Process for Producing a Hyper-Elastic, High Strength Dilatation Balloon made from Multi-Block Copolymers

Abstract

A self-wrapping dilatation balloon comprising a multiblock copolymer having high elasticity and elastic recovery from nominal strains greater than about 30% is described. Also described herein, is a polymeric extrudate for making a dilatation balloon comprising a multiblock copolymer having tensile strength in the range of about 50 MPa to about 450 MPa, strain at break in the range of about 50% to about 600% and substantially complete elastic recovery from nominal strains of at least about 30%. The extrudate has phase-separated microdomains that are macroscopically aligned in parallel, perpendicular, transverse or a combination thereof. Also described herein is a process for producing a polymeric extrudate for use as a dilatation balloon. The process comprises extruding a multiblock copolymer mixture or composition to form an extrudate. The extruding is done such that the extrudate has phase-separated microdomains that are macroscopically aligned in parallel, perpendicular, transverse or a combination thereof. After extrusion, the process optionally comprises the steps of drawing and coagulating the extrudate.

1 - 25 . (canceled) 
     
     
         26 . A process for producing a dilatation balloon, the process comprising:
 providing a multiblock copolymer composition comprising a multiblock Copolymer, wherein the multiblock copolymer comprises glassy phase end blocks, and blocks adjacent to the end blocks comprising rubber and semi-crystalline phases; and   forming a dilation balloon comprising extruding the multiblock copolymer composition to form an extrudate comprising phase-separated glassy, rubber, and semi-crystalline microdomains that are macroscopically ordered in a perpendicular alignment;   wherein the dilatation balloon demonstrates, during inflation, a true stress vs. nominal strain response curve comprising a first zone representative of a low modulus balloon, a second zone representative of a high strength balloon, and a sharp transition from the first zone to the second zone.   
     
     
         27 . (canceled) 
     
     
         28 . The process of  claim 26 , wherein said multiblock copolymer is a pentablock copolymer, a heptablock copolymer, or a nonablock copolymer. 
     
     
         29 . The process of  claim 26 , wherein at least one block of said multiblock copolymer is polyethylene, polypropylene, poly(cylohexylethylene), polyisoprene, poly(1,3-butadiene), poly(vinyl chloride), poly(vinyl fluoride), poly(chloroprene), poly(methyl acrylate), poly(methyl methacrylate), poly(acrylonitrile), polystyrene or poly(4-vinylpyridine). 
     
     
         30 . The process of  claim 28 , wherein said multiblock copolymer is a pentablock copolymer comprising poly(cyclohexylethylene) and polyethylene blocks. 
     
     
         31 . The process of  claim 26 , wherein said multiblock copolymer composition further comprises an additive. 
     
     
         32 . The process of  claim 31 , wherein said additive is a homopolymer. 
     
     
         33 . The process of  claim 32 , wherein said homopolymer is a polydialkylsiloxane or polyethylene. 
     
     
         34 - 38 . (canceled) 
     
     
         39 . The process of  claim 31 , wherein said additive comprises at least one of a filler, antioxidant, colorant, crosslinking agent, impact strength modifier, drug or biologically active material. 
     
     
         40 . The process of  claim 26 , wherein said multiblock copolymer composition further comprises a plasticizer. 
     
     
         41 . The process of  claim 40 , wherein said plasticizer is a carbonamide, sulfonamide, phenolic compound, cyclic ketone, mixture of phenols and esters, sulfonated ester, sulfonated amide, N-alkylolarylsulfonamide, phthalate ester, amine, aliphatic diol or phosphite ester of an alcohol. 
     
     
         42 . The process of  claim 26 , wherein said multiblock copolymer composition further comprises a solvent. 
     
     
         43 . The process of  claim 42  further including coagulating the extrudate to remove solvent. 
     
     
         44 . The process of  claim 42 , wherein the solubility parameter of said solvent and at least one block of said multiblock copolymer are about equal. 
     
     
         45 . The process of  claim 26 , wherein said extruding comprises extruding at a constant shear rate. 
     
     
         46 . The process of  claim 26 , wherein said dilatation balloon formed is a zero-fold balloon. 
     
     
         47 . The process of  claim 46 , wherein said zero-fold dilatation balloon is self-wrapping. 
     
     
         48 . The process of  claim 26 , wherein said multiblock copolymer composition is a blend of two or more multiblock copolymers. 
     
     
         49 . The process of  claim 26 , wherein forming a dilation balloon further comprises drawing said extrudate. 
     
     
         50 . The process of  claim 26 , wherein forming a dilation balloon further comprises stretch blow-molding said extrudate. 
     
     
         51 . A process for producing a dilatation balloon, the process comprising:
 providing a multiblock copolymer composition comprising a pentablock copolymer, wherein the multiblock copolymer is a pentablock copolymer, a heptablock copolymer, or a nonablock copolymer, and wherein the multiblock copolymer comprises glassy phase end blocks, and blocks adjacent to the end blocks comprising rubber and semi-crystalline phases; and   forming a dilatation balloon comprising extruding the multiblock copolymer composition at a constant shear rate to form an extrudate comprising phase-separated glassy, rubber, and semi-crystalline microdomains that are macroscopically ordered in a perpendicular alignment;   wherein the dilatation balloon, during inflation, demonstrates a true stress vs. nominal strain response curve comprising a first zone representative of a low modulus balloon, a second zone representative of a high strength balloon, and a sharp transition from the first zone to the second zone.   
     
     
         52 . The process of  claim 51 , wherein forming a dilation balloon further comprises drawing said extrudate. 
     
     
         53 . The process of  claim 51 , wherein forming a dilation balloon further comprises stretch blow-molding said extrudate. 
     
     
         54 . A process for producing a dilatation balloon, the process comprising:
 providing a multiblock copolymer composition comprising a pentablock copolymer, wherein the pentablock copolymer comprises glassy phase end blocks, and blocks adjacent to the end blocks comprising rubber and semi-crystalline phases; and   forming a dilatation balloon comprising:
 extruding the multiblock copolymer composition at a constant shear rate to form an extrudate comprising phase-separated glassy, rubber, and semi-crystalline microdomains that are macroscopically ordered in a perpendicular alignment; and 
 drawing said extrudate, 
   wherein the dilatation balloon, during inflation, demonstrates a true stress vs. nominal strain response curve comprising a first zone representative of a low modulus balloon, a second zone representative of a high strength balloon, and a sharp transition from the first zone to the second zone.