KR20160091195A - A resorbable guided bone regeneration membrane and an ampoule for storing the same - Google Patents

Abstract

An absorbent periodontal tissue regeneration membrane of the present invention is manufactured of biodegradable polymer sheets, thereby having space-maintaining properties and bone grafting substitute fixation properties and preventing soft tissue cells from infiltrating inside the bone grafting substitute when the lack of alveolar bone is recovered to a normal condition so as to provide space for bone formation. Accordingly, the present invention provides the absorbent periodontal tissue regeneration membrane having an effect of being completely decomposed and absorbed without causing a foreign body reaction following four to six month of a recovery time for the alveolar bone and an ampoule for storing the same.

Description

An absorbable periodontal tissue regeneration membrane and an ampoule for storing the same,

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a dental tissue regeneration membrane and an ampoule for storing the same, and more particularly, to an ampoule for storing a bone graft material during a period during which a deficient alveolar bone is recovered to a normal level, To an absorbable periodontal tissue regeneration membrane comprising a biodegradable polymer that provides a space for bone formation by preventing the infiltration of soft tissue cells into the inside thereof, and to an ampoule storing the same.

The procedure of the implant includes a step of drilling the alveolar bone to fix the root fixture, connecting the abutment like a column into the oral cavity, and then forming a crown on the abutment ≪ / RTI >

Therefore, in order to place the implant on the site where the tooth has been lost, the implant can be firmly fixed only by a sufficient amount of unaltered alveolar bone, and this process is one of the important factors determining the long-term prognosis of the implant. However, in some cases, it is difficult to sufficiently support an implant used as an artificial root with only the remaining alveolar bone due to the partial osteolysis of the alveolar bone due to trauma, destruction of periodontal tissue due to periodontal disease, extraction, and apical lesion. In this case, after the bone graft material such as the autogenous bone or the artificial bone is filled in the defected part, the bone graft material is operated to function as a new alveolar bone. In this case, This is called Guided Bone Regeneration (GBR).

In order to perform bone induction regeneration, a bone graft such as artificial bone or autogenous bone is filled in a defective site, and a periodontal regeneration membrane is covered so that the filled bone graft material can maintain the required shape. The periodontal tissue regenerating membrane functions as a membrane that functions to block incoming cells penetrating from the soft tissues. More specifically, since fibroblasts derived from soft tissues obstruct the alveolar bone formation by filling the alveolar bone graft, the alveolar bone graft is separated from the gum, and the gap between the graft material and the alveolar bone is sealed so that the fibrous connective tissue is exposed to the defect And prevents the invasion of germs even if exposed, and plays a role in securing adequate space for functional reconstruction for alveolar bone regeneration.

As such a conventional periodontal regeneration membrane, Japanese Patent Laid-Open Publication No. 2013-0006616 (published on Nov. 19, 2013) proposes a periodontal regeneration membrane produced by perforating a hole in a titanium plate material. These titanium-based regeneration membranes of the periodontal tissue are easy to handle and exhibit excellent prognosis for bone regeneration. However, after the alveolar bone is created, the periodontal tissue regeneration membrane must be removed through secondary surgery and the gingival tissue There is still a problem that the possibility of infection is very high because there is a problem of thinning, a tendency of the barrier to be exposed, and a large amount of deposition of the plaque once exposed.

Published Patent No. 2013-0006616 (November 19, 2013)

SUMMARY OF THE INVENTION It is an object of the present invention to solve the problems of the prior art by providing a biodegradable polymer plate which is a biodegradable polymer plate that covers a graft material filling the alveolar bone defects and induces alveolar bone regeneration before implantation, The present invention provides an absorbable periodontal tissue regeneration membrane having advantages such as space retention and bone graft fixation ability while being completely decomposed and absorbed in the body without a foreign body reaction and an ampoule capable of storing the same.

In order to achieve the above object, an absorbent periodontal tissue regeneration membrane (100), which is a biodegradable polymer material disposed in a defect site of alveolar bone according to an embodiment of the present invention to form a space for alveolar bone to be regenerated or to wrap a bone graft material, An engaging portion 20 surrounding the upper surface of the alveolar bone deficient portion filled with the bone graft material; And a side bending portion 30 bent and bent downward from the coupling portion 20 so as to have a curved shape and a plurality of holes, wherein the coupling portion 20 is configured to be inserted into the alveolar bone, A central hole (21) through which the insert can be pierced; An engaging side portion 22 projecting from a side edge of the engaging portion 20 and bent to surround the graft material; And an engaging upper side portion 23 protruded from an upper end of the engaging portion 20 so as to surround the bone graft material. The side curved portion 30 is formed on the side edge portions 30 of the side bent portion 30, A side cover portion 31 which is bent and bent toward the alveolar bone defect portion; And a lower bent part 32 protruding from a lower end of the side bent part 30 and disposed adjacent to the side cover part 31 and being capable of being bent independently of the side cover part 31; .

