Fluid collection device with retractable needle

• US 6,004,278 A
• Filed: 12/05/1996
• Issued: 12/21/1999
• Est. Priority Date: 12/05/1996
• Status: Expired due to Term

• Current Assignee: MDC Investment Holdings Incorporated (Becton, Dickinson & Co)
• Original Assignee: MDC Investment Holdings Incorporated (Becton, Dickinson & Co)
• Inventors: Botich, Michael J., Halseth, Thor R.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/761,088
• Time in Patent Office: 1,111 Days
• Field of Search: 600/576, 600/577, 600/583, 604/110, 604/195, 604/198
• US Class Current: 600/576
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150404 Specific design of proximal end
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes hollow piercing element tip design A61B5/150396; needle sets for catheters A61M25/06; needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150656 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
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means

Abstract

A needle retraction mechanism for a needle bearing medical device is provided. The needle retainer selectively retains the needle in a projecting configuration in which the sharpened tip of the needle projects outwardly from the device. The needle retaining mechanism has an axial projection configured to provide at least one finger, and preferably a plurality of separable fingers that are joined together to form a bore.

Claims

1. A needle-bearing medical device having a retractable needle with a sharpened tip for penetrating the skin of a patient for diagnostic or therapeutic purposes, the device comprising:

a barrel;

a needle retainer positioned in the barrel and holding the needle axially to project forward from the barrel in an initial configuration;

an actuating member positioned in the barrel and operable by the user to effect automatic retraction of the needle into the barrel after use; and

fluid retention means associated with the needle for substantially preventing ejection of residual fluid from the needle during retraction of the needle.

2. The device of claim 1 wherein the fluid retention means comprises means for producing a partial vacuum within the rear of the needle during retraction.

3. The device of claim 1 wherein the fluid retention means comprises a one way valve connected with the rear of the needle.

4. The device of claim 3 wherein the one way valve comprises a ball valve.

5. The device of claim 3 wherein the one way valve comprises a resilient member having a resealable opening formed therein and configured to allow fluid flow in one direction and substantially resist fluid flow in an opposite direction.

6. The device of claim 5 wherein the resealable opening in the resilient member comprises a slit formed therein to provide the resealable opening.

7. The device of claim 1 wherein the fluid retention means comprises a closure in the rear end of the needle, the needle having an aperture formed through a side thereof at a location toward the rear of the needle to be positioned adjacent a zone of reduced pressure along the needle during retraction of a needle.

8. A hand-held medical device, comprising a barrel;

a needle projecting forward from the barrel and having a sharpened tip for penetrating the skin of a patient for transmitting fluid for diagnostic or therapeutic purposes;

an automatic needle retraction mechanism positioned in the barrel and actuable by a user to effect retraction of the needle into the barrel after use; and

fluid retention means associated with the needle for substantially preventing ejection of residual fluid from the needle during retraction of the needle.

9. The device of claim 8 wherein the needle retraction mechanism comprises:

a spring connected with the needle and compressed within the barrel to exert a rearward bias upon the needle;

a needle retainer for holding the needle in an initial projecting configuration against the bias exerted by the spring;

a first actuating member positioned in the housing and operable by the user to release the needle retainer from holding the needle.

10. The device of claim 9 comprising an actuator member configured to prevent operation of the actuating member such that a compound operation of both the actuating member and actuator member is required to effect retraction of the needle.

11. The device of claim 10 comprising a second needle positioned to extend rearwardly from the barrel, and a housing connected with the barrel and configured to receive a sampling vial therein for penetration by the second needle.

12. The device of claim 11 wherein the second needle extends rearwardly from the actuating member, such that actuation of the actuating member is operable by urging against the rear of the vial.

13. The device of claim 10 wherein the actuating member and actuator member are configured to be operated by the user along distinct directional axes to effect retraction.

14. The device of claim 13 wherein the actuating member comprises a tubular member positioned in the barrel and axially advanceable therein to release the needle retainer;

and wherein the actuator member comprises an interference gate for selectively preventing advancement of the tubular member.

