System and method for vessel access closure

• US 9,078,632 B2
• Filed: 08/08/2011
• Issued: 07/14/2015
• 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): Woo, Julian W
• Application Number:
  US13/205,528
• Publication Number:
  US 20120065668A1
• Time in Patent Office: 1,436 Days
• Field of Search: 606/151, 606/213, 606/232
• 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 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 for closing a hole in a vessel having a vascular lumen formed by the vessel, comprising:

a. inserting through the hole and into the lumen (i) an introducer sheath and (ii) then inserting an implantable closure device having proximal and distal ends and being expandable within the lumen from a collapsed state to an expanded state, the expanded state providing a geometry sufficient to at least substantially occlude the hole, the introducer sheath defining a an introducer lumen sized to accommodate insertion of the closure device in its collapsed state;

b. inserting a distal portion of an elongate guiding member through the hole and into the vascular lumen; and

c. expanding the implantable closure device to the expanded state within the lumen to at least substantially occlude the hole, while leaving the distal portion of the elongate guiding member extending into the vascular lumen whereby the guiding member can be used to access the lumen in subsequent operations performed on the vessel.

2. The method of claim 1, wherein inserting comprises advancing the implantable closure device relative to the hole with a deployment member having a proximal portion configured for manual manipulation and a distal portion configured to be removably coupled to the implantable closure device.

3. The method of claim 2, further comprising controllably moving the collapsed closure device relative to the deployment member to place the closure device into a geometric configuration relative to the vascular lumen that is selected to prevent withdrawal of the closure device back out of the hole.

4. The method of claim 3, 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.

5. The method of claim 3, 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.

6. The method of claim 5, wherein translating 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.

7. The method of claim 2, wherein inserting the elongate guiding member through the hole comprises advancing the elongate guiding member through a lumen defined through the deployment member.

8. The method of claim 1, further comprising advancing an assembly of a delivery sheath and collapsed implantable closure device, at least a portion of which is removably positioned within the introducer lumen, to a deployment position within the vascular lumen wherein reconfiguration of the implantable device from the collapsed state to the expanded state is desired, and maintaining the position of the collapsed implantable device while retracting the delivery sheath to expose the collapsed implantable device to the vascular lumen.

9. The method of claim 8, further comprising selecting the deployment position based at least in part upon an indication from a bleedback indicator channel.

10. 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.

11. 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.

12. The method of claim 11, wherein controllably expanding comprises moving a portion of a deployment tensile element relative to the self expanding structure to allow the self expanding structure to expand itself to the expanded state.

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

14. The method of claim 1, wherein the elongate guiding member comprises a guidewire.

15. The method of claim 1, wherein the elongate guiding member is removably coupled to the implantable closure device.

16. The method of claim 1, further comprising engaging the elongate guiding member to re-enter the vascular lumen in an over-the-wire configuration.

17. The method of claim 16 wherein an instrument engages the guiding member to reenter the lumen following expansion of the closure device to at least substantially occlude the hole.

18. The method of claim 1, further comprising removing the elongate guiding member from the vascular lumen.

19. The method of claim 1, wherein at least the distal portion of the elongate guiding member comprises a radioopaque material selected to be visible with fluoroscopic imaging.

20. The method of claim 1, wherein the implantable closure device is inserted through the hole before the elongate guiding member.

21. The method of claim 1, wherein the elongate guiding member is inserted through the hole before the implantable closure device.

22. The method of claim 21, wherein the implantable closure device is inserted through the hole and over the elongate guiding member in an over-the-wire configuration.

23. A method for closing a hole in a vessel having a vascular lumen formed by the vessel, comprising:

a. inserting through the hole and into the lumen an implantable closure device having proximal and distal ends and being expandable within the lumen from a collapsed state to an expanded state, the expanded state providing a geometry sufficient to at least substantially occlude the hole;

b. inserting a distal portion of an elongate guiding member through the hole and into the vascular lumen, wherein inserting the implantable closure device through the hole and into the lumen comprises advancing the implantable closure device relative to the hole with a deployment member having a proximal portion configured for manual manipulation and a distal portion configured to be removably coupled to the implantable closure device; and

c. expanding the implantable closure device to the expanded state within the lumen to at least substantially occlude the hole, while leaving the distal portion of the elongate guiding member extending into the vascular lumen whereby the guiding member can be used to access the lumen in subsequent operations performed on the vessel.

24. The method of claim 23, further comprising controllably moving the collapsed closure device relative to the deployment member to place the closure device into a geometric configuration relative to the vascular lumen that is selected to prevent withdrawal of the closure device back out of the hole.

25. The method of claim 24, 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.

26. The method of claim 24, 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.

27. The method of claim 26, wherein translating 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.

28. The method of claim 23, wherein inserting the elongate guiding member through the hole comprises advancing the elongate guiding member through a lumen defined through the deployment member.