EP4065053A1 - Prosthesis socket and method for producing same - Google Patents
Prosthesis socket and method for producing sameInfo
- Publication number
- EP4065053A1 EP4065053A1 EP20816446.7A EP20816446A EP4065053A1 EP 4065053 A1 EP4065053 A1 EP 4065053A1 EP 20816446 A EP20816446 A EP 20816446A EP 4065053 A1 EP4065053 A1 EP 4065053A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- textile
- frame
- prosthesis
- prosthesis socket
- prepregs
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000004519 manufacturing process Methods 0.000 title claims description 8
- 239000004753 textile Substances 0.000 claims abstract description 100
- 239000000463 material Substances 0.000 claims abstract description 58
- 229920002430 Fibre-reinforced plastic Polymers 0.000 claims abstract description 13
- 239000011151 fibre-reinforced plastic Substances 0.000 claims abstract description 13
- 239000010410 layer Substances 0.000 claims description 33
- 239000011347 resin Substances 0.000 claims description 25
- 229920005989 resin Polymers 0.000 claims description 25
- 229920001971 elastomer Polymers 0.000 claims description 19
- 239000004744 fabric Substances 0.000 claims description 17
- 239000000806 elastomer Substances 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 14
- 125000006850 spacer group Chemical group 0.000 claims description 14
- 239000002344 surface layer Substances 0.000 claims description 9
- 239000000543 intermediate Substances 0.000 description 25
- 210000003414 extremity Anatomy 0.000 description 10
- 239000000835 fiber Substances 0.000 description 9
- 239000002131 composite material Substances 0.000 description 6
- 238000011161 development Methods 0.000 description 5
- 230000018109 developmental process Effects 0.000 description 5
- 210000000245 forearm Anatomy 0.000 description 5
- 239000011248 coating agent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- 229920003023 plastic Polymers 0.000 description 4
- 239000004033 plastic Substances 0.000 description 4
- 230000007704 transition Effects 0.000 description 4
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 230000035699 permeability Effects 0.000 description 3
- 239000011505 plaster Substances 0.000 description 3
- 229920001296 polysiloxane Polymers 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 239000005060 rubber Substances 0.000 description 3
- 229920000049 Carbon (fiber) Polymers 0.000 description 2
- 206010040880 Skin irritation Diseases 0.000 description 2
- 239000004917 carbon fiber Substances 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000003365 glass fiber Substances 0.000 description 2
- 210000000629 knee joint Anatomy 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000036556 skin irritation Effects 0.000 description 2
- 231100000475 skin irritation Toxicity 0.000 description 2
- 210000000689 upper leg Anatomy 0.000 description 2
- 210000000707 wrist Anatomy 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000004760 aramid Substances 0.000 description 1
- 229920006231 aramid fiber Polymers 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Inorganic materials [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 description 1
- ZOMBKNNSYQHRCA-UHFFFAOYSA-J calcium sulfate hemihydrate Chemical compound O.[Ca+2].[Ca+2].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O ZOMBKNNSYQHRCA-UHFFFAOYSA-J 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 239000003733 fiber-reinforced composite Substances 0.000 description 1
- 239000002657 fibrous material Substances 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 239000011507 gypsum plaster Substances 0.000 description 1
- 210000004247 hand Anatomy 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 1
- 230000003183 myoelectrical effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 230000035900 sweating Effects 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 229920001187 thermosetting polymer Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 238000009816 wet lamination Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
- A61F2/80—Sockets, e.g. of suction type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
- A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/5044—Designing or manufacturing processes
- A61F2002/5056—Laminates, i.e. layered products
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
- A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
- A61F2002/7818—Stockings or socks for the limb stump
Definitions
- the invention relates to a prosthesis shaft with a proximal entry opening and a distal end or a distal end region and a fastening device for a prosthesis component arranged there, the prosthesis shaft having a frame made of a fiber-reinforced plastic with at least one free space and a method for its production.
