KR20010027979A - A guided tissue regeneration membrane - Google Patents

Abstract

PURPOSE: A regenerating membrane of periodontal tissue is provided which consists of biodegradable polymer or nondegradable polymer and is coated with adhesive composition capable of binding firmly tooth thereto. Therefore, it is used for recombination of an osteocyte and a ligament. CONSTITUTION: The regenerating membrane for periodontal tissue is coated with an adhesive composition comprising cyanoacrylate, fibrinogen, thrombin, rosin, their derivatives, or their mixture as a main substance. Wherein, 3-75 wt.% of main substituent is contained in the composition. The membrane is characterized by thermocompression of unwoven fabric or scaffold consisting of biodegradable polymer and having micropore of less than 10 micro meter in its average diameter, and unwoven fabric or scaffold consisting of biodegradable polymer and having micropore of 100-400 micro meter in its diameter.

Description

Periodontal tissue regeneration membrane

The present invention relates to a periodontal tissue regeneration membrane used for the treatment of periodontal disease.

Periodontal tissue regeneration membranes are inserted in the gums during periodontal disease surgery and are used to treat periodontal disease for the purpose of improving recombination of ligaments and bone cells by retarding the growth rate of gum epithelial cells.

Conventionally, as the periodontal tissue regeneration membrane, a regeneration membrane made of a non-degradable polymer such as natural or synthetic latex (Latex) and polytetrafluoroethylene was used, but since the regeneration membrane is not naturally degraded in the human body, Primary surgery was inevitable. In addition, there was a problem that the convenience of the procedure can not be designed in various forms according to the tooth shape during the procedure.

Meanwhile, in order to solve the above problem, a periodontal tissue regeneration membrane treated with a polyglycolide-lactide copolymer solution on a knitted fabric made of biodegradable polyglycolic acid fibers has been used, but micropores are used in the regeneration membrane. ) There is a problem that the periodontal bone growth is delayed and the healing time is longer.

In addition, the regeneration film is not only harmful to the human body because it uses an organic solvent in the preparation of the polyglycolide-lactide copolymer solution, but also has a bad problem of the ease of treatment because it can not be designed in various forms according to the tooth shape during the procedure.

Recently, in order to selectively promote growth of periodontal tissues, periodontal tissue regeneration membranes in which micropores are formed in a regeneration film by stacking two or more biodegradable nonwoven fabrics or biodegradable porous sheets are being developed.

Since various kinds of conventional periodontal tissue regeneration membranes described above do not have adhesion to teeth in common, sutures have been used to fix them to teeth. As a result, the procedure is difficult, and after the procedure, the periodontal tissue regeneration membrane is not firmly fixed to a certain position, and thus there is a problem in that the growth rate of the gum epithelial tissue cannot be effectively delayed.

An object of the present invention is to provide a periodontal tissue regeneration membrane with excellent adhesion to teeth in order to solve this problem.

The present invention provides a periodontal tissue regeneration membrane that can easily and firmly adhere to the periodontal tissue regeneration membrane to the teeth to facilitate the periodontal disease surgery and to effectively delay the growth rate of gum epithelial cells to promote recombination of ligaments and bone cells. To provide.

1 is a model of the periodontal tissue regeneration membrane of the present invention.

2 is an enlarged cross-sectional photograph of a polyglycolic acid nonwoven fabric.

3 is an enlarged cross-sectional view of a poly (lactide-glycolide) copolymer porous sheet containing salt.

Figure 4 is an enlarged cross-sectional picture of the salt-dissolved poly (lactide-glycolide) copolymer porous sheet.

※ Code explanation for main part of drawing

1 side coated with an adhesive composition 2 side coated with an adhesive composition

The present invention relates to a periodontal tissue regeneration membrane used for the treatment of periodontal disease.

More specifically, in the periodontal tissue regeneration membrane composed of a biodegradable polymer or a non-degradable polymer, cyanoacrylate, fibrinogen, thrombin, rosin, derivatives thereof on the regeneration membrane Or it relates to a periodontal tissue regeneration film characterized in that the adhesive composition containing a mixture thereof as a main component (adhesive component) is coated.

Hereinafter, the present invention will be described in detail.

The periodontal tissue regeneration film of the present invention is a cyanoacrylate (Fiynoacrylate), fibrinogen (Thrubin), thrombin (Trombin), rosin, derivatives or mixtures thereof by coating the adhesive composition as a main component (adhesive component) on the regeneration film Are manufactured. As the periodontal tissue regeneration membrane used in the present invention, both a regeneration membrane made of a non-degradable polymer and a regeneration membrane made of a biodegradable polymer can be used.

