Reusable cannula with disposable seal

• US 6,123,689 A
• Filed: 03/28/1997
• Issued: 09/26/2000
• Est. Priority Date: 06/11/1996
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Kramer, Thomas, To, John T., Lunsford, John P., Davis, John, Gresl, Charles, Kovac, Tim J.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/825,478
• Time in Patent Office: 1,278 Days
• Field of Search: 604/164, 604/167, 604/169, 604/246, 604/249, 604/256, 604/264, 604/164.01, 604/164.02, 604/167.01, 604/167.03
• US Class Current: 604/256
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/349 Trocar with thread on outside

Abstract

A disposable seal assembly for use with a reusable cannula preferably includes a flapper valve fluid seal and at least one instrument seal. The instrument seal has a sacrificial flange and a sealing flange that protrude from an inner baffle connected to the assembly'"'"'s main body by a flexible outer baffle, and at least one elastomeric rib extending between the inner baffle and the body to prevent inversion of the inner baffle. Preferably, a surface of the sacrificial flange is configured to prevent the flanges from sticking together during use. An adaptor, tethered to the assembly'"'"'s main body, has a central channel with an hourglass profile, a concave distal flange, distal bumpers for preventing the adaptor from translating too far into the main body, and a grip portion shaped to allow a user conveniently to separate the adaptor from the main body. Other aspects include systems with a reusable cannula, and methods for using such systems.

Claims

1. A disposable seal assembly, including:

a body having a central longitudinal axis and a flange shaped for removably attaching the body to a cannula, wherein a channel extends through the body along the axis;

a flexible outer baffle extending from the body into the channel;

an inner baffle extending from the outer baffle into the channel;

a sealing flange extending toward the axis from the inner baffle at a first location along the channel, wherein the sealing flange provides a seal around an instrument having a first diameter when the instrument is positioned in the channel, and wherein the inner baffle and the sealing flange are free to move laterally relative to the body as the outer baffle flexes.

2. The assembly of claim 1, also including:

at least one elastomeric rib extending between the inner baffle and the body, the rib being sufficiently elastic to stretch in response to force that tends to pull the inner baffle away from the body and then to relax to its original length following application of said force, thereby preventing inversion of the inner baffle.

3. The assembly of claim 1, also including:

a second sealing flange extending toward the axis from the inner baffle at a second location along the channel, wherein the second sealing flange provides a seal around a second instrument having a second diameter when the second instrument is positioned in the channel, and wherein the inner baffle, the sealing flange, and the second sealing flange are free to move laterally relative to the body as the outer baffle flexes.

4. The assembly of claim 1, also including:

a second sealing flange extending toward the axis from the inner baffle at a second location along the channel, wherein the second sealing flange provides a seal around a second instrument having a second diameter when the second instrument is positioned in the channel; and

a sacrificial flange extending toward the axis from the inner baffle at a third location along the channel, where the third location is between the first location and the second location along the channel, and the inner baffle, the sealing flange, the second sealing flange, and the sacrificial flange are free to move laterally relative to the body as the outer baffle flexes.

5. The assembly of claim 4, wherein the sacrificial flange is shaped so that in response to displacement of a portion of the sacrificial flange by the instrument while the instrument is inserted through the channel, a displaced portion of the sacrificial flange will fold toward the sealing flange, thereby displacing the sealing flange to prevent said sealing flange from being cut by the instrument as said instrument continues translating along the channel.

6. The assembly of claim 1, wherein the outer baffle is oriented substantially parallel to the axis and has a distal end connected to the body and a proximal end, wherein the inner baffle has a proximal end, and wherein the proximal end of the inner baffle is connected to the proximal end of the outer baffle so that the inner baffle is oriented at an acute angle to the outer baffle.

7. The assembly of claim 6, wherein the body has a side wall and a bumper portion extending out from the side wall toward the axis, a distal end of the bumper portion is positioned at a fourth location along the channel, and there is no more than a small gap between the distal end of bumper portion and the proximal end of the inner baffle.

8. The assembly of claim 7, wherein the channel has a first radius at a first end of the body, the bumper portion is positioned along the channel away from the first end, and the bumper portion has a second radius smaller than the first radius, so that the bumper limits lateral movement of the instrument when said instrument is positioned in the channel.

9. The assembly of claim 1, wherein the body, the flange, the outer baffle, the inner baffle, and the sealing flange are portions of a single piece of molded elastomeric material.

10. The assembly of claim 1, also including:

a flexible extension which protrudes out from the body;

a trap door mounted to the flexible extension, so that the flexible extension biases the door into a closed position which seals the channel, and the flexible extension moves in response to displacement of the door from the closed position by an object translating through the channel.

