Method and device for providing hemostasis at vascular penetration sites

• US 5,746,755 A
• Filed: 11/15/1995
• Issued: 05/05/1998
• Est. Priority Date: 06/01/1994
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Perclose Incorporated (Abbott Laboratories Incorporated)
• Inventors: Andreas, Bernard H., Wood, Timothy J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/559,254
• Time in Patent Office: 902 Days
• Field of Search: 606/144, 606/148, 606/151, 606/157, 606/159, 606/194, 606/213-216
• US Class Current: 606/148
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen

Abstract

A device for providing or enhancing hemostasis at a vascular puncture site disposed at the distal end of a tissue tract comprises a shaft having a non-compliant surface at its distal end. The non-compliant surface is oriented at an angle which allows it to lie flat over tissue puncture when the tissue tract is oriented obliquely, e.g., as the result of the Seldinger catheter introduction technique. The device may be used by itself or in combination with suturing of the vascular puncture, where the device enhances hemostasis and prevents blood leakage through the primary suture closure.

Claims

1. A method for occluding a puncture of a blood vessel at the end of a tissue tract, said method comprising:

applying pressure without applying heat directly to an adventitial surface of the blood vessel with a surface which is engaged against the adventitial surface, wherein a force in the range from 5 g to 50 g is applied over an area in the range from about 6 mm² to 30 mm² for a time in the range from about 10 minutes to 24 hours, the pressure applied at least in part by tensioning a member, the member selected from the group consisting of suture and a guidewire, and anchoring the member to a shaft which extends out the tissue tract from the surface, the force being transferred along the shaft and to the surface from outside the tissue tract; and

removing the shaft with the surface through the tissue tract after applying the pressure.

2. A method as in claim 1, wherein the pressure is applied with an annular flat surface which is engaged against the adventitial surface.

3. A method as in claim 2, wherein the annular surface is introduced over the member, the member passing through the adventitial surface and extending through the tissue tract.

4. A method as in claim 1, further comprising applying a tissue glue at the puncture while applying pressure.

5. A method as in claim 4, wherein the applying tissue glue step comprises applying at least one member of the clotting cascade selected from the group consisting of fibrinogen and thrombin.

6. A method as in claim 1, further comprising focussing the pressure at the puncture, the pressure being applied with a convex surface having a center raised in the range from 0.1 mm to 1 mm relative to an edge.

7. A method as claimed in claim 1, wherein the member is not attached to a fastener within a lumen of the blood vessel.

8. A method for occluding a puncture of a blood vessel at the end of a tissue tract, said method comprising:

contacting an annular surface against the adventitial surface of the blood vessel over the puncture with sufficient pressure to substantially inhibit blood flow through the puncture, the surface defining an opening through which suture extends, the suture forming a suture loop which passes through the adventitial surface to attach the suture loop to the blood vessel, wherein the suture is not attached to a fastener within a lumen of the blood vessel, the surface contacting the adventitial surface surrounding the suture loop, wherein the surface is a distal end of a shaft, wherein said shaft and said surface form an angle which is substantially equal to an angle of the tissue tract relative to the adventitial surface so that the surface lies substantially flat over the adventitial surface while pressure is being applied, and wherein a force in the range from 5 g to 50 g is applied over an area in the range from about 6 mm² to 30 mm² for a time in the range from about 10 minutes to 24 hours; and

removing the shaft with the surface through the tissue tract after contacting the adventitial surface with the surface for the time.

9. A method as in claim 8, further comprising applying a tissue glue at the puncture while applying pressure.

10. A method as in claim 9, wherein the applying tissue glue step comprises applying at least one member of the clotting cascade selected from the group consisting of fibrinogen and thrombin.

11. A method as in claim 8, further comprising focussing the pressure at the puncture, the surface being elliptical and convex, having a center raised in the range from 0.1 mm to 1 mm relative to an edge.

12. A method for occluding a puncture of a blood vessel at the end of a tissue tract, said method comprising:

providing an occlusion device having a shaft defining a proximal end and a distal end, the shaft forming an angle in the range from about 30°

to 60°

with a surface at its distal end, wherein said angle is substantially equal to an angle of the tissue tract relative to an adventitial surface of the blood vessel, and wherein the surface includes an opening defined by a hole or a slot;

manually grasping the proximal end of the device, inserting a suture into the opening, passing the distal end through the tissue tract over the suture, and contacting the surface generally flat directly against the adventitial surface of the blood vessel over the puncture with sufficient pressure to substantially inhibit blood flow through the puncture; and

removing the shaft and the surface through the tissue tract.

