CA2382459A1 - Combination safety needle assembly and medical apparatus - Google Patents

Combination safety needle assembly and medical apparatus Download PDF

Info

Publication number
CA2382459A1
CA2382459A1 CA002382459A CA2382459A CA2382459A1 CA 2382459 A1 CA2382459 A1 CA 2382459A1 CA 002382459 A CA002382459 A CA 002382459A CA 2382459 A CA2382459 A CA 2382459A CA 2382459 A1 CA2382459 A1 CA 2382459A1
Authority
CA
Canada
Prior art keywords
needle
shield
connector
housing
medical device
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.)
Granted
Application number
CA002382459A
Other languages
French (fr)
Other versions
CA2382459C (en
Inventor
Michael J. Botich
Thor Halseth
John Barker
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MDC Investment Holdings Inc
Original Assignee
Mdc Investment Holdings, Inc.
Michael J. Botich
Thor Halseth
John Barker
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mdc Investment Holdings, Inc., Michael J. Botich, Thor Halseth, John Barker filed Critical Mdc Investment Holdings, Inc.
Publication of CA2382459A1 publication Critical patent/CA2382459A1/en
Application granted granted Critical
Publication of CA2382459C publication Critical patent/CA2382459C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A61B5/150641Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • A61B5/150656Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694Procedure for removing protection means at the time of piercing
    • A61B5/150717Procedure for removing protection means at the time of piercing manually removed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150885Preventing re-use
    • A61B5/150916Preventing re-use by blocking components, e.g. piston, driving device or fluid passageway
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3261Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between sleeve and syringe barrel, e.g. spreading of sleeve retaining hooks having slanted surfaces by engagement with conically shaped collet of the piston rod during the last portion of the injection stroke of the plunger

Abstract

A method and apparatus are provided for using a medical device (10) comprise d of a medical apparatus (20) and a needle assembly (30). The needle assembly includes a needle (70) having a sharpened tip. Preferably,the medical apparatus (20) is a standard apparatus, such as a syringe or phlebotomy device. The medical apparatus(20) includes a connector (24), such as a Luer connector. The needle assembly (30) is configured so that it can be attached to the medical apparatus (20) and the sharpened tip of the needle (70) is automatically shielded after use to prevent inadvertent contact with the contaminated needle.

Claims (21)

