Tip protector for a safety catheter

• US 8,257,322 B2
• Filed: 06/02/2010
• Issued: 09/04/2012
• Est. Priority Date: 06/02/2010
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Inventors: Koehler, Thomas T., Felicito, Kathryn L., Chheda, Harsh, Abriles, Oscar R.
• Primary Examiner(s): Koharski, Christopher D
• Application Number:
  US12/792,290
• Publication Number:
  US 20110301551A1
• Time in Patent Office: 825 Days
• Field of Search: 604/164.08, 604/110, 604/111, 604/192, 604/198, 604/263, 604/272
• US Class Current: 604/263
• 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 25/0637 Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
• CPC Class Codes: A61M 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/321 Means for protection against accidental injuries by used needles
• CPC Class Codes: A61M 5/3213 Caps placed axially onto the needle, e.g. equipped with finger protection guards axially-extensible protective sleeves A61M5/3243
• CPC Class Codes: A61M 5/329 characterised by features of the needle shaft

Abstract

A safety catheter includes a catheter hub, a catheter tube, a needle hub, a needle cannula having a tip, and a tip protector. The tip protector includes an outer member having a flexible tab configured to releasably engage with the catheter hub and release therefrom upon inward flexing of the tab. An inner member is positioned entirely within the outer member and has a portion that impedes inward flexing of the tab when disposed adjacent the tab. The inner member is axially shiftable relative to the outer member between a first position wherein the needle tip is distal of the tip protector and the inner member portion is disposed adjacent the tab to impede release from the catheter hub, and a second position wherein the tip is within the outer member and the inner member portion is no longer adjacent the tab and no longer impedes release from the catheter hub.

Claims

1. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub, wherein the inner member includes a central axis and at least one arm, the arm being biased radially outward relative to the central axis.

2. The safety catheter of claim 1, wherein the outer member includes a central axis and the at least one flexible tab is biased radially inward relative to the central axis.

3. The safety catheter of claim 1, wherein the interior of the catheter hub includes a retention groove for engaging the flexible tab.

4. The safety catheter of claim 1, further comprising a locking mechanism configured to limit axial shifting of the inner member relative to the outer member when the inner member is in the second position.

6. The safety catheter of claim 1, further comprising an anti-rotation mechanism configured to limit the rotation of the inner member relative to the outer member.

9. The safety catheter of claim 1, further comprising a positive stop configured to limit axial shifting of the inner member relative to the outer member in at least one direction when the inner member is in the first position.

11. The safety catheter of claim 1, wherein the inner member is axially shifted from the first position to the second position by movement of the needle cannula.

12. The safety catheter of claim 1, wherein the needle cannula includes an engagement feature for engaging the inner member to axially shift the inner member from the first position to the second position.

13. The safety catheter of claim 12, wherein the engagement feature includes a protuberance.

14. The safety catheter of claim 1, wherein the inner member includes a stop member for engaging a portion of the needle cannula to axially shift the inner member from the first position to the second position.

15. The safety catheter of claim 14, wherein the stop member includes a stop washer.

16. The safety catheter of claim 1, wherein the inner member includes a second arm disposed opposite the at least one arm.

17. The safety catheter of claim 16, wherein the second arm is biased radially outward relative to the central axis.

18. The safety catheter of claim 1, wherein movement of the arm is constrained by the outer member when the inner member is in the second position.

19. The safety catheter of claim 1, wherein movement of the arm is constrained by the outer member when the inner member is in the first position.

20. The safety catheter of claim 1, wherein axial shifting of the inner member from the first position toward the second position moves the arm so as to block the path of the needle cannula.

21. The safety catheter of claim 1, wherein the inner member blocks the path of the needle cannula when the inner member is in the second position.

26. The safety catheter of claim 1, wherein the needle hub contacts the catheter hub when in a ready position of the safety catheter.

27. The safety catheter of claim 1, wherein the needle hub contacts the tip protector when in a ready position of the safety catheter.

30. The safety catheter of claim 1, the distal tip being sharp.

5. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip;

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub; and

a locking mechanism including at least one flexible locking tab on the outer member and at least one cavity on the inner member, the locking tab engaging the cavity when the inner member is in the second position to limit axial shifting of the inner member relative to the outer member in at least one direction.

7. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip;

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub; and

an anti-rotation mechanism including at least one flexible locking tab on the outer member and at least one groove on the inner member, the locking tab being disposed within the groove to limit rotation of the inner member relative to the outer member.

8. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip;

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub; and

an anti-rotation mechanism including at least one cutout in the outer member and at least one raised boss on the inner member, the raised boss being disposed within the cutout to limit rotation of the inner member relative to the outer member.

10. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip;

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub; and

a positive stop configured to limit axial shifting of the inner member relative to the outer member in at least one direction when the inner member is in the first position, wherein the positive stop includes at least one cutout in the outer member and at least one raised boss on the inner member, the raised boss being disposed within the cutout to limit axial shifting of the inner member relative to the outer member.

22. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member, the inner member blocks the path of the needle cannula, and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub, wherein the inner member includes a tapered bore having a cross dimension smaller than a cross dimension of the needle cannula to as to block the path of the needle cannula when the inner member is in the second position.

23. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member, the inner member blocks the path of the needle cannula, and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub, wherein the inner member includes at least one rib that blocks the path of the needle cannula when the inner member is in the second position.

24. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub, wherein the inner member includes at least one projection for limiting side out of the needle cannula when the inner member is in the second position.

