Multi-material incontinence treatment constriction device

Abstract

An implantable constriction device for treating an incontinent patient comprises an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient. The elongate composite structure is composed of a base material, such as hard silicone, making the composite structure self-supporting. Property improving means is provided for improving at least one physical property of the composite structure other than self-supporting properties, such as fatigue resistance, liquid impermeability, aggressive body cells resistance, anti-friction properties and lifetime.

What is claimed is:  
     
         1 . An implantable constriction device for treating an incontinent patient, comprising an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient, wherein said elongate composite structure is composed of a base material making said composite structure self-supporting and property improving means for improving at least one physical property of said composite structure other than self-supporting properties.  
     
     
         2 . An implantable constriction device according to  claim 1 , wherein said property improving means comprises a coating on said base material at least along a side of said elongate composite structure that is intended to contact the urethra, urine bladder, anus, colon or rectum, said coating having better aggressive body fluid resistant properties than said base material.  
     
     
         3 . An implantable constriction device according to  claim 2 , wherein said coating is selected from the group consisting of a Teflon™, Parylene™, and a biocompatible metal coating.  
     
     
         4 . An implantable constriction device according to  claim 3 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         5 . An implantable constriction device according to  claim 2 , wherein said property improving means comprises a core of a viscoelastic material covered with said self-supporting base material.  
     
     
         6 . An implantable constriction device according to  claim 5 , wherein hard silicone constitutes said base material.  
     
     
         7 . An implantable constriction device according to  claim 5 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         8 . An implantable constriction device according to  claim 2 , wherein said base material forms an inflatable tubing.  
     
     
         9 . An implantable constriction device according to  claim 8 , wherein said tubing has an inner surface defining the interior of said tubing, and said coating covers said inner surface.  
     
     
         10 . An implantable constriction device according to  claim 8 , wherein said coating is selected from the group consisting of Teflon™, Parylene™, and a biocompatible metal coating.  
     
     
         11 . An implantable constriction device according to  claim 10 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         12 . An implantable constriction device according to  claim 8 , wherein hard silicone constitutes said base material.  
     
     
         13 . An implantable constriction device according to  claim 8 , wherein said base material forms two coaxial tubular layers and said property improving means comprises a tubular intermediate layer of a viscoelastic material located between said coaxial tubular layers.  
     
     
         14 . An implantable constriction device according to  claim 13 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         15 . An implantable constriction device according to  claim 8 , wherein said base material forms an outer tubular layer, an inner arcuate layer attached to said outer tubular layer, said outer and inner layers defining a curved space extending longitudinally along said tubing, and said property improving means comprises viscoelastic material filling said space.  
     
     
         16 . An implantable constriction device according to  claim 15 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         17 . An implantable constriction device according to  claim 1 , wherein said property improving means comprises a coating on said base material at least along a side of said elongate composite structure that is intended to contact the urethra, urine bladder, anus, colon or rectum, said coating having better anti-friction properties than said base material.  
     
     
         18 . An implantable constriction device according to  claim 17 , wherein said coating is selected from the group consisting of a Teflon™, Parylene™, and a biocompatible metal coating.  
     
     
         19 . An implantable constriction device according to  claim 18 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         20 . An implantable constriction device according to  claim 17 , wherein said property improving means comprises a core of a viscoelastic material covered with said self-supporting base material.  
     
     
         21 . An implantable constriction device according to  claim 20 , wherein hard silicone constitutes said base material.  
     
     
         22  An implantable constriction device according to  claim 20 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         23 . An implantable constriction device according to  claim 17 , wherein said base material forms an inflatable tubing.  
     
     
         24 . An implantable constriction device according to  claim 23 , wherein said tubing has an inner surface defining the interior of said tubing, and said coating covers said inner surface.  
     
     
         25 . An implantable constriction device according to  claim 23 , wherein said coating is selected from the group consisting of a Teflon™, Parylene™, and a biocompatible metal coating.  
     
     
         26 . An implantable constriction device according to  claim 25 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         27 . An implantable constriction device according to  claim 23 , wherein hard silicone constitutes said base material.  
     
     
         28 . An implantable constriction device according to  claim 23 , wherein said base material forms two coaxial tubular layers and said property improving means comprises a tubular intermediate layer of a viscoelastic material located between said coaxial tubular layers.  
     
     
         29 . An implantable constriction device according to  claim 28 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         30 . An implantable constriction device according to  claim 23 , wherein said base material forms an outer tubular layer, an inner arcuate layer attached to said outer tubular layer, said outer and inner layers defining a curved space extending longitudinally along said tubing, and said property improving means comprises a viscoelastic material filling said space.  
     