At this time, the lower bent portion 32 may be provided with an independent portion that is cut toward the side bent portion 30 so that the lower bent portion 32 may be bent independently of the side cover portion 31.

The absorptive periodontal tissue regeneration membrane 100, which is a biodegradable polymer material that is disposed at a defect site of the alveolar bone according to another embodiment of the present invention to form a space for alveolar bone to be regenerated or wraps the bone graft material, (20) for covering an upper surface of the body (10); And a side bending portion 30 extending horizontally from the joining portion 20 and having a plurality of holes formed therein. The joining portion 20 is formed by fixing the absorbent periodontal regeneration membrane 100 to the alveolar bone (24); And a wave filer forming part 25 disposed to surround at least a part of the center part 24 and projecting upward from the center part 24 to guide a wave filer protruding upward convexly to the regenerated alveolar bone And the wave filer forming portion 25 may be arranged in an annular shape so as to surround the central portion 24.

At this time, the absorptive periodontal regeneration membrane 100 and the alveolar bone can be fixed through the central hole 21 formed at the central part by being fixedly inserted or fixed to the edge of the central part 24 by a plurality of fixing screws have.

The engaging portion 20 includes an engaging side portion 22 extending from both side edges of the engaging portion 20 and bent downward to enclose the bone graft material. And a coupling upper layer 23 extending from an upper end of the coupling portion 20 and bent downward to wrap the bone graft material. The side bent portion 30 may be formed with the side bent portion 30, A side cover portion 31 extending from both side edges of the side cover portion 31 and bent inward; And a lower bent portion 32 extending downward from the side bent portion 30 and bent inward.

The biodegradable polymer is a biodegradable polymer sheet having a thickness of 0.1 to 0.35 mm, a weight average molecular weight of 100,000 to 1,000,000 and a density of 0.8 to 7.0 dL / g to be. The biodegradable polymer may be selected from the group consisting of polyglycolic acid (PGA), polylactic acid (PLA), poly-lactic-co-glycolic acid (PLGA), polylactic acid (PLLA), polycaprolactone (PCL), polyhydroxybutyrate , Polyhydroxyvalerate (PHV), polydioxanone (PDO), and polytrimethylenecarbonate (PTMC).

A biomaterial layer may be additionally formed on the upper and / or lower surface of the biodegradable polymeric sheet material, wherein the biomaterial layer is composed of collagen, chitosan, hyaluronic acid, carboxymethylcellulose, heparan sulfate, dextran and alginate And at least one selected from the group consisting of

In addition, the biomaterial layer may further include growth factors such as bone morphogenetic protein (BMP), epithelial growth factor (EGF), fibroblast growth factor (FGF), transforming growth factor (TGF- (IGF-1), thioredoxin (TRX), stem cell factor (SCF), hepatocyte growth factor (HGF), hepatocyte growth factor (HGF), platelet derived growth factor (VEGF) , Human growth hormone (HGF), and angiogenin.

The ampoule 200 for storing the regenerated membrane of an absorbable periodontal tissue, which is a biodegradable polymer material according to another embodiment of the present invention, includes a container capable of at least temporary or temporary hermetic sealing; And a membrane (43) partitioning the accommodating space inside the container into two spaces, a first space (41) and a second space (51), wherein the membrane (43) is capable of moving vaporized water molecules between the compartmented spaces , The membrane 43 may be a porous membrane or a non-porous membrane. At this time, a desiccant 42 for absorbing and removing the vaporized water molecules from the two spaces partitioned by the membrane 43 is accommodated in the first space 41, The aforementioned absorbent periodontal regeneration membrane 100 of the present invention is mounted.

The material of the porous membrane may be selected from the group consisting of PVDF (Polyvinylidene fluoride), PES (Polyether sulfone), MCE (Mixed cellulose esters), cellulose acetate, Nitrocellulose, Polycarbonate, Polytetrafluoroethylene, (Polypropylene), PVC (polyvinyl chloride), and nylon.

The desiccant 42 may be at least one selected from the group consisting of silica gel, bentonite, zeolite, aluminum silicate and upsalite, LiCl, CaCl ₂ , MgCl ₂ and ZnCl ₂ . Or more.

