CN210932937U - Oral bone induction regeneration membrane - Google Patents
Oral bone induction regeneration membrane Download PDFInfo
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- CN210932937U CN210932937U CN201921173139.0U CN201921173139U CN210932937U CN 210932937 U CN210932937 U CN 210932937U CN 201921173139 U CN201921173139 U CN 201921173139U CN 210932937 U CN210932937 U CN 210932937U
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Abstract
The utility model relates to an oral cavity bone induction regeneration membrane, which comprises a hydrophobic layer a, a hydrophobic layer b and a hydrophilic layer c which are arranged in sequence; the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c all have porous three-dimensional structures. The thickness of the hydrophobic layer a is 0.1-0.2mm, the thickness of the hydrophobic layer b is 0.15-0.3mm, and the thickness of the hydrophilic layer c is 0.1-0.2 mm. The induced regeneration membrane has a special space structure, is beneficial to the growth of epithelial tissues, gingival tissues and the like, further fixes the implantation position of the membrane and prevents the displacement of the membrane.
Description
Technical Field
The utility model relates to an osteoinductive regeneration membrane technical field, specifically speaking relates to an oral cavity osteoinductive regeneration membrane.
Background
With the improvement of the oral medical level, the oral implant surgery technology is mature day by day, and sufficient alveolar bone mass is the key of successful surgery. Many patients have a severe loss of bone mass due to aging and fail to provide sufficient strength support to the implant. Therefore, it is necessary to repair the alveolar bone through surgical intervention before the implant operation.
Guided Bone Regeneration (GBR) has its origin in Guided Tissue Regeneration (GTR), which is a well-known effective method for increasing bone mass. Under normal conditions, alveolar bone may be regenerated or repaired as if damaged bone grows itself, but gingival tissue is regenerated faster than alveolar bone, and thus, to ensure a regeneration space of alveolar bone and to serve as a barrier for gingival tissue and alveolar bone, a GBR membrane is placed between alveolar bone and periodontal tissue. Thus, the bone defect can be prevented from being covered by soft tissues, and the regeneration time and space of periodontal ligament tissues and bone tissues are ensured.
The raw materials and structure of GBR membranes directly affect the osteogenic effect. The membrane material should have good biocompatibility, controllable degradation behavior and certain supporting strength; the structure of the membrane material has the function of a barrier, so that the epithelial tissue cells are prevented from entering the bone defect area, and meanwhile, the transmission of nutrient substances is met.
GBR membranes in the current market are of two major types, one is prepared from non-degradable materials, and has good biocompatibility and supporting performance and good osteogenesis effect; the defects are that the patient needs to be taken out by a secondary operation, the pain of the patient is increased, and the clinical cases of secondary infection, membrane exposure and the like exist. The other is made of degradable materials, which can be divided into two main categories of natural materials and synthetic materials. The existing widely-used collagen GBR membrane in the market has wide material source, can be degraded without taking out the membrane by a secondary operation, but has poor support performance, short degradation time, easy occurrence of clinical cases such as membrane collapse, infection and the like, and simultaneously has the defects of easy occurrence of rejection reaction, religious problems, uncontrollable product batch difference and the like of allograft. The synthesized polymer material has the advantages of excellent biocompatibility, controllable degradation period, good support performance and the like, and can achieve ideal treatment effect according to the combination of different materials and the design of the structure. Therefore, the GBR film prepared by the synthetic material has higher research value and wide market application prospect.
Chinese patent publication No. CN103877620A provides an oral matrix membrane and a method for preparing the same. The method comprises the steps of selecting mixed-spinning polylactic acid and levorotatory polylactic acid as base materials, selecting acetyl tributyl citrate as a plasticizer, and preparing three layers of sheets with different apertures in a hot pressing or laser drilling mode, wherein the apertures of the upper layer and the lower layer are the same, and are square holes with the length of 100-600 mu m and the width of 100-400 mu m; the middle layer has smaller aperture, is a round hole with 50-150 μm, and is fixed and formed by cold pressing or bonding to obtain the oral cavity matrix membrane.
