Vasculature closure devices and methods

• US 8,845,682 B2
• Filed: 08/09/2010
• Issued: 09/30/2014
• Est. Priority Date: 10/13/2009
• Status: Active Grant

• Current Assignee: E-Pacing Inc.
• Original Assignee: E-Pacing Inc.
• Inventors: Penner, Abraham, Wolinsky, Lone, Ben-Yosef, Alon
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US12/852,893
• Publication Number:
  US 20110087270A1
• Time in Patent Office: 1,513 Days
• Field of Search: 606/213, 606/215, 606/151, 606/191, 623/1.11, 623/1.13, 623/1.15, 623/1.18, 623/1.22, 623/1.44
• 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 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• 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 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

Vasculature closure devices, and systems and methods for their use, are provided. In one embodiment, the vasculature closure device includes an expandable support frame deployable within a vessel and a sealing membrane at least partially supported by the expandable support frame. Upon expanding the support frame, the vasculature closure device is configured to intraluminally position the sealing membrane against a puncture site existing in a vessel wall.

Claims

1. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel;

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

a cross-member support extending across at least a portion of the sealing membrane and attached to opposing sides of the support frame; and

an anchoring tab or a pull string fixedly attached to at least one of the support frame, the sealing membrane, and the cross-member support;

wherein, upon deploying the support frame within the vessel, the device is positioned entirely within the vessel except for the anchoring tab or the pull string; and

wherein, upon expanding the support frame within the vessel, the device is configured to intraluminally push the sealing membrane against a puncture site existing in a vessel wall, such that the sealing membrane prevents fluid blood leakage through the puncture site.

2. The device of claim 1, wherein, upon expanding the support frame within the vessel, the device is configured to intraluminally position the support frame, the sealing membrane, and the cross-member support on an inner surface of the vessel wall such that the sealing membrane is pushed against the puncture site.

3. The device of claim 1, wherein the device comprises at least two cross-member supports extending across at least a portion of the sealing membrane and attached to opposing sides of the support frame, and wherein the cross-member supports are generally parallel to one another.

4. The device of claim 1, wherein the support frame is formed of a non-biodegradable material, and wherein the cross-member support comprises a wire formed of a biodegradable material.

5. The device of claim 4, wherein the support frame is formed of a non-biodegradable metal, and wherein the wire is formed of a biodegradable polymer.

6. The device of claim 1, further comprising two ear supports extending away from the sealing membrane in opposite directions and attached to opposing sides of the support frame.

7. The device of claim 1, wherein the device is adapted for rolling and unrolling along a longitudinal axis generally aligned with and extending along the length of the vessel.

8. The device of claim 7, wherein, when expanding, the support frame is adapted at least partially to unroll into an expanded configuration having a radius of curvature larger than a radius of curvature of the vessel.

9. The device of claim 7, wherein the device is adapted for rolling into a collapsed configuration such that opposing sides of the support frame overlap one another.

10. The device of claim 1, wherein the sealing membrane defines an outer edge around its periphery, and wherein the support frame comprises a peripheral support frame, at least a portion of which is positioned at or near at least a portion of the outer edge of the sealing membrane.

11. The device of claim 1, wherein, upon expanding, the support frame is adapted to exert a radial pressure against the vessel wall, the radial pressure ranging between approximately 2 mm Hg and approximately 400 mm Hg.

12. The device of claim 1, wherein the sealing membrane is formed of a biodegradable material.

13. The device of claim 1, wherein at least a portion of the support frame is formed of a biodegradable material.

14. The device of claim 1, wherein the support frame is formed of a pre-shaped material adapted for expanding the sealing membrane when in its stable state.

15. The device of claim 14, wherein the pre-shaped material comprises at least one of:

(a) a shape memory metal or (b) a shape memory polymer.

16. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel;

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

a cross-member support extending across at least a portion of the sealing membrane and attached to opposing sides of the support frame;

wherein the support frame is formed of a non-biodegradable material; and

wherein the cross-member support comprises a wire formed of a biodegradable material.

