Method for producing a multi-layer HTV silicone body, method for producing a multi-layer silicone liner, multi-layer HTV silicone body, multi-layer silicone liner, and system for sensory feedback
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SILICORE GMBH
- Filing Date
- 2026-01-27
- Publication Date
- 2026-07-30
Smart Images
Figure EP2026051954_30072026_PF_FP_ABST
Abstract
Description
[0001] Description
[0002] Method for manufacturing a multilayer HTV silicone body, method for manufacturing a multilayer silicone liner, multilayer HTV silicone body, multilayer silicone liner and sensory feedback system
[0003] The invention relates to a method for producing a multilayer HTV silicone body and a multilayer HTV silicone body produced therefrom, as well as a method for producing a multilayer silicone liner and a multilayer silicone liner produced therefrom. Furthermore, the invention relates to a system for sensory feedback.
[0004] When a person receives care following an amputation, the specific circumstances and needs of the individual are taken into account. Prostheses are commonly used to replace or restore missing or impaired body parts. To create a prosthesis, a rough blank is initially produced, which is then gradually and individually adapted to the shape and form of the affected body part by an orthotist. The patient often visits the orthotist several times to fine-tune the custom-made prosthesis.
[0005] When 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 strength. 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] However, even the most lifelike prosthesis cannot replace the sensory abilities of the missing or impaired body part. Due to the high minimum wall thickness of the rolled HTV silicone, it is difficult to detect measurement signals from physical quantities acting on the outside of the prosthesis, such as force, pressure, temperature, or the like, through the rolled HTV silicone to the inside of the prosthesis using appropriate sensors. Externally placed sensors would significantly impair the lifelike appearance of the prosthesis. Therefore, a prosthesis wearer will always be aware that the prosthesis is a foreign object, which reduces its acceptance by the wearer.Increased acceptance of the prosthesis by its user is desirable not only to improve the user's overall well-being, but also to better cope with the trauma associated with the loss or impairment of the limb. Furthermore, prosthesis users increasingly report experiencing phantom pain. It is believed that phantom pain results from complex processes in the user's brain, caused by the lack of stimulation of the relevant brain regions due to the absence of sensory signals from the missing or impaired limb.
[0009] Therefore, it would be desirable to produce (lifelike) silicone prostheses that can at least partially replace the sensory abilities of the missing or impaired body part, particularly to reduce the occurrence of phantom pain. The invention is thus based on the objective of creating a prosthesis for a missing or impaired body part with improved functionality, which increases the acceptance and well-being of its wearer.
[0010] The problem according to the invention is solved by a method for producing a multilayer HTV silicone body for a prosthesis or a covering of the prosthesis and a multilayer HTV silicone body produced therefrom, a method for producing a multilayer silicone liner and a multilayer silicone liner produced therefrom, and a system for sensory feedback comprising the multilayer HTV silicone body and the multilayer silicone liner according to the independent claims. Preferred embodiments are the subject of the respective dependent claims.
[0011] A first aspect relates to a method for producing a multilayered HTV (high-temperature curing) silicone body for a prosthesis or a covering for the prosthesis, particularly for an exoprosthesis. According to the present disclosure, the term "prosthesis" preferably includes the complete prosthesis or only a part thereof. The term "covering" preferably includes the complete covering or only a part thereof. In other words, the method is a method for producing a multilayered 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 its covering, serves in particular to replace a missing or impaired body part, especially an external body part such as an extremity, for example, a finger, hand, arm, leg, foot, ear, and the like, or even just a part thereof, for example, a partial hand or foot. In other words, the prosthesis is preferably an exoprosthesis. An exoprosthesis is an artificial aid that is worn by the user outside the body or on the outside of the body and serves to replace a missing or impaired external body part, such as an extremity, for example, a finger, hand, arm, leg, foot, ear, and the like, or even just a part thereof, for example, a partial hand or foot.An exoprosthesis is designed to mimic or replace the function and / or aesthetics of a missing or limited body part. Unlike an implant, which replaces an internal body part within the body, an exoprosthesis must withstand external environmental influences and offer a high degree of freedom of movement and flexibility to allow the natural range of motion of the replaced body part. Furthermore, the comfort and lifelike appearance of the exoprosthesis play a crucial role in increasing user acceptance. A low weight is also advantageous for improving user acceptance. The process involves producing an initial HTV silicone layer (of the multilayered HTV silicone body) based on an HTV silicone-containing solution and a mold of the prosthesis or covering. The HTV silicone in the HTV silicone-containing solution is dissolved in a solvent.In other words, a diluted HTV silicone, i.e., a solid silicone rubber normally processed as a solid, is used and processed as a fluid or solution in a liquid or flowable state. It has been found that processing HTV silicone as a solution simplifies the processing of the HTV silicone without altering or losing the (desired) mechanical properties of the vulcanized end product. Therefore, it has been recognized that, in particular, the liquefaction of HTV silicones enables their use in areas that were previously inaccessible to HTV silicones due to their solid-state properties, and which were thus previously reserved 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 not considered HTV silicone and are therefore explicitly excluded. Paste-like HTV silicones are more expensive than LSR silicones, so in applications using liquid silicones, LSR silicones are automatically chosen in the industry. Furthermore, the volume of the HTV silicone-containing solution increases up to threefold when the HTV silicone is dissolved. Until now, it has been avoided in the industry to dissolve paste-like 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.By using the HTV silicone-containing solution, HTV silicone layers can be produced with layer thicknesses (wall thicknesses) that are significantly less than those achievable with conventional solid-state processing steps for HTV silicones. 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).
[0012] Furthermore, at least one sensor unit designed to detect temperature and / or pressure is arranged on the first HTV silicone layer (of the multilayer HTV silicone body).Examples of the sensor unit include electronic components such as temperature-sensitive electrical / electronic / thermoelectric components, for example, temperature-dependent electrical resistors, Seebeck-effect-based components, or platinum or NTC (Negative Temperature Coefficient Thermistor) semiconductor temperature sensors that are excited by a measuring current and whose electrical resistance depends predictably on the applied temperature; and pressure-sensitive electrical / electronic components, for example, pressure-dependent electrical resistors, piezoelectric-effect-based components, or silicone-based, elastically deformable resistors between two electrical contacts on flexible conductor tracks that change their electrical resistance predictably under pressure. A measuring area of the sensor unit preferably comprises an area of 1 cm². 2 up to 10 cm 2 , preferably 2 cm 2 up to 8 cm 2, especially preferred 4 cm 2 up to 6 cm 2 , for example 5 cm 2Exemplary orders of magnitude for detectable pressures are preferably in the range of 100 g (0.1 N) to 5 kg (5 N) in the case of a hand prosthesis. Exemplary orders of magnitude for detectable temperatures are in the range of 0 °C to 50 °C. It is understood that the present disclosure is not limited to the aforementioned orders of magnitude and that the detectable parameters may be in other orders of magnitude, particularly depending on the body part to be replaced by the prosthesis. Preferably, a plurality of sensor units designed to detect temperature and / or pressure are distributed across the first HTV silicone layer. In other words, the number and location of the sensor units can be individually tailored to the specific prosthesis in order to cover the relevant areas of the prosthesis with the sensor units.The use of multiple sensor units therefore enables the (location-selective) detection of temperatures and / or pressures relating to different (local) areas of the multilayer HTV silicone body.
