Split ends closure device and methods of use
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.
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.