Vasculature closure devices and methods

• US 10,085,731 B2
• Filed: 07/14/2014
• Issued: 10/02/2018
• Est. Priority Date: 07/15/2013
• Status: Active Grant

• Current Assignee: E-Pacing Inc.
• Original Assignee: E-Pacing Inc.
• Inventors: Penner, Abraham, Wolinsky, Lone, Ben-Yosef, Alon
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/905,456
• Publication Number:
  US 20160151613A1
• Time in Patent Office: 1,541 Days
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Vasculature closure devices, and systems and methods for their use, are provided. In one or more embodiments, a vasculature closure device (200) includes an expandable support frame (210) deployable within a vessel (10), and a sealing membrane (205) at least partially supported by the support frame (210). Upon expanding the support frame (210) within the vessel (10), the device is configured to intraluminally position the sealing membrane (205) against a puncture site existing in a wall of the vessel. The sealing membrane includes an area of excess membrane (245) configured to facilitate coupling of the sealing membrane to the wall of the vessel.

Claims

1. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel and configured to expand from a collapsed configuration into an expanded configuration; and

a sealing membrane at least partially supported by the support frame;

wherein the support frame is configured to intraluminally move the sealing membrane against a puncture site existing in a wall of the vessel when the support frame is in the expanded configuration across the puncture site within the vessel;

wherein the device has a longitudinal axis configured to align with a length of the vessel and a radial axis perpendicular to the longitudinal axis; and

wherein the sealing membrane comprises an area of excess membrane comprising one or more folds or one or more wrinkles defined by overlapping regions of the sealing membrane when the support frame is in the expanded configuration and configured to allow extension of the area of excess membrane relative to the support frame along the radial axis of the device when the support frame is in the expanded configuration to facilitate coupling of the sealing membrane to the wall of the vessel.

2. The vasculature closure device of claim 1, wherein the area of excess membrane is positioned along a perimeter of the sealing membrane.

3. The vasculature closure device of claim 1, wherein the support frame extends along the perimeter of the sealing membrane.

4. The vasculature closure device of claim 1, wherein the area of excess membrane comprises one or more folds configured to allow extension of the area of excess membrane along the radial axis of the device.

5. The vasculature closure device of claim 4, wherein the one or more folds comprise a first fold and a second fold positioned adjacent to one another and forming an S-shape.

6. The vasculature closure device of claim 4, wherein the one or more folds are positioned within a perimeter of the support frame.

7. The vasculature closure device of claim 4, wherein the one or more folds extend beyond a perimeter of the support frame.

8. The vasculature closure device of claim 4, wherein the one or more folds at least partially overlap the support frame.

9. The vasculature closure device of claim 4, wherein the one or more folds are connected to the support frame.

10. The vasculature closure device of claim 1, wherein the area of excess membrane comprises a plurality of wrinkles configured to allow extension of the area of excess membrane along the radial axis of the device.

11. The vasculature closure device of claim 10, wherein the plurality of wrinkles are positioned adjacent to the support frame.

12. The vasculature closure device of claim 10, wherein the plurality of wrinkles are positioned within a perimeter of the support frame.

13. The vasculature closure device of claim 1, wherein the area of excess membrane is positioned along a perimeter of the sealing membrane, and wherein the support frame extends along the perimeter of the sealing membrane.

14. The vasculature closure device of claim 1, wherein the area of excess membrane is positioned about a center of the sealing membrane along the radial axis of the device.

15. The vasculature closure device of claim 1, wherein the area of excess membrane is positioned about a radial end of the sealing membrane along the radial axis of the device.

16. The vasculature closure device of claim 1, wherein the area of excess membrane is spaced apart from the support frame.

17. The vasculature closure device of claim 1, wherein the sealing membrane comprises a first area of excess membrane and a second area of excess membrane spaced apart from one another along the radial axis of the device.

18. The vasculature closure device of claim 1, wherein the sealing membrane comprises a first area of excess membrane positioned about a first radial end of the sealing membrane along the radial axis of the device, and a second area of excess membrane positioned about a second radial end of the sealing membrane along the radial axis of the device.

19. The vasculature closure device of claim 1, wherein the area of excess membrane is formed by the sealing membrane being larger than the support frame by about 0.1 millimeters to about 10 millimeters along the radial axis of the device.

20. The vasculature closure device of claim 1, wherein the area of excess membrane is formed by the sealing membrane being larger than the support frame by about 1 millimeter to about 10 millimeters along the radial axis of the device.

21. The vasculature closure device of claim 1, wherein the area of excess membrane is formed by the sealing membrane being larger than the support frame by about 2 millimeters to about 4 millimeters along the radial axis of the device.

22. A method for sealing a puncture site in a vessel wall of a patient, the method comprising:

deploying a balloon catheter through the puncture site and into the vessel;

deploying the vasculature closure device of claim 1 through the puncture site and into the vessel; and

securing at least a portion of the vasculature closure device against the puncture site for sealing thereabout.

23. The method of claim 22, further comprising, prior to deploying the vasculature closure device through the puncture, inflating a balloon of the balloon catheter to control blood flow within the vessel.

24. The vasculature closure device of claim 1, further comprising a cross-member support extending across at least a portion of the sealing membrane, wherein the cross-member support comprises a pair of wire segments extending between opposite sides of the support frame.

25. The vasculature closure device of claim 1, further comprising a cross-member support extending across at least a portion of the sealing membrane, wherein the cross-member support comprises a pair of longitudinal wire segments extending between opposite sides of the support frame and parallel to one another along the longitudinal axis of the device.

26. The vasculature closure device of claim 1, further comprising a cross-member support extending across at least a portion of the sealing membrane, wherein the support frame comprises a pair of longitudinal supports extending across at least a portion of the sealing membrane and parallel to one another along the longitudinal axis of the device, and wherein the cross-member support comprises a pair of radial wire segments extending between the pair of longitudinal supports and parallel to one another along the radial axis of the device.

27. The vasculature closure device of claim 1, further comprising a patch extending along a portion of the sealing membrane and having a perimeter that is smaller than a perimeter of the sealing membrane.

28. The vasculature closure device of claim 1, further comprising a cross-member support extending across at least a portion of the sealing membrane, wherein the cross-member support comprises a rigid member extending between opposite sides of the support frame along the longitudinal axis of the device.

29. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel;

a sealing membrane at least partially supported by the support frame; and

a cross-member support extending across at least a portion of the sealing membrane;

wherein the device is configured to intraluminally position the sealing membrane against a puncture site existing in a wall of the vessel when the support frame is in an expanded configuration across the puncture site within the vessel;

wherein the device has a longitudinal axis configured to align with a length of the vessel; and

wherein the cross-member support comprises a pair of longitudinal wire segments extending between opposite sides of the support frame and parallel to one another along the longitudinal axis of the device.

30. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel;

a sealing membrane at least partially supported by the support frame; and

a cross-member support extending across at least a portion of the sealing membrane;

wherein the device is configured to intraluminally position the sealing membrane against a puncture site existing in a wall of the vessel when the support frame is in an expanded configuration across the puncture site within the vessel;

wherein the device has a longitudinal axis configured to align with a length of the vessel and a radial axis perpendicular to the longitudinal axis;

wherein the support frame comprises a pair of longitudinal supports extending across at least a portion of the sealing membrane and parallel to one another along the longitudinal axis of the device; and

wherein the cross-member support comprises a pair of radial wire segments extending between the pair of longitudinal supports and parallel to one another along the radial axis of the device.