11. The assembly of claim 10, wherein the body, the flange, the outer baffle, the inner baffle, the sealing flange, and the flexible extension are portions of a single piece of molded elastomeric material.

12. The assembly of claim 11, wherein the elastomeric material is medical grade silicon rubber, and the trap door is made of rigid material.

13. The assembly of claim 10, wherein the trap door rests against the sealing flange when the trap door is in said closed position.

14. The assembly of claim 1, also including:

a reusable cannula, which includes neither a fluid seal nor an instrument seal, wherein the cannula has a surface with a groove therein, and the flange has been snapped into the groove.

15. The assembly of claim 1, also including:

a second sealing flange extending toward the axis from the inner baffle at a second location along the channel, wherein the second sealing flange provides a seal around a second instrument having a second diameter when the second instrument is positioned in the channel, and wherein the inner baffle, the sealing flange, and the second sealing flange are free to move laterally relative to the body as the outer baffle flexes; and

an adaptor connected to the body, wherein the adaptor includes;

an adaptor body through which an adaptor channel extends;

a tether connected between the body and the adaptor body;

an adaptor flange shaped for removably attaching the adaptor body to the body with the adaptor channel aligned with the channel; and

an adaptor seal flange which provides a seal around a small diameter instrument when said small diameter instrument is positioned in the adaptor channel, where the small diameter instrument has a third diameter and the third diameter is smaller than both the first diameter and the second diameter.

16. The assembly of claim 15, wherein the body, the adaptor including the tether, the flange, and the flexible extension are portions of a single piece of molded elastomeric material.

17. A disposable seal assembly, including:

a body having a central longitudinal axis and a flange shaped for removably attaching the body to a cannula, wherein a channel extends through the body along the axis;

a sealing flange extending toward the axis from the body at a first location along the channel;

a sacrificial flange extending toward the axis from the body at a second location along the channel; and

a second sealing flange extending toward the axis from the body at a third location along the channel, wherein the second location is between the first location and the third location, the sealing flange provides a seal around an instrument having a first diameter when the instrument is positioned in the channel, the second sealing flange provides a seal around a second instrument having a second diameter when the instrument is positioned in the channel, and the sacrificial flange is shaped so that in response to displacement of a portion of the sacrificial flange by the instrument while the instrument is inserted through the channel, a displaced portion of the sacrificial flange will fold toward the sealing flange, thereby displacing the sealing flange to prevent said sealing flange from being cut by the instrument as said instrument continues translating along the channel.

18. The assembly of claim 17, also including:

a flexible outer baffle extending from the body into the channel; and

an inner baffle extending from the outer baffle into the channel, wherein each of the sealing flange, the sacrificial flange, and the second sealing flange extends toward the axis from the inner baffle, and wherein the inner baffle, the sealing flange, the sacrificial flange, and the second sealing flange are free to move laterally relative to the body as the outer baffle flexes.

19. The assembly of claim 18, also including:

at least one elastomeric rib extending between the inner baffle and the body, the rib being sufficiently elastic to stretch in response to force that tends to pull the inner baffle away from the body and then to relax to its original length following application of said force, thereby preventing inversion of the inner baffle.

20. The assembly of claim 18, wherein the outer baffle is oriented substantially parallel to the axis and has a distal end connected to the body and a proximal end, wherein the inner baffle has a proximal end, and wherein the proximal end of the inner baffle is connected to the proximal end of the outer baffle so that the inner baffle is oriented at an acute angle to the outer baffle.

21. The assembly of claim 20, wherein the body has a side wall and a bumper portion extending out from the side wall toward the axis, a distal end of the bumper portion is positioned at a fourth location along the channel, and there is no more than a small gap between the distal end of bumper portion and the proximal end of the inner baffle.

22. The assembly of claim 21, wherein the channel has a first radius at a first end of the body, the bumper portion is positioned along the channel away from the first end, and the bumper portion has a second radius smaller than the first radius, so that the bumper limits lateral movement of the instrument when said instrument is positioned in the channel.

23. The assembly of claim 17, wherein the body, the flange, the sealing flange, the sacrificial flange, and the second sealing flange are portions of a single piece of molded elastomeric material.

24. The assembly of claim 17, also including:

a flexible extension which protrudes out from the body;

a trap door mounted to the flexible extension, so that the flexible extension biases the door into a closed position which seals the channel, and the flexible extension moves in response to displacement of the door from the closed position by an object translating through the channel.

25. The assembly of claim 24, wherein the body, the flange, the sealing flange, the sacrificial flange, the second sealing flange, and the flexible extension are portions of a single piece of molded elastomeric material.

26. The assembly of claim 25, wherein the elastomeric material is medical grade silicon rubber, and the trap door is made of rigid material.

27. The assembly of claim 24, wherein the trap door rests against the sealing flange when the trap door is in said closed position.