Chinese patent publication No. CN104707175A provides a membrane for guiding bone tissue regeneration in oral cavity and a method for preparing the same. Mixing a 4% chitosan acetic acid solution and an 8% polyvinyl alcohol aqueous solution according to a ratio of 3:7(v/v), stirring and standing overnight to obtain a spinning solution; and then regulating the voltage to be 14KV and the negative voltage to be-2 KV at room temperature by an electrostatic spinning process, wherein the receiving distance is 20cm, and preparing the guided bone tissue regeneration membrane with the thickness of 0.3 mm.
Chinese patent publication No. CN1216653C provides a method for preparing a composite membrane for guiding tissue regeneration. The invention takes polylactic-co-glycolic acid (PLGA), collagen and nanocrystalline hydroxyapatite as raw materials, prepares a composite film with a two-layer structure by a suspension coating method, and is characterized in that one side is smooth, the other side is rough, and the degradation is controllable.
The bone induction regeneration membrane and the preparation method thereof provided by the invention have good biocompatibility and can play a certain role in supporting and shielding, but have some defects. The defects are that the membrane space structure is simple, the bone induction regeneration effect is poor, the requirements of migration and growth of epithelial tissue cells and osteoblasts cannot be met, the treatment period is long, the membrane material cannot continuously provide a barrier effect, the osteogenesis amount is insufficient, and finally the operation fails.
SUMMERY OF THE UTILITY MODEL
Aiming at the problems of simple structure and poor treatment effect of the current oral bone induction regeneration membrane, the utility model provides an oral bone induction regeneration membrane. The three layers a, b and c of the membrane are porous structures, wherein the upper surface and the lower surface of the layer b are provided with regularly arranged bulges, so that the membrane is convenient to weld, and the inner space of the membrane is supported, and the porous three-dimensional structure can play a role in supporting and preventing the membrane from shifting; the layer c is of a hydrophilic and hydrophobic structure, and is grafted with a hydrophilic material (PEG) on the basis of hydrophobic polyester (PCL, PLA, PPDO, PGA and the like), wherein a hydrophobic section (PCL chain segment) provides an adhesion growth environment for bone cells, and a hydrophilic section (PEG chain segment) formed by grafting provides nutrients for the bone cells, so that the bone growth is accelerated, and the treatment period is shortened.
The utility model aims at realizing through the following technical scheme:
the utility model provides an oral cavity bone induction regeneration membrane, this bone induction regeneration membrane mainly comprise a, b, c three-layer, extrude through the melting, solution pouring, compression moulding or solvent volatilize method film forming, then through laser engraving process, obtain porous spatial structure, rethread laser welding, ultrasonic bonding, solvent method are in the same place three-layer membrane is compound, are got oral cavity bone induction regeneration membrane. The two layers a and b are hydrophobic layers and are composed of mixed spinning polylactic acid, levorotatory polylactic acid and acetyl tributyl citrate, and the hydrophobic layers mainly play a role in shielding and supporting; the layer c is a hydrophilic layer, and is prepared by copolymerizing one or more monomers of caprolactone, lactide, p-dioxanone and glycolide to obtain polyester polyol under the initiation of 1, 3-propylene glycol or glycerol, adding excessive lysine diisocyanate to react to obtain a prepolymer, and adding excessive polyethylene glycol to seal ends. The hydrophilic layer is used for providing a place for the adhesion growth of osteoblasts and continuously providing nutrient substances and metabolite exchange for the osteoblasts, so that the growth of bones is accelerated, and the treatment period is shortened.
The utility model provides an oral cavity bone induction regeneration membrane, which comprises a hydrophobic layer a, a hydrophobic layer b and a hydrophilic layer c which are arranged in sequence; the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c all have porous three-dimensional structures.
Preferably, the thickness of the hydrophobic layer a is 0.1-0.2mm, the thickness of the hydrophobic layer b is 0.15-0.3mm, and the thickness of the hydrophilic layer c is 0.1-0.2 mm.
Preferably, the hydrophobic layer a and the hydrophilic layer c are provided with uniformly distributed square holes, and the density of the square holes is 500-600/cm2；
Preferably, the hydrophobic layer b is uniformly distributedRound holes with the density of 5000-2。
Preferably, the upper side surface and the lower side surface of the hydrophobic layer b are both provided with a plurality of bulges, the diameters of the bulges are 500-600 μm, and the heights of the bulges are 300-500 μm.