Specifically, a regenerated film made of natural latex, synthetic latex, or polytetrafluoroethylene which is a non-degradable polymer may be used.

Also, biodegradable polymers such as polyglycolide, polylactide, polyglycolic acid, polylactic acid, polydioxane source, polytrimethylene carbonate, polycaprolactone, poly (ortho ester), poly (anhydro), poly (phosphazene ), A regeneration membrane made of one polymer selected from the group consisting of poly (amino acid), cellulose derivative, poly (saccharide), poly (hydroxy butylate) or copolymers or blends thereof may be used. .

Representative periodontal tissue regeneration membrane and method for producing the same used in the present invention are as follows. In the present invention, (i) composed of a biodegradable polymer, non-woven fabric or porous sheet (Scaffold) formed with a micropore having an average diameter of less than 10㎛ and (ii) a biodegradable polymer, the average diameter of 100 ~ 400㎛ It is preferable to use a periodontal tissue regeneration membrane, which is characterized in that the porous sheet (Scaffold) in which the pore is formed is laminated by thermocompression, and the periodontal tissue regeneration membrane can be prepared by the following process.

First, the biodegradable polymer is spun in a conventional melt blowing method to prepare a nonwoven fabric, or a filament is prepared by conventional melt spinning, and then a nonwoven fabric is prepared by cutting and needle punching it.

Next, the biodegradable polymer is pulverized and separated into a predetermined size using a mesh, and then put into a molding mold, followed by compression molding with a heating compression roller to prepare a sheet. At this time, the pressure of the heating compression roller is about 0.1kg / ㎠ and the molding time is preferably about 2 minutes. In addition, it is more preferable to raise the pressure to 1 ton / cm 2 10 seconds before the completion of molding.

1 to 2 sheets of the nonwoven fabric and 2 to 3 sheets or sheets are thermocompressed in a heat press roller to prepare a laminate having a 2-3 layer structure. Specifically, after laminating the nonwoven fabric and the sheet or two sheets, by molding in a heating compression roller at a pressure of 0.1 ~ 0.5kg / ㎠ for about 2 minutes to prepare a laminate having a 2-3 layer structure by thermocompression. It is more preferable for thermocompression bonding to raise the pressure to about 5 kg / cm 2 10 seconds before the molding is completed.

Next, a water-soluble substance having an average diameter of less than 10 μm is sprayed and dispersed on the surface of one layer composed of nonwoven fabric or sheet among two to three layer structure laminates produced by thermocompression molding, and averaged on the remaining one layer (sheet) surface. Sprinkle and disperse a water-soluble substance with a diameter of 100 ~ 400㎛.

Subsequently, the laminate in which the water-soluble substance is dispersed is molded in a heat compression roller at a pressure of about 0.1 kg / cm 2 for about 2 minutes. At this time, the molding temperature is preferably 5 ~ 20 ℃ higher than the melting point of the biodegradable polymer, it is advantageous to evenly disperse the water-soluble material to gradually increase the pressure to 0.5 ~ 1kg / ㎠ 10 seconds before the completion of molding.

Next, the laminate in which the water-soluble substance is dispersed in each layer is immersed in distilled water for a predetermined time to dissolve, extract, and dry the water-soluble substance to prepare the periodontal tissue regeneration membrane of the present invention. At this time, the drying is preferably such that the moisture content is 100ppm or less under vacuum. Microporous is formed in the nonwoven fabric or sheet constituting the present invention by dissolving and extracting a water-soluble substance.

As the water-soluble substance, salt, magnesium chloride, calcium chloride, potassium chloride, stearic acid or gelatin is used.

The thickness of the periodontal tissue regeneration membrane is preferably 0.1 ~ 10mm. If the thickness is lower than 0.1mm, the mechanical properties and the like worsens, and if the thickness is more than 10mm, shape deformation becomes difficult during the procedure, resulting in poor convenience of the procedure.

The present invention may also use a periodontal tissue regeneration membrane, wherein (i) a biodegradable nonwoven fabric having a fiber thickness of 0.1 µm or less and (ii) a biodegradable nonwoven fabric having a fiber thickness of 0.1 µm or more is laminated by thermocompression bonding.

