System for closing a percutaneous puncture formed by a trocar to prevent tissue at the puncture from herniating

• US 5,531,759 A
• Filed: 04/29/1994
• Issued: 07/02/1996
• Est. Priority Date: 04/29/1994
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Nash, John E., Evans, Douglas, Kensey, Kenneth
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/235,825
• Time in Patent Office: 795 Days
• Field of Search: 606/139, 606/213, 606/215, 606/216, 606/228, 606/230
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

A system and method for sealing a percutaneous puncture extending into internally located tissue, e.g., the peritoneum, of a living being. The system includes a reinforcing device and a deployment instrument. The device comprises a substantially rigid anchor, a resorbable holding member, a collagen plug, and a resorbable thin filament connecting the anchor, holding member, and plug in a pulley-like arrangement. The anchor or the plug or both may be formed of a resorbable material having a non-resorbable mesh reinforcement embedded therein. The deployment instrument includes a tubular carrier in which the closure and a tamping member are located. The tamping member is operated to expel the closure so that the anchor is in the interior of the peritoneum and the plug and the holding member are in the puncture tract, with both ends of the filament extending out of the puncture and with the holding member fixedly secured to a portion of the filament adjacent one end. The other end of the filament is then drawn proximally while the tamping is pushed distally to draw the anchor member against the tissue contiguous with the opening. The tamper mechanically deforms the plug within the tract. The extending ends of the filament are formed into a knot, a portion of which extends through the skin contiguous with the puncture, to lock the closure in place. The reinforced mesh of the closure reinforces any scar tissue which forms at the opening.

Claims

1. A device arranged for introduction through a percutaneous puncture into the abdomen of a living being formed during a minimally invasive surgical procedure to prevent the formation of a hernia thereat, the puncture comprising an opening in the peritoneum and a tract extending from the skin of the being to the opening, said device including a portion arranged for disposition within the puncture and constructed of a material which serves to improve the long-term strength of tissue forming at the opening when said device is in place within the puncture, said device comprising a first member, a second member, and suturing means, said first member being arranged to be extended through the tract and the opening and into engagement with the interior of the peritoneum adjacent the opening to render said first member resistant to passage back through the opening, said second member being arranged for extension through the tract outside the peritoneum and coupled to said first member and cooperating with said first member for holding said first member in engagement with the interior of the peritoneum adjacent the opening, said suturing means being coupled to said second member and operative to cause a part of said second member to penetrate tissue of the being contiguous with the tract to permanently hold said device in place within said puncture.

2. The device of claim 1 wherein said first member comprises anchoring means and said second member comprises filament means, said device additionally comprising plug means, said filament means connecting said anchoring means and said plug means together.

3. The device of claim 2 wherein said filament means connects said anchoring means to said plug means in a pulley-like arrangement.

4. The device of claim 2 wherein said plug means is deformable within the tract into a deformed state to seal the tract.

5. The device of claim 4 additionally comprising a holding member connected to said filament means, said holding member being disposed proximally of said plug means within the puncture tract and arranged to maintain said plug means in said deformed state.

6. The device of claim 1 additionally comprising reinforcing means formed of a reinforcing material, whereupon scar tissue forming at the opening is reinforced by said reinforcing material to prevent herniation of said tissue.

7. The device of claim 6 wherein said reinforcing material is non-resorbable.

8. The device of claim 6 wherein said reinforcing material comprises a mesh.

9. The device of claim 1 wherein said second member comprises filament means including a pair of ends extending out of the puncture for securement to each other adjacent the skin to hold said device in place.

10. The device of claim 9 wherein said suturing means comprises a needle, said needle being connected to one of said pair of ends to enable said one of said pair of ends to be extended through the skin contiguous with the puncture and formed into a knot with a portion of the other of said pair of ends.

11. A system for introduction through a percutaneous puncture into the abdomen of a living being formed during a minimally invasive surgical procedure, the puncture comprising an opening in the peritoneum and a tract extending from the skin of the being to the opening, said system comprising a deployment instrument and an implantable device, said device being arranged for disposition within the puncture and constructed of a material which serves to improve the long-term strength of tissue forming at the opening when said device is in place within the puncture, said device comprising a first member, a second member, and suturing means, said first member being arranged to be extended by said instrument through the tract and the opening and into engagement with the interior of the peritoneum adjacent the opening to render said first member resistant to passage back through the opening, said second member being arranged for extension through the tract outside the peritoneum and coupled to said first member and cooperating with said first member for holding said first member in engagement with the interior of the peritoneum adjacent the opening, said suturing means being coupled to said second member and operative to cause a part of said second member to penetrate tissue of the being contiguous with the tract to permanently hold said device in place within said puncture, whereupon said tissue is rendered resistant to herniation.