Preferably, the protrusions are prepared by a laser engraving process or a hot press molding process.
The layer a is designed into a square hole, so that on the basis of not influencing the supporting strength of the membrane, epithelial tissue cells enter between the layer a and the layer b of the regeneration membrane as much as possible to grow; the purpose of the round hole designed on the layer b is to prevent epithelial tissue cells from entering between the layer b and the layer c and the bone defect area, and the transportation of nutrient substances and blood is not influenced.
Preferably, the hydrophobic layer a and the hydrophobic layer b are prepared as follows:
A. dissolving the mixed polylactic acid, the levorotatory polylactic acid and the acetyl tributyl citrate into an organic solvent according to a certain proportion to prepare a polymer solution with the concentration of 10-20% (m/v), and uniformly stirring for later use;
B. coating the polymer solution obtained in the step A to form a film, and preparing a hydrophobic layer a and a hydrophobic layer b by adopting a solvent evaporation method;
or adding the polymer solution obtained in the step A into ethanol for precipitation, stirring, performing suction filtration to obtain a solid mixture, and then performing reduced pressure drying to obtain a blend, extruding the blend into a film, thus obtaining the hydrophobic layer a and the hydrophobic layer b.
Preferably, in the step A, the mass ratio of the mixed-spinning polylactic acid to the levorotatory polylactic acid to the acetyl tributyl citrate is 6-8.5: 1-2.5: 0.5-1.5; the levorotatory polylactic acid is a semi-crystalline polymer and mainly plays a role in regulating the hardness and the supporting strength of the bone-induced regeneration membrane; the organic solvent is dichloromethane or trichloromethane.
Preferably, in the step B, the volume of the ethanol is 4-6 times of that of the polymer solution, the stirring time is 0.5-4h, the temperature for reduced pressure drying is 40-60 ℃, and the time is 6-8 h;
in the extrusion film forming process, the temperature of each section is respectively as follows: the charging section is 150-170 ℃, the compression section is 190-220 ℃, and the homogenization section is 200-220 ℃; the horizontal and vertical stretching multiplying power of the hydrophobic layer a and the hydrophobic layer b is 2-6 times.
Preferably, the hydrophilic layer c is prepared as follows:
C. adopting polyalcohol to initiate monomer copolymerization to obtain polyester polyol, adding lysine diisocyanate into the polyester polyol to react to obtain prepolymer, and then adding excessive polyethylene glycol to terminate;
D. c, dissolving the product obtained after the reaction in the step C by using an organic solvent, pouring the solution into ethanol for precipitation, stirring, performing suction filtration to obtain a solid, and performing reduced pressure drying to obtain a hydrophilic modified polyester material;
E. dissolving a hydrophilic modified polyester material in an organic solvent to prepare a hydrophilic modified polyester solution with the concentration of 10-20% (m/v), and uniformly stirring for later use;
F. and E, coating the hydrophilic modified polyester solution obtained in the step E to form a film, and preparing a hydrophilic layer c by adopting a solvent volatilization method.
Preferably, in step C, the polyol is 1, 3-propanediol or glycerol, and the monomer is one or more of caprolactone, lactide, p-dioxanone and glycolide.
Preferably, in step C, the mole amount of the lysine diisocyanate is 2-5 times that of the polyester polyol; in the steps D and E, the organic solvent is dichloromethane or trichloromethane; in the step D, the volume of the ethanol is 4-6 times of that of the hydrophilic modified polyester solution, the stirring time is 0.5-4h, the temperature of the reduced pressure drying is 40-60 ℃, and the time is 6-8 h.
Preferably, the preparation method further comprises the step of respectively adopting a laser engraving process to the hydrophobic layer a and the hydrophobic layer B prepared in the step B and the hydrophilic layer c prepared in the step F to prepare the hydrophobic layer a, the hydrophobic layer B and the hydrophilic layer c which respectively have porous three-dimensional structures.
