Vascular wound closure device

• US 6,004,341 A
• Filed: 12/05/1996
• Issued: 12/21/1999
• Est. Priority Date: 12/05/1996
• Status: Expired due to Term

• Current Assignee: LOMA Linda University Medical Center (Mission Healthcare Services LLC)
• Original Assignee: LOMA Linda University Medical Center (Mission Healthcare Services LLC)
• Inventors: Zhu, Yong Hua, Kirsch, Wolff M.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): PHAM, THUY D
• Application Number:
  US08/764,611
• Time in Patent Office: 1,111 Days
• Field of Search: 606/108, 606/185, 606/191, 606/198, 606/142, 604/158, 604/160, 604/161, 600/201, 600/208, 600/219, 600/220, 600/222
• US Class Current: 606/198
• 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 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips

Abstract

A device which facilitates the closure of puncture wounds in the vasculature of a patient is used in conjunction with a guidewire, and helps locate and isolate the site of the puncture wound in the patient. The retractor moves the surrounding tissue laterally when positioned in the patient, and acts as a guide for the physician in locating the exact site of the wound. A double-sleeved balloon can be used in conjunction with the retractor to move the tissues laterally and form a tunnel from the surface of the patient'"'"'s body to the puncture site. The retractor is preferably used in combination with a surgical clip applicator which delivers clips to the site of the wound, but can also be used with other methods of wound closure such as suturing and stapling.

Claims

1. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having an externally threaded proximal end and a tapered distal end, wherein said body portion has two separate, halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end;

at least one connector pin extending from one of said halves of said body portion, said one connector pin dimensioned to be received within a correspondingly dimensioned bore defined in the other of said halves of said body portion to operatively connect said halves; and

an internally threaded cap having a hole therethrough, said internal threads adapted to engage said externally threaded proximal end of said body portion, such that when said cap engages said body portion, said hole is positioned directly above said channel in said body portion.

2. The device of claim 1, further comprising at least one handle located on said proximal end of said body portion and extending laterally from said body portion.

3. The device of claim 1, wherein said body portion and said cap are comprised of a biocompatible engineering polymer.

4. The device of claim 3, wherein said polymer is selected from the group consisting of polypropylene, polyethylene, or polyterephthalate.

5. The device of claim 1, wherein said body portion and said cap are comprised of an elastomer.

6. The device of claim 1, wherein said body portion and said cap are comprised of a metal.

7. The device of claim 1, wherein said body portion and said cap are comprised of stainless steel.

8. The device of claim 1, further comprising a guidewire, wherein said guidewire can be inserted through said channel in said body portion and through said hole in said cap.

9. The device of claim 8, wherein said guidewire has an inflatable balloon attached thereto.

10. A system for facilitating the closure of wounds in the vasculature of a patient, comprising:

a retractor comprising a body portion having an externally threaded proximal end and a tapered distal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end; and

an internally threaded cap having a hole therethrough, said internal threads adapted to engage said external threads on said body portion, such that when said cap engages said body portion, said hole is positioned directly above said channel in said body portion;

a guidewire having an inflatable balloon attached thereto, wherein said guidewire can be inserted through said channel in said body portion and through said hole in said cap; and

a surgical clip applicator having a distal end, wherein said distal end of said applicator has two laterally protruding wings attached, said wings being adapted to fit within the channel in said body portion of said retractor.

11. The system of claim 10, wherein said surgical clip applicator further comprises a guide attached to said distal end of said applicator and extending laterally therefrom, wherein said guide is adapted to receive said guidewire therethrough.

12. A method for facilitating the closure of wounds in the vasculature of a patient, comprising the steps of:

inserting a guidewire having a proximal end and a distal end and an inflatable balloon into said vasculature through said wound, until said distal end of said guidewire is within the vasculature and the proximal end remains outside the patient'"'"'s body;

inflating said inflatable balloon;

withdrawing said proximal end of said guidewire from said patient'"'"'s body until said inflated balloon is located in said vasculature at said wound;

inserting the proximal end of said guidewire into a distal end of a retractor comprising a body portion having an externally threaded rounded proximal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end; and

an internally threaded cap having a hole therethrough, said internal threads adapted to engage said external threads on said body portion, such that when said cap engages said body portion, said hole is positioned directly above said channel in said body portion, until said proximal end of said guidewire emerges through said hole in said cap;

advancing said retractor along said guidewire and into said patient'"'"'s body until said distal tip of said retractor contacts said inflated balloon;

removing said cap from said body portion of said retractor;

separating said two halves of said retractor until said wound is visible;

removing said guidewire from said patient'"'"'s body; and

closing said wound.