[0013] In a further step of the process, a second HTV silicone layer (of the multilayered HTV silicone body) is produced on the sensor unit and the first HTV silicone layer, based on the HTV silicone-containing solution. In other words, the sensor unit is embedded between the first and second HTV silicone layers. Consequently, a multilayered HTV silicone body for the prosthesis or the prosthesis coating is formed. The multilayered structure makes it possible to position electronic components and other parts between the HTV silicone layers and conceal or shield them from the outside. This ensures that the sensor unit is concealed, protected, and positioned close enough to the outer surface of the silicone body to provide high-quality measurement signals of temperatures and / or pressures acting on the prosthesis's surface.This results in the production of a lifelike silicone prosthesis that can at least partially replace the sensory capabilities of the missing or impaired body part, at least with regard to temperature and / or pressure. Furthermore, multi-layered HTV silicone bodies can be designed with greater variability in their properties. For example, the thickness and / or material of the individual layers can be varied, and / or different materials—in addition to the sensor unit—can be inserted or embedded between the layers.
[0014] Preferably, different HTV silicone-containing solutions are used, particularly for forming the various HTV silicone 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 HTV silicone layers of the multilayer HTV silicone body is selected such that the mechanical properties of these HTV silicone layers, i.e., the outer layers of the multilayer HTV silicone body, differ from the mechanical properties of the remaining layers of the multilayer HTV silicone body, i.e., the inner layers of the multilayer HTV silicone body.Preferably, one or both of the outer layers of the multilayer HTV silicone body are made of an HTV silicone with a higher Shore hardness and / or a greater layer thickness. This increases the resistance and thus the service life of the multilayer HTV silicone body, while simultaneously ensuring sufficient flexibility through the thinner or softer inner layers.
[0015] Preferably, the prosthesis or covering is manufactured using a 3D printing process or an impression. According to the first alternative, 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. Preferably, the digital 3D image is mirrored to utilize the chirality of paired body parts for the purpose of shaping the form. This avoids a complex design process.Furthermore, a customized prosthesis is created that mimics the patient's own body, which can provide psychological support, especially in cases of recent (partial) amputation. The digital 3D image is preferably transferred into the physical form using a 3D printer. Preferably, the digital 3D image is first individually adapted to the patient's wishes. According to the second alternative, the form is preferably created using a silicone or alginate mold and a full-body model produced from it. Other methods, such as freehand modeling in clay or modeling compound, are also preferred.
[0016] 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. A preferred solvent is hexamethyldisiloxane. 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 2.5 parts HTV silicone. 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 thicknesses of the HTV silicone layers will then be very thin. The wall thickness of the manufactured multilayer HTV silicone body can therefore be varied depending on the properties of the chosen HTV silicone-containing solution.Due to the reduced wall thickness of the manufactured multi-layered HTV silicone body, greater flexibility and a lower weight of the subsequent prosthesis are achieved.
[0017] The solvent 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 an HTV silicone layer.
[0018] 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 are particularly suitable solvents for HTV silicones, offering especially good solubility. Preferably, the solvent is a siloxane. 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 cross-linked siloxanes, such as silicone resins or silicone elastomers, are preferred. Siloxanes are considered to be relatively chemically inert solvents when used properly.Due to their inertness, 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 facilitated by using a siloxane as a solvent. The solvent is preferably nonpolar. A solvent polarity below 0.5 Debye is preferred, preferably below 0.4 Debye, 0.3 Debye, 0.2 Debye, or 0.1 Debye, and particularly preferably below 0.05 Debye. The aforementioned solvents 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 themselves 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 hardly react 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.
[0019] 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.
[0020] 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.
[0021] Preferably, the HTV silicone-containing solution is combined with other components, such as color pigments. This allows for easier 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. 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] In a preferred embodiment, the form of the prosthesis or coating comprises a negative and / or positive mold of the prosthesis or coating. Preferably, in the manufacturing step of the first HTV silicone layer, the HTV silicone-containing solution is swept out of the negative mold of the prosthesis or the negative mold of the coating, or a positive mold of the prosthesis or a positive mold of the coating is poured over and / or immersed in the HTV silicone-containing solution. For swept out, pouring over, and / or immersion, a fluid containing or consisting of the aforementioned HTV silicone-containing solution is used. By swept out, pouring over, and / or immersing a mold with the HTV silicone-containing solution, the HTV silicone-containing solution is applied to the prosthesis or coating.Using an HTV silicone-containing solution, HTV silicone bodies with wall thicknesses far exceeding those achievable with conventional solid-state processing methods can be produced. Consequently, multilayered HTV silicone bodies with lifelike structures can be manufactured easily and cost-effectively. This allows for the production of prostheses and denture coverings that are individually tailored to each patient, visually superior to conventional alternatives, and significantly thinner. The use of negative and positive molds reduces the production time for each subsequent prosthesis (i.e., each subsequent fitting for the patient) by approximately 70%. Furthermore, this process is reliable and not (significantly) dependent on the skill or daily condition of the person manufacturing the prosthesis.Preferably, at least one, some, or all of the manufacturing steps for the HTV silicone layers are carried out using a negative and / or positive mold of the prosthesis or coating. For example, to form the second silicone layer, the HTV silicone-containing solution is preferably swished around in the first HTV silicone layer, which is still in the negative mold, or the first HTV silicone layer, which is still on the positive mold, is poured with the HTV silicone-containing solution, and / or the first HTV silicone layer, which is still on the positive mold, is immersed in the HTV silicone-containing solution. Because the first HTV silicone layer remains in or on the respective mold, it retains its shape when the second HTV silicone layer is applied to it.Preferably, the negative mold is pretreated with a release agent before being swept out, or the positive mold is pretreated with a release agent before being poured and / or immersed. This simplifies the removal or demolding of the HTV silicone body from the respective mold.