Both sides of the regeneration membrane have an advantage of selectively inhibiting or promoting the growth rate of the cell tissue due to the difference in porosity due to the difference in fiber thickness. The regenerated film may be prepared by manufacturing each nonwoven fabric by a conventional spunbond manufacturing method and then thermocompressing them.

Periodontal tissue regeneration membrane of the present invention is the cyanoacrylate (Fiynoacrylate), fibrinogen (Fibrinogen), thrombin (Thrombin), rosin, derivatives thereof or mixtures thereof on the various types of periodontal tissue regeneration membrane described above It is manufactured by coating the adhesive composition). The adhesive composition is composed of cyanoacrylate, fibrinogen, thrombin, rosin, derivatives or mixtures thereof (adhesive component), a matrix resin and a solvent as main components, and one side of the regeneration film. It is applied by a knife coating method or the like.

As the rosin derivative, glycerol rosin ester (trade names such as Herculus Corporation, Formal 65, Foral 85, Foral 105, etc.), a compound of formula (I), and the like are used.

Biodegradable polymers and non-degradable polymers are used as the matrix resin, and propylene carbonate, glyceryl triacetate, triethyl acetate, chloroform and the like are used as the solvent. The content of the cyanoacrylate, fibrinogen, thrombin, rosin, rosin, derivatives thereof, or a mixture thereof (adhesive component) is preferably 3 to 75% by weight based on the total weight of the adhesive composition. Do.

The periodontal tissue regeneration membrane of the present invention is inserted into the gum so that the adhesive coating surface and the teeth in contact with each other during surgery. The periodontal tissue regeneration membrane of the present invention can be easily adhered to the teeth during surgery because the adhesive composition is coated on the surface in contact with the teeth, it is maintained in a state that is firmly adhered to the teeth even after surgery. As a result, the convenience of surgery is improved and the growth rate of the epithelial cells of the gum is effectively delayed to promote recombination of ligaments and bone cells.

Hereinafter, the present invention will be described in more detail with reference to the following examples. However, the present invention is not limited only to the following examples.

Example 1

A nonwoven fabric is prepared by melt-blowing a polyglycolic acid polymer having a melt viscosity of 20,000 poises at 240 ° C. and 10 rad / sec at 240 ° C. at a spinning speed of 1,500 m / min.

Meanwhile, the poly (lactide-glycolide) copolymer polymer (pellets) is pulverized with a grinder to prepare a powder having an average diameter of 100 μm, and then put into a flat plate, followed by molding with a hot pressing roller to form a sheet. Manufacture. At this time, the temperature is 50 ℃, the pressure is 0.01kg / ㎠, the time is 1 minute and the pressure rises to 1 ton / ㎠ 10 seconds before the completion of molding.

Next, the two nonwoven fabrics are laminated on the upper and lower surfaces of the sheet, and then thermally press-bonded them in a heat compression roller to prepare a laminate having a three-layer structure. At this time, the temperature is 50 ℃, the pressure is 0.01kg / ㎠, the time is 1 minute and the pressure gradually rises to 7kg / ㎠ 10 seconds before the completion of molding.

Next, the upper surface of the laminate is sprinkled with salt having an average diameter of 10 μm, and the bottom surface of the sheet is sprinkled with salt having an average diameter of 400 μm, and then molded in a heat compression roller. At this time, the temperature is 90 ℃, the pressure is 0.01kg / ㎠, the time is 2 minutes and 10 seconds before the completion of molding gradually increases the pressure to 5kg / ㎠.

Subsequently, the salt-decomposed laminate was immersed in distilled water at 30 ° C. to dissolve and extract salt, and an adhesive composed of glycerol rosin ester (30 wt%), polyglycolic acid and triethyl acetate on one side of the laminate. The composition is applied by knife coating method. Subsequently, it is dried under vacuum or nitrogen atmosphere to prepare a periodontal tissue regeneration membrane having a thickness of 0.52 mm.

Example 2

A nonwoven fabric is prepared by melt-blowing a polyglycolic acid polymer having a melt viscosity of 40,000 poise at 240 ° C. and 10 rads / sec at 240 ° C. at a spinning speed of 1,500 m / min.

Meanwhile, a polydioxane source polymer (pellet) having a weight average molecular weight of 280,000 is pulverized by a pulverizer to prepare a powder having an average diameter of 100 μm. Manufacture. At this time, the temperature is 80 ℃, the pressure is 0.01kg / ㎠, the time is 1 minute and the pressure 10 seconds before the completion of molding rises to 1 ton / ㎠.