     
         31 . An implantable constriction device according to  claim 30 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         32 . An implantable constriction device according to  claim 1 , wherein said base material forms a first layer and said property improving means comprises a second layer applied on said first layer, said second layer being more fatigue resistant than said first layer.  
     
     
         33 . An implantable constriction device according to  claim 32 , wherein said second layer covers said first layer of said base material along a side of said elongate composite structure that is intended to contact the urethra, urine bladder, anus, colon or rectum.  
     
     
         34 . An implantable constriction device according to  claim 32 , wherein said second layer comprises a polyurethane layer.  
     
     
         35 . An implantable constriction device according to  claim 32 , wherein said property improving means comprises a coating coated on said first layer and/or said second layer, said coating having better aggressive body fluid resistance properties and/or better anti-friction properties than said base material.  
     
     
         36 . An implantable constriction device according to  claim 35 , wherein said coating is selected from the group consisting of Teflon™, Parylene™, and biocompatible metal coating.  
     
     
         37 . An implantable constriction device according to  claim 36 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         38 . An implantable constriction device according to  claim 32 , wherein hard silicone constitutes said base material.  
     
     
         39 . An implantable constriction device according to  claim 32 , wherein said first layer of said base material forms an inflatable tubing, and said second layer covers said base material within said tubing.  
     
     
         40 . An implantable constriction device according to  claim 1 , wherein said base material forms an inflatable tubing and said property improving means comprises a liquid impermeable coating coated on said base material.  
     
     
         41 . An implantable constriction device according to  claim 40 , wherein said tubing has an external surface of said base material and an internal surface of said base material defining the interior of said tubing, said coating being coated on said external surface and/or internal surface.  
     
     
         42 . An implantable constriction device according to  claim 40 , wherein said coating is selected from the group consisting of Parylene™ and a biocompatible metal coating.  
     
     
         43 . An implantable constriction device according to  claim 42 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         44 . An implantable constriction device according to  claim 40 , wherein hard silicone constitutes said base material.  
     
     
         45 . An implantable constriction device according to  claim 40 , wherein said base material forms two coaxial tubular layers and said property improving means comprises a tubular intermediate layer of a viscoelastic material located between said coaxial tubular layers.  
     
     
         46 . An implantable constriction device according to  claim 44 , wherein said viscoelastic material comprises silicone gel, cellulose gel or collagen gel.  
     
     
         47 . An implantable constriction device according to  claim 40 , wherein said base material forms an outer tubular layer and an inner arcuate layer attached to said outer tubular layer, said outer and inner layers defining a curved space extending longitudinally along said tubing, and said property improving means comprises viscoelastic material filling said space.  
     
     
         48 . An implantable constriction device according to  claim 47 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         49 . An implantable constriction device according to  claim 1 , wherein said property improving means comprises gas contained in a multiplicity of cavities formed in said base material to improve the flexibility of said composite structure.  
     
     
         50 . An implantable constriction device according to  claim 49 , wherein said cavities are defined by net structures of said base material.  
     
     
         51 . An implantable constriction device according to  claim 49 , wherein Teflon™ constitutes said base material.  
     
     
         52 . An implantable constriction device according to  claim 49 , wherein said composite structure forms an inflatable tubing.  
     
     
         53 . An implantable constriction device for treating an incontinent patient, comprising an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient, wherein the composite structure includes an elongate biocompatible self-supporting base material having surfaces exposed to aggressive body cells, when the constriction device is implanted in the patient, and a cell barrier coating coated on said surfaces to prevent body cells from breaking down the base material.  
     
     
         54 . An implantable constriction device according to  claim 53 , wherein said barrier coating is selected from the group consisting of Parylene™ and a biocompatible metal coating.  
     
     
         55 . An implantable constriction device according to  claim 54 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         56 . An implantable constriction device for treating an incontinent patient, comprising: 
 elongate means for constricting the urethra, urine bladder, anus, colon or rectum of the patient, the constricting means including 
 means for making the constricting means self-supporting, and  
 means for improving at least one physical property of said constricting means other than self-supporting properties.  
   
     
     
         57 . An implantable constriction device according to  claim 56 , wherein said property improving means improves the resistance to aggressive body cells or the anti-friction properties of said constricting means.  
     
     
         58 . An implantable constriction device according to  claim 57 , wherein said property improving means comprises a coating on said self-supporting means at least along a side of said elongate constricting means that is intended to contact the urethra, urine bladder, anus, colon or rectum.  
     