[0023] In a further preferred embodiment, the first HTV silicone layer and the second HTV silicone layer arranged on it, along with the sensor unit positioned between them, are vulcanized under heat. In other words, the first and second HTV silicone layers are vulcanized in a single process step, i.e., in a combined state. Through vulcanization, the HTV silicone acquires its (desired) mechanical properties in the (vulcanized) final product. Furthermore, the two HTV silicone layers, present in the combined state, bond together during vulcanization, forming a multilayered HTV silicone body with a sensor unit reliably embedded between the HTV silicone layers.Preferably, the multilayer HTV silicone body is annealed in an oven according to the manufacturer's instructions for the selected HTV silicone to initiate the vulcanization process. For example, the multilayer HTV silicone body is annealed at 90 °C for two hours.
[0024] In a further preferred embodiment, the production of the second HTV silicone layer is carried out using an additional mold that corresponds to a shape of the prosthesis or coating adapted by one layer thickness of the first HTV silicone layer. In other words, the additional mold is reduced by the layer thickness of the first HTV silicone layer in the case of a negative mold, or extended by the layer thickness of the first HTV silicone layer in the case of a positive mold. Preferably, the first HTV silicone layer, together with the sensor unit arranged on it and the separate second HTV silicone layer, is vulcanized under heat. In other words, the first HTV silicone layer and the second HTV silicone layer are vulcanized in a separate state.To form the multilayer HTV silicone body, the vulcanized first HTV silicone layer and the vulcanized second HTV silicone layer are preferably bonded together using a silicone adhesive. This design has the advantage that access to the respective inner surfaces of the first and second HTV silicone layers, which face each other, is still possible even in the vulcanized state. This allows, for example, for rework and / or for embedding additional components between the first and second HTV silicone layers, such as temperature-sensitive materials or components that would be damaged by the heat input during the vulcanization step. The further shape is preferably analogous to the shape described above. Therefore, a repeated description of the features is omitted.
[0025] In a further preferred embodiment, an electrical conductor for connecting the sensor unit to an interface is arranged on the first HTV silicone layer, the electrical conductor preferably running at least partially in a meandering pattern between the sensor unit and the interface. An electrical conductor is a linear electrical conductor for transporting electrical energy or for signal transmission in wired communications and high-frequency technology. In other words, the electrical conductor serves, in particular, the purpose of transmitting the measurement signals acquired by the sensor unit to an evaluation and / or control unit, for example, via the interface mentioned above. Preferably, the multilayer HTV silicone body includes an interface configured to provide a temperature and / or pressure detected by the sensor unit.Preferably, the electrical conductor is arranged on the first HTV silicone layer before the second HTV silicone layer is produced. Because the electrical conductor runs at least partially in a meandering pattern, improved flexibility of the multilayer HTV silicone body is achieved in the meandering area. Preferably, the electrical conductor has a meandering course in the intended movement and bending areas of the prosthesis or the prosthesis covering. Preferably, the electrical conductor is meandering for at least 10 percent, preferably at least 25 percent, and particularly preferably at least 50 percent of the distance between the sensor unit and the evaluation or control unit or the interface. For example, the electrical conductor is designed as a copper trace. However, the present disclosure is not limited to copper. Rather, all electrically conductive materials can be used.In a further preferred embodiment, at least one second sensor unit designed to detect temperature and / or pressure is arranged on the second HTV silicone layer (of the multilayer HTV silicone body), and a third HTV silicone layer is produced on top of the second sensor unit and the second HTV silicone layer based on the HTV silicone-containing solution. In other words, a multilayer HTV silicone body with a plurality of sensor units between the different HTV silicone layers (at least three HTV silicone layers) is constructed. This enables depth-selective detection of temperature and / or pressure on the outside of the prosthesis.In the case where only the outermost sensor unit detects a signal, while the deeper sensor unit does not, it can be concluded that the measured temperature and / or pressure on the outside of the prosthesis is comparatively low compared to when both sensor units detect signals. Consequently, the presence or absence of signals between the different sensor units alone provides an initial indication, without requiring a detailed analysis of the signals. This facilitates the evaluation and interpretation of the measurement signals.It is understandable that the number of HTV silicone layers and the number of sensor units between the different HTV silicone layers can preferably be chosen depending on a desired overall wall thickness and a desired measurement sensitivity of the multilayer HTV silicone body to be produced.
[0026] In a further preferred embodiment, the multilayered HTV silicone body is manufactured with a total thickness of 0.15 mm to 1.5 mm. In other words, the total wall thickness of the multilayered HTV silicone body, for example, the distance between the opposing outer surfaces of the multilayered HTV silicone body, is preferably at least 0.15 mm, more preferably at least 0.25 mm, more preferably at least 0.5 mm and / or at most 1.5 mm, more preferably at most 1.25 mm, and more preferably at most 1 mm. For example, the total wall thickness of the HTV silicone body can be 0.8 mm. Conventionally manufactured prostheses made of HTV silicone usually require a surface with a "modulating thickness," i.e., a total wall thickness, of at least 1.5 mm, 2 mm, or sometimes up to 5 mm, in order to be able to manually incorporate fine surface structures into the individual prosthesis.The comparatively thick walls of conventionally manufactured HTV silicone bodies have the disadvantage of being bulky and inflexible, and can sometimes impair or even damage the mechanisms of the prosthetic hands. Furthermore, the prosthesis is relatively heavy, reducing patient comfort. As previously mentioned, acquiring measurement signals through such thick walls is also difficult.
[0027] Another aspect concerns a process for manufacturing a multi-layered silicone liner. A (silicone) liner forms the connection between the residual limb and a worn prosthesis. The liner is pulled or rolled over the residual limb before the prosthesis is put on. A liner's primary purpose is to increase the comfort of the prosthesis, for example, by protecting the residual limb from pressure sores, heat, and moisture, distributing loads evenly, and providing cushioning under high pressure.
[0028] In one step, a positive mold of the stump of a body part to be replaced is provided. The positive mold is preferably produced analogously to the mold production process described above. Therefore, a repeated description of the features is omitted.
