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 . A process for producing a polymeric extrudate for use as a dilatation balloon, the process comprising: 
 contacting a multiblock copolymer with a solvent to form a multiblock copolymer mixture;    extruding said multiblock copolymer mixture to form an extrudate; and    drawing said extrudate,    wherein said extrudate has 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 elasticity at nominal strains of at least about 30%.    
     
     
         2 . The process of  claim 1 , wherein said extrudate has substantially complete elastic recovery from nominal strains of at least about 30%.  
     
     
         3 . The process of  claim 1 , wherein said extrudate has tensile strength in the range of about 150 MPa to about 250 MPa, strain at break in the range of about 300% to about 500% and substantially complete elastic recovery from strains of at least about 30%.  
     
     
         4 . The process of  claim 1 , wherein said extrudate has tensile strength in the range of about 50 MPa to about 150 MPa, strain at break in the range of about 50% to about 300% and substantially complete elastic recovery from strains of at least about 30%.  
     
     
         5 . The process of  claim 1 , wherein said extrudate has tensile strength in the range of about 250 MPa to about 450 MPa, strain at break in the range of about 500% to about 600% and substantially complete elastic recovery from strains of at least about 30%.  
     
     
         6 . The process of  claim 1 , wherein said extrudate has tensile strength of at least 150 MPa, strain at break at least 120% and substantially complete elastic recovery from strains of at least about 40%.  
     
     
         7 . The process of  claim 1 , wherein said extruding further comprises: 
 extruding said multiblock copolymer mixture at a constant rate such that said extrudate has phase-separated microdomains that are macroscopically aligned in parallel, perpendicular, transverse, or a combination thereof.    
     
     
         8 . The process of  claim 7 , wherein said microdomains are about 5 nm to about 1000 nm in size.  
     
     
         9 . The process of  claim 1 , wherein said extruding further comprises: 
 extruding said multiblock copolymer mixture at a variable rate such that said extrudate has two or more portions with different macroscopically aligned phase-separated microdomains, wherein said microdomains are macroscopically aligned in parallel, perpendicular, transverse, or a combination thereof.    
     
     
         10 . The process of  claim 1 , wherein said extruding further comprises: 
 extruding said material at a temperature that is about equal to or less than the order-disorder transition temperature for said multiblock copolymer mixture.    
     
     
         11 . The process of  claim 1 , wherein said multiblock copolymer mixture comprises about 75 wt. % multiblock copolymer and about 25 wt. % solvent.  
     
     
         12 . The process of  claim 1 , wherein the solubility parameter of said solvent and at least one block of said multiblock copolymer are about equal.  
     
     
         13 . The process of  claim 1 , wherein said solvent comprises a plasticizer.  
     
     
         14 . The process of  claim 13 , wherein the solubility parameter of said plasticizer and at least one block of said multiblock copolymer are about equal.  
     
     
         15 . The process of  claim 13 , 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.  
     
     
         16 . The process of  claim 1 , wherein said extruding further comprises: 
 extruding a multiblock copolymer mixture comprising a diblock, triblock, butablock, pentablock, hexablock, heptablock, octablock, nonablock, decablock, undecablock or dodecablock copolymer.    
     
     
         17 . The process of  claim 16 , 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).  
     
     
         18 . The process of  claim 1 , wherein said multiblock copolymer is a triblock or pentablock copolymer comprising poly(cyclohexylethylene) and polyethylene blocks.  
     
     
         19 . The process of  claim 1 , wherein said multiblock copolymer mixture further comprises at least one of a filler, antioxidant, colorant, crosslinking agent, impact strength modifier, drug or biologically active material.  
     
     
         20 . The process of  claim 1 , wherein said drawing comprises: 
 drawing said extrudate uniaxially or biaxially.    
     
     
         21 . The process of  claim 20 , wherein said drawing comprises: 
 drawing said extrudate biaxially in radial and longitudinal directions.    
     
     
         22 . The process of  claim 1 , further comprising: 
 coagulating said extrudate after said extruding.    
     
     
         23 . The process of  claim 22 , wherein said coagulating comprises: 
 coagulating said extrudate under vacuum.    
     
     
         24 . The process of  claim 22 , wherein said coagulating comprises: 
 coagulating said extrudate in a fluid.    
     
     
         25 . The process of  claim 22 , wherein said fluid is a C 1 -C 6  alcohol.  
     
     
         26 . A process for producing a polymeric extrudate for use as a dilatation balloon, the process comprising: 
 extruding a multiblock copolymer composition to form an extrudate; and    drawing said extrudate,    wherein said extrudate has 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 elasticity at nominal strains of at least about 30%.    
     
     
         27 . The process of  claim 26 , wherein said etrudate has substantially complete elastic recovery from nominal strains of at least about 30%.  
     
     
         28 . The process of  claim 26 , wherein said extruding further comprises: 
 extruding a multiblock copolymer mixture comprising a diblock, triblock, butablock, pentablock, hexablock, heptablock, octablock, nonablock, decablock, undecablock or dodecablock copolymer.    
     
     
         29 . The process of  claim 27 , 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 triblock or pentablock copolymer comprising poly(cyclohexylethylene) and polyethylene blocks.  
     
     
         31 . The process of  claim 26 , wherein said composition further comprises an additive, modifier or plasticizer.  
     
     
         32 . The process of  claim 26 , wherein said composition further comprises a homopolymer.  
     
     
         33 . The process of  claim 31 , wherein said homopolymer is a polydialkylsiloxane or polyethylene.  
     
     
         34 . The process of  claim 26 , wherein said extrudate has tensile strength in the range of about 150 MPa to about 250 MPa, strain at break in the range of about 300% to about 500% and substantially complete elastic recovery from strains of at least about 30%.  
     
     
         35 . The process of  claim 26 , wherein said extrudate has tensile strength in the range of about 50 MPa to about 150 MPa, strain at break in the range of about 50% to about 300% and substantially complete elastic recovery from strains of at least about 30%.  
     
     
         36 . The process of  claim 26 , wherein said extrudate has tensile strength in the range of about 250 MPa to about 450 MPa, strain at break in the range of about 500% to about 600% and substantially complete elastic recovery from strains of at least about 30%.  
     
     
         37 . The process of  claim 26 , wherein said extrudate has tensile strength of at least 150 MPa, strain at break at least 120% and substantially complete elastic recovery from strains of at least about 40%.  
     
     
         38 . A process for producing a polymeric extrudate for use as a dilatation balloon, the process comprising: 
 contacting a multiblock copolymer with a solvent to form a multiblock copolymer mixture;    extruding said multiblock copolymer mixture to form an extrudate; and    drawing said extrudate,    wherein said extrudate has 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%.