Heart-shaped PFO closure device

• US 8,361,110 B2
• Filed: 04/21/2005
• Issued: 01/29/2013
• Est. Priority Date: 04/26/2004
• 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.
• Primary Examiner(s): Hughes, S. Thomas
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US11/111,675
• Publication Number:
  US 20050267525A1
• Time in Patent Office: 2,840 Days
• Field of Search: 606/213, 606/151
• 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 17/083 Clips, e.g. resilient
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

Patent foramen ovale (PFO) closure clip include two closure members, which may be heart shaped, joined by at least two spaced central connecting members. Each of the at least two spaced central connecting members is attached to each closure member at a location on the periphery of the closure member. The connecting member may be generally square shaped or include other shapes. The clips of the present invention may be formed of various materials, including metals, nonmetallic materials, bioresorbable polymers, spring steel, shape memory materials, bioresorbable shape memory polymers, or combinations thereof. The clips can take various forms depending, in part, upon the distribution of force required to close a given PFO. At least one of the closure members can include a tissue scaffold.

Claims

1. An occluder device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising:

first and second opposed closure members configured to be disposed on opposite sides of the septum, each of said closure members generally defining a plane with a periphery, wherein the planes are configured to be generally parallel to each of septum primum and septum secundum; and

a center joint connecting the first and second opposed closure members, the center joint comprising pairs of parallel wire paths and at least two collars having first and second opposing ends, wherein each wire path begins at the first end of a first collar and terminates at a first end of a second collar, wherein further each wire path forms a center vertex between the collars;

wherein the center joint is configured so the center vertex of each wire path extends between the overlapping layers of septum primum and septum secundum leaving the collars and closure members outside the layers, wherein further at least one of said closure members has a generally heart shape and includes two lobes that come together at the center joint, the lobes having contact points at adjacent corners to provide a compressive force to the overlapping layers of septum primum and septum secundum wherein said closure members are configured to prevent the device from moving along a longitudinal axis formed by the passage between septum primum and septum secundum when the device is deployed.

2. The device of claim 1, wherein said first closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the right atrium, and said second closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the left atrium.

3. The device of claim 1, wherein the device includes a material selected from the group consisting of metals, nonmetallic materials, bioresorbable polymers, spring steel, shape memory materials, bioresorbable shape memory polymers, and combinations thereof.

4. The device of claim 3, wherein the device is constituted at least in part of nitinol.

5. The device of claim 1, wherein each of said closure members has a generally heart shape including two lobes that come together at the center joint.

6. The device of claim 1, wherein at least one of said closure members is a loop.

7. A delivery assembly comprising a catheter and the device according to claim 1, wherein the catheter contains the device in an elongated form.