Method for producing an HTV silicone-containing solution, HTV silicone-containing solution, method for producing an HTV silicone body, method for producing an HTV silicone body laminate, HTV silicone body, HTV silicone body laminate, prosthesis, and coating for a prosthesis

Abstract

The invention relates to a method for producing an HTV silicone-containing solution and to an HTV silicone-containing solution which can be produced therefrom, to a method for producing an HTV silicone body (10) and to an HTV silicone body (10) which can be produced therefrom, and to a method for producing an HTV silicone body laminate (16) and to an HTV silicone body laminate (16) which can be produced therefrom. The invention further comprises a prosthesis and a coating for a prosthesis. According to the invention, a solid silicone rubber (HTV silicone) for producing a prosthesis from HTV silicone, a coating for such a prosthesis, and / or an intermediate product thereof is liquefied by a solvent and processed in the liquefied state without the desired mechanical properties of the HTV silicone in the vulcanised end product being changed.

Description

[0001] Description

[0002] Method for producing an HTV silicone-containing solution, HTV silicone-containing solution, method for producing an HTV silicone body, method for producing an HTV silicone body laminate, HTV silicone body, HTV silicone body laminate, prosthesis and coating for a prosthesis

[0003] The invention relates to a method for producing an HTV silicone-containing solution and an HTV silicone-containing solution producible therefrom, a method for producing an HTV silicone body, and a method for producing an HTV silicone body laminate, as well as an HTV silicone body and an HTV silicone body laminate producible therefrom. Furthermore, the invention relates to a prosthesis and a covering for a prosthesis.

[0004] When a person receives a prosthesis following an amputation, the specific care provided depends on their individual circumstances and needs. Prostheses are commonly used to replace or restore missing or impaired body parts. To create a prosthesis, a rough blank is initially produced, which an orthotist then gradually and individually adapts to the shape and form of the affected body part. The patient often visits the orthotist several times to fine-tune the custom-made prosthesis. In particular, to create lifelike prostheses, fine surface textures must be manually incorporated into the individual prosthesis.

[0005] Therefore, if a lifelike, customized cosmetic finish is desired, whether as a cosmetic covering for a prosthesis, such as a hand or arm prosthesis, or as a prosthesis for overall appearance, it is advisable to use high-temperature vulcanizing (HTV) silicones. HTV silicones are preferably high-consistency rubber (HCR), heat-cured rubber, or HTV silicone rubber. In other words, an HTV silicone (before the vulcanization process) is a preferably malleable silicone. HTV silicones are a specific type of silicone characterized by excellent mechanical properties, such as high elongation at break and tear resistance. This is absolutely essential for a prosthesis worn daily and subjected to high stresses to ensure an adequate lifespan.It is believed that the malleable (paste-like) HTV silicone has such good physical properties because it primarily contains silica as a filler. The fine silica particles provide mechanical reinforcement to the silicone by supporting the polymer chains. This results in the rubber having a firm yet malleable (kneadable) consistency.

[0006] The major disadvantage of HTV silicones is that, unlike other silicones such as cold-curing (room temperature curing - RTV) silicones or liquid silicone rubber (LSR), they must be processed as a solid. Typically, both components required to produce an HTV silicone (along with specific color pigments) are mixed in a roller, rolled out, and then molded onto a plaster cast. Accordingly, a distinguishing feature between LSR silicones and HCR is the flowable or liquid consistency of LSR materials.

[0007] This solid material manufacturing process presents enormous limitations: a thin wall thickness is only possible to a certain extent, the color design requires the “kneading in” differently colored silicone parts, the artistic and technical skill of the technician is crucial for the lifelike character of the prosthesis or prosthetic covering, and only a single piece is ever produced using this process.

[0008] Therefore, it would be desirable to simplify the production of lifelike prostheses made from HTV silicones.

[0009] The invention is therefore based on the objective of creating a way to produce lifelike prostheses from HTV silicone in a cost-effective manner.

[0010] The problem according to the invention is solved by a method for producing an HTV silicone-containing solution and an HTV silicone-containing solution produced therefrom, a method for producing an HTV silicone body, a method for producing an HTV silicone body laminate and an HTV silicone body produced therefrom, an HTV silicone body laminate produced therefrom, a prosthesis, and a coating for a prosthesis comprising the HTV silicone body and / or the HTV silicone body laminate according to the independent claims. Preferred embodiments are the subject of the respective dependent claims.

[0011] A first aspect concerns a method for producing an HTV silicone-containing solution. Preferably, the HTV silicone-containing solution is used for the production of a prosthesis or a coating for a prosthesis, or for the production of any intermediate products in the production of the prosthesis or the coating for a prosthesis.

[0012] In one process step, HTV silicone is dissolved in a solvent. In other words, an HTV silicone, a solid silicone rubber normally processed as a solid, is diluted, i.e., converted into a liquid or flowable state, so that it can subsequently be processed as a fluid or solution. It has been found that processing HTV silicone as an HTV silicone-containing solution simplifies the processing of the HTV silicone without altering or losing the (desired) mechanical properties of the HTV silicone in the vulcanized end product.It was therefore recognized that the liquefaction of HTV silicones, in particular, enables a world-first application of HTV silicones in areas such as the removal of printed negative molds, which was previously impossible with HTV silicones due to their solid-state properties and thus reserved, for example, for LSR silicones processed in liquid form. Other potential applications are also conceivable. The term HTV silicone preferably excludes LSR silicones. In other words, LSR silicones are preferably not included under the term HTV silicone and are therefore explicitly excluded. Paste-like HTV silicones are more expensive compared to LSR silicones, so in applications requiring liquid silicones, an LSR silicone is usually chosen automatically. Furthermore, the volume of the HTV silicone-containing solution increases up to threefold when the HTV silicone is dissolved.In the professional community, it has been generally avoided to dissolve pasty HTV silicones with a solvent, as it was assumed that the high solvent content would damage the HTV silicone, leading to blistering during the subsequent vulcanization process. The "high temperature" in the term "HTV silicone" refers to a temperature of at least 60 °C, preferably at least 70 °C, and particularly preferably at least 90 °C. Preferably, the "high temperature" in the term "HTV silicone" is less than 230 °C or less than 200 °C, more preferably less than 150 °C, and particularly preferably less than 125 °C or 120 °C. In other words, the term "HTV silicone" preferably refers to solid rubber silicones that vulcanize at a temperature of at least 60 °C (or a temperature according to the other temperature limits mentioned).

