Occlusion Device And Surgical Instrument And Method For Its Implantation/Explantation

Abstract

An occlusion device includes a braiding of thin wires or threads tapering to the diameter of a catheter used for an intravascular implantation/explantation procedure and having a proximal retention area, a distal retention area at which ends of the wires or threads converge into a holder, and a cylindrical crosspiece interposed between the proximal retention area and the distal retention area, whereby the two retention areas are positioned on two sides of a shunt to be occluded in a septum following implantation while the crosspiece transverses the shunt. The holder exhibits a head section at its free end having an eyelet as a cross-hole which can be gripped and held in form-fit fashion by an implantation/explantation instrument. A surgical instrument having such a holder includes gripper tongs with gripping jaws which open and close by a push/pull system, and which force-fit grips the head section of the holder.

1 . An occlusion device comprising:
 a braiding of one of thin wires or threads which is given a suitable final form by means of a molding and heat treatment procedure and which tapers to the diameter of a catheter used for an intravascular implantation or explantation procedure, including:
 a proximal retention area; 
 a distal retention area, at which the ends of the wires or threads converge into a holder, and 
 a cylindrical crosspiece interposed between said proximal retention area and said distal retention area; 
   wherein the two retention areas are positioned on two sides of a shunt to be occluded in a septum following implantation while the crosspiece transverses the shunt; and   wherein said holder exhibits a head section at a free end that is disposed with an eyelet in a form of a cross-hole which can be force-fit to and held by an implantation or explantation instrument.   
     
     
         2 . The occlusion device in accordance with  claim 1 , wherein the head section is configured as a spherical head. 
     
     
         3 . The occlusion device in accordance with  claim 2 , further comprising a dual-sided cut discharge surface of the cross-hole that is configured to converge with an outer surface of the spherical head toward the free end of the holder. 
     
     
         4 . The occlusion device in accordance with  claim 1 , wherein said eyelet is slit diagonally to the cross-hole, whereby the ends of the diagonal slot overlap with respect to the longitudinal direction of the cross-hole. 
     
     
         5 . (canceled) 
     
     
         6 . A surgical instrument for implantation and explantation of an implant having a holder, in particular an occlusion device, comprising:
 a braiding of one of thin wires or threads which is given a suitable final form by means of a molding and heat treatment procedure and which tapers to the diameter of a catheter used for an intravascular implantation or explantation procedure, including:
 a proximal retention area; 
 a distal retention area, at which the ends of the wires or threads converge into said holder, and 
 a cylindrical crosspiece interposed between said proximal retention area and said distal retention area; 
   wherein the two retention areas are positioned on the two sides of a shunt to be occluded in a septum following implantation while the crosspiece transverses the shunt; and   wherein said holder exhibits a head section at its a free end that is disposed with an eyelet in a form of a cross-hole which can be force-fit to and held by an implantation or explantation instrument;   further comprising:
 gripper tongs having gripping jaws which can be opened and closed by a push/pull system and which are configured so as to be able to grip the head section of the holder of the implant in a force-fit lock. 
   
     
     
         7 . The surgical instrument in accordance with  6 , wherein the push/pull system comprises the following components:
 a coil spring, through the interior of which an actuator means extends axially being rigid in the axial direction yet still sufficiently flexible;   a shaft of gripper tongs being affixed at its a proximal end and a first gripping section at a distal end;   a taper sleeve which receives the shaft of the axially-displaceable gripper tongs at the proximal end section and the proximal end of the coil spring at the distal end section by abutting against a stop; and   a second gripping section, at which the distal end of the coil spring is received by abutting against a stop, whereby gripping jaws close from the force exerted by the coil spring on the outer adjacent proximal frontal end of the taper sleeve and open as a result of the forward advancing of actuator means.   
     
     
         8 . The surgical instrument in accordance with  claim 6 , further comprising:
 an insertion thread or guidewire, which extends out of gripper tongs in the delivery state of said surgical instrument from the proximal end in the form of a loop and which is guided by the two loose ends through the interior of taper sleeve and the interior of the coil spring to said first gripping section at the distal end of the surgical instrument, whereby the loop can be guided through the eyelet of holder of the implant and affixed to gripper tongs prior to the implantation of the implant.   
     
     
         9 . The surgical instrument in accordance with  claim 7 , wherein a first loose end of said insertion thread or guidewire is attachable in the area of the first gripping section while the second loose end of said insertion thread or guidewire is provided with a nipple, wherein the insertion thread or guidewire is stretched in the coupled state of the implant or retracted from the surgical instrument after the connection between the first end and the first gripping section has been disengaged. 
     
     
         10 . The surgical instrument in accordance with  claim 7 , for the implantation and explantation of an implant having the holder, in particular an occlusion device, wherein said eyelet is slit diagonally to the cross-hole, and whereby the ends of the diagonal slot overlap with respect to the longitudinal direction of the cross-hole; and
 wherein a first loose end of said insertion thread or guidewire is attachable in the area of the first gripping section while the second loose end of said insertion thread or guidewire is provided with a nipple, wherein the insertion thread or guidewire is stretched in the coupled state of the implant after loop having moved through the diagonal slot in eyelet or is made loose upon the uncoupling of the implant from the operative device that said loop is moved out of the eyelet through diagonal slot.   
     
     
         11 . The surgical instrument in accordance with  claim 8 , wherein said insertion thread or guidewire is made from nitinol wire. 
     
     
         12 - 17 . (canceled) 
     
     
         18 . A method for a repeatable coupling of an implant having a holder, in particular an occlusion device, to a surgical instrument, comprising:
 guiding a loop of insertion thread or guidewire through an eyelet of the holder of the implant prior to beginning an intravascular procedure and hooking on a fixed point provided for that purpose on gripper tongs while first and second loose ends of the insertion thread or guidewire are held or fastened in an area of first gripping sections;   grabbing a head section of the holder of the implant by gripping tongs; tightening the second loose end of insertion thread/guidewire provided with a nipple until said head section is fully accommodated within gripping jaws of said gripping tongs;   releasing the second loose end provided with the nipple which releases said gripper tongs from said head section of the implant and checking a seating of the implant;   allowing insertion thread/guidewire to recouple said gripper tongs with said holder of the implant at any time.   
     
     
         19 - 20 . (canceled)