Apparatus and methods for sealing a vascular puncture

• US 10,595,838 B2
• Filed: 02/26/2014
• Issued: 03/24/2020
• 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): Dornbusch, Dianne
• Application Number:
  US14/191,237
• Publication Number:
  US 20140180334A1
• Time in Patent Office: 2,218 Days
• Field of Search: 606213, 604 9601, 604506-510, 604513, 604104
• 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through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is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 elongate positioning member comprising a proximal end, a distal end sized for insertion into a puncture extending through tissue, and a positioning element on the distal end;

a single housing on the positioning member proximal end, the single housing comprising a first portion substantially fixed to the proximal end of the elongate positioning member, a second portion movable relative to the first portion from a first position to a second position upon contact to a blood vessel by the positioning element and biased towards the first position, and a visual indicator that indicates that a force being applied to a blood vessel by the positioning element is within a predetermined range when the second portion is in the second position; and

a sealant disposed near the distal end of the elongate positioning member and proximal to the positioning element.

2. 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.

3. The system of claim 2, further comprising 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.

4. The system of claim 1, further comprising a biasing element within an interior of the second portion for biasing the second portion towards the first position.

5. The system of claim 1, wherein the first position is a distal position and the second position is a proximal position, wherein the second portion is closer to the positioning element in the first position than in the second position.

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

7. The system of claim 1, wherein the positioning element comprises an expandable member.

8. The system of claim 7, wherein the expandable member 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.

9. 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 a proximal end, a distal end, and a positioning element on the distal end thereof; and

a tension indicator comprising a first portion substantially fixed to the positioning member proximal end, a second portion slideable from a first position to a second position along the first portion upon contact to a blood vessel by the positioning element and biased towards the first position, and a marker that provides a visual indication that a desired force is being applied to a blood vessel by the positioning element when the second portion is in the second position.

10. The system of claim 9, further comprising a biasing element within an interior of the second portion for biasing the second portion towards the first position.

11. The system of claim 9, wherein the first position is a distal position and the second position is a proximal position, wherein the second portion is closer to the positioning element in the first position than in the second position.

12. The system of claim 9, wherein the second portion is shaped to provide a handle on the proximal end.

13. The system of claim 9, wherein the positioning element comprises an expandable member.

14. The system of claim 13, wherein the expandable member comprises a balloon.

15. The system of claim 9, 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.

16. 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;

a positioning element on the distal end sized for introduction into a puncture in a collapsed condition; and

a tension indicator comprising a first portion substantially fixed to the elongate member proximal end, a second portion slideable from a first position to a second position along the first portion upon contact to a vessel by the positioning element and biased towards the first position, and a visual indicator that indicates that a desired force is being applied to the blood vessel by the positioning element when the second portion is in the second position.

17. The apparatus of claim 16, further comprising a biasing element within an interior of the second portion for biasing the second portion towards the first position.

18. The apparatus of claim 16, wherein the first position is a distal position and the second position is a proximal position, wherein the second portion is closer to the positioning element in the first position than in the second position.

19. The apparatus of claim 16, wherein the second portion is shaped to provide a handle on the proximal end.

20. The apparatus of claim 16, wherein the positioning element comprises an expandable member.