[0013] Preferably, the mixing ratio of the HTV silicone-containing solution is 1 part HTV silicone to 1 part solvent, preferably at least 1 part HTV silicone to 2.5 parts solvent, and particularly preferably up to 1 part HTV silicone to 4.5 parts solvent. Hexamethyldisiloxane is a preferred solvent. It has been found that the HTV silicone does not suffer any of the expected damage at a mixing ratio of 1 part HTV silicone to at least 1 part hexamethyldisiloxane. However, blistering can occur in the HTV silicone-containing solution during the evaporation process if the mixing ratio is less than 1 part HTV silicone to 2.5 parts hexamethyldisiloxane. However, blistering no longer occurs at a mixing ratio of 1 part HTV silicone to 2.5 parts or more. Preferably, the mixing ratio of the HTV silicone-containing solution is 1 part HTV silicone to 2.5 parts or more.In this mixing ratio, the HTV silicone-containing solution has a viscosity of approximately 20,000 mPas. In other words, the viscosity of the HTV silicone-containing solution is preferably at most 25,000 mPas, more preferably at most 22,500 mPas. A particularly preferred mixing ratio is 1 part silicone to 3.5 to 4 parts hexamethyldisiloxane. Here, the viscosity is approximately 4,000–2,500 mPas. In other words, the viscosity of the HTV silicone-containing solution is preferably at least 500 mPas, more preferably at least 1,000 mPas and / or at most 25,000 mPas, more preferably at most 22,500 mPas. Preferably, the mixing ratio can be 1 part HTV silicone to >4 parts hexamethyldisiloxane. However, it should be noted that the resulting HTV layer thicknesses will then be very thin.

[0014] The solvent used is preferably volatile. Volatility (also called evaporation rate) is a dimensionless relative parameter that describes the evaporation of a solvent. Volatility is preferably measured at room temperature, approximately 20°C. The solvent is preferably highly volatile (evaporation rate less than 10) or moderately volatile (evaporation rate 10 to 35), measured according to DIN 53170. A volatile solvent allows the solvent in the molded or swirled HTV silicone-containing solution to evaporate spontaneously, meaning the HTV silicone separates from the solvent independently without noticeable effort to form a molded HTV silicone body.

[0015] Preferably, the solvent is selected from hexamethyldisiloxane, octamethyltrisiloxane, other solvents of the silane group, cold cleaners, heptane, C6-C7 hydrocarbons, N-alkanes, isoalkanes, cyclic compounds, and N-hexanes (e.g., white spirit). Hexamethyldisiloxane, heptane, and white spirit, in particular, are especially suitable solvents for HTV silicones, offering particularly good solubility. The solvent is preferably nonpolar. The polarity of the solvent is preferably below 0.5 Debye, preferably below 0.4 Debye, or below 0.3 Debye, below 0.2 Debye, or below 0.1 Debye, and particularly preferably below 0.05 Debye. The solvents mentioned are all essentially nonpolar. A nonpolar solvent offers the advantage in the production of an HTV silicone body that nonpolar silicone precursors and polymers can be dissolved particularly well.Silicones and their starting materials are usually nonpolar or only weakly polar. Following the principle of "like dissolves like," nonpolar substances are easier to process and homogenize in nonpolar solvents, which facilitates reaction control and uniform crosslinking. Furthermore, nonpolar solvents react minimally with the silicone components, improving the purity and quality of the final product. Aliphatic alkanes and siloxanes are very nonpolar and exhibit a dipole moment below 0.05 Debye. A siloxane is preferred as the solvent. Linear siloxanes, such as hexamethyldisiloxane, octamethyltrisiloxane, decamethyltetrasiloxane, or polydimethylsiloxane (PDMS), and / or cyclic siloxanes, such as hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, or dodecamethylcyclohexasiloxane, and / or branched and crosslinked siloxanes, such as silicone resins or silicone elastomers, are preferred.Siloxanes are considered relatively chemically inert solvents when used properly. Due to their low reactivity, the use of siloxanes is less hazardous to health than that of other, often more harmful, solvents such as toluene, xylene, or tetrahydrofuran. Therefore, the production of an HTV silicone body can be achieved by using a siloxane as a solvent.

[0016] The solvent is preferably a solvent with a boiling point below 135 °C or 130 °C, more preferably below 125 °C or below 120 °C, and particularly preferably below 115 °C or below 110 °C. A lower boiling point allows for less heat input, so that the solvent can evaporate from the HTV silicone body being produced with less energy input. This simplifies the production of an HTV silicone body.

[0017] Preferably, the HTV silicone is a two-component HTV silicone. In other words, the HTV silicone is preferably an addition-curing, for example, platinum-curing, HTV silicone. In contrast to peroxide-curing silicones, platinum-curing HTV silicone exhibits higher purity and meets stricter biocompatibility standards. Unlike peroxide-curing systems, which can produce acid residues as byproducts, platinum-curing HTV silicones produce no or negligible byproducts during the curing process. Therefore, platinum-curing HTV silicone is characterized by its odorlessness (after curing / vulcanization). Platinum-curing HTV silicone also meets specific standards, such as ISO 10993 and FDA approvals, and is thus food-safe.

[0018] With two-component HTV silicones, the two components are preferably dissolved separately and then combined into a common solution. Alternatively, both components are preferably dissolved together in a solvent mixture. This allows for a wide range of processing options.

[0019] Preferably, the HTV silicone to be dissolved (or its components) is pre-swelled in the solvent for a suitable period, for example, at least 20 minutes, before the solution is adjusted to the required strength. A suitable period is, for example, 20 minutes or one hour up to twelve hours. The suitable period depends on the properties of the HTV silicone and can be shortened, for example, by coarsely (or even finely) grinding the HTV silicone beforehand to increase its overall surface area and accelerate the swelling process. After the suitable period has elapsed, the (viscous) HTV silicone-solvent mixture is preferably mixed, in particular whisked, to dilute the HTV silicone with the remaining solvent in the mixture, i.e., to essentially homogenize the mixture. Mixing is preferably carried out using a mechanical whisk.

[0020] Preferably, the HTV silicone-containing solution is combined with other components, such as color pigments. This allows for simpler color customization of the HTV silicone by stirring, as opposed to rolling, which is usually required with HTV silicones. Furthermore, the HTV silicone-containing solution is preferably filtered and / or deaerated under vacuum to increase the purity of the HTV silicone-containing solution and the subsequent HTV silicone.

[0021] Preferably, an HTV silicone of any Shore hardness is used, for example Shore A 00-10 to Shore A 80, measured according to DIN ISO 48-4. Consequently, a wide range of applications is possible for the HTV silicone-containing solution.

[0022] Another aspect concerns an HTV silicone-containing solution that can be produced using the method described above. The optional features and their advantages described in the method can be implemented analogously with the HTV silicone-containing solution and are therefore freely combinable.

