Occlusion device having spherical secondary shape and mandrel for forming same

Abstract

Some aspects of the present disclosure pertain to spherical devices that comprise a wire having a memorized shape comprising a spherical outer wire layer and a spherical inner wire layer disposed within the spherical outer wire layer. Other aspects of the disclosure pertain to methods of forming such devices, mandrels for forming such devices, and methods of using such devices.

What is claimed is: 
     
         1 . An occlusion device having a memorized spherical shape and comprising a wire having a memorized shape in which the wire comprises a spherical outer wire layer and a spherical inner wire layer disposed within the spherical outer wire layer. 
     
     
         2 . The occlusion device of  claim 1 , wherein the wire is in the form of a coil with a helically wound primary shape and wherein the memorized shape comprises a spherical outer coil layer and a spherical inner coil layer disposed within the spherical outer coil layer. 
     
     
         3 . The occlusion device of  claim 2 , wherein the inner coil layer has a first shape that comprises multiple turns of a first spherical helix having a first axis and the outer coil layer has a second shape that comprises multiple turns of a second spherical helix having a second axis. 
     
     
         4 . The occlusion device of  claim 2 , wherein the inner coil layer has a first shape that comprises 2 to 5 turns of a first spherical helix having a first axis and the outer coil layer has a second shape that comprises 2 to 5 turns of a second spherical helix having a second axis. 
     
     
         5 . The occlusion device of  claim 3 , wherein the first and second axes intersect at an angle ranging from 45° to 90°. 
     
     
         6 . The occlusion device of  claim 2 , comprising an atraumatic distal coil tip. 
     
     
         7 . The occlusion device of  claim 2 , wherein the inner coil layer and the outer coil layer each comprise ends that do not protrude outside the spherical shape. 
     
     
         8 . A spherical mandrel for producing an occlusion device having a memorized spherical shape and comprising a first groove encircling the mandrel for multiple turns and a second groove encircling the mandrel for multiple turns, wherein the first and second grooves intersect and wherein the second groove is shallower than the first groove. 
     
     
         9 . The spherical mandrel of  claim 8 , wherein the first groove has a first shape that comprises multiple turns of a first spherical helix having a first axis and wherein the second groove has a second shape that comprises multiple turns of a second spherical helix having a second axis. 
     
     
         10 . The spherical mandrel of  claim 9 , wherein the first and second axes intersect at an angle ranging from 45° to 90°. 
     
     
         11 . The spherical mandrel of  claim 8 , wherein the mandrel comprises a first anchor adjacent to the first groove and a second anchor adjacent the second groove. 
     
     
         12 . The spherical mandrel of  claim 11 , further comprising a directional member that is configured to permit a wire disposed on the mandrel to transition from the first groove to the second groove. 
     
     
         13 . A method of making an occlusion device comprising (a) winding a wire onto the spherical mandrel of  claim 8  such that the wire is disposed within the first and second grooves; and (b) annealing the wire to form an occlusion device having a memorized shape comprising a spherical outer wire layer and a spherical inner wire layer disposed within the outer wire layer. 
     
     
         14 . A method of making an occlusion device comprising (a) loading a wire onto the spherical mandrel of  claim 12  by a process that comprises fixing a first end of the wire to the first anchor, winding the wire around the spherical mandrel using the first groove as a guide, changing a direction of a wind of the wire by engagement with the direction changing member, winding the wire around the spherical mandrel using the second groove as a guide, and attaching a second end of the wire to the second anchor and (b) annealing the wire to form an occlusion device having a memorized shape comprising a spherical outer wire layer and a spherical inner wire layer disposed within the outer wire layer. 
     
     
         15 . The method of  claim 14 , wherein the wire is in a form of a coil with a helically wound primary shape, which is loaded onto the spherical mandrel. 
     
     
         16 . A method of forming an occlusion comprising (a) advancing a catheter to an entrance of an aneurysm, (b) delivering an occlusion device comprising a wire through the catheter into the aneurysm, wherein the wire is constrained to a substantially linear shape when in the catheter and wherein, upon relaxation after delivery, the wire relaxes to a memorized spherical shape that comprises an outer wire layer and an inner wire layer disposed within the outer wire layer. 
     
     
         17 . The method of  claim 16 , wherein the wire is in a form of a helical coil that forms a spherical outer coil layer and a spherical inner coil layer disposed within the spherical outer coil layer. 
     
     
         18 . The method of  claim 17 , wherein the inner coil layer has a first shape that comprises multiple turns of a first spherical helix having a first axis and the outer coil layer has a second shape that comprises multiple turns of a second spherical helix having a second axis. 
     
     
         19 . The method of  claim 17 , wherein the inner coil layer has a first shape that comprises 2 to 5 turns of a first spherical helix having a first axis and the outer coil layer has a second shape that comprises 2 to 5 turns of a second spherical helix having a second axis. 
     
     
         20 . The method of  claim 19 , wherein the first and second axes intersect at an angle ranging from 45° to 90°.