[0029] Furthermore, at least one actuator unit, configured to generate temperature and / or pressure, is arranged between the positive mold and a first silicone layer, the first silicone layer having an opening that partially exposes the actuator unit. The first silicone layer is preferably a (thin) layer of (rolled) HTV silicone with a medium Shore hardness. A medium Shore hardness is preferably in the range of at least Shore 20 to Shore 50, more preferably at least Shore 30 to Shore 40, and particularly preferably Shore 35, as measured according to DIN ISO 48-4. For example, the actuator unit is (provisionally) fixed to the positive mold, and the first silicone layer is applied to the actuator unit and at least partially to the positive mold. Preferably, the opening that partially exposes the actuator unit is then cut out of the first silicone layer.In a preferred alternative embodiment, the opening is contained within the first silicone layer before it is placed on the actuator unit and at least partially on the positive mold. Accordingly, the first silicone layer must be positioned such that the opening at least partially overlaps the actuator unit. The opening is preferably smaller than the actuator unit. This ensures that the actuator unit is not completely exposed, as it would otherwise be held to the positive mold by the first silicone layer. Preferably, the first silicone layer is wrapped around the positive mold at least once. This improves the stability of the silicone liner and ensures a proper fit (of the silicone liner) on the butt. In a further step, a conductor is guided through the opening in the first silicone layer to connect the conductor to the actuator unit.The purpose of the cable is to connect the actuator unit through the opening to another component, for example, a component for controlling the actuator unit. Examples of such a cable include a silicone tube for conveying a fluid and an electrical cable for conveying an electronic control signal. Depending on the design, the cable is preferably fixed to the actuator unit or coupled to it.
[0030] Furthermore, a second silicone layer made of a different silicone is applied to the side of the first silicone layer facing away from the positive mold. The second silicone layer at least partially covers the opening of the first silicone layer and the conduit. Preferably, the second silicone layer almost completely covers the opening and the first silicone layer. The second silicone layer also has a higher Shore hardness than the first silicone layer. Preferably, the second silicone layer is a (rolled) HTV silicone layer with a high Shore hardness. A high Shore hardness is preferably in the range of at least Shore 50 to Shore 100, preferably at least Shore 60 to Shore 80, and particularly preferably Shore 65, as measured according to DIN ISO 48-4. Due to its higher Shore hardness compared to the first silicone layer, the second silicone layer provides better protection against external influences on the silicone liner. Preferably, the second silicone layer forms the outer layer of the silicone liner.
[0031] In a further process step, the first silicone layer and the second silicone layer, along with the interposed conductor, are vulcanized under heat. In other words, the first and second silicone layers are vulcanized in a single process step, i.e., in a combined state. Preferably, the multilayer silicone liner is annealed in an oven according to the manufacturer's instructions for the selected silicone to initiate the vulcanization process. For example, the silicone liner is annealed at 90 °C for two hours. Through vulcanization, the silicone acquires its (desired) mechanical properties in the (vulcanized) final product.Furthermore, the two silicone layers present in the combined state bond together during vulcanization, so that a multi-layered silicone liner is formed with an actuator unit and conductor reliably embedded between the silicone layers.
[0032] The silicone liner according to the invention, when worn on the stump, is therefore able, by means of the actuator unit, to generate a temperature and / or pressure on the stump surface that is perceptible to the wearer of the silicone liner. It is assumed that the occurrence of phantom pain can be prevented or at least reduced by replacing the lack of stimulation of the relevant brain areas due to the absence of sensory signals from the missing or impaired body part, which presumably leads to the phantom pain, with stimulation of the stump to generate temperature- and / or pressure-based sensory signals. Thus, the silicone liner's ability to generate temperature and / or pressure on the wearer's stump can counteract the complex processes in the wearer's brain that lead to phantom pain and improve the wearer's well-being.In particular, when combined with the multilayer HTV silicone body mentioned herein for the sensory detection of temperatures and / or pressures on the prosthesis, the measured signals thus acquired can be used to control the actuator unit of the silicone liner. Preferably, the multilayer silicone liner includes an interface configured to receive sensor-detected temperatures and / or pressures on the prosthesis—i.e., provided temperature and / or pressure parameters—and transmit them to the actuator unit for control. This allows the prosthesis wearer to perceive the temperature and / or pressure applied to the prosthesis at the residual limb via the actuator unit of the silicone liner. After an adaptation period, the wearer's brain is able to associate the actuator unit acting on the residual limb with stimulus signals from the prosthesis. Consequently, the functionality of the prosthesis is enhanced.Furthermore, the prosthesis is perceived less as a foreign object by the wearer, thus increasing the wearer's acceptance of the prosthesis. It is understandable that the actuator unit, or a multitude of actuator units, can be distributed (arbitrarily) within the corresponding areas of the silicone liner to provide the wearer with spatially resolved feedback regarding temperature and / or pressure. Preferably, the actuator unit comprises pressure-generating actuators, such as piezoelectric actuators with mechanical transmission (e.g., gears), variable-volume pressure vessels and pressure pads, and / or temperature-generating actuators, i.e., cooling and / or heating actuators, such as heating wires and / or cooling / heating circuits connected to a heat exchanger.
[0033] In a preferred embodiment, the actuator unit comprises a pressure pad which includes a fabric embedded in a third silicone. The third silicone preferably has a lower Shore hardness than the first silicone. Preferably, the third silicone is an addition-curing RTV silicone with a low Shore hardness. A low Shore hardness is preferably in the range of at least Shore 0020 to Shore A2, as measured according to DIN ISO 48-4. Preferably, the third silicone is poured onto a smooth surface, the fabric is placed inside, and the third silicone is spread over the fabric. The fabric preferably includes a stretchable reinforcing fabric. The stretchable reinforcing fabric improves the pressure-generating properties of the pressure pad.After the third silicone layer has been vulcanized, the pressure pad, for example as a round or rectangular disc, can be cut or punched out from the vulcanized product and positioned on the positive mold for temporary fixation. Due to the low Shore hardness of the third silicone, it is sufficiently soft to form an inflatable pressure chamber in the opening of the first silicone layer, between the third and second silicone layers. The pressure chamber can be filled and emptied via the line with fluids to generate the pressure felt by the wearer of the silicone liner.
[0034] In a further preferred embodiment, the tube is a silicone hose. The silicone hose includes a fabric covering at the end coupled to the actuator unit. The fabric covering is preferably a felt fabric. The use of the fabric covering improves the fluid distribution into the pressure pad. Preferably, the tube is provided with the fabric covering before being inserted into the opening, which simplifies the production of the silicone liner. In a further preferred embodiment, the tube includes an end that is free of the first silicone layer and / or the second silicone layer for coupling to a control unit. The free end is opposite the end coupled to the actuator unit. In other words, at least one end of the tube protrudes laterally from the silicone liner between the first and second silicone layers. The free end is preferably connected to a control unit.The control unit is preferably configured to control the actuator unit, for example by means of electronic control signals and / or by means of movement of a fluid in the line, for example to generate pressure and / or to transport heat (or cold) to the actuator unit.