Next, the two nonwoven fabrics are laminated on the upper and lower surfaces of the sheet, and then thermally press-bonded them in a heat compression roller to prepare a laminate having a three-layer structure. At this time, the temperature is 120 ℃, the pressure is 0.01kg / ㎠, the time is 1 minute and 10 seconds before the completion of molding gradually increases the pressure to 7kg / ㎠.

Next, the upper surface of the laminate is sprinkled with salt having an average diameter of 10 μm, and the bottom surface of the sheet is sprinkled with salt having an average diameter of 400 μm, and then molded in a heat compression roller. At this time, the temperature is 90 ℃, the pressure is 0.01kg / ㎠, the time is 2 minutes and 10 seconds before the completion of molding gradually increases the pressure to 5kg / ㎠.

Subsequently, the salt-decomposed laminate was immersed in distilled water at 30 ° C. to dissolve and extract the salt, and glycerol rosin ester (30% by weight), polyglycolide-lactide copolymer and propylene on one side of the laminate. An adhesive composition composed of carbonate is applied by knife coating method. Subsequently, it is dried under vacuum or nitrogen atmosphere to prepare a periodontal tissue regeneration membrane having a thickness of 0.51 mm.

Example 3

A polyglycolic acid polymer (pellet) having a melt viscosity of 8,000 poise at 240 ° C. and 10 rads / sec is pulverized with a grinder to prepare a powder having an average diameter of 100 μm. To prepare a sheet. This temperature is 180 ℃, the pressure is 0.01kg / ㎠, the time is 2 minutes and 10 seconds before the completion of molding, the pressure rises to 1 ton / ㎠.

Meanwhile, the poly (lactide-glycolide) copolymer polymer (pellets) is pulverized with a grinder to prepare a powder having an average diameter of 100 μm, and then put into a flat plate, followed by molding with a hot pressing roller to form a sheet. Manufacture. At this time, the temperature is 50 ℃, the pressure is 0.01kg / ㎠, the time is 1 minute and the pressure rises to 1 ton / ㎠ 10 seconds before the completion of molding.

Next, the sheets are laminated, and then thermally compressed in a heat compression roller to prepare a laminate having a two-layer structure. At this time, the temperature is 150 ℃, the pressure is 0.07kg / ㎠, the time is 2 minutes and 10 seconds before the completion of molding gradually increases the pressure to 0.1 ton / ㎠.

Next, one side of the laminate is sprinkled with salt having an average diameter of 10 μm, and the other side is sprinkled with salt having an average diameter of 400 μm and then molded in a heat compression roller. At this time, the temperature is 150 ℃, the pressure is 0.01kg / ㎠, the time is 2 minutes and 10 seconds before the completion of molding gradually increases the pressure to 5kg / ㎠.

Subsequently, the salt-decomposed laminate was immersed in distilled water at 30 ° C. to dissolve and extract salt, and glycerol rosin ester (30 wt%) and glycolide-lactide-trimethylene carbonate block were disposed on one side of the laminate. The adhesive composition consisting of the copolymer and glyceryl triacetate is applied in a knife coating manner. Subsequently, it is dried under vacuum or nitrogen atmosphere to prepare a periodontal tissue regeneration membrane having a thickness of 0.40 mm.

Example 4

A polyglycolic acid polymer (pellet) having a melt viscosity of 8,000 poise at 240 ° C. and 10 rads / sec is pulverized with a grinder to prepare a powder having an average diameter of 100 μm. To prepare a sheet. This temperature is 180 ℃, the pressure is 0.01kg / ㎠, the time is 2 minutes and 10 seconds before the completion of molding, the pressure rises to 1 ton / ㎠.

Meanwhile, a polydioxane source polymer (pellet) having a weight average molecular weight of 340,000 is pulverized by a pulverizer to prepare a powder having an average diameter of 100 μm. Manufacture. At this time, the temperature is 80 ℃, the pressure is 0.01kg / ㎠, the time is 1 minute and the pressure 10 seconds before the completion of molding rises to 1 ton / ㎠.

Next, the sheets are laminated, and then, these are thermocompressed in a heat press roller to prepare a laminate having a two-layer structure. At this time, the temperature is 80 ℃, the pressure is 0.01kg / ㎠, the time is 1 minute and 10 seconds before the completion of molding gradually increases the pressure to 7kg / ㎠.

