Hemostatic puncture closure system including vessel location device and method of use

• US 5,676,689 A
• Filed: 02/28/1996
• Issued: 10/14/1997
• Est. Priority Date: 11/08/1991
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Nash, John, Evans, Douglas, Kensey, Kenneth
• Primary Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/608,428
• Time in Patent Office: 594 Days
• Field of Search: 606/213, 606/215, 606/216, 604/15, 604/60, 604/285, 604/288, 604/168, 623/1, 623/11, 128/898
• US Class Current: 606/213
• 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 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 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2090/032 pressure limiting, e.g. hydrostatic
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: F16G 11/108 using a ball or a cylinder
• CPC Class Codes: Y10S 604/90 Telltale showing entry of blood into body inserted conduit

Abstract

A system for sealing a percutaneous puncture in a blood vessel in a living being and method of use thereof. The system includes a hemostatic closure, a blood vessel locator device for determining the position of the blood vessel via the percutaneous puncture, and a deployment instrument for deploying the closure within the puncture to seal the puncture. The vessel locator includes means for enabling blood from the vessel to flow therethrough so that the position of the vessel can be rapidly determined. Once the vessel has been located the deployment instrument, which includes a tubular carrier storing the closure, is extend into the puncture to deploy the closure. The closure basically comprises a radiopaque rigid anchor for location within the blood vessel, a compressed collagen plug for location within the puncture tract leading to the vessel, and a thin filament connecting the two in a pulley-like arrangement. The deployment instrument also includes a tamper which is used to mechanically deform the plug within the tract. Once the closure is positioned hemostasis occurs rapidly, thereby locking the closure in place.

Claims

1. A system for sealing a percutaneous puncture in the wall of a vessel, duct or lumen of a living being, the vessel, duct or lumen having a fluid therein, the puncture comprising an opening in the wall of the vessel, duct or lumen and a tract contiguous with the opening and extending through tissue overlying the vessel, duct or lumen, said system comprising a closure device and a location detector, said location detector being arranged for introduction into the puncture to provide a perceptible signal indicative of the location of the wall of the vessel, duct or lumen, whereupon a desired position for said closure with respect to the vessel, duct or lumen may be determined, said location detector comprising means for insertion in the puncture tract to a position at which the fluid within the vessel, duct or lumen is enabled to flow from the interior thereof into said location detector to provide said perceptible signal, said closure device being arranged to be positioned within a portion of the puncture in accordance with said desired position to enable the effective sealing of the puncture by said closure device.

2. The system of claim 1 wherein said location detector includes means for conveying the fluid from the interior of the vessel, duct or lumen to a location outside the body of the being for detection thereof.

3. The system of claim 2 wherein said means for conveying the fluid comprises a conduit and associated valve means.

4. The system of claim 3 wherein said valve means is located outside the body of the being.

5. The system of claim 2 wherein said means for conveying the fluid comprises a tubular member through which an elongated member extends.

6. The system of claim 5 wherein said tubular member and said elongated member form a lumen between them through which the fluid is enabled to flow to the location outside of the body of the being for detection thereof.

7. The system of claim 1 additionally comprising a deployment instrument, said closure comprising a first portion and a second portion coupled to said first portion and adapted to extend through the tract, said location detector comprising a first port adapted to be located within the interior of the vessel, duct or lumen and a passageway coupled thereto into which the fluid may enter for detection when said first port is located within the interior of the vessel, duct or lumen, said deployment instrument being arranged to deploy said closure in accordance with said desired position, said closure being operable once deployed to seal the puncture.

8. The system of claim 7 wherein said location detector includes a second port coupled to said passageway and adapted to be located outside the body of the being, said second port being arranged to receive the fluid from said passageway when said first port is located within the interior of the vessel, duct, or lumen, whereupon the existence of the fluid at said second port provides an indication of the location of the vessel, duct or lumen.

