RU2626691C1 - Method for barrier membrane manufacture for prevention of mucous tissues growth into bone formation area at oral surgeries - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: patient's blood is taken to the Plasmolifting tube. The Plasmolifting tube is then centrifuged in the 850-1250 g mode for 5 minutes. The plasma obtained from the Plasmolifting tube is collected in a 2 ml syringe and heated in a thermostat at a temperature of 95°C for 5 minutes. The resulting gel is spread on a foil, so that the resulting membrane size could overlap the closed defect 1.5-2 cm outside its limits. Then the gel is covered by another layer of foil. Then the foil with the gel on the inside is laid in the tray and thermostated at a temperature of 180°C for 20 minutes. Then the obtained membrane is separated from the foil, cooled and placed into the bone formation zone.

EFFECT: method allows to obtain a membrane for directed tissue regeneration, not toxic, not carcinogenic, not antigenic, biodegradable, easily controlled with high mechanical properties, preventing mucous tissues growth into the bone formation area.

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Description

The invention relates to medicine and can be used as an insulating membrane for osteoplastic surgery, for restoration of bone defects, destruction of bone tissue, in plastic and reconstructive surgery, in surgical dentistry, maxillofacial surgery and in traumatology.

The issues of quality formation of bone tissue, its formation in a short time and in full with any osteoplastic interventions remain relevant. One of the methods that influence these processes is the use of the method of directed tissue regeneration using barrier membranes. These membranes optimize the formation of free space between the bone surface in the area of the bone defect and the soft tissues above them by physically separating the anatomical formations (part of the gum from the bone or implant) from each other. But they must possess a number of properties: 1) be biocompatible; 2) during the reorganization, to prevent the formation of fibrous tissue instead of bone; 3) prevent the germination of the epithelium and the penetration of bacteria; 4) to provide the necessary space in which bone regeneration should take place, or to tightly connect with implanted plastic material; 5) easy to integrate into the surrounding bone tissue.

For directed tissue regeneration, resorbable and non-resorbable membranes are used.

A known polymer material is polytetrafluoroethylene for the manufacture of a barrier membrane (Lekovic V., Klokkevold PR, Kenney E.V., Dimitrijelic B., Nedic M., Weinlaender M. Histologic Evaluationof Guided Tisue Regeneration Using 4 Barrier Membranes // J. Periodontol. - 1998. - No. 69 (1). - p. 54-61.), Intended for temporary implantation in the gum tissue to prevent excessive penetration of the epithelium into the area of bone tissue formation. However, this membrane has a number of significant drawbacks associated with the insufficient permeability of the membrane for nutrients and low molecular weight substances and, as a consequence, a violation of the trophism of surrounding tissues. In addition, such a membrane has a high adhesive ability to peptides, which are able to completely block the transport of substances through the membrane and cause inflammation of the surrounding tissues.

A known method of manufacturing polymer membranes for use in dentistry. The material contains polymers of acrylic and / or vinyl series with a pore system with a diameter of not more than 0.22 microns and antiseptics and / or antibiotics. The disadvantages of this method is that the membrane of polymer (synthetic) origin may contain residual monomer in its composition, which will cause additional tissue irritation. In addition, the authors do not exclude its swelling in tissues, although it is considered limited, allowing the membrane to freely transport nutrients (RU 2136262, A61K 6/08, 09/10/1999).

The main disadvantage of membranes made of polymer non-absorbable materials is the need to remove them after a certain period of time, which requires repeated surgical intervention and can lead to complications (Cortellini P., Pini Prato GP, Baldi C., Clauser C. Guided tissue regeneration with different materials // International Journal of Periodonticsand Restorative Dentistry. - 1990. - No. 10: 137-51).

A method for producing a membrane for use in directed tissue regeneration in the form of a plate of collagen saturated with sGAG is proposed; however, it is made of collagen type I bone tissue obtained from bones of farm animals, saturated sGAG in a mixture of heparin and chondroitin sulfate in a ratio of 1: 3; moreover, it is made of non-demineralized or demineralized collagen type I, isolated from the spongy part of the bone, while with dental implantation it contains at least one hole, which is analogous to the present invention [Patent No. 2367475].

The disadvantage of this membrane is the complexity and multi-stage of its receipt. At the first stage, it is necessary to obtain non-demineralized or demineralized collagen from animal bone tissue, which is a membrane. The membrane is cut and a trepan is made into the hole for the implant, then the membrane is placed in a mixture of a solution of heparin and chondroitin sulfate and incubated for 24 hours. Then the solution is drained, the membrane is washed, dried, packaged and sterilized. In addition, it is necessary to first obtain chondroetin sulfate from the trachea, bone or cornea of animals also by a certain method.