28. A disposable seal assembly, including:

a body having a central longitudinal axis and a flange shaped for removably attaching the body to a cannula, wherein a channel extends through the body along the axis;

a sealing flange extending toward the axis from the body at a first location along the channel; and

a sacrificial flange extending toward the axis from the body at a second location along the channel, wherein the sealing flange provides a seal around an instrument when the instrument is positioned in the channel, and the sacrificial flange is shaped so that in response to displacement of a portion of the sacrificial flange by the instrument while the instrument is inserted through the channel, a displaced portion of the sacrificial flange will fold toward the sealing flange, thereby displacing the sealing flange to prevent said sealing flange from being cut by the instrument as said instrument continues translating along the channel, and

wherein the sealing flange has a proximal surface, the sacrificial flange has a distal surface facing the proximal surface, the proximal surface of the sealing flange and the distal surface of the sacrificial flange are shaped so that there is a gap between them at all times, and fluid is free to flow in the gap so that the sealing flange will not stick to the sacrificial flange.

29. The assembly of claim 28, wherein the distal surface of the sacrificial flange has at least one bead protruding therefrom.

30. The assembly of claim 28, also including:

a flexible outer baffle extending from the body into the channel; and

an inner baffle extending from the outer baffle into the channel, wherein each of the sealing flange and the sacrificial flange extends toward the axis from the inner baffle, and wherein the inner baffle, the sealing flange and the sacrificial flange are free to move laterally relative to the body as the outer baffle flexes.

31. The assembly of claim 30, also including:

at least one elastomeric rib extending between the inner baffle and the body, the rib being sufficiently elastic to stretch in response to force that tends to pull the inner baffle away from the body and then to relax to its original length following application of said force, thereby preventing inversion of the inner baffle.

32. A disposable seal assembly, including:

a body having a central longitudinal axis and a flange shaped for removably attaching the body to a cannula. wherein a channel extends through the body along the axis;

a sealing flange extending toward the axis from the body at a first location along the channel; and

a sacrificial flange extending toward the axis from the body at a second location along the channel, wherein the sealing flange provides a seal around an instrument when the instrument is positioned in the channel, and the sacrificial flange is shaped so that in response to displacement of a portion of the sacrificial flange by the instrument while the instrument is inserted through the channel, the displaced portion of the sacrificial flange will fold toward the sealing flange, thereby displacing the sealing flange to prevent said sealing flange from being cut by the instrument as said instrument continues translating along the channel;

wherein the sealing flange has a proximal surface, the sacrificial flange has a distal surface facing the proximal surface, the proximal surface of the sealing flange and the distal surface of the sacrificial flange are shaped so that there is a gap between them at all times, and fluid is free to flow in the gap so that the sealing flange will not stick to the sacrificial flange;

a flexible outer baffle extending from the body into the channel;

an inner baffle extending from the outer baffle into the channel, wherein each of the sealing flange and the sacrificial flange extends toward the axis from the inner baffle, and wherein the inner baffle, the sealing flange. and the sacrificial flange are free to move laterally relative to the body as the outer baffle flexes; and

wherein the outer baffle is oriented substantially parallel to the axis and has a distal end connected to the body and a proximal end, wherein the inner baffle has a proximal end, and wherein the proximal end of the inner baffle is connected to the proximal end of the outer baffle so that the inner baffle is oriented at an acute angle to the outer baffle.

33. The assembly of claim 32, wherein the body has a side wall and a bumper portion extending out from the side wall toward the axis, a distal end of the bumper portion is positioned at a third location along the channel, and there is no more than a small gap between the distal end of bumper portion and the proximal end of the inner baffle.

34. A disposable seal assembly, including:

a body having a distal end, a proximal end, a central longitudinal axis, and a flange shaped for removably attaching the body to a cannula, wherein a channel extends through the body along the axis;

a sealing flange extending toward the axis from the body at a first location along the channel, wherein the sealing flange provides a seal around an instrument having a first diameter when the instrument is positioned in the channel; and

an adaptor connected to the body, wherein the adaptor includes;

an adaptor body, having a distal end and a proximal end, through which an adaptor channel extends;

a tether connected between the body and the adaptor body;

an adaptor flange, near the distal end of the adaptor body, and shaped for removably attaching the adaptor body to the body with the adaptor channel aligned with the channel; and

an adaptor seal flange which provides a seal around a small diameter instrument when said small diameter instrument is positioned in the adaptor channel, where the small diameter instrument has a second diameter and the second diameter is smaller than the first diameter, wherein

the adaptor body has a grip portion positioned away from the distal end of said adaptor body, wherein the grip portion is shaped to allow a user conveniently to exert manual force on said grip portion to separate the adaptor from said body when the adaptor flange and the body have been removably attached together.