12. The system of claim 11 wherein said first member comprises anchoring means and said second member comprises filament means, said device additionally comprising plug means, said filament means connecting said anchoring means and said plug means together.

13. The system of claim 12 wherein said plug means is deformable within the tract into a deformed state to seal the tract and wherein said system includes tamping means extendable into said puncture to deform said plug means within the tract.

14. The system of claim 13 additionally comprising a holding member connected to said filament means, said holding member being disposed proximally of said plug means within the puncture tract and arranged to maintain said plug means in said deformed state.

15. The system of claim 12 wherein said filament means connects said anchoring means to said plug means in a pulley-like arrangement.

16. The system of claim 11 additionally comprising reinforcing means formed of a reinforcing material, whereupon scar tissue forming at the opening is reinforced by said reinforcing material to prevent the herniation of said tissue.

17. The system of claim 16 wherein said reinforcing material is non-resorbable.

18. The system of claim 11 wherein said second member comprises filament means including a pair of ends extending out of the puncture for securement to each other adjacent the skin to hold said device in place.

19. The system of claim 18 wherein said suturing means comprises a needle, said needle being connected to one of said pair of ends to enable said one of said pair of ends to be extended through the skin contiguous with the puncture and formed into a knot with a portion of the other of said pair of ends.

20. A method of preventing the formation of a hernia in an opening in the peritoneum of a living being, the opening comprising a portion of a percutaneous puncture having a tract extending from the skin of the being to the opening and being formed during a minimally invasive surgical procedure on the being, said method comprising:

(a) providing a device arranged for disposition within the puncture comprising securement means for holding said device in place within the puncture, said securement means comprising a first portion and a second portion;

(b) providing an instrument for placing said device within the puncture;

(c) using said instrument to insert said device into the puncture from the outside of the being'"'"'s body so that said first portion of said securement means is extended through the tract and the opening and into engagement with the interior of the peritoneum adjacent the opening to render said first portion of said securement means resistant to passage back through the opening; and

(d) causing said second portion of said securement means to be located outside the peritoneum but coupled to said first portion of said securement means and cooperating therewith for holding said device in place within the puncture, whereupon the placement of said device within the puncture prevents a hernia from forming thereat.

21. The method of claim 20 additionally comprising providing reinforcing means as a portion of said device, and wherein the placement of said device within the puncture causes said reinforcement means to be located within the puncture, whereupon any tissue forming at the opening is reinforced by said reinforcing means.

22. The method of claim 21 additionally comprising providing said reinforcing means with said first portion of said securement means through said opening so that said reinforcing means is located over the opening within the interior of the peritoneum.

23. The method of claim 21 additionally comprising providing said reinforcing means with said second portion of said securement means in the tract so that said reinforcing means is located over the opening outside of the peritoneum.

24. The method of claim 22 additionally comprising providing said reinforcing means with said second portion of said securement means in the tract so that said reinforcing means is located over the opening outside of the peritoneum.

25. The method of claim 21 additionally comprising providing said reinforcing means of a non-resorbable material.

26. The method of claim 21 additionally comprising providing said device with deformable means, disposing said deformable means within the tract to be deformed therein to close the tract.

27. The method of claim 26 additionally comprising tamping said deformable means within said tract from the outside of the puncture to deform said deformable means therein.

28. The method of claim 20 additionally comprising providing said device with filament means, extending said filament means from said device within the puncture to outside of the body of the being and securing said filament means to the skin of the being to lock the device in place.

29. The method of claim 20 additionally comprising providing said device with filament means, and securing said filament means to tissue adjacent the tract by suturing.