- Prostheses replace limbs or parts of limbs that are not or no longer present, whereby the prosthesis is intended to replace the shape and / or function of the natural limb as best as possible.
- Different designs and technologies are known for attaching prostheses to the respective user.
- a widespread possibility is the definition of prosthetic components, for example prosthetic joints and distal prosthetic components, over a prosthetic shaft that is applied to a stump.
- a prosthesis liner can be arranged between the prosthesis socket, which can have a receptacle for a prosthesis joint or other component at its distal end, and the stump in order to reduce pressure, provide padding and, if necessary, a sealing effect within the scope of suction socket technology guarantee.
- the prosthesis shafts are often designed as custom-made, dimensionally stable components made from fiber-reinforced plastics.
- the fibers are usually high-strength inorganic or organic fibers such as carbon fibers, glass fibers or aramid fibers; thermoplastics or thermosets are used as the plastic matrix.
- the distal end of such a prosthesis socket is often designed to be closed, so that the prosthesis socket extends completely around the stump.
- such prosthetic sockets are comparatively heavy and only allow moisture to be removed to a limited extent.
- frame sockets As an alternative to prosthesis sockets with closed walls, so-called frame sockets have been developed in order to reduce weight and to build up pressure or stiffening only in the necessary and suitable places.
- frame shafts for example, a surface on a rear thigh can be recessed so that the shaft is formed onto the seat surface and the The prosthesis wearer does not sit on the hard prosthesis socket when sitting.
- the frame shafts are mainly made of prepregs that cure under vacuum and heat, or are built up using the wet lamination technique.
- Frame shafts usually have an inner shaft that is often made of thermoplastically deformable plastics. These materials are relatively heavy and thick and therefore require a large volume.
- the inner shafts are airtight, which promotes sweating. This can cause skin irritation.
- the object of the present invention is to provide a prosthesis socket and a method for producing a prosthesis socket with which it is possible to increase the wearing comfort of prosthesis sockets without reducing the functionality.
- this object is achieved by a prosthesis shaft with the Merkma len of the main claim and a method with the features of the Maugeord Neten claim.
- the prosthesis socket with a proximal entry opening and a distal end or a distal end area and a fastening device arranged there for a prosthesis component the prosthesis socket having a frame made of a fiber-reinforced plastic with at least one free space, provides that a textile is fixed to the frame that bridges the space.
- the free space is formed in the wall of the prosthesis socket, whereby material of the dimensionally stable frame is saved. This reduces the weight of the prosthesis socket.
- a textile is attached to the frame in order to at least partially cover or fill the free space and to at least reduce the area of the free space or the window.
- the textile completely bridges the free space and completely covers it, so that the window is closed and a closed cross-section consisting of a frame, for example, is formed in this area of the prosthesis socket a fiber-reinforced plastic, and a textile attached to it over the entire lengthwise extension, so the entire distal-proximal extension of the prosthesis sschaftes results.
- the free space can be designed as a window that is completely surrounded by the frame material.
- the hard, dimensionally stable material of the frame for example frame pieces formed from prepregs or resin-impregnated glass fiber or carbon fiber blanks, are cut out, the cutouts and windows then being bridged by the textile and in particular completely getting closed.
- the textile can be designed as a spacer knitted fabric, spacer knitted fabric or spacer fabric, which has the advantage that, in addition to air permeability, it provides a support and cushioning effect.
- a knitted spacer fabric is able to enable a cushioning effect due to the support threads and a liquid transport due to the air permeability.
- a further development of the invention provides that the textile is glued and / or baked to the frame.
- the textile can, for example, be glued to the frame before the prepregs harden and held in place by the resin content of the prepregs.
- the prosthesis socket with the glued-on textile components or the glued-on textile component is then heated with the application of a vacuum on an individual model of the residual limb or on a ready-made model, so that the frame elements harden and the textile is connected directly to the material of the frame. This saves work steps and provides a washable prosthesis socket with sufficient strength to be attached to a stump and to accommodate further prosthesis components.
