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

• US 5,545,178 A
• Filed: 10/21/1994
• Issued: 08/13/1996
• 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:
  US08/327,262
• Time in Patent Office: 662 Days
• Field of Search: 606/139, 606/213, 606/215, 606/216, 606/228-232, 604/15
• 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 2017/00663 the implement being a suture
• 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 sealing device and a deployment instrument. In one embodiment the sealing 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. 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 is operated to place the anchor in the interior of the peritoneum and the plug and the holding member in the puncture tract, with both ends of the filament extending out of the puncture. 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. In an alternative embodiment the sealing device comprises only the anchoring member and the filament.

Claims

1. A device arranged for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure to prevent the egress of tissue into the puncture, the puncture comprising an opening in internal tissue in the body of the being and a tract extending from the skin of the being to the opening in the tissue, said device comprising anchoring means, filament means, and suturing means, said anchoring means being an elongated substantially rigid member arranged to be extended through the tract and the opening and being orientable for engaging the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first portion and a second portion, said first portion extending between said anchoring means and said second portion and being coupled to said anchoring means for location within the tract, said second portion of said filament means extending out of the tract, said suturing means being coupled to said second portion of said filament means and being operative to cause said second portion of said filament means to penetrate tissue contiguous with the tract for holding said anchoring means permanently in place with respect to the puncture, with said anchoring means blocking at least a portion of the opening to prevent tissue from gaining egress into the puncture.

2. The device of claim 1 wherein said suturing means is releasably secured to said second portion of said filament means.

3. The device of claim 1 wherein said anchoring means additionally comprises a projecting portion for disposition within the opening when the device is in place.

4. The device of claim 1 wherein said anchoring means is formed of a resorbable material.

5. The device of claim 1 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.

6. The device of claim 1 additionally comprising an elongated member arranged for location and securement within the puncture tract.

7. The device of claim 1 wherein said device includes at least a portion which is radio-opaque.

8. The device of claim 1 wherein said device includes a biologically active material.

9. The device of claim 1 wherein said anchoring means includes means enabling tissue ingrowth into at least a portion of said anchoring means.

10. The device of claim 9 wherein said last mentioned means comprises plural perforations in said anchoring means.

11. A system for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure, the puncture comprising an opening in internal tissue in the body of the being and a tract extending from the skin of the being through the fascia to the opening, said system comprising a deployment instrument and an implantable device, said device comprising anchoring means, filament means, and suturing means, said anchoring means comprising an elongated substantially rigid member arranged to be extended by said instrument through the tract and the opening and being orientable for engaging the interior of the peritoneum adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first portion and a second portion, said first portion extending between said anchoring means and said second portion and being coupled to said anchoring means for location with the tract, said second portion of said filament means extending out of the tract, said suturing means being coupled to said second portion of said filament means and being operative to cause said second portion of said filament means to penetrate tissue contiguous with the tract for holding said anchoring means permanently in place with respect to the puncture, with said anchoring means blocking at least a portion of the opening to prevent tissue from gaining egress through the puncture.

12. The system of claim 11 wherein said suturing means is releasably secured to said first portion of said filament means.

13. The system of claim 11 wherein said anchoring means additionally comprises a projecting portion for disposition within the opening when the device is in place.

14. The system of claim 11 wherein said anchoring means is formed of a resorbable material.

15. The system of claim 11 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.

16. The system of claim 11 wherein said device additionally comprises an elongated member arranged for location and securement within the puncture tract.

17. The system of claim 11 wherein said device includes at least a portion which is radio-opaque.

18. The system of claim 11 wherein said device includes a biologically active material.

19. The system of claim 11 wherein said anchoring means includes means enabling tissue ingrowth into at least a portion of said anchoring means.

20. The system of claim 11 wherein said last mentioned means comprises plural perforations in said anchoring means.

21. A device arranged for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure to prevent the ingress or egress of fluid through the puncture, the puncture comprising an opening in internal tissue in the body of the being and a tract extending from the skin of the being to the opening, said device comprising anchoring means, filament means, and suturing means, said anchoring means being an elongated substantially rigid member arranged to be extended through the tract and the opening and being orientable for engaging the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first portion and a second portion, said first portion extending between said anchoring means and said second portion and being coupled to said anchoring means for location within the tract, said second portion of said filament means extending out of the tract, said suturing means being coupled to said second portion of said filament means and being operative to cause said second portion of said filament means to penetrate tissue contiguous with the tract for holding said anchoring means permanently in place with respect to the puncture, with said anchoring means blocking the opening to prevent fluid from flowing through the opening.

22. The device of claim 21 wherein said suturing means is releasably secured to said first portion of said filament means.