30. A method of strengthening tissue which forms at an opening in internal tissue within the body of a living being, the opening comprising a portion of a percutaneous puncture having a tract extending from the skin of the being to the opening and being formed during a minimally invasive surgical procedure on the being, said method comprising:

(a) providing a device arranged for disposition within the puncture to improve the long-term strength of tissue forming at the opening, said device comprising securement means for holding said device in place within said puncture, said securement means comprising a first portion and a second portion;

(b) providing an instrument for placing said device within the puncture;

(c) using said instrument to insert said device into the puncture from the outside of the being'"'"'s body so that said first portion of said securement means is extended through the tract and the opening and into engagement with the interior of the internal tissue adjacent the opening to render said first portion of said securement means resistant to passage back through the opening; and

(d) causing said second portion of said securement means to be located outside the internal tissue but coupled to said first portion of said securement means and cooperating therewith for holding said device in place within the puncture, whereupon the placement of said device within the puncture improves the long-term strength of tissue forming at the opening.

31. The method of claim 30 wherein said internal tissue comprises the peritoneum and wherein said method additionally comprises providing reinforcing means as a portion of said device, and wherein the placement of said device within the puncture causes said reinforcement means to be located within the puncture, whereupon any tissue forming at the opening in the peritoneum is reinforced by said reinforcing means.

32. The method of claim 31 additionally comprising providing said reinforcing means with said first portion of said securement means through said opening so that said reinforcing means is located over the opening within the interior of the peritoneum.

33. The method of claim 31 additionally comprising providing said reinforcing means with said second portion of said securement means in the tract so that said reinforcing means is located over the opening outside of the peritoneum.

34. The method of claim 32 additionally comprising providing said reinforcing means with said second portion of said securement means in the tract so that said reinforcing means is located over the opening outside of the peritoneum.

35. The method of claim 31 additionally comprising providing said reinforcing means of a non-resorbable material.

36. The method of claim 31 additionally comprising providing said device with deformable means, disposing said deformable means within the tract to be deformed therein to seal the tract.

37. The method of claim 36 additionally comprising tamping said deformable means within said tract from the outside of the puncture to deform said deformable means therein.

38. The method of claim 30 wherein said tissue comprises the lining of the thoracic cavity and wherein said method additionally comprises providing sealing means as a portion of said device, and wherein the placement of said device within the puncture seals the puncture to preclude the ingress of a fluid to the interior of the thoracic cavity.

39. The method of claim 38 additionally comprising providing said device with deformable means, disposing said deformable means within the tract to be deformed therein to seal the tract.

40. The method of claim 39 additionally comprising tamping said deformable means within said tract from the outside of the puncture to deform said deformable means therein.

41. The method of claim 38 additionally comprising providing said device with filament means, extending said filament means from said device within said puncture to outside of the body of the being and securing said filament means to the skin of the being to lock the device in place.

42. The method of claim 41 additionally comprising providing said filament means with a pair of end portions so that said end portions extend outside of the body of the being, and securing said end portions to the skin by suturing.

43. The method of claim 30 additionally comprising providing said device with filament means, extending said filament means from said device within the puncture to outside of the body of the being and securing said filament means to the skin of the being to lock the device in place.

44. The method of claim 30 additionally comprising providing said device with filament means, and securing said filament means to tissue adjacent the tract by suturing.

45. A method of repairing internal tissue within the body of a living being, said method comprising:

(a) creating a percutaneous puncture to said internal tissue, said puncture having an opening in said tissue and a tract extending from the skin of the being to the opening;

(b) providing a device arranged for disposition within the puncture comprising securement means for holding said device in place within the puncture, said securement means comprising a first portion and a second portion;

(c) providing an instrument for placing said device within the puncture;

(d) using said instrument to insert said device into the puncture from the outside of the being'"'"'s body so that said first portion of said securement means is extended through the tract and the opening and into engagement with the interior of the internal tissue adjacent the opening to render said first portion of said securement means resistant to passage back through the opening; and

(e) causing said second portion of said securement means to be located outside the internal tissue but coupled to said first portion of said securement means and cooperating therewith for holding said device in place within the puncture, whereupon the placement of said device within the puncture prevents a hernia from forming thereat.

46. A device arranged for introduction through a percutaneous puncture into the thoracic cavity of a living being formed during a minimally invasive surgical procedure to prevent the leakage of air therein, the puncture comprising an opening in the thoracic cavity wall and a tract extending from the skin of the being to the opening, said device including a first member, a second member, and suturing means, said first member being arranged to be extended through the tract and the opening and into engagement with the interior of the thoracic wall adjacent the opening to render said first member resistant to passage back through the opening, said second member being arranged for extension through the tract outside the thoracic wall and coupled to said first member and cooperating with said first member for holding said first member in engagement with the interior of the thoracic wall adjacent the opening, said suturing means being coupled to said second member and operative to cause a part of said second member to penetrate tissue of the being contiguous with the tract to permanently hold said device in place within said puncture, whereupon said device seals the puncture to prevent air from gaining ingress to the thoracic cavity through the puncture.