Based on the foregoing, both collagen and chondroitin sulfate are obtained from animals, which can cause the risk of allergic reactions, tissue irritation and, as a consequence, the difficulty of its adaptation. The membrane is initially a fairly dense structure, which requires making holes with a trephine to install the implant.

In addition, since this membrane is made of collagen and chondroitin sulfate, it can swell in a humid environment, which will cause difficult diffusion of nutrients, trace elements and cells [Patent - No. 2367475].

The technical result, according to the invention, is the creation of a membrane for use in targeted tissue regeneration, non-toxic, non-carcinogenic, non-antigenic, biodegradable, easily controlled material with high mechanical properties. The method consists in the fact that the patient is sampled in a "Plasmolifting" test tube. The "Plasmolifting" tube is centrifuged in the regime of 850-1250 g for 5 minutes. The resulting plasma from the plasma-lifting tube is collected in a 2 ml syringe and heated in a thermostat at a temperature of 95 ° C for 5 minutes. The resulting gel, according to the size of the defect, is placed on the aluminum food foil, the membrane must overlap the defect by 1.5-2 cm in size, going beyond it. Then, the gel is coated on top with another layer of foil. And this foil with the gel laid inside is placed in a tray and thermostated at a temperature of 180 ° C for 20 minutes. Then the resulting membrane is separated from the foil, cooled and used to prevent the growth of mucous tissues in the bone formation zone during any maxillofacial surgery.

This method is different in that it uses its own autologous plasma, which eliminates allergic reactions, carcinogenicity and toxicity of the resulting membrane.

The plasma obtained from the patient is rich in protein components, therefore, after a 20-minute heat treatment, a coagulated protein network with porosity is formed on one side and a strong structure is able to keep soft tissues from growing into the defect zone on the other.

The resulting membrane is flexible, it allows you to overlap a bone defect above the membrane without tension and tension. It can be used in cases where the use of rigid membranes is difficult. The membrane is easily controllable in use, it is possible to simulate the membrane directly during the operation.

The membrane due to its autologousness and strength has osteconductive properties. Due to the fact that after heat treatment the membrane is a coagulated protein, its swelling after installation is excluded.

The membrane integrates with surrounding tissues without fibrosis, is completely resorbed after 4-6 months from the moment of implantation.

In addition, important advantages of this membrane are their accessibility and ease of preparation. The membrane production time is only about 30 minutes, and since the patient’s own blood is the starting material; it is always available to the doctor.

Thus, with the use of this membrane, the bone defect is timely replaced with the bone structure, the membrane has good delineating properties and the mucosa does not grow into the area of the bone defect, while the membrane is resorbed on time. All this can increase the effectiveness of osteoplastic operations, reduce the frequency of complications after them, and get good local functional results.

Literature

1. Patent - 2136262 RF, IPC A61K 6/08. Material for dentistry / Ivanov S.Yu .; Novikov S.V .; Larionov E.V .; Tregubov A.A .; Akhundov I.Y .; Leontiev G.D .; Panin A.M .; Serbulov V.V. No. 98119652/14; application filing date: 10/29/1998; publication date 09/10/1999.

2. Patent - No. 2367475 of the Russian Federation A membrane for use in directed tissue regeneration / Larionov EV, Ivanov S.Yu., Solodky V.G .; application filing date: 2008-04-29; publication date: 09/20/2009

3. Lekovic V., Klokkevold P.R., Kenney E.V., Dimitrijelic B., Nedic M., Weinlaender M. Histologic Evaluation of Guided Tisue Regeneration Using 4 Barrier Membranes // J. Periodontol. - 1998. - No. 69 (1). - p. 54-61.

4. Cortellini P., Pini Prato G. P., Baldi C., Clauser C. Guided tissue regeneration with different materials // International Journal of Periodontics and Restorative Dentistry. - 1990. - No. 10. - p. 137-51.

Claims (1)

A method of manufacturing a barrier membrane to prevent the penetration of mucous tissues into the bone formation zone during maxillofacial operations is characterized in that the patient is sampled in the Plazmolifting tube, the Plazmolifting tube is centrifuged in the 850-1250 g mode for 5 minutes, then the obtained the plasma from the Plasmolifting tube is collected in a 2 ml syringe and heated in a thermostat at a temperature of 95 ° C for 5 minutes, the resulting gel is laid on a foil, and laid out so that the resulting membrane is sized covered the defect being closed by 1.5-2 cm going beyond it, then the gel was coated on top with another layer of foil, after which this foil with the gel laid out inside was put into the tray and thermostated at 180 ° C for 20 minutes, the resulting membrane was separated from the foil, cool and place in the bone formation zone.