Hypodermic syringe needle assembly and method of making the same

• US 6,776,775 B1
• Filed: 04/29/2002
• Issued: 08/17/2004
• Est. Priority Date: 12/23/1999
• Status: Expired due to Fees

• Current Assignee: Owais Mohammad
• Original Assignee: Owais Mohammad
• Inventors: Mohammad, Owais
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US10/133,491
• Time in Patent Office: 841 Days
• Field of Search: 604/195, 604/263, 604/264, 604/162, 604/196, 604/198, 604/218, 604/128, 604/919, 604/181
• US Class Current: 604/195
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150503 Single-ended needles 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/150732 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 2005/3228 the needle being retracted by a member protruding laterally through a slot in the barrel, e.g. double-ended needles
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612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 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61M 5/3272 having projections following labyrinth paths
• CPC Class Codes: A61M 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014

Abstract

A retractable needle assembly for use in medical procedures, comprising:

a needle assembly including a hub, a hollow needle passing through the hub and projecting from the posterior end of the hub, and a tubular sleeve having a radially directed hole therethrough connected with the anterior end of the hub;

a tubular sheath having a wall with a radially directed hole therethrough, wherein the needle assembly is positioned within the tubular sheath so that it may be moved reversibly between an exposed position and a retracted position;

a means for reversibly locking the needle assembly in its exposed position;

a means for reversibly locking the needle assembly in its retracted position; and

a means for permanently locking the needle assembly in its retracted position, said permanent locking means comprising a radially-directed peg mounted on an exterior surface of the tubular sheath so that one end of the radially-directed peg is adapted to be pushed inwardly through the hole in the wall of the tubular sheath and through the hole in the tubular sleeve, wherein said one end of the radially-directed peg may not be withdrawn through the hole in the tubular sleeve after it has been pushed through the hole in the tubular sleeve.

Claims

1. A retractable needle assembly for use in medical procedures, comprising:

a) a needle assembly, said needle assembly comprising a hub having an anterior end and a posterior end, a hollow needle passing through the hub and projecting from the posterior end of the hub; and

a tubular sleeve connected with a peripheral edge of the hub and projecting from the anterior end of the hub, said sleeve having a radially directed hole therethrough;

b) a tubular sheath having a wall with a radially directed hole therethrough, an anterior end, and a posterior end, said posterior end having an opening therethrough,

wherein the needle assembly is positioned within the tubular sheath with the hollow needle projecting from the posterior end of the hub being directed toward the opening in the posterior end of the sheath,

wherein said needle assembly may be moved reversibly along an axis of the sheath between an exposed position in which the hollow needle passes through the opening in the posterior end of the sheath and a retracted position in which the hollow needle is contained within the tubular sheath, and

wherein the opening in the posterior end of the sheath is large enough to allow the hollow needle to pass therethrough, but too small to allow the hub to pass therethrough;

c) a means for reversibly locking the needle assembly in its exposed position;

d) a means for reversibly locking the needle assembly in its retracted position; and

e) a means for permanently locking the needle assembly in its retracted position, said permanent locking means comprising a radially-directed peg, said radially-directed peg being mounted on an exterior surface of the tubular sheath so that one end of the radially-directed peg is adapted to be pushed inwardly through the hole in the wall of the tubular sheath and through the hole in the tubular sleeve, wherein said one end of the radially-directed peg cannot be withdrawn through the hole in the tubular sleeve after it has been pushed through the hole in the tubular sleeve.

2. The retractable needle assembly of claim 1, wherein the means for permanently locking the needle assembly in its retracted position cannot be used unless the needle has first been reversibly locked in its retracted position.

3. The retractable needle assembly for use in medical procedures of claim 1, wherein the means for permanently locking the needle assembly in its retracted position further comprises a tubular mount connected with the external surface of the tubular sheath and a stop on the external surface of the radially-directed peg, said tubular mount having an inwardly projecting flange on an outer end thereof;

wherein the radially-directed peg is slidably mounted within the tubular mount; and

wherein the flange on the tubular mount retains the stop on the external surface of the radially-directed peg within the tubular mount.