9. The system of claim 8 wherein said second portion of said closure comprises a filament, and wherein said first portion of said closure is arranged to be located within the interior of the vessel, duct, or lumen, with said filament extending into the puncture tract.

10. The system of claim 9 wherein the vessel, duct, or lumen comprises a blood vessel and the fluid comprises blood, and wherein said first portion of said closure is arranged to be located within the interior of the blood vessel with said filament extending into the puncture tract.

11. The system of claim 8 wherein said passageway extends longitudinally through the puncture tract.

12. The system of claim 9 wherein said first portion of said closure comprises an anchor member adapted to be brought into engagement with tissue contiguous with the opening in the vessel, duct, or lumen in the interior of the vessel, duct, or lumen.

13. The system of claim 7 wherein said second portion of said closure comprises a filament, and wherein said first portion of said closure is arranged to be located within the interior of the vessel, duct, or lumen, with said filament extending into the puncture tract.

14. The system of claim 13 wherein the vessel, duct, or lumen comprises a blood vessel and the fluid comprises blood, and wherein said first portion of said closure is arranged to be located within the interior of the blood vessel with said filament extending into the puncture tract.

15. The system of claim 13 wherein said first portion of said closure comprises an anchor member adapted to be brought into engagement with tissue contiguous with the opening in the vessel, duct, or lumen in the interior of the vessel, duct, or lumen.

16. The system of claim 1 wherein said closure device includes at least one portion which extends through at least a portion of the tract, said location detector comprising a first port adapted to be located within the interior of the vessel, duct or lumen and a passageway coupled thereto into which the fluid may flow for providing said perceptible signal, said deployment instrument being arranged to deploy said closure device in accordance with said desired position once the location of the wall of the vessel, duct or lumen has been determined to seal the puncture.

17. The system of claim 16 wherein said location detector includes a second port coupled to said passageway and adapted to be located outside the body of the being, said second port being arranged to receive the fluid from said passageway when said first port is located within the interior of the vessel, duct or lumen, whereupon the presence of the fluid at said second port provides an indication that the first port is in the interior of the vessel, duct or lumen.

18. The system of claim 17 wherein the vessel, duct or lumen comprises a blood vessel and the fluid comprises blood, and wherein said at least one portion of said closure device is arranged to be located within the interior of the blood vessel, said filament being arranged to extend into the puncture tract.

19. The system of claim 16 wherein said at least one portion of said closure device comprises a filament, and wherein said closure device includes another portion arranged to be located within the interior of the vessel, duct or lumen, said filament being arranged to extend into the puncture tract.

20. The system of claim 1 wherein said closure device is bioabsorbable.

21. The system of claim 1 wherein said closure device comprises a plug adapted for insertion in the tract.

22. The system of claim 21 wherein said plug is resorbable.

23. The system of claim 22 wherein said plug comprises collagen.

24. The system of claim 21 wherein said closure device additionally comprises a filament.

25. A method for sealing a percutaneous puncture in the wall of a vessel, duct or lumen of a living being, the vessel, duct or lumen having a fluid therein, the puncture comprising an opening in the wall of the vessel, duct or lumen and a tract contiguous with the opening and extending through tissue overlying the vessel, duct or lumen, said method comprising:

(a) providing a closure device and location detector;

(b) introducing the location detector into the puncture to a position whereupon the fluid within the vessel, duct or lumen is enabled to flow from the interior of the vessel, duct or lumen into the location detector to provide a perceptible signal indicative of the location of the wall of the vessel, duct or lumen, whereupon a desired position for the closure with respect to the vessel, duct or lumen may be determined; and

(c) introducing the closure device within a portion of the puncture in accordance with the desired position to enable the effective sealing of the puncture by said closure device.

26. The method of claim 25 additionally comprising the step of conveying the fluid from the interior of the vessel, duct or lumen to a location outside the body of the being for detection thereof.

