Gastric occlusive device fabrication

Abstract

A multilayer film including a layer of sealing film, having main top and bottom surfaces, and a layer of thermoplastic polymer film, laminated to the layer of sealing film, on at least one of the main top and bottom surfaces. The sealing film has a composition and thickness imparting gas barrier character to the multilayer film, of which the layer(s) of thermoplastic polymer film by themselves lack such gas barrier character. Sheets of multilayer film are vacuum thermoformed in at least one non-planar die to form shaped sections that are bonded along peripheral portions thereof to form a non-pillowed spheroidal balloon that is inflatable in vivo.

1 . A method of fabricating a non-pillowed gastric occlusive device, the method comprising: 
 vacuum thermoforming in at least one non-planar thermoforming die a plurality of sheets of multilayer film having a thickness of up to 10 mils (0.254 mm) to form a plurality of thermoformed shaped sections;    providing an inflation element in, on, or between the plurality of shaped sections; and    bonding the plurality of shaped sections along peripheral portions thereof to form a spheroidal balloon having at least one peripheral seam;    wherein the inflation element is adapted to permit inflation of the balloon within the gastric cavity of a subject.    
   
   
       2 . The method of  claim 1 , wherein the multilayer film comprises: 
 a layer of sealing film, having a main top surface and a main bottom surface; and    at least one layer of thermoplastic polymer film, laminated to the layer of sealing film, on at least one of the main top surface and the main bottom surface;    wherein the sealing film has a composition and thickness imparting gas barrier character to the multilayer film, and wherein the at least one layer of thermoplastic polymer film alone lacks such gas barrier character.    
   
   
       3 . The method of  claim 2 , further comprising the step of extrusion laminating the layer of sealing film and the at least one layer of thermoplastic polymer film to form the multilayer film.  
   
   
       4 . The method of  claim 2 , wherein the sealing film comprises any of a polyvinylidene chloride (PVDC) polymer, a polyvinylidene bromide polymer, and an ethylene vinyl alcohol polymer.  
   
   
       5 . The method of  claim 2 , wherein the thermoplastic polymer film comprises any of polyurethane and a polyurethane co-polymer.  
   
   
       6 . The method of  claim 1 , wherein the thermoplastic polymer film has a thickness in a range of from about 2.0 mils to about 5.0 mils (0.0508 mm to 0.127 mm).  
   
   
       7 . The method of  claim 1 , wherein providing the inflation element comprises inserting an effervescent material between the plurality of shaped sections, wherein said effervescent material is arranged for contact with introduced liquid reactive with the effervescent material to liberate gas for inflation of the balloon.  
   
   
       8 . The method of  claim 1 , wherein providing the inflation element comprises securing an effervescent material along any shaped section of the plurality of shaped sections to reside along an inner surface of the resulting balloon, wherein said effervescent material is arranged for contact with introduced liquid reactive with the effervescent material to liberate gas for inflation of the balloon.  
   
   
       9 . The method of  claim 7 , wherein the effervescent material is substantially centrally located along one shaped section.  
   
   
       10 . The method of  claim 1 , wherein the inflation element comprises a self-healing seal valve.  
   
   
       11 . The method of  claim 1 , further comprising providing a deflation element on or along any shaped section the plurality of shaped sections.  
   
   
       12 . The method of  claim 11 , wherein the deflation element comprises a biodegradable material.  
   
   
       13 . The method of  claim 1 , wherein the peripheral seam forms a 360° seal and the peripheral seam is devoid of any neck or opening therein.  
   
   
       14 . The method of  claim 1 , wherein said sealing comprises radio frequency welding.  
   
   
       15 . The method of  claim 1 , wherein said sealing comprises welding under heat and pressure conditions effecting bonding between portions of the plurality of shaped sections.  
   
   
       16 . The method of  claim 1 , further comprising turning the balloon inside out to position free edges of the at least one peripheral seam within an interior volume of the balloon.  
   
   
       17 . The method of  claim 1 , further comprising coating at least a portion of any sheet of the plurality of sheets with a therapeutic agent.  
   
   
       18 . The method of  claim 17 , wherein the therapeutic agent comprises any of an anti-viral agent, an anti-inflammatory agent, a time-release analgesic formulation, and a clotting factor.  
   
   
       19 . The method of  claim 1 , wherein the at least one thermoforming die is substantially hemispherical in shape.  
   
   
       20 . The method of  claim 1 , wherein balloon in an inflated state has a diameter in a range of from 3 to 5 inches, and the balloon is generally spherical in shape.  
   
   
       21 . A non-pillowed gastric occlusive device fabricated according to the method of  claim 1 .  
   
