Laminate catheter balloons with additive burst strength and methods for preparation of same

Abstract

A laminate balloon comprising at least two layers of separately oriented thermoplastic polymer material, which are coextensive over the body of the balloon. The two layers may be made of different polymer materials, including an underlying layer made of a low compliant, high strength polymer, such as PET, and an overlying layer of a softer and more flexible polymer material relative to the first polymer material, such as a polyester-polyether block copolymer. The balloon structures have an additive burst pressure, meaning that they are stronger than a single-layer reference balloon corresponding to the underlying polymer layer. The balloons are characterized by a combination of flexibility and surface softness which allows catheters to track down into lesions relatively easily, puncture resistance, abrasion resistance and refoldability, in addition to low compliance and high burst strength. The balloons may be prepared with generally linear or with stepped compliance profiles. Methods of preparation of such balloons are also disclosed.

What is claimed is:  
     
         1 . A process for producing a laminate balloon for mounting on an a catheter, the process comprising the steps of: 
 a) providing a first tubing segment of a first polymer material;    b) stretching the first tubing segment at a first stretch ratio to produce a first stretched tube having an outer diameter;    c) providing a second tubing segment of a second polymer material having an inner diameter greater than the outer diameter of the first stretched tube;    d) inserting the first stretched tube into the second tubing segment;    e) stretching the second tubing segment at a second stretch ratio to produce a second stretched tube, the first and second stretched tubes being brought into direct annular contact during the stretching of said second tubing segment, to form a laminate stretched tubing structure; and    f) forming the laminate balloon by pressurizing the laminate stretched tubing structure at a temperature and pressure above ambient so as to expand the laminate stretched tubing structure.    
     
     
         2 . A process as in  claim 1  wherein the first and second polymer materials are different.  
     
     
         3 . A process as in  claim 2  wherein the first polymer material is a low compliant, high strength polymer and the second polymer is a softer and more flexible polymer material relative to the first polymer material.  
     
     
         4 . A process as in  claim 3  wherein the first polymer material is selected from the group consisting of polyesters, polyamides, thermoplastic polyimides, liquid crystal polymers and high strength engineering thermoplastic polyurethanes and the second polymer material is a thermoplastic elastomer.  
     
     
         5 . A process as in  claim 4  wherein said thermoplastic elastomer is a polyester/polyether segmented block copolymer.  
     
     
         6 . A process as in  claim 1  wherein the first and second stretch ratios are different.  
     
     
         7 . A process as in  claim 6  wherein in said balloon forming step (f) said laminate stretched tubing structure is expanded to a preselected diameter.  
     
     
         8 . A process as in  claim 7  wherein said balloon forming step (f) is performed in a mold.  
     
     
         9 . A process as in  claim 7  wherein said first and second stretch ratios are individually selected to produce in said laminate balloon at least one preselected strength or compliance characteristic.  
     
     
         10 . A process as in  claim 9  wherein said first polymer material is a low compliant, high strength polymer, said second polymer is a softer and more flexible polymer material relative to the first polymer material, whereby said laminate balloon comprises an underlayer of said first polymer and an overlayer of said second polymer material, said at least one preselected characteristic includes a laminate balloon burst strength value greater than the burst strength of a first reference balloon of said first polymer formed at a wall thickness, a stretch ratio and a hoop expansion ratio substantially the same as the wall thickness, stretch ratio and hoop expansion ratio of said laminate balloon underlayer.  
     
     
         11 . A process as in  claim 10  wherein said laminate balloon burst strength value exceeds the burst strength of the first reference balloon by an amount which is at least 50% of the burst strength of a second reference balloon of said second polymer formed at a wall thickness, a stretch ratio and a hoop expansion ratio substantially the same as the wall thickness, stretch ratio and hoop expansion ratio of said laminate balloon overlayer.  
     
     
         12 . A process as in  claim 11  wherein said laminate balloon burst strength value exceeds the burst strength of said first reference balloon by an amount which is at least 75% of the burst strength of said second reference balloon.  
     
     
         13 . A laminate balloon produced by the process of  claim 1 .  
     
     
         14 . A laminate balloon produced by the process of  claim 10 .  
     
     
         15 . A laminate balloon comprising at least two layers of separately oriented thermoplastic polymer material, which are coextensive over the body of the balloon.  
     
     
         16 . A laminate balloon as in  claim 15  wherein said two layers are made of different polymer materials.  
     
     
         17 . A laminate balloon as in  claim 16  a first of said polymer materials is a low compliant, high strength polymer and a second of said polymer materials is a softer and more flexible polymer material relative to the first polymer material.  
     
     
         18 . A laminate balloon as in  claim 17  comprising a first layer of said first polymer material and an adjacent second layer of said second polymer material.  
     
     
         19 . A laminate balloon as in  claim 18  having a central axis, said second layer being located outwardly from said central axis relative to said first layer.  
     
     
         20 . A laminate as in  claim 18  wherein said second layer defines the outer surface of the balloon.  
     
     
         21 . A laminate balloon as in  claim 18  wherein the first polymer material is selected from the group consisting of polyesters, polyamides, thermoplastic polyimides, liquid crystal polymers and high strength engineering thermoplastic polyurethanes and the second polymer material is a thermoplastic elastomer.  
     
     
         22 . A laminate balloon as in  claim 21  wherein said thermoplastic elastomer is a polyester/polyether segmented block copolymer.  
     
     
         23 . A laminate balloon as in  claim 19  wherein said balloon has a burst strength value greater than the burst strength of a first reference balloon of said first polymer formed at a wall thickness, a stretch ratio and a hoop expansion ratio substantially the same as the wall thickness, stretch ratio and hoop expansion ratio of said first layer.  
     
     
         24 . A laminate balloon as in  claim 23  wherein said laminate balloon burst strength value exceeds the burst strength of the first reference balloon by an amount which is at least 50% of the burst strength of a second reference balloon of said second polymer formed at a wall thickness, a stretch ratio and a hoop expansion ratio substantially the same as the wall thickness, stretch ratio and hoop expansion ratio of said second layer.  
     
     
         25 . A laminate balloon as in  claim 24  wherein said laminate balloon burst strength value exceeds the burst strength of said first reference balloon by an amount which is at least 75% of the burst strength of said second reference balloon.  
     
     
         26 . A laminate balloon as in  claim 15  wherein at least two of said layers are made of the same polymer material.  
     
     
         27 . A laminate balloon as in  claim 15  wherein said layers are sufficiently adherent to each other so that the balloon maintains a unitary structure at rest.  
     
     
         28 . A laminate balloon as in  claim 1   5  having a generally linear compliance curve.  
     
     
         29 . A laminate balloon as in  claim 15  having a stepped compliance curve.  
     
     
         30 . A process for forming a laminate balloon which includes the steps of. 
 a) providing a first tubing segment of a first polymer material;    b) stretching the first tubing segment at a first stretch ratio to produce a first stretched tube;    c) blowing the first stretched tube in a mold to produce a first layer structure, said first layer structure including waist, cone and body portions, the waist portion having an inner diameter;    c) providing a second tubing segment of a second polymer material;    d) stretching the second tubing segment at a second stretch ratio to produce a second stretched tube having an outer diameter less than the inner diameter of the waist portion of said first layer structure;    e) inserting the second stretched tube into the first layer structure and    f) forming the laminate balloon by pressurizing the second stretched tube at a temperature and pressure above ambient to expand the second layer tube, forming a second layer which is in direct annular contact with the first layer structure.