The preparation method of the oral cavity bone induction regeneration membrane comprises the following steps: and (3) performing laser welding or ultrasonic welding on the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c, and compounding to form a film.
Compared with the prior art, the utility model discloses following beneficial effect has:
1. the utility model provides an oral cavity osteoinduction regeneration membrane has special spatial structure, is favorable to epithelial tissue, gum tissue etc. to grow into, further fixes the implantation position of membrane, prevents the displacement of membrane.
2. The utility model provides an oral cavity osteoinduction regeneration membrane is hydrophilic layer c in the one side that is close to the osteoblast district, and it has special hydrophilic and hydrophobic structural design, and its hydrophobic section can provide the place of adhereing for osteoblast, and hydrophilic section can be for osteoblast continuous nutrient substance and metabolite exchange that provides for osteoblast's hyperplasia, the required cycle of the treatment that significantly reduces.
Drawings
Other features, objects and advantages of the invention will become more apparent upon reading of the detailed description of non-limiting embodiments with reference to the following drawings:
fig. 1 is a structure of the oral cavity bone induction regeneration membrane of the present invention;
FIG. 2 is a cross-sectional view of the oral cavity bone-induced regeneration membrane of the present invention;
wherein, 1-hydrophobic layer a; 2-a hydrophobic layer b; 3-a hydrophilic layer c; 4-bulge; 5-a circular hole; 6-square hole.
Detailed Description
The present invention will be described in detail with reference to the following embodiments. The following examples will assist those skilled in the art in further understanding the present invention, but are not intended to limit the invention in any way. It should be noted that various changes and modifications can be made by one skilled in the art without departing from the spirit of the invention. These all belong to the protection scope of the present invention.
Example 1
The embodiment provides an oral cavity bone induction regeneration membrane, as shown in fig. 1 and fig. 2, which includes a hydrophobic layer a 1, a hydrophobic layer b 2, and a hydrophilic layer c 3, which are sequentially disposed; the hydrophobic layer a 1, the hydrophobic layer b 2 and the hydrophilic layer c 3 all have porous three-dimensional structures; the thickness of the hydrophobic layer a 1 is 0.1mm, the thickness of the hydrophobic layer b 2 is 0.15mm, and the thickness of the hydrophilic layer c 3 is 0.1 mm.
The obtained hydrophobic layer a 1 and hydrophilic layer c 3 are provided with square holes 6 with the length of 500 μm and the width of 150 μm which are uniformly distributed, and the density of the square holes 6 is 500-600/cm2；
The preparation method of the oral cavity bone induction regeneration membrane comprises the following steps:
A. dissolving the mixed polylactic acid, the levorotatory polylactic acid and the acetyl tributyl citrate into dichloromethane according to the mass ratio of 7:2:1 to prepare a polymer solution with the concentration of 10% (m/v), and uniformly stirring for later use;
B. pouring the polymer solution obtained in the step A into a coating machine, and preparing a hydrophobic layer a and a hydrophobic layer b by adopting a solvent volatilization method;
C. 1, 3-propylene glycol is adopted to initiate caprolactone copolymerization to obtain polyester polyol, lysine diisocyanate with the molar weight 2 times of that of the polyester polyol is added into the polyester polyol to react to obtain prepolymer, and then excessive polyethylene glycol is added to seal the end;
D. c, dissolving the product obtained after the reaction in the step C by using dichloromethane, pouring the product into ethanol with 4-6 times of volume for precipitation, stirring for 30min, performing suction filtration by using a Buchner funnel to obtain a solid, and performing reduced pressure drying at 40-60 ℃ for 6-8h to obtain a hydrophilic modified polyester material;
E. dissolving a hydrophilic modified polyester material in dichloromethane to prepare a hydrophilic modified polyester solution with the concentration of 10% (m/v), and uniformly stirring for later use;
F. pouring the hydrophilic modified polyester solution obtained in the step E into a coating machine, and preparing a hydrophilic layer c by adopting a solvent volatilization method;
G. respectively adopting a laser engraving process to the hydrophobic layer a and the hydrophobic layer B prepared in the step B and the hydrophilic layer c prepared in the step F to prepare the hydrophobic layer a, the hydrophobic layer B and the hydrophilic layer c which respectively have porous three-dimensional structures;
H. and G, performing laser welding on the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c with the porous three-dimensional structure obtained in the step G, and compounding to form a film to obtain the oral cavity bone induction regeneration film.
