Multi-layer film welded articulated balloon

Abstract

A method of fabrication of a medical balloon, and a balloon device useful for various medical balloon procedures, such as gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications. At least two layers of a thermoplastic film are sealed at their peripheral edges and heat sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, in one implementation of the balloon device. Such configuration enables the balloon to articulate to a desired shape upon inflation, with the desired shape being selected to accommodate a specific medical application.

1 .- 9 . (canceled) 
     
     
         10 . A method for the fabrication of a medical balloon device, said method comprising:
 providing a multiplicity of layers of thermoplastic film having peripheral edges;   sealing the peripheral edges to form an inflatable interior volume enclosed by the sealed edges so that the inflatable interior volume is sealed by a single seal; and   sealing at least one of the layers directly to another of the layers at one or more locations in the interior volume to enable the device to articulate to a predetermined shape upon inflation of the interior volume with an inflation fluid, to accommodate a predetermined medical application.   
     
     
         11 . The method of  claim 10 , wherein said sealing is performed by welding one layer to another. 
     
     
         12 . The method of  claim 10 , wherein said sealing is performed by RF welding one layer to another. 
     
     
         13 . The method of  claim 10 , wherein two layers of thermoplastic film are provided. 
     
     
         14 . The method of  claim 10 , wherein three layers of thermoplastic film are provided. 
     
     
         15 . The method of  claim 10 , wherein said multiplicity of layers comprise layers of different modulus of elasticity. 
     
     
         16 . The method of  claim 10 , wherein said multiplicity of layers comprise layers of different thickness. 
     
     
         17 . The method of  claim 10 , wherein said multiplicity of layers comprise layers of thermoplastic polymeric film. 
     
     
         18 . The method of  claim 10 , further comprising connecting a fluid passage to the interior volume. 
     
     
         19 . The method of  claim 18 , wherein the fluid passage contains a valve. 
     
     
         20 . The method of  claim 19 , wherein said valve comprises a check valve. 
     
     
         21 . The method of  claim 19 , wherein said valve comprises a rotatable stem valve. 
     
     
         22 . The method of  claim 19 , wherein said valve comprises an anti-reflux valve. 
     
     
         23 . The method of  claim 10 , wherein the predetermined shape upon inflation of the interior volume with an inflation fluid supports a prostate in spaced relation to other organs, in prostate surgery as said predetermined medical application. 
     
     
         24 . The method of  claim 10 , wherein the predetermined shape includes a distal bulging shape upon inflation of the interior volume with an inflation fluid for said predetermined medical application. 
     
     
         25 . The method of  claim 10 , wherein the predetermined shape upon inflation of the interior volume with an inflation fluid for said predetermined medical application, configures the medical balloon device for a gastrointestinal, vascular, reproductive system, urinary system, or pulmonary procedure.