[0035] In a further preferred embodiment, prior to vulcanizing the first and second silicone layers with the intervening conduit, one end of a cuff is incorporated into the first and / or second silicone layer. The cuff is preferably a fiber-based covering, for example, made of textiles, preferably natural fibers such as cotton, and / or synthetic fibers such as nylon (chemical name: polyhexamethylene adipamide), which is pulled over the intact body part beyond the stump. Because the cuff is incorporated into one or both silicone layers before the vulcanization step, it bonds with the silicone layer(s) during the vulcanization process. Consequently, a robust connection between the cuff and the silicone is easily established.Preferably, the aforementioned control unit and / or other components for controlling or activating the actuator unit are arranged on the cuff. Examples of other components include communication units for wireless and / or wired communication with the prosthesis (for receiving measurement signals from the sensor unit(s)), data processing units such as microcontrollers, and battery storage for providing the necessary electrical energy. Preferably, communication between the prosthesis and the silicone liner is wireless, for example, by exchanging Bluetooth signals. In other words, the prosthesis preferably comprises a communication unit embedded between the first and second HTV silicone layers, which is configured to transmit communication signals, in particular the measurement signals from the sensor unit(s), to the silicone liner.The silicone liner preferably includes a communication unit on the cuff, which is configured to receive communication signals, in particular the measurement signals from the sensor unit(s), from the prosthesis. The received communication signals are preferably forwarded to the control unit on the cuff to control or activate the actuator unit(s) of the silicone liner according to the measurement signals from the sensor unit(s) of the prosthesis. Thus, the wearer of the prosthesis can perceive the temperature and / or pressure present at the prosthesis using the actuator unit(s). Consequently, the acceptance and functionality of the prosthesis are improved.
[0036] Another aspect concerns a multi-layered HTV silicone body for a prosthesis or a prosthesis covering. The multi-layered HTV silicone body can be manufactured using the aforementioned method for producing a multi-layered HTV silicone body for a prosthesis or a prosthesis covering. The (optional) features and their advantages described in the method are implemented analogously in the multi-layered HTV silicone body and can therefore be combined as desired. The prosthesis is preferably an exoprosthesis, i.e., a prosthesis for replacing a missing or impaired external body part, such as an extremity, for example, a finger, hand, arm, leg, foot, ear, and the like, or even just a part thereof, for example, a partial hand or partial foot.
[0037] Another aspect concerns a multi-layered silicone liner (for wearing under a prosthesis or as a prosthesis cover). The multi-layered silicone liner can be produced using the aforementioned method. The (optional) features and their advantages described in the method are implemented analogously in the multi-layered silicone liner and can therefore be combined as desired. Preferably, the first silicone and / or the second silicone (each) is an HTV silicone. Compared to other silicone types, such as RTV or LSR, HTV silicone is stronger in its vulcanized state and offers higher abrasion resistance and resistance to chemical and mechanical stresses, making it more suitable for long-term use in frequently used multi-layered silicone liners. In other words, HTV silicone offers greater durability.This is particularly advantageous for silicone liners, as these are usually worn between the body and the prosthesis and are therefore exposed to abrasion or mechanical stress with almost every movement of the wearer of the prosthesis.
[0038] Another aspect concerns a system for sensory feedback to a wearer of a prosthesis or a prosthesis covering. The system comprises the aforementioned multi-layered HTV silicone body or a prosthesis with a silicone covering and a sensor unit positioned between the prosthesis and the silicone covering, designed to detect temperature and / or pressure, and the aforementioned multi-layered silicone liner. The multi-layered HTV silicone body or prosthesis and the multi-layered silicone liner are configured to exchange data such that a temperature and / or pressure detected by the sensor unit of the multi-layered HTV silicone body or prosthesis is transmitted to the multi-layered silicone liner as a communication signal to drive its actuator unit.The (optional) features and advantages described for the multilayer HTV silicone body and the multilayer silicone liner are implemented analogously in the system and can therefore be combined as desired. The prosthesis with the silicone coating preferably comprises a basic mechanical structure that restores at least one original function of the missing limb, for example, a mechanism that provides at least one movement function for the missing limb. Preferably, an intermediate layer, for example, a textile fabric, is applied over the basic mechanical structure. The sensor unit, designed to detect temperature and / or pressure, is preferably embedded in or arranged on the outside of the intermediate layer. The silicone coating is preferably arranged over or on top of the intermediate layer.Furthermore, preferably the silicone coating is produced analogously to the first HTV silicone layer according to the above method, i.e., based on an HTV silicone-containing solution and a coating mold. Advantageously, the silicone coating can thus be produced particularly thin, for example between 0.15 mm and 1.5 mm, and with a lifelike appearance.
[0039] Further preferred embodiments of the invention result from the other features mentioned in the dependent claims.
[0040] Unless otherwise stated in individual cases, the various embodiments of the invention mentioned in this application can be advantageously combined with one another.
[0041] The invention is explained below using exemplary embodiments with reference to the accompanying drawings. These show:
[0042] Figure 1 shows a schematic representation of a sensory feedback system according to one embodiment;
[0043] Figure 2 is a schematic representation of a manufactured multilayer HTV silicone body according to one embodiment; Figure 3 is a schematic cross-sectional representation of the manufactured multilayer HTV silicone body according to one embodiment;
[0044] Figures 4a-c schematic representations of individual manufacturing steps of a multilayer silicone liner according to one embodiment;
[0045] Figure 5 shows a schematic cross-sectional representation of a multilayer silicone liner according to one embodiment;
[0046] Figure 6 shows a schematic representation of a method for producing a multilayer HTV silicone body according to a feedthrough mold; and
[0047] Figure 7 shows a schematic representation of a method for producing a multilayer silicone liner according to a feedthrough mold.
[0048] Figure 1 shows a schematic representation of a system 10 for providing sensory feedback to a wearer of a prosthesis or a prosthesis covering according to one embodiment. The system 10 comprises a multilayered HTV silicone body 100 and a multilayered silicone liner 200, each shown schematically in Figure 1. Possible embodiments of the multilayered silicone body 100 are described in more detail with reference to Figures 2 and 3. Embodiments of the multilayered silicone liner 200 are explained in more detail in Figures 4a-c and 5.
[0049] The multi-layered HTV silicone body 100 is used as a prosthesis or as a covering for a prosthesis, enabling the sensory detection of temperatures occurring at and / or pressures acting on the prosthesis. The multi-layered HTV silicone body 100 comprises a variety of sensor units 102, 104 configured for detecting temperature and / or pressure, an electrical conductor 106, and an interface 108.