[0023] Another aspect concerns a method for manufacturing an HTV silicone body for a prosthesis or for a covering for a prosthesis. According to the present disclosure, the term "prosthesis" preferably includes the complete prosthesis or only a part thereof, and the term "cover" preferably includes the complete covering or only a part thereof. In other words, the method is a method for manufacturing an HTV silicone body for a prosthesis or a part thereof, or for a covering for a prosthesis or a part thereof. The manufactured prosthesis or the covering therefor serves, in particular, to replace an extremity of a living being, such as a finger, hand, arm, leg, foot, ear, and / or the like. An extremity is a limb, i.e., a movable body appendage. The extremity preferably refers to a human being or an animal.

[0024] According to the process, a negative mold of the prosthesis or a negative mold of the coating is swept out, or a positive mold of the prosthesis or a positive mold of the coating is poured and / or dipped. For the swept out, pouring, and / or dipping, a fluid containing or consisting of the aforementioned HTV silicone-containing solution is used. By swept out, pouring, and / or dipping a mold with the HTV silicone-containing solution, HTV silicone bodies with wall thicknesses significantly thinner than those achievable with conventional solid-state processing steps for HTV silicones can be produced. Consequently, HTV silicone bodies with lifelike structures can be manufactured simply and cost-effectively.This allows for the production of prostheses and prosthesis covers that are individually tailored to each patient, visually superior to conventional alternatives, and significantly thinner. Consequently, the wall thickness of the HTV silicone body produced according to the invention can be varied. The wall thickness of the HTV silicone body produced according to the invention is preferably at least 0.15 mm, preferably at least 0.5 mm and / or at most 1.5 mm, preferably at most 1.25 mm, and particularly preferably at most 1 mm. For example, the total wall thickness of the HTV silicone body produced according to the invention can be 0.8 mm. Conventionally manufactured prostheses made of HTV silicones usually require a surface with a "modulation thickness" of at least 1.5 mm or 2 mm up to 5 mm in order to manually incorporate fine surface structures into the individual prosthesis.The comparatively thicker walls of conventionally manufactured silicone bodies have the disadvantage of making them bulky and potentially impairing or even damaging the mechanisms of the prosthetic hands. Furthermore, the prosthesis is relatively heavy, reducing patient comfort. In other words, a thinner wall of the manufactured HTV silicone body allows for greater flexibility and a lighter prosthesis. Using negative or positive molds saves approximately 70% of the manufacturing time for each subsequent prosthesis (i.e., each subsequent fitting for the patient). Moreover, this process is reliable and not (significantly) dependent on the skill or daily condition of the person manufacturing the prosthesis.

[0025] Preferably, the negative mold is pretreated with a release agent before being swung out, or the positive mold is pretreated with a release agent before being poured. This simplifies the removal or demolding of the HTV silicone body from the respective mold.

[0026] Preferably, the negative and / or positive mold is first created. For this purpose, a digital 3D image of the healthy body part, particularly as a high-density mesh, is preferably created from the patient. This is preferably done by (directly) scanning the skin or the corresponding body part using a 3D scanner and / or an imaging technique such as computed tomography (CT), digital volume tomography (DVT), and the like. The digital 3D image is preferably mirrored to utilize the chirality of paired body parts for the purpose of creating the negative or positive mold. This avoids the need for complex design of the corresponding shape. Furthermore, an individualized prosthesis is created that mimics the patient's own body, which can provide psychological support for the patient, especially in the case of a recent (partial) amputation of the body part.

[0027] Alternatively, the negative or positive mold is preferably produced using a silicone or alginate mold and a solid model created from it. Other methods, such as freehand modeling in clay or modeling compound, 3D modeling, and 3D printing, are also preferred.

[0028] Preferably, after swirling or pouring, the excess fluid or HTV silicone-containing solution is discarded. In other words, not all of the fluid or HTV silicone-containing solution used ends up in the manufactured HTV silicone body. This ensures that the manufactured HTV silicone body is complete, meaning that the swirled or poured mold is sufficiently covered with fluid or HTV silicone-containing solution. Preferably, the excess fluid or HTV silicone-containing solution is discarded, at least for the HTV silicone body being manufactured. The discarded excess fluid or HTV silicone-containing solution is preferably collected to be processed or used for the manufacture of another HTV silicone body.

[0029] In a preferred embodiment, the swung-out negative mold or the cast positive mold is stored until the solvent contained in the HTV silicone-containing solution has been substantially removed. In other words, the solvent is removed by at least 95%, preferably at least 98%, and particularly preferably at least 99.9%. If a significant portion of solvent remains in the HTV silicone-containing solution or in the HTV silicone body, the HTV silicone body will foam and / or form bubbles during the vulcanization process, thereby significantly reducing the quality of the vulcanized HTV silicone body.

[0030] Preferably, the steps of swirling or pouring and subsequent removal of the solvent are repeated to form a multi-layered HTV silicone body of the prosthesis or the coating for the prosthesis. The solvent is preferably removed by positioning the negative mold with the filling opening facing downwards (i.e., in the direction of gravity). Since the solvent is heavier than the surrounding air and settles in the negative mold, this positioning of the HTV silicone body being produced accelerates the solvent removal. For example, the corresponding mold is left to deteriorate for at least five minutes, preferably at least ten minutes, particularly preferably at least 15 minutes, and / or at most 24 hours, preferably at most one hour, and particularly preferably at most 45 minutes.Preferably, the steps of rinsing or pouring and subsequent removal of the solvent are repeated at least twice, preferably at least three times, particularly preferably at least five times and / or at most 100 times, preferably at most 50 times, particularly preferably at most 25 or at most 10 times. In other words, the process can preferably be used to build up a multilayer HTV silicone body with a plurality of layers of HTV silicone. It is understandable that the number of repetitions is preferably selected, or should be selected, depending on the desired overall wall thickness of the HTV silicone body to be produced. Multilayer HTV silicone bodies can be designed with more variable properties. For example, the layer thickness and / or the layer material of the individual layers can be different, and / or different materials can be introduced between the layers.be embedded.

[0031] Preferably, different HTV silicone-containing solutions are used, particularly for forming the various layers of the multilayer HTV silicone body. Preferably, HTV silicone-containing solutions with HTV silicones of different Shore hardnesses are used and / or HTV silicone-containing solutions mixed with different color pigments are used. Preferably, the application of the first and last layers of the multilayer HTV silicone body is selected such that the mechanical properties of these layers, i.e., the outer layers of the HTV silicone body, differ from the mechanical properties of the remaining layer(s) of the HTV silicone body, i.e., the inner layers of the HTV silicone body. Preferably, one or both of the outer layers of the HTV silicone body are formed from an HTV silicone with a higher Shore hardness and / or a greater layer thickness.This allows the resistance and therefore the service life of the HTV silicone body to be increased, while at the same time sufficient flexibility is achieved through the thinner or softer inner layers of the HTV silicone body.

