Occlusion Device and Method for its Manufacture

Abstract

The present invention relates to an occlusion device ( 1 ) consisting of a braiding ( 2 ) of thin wires or threads ( 4 ) which is given a suitable form in a molding and heat treatment procedure. The occlusion device ( 1 ) has a proximal retention area ( 6 ) and a distal retention area ( 8 ), whereby the ends of the wires or threads ( 4 ) converge into a holder ( 5 ) in distal retention area ( 8 ). A cylindrical crosspiece ( 10 ) is furthermore disposed between the proximal and distal retention areas ( 6, 8 ). With the objective of providing an occlusion device which positions as flat as possible against the septum at the proximal side of a septal defect in the inserted state, the invention provides for the proximal retention area ( 6 ) of the braiding ( 2 ) to exhibit a completely closed proximal wall ( 112 ) disposed with a continuous surface at the proximal end of the occlusion device ( 1 ) which forms the proximal end ( 12 ) of said occlusion device ( 1 ).

1 . An occlusion device consisting of a holder and a braiding of thin wires or threads, which is given a suitable form in a molding and heat treatment procedure, having a proximal retention area and a distal retention area, wherein the ends of the wires or threads converge into a holder in the distal retention area, and a cylindrical crosspiece interposed between said proximal and distal retention areas, wherein the two retention areas are positioned on the two sides of a shunt to be occluded in a septum usually by way of an intravascular surgical procedure while said crosspiece transverses the shunt, characterized in that 
 the proximal retention area of braiding exhibits a completely closed proximal wall having a continuous surface at the proximal end of the occlusion device which forms the proximal end of said occlusion device.    
   
   
       2 . The occlusion device according to  claim 1 , wherein the proximal wall exhibits a curved surface as the continuous surface.  
   
   
       3 . The occlusion device according to  claim 2 , wherein the curved surface conforms to the surface of a section of a ball-shaped, bulb-shaped or teardrop-like body.  
   
   
       4 . The occlusion device according to  claim 1 , wherein the braiding consists of nitinol or another material having shape-memory or memory effect.  
   
   
       5 . The occlusion device according to  claim 4 , wherein the shape-memory material is a biodegradable material.  
   
   
       6 . The occlusion device according  claim 1 , wherein the braiding tapers to the diameter of a catheter to be used in an intravascular surgical procedure.  
   
   
       7 . The occlusion device according to  claim 6 , wherein the proximal retention area with its proximal wall is configured such that said proximal wall curves outward upon expansion of the occlusion device so as to come into position in such manner with the septal wall.  
   
   
       8 . The occlusion device according to  claim 1 , wherein the distal retention area exhibits a holder preferably arranged axially to crosspiece.  
   
   
       9 . The occlusion device according to  claim 8 , wherein at least one connecting element is further provided at distal retention area, wherein said connecting element is engageable with a catheter.  
   
   
       10 . The occlusion device according  claim 1 , wherein the occlusion device is configured to be reversibly foldable and expandable such that the expanded occlusion device can be folded up using an explantation catheter, wherein the force-fit connection between the proximal wall and the septal wall is disengaged.  
   
   
       11 . A method of manufacturing an occlusion device, in particular an occlusion device according to any one of the preceding claims, wherein the method comprises the following procedural steps: 
 forming a ball-shaped, bulb-shaped or teardrop-shaped hollow braiding by means of a braiding process known per se, wherein said hollow braiding is bundled at a first distal end and exhibits a completely closed proximal wall having a continuous surface on an opposite second proximal end; and    forming a proximal retention area on the proximal wall, a distal retention area on the bundled first end, and a cylindrical crosspiece arranged between said proximal and distal retention areas.    
   
   
       12 . The method according to  claim 11  further comprising the procedural step of forming a holder on the bundled distal end of the hollow braiding.  
   
   
       13 . The method according to  claim 11 , wherein the procedural step of forming the retention areas and the crosspiece includes molding and/or heat treatment.