Polymer covered vaso-occlusive devices and methods of producing such devices

Abstract

This is a medical device for forming an embolism within the vasculature of a patient. More particularly, it concerns an occlusion device comprising an inner core covered with a polymer. The medical device encourages cellular attachment and growth while maintaining favorable handling, deployment and visualization characteristics.

1 . A method for making a vaso-occlusive device, comprising: 
 a) winding at least one polymeric fiber about a wire; and    b) shaping the polymer wrapped wire of step (a) into a primary shape.    
     
     
         2 . The method of  claim 1  further shaping the polymeric covered wire into a secondary shape.  
     
     
         3 . The method of  claim 2  where the secondary shape is shaped by pulling a stylet through the primary shape of the polymeric covered wire.  
     
     
         4 . The method of  claim 2  wherein the secondary shape is selected from the group consisting of clover-leaf shaped, figure-8 shaped, flower-shaped, vortexshaped, ovoid, randomly shaped, spherical shaped, and substantially spherical.  
     
     
         5 . The method of  claim 1  wherein the primary shape comprises an elongated helical coil.  
     
     
         6 . The method of  claim 1  wherein the primary shape is a cylindrical helical coil.  
     
     
         7 . The method of  claim 1  wherein the wire comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, and alloys thereof.  
     
     
         8 . The method of  claim 1  wherein the polymeric fiber is selected from the group consisting of protein-based polymers, absorbable polymers, and nonprotein based polymers.  
     
     
         9 . The method of  claim 1  where the polymeric fiber comprises a mono-filament.  
     
     
         10 . The method of  claim 1  where the polymeric fiber comprises a multifilament comprised of a plurality of filaments.  
     
     
         11 . The product made by the method of  claim 1 .  
     
     
         12 . A method for making a vaso-occlusive device, comprising: 
 a) shaping a wire into a primary shape;    b) winding at least one polymeric fiber about a mandrel;    c) applying heat to the at least one polymeric fiber;    d) removing the at least one polymeric fiber from the mandrel; and    e) attaching the at least one polymeric fiber about the primary shape of the wire.    
     
     
         13 . The method of  claim 12  further comprising the step of heating the wire to further shape the wire into a secondary shape prior to the step of attaching the at least one polymeric fiber about the primary shape of the wire.  
     
     
         14 . The method of  claim 12  further shaping the polymeric covered device into a secondary shape.  
     
     
         15 . The method of  claim 1  where the secondary shape is shaped by pulling a stylet through the primary shape of the polymeric covered wire.  
     
     
         16 . The method of  claim 12  further heating the polymeric covered wire.  
     
     
         17 . The method of  claim 12  wherein the primary shape comprises an elongated helical coil.  
     
     
         18 . The method of  claim 12  wherein the primary shape is a cylindrical helical coil.  
     
     
         19 . The method of  claim 12  wherein the wire comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, and alloys thereof.  
     
     
         20 . The method of  claim 12  wherein the polymeric fiber is selected from the group consisting of protein-based polymers, bio-absorbable polymers, and nonprotein based polymers.  
     
     
         21 . The method of  claim 12  wherein the secondary shape is selected from the group consisting of clover-leaf shaped, figure-8 shaped, flower-shaped, vortexshaped, ovoid, randomly shaped, and substantially spherical.  
     
     
         22 . The method of  claim 12  where the polymeric fiber comprises a monofilament.  
     
     
         23 . The method of  claim 12  where the polymeric fiber comprises a multifilament comprised of a plurality of filaments.  
     
     
         24 . The product made by the process of  claim 12 .  
     
     
         25 . A method of at least partially occluding an aneurysm comprising: 
 a) making a polymer covered coil according to the method of  claim 4;  and    b) deploying the polymer covered coil into the aneurysm.    
     
     
         26 . The method of  claim 25 , wherein the polymer covered coil includes an electrolytically detachable tip and is deployed using an electrical current.  
     
     
         27 . The method of  claim 25 , wherein the polymer wrapper coil includes a mechanically detachable tip and is deployed using a mechanical detachment.  
     
     
         28 . A vaso-occlusive device comprising a wire formed into a primary shape wherein said primary shape is covered with a non-woven wrap.  
     
     
         29 . The vaso-occlusive device of  claim 28  where the wrap comprises at least one polymeric fiber.  
     
     
         30 . The vaso-occlusive device of  claim 28  where the wrap is helically wound about the primary shape.  
     
     
         31 . The vaso-occlusive device of  claim 28  where the wrap is wound about the wire with a closed pitch.  
     
     
         32 . The vaso-occlusive device of  claim 28  where the wrap is wound about the wire with an open pitch.  
     
     
         33 . The vaso-occlusive device of  claim 28  where the device is radiopaque.  
     
     
         34 . The vaso-occlusive device of  claim 33  where the wrap further comprises a radiopaque additive.  
     
     
         35 . The vaso-occlusive device of  claim 33  where the wire is radiopaque.  
     
     
         36 . The vaso-occlusive device of  claim 28  further having a detachable tip.  
     
     
         37 . The vaso-occlusive device of  claim 36  where said detachable tip is an electrolytically severable joint attached to the device, said electrolytically severable joint being relatively more susceptible to electrolysis in an ionic solution than is the device, wherein the device is electrically isolated from said electrolytically severable joint.  
     
     
         38 . The vaso-occlusive device of  claim 28  where said primary shape is a substantially helical coil.  
     
     
         39 . The vaso-occlusive device of  claim 38  where said wire has a secondary shape.  
     
     
         40 . The vaso-occlusive device of  claim 39  where said secondary shape is selected from the group consisting of clover-leaf shaped, figure-8 shaped, flowershaped, vortex-shaped, ovoid, randomly shaped, and substantially spherical.  
     
     
         41 . The vaso-occlusive device of  claim 28  where the wrap comprises a mono-filament.  
     
     
         42 . The vaso-occlusive device of  claim 28  where the wrap comprises multi-filament comprised of a plurality of filaments.  
     
     
         43 . The vaso-occlusive device of  claim 39  further comprising a stretchresisting member having a first end and a second end, the stretch-resisting member extending through at least a portion of an interior of said primary shape, said stretchresisting member not substantially affecting the shape of said wire when said wire is in said secondary shape, and said stretch-resisting member being attached to said device in at least two locations.  
     
     
         44 . The vaso-occlusive device of  claim 28  where the wrap is a biodegradable polymer.  
     
     
         45 . The vaso-occlusive device of  claim 44  where the biodegradable polymer is comprised of at least one polymer selected form group consisting of: lactide, glycolide, and caprolactone polymers and their copolymers; hydroxybutyrate and polyhydroxyvalerate and their block and random copolymers; a polyether ester; anhydrides, polymers and copolymers of sebacic acid, hexadecandioic acid; and orthoesters.  
     
     
         46 . The vaso-occlusive device of  claim 45  where the biodegradable polymer comprises polydioxinone.  
     
     
         47 . The vaso-occlusive device of  claim 44  where the biodegradable polymer is comprised of at least one polymer selected from the group consisting of: polyglycolic and polylactic acids, their block and random copolymers.