The container includes a cover 40 which can be opened and closed and a main body 50 which is hermetically sealed by the cover. The first space 41 is formed in the lid 40, Is formed in the main body (50). The membrane 43 is formed integrally with the lid 40 and the lid 40 communicates the first space 41 and the second space 51.

The main body 50 of the ampule 200 may have a double wall structure including an inner tube 52 and an outer tube 53.

Since the absorbent periodontal tissue regeneration membrane of the present invention is made of a biodegradable polymeric sheet, it is possible to maintain the bone formation space by preventing the infiltration of the soft tissue cells into the bone graft material during alveolar bone regeneration like the conventional periodontal regeneration membrane, But it has the advantage of being completely decomposed and absorbed in the body 4 to 6 months after the alveolar bone is restored to normal level without any foreign body reaction. However, since the absorbent periodontal regeneration membrane is vulnerable to moisture, it is possible to store the absorbent periodontal regeneration membrane for a long time from the external environment such as moisture through the absorbent periodontal tissue regeneration membrane storage ampoule of the present invention.

1 is a schematic diagram showing a section of an absorbent periodontal tissue regeneration membrane according to an embodiment of the present invention.
FIG. 2 is a schematic view showing a section of an absorbent periodontal tissue regeneration membrane including a filler-forming portion according to an embodiment of the present invention.
Fig. 3 is a schematic view showing that the absorbent periodontal tissue regeneration membrane of Fig. 2 further includes a center hole.
FIG. 4 is a schematic diagram showing a state in which a collagen layer is formed on an absorbent periodontal regeneration membrane of FIG. 1 and formed into three dimensions. FIG.
Fig. 5 is a schematic diagram showing a state in which the collagen layer is formed in the three-dimensional shape after the absorbable periodontal regeneration membrane of Fig. 2 is formed.
FIG. 6 is an exploded perspective view of an absorptive periodontal tissue regeneration membrane storing ampule according to an embodiment of the present invention. FIG.
7 is a cross-sectional view of an absorbent periodontal tissue regeneration membrane storing ampule according to an embodiment of the present invention.
FIG. 8 is a photograph showing a comparison of the gingival retention ability of the periodontal tissue regenerating membrane made of a conventional titanium mesh and the absorbent periodontal tissue regenerating membrane of the present invention.
9 is a photograph showing an experimental method for comparing the space retention capacity of the periodontal tissue regenerating membrane made of the conventional titanium mesh and the absorbent periodontal tissue regenerating membrane of the present invention.
10 is a graph comparing the space retention capacity of the periodontal tissue regeneration membrane fabricated with the conventional titanium mesh and that of the absorbent tissue regeneration membrane of the present invention.
Fig. 11 is a graph comparing molecular weight reduction rates of the absorbent periodontal tissue regenerating membrane of the present invention by humidity.
FIG. 12 is a graph comparing the molecular weight reduction rate with time of the absorbent periodontal regenerated membrane stored in the absorbable periodontal tissue regeneration membrane storage ampoule of the present invention. FIG.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. Prior to the description, terms and words used in the present specification and claims should not be construed as limited to ordinary or dictionary meanings and should be construed in accordance with the technical concept of the present invention.

Throughout this specification, when an element is referred to as "including" an element, it is understood that it may include other elements as well, without departing from the other elements unless specifically stated otherwise.

Each step may be performed differently than the order specified unless explicitly stated in the context of the specific order. That is, each of the steps may be performed in the same order as described, or may be performed substantially concurrently or in the reverse order.

Hereinafter, the absorbent periodontal regeneration membrane of the present invention and the ampoule storing the same will be described in more detail.

The absorptive periodontal tissue regeneration membrane 100, which is a biodegradable polymer material disposed at a defect site of the alveolar bone according to an embodiment of the present invention to form a space for alveolar bone to be regenerated or to surround the bone graft material, So as to induce alveolar bone regeneration in the alveolar bone defect. The two-dimensional plan view of the absorbent periodontal tissue regeneration membrane 100 is shown in FIG. 1, and the two-dimensional type of the absorbent periodontal tissue regeneration membrane 100 is three-dimensionally bent by a predetermined bending mechanism As shown in Fig.

The absorbent gum tissue regeneration membrane 100 according to the present embodiment is characterized in that the regenerated membrane of the periodontal ligament tissue 100 of the periodontal ligament regeneration membrane of the present invention comprises the lamination portion 20, the central hole 21, the engaging side portion 22, the engaging upper portion 23, And includes a cover portion 31 and a lower bent portion 32.

