SYSTEM AND METHOD FOR VESSEL ACCESS CLOSURE

• US 20110295316A1
• Filed: 12/21/2010
• Published: 12/01/2011
• Est. Priority Date: 02/26/2010
• Status: Active Grant

• Current Assignee: Promed, Inc.
• Original Assignee: Promed, Inc.
• Inventors: DeCou, Robert Elliott, Ginn, Richard S., Yerby, Scott, Valencia, Hans F., Domingo, Nicanor
• Granted Patent: US 8,906,080 B2
• Time in Patent Office: Days
• 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 2017/00592 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 deployment member having proximal and distal ends;

b. an implantable closure device having proximal and distal ends, the implantable device being removably coupled to the distal end of the delivery member and being expandable from a collapsed state to an expanded state after the implantable device is inserted through the hole into a lumen defined by the vessel, the expanded state providing a geometry sufficient to substantially occlude the hole; and

c. a catch member coupled to the delivery member and configured to extend away from the proximal end of the implantable device by a catch member length, wherein the catch member length is selected to extend within the lumen to prevent withdrawal of the implantable closure device back through the hole.

2. The apparatus of claim 1, wherein the deployment member has a proximal portion and a controllably movable distal portion, the distal portion being coupled to the closure device, wherein the distal portion may be moved from a first configuration wherein the distal portion is substantially aligned with the proximal portion, to a second configuration, wherein the distal portion is rotated relative to the proximal portion in a manner selected to prevent the closure device from exiting the opening in the blood vessel.

3. The apparatus of claim 2, wherein the controllably movable distal portion is biased to rotate to the second configuration when not constrained to remain in the first configuration.

4. The apparatus of claim 2, further comprising a rotation actuating member that may be utilized to apply a tensile load to the movable distal portion to cause the distal portion to rotate.

5. The apparatus of claim 1, wherein the closure device is a self expanding structure configured to expand itself from the collapsed state to the expanded state when not restrained in the collapsed state.

6. The apparatus of claim 5, wherein the closure device expanded state forms a generally cylindrical shape defining a lumen therethrough.

7. The apparatus of claim 1, wherein the closure device comprises a frame structure and a cover member coupled to the frame structure in at least one location, wherein the frame structure is configured to retain a position within the blood vessel in its expanded state, and wherein the cover member has a thickness and is configured to at least temporarily resist the flow of blood across the thickness.

8. The apparatus of claim 7, wherein the cover member has a length and width selected to cover substantially all of the frame structure when the closure device is in the collapsed state.

9. The apparatus of claim 7, wherein the frame structure comprises a metal selected from the group consisting of:

nitinol, stainless steel, cobalt chrome, titanium, nickel, gold, tantalum, and alloys thereof.

10. The apparatus of claim 7, wherein the frame structure comprises a polymer selected from the group consisting of:

silicone, polyethylene, polyurethane, polyester, polyglycolic acid, polylactic acid, poly-lactic-co-glycolic acid, and copolymers thereof.

11. The apparatus of claim 7, wherein the frame structure comprises a stent.

12. The apparatus of claim 7, wherein the cover member comprises a material selected from the group consisting of:

polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene terepthalate, polyester, polylactic acid, poly glycolic acid, poly-lactic-co-glycolic acid, fluorinated ethylene-propylene, silicone, polyethylene, polyurethane, copolymers of any of the above, porcine submucosa, and equine submucosa.

13. The apparatus of claim 1, further comprising a foot member having proximal and distal ends and a flexible portion therebetween, the flexible portion accommodating rotation of the distal end relative to the proximal end, wherein the distal end of the foot member is releasably coupled to the closure device, and wherein the proximal end of the foot member is coupled to the deployment member.

14. The apparatus of claim 13, wherein the flexible portion comprises a flexion feature selected from the group consisting of:

a hinge, a crease, a relatively elastic material portion, and a relatively elastic geometric portion.

15. The apparatus of claim 13, further comprising a rotation actuating member coupled to the distal end of the foot member, the rotation actuating member causing the distal end of the foot member to controllably rotate relative to the proximal end of the foot member.

16. The apparatus of claim 15, wherein the rotation actuating member comprises an elongate bending spring member coupled to the proximal and distal portions of the foot member.

17. The apparatus of claim 1, wherein the catch member is controllably and movably coupled to the delivery member such that it may be reconfigured from a deployed configuration, wherein it extends to prevent withdrawal of the implantable closure device, to a retracted configuration, wherein it is retracted back toward the delivery member to facilitate removal of the delivery member back through the hole.

18. The apparatus of claim 17, wherein the catch member comprises a cantilevered portion coupled to a manually advanceable portion, the advanceable portion being approximately aligned with a longitudinal axis of the deployment member and configured to pull the cantilevered portion into alignment with the advanceable portion with increased advancement of the advanceable portion.

19. The apparatus of claim 17, wherein the advanceable portion comprises proximal and distal ends, and wherein the catch member is coupled to the advanceable member at a coupling point in between the proximal and distal ends and is directed away from the deployment member at the coupling point through an aperture in the deployment member.

20. The apparatus of claim 17, wherein the catch member comprises a guidewire having a distal portion curved to bend proximally when the guidewire is advanced toward the distal end of the deployment member.

21. An apparatus for closing a hole in a vessel, comprising:

a. a deployment member having proximal and distal ends;

b. an implantable closure device having proximal and distal ends, the implantable device being removably coupled to the distal end of the delivery member and being expandable from a collapsed state to an expanded state after the implantable device is inserted through the hole into a lumen defined by the vessel, the expanded state providing a geometry sufficient to substantially occlude the hole; and

c. a catch member coupled to the implantable closure device and configured to extend away from the proximal end of the implantable closure device by a catch member length, wherein the catch member length is selected to extend within the lumen to prevent withdrawal of the implantable closure device back through the hole.

22. The apparatus of claim 21, wherein the catch member is fixedly attached to the implantable closure device.

23. The apparatus of claim 21, wherein the closure device comprises a frame structure and a cover member coupled to the frame structure in at least one location, wherein the frame structure is configured to retain a position within the blood vessel in its expanded state, and wherein the cover member has a thickness and is configured to at least temporarily resist the flow of blood across the thickness.

24. The apparatus of claim 23, wherein the catch member comprises a portion of the frame structure.