- a further development of the invention provides that the frame is formed from prepregs that are placed on the outside of the textile facing away from the user. This makes it possible that the sharp-edged edges of the frame, which can occur during the production and processing of fiber-reinforced composite materials, are not in direct contact with the user or with someone below. pulled liner, which reduces the risk of injury or damage to the liner can be avoided. In addition, ventilation and padding are still provided by the textile on the inside.
- a further development of the invention provides that at least one material is arranged and incorporated as a further layer, in particular an intermediate layer between the fiber-reinforced plastic, in particular prepreg and the textile, the material or materials having a degree of hardness in the finished state of the prosthesis socket or have, which are between the hardness of the fiber reinforced plastic or prepreg and the hardness of the textile.
- the material can additionally or alternatively be attached as a surface layer on the outside of the fiber-reinforced plastic and / or inside on the textile and / or on an edge of the prosthesis socket as a cushion to cover and cushion the partially sharp edges of the hardened prepregs.
- the material or the materials as an intermediate material or surface material or the cushioning material or the cushioning materials allow an improved connection on the one hand to the fiber-reinforced plastic or the prepregs and on the other hand to the textile as well as a smoother transition from the comparatively soft textile and the one in the finished state hard frame shaft or the prepregs.
- the additional material as a surface layer and / or cushion serves as protection for both the prosthesis component and the user, i.e. as a protective cover, and also as a means of increasing comfort by covering the hard and sometimes sharp edges.
- the additional material or the intermediate, surface or cushioning materials can, for example, be an elastomer or several elastomers, possibly with a modified surface, whereby the frame edges can be made softer and places for installing electrodes can be cut out.
- the elastomer can be, for example, an initially uncrosslinked or slightly crosslinked silicone or an initially uncrosslinked or slightly crosslinked rubber or initially uncrosslinked or slightly crosslinked rubber or initially uncrosslinked or slightly crosslinked silicone, which is applied to the textile together with the prepregs, with the resin of the prepreg is fixed on the textile and when the prosthesis socket is finished it is crosslinked and hardened under the action of heat.
- the intermediate layer remains elastic to a certain extent and, in terms of hardness, lies between the textile and the hardened frame share.
- the material of the intermediate layer can also be arranged as a cushioning material on the side of the frame facing away from the textile or on a frame edge and serve as a cushion or base for fixing further components, for example electrodes.
- the frame can be connected to the textile - and if at least one intermediate layer, surface layer and / or cushion is arranged, also the intermediate layer, the surface layer and / or the cushion and the textile - via resin made from prepregs that form the frame.
- Other adhesives are used to attach the textile, if necessary with the interposition of additional materials made of elastomers such as rubber or the like.
- the resin from the prepregs or the other fiber-reinforced base materials in the assembled and finished state of the prosthesis shaft does not penetrate to the inside of the textile, i.e. not to the surface that rests against the user or is on the side facing the user. This prevents the hardened resin from causing skin irritation, impairing wearing comfort and also hindering air permeability.
- the textile is designed as a tube or a distally closed liner which, for example, is first drawn onto a model or an impression of the stump and forms the basis for placing the prepregs on the outside.
- the tube and / or the liner with the distally closed end can be designed as prefabricated mass-produced articles and pulled onto the model or cast of the stump.
- the method according to the invention for producing a prosthesis socket provides that a textile is applied to a stump model, that at least one prepreg is applied to the outside of the textile, forming a frame with at least one free space, in such a way that the textile at least partially bridges the free space, wherein the textile and the at least one prepreg are then baked at an elevated temperature and a vacuum is applied to form a prosthesis shaft.
- At least one intermediate layer for example a film or a fiber composite material with an elastomer component, can be directly connected, since the flarz from the prepreg connects directly to the textile or connects to the textile or at least part of the textile via the intermediate layer.