23. The device of claim 21 wherein said anchoring means additionally comprises a projecting portion for disposition within the opening when the device is in place.

24. The device of claim 21 wherein said anchoring means is formed of a resorbable material.

25. The device of claim 21 wherein said anchoring means includes reinforcing means formed of a reinforcing material.

26. The device of claim 21 additionally comprising an elongated member arranged for location and securement within the puncture tract.

27. The device of claim 21 wherein said device includes at least a portion which is radio-opaque.

28. The device of claim 21 wherein said device includes a biologically active material.

29. The device of claim 21 wherein said anchoring means includes means enabling tissue ingrowth into at least a portion of said anchoring means.

30. The device of claim 21 wherein said last mentioned means comprises plural perforations in said anchoring means.

31. A system for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure, the puncture comprising an opening in internal tissue in the body of the being 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 anchoring means, filament means, and suturing means, said anchoring means comprising an elongated substantially rigid member arranged to be extended by said instrument through the tract and the opening and being orientable for engaging the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first portion and a second portion, said first portion extending between said anchoring means and said second portion and being coupled to said anchoring means for location within the tract, said second portion of said filament means extending out of the tract, said suturing means being coupled to said second portion of said filament means and being operative to cause said second portion of said filament means to penetrate tissue contiguous with the tract for holding said anchoring means permanently in place with respect to the puncture, with said anchoring means blocking at least a portion of the opening to the flow of fluid therethrough.

32. The system of claim 31 wherein said suturing means is releasably secured to said first portion of said filament means.

33. The system of claim 31 wherein said anchoring means additionally comprises a projecting portion for disposition within the opening when the device is in place.

34. The system of claim 31 wherein said anchoring means is formed of a resorbable material.

35. The system of claim 31 wherein said anchoring means includes reinforcing means formed of a reinforcing material.

36. The system of claim 31 wherein said additionally comprises an elongated member arranged for location and securement within the puncture tract.

37. The system of claim 31 wherein said device includes at least a portion which is radio-opaque.

38. The system of claim 31 wherein said device includes a biologically active material.

39. The system of claim 31 wherein said anchoring means includes means enabling tissue ingrowth into at least a portion of said anchoring means.

40. The system of claim 39 wherein said last mentioned means comprises plural perforations in said anchoring means.

41. A method of preventing the egress of tissue into a percutaneous puncture formed during a minimally invasive surgical procedure on the body of a living being, said puncture having an opening in internal tissue in the body of the being and a tract extending from the skin of the being to the opening, said method comprising:

(a) providing a sealing device comprising anchoring means and filament means, said filament means being coupled to said anchoring means and including at least a first portion,

(b) introducing said device through the puncture from the outside of the being'"'"'s body and orienting said anchoring means so that said anchoring means engages the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, and

(c) causing said first portion of said filament means to extend through the tract and securing said first portion of said filament means in place with respect to the tract for holding said anchoring means in place within the puncture, whereupon said anchoring means serves to block at least a portion of the opening to prevent the egress of tissue into the puncture.

42. The method of claim 41 wherein said internal tissue comprises the peritoneum.

43. The method of claim 42 wherein said method reduces the risk of the formation of a hernia at said opening.

44. The method of claim 43 wherein said anchoring means when in position serves to improve the long-term strength of scar tissue forming at the opening.

45. The method of claim 44 wherein said improvement of long-term strength of said scar tissue is accomplished by providing reinforcing means with said anchor, said reinforcing means being formed of a reinforcing material.

46. The method of claim 41 wherein said anchoring means when in position serves to improve the long-term strength of scar tissue forming at the opening.

47. The method of claim 46 wherein said improvement of long-term strength of said scar tissue is accomplished by providing reinforcing means with said anchor, said reinforcing means being formed of a reinforcing material.

48. The method of claim 41 additionally comprising securing said filament means to the skin of the being adjacent the tract to hold said device in place.

49. The method of claim 48 wherein said securement of said filament means to the skin is accomplished by suturing.

50. The method of claim 41 additionally comprising securing said filament means to tissue within the puncture tract to hold said device in place.

51. The method of claim 50 wherein said securement of said filament means to tissue within the puncture tract is accomplished by a fixing member located within the tract.

52. The method of claim 41 additionally comprising providing means to render said sealing device radio-opaque.

53. The method of claim 41 additionally comprising providing a biologically active agent carried by said sealing device.

54. The method of claim 41 additionally comprising promoting tissue ingrowth into said sealing device.

55. A method of sealing a percutaneous puncture extending into the body of a living being to prevent the flow of a fluid through the puncture, the percutaneous puncture having an opening in internal tissue within the body of the being 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 sealing device comprising anchoring means and filament means, said filament means being coupled to said anchoring means and including at least a first portion,

(b) introducing said device through the puncture from the outside of being'"'"'s body and orienting said anchoring means so that said anchoring means engages the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, and

(c) causing said first portion of said filament means to extend through the tract securing said first portion of said filament means in place with respect to the tract for holding said anchoring means in place within the puncture, whereupon said anchoring means serves to block the opening to prevent the flow of fluid through the opening.

