Double spiral patent foramen ovale closure clamp

Abstract

The present invention provides a device which is adapted to press together the septum primum and the septum secundum between the atrial chambers to close any tunnel in the septum. The device in its preferred form has two clamping members, one on each side of the septum and a central connector which connects the two clamping members and passes through the tunnel. The device is configured to conform to the anatomy such that the tunnel is not substantially deformed by the device. The central connector, in its preferred form has two wires that are spaced apart so that the wires are proximate the lateral sides of the tunnel. The spacing allows the device to be centered at an appropriate location.

1 . A device adapted to press together the septum primum and the septum secundum between the atrial chambers, the device comprising: 
 two clamping members, one on each side of the septum and a central connector which connects the two clamping members and passes through the tunnel wherein the central connector includes two wires that are spaced apart at a portion of their length so that the wires are proximate the lateral sides of the tunnel so that the device may be centered in a passage between the atrial chambers.    
     
     
         2 . The device of  claim 1  wherein at least one of the clamping members include elongate wire members that are spiral shaped.  
     
     
         3 . The device of  claim 2 , wherein the central connector is connected to at least one clamping member at an inner part of the spiral shape.  
     
     
         4 . The device of  claim 2 , wherein the central connector is connected to at least one clamping member at the outer part of the spiral shape.  
     
     
         5 . The device of  claim 2 , wherein the force applied to the septum primum and septum secundum is created by the spiral shape of the elongate member.  
     
     
         6 . The device of  claim 1  wherein the clamping members are formed from nitinol.  
     
     
         7 . The device of  claim 1 , wherein the central connector is formed from nitinol.  
     
     
         8 . The device of  claim 1 , wherein the central connector is adapted to center the device in the lateral direction along a longitudinal passageway.  
     
     
         9 . The device of  claim 2 , wherein the claimping members are constructed of nitinol sheets which have been shaped to form the spirals.  
     
     
         10 . The device of  claim 2  wherein the spirals circle around more than 360 degrees.  
     
     
         11 . The device of  claim 10  wherein the spirals have a helical form.  
     
     
         12 . The device of  claim 1 , wherein the clamping members are formed by a plurality of wires and the wires are adapted to spread out along the septum to provide a desired clamping force.  
     
     
         13 . A connecting member for a PFO closure device configured to join two end pieces adapted to be disposed along a Patent Foramen Ovale tunnel, the connecting member comprising at least one wire that forms an S shaped curve wherein the outermost lateral sides of the S shaped curves are configured to be adjacent the lateral sides of the Patent Foramen Ovale tunnel.  
     
     
         14 . The connecting member for a PFO closure device of  claim 13  wherein the connecting member includes a wire that is helically wound to minimize trauma to the PFO tissue.  
     
     
         15 . The connecting member for a PFO closure device of  claim 14  wherein the connecting member includes a helically wound wire wrapped around a central wire that provides stability to the connecting member.  
     
     
         16 . The connecting member for a PFO closure device of  claim 13  wherein the connecting member includes whiskers to facilitate the implantation of the device at an implantation location.  
     
     
         17 . The connecting member for a PFO closure device of  claim 13  wherein the surface of the connecting member is roughened to facilitate implantation of the device at an implantation location.  
     
     
         18 . The connecting member for a PFO closure device of  claim 17  wherein the surface of the connecting member is roughened such that friction along the wire from movement in one direction is higher than movement along the wire in the opposite direction.  
     
     
         19 . The connecting member for a PFO closure device of  claim 13  wherein at least one of the wires includes at least two wire segments joined at a location such that the wires are able to move with respect to on another.  
     
     
         20 . The connecting member for a PFO closure device of  claim 19  werein the at least two wires are joined by a trailer hitch-type joint.  
     
     
         21 . A connecting member configured to join two end pieces adapted to be disposed along a Patent Foramen Ovale tunnel, the connecting member comprising at least two wires that are joined at each end and spread apart between the ends, wherein wires are adapted to spread out a predetermined amount that is less than a predetermined distance between the lateral sides of a Patent Foramen Ovale tunnel.  
     
     
         22 . The connecting member for a PFO closure device of  claim 21  wherein the connecting member includes a wire that is helically wound to minimize trauma to the PFO tissue.  
     
     
         23 . The connecting member for a PFO closure device of  claim 22  wherein the connecting member includes a helically wound wire wrapped around a central wire that provides stability to the connecting member.  
     
     
         24 . The connecting member for a PFO closure device of  claim 21  wherein the connecting member includes whiskers to facilitate the implantation of the device at an implantation location.  
     
     
         25 . The connecting member for a PFO closure device of  claim 21  wherein the surface of the connecting member is roughened to facilitate implantation of the device at an implantation location.  
     
     
         26 . The connecting member for a PFO closure device of  claim 25  wherein the surface of the connecting member is roughened such that friction along the wire from movement in one direction is higher than movement along the wire in the opposite direction.  
     
     
         27 . The connecting member for a PFO closure device of  claim 21  wherein at least one of the wires includes at least two wire segments joined at a location such that the wires are able to move with respect to on another.  
     
     
         28 . The connecting member for a PFO closure device of  claim 27  wherein the at least two wires are joined by a trailer hitch-type joint.  
     
     
         29 . The connecting member for a PFO closure device of  claim 21  wherein the at least two wire are adapted to have a hook to pierce the tissue where the device is intended to be implanted.  
     
     
         30 . The connecting member for a PFO closure device of  claim 21  further comprising a membrane attached to the connecting member.  
     
     
         31 . The connecting member for a PFO closure device of  claim 21  wherein the connecting member includes a surface coating that promotes tissue growth.  
     
     
         32 . The connecting member for a PFO closure device of  claim 13  further comprising a membrane attached to the connecting member.  
     
     
         31 . The connecting member for a PFO closure device of  claim 13  wherein the connecting member includes a surface coating that promotes tissue growth.  
     
     
         33 . The device of  claim 1  further including a membrane attached to the connecting member.  
     
     
         34 . The device of  claim 1  wherein the connecting member includes a surface coating that promotes tissue growth.