Biological nasal bridge implant and method for making it

FIELD: medicine.

SUBSTANCE: invention refers to a medical prosthesis to be implanted into the human body, particularly to a biological nasal bridge implant used in nasal bridge reparative surgery. The nasal bridge implant is made according to the method which involves sampling, sterilisation and cutting to the required size of the animal material in the form of cattle or swine tendons; cell recovery from the animal material; shaping of the animal material for establishing the required form of the nasal bridge; cross-linking of the animal material; antigen recovery of the animal material, alkaline treatment and introduction of the active substances promoting adhesion of a growth factor and stem cells; packaging of the implant into the container with a sterilisation solution.

EFFECT: preparing the biological nasal bridge implant.

16 cl, 2 dwg, 1 ex

 

The technical FIELD TO WHICH the INVENTION RELATES.

[0001] the Present invention relates to a medical prosthesis for implantation in the human body and, in particular, to the biological implant bridge used in plastic surgery of the nose.

DISCLOSURE of INVENTIONS

[0002] Plastic surgery of the nose is the most common in the field of plastic surgery, and implants, which are currently used for augmentation of the upper part of the bridge of the nose, are all made of silicone or Teflon. Although these two materials are biologically inert and can coexist peacefully in the human body after implantation, their composition and structure are not completely analogous to the human body, so they can become part of the fabric of the host body. And as a result, the implant can easily change the location, to tear off and eat away at the skin, and therefore can be easily detected by visual observation, along with other defects.

[0003] Thus, there is still a need to implant the bridge of the nose, which can avoid the disadvantages described above.

[0004] in order To perform product according to the present invention, the present invention provides an implant bridge, constructed in accordance with the method including the trail is the following stages:

[0005] a) selection of material of animal origin from the body of cattle or pigs, and a material of animal origin can be either a tendon or ligament;

[0006] b) removing cells from a material of animal origin;

[0007] c) shaping the material of animal origin to ensure the desired shape of the implant to the bridge of the nose;

[0008] d) the linking material of animal origin;

[0009] e) removing antigens from material of animal origin;

[0010] f) exposure of the material of animal origin alkaline treatment;

[0011] (g) enter into the material of animal origin active substances that promote the bonding of growth factor and stem cells; and

[0012] h) packing material of animal origin in a container containing a sterilizing solution.

[0013] Figure 1 is a top view of the implant bridge in accordance with one example implementation of the present invention.

[0014] Figure 2 is a thumbnail image of the implant to the bridge of the nose.

[0015] the Following detailed description is one of preferred in the present embodiments of the invention. This description should not be construed in a narrow sense, it is made simply for the purpose of illustrating the General principles of execution of the invention. The content of the invention in the best way opredelaetsa is in the attached claims.

[0016] the Present invention relates to biological layout of the implant to bridge that passes technological processing and acquisition forms, using as raw material tendons/ligaments of animals. The raw materials are first cleaned and technological processing, extracted cells, and then the material is fixed by means of resin. Then apply technology for complex extraction of antigens, induction technology fabric and a number of other biochemical processes. The composition and design of the implant for the nose according to the present invention is similar to the fabric of the human body, has good biocompatibility and high resistance, is not subject to destruction easily, passively destroyed only when the tissue of the host body begins to grow into it and not trigger a reaction in the form of immunological rejection. The implant according to the present invention is also able to induce upgrade tissue, to grow together with the tissue of the host body and gradually transformed into the fabric of the host body. The implant is felt as real, and will not cause displacement of the position, abrasion or corrosive to the skin.

[0017] the Present invention provides a method of preparing a biological implant for the bridge of the nose; the implant to the bridge of the nose is created with what ispolzovaniem as raw material tendons/ligaments of animals (preferably cattle or pigs). Further, in respect of the raw materials are pre-processing, extraction of cells, shape, stitching and fixing complex extraction of antigens, alkaline treatment, modification of the surface of the active layer to induce activity and sterilization by irradiation. The exact sequence of processing is as follows:

[0018] 1. Pre-treatment of tendons/ligaments of animals.

[0019] 2. The extraction cells.

[0020] 3. The shaping/forming.

[0021] 4. The linking.

[0022] 5. Removing antigens.

[0023] 6. Alkaline processing.

[0024] 7. Modification of the surface of the active layer to induce activity.

[0025] 8. Packaging and sterilization.

The IMPLEMENTATION of the INVENTION

[0026] Step 1: In step 1 mentioned above, going tendons/ligaments of animals, the basic ingredient of which is collagen fiber. It is desirable to select the tendons/ligaments of the body of cattle or pigs, using techniques widely known in the industry. There is a wide range of disinfectants for soaking and disinfecting materials, excess tissue and foreign substances are removed, and then the material is cut to the desired size/length, and then can be processed by shaping in step 3, described below.

[0027] Step 2: At the stage of extraction of CL is current used enzymatic method or way elution using detergents (surfactants) for the extraction of raw materials (tendon or ligament) all cell types. Enzymes, it can be trypsin and/or pepsin, are used for the enzymatic degradation of the cell. Surface-active substances, which may be Triton X100, Tween-20 or emulsifier OP-10, used for the destruction and washing the cell walls.