[0032] Preferably, the resulting HTV silicone body is tempered and vulcanized. For example, the HTV silicone body is tempered in an oven according to the manufacturer's instructions for the selected HTV silicone to initiate the vulcanization process. For instance, the HTV silicone body is tempered at 90 °C for two hours. Through the vulcanization process, the HTV silicone acquires the desired mechanical properties for later use. Another aspect concerns a method for manufacturing an HTV silicone body laminate for a prosthesis or a coating for a prosthesis. A laminate refers to a material or product consisting of two or more layers bonded together, for example, by adhesive. These layers can be made of the same or different materials.

[0033] In each step, at least two negative and / or positive molds of a body part to be replaced (by the subsequent prosthesis) are provided. The two negative and / or positive molds differ in their spatial representation of a movement position of the body part to be replaced (for example, a finger in extended and flexed positions). For instance, negative and / or positive molds of a finger, thumb, or knuckle are provided in both flexed and extended positions. Depending on the application and requirements, the movement positions and angles of the individual positions of the negative molds can vary.

[0034] Furthermore, at least one HTV silicone body is produced for each of the two negative and / or positive molds. At least one of the at least two HTV silicone bodies is produced according to the above method for producing an HTV silicone body. Preferably, both of the at least two HTV silicone bodies are produced according to the above method for producing an HTV silicone body. Particularly preferably, each of the HTV silicone bodies is produced according to the above method for producing an HTV silicone body.

[0035] In a further step, the at least two HTV silicone bodies are joined to form an HTV silicone body laminate. This joining is preferably achieved using a positive model of the prosthesis or the body part to be replaced, for example, a positive mold of the prosthesis. The at least two HTV silicone bodies are then successively mounted onto the positive model. The positive model is preferably positioned midway between the two different shapes of the at least two negative and / or positive molds. This facilitates the mounting of the HTV silicone bodies onto the positive mold. The positive model is preferably manufactured from 3D printing materials or other materials such as silicone, plaster, or similar substances.

[0036] Due to the constant mechanical stress on frequently moving parts of prostheses or prosthetic gloves, the silicone increasingly tears, for example at the finger joints. To improve the durability of the silicone in these areas and thus extend the lifespan of the prostheses or prosthetic gloves, the HTV silicone bodies are not manufactured in one piece, but from different laminate layers, i.e., an HTV silicone body laminate. Due to the different spatial configurations of the at least two HTV silicone bodies according to the invention with respect to their movement position, the resulting HTV silicone body laminate remains in an intermediate position between the two movement positions, and the stress exerted on the HTV silicone by movement is reduced, thus delaying premature tearing.With conventional one-piece HTV silicone bodies, the HTV silicone begins to break down after approximately 50,000 movement cycles. With the HTV silicone body laminate according to the invention, more than 280,000 movement cycles without breakage have already been demonstrated. The movement positions can be selected depending on the application. Preferably, the movement positions are chosen such that they reflect the most frequent movement positions of the body part to be replaced, for example, a finger in (essentially fully) extended and (essentially fully) flexed positions. If more than two HTV silicone bodies are used to form the HTV silicone body laminate, the remaining HTV silicone bodies are preferably formed in a neutral position. Alternatively, they can also be formed in the movement positions of the at least two HTV silicone bodies.It is understandable that any desired movement position of the body part to be replaced can be chosen. In other words, a first set of HTV silicone bodies is preferably produced in one movement position, and a second set of HTV silicone bodies is produced in a different second movement position.

[0037] The principle according to the invention can in principle be extended to a laminate structure with several different positions of the body part to be replaced, for example the fingers, thumbs and ankles and / or toes, as well as to entire model hands and / or feet, individual fingers and parts of a model hand and / or foot.

[0038] In a preferred embodiment, a silicone adhesive is used to join the at least two HTV silicone bodies to form an HTV silicone body laminate. This ensures a long-lasting bond between the HTV silicone bodies to form the HTV silicone body laminate. Preferably, an acetate-curing silicone adhesive, for example Wacker ELASTOSIL® E43 or E4, or a solvent-curing silicone adhesive, for example LSR silicone diluted with hexamethyldisiloxane, is used. The bonding of the HTV silicone bodies preferably takes place on the aforementioned positive model.

[0039] In a further preferred embodiment, the negative mold and / or the positive mold are produced using 3D printing. The negative mold and / or the positive mold are preferably printed directly from the digital image of the prosthesis or its covering using an SLS or resin 3D printer. SLS 3D printers (Selective Laser Sintering) are characterized by high resolution and layer transitions that are essentially invisible (to the human eye), i.e., no individual visible layers. When using an SLS 3D printer, a layer of fine-grained powder is fed into the printer and fused into a single part by a laser. Resin 3D printers are distinguished by their exceptional print quality.Resin 3D printers use 3D printing processes such as stereolithography (SLA) or digital light processing (DLP), where the resolution is determined by the optical point of the laser or projector (SLA) or the pixel (DLP). Since light is used for polymerization, no force is applied during printing, resulting in particularly smooth surfaces.

[0040] Another aspect concerns an HTV silicone body for a prosthesis or a covering for a prosthesis. The HTV silicone body can be produced using the aforementioned method for manufacturing an HTV silicone body for a prosthesis or for a covering for a prosthesis. The optional features and their advantages described in the method are implemented analogously in the HTV silicone body and can therefore be combined with one another as desired. Preferably, the HTV silicone body represents an HTV silicone-containing prosthesis or an HTV silicone-containing covering for a prosthesis, which can be manufactured using the aforementioned method for manufacturing an HTV silicone body for a prosthesis or for a covering for a prosthesis. The HTV silicone body manufactured according to the invention comprises a variably adjustable wall thickness and is characterized by the fact that there are no visually apparent material transitions, i.e., protrusions or...Impressions in the silicone, which arise during the conventional production of silicone bodies when two shaping half-shell bodies are pressed together to form the silicone body.

[0041] Another aspect concerns an HTV silicone body laminate for a prosthesis or a prosthesis covering. The HTV silicone body laminate can be manufactured using the aforementioned process. The optional features and their advantages described in the process are implemented analogously in the HTV silicone body laminate and can therefore be combined as desired.