- a spacer knitted fabric, spacer knitted fabric or spacer fabric is used as the textile, which has an upper fabric side and a lower fabric side with support threads arranged in between.
- the flarz from the prepregs can then be connected to the upper or lower side of the goods and, after curing, establish the connection between the then cured material and the textile.
- One way to fix the prosthesis socket provides that the textile is pulled onto the stump on the patient and support areas for the at least one prepreg or the at least one prepreg cut are marked before the prepregs are placed or placed on the outside of the textile. This ensures that after the textile has been drawn onto the stump model that has been molded from the actual stump, the blanks made of the resin-impregnated fiber materials are positioned in the correct places.
- the textile is preferably drawn onto the stump model in such a way that the stump model is at least enveloped, advantageously completely encased, by the textile, so that an at least circumferentially closed textile can be placed around the stump or stump model.
- the at least one free space that is formed by the frame is preferably arranged medially or laterally.
- at least one closed, distal cap is formed on the prosthesis shaft over the prepreg or the fiber-reinforced plastic layers in order to provide sufficient stability in the connection area for the further prosthesis component, for example a joint or a receptacle for, for example, a prosthetic hand.
- the closed, distal cap also makes it possible to design the distal area of the prosthesis shaft to be particularly stiff and stable, to which elastic regions of the prosthesis shaft in the form of the frame or frame ab- connect cuts, between which the textile is arranged, in order to provide a closed-walled receptacle for the stump.
- At least one additional layer e.g. intermediate layer or surface layer
- at least one additional layer can be placed on and / or between the textile and the prepregs and / or a cushioning material around the edge of the prosthesis socket and cured together to create space for cables and / or electrodes or the like to train a protection and also to provide padding.
- the further layer of material and / or the cushion can contain or consist of at least one initially uncrosslinked or slightly crosslinked elastomer and optionally be provided with a coating that enables adhesion to the prepreg or the fiber composite material and / or the textile or facilitated.
- the textile, the intermediate layer and / or cushioning layer and the fiber composite material are permanently connected to one another.
- Figure 1 - a schematic representation of a prosthesis shaft in side view
- FIG. 2 - a rear partial view of the prosthesis shaft according to FIG. 1;
- FIG. 3 - a schematic sectional view through a region of the prosthesis shaft
- FIG. 4 - a variant of FIG. 3.
- a prosthesis shaft 10 is shown in a schematic representation in a side view.
- the prosthesis shaft 10 is shown in a schematic representation in a side view.
- the prosthesis shaft 10 is shown in a schematic representation in a side view. In the illustrated embodiment, the prosthesis shaft
- the prosthesis socket 10 designed as a forearm shaft that is to be placed on a forearm stump.
- the prosthesis socket 10 is provided with a proximal entry opening
- the prosthesis shaft 10 has a distal, closed end 12 on which a fastening device 13 is arranged for a prosthetic hand.
- the fastening device 13 is a schematic representation of a device for attaching an adapter to which the prosthetic hand or a prosthetic wrist can be attached.
- the prosthesis socket 10 is configured, for example, as an upper leg socket, a prosthetic knee joint is advantageously fastened to the prosthetic knee joint using a pyramid adapter with a corresponding fastening device.
- the pyramid adapter is then usually formed in the area of the distal end of the closed prosthesis shaft 10.
- other fastening devices for fixing a prosthetic foot can also be provided.
- a prosthetic wrist is advantageously attached and usually via a sprue ring.
- a fastening device other than a sprue ring for securing the prosthetic hand on the forearm shaft can also be provided.
- the illustrated fastening device 13 can also be configured differently on the prosthesis socket 10.
- the prosthesis socket 10 is designed as a frame socket and has a frame 20 which is made of a fiber-reinforced plastic.
- the frame 20 is made up of so-called prepregs, which are cut to the desired shape and placed on a stump model (not shown).
- the prepregs are fiber fabrics soaked with flarz that adhere to one another. The excess resin on the prepregs ensures that the blanks also adhere to the respective substrate.
