Method for vessel access closure

• US 8,870,937 B2
• Filed: 07/21/2010
• Issued: 10/28/2014
• Est. Priority Date: 02/26/2010
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Promed, Inc.
• Inventors: Ginn, Richard S., Domingo, Nicanor, Valencia, Hans F., DeCou, Robert Elliott, Yerby, Scott
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US12/841,052
• Publication Number:
  US 20110213410A1
• Time in Patent Office: 1,560 Days
• Field of Search: 606/213, 623/1.1, 623 111- 114, 623/1.18, 623/1.2, 623/1.21
• US Class Current: 623/1.12
• 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 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Claims

1. A method of closing an opening in the wall of a blood vessel comprising:

introducing a deployment assembly through an introducer into the opening, wherein the deployment assembly comprises a restraining member, a foot member, a collapsed closure device removably coupled to a distal end of the foot member, and a control member which passes through said foot member and is attached to said closure device;

retracting the restraining member, thereby exposing the distal end of the foot member;

activating said control member thereby controllably causing the foot member to flex, and thereby causing the closure device removably coupled thereto, to rotate within the blood vessel to a rotated orientation;

decoupling the closure device from the distal end of the foot member, wherein at least a portion of the closure device is positioned adjacent to the opening; and

retracting the deployment assembly.

2. The method of claim 1, wherein the closure device is removably coupled to the foot member with a first tether.

3. The method of claim 2, further comprising tensioning the first tether to urge the closure device against the vessel wall adjacent the opening.

4. The method of claim 2 wherein said first tether is looped around the closure device and is provided with a restraining knot.

5. The method of claim 4, comprising decoupling the closure device from the foot member by pulling the first tether in a proximal direction.

6. The method of claim 5, wherein pulling the first tether unties a restraining knot.

7. The method of claim 6, wherein the restraining knot is a highwayman'"'"'s hitch.

8. The method of claim 1, wherein said foot member is provided with a crease to create a bending axis.

9. The method of claim 1, wherein said control member is a second tether, and further comprising applying a tensile load to said second tether to flex said foot member and to move the closure device to the rotated orientation.

10. The method of claim 1, wherein the restraining member comprises an elongate sheath.

11. The method of claim 1, further comprising leaving behind the closure device and the control member after withdrawing the deployment assembly.

12. The method of claim 1, wherein the closure device has a proximal end, a distal end, and a longitudinal length therebetween, the distal end being inserted most distally past the opening in the blood vessel, wherein the method further comprises positioning a portion of the closure device that lies in between the proximal and distal ends of the closure device against the opening in the blood vessel after rotating the closure device to the rotated orientation.

13. The method of claim 12, wherein the longitudinal length of the closure device is larger than a diameter of the opening in the blood vessel, such that after rotating the closure device to the rotated orientation, the closure device is geometrically prevented from exiting the opening.

14. The method of claim 1 wherein the control member is bioabsorbable.

15. A method of closing an opening in the wall of a blood vessel comprising:

introducing a deployment assembly through an introducer into the opening, wherein the deployment assembly comprises a restraining member, a foot member which is restrained by said restraining member and which is prebiased to flex when not restrained by said restraining member, a collapsed closure device removably coupled to a distal end of the foot member and a control member which passes through said foot member and is attached to said closure device;

retracting the restraining member, thereby exposing the distal end of the foot member thereby allowing the foot member to flex and activating said control member thereby controllably assisting said foot member to flex, and thereby causing the closure device removably coupled thereto, to rotate within the blood vessel to a rotated orientation;

decoupling the closure device from the distal end of the foot member, wherein at least a portion of the closure device is positioned adjacent to the opening; and

retracting the deployment assembly.

16. The method of claim 15, wherein said foot member is removably coupled to said closure device by a first tether.

17. The method of claim 16, further comprising tensioning the first tether to urge the closure device against the vessel wall adjacent the opening.

18. The method of claim 16, comprising decoupling the closure device from the foot member by pulling the first tether in a proximal direction.

19. The method of claim 18 wherein pulling the first tether element unties a restraining knot.

20. The method of claim 19, wherein the restraining knot is a highwayman'"'"'s hitch.

21. The method of claim 15 wherein said control member is a second tether and further comprising applying a tensile load to said second tether to assist in flexing said foot member and in moving the closure device to the rotated orientation.

22. The method of claim 15, wherein the restraining member comprises an elongate sheath.

23. The method of claim 15, wherein the closure device has a proximal end, a distal end, and a longitudinal length therebetween, the distal end being inserted most distally past the opening in the blood vessel, wherein the method further comprises positioning a portion of the closure device that lies in between the proximal and distal ends of the closure device against the opening in the blood vessel after rotating the closure device to the rotated orientation.

24. The method of claim 23, wherein the longitudinal length of the closure device is larger than a diameter of the opening in the blood vessel, such that after rotating the closure device to the rotated orientation, the closure device is geometrically prevented from exiting the opening.

25. The method of claim 15, further comprising leaving behind the closure device and the control member after withdrawing the deployment assembly.

26. The method of claim 15 wherein the control member is bioabsorbable.