Occlusion device and surgical instrument and method for its implantion/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 . A method for the repeatable coupling of an implant, in particular, an occlusion device to a surgical instrument, said implant having a holder which exhibits a head section at its free end disposed with an eyelet in the form of a cross-hole which can be force-fit to and held by an implantation or explantation instrument, said surgical instrument being provided with gripper tongs, the gripping jaws of which can be opened and closed by means of a push/pull system and which are configured so as to be able to grip head section of holder of the implant in a force-fit lock comprising by the following process steps: 
 a. loop of insertion thread or guidewire is guided through eyelet of the holder of the implant prior to beginning the intravascular procedure and hooked on a fix point provided for the purpose on gripper tongs while the first and second loose ends of the insertion thread or guidewire are held or fastened in the area of first gripping sections,    b. head section of holder of the implant is grabbed by gripping tongs;    c. the second loose end of insertion thread/guidewire provided with nipple is tightened until head section is fully accommodated within gripping jaws;    d. releasing the second loose end provided with the nipple releases gripper tongs from head section of the implant and the seating of the implant is checked;    e. insertion thread/guidewire allows gripper tongs to recouple with holder of the implant at any time.    
   
   
       2 . The method of  claim 1 , wherein the implant is an occlusion device consisting of a braiding 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, having a proximal retention area, a distal retention area, at which the ends of the wires or threads converge into a holder, and having a cylindrical crosspiece interposed between said proximal retention area and said distal retention area, whereby the two retention areas position on the two sides of a shunt to be occluded in a septum following implantation while the crosspiece transverses the shunt.  
   
   
       3 . The method of  claim 1 , wherein the head section of the implant is configured as a spherical head.  
   
   
       4 . The method of  claim 1 , wherein the dual-sided cut discharge surface of the cross-hole is configured to converge with the outer surface of the spherical head toward the free end of the holder.  
   
   
       5 . The method of  claim 1 , wherein the push/pull system of the surgical instrument essentially comprises the following components: a coil spring, through the interior of which an actuator means  107  extends axially being rigid in the axial direction yet still sufficiently flexible, a shaft of gripper tongs being affixed at its proximal end and a first gripping section at its distal end; a taper sleeve which receives the shaft of the axially-displaceable gripper tongs at its proximal end section and the proximal end of coil spring at its distal end section by abutting against a stop; and a second gripping section, at which the distal end of 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 taper sleeve and open as a result of the forward advancing of actuator means.  
   
   
       6 . The method of  claim 1 , wherein the surgical instrument is provided with an insertion thread or guidewire which extends out of gripper tongs in the delivery state of said surgical instrument from its 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 coil spring to said first gripping section at the distal end of the surgical instrument, whereby loop can be guided through eyelet of holder of the implant and affixed to gripper tongs prior to the implantation of the implant.  
   
   
       7 . A method for the repeatable coupling of an implant, in particular, an occlusion device, to a surgical instrument, said implant having a holder, which exhibits a head section at its free end disposed with an eyelet in the form of a cross-hole which can be force-fit to and held by an implantation or explantation instrument, said eyelet being slit diagonally to the cross-hole, whereby the ends of the diagonal slot overlap with respect to the longitudinal direction of the cross-hole, said surgical instrument being provided with gripper tongs, the gripping jaws of which can be opened and closed by means of a push/pull system and which are configured so as to be able to grip head section of holder of the implant in a force-fit lock, wherein the push/pull system essentially 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 proximal end and a first gripping section at its distal end; a taper sleeve which receives the shaft of the axially-displaceable gripper tongs at its proximal end section and the proximal end of coil spring at its distal end section by abutting against a stop; and a second gripping section, at which the distal end of 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 taper sleeve and open as a result of the forward advancing of actuator means, 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, with the help of which the insertion thread or guidewire can either be stretched in the coupled state of the implant after loop having moved through the diagonal slot in eyelet or has again become so loose upon the uncoupling of the implant from the operative device that said loop can be moved out of the eyelet through diagonal slot, 
 comprising by the following process steps:    (a) loop of insertion thread or guidewire is guided through the diagonal slot in eyelet of holder of the implant prior to beginning the (intravascular procedure while the first and second loose ends of insertion thread or guidewire) are held or fastened in an area of said first gripping section;    (b) head section of holder of the implant is grabbed by gripping tongs;    (c) the second loose end of insertion thread or guidewire provided with nipple is tightened until head section is accommodated within gripping jaws;    (d) releasing the second loose end provided with the nipple prompts the releasing of gripping tongs from head section of the implant and the seating of the implant is checked;    (e) insertion thread/guidewire allows gripper tongs to recouple with holder of the implant at any time.    
   