Example 2
The embodiment provides an oral cavity bone induction regeneration membrane, which comprises a hydrophobic layer a, a hydrophobic layer b and a hydrophilic layer c which are sequentially arranged; the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c all have porous three-dimensional structures; the thickness of the hydrophobic layer a is 0.2mm, the thickness of the hydrophobic layer b is 0.2mm, and the thickness of the hydrophilic layer c is 0.2 mm.
The obtained hydrophobic layer a and hydrophilic layer c are provided with square holes with the length of 500 μm and the width of 150 μm which are uniformly distributed, and the density of the square holes is 500-2；
The hydrophobic layer b is provided with round holes with the aperture of 20-45 μm and uniform distribution, and the density of the round holes is 5000-2The upper surface and the lower surface of the base plate are both provided with a plurality of bulges with the diameter of 500-600 mu m and the height of 300-500 mu m, and the bulges are prepared by adopting a laser engraving process or a hot press molding process;
the preparation method of the oral cavity bone induction regeneration membrane comprises the following steps:
A. dissolving the mixed polylactic acid, the levorotatory polylactic acid and the acetyl tributyl citrate into dichloromethane according to the mass ratio of 6:1:0.5 to prepare a polymer solution with the concentration of 20% (m/v), and uniformly stirring for later use;
B. adding the polymer solution obtained in the step A into ethanol with 4-6 times volume for precipitation, stirring for 1h, performing suction filtration by using a Buchner funnel to obtain a solid mixture, performing reduced pressure drying at 40-60 ℃ for 6-8h, adding the obtained blend into a single-screw extruder, and extruding to form a film, wherein the temperatures of all sections of the extruder are respectively 150-170 ℃ in a feeding section, 220 ℃ in a compression section and 220 ℃ in a homogenization section, and the transverse and longitudinal stretching ratios of the film are 2-6 times respectively, so as to obtain a hydrophobic layer a and a hydrophobic layer b;
C. adopting glycerol to initiate lactide copolymerization to obtain polyester polyol, adding lysine diisocyanate with the molar weight 4 times that of the polyester polyol into the polyester polyol to react to obtain prepolymer, and then adding excessive polyethylene glycol to seal the end;
D. c, dissolving the product obtained after the reaction in the step C by using dichloromethane, pouring the product into ethanol with 4-6 times of volume for precipitation, stirring for 1h, performing suction filtration by using a Buchner funnel to obtain a solid, and performing reduced pressure drying at 40-60 ℃ for 6-8h to obtain a hydrophilic modified polyester material;
E. dissolving a hydrophilic modified polyester material in dichloromethane to prepare a hydrophilic modified polyester solution with the concentration of 20% (m/v), and uniformly stirring for later use;
F. pouring the hydrophilic modified polyester solution obtained in the step E into a coating machine, and preparing a hydrophilic layer c by adopting a solvent volatilization method;
G. respectively adopting a laser engraving process to the hydrophobic layer a and the hydrophobic layer B prepared in the step B and the hydrophilic layer c prepared in the step F to prepare the hydrophobic layer a, the hydrophobic layer B and the hydrophilic layer c which respectively have porous three-dimensional structures;
H. and G, performing laser welding on the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c with the porous three-dimensional structure obtained in the step G, and compounding to form a film to obtain the oral cavity bone induction regeneration film.
Example 3
The embodiment provides an oral cavity bone induction regeneration membrane, which comprises a hydrophobic layer a, a hydrophobic layer b and a hydrophilic layer c which are sequentially arranged; the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c all have porous three-dimensional structures; the thickness of the hydrophobic layer a is 0.2mm, the thickness of the hydrophobic layer b is 0.3mm, and the thickness of the hydrophilic layer c is 0.1 mm.