The joint portion 20 is formed with a center hole 21 through which an implant for insertion into the alveolar bone can pass, and is coupled with the implant for implant. The engaging portion 20 covers the upper side of the region where the bone graft material is accumulated as a bone defect site, and is formed in a substantially flat shape. The center hole 21 is formed at a central portion of the coupling portion 20 and a plurality of holes are formed in the periphery of the center hole 21. The hole is formed of a graft material filling the bone defect portion, The physiological reaction between the blood is activated and the graft material is firmly and stably fused with the surrounding bone tissue, and it is preferable that the size of the graft material has a size suitable for bone fusion.

The engaging side surface portion 22 is bent so as to surround the bone graft material while protruding from the side edge of the engaging portion 20. [ The engaging side portion 22 may protrude from a part of the side edge of the engaging portion 20, thereby facilitating bending.

The engaging upper side portion 23 is bent so as to protrude from the upper end of the engaging portion 20 so as to enclose the bone graft material and is preferably two-dimensionally preformed in conformity with the final shape of the alveolar bone to be regenerated.

The side curved portion 30 is provided with a graft material therein and bent downward from the engaging portion 20 so as to be curved so as to have a gently curved shape as a whole.

The side cover part 31 is provided with a graft material inside and protrudes from both side edges of the side curved part 30 and is bent to bend toward the graft material.

The lower bent portion 32 is formed at the lower end of the side bent portion 30 and is bent inward. The lower bent portion 32 may be provided with an independent portion that is cut or recessed toward the side bent portion 30 so that the lower bent portion 32 may be bent independently of the side cover portion 31.

The absorptive periodontal tissue regeneration membrane 100, which is a biodegradable polymer material disposed in a defect site of the alveolar bone according to another embodiment of the present invention to form a space for alveolar bone to be regenerated or to enclose the bone graft material, To induce alveolar bone regeneration in the alveolar bone defect, and at the same time to form the alveolar bone. The two-dimensional plan view of the absorbent periodontal regeneration membrane 100 is shown in FIGS. 2 and 3, and the two-dimensional absorbent periodontal regeneration membrane 100 is bent three-dimensionally by a predetermined bending mechanism One form is as shown in Fig.

Thus, the absorbent periodontal tissue regeneration membrane 100 according to the present embodiment includes the overlapping portion 20, the central portion 24, the filler-forming portion 25, and the side bent portion 30.

The joining portion 20 includes a central portion 24 for fixing the absorbent periodontal regeneration membrane to the alveolar bone, and a wave filer forming portion 25 for guiding the wave filer to be formed, including the upper surface of the alveolar bone deficient portion filled with the bone graft material do.

The absorbent periodontal regeneration membrane 100 and the alveolar bone are fixed through the center portion 24. The alveolar bone is fixed to the edge of the center portion 24 using a plurality of fixing screws or a center hole 21 is formed at the center portion Thereby allowing the implant itself to be fixedly inserted.

The wave filer forming portion 25 is disposed so as to surround at least a part of the middle portion 24 and protrudes upward from the center portion 24 to induce a wave filer protruding upward convexly to the alveolar bone being regenerated will be. The end face of the wave filer forming portion 25 is formed in a substantially arch shape and is arranged in an annular shape so as to surround the central portion 24. [ At this time, it is preferable that the distance from the central portion 24 to the uppermost end of the wave filer forming portion 25 is approximately 0.1 to 3 mm. If it exceeds 3 mm, the wave filer portion of the generated alveolar bone protrudes excessively high, If it is less than 0.1 mm, the height of the protruding portion is lowered, which may easily collapse after regeneration.

The side bending portion 30 extends horizontally from the joining portion 20 and has a plurality of holes formed therein. In order to wrap the side of the alveolar bone deficient portion filled with the bone graft material, Shaped as shown in Fig. 5, or may be configured to have a "]" shape as shown in Fig.

The engaging portion 20 includes an engaging side portion 22 extending from both side edges of the engaging portion 20 and bent downward to enclose the bone graft material. And a coupling upper layer 23 extending from an upper end of the coupling portion 20 and bent downward to wrap the bone graft material. The side bent portion 30 may be formed with the side bent portion 30, A side cover portion 31 extending from both side edges of the side cover portion 31 and bent inward; And a lower bent portion 32 extending downward from the side bent portion 30 and bent inward.

Meanwhile, the biodegradable polymer is a biodegradable polymer plate produced by injection molding in a sheet form including perforations. In order to have the strength equivalent to that of a conventional titanium mesh product (Osteo-mesh, Osteogenics. Co.), The thickness is preferably 0.35 mm, more preferably 0.2 to 0.35 mm. When the thickness of the biodegradable polymer plate is less than 0.1 mm, it is difficult to secure sufficient space after the treatment due to low strength due to low strength. When it exceeds 0.35 mm, it takes a long time to decompose in vivo.

