Percutaneous arterial puncture seal device and insertion tool therefore

• US 5,350,399 A
• Filed: 10/07/1992
• Issued: 09/27/1994
• Est. Priority Date: 09/23/1991
• Status: Expired due to Term

• Current Assignee: John I. Shipp
• Original Assignee: Jay Erlebacher, Richard S. Goldweit
• Inventors: Goldweit, Richard S., Erlebacher, Jay
• Primary Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US07/958,446
• Time in Patent Office: 720 Days
• Field of Search: 606/151, 606/213, 606/215, 606/232, 606/139, 604/15, 604/60, 604/285, 604/286, 604/288, 128/898, 128/899
• 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 2017/00654 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 2090/064 for measuring force, pressure or mechanical tension

Abstract

The sealing device is composed of an intra-arterial occluder and an extra-arterial occluder, both made of resilient biocompatible and/or bioabsorbable material and held in place via a saw-toothed guide extending integrally from the intra-arterial occluder. An insertion tool is provided to effect sliding of the extra-arterial occluder over the guide and fixation of the extra-arterial occluder to the guide in sealed relation over an opening in body tissue and safe cutting of the guide. A force gauge is provided on the tool to indicate the sealing pressure on the intra-arterial occluder.

Claims

1. A sealing device for sealing an opening in a vessel comprising

a first resiliently expandable member for positioning in a vessel to one side of an opening therein for closing over said opening;

a guide means integral with and extending centrally from said member for passage through the opening in the vessel, said guide including a portion containing a plurality of saw teeth; and

a second resiliently expandable member movably mounted on said guide means for positioning outside the vessel on an opposite side of the opening therein and in opposition to said first member to seal the opening, said second member being slidably mounted on said guide means to pass over said portion in a direction towards said first member and to be retained against movement in an opposite direction by said saw teeth.

2. A sealing device as set forth in claim 1 wherein each said member is made one of a biocompatible material and a bioabsorbable material.

3. A sealing device as set forth in claim 2 wherein said members and said guide means are made of bioabsorbable material and said first member has a faster rate of absorption than said second member and said guide means.

4. A sealing device as set forth in claim 1 wherein at least one of said members has at least one of an anti-thrombotic material and a clot-promoting material therein.

5. A sealing device as set forth in claim 1 wherein said guide means is an elongated flexible wire.

6. A sealing device as set forth in claim 1 wherein said first member is resiliently expandable into a circular disc shape and said second member is resiliently expandable into an umbrella shape.

7. A sealing device as set forth in claim 6 wherein said second member is of larger outer dimensions than said first member.

8. A sealing device comprising

a collapsible intra-arterial occluder for positioning in a vessel to one side of an opening therein;

a guide wire non-removably connected to said occluder, said wire being integral with and extending centrally from said occluder for passage through the opening in the vessel;

a collapsible extra-arterial occluder movably mounted on said guide wire for positioning on an opposite side of the opening in the vessel; and

means between said extra-arterial occluder and said guide wire for fixing said extra-arterial occluder directly to said guide wire opposite said intra-arterial occluder to seal the opening in the vessel.

9. A sealing device as set forth in claim 8 wherein said extra-arterial occluder is resiliently expandable into an umbrella shape.

10. A sealing device as set forth in claim 9 wherein said intra-arterial occluder is resiliently expandable from a collapsed state into a circular disc shape.

11. A sealing device as set forth in claim 8 wherein said guide wire includes a portion containing a row of saw teeth and said extra-arterial occluder is slidably mounted on said guide wire to pass over said portion in a direction towards said intra-arterial occluder and to be retained against movement in an opposite direction.

12. A sealing device as set forth in claim 8 wherein each occluder and guide is bioabsorbable.

13. A sealing device comprising

a collapsible intra-arterial occluder for positioning in a vessel to one side of an opening therein;

a guide means extending centrally from said occluder for passage through the opening in the vessel and including a portion containing a row of saw teeth; and

an extra-arterial occluder movably mounted on said guide for positioning on an opposite side of the opening in the vessel, said extra-arterial occluder being slidably mounted on said guide means to pass over said portion in a direction towards said intra-arterial occluder and to be retained against movement in an opposite direction.