56. The method of claim 55 wherein said internal tissue comprises the wall of the thoracic cavity.

57. The method of claim 56 wherein said anchoring means when in position serves to improve the long-term strength of scar tissue forming at the opening.

58. The method of claim 57 wherein said improvement of long-term strength of said scar tissue is accomplished by providing reinforcing means with said anchor, said reinforcing means being formed of a reinforcing material.

59. The method of claim 55 wherein said anchoring means when in position serves to improve the long-term strength of scar tissue forming at the opening.

60. The method of claim 59 wherein said improvement of long-term strength of said scar tissue is accomplished by providing reinforcing means with said anchor, said reinforcing means being formed of a reinforcing material.

61. The method of claim 55 additionally comprising securing said filament means to the skin of the being adjacent the tract to hold said device in place.

62. The method of claim 61 wherein said securement of said filament means to the skin is accomplished by suturing.

63. The method of claim 55 additionally comprising securing said filament means to tissue within the puncture tract to hold said device in place.

64. The method of claim 63 wherein said securement of said filament means to tissue within the puncture tract is accomplished by a fixing member located within the tract.

65. The method of claim 55 additionally comprising providing means to render said sealing device radio-opaque.

66. The method of claim 55 additionally comprising providing a biologically active agent carried by said sealing device.

67. The method of claim 55 additionally comprising promoting tissue ingrowth into said sealing device.

68. A device arranged for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure to prevent egress of tissue into the puncture, the puncture comprising an opening in internal tissue in the body of the being and a tract extending from the skin of the being to the opening in the tissue, said device comprising anchoring means, filament means, suturing means, and retainer means, said anchoring means being an elongated substantially rigid member arranged to be extended through the tract and the opening and being orientable for engaging the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first filament portion which is coupled to the anchoring means and the retainer means, and a second filament portion which passes at least partially along the remaining puncture tract to the skin, said suturing means being coupled to said second filament portion.

69. A device arranged for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure to prevent egress of tissue into the puncture, the puncture comprising an opening in internal tissue in the body of the being and a tract extending from the skin of the being to the opening in the tissue, said device comprising anchoring means, filament means, carrier means, and retainer means, said anchoring means being an elongated substantially rigid member arranged to be extended through the tract and the opening and being orientable for engaging the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first filament portion which is coupled to the anchoring means and the retainer means, and a second filament portion which passes at least partially along the remaining puncture tract to the skin, said carrier means being a thin, relatively stiff member coupled to said second filament portion and arranged to be grasped for carrying said second filament portion to a position whereupon said second filament portion is permanently fixed with respect to the tract.

70. The device of claim 69 wherein said carrier means comprising a needle for penetrating tissue of the being adjacent the tract.

71. The device of claim 70 wherein said needle is releasably secured to said second filament portion.

72. A device arranged for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure for preventing the ingress or egress of fluid through the puncture, the puncture comprising an opening in internal tissue in the body of the being and a tract extending from the skin of the being to the opening in the tissue, said device comprising anchoring means, filament means, suturing means, and retainer means, said anchoring means being an elongated substantially rigid member arranged to be extended through the tract and the opening and being orientable for engaging the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first filament portion which is coupled to the anchoring means and the retainer means, and a second filament portion which passes at least partially along the remaining puncture tract to the skin, said suturing means being coupled to said second filament portion.

73. A device arranged for introduction through a percutaneous puncture into the body of a living being formed during a minimally invasive surgical procedure for preventing the ingress or egress of fluid through the puncture, the puncture comprising an opening in internal tissue in the body of the being and a tract extending from the skin of the being to the opening in the tissue, said device comprising anchoring means, filament means, carrier means, and retainer means, said anchoring means being an elongated substantially rigid member arranged to be extended through the tract and the opening and being orientable for engaging the interior of the tissue adjacent the opening to render said anchoring means resistant to passage back through the opening, said filament means including a first filament portion which is coupled to the anchoring means and the retainer means, and a second filament portion which passes at least partially along the remaining puncture tract to the skin, said carrier means being a thin, relatively stiff member coupled to said second filament portion and arranged to be grasped for carrying said second filament portion to a position whereupon said second filament portion is permanently fixed with respect to the tract.

74. The device of claim 73 wherein said carrier means comprising a needle for penetrating tissue of the being adjacent the tract.

75. The device of claim 74 wherein said needle is releasably secured to said second filament portion.