Split ends closure device and methods of use

• US 8,828,049 B2
• Filed: 01/21/2010
• Issued: 09/09/2014
• Est. Priority Date: 04/09/2004
• 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): TYSON, MELANIE RUANO
• Application Number:
  US12/691,648
• Publication Number:
  US 20100131006A1
• Time in Patent Office: 1,692 Days
• Field of Search: 606151-158, 606213-217, 623 2372- 2376
• 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 2017/00243 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

Abstract

Devices for and methods of closing a patent foramen ovale (PFO), thus reducing or eliminating blood flow through the defect The device is formed from a tubular structure having split ends, such that, after insertion, struts defined by the split ends pivot in a radial direction away from the tube, thereby securing the device within the septal defect. Methods include inserting the device as a tubular structure into the PFO and causing the struts to extend radially away from the central axis of the device.

Claims

1. A method for closing a PFO, the method comprising:

inserting a tubular structure into the PFO via a catheter, the tubular structure having a central axis, a proximal end, and a distal end, wherein both of the ends has a first plurality of slits having a first length that extend in an axial direction from the proximal and distal end of the tubular structure to form bases for struts, and a second plurality of slits having a second length shorter than the first length that extend in an axial direction from the bases of the tubular structure and are offset from the first plurality of slits to form struts, said struts having a free end, wherein the tubular structure is a polymer, a metal with shape memory properties, or a metal with elastic recovery properties, such that radial extension of the struts is caused by at least one of a temperature change associated with insertion into the PFO and elastic recovery upon removal of the tubular structure from the catheter;

causing the struts to extend radially away from the central axis such that the free ends of the struts on both the proximal and distal ends curve toward one another to form a plurality of opposing parallel open loops on both the proximal and distal ends, so the struts secure a central portion of the tubular structure within a tunnel of the PFO; and

closing the PFO.

2. The method of claim 1, wherein the radial extension of the struts is assisted by at least one tensioner comprising at least one of an elastic band and a string, the tensioner attached at one end to a strut extending from the distal end of the tubular structure and at the other end to an opposing strut extending from the proximal end of the tubular structure.

3. The method of claim 1, wherein a tissue scaffold is attached to at least one of the struts.

4. The method of claim 1, wherein the tubular structure includes a central structure that assists a healing of a tissue adjacent to the PFO following insertion of the tubular structure, the central structure comprising at least one of whiskers attached to the exterior of the tubular structure and a collar including a drug-dispensing sponge-like material.

5. The method of claim 1, wherein the first plurality of slits comprises two slits that are 180°

apart, and the second plurality of slits comprises two slits that are radially offset by 90°

from the first plurality of slits.

6. The method of claim 1, wherein the first plurality of slits on the proximal end are aligned with the first plurality of slits on the distal end.

7. The method of claim 1, wherein the first plurality of slits on the proximal end are circumferentially offset from the first plurality of slits on the distal end.

8. The method of claim 1, wherein ends of the struts are rounded to reduce trauma when the device is implanted.