13. The method of claim 12, wherein said closing step comprises a method selected from the group consisting of clipping, stapling, and suturing said wound.

14. The method of claim 12, further comprising the steps of inserting a surgical clip applicator into said retractor body portion after said cap is removed and advancing said clip applicator through said channel in said body portion until said applicator contacts said wound, and wherein said closing step comprises applying at least one surgical clip to said wound.

15. The method of claim 12, further comprising the step of deflating said balloon and withdrawing said guidewire from said patient'"'"'s body prior to said closing step.

16. A method for facilitating the closure of wounds in the vasculature in a patient'"'"'s body, comprising the steps of:

inserting a guidewire having a proximal end and a distal end into said vasculature through said wound, until said distal end of said guidewire is within the vasculature and the proximal end remains outside the patient'"'"'s body;

inserting a catheter having a proximal end and a distal end and having an inflatable balloon attached at said distal end, into said vasculature over said guidewire until said distal end is within said artery and said proximal end remains outside said patient'"'"'s body;

inflating said inflatable balloon;

withdrawing said catheter from said patient'"'"'s body until said inflated balloon is located in said vasculature at said wound;

inserting the proximal end of said guidewire into a distal end of a retractor comprising a body portion having an externally threaded rounded proximal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end; and

an internally threaded cap having a hole therethrough, said internal threads adapted to engage said external threads on said body portion, such that when said cap engages said body portion, said hole is positioned directly above said channel in said body portion;

until said proximal end of said guidewire emerges through said hole in said cap;

advancing said retractor along said guidewire and into said patient'"'"'s body until said distal tip of said retractor contacts said inflated balloon;

removing said cap from said body portion of said retractor;

separating said two halves of said retractor until said wound is visible; and

removing said guidewire from said patient'"'"'s body; and

closing said wound.

17. The method of claim 16, wherein said closing step is a method selected from the group consisting of clipping, stapling, and suturing said wound.

18. The method of claim 16, further comprising the steps of inserting a surgical clip applicator into said retractor body portion after said cap is removed and advancing said clip applicator through said channel in said body portion until said applicator contacts said wound, and wherein said closing step comprises applying at least one surgical clip to said wound.

19. The method of claim 16, further comprising the step of deflating said balloon and withdrawing said catheter and said guidewire from said patient'"'"'s body prior to said closing step.

20. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having an externally threaded proximal end and a distal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end;

a collar portion distal the externally threaded proximal end comprising at least one guide passage which traverses one half of said body portion;

at least one pin extending from one half of said body portion and insertable into said guide passage in the other half of said body portion; and

an internally threaded annular cap, said internal threads adapted to engage said external threads on said body portion.

21. The device of claim 20, further comprising a handle extending laterally from said pin.

22. The device of claim 20, wherein device is comprised of a biocompatible engineering polymer.

23. The device of claim 22, wherein said polymer is selected from the group consisting of polypropylene, polyethylene, or polyterephthalate.

24. The device of claim 20, wherein said device is comprised of an elastomer.

25. The device of claim 20, wherein said device is comprised of a metal.

26. The device of claim 20, wherein said device is comprised of stainless steel.

27. The device of claim 20, further comprising at least one set screw hole in said collar portion at a right angle to said guide passage, and at least one set screw insertable into said set screw hole.

28. The device of claim 20, wherein said distal tip is tapered.

29. The device of claim 20, wherein said distal tip is cylindrical.

30. The device of claim 20, further comprising a hollow dilator having an open proximal end and an open distal end adapted to receive a guidewire therethrough, wherein said dilator can be inserted through said channel in said body portion and through said annular cap.

31. The device of claim 30, wherein said distal tip is tapered and wherein said dilator further comprises a notch near said distal end sized to receive the tapered distal end of the body portion of the device.

