Vascular sealing apparatus and method

• US 5,868,778 A
• Filed: 05/05/1997
• Issued: 02/09/1999
• Est. Priority Date: 10/27/1995
• Status: Expired due to Term

• Current Assignee: Vascular Solutions Incorporated
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Horzewski, Michael J., Kasprzyk, Daniel J., Gershony, Gary
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/850,477
• Time in Patent Office: 645 Days
• Field of Search: 606/194, 606/108, 606/192, 606/191, 606/213, 604/96, 604/101
• US Class Current: 606/194
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like

Abstract

A vascular sealing device for effecting closure of a puncture or other opening in a blood vessel, or other body cavity, which has been entered through percutaneous techniques. The device is useable with a standard percutaneous vascular introducer. The vascular sealing device generally comprises a body or shaft, an adapter disposed at a proximal end of the shaft, and a balloon portion disposed generally at a distal end of the shaft. A core wire is connected to the distal end and extends, internally, through a lumen of the device for deflation of the balloon. A procoagulant is introduced through the introducer, or alternatively through an additional lumen and associated apertures, and to the puncture sealed by the inflated balloon. Subsequently, the balloon is deflated and the device is removed from the sealing puncture, with or without the aid of a reaccess sheath.

Claims

1. A method for closing a puncture or other opening in a blood vessel, comprising the steps of:

(a) inserting a balloon apparatus through an introducer which is disposed in the blood vessel opening;

(b) inflating said balloon apparatus;

(c) moving said balloon apparatus into contact with the opening sufficient to effect a hemostatic seal at the puncture site;

(d) introducing a procoagulant to the opening;

(e) deflating said balloon apparatus; and

(f) removing said balloon apparatus through the opening and through the procoagulant.

2. The method of claim 1, in which the procoagulant is injected, the introducer is retracted, and balloon deflation is commenced within a time period of about one minute.

3. The method of claim 1, in which the procoagulant is injected, the introducer is retracted, and balloon deflation is commenced within a time period of between about one to three minutes.

4. The method of claim 1, in which the retraction of the introducer is facilitated by the injection of the procoagulant.

5. The method of claim 1, further comprising the step of moving said balloon apparatus into contact with the opening so that the balloon apparatus functions as an internal marker to permit the user to accurately gauge the depth of the puncture and the thickness of the tissues surrounding the puncture.

6. The method of claim 1, in which the step of inserting a balloon apparatus through an introducer which is displaced in the blood vessel opening comprises the step of connecting an elongated and tapered wire member to an inflatable balloon apparatus and configuring the taper of the wire member so that a predetermined distal region has a smaller diameter than a proximal region, and the step of removing said balloon apparatus through the opening comprises removal of the deflated balloon apparatus having the smaller diameter distal region therein so as to reduce the size of the apparatus being withdrawn through the procoagulant clot being formed at the puncture site.

7. The method of claim 1, in which the procoagulant is characterized by its viscous-like properties.

8. The method of claim 7, in which the procoagulant is selected from the group consisting of a liquid and a gel.

9. The method of claim 7, in which the procoagulant is injected through the introducer.

10. The method of claim 7, in which the procoagulant is injected through the balloon apparatus.

11. The method of claim 1, in which the procoagulant fills a portion of the entire depth of the puncture.

12. A method for rapid closure of a puncture or other opening in a blood vessel, comprising the steps of:

(a) inserting a balloon apparatus through an introducer which is displaced in the blood vessel opening;

(b) inflating said balloon apparatus;

(c) moving said balloon apparatus into contact with the opening sufficient to effect a hemostatic seal at the puncture site;

(d) introducing a procoagulant to the opening by injection through the introducer as the introducer is retracted, and then commencing deflation of said balloon apparatus so that the procoagulant is injected, the introducer is retracted, and the balloon deflation is commenced within a time period of between about one and three minutes;

(e) deflating said balloon apparatus; and

(f) removing said balloon apparatus through the opening.

13. The method of claim 12, in which the retraction of the introducer is facilitated by the injection of the procoagulant.

14. The method of claim 12, further comprising the step of moving said balloon apparatus into contact with the opening so that the balloon apparatus functions as an internal marker to permit the user to accurately gauge the depth of the puncture and the thickness of the tissues surrounding the puncture.

15. The method of claim 12, in which the step of inserting a balloon apparatus through an introducer which is displaced in the blood vessel opening comprises the step of connecting an elongated and tapered wire member to an inflatable balloon apparatus and configuring the taper of the wire member so that a predetermined distal region has a smaller diameter than a proximal region, and the step of removing said balloon apparatus through the opening comprises removal of the deflated balloon apparatus having the smaller diameter distal region therein so as to reduce the size of the apparatus being withdrawn through the procoagulant clot being formed at the puncture site.

