Split ends closure device

Abstract

A device closes 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.

1 . A device for use with a septal defect comprising a first configuration having dimensions suitable for insertion into a catheter, the device in the first configuration including a tubular structure with a central axis, a proximal end, and a distal end, wherein at least one of the ends has a plurality of slits extending in an axial direction away from the end, the slits defining struts that are pivotable away from the rest of the tubular structure.  
   
   
       2 . The device of  claim 1 , wherein the plurality of slits is selected from the group consisting of 2, 3, 4, 5, 6, 7, 8, 9, and 10 slits.  
   
   
       3 . The device of  claim 1 , wherein the plurality of slits have different lengths.  
   
   
       4 . The device of  claim 1 , wherein the slits are distributed evenly around the circumference.  
   
   
       5 . The device of  claim 1 , wherein the slits are distributed unevenly around the circumference.  
   
   
       6 . The device of  claim 1 , wherein the proximal and distal ends each have slits, wherein each slit extending from the proximal end is aligned with a corresponding slit extending from the distal end.  
   
   
       7 . The device of  claim 1 , wherein the proximal and distal ends each have slits, wherein each slit extending from the proximal end is offset at a circumferential angle of less than 180 degrees with respect to a corresponding slit from the distal end.  
   
   
       8 . The device of  claim 1 , wherein an axially central portion of the structure has whiskers that provoke an inflammatory response.  
   
   
       9 . The device of  claim 1 , further comprising a collar including a sponge-like material at an axially central portion of the structure.  
   
   
       10 . The device of  claim 1 , further comprising a drug coating at an axially central portion of the structure.  
   
   
       11 . The device of  claim 1 , further comprising an anticoagulant at an axially central portion of the structure.  
   
   
       12 . The device of  claim 1  further comprising means for causing the struts to extend radially away from the central axis of the tubular structure in a second configuration when released from a catheter and into the body.  
   
   
       13 . The device of  claim 12 , wherein the means includes a tissue scaffold attached to at least one of the struts.  
   
   
       14 . The device of  claim 13 , wherein the tissue scaffold includes at least one of a bioresorbable material, a flexible biocompatible material capable of promoting tissue growth, a polyester fabric, a Teflon-based material, a polyurethane, a metallic mesh, polyvinyl alcohol, an extracellular matrix, a synthetic bioabsorbable polymeric scaffold, and collagen.  
   
   
       15 . The device of  claim 12 , wherein the means includes a 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.  
   
   
       16 . The device of  claim 12 , wherein the structure comprises a polymer with shape memory properties.  
   
   
       17 . The device of  claim 12 , wherein the second configuration is suitable for blocking part or all of a patent foramen ovale (PFO) and the struts secure the device within the PFO.  
   
   
       18 . The device of  claim 12 , wherein prior to insertion into the body, the second configuration comprises distal end struts having ends that are closer to the proximal end of the structure than the ends of the proximal end struts.  
   
   
       19 . The device of  claim 12 , wherein the second configuration comprises at least one pair of distal end struts that are curved so as to touch in a region near the end of each member of the pair, and at least one pair of proximal end struts that are curved so as to touch in a region near the end of each member of the pair.  
   
   
       20 . The device of  claim 12 , further comprising a recovery wire attached to a plurality of struts, such that a tension applied to the recovery wire causes the second configuration to deform in a manner that permits the device to be retracted into the catheter.  
   
   
       21 . A PFO closure device comprising a tubular structure having a central axis, a proximal end, and a distal end, wherein at least one of the ends has a plurality of slits extending in an axial direction from the end, the slits defining struts that extend radially away from the central axis of the tubular structure, the struts securing the device within a tunnel of the PFO.  
   
   
       22 . The device of  claim 21 , wherein each proximal end strut is circumferentially aligned with a corresponding distal end strut.  
   
   
       23 . The device of  claim 21 , wherein at least one proximal end strut is circumferentially offset with respect to a corresponding distal end strut.  
   
   
       24 . The device of  claim 21  further comprising a tissue scaffold attached to at least one of the struts.  
   
   
       25 . A method for closing a PFO, the method comprising: 
 inserting a tubular structure into the PFO via a catheter, the tubular device having a central axis, a proximal end, and a distal end, wherein at least one of the ends has a plurality of slits extending in an axial direction from the end, the slits defining struts;    causing the struts to extend radially away from the central axis such that the struts secure a central portion of the tubular structure within a tunnel of the PFO; and    closing the PFO.    
   
   
       26 . The method of  claim 25 , wherein the tubular structure comprises a material selected from the group consisting of a polymer, a metal with shape memory properties, and a metal with elastic recovery properties, such that the 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 device from the catheter.  
   
   
       27 . The method of  claim 25 , 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.  
   
   
       28 . The method of  claim 25 , wherein a tissue scaffold is attached to at least one of the struts.  
   
   
       29 . The method of  claim 25 , wherein the tubular device includes a central structure that assists a healing of a tissue adjacent to the PFO following insertion of the device, 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.