13. A method as in claim 12, wherein a force in the range from 5 g to 50 g is applied over an area in the range from about 6 mm² to 30 mm² for a time in the range from about 10 minutes to 24 hours.

14. A method as in claim 12, further comprising securing the device within the tissue tract so that said sufficient pressure is applied without manual grasping.

15. A method as in claim 12, further comprising applying a tissue glue at the puncture while applying pressure.

16. A method as in claim 15, wherein the applying tissue glue step comprises applying at least one member of the clotting cascade selected from the group consisting of fibrinogen and thrombin.

17. A method as in claim 12, further comprising focussing the pressure at the puncture, the surface being elliptical and convex, having a center raised in the range from 0.1 mm to 1 mm relative to an edge.

18. A method for closing a puncture of a blood vessel at the distal end of a tissue tract, said method comprising:

forming a suture loop which passes through a blood vessel wall on opposite sides of the puncture beyond the puncture with free ends of the suture passing out through the tissue tract;

tightening and securing the free ends of the suture to close the puncture;

introducing a surface through the tissue tract over the tightened and secured suture ends;

applying sufficient pressure directly to an adventitial surface of the blood vessel with the surface to inhibit blood leakage through the sutured puncture; and

removing the surface through the tissue tract.

19. A method as in claim 18, wherein a force in the range from 5 g to 50 g is applied over an area in the range from about 6 mm² to 30 mm² for a time in the range from about 10 minutes to 24 hours.

20. A method as in claim 18, further comprising securing the surface within the tissue tract so that said sufficient pressure is applied without manual grasping.

21. A method as in claim 20, wherein the surface comprises the distal end of a shaft which further defines a proximal end, wherein the introducing step comprises passing the free ends of the suture through an opening in the surface into a lumen of the shaft and out a proximal opening in the shaft, and further comprising tensioning the free ends of the suture and fixing the free ends of the tensioned suture to the shaft proximal of the tissue tract so that the shaft is loaded in compression.

22. A method as claimed in claim 21, wherein the fixing of the free ends of the suture to the shaft comprises tying the suture ends to slots cut in the proximal end of the shaft.

23. A method as in claim 21, wherein the fixing of the free ends of the suture to the shaft comprises disposing the free ends of the suture between an O-ring and the shaft.

24. A method as in claim 21, wherein the surface is compliant.

25. A method as in claim 18, further comprising applying a tissue glue at the puncture while applying pressure.

26. A method as in claim 25, wherein the applying tissue glue step comprises applying at least one member selected from the group containing fibrinogen and thrombin.

27. A method as claimed in claim 18, wherein the surface comprises the distal end of a shaft which further defines a proximal end, and wherein the suture securing step comprises advancing a knot distally along the free ends of the suture using a pair of circumferentially spaced apart slots on one end of the shaft.

28. A method as in claim 27, further comprising securing the surface within the tissue tract so that said sufficient pressure is applied without manual grasping by fixing the free ends of the suture to the shaft proximal of the tissue tract.

29. A method as claimed in claim 18, wherein the suture is not attached to a fastener within a lumen of the blood vessel.

30. A method for occluding a puncture of a blood vessel at the end of a tissue tract, said method comprising:

providing an occlusion device having a shaft defining a proximal end and a distal end, the shaft including a hole or a slot defining an opening in a surface at the distal end;

introducing a guidewire through the puncture;

inserting the guidewire into the opening;

passing the surface through the tissue tract over the guidewire;

contacting the surface generally flat against the adventitial surface of the blood vessel over the puncture with sufficient pressure to substantially inhibit blood flow through the puncture; and

anchoring the guidewire to the shaft proximally of the tissue tract so that the shaft is held in place for a time between 10 minutes and 24 hours.

31. A method for occluding a puncture of a blood vessel at the end of a tissue tract, the method comprising:

passing suture through an adventitial surface of the blood vessel beyond the puncture to form a suture loop which is attached to the blood vessel and which helps close the puncture;

introducing an end of the suture into a hole or a slot of a surface, the surface being at a distal end of a shaft;

inserting the shaft with the surface through the tissue tract;

contacting the surface directly against the adventitial surface of the blood vessel over the sutured puncture with sufficient pressure and for sufficient time to substantially inhibit blood flow through the sutured puncture; and

removing the shaft with the surface through the tissue tract.

32. A method as claimed in claim 31, wherein the suture is not attached to a fastener within a lumen of the blood vessel.