The biodegradable polymer preferably has a weight average molecular weight of 100,000 to 1,000,000 and a density of 0.8 to 7.0 dL / g. Generally, the higher the molecular weight and density of the biodegradable polymer, the higher the melt viscosity of the biodegradable polymer. If the melt viscosity of the biodegradable polymer is too high, the characteristics of the injection molding process under high temperature and high pressure conditions, There are restrictions on operation.

That is, in terms of productivity, since the retention time (heating time) in the injection molding machine is prolonged for the complete melting of the biodegradable polymer having a too high molecular weight and density, the biodegradable polymer having the molecular weight and density is reduced It is preferable to use injection molding operation conditions.

In terms of efficacy, the regenerated membrane of the periodontal tissue should exhibit a period of about 4 to 6 months in the body. The longer the molecular weight, the longer the maintenance period in the body. Considering this aspect, the molecular weight of the biodegradable polymer used in the present invention is preferably in the range of about 100,000 to 1,000,000 based on the weight-average molecular weight, as a material for a periodontal regeneration membrane.

The biodegradable polymer is a hydrolyzable biodegradable polymer, and may be a polyglycolic acid (PLGA), polylactic-co-glycolic acid (PLGA), polylactic acid (PLA), polylactic acid (PLLA) At least one selected from the group consisting of Polycaprolactone, PHB (Polyhydroxybutyrate), PHV (Polyhydroxyvalerate), PDO (Polydioxanone) and PTMC (Polytrimethylenecarbonate) PLGA (poly-lactic-co-glycolic acid) can be used.

On the other hand, a biomaterial layer may be further formed on the upper and / or lower surface of the biodegradable polymeric sheet, wherein the biomaterial layer is formed of collagen, chitosan, hyaluronic acid, carboxymethylcellulose, heparan sulfate, dextran and alginate , And collagen is preferably used.

When the biomaterial layer is formed on the biodegradable polymer plate, the biomaterial layer prevents the perforation of the biodegradable polymer plate, thereby preventing the soft tissue from penetrating into the bone graft through the perforation. When a biodegradable polymer plate having strength is implanted into the body without any processing, the relatively soft gingival tissue tends to be thinned by the frictional force. By forming a biomaterial layer on the biodegradable polymer plate, Can be solved.

In addition, the biomaterial layer may further include growth factors such as bone morphogenetic protein (BMP), epithelial growth factor (EGF), fibroblast growth factor (FGF), transforming growth factor (TGF- (IGF-1), thioredoxin (TRX), stem cell factor (SCF), hepatocyte growth factor (HGF), hepatocyte growth factor (HGF), platelet derived growth factor (VEGF) , Human growth hormone (HGF), and angiogenin.

The ampoule 200 for storing the biodegradable polymeric regenerated membrane of the biodegradable polymer according to another embodiment of the present invention is composed of a container capable of at least temporary or temporary hermetic sealing, (43) as a boundary. Here, the hermetically sealed hermetically sealing of the container means "at least temporarily or temporarily possible" means that the hermetically sealed hermetically sealing of the container includes both the case where it is possible repeatedly,

The porous membrane 43 means a member that allows the free movement of vaporized water molecules while partitioning the receiving space inside the vessel into two spaces, namely a first space 41 and a second space 51. The porous membrane 43 may be made of polyvinylidene fluoride (PVDF), polyether sulfone (PES), mixed cellulose esters (MCE), cellulose acetate, nitrocellulose, polycarbonate, PTFE Polytetrafluoroethylene, polypropylene (PP), polyvinyl chloride (PVC), nylon, and the like.

In the first space 41, which is one of the two spaces defined by the porous membrane 43 as described above, a dehumidifying agent for absorbing and removing vaporized water molecules is accommodated. In the second space, Is fixed by a fixing pin (55) for fixing the membrane (100) through the fastening hole (54) so as not to move. At this time, since the absorbent periodontal regeneration membrane 100 is made of a biodegradable polymer and is vulnerable to moisture, it is stored in an airtight container, and a dehumidifying agent is used to remove moisture in the container. The dehumidifying agent may be at least one selected from the group consisting of bentonite, zeolite, aluminum silicate, and upsalite, LiCl, CaCl ₂ , MgCl ₂ and ZnCl ₂ . But is not particularly limited thereto.