17. The device of claim 16, wherein, upon expanding the support frame within the vessel, the device is configured to intraluminally push the sealing membrane against a puncture site existing in a vessel wall.

18. The device of claim 16, wherein the support frame is formed of a non-biodegradable metal, and wherein the wire is formed of a biodegradable polymer.

19. The device of claim 16, wherein, upon expanding the support frame within the vessel, the device is configured to intraluminally position the support frame, the sealing membrane, and the cross-member support on an inner surface of the vessel such that the sealing membrane is pushed against a puncture site existing in a vessel wall.

20. The device of claim 16, further comprising an anchoring tab or a pull string fixedly attached to at least one of the support frame, the sealing membrane, and the cross-member support, wherein, upon deploying the support frame within the vessel, the device is positioned entirely within the vessel except for the anchoring tab or the pull string.

21. The device of claim 16, wherein the device comprises at least two cross-member supports extending across at least a portion of the sealing membrane and attached to opposing sides of the support frame, and wherein the cross-member supports are generally parallel to one another.

22. The device of claim 16, further comprising two ear supports extending away from the sealing membrane in opposite directions and attached to opposing sides of the support frame.

23. The device of claim 16, wherein the device is adapted for rolling and unrolling along a longitudinal axis generally aligned with and extending along the length of the vessel.

24. The device of claim 23, wherein, when expanding, the support frame is adapted at least partially to unroll into an expanded configuration having a radius of curvature larger than a radius of curvature of the vessel.

25. The device of claim 23, wherein the device is adapted for rolling into a collapsed configuration such that opposing sides of the support frame overlap one another.

26. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel;

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

a cross-member support extending across at least a portion of the sealing membrane and attached to opposing sides of the support frame; and

two ear supports extending away from the sealing membrane in opposite directions and attached to opposing sides of the support frame;

wherein, upon expanding the support frame within the vessel, the device is configured to intraluminally push the sealing membrane against a puncture site existing in a vessel wall, such that the sealing membrane prevents fluid blood leakage through the puncture site.

27. The device of claim 26, wherein, upon expanding the support frame within the vessel, the device is configured to intraluminally position the support frame, the sealing membrane, the cross-member support, and the ear supports on an inner surface of the vessel such that the sealing membrane is pushed against a puncture site existing in a vessel wall.

28. The device of claim 26, further comprising an anchoring tab or a pull string fixedly attached to at least one of the support frame, the sealing membrane, and the cross-member support, wherein, upon deploying the support frame within the vessel, the device is positioned entirely within the vessel except for the anchoring tab or the pull string.

29. The device of claim 26, wherein the support frame is formed of a non-biodegradable material, and wherein the cross-member support comprises a wire formed of a biodegradable material.

30. The device of claim 26, wherein the device is adapted for rolling and unrolling along a longitudinal axis generally aligned with and extending along the length of the vessel.

31. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel;

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

a cross-member support extending across at least a portion of the sealing membrane and attached to opposing sides of the support frame; and

an anchoring tab or a pull string fixedly attached to at least one of the support frame, the sealing membrane, and the cross-member support;

wherein the support frame is formed of a non-biodegradable material;

wherein the sealing membrane is formed of a biodegradable material; and

wherein, upon deploying the support frame within the vessel, the device is positioned entirely within the vessel except for the anchoring tab or the pull string.

32. A vasculature closure device, comprising:

an expandable support frame deployable within a vessel;

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

a cross-member support extending across at least a portion of the sealing membrane and attached to opposing sides of the support frame; and

an anchoring tab or a pull string fixedly attached to at least one of the support frame, the sealing membrane, and the cross-member support;

wherein the device is adapted for rolling and unrolling along a longitudinal axis generally aligned with and extending along the length of the vessel;

wherein the device is adapted for rolling into a collapsed configuration such that opposing sides of the support frame overlap one another; and

wherein, upon deploying the support frame within the vessel, the device is positioned entirely within the vessel except for the anchoring tab or the pull string.