[0028] Step 3: At the stage of shaping/forming, the desired shape of the prosthesis to the bridge of the nose, as shown in the drawing Figure 1, is achieved using a subsequent process, is widely known in the industry.

[0029] Step 4: Step corneal crosslinking and fixation involves the use of fixer for stitching, which uses collagen proteins for stitching, giving the raw materials sustainability. Used fixer for stitching may be epoxysilane, which has the following formula:

where R=CnH2n+1group or

n=0, 1, 2, 3 ... 12.

The concentration of the reagent - 0.1-1N. The reaction temperature is selected within 0-45°C (preferably not higher than 50°C), reaction time can be selected in the range 2-96 hours.

[0030] Step 5: According to modern immunological theory, the antigenic properties of tissues of the animal are derived mainly active groups located in the active points and in particular conformations, and these active groups include H2*, OH*, -SH* and other Special conformation, mainly pochutla by the formation of specific hydrogen bonds, formed spirally twisted protein chains. Active points and special conformations are referred to as "antigenic determinants". At the stage of extraction of antigens to block active groups and changes to the particular conformation of uses complex reagents. The reagents used to block specific active groups are mainly nucleophilic reagents that can easily react with H2*, OH*, -SH* and other similar groups. These reagents include carboxylic acid anhydrides, acid chlorides, acyl-amides, epoxysilane etc. Reagents that can be used to change particular conformation, include one class of agents for the formation of strong hydrogen bonds - guanidine hydrochloride. As a special conformation obtained mainly by the formation of specific hydrogen bonds formed spirally twisted protein chains, the use of agents for the formation of strong hydrogen bonds to replace the special hydrogen bonds makes it possible to change the particular conformation. Here the symbol * next to groups indicates that they represent a small number of specific groups, which are located at specific sites and are able to produce response signals of the immune system, and they are not I have are standard groups-NH 2, -OH, -SH. These specific groups are in a state of high activity, preferred for reactions induced nucleophilic reagents, as well as the active center of the catalyst is preferred to reactant or reaction of toxins.

[0031] Step 6: the Alkaline treatment is intended primarily for destruction of potentially present prion. For example, a solution of sodium hydroxide, 1-4N can be used for dipping the prosthesis 60 minutes at a temperature of 35±2°C. This procedure has proven effective for the destruction of prions during numerous studies.

[0032] Step 7: In step 7, above, the surface modification includes the process of joining active substances, allowing the bonding of growth factor and stem cells with the material of the prosthesis, thus, the prosthesis can tightly link and enrich the growth factor and stem cells produced by the mechanism of self-healing of the human body after implantation, and thus, rostovomu factor and stem cells for high expression in the graft for a long period of time, as well as to stimulate stem cells to adapt to the rejuvenating Metrocity creates, to re-partition and reproduction, for the recovery of new tissue, and in the end the second account, to obtain autologous tissue of the nose. Input active substances can be specific polypeptide or compound fractions. Here specific polypeptides are mainly formed by lysine oligopeptides 16 with arginine, glycine, aspartic acid and other components, for example, the polypeptide has a lysine (16) - glycine-arginine-glycine-aspartic acid-serine-Proline-cysteine, with glycosaminoglycans connection, which are mainly hyaluronic acid, chondroitin sulfate, cortisone sulfate, keratin sulfate, heparin, heparin sulfate and other route of administration may be accomplished by conjugation, chemical adsorption, physical adsorption or encapsulation of the collagen film. The pairing is preferable, and binders that can be used is the internal anhydrides, dibasic carboxylic acids, diarrhorea, valldolid, carbodiimide and diepoxide.

[0033] Step 8: At the stage of packaging and sterilizing the prosthesis is sealed in double-layer plastic bag containing physiological salt solution for storage. The packaged product is then sterilized with γ-irradiation at a minimum of 25 kGy. This sterilization method has proven effective for the destruction of known pathogens, except for the receiving prion.

[0034] compared to traditional silicone and Teflon implants to nose advantages of the present invention on the biological layout of the implant to the bridge of the nose lies in the fact that it is made from natural material without impurities, its composition is based is similar to the composition of the tissues of the human body, he has good biological compatibility, and does not initiate the reaction in the form of immunological rejection. After implantation, the implant according to this invention may cause tissue ingrowth of the host body into the implant and shivsena with the tissue of the host body inseparably, it felt real, any irritating foreign substance is missing, he can't move, to corrode, to strip or to undergo other complications.

EXAMPLE.

