Apparatus and methods for sealing a vascular puncture

• US 8,029,533 B2
• Filed: 04/04/2008
• Issued: 10/04/2011
• Est. Priority Date: 04/04/2008
• Status: Active Grant

• Current Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Original Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Inventors: Bagaoisan, Celso J., Duong, Sieu
• Primary Examiner(s): Erezo; Darwin
• Assistant Examiner(s): Dornbusch; Dianne
• Application Number:
  US12/098,380
• Publication Number:
  US 20090254110A1
• Time in Patent Office: 1,278 Days
• Field of Search: 606/213, 604/96.01, 604506-510, 604/513, 604/104
• 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 17/12136 Balloons
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2090/0807 Indication means

Abstract

An apparatus for sealing a puncture includes a positioning member including a proximal end, a distal end sized for insertion into a puncture, an expandable element on the distal end, and a tension indicator on the proximal end. The tension indicator includes a distal housing portion fixed relative to the proximal end, and a proximal housing portion or handle movable proximally relative to the distal housing portion. The handle is biased towards the distal housing portion such that, when sufficient tensile force is applied between the expandable element and the handle, the handle moves away from the distal housing portion. During use, the distal end is introduced through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is applied.

Claims

1. A system for sealing a puncture extending through tissue, comprising:

an introducer sheath comprising a proximal end, a distal end sized for insertion through a puncture, and a lumen extending between the proximal and distal ends;

an elongate positioning member sized for insertion into the introducer sheath lumen and having an expandable element on a distal end thereof and a tension indicator on a proximal end thereof; and

wherein the tension indicator comprises a distal housing portion substantially fixed on the positioning member proximal end, and a proximal housing portion movable proximally relative to the distal housing portion, the proximal housing portion biased distally towards the distal housing portion.

2. The system of claim 1, further comprising a biasing element for biasing the proximal housing portion distally towards the distal housing portion.

3. The system of claim 2, wherein the biasing element is configured to allow the proximal housing portion to separate from the distal housing portion when the biasing element is deformed, thereby creating a space between the proximal and distal housing portions that provides a visual indicator that a desired force is being applied between the positioning member distal end and the proximal housing portion.

4. The system of claim 2, wherein the biasing element comprises a spring having a spring constant set to allow movement of the proximal housing portion relative to the distal housing portion when a desired tension is applied when the expandable element, in an expanded position, is pulled against a wall of a body lumen sufficient to substantially seal the body lumen from the puncture while avoiding substantial tenting of the wall of the body lumen.

5. The system of claim 2, wherein the biasing element extends between a retaining ring substantially fixed relative to the distal housing portion and a shoulder portion of the proximal housing portion such that the biasing element is compressible between the retaining ring and the shoulder for biasing the proximal housing portion towards the distal housing portion.

6. The system of claim 5, wherein the biasing element comprises a spring disposed around a sleeve on the distal housing portion.

7. The system of claim 6, wherein the sleeve is disposed around an internal cylindrical element and the internal cylindrical element and the sleeve are coupled to the retaining ring.

8. The system of claim 1, wherein the proximal housing portion is shaped to provide a handle on the proximal end.

9. The system of claim 1, further comprising:

a tubular member carried on the positioning member, the tubular member comprising a proximal end, a distal end sized for insertion into a puncture, and a lumen extending between the tubular member proximal and distal ends;

a sealant disposed within the tubular member lumen; and

a pusher member disposed within the tubular member lumen for deploying the sealant distally from the tubular member lumen when the tubular member is retracted proximally relative to the pusher member.

10. A tension indicator apparatus for providing temporary hemostasis within a puncture extending through tissue to a body lumen, comprising:

an elongate member comprising a proximal end and a distal end sized for introduction into a puncture;

an expandable element on the distal end sized for introduction into a puncture in a collapsed condition, the expandable element being larger than the puncture in an expanded condition; and

a tension indicator on the proximal end for indicating when a desired tensile force between the distal end and the tension indicator is applied; and

wherein the tension indicator comprises a distal housing portion substantially fixed on the proximal end and a proximal housing portion movable proximally relative to the distal housing portion, the proximal housing portion biased distally towards the distal housing portion.