4. The retractable needle assembly for use in medical procedures of claim 1, wherein the radially directed peg has at least one flexible projection thereon, said flexible projection is adapted to bend as said one end of the radially-directed peg is pushed inwardly through the hole in the wall of the tubular sheath, but is unable to bend when an attempt to withdraw said one end of the radially-directed peg through the hole in the wall of the tubular sheath is made.

5. The retractable needle assembly for use in medical procedures of claim 1, wherein the radially directed peg has a flexible frustoconical tube attached thereto, said frusto-conical tube having walls which are adapted to bend as said one end of the radially-directed peg is pushed inwardly through the hole in the tubular sleeve, but which are unable to bend when an attempt to withdraw said one end of the radially-directed peg through the hole in the tubular sleeve is made.

6. The retractable needle assembly for use in medical procedures of claim 1, wherein the radially directed peg has at least one rigid projection thereon, wherein said rigid projection is adapted to irreversibly penetrate the hole in the tubular sleeve when one end of the radially-directed peg is pushed inwardly therethrough.

7. The retractable needle assembly for use in medical procedures of claim 4 wherein the said needle assembly may be moved reversibly along an axis of the sheath by means of a radially projecting member rigidly connected with the hub of the needle assembly and a longitudinal slot through the wall of the tubular sheath, wherein the radially projecting member is slidably engaged by the longitudinal slot.

8. The retractable needle assembly of claim 7, wherein the means for reversibly locking the needle assembly in its exposed position comprises a first locking slot which intersects the longitudinal slot near the posterior end of the tubular sheath, said first locking slot being adapted to admit the radially projecting member.

9. The retractable needle assembly of claim 8, wherein the first locking slot is a straight slot, a curved slot, an L-shaped slot, a T-shaped slot, or a C-shaped slot.

10. The retractable needle assembly of claim 8, wherein the first locking slot is an L-shaped slot.

11. The retractable needle assembly of claim 8, wherein the first locking slot comprises a tooth near its entrance, wherein said tooth narrows the entrance to a width which is less than the width of the radially projecting member, but which is large enough to allow the radially projecting member to be pushed therethrough.

12. The retractable needle assembly of claim 7, wherein the means for reversibly locking the needle assembly in its retracted position comprises a second locking slot which intersects the longitudinal slot near the anterior end of the tubular sheath, said second locking slot being adapted to admit the radially projecting member.

13. The retractable needle assembly of claim 12, wherein the second locking slot is a straight slot or an L-shaped slot.

14. The retractable needle assembly of claim 12, wherein the second locking slot is a straight slot.

15. The retractable needle assembly of claim 12, wherein the radially directed hole through the tubular sleeve and the radially directed hole through the tubular sheath are aligned only when the radially projecting member enters the second locking slot.

16. The retractable needle assembly of claim 12, wherein the second locking slot comprises a tooth near its entrance, wherein said tooth narrows the entrance to a width which is less than the width of the radially projecting member, but which is large enough to allow the radially projecting member to be pushed therethrough.

17. The retractable needle assembly of claim 7, wherein the means for reversibly locking the needle assembly in its exposed position comprises a first locking slot which intersects the longitudinal slot near the posterior end of the tubular sheath, and the means for reversibly locking the needle assembly in its retracted position comprises a second locking slot which intersects the longitudinal slot near the anterior end of the tubular sheath, said first and second locking slots being adapted to admit the radially projecting member.

18. The apparatus of claim 7, wherein the means for reversibly locking the needle assembly in its exposed position comprises a pair of teeth on opposite sides of the longitudinal slot, said pair of teeth being positioned near a posterior end of the tubular sheath, wherein a locking position is defined between the teeth and the posterior end of the longitudinal slot;

and wherein the teeth cause the width of the slot to narrow to a width which is smaller than the diameter of the radially projecting member, but large enough to allow a user to push the radially projecting member through the teeth.