   
       22 . A method of fabricating a non-pillowed gastric occlusive device, the method comprising: 
 vacuum thermoforming in at least one non-planar thermoforming die a plurality of sheets of a multilayer film having a thickness of up to 10 mils (0.254 mm), the multilayer film comprising (A) a layer of sealing film, having main top and bottom surfaces; and (B) at least one layer of thermoplastic polymer film, laminated to the layer of sealing film, on at least one of the main top and bottom surfaces; wherein the sealing film has a composition and thickness imparting gas barrier character to the multilayer film and wherein the at least one layer of thermoplastic polymer film alone lacks such gas barrier character, to yield a plurality of thermoformed shaped sections;    providing an inflation element in, on, or between the plurality of shaped sections; and    welding the plurality of shaped sections along peripheral portions thereof to form a spheroidal balloon having at least one peripheral seam;    wherein the inflation element is adapted to permit inflation of the balloon within the gastric cavity of a subject.    
   
   
       23 . The method of  claim 22 , wherein the sealing film comprises any of polyvinylidene chloride (PVDC), polyvinylidene bromide, and ethylene vinyl alcohol polymers, and the thermoplastic polymer film comprises any of polyurethane, and wherein the thermoplastic polymer film comprises any of polyurethane and a polyurethane co-polymer.  
   
   
       24 . The method of  claim 22 , wherein providing the inflation element comprises inserting an effervescent material between the plurality of shaped sections, wherein said effervescent material is arranged for contact with introduced liquid reactive with the effervescent material to liberate gas for inflation of the balloon.  
   
   
       25 . The method of  claim 22 , wherein the inflation element comprises a self-healing seal valve disposed in or on any shaped section of the plurality of shaped sections.  
   
   
       26 . The method of  claim 22 , further comprising providing a deflation element on or along any shaped section of the plurality of shaped sections.  
   
   
       27 . The method of  claim 26 , wherein the deflation element comprise a biodegradable material.  
   
   
       28 . The method of  claim 22 , further comprising coating at least a portion of any shaped section of the plurality of shaped sections with a therapeutic agent.  
   
   
       29 . The method of  claim 22 , wherein the at least one thermoforming die is substantially hemispherical in shape.  
   
   
       30 . The method of  claim 22 , wherein balloon in an inflated state has a diameter in a range of from 3 to 5 inches, and the balloon is generally spherical in shape.  
   
   
       31 . A non-pillowed gastric occlusive device fabricated according to the method of  claim 22 .  
   
   
       32 . A method of fabricating a non-pillowed gastric occlusive device, the method comprising: 
 vacuum thermoforming in at least one non-planar thermoforming die a plurality of polymeric sheets having a thickness of up to 10 mils (0.254 mm) to form a plurality of thermoformed shaped sections;    providing an inflation element in, on, or between the plurality of shaped sections;    providing a deflation element on or along any shaped section of the plurality of sections; and    bonding the plurality of shaped sections along peripheral portions thereof to form a spheroidal balloon having at least one peripheral seam;    wherein the inflation element is adapted to permit inflation of the balloon within the gastric cavity of a subject.    
   
   
       33 . The method of  claim 32 , wherein each polymeric sheet comprises a multilayer film including: 
 a layer of sealing film, having a main top surface and a main bottom surface; and    at least one layer of thermoplastic polymer film, laminated to the layer of sealing film, on at least one of the main top surface and the main bottom surface;    wherein the sealing film has a composition and thickness imparting gas barrier character to the multilayer film, and wherein the at least one layer of thermoplastic polymer film alone lacks such gas barrier character.    
   
   
       34 . The method of  claim 32 , wherein the sealing film comprises any of polyvinylidene chloride (PVDC), polyvinylidene bromide, and ethylene vinyl alcohol polymers, and the thermoplastic polymer film comprises any of polyurethane, and wherein the thermoplastic polymer film comprises any of polyurethane and a polyurethane co-polymer.  
   
   
       35 . The method of  claim 32 , wherein providing the inflation element comprises inserting an effervescent material between the plurality of shaped sections, wherein said effervescent material is arranged for contact with introduced liquid reactive with the effervescent material to liberate gas for inflation of the balloon.  
   
   
       36 . The method of  claim 32 , wherein the inflation element comprises a self-healing seal valve disposed in or on any shaped section of the plurality of shaped sections.  
   
   
       37 . The method of  claim 32 , further comprising coating at least a portion of any shaped section of the plurality of shaped sections with a therapeutic agent.  
   
   
       38 . The method of  claim 32 , wherein the at least one thermoforming die is substantially hemispherical in shape.  
   
   
       39 . The method of  claim 32 , wherein balloon in an inflated state has a diameter in a range of from 3 to 5 inches, and the balloon is generally spherical in shape.  
   
   
       40 . The method of  claim 32 , wherein the deflation element comprises a biodegradable material.  
   
   
       41 . A non-pillowed gastric occlusive device fabricated according to the method of  claim 32.