[0035] to Hire fresh and healthy tendon/ligament animal, place in a sterile solution of 0.1% benzalkonium chloride and soak for 60 minutes, then remove foreign substances, tidy and cut to the desired size and length. Next, remove, clean, place in hydrochloric buffer solution trypsin-Tris at room temperature to perform the enzymatic degradation of substances for 2-24 hours. Then remove, rinse with water, placed the ITA in 1% solution of the PR-10, containing 1 µM benzyl fluoride sulfide protease inhibitor soak for 8 hours, and again remove. During mixing, the use of water for triple rinsing procedure again remove, videlicit water content and create the desired structural shapes and forms, as shown in figure 1. Place in the reactor for fixing and use of a crosslinking agent to commit stitching using a crosslinking agent selected from epoxysilane mentioned above, or adipoyl chloride concentration of 0.1-1 N, and call the reaction at room temperature for 2-96 hours. After completion of the reaction stitching, remove, clean, place in antigenic reactor, add one of the above nucleophilic reagents, and call the reaction at room temperature for 10-16 hours. Select two different types of reagents and double-call response. Then use a solution of guanidine hydrochloride for a single reaction at a temperature of 5-30°C with duration of reaction 8-24 hours. Remove, clean, place in a solution of sodium hydroxide 1-24 at a temperature of 30-35°C, soak and process for 60 minutes, and then remove the reaction liquid. Use a dilute acid to neutralize the residue of sodium hydroxide, and then clean. Place in the reactor, the special is th use for surface modification, add lysine (16) - polypeptide glycine-arginine-glycine-aspartic acid-serine-Proline-cysteine and binding reactant adipoyl chloride, then call the reaction under mild conditions for 8-16 hours at a temperature of 25±2°C. Remove and rinse thoroughly. Seal, using physiological saline for storage in double-layer plastic bag, send to the sterilization by irradiation, and get the final product.

[0036] When the above description relates to the partial implementation of the present invention, it has been interpreted in such a way as to allow many modifications without separating them from the General idea. It is assumed that the formula of the invention includes such modifications as really within the scope and idea of the present invention.

1. The method of manufacture of an implant for augmentation of the nasal bridge, including the selection, sterilization and cutting to the desired size of animal material in the form of tendons or ligaments of the organisms in cattle or pigs, removing cells from animal material, shaping the implant material of animal origin to create the desired shape of the nose, the linking material of animal origin, extraction of antigens from animal material, conducting saloon the th input and processing in the material of animal origin active substances, facilitate the bonding of the growth factors and stem cells, as well as the packaging of the implant in a container containing a sterilizing solution.

2. The method according to claim 1, characterized in that the extraction of cells from a material of animal origin is an enzymatic method or method of elution using surface-active substances.

3. The method according to claim 2, characterized in that the enzymatic method for the implementation of the enzymatic degradation of substances used trypsin or pepsin.

4. The method according to claim 2, characterized in that in the method of elution using surfactants are used in detergents Triton X100, Tween-20 and emulsifier OP-10.

5. The method according to claim 1, characterized in that the linking is performed using as a crosslinking agent epoxysilane:

where R=CnH2n+1group or

where n=0, 1, 2, 3...12.

6. The method according to claim 1, characterized in that the extraction of the antigens used nucleophilic reagents and binding agents for the formation of strong hydrogen bonds, which are easily activate the reaction of hydrogen with-NH2, -OH, -SH, and other groups to block specific groups and to change specific conformations.

7. The method according to claim 6, characterized in that the nucleophilic reagents include anhydrides carbó the OIC acid, the anhydrides, acyl-amides and epoxides.

8. The method according to claim 6, characterized in that the binding agent for the formation of strong hydrogen bonds include guanidine compounds.

9. The method according to claim 1, characterized in that during alkaline treatment is sodium hydroxide 1-4N for immersion material of animal origin for a specified period of time.

10. The method according to claim 1, characterized in that the active substances are polypeptides containing oligopeptides lysine 16 with arginine, glycine and aspartic acid.

11. An implant for augmentation of the nasal bridge, made from sterilized and cut to the desired size of animal material in the form of tendons or ligaments of the organisms in cattle or pigs with the extraction of cells from this material of animal origin and is made in the form, suitable to create the desired shape of the nose, with linking material of animal origin, extraction of antigens from animal material, carrying out the alkali treatment and the introduction of the material of animal origin active substances that promote the bonding of the growth factors and stem cells, Packed in a container with a sterilizing solution.

12. The implant according to claim 11, characterized in that the extraction of cells produced EN zymes is the principal method or way elution using surface-active substances.

13. The implant according to claim 11, characterized in that the linking is performed using as a crosslinking agent epoxysilane:

where R=CnH2n+1group
or

where n=0, 1, 2, 3...12

14. The implant according to claim 11, characterized in that the extraction of the antigens used nucleophilic reagents and binding agents for the formation of strong hydrogen bonds, which are easily activate the reaction of hydrogen with-NH2, -OH, -SH, and other groups to block specific groups and changes in specific conformations.

15. The implant according to claim 11, characterized in that during alkaline treatment used sodium hydroxide 1-4N for immersion material of animal origin for a specified period of time.

16. The implant according to claim 11, characterized in that the active substances used polypeptides containing oligopeptides lysine 16 with arginine, glycine and aspartic acid.



 

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