32. The device of claim 30, wherein said dilator has at least one indicator hole through a side wall located distal said notch.

33. The device of claim 30, wherein said dilator further comprises a pressure sensor mounted on an outside wall of said dilator.

34. The device of claim 20, further comprising a guidewire, wherein said guidewire can be inserted through said hollow dilator.

35. The device of claim 20, further comprising a hollow dilator having an open proximal end and an open distal end adapted to receive a guidewire therethrough, wherein said dilator can be inserted through said channel in said body portion and through said annular cap, said hollow dilator having a double-sleeved inflatable balloon mounted on its distal end.

36. The device of claim 35, wherein said dilator further comprises at least one indicator hole at its distal end through a side wall, and wherein said double-sleeved inflatable balloon is mounted approximately 1.5 mm proximal said indicator hole.

37. A system for facilitating the closure of wounds in the vasculature of a patient, comprising:

a retractor comprising a body portion having an externally threaded proximal end and a distal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end;

a collar portion distal the externally threaded proximal end comprising at least one guide passage which traverses both halves of said body portion;

at least one pin insertable into said guide passage; and

an internally threaded annular cap, said internal threads adapted to engage said external threads on said body portion;

a hollow dilator having an open proximal end and an open distal end adapted to receive a guidewire therethrough, wherein said dilator can be inserted through said channel in said body portion and through said annular cap; and

a guidewire insertable through said dilator.

38. The system of claim 37, further comprising a guide assembly adapted for attachment to a distal end of a surgical clip applicator, said assembly comprising a guide plate which is reversibly attachable to a guide body having an attached guide tube sized to receive a guidewire therethrough, wherein said guide plate has two laterally protruding wings attached, said wings being adapted to fit within the channel in said body portion of said retractor.

39. The system of claim 37, further comprising a source of negative pressure attached to said open proximal end of said dilator.

40. The system of claim 39, wherein said source of negative pressure comprises a syringe.

41. The system of claim 37, further comprising a Y-connector having a plurality of ports attached to the proximal end of the dilator at one of said ports.

42. The system of claim 41, further comprising a source of negative pressure attached to one of the ports of said Y-connector.

43. A method for facilitating the closure of a wound in the vasculature of a patient, comprising the steps of:

inserting a proximal end of a hollow dilator having a notch formed near its distal end into a distal end of a retractor comprising a body portion having an externally threaded rounded proximal end, and a tapered distal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end; and

an internally threaded annular cap, said internal threads adapted to engage said external threads on said body portion, such that when said cap engages said body portion, said proximal end of said hollow dilator pass through said channel in said body portion and out said annular cap;

mounting said retractor on said hollow dilator such that said distal tapered end is positioned within said notch;

inserting a guidewire having a proximal end and a distal end into said vasculature through said wound, until said distal end of said guidewire is within the vasculature and the proximal end remains outside the patient'"'"'s body;

inserting the proximal end of said guidewire into said distal end of said hollow dilator until the proximal end of the guidewire emerges through said proximal end of said dilator;

advancing said dilator and retractor along said guidewire and into said patient'"'"'s body, while providing a source of negative pressure on said dilator until blood is drawn into said dilator from said vasculature;

removing said cap from said body portion of said retractor;

separating said two halves of said retractor;

removing said guidewire and said dilator from said patient'"'"'s body; and

closing said wound.

44. The method of claim 43, wherein said closing step comprises a method selected from the group consisting of clipping, stapling, and suturing said wound.

45. The method of claim 43, further comprising the steps of attaching to a distal end of a surgical clip applicator a guide having laterally extending wings, inserting said wings into said retractor body portion after said cap is removed and advancing said clip applicator through said channel in said body portion until said applicator contacts said wound, and wherein said closing step comprises applying at least one surgical clip to said wound.

46. The method of claim 45, wherein said guide further comprises a guidetube for receiving said guidewire, and said method further comprises inserting the proximal end of the guidewire through said guidetube and advancing said applicator over said guidewire and through said channel in said body portion until said applicator contacts said wound.

