Compositions, methods, and kits for closure of lumen openings, and for bulking of tissue

Abstract

Disclosed and claimed are compositions, devices, methods and kits that are useful in occluding lumens or bulking-up regions of tissues or organs in a living mammal. The invention pertains to a composition containing specific particulate components, wherein the particulates promote responsive body processes that contribute to the formation of the occlusion or bulked-up region.

What is claimed is:  
     
         1 . A method of administering a closure-forming or bulking up composition in a living mammal, comprising 
 a. mixing together, to form a composition, at least one type of water-insoluble particle and a carrier; and    b. applying the composition to at least one specific area of a lumen or other body region in need of closure; 
 whereby applying the composition results in closure or bulking up of the at least one specific area.  
   
     
     
         2 . A method of administering a closure-forming or bulking up composition in a living mammal, comprising 
 a. mixing together, to form a composition, at least one type of water-insoluble particle that promotes responsive body processes and a carrier; and    b. applying the composition to at least one specific area of a lumen or other body region in need of closure; 
 whereby applying the composition results in closure or bulking up of the at least one specific area.  
   
     
     
         3 . A method of administering a closure-forming or bulking up composition in a living mammal, comprising 
 a. obtaining at least one type of water-insoluble particle that promotes responsive body processes, from the group consisting fine particles of bone; fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range; non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range; collagen shards, preferably in the 125-250 micrometer particle size range; insoluble salts, and talc;    b. mixing together, to form a composition, said at least one type of water-insoluble particle and a carrier; and    c. applying the composition to at least one specific area of a lumen or other body region in need of closure, or tissue or organ in need of bulking up; 
 whereby applying the composition results in closure or bulking up of the at least one specific area.  
   
     
     
         4 . The method according to  claim 3 , wherein said carrier is selected from the group consisting of: collagen; gelatin; carboxymethyl cellulose; hyaluronic acid; polyvinyl alcohol; thrombin; fibrin; albumin; and mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyortho-esters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.  
     
     
         5 . The method according to  claim 3 , additionally comprising the step of including an additive in the carrier, said additive selected from the group consisting of growth factors, biologically active agents, and combinations thereof.  
     
     
         6 . The method according to  claim 5 , wherein at least one growth factor is selected from the group consisting of PDGF, FGF, VEGF, BMP, EGF, ECGF, and PDGF.  
     
     
         7 . The method of  claim 3  wherein said applying of the composition is done by percutaneous injection to a location in need thereof  
     
     
         8 . An implantable composition for administration to a lumen of a living mammal, to close the lumen, comprising: 
 a. water-insoluble particles, and    b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.    
     
     
         9 . An implantable composition for administration to a lumen of a living mammal, to close the lumen, comprising: 
 a. water-insoluble particles that promote responsive body processes, and    b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.    
     
     
         10 . An implantable composition for administration to a lumen of a living mammal, to close the lumen, comprising: 
 a. water-insoluble particles that promote responsive body processes, and    b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution, 
 wherein said carrier compound is thermoplastic gelatin and said solution is flowable at a temperature above the body temperature of a subject living mammal, and is not flowable at the said body temperature.  
   
     
     
         11 . The implantable composition according to  claim 9 , wherein the carrier is selected from the group consisting of: collagen; gelatin; carboxymethyl cellulose; hyaluronic acid; polyvinyl alcohol; thrombin; fibrin; albumin; and mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyortho-esters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.  
     
     
         12 . The implantable composition according to  claim 11 , wherein the water-insoluble particles are selected from the group consisting of fine particles of bone; fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range; non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range; collagen shards, preferably in the 125-250 micrometer particle size range; insoluble salts, and talc.  
     
     
         13 . An implantable composition for administration to a tissue or organ of a living mammal, to add bulk to the tissue or organ, comprising: 
 a. water-insoluble particles,    b. carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.    
     
     
         14 . An implantable composition for administration to a tissue or organ of a living mammal, to add bulk to the tissue or organ, comprising: 
 a. water-insoluble particles that promote responsive body processes, and    b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.    
     
     
         15 . An implantable composition for administration to a tissue or organ of a living mammal, to add bulk to the tissue or organ, comprising: 
 a. water-insoluble particles that promote responsive body processes, and    b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution, 
 wherein said carrier compound is thermoplastic gelatin and said solution is flowable at a temperature above the body temperature of a subject living mammal, and is not flowable at the said body temperature.  
   
     
     
         16 . The implantable composition according to  claim 14 , wherein the carrier is selected from the group consisting of: collagen; gelatin; carboxymethyl cellulose; hyaluronic acid; polyvinyl alcohol; thrombin; fibrin; albumin; and mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyortho-esters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.  
     