19. The apparatus of claim 7, wherein the means for reversibly locking the needle assembly in its retracted position comprises a pair of teeth on opposite sides of the longitudinal slot, said pair of teeth being positioned near an anterior end of the tubular sheath, wherein a locking position is defined between the teeth and the anterior end of the longitudinal slot;

and wherein the teeth cause the width of the slot to narrow to a width which is smaller than the diameter of the radially projecting member, but large enough to allow a user to push the radially projecting member through the teeth.

20. The retractable needle assembly of claim 7, wherein the means for reversibly locking the needle assembly in its exposed position comprises a first hook which engages the radially projecting member, and the means for reversibly locking the needle assembly in its retracted position comprises a second hook which engages the radially projecting member, wherein the first hook is located at the posterior end of the longitudinal slot and the second hook is located at the anterior end of the longitudinal slot.

21. The retractable needle assembly of claim 7, wherein one end of the radially projecting member is exposed through the longitudinal slot, and a thumbrest is attached to said one end of said radially projecting member.

22. The retractable needle assembly of claim 1, wherein the longitudinal slot in the tubular sheath is open at a first end of the tubular sheath, and closed at the other end of the tubular sheath;

and wherein a separate element is secured to the exterior surface of the first end of the tubular sheath to close the open end of the longitudinal slot.

23. The retractable needle assembly of claim 22, wherein the longitudinal slot in the tubular sheath is open at the anterior end of the tubular sheath;

and wherein the separate element is a ring having a radially-directed hole therethrough, that fits over the exterior surface of the anterior end of the tubular sheath, an exterior surface of said ring having a radially projecting cylinder thereon, said radially projecting cylinder having a bore therethrough, said bore in said radially projecting cylinder being aligned with said radially directed hole in said ring and said radially directed hole in said tubular sheath;

wherein said radially directed peg is slidably positioned within the bore of said radially projecting cylinder.

24. The retractable needle assembly of claim 23, wherein the ring closes the open end of the longitudinal slot while leaving an opening at the anterior end of the tubular sheath.

25. The retractable needle assembly of claim 23, further comprising a catheter;

wherein the needle assembly is in its exposed position and the catheter is releasably supported by the hollow needle;

wherein the anterior end of the tubular sheath is closed; and

wherein the means for reversibly locking the needle assembly in its exposed position comprises a first locking slot which intersects the longitudinal slot near the posterior end of the tubular sheath, said first locking slot being adapted to admit the radially projecting member, wherein the first locking slot is an L-shaped slot.

26. The retractable needle assembly of claim 25, wherein the catheter comprises:

a) a female joint;

b) a catheter hub having a longitudinal bore therethrough, said catheter hub being connected with the female joint;

c) a cannula having a longitudinal bore therethrough, where the bore of the cannula is in fluid communication with the longitudinal bore of the catheter hub; and

d) a stopcock having a transverse bore therethrough; and

e) a stopcock handle;

wherein the catheter hub additionally features a tranverse bore which intersects the longitudinal bore therethrough, said stopcock being mounted within the transverse bore of the catheter hub;

wherein the stopcock handle is adapted to allow the user to reversibly rotate the stopcock between a first open position which allows the flow of fluid through the longitudinal bore of the catheter hub, and a second closed position which blocks the flow of fluid through the longitudinal bore of the catheter hub.

27. The retractable needle assembly of claim 22, wherein the tubular sheath has a constant internal diameter and the longitudinal slot in the tubular sheath is open at the posterior end of the tubular sheath;

and wherein the separate element is a cover that fits over the posterior end of the tubular sheath, said cover having an opening which is large enough to allow the hollow needle to pass therethrough, but too small to allow the hub to pass therethrough.

28. The retractable needle assembly of claim 27, wherein the cover has a skirt that fits over the posterior end of the tubular sheath, said skirt having an external surface with a means for gripping the posterior end of the tubular sheath thereon.

29. The retractable needle assembly of claim 27, wherein an exterior surface of said tubular sheath has a radially projecting cylinder thereon, said radially projecting cylinder having a bore therethrough, said bore in said radially projecting cylinder being aligned with said radially directed hole in said tubular sheath;

wherein said radially directed peg is slidably positioned within the bore of said radially projecting cylinder.