14. A sealing device comprising

a collapsible intra-arterial occluder of bioabsorbable material for positioning in a vessel to one side of an opening therein;

a guide means of bioabsorbable material extending centrally from said occluder for passage through the opening in the vessel; and

an extra-arterial occluder of bioabsorbable material movably mounted on said guide means for positioning on an opposite side of the opening in the vessel.

15. A sealing device for sealing an opening in a vessel comprising

a first circumferentially collapsible bioabsorbable member for positioning in a vessel to one side of an opening therein;

a guide means with and extending centrally from said member for passage through the opening in the vessel; and

a second circumferentially collapsible member movably mounted on said guide for positioning outside a vessel on an opposite side of an opening therein and in opposition to said first member to seal the opening.

16. A sealing device as set forth in claim 15 wherein said second member has a plurality of radially disposed struts for engaging tissue outside of the vessel to encourage circumferential opening of said second member.

17. A sealing device for sealing an opening in a vessel comprising

a first member made of at least one of a biocompatible material and a bioabsorbable material for positioning inn a vessel to one side of an opening therein for closing over the opening;

a guide means integral with and extending centrally from said member for passage through the opening in the vessel, said guide including a portion containing a plurality of saw teeth; and

a second member made of at least one of a biocompatible material and a bioabsorbable material movably mounted on said guide means for positioning outside a vessel on an opposite side of an opening therein and in opposition to said first member to seal the opening, said second member having a slower rate of absorption than said second member and said guide means, said first member being slidably mounted on said guide means to pass over said portion in a direction towards said first member and to be retained against movement in an opposite direction by said saw teeth.

18. A sealing device for sealing an opening in a vessel comprising

a first member of bioabsorbable material for positioning in a vessel to one side of an opening therein;

a guide means of bioabsorbable material extending centrally from said member for passage through the opening in the vessel; and

a second member of bioabsorbable material mounted on said guide means for positioning outside the vessel on an opposite side of the opening therein an din opposition to said first member to seal the opening, said second member having a slower rate of absorption than said first member.

19. In combination,

a first occluder for positioning in a vessel to one side of an opening therein;

a guide extending from said occluder;

a tool having a barrel;

a positioner member slidably mounted in said barrel to define a chamber at one end thereof, said member having a bore extending longitudinally therethrough and having said guide extending therethrough;

a clamp for clamping said guide relative to said barrel;

means for moving said positioner member in a direction out of said barrel; and

a second occluder received in said chamber of said barrel in slidably mounted relation on said guide for movement along said guide in response to movement of said member in said barrel.

20. The combination as set forth in claim 19 wherein said tool includes a force gauge on said barrel for indicating a degree of pressure exerted via said clamp guide to said first occluder during movement of said positioner member relative thereto.

21. The combination as set forth in claim 19 wherein said tool includes a cutting means on said positioner member for severing the guide within said positioner member in response to retraction of said member into said barrel.

22. The combination as set forth in claim 19 wherein said tool includes a handle having said barrel mounted thereon, and a trigger pivotally mounted on said handle with one end within said barrel for actuating said means to push said positioner member relative to said barrel.

23. The combination as set forth in claim 22 which further comprises means articulated between said trigger and said clamp for actuating said clamp in response to pivoting of said trigger to clamp said guide therein.

24. The combination as set forth in claim 22 wherein said trigger has a recess at one end and said means for moving includes an extension on said positioner member having an enlarged head received in said recess.

25. A seal insertion tool comprising

a barrel;

a positioner member slidably mounted in said barrel to define a chamber at one end of said barrel for receiving an extra-arterial occluder therein, said member being hollow to define a bore for passage of an elongated guide therethrough;

a handle at one end of said barrel;

a trigger pivotally mounted on said handle and having one end disposed in said barrel;

means in said barrel between said one end of said trigger and said positioner member for pushing said member in a direction out of said barrel in response to pivoting of said one end of said trigger towards said member to expel an extra-arterial occluder therefrom; and

a clamp in said handle for passage of the elongated guide therethrough and for selectively clamping the elongated guide in response to pivoting of said trigger and prior to movement of said positioner member in said barrel.