The container is composed of a cover 40 which can be opened and closed and a main body 50 which is sealed by the cover 40. A first space 41 is formed in the lid 40 and a second space 51 Are formed in the main body 50. [ The porous membrane 43 is formed integrally with the lid 40 and the lid 40 communicates the first space 41 and the second space 51. [

The main body 50 of the ampule 200 may form a double wall structure including an inner tube 52 and an outer tube 53. The main body 50 having such a double structure improves the sealing performance of the container It is effective to more reliably protect the absorbent periodontal regeneration membrane 100 from external impacts.

It is also possible to make the entire body 50 made of a transparent material by further including the inner tube 52 or the outer tube 53 so that the state of the absorbent periodontal regeneration membrane 100 can be visually confirmed.

Hereinafter, the technical features of the present invention will be described in detail with reference to embodiments and drawings. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims and their equivalents. shall.

Absorbable periodontal tissue Regenerated membrane  Produce

① Manufacture of biodegradable polymer sheet

The PLGA was melted at a temperature of 200 ° C before being transferred into the barrel of a Fanuc (i30A-injection molding machine), then injection molded at a temperature of 200 ° C at a pressure of 1800 bar into a molding of sheet form. The injection molded PLGA was cooled at 25 DEG C for 10 seconds and then removed from the molding part to obtain a PLGA plate.

② collagen layer ( The biomaterial layer ) And forming into three dimensions

The PLGA was laminated with a sheet type collagen layer having a thickness of 0.2 mm and thermally compressed with a plate-type thermocompressor (QM900M). The PLGA having the thermocompressed collagen layer formed therein was placed in a thermocompressor molding part having a three-dimensional structure, heated at 90 DEG C for 15 seconds, and cooled for 30 seconds to obtain a PLGA having a banding structure with a collagen layer. And Fig. FIGS. 4 and 5 show that the PLGA has a three-dimensional banding structure in which a collagen layer is formed, and that a large number of perforations are shielded by the collagen layer.

③ growth factor Impregnation

The PLGA laminated with the three-dimensional banding structure was loaded on 1.5 mg / ml BMP-2 (R & D Systems, USA) and allowed to stand for 6 hours at an average temperature of 5 ° C. , Followed by gamma sterilization with a 25 kGy gamma ray under vacuum to prepare an absorbable periodontal regeneration membrane impregnated with growth factors.

Gingiva  Prevent thickness reduction

The effect of preventing the reduction of gingival thickness of the periodontal tissue regeneration membrane manufactured using the conventional titanium mesh and the absorbent periodontal tissue regeneration membrane prepared according to the first embodiment was examined.

After 8 weeks of healing period, the teeth of P1 ~ M2 teeth of Montgrel 's mandible were excised and 15 mm wide, 5 mm wide and 8 mm deep were produced. After the implantation of the heterogeneous bone graft material (Bio-Oss, Geistlich), the titanium mesh having the three-dimensional structure formed to fit the size of the defect and the absorbable periodontal tissue regeneration membrane of the present invention having the same shape were respectively implanted. The gingival thickness and appearance of the implanted site after 16 months of transplantation are shown in FIG.

According to the results shown in FIG. 8, it can be seen that the titanium mesh is transparent under the gingiva when the titanium mesh is implanted. On the other hand, in the case of the absorbent periodontal regeneration membrane of the present invention, it was confirmed that the thickness of the gingiva was maintained at the initial stage of implantation. This suggests that the regenerated membrane of the periodontal tissue is more effective in maintaining the thickness of the gingival tissue than the conventional titanium mesh.

Space-maintaining ability  compare

The space retention ability of the periodontal tissue regenerating membrane prepared using the conventional titanium mesh and the absorbent periodontal tissue regenerating membrane of the present invention prepared according to Example 1 was compared with the method of FIG.

Each of the regenerated periodontal regenerated membranes was prepared in the same size and shape, and the strength was measured by applying a constant force of 10 mm / min downward in reference to ASTM D 790, a bending strength measurement standard. The results are summarized in FIG.

FIG. 10 is a graph showing the results of the above space retention ability test. FIG. 10 shows that the absorbent periodontal tissue regenerating membrane of the present invention has almost the same or slightly better space retention ability as the conventional titanium mesh.

Comparison of molecular weight reduction rate by humidity

A 10 x 20 x 0.3 mm plate-like absorptive periodontal tissue regenerated membrane prepared according to Example 1 using the biodegradable polymer PLLA was stored in a 25 ° C chamber for 6 months under the conditions of 70, 50, 30, and 10% wetness, respectively. After storing the sample for a certain period of time, the residual moisture was removed by vacuum drying for 24 hours to measure the molecular weight, and the molecular weight was measured with a Waters 515 Pump / 7017 Auto Sampler / 410 RI GPC Waters Ststem instrument.

