Method for vessel access closure

• US 9,439,635 B2
• Filed: 08/08/2011
• Issued: 09/13/2016
• 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): Templeton, Christopher L
• Application Number:
  US13/205,482
• Publication Number:
  US 20120083829A1
• Time in Patent Office: 1,863 Days
• Field of Search: 606/213, 604/164.04, 604/174, 600/434
• US Class Current: 1/1
• 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
• 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 for closing a hole in a wall of a vessel, the vessel defining a vascular lumen, comprising:

a. inserting a guidewire having proximal and distal ends through the hole and into said lumen;

b. inserting over the guidewire and through the hole (i) an elongate deployment member housing an implantable closure device having proximal and distal ends and being expandable from a collapsed state to an expanded state, the expanded state providing a geometry sufficient to substantially occlude the hole and (ii) then first inserting the distal end of said closure device through said hole and into said lumen until the proximal end of said closure device passes through said hole and into said lumen;

c. positioning the collapsed state of the implantable closure device adjacent the wall of the vessel in a configuration wherein the collapsed implantable closure device spans the hole from within the vascular lumen;

d. deploying a catch member configured to extend away from the proximal end of the closure device to prevent withdrawal of the closure device in its collapsed state through the hole;

e. expanding the implantable closure device from the collapsed state to the expanded state by decoupling the implantable closure device from the deployment member;

f. controllably moving the catch member to a retracted configuration wherein the catch member is moveably coupled to and substantially aligned with the deployment member; and

g. withdrawing said deployment member out through the hole and leaving behind said closure device.

2. The method of claim 1, further comprising inserting an introducer sheath through the hole, the introducer sheath defining an introducer lumen sized to accommodate insertion of the deployment member and the closure device in its collapsed state.

3. The method of claim 1, wherein said deployment member has a proximal portion configured for manual manipulation and a distal portion configured to be removably coupled to the implantable closure device.

4. The method of claim 1, further comprising rotating the collapsed closure device relative to the deployment member to place the closure device into a deployment position having a rotated orientation selected to prevent withdrawal of the closure device back out of the hole when the deployment member is withdrawn.

5. The method of claim 4, further comprising selecting the deployment position based at least in part upon an indication from a bleedback indicator channel.

6. The method of claim 1, further comprising urging the expanded implantable closure device toward the hole, wherein the expanded state is configured to contact at least 90 degrees of an inner surface of the vessel adjacent the hole relative to a longitudinal axis of the vascular lumen, and to restrict fluids from exiting the vascular lumen through the hole.

7. The method 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.

8. The method of claim 7, wherein a deployment tensile element is removably coupled to said closure device and said expanding step comprises moving a portion of the deployment tensile element relative to the self expanding structure to allow the self expanding structure to expand itself to the expanded state.

9. The method of claim 1, wherein the closure device expanded state forms a substantially tubular shape defining a lumen therethrough.

10. The method of claim 1, wherein controllably moving the catch member comprises manually advancing or retracting the catch member relative to the deployment member.

11. The method of claim 10, wherein the catch member is cantilevered and 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 catch member into alignment with the advanceable portion.

12. The method of claim 11, 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 of the advanceable portion and is directed away from the deployment member at the coupling point through an aperture in the deployment member.

13. A method for closing a hole in a vessel, the vessel defining a vascular lumen, comprising:

a. inserting a guidewire through the hole and into said lumen;

b. inserting over said guidewire and through the hole an introducer sheath defining an introducer lumen;

c. inserting through the introducer lumen a closure assembly comprising an implantable closure device and a delivery sheath, wherein the implantable closure device has proximal and distal ends and is expandable from a collapsed state to an expanded state, the expanded state providing a geometry sufficient to substantially occlude the hole, and wherein the delivery sheath is configured to at least partially removably encapsulate the implantable closure device;

d. monitoring a position of the implantable closure device based upon an indication from a bleedback indicator channel;

e. controllably withdrawing the delivery sheath relative to the implantable closure device while maintaining the position of the implantable closure device to facilitate expandability of the implantable closure device from the collapsed state to the expanded state;

f. deploying a catch member configured to extend proximally away from the proximal end of the implantable closure device by a catch member length selected to extend within the vascular lumen to prevent withdrawal of the collapsed state of the closure device back through the hole;

g. urging the collapsed state of the implantable closure device against the hole;

h. controllably expanding the implantable closure device from the collapsed state to the expanded state; and

i. moving said catch member to a non-deployed position and removing said delivery sheath and said catch member from said vascular lumen; and

j. controllably decoupling the delivery sheath from the implantable closure device and removing the delivery sheath proximally through the introducer lumen.

14. The method of claim 13, wherein a second catch member is provided which can be deployed to extend away from the distal end of said closure device.

15. The method of claim 13, wherein said delivery sheath comprises a foot member which has a lumen and said guidewire is passed through the lumen in said foot member.

16. A method for closing a hole in a wall of a vessel, the vessel defining a vascular lumen, comprising:

a. inserting a guidewire having proximal and distal ends through the hole and into said lumen;

b. inserting over the guidewire and through the hole (i) an elongate deployment member housing an implantable closure device having proximal and distal ends and being expandable from a collapsed state to an expanded state, the expanded state providing a geometry sufficient to substantially occlude the hole and (ii) then first inserting the distal end of said closure device through said hole and into said lumen until the proximal end of said closure device passes through said hole and into said lumen;

c. positioning the collapsed state of the implantable closure device adjacent the wall of the vessel in a configuration wherein the collapsed implantable closure device spans the hole from within the vascular lumen;

d. deploying a catch member configured to extend away from the proximal end of the closure device to prevent withdrawal of the closure device in its collapsed state through the hole;

e. expanding said closure device;

f. withdrawing said deployment member and leaving behind said closure device and at least a distal portion of said guidewire;

g. controllably moving the catch member to a retracted configuration wherein the catch member is movably coupled to and aligned with the deployment member;

h. wherein controllably moving the catch member comprises manually advancing or retracting the catch member relative to the deployment member; and

i. wherein the catch member is cantilevered and 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 catch member into alignment with the advanceable portion with increased advancement of the advanceable portion; and

j. 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 of the advanceable portion and is directed away from the deployment member at the coupling point through an aperture in the deployment member.