Device for sealing percutaneous puncture in a vessel

• US 4,744,364 A
• Filed: 02/17/1987
• Issued: 05/17/1988
• Est. Priority Date: 02/17/1987
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Intravascular Surgical Instruments Incorporated
• Inventors: Kensey, Kenneth
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/015,267
• Time in Patent Office: 455 Days
• Field of Search: 138/97, 138/98, 152/367, 152/368, 604/15-17, 604/60, 604/158, 604/159, 604/161, 604/164, 604/167, 604/169, 604/170, 604/285, 604/288, 128/325, 128/334 R, 128/334 C, 128/335, 128/337, 128/207.14, 128/207.15
• 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 2017/00659 located only on one side of the opening
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2210/0061 swellable

Abstract

A device for sealing an opening or puncture in the wall of a blood vessel, duct or other lumen of a living being. The device includes an elongated tubular body having an outlet at the distal end thereof and which is arranged to be inserted, such as percutaneously, through the puncture in the blood vessel so that the outlet is located within the vessel'"'"'s interior. An expandible closure is disposed within the tubular body and is formed so as to be held in a compact configuration therein. The tubular body also includes ejecting means for forcing the closure out of the outlet into the interior of the blood vessel, whereupon the closure automatically expands to form an enlarged engagement surface. A retraction filament is secured to the closure for pulling it to the puncture after the tubular body has been withdrawn from the puncture so that the engagement surface of the closure means hemostatically engages the inner surface of the blood vessel contiguous with the puncture. The filament held taut and taped or otherwise secured in place on the patient'"'"'s skin to hold the closure in position. The closure and filament are each formed of a biodegradable material to enable the closure to be left in place. Preferably the closure also includes a non-thrombogenic coating on its surface. The closure is constructed so that when it is opened and is in place sealing the puncture in the blood vessel it doesn'"'"'t appreciably block the flow of any blood through the blood vessel.

Claims

1. A device for sealing a percutaneous incision or puncture in the wall of a blood vessel of a living being, said device comprising first means having an outlet at the distal end thereof and adapted to be inserted through said incision or puncture so that said outlet is located within the interior of said vessel, expandable closure means disposed within said first means and being formed of a material which is held in a compact configuration within said first means, ejecting means for causing said closure means to pass out of said outlet into the interior of said vessel, said closure means being expandable to expand to form an engagement surface, said engagement surface conforming to the arcuate inner surface of said vessel contiguous with said incision or puncture, and retraction means for moving said closure to said opening after said first means has been removed therefrom, whereupon said engagement surface hemostatically engages said arcuate inner surface of said vessel contiguous with said incision or puncture to seal said incision or puncture, said retraction means serving to hold said closure in place and without said closure appreciably blocking the flow of blood through said vessel.

2. The device of claim 1 wherein said retraction means comprises a filament fixedly secured to said closure means and extending through said opening to the outside of said vessel.

3. The device of claim 2 wherein said closure means is formed of a biodegradable material.

4. The device of claim 2 wherein said first member is a tubular member which has a longitudinal axis and wherein said ejection means comprises a pusher member located within said tubular member and arranged to move down said axis to force said closure means out of said outlet.

5. The device of claim 4 wherein said pusher includes a portion arranged to be engaged by a person'"'"'s thumb and wherein said tubular means includes a portion arranged to be engaged by a person'"'"'s fingers to enable the pusher means to be moved down said axis.

6. The device of claim 5 wherein said closure is formed of a biodegradable material.

7. The device of claim 6 wherein said filament is biodegradable.

8. The device of claim 1 wherein said closure includes a facing formed of a non-thrombogenic material.

9. The device of claim 1 wherein said closure, when expanded, includes an enlarged head portion of substantial area but being substantially thin.

10. The device of claim 9 wherein said enlarged head is of a disk-like shape.

11. The device of claim 10 wherein said retraction means comprises a filament fixedly secured to said closure and extending through said opening to the outside of said vessel, duct or lumen.

12. The device of claim 11 wherein said closure is formed of a biodegradable material.

13. The device of claim 12 wherein said filament is formed of a biodegradable material.

14. The device of claim 1 wherein said material forming said closure is a porous absorbable gelatin.

15. A method for sealing a percutaneous incision or puncture in the wall of a blood vessel of a living being to preclude the flow of blood from said vessel through said incision or puncture by introducing plug means therein, said plug means having a shape which when said plug means is in place conforms to the arcuate inner surface of said vessel contiguous with said incision or puncture, said method comprising introducing said plug means into said vessel, with a portion of said plug means extending through said incision or puncture and causing said plug means to engage the arcuate inner surface of said vessel contiguous with said incision or puncture to seal said incision or puncture while not appreciably restricting the flow of blood through said vessel, and thereafter leaving said plug means in place therein, whereupon said incision or puncture is permanently sealed against the flow of blood therethrough.

16. The method of claim 15 additionally comprising forming at least a portion of said plug means of a material which the body will absorb.

17. The method of claim 15 wherein said plug means is in a compacted condition when introduced into said vessel and is enabled to expand thereafter.

18. The method of claim 15 additionally comprising pulling on said plug means to bring said plug means into engagement with said arcuate inner surface of said vessel after said plug means has been introduced into said vessel.

19. The method of claim 18 additionally comprising holding said plug means in engagement with said tissue.

20. A device for sealing a percutaneous incision or puncture in the wall of a blood vessel of a living being comprising introducer means for introducing plug means through said incision or puncture and into the interior of said vessel, said plug means being configured to conform to the arcuate inner surface of said vessel contiguous with said incision or puncture and comprising a first portion extending into said incision or puncture and a second portion engaging the arcuate inner surface of said vesel contiguous with said incision or puncture to seal said incision or puncture while not appreciably restricting the flow of blood through said vessel.

21. The device of claim 20 wherein said plug means is expandable and wherein said plug means is in a compacted condition when introduced into said vessel and thereafter expands.

22. The device of claim 21 wherein said plug means, when expanded, comprises an enlarged head portion of substantial area, but being substantially thin.

23. The device of claim 20 wherein said plug means comprises retraction means to enable said plug means to be drawn into engagement with said tissue after said plug means has been introduced into said vessel.

24. The device of claim 23 wherein said retraction means comprises a filament connected to said plug means and extending through said opening to the outside of said vessel.

25. The device of claim 24 wherein said plug means and said retraction means are formed of materials which the body will absorb.

26. The device of claim 20 wherein said plug means is constructed so that it does not appreciably block the interior of said vessel, duct or lumen when it is in engagement with said tissue.

27. The device of claim 29 wherein said plug means comprises material which the body will absorb.

28. The device of claim 20 wherein said plug means hemostatically seals said opening.

29. The device of claim 28 wherein said plug means comprises non-thrombogenic material.

30. The device of claim 20 wherein said introducer means comprises tubular means having an outlet adjacent the distal end thereof and ejector means, said tubular means being adapted to be inserted through said opening so that said outlet is located within the interior of said vessel, said ejector means being operative for causing said plug means to pass out of the outlet into the interior of said vessel.

31. The device of claim 30 wherein said ejector means comprises a pusher member located within said tubular means to force said plug means out of said outlet.

32. The device of claim 20 wherein said plug means is a porous absorbable gelatine.