The obtained hydrophobic layer a and hydrophilic layer c are provided with square holes with the length of 500 μm and the width of 150 μm which are uniformly distributed, and the density of the square holes is 500-2；
The hydrophobic layer b is provided with round holes with the aperture of 20-45 μm and uniform distribution, and the density of the round holes is 5000-2And the upper and lower surfaces are provided with a plurality of bulges with the diameter of 500-600 mu m and the height of 300-500 mu m, and the bulges are prepared by adopting a laser engraving process or a hot-press molding process.
The preparation method of the oral cavity bone induction regeneration membrane comprises the following steps:
A. dissolving the mixed polylactic acid, the levorotatory polylactic acid and the acetyl tributyl citrate into dichloromethane according to the mass ratio of 8.5:2.5:1.5 to prepare a polymer solution with the concentration of 15% (m/v), and uniformly stirring for later use;
B. adding the polymer solution obtained in the step A into ethanol with 4-6 times volume for precipitation, stirring for 4h, performing suction filtration by using a Buchner funnel to obtain a solid mixture, performing reduced pressure drying at 40-60 ℃ for 6-8h, adding the obtained blend into a single-screw extruder, and extruding to form a film, wherein the temperatures of all sections of the extruder are respectively 150-170 ℃ in a feeding section, 220 ℃ in a compression section and 220 ℃ in a homogenization section, and the transverse and longitudinal stretching ratios of the film are 2-6 times respectively, so as to obtain a hydrophobic layer a and a hydrophobic layer b;
C. adopting glycerol to initiate copolymerization of dioxanone to obtain polyester polyol, adding lysine diisocyanate with the molar weight 5 times that of the polyester polyol into the polyester polyol to react to obtain prepolymer, and then adding excessive polyethylene glycol to seal the end;
D. c, dissolving the product obtained after the reaction in the step C by using dichloromethane, pouring the product into ethanol with 4-6 times of volume for precipitation, stirring for 4 hours, performing suction filtration by using a Buchner funnel to obtain a solid, and performing reduced pressure drying at 40-60 ℃ for 6-8 hours to obtain a hydrophilic modified polyester material;
E. dissolving a hydrophilic modified polyester material in dichloromethane to prepare a hydrophilic modified polyester solution with the concentration of 15% (m/v), and uniformly stirring for later use;
F. pouring the hydrophilic modified polyester solution obtained in the step E into a coating machine, and preparing a hydrophilic layer c by adopting a solvent volatilization method;
G. respectively adopting a laser engraving process to the hydrophobic layer a and the hydrophobic layer B prepared in the step B and the hydrophilic layer c prepared in the step F to prepare the hydrophobic layer a, the hydrophobic layer B and the hydrophilic layer c which respectively have porous three-dimensional structures;
H. and G, ultrasonically welding the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c with the porous three-dimensional structure obtained in the step G, and compounding to form a film to obtain the oral cavity bone induction regeneration film.
Effect verification:
the oral cavity bone induction regeneration membrane prepared in each example is subjected to performance tests (including physical properties, biocompatibility and safety, and treatment effect), and the test method is as follows:
1. tensile modulus the tensile strength and elongation at break of the regenerated film were measured according to the test method for tensile properties of plastics of GB/T1040-;
△ p-the minimum load to cause pattern deformation, in N;
b-the width of the pattern in mm;
d-the thickness of the sample in mm;
△ L-Absolute Length of Pattern in mm;
L0-Pattern starting Length, in mm.
2. Heavy metal content: detecting the tin content by adopting an atomic absorption method; the heavy metal content is tested according to the regulation of GB/T14233.1-2008 method 1 of 5.6.1;
3. and (3) sterile test: the method is carried out according to the method specified in GB/T14233.2;
4. hemolysis test: the method is carried out according to the method specified in GB/T14233.2;
5. cytotoxicity test: according to the "leaching liquor test" method specified in GB/T16886.5;
6. and (3) genetic toxicity test: according to the test method specified in GB/T16886.3;
7. implantation experiments: the preparation is carried out according to the subcutaneous implantation method specified in GB/T16886.6;
8. acute systemic toxicity: according to the test method specified in GB/T16886.11;
9. sub-chronic systemic toxicity: the test was carried out according to the test method specified in GB/T16886.11.