Next, the surface of the nonwoven fabric of the laminate is sprinkled with salt having an average diameter of 10 μm, and the surface of the sheet is sprinkled with salt having an average diameter of 400 μm, and then molded in a hot pressing roller. At this time, the temperature is 90 ℃, the pressure is 0.01kg / ㎠, the time is 2 minutes and 10 seconds before the completion of molding gradually increases the pressure to 5kg / ㎠.

Subsequently, the salt-decomposed laminate was immersed in distilled water at 30 ° C. to dissolve and extract the salt, and glycerol rosin ester (30 wt%), dioxane-lactide copolymer and propylene carbonate were disposed on one side of the laminate. The adhesive composition consisting of is applied by a knife coating method. Subsequently, it is dried under vacuum or nitrogen atmosphere to prepare a periodontal tissue regeneration membrane having a thickness of 0.42 mm.

Example 5

Melt-blowing spinning a polyglycolic acid polymer having a melt viscosity of 40,000 poise at 240 ° C. and 10 rads / sec at 240 ° C. at a spinning speed of 1,500 m / min to produce a nonwoven fabric having a fiber thickness of 0.05 μm and a nonwoven fabric having a fiber thickness of 0.15 μm. To prepare each.

Next, the two kinds of nonwoven fabrics are laminated, and then thermally compressed in a heat compression roller to prepare a laminate having a two-layer structure. Thermocompression conditions were the same as in Example 2.

Subsequently, the salt-decomposed laminate was immersed in distilled water at 30 ° C. to dissolve and extract the salt, and glycerol rosin ester (30% by weight) and dioxane-lactide-glycolide block air on one side of the laminate. An adhesive composition composed of coalescing and propylene carbonate is applied by knife coating. Subsequently, it is dried under vacuum or nitrogen atmosphere to prepare a periodontal tissue regeneration membrane having a thickness of 0.38 mm.

One side of the periodontal tissue regeneration membrane of the present invention is coated with an adhesive composition can easily adhere the periodontal tissue regeneration membrane to the teeth during surgery.

In addition, after surgery, the periodontal tissue regeneration membrane is firmly in contact with the teeth is maintained as it is inserted. As a result, the growth rate of the gum epithelial cells can be effectively delayed to promote recombination of ligaments and bone cells.

Claims (9)

In the periodontal tissue regeneration membrane composed of a biodegradable polymer or a non-degradable polymer, cyanoacrylate, fibrinogen, thrombin, rosin, derivatives thereof, or mixtures thereof are formed on the regeneration membrane. A periodontal tissue regenerating film characterized by coating an adhesive composition comprising (adhesive component). The periodontal tissue regeneration membrane according to claim 1, wherein the rosin derivative is glycerol rosin ester. The periodontal tissue regeneration membrane according to claim 1, wherein the content of the main component (adhesive component) is 3 to 75 wt% based on the total adhesive composition. The periodontal tissue regeneration of claim 1, wherein the adhesive composition is composed of a biodegradable polymer, cyanoacrylate, fibrinogen, thrombin, rosin, derivatives thereof, mixtures thereof, and solvents. membrane. The method of claim 1, wherein the biodegradable polymer is selected from polyglycolide, polylactide, polyglycolic acid, polylactic acid, polydioxane source, polytrimethylene carbonate, polycaprolactone, poly (ortho ester), poly (anhydro), It is characterized in that it is one polymer selected from the group consisting of poly (phosphazene), poly (amino acid), cellulose derivative, poly (saccharide), poly (hydroxy butylate) or copolymers or blends thereof. Periodontal tissue regeneration. The periodontal tissue regeneration membrane according to claim 1, wherein the non-degradable polymer is natural latex, synthetic latex or polytetrafluoroethylene. The method of claim 1, wherein the regeneration membrane is composed of (i) a biodegradable polymer, a non-woven fabric or a porous sheet (Scaffold) formed with a micropore having an average diameter of less than 10㎛ and (ii) a biodegradable polymer, the average diameter is 100 ~ Periodontal tissue regeneration membrane, characterized in that the porous sheet (Scaffold) formed with a micropore of 400㎛ laminated by thermocompression bonding. The periodontal tissue regeneration membrane according to claim 1, wherein the regenerated membrane is laminated with (i) a biodegradable nonwoven fabric having a fiber thickness of 0.1 m or less and (ii) a biodegradable nonwoven fabric having a fiber thickness of 0.1 m or more. The periodontal tissue regeneration membrane according to claim 4, wherein the solvent is propylene carbonate, glyceryl triacetate, trimethyl acetate or chloroform.