Tissue distention device and related methods for therapeutic intervention

• US 7,648,532 B2
• Filed: 01/03/2006
• Issued: 01/19/2010
• Est. Priority Date: 05/19/2003
• Status: Expired due to Fees

• Current Assignee: SeptRx, Inc.
• Original Assignee: SeptRx, Inc.
• Inventors: Greenhalgh, E. Skott, Kleshinski, Stephen J
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): Tyson; Melanie
• Application Number:
  US11/323,640
• Publication Number:
  US 20060178694A1
• Time in Patent Office: 1,477 Days
• Field of Search: 606/213, 606/215, 606/216, 606/191, 606151-158, 623/1.1, 623/1.11, 623/1.36, 623/23.72, 128/898
• US Class Current: 623/23.72
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2250/0039 : differing in diameter

Abstract

A device positionable in an opening in a flexible membrane or in the lumen of a vessel having a flexible sidewall. The device distends or biases opposite portions defining the opening or forming the vessel sidewall outwardly in the plane of the device. The outward biasing draws opposing portions of the opening or sidewall inwardly in a direction perpendicular to the plane of the device and into apposition or contact.

Claims

1. A method for repairing a septum wall having an opening through the wall, wherein the opening is defined by an opening sidewall, the method comprising:

positioning a repair device in the opening, wherein the repair device comprises first, second, third and fourth sidewall engaging members, and an expandable and contractable joinder member connected between the first and second sidewall engaging members, and wherein the repair device is attachable to a tissue growth element configured to enable tissue growth on the tissue growth element;

planarly expanding the repair device from a radially contracted configuration to a radially expanded configuration, wherein the plane of the planar expansion is defined by the first, second, third and fourth sidewall engaging members extending from a closed loop;

wherein the planarly expanding comprises anchoring the repair device in the opening, wherein the first sidewall engaging member comprises a first anchoring mechanism at a first end of the first sidewall engaging member and a second anchoring mechanism at a second end of the first sidewall engaging member, and wherein the first anchoring mechanism and the second anchoring mechanism extend from and are extendably attached to the first sidewall engaging member, and wherein anchoring comprises engaging the wall at a first location, and engaging the wall at a second location, and wherein anchoring comprises the first anchoring mechanism substantially unidirectionally restraining the repair device in a first direction, and the second anchoring mechanism substantially unidirectionally restraining the repair device in a second direction, wherein the first direction faces substantially in the direction of the second anchoring mechanism;

contacting the opening sidewall with the first anchoring mechanism at least at a first contact point on the wall outside of the opening and with the second anchoring mechanism at a second contact point on the wall outside of the opening; and

forming a scaffold between the first contact point and the second contact point, wherein the forming comprises forming with the repair device.

2. The method of claim 1, wherein the device is positioned within the opening using a catheter.

3. The method of claim 1, wherein forming a substantially continuous scaffold comprises forming with at least one of the sidewall engaging members.

4. The method of claim 3, wherein the second sidewall engaging member comprises a third anchoring mechanism at a first end of the second sidewall engaging member, and a fourth anchoring mechanism at a second end of the second sidewall engaging member, and wherein the third anchoring mechanism and the fourth anchoring mechanism extend from the second sidewall engaging member, and wherein anchoring further comprises engaging the wall at a third location with the third anchoring mechanism, and engaging the wall at a fourth location with the fourth anchoring mechanism.

5. The method of claim 4, wherein positioning further comprises translating the repair device in a first direction into the opening;

and

wherein anchoring further comprises substantially unidirectionally anchoring the repair device in the first direction with the third anchoring mechanism, and substantially unidirectionally anchoring the repair device in the second direction with the fourth anchoring mechanism.

6. The method of claim 3, wherein the opening comprises an atrial septum.

7. The method of claim 3, wherein the opening comprises an atrial septal defect.

8. The method of claim 3, wherein forming a substantially continuous scaffold provides a matrix onto which cells from the wall can grow.

9. The method of claim 1, wherein the second direction faces substantially in the direction of the first anchoring mechanism.

10. The method of claim 1, further comprising promoting tissue growth onto the repair device, wherein the repair device comprises an ingrowth element configured to promote tissue growth on the ingrowth element.