47. A method for facilitating the closure of a wound in the vasculature of a patient, comprising the steps of:

inserting a guidewire having a proximal end and a distal end into said vasculature through said wound, until said distal end of said guidewire is within the vasculature and the proximal end remains outside the patient'"'"'s body;

inserting the proximal end of said guidewire into a distal end of a hollow dilator having a double-sleeved balloon having an inner sleeve and an outer sleeve mounted on said distal end;

advancing said dilator over said guidewire until it reaches said wound;

inflating said double-sleeved balloon;

inserting said proximal end of said guidewire into a distal end of a retractor comprising a body portion having an externally threaded rounded proximal end, and a distal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end; and

an internally threaded annular cap, said internal threads adapted to engage said external threads on said body portion, such that when said cap engages said body portion, said proximal end of said hollow dilator pass through said channel in said body portion and out said annular cap;

mounting said retractor on said hollow dilator until said distal end is positioned between the inner and outer sleeves of the double-sleeved balloon;

removing said cap from said body portion of said retractor;

separating the two halves of said retractor and removing said dilator and the inner sleeve of said double-sleeved balloon therethrough; and

closing said wound.

48. The method of claim 47, wherein said closing step comprises a method selected from the group consisting of clipping, stapling, and suturing said wound.

49. The method of claim 47, further comprising the steps of attaching to a distal end of a surgical clip applicator a guide having laterally extending wings, inserting said wings into said retractor body portion after said cap is removed and advancing said clip applicator through said channel in said body portion until said applicator contacts said wound, and wherein said closing step comprises applying at least one surgical clip to said wound.

50. The method of claim 47, wherein said guide further comprises a guidetube for receiving said guidewire, and said method further comprises inserting the proximal end of the guidewire through said guidetube and advancing said applicator over said guidewire and through said channel in said body portion until said applicator contacts said wound.

51. The method of claim 47, further comprising providing a source of negative pressure on said dilator until blood is drawn into said dilator from said vasculature, during said advancing of said dilator over said guidewire.

52. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having an externally threaded proximal end and a tapered distal end, wherein said body portion has two separate halves operatively connected to each other through cooperative reception of a connecting pin extending from one of the halves of the body portion and a cooperating slot which receives the connecting pin, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end; and

an internally threaded cap having a hole therethrough, said internal threads adapted to engage said externally threaded proximal end of said body portion, such that when said cap engages said body portion, said hole is positioned directly above said channel in said body portion; and

a guidewire, wherein said guidewire can be inserted through said channel in said body portion and through said hole in said cap.

53. The device of claim 52, wherein said guidewire has an inflatable balloon attached thereto.

54. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having an externally threaded proximal end and a distal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end;

a collar portion distal the externally threaded proximal end comprising at least one guide passage which traverses one half of said body portion;

at least one pin extending from one half of said body portion and insertable into said guide passage in the other half of said body portion;

an internally threaded annular cap, said internal threads adapted to engage said external threads on said body portion; and

and least one set screw hole in said collar portion at a right angle to said guide passage, and at least one set screw insertable into said set screw hole.

55. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having an externally threaded proximal end and a distal end, wherein said body portion has two separate halves, each of said halves having a flat internal surface with a groove therein, such that when said internal surfaces abut one another, said grooves form a channel extending completely through said body portion from said proximal end to said distal end;

a collar portion distal the externally threaded proximal end comprising at least one guide passage which traverses one half of said body portion;

at least one pin extending from one half of said body portion and insertable into said guide passage in the other half of said body portion;

an internally threaded annular cap, said internal threads adapted to engage said external threads on said body portion; and

a hollow dilator having an open proximal end and an open distal end adapted to receive a guidewire therethrough, wherein said dilator can be inserted through said channel in said body portion and through said annular cap.

56. The device of claim 55, wherein the distal end of the body portion is tapered and wherein said dilator further comprises a notch near said distal end sized to receive the tapered distal end of the body portion of the device.

57. The device of claim 55, wherein said dilator has at least one indicator hole through a side wall located distal said notch.

58. The device of claim 55, wherein said dilator further comprises a pressure sensor mounted on an outside wall of said dilator.

59. The device of claim 55, further comprising a guidewire, wherein said guidewire can be inserted through said hollow dilator.

60. The device of claim 55, wherein said hollow dilator has a double-sleeved inflatable balloon mounted on its distal end.

