pair of resilient pistons 522 ~;paced apart, with the fluid to be disr~r~
cont~ P~ between the pistons. A plunger rod 524 pushes the pistons forward until the forward most piston engages ~g~ t an entry port 526 which extends in a direction opposite the blunt c;~nr~lll a 518. The forwardmost piston has a frangible portion, which is pierced by the entry port, rele~sing the liquid cont~in~ between the pistons for ~ ion through the blunt cAnn1ll~.
In accordance with the present invention, the blunt c;~nt~ portion 518 is ~ubstantially protected from inadvertent touch contz~mination by the outer cylindrical wall Sl6. To permit the blunt c~nl~lll a to be used, however, with the in-line injection site 492 or a similar device, a pair of ~_~r~l, generally U-~hApe~ receC-es 528 are provided in the cylindrical wall for recei~ring the inlet- and outlet portions 494, 496 of the in-line in~ection ~;ite when the c~nn~ is ~tt~he~ to it. This arrzmgement is depicted in a perspective view in Figure s6. As shown there, the blunt c~nnnla device 512 may be attAfh~ to the in-line injection site by inserting the 3S blunt rAnr~ portion into the pre-slit injection site, with the U-~hApGd r~C~^C 528 receive the inlet and outlet portions 494, 496 of the in-line injection site, -2~7~g~ .
WO90/11103 PCT/US~/01350 thus allowing the bare c~nn~lla to be inserted suffi-ciently far into the pre-slit injection site.
Figure 54 shows a shield or tip protector 530 for a blunt ~nnl~la device of the type shown in Figure ~3.
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 c~n~ a device 512, and is sufficiently long to extend ~eyond the U-~hArD~ rec~c~es to completely enclose and protect the blunt c~n~t~la 518 during shipping, storing and between uses, if so desired.
Concentrically disposed within the cylindrical wall 532, the tip protector has an ~YiAlly exten~;ng, hollow tube 536 for slidably receiving the blunt cannula 518 therewithin. The shield or tip protector 530 would - typically be attached to the blunt ~Anntll A device 512 during manufacture, and removed when the syringe and blunt c~nn-~la device ~re used. If so desired, it mày be reat-tached between uses to protect the cannula from any further contamination.
Figure 55 is an ~lternative embodiment of the blunt cAnnl~la device ~hown in Figure 53, and is depicted without a syringe at~oh~ to it. As shown in Figure 55, the blunt c~n~tlla device 538 similarly has a cylindrical outer wall 540, a transverse intermediate inner wall 542, a blunt c~n~la 544 ex*e~ing axially from the transverse intermediate wall and an entry port 546 exte~di ng in the opposite direction from ~he blunt C~nnlll A . The essential difference between this embodiment and the one shown in Figure 53 is the ~hcenre of U-~h~pe~ rec~C-es for use with an in-line injection ~ite such as depicted in Figure 56.
For ease of attachment to an injection site, the inner surface of the cylindrical wall i8 preferably tapered at 548.
~rom the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the spirit and ~cope of the novel co~cept of the invention. It is to be understood that no 2027~91 WO90~11103 PCT/US90/01350 ~ '~' 41 limitation with respect to the specific apparatus illustrated herein is inten~ 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 (18)
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.
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 combination 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.
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 combination 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 a 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 a can be sealingly inserted through said opening and placed in fluid flow communication with said channel and such that the blunt cannula a can be removed therefrom with said flexible means interacting with said housing so as to reseal said resealable opening.
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 a can be sealingly inserted through said opening and placed in fluid flow communication with said channel and such that the blunt cannula a 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 resealable 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, the distal end portion including an outer circumference along its length that gradually and uniformly decreases toward the blunt end edge and the distal end portion and being sufficiently tapered to allow the elongated member to penetrate the pre-slit injection site; and a substantially cylindrical sheath surrounding said elongated member and being at least coextensive with and spaced apart from said elongated member to protect said member from inadvertent touch contamination.