11. The method of claim 1, wherein the first anchoring mechanism comprises a hooked end.

12. A method for repairing a septum wall having an opening through the wall, wherein the opening is defined by an opening sidewall, the method comprising:

positioning a repair device in the opening, wherein the repair device comprises at least first, second, third and fourth sidewall engaging members, and at least one expandable and contractable joinder member connected between the first and second sidewall engaging members, and wherein the repair device is attachable to a tissue growth element configured to enable tissue growth on the tissue growth element;

planarly expanding the repair device from a radially contracted configuration to a radially expanded configuration, wherein the plane of the planar expansion is defined by the first, second, third and fourth sidewall engaging members extending from a closed loop;

wherein the planarly expanding comprises anchoring the repair device in the opening, wherein the first sidewall engaging member comprises a first anchoring mechanism at a first end of the first sidewall engaging member and a second anchoring mechanism at a second end of the first sidewall engaging member, and wherein the second sidewall engaging member comprises a third anchoring mechanism at a first end of the second sidewall engaging member, and a fourth anchoring mechanism at a second end of the second sidewall engaging member, and wherein the first anchoring mechanism and the second anchoring mechanism extend from the first sidewall engaging member, and wherein the third anchoring mechanism and the fourth anchoring mechanism extend from and are extendably attached to the second sidewall engaging member,

and wherein anchoring comprises engaging the wall at a first location, and engaging the wall at a second location, and wherein anchoring further comprises engaging the wall at a third location with the third anchoring mechanism, and engaging the wall at a fourth location with the fourth anchoring mechanism, and wherein anchoring comprises the first anchoring mechanism substantially unidirectionally restraining the repair device in a first direction, and the second anchoring mechanism substantially unidirectionally restraining the repair device in a second direction, wherein the first direction faces substantially toward the second anchoring mechanism;

contacting the opening sidewall with the first anchoring mechanism at least at a first contact point and with the second anchoring mechanism at a second contact point; and

forming a scaffold between the first contact point and the second contact point, wherein the forming comprises forming with the repair device.

13. The method of claim 12, wherein forming a scaffold provides a matrix onto which cells from the wall can grow.

14. The method of claim 12, wherein anchoring further comprises substantially unidirectionally anchoring the repair device in the first direction with the third anchoring mechanism, and substantially unidirectionally anchoring the repair device in a second direction with the fourth anchoring mechanism.

15. The method of claim 12, wherein the second direction faces substantially toward the first anchoring mechanism.

16. The method of claim 12, wherein the first anchoring mechanism comprises a hooked end.

17. A method for repairing a septum wall having an opening through the wall, wherein the opening is defined by an opening sidewall, the method comprising:

positioning a repair device in the opening comprising translating the repair device in a first direction into the opening, wherein the repair device comprises first, second, third and fourth sidewall engaging members, and an expandable and contractable joinder member connected between the first and second sidewall engaging members, and wherein the repair device is attachable to a tissue growth element configured to enable tissue growth on the tissue growth element;

planarly expanding the repair device from a radially contracted configuration to a radially expanded configuration, wherein the plane of the planar expansion is defined by the first, second, third and fourth sidewall engaging members extending from a closed loop;

wherein the planarly expanding comprises anchoring the repair device in the opening, wherein the first sidewall engaging member comprises a first anchoring mechanism at a first end of the first sidewall engaging member and a second anchoring mechanism at a second end of the first sidewall engaging member, and wherein the first anchoring mechanism and the second anchoring mechanism extend from the first sidewall engaging member, and wherein anchoring comprises engaging the wall at a first location, and engaging the wall at a second location with an atraumatic surface of the second member, wherein anchoring further comprises substantially unidirectionally anchoring the repair device in the first direction with the first anchoring mechanism, and substantially unidirectionally anchoring the repair device in a second direction with the second anchoring mechanism, and wherein the first direction faces substantially toward the second anchoring mechanism;

contacting the opening sidewall with the first anchoring mechanism at least at a first contact point and with the second anchoring mechanism at a second contact point; and

forming a scaffold between the first contact point and the second contact point, wherein the forming comprises forming with the repair device.

18. The method of claim 17, wherein forming a substantially continuous scaffold comprises forming with at least one of the sidewall engaging members.

