RU2077287C1 - Method to produce endoprosthesis of soft tissues - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method deals with membrane formation made of dimethylsiloxane rubber, its thermal treatment, membrane boiling in distilled water, application of amorphous carbon layer onto its surface, membrane drying, repeated thermal treatment, treatment by hydrogen peroxide solution. Then membrane is filled in with low molecular organosilicon rubber premodified with radiation method, that is radiation of filled in membrane, its thermal treatment with subsequent keeping membrane in thermostat, treatment by hydrogen peroxide solution, manifold boiling of filled in membrane in distilled water. EFFECT: higher quality, increased biocompatibility of endoprosthesis surface and active tissue, absence of postoperative complications. 3 cl

Description

 The invention relates to medicine and for the manufacture of implantable soft tissue prostheses.

 A known method of manufacturing implantable soft tissue prostheses, Acta Chirurgical Plastical, 1976, 182, p. 49.

 The method is based on the formation of a shell based on high molecular weight silicone rubber and filling it with low molecular weight rubber.

 The disadvantage of this method is that the endoprostheses obtained by this method are of poor quality, have insufficient mechanical strength, and the method of obtaining low-tech.

There is also known a method of manufacturing implantable soft tissue prostheses (auth. St. N 1572601), in which an implantable soft tissue prosthesis is made by forming a shell based on high molecular weight siloxane rubber and filling it with low molecular weight rubber, while the shell is formed from a solution in glue heptane based on dimethylvinyl siloxane rubber and silicon oxide taken in a mass ratio of 10 (3.5 4.0) followed by surface treatment with a vulcanizing agent with a solution of 2,4-dichlorobenzoyl peroxide in toluo e, then subjected to heat treatment at 115 120 ^o C for 15 20 minutes and at 165 170 ^o C for 1 hour, fill dimetilvinilsiloksanovym low molecular weight rubber with an initial viscosity of 0.3 0.4 Pa * s, polymerized γ - irradiation dose (20 25) * 10 ³ Gray to a viscosity of (3.0 - 3.5) * 10 ³ Pa * c and the obtained polymerized rubber fill the casing, seal it, expose it to γ-radiation with a dose of (32 35) * 10 ³ Gray and maintain it at 170 180 ^o C for 1 hour

 The disadvantage of the endoprosthesis obtained by this method is that it has a low quality, low mechanical strength, and also has low aesthetic properties.

The closest in terms of the problem and technical essence is the method of manufacturing a soft tissue endoprosthesis according to the application N 5043227/14 of 05.22.92 (pos. Decision of 09.19.93), which consists in forming a shell with an adhesive solution in heptane based on dimethylvinylsiloxane rubber and silicon oxide, followed by surface treatment with a vulcanizing agent, heat treatment, repeated boiling of the shell in distilled water with a change of water after each boiling cycle, drying, sealing the shell, re-heat Coy treatment, treatment with 3 - 5% hydrogen peroxide solution, followed by filling the low molecular silicone rubber membrane, previously modified by radiation, γ-radiation-filled shell, its heat treatment, followed by aging shell in an oven at 185 ^o C T for January 1 , 5 hours, by treating it first with a 5% solution of hydrogen peroxide, and then repeatedly boiling the filled shell in distilled water, replaceable after each boiling cycle.

 An endoprosthesis made in this way has several advantages: increased mechanical strength and relatively high aesthetic properties.

 However, with all its advantages, the endoprosthesis does not have a sufficient need for a surface with living tissue.

 The invention is aimed at increasing the biocompatibility of the surface of the endoprosthesis with living tissue and improving the quality of the endoprosthesis.

The proposed method for the manufacture of soft tissue endoprosthesis is that
form the endoprosthesis sheath with a glue solution in heptane based on dimethylvinylsiloxane rubber and silicon oxide,
carry out surface treatment with a vulcanizing agent,
carry out heat treatment,
spend multiple boiling of the shell in distilled water with a change of water after each boiling cycle,
dry the shell
seal the shell
re-heat the shell,
treat the shell 3 5% solution of hydrogen peroxide,
fill the shell with low molecular weight silicone rubber, pre-modified by the radiation method,
carry out γ-irradiation of the filled shell,
conduct heat treatment of the filled shell,
maintain the filled shell in a thermostat at t 185 ^o C for 1 1.5 hours,
treat the filled shell 3 5% solution of hydrogen peroxide,
spend repeated boiling of the filled shell in distilled water, replaceable after each boiling cycle.

или слоя аморфной алмазоподобной или α-C:H пленки той же толщины. Этот слой наносится на поверхность оболочки эндопротеза после многократногокипячения незаполненной оболочки в дистиллированной воде.Distinctive features of the proposed method are: applying to the surface of the endoprosthesis shell an oriented carbon layer of a chain structure with a thickness of 500 3000

or a layer of amorphous diamond-like or α-C: H film of the same thickness. This layer is applied to the surface of the endoprosthesis shell after repeated boiling of the unfilled shell in distilled water.

A layer of chain carbon, in particular with a carbine or α-C: H structure, can be deposited in vacuum by pulsed evaporation of graphite at a temperature of 30 to 80 ^o C.

 The layer structure is a close-packed linear carbon chain oriented normally to the surface of the substrate.

Besides
vulcanization of the shell is carried out by a vulcanizing agent at a temperature of 115 130 ^o C,
the heat treatment of the sealed shell is carried out at a temperature of 150 180 ^o C for 1 3 hours,
the shell is filled with low molecular weight silicone rubber with a viscosity of 5 9 Pa * s,
repeated heat treatment of the filled shell is carried out at a temperature of 150 180 ^o C for 2 to 5 hours

Layers or films of carbon can solve the following problem:
ensure high biocompatibility of the surface of the implant with living tissue, as their structure is extremely close to the structure of the membranes of tissue cells built from linear organic chains (liposomes).