61. The device of claim 60, wherein said dilator further comprises at least one indicator hole at its distal end through a side wall, and wherein said double-sleeved inflatable balloon is mounted approximately 1.5 mm proximal said indicator hole.

62. A surgical retractor which comprises:

an elongated body portion having proximal and distal ends and defining a longitudinal axis, the elongated body portion including at least two separate cooperating members operatively connected to each other and adapted for relative movement between an approximated position and a displaced position, each cooperating member having internal surfaces dimensioned to define a longitudinal passage extending through the elongated body portion for reception of surgical instrumentation, the elongated body portion having a distal tapered portion for facilitating entry into tissue;

an end cap removably mounted to the proximal end of the elongated body portion, the end cap configured to retain the cooperating members in the approximated position wherein upon removal of the end cap from the elongated body portion the cooperating members may be displaced relative to each other to move to the displaced position thereof, and

a locking member independent of the end cap for securing the cooperating members at desired relative positions between the approximated and displaced positions.

63. The surgical retractor according to claim 62 wherein the elongated body portion and the end cap include threaded portions, the threaded portions cooperating to mount the end cap to the elongated body portion.

64. The surgical retractor according to claim 62 wherein the end cap includes an opening in general alignment and in communication with the longitudinal passage of the elongated body portion.

65. The surgical retractor according to claim 62 including a connector extending between the cooperating members to operatively connect the cooperating members.

66. The surgical retractor according to claim 65 wherein at least one of the cooperating members is movable relative to the connector.

67. The surgical retractor according to claim 66 wherein the locking member is mounted to the one cooperating member, the locking member movable to engage the connector to secure the one cooperating member at a desired relative position.

68. The surgical retractor according to claim 65 wherein the connector is fixedly mounted to a first of the cooperating members and wherein a second of the cooperating members is movable relative to the first cooperating member and the connector.

69. The surgical retractor according to claim 68 wherein the locking member is mounted to the other second cooperating member and is positioned to selectively engage the connector to secure the cooperating members at the desired relative position.

70. A method for facilitating closure of an opening in a blood vessel where access to the opening is through a tissue passage extending through tissue overlying the blood vessel, comprising the steps of:

positioning a retractor at least partially within the tissue passage, the retractor including an elongated body having proximal and distal ends and defining a longitudinal axis, the elongated body having first and second body portions defining a longitudinal passage therebetween and being adapted for relative movement between an approximated position and a displaced position;

advancing the retractor through the tissue passage whereby the distal end thereof is proximal the opening in the blood vessel;

moving at least the first body portion relative to the second body portion to cause the elongated body to assume the displaced position whereby the body portions retract the tissue defining the tissue passage to increase a dimension of the tissue passage to facilitate access to the opening; and

closing the opening in the blood vessel while the retractor is partially positioned within the tissue passage.

71. The method according to claim 70 wherein the step of closing including introducing a wound closure device through the tissue passage between the first and second body portions, and actuating the wound closure device.

72. The method according to claim 71 including the step of introducing a guide wire within the tissue passage such that a distal end thereof extends through the opening within the blood vessel.

73. The method according to claim 72 wherein the step of advancing includes positioning the guide wire within the longitudinal passage and guiding the retractor along the guide wire.

74. The method according to claim 73 wherein the guide wire includes an inflatable balloon adjacent the distal end thereof and further including the steps of:

inflating said inflatable balloon; and

moving said guide wire such that said inflatable balloon engages an inner surface of the blood vessel adjacent the opening.

75. The method according to claim 74 wherein the step of advancing the retractor includes advancing the retractor such that the distal end of the elongated body contacts the inflated balloon.

76. The method according to claim 73 wherein the step of closing includes advancing the would closure device along the guide wire to a position adjacent the opening in the blood vessel.

77. The method according to claim 76 wherein the wound closure device includes a guide having a guide wire passage for reception of the guide wire and wherein the step of advancing the wound closure device includes positioning the guide wire within the guide wire passage of the guide.

78. The method according to claim 70 wherein the retractor includes a dilator mounted within the longitudinal passage of the elongated body and wherein the step of advancing includes moving the retractor and dilator through the tissue passage.