26. A tool as set forth in claim 25 which further comprises a force gauge on said barrel for indicating a degree of pressure exerted via said clamped guide onto an intra arterial occluder positioned on one side of a puncture during movement of said positioner member relative thereto.

27. A tool as set forth in claim 25 which further comprises a cutting means for severing the guide within said positioner member in response to retraction of said member into said barrel.

28. A tool as set forth in claim 27 wherein said cutting means includes a pair of pincers in said positioner member disposed on opposite sides of said bore, a cam surface on said member and a cam on said barrel for slidably engaging said cam surface to radially deform said member to effect closing of said pincers together to sever the guide therebetween.

29. A tool as set forth in claim 28 wherein said member has a flexible distal portion containing said pincers therein.

30. A tool as set forth in claim 25 wherein said trigger has a recess at said one end and said means for pushing includes an extension on said positioner member having an enlarged head received in said recess.

31. A tool for inserting an arterial wound puncture seal device, said tool comprising

a barrel;

a positioner member slidably mounted in said barrel to define a chamber at one end of said barrel for receiving an extra-=arterial occluder having a bore therein, said member defining a bore for passage of an elongated guide extending from an intra-arterial occluder positioned on one side of the puncture;

means for pushing said member in a direction out of said barrel to expel the extra-arterial occluder along the elongated guide passing therethrough to a position on an opposite side of the puncture from the intra-arterial occluder;

a clamp for selectively clamping the guide passing therethrough prior to movement of said positioner member relative to said barrel; and

a force gauge for indicating a degree of pressure exerted on a clamped guide during movement of said positioner member relative to the guide on said barrel.

32. A tool as set forth in claim 31 which further comprises a cutting means for severing the guide within said positioner member after implantation of the extra-arterial occluder.

33. A tool for inserting an arterial wound puncture seal device, said tool comprising

a barrel;

a positioner member slidably mounted in said barrel to define a chamber at one end of said barrel for receiving an extra-arterial occluder having a bore therein, said member defining a bore for passage of an elongated guide extending from an intra-arterial occluder positioned on one side of a puncture;

means for pushing said member in a direction out of said barrel to expel the extra-arterial occluder along the elongated guide passing therethrough to a position on an opposite side of the puncture from the intra-arterial occluder; and

a cutting means for severing the guide on said positioner member after implantation of the extra-arterial occluder.

34. A seal insertion tool for sealing a puncture comprising

a barrel for receiving an elongated guide extending from a first occluder disposed on one side of a puncture and with said guide passing through the puncture;

a positioner member slidably mounted in said barrel for abutting a second occluder thereat, said member being hollow to define a bore for passage of the guide therethrough;

a handle at one end of said barrel;

a trigger pivotally mounted on said handle and having one end disposed in said barrel;

means in said barrel between said one end of said trigger and said positioner member for pushing said member in a direction out of said barrel and along the elongated guide in response to pivoting of said one end of said trigger towards said member to expel the second occluder therefrom;

a clamp in said handle for passage of the elongated guide therethrough and for selectively clamping the elongated guide in response to pivoting of said trigger and prior to movement of said positioner member in said barrel; and

a force gauge for indicating a degree of pressure exerted via said clamped guide onto the first occluder during movement of said positioner member relative thereto.

35. A tool as set forth in claim 34 which further comprises a cutting means for severing the guide within said positioner member in response to retraction of said member into said barrel.

36. A method of sealing an arterial wound puncture comprising the steps of

passing a resiliently expandable intra-arterial occluder through a percutaneous sheath into a lumen of an artery, said occluder having an elongated guide extending therefrom;

removing the sheath from the artery;

pulling the occluder against an inside wall of the artery over a puncture therein;

passing the elongated guide through an extra-arterial occluder nested in a chamber of an insertion tool and through a barrel of the tool while sliding the tool over the guide to position the tool opposite the artery;

thereafter clamping the guide within the tool;

thereafter expelling the extra-arterial occluder from the tube and along the guide to position the extra-arterial occluder outside the artery on a side of the puncture opposite the intra-arterial occluder; and

thereafter severing the guide within the tool at a point spaced from the extra-arterial occluder.