Suturable adhesion-preventing membrane

Abstract

A suturable adhesion-preventing membrane has high suture strength, good biocompatibility, decomposition and absorption in a living body, sufficient adhesion-preventing effect, and desirable guided tissue regeneration. The membrane is composed of at least one non-woven fabric layer made of collagen fibers, or a laminated membranous substance consisting of at least one non-woven fabric layer made of collagen fibers and at least one sponge layer made of collagen, and a coating layer of gelatin or hyaluronic acid on the surface or surfaces of the above membrane. Preferably, the membrane comprises one to six compressed cross-linked collagen non-woven fabric layers wherein a layer has a fibers having a fiber diameter of 0.05 mm to 1.0 mm, a bulk density of 5.0×10 −4 to 5 g/cm 3 and a thickness of 0.1 mm to 50 mm, and a coating layer containing gelatin or hyaluronic acid and having a thickness of 0.05 mm to 20 mm, wherein the coating layer covers one or both sides or a part or whole of the surface of the membrane.

1 . A suturable adhesion-preventing membrane for guided tissue regeneration comprising: a compressed non-woven fabric layer composed of cross-linked collagen fibers wherein the layer has fibers having a fiber diameter of 20 to 100 μm, a bulk density of 1.0×10 −3  to 2.0 g/cm 3  and a thickness of 0.2 mm to 1.0 mm; and a coating layer containing gelatin or hyaluronic acid covering each surface of the compressed collagen non-woven fabric layer; and wherein the membrane has a thickness of 0.5 mm to 2.0 mm.  
   
   
       2 . A suturable adhesion-preventing membrane for guided tissue regeneration comprising: a laminate of two or three compressed non-woven fabric layers each composed of cross-linked collagen fibers wherein each layer has fibers having a fiber diameter of 150 to 250 μm, a bulk density of 0.05 to 2.0 g/cm 3  and a thickness of 0.5 mm to 2.0 mm; and a coating sponge layer containing gelatin or hyaluronic acid covering each surface of the laminate of non-woven fabric layers; and wherein the membrane has a thickness of 1.0 mm to 4.0 mm and is heat cross-linked.  
   
   
       3 . A suturable adhesion-preventing membrane for guided tissue regeneration comprising a laminated membranous substance having at least one non-woven fabric layer made of collagen fibers and at least one sponge layer made of collagen, characterized in that a surface of the laminated membranous substance is provided with at least one layer containing gelatin or hyaluronic acid.  
   
   
       4 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the coating layer containing gelatin or hyaluronic acid is a sponge or film.  
   
   
       5 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the coating layer containing gelatin or hyaluronic acid comprises cross-linked gelatin or hyaluronic acid.  
   
   
       6 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the layer containing gelatin or hyaluronic acid is formed by lyophilization.  
   
   
       7 . A suturable adhesion-preventing membrane according to  claim 3 , wherein either the at least one non-woven fabric layer or at least one sponge layer in the laminated membranous substance is compressed, or the membranous substance is compressed.  
   
   
       8 . A suturable adhesion-preventing membrane for guided tissue regeneration according to  claim 3 , wherein the coating layer containing gelatin or hyaluronic acid has a thickness of 0.05 mm to 20 mm.  
   
   
       9 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the collagen of the collagen fibers-and the collagen of the at least one sponge layer are independently selected from enzyme-solubilized collagen, acid-solubilized collagen, alkali-solubilized collagen or neutral solubilized collagen.  
   
   
       10 . A suturable adhesion-preventing membrane according to  claim 3 , wherein a part or all of the laminated membranous substance comprising at least one non-woven fabric layer made of collagen fibers and at least one sponge layer made of collagen comprises a cross-linked collagen.  
   
   
       11 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the at least one non-woven fabric layer made of collagen fibers is a layer obtained by coagulating collagen fibers which are extruded and crossed over in multiple folds, or extruded and wound on a plate in a certain direction to have parallel lines of fibers, and compressing the coagulated fibers.  
   
   
       12 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the at least one non-woven fabric layer made of collagen fibers is a layer in which the fibers are joined together using a binder comprised of solubilized collagen solution.  
   
   
       13 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the at least one non-woven fabric layer made of collagen fibers has a thickness of 0.05 mm to 10 mm, the at least one sponge layer made of collagen has a thickness of 0.05 mm to 20 mm and the coating layer containing gelatin or hyaluronic acid has a thickness of 0.05 mm to 20 mm.  
   
   
       14 . A suturable adhesion-preventing membrane according to  claim 3 , wherein one to six layers of the at least one non-woven fabric layer made of collagen fibers are laminated with one to four layers of the at least one sponge layer made of collagen, and further, one to four layers of gelatin or hyaluronic acid layer are laminated thereon, and as a whole, three to fourteen layers are contained.  
   
   
       15 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the at least one non-woven fabric layer made of collagen fibers has fibers having a fiber diameter of 5 μm to 1 mm and a bulk density (fiber density) of 5×10 −4  to 5 g/cm 3 .  
   
   
       16 . A suturable adhesion-preventing membrane for guided tissue regeneration according to  claim 3 , wherein the overall thickness of the membrane is 0.1 mm to 50 mm.  
   
   
       17 . A suturable adhesion-preventing membrane according to  claim 3 , wherein the at least one sponge layer made of has a porosity area of 10 to 90%.  
   
   
       18 . A suturable adhesion-preventing membrane for guided tissue regeneration, comprising: a laminated membranous substance that has a first layer of a compressed collagen sponge layer, a second layer of a chemically cross-linked and compressed collagen non-woven fabric layer, and a third layer of a compressed collagen sponge layer; and a coating layer containing gelatin or hyaluronic acid, covering each surface of the laminated membranous substance.  
   
   
       19 . A suturable adhesion-preventing membrane for guided tissue regeneration comprising: a laminated membranous substance that has a first layer and a second layer of a chemically cross-linked and compressed collagen non-woven fabric; compressed collagen sponge layers provided on both sides of the laminated membranous substance; and a coating layer containing gelatin or hyaluronic acid, covering each sponge layer.