Double coil occluder

• US 7,842,053 B2
• Filed: 03/30/2005
• Issued: 11/30/2010
• Est. Priority Date: 05/06/2004
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Chanduszko, Andrzej J., Widomski, David R.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/093,348
• Publication Number:
  US 20050251154A1
• Time in Patent Office: 2,071 Days
• Field of Search: 606/215, 606/139, 606/151, 606/157, 606/159, 606/213, 606/232, 623/3.1
• US Class Current: 606/157
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

An occluder that has a coil on one or both sides of a medical defect, particularly a septal defect such as a patent foramen ovale (PFO). Each coil can be formed as a tube that is hollow, with or without a closed end. The tube can be delivered over a wire. For occluding a PFO, the coils can be designed to provide a compressive force to one or both of septum primum and septum secundum.

Claims

1. A device adapted to press together the septum primum and the septum secundum between the atrial chambers, the device comprising:

first and second clamping spirals, each having a size suitable for use on each side of the septum, wherein each of the first and second clamping spirals has a first end at an outer edge and a free end; and

a central connector for connecting the first end of the first and second clamping spirals and passing through the tunnel between the septum primum and the septum secundum,

wherein at least one of the spirals includes a length of wire extending in a radial direction from an inner portion of the spiral to the outer edge of the spiral and locking the free end of the spiral to the central connector.

2. The device of claim 1, wherein the spirals spiral outwardly from the central connector to the free ends.

3. The device of claim 1, wherein the central connector includes at least one hollow rod extending from a central region of the first spiral to a central region of the second spiral.

4. The device of claim 1, wherein the spirals and the central connector are formed from a single wire.

5. The device of claim 1, wherein at least one of the spirals has a radially extending portion extending from the central connector, the at least one spiral extends inwardly back to the central connector, and the center joint is flexible.

6. The device of claim 1, wherein the device is formed from a bioresorbable polymer.

7. The device of claim 1, wherein the spirals each circle around more than 360°

.

8. The device of claim 1, wherein the central connector includes a scaffold for promoting tissue growth.

9. The device of claim 1, wherein the first end of each of the first and second spirals includes a radial portion connected to the central connector.

10. The device of claim 1, wherein the central connector has an opening at least one end, and the free end of at least one of the spirals is adapted to extend through the opening to form a connection.

11. The device of claim 9, wherein the central connector and the second end have a snap-fit connection.

12. The device of claim 1, wherein the first spiral spirals outwardly from the central connector and extends from an outermost point radially back to the central connector where the radial portion is connected to the central connector.

13. The device of claim 12, wherein the radial portion is detachably connected to the central connector.

14. The device of claim 12, wherein the radial portion is non-detachably connected to the central connector.

21. A method comprising introducing into a patent foramen ovale (PFO) the device of claim 1.

22. The method of claim 21, wherein the introducing includes first providing a wire into the body, and then providing the device over the wire.

23. The method of claim 22, wherein the method includes loading the device into a sheath, providing a catheter to limit movement of the device in the proximal direction, and providing the catheter, device, and sheath to the region near the PFO.

24. The method of claim 23, further comprising extending the sheath and device through a PFO tunnel to a left atrium, limiting movement of the device in the proximal direction, and withdrawing the sheath in the proximal direction to release the second spiral on the left atrium side of the PFO.

25. The method of claim 24, further comprising further withdrawing the sheath in the proximal direction.

15. A device adapted to be disposed in a patent foramen ovale tunnel and comprising first and second separate spirals and a connecting member together connected to the spirals with respective first and second joints, wherein each spiral has one end at an outer edge connected to one of the first and second joints, and a second end connectible to the respective first or second joint, the spirals forming closed loops when the second end is connected.

16. The device of claim 15, wherein the spirals spiral outwardly from the first and second joints and have a radial portion extending inwardly from an outermost part of a spiral.

17. The device of claim 15, wherein the connecting member includes two wires extending between the first and second joints.

18. The device of claim 15, further comprising a membrane attached to the connecting member for promoting tissue growth.

19. The device of claim 15, wherein the first and second joints have an opening for the second end to extend through.

20. The device of claim 15, wherein the first and second joints have snap fit connectors for connection to the respective second ends.