Closure device with hinges

• US 20050288786A1
• Filed: 04/21/2005
• Published: 12/29/2005
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Chanduszko, Andrzej J.
• Granted Patent: US 7,704,268 B2
• Time in Patent Office: Days
• US Class Current: 623/11.11
• 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 2017/00243 cardiac
• 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

Abstract

A device for closing a defect, such as a patent foramen ovale (PFO) or an atrial septal defect (ASD), has first and second sides on either side of the defect, a center joint that passes through the defect, and end pieces at the outer ends of the sides. One or both sides of the device have a plurality of petals. At least one petal on each side extends away from the center joint, and at least one petal on each side extends away from an end piece. Adjacent petals are coupled together with hinges.

Claims

1. A medical device for closing a septal defect comprising:

a distal portion for use on one side of the septal defect and including a distal end;

a proximal portion for use on another side of the defect and including a proximal end;

a center joint connected to and separating the distal and proximal portions;

the device being movable between an elongated delivery position and a compressed deployed position in which the proximal and distal ends are closer together than the proximal and distal ends are in the elongated delivery position;

at least one of the portions including a plurality of petals configured to provide a force against the area around the septal defect, each petal including two segments for extending generally radially away from one of the end pieces or from the center joint, and a portion at the outer perimeter of the petal and connecting the two segments, wherein at least one petal is further connected to an adjacent petal through a hinge that connects to one of the segments of one petal and to one of the segments of another petal.

2. The device of claim 1, wherein the segments of the petal meet at the center joint.

3. The device of claim 1, wherein the segments of the petal meet at a point spaced radially away from the center joint.

4. The device of claim 1, wherein the segments of the petal connect to the center joint without fully converging at the center joint.

5. The device of claim 1, wherein the petals alternate such that every other petal has a vertex at an end piece, with the petals between them having a vertex at the center joint.

6. The device of claim 5, wherein the petals that extend away from the center joint are shorter than those that extend away from one of the two end pieces.

7. The device of claim 1, wherein the petals have substantially the same size and shape, and are evenly distributed around the circumference of the device.

8. The device of claim 1, wherein the proximal and distal portions each have petals.

9. The device of claim 1, wherein the petals on the proximal and distal portions are different on different sides of the defect.

10. The device of claim 1, wherein the septal defect has an opening, and wherein the portions, when deployed, have a roughly planar configuration in a manner that is roughly parallel to the septal defect.

11. The device of claim 1, further comprising a catch for holding the device in the compressed position, the catch compressing the end pieces.

12. The device of claim 11, wherein the catch includes first means for holding the proximal end to a center joint, and second means for holding the distal end to the center joint.

13. The device of claim 11, wherein the catch includes means for holding the proximal end to the distal end and through the center joint.

14. The device of claim 1, further comprising a tissue scaffold extending over an area defined by at least one of the petals.

15. The device of claim 14, wherein the tissue scaffold is formed of a flexible, biocompatible material capable of promoting tissue growth.

16. The device of claim 1, wherein the device is used for closing an atrial septal defects.

17. The device of claim 1, wherein the device is used for closing a patent foramen ovale (PFO).

18. The device of claim 1, wherein the device is made of a bioresorbable polymer.

19. A generally hollow tubular device having slits formed therein to produce the device of claim 1.

20. The device of claim 19, wherein the tubular device has end portions and a center portion without slits for forming petals.

21. A system including the device of claim 1, a catching mechanism for holding the device in its compressed deployed position, and a delivery system for delivering the device percutaneously and including a delivery sheath, an inner catheter for holding the device in place to prevent it from being pulled toward the proximal end when proximal movement is not desired, and a wire extending coaxially through the sheath and releasably connected to the catching mechanism.

22. A method comprising using the delivery system of claim 21 to deliver the device and catching mechanism of claim 21.

23. The method of claim 22, wherein the method is for delivering a device to a patent foramen ovale (PFO) that includes a tunnel between septum primum and septum secundum, the method including inserting the delivery sheath into a left atrial side, using a delivery catheter to push the device into the left atrial side, causing the distal end and the center joint to move toward each other within the left atrium into contact with septum secundum and septum primum, causing the center joint to be deployed within the tunnel, and causing the proximal end and the center joint to move toward each other within the right atrial side into contact with septum primum and septum secundum.

24. The method of claim 23, further comprising removing the device percutaneously after it has been positioned rather than leave it in the body for deployment.