27. The method of claim 25, wherein the location detector is provided with a first port and a passageway coupled thereto, and wherein said method comprises:

(d) providing an instrument for inserting the closure device in the puncture;

(e) inserting the location detector into the puncture so that the first port is located within the interior of the vessel, duct or lumen, whereupon the fluid is enabled to flow into the port and through the passageway for detection to indicate that the first port is within the interior of the vessel, duct or lumen;

(f) operating said instrument to deploy the closure device into the puncture; and

(g) causing the closure device to seal the puncture.

28. The method of claim 27 wherein said closure device comprises a first portion arranged to be located within the interior of the vessel, duct or lumen, and a filament portion extending from the first portion, and wherein the step of operating said instrument to deploy said closure device comprises causing said first portion of said closure device to be located within the interior of the vessel, duct, or lumen, and said filament portion to extend into the puncture tract.

29. The method of claim 28 wherein said vessel, duct or lumen comprises a blood vessel and wherein said fluid comprises blood.

30. The method of claim 29 wherein said blood vessel comprises the femoral artery.

31. The method of claim 28 wherein said first portion of said closure device comprises an anchor member which is arranged to be brought into engagement with tissue contiguous with the opening in the vessel, duct or lumen on the interior of the vessel, duct or lumen.

32. The method of claim 31 wherein said vessel, duct or lumen comprises a blood vessel and wherein said fluid comprises blood.

33. The method of claim 32 wherein said blood vessel comprises the femoral artery.

34. The method of claim 27 wherein said vessel, duct or lumen comprises a blood vessel and wherein said fluid comprises blood.

35. The method of claim 34 wherein said blood vessel comprises the femoral artery.

36. The method of claim 34 wherein said first portion of said closure device comprise an anchor member which is arranged to be brought into engagement with tissue contiguous with the opening in the vessel, duct or lumen on the interior of the vessel, duct or lumen.

37. The method of claim 36 wherein said vessel, duct or lumen comprises a blood vessel and wherein said fluid comprises blood.

38. The method of claim 37 wherein said blood vessel comprises the femoral artery.

39. The method of claim 25 wherein said fluid is an observable liquid, the location detector being provided with a first port and a passageway coupled to the first port, and wherein said step of introducing the location detector into the puncture comprises

inserting the location detector into the puncture so that the first port is located within the interior of the vessel, duct or lumen, whereupon the observable liquid is enabled to flow into the first port and through the passageway for detection to indicate that the first port is within the interior of the vessel, duct or lumen.

42. The method of claim 25 wherein the closure device is provided with a bioabsorbable material.

43. The method of claim 42 wherein the closure device is provided with a first portion and a filament portion extending from the first portion, and wherein the first portion is located immediately adjacent the opening in the wall of the vessel, duct or lumen and the filament portion is extended into the puncture tract.

44. The method of claim 25 wherein the closure device is provided with a first portion and a filament portion extending from the first portion, and wherein the first portion is located immediately adjacent the opening in the wall of the vessel, duct or lumen and the filament portion is extended into the puncture tract.

45. The method of claim 25 wherein the closure device is provided with an anchor member, and wherein said method comprises bringing the anchor member into engagement with tissue contiguous with the opening in the wall of the vessel, duct or lumen on the interior of the vessel, duct or lumen.

46. The method of claim 39 wherein the closure device is additionally provided with a collagen member, the collagen member being positioned in the tract to seal the vessel, duct or lumen.

47. The method of claim 25 wherein the closure device is provided with a plug and wherein said method comprises

positioning the lumen so that a portion thereof is in fluid communication with the interior of the blood vessel so that blood can flow therein to thereby indicate the location of the blood vessel;

and

placing the plug in accordance with said desired position for sealing the puncture.

48. The method of claim 47 wherein said vessel, duct or lumen is a blood vessel.

49. The method of claim 47 wherein the closure device is formed of a resorbable material.

50. The method of claim 49 wherein said resorbable material comprises collagen.

40. The method of 39 wherein the vessel, duct or lumen comprises a blood vessel and wherein the observable liquid is blood.

41. The method of claim 40 wherein said blood vessel is the femoral artery.