Relining for prostheses and process for the manufacturing thereof

A relining for prostheses on the basis of silicone and an adhesive for a durable bond between a prosthesis plastic with the silicone, characterized in that

• the relining is prepared from the following components:
• a one-component relining adhesive, the adhesive component Z thereof having the following general formula:
• 5
• wherein n and m are integers in the range from 0 to 1000;
• R1:
• H, halogen, a substituted alkyl, CN;
• R2, R3:
• H, halogen, alkyl, substituted alkyl
• and
• B=O, S, NH, NR, PH, PR;
• A=spacer, a straight-chain or branched hydrocarbon moiety having from 0 to 30 C atoms which may also contain an aromatically unsaturated of a cycloaliphatic ring;
• a polydialkylsiloxy unit;
• a siloxane containing a trifunctional T and/or a tetrafunctional Q unit;
• wherein R4 is an unsaturated group and/or one of the following groups:
• alkyl, aryl, aralkyl and halogen substituted alkyl and aryl groups, cyanoalkyl, cycloalkyl;
• wherein R5 may be equal to R4 or R6, wherein R6 is composed of the moieties, namely
• A, B, the polydialkylsiloxy moiety and the ethylenically unsaturated moiety:
• 6
• wherein the one-component relining adhesive is a copolymer synthesized from the adhesive component -Z and a mono- or polyfunctional (methyl)acrylate and/or (alkyl) methacrylate having acrylates and/or methacrylates as additional monomers, or wherein the one-component relining adhesive has the following composition:
• a) an adhesive component according to the general formula Z
• or
• b) a copolymer containing the adhesive component according to the general formula Z as a component;
• or
• c) a copolymer according to b) in admixture with the starting materials of the polymerization, an adhesive component according to a) and a monomer;
• d) catalysts for the addition crosslinking of the silicone, namely salts, complexes and/or colloidal forms of the transition metals of the 8th subgroup of the periodic table;
• e) a solvent;
• f) colourants;
• g) surfactants, emulsifiers, stabilizers;
• h) an organohydrogensiloxane having a SiH content from 1-15 mmol/g as a crosslinking agent;
• i) a α,ω-divinylpolydialkylsiloxane having a viscosity between 21 and 200,000 mPa·s;
• a two-component relining silicon from
• a1) organohydrogenpolysiloxanes or mixtures thereof having a SiH content from 2.0 to 15.0 mmol/g SiH, based on the polymer, and a viscosity from 10 to 10,000 mPa·s,
• a2) organohydrogenpolysiloxanes or mixtures thereof having a SiH content from 0.03-2.0 mmol/g SiH, based on the polymer, and a viscosity from 10 to 70,000 mPa·s,
• wherein the organopolysiloxanes a1) and a2) can have the following structure:
• A. structural formula of the linear organohydrogensiloxanes
• 7
• with p=0 to 1500;
• with q=0 to 1500;
• with R7=alkyl, aryl, aralkyl, and halogeno-substituted alkyl and aryl groups, cyanoalkyl, cycloalkyl and cycloalkenyl;
• with R8═R7, H;
• B. SiH-containing MQ resins consisting of:
• (R7)3SiO1/2, (R7)2(H)SiO1/2 and SiO4/2 units, where additionally the trifunctional R8SiO3/2 can be present as T units and the bifunctional R7R8SiO2/2 can be present as D units,
• wherein R7 and R8 have the meaning defined in A
• b) vinyl-containing organopolysiloxanes having two vinyl groups within the molecule of the general formula:
• CH2═CH—SiR2O—(SiR2O)n—SiR2—CH═CH2
• wherein
• R=alkyl, aralkyl, and halogen substituted alkyl and aryl groups, cyanoalkyl, cycloalkyl, and cycloalkenyl and
• n=an integer having a value from 21 to 1500, “n” representing theoretically calculated values calculated from the experimentally determined vinyl content on the assumption that each molecule contains two vinyl groups and R=methyl;
• c) hydrosilylation catalysts, namely salts, complexes, or colloidal forms of the transition metals of the 8th subgroup of the periodic table;
• d) a highly disperse, active filler having a BET surface of at least 25 m2/g;
• e) fibrous or lamellar fillers;
• f) colourants;
• g) moisture binders;
• h) vinyl-terminated and vinyl side chain-containing organopolysiloxanes containing more than two vinyl groups within the molecule and having a viscosity from 20 to 350,000 mPa·s;
• i) short-chain organopolysiloxanes for inhibiting the adjustment of the reactivity of the hydrosilylation reaction of the general formula:
• CH2═CH—SiR2O—(SiR2O)n—SiR2—CH═CH2
• wherein
• R are the same or different, optionally substituted hydrocarbon moieties, such as, e.g., alkyl, alkenyl, alkinyl and
• n=0 or an integer from 1 to 6;
• in addition, R can be an alkenyl- or alkinyl-terminated siloxane moiety or organic hydroxyl compounds containing cyclic siloxanes or terminal double or triple bonds for modifying the crosslinking rate;
• j) vinyl and ethoxy group-containing, solid or liquid MQ resins containing the tetrafunctional SiO4/2 as Q units and the monofunctional R3SiO1/2 as the M unit, where R can be vinyl, methyl, ethyl, phenyl and where the threefunctional RSiO3/2 can be present as T units and the bifunctional R2SiO2/2 can be present as D units with R=vinyl, methyl, ethyl, phenyl, where these MQ resins can be dissolved in organopolysilixanes having two or more vinyl groups within the molecule and a viscosity from 21 to 350,000 mPa·s and the vinyl group content of the above-mentioned MQ resins, is within the range from 0.1 to 8 mmol/g and the ethoxy group content is below 4 mmol/g;
• k) Compounds of organopolysiloxanes containing two or more vinyl groups within the molecule and having a viscosity from 21 to 350,000 mPa·s and the fillers according to d);
• l) surfactants, emulsifiers and/or stabilisers;
• m) radiopaque substances;
• n) H2 absorbers/absorbers in the form of finely-divided palladium or platinum or the alloys thereof which may be contained within alumosilicates or substances reducing or eliminating the development of H2;
• o) plasticizers, neutral or distributing oils;
• a two-component sealing lacquer, wherein both components chemically crosslink by a hydrosilylation reaction catalysed by noble metals, said components being an organopolysiloxane having a high SiH content from 2.0 to 15 mmol/g, based on the polymer, and an organohydrogenpolysiloxan having a low SiH content from 0.05 to 2 mmol/g, based on the polymer, the sealing lacquer having a viscosity from 25 to 10,000 mPa·s,
• wherein
• the two-component sealing lacquer contains the same ingredients as the two-component relining silicone and said ingredients can be present in the same percentages.