47. The device of claim 46 wherein said first member comprises anchoring means and said second member comprises filament means, said device additionally comprising plug means, said filament means connecting said anchoring means and said plug means together.

48. The device of claim 47 wherein said plug means is deformable within the tract into a deformed state to seal the tract.

49. The device of claim 47 wherein said anchoring means comprises an elongated, substantially stiff member.

50. The device of claim 47 wherein said anchoring means is formed of a resorbable material.

51. The device of claim 47 wherein said anchoring means includes reinforcing means formed of a reinforcing material, whereupon scar tissue forming at the opening is reinforced by said reinforcing material to prevent the herniation of said tissue.

52. A system for introduction through a percutaneous puncture into the thoracic cavity of a living being formed during a minimally invasive surgical procedure to seal the puncture to prevent air from gaining ingress to the thoracic cavity through the puncture, the puncture comprising an opening in the wall of the thoracic cavity and a tract extending from the skin of the being to the opening, said system comprising a deployment instrument and an implantable device, said device comprising a first member, a second member, and suturing means, said first member arranged to be extended by said instrument through the tract and the opening for engaging the interior of the thoracic wall adjacent the opening to render said first member resistant to passage back through the opening, said second member being arranged for extension through the tract outside the thoracic wall and coupled to said first member and cooperating with said first member for holding said first member in engagement with the interior of the thoracic cavity adjacent the opening, said suturing means being coupled to said second member and operative to cause a part of said second member to penetrate tissue of the being contiguous with the tract to permanently hold said device in place within the puncture, whereupon the puncture is sealed to prevent air from gaining ingress to the thoracic cavity through the puncture.

53. The system of claim 52 wherein said first member comprises anchoring means and said second member comprises filament means, said device additionally comprising plug means, said filament means connecting said anchoring means and said plug means together.

54. The system of claim 53 wherein said plug means is deformable within the tract into a deformed state to seal the tract.

55. The system of claim 52 wherein said anchoring means comprises an elongated, substantially stiff member.

56. The system of claim 52 wherein said anchoring means is formed of a resorbable material.

57. The device of claim 52 wherein said anchoring means includes reinforcing means formed of a reinforcing material, whereupon scar tissue forming at the opening is reinforced by said reinforcing material to prevent the herniation of said tissue.

58. A method of sealing a percutaneous puncture extending into the thoracic cavity of a living being to prevent the leakage of air through the puncture, the percutaneous puncture having an opening in the thoracic wall and a tract extending from the skin of the being to the opening and being formed during a minimally invasive surgical procedure on the being, said method comprising:

(a) providing a device arranged for disposition within the puncture, said device comprising securement means for holding said device in place within the puncture, said securement means comprising a first portion, a second portion, and a filament portion;

(b) providing an instrument for placing said device within the puncture;

(c) using said instrument to insert said device into said puncture from the outside of the being'"'"'s body so that said first portion of said securement means is extended through the tract and the opening and into engagement with the interior of the thoracic wall adjacent the opening to render said first portion of said securement means resistant to passage back through the opening;

(d) causing said second portion of said securement means to be located outside the thoracic wall but coupled to said first portion of said securement means by said filament means and cooperating therewith for holding said device in place within said puncture; and

(e) causing a portion of said filament means to penetrate tissue of the being contiguous with the puncture to fixedly secure said device in place, whereupon the placement and securement of said device within the puncture seals the puncture to prevent the leakage of air into the thoracic cavity.

59. The method of claim 58 wherein said first portion of said device comprises anchoring means and said second portion of said device comprises plug means, said filament means connecting said anchoring means and said sealing means together, and wherein method comprises locating said plug means within said tract.

60. The method of claim 59 wherein said plug means is deformable, and wherein said method additionally comprises deforming said plug means within the tract so that said plug means is in a deformed state to seal the tract.

61. The method of claim 59 wherein said method additionally comprises providing reinforcing means with said anchoring means, said reinforcing means being formed of a reinforcing material.