   
       8 . A method for the repeatable coupling of an implant, in particular, an occlusion device having a holder, to a surgical instrument, said implant consisting of a braiding 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, having a proximal retention area a distal retention area, at which the ends of wires or threads converge into a holder, and having a cylindrical crosspiece between said proximal retention area and said distal retention area, whereby the two retention areas position on the two sides of a shunt to be occluded in a septum following implantation while the crosspiece transverses the shunt, whereby said holder exhibits a head section at its free end configured as a semi-spherical centering sleeve in longitudinal section comprising an eyelet in the form of a cross-hole and able to be held to an implantation/explantation instrument by means of running a fastening loop through said eyelet, said surgical instrument having a hook is provided which is axially movable toward and away from eyelet by means of a push/pull system as well as a fastening loop extending through said eyelet and hookable to hook, by means of which the implant can be held to the surgical instrument by tensioning the fastening loop when the hook is moved away from the eyelet, 
 comprising by the following process steps:    (a) a fastening loop of defined length is fastened to eyelet of holder of the implant;    (b) said fastening loop is then inserted into cross-groove of cylindrical sleeve such that knot of fastening loop fits centrically through protrusion and the section of fastening loop positioning in cross-groove is held diametrically;    (c) upon a defined forward shifting of hook, the section of fastening loop in the cross-groove slips over hook in the second longitudinal groove and remains anchored there;    (d) withdrawing of said hook pulls and clamps holder of the implant to the proximal face side of sleeve;    (e) a renewed defined forward displacing of hook will again loosen fastening loop and the proximal front side of sleeve loosens from holder and the seating of the implant can be checked;    (f) the use of fastening loop allows recoupling of sleeve to holder of the implant at any time.    
   
   
       9 . The method of  claim 8 , wherein the push/pull system of said surgical instrument essentially comprises the following components: a coil spring, an actuator means extending axially through its interior which is sufficiently rigid in the axial direction yet still flexible, having a shaft of hook attached at its proximal end and a first gripping section affixed at its distal end; a cylindrical sleeve which receives the proximal end of the coil spring by abutting against a stop at its distal end section and which accommodates the shaft of hook in axially-displaceable fashion; and a second gripping section which receives the distal end of the coil spring by abutting against a stop, whereby the hook is axially displaced away from eyelet from the force exerted by the coil spring and which is moved toward eyelet by the forward advancing of said actuator means.  
   
   
       10 . The method of  claim 9 , wherein cylindrical sleeve is disposed with a continuous first longitudinal groove on the proximal forward side, a second longitudinal groove at one side of its center section for the anti-twist guiding of the axially-displaceable hook in the sleeve, and a cross-groove disposed at a right angle to the second longitudinal groove on the one side which extends to the longitudinal axis of the sleeve and has a protrusion at its center for receiving a knot of fastening loop.  
   
   
       11 . The method of  claim 10 , wherein the cross-section of the forward section of hook is configured roughly one-third flatter than the cross-section of the shaft and exhibits play when fitted into the second longitudinal groove of cylindrical sleeve.  
   
   
       12 . The method of  claim 8 , wherein a blade is disposed at the gap formed behind hook at the distal end.