Safety needle system operable with a medical device

• US 8,814,833 B2
• Filed: 05/19/2011
• Issued: 08/26/2014
• Est. Priority Date: 05/19/2010
• Status: Active Grant

• Current Assignee: Tangent Medical Technologies, Inc (ICU Medical Incorporated)
• Original Assignee: Tangent Medical Technologies, LLC
• Inventors: Farrell, Nathan, Harris, Adrienne Rose, White, Steven B., Duis, Ronald Dean, Brown, Henry J. H.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/111,716
• Publication Number:
  US 20110288482A1
• Time in Patent Office: 1,195 Days
• Field of Search: 604/110, 604/164.04, 604/164.08, 604/192, 604/198
• US Class Current: 604/164.04
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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 25/0693 Flashback chambers
• CPC Class Codes: A61M 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

A safety needle system operable with a medical device includes: a housing with a needle mount having a needle; and a sheath telescopically engaged with the housing and surrounding the needle such that the sheath operates in a retracted position, in which the sheath exposes the needle, and an extended position, in which the sheath surrounds the needle. The sheath is coupleable to the medical device such that removal of the needle from the medical device draws the sheath over the needle, transitioning the sheath from the retracted position to the extended position. In one embodiment, the system includes a slider engaged with the sheath and/or housing and including a restraint that engages and disengages the sheath to respectively reinforce and weaken the coupling of the sheath and medical device. In another embodiment, the sheath includes a longitudinal track that slidingly engages a setting of the housing between sheath positions.

Claims

1. A safety needle system operable with a medical device, comprising:

a housing including a needle mount;

a needle having a distal end insertable through the medical device and a proximal end coupled to the needle mount;

a sheath telescopically engaged with the housing and circumferentially surrounding at least a portion of the needle, wherein the sheath operates in;

a retracted position, wherein the sheath exposes the distal end of the needle; and

an extended position, wherein the sheath substantially surrounds the distal end of the needle;

wherein the sheath is coupleable to the medical device such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position; and

a slider, longitudinally engaged with at least one of the housing, sheath, and needle and including a restraint that selectively engages the sheath, wherein;

the restraint is engaged with the sheath in the retracted position, thereby reinforcing coupling of the sheath to the medical device in the retracted position; and

the restraint is disengaged from the sheath in the extended position, thereby weakening the coupling of the sheath to the medical device in the extended position.

2. The system of claim 1, wherein the housing includes an inner portion that is contained within the sheath.

3. The system of claim 2, wherein the inner portion includes a track along which the slider is slidingly engaged.

4. The system of claim 3, wherein the sheath is telescopically engaged around the slider.

5. The system of claim 4, wherein the housing includes at least one arch that forms an outer framework at least partially around the sheath and slider.

6. The system of claim 1, wherein the needle has a lumen.

7. The system of claim 1, wherein the sheath includes flexible jaws extending from the distal end of the sheath and biased to couple to the medical device.

8. The system of claim 7, wherein the flexible jaws surround a portion of the medical device.

9. The system of claim 7, wherein the restraint of the sheath is coupleable to the flexible jaws.

10. The system of claim 9, wherein the distal end of the sheath includes two split portions, each split portion including one of the flexible jaws and a slot, and wherein the restraint of the sheath includes two tabs, wherein:

when the restraint is coupled to the sheath, each tab is engaged with a respective slot, thereby substantially fixing the flexible jaws relative to one another, and

wherein when the restraint is uncoupled from the sheath, each tab is disengaged from its respective slot, thereby substantially allowing movement of the flexible jaws relative to one another.

11. The system of claim 7, wherein when the restraint is engaged with the sheath the jaws are in a closed configuration and when the restraint is disengaged from the sheath jaws are in an open configuration.

12. The system of claim 1, wherein the sheath includes a holding tab extending laterally outward from a distal end of the sheath.

13. The system of claim 1, wherein the slider includes a substantially planar portion and a substantially nonplanar sheath insert portion that is telescopically engaged within the sheath.

14. The system of claim 1, wherein the housing, sheath, and slider are longitudinally movable relative to one another.

15. The system of claim 1, wherein the slider includes a proximal articulation and a distal articulation, wherein when the sheath is in the extended position the proximal articulation is coupled to the housing and the distal articulation is coupled to the sheath, thereby locking the sheath in the extended position.

16. The system of claim 15, wherein the housing includes a housing stop that is configured to abut the proximal articulation of the slider when the sheath is in the extended position.

17. The system of claim 16, wherein the housing stop includes a snap lock cantilevered arm.

18. The system of claim 17, wherein the proximal articulation of the slider is a laterally outward extending tab.

19. The system of claim 15, wherein the sheath includes a sheath stop that is configured to abut the distal articulation of the slider when the sheath is in the extended position.

20. The system of claim 19, wherein the sheath stop is an aperture defined in a side wall of the sheath.

21. The system of claim 20, wherein the distal articulation of the slider is an extension that catches in the aperture.

22. The system of claim 1, further comprising a locking mechanism configured to lock the sheath in the extended position.

23. The system of claim 1, further including a septum, coupled to the sheath, that surrounds the distal end of the sheath when the sheath is in the extended position.