19. The method of claim 18, wherein forming a scaffold provides a matrix onto which cells from the wall can grow.

20. The method of claim 17, wherein the second direction faces substantially toward the first anchoring mechanism.

21. The method of claim 17, wherein the first anchoring mechanism comprises a hooked end.

22. A method for repairing a septum wall having an opening through the wall, wherein the opening is defined by an opening sidewall, the method comprising:

positioning a repair device in the opening, wherein the repair device comprises first, second, third and fourth sidewall engaging members, and an expandable and contractable joinder member connected between the first and second sidewall engaging members, and wherein the repair device is attachable to a tissue growth element configured to enable tissue growth on the tissue growth element;

planarly expanding the repair device from a radially contracted configuration to a radially expanded configuration, wherein the plane of the planar expansion is defined by the first, second, third and fourth sidewall engaging members extending from a closed loop;

wherein the planarly expanding comprises anchoring the repair device in the opening, wherein the first sidewall engaging member comprises a first anchoring mechanism at a first end of the first sidewall engaging member and a second anchoring mechanism at a second end of the second sidewall engaging member, and wherein the first anchoring mechanism and the second anchoring mechanism extend from the first sidewall engaging member, and wherein anchoring comprises engaging the wall at a first location with the first anchoring mechanism, and engaging the wall at a second location with the second member;

contacting the opening sidewall with the shroud at least at a first contact point and a second contact point; and

forming a scaffold between the first contact point and the second contact point, wherein the forming comprises forming with the repair device.

23. The method of claim 22, wherein the first anchoring mechanism comprises a hooked end.

24. A method for repairing a septum wall having an opening through the wall, wherein the opening is defined by an opening sidewall, the method comprising:

positioning a repair device in the opening, wherein the repair device comprises first, second, third and fourth sidewall engaging members, and at least one expandable and contractable joinder member connected between the first and second sidewall engaging members, and a shroud covering the first and second sidewall engaging members, wherein the first and second sidewall engaging members are flexible, wherein the repair device is attachable to a tissue growth element configured to enable tissue growth on the tissue growth element;

planarly expanding the repair device from a radially contracted configuration to a radially expanded configuration, wherein the plane of the planar expansion is defined by the first, second, third and fourth sidewall engaging members extending from a closed loop;

wherein the planarly expanding comprises anchoring the repair device in the opening, wherein the first sidewall engaging member comprises a first anchoring mechanism at a first end of the first sidewall engaging member and a second anchoring mechanism at a second end of the first sidewall engaging member, and wherein the first anchoring mechanism and the second anchoring mechanism extend from the first sidewall engaging member, and wherein anchoring comprises engaging the wall at a first location with the first anchoring mechanism, and engaging the wall at a second location with the second member;

contacting the opening sidewall with the first anchoring mechanism at least at a first contact point and with the second anchoring mechanism at a second contact point; and

forming a scaffold between the first contact point and the second contact point, wherein the forming comprises forming with the repair device.

25. The method of claim 24, wherein the first anchoring mechanism comprises a hooked end.

26. A method for repairing a septum wall having a substantially planar opening through the wall, wherein the opening is defined by an opening sidewall, the method comprising:

positioning a repair device in the opening, wherein the repair device comprises first, second, third and fourth sidewall engaging members, and at least one expandable and contractable joinder member connected between the first and second sidewall engaging members, wherein the first and second sidewall engaging members are flexible;

planarly expanding the repair device from a radially contracted configuration to a radially expanded configuration, wherein the plane of the planar expansion is defined by the first, second, third and fourth sidewall engaging members extending from a closed loop;

wherein the planarly expanding comprises anchoring the repair device in the opening, wherein the first sidewall engaging member comprises a first anchoring mechanism at a first end of the first sidewall engaging member and a second anchoring mechanism at a second end of the first sidewall engaging member, and wherein the first anchoring mechanism and the second anchoring mechanism extend from the first sidewall engaging member, and wherein anchoring comprises engaging the wall at a first location with the first anchoring mechanism, and engaging the wall at a second location with the second member, and wherein the first anchoring mechanism is substantially longer than the second anchoring mechanism;

contacting the opening sidewall at least at a first contact point and at a second contact point; and

forming a scaffold between the first contact point and the second contact point, wherein the forming comprises forming with the repair device.

27. The method of claim 26, wherein the first anchoring mechanism comprises a hooked end.