30. The retractable needle assembly of claim 7, wherein the anterior end of the tubular sheath has an opening which is adapted to admit a syringe barrel, and an interior surface of the tubular sleeve defines a cavity which is adapted to engage a male joint on the syringe barrel, where a longitudinal bore through the male joint places an interior of the hollow needle in fluid communication with an interior of the syringe barrel.

31. The retractable needle assembly of claim 30, wherein the tubular sleeve is adapted to:

frictionally engage a male joint on the syringe barrel;

engage a threaded joint on the syringe barrel;

or

engage a Luer-Loc connector on the syringe barrel.

32. The retractable needle assembly of claim 7, wherein the anterior end of the tubular sheath has an opening which is adapted to admit an evacuated test tube sealed with a rubber septum, and wherein the hollow needle passing through the hub has a first end which projects from the posterior end of the hub and a second end which projects from the anterior end of the hub, said second end of the needle being adapted to penetrate said rubber septum so that an interior of the hollow needle is in fluid communication with an interior of the evacuated tube.

33. The retractable needle assembly of claim 7, wherein the needle assembly comprises a hub having an anterior end and a posterior end;

a hollow needle passing through the hub and projecting from the posterior end of the hub;

a flash chamber having an anterior end and a posterior end which is connected with the anterior end of the hub, an interior of said flash chamber being in fluid communication with an interior of the hollow needle; and

a tubular sleeve connected with the anterior end of the flash chamber, said sleeve having a radially directed hole therethrough.

34. The retractable needle assembly of claim 33, further comprising a catheter, and a catheter engaging means on the posterior end of the tubular sheath;

wherein the needle assembly is initially in its exposed position;

wherein the catheter is supported by the hollow needle; and

wherein the catheter is releasably engaged by the catheter engaging means on the tubular sheath.

35. The retractable needle assembly of claim 33, further comprising a pair of finger grips on opposite sides of the tubular sheath, with the longitudinal slot being positioned between the finger grips.

36. The retractable needle assembly of claim 7, wherein the needle assembly further comprises a female joint rigidly connected with the anterior end of the tubular sheath, and an adjustable-length tube connecting the female joint with the anterior end of the hub of the needle assembly, said adjustable-length tube being reversibly adjustable between an extended configuration and a contracted configuration;

wherein when the adjustable-length tube is in its contracted configuration, the needle assembly is in its retracted position, and when the adjustable-length tube is in its extended configuration, the needle assembly is in its exposed position; and

wherein the female joint is adapted to frictionally engage the tip of a syringe barrel, so as to place an interior of said syringe barrel in fluid communication with an interior of the adjustable-length tube and an interior of the hollow needle.

37. The retractable needle assembly of claim 36, wherein the tubular sleeve is coaxial with the adjustable-length tube.

38. The retractable needle assembly of claim 36, wherein the adjustable-length tube is connected to the tubular sheath by a collar ring which comprises an outer skirt which fits over an outer surface of the tubular sheath, the outer skirt being connected with an inner skirt which fits inside the tubular sheath;

wherein the female joint is rigidly connected with the inner skirt of the collar ring.

39. The retractable needle assembly of claim 36, wherein the tubular sleeve surrounds the end of the adjustable-length tube which is connected to the anterior end of the hub of the needle assembly.

40. The retractable needle assembly of claim 36, wherein the adjustable-length tube has corrugated walls which are collapsible.

41. The retractable needle assembly of claim 36, wherein the adjustable-length tube is made from an inner tube and an outer tube, wherein the inner tube is movable in an axial direction, relative to the outer tube.

42. The retractable needle assembly of claim 7, wherein the radially projecting member has a circular cross section.

43. The retractable needle assembly of claim 7, wherein the radially projecting member has a non-circular cross-section.

44. The retractable needle assembly of claim 7, wherein the radially projecting member has a cross section selected from the group consisting of an oval cross section, a square cross section, or a rectangular cross section.

45. The retractable needle assembly of claim 7, further comprising a means for reversibly biasing the needle assembly into its retracted position.

46. The retractable needle assembly of claim 45, wherein the reversible biasing means is a spring.