     
         17 . The implant according to  claim 16 , wherein the water-insoluble particles are selected from the group consisting of fine particles of bone; fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range; non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range; collagen shards, preferably in the 125-250 micrometer particle size range; insoluble salts, and talc.  
     
     
         18 . A method of promoting the formation of an occlusion in a lumen, or a bulked-up region in a tissue or organ, comprising the steps of: 
 a. preparing a composition comprising water insoluble particles, said particles promoting formation of an adhesion, and    b. injecting a quantity of said composition into a body area of a living mammal, such that adhesion formation is promoted in the area of the injecting.    
     
     
         19 . The method according to  claim 18 , wherein the injection is percutaneous.  
     
     
         20 . The method according to  claim 3 ,wherein said closure is for a lumen or channel in a structure selected from the group consisting of a vas deferens duct, a tear duct, a salivary gland duct, a sweat gland duct, an arteriovenous connection, an arteriovenous anastomosis, an artery supplying a tumor, a capillary plexus supplying a tumor, or a manmade channel in need of said closure.  
     
     
         21 . The method according to  claim 3 ,wherein said bulking up is for a tissue or organ selected from the group consisting of sphincter muscles and vocal chords  
     
     
         22 . The implantable composition according to  claim 9 , wherein said lumen is selected from the group consisting of a vas deferens duct, a tear duct, a salivary gland duct, a sweat gland duct, an arteriovenous connection, an arteriovenous anastomosis, an artery supplying a tumor, a capillary plexus supplying a tumor, or a man-made channel in need of said closure.  
     
     
         23 . The method according to  claim 14 , wherein said administration to add bulk is to a tissue or organ selected from the group consisting of sphincter muscles and vocal chords.  
     
     
         24 . The implantable composition according to  claim 18 , wherein said adhesion formation is in a lumen selected from the group consisting of a vas deferens duct, a tear duct, a salivary gland duct, a sweat gland duct, an arteriovenous connection, an arteriovenous anastomosis, an artery supplying a tumor, a capillary plexus supplying a tumor, or a manmade channel in need of said closure.  
     
     
         25 . The method according to  claim 18 , wherein said adhesion formation is in a tissue or organ selected from the group consisting of sphincter muscles and vocal chords.  
     
     
         26 . A kit for lumen-closing or a tissue-bulking implant for a living mammal, comprising: 
 a. an implantable composition comprising water-insoluble particles that promote one or more of cellular inflammation, infiltration, or adhesion, and a carrier to form a paste or suspension; and    b. instructions for delivering said implantable composition to a lumen, tissue or organ in need of occlusion or bulking, 
 wherein upon said delivering, an occlusion forms in the lumen, or a bulked up area forms in the tissue or organ of the living mammal.  
   
     
     
         27 . The kit according to  claim 26 , wherein said carrier is selected from the group consisting of: collagen; gelatin; carboxymethyl cellulose; hyaluronic acid; polyvinyl alcohol; thrombin; fibrin; albumin; and mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyorthoesters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.  
     
     
         28 . The kit according to  claim 26 , wherein said water-insoluble particles are selected from the group consisting of fine particles of bone; fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range; non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range; collagen shards, preferably in the 125-250 micrometer particle size range; insoluble salts, and talc.  
     
     
         29 . The kit according to  claim 26 , wherein said instructions provide for mixing said water-insoluble particles and said carrier in a syringe.  
     
     
         30 . The kit according to  claim 29 , wherein said syringe has a flexible area of its barrel to facilitate mixing.  
     
     
         31 . The kit according to  claim 26 , wherein at least one of said water insoluble particles and said carrier is provided in a syringe.  
     
     
         32 .A method for closure of a lumen, or bulking up of a tissue or organ in a living mammal, comprising: 
 a. obtaining a kit comprising an implantable composition comprising water-insoluble particles that promote one or more of cellular inflammation, infiltration, or adhesion, and a carrier to form a paste or suspension; and    b. administering said implantable composition to a lumen in need of closure, or to a tissue or organ in need of bulking up.    
     
     
         33 .The method according to claim  32 , additionally comprising following prescribed instructions for the preparation and mixing of said water-insoluble particles and said carrier to form said implantable composition.  
     
     
         34 .The method according to claim  32 , wherein said carrier is selected from the group consisting of: collagen; gelatin; carboxymethyl cellulose; hyaluronic acid; polyvinyl alcohol; thrombin; fibrin; albumin; and mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyorthoesters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.  
     
     
         35 .The method according to claim  32 , wherein said, wherein said water-insoluble particles are selected from the group consisting of fine particles of bone; fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range; non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range; collagen shards, preferably in the 125-250 micrometer particle size range; insoluble salts, and talc.