25. The safety catheter of claim 24, wherein the inner member includes at least one notch configured to receive the at least one projection when the inner member is in the second position.

28. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub, wherein the needle hub includes a distal nose portion having a plurality of spines extending therealong, wherein a distal end of the spines is distal of a distal end of the distal nose portion.

29. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member being axially received entirely within the outer member and having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub, wherein the outer member includes at least one flexible locking tab, the inner member includes a groove having a cavity, the at least one flexible locking tab disposed in the groove and being received in the cavity when the inner member is in the second position to restrict axially shiftable movement of the inner member relative to the outer member.

31. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer thin-walled metal body member extending into the catheter hub and including a flexible tab configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, a plastic inner member having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that the inner member no longer impedes release of the outer member from the catheter hub, and a metal stop member fixedly secured to the inner member for engaging a feature of the needle cannula adjacent the distal tip for axially shifting the inner member relative to the outer member between the first and second positions with movement of the needle cannula, wherein the inner member includes a central axis and at least one arm, the arm being biased radially outward relative to the central axis.

32. The safety catheter of claim 31, wherein the stop member includes a central aperture through which the needle cannula is received.

33. The safety catheter of claim 31, wherein the stop member includes a stop washer.

34. The safety catheter of claim 31, wherein the feature on the needle cannula configured to engage the stop member is a protuberance.

35. The safety catheter of claim 31, wherein the inner member includes a multi-thickness body.

36. The safety catheter of claim 31, wherein the inner member includes a tapered bore having a cross dimension smaller than a cross dimension of the needle cannula to as to block the path of the needle cannula when the inner member is in the second position.

37. The safety catheter of claim 31, wherein the inner member includes at least one rib that blocks the path of the needle cannula when the inner member is in the second position.

38. The safety catheter of claim 31, wherein the inner member includes at least one projection for limiting side out of the needle cannula when the inner member is in the second position.

39. The safety catheter of claim 38, wherein the inner member includes at least one notch configured to receive the at least one projection when the inner member is in the second position.

40. The safety catheter of claim 31, the distal tip being sharp.

41. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the distal tip, comprising an outer member including a flexible tab configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the distal tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the distal tip is within the outer member and the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that inner member no longer impedes release of the outer member from the catheter hub, the inner member having an arm having a portion configured to block the path of the needle cannula when in the second position, the arm being biased away from the needle cannula such that the arm is spaced therefrom when in at least the first position.

42. The safety catheter of claim 41, wherein movement of the arm is constrained by the outer member when the inner member is in the second position.

43. The safety catheter of claim 41, wherein movement of the arm is constrained by the outer member when the inner member is in the first position.

44. The safety catheter of claim 41, wherein axial shifting of the inner member from the first position toward the second position moves the arm so as to block the path of the needle cannula.

45. The safety catheter of claim 41, wherein the inner member includes a tapered bore having a cross dimension smaller than a cross dimension of the needle cannula so as to block the path of the needle cannula when the inner member is in the second position.

46. The safety catheter of claim 45, wherein the inner member includes a pair of arms, each arm having a tapered bore portion such that when the inner member is in the closed position, the tapered bore portions collectively define the tapered bore.

47. The safety catheter of claim 41, wherein the arm includes at least one rib that at least in part blocks the path of the needle cannula when the inner member is in the second position.

48. The safety catheter of claim 47, wherein the at least one rib is spaced from the needle cannula when the inner member is in the first position.

49. The safety catheter of claim 47, wherein the inner member includes a pair of arms, each arm having at least one rib, the ribs cooperating to block the path of the needle cannula when the inner member is in the second position.

50. The safety catheter of claim 41, wherein the arm includes at least one projection for limiting side out of the needle cannula when the inner member is in the second position.

51. The safety catheter of claim 50, wherein the inner member includes a pair of arms, one arm having at least one projection for limiting side out of the needle cannula, the other arm having at least one notch configured to receive the at least one projection when the inner member is in the second position.

52. The safety catheter of claim 41, wherein the catheter hub includes at least one wing.

53. The safety catheter of claim 41, wherein the catheter hub includes a side port.

54. The safety catheter of claim 41, the distal tip being sharp.

55. A safety catheter, comprising:

a catheter hub and a catheter tube extending distally thereof;

a needle hub and a needle cannula extending distally thereof, the needle cannula having a distal tip; and

a tip protector for shielding the tip, comprising an outer member including a flexible tab extending radially outward of the outer member configured to releasably engage with the interior of the catheter hub and to release therefrom on radially inward movement of the tab, and an inner member having a portion to impede radially inward movement of the flexible tab when the inner member portion is disposed axially adjacent the flexible tab, the needle cannula being received in the inner and outer members, the inner member configured to be axially shiftable relative to the outer member between a first position wherein the tip extends distally of the tip protector and the inner member portion is disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, an intermediate position wherein the inner member blocks the path of the needle cannula, the inner member is prevented from axially shifting relative to the outer member in at least one direction, and the inner member portion remains disposed axially adjacent the flexible tab so as to impede release of the outer member from the catheter hub, and a second position wherein the inner member is axially shifted such that the inner member portion is no longer disposed axially adjacent the flexible tab such that the inner member no longer impedes release of the outer member from the catheter hub, wherein the inner member includes a central axis and at least one arm, the arm being biased radially outward relative to the central axis.

56. The safety catheter of claim 55, the distal tip being sharp.