System and method for vessel access closure

• US 10,039,535 B2
• Filed: 12/21/2010
• Issued: 08/07/2018
• Est. Priority Date: 02/26/2010
• Status: Active Grant

• 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): SCHERBEL, TODD J
• Application Number:
  US12/974,543
• Publication Number:
  US 20110288580A1
• Time in Patent Office: 2,786 Days
• Field of Search: 606213, 606215, 606151, 606153, 606191, 606194
• 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. An apparatus for closing a hole in a vessel comprising:

(a) a closure device that is insertable into the vessel through the hole, the closure device being expandable from a substantially cylindrical collapsed state to a substantially cylindrical expanded state when placed under tension at one or more locations at its periphery to a geometry sufficient to substantially occlude the hole;

(b) one or more tensioning members coupled to one or more peripheral locations on the closure device and capable of placing the closure device under tension at the peripheral locations to cause the closure device to expand into the substantially cylindrical expanded state; and

(c) a cinching member that engages the one or more tensioning members and is capable of causing them to put the closure device under tension at said peripheral locations and expand to the geometry whereby the hole is substantially occluded and to maintain said closure device in the expanded state.

2. The apparatus of claim 1, wherein the closure device comprises a substantially rectangular sheetlike member.

3. The apparatus of claim 2, wherein corners of the rectangular sheetlike member are rounded to an atraumatic radius of curvature.

4. The apparatus of claim 2, wherein the collapsed state comprises a rolled-up configuration.

5. The apparatus of claim 2, wherein the expanded state comprises an at least partially cylindrical configuration.

6. The apparatus of claim 5, wherein the vessel is a hollow cylinder having an inner circumference at the location of the hole and the at least partially cylindrical configuration has an arc length dimension less than the inner circumference of the vessel at the hole.

7. The apparatus of claim 6, wherein the arc length dimension is equal to about half of the inner circumference of the vessel.

8. The apparatus of claim 2, comprising a single tension member fixedly coupled to one margin of the substantially rectangular sheetlike member, and slidably coupled to an opposite margin of the substantially rectangular sheetlike member.

9. The apparatus of claim 2, comprising two separate tension members, a first fixedly coupled to one margin of the substantially rectangular sheetlike member, and a second fixedly coupled to an opposite margin of the substantially rectangular sheetlike member.

10. The apparatus of claim 2, comprising four separate tension members, each of which is coupled to a location substantially adjacent a corner of the substantially rectangular sheetlike member.

11. The apparatus of claim 1, wherein the one or more tension members comprise sutures.

12. The apparatus of claim 1, wherein the cinching member comprises a housing through which the one or more bioresorbable tension members may be passed and captured.

13. The apparatus of claim 12, wherein the cinching member comprises a one-way tension member movement lock.

14. The apparatus of claim 1, wherein an elongate delivery member comprising a tubular member defining a delivery lumen is removably coupled to the closure device.

15. The apparatus of claim 14, wherein the delivery lumen is sized to accommodate at least partial removable encapsulation of a portion of the closure device in its collapsed state.

16. The apparatus of claim 1, further comprising a tether tensile member comprising a distal end fixedly coupled to the closure device and a proximal end configured to be tensioned from an extracorporeal location to urge the closure device against an inside surface of the vessel.

17. The apparatus of claim 1, further comprising an introducer sheath having a distal end configured to be passed through the hole, the introducer sheath defining an introducer lumen sized to accommodate passage of the collapsed state of the closure device through the hole and into a vascular lumen defined by the vessel.

18. The apparatus of claim 1 wherein said closure device comprises an expandable frame coupled to a sheetlike member.

19. The apparatus of claim 1 wherein said closure device is bioresorbable.

20. The apparatus of claim 19, wherein the bioresorbable closure device comprises a material selected from the group consisting of:

polylactic acid, poly glycolic acid, poly-lactic-co-glycolic acid, copolymers of any of the above, porcine submucosa, and equine submucosa.

21. The apparatus of claim 1 wherein said one or more tensioning members are bioresorbable.

22. The apparatus of claim 21, wherein the one or more bioresorbable tension members comprise a material selected from the group consisting of:

polylactic acid, poly glycolic acid, poly-lactic-co-glycolic acid, and copolymers of any of the above.

23. The apparatus of claim 1 wherein said cinching member is bioresorbable.

24. The apparatus of claim 23, wherein the bioresorbable cinching member comprises a material selected from the group consisting of:

polylactic acid, poly glycolic acid, poly-lactic-co-glycolic acid, and copolymers of an of the above.

25. In an apparatus for closing a hole in a vessel of the type comprising an expandable closure device configured to be inserted into the lumen of a blood vessel, the improvement comprising:

(a) the closure device being expandable from a substantially cylindrical collapsed state to a substantially cylindrical expanded state when placed under tension at one or more locations at its periphery to a geometry sufficient to substantially occlude the hole;

(b) one or more tensioning members coupled to one or more peripheral locations on the closure device and capable of placing the closure device under tension at the peripheral locations to cause the closure device to expand into the substantially cylindrical expanded state; and

(c) a cinching member that engages the one or more tensioning members and is capable of causing them to put the closure device under tension at said peripheral locations and expand to the geometry whereby the hole is substantially occluded and to maintain said closure device in the expanded state.

26. The apparatus of claim 25 wherein said closure device comprises an expandable frame coupled to a sheetlike member.

27. The apparatus of claim 25 wherein said closure device is bioresorbable.

28. The apparatus of claim 25 wherein said one or more tensioning members are bioresorbable.

29. The apparatus of claim 25 wherein said clinching member is bioresorbable.