[0042] In a preferred embodiment, at least two layers of the laminate comprise HTV silicones that differ in Shore hardness and / or layer thickness. In other words, different layers of the laminate have HTV silicones with different Shore hardnesses and / or layer thicknesses. Preferably, a first layer and a last layer of the laminate are selected such that the mechanical properties of these layers, i.e., the outer layers of the laminate, differ from the mechanical properties of the remaining layer(s) of the laminate, i.e., the inner layers. Preferably, one or both of the outer layers of the laminate are formed from an HTV silicone with a higher Shore hardness (compared to the inner layers) and / or with a greater layer thickness.This allows the resistance and thus the service life of the laminate to be increased, while simultaneously achieving sufficient flexibility through the thinner or softer inner layers of the laminate. Furthermore, the HTV silicone body laminate preferably comprises at least one additional layer made of a material different from HTV silicone, for example, an RTV and / or LSR silicone.

[0043] In a preferred embodiment, the above HTV silicone body and / or the above HTV silicone body laminate are provided with reinforcing elements and / or reinforcing fabrics incorporated on and / or between the layers of the silicone body or between the laminate layers of the HTV silicone body laminate. Reinforcing elements are, for example, plastic or metal bodies (or a combination thereof), preferably in the form of individual, point-like microstructures (powders, spheres, and the like) or planar structures (platelets, strips, and the like). Reinforcing fabrics are preferably textiles, such as nylon. The tensile strength and / or compressive strength of the HTV silicone body or the HTV silicone body laminate can be increased by the presence of reinforcing elements and / or reinforcing fabrics embedded between the layers.The reinforcing elements and / or reinforcing tissue are preferably arranged fully or partially between the layers. Consequently, the advantages can be realized for the entire HTV silicone body or the entire HTV silicone body laminate, or only for local sections thereof. For example, the fingertip of a finger prosthesis could be reinforced by reinforcing elements and / or reinforcing tissue arranged locally between the layers to increase the prosthesis's resistance and allow for a higher gripping force without damage. Preferably, a reinforcing element and / or reinforcing tissue is arranged on an outer surface of one of the outer laminate layers of the HTV silicone body laminate, for example, by being incorporated into it.For this purpose, the reinforcing body and / or the reinforcing fabric can be applied to the positive form, for example of the finger, and then the first HTV silicone layer of the laminate is applied to the positive form.

[0044] Another aspect concerns a prosthesis or a covering for a prosthesis comprising the above-mentioned HTV silicone body and / or the above-mentioned HTV silicone body laminate. The optional features and their advantages described for the HTV silicone body and the HTV silicone body laminate are implemented analogously in the prosthesis or the covering and can therefore be combined with one another as desired. Further preferred embodiments of the invention result from the remaining features mentioned in the dependent claims.

[0045] Unless otherwise stated in individual cases, the various embodiments of the invention mentioned in this application can be advantageously combined with one another.

[0046] The invention is explained below using exemplary embodiments with reference to the accompanying drawings. These show:

[0047] Figure 1 is a schematic representation of three methods, each according to a

[0048] Implementation method;

[0049] Figure 2 shows a schematic representation of a manufactured first HTV silicone body in a first movement position according to one embodiment;

[0050] Figure 3 is a schematic representation of a manufactured second HTV.

[0051] silicone body in a second movement position according to a further embodiment;

[0052] Figure 4 shows a schematic representation of a positive form of a part to be replaced.

[0053] body part in a neutral position; and

[0054] Figure 5 shows a schematic cross-sectional view of an HTV silicone body.

[0055] Laminates according to one embodiment.

[0056] Figure 1 shows a schematic representation of three methods, each according to one embodiment. The methods shown in Figure 1 are explained in more detail with reference to Figures 2 to 5 using a prosthesis (or a covering for it) for a finger as the body part to be replaced, without being limited to this. Rather, the underlying inventive idea is merely to be illustrated. The prosthesis or covering produced can also be used analogously for other body parts to be replaced, such as a hand, an arm, a leg, a foot, an ear, and the like. The present invention makes it possible to produce individual prostheses from HTV silicone simply and cost-effectively. In this respect, the present invention offers an innovative manufacturing process that negates the disadvantages arising from the difficult processing of HTV silicones.This process, for example, combines the use of the latest 3D technology and HTV silicone for the first time. Highly precise 3D scanners can capture the healthy body part corresponding to the one being replaced, including all its proportions and fine textures, in order to create corresponding negative molds that are then filled with HTV silicone. Subsequently, the use of a color system allows, for example, lifelike, colored painting of the HTV silicone-containing prosthesis using an airbrush system.

[0057] The core of the inventive process lies in being able to dissolve or dilute HTV silicone and subsequently process it as a fluid or solution (i.e., in a liquid or flowable state) without altering the mechanical properties of the HTV silicone in the vulcanized end product. The process for a complete prosthetic glove comprises many steps, the details of which are crucial. However, it has been recognized that, in particular, the liquefaction of HTV silicones enables a use—first of its kind worldwide—via the extraction of printed negative molds. Other potential applications are also conceivable.

[0058] Figure 1 schematically illustrates three processes and their interrelationships. A first process 100 deals with the production of an HTV silicone-containing solution. The further processes 200 and 300 serve to produce an HTV silicone body 10, 10a, 12, 12a (see Figures 2 and 3) and an HTV silicone body laminate 16 (see Figure 5), respectively.

[0059] In process 100 for producing an HTV silicone-containing solution, 50 parts of HTV silicone are dissolved in a solvent in a first process step. HTV silicone, a solid silicone rubber, is normally processed in its solid state. By diluting the HTV silicone, i.e., converting it from a (essentially) solid state to a liquid or flowable state, it can be processed in this liquid or flowable state. Hexamethyldisiloxane, which is volatile, is used as the solvent. However, the use of other solvents is also possible. The mixing ratio is 4 parts solvent to 1 part HTV silicone. This ensures that the HTV silicone-containing solution does not form bubbles in subsequent processing steps.The HTV silicone (or its components) to be dissolved is pre-swelled in the solvent for a suitable period of time before the working strength of the solution is adjusted for the subsequent steps.

[0060] In a second process step 52, a negative mold and / or a positive mold 14 of a body part to be replaced (by the prosthesis) is provided. An example of a positive mold 14 of a finger is shown in Figure 4. The provided negative and / or positive mold(s) 14 are preferably produced based on a healthy body part of the patient. For example, a digital 3D image of the healthy body part, particularly as a high-density mesh, is created from the patient by directly scanning the corresponding healthy body part. Subsequently, the generated digital 3D image of the healthy body part is mirrored to exploit the chirality of paired body parts for the purpose of designing the negative or positive mold. The mirrored digital 3D image is then fed to a 3D printer to produce a corresponding negative and / or positive mold 14 of the body part to be replaced.