24. The system of claim 23, wherein the septum includes a septum cavity.

25. The system of claim 24, wherein the septum includes a rigid core and an elastomeric plug surrounding at least a portion of the rigid core.

26. The system of claim 25, wherein the rigid core includes a wall defining an aperture, and a plurality of members extending from the wall.

27. The system of claim 26, wherein the elastomeric plug surrounds the plurality of members to define the septum cavity between the members.

28. The system of claim 24, wherein the septum includes a hollow, rigid septum housing and an elastomeric plug disposed within the rigid septum housing.

29. The system of claim 24, wherein the needle further includes a needle catch that secures the septum cavity over the distal end of the needle.

30. The system of claim 29, wherein the septum cavity includes a spring clip that secures the septum cavity over the distal end of the needle.

31. The system of claim 30, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch.

32. The system of claim 31, wherein the length of the septum is greater than or equal to the notch extent distance.

33. The system of claim 1, wherein the housing further includes a vent chamber with a vent cap.

52. The system of claim 1, wherein the needle is a solid needle.

53. The system of claim 31, wherein the needle has a lumen.

54. The system of claim 31, wherein the needle is a solid needle.

34. A safety needle system operable with a medical device, comprising:

a housing including a needle mount coupled to a setting that approximately axially centers the needle mount within the housing;

a needle having a distal end insertable through the medical device and a proximal end coupled to the needle mount;

a sheath telescopically engaged with the housing and having a distal wall defining a needle aperture and a longitudinal track that is substantially parallel to a longitudinal axis of the sheath and slidingly engaged with the setting of the housing, wherein the sheath operates in;

a retracted position, wherein the sheath exposes the distal end of the needle; and

an extended position, wherein the sheath substantially surrounds the distal end of the needle;

wherein the sheath is coupleable to the medical device such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position; and

a locking mechanism configured to about a proximal portion of the sheath against a stop in the extended configuration, thereby locking the sheath in the extended configuration.

35. The system of claim 34, wherein the longitudinal track includes a first track portion that slidingly engages the setting of the housing to allow the sheath to pass in a proximal direction up to a first limit.

36. The system of claim 35, wherein the longitudinal track further includes a second track portion, parallel to and circumferentially offset from the first portion, that slidingly engages the setting to allow the sheath to pass beyond the first limit in the proximal direction up to a second limit, towards the retracted position of the sheath.

37. The system of claim 36, wherein the first and second portions of the longitudinal track are adjacent to one another.

38. The system of claim 36, wherein the second track portion further slidingly engages the setting to allow the sheath to pass in a distal direction towards the extended position of the sheath.

39. The system of claim 34, wherein a proximal portion of the sheath abuts a stop in the housing when the sheath is in the extended position, thereby preventing overextension of the sheath in a distal direction beyond the housing.

40. The system of claim 34, wherein the sheath includes a proximal sheath piece and a separate distal sheath piece coupled to the proximal sheath piece.

41. The system of claim 34, wherein when the sheath is in the extended position, the locking mechanism is configured to abut the proximal portion of the sheath against the setting of the housing.

42. The system of claim 41, wherein the locking mechanism includes a snap lock cantilevered arm.

43. The system of claim 34, further including a septum, coupled to the sheath, that surrounds the distal end of the sheath when the sheath is in the extended position.

44. The system of claim 43, wherein the septum includes a septum cavity.

45. The system of claim 44, wherein the septum includes a rigid core and an elastomeric plug surrounding at least a portion of the rigid core.

46. The system of claim 44, wherein the needle further includes a needle catch that secures the septum cavity over the distal end of the needle.

47. The system of claim 44, wherein the septum cavity includes a spring clip that secures the septum cavity over the distal end of the needle.

48. The system of claim 43, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch.

49. The system of claim 48, wherein the length of the septum is greater than or equal to the notch extent distance.

50. The system of claim 35, wherein the housing further includes a vent chamber with a vent cap.

55. The system of claim 34, wherein the needle has a lumen.

56. The system of claim 34, wherein the needle is a solid needle.

51. A safety needle system operable with a vascular delivery system adapted to be placed about a catheter insertion site on a patient, wherein the vascular delivery system includes a frame with a catheter hub providing a first anchoring point on the patient, a stabilization hub providing a second anchoring point on the patient, and at least one lateral member extending between the catheter hub and stabilization hub, wherein the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter, the safety needle system comprising:

a housing including a needle mount;

a needle having a distal end insertable through the catheter hub and a proximal end coupled to the needle mount;

a sheath telescopically engaged with the housing and circumferentially surrounding at least a portion of the needle, wherein the sheath operates in;

a retracted position, wherein the sheath exposes the distal end of the needle; and

an extended position, wherein the sheath substantially surrounds the distal end of the needle;

wherein the sheath is coupleable to the catheter hub such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position; and

a slider, longitudinally engaged with at least one of the housing, sheath, and needle and including a restraint that selectively couples to the sheath, wherein;

when the restraint is coupled to the sheath, the restraint reinforces the coupling of the sheath to the catheter hub; and

when the restraint is uncoupled from the sheath, the restraint weakens the coupling of the sheath to the catheter hub.

57. The system of claim 51, wherein the needle has a lumen.

58. The system of claim 51, wherein the needle is a solid needle.