According to FIG. 11, the absorbent periodontal tissue regenerating membrane stored at a high humidity condition showed a relatively high molecular weight reduction rate. This suggests that the hydrolyzable biodegradable polymer based absorbent regenerated membrane is relatively weak to moisture and promotes the hydrolysis of the biodegradable polymer, resulting in a decrease in molecular weight. Also, when the humidity in the chamber was 70%, it was observed that about 70% of the initial molecular weight was lost at about 4 months.

The molecular weight loss of the biodegradable polymer means that the biodegradable polymer, which is vulnerable to moisture, is stored in an environment of less than 10% humidity .

Comparison of molecular weight reduction rate by dehumidifying ampoule

The three-dimensional shaped absorbent periodontal regeneration membrane prepared according to Example 1 was prepared using the biodegradable polymer PLLA and loaded into the absorbable periodontal tissue regeneration membrane-loaded ampule on which the silica gel was mounted, and stored in a chamber at 25 ° C for 6 months . After the sample was stored for a certain period of time, the remaining water was removed by vacuum drying for 24 hours to measure the molecular weight, and the molecular weight was measured by a Waters 515 Pump / 7017 Auto Sampler / 410 RI GPC Waters Ststem instrument.

According to Fig. 12, the absorbable periodontal tissue regeneration membrane storage ampoule effectively removes the moisture inside the ampoule, and more effectively maintains the molecular weight of the regenerated periodontal regenerated membrane for a longer period of time than the absorbent periodontal regeneration membrane stored under the wet condition of 10% Respectively.

The results of Examples 1 to 3 are as follows. The biodegradable polymer-based absorbable periodontal regeneration membrane is effective in maintaining the thickness of the gingiva while maintaining the same level of space retention as the titanium mesh, while it is completely decomposed and absorbed after 4 to 6 months without reaction with the living body It is a regenerative membrane with improved clinical usability as a membrane that does not require secondary removal surgery.

On the other hand, according to Example 4, the biodegradable polymer is susceptible to moisture and is hydrolyzed when it is exposed to water. Especially, in an environment with a humidity of 10% or more, such phenomenon is further accelerated. It is important to do.

Therefore, it can be seen that when the absorbable periodontal regeneration membrane based on the biodegradable polymer is stored in the ampoule for absorbing periodontal tissue regeneration membrane according to the present invention as in Example 5, moisture can be effectively controlled, have.

100: Absorbent periodontal regeneration membrane 200: ampoule
20: engaging portion 21: center hole
22: engaging side portion 23: engaging upper portion
24: center portion 25: wave filer forming portion
30: side bent portion 31: side cover portion
32: lower bent portion 40: lid
41: first space 42: desiccant
43: Membrane 50: Body
51: second space 52: inner tube
53: outer tube 54: fastening hole
55: Fixing pin

Claims (22)