[0061] To produce an HTV silicone body 10, 10a, 12, 12a according to process 200, the HTV silicone-containing solution obtained in the first process step 52 is poured into the negative mold and swished around (third process step 54). Depending on the mold used, the positive mold 14 can also be poured over and / or immersed in the HTV silicone-containing solution (fourth process step 56). By swishing or pouring over and / or immersing a mold with the HTV silicone-containing solution, HTV silicone bodies 10, 10a, 12, 12a can be produced with wall thicknesses that are significantly thinner than those achievable with conventional solid-state processing steps for HTV silicones. Consequently, HTV silicone bodies 10, 10a, 12, 12a with lifelike structures can be manufactured easily and cost-effectively.

[0062] According to the process for manufacturing an HTV silicone body laminate 16, at least two negative molds and / or positive molds 14 of a body part to be replaced (by the prosthesis) are provided. The two negative molds and / or positive molds 14 differ in their spatial representation with respect to a movement position of the body part to be replaced. For example, the two negative molds and / or positive molds 14 each correspond to a finger in an extended and flexed position, in order to obtain the HTV silicone bodies 10, 12 shown in Figures 2 and 3.Figure 2 shows a schematic representation of a manufactured, vulcanized first HTV silicone body 10 in a first movement position, i.e. a bent state of the finger, according to one embodiment, and Figure 3 shows a schematic representation of a manufactured, vulcanized second HTV silicone body 12 in a second movement position, i.e. a stretched state of the finger, according to another embodiment.

[0063] In a fifth process step 58, at least one HTV silicone body 10, 10a, 12, 12a is produced for each of the two negative molds and / or positive molds 14. In this step, the solvent is removed from the HTV silicone-containing solution that has been swept out or poured over. Since the solvent is volatile, this is done primarily by waiting. The filling opening of the negative mold points downwards to allow the solvent, which is heavier than air, to flow out of the negative mold more easily.

[0064] Process steps 54, 56, and 58 can then be repeated (multiple times) to obtain a multilayered first HTV silicone body 10, 10a and / or a multilayered second HTV silicone body 10, 10a, 12, 12a. It is understood that the number of repetitions is chosen depending on the desired overall wall thickness of the HTV silicone body 10, 10a, 12, 12a to be produced. In other words, each repetition adds another layer of HTV silicone.

[0065] In a sixth process step 60, a reinforcing fabric 18 (see Figure 5) and / or reinforcing body is incorporated into or between the manufactured HTV silicone bodies 10, 10a, 12, 12a. The incorporated reinforcing fabric 18 is a textile material, such as nylon. The embedded reinforcing fabric 18 improves the tensile strength of the HTV silicone bodies 10, 10a, 12, 12a.

[0066] In a seventh process step 62, the resulting HTV silicone body(s) 10, 10a, 12, 12a are tempered and vulcanized. For example, the HTV silicone body 10, 10a, 12, 12a is tempered in an oven according to the manufacturer's instructions for the selected HTV silicone to initiate the vulcanization process. For example, the HTV silicone body 10, 10a, 12, 12a is tempered at 90 °C for one hour. Through the vulcanization process, the HTV silicone body 10, 10a, 12, 12a acquires the desired mechanical properties of the HTV silicone for later use.

[0067] Process steps 60 and 62 can also be interchanged in chronological order. In other words, the HTV silicone bodies 10, 10a, 12, 12a can first be tempered and vulcanized before a reinforcing fabric 18 is incorporated.

[0068] In an eighth process step 64, the manufactured HTV silicone bodies 10, 10a, 12, 12a are joined to form an HTV silicone body laminate 16. For joining the HTV silicone bodies 10, 10a, 12, 12a to form an HTV silicone body laminate 16, a silicone adhesive is used, for example.

[0069] Due to the different spatial configurations of the at least two HTV silicone bodies 10, 10a, 12, 12a according to the invention with respect to their movement position, the resulting HTV silicone body laminate 16 remains in an intermediate position between the two movement positions, and the stress acting on the HTV silicone due to movement is reduced, thus delaying premature tearing. The movement positions can be selected depending on the application. Preferably, the movement positions are chosen such that they reflect the most common movement positions of the body part to be replaced, for example, a finger in (essentially completely) extended and (essentially completely) flexed positions, as shown in Figures 2 and 3.

[0070] Figure 4 shows a schematic representation of a positive mold 14 of a body part to be replaced in a neutral position. The neutral position refers to the movement positions of the HTV silicone bodies 10 and 12 shown in Figures 2 and 3. During the joining of the silicone bodies 10, 10a, 12, 12a in the eighth process step 64, the HTV silicone bodies 10, 10a, 12, 12a are successively applied to the positive mold 14. Because the positive mold 14 shown in Figure 4 is in the neutral position, this application process is particularly easy.

[0071] Figure 5 shows a schematic cross-sectional view of an HTV silicone body laminate 16 according to one embodiment. The HTV silicone body laminate 16 was produced according to methods 100, 200 and 300 shown in Figure 1.

[0072] The illustrated HTV silicone body laminate 16 comprises, by way of example, four first HTV silicone bodies 10, 10a and four second HTV silicone bodies 12, 12a, without being limited to the number shown. The first silicone bodies 10, 10a are configured in the first movement position, i.e., a flexed state of the finger, corresponding to the first HTV silicone body 10 shown in Figure 2. The second silicone bodies 12, 12a are configured in the second movement position, i.e., an extended state of the finger, corresponding to the second HTV silicone body 12 shown in Figure 3.

[0073] Each of the HTV silicone bodies 10, 10, 12, 12a shown in Figure 5 represents an HTV silicone layer of the HTV silicone body laminate 16. The outer HTV silicone layers are formed by a first HTV silicone body 10a and a second silicone body 12a. The remaining HTV silicone bodies 10, 12, which essentially form the inner HTV silicone layers of the HTV silicone body laminate 16, each have, for example, a first layer thickness Di, and the outer HTV silicone bodies 10a and 12a have a second layer thickness D2, which is greater than the first layer thickness Di. Furthermore, the outer HTV silicone bodies 10a and 12a are made of an HTV silicone with a higher Shore hardness than the HTV silicone of the remaining HTV silicone bodies 10, 12. This allows the resistance and therefore the service life of HTV silicone body laminate 16 to be increased, while at the same time ensuring sufficient flexibility through the thinner or...The softer inner layers of the HTV silicone body laminate 16 are achieved. Furthermore, it is shown that reinforcing fabric 18 is embedded essentially over the entire surface between the outer HTV silicone bodies 10a and 12a and the respective adjacent inner HTV silicone bodies 10, 12. The arrangement of the reinforcing fabric 18 is purely exemplary and not limited to this. For example, only one reinforcing fabric 18 may be provided, which is preferably arranged centrally between the first and second HTV silicone bodies 10, 10a, 12, 12a. In addition, depending on the application, further or alternative reinforcing bodies (not shown) may also be incorporated.