[0050] The sensor units 102 and 104 are each configured to detect the temperature and / or pressure on the outside of the HTV silicone body 100, i.e., on the outside of the prosthesis or the covering. The sensor units 102 and 104 are each embedded at least between a first HTV silicone layer 110 and a second HTV silicone layer 112, as described in more detail with reference to Figure 3.
[0051] In the exemplary embodiment shown in Figure 1, the HTV silicone body 100 comprises four sensor units 102 configured for sensing pressure and one sensor unit 104 configured for sensing temperature. Since temperature can be distributed more readily across the material of a prosthesis than pressure, the number of sensor units 104 configured for temperature sensing is preferably lower than the number of sensor units 102 configured for pressure sensing. However, the number of sensor units 102, 104 shown is merely exemplary and not limited to this. Rather, any number of sensor units 102, 104 can be provided in any ratio to one another. It is understandable that the number and ratio of the sensor units 102, 104 can depend on the prosthesis used, its size, and the desired sensory capability.The sensor units 102 designed to detect pressure are, for example, pressure-dependent electrical resistors or components based on the piezoelectric effect, but are not limited to these. The sensor unit 104 designed to detect temperature is, for example, a temperature-dependent electrical resistor or a component based on the Seebeck effect, but are not limited to these.
[0052] The sensor units 102 and 104 of the HTV silicone body 100 are connected to an optional microcontroller (no reference symbol) which receives the measured signals from the sensor units 102 and 104 and transmits them to the interface 108 via the electrical line 106. The microcontroller and the electrical line 106 are also embedded between the first HTV silicone layer 110 and the second HTV silicone layer 112. Thus, the sensor units 102 and 104, the electrical line 106, and the microcontroller are concealed from the outside by the HTV silicone layers 110 and 112 and protected from external influences.
[0053] Figure 2 shows a schematic representation of a manufactured multilayer HTV silicone body 100 according to one embodiment. In the embodiment shown in Figure 2, the multilayer HTV silicone body 100 is depicted as a hand prosthesis. However, the present disclosure is not limited to this. It is understandable that the multilayer HTV silicone body 100 disclosed herein serves as a prosthesis or covering for a prosthesis to replace an extremity of a living being, such as a missing or impaired body part. Affected body parts include, for example, fingers, a hand, an arm, a leg, a foot, and the like, or even just parts thereof, such as a partial hand or a partial foot. An extremity is a limb, i.e., a movable body appendage. The extremity preferably refers to a human being or an animal.
[0054] The illustrated hand prosthesis shows three sensor units 102, 104 on the index finger of the inner side of the hand. It is understandable that, analogously, sensor units 102, 104 can be arranged on several or all fingers and / or on the palm and / or on the outer side of the hand. Essentially, the sensor units 102, 104 can be arranged wherever measuring the temperature and / or pressure on the prosthesis seems useful, for example, because it frequently comes into contact with other objects. The sensor units 102, 104 are connected to the interface 108 via at least one electrical conductor 106. The interface 108 is, for example, located in the wrist area. Figure 2 further shows that the electrical conductor 106 runs at least partially in a meandering pattern between the sensor units 102, 104 and the interface 108.Because the electrical conductor 106 runs at least partially in a meandering pattern, improved flexibility of the multilayered HTV silicone body 100 is achieved in the meandering areas, in contrast to a (purely) straight course. Therefore, the electrical conductor 106 exhibits a meandering course in the intended movement and bending areas of the prosthesis or the prosthesis covering, such as the finger joints and the palm of the hand. For example, the electrical conductor 106 is designed as a copper track.
[0055] Figure 3 shows a schematic cross-sectional view of the manufactured multilayer HTV silicone body 100 according to one embodiment. The cross-sectional view illustrates the embedding of the sensor units 102, 104 between three exemplary HTV silicone layers 110, 112, 114.
[0056] The first HTV silicone layer 110 was produced using an HTV silicone-containing solution and a mold of the prosthesis or prosthesis coating. The HTV silicone in the HTV silicone-containing solution was dissolved in a solvent. Using this HTV silicone-containing solution, HTV silicone layers 110, 112, and 114 can be produced with significantly lower layer thicknesses Di and D2 (wall thicknesses) than with conventional solid-state processing of HTV silicones. Furthermore, different HTV silicone-containing solutions can be prepared to form HTV silicone layers 110, 112, and 114 with varying layer thicknesses Di and D2. In the exemplary embodiment of the HTV silicone body 100 shown in Figure 3, the first HTV silicone layer 110 has a greater first layer thickness Di than the second and third HTV silicone layers 112, 114. This gives the first HTV silicone layer 110 increased resistance.Since the first HTV silicone layer 110 acts as the outer layer of the prosthesis, the prosthesis's lifespan is increased, while sufficient flexibility is achieved through the thinner inner HTV silicone layers 112 and 114. To illustrate external influences acting on the prosthesis, such as pressure or temperature, an arrow pointing towards the first HTV silicone layer 110 is shown. The first layer thickness Di is, for example, 0.4 mm, while the second layer thickness D2 is, for example, 0.2 mm. Consequently, the total wall thickness of the multilayered HTV silicone body 100 is essentially 0.8 mm.
[0057] After the first HTV silicone layer 110 is formed using the mold, a first plurality of sensor units 102, 104 are arranged on the first HTV silicone layer 110. Subsequently, the second HTV silicone layer 112 is produced on the first HTV silicone layer 110 and the first plurality of sensor units 102, 104 arranged thereon. Furthermore, a second plurality of sensor units 102, 104 are arranged on the second HTV silicone layer 112, and a third HTV silicone layer 114 is produced on the second plurality of sensor units 102, 104 and the second HTV silicone layer 112. Through the subsequent vulcanization of the HTV silicone layers 110, 112, 114, the sensor units 102, 104 are reliably embedded in the HTV silicone body 100, as shown in Figure 3.
[0058] The multilayer silicone liner 200 is described in more detail below with reference to Figures 1, 4a-c and 5.
[0059] The multi-layer silicone liner 200 comprises a variety of actuator units 202, 204 set up to generate temperature and / or pressure, a variety of lines 206, a control unit 208 connected to the actuator units 202, 204 via the lines 206, an interface 210 connected to the control unit 208, as well as a pressure generation unit 212 and a temperature generation unit 214.
[0060] The actuator units 202, 204 comprise a plurality of actuator units 202 configured for generating pressure, for example, pressure pads, and a plurality of actuator units 204 configured for generating temperature, for example, heating wires. The lines 206 of the actuator units 202 configured for generating pressure are each configured to convey a fluid back and forth between the pressure generating unit 212 and the respective actuator unit 202. The lines 206 of the actuator units 204 configured for generating temperature are each configured to convey an electrical current back and forth between the temperature generating unit 214 and the respective actuator unit 204. The control unit 208 is configured to control the pressure generating unit 212 and the temperature generating unit 214 to activate the respective actuator units 202, 204, for example, by means of electronic control signals.