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, the distal end portion including an outer circumference along its length that gradually and uniformly decreases toward the blunt end edge and the distal end portion and being sufficiently tapered to allow the elongated member to penetrate the pre-slit injection site; and a substantially cylindrical sheath surrounding 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.
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.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US32561789A | 1989-03-17 | 1989-03-17 | |
US325,617 | 1989-03-17 |
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CA2027591C true CA2027591C (en) | 1996-02-27 |
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CA 2027591 Expired - Lifetime CA2027591C (en) | 1989-03-17 | 1990-03-16 | Pre-slit injection site and tapered cannula |
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US (5) | US6217568B1 (en) |
EP (3) | EP0541515B1 (en) |
JP (5) | JPH07110284B2 (en) |
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CA (1) | CA2027591C (en) |
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IE (3) | IE62767B1 (en) |
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1990
- 1990-03-15 IE IE93890A patent/IE62767B1/en not_active IP Right Cessation
- 1990-03-15 IE IE940634A patent/IE66526B1/en not_active IP Right Cessation
- 1990-03-15 MX MX1991590A patent/MX173202B/en unknown
- 1990-03-15 IE IE940633A patent/IE72466B1/en not_active IP Right Cessation
- 1990-03-16 EP EP19930200022 patent/EP0541515B1/en not_active Expired - Lifetime
- 1990-03-16 DE DE1990619170 patent/DE69019170D1/en not_active Expired - Lifetime
- 1990-03-16 AU AU53332/90A patent/AU634532B2/en not_active Expired
- 1990-03-16 EP EP19930200021 patent/EP0540507B1/en not_active Expired - Lifetime
- 1990-03-16 DE DE1990619170 patent/DE69019170T4/en not_active Expired - Lifetime
- 1990-03-16 ES ES90905119T patent/ES2057546T3/en not_active Expired - Lifetime
- 1990-03-16 DE DE1990609131 patent/DE69009131T2/en not_active Expired - Lifetime
- 1990-03-16 WO PCT/US1990/001350 patent/WO1990011103A2/en active IP Right Grant
- 1990-03-16 EP EP19900905119 patent/EP0419620B1/en not_active Expired - Lifetime
- 1990-03-16 CA CA 2027591 patent/CA2027591C/en not_active Expired - Lifetime
- 1990-03-16 ES ES93200021T patent/ES2083247T3/en not_active Expired - Lifetime
- 1990-03-16 DE DE1990623926 patent/DE69023926T2/en not_active Expired - Lifetime
- 1990-03-16 ES ES93200022T patent/ES2074909T3/en not_active Expired - Lifetime
- 1990-03-16 JP JP50509590A patent/JPH07110284B2/en not_active Expired - Lifetime
-
1993
- 1993-04-22 AU AU37183/93A patent/AU666181B2/en not_active Ceased
-
1994
- 1994-12-06 AU AU80222/94A patent/AU678071B2/en not_active Expired
-
1995
- 1995-05-12 US US08/440,510 patent/US6217568B1/en not_active Expired - Lifetime
- 1995-06-23 JP JP15747795A patent/JP3411984B2/en not_active Expired - Lifetime
- 1995-08-25 AU AU30221/95A patent/AU3022195A/en not_active Abandoned
- 1995-11-20 AU AU37960/95A patent/AU681317B2/en not_active Ceased
-
1996
- 1996-08-09 US US08/695,040 patent/US5899888A/en not_active Expired - Fee Related
-
1998
- 1998-10-29 US US09/182,260 patent/US6213996B1/en not_active Expired - Fee Related
- 1998-10-29 US US09/181,975 patent/US6261266B1/en not_active Expired - Fee Related
-
2001
- 2001-07-17 US US09/907,234 patent/US6569125B2/en not_active Expired - Fee Related
- 2001-10-17 JP JP2001319511A patent/JP2002191583A/en not_active Withdrawn
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2002
- 2002-07-25 JP JP2002217087A patent/JP2003126269A/en active Pending
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2005
- 2005-11-11 JP JP2005328129A patent/JP2006055670A/en active Pending
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