1. A medical device, comprising:
a syringe, comprising:
a barrel;
a plunger slidably displaceable within the barrel;
a needle assembly, comprising:
a housing adapted to receive the syringe;
a needle operable between an extended position in which the needle projects forwardly from the housing and a retracted position in which the sharpened tip of the needle is enclosed within the housing;
a biasing element biasing the needle toward the retracted position;
a needle retainer releasably retaining the needle in the extended position against the bias of the biasing element;
wherein upon forward displacement of the syringe relative to the needle retainer, the needle is released for retraction so that the biasing element retracts the needle into the housing.
2. The medical device of claim 1 wherein the biasing element displaces the syringe rearwardly upon actuation of retraction of the needle.
3. The medical device of claim 1 comprising a connector for connecting the syringe to the needle assembly.
4. The medical device of claim 1 wherein the needle assembly comprises a hub that is axially displaceable relative to the needle retainer to effectuate retraction of the needle.
5. The medical device of claim 4 wherein the needle retainer comprises a radially deformable arm engaging the housing, wherein the hub displaces the arm radially inwardly to effectuate retraction of the needle.
6. A medical device, comprising:
a barrel;
a needle assembly connected with the barrel having a needle operable between an extended position in which the needle is exposed for use and a retracted position in which the needle is shielded to prevent inadvertent contact with the sharpened tip of the needle;
a biasing element biasing the needle toward the retracted position; and a needle retainer releasably retaining the needle in the extended position against the bias of the biasing element;
wherein after use of the device, the needle retainer releases the needle and the needle is displaced into the retracted position under the biasing force of the biasing element.
7. A safety medical device, comprising:
a medical apparatus comprising:
a housing; and a first connector attached to the housing;
a shielded needle assembly, comprising:
a needle having a sharpened tip;
a shield surrounding at least a portion of the housing, operable between a retracted position in which the sharpened tip of the needle projects forwardly from the shield and an extended position in which the sharpened tip of the needle is enclosed within the shield;
a second connector cooperable with the first connector to attach the needle to the housing;
a biasing element biasing the shield forwardly relative to the housing toward the extended position;
a retainer releasably retaining the shield in the retracted position against the bias of the biasing element; and means for releasing the shield from the retainer in response to advancing the housing forwardly relative to the shield, wherein upon releasing the shield, the biasing element displaces the shield into the extended position.
8. The safety medical device of claim 7, wherein the needle is fixedly attached to the second connector.
9. The safety medical device of claim 7 comprising an actuator connected with the second connector, and configured to engage the needle retainer upon axial advancement of the housing relative to the shield.
10. The safety medical device of claim 7, wherein the retainer comprises a radially deformable arm.
11. The safety medical device of claim 10 comprising an actuator connected with the second connector, and configured to radially deform the retainer arm upon axial advancement of the housing relative to the shield.
12. The safety medical device of claim 7 wherein the medical apparatus comprises a plunger slidable within the housing, and the housing comprises a forward end wall such that advancing the plunger forwardly displaces the plunger into engagement with the end wall, and continued advancement of the plunger displaces the housing forwardly relative to the shield to release the shield from the retainer.
13. The safety medical device of claim 7, comprising a lock for automatically substantially permanently locking the shield after the shield is displaced into the extended position to prevent displacement of the shield relative to the needle after the shield is extended.
14. The safety medical device of claim 13 wherein the lock comprises a radially deformable locking arm and the shield comprises a recess that cooperates with the locking arm.
15. The safety medical device of claim 7 wherein the shield comprises a pair of flanges projecting radially outwardly and configured to provide a surface for a user to engage during use of the device.
16. The safety medical device of claim 7 wherein the second connector is cooperable with the first connector to substantially permanently attach the needle to the housing.
17. A method for assembling and using a safety medical device, comprising the steps of:
providing a sterile needle assembly, comprising a needle having a sharpened tip, a shield and a first connector;
providing a sterile medical apparatus, comprising a housing and a second connector;
sealing the sterile needle assembly and the sterile medical apparatus within one or more containers to prevent contamination of the needle assembly and medical apparatus from becoming contaminated;
removing the needle assembly and medical apparatus from the one or more containers;
connecting the first connector to the second connector to attach the needle assembly to the medical apparatus;
performing a medical procedure with the combined medical apparatus and needle assembly;
retaining the shield against advancing over the sharpened tip of the needle during the step of performing a medical procedure;
automatically releasing the shield and displacing the shield to enclose the sharpened tip of the needle in response to axial displacement of the housing relative to the shield.
18. A method for assembling and using a safety medical device, comprising the steps of:
providing a sterile needle assembly, comprising a needle having a sharpened tip, a shield and a first connector;
providing a sterile medical apparatus, comprising a barrel for receiving medicine, a plunger slidable within the barrel, and a second connector;
sealing the sterile needle assembly and the sterile medical apparatus within one or more containers to prevent the needle assembly and medical apparatus from becoming contaminated;
removing the needle assembly and medical apparatus from the one or more containers;
connecting the first connector to the second connector to attach the needle assembly to the medical apparatus;
injecting medicine from the barrel and through the attached needle assembly by displacing the plunger forwardly within the barrel;
retaining the shield against advancing over the sharpened tip of the needle during the step of injecting medicine;
automatically releasing the shield and displacing the shield to enclose the sharpened tip of the needle in response to axial displacement of the plunger.
19. The method of claim 18 wherein the first connector and second connector are cooperating Luer connectors.
20. The method of claim 18 wherein the needle assembly comprises a biasing element, and the step of automatically releasing the shield and displacing the shield comprises automatically advancing the shield with the spring after the shield is released.
21. The method of claim 18 comprising the step of automatically locking the shield to prevent axial displacement of the shield relative to the needle after the shield encloses the sharpened tip of the needle.
CA002382459A 1999-11-29 2000-11-29 Combination safety needle assembly and medical apparatus Expired - Lifetime CA2382459C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16814699P 1999-11-29 1999-11-29
US60/168,146 1999-11-29
PCT/US2000/042328 WO2001037898A2 (en) 1999-11-29 2000-11-29 Combination safety needle assembly and medical apparatus

Publications (2)

Publication Number Publication Date
CA2382459A1 true CA2382459A1 (en) 2001-05-31
CA2382459C CA2382459C (en) 2009-12-29

Family

ID=22610322

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002382459A Expired - Lifetime CA2382459C (en) 1999-11-29 2000-11-29 Combination safety needle assembly and medical apparatus

Country Status (9)

Country Link
US (1) US6945960B2 (en)
EP (1) EP1233803B1 (en)
JP (1) JP4295821B2 (en)
AT (1) ATE317712T1 (en)
AU (1) AU783693B2 (en)
CA (1) CA2382459C (en)
DE (1) DE60026079T2 (en)
MX (1) MXPA02005262A (en)
WO (1) WO2001037898A2 (en)

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AU783693B2 (en) 2005-11-24
AU4138001A (en) 2001-06-04
MXPA02005262A (en) 2004-04-21
JP4295821B2 (en) 2009-07-15
EP1233803B1 (en) 2006-02-15
US20030149403A1 (en) 2003-08-07
WO2001037898A2 (en) 2001-05-31
EP1233803A2 (en) 2002-08-28
JP2003514627A (en) 2003-04-22
EP1233803A4 (en) 2003-06-04
WO2001037898A3 (en) 2002-01-10
US6945960B2 (en) 2005-09-20
DE60026079D1 (en) 2006-04-20
CA2382459C (en) 2009-12-29
ATE317712T1 (en) 2006-03-15
DE60026079T2 (en) 2006-08-31

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