Self-retracting medical needle apparatus and methods

• US 6,024,727 A
• Filed: 06/25/1997
• Issued: 02/15/2000
• Est. Priority Date: 01/10/1995
• Status: Expired due to Term

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Nelson, Mark, Owen, Charles V., Thorne, Sandra A., Thorne, David L., Thorne, Gale H.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/882,644
• Time in Patent Office: 965 Days
• Field of Search: 604/195, 604/192, 604/187, 604/263, 604/110, 128/763-765
• US Class Current: 604/195
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150488 Details of construction of shaft
• CPC Class Codes: A61B 5/150496 Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
• 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 5/150595 by snap-lock (i.e. based on axial displacement)
• CPC Class Codes: A61B 5/150603 by rotation, e.g. bayonet or screw
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• 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 5/150908 by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61M 2005/3101 Leak prevention means for proximal end of syringes, i.e. syringe end opposite to needle mounting end
• CPC Class Codes: A61M 2005/3106 Plugs for syringes without needle
• CPC Class Codes: A61M 2005/3121 via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
• CPC Class Codes: A61M 2005/3206 : Needle or needle hub disconnecting devices forming part of or being attached to the hub or syringe body
• CPC Class Codes: A61M 2005/3223 : Means impeding or disabling repositioning of used needles at the syringe nozzle
• CPC Class Codes: A61M 2005/3224 : Means to disalign the needle tip and syringe nozzle
• CPC Class Codes: A61M 2005/3226 : with means obstructing or blocking the needle mounting opening
• CPC Class Codes: A61M 2005/3242 : Needle retraction by vacuum
• CPC Class Codes: A61M 2005/3247 : Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 25/0612 : Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 25/0631 : having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 5/283 : by telescoping of ampoules or carpules with the syringe body
• 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 5/322 : Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612
• 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
• CPC Class Codes: A61M 5/3234 : Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3275 : being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands

Abstract

Method and apparatus associated with safe retraction of medical needles after use. Embodiments are disclosed for self-retracting needle systems for both blood draw, syringe and catheter insertion systems. Invention manufacture requires only a minimal number and complexity of parts such that a projected manufacturing cost is potentially low enough to permit the apparatus to be cost competitive with contemporary non-self retracting needle systems. Methods for making and assembling each of the disclosed the embodiments is also disclosed. One blood draw embodiment can be made with as few as three molded parts. Energy-storing, needle-retracting mechanisms comprise elastic tubing and vacuum generating piston parts. In an elastic tubing embodiment, selective, constrictive control of stretched tubing volumes effectively inhibits regurgitant flow from the needle. In all embodiments, needle retraction is a single handed operation permitting a technician'"'"'s other hand to be used in wound care. A combination of parts, comprising the apparatus housing and a needle cover, are used as a transport container which protects a medical needle from inadvertent contamination with requiring special packaging, thereby, further reducing apparatus costs.

Claims

1. A needle retraction device comprising:

a housing;

a needle hub initially disposed in the housing in a retracted position, said needle hub being movable from the retracted position to an extended position relative to the housing;

a needle connected to the needle hub;

a needle cover removably connected to the needle hub and initially disposed at least partially in the housing when the needle hub is in the retracted position;

a latch associated with the housing and cooperating with the needle hub to hold the needle hub in the extended position and to release the needle hub to the retracted position; and

a biasing mechanism to retract the needle hub to the retracted position from the extended position.

2. A needle retraction device according to claim 1 wherein said needle comprises a sharpened tip on both ends of the needle.

3. A needle retraction device according to claim 1 wherein said device comprises and intravascular catheter.

4. A needle retraction device according to claim 1 wherein said biasing mechanism comprises a chamber in which a vacuum is drawn when the needle is extended.

5. A needle retraction device according to claim 1 wherein said biasing mechanism comprises an elastic tube.

6. A needle retraction device according to claim 5 wherein said elastic tube comprises a fluid pathway.

7. A needle retraction device according to claim 1 wherein said housing comprises a deformable section, deformation of which releases said latch.

8. A needle retraction device according to claim 7 wherein said housing comprises a needle protective environment prior to extension of said needle.

9. A needle retraction device according to claim 8 wherein said housing comprises a membrane portion which maintains a seal about the deformable section.

10. A needle retraction device comprising:

a housing;

a needle hub disposed in the housing in a retracted position, said needle hub being movable from the retracted position to an extended position relative to the housing;

a needle connected to the needle hub;

a means associated with the needle hub for moving the needle from the retracted position to the extended position;

a means associated with the housing for temporarily locking the needle hub in the extended position; and

a biasing mechanism disposed between the housing and the needle hub that is biased when the needle hub is in the extended position for biasing the needle hub to the retracted position.

11. A needle retraction device according to claim 10 wherein said moving means comprises a needle cover.

12. A needle retraction device according to claim 11 wherein said moving means further comprises a quick release component which cooperates with an inner engagement between the housing and the needle hub to free the needle cover from the housing as a result of simply continuing action of extending the needle.