A regenerated periodontal regenerating membrane which is arranged at a defect site of alveolar bone to form a space for alveolar bone to be regenerated or to wrap a bone graft material,
An engaging portion surrounding the upper surface of the alveolar bone deficient portion filled with the bone graft material; And
And a side bent portion bent downwardly from the coupling portion to have a curved shape as a whole and having a plurality of holes,
The coupling portion
A central hole through which the implant for implantation inserted into the alveolar bone can penetrate;
An engaging side portion protruded from a side edge of the engaging portion and bent to enclose the bone graft material; And
And an engaging upper portion protruded from an upper end of the engaging portion and bent to surround the bone graft material,
The side-
A side cover portion formed to protrude from both side edges of the side bending portion and to be bent and bent toward the alveolar bone defect portion; And
And a lower bent portion protruding from a lower end of the side bent portion and disposed adjacent to the side cover portion and being capable of being bent independently of the side cover portion,
Wherein the periodontal regeneration membrane is a biodegradable polymeric material. The method according to claim 1,
Wherein the lower bent portion is provided with an independent portion that is cut toward the side bent portion so that the lower bent portion can be bent independently of the side cover portion. A regenerated periodontal regenerating membrane which is arranged at a defect site of alveolar bone to form a space for alveolar bone to be regenerated or to wrap a bone graft material,
An engaging portion surrounding the upper surface of the alveolar bone deficient portion filled with the bone graft material; And
And a side bent portion extending in the horizontal direction from the coupling portion to form a plurality of holes,
The coupling portion
A center portion for fixing the absorbent periodontal regeneration membrane to the alveolar bone;
And a wave filer forming part which is disposed to surround at least a part of the center part and protrudes upward from the center part to guide the wave filer protruding upward convexly to the alveolar bone to be reproduced,
Wherein the periodontal regeneration membrane is a biodegradable polymeric material. The method of claim 3,
A center hole is formed in the center portion, and the implant itself is inserted into the center hole to fix the alveolar bone and the absorbent periodontal regeneration membrane. The method of claim 3,
Wherein a plurality of fixing screws are used to fix the alveolar bone and the absorbent periodontal regeneration membrane at the edge of the center part. The method of claim 3,
Wherein the wave filer forming portion is annularly arranged so as to surround the center portion. The method of claim 3,
The engaging portion
An engaging side portion extending from both side edges of the engaging portion and bent downward to enclose the bone graft material; And
And an engaging upper layer extending from an upper end of the engaging portion and bent downward to enclose the bone graft material. The method of claim 3,
The side bent portion
A side cover portion extending from both side edges of the side curved portion and bent inward; And
And a lower bent portion extending downward from the side bent portion and bent inward. 9. The method according to any one of claims 1 to 8,
Wherein the biodegradable polymer is a biodegradable polymer sheet in the form of a sheet including perforations and has a thickness of 0.1 to 0.35 mm. 10. The method of claim 9,
The biodegradable polymer may be selected from the group consisting of polyglycolic acid (PGA), polylactic acid (PLA), poly-lactic-co-glycolic acid (PLGA), polylactic acid (PLLA), polycaprolactone (PCL), polyhydroxybutyrate Wherein the at least one selected from the group consisting of PHV (Polyhydroxyvalerate), PDO (Polydioxanone) and PTMC (Polytrimethylenecarbonate). 10. The method of claim 9,
Wherein the biodegradable polymer has a weight average molecular weight of 100,000 to 1,000,000 and a density of 0.8 to 7.0 dL / g. 10. The method of claim 9,
And a biomaterial layer is further formed on the upper and / or lower surface of the biodegradable polymeric sheet material. 13. The method of claim 12,
Wherein the biomaterial layer is at least one or more selected from the group consisting of collagen, chitosan, hyaluronic acid, carboxymethyl cellulose, heparan sulfate, dextran and alginate. 12. The method of claim 11,
Wherein the biomaterial layer further comprises a growth factor. 15. The method of claim 14,
The growth factor may be selected from the group consisting of bone morphogenetic protein (BMP), epithelial growth factor (EGF), fibroblast growth factor (FGF), transforming growth factor (TGF-beta), platelet derived growth factor (PDGF), vascular endothelial cell growth factor VEGE), insulin-like growth factor (IGF-1), thioredoxin (TRX), stem cell factor (SCF), hepatocyte growth factor (HGF), human growth hormone and angiogenin The periodontal tissue regeneration membrane being at least one selected from the group consisting of: A container capable of at least temporary or temporary hermetic sealing; And
And a membrane that divides the container space inside the container into two spaces, a first space and a second space, wherein a membrane capable of moving vaporized water molecules between the partitioned spaces,
Wherein the moisture absorbent for absorbing the vaporized water molecules is accommodated in the first space and the absorbent gum tissue regeneration membrane according to any one of claims 1 to 8 is placed in the second space, Ampoules for tissue regenerative membrane storage. 17. The method of claim 16,
Wherein the membrane is a porous membrane or a non-porous membrane. 18. The method of claim 17,
The material of the porous membrane may be selected from the group consisting of PVDF (Polyvinylidene fluoride), PES (Polyether sulfone), MCE (Mixed cellulose esters), cellulose acetate, Nitrocellulose, Polycarbonate, Polytetrafluoroethylene, Polypropylene, polyvinyl chloride (PVC), nylon (Nylon), and the like. 17. The method of claim 16,
The desiccant is at least one selected from the group consisting of silica gel, bentonite, zeolite, aluminum silicate and upsalite, LiCl, CaCl ₂ , MgCl ₂ and ZnCl ₂ And an absorbable ampoule for regenerating regenerated tissue. 17. The method of claim 16,
The ampoule for storing an absorbent periodontal tissue regeneration membrane, wherein the container is composed of a lid capable of being opened and closed and a body sealingly coupled by the lid, wherein the first space is formed in the lid and the second space is formed in the body. 21. The method of claim 20,
Wherein the membrane is formed integrally with the lid and the lid communicates the first space with the second space. 21. The method of claim 20,
Wherein the main body is a double wall structure including an inner passage outer tube.

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