[0074] For clarity, the individual HTV silicone bodies 10, 10a, 12, 12a of the HTV silicone body laminate 16 shown in Figure 5 are not yet bonded together with a silicone adhesive. After bonding, the HTV silicone body laminate 16 assumes a central position between the movement positions of the respective first and second HTV silicone bodies 10, 10a, 12, 12a, i.e., approximately the central position of the positive form 14 of the finger in its central position shown in Figure 4.

[0075] Creating the negative mold

[0076] 1. A digital 3D model of the patient's healthy body part is created. This can be done by directly scanning the skin, or by taking a silicone or alginate impression and creating a full-body model from it. Other methods, such as freehand modeling in clay or modeling compound, 3D modeling, and 3D printing, can also be used. A negative mold is then created, for example, by 3D printing or by making negative molds with silicone, fiber-reinforced composites, plaster, or similar mold-making materials.

[0077] Pouring

[0078] 1. HTV silicone can be thinned to any available Shore hardness.

[0079] 2. Components A and B can be prepared separately (but can also be diluted as a complete mixture). The following list refers to only one of the two components; these steps are repeated identically for the other component.

[0080] 3. Place 1 part of the HTV silicone in a container with, for example, 4.5 parts of a suitable solvent such as hexamethyldisiloxane, octamethyltrisiloxane, cold cleaner, heptane, or hydrocarbons C6-C7, N-alkanes, iso-alkanes, cyclic compounds, or N-hexanes (e.g., white spirit). 4. Allow the silicone to expand.

[0081] 5. Alternatively, the HTV can be coarsely crushed beforehand to increase the surface area and accelerate the swelling process.

[0082] 6. After at least 30 minutes or at least 1-2 hours, the still viscous silicone mixture can be slowly mixed with the remaining solvent. Machine mixers are suitable for this.

[0083] 7. The diluted silicone mixture can also be filtered and deaerated under vacuum.

[0084] 8. For processing, both mixtures are now mixed together in equal proportions by weight, alternatively colored and deaerated.

[0085] 9. Next, the negative mold is pretreated with a suitable release agent, filled with the HTV silicone mixture and swirled around so that the walls are evenly coated; the excess is poured off.

[0086] 10. The mold is now hung at room temperature for approximately 15-45 minutes to allow the solvent contained in the HTV to evaporate.

[0087] 11. Steps 9 and 10 can be repeated as often as necessary until the desired wall thickness is achieved.

[0088] 12. Alternatively, steps 9 and 10 can be combined as desired with diluted HTV mixtures of different Shore hardness or color.

[0089] 13. In the final step, the molds are tempered in the oven according to the manufacturer's instructions for HTV silicone.

[0090] Production of prosthetic gloves using silicone laminates

[0091] Due to the constant mechanical stress on prosthetic gloves, the silicone increasingly tears at frequently moving points, such as the finger joints. To improve the durability of these areas and thus extend the lifespan of the prosthetic gloves, the gloves are not manufactured in one piece, but from different laminate layers.

[0092] Two negative molds are made from the same model, as described in the procedure above. In one mold, the fingers, thumbs, and knuckles are positioned in a bent position, and a negative mold is created from this. For the second mold, the fingers are positioned straight, and a negative mold is also created from this.

[0093] The angles of the individual positions can vary depending on the requirements.

[0094] The molds are poured as described above, however, the desired final thickness of the laminate is divided between both molds. After the HTV silicone has vulcanized, both parts are demolded and cleaned. The silicone parts, each half the thickness of the laminate, are then joined together on a positive model, where the fingers, thumbs, and knuckles are positioned in the center, based on the two negative molds.

[0095] This positive model is manufactured separately from 3D printing materials or other materials such as silicone, plaster, or similar. Bonding to this model is preferably done using silicone adhesive.

[0096] After the silicone adhesive has vulcanized, the prosthetic glove can be demolded, leaving the fingers, thumb, and knuckles in their neutral position. This reduces the stress exerted on the silicone by movement, thus delaying premature tearing.

[0097] This principle can be extended to a laminate structure with several different positions of the fingers, thumb and knuckles, and is applicable to the entire model hand, individual fingers and parts of the model hand.

[0098] It is possible to insert and reinforce the silicone parts by means of a suitable reinforcing fabric between the layers of the laminate.

[0099] This manufacturing process can also be used for the production of silicone coverings for prosthetic feet and prostheses / epitheses for other body regions.

[0100] Other aspects:

[0101] 1. Aspect: A process for producing an HTV silicone-containing solution comprising the step of dissolving HTV silicone in a solvent, wherein the solvent is preferably volatile; preferably the solvent is selected from hexamethyldisiloxane, octamethyltrisiloxane, cold cleaner, heptane or hydrocarbons C6-C7, N-alkanes, iso-alkanes, cyclic compounds, N-hexanes (e.g., white spirit); preferably the two components of the HTV silicone are dissolved separately and then transferred into a common solution, or both components of the HTV silicone are dissolved together in a solvent mixture; preferably the HTV silicone to be dissolved (or the components thereof) is pre-swelled in the solvent for a suitable period of time before the working strength of the solution is adjusted; optionally, the HTV silicone-containing solution can be provided with further components such as color pigments.

[0102] 2. Aspect HTV silicone-containing solution producible according to a process according to aspect 1.

[0103] 3. Aspect: Method for producing an HTV silicone body for a prosthesis or part thereof, or for a coating for a prosthesis or part thereof, wherein the method comprises pivoting out a negative mold of the prosthesis or part thereof, wherein a fluid containing or consisting of an HTV silicone-containing solution according to Aspect 2 is used for pivoting; preferably the negative mold is pretreated with a release agent before pivoting.

[0104] 4. Aspect procedure according to aspect 3, wherein after rinsing out the excess fluid or HTV silicone-containing solution is discarded.

[0105] 5. Aspect: Procedure according to one of aspects 3 or 4, wherein the swung-out negative mold is stored until the solvent contained in the HTV silicone-containing solution is substantially removed.

[0106] 6. Aspect procedure according to aspect 5, wherein the steps of swishing and subsequent removal of the solvent are repeated to form a multilayer HTV silicone body of the prosthesis or part thereof or of the coating for the prosthesis or part thereof.

[0107] 7. Aspect: Procedure according to one of aspects 3 to 6, wherein the obtained HTV silicone body is tempered or vulcanized.

[0108] 8. Aspect: Method according to one of aspects 3 to 7, wherein different HTV silicone-containing solutions are used, preferably HTV silicone-containing solutions with HTV silicones of different Shore hardness are used and / or HTV silicone-containing solutions mixed with different color pigments are used.