[0061] The pressure generation unit 212, for example a pump module, is connected via a line 206 to four actuator units 202 configured for generating pressure and via an electrical line to the control unit 208. The temperature generation unit 214, for example a controllable current transformer for activating the heating wire, is connected via a line 206 to an actuator unit 204 configured for generating temperature and via another electrical line to the control unit 208. The number of actuator units 202, 204 shown is merely exemplary and not limited. Any number of actuator units 202, 204 can be provided in any ratio to one another. It is understandable that the number and ratio of the actuator units 202, 204 can depend on the multilayer silicone liner 200 used, its size, and the desired actuating capabilities.Preferably, the number of actuator units 202, 204 corresponds to the number of sensor units 102, 104 of the HTV silicone body described above, i.e., the prosthesis used. Therefore, each actuator unit 202, 204 can be controlled according to the measurement signals of a sensor unit 102, 104. The multilayer HTV silicone body 100 and the multilayer silicone liner 200 are configured to exchange data such that temperatures and pressures detected by the sensor units 102, 104 of the multilayer HTV silicone body 100 are transmitted to the multilayer silicone liner 200. This is done using the two interfaces 108 and 210. Interface 108 includes a communication unit configured to transmit communication signals, namely the detected measurement signals from the sensor units 102, 104, to the multilayer silicone liner 200.Interface 210 of the multilayer silicone liner 200 also includes a communication unit designed to receive communication signals, namely the measured signals from the sensor units 102 and 104, from the prosthesis. These received communication signals are forwarded to the control unit 208 and used to control the actuator units 202 and 204 of the multilayer silicone liner 200. Thus, the wearer of the prosthesis can perceive the temperature and pressure present at the prosthesis using the actuator units 202 and 204. Consequently, the acceptance and functionality of the prosthesis are improved.
[0062] Figures 4a-c show schematic representations of individual manufacturing steps of a multilayer silicone liner 200 according to one embodiment. Actuator units 202, designed as pressure pads, are temporarily fixed to a provided positive mold 216 of an exemplary arm stump (see Figure 4a). A first silicone layer 220, in the form of a layer of rolled HTV silicone with a medium Shore hardness between Shore 20 and Shore 50, is placed on the pressure pads and wrapped around the positive mold 216. Then, an opening 218 is made in the first silicone layer 220 in the areas overlapping the actuator units 202 (see Figure 4b). A conductor 206 is then guided through each of the openings 218 in the first silicone layer 220 for coupling with the respective actuator unit 202. The lines 206 serve the purpose of connecting the actuator units 202 through the openings 218 to the pressure generation unit 212.
[0063] A second silicone layer 222, made of a second type of silicone, is then applied to the side of the first silicone layer 220 facing away from the positive mold 216 (see Figure 4c). The second silicone layer covers the openings 218 and the first silicone layer 220 substantially completely, and at least partially covers the conduits 206. The second silicone is a rolled HTV silicone with a high Shore hardness of at least Shore 50 to Shore 100. Due to its higher Shore hardness compared to the first silicone layer 220, the second silicone layer 222 provides better protection against external influences for the multilayer silicone liner 200. Thus, the second silicone layer 220 forms the outer layer of the multilayer silicone liner 200. Before vulcanizing the silicones of the resulting multilayer silicone body 200, a cuff 224 is incorporated between the first and second silicone layers 220.In the vulcanization step, the cuff 224 then bonds with the silicone layers 220, 222. Consequently, a robust connection between the cuff 224 and the silicone layers 220, 222 is provided in a simple manner.
[0064] Figure 5 shows a schematic cross-sectional view of a multilayer silicone liner 200 in the vulcanized state according to one embodiment. Further components, such as the control unit 208, the interface 210 comprising the communication unit described above, and the pressure generation unit 212, are arranged on the cuff 224. The pressure generation unit 212 is connected to the ends of the lines 206, which protrude between the first silicone layer 220 and the second silicone layer 222. A communication signal emitted from the interface 108 of the HTV silicone body 100 and received by the communication unit of the interface 210 of the silicone liner 200 is transmitted to the control unit 208 and converted into a control signal for the pressure generation unit 212. The pressure generation unit 212 generates pressure in the lines 206, which is transferred to the actuator units 202, designed as pressure pads.The pressure pads are expanded by the pressure. Since the second silicone layer has a high Shore hardness, the pressure pad essentially expands towards the residual limb. There, it is detected by the carrier of the multilayer silicone liner 200. It is understandable that the multilayer silicone liner 200 disclosed in Figures 4a-c and 5 is not limited to the pure pressure generation function. Rather, the multilayer silicone liner 200 can additionally or alternatively have an analogous temperature generation function.
[0065] Figure 6 shows a schematic representation of a method for producing a multilayer HTV silicone body 100 according to a feedthrough mold.
[0066] In a first process step 50, a first HTV silicone layer 110 is produced based on an HTV silicone-containing solution and a mold of the prosthesis or coating. The HTV silicone of the HTV silicone-containing solution is dissolved in a solvent.
[0067] According to a second process step 52, at least one sensor unit 102, 104 designed to detect a temperature and / or pressure is arranged on the first HTV silicone layer 110.
[0068] In a third process step 54, a second HTV silicone layer 112 is produced on the sensor unit 102, 104 and the first HTV silicone layer 110 based on the (or another) HTV silicone-containing solution.
[0069] Figure 7 shows a schematic representation of a process for producing a multilayer silicone liner 200 according to a mold. In a first process step 150, a positive mold 216 of a stump of a body part to be replaced is provided.
[0070] According to a second process step 152, at least one actuator unit 202, 204 designed to generate temperature and / or pressure is arranged between the positive mold 216 and a first silicone layer 220 made of a first silicone with an opening 218 that partially exposes the actuator unit 202, 204 (see Figures 4a+b).
[0071] In a third process step 154, a line 206 is guided through the opening 218 of the first silicone layer 220 to couple the line 206 with the actuator unit 202, 204.
[0072] According to a fourth process step 156, a second silicone layer 222 made of a second silicone is applied to the side of the first silicone layer 220 facing away from the positive mold 216 (see Figure 4c). The second silicone at least partially covers the opening 218 of the first silicone layer 220 and the conduit 206 and has a higher Shore hardness than the first silicone.