35. The assembly of claim 34, wherein the grip portion is an outer portion of the adaptor body having a stepped profile.

36. The assembly of claim 35, wherein the body, the adaptor including the tether, the flange, and the sealing flange are portions of a single piece of molded elastomeric material.

37. The assembly of claim 34, wherein the adaptor body is shaped so that the adaptor channel has an hourglass profile.

38. The assembly of claim 34, wherein the adaptor flange is a non-planar connection flange.

39. The assembly of claim 34, wherein the body has a groove for receiving the adaptor flange, and the adaptor body has at least one bumper extending toward the adaptor flange, and wherein the bumper and the body are shaped so as to meet each other when the adaptor flange is snapped into the groove of the body, thereby limiting further displacement of the adaptor body toward the distal end of the body.

40. The assembly of claim 34, also including:

a sacrificial flange extending toward the axis from the body at a second location along the channel; and

a second sealing flange extending toward the axis from the body at a third location along the channel, wherein the second location is between the first location and the third location, the second sealing flange provides a seal around a second instrument having a second diameter when the instrument is positioned in the channel, and the sacrificial flange is shaped so that in response to displacement of a portion of the sacrificial flange by the instrument while the instrument is inserted through the channel, a displaced portion of the sacrificial flange will fold toward the sealing flange, thereby displacing the sealing flange to prevent said sealing flange from being cut by the instrument as said instrument continues translating along the channel.

41. The assembly of claim 40, also including:

a flexible outer baffle extending from the body into the channel; and

an inner baffle extending from the outer baffle into the channel, wherein each of the sealing flange, the sacrificial flange, and the second sealing flange extends toward the axis from the inner baffle, and wherein the inner baffle, the sealing flange, the sacrificial flange, and the second sealing flange are free to move laterally relative to the body as the outer baffle flexes.

42. The assembly of claim 41, also including:

at least one elastomeric rib extending between the inner baffle and the body, the rib being sufficiently elastic to stretch in response to force that tends to pull the inner baffle away from the body and then to relax to its original length following application of said force, thereby preventing inversion of the inner baffle.

43. The assembly of claim 42, wherein the outer baffle is oriented substantially parallel to the axis and has a distal end connected to the body and a proximal end, wherein the inner baffle has a proximal end, and wherein the proximal end of the inner baffle is connected to the proximal end of the outer baffle so that the inner baffle is oriented at an acute angle to the outer baffle.

44. The assembly of claim 41, wherein the body, the flange, the outer baffle, the inner baffle, the sealing flange, the sacrificial flange, and the second sealing flange are portions of a single piece of molded elastomeric material.

45. The assembly of claim 41, also including:

a flexible extension which protrudes out from the body;

a trap door mounted to the flexible extension, so that the flexible extension biases the door into a closed position which seals the channel, and the flexible extension moves in response to displacement of the door from the closed position by an object translating through the channel.

46. The assembly of claim 45, wherein the body, the flange, the outer baffle, the inner baffle, the sealing flange, the sacrificial flange, the second sealing flange, and the flexible extension are portions of a single piece of molded elastomeric material.

47. The assembly of claim 34, also including:

a reusable cannula, which includes neither a fluid seal nor an instrument seal, wherein the cannula has a surface with a groove therein, and the flange is dimensioned to be snapped into the groove.

48. A disposable seal assembly, including:

a body having a distal end, a proximal end, a central longitudinal axis, and a flange shaped for removably attaching the body to a cannula, wherein a channel extends through the body along the axis;

a sealing flange extending toward the axis from the body at a first location along the channel, wherein the sealing flange provides a seal around an instrument having a first diameter when the instrument is positioned in the channel; and

an adaptor connected to the body, wherein the adaptor includes;

an adaptor body through which an adaptor channel extends;

a tether connected between the body and the adaptor body;

an adaptor flange near one end of the adaptor body, said adaptor flange having a concave shape for fitting into a groove in the body, so as to removably attach the adaptor body to the body with the adaptor channel aligned with the channel; and

an adaptor seal flange which provides a seal around a small diameter instrument when said small diameter instrument is positioned in the adaptor channel, where the small diameter instrument has a second diameter and the second diameter is smaller than the first diameter.

49. The assembly of claim 48, wherein the body, the adaptor including the tether, the flange, and the sealing flange are portions of a single piece of molded elastomeric material.

50. The assembly of claim 49, wherein the adaptor body is shaped so that the adaptor channel has an hourglass profile.

51. The assembly of claim 48, also including:

a reusable cannula, which includes neither a fluid seal nor an instrument seal, wherein the cannula has a surface with a groove therein, and the flange is dimensioned to be snapped into the groove.