METHOD FOR VESSEL ACCESS CLOSURE

• US 20110213410A1
• Filed: 07/21/2010
• Published: 09/01/2011
• Est. Priority Date: 02/26/2010
• Status: Active Grant

• Current Assignee: Promed, Inc.
• Original Assignee: Promed, Inc.
• Inventors: VALENCIA, HANS F., DOMINGO, NICANOR, GINN, RICHARD S., DECOU, ROBERT ELLIOTT, YERBY, SCOTT
• Granted Patent: US 8,870,937 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. A method of closing a hole formed in a wall of a blood vessel, comprising:

a. inserting a closure device through the hole using a deployment member to which the closure device is removably coupled;

b. controllably moving the collapsed closure device relative to the deployment member to place the closure device into a geometric configuration selected to prevent withdrawal of the closure device back out of the hole; and

c. decoupling the closure device from the deployment member.

2. The method of claim 1, further comprising expanding the closure device from a collapsed state to an expanded state after inserting the closure device through the hole.

3. The method of claim 1, wherein controllably moving comprises rotating the collapsed closure device relative to the deployment member to place the closure device into a rotated orientation selected to prevent withdrawal of the closure device back out of the hole when the deployment member is withdrawn.

4. The method of claim 1, wherein controllably moving comprises translating the collapsed closure device relative to the deployment member to place the closure device into compression against a portion of the deployment member.

5. The method of claim 4, wherein the compression causes the collapsed closure device to controllably rotate to a rotated orientation selected to prevent withdrawal of the closure device back out of the hole when the deployment member is withdrawn.

6. The method of claim 5, further comprising applying a tensile load to a portion of the collapsed closure device to assist in moving the device to the rotated orientation.

7. The method of claim 3, wherein rotating comprises moving a restraining member relative to the closure device.

8. The method of claim 7, wherein the restraining member comprises an elongate sheath defining a sheath lumen through which at least a portion of the closure device is positioned before said rotating and wherein moving comprises translating the sheath relative to the closure device.

9. The method of claim 7, wherein the closure device is biased to rotate to the rotated orientation upon moving of the restraining member, and wherein causing the closure device to rotate comprises moving the retraining member.

10. The method of claim 7, wherein rotating the collapsed closure device comprises allowing a spring-loaded assembly to rotate the scaffold.

11. The method of claim 10, wherein the spring-loaded assembly comprises an elongate bending spring member, and rotating the collapsed closure device comprises allowing the elongate bending spring member to rotate the collapsed closure device.

12. The method of claim 10, wherein the spring-loaded assembly comprises a compression spring member, and rotating the collapsed closure device comprises allowing the compression spring member to rotate the collapsed closure device.

13. The method of claim 3, wherein rotating comprises manually manipulating an actuation assembly coupled to the deployment member.

14. The method of claim 13, wherein manually manipulating comprises loading a tensile element coupled to the closure device.

15. The method of claim 13, wherein manually manipulating comprises loading a compressive member coupled to the closure device.

16. The method of claim 1, wherein decoupling comprises pulling a tensile element that is looped around the closure device.

17. The method of claim 16, wherein pulling the tensile element unties a restraining knot tied to keep the tensile element looped around the closure device.

18. The method of claim 3, further comprising controllably expanding the scaffold from a first compressed configuration to a second expanded configuration after inserting through the hole.

19. The method of claim 18, wherein the closure device is controllably expanded after it is rotated to the rotated orientation.

20. The method of claim 3, wherein the closure device has proximal and distal ends and a longitudinal length in a direction parallel to a longitudinal axis of the closure device, the distal end being inserted most distally past the hole 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 hole in the blood vessel after rotating the closure device to the rotated orientation.

21. The method of claim 20, wherein the longitudinal length of the closure device is larger than a diameter of the hole in the blood vessel, such that after rotating the closure device to the rotated orientation, the closure device is geometrically prevented from exiting the arteriotomy.

22. The method of claim 20, further comprising tensioning a tether tensile element, which is coupled to the closure device adjacent to the position wherein the closure device is positioned against the hole in the blood vessel, to urge the closure device against the vessel wall adjacent the hole.

23. The method of claim 22, further comprising withdrawing the deployment member and leaving behind only the closure device and tether tensile element.

24. The method of claim 1, further comprising inserting an introducer sheath defining an introducer lumen sized to accommodate insertion of the closure device and deployment member.