Tubular patent foramen ovale (PFO) closure device with catch system

• US 8,480,706 B2
• Filed: 03/31/2006
• Issued: 07/09/2013
• Est. Priority Date: 07/14/2003
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Chanduszko, Andrzej J., Callaghan, David J.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): MASHACK, MARK F
• Application Number:
  US11/395,718
• Publication Number:
  US 20070010851A1
• Time in Patent Office: 2,657 Days
• Field of Search: 606/213, 606139-142, 606/151, 606157-158, 128/831
• 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 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

The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. The occluder is formed from a tube, which is cut to produce struts in each side. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one of the sides includes a tissue scaffold. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is deployed so that the occluder exerts a compressive force on the septal tissue and closes the aperture.

Claims

1. An occluder for a defect adapted to be introduced into the body through the vasculature, the occluder comprising:

a tube comprising a proximal side, a central tube portion, and a distal side that cooperate to close the defect, the proximal side having a tip, and the distal side having an end, wherein the proximal and distal sides of the occluder include a plurality of struts, the plurality of struts defining an elongate shape in a first configuration,

wherein upon compression of the proximal side and the distal side, the plurality of struts form a plurality of proximal loops and distal loops in a second configuration; and

a catch system adapted to secure the occluder in a deployed position such that the occluder is not secured during delivery and becomes secured during deployment, the catch system comprising;

a) a first catch element configured to pass through the central tube portion and the tip upon application of a first pulling force F₁ to secure the occluder in the deployed position, wherein the first catch element cannot return through the central portion and tip without application of a sufficient additional force thereto;

b) a second catch element configured to pass through the end and the central tube portion upon application of a second pulling force F₂ to release the distal side and proximal side from the deployed position, wherein the second catch element cannot pass through the tip; and

c) a wire connecting the first catch element and the second catch element.

2. The occluder of claim 1, wherein the struts extend along a line parallel to the axis of the tube.

3. The occluder of claim 1, wherein at least one of the catch elements is a ball.

4. The occluder of claim 1, wherein the occluder is adapted to be secured in the heart with tissue between the proximal side and the distal side of the occluder.

5. The occluder of claim 1, wherein the loops have identical cross section.

6. The occluder of claim 1, wherein the number of loops formed is 4.

7. The occluder of claim 1, wherein the loops twist when the axial length of the tube is reduced.

8. The occluder of claim 1, wherein the loops align with one another.

9. The occluder of claim 1, wherein the occluder is formed of a bioabsorbable material.

10. The occluder of claim 1, wherein the occluder further comprises tissue scaffolding attached to the loops.

11. The occluder of claim 10, wherein the tissue scaffolding is bioabsorbable.

12. The occluder according to claim 1, where the occluder is formed of nitinol.