     
         59 . An implantable constriction device according to  claim 58 , wherein said coating is selected from the group consisting of a Teflon™, Parylene™, and a biocompatible metal coating.  
     
     
         60 . An implantable constriction device according to  claim 59 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         61 . An implantable constriction device according to  claim 56 , wherein said property improving means improves the flexibility of said constricting means.  
     
     
         62 . An implantable constriction device according to  claim 61 , wherein said property improving means comprises a core of a viscoelastic material covered with said self-supporting base material.  
     
     
         63 . An implantable constriction device according to  claim 62 , wherein hard silicone constitutes said self-supporting means.  
     
     
         64 . An implantable constriction device according to  claim 62 , wherein said viscoelastic material is selected from the group consisting of silicone gel, cellulose gel, and collagen gel.  
     
     
         65 . An implantable constriction device according to  claim 61 , wherein said property improving means comprises gas contained in a multiplicity of cavities formed in said self-supporting means to improve the flexibility of said constricting means.  
     
     
         66 . An implantable constriction device according to  claim 65 , wherein said cavities are defined by net structures of said self-supporting means.  
     
     
         67 . An implantable constriction device according to  claim 65 , wherein Teflon™ constitutes said self-supporting means.  
     
     
         68 . An implantable constriction device according to  claim 56 , wherein said property improving means improves the fatigue resistance of said constricting means.  
     
     
         69 . An implantable constriction device according to  claim 68 , wherein said self-supporting means forms a first layer and said property improving means comprises a second layer applied on said first layer, said second layer being more fatigue resistant than said first layer.  
     
     
         70 . An implantable constriction device according to  claim 69 , wherein said second layer covers said first layer of said self-supporting means along a side of said elongate constricting means that is intended to contact the urethra, urine bladder, anus, colon or rectum.  
     
     
         71 . An implantable constriction device according to  claim 69 , wherein said second layer comprises a polyurethane layer.  
     
     
         72 . An implantable constriction device according to  claim 56 , wherein said property improving means improves the liquid impermeability of said constricting means.  
     
     
         73 . An implantable constriction device according to  claim 72 , wherein said self-supporting means forms an inflatable tubing and said property improving means comprises a liquid impermeable coating coated on said self-supporting means.  
     
     
         74 . An implantable constriction device according to  claim 73 , wherein said tubing has an external surface of said self-supporting means and an internal surface of said self-supporting means defining the interior of said tubing, said coating being coated on said external surface and/or internal surface.  
     
     
         75 . An implantable constriction device according to  claim 73 , wherein said coating is selected from the group consisting of Parylene™ and a biocompatible metal coating.  
     
     
         76 . An implantable constriction device according to  claim 75 , wherein the biocompatible metal coating is selected from the group consisting of gold, silver and titanium.  
     
     
         77 . An implantable constriction device according to  claim 55 , wherein hard silicon constitutes said self-supporting means.  
     
     
         78 . An implantable constriction device for treating an incontinent patient, comprising: 
 an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient,    a base material of said composite structure making said composite structure self-supporting, and    a coating on said base material at least along a side of said elongate composite structure that is intended to contact the urethra, urine bladder, anus, colon or rectum, said coating having better aggressive body fluid resistant properties than said base material.    
     
     
         79 . An implantable constriction device for treating an incontinent patient, comprising: 
 an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient,    a base material of said composite structure making said composite structure self-supporting, and    a coating on said base material at least along a side of said elongate composite structure that is intended to contact the urethra, urine bladder, anus, colon or rectum, said coating having better anti-friction properties than said base material.    
     
     
         80 . An implantable constriction device for treating an incontinent patient, comprising: 
 an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient,    a base material of said composite structure making said composite structure self-supporting, said base material forming a first layer, and    a second layer applied on said first layer, said second layer being more fatigue resistant than said first layer.    
     
     
         81 . An implantable constriction device for treating an incontinent patient, comprising: 
 an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient,    a liquid semi-permeable base material of said composite structure forming an inflatable tubing and making said composite structure self-supporting, and    a liquid impermeable coating coated on said base material.    
     
     
         82 . An implantable constriction device for treating an incontinent patient, comprising: 
 an elongate composite structure adapted to constrict the urethra, urine bladder, anus, colon or rectum of the patient, and    a base material of said composite structure making said composite structure self-supporting, said base material forming a multiplicity of gas-containing cavities to improve the flexibility of said composite structure.