13. A needle retraction device according to claim 10 wherein said biasing mechanism comprises an elastic tube.

14. A needle retraction device according to claim 10 wherein said biasing mechanism comprises a plunger used to draw a vacuum.

15. A needle retraction device according to claim 10 further comprising a medical catheter.

16. A needle retraction device according to claim 10 wherein said housing comprises a syringe plunger.

17. A needle retraction device according to claim 10 wherein said housing comprises a phlebotomy barrel.

18. A method of using a needle retraction device, comprising the steps of:

providing a device having a housing, a needle movably disposed in the housing in an initial retracted position and a biasing mechanism between the needle and the housing;

moving the needle distally with respect to the housing from a retracted position to an extended position;

biasing the biasing mechanism upon distal movement of the needle; and

retracting the needle from the extended position to the retracted position.

19. A method according to claim 18 wherein said biasing step comprises pulling vacuum.

20. A method according to claim 18 wherein said biasing step comprise compressing an elastic tube.

21. A method according to claim 18 wherein said moving step comprises pulling the needle distally from the housing as a needle cover is pulled from the housing.

22. A method according to claim 21 wherein said needle pulling step comprises freeing the cover from the needle once the needle is extended by the same action as the action which extended the needle.

23. A method according to claim 18 wherein the moving step comprises moving a intravascular catheter as well as the needle.

24. A method of using a medical needle safety device comprising the steps of:

providing a device having a needle tip protecting shroud, a medical needle assembly comprising a needle hub movable from a retracted position to an extended position, a medical needle connected to the needle hub and having a sharpened tip initially disposed in said shroud, a biasing mechanism disposed in a substantially relaxed state between said hub and shroud and a releasible latch;

exposing said needle tip by moving said needle relative to said shroud to a needle tip extended position for use in a medical procedure;

with needle movement, biasing the biasing mechanism and retaining said bias by the releasible latch; and

releasing the latch to protectively cover the needle tip by the shroud.

25. An extendable and retractable medical needle apparatus adapted for use in fluid collecting and dispensing procedures comprising:

a housing;

a medical needle, at least partially disposed within said housing;

an extension assembly initially disposed in a retracted state in said housing for extending said needle from said housing from the retracted state to an extended state for use in a medical procedure, said extension assembly comprising;

a removable, needle tip protecting cover;

an energy storing member disposed between a portion of said housing and said needle such that said energy storing member stores energy as the needle is disposed for use;

a latching mechanism by which the needle is latched to the housing in the extended state for use in a medical procedure; and

a release mechanism for releasing the latching mechanism from the latched state, thereby causing the energy storing mechanism to retract the needle to be safely disposed in the housing.

26. An extendable and retractable medical needle apparatus according to claim 25, wherein said energy storing member comprises an elastic tube.

27. An extendable and retractable medical needle apparatus according to claim 25, wherein said energy storing member comprises a hollow elongated cylindrical tube and a plunger part which is moved when said needle is extended to produce a vacuum within said cylindrical tube which, in cooperation with pressure of ambient atmosphere, produces a pressure differential across said plunger for retracting the needle into the housing.

28. An extendable and retractable medical needle apparatus according to claim 25, wherein said latching mechanism comprises a catch integrally molded to said housing.

29. An extendable and retractable medical needle apparatus according to claim 25, wherein said release mechanism comprises a button, disposed on the housing, which is depressed to release the latching mechanism.

30. An extendable and retractable medical needle apparatus according to claim 29, wherein said button is integrally molded as a part of said housing.

31. An extendable and retractable medical needle apparatus according to claim 25, wherein said apparatus further comprises an intravenous catheter disposed about said medical needle.

32. An extendable and retractable medical needle apparatus according to claim 25, wherein said extension assembly further comprises a removable needle cover which, in cooperation with said housing, provides evidence of tampering prior to extending said needle.

33. An extendable and retractable medical needle apparatus according to claim 25, wherein said latching mechanism is diposed in a non-stressed state, relative to forces applied to said lathcing mechanism in-line with direction of retraction of the needle, prior to extending said needle.

34. An extendable and retractable medical needle apparatus according to claim 25, wherein said energy storing member is disposed in a non-stressed state prior to extending said needle.

35. A method for using an extendable and retractable medical needle apparatus comprising the steps of:

providing the medical needle apparatus comprising;

a housing;

a medical needle at least partially disposed within said housing;

an extension assembly for extending said needle from the housing to an extended state for use in a medical procedure, said extension assembly comprising;

a cover for protection of the needle;

an energy storing member disposed between a portion of said housing and said needle such that said energy storing member stores energy as the needle is disposed for use;

a latching mechanism by which the needle is latched in the extended state for use in a medical procedure; and

a release mechanism disposed for releasing the latching mechanism from the latched state, thereby causing the energy storing member to retract the needle until safely disposed within the housing;

storing the energy storing member and latching mechanism in a non-stressed state relative to the direction of needle retraction during a period prior to readying the needle for use;

readying the needle for use by extending the needle from the housing; and

releasing the latching mechanism and retracting the needle by force of energy stored in the energy storing member, after using the medical needle in a medical procedure.