The test results were as follows:
1. the tensile modulus of the bone induction regeneration membrane (E) of each embodiment is 8.5-75MPa, which meets the technical requirements of products;
2. heavy metal content: the tin content of each example was less than 50 μ g/g; heavy metal content (in Pb) was not detected; meets the requirements of YY/T0661-2008 standard;
3. the bone induction regeneration membrane of each embodiment is sterile, the hemolysis rate is less than 5%, the cytotoxicity is not more than grade I, the bone induction regeneration membrane has no genetic toxicity, the tissue around a sample has no tissue reaction after being implanted for four weeks, the bone induction regeneration membrane has no acute or sub-chronic systemic toxicity, and the product safety is good.
In animal experiments, 30 adult white rabbits with the weight of 2-3kg are adopted, a hole-shaped bone defect with the depth and the diameter of 5mm is formed at the position of the mandibular alveolar bone at the two sides of the white rabbits after anesthesia, then the bone defect is covered with the bone induction regeneration membrane prepared in the example 1, the bone induction regeneration membrane is well sewed by absorbable suture, and penicillin is injected at regular time and quantity to prevent infection. 15 rabbits were sacrificed at 8 and 12 weeks, respectively, and osteogenesis thickness, success rate and adverse reaction conditions were examined.
After 8 weeks, new bones basically grow, 30 experiments succeed 29, the success rate is 96.7%, and no adverse reaction occurs. Animal experiment results show that the oral cavity bone induction regeneration membrane prepared in example 1 is safe and reliable, has excellent bone induction regeneration capacity, and can greatly improve the treatment period and the success rate of osteogenesis surgery.
In the description of the present application, it is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present application.
The utility model has a plurality of specific application ways, and the above description is only the preferred embodiment of the utility model. It should be noted that the above embodiments are only used for illustrating the present invention, and are not used for limiting the protection scope of the present invention. For those skilled in the art, without departing from the principle of the present invention, several improvements can be made, and these improvements should also be regarded as the protection scope of the present invention.
Claims (7)
1. An oral cavity bone induction regeneration membrane is characterized by comprising a hydrophobic layer a, a hydrophobic layer b and a hydrophilic layer c which are sequentially arranged; the hydrophobic layer a, the hydrophobic layer b and the hydrophilic layer c all have porous three-dimensional structures.
2. The oral cavity bone-induced regeneration membrane according to claim 1, wherein the thickness of the hydrophobic layer a is 0.1-0.2mm, the thickness of the hydrophobic layer b is 0.15-0.3mm, and the thickness of the hydrophilic layer c is 0.1-0.2 mm.
3. The oral cavity bone-induced regeneration membrane as claimed in claim 1, wherein the hydrophobic layer a and the hydrophilic layer c are provided with uniformly distributed square holes with a density of 500-600 square holes/cm2。
4. The membrane according to claim 1, wherein the hydrophobic layer b has uniformly distributed round holes with a density of 5000-2。
5. The oral cavity bone-inducing regeneration membrane according to claim 1, wherein the hydrophobic layer b is provided with a plurality of protrusions on both upper and lower sides thereof, the protrusions having a diameter of 500 μm to 600 μm and a height of 300 μm to 500 μm.
6. The oral cavity bone-induced regeneration membrane according to claim 5, wherein the protrusions are prepared by a laser engraving process or a hot press molding process.
7. The oral cavity bone-induced regeneration membrane according to claim 1, wherein the hydrophobic layer a and the hydrophobic layer b and the hydrophilic layer c are respectively prepared by a laser engraving process.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110314248A (en) * | 2019-07-24 | 2019-10-11 | 上海典范医疗科技有限公司 | A kind of oral cavity self-bone grafting regeneration membrane and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110314248A (en) * | 2019-07-24 | 2019-10-11 | 上海典范医疗科技有限公司 | A kind of oral cavity self-bone grafting regeneration membrane and preparation method thereof |
| CN110314248B (en) * | 2019-07-24 | 2021-11-02 | 上海典范医疗科技有限公司 | Oral bone induction regeneration membrane and preparation method thereof |
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