The optimal modes of some technological operations:
temperature at which curing is carried out,
repeated heat treatment of the filled shell,
time interval during which repeated heat treatment of the filled endoprosthesis shell is carried out,
filling the shell with low molecular weight silicone rubber with a viscosity of 5 9 Pa * s,
provide the manufacture of an endoprosthesis of higher quality with increased mechanical strength.

 Endoprostheses obtained by this method have a high biocompatibility of the surface of the endoprosthesis with living tissue and, as a result, the likelihood of postoperative complications is reduced in patients.

The method is as follows:
A duralumin hollow mold is made on a lathe, its surface is polished to a mirror shine, then the prosthesis sheath is made of a film based on dimethylvinylsiloxane rubber, which is obtained by repeatedly dipping the duralumin form in an adhesive composition consisting of a 10-15% solution of dimethylvinylsiloxane rubber in heptane filled with silicon oxide in a ratio of 1 to 0.4 wt.h.

, после чего оболочку сушат, герметизируют и повторно помещают на 5 ч в термостат с принудительной циркуляцией воздуха с температурой 120 185^oC, после чего оболочку помещают в контейнер с 3 5%-ным раствором перекиси водорода, после чего осуществляют заполнение оболочки низкомолекулярным кремнийорганическим каучуком, предварительно модифицированным радиационным методом (дозой 2.3 МРад) до вязкости 3 5 Па*с, затем заполненную оболочку подвергают γ-облучению дозой 1,5 МРад, послеоболочку дополнительно термостатируют с принудительной циркуляцией воздуха при плавном поднятии температуры от нормальной до 185^oC, после чего выдерживают в термостате при t 185^oC в течение 1 1,5 ч, после чего оболочку помещают в 3 5%-ный раствор перекиси водорода, а затем помещают в контейнер со сменной дистиллированной водой.The film form is placed for 2 3 minutes in a 1% solution of 2,4-dichlorobenzoyl peroxide in toluene, then the shell is placed for 30 40 minutes in a thermostat with a temperature of 115 130 ^o C, after which the shell is placed in an aluminum container with distilled water, repeated boiling of the shell is carried out with a change of water after each boiling cycle, after which a layer of amorphous carbon of a chain structure, for example, carbine 500 500 thick, is applied to the surface of the endoprosthesis shell in vacuum by flash evaporation of graphite at a temperature of 30 to 80 ^o C

after which the shell is dried, sealed and re-placed for 5 hours in a thermostat with forced air circulation with a temperature of 120 185 ^o C, after which the shell is placed in a container with 3 5% hydrogen peroxide solution, after which the shell is filled with low molecular weight silicone rubber pre-modified by the radiation method (dose 2.3 MPaD) to a viscosity of 3 5 Pa * s, then the filled shell is subjected to γ-radiation with a dose of 1.5 MPa, the post-shell is additionally thermostated with forced circulation in air at a smooth rise in temperature from normal to 185 ^o C, then kept in a thermostat at t 185 ^o C for 1 1.5 hours, after which the shell is placed in a 3 5% solution of hydrogen peroxide, and then placed in a container replaceable distilled water.

 The proposed method allows to produce an endoprosthesis of soft tissues, which has a significantly higher quality, high biocompatibility of the surface of the endoprosthesis with living tissue, which is confirmed by the test protocol.

 Endoprostheses manufactured by the proposed method have received a positive opinion of specialists. Medical tests were conducted at the Institute of Surgery. A.V. Vishnevsky AMS RF.

 A clinical examination of patients showed the absence of any postoperative complications associated with endoprosthetics.

 The soft tissue endoprostheses developed at the Plastis MMPP, according to the proposed manufacturing method, are recommended for production by the Committee on New Medical Equipment by the Ministry of Health of the Russian Federation.

Claims (3)

1. A method of manufacturing a soft tissue endoprosthesis based on the formation of a shell from a solution of dimethylvinylsiloxane rubber filled with silicon oxide in heptane, followed by surface treatment with a vulcanizing agent, heat treatment, repeated boiling of the shell in distilled water with water change after each boiling cycle, drying, sealing shell, repeated heat treatment, treatment of 3 5% hydrogen peroxide solution, followed by filling the shell with a low molecular weight silicon rubber rubber, a pre-modified radiation method, gamma irradiation of a filled shell, its heat treatment, followed by holding the shell in a thermostat at a temperature of 185 ^o C for 1 1.5 hours, treating it first with a 3 5% hydrogen peroxide solution, and then repeated boiling of the shell in distilled water, changing after each boiling cycle, characterized in that after repeated boiling of the unfilled shell in distilled water, a carbon layer is applied on the surface of the shell chain a final structure, moreover, the shell is vulcanized by a vulcanizing agent at a temperature of 115 130 ^o С, the sealed shell is heat treated at a temperature of 150 180 ^o С for 1 3 h, while the shell is filled with low molecular weight silicone rubber with a viscosity of 7 10 Pa • s, and repeated thermal the processing is carried out at a temperature of 150 to 180 ^o C for 2 to 5 hours 2. The method according to claim 1, characterized in that the carbon layer of the chain structure with a thickness of 500 to 3000

applied to the shell surface in a vacuum by ion-stimulated carbon condensation at a substrate temperature of 30 120 ^o C. 3. The method according to claim 1, characterized in that the carbon layer of the chain structure with a thickness of 500 to 3000

applied in vacuum by flash evaporation of a graphite machine at a substrate temperature of 30 120 ^o C.