36. A method for using an extendable and retractable medical apparatus according to claim 35, wherein the readying step comprises pulling a vacuum within said housing which, in cooperation with ambient air pressure, provides energy for said energy storing member.

37. A method for using an extendable and retractable medical apparatus according to claim 35, wherein the readying step comprises changing both the energy storing member and latching mechanism from a non-stressed state, whereby no forces are acting upon either the energy storing member or the latching mechanism in-line with direction of needle retraction, to a stressed state, where forces do act upon both the energy storing member and the latching mechanism in-line with direction of needle retraction, such that the releasing step causes the needle to retract.

38. A method for using an extendable and retractable medical apparatus according to claim 35, wherein the readying step comprises breaking a tamper-proof seal.

39. A method for using an extendable and retractable medical apparatus according to claim 35, wherein the readying step comprises removing a needle cover which previously protected said needle.

40. An extendable and retractable catheter needle device, comprising:

a housing;

a catheter needle disposed within an IV catheter, said catheter needle and said IV catheter being at least partially, protectively disposed within said housing prior to use in a medical procedure;

an extension assembly initially disposed in a retracted state for extending said needle from the housing in the retracted state to an extended state for use in a medical procedure, said extension assembly comprising;

a cover for protection of the needle and catheter;

an energy storing member disposed between said container and said needle such that said energy storing member stores energy as the needle is disposed for use;

a latching mechanism by which the needle is latched to the housing in the extended state for use in a medical procedure; and

a release mechanism for releasing the latching mechanism from the latched state, thereby causing the energy storing member to retract the needle into the housing.

41. An extendable and retractable catheter needle device according to claim 40, wherein said energy storing member comprises a vacuum chamber and a plunger which is disposed withing said chamber to pull a vacuum when said needle is extended and disposed for use and which is disposed to retract said needle when forces associated with said vacuum are permitted to push the plunger into the vacuum chamber.

42. An extendable and retractable catheter needle device according to claim 40, wherein said latching mechanism comprises a release button integrally molded as a part of said housing.

43. An extendable and retractable catheter needle device according to claim 40, wherein said extension assembly comprises a needle hub and needle cover hub attachment by which said needle is pulled outwardly relative to said housing.

44. An extendable and retractable catheter needle device according to claim 43, wherein said needle hub, needle cover hub attachment and housing which, in combination, fashion a release which frees the needle cover from capture by the housing once the needle is disposed in an extended state.

45. An extendable and retractable catheter needle assembly comprising:

a housing;

a catheter needle which is disposed within an IV catheter to be used for transcutaneous insertion of the catheter into a patient, said catheter needle and IV catheter being at least partially, protectively disposed in said housing prior to use in a medical procedure;

apparatus for extending said catheter needle and catheter from the housing for use in the medical procedure, said extending apparatus comprising a cover which provides protection for both needle and catheter and by which the needle is extended for use;

an energy storing part which is unstressed prior to extending of the catheter needle and which stores energy as the catheter needle and catheter are extended;

a releasible latch by which the catheter needle is latched in an extended state for use in a medical procedure; and

said housing comprising a cantilevered button which is integral with said housing and which is depressed to release the latch from the latched state, thereby causing the needle to be safely retracted into the housing under force of the energy stored in the energy storing part.

46. An extendable and retractable catheter needle assembly according to claim 45, wherein said, in combination said housing, cover and latch comprise a quick release such that the cover is released from further extending the needle when the cover is pulled out of the housing.

47. An extendable and retractable catheter needle assembly according to claim 45, wherein said energy storing part comprises a plunger part for pulling a vacuum which is acted upon by atmospheric pressure to provide retractable force for the needle.

48. A method for using a self-retracting needle apparatus comprising the steps of:

providing the self-retracting needle apparatus comprising a housing for the apparatus;

a medical needle which is generally stored in the housing, extended from the housing for use in a medical procedure and retracted into the housing for safe containment after use;

an energy storing part which provides retractive force for the needle;

a latch which releasibly secures the needle while extended from the housing; and

an actuator which is used to release the latch to cause the needle to be retracted back into the housing;

storing the energy storing part and latch in a non-stressed state during a period prior to readying the needle for use;

readying the needle for use by extending the needle from the housing;

while extending the needle, stressing the energy storing part to store energy therein and also releasibly securing the latch when the needle is fully extended;

using the medical needle in a medical procedure; and

releasing the latch and retracting the needle by force of energy stored in the energy storing part.

49. A method according to claim 48, wherein the releasing step comprises distorting a deformable portion of the housing to release the latch and retract the needle.