Blow molded composite devices and method

Abstract

The present disclosure is directed toward a composite balloon comprising a layer of material having a porous microstructure (e.g., ePTFE or expanded polyethylene) and a thermoplastic polymeric layer useful for medical applications. The layers of the composite balloons become adhered through a stretch blow-molding process. Methods of making and using such composite balloons are also described amongst others.

1 . A medical balloon comprising a balloon wall defining a chamber and comprising a layered material, wherein the layered material comprises:
 a first polymeric layer, and   a second porous, polymeric layer defining a porous microstructure,   wherein the first polymeric layer is mechanically coupled to the second porous, polymeric layer by conforming and interlocking the first polymeric layer with the second porous, polymeric layer without an adhesive agent such that material of the first polymeric layer and the second porous, polymeric layer are in an overlying and interlocking relationship to each other.   
     
     
         2 . The medical balloon of  claim 1 , wherein the layered material defines at least one recessed region on an outer surface of the second layer, and wherein the at least one recessed region comprises a region of more collapsed pores in the second layer relative to a non-recessed region. 
     
     
         3 . The medical balloon of  claim 1 , wherein the second layer includes a fluoropolymer material. 
     
     
         4 . The medical balloon of  claim 1 , wherein the first polymeric layer includes at least one of a thermoplastic, an expanded fluoropolymer, and a polyamide. 
     
     
         5 . The medical balloon of  claim 4 , wherein the thermoplastic comprises a blow-moldable thermoplastic. 
     
     
         6 . The medical balloon of  claim 1 , wherein a surface of the first polymeric layer conforms and interlocks with an opposing surface of the porous microstructure of the second porous, polymeric layer. 
     
     
         7 . The medical balloon of  claim 1 , wherein an interface between the first polymeric layer and the second porous, polymeric layer are characterized by an absence of an adhesive agent. 
     
     
         8 . The medical balloon of  claim 1 , wherein the first polymeric layer and the second, porous polymeric layer are mechanically coupled in overlying and interlocking relationship by having been stretched and engaged with one another by a stretch blow molding process. 
     
     
         9 . The medical balloon of  claim 1 , wherein the first polymeric layer is seamless. 
     
     
         10 . A medical balloon comprising a balloon wall defining a chamber and comprising a layered material, wherein the layered material comprises:
 a first, seamless polymer layer mechanically coupled to a second seamless polymer layer without an adhesive agent, the second seamless polymer layer comprising a porous microstructure,   wherein the first, seamless polymer layer conforms to and interlocks with the second seamless polymer layer, the second seamless polymer layer being an outer layer such that the balloon wall is seamless, and   wherein the first, seamless polymer layer and the second, seamless polymer layer in an overlying and interlocking relationship to each other.   
     
     
         11 . The medical balloon of  claim 10 , wherein the layered material defines at least one recessed region on an outer surface of the second layer, and wherein the at least one recessed region comprises a region of more collapsed pores in the second layer relative to a non-recessed region. 
     
     
         12 . The medical balloon of  claim 10 , wherein the first, seamless polymer layer comprises at least one of a compliant, semi-compliant, or non-compliant thermoplastic material. 
     
     
         13 . The medical balloon of  claim 12 , wherein the thermoplastic material is blow moldable. 
     
     
         14 . The medical balloon of  claim 10 , wherein the second layer is anisotropic or isotropic. 
     
     
         15 . The medical balloon of  claim 10 , wherein the first, seamless polymer layer and the second, seamless polymer layer are mechanically coupled in overlying and interlocking relationship by having been stretched and engaged with one another by a stretch blow molding process. 
     
     
         16 . A medical balloon comprising a balloon wall defining a chamber and comprising a layered material wherein the layered material comprises:
 a first layer at least partially mechanically adhered to a second layer without adhesive agent,   wherein the first layer is a thermoplastic polymer layer and the second layer is a fluoropolymer layer comprising a porous microstructure,   wherein the second layer is an outermost layer of the balloon wall, and   wherein the first layer is mechanically adhered to the second layer by conforming and interlocking with the porous microstructure of the second layer during a blow molding process at a temperature that is above the glass transition temperature but below the melt temperature of the first layer.   
     
     
         17 . The medical balloon of  claim 16 , wherein the first layer is a tube, the second layer is a tube, and the second layer is circumferentially wrapped about the first layer. 
     
     
         18 . The medical balloon of  claim 16 , wherein the layered material defines at least one recessed region on an outer surface of the second layer, and wherein the at least one recessed region comprises a region of more collapsed pores in the second layer relative to a non-recessed region. 
     
     
         19 . The medical balloon of  claim 16 , wherein the first layer and the second layer are capable of separating with 1 N/m of average kinetic force in a 157 degree Peel Test. 
     
     
         20 . The medical balloon of  claim 16 , wherein the first layer and the second layer are capable of separating with 3 N/m of average kinetic force in a 157 degree Peel Test.