Patent foramen ovale closure system

• US 7,780,700 B2
• Filed: 02/04/2004
• Issued: 08/24/2010
• Est. Priority Date: 02/04/2003
• Status: Active Grant

• Current Assignee: ev3 Endovascular, Inc.
• Original Assignee: ev3 Endovascular, Inc.
• Inventors: Frazier, Andrew G. C., Khairkhahan, Alexander K., Roue, Chad C., van der Burg, Erik J., Klenk, Alan R.
• Primary Examiner(s): Woo; Julian W
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US10/771,845
• Publication Number:
  US 20040220596A1
• Time in Patent Office: 2,393 Days
• Field of Search: 606/151, 606/213, 606/221, 606/216, 623/23.72
• US Class Current: 606/216
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 2017/00606 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 2017/0649 Coils or spirals

Abstract

A patent foramen ovale closure device, method of delivering and a delivery system are provided. The device may include a closure device releasably connectable to an actuator. The device may include a proximal segment, an intermediate segment and a distal segment. When delivered, the proximal segment and intermediate segment form a first clip-shaped portion sized and configured to be positioned over a septum secundum of the patent foramen ovale, and the intermediate segment and distal segment form a second clip-shaped portion sized and configured to be positioned over a septum primum of the patent foramen ovale.

Claims

1. A method of closing a patent foramen ovale having a channel formed between overlapping surfaces of a septum primum and a septum secundum, the septum primum having a proximal surface and a distal surface adjacent the left atrium, the septum secundum having a proximal surface adjacent the right atrium and a distal surface, the channel disposed between the overlapping proximal surface of the septum primum and the distal surface of the septum secundum, the method comprising:

providing a closure device having a proximal end, a distal end, a proximal segment, an intermediate segment and a distal segment, the proximal and intermediate segments defining a first clip-shaped portion and the intermediate and distal segments defining a second clip-shaped portion, wherein the closure device is self-expandable to a deployment shape wherein the proximal, intermediate and distal segments are generally parallel to one another;

deploying the closure device at the patent foramen ovale such that the second clip-shaped portion is positioned over a tip of the septum primum and the first clip-shaped portion is positioned over a tip of the septum secundum, with the intermediate segment lying in the channel between the overlapping septum primum and the septum secundum; and

locking the position of the proximal segment, the intermediate segment and the distal segment of the closure device after deployment with a locking element;

wherein the closure device when locked exerts a force to draw the septum primum and septum secundum together in an overlapping configuration to close the channel formed between the overlapping proximal surface of the septum primum and the distal surface of the septum secundum;

wherein the locking element remains at the patent foramen ovale after locking.

2. The method of claim 1, wherein the intermediate and distal segments of the closure device when deployed are positioned along the proximal and distal surfaces, respectively, of the septum primum and the proximal and intermediate segments of the closure device when deployed are positioned along the proximal and distal surfaces, respectively, of the septum secundum.

3. The method of claim 1, wherein the first clip-shaped portion and second clip-shaped portions are integrally formed.

4. The method of claim 1, wherein the first clip-shaped portion and second clip-shaped portions are made of wire.

5. The method of claim 1, wherein the first clip-shaped portion and second clip-shaped portions when the device is deployed forms generally an S-shape.

6. The method of claim 1, wherein each clip-shaped portion is formed from two adjacent loops connected by a connecting portion.

7. The method of claim 1, wherein deploying the closure device comprises releasing the closure device from a detachment element provided on the device.

8. The method of claim 1, wherein the intermediate segment comprises at least two side-by-side wire portions.

9. The method of claim 1, wherein the locking element is provided as a retained part of the closure device after deployment.

10. The method of claim 1, wherein the locking element connects to the proximal and distal ends of the device, and locking the position of the closure device after deployment comprises longitudinally shortening and radially expanding the device.

11. The method of claim 10, wherein the locking element comprises a locking string connected to eyelets provided on the closure device.

12. A method of closing a patent foramen ovale having a channel formed between overlapping surfaces of a septum primum and a septum secundum, the septum primum having a proximal surface and a distal surface adjacent the left atrium, the septum secundum having a proximal surface adjacent the right atrium and a distal surface, the channel disposed between the overlapping proximal surface of the septum primum and the distal surface of the septum secundum, the method comprising:

providing a closure device having a proximal end and a distal end and having a generally elongate configuration and a clip configuration, wherein when the closure device is in its elongate configuration the proximal and distal ends are pulled away from each other and when the closure device is in its clip configuration the closure device has generally an S-shape, the closure device being releasably attached relative to a delivery device;

delivering the closure device to the patent foramen ovale with the delivery device, the closure device being held relative to the delivery device in its elongate configuration;

deploying the closure device in the channel of the patent foramen ovale, wherein the closure device when deployed includes a first clip-shaped portion positioned around the septum secundum and a second clip-shaped portion positioned around the septum primum; and

locking the closure device in its clip configuration after deployment with a locking element to increase the clamping force of the closure device on the septa of the patent foramen ovale;

wherein the closure device when deployed exerts a force to draw the overlapping septum primum and septum secundum together in an overlapping configuration to close the channel disposed between the overlapping proximal surface of the septum primum and the distal surface of the septum secundum;

wherein the locking element remains at the patent foramen ovale after locking.

13. The method of claim 12, wherein the closure device includes a detachment element at its proximal end, and the closure device is delivered using a core wire that releasably engages the detachment element.

14. The method of claim 12, wherein the closure device is held in its elongate configuration distal to a deployment catheter.

15. The method of claim 12, wherein the closure device is delivered by positioning a catheter between the septum primum and septum secundum.

16. The method of claim 12, wherein the closure device self-expands to its deployment configuration.

17. The method of claim 12, wherein the closure device includes a plurality of eyelets, and the closure device is releasably attached to the delivery device by engaging a core through at least some of the eyelets.

18. The method of claim 12, wherein the locking element is provided as a retained part of the closure device after deployment.

19. The method of claim 12, wherein the locking element connects to the proximal and distal ends of the device, and locking the closure device in its clip configuration after deployment comprises longitudinally shortening and radially expanding the device.

20. The method of claim 19, wherein the locking element comprises a locking string connected to eyelets provided on the closure device.