[0109] 9. Aspect: Method for manufacturing an HTV silicone body laminate for a prosthesis or part thereof or for a covering for a prosthesis or part thereof, wherein the method comprises the following steps:

[0110] - Provision of at least two negative molds of the body part or part thereof to be replaced, wherein the two negative molds differ in the spatial representation of the body part or part thereof to be replaced (for example, a finger in extended and bent positions); - Production of at least one HTV silicone body for each of the two negative molds, wherein each of the at least two HTV silicone bodies is produced according to a method according to one of aspects 3 to 8;

[0111] - Joining the at least two HTV silicone bodies to form an HTV silicone body laminate; preferably, the joining can be carried out by using a positive model of the prosthesis or a part thereof or of the body part to be replaced, wherein the positive model is preferably positioned in a central position between the two different versions of the at least two negative forms.

[0112] 10. Aspect: Method according to aspect 9, wherein a silicone adhesive is used to join the at least two HTV silicone bodies to form an HTV silicone body laminate.

[0113] 11. Aspect: Procedure according to one of aspects 3 to 10, wherein the negative form and / or the positive model has been produced using 3D printing.

[0114] 12. Aspect HTV silicone body for a prosthesis or part thereof or for a covering for a prosthesis or part thereof, HTV silicone-containing prosthesis or part thereof or an HTV silicone-containing covering for a prosthesis or part thereof, each manufacturable according to a process according to one of aspects 3 to 8 or 11.

[0115] 13. Aspect HTV silicone body laminate for a prosthesis or part thereof or for a covering for a prosthesis or part thereof, each manufacturable according to a process according to one of aspects 9 to 11.

[0116] 14. Aspect HTV silicone body laminate according to aspect 13, wherein different layers of the laminate have HTV silicones of different Shore hardnesses.

[0117] 15. Aspect HTV silicone body according to aspect 12 or HTV silicone body laminate according to aspect 13 or 14, wherein reinforcing bodies or reinforcing fabrics are incorporated between the layers of the silicone body or between the laminate layers of the HTV silicone body laminate.

[0118] 16. Aspect: Prosthesis, part of a prosthesis or covering for a prosthesis or part thereof, comprising an HTV silicone body according to one of aspects 12 and 15 or an HTV silicone body laminate according to one of aspects 13 to 15. Reference list

[0119] 10, 10a first HTV silicone bodies

[0120] 12, 12a second HTV silicone body

[0121] 14 Positive form

[0122] 16 HTV silicone body laminate

[0123] 18 Reinforcing fabrics

[0124] The first layer thickness

[0125] D2 second layer thickness

[0126] 50 First process step - Dissolving HTV silicone

[0127] 52 Second process step - Providing negative / positive forms

[0128] 54 Third process step - Swinging out the negative mold

[0129] 56 Fourth process step - Pouring over the positive mold

[0130] 58 fifth process step - Production of HTV silicone bodies

[0131] 60 sixth optional process step - incorporation of reinforcing fabric

[0132] 62 Seventh process step - Vulcanizing the HTV silicone body

[0133] 64 Eighth process step - Joining the HTV silicone bodies

[0134] 100 methods for producing an HTV silicone-containing solution

[0135] 200 methods for producing an HTV silicone body

[0136] 300 processes for manufacturing an HTV silicone body laminate

Claims

Patent claims 1. Method (100) for producing an HTV silicone-containing solution comprising the step of dissolving (50) HTV silicone in a solvent.

2. HTV silicone-containing solution producible according to a method according to claim 1.

3. Method (200) for manufacturing an HTV silicone body (10, 10a, 12, 12a) for a prosthesis or for a covering for a prosthesis, the method comprising the steps: Swinging out (54) a negative form of the prosthesis or a negative form of the covering or Pouring (56) and / or immersing a positive form (14) of the prosthesis or a positive form (14) of the covering, wherein a fluid containing or consisting of an HTV silicone-containing solution according to claim 2 is used for the sweeping or pouring and / or immersion.

4. Method according to claim 3, wherein after swiveling or pouring, the excess fluid or HTV silicone-containing solution is discarded.

5. Method according to one of claims 3 or 4, wherein the swung-out negative mold or the poured positive mold (14) is stored until the solvent contained in the HTV silicone-containing solution is substantially removed.

6. Method according to claim 5, wherein the steps of swiveling or pouring and subsequent removal of the solvent are repeated to form a multilayer HTV silicone body (10, 10a, 12, 12a) of the prosthesis or the coating for the prosthesis.

7. Method according to any one of claims 3 to 6, wherein different HTV silicone-containing solutions are used, preferably HTV silicone-containing solutions with HTV silicones of different Shore hardness are used and / or HTV silicone-containing solutions mixed with different color pigments are used.

8. Method (300) for producing an HTV silicone body laminate (16) for a prosthesis or a covering for a prosthesis, the method comprising the following steps: Providing (52) at least two negative forms and / or positive forms (14) of a body part to be replaced, wherein the two negative forms and / or positive forms (14) differ in their spatial expression with respect to a movement position of the body part to be replaced; (58) producing at least one HTV silicone body (10, 10a, 12, 12a) for each of the two negative molds and / or positive molds (14), wherein at least one of the at least two HTV silicone bodies (10, 10a, 12, 12a) is produced according to a method according to any one of claims 3 to 7; Connect (64) the at least two HTV silicone bodies (10, 10a, 12, 12a) to form an HTV silicone body laminate (16).

9. Method according to claim 8, wherein a silicone adhesive is used for joining the at least two HTV silicone bodies (10, 10a, 12, 12a) to form an HTV silicone body laminate (16).

10. Method according to any one of claims 3 to 9, wherein the negative mold and / or the positive mold (14) has been produced by means of a 3D printing process.

11. HTV silicone bodies (10, 10a, 12, 12a) for a prosthesis or a covering for a prosthesis can be produced according to a method according to one of claims 3 to 7 or 10.

12. HTV silicone body laminate (16) for a prosthesis or for a covering for a prosthesis can be produced according to a method according to any one of claims 8 to 10.

13. HTV silicone body laminate (16) according to claim 12, wherein at least two layers of the laminate (16) comprise HTV silicones that differ in Shore hardness and / or layer thickness.

14. HTV silicone body (10, 10a, 12, 12a) according to claim 11 or HTV silicone body laminate (16) according to claim 12 or 13, wherein reinforcing bodies and / or reinforcing fabrics (18) are incorporated on and / or between the layers of the silicone body or between the laminate layers of the HTV silicone body laminate (16).

15. Prosthesis or covering for a prosthesis comprising an HTV silicone body (10, 10a, 12, 12a) according to one of claims 11 and 14 and / or an HTV silicone body laminate (16) according to one of claims 12 to 14.

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