[0073] In a fifth process step 158, the first silicone layer 220 and the second silicone layer 222 with the interposed conductor 206 are vulcanized under heat. Reference numeral list
[0074] 10 Sensory feedback systems
[0075] 100 multi-layered HTV silicone bodies
[0076] 102 Sensor unit (pressure)
[0077] 104 Sensor unit (temperature)
[0078] 106 electrical line
[0079] 108 Interface
[0080] 110 first HTV silicone layer
[0081] 112 second HTV silicone layer
[0082] 114 third HTV silicone layer
[0083] 200 multi-layer silicone liners
[0084] 202 Actuator unit (pressure)
[0085] 204 Actuator unit (temperature)
[0086] 206 Management
[0087] 208 Control unit
[0088] 210 interface
[0089] 212 Printing unit
[0090] 214 Temperature generation unit
[0091] 216 Positive form of a stump
[0092] 218 Opening
[0093] 220 first silicone layer
[0094] 222 second silicone layer
[0095] 224 cuff
[0096] The first layer thickness
[0097] D2 second layer thickness
[0098] 50 First process step - Creating a first HTV silicone layer 52 Second process step - Arranging a sensor unit
[0099] 54 Third process step - Creating a second HTV silicone layer
[0100] 150 First process step - Providing a positive mold 152 Second process step - Arranging an actuator unit between a first silicone layer and the positive mold
[0101] 154 Third procedure step - Guiding a line through an opening
[0102] 156 Fourth process step - Applying a second silicone layer
[0103] 158 fifth process step - vulcanizing the silicone layers
Claims
- 27 - Patent claims 1. Method for manufacturing a multilayer HTV silicone body (100) for a prosthesis or a covering of the prosthesis, the method comprising the steps: Producing (50) a first HTV silicone layer (110) based on an HTV silicone-containing solution and a form of the prosthesis or coating, wherein the HTV silicone of the HTV silicone-containing solution is dissolved in a solvent, arranging (52) at least one sensor unit (102, 104) configured to detect a temperature and / or pressure on the first HTV silicone layer (110), and Producing (54) a second HTV silicone layer (112) on the sensor unit (102, 104) and the first HTV silicone layer (110) based on the HTV silicone-containing solution.
2. The method of claim 1, wherein the shape of the prosthesis or coating comprises a negative and / or positive mold of the prosthesis or coating and the production of the first HTV silicone layer (110) comprises one of the following steps: Swirling the HTV silicone-containing solution in the negative mold or pouring the HTV silicone-containing solution over the positive mold and / or immersing the positive mold in the HTV silicone-containing solution.
3. A method according to any of the preceding claims, further comprising the step of: Vulcanizing the first HTV silicone layer (110) and the second HTV silicone layer (112) arranged on it with the sensor unit (102, 104) arranged in between under heat supply.
4. A method according to claim 1 or 2, wherein the production (54) of the second HTV silicone layer (112) is further based on a further mold which corresponds to a shape of the prosthesis or covering adapted by one layer thickness of the first HTV silicone layer (110), and wherein the method further comprises the steps: Vulcanizing the first HTV silicone layer (110) with the sensor unit (102, 104) arranged on it and the second HTV silicone layer (112) separated from it under heat input and 5. Joining the vulcanized first HTV silicone layer (110) and the vulcanized second HTV silicone layer (112) using a silicone adhesive.
6. Method according to one of the preceding claims, wherein an electrical conductor (106) for connecting the sensor unit (102, 104) to an interface (108) is arranged on the first HTV silicone layer (110), wherein the electrical conductor (106) runs at least partially meandering between the sensor unit (102, 104) and the interface (108).
6. Method according to any of the preceding claims, further comprising the step: Arranging at least one second sensor unit (102, 104) designed to detect temperature and / or pressure on the second HTV silicone layer (112), and Producing a third HTV silicone layer (114) on the second sensor unit (102, 104) and the second HTV silicone layer (112) based on the HTV silicone-containing solution.
7. Method according to any of the preceding claims, wherein the multilayer HTV silicone body (100) is produced with a total thickness of 0.15 mm to 1.5 mm.
8. Method for producing a multilayer silicone liner (200), the method comprising the following steps: Providing (150) a positive form (216) of a stump of a body part to be replaced, Arranging (152) at least one actuator unit (202, 204) designed to generate temperature and / or pressure between the positive mold (216) and a first silicone layer (220) made of a first silicone with an opening (218) partially exposing the actuator unit (202, 204), (154) guiding a line (206) through the opening (218) of the first silicone layer (220) to couple the line (206) with the actuator unit (202, 204), (156) arranging a second silicone layer (222) made of a second silicone on a side of the first silicone layer (220) facing away from the positive form (216), wherein the second silicone at least partially covers the opening (218) of the first silicone layer (220) and the line (206) and has a higher Shore hardness than the first silicone, and Vulcanizing (158) the first silicone layer (220) and the second silicone layer (222) with the interposed conduit (206) under heat supply.
9. Method according to claim 8, wherein the actuator unit (202, 204) comprises a pressure pad which comprises a fabric embedded in a third silicone, wherein the third silicone has a lower Shore hardness than the first silicone.
10. Method according to one of claims 8 or 9, wherein the line (206) is a silicone tube comprising a fabric at the end coupled to the actuator unit (202, 204).
11. Method according to any one of claims 8 to 10, wherein the conductor (206) comprises an end free from the first silicone layer (220) and / or the second silicone layer (222) for coupling with a control unit (208).
12. Method according to one of claims 8 to 11, wherein, prior to the step of vulcanizing (158) the first silicone layer (220) and the second silicone layer (222) with the line (206) arranged between them, an end of a cuff (224) is incorporated into the first silicone layer (220) and / or the second silicone layer (222).
13. Multilayer HTV silicone body (100) for a prosthesis or a covering of the prosthesis can be produced according to a method according to any one of claims 1 to 7.
14. Multilayer silicone liner (200) producible by a method according to any one of claims 8 to 12.
15. System (10) for providing sensory feedback to a wearer of a prosthesis or a cover of the prosthesis, comprising: a multi-layered HTV silicone body (100) according to claim 13 or a prosthesis with a silicone coating and a sensor unit (102, 104) arranged between the prosthesis and the silicone coating for detecting temperature and / or pressure and a multilayer silicone liner (200) according to claim 14, wherein the multi-layered HTV silicone body (100) or the prosthesis and the multi-layered silicone liner (200) are configured to be in such a data exchange that a temperature and / or a pressure detected by the sensor unit (102, 104) of the multi-layered HTV silicone body (100) or the prosthesis is transmitted to it as a communication signal to drive the actuator unit (202, 204) of the multi-layered silicone liner (200).