16. The method of claim 12, in which the procoagulant is characterized by its viscous-like properties.

17. The method of claim 16, in which the procoagulant is selected from the group consisting of a liquid and a gel.

18. The method of claim 16, in which the procoagulant is injected through the balloon apparatus.

19. The method of claim 12, in which the procoagulant fills a portion of the entire depth of the puncture.

20. A method for closing a puncture or other opening in a blood vessel, comprising the steps of:

(a) inserting a balloon apparatus through an introducer which is disposed in the blood vessel opening;

(b) inflating said balloon apparatus;

(c) moving said balloon apparatus into contact with the opening sufficient to effect a hemostatic seal at the puncture site;

(d) introducing a procoagulant to the opening;

(e) deflating said balloon apparatus; and

(f) removing said balloon apparatus through the opening and the procoagulant clot being formed at said opening.

21. The method of claim 20, in which the procoagulant is injected, the introducer is retracted, and balloon deflation is commenced within a time period of about one minute.

22. The method of claim 20, in which the procoagulant is injected, the introducer is retracted, and balloon deflation is commenced within a time period of between about one to three minutes.

23. The method of claim 20, in which the retraction of the introducer is facilitated by the injection of the procoagulant.

24. The method of claim 20, further comprising the step of moving said balloon apparatus into contact with the opening so that the balloon apparatus functions as an internal marker to permit the user to accurately gauge the depth of the puncture and the thickness of the tissues surrounding the puncture.

25. The method of claim 20, in which the step of inserting a balloon apparatus through an introducer which is displaced in the blood vessel opening comprises the step of connecting an elongated and tapered wire member to an inflatable balloon apparatus and configuring the taper of the wire member so that a predetermined distal region has a smaller diameter than a proximal region, and the step of removing said balloon apparatus through the opening comprises removal of the deflated balloon apparatus having the smaller diameter distal region therein so as to reduce the size of the apparatus being withdrawn through the procoagulant clot being formed at the puncture site.

26. The method of claim 20, in which the procoagulant is characterized by its viscous-like properties.

27. The method of claim 26, in which the procoagulant is selected from the group consisting of a liquid and a gel.

28. The method of claim 26, in which the procoagulant is injected through the introducer.

29. The method of claim 26, in which the procoagulant is injected through the balloon apparatus.

30. The method of claim 20, in which the procoagulant fills a portion of the entire depth of the puncture.

31. A method for closing a puncture or other opening in a blood vessel, comprising the steps of:

(a) inserting a balloon apparatus through an introducer which is disposed in the blood vessel opening;

(b) inflating said balloon apparatus;

(c) moving said balloon apparatus into contact with the opening sufficient to effect a hemostatic seal at the puncture site;

(d) introducing a procoagulant to the opening;

(e) deflating said balloon apparatus; and

(f) removing said balloon apparatus through the opening and the procoagulant clot being formed at said opening, with said procoagulant clot substantially simultaneously filling the void resulting from removal of said balloon apparatus.

32. The method of claim 31, in which the procoagulant is injected, the introducer is retracted, and balloon deflation is commenced within a time period of about one minute.

33. The method of claim 31, in which the procoagulant is injected, the introducer is retracted, and balloon deflation is commenced within a time period of between about one to three minutes.

34. The method of claim 31, in which the retraction of the introducer is facilitated by the injection of the procoagulant.

35. The method of claim 31, further comprising the step of moving said balloon apparatus into contact with the opening so that the balloon apparatus functions as an internal marker to permit the user to accurately gauge the depth of the puncture and the thickness of the tissues surrounding the puncture.

36. The method of claim 31, in which the step of inserting a balloon apparatus through an introducer which is displaced in the blood vessel opening comprises the step of connecting an elongated and tapered wire member to an inflatable balloon apparatus and configuring the taper of the wire member so that a predetermined distal region has a smaller diameter than a proximal region, and the step of removing said balloon apparatus through the opening comprises removal of the deflated balloon apparatus having the smaller diameter distal region therein so as to reduce the size of the apparatus being withdrawn through the procoagulant clot being formed at the puncture site.

37. The method of claim 31, in which the procoagulant is characterized by its viscous-like properties.

38. The method of claim 37, in which the procoagulant is selected from the group consisting of a liquid and a gel.

39. The method of claim 37, in which the procoagulant is injected through the introducer.

40. The method of claim 37, in which the procoagulant is injected through the balloon apparatus.

41. The method of claim 31, in which the procoagulant fills a portion of the entire depth of the puncture.