11. The tension indicator apparatus of claim 10, further comprising a biasing element for biasing the proximal housing portion distally towards the distal housing portion.

12. The tension indicator apparatus of claim 11, wherein the biasing element comprises a spring having a spring constant set to allow separation of the proximal housing portion from the distal housing portion when a desired tension is applied when the expandable element, in an expanded position, is pulled against a wall of a body lumen sufficient to substantially seal the body lumen from the puncture while avoiding substantial tenting of the wall of the body lumen.

13. The tension indicator apparatus of claim 11, wherein the biasing element comprises a spring having a spring constant set to allow separation of the proximal housing portion from the distal housing portion to prevent excessive force being applied by the expandable element when the expandable element, in an expanded position, is pulled against a wall of a body lumen to substantially seal the body lumen from the puncture.

14. The tension indicator apparatus of claim 10, further comprising a space created when the proximal housing portion is separated from the distal housing portion, the space providing a visual cue that a desired amount of tension is being applied to the positioning member.

15. The tension indicator apparatus of claim 10, wherein the expandable element comprises a balloon, and wherein the proximal end comprises a chamber communicating with an interior of the balloon via a lumen extending between the proximal and distal ends.

16. The tension indicator apparatus of claim 15, wherein the distal housing portion is substantially fixed relative to the chamber, and wherein the proximal housing portion is movable proximally relative to the chamber.

17. A system for sealing a puncture extending through tissue, comprising:

an elongate positioning member comprising a proximal end, a distal end sized for insertion into a puncture extending through tissue, an expandable element on a distal end thereof, and a housing on the proximal end, the housing comprising a first housing portion substantially fixed on the proximal end, and a second housing portion movable relative to the first housing portion to allow the second housing portion to separate from the first housing portion biased distally towards the first housing portion, thereby providing a visual indicator that a desired force is being applied between the positioning member distal end and the second housing portion;

a tubular member carried on the positioning member, the tubular member comprising a proximal end, a distal end sized for insertion into a puncture, and a lumen extending between the tubular member proximal and distal ends;

a sealant disposed within the tubular member lumen; and

a pusher member disposed within the tubular member lumen for deploying the sealant distally from the tubular member lumen when the tubular member is retracted proximally relative to the pusher member.

18. The system of claim 17, further comprising a biasing element for biasing the second housing portion distally towards the first housing portion.

19. The system of claim 18, wherein the biasing element is configured to allow the second housing portion to separate from the first housing portion when the biasing element is deformed, thereby creating a space between the first and second housing portions that provides the visual indicator that the desired force is being applied between the positioning member distal end and the proximal housing portion.

20. The system of claim 18, wherein the biasing element comprises a spring having a spring constant set to allow movement of the second housing portion relative to the first housing portion when a desired tension is applied when the expandable element, in an expanded position, is pulled against a wall of a body lumen sufficient to substantially seal the body lumen from the puncture while avoiding substantial tenting of the wall of the body lumen.

21. The system of claim 18, wherein the biasing element extends between a retaining ring substantially fixed relative to the first housing portion and a shoulder portion of the second housing portion such that the biasing element is compressible between the retaining ring and the shoulder for biasing the second housing portion towards the first housing portion.

22. The system of claim 17, wherein the second housing portion is shaped to provide a handle on the proximal end.

23. The system of claim 17, wherein the expandable element comprises a balloon, and wherein the housing comprises a chamber communicating with an interior of the balloon via a lumen extending between the proximal and distal ends of the positioning member.

24. The system of claim 23, wherein the expandable element comprises a balloon, and wherein the system further comprises a source of inflation media coupled to the first housing portion for expanding the balloon.