15. The device of claim 14 wherein the tubular member includes an abutment surface thereon, and wherein the interference gate is configured to engage the abutment surface;

said actuator member being operable by the user to disengage the gate from the abutment surface.

16. The device of claim 15 wherein the actuator member includes a resilient member for biasing the gate into engagement with the abutment surface.

17. The device of claim 16 comprising a second needle positioned to extend rearwardly from the actuating member, and a housing connected with the barrel and configured to receive a sampling vial therein for penetration by the second needle, such that actuation of the actuating member is operable by urging against the rear of the vial.

18. The device of claim 17 wherein the actuator member is connected with an actuating surface positioned along a side of the housing, such that a compound operation is required and actuating force applied to the actuating surface of the actuator member and to the rear of the vial in contact with the actuating member for effecting retraction of the needle.

19. A hand-held medical device, comprising:

a barrel;

a needle projecting forward from the barrel and having a sharpened tip for penetrating the skin of a patient;

a spring connected with the needle and compressed within the barrel to exert a rearward bias upon the needle;

a needle retainer for holding the needle in an initial projecting configuration from the barrel against the bias exerted by the spring;

an actuating member positioned in the housing and operable by the user to release the needle retainer from holding the needle; and

an actuator member configured to prevent operation of the actuating member, such that a compound operation of both the actuator member and the actuating members is required to effect retraction of the needle.

20. The device of claim 19 comprising a second needle positioned to extend rearwardly from the barrel, and a housing connected with the barrel and configured to receive a sampling vial therein for penetration by the second needle.

21. The device of claim 20 wherein the second needle extends rearwardly from the actuating member, such that actuation of the actuating member is operable by urging the rear of the vial into the housing.

22. The device of claim 19 wherein the actuator member and actuating member are configured to be operated by the user along distinct directional axes to effect retraction.

23. The device of claim 22 wherein the actuating member comprises a tubular member positioned in the barrel and axially advanceable therein to release the needle retainer;

and wherein the actuator member comprises an interference gate for selectively preventing advancement of the tubular member.

24. The device of claim 23 wherein the tubular member includes an abutment surface thereon, and wherein the interference gate is configured to engage the abutment surface;

said actuator member being operable by the user to disengage the gate from the abutment surface.

25. The device of claim 24 wherein the actuator member includes a resilient member for biasing the gate into engagement with the abutment surface.

26. The device of claim 25 comprising a second needle positioned to extend rearwardly from the actuating member, and a housing connected with the barrel and configured to receive a sampling vial therein for penetration by the second needle, such that actuation of the actuating member is operable by urging against the rear of the vial.

27. The device of claim 26 wherein the actuator member is connected with an actuating surface positioned along a side of the housing, such that a compound operation is required and actuating force to be applied to the actuating surface of the actuator member and to the rear of the vial in contact with the actuating member for effecting retraction of the needle.

28. An automatic needle retraction mechanism for a needle-bearing medical device having a barrel, the retraction mechanism comprising:

a spring connected to the needle and compressed within the barrel for exerting a bias upon the needle for withdrawing the needle into the barrel;

a needle retainer positioned in the barrel and bonded to the needle for restraining the needle against the bias exerted by the spring; and

an actuating member slidably positioned in the barrel and configured for disengaging the needle retainer from the needle upon advancement of the actuating member against the needle retainer.

29. The retraction mechanism of claim 28 wherein the needle retainer comprises a plurality of separable fingers configured to provide a continuous interior surface bonded to the needle.

30. The retraction mechanism of claim 29 wherein the bonding surface is adhesively bound to the exterior of the needle, and wherein the actuating member is configured to break the adhesive bond between the needle retainer and the needle.

31. In a medical device comprising a barrel and an actuating member slidably positioned in the barrel, a fluid seal comprising:

an integral head portion formed on the actuating member having an integral annular peripheral surface in contact with the interior of the barrel;

the barrel having a constricted portion formed therein and the actuating member being positioned in the barrel initially at a first position prior to use and slidable to a second position in the barrel to have the head located within the constricted portion of the barrel, whereby a fluid seal is provided during use.