- the frame shaft has two free spaces 21, 22 in the form of windows.
- a first window 21 is formed in the rear or posterior area, the second window or the second free space 22 in the frontal or front area.
- the distal end region 12 is designed to be closed and includes the blunt end around its entire circumference.
- a pull-in hole 14 is formed in the frame 20, through which a pull-in aid drawn over a liner, for example a tube made of a non-adhesive material, can be removed after insertion into the prosthesis shaft 10.
- a liner for example a tube made of a non-adhesive material
- Both free spaces 21, 22 are completely bridged by a textile 30 and closed.
- the textile 30 is designed as a knitted spacer which is arranged on the inside of the frame 20. The textile 30 is over the excess resin, which is located on the surface of the not yet cured prepregs, first attached to the prepregs and then permanently connected to the hardening fiber composite material when the Pro thesschaftes 10 is completed, applying a negative pressure or vacuum and at an elevated temperature.
- the vacuum is preferably set so that the resin does not penetrate to the inside of the textile 30, but that a soft inner surface of the textile continues to be guaranteed.
- the vacuum or the negative pressure it is possible to adjust the contact pressure of the prepregs on the textile and thus to change the degree of penetration of the fabric.
- the prosthesis socket 10 is manufactured, for example, by taking an impression from the stump of the limb, from which a positive model of the stump is created.
- the positive model can be made of plaster of paris, for example.
- a standard liner or an individually made liner is drawn onto the plaster model so that it lies as smoothly as possible on the surface of the plaster model.
- the prepregs are placed on the outer surface of the liner and fixed thereon via the adhesive force of the excess resin, so that the frame 20 is formed.
- the free spaces 21, 22 or frame windows can be marked in advance on the textile 30 or the liner. The marking of those areas on which no prepregs should be placed and which should not be covered by the fiber composite material can be done either on the plaster model or directly on the limb stump.
- the liner or the textile 30 is pulled onto the limb stump.
- One or more layers of an additional material, in this application form as an intermediate material 40 can be arranged between the prepregs or the layers of prepregs and the textile 30.
- the intermediate material 40 is preferably an elastomer or has at least one elastomer component.
- the intermediate material 40 combines advantageously with the material of the prepregs and also with the textile 30.
- the intermediate material 40 is selected such that the resin of the prepregs penetrates through the intermediate layer, for example because there is a perforation or the material is permeable to the resin.
- the intermediate material 40 provides cushioning and is preferably designed to be elastic.
- the intermediate material 40 can serve to receive leads and / or electrodes, so that, for example, electrodes arranged within the prosthesis socket 10 for receiving myoelectric signals can be easily integrated.
- Electrodes window 50 On the outside of the prosthesis shaft 10 can be formed on the frame 20 electrical denhim 50.
- electrodes or pairs of electrodes For example, control signals from the limb are picked up via the electrodes, processed in a control unit with processor and memory, and used to activate or deactivate drives.
- a vacuum is applied.
- the model with the textile 30, optionally with the intermediate layer or layers, and the not yet cured fiber composite materials, for example, is wrapped in a plastic cover on the model.
- the plastic cover is evacuated and the model is heated. The vacuum and the heat are maintained until the prepregs have hardened, so that a dimensionally stable frame 20 results.
- FIG. 2 a rear view of the prosthesis shaft 10 is shown in detail. It can be seen that the textile 30 is arranged and fastened on the inside of the frame 20. On the inside of the textile 30, a coating 31 can be applied to improve the adhesion of the textile 30 to the limb, for example the stump of the forearm.
- the coating 31 in the exemplary embodiment shown consists of silicone and runs in two strips which extend from the proximal entry opening 11 to the distal end area, which is not shown.
- the resin from the prepregs, which form the dimensionally stable frame 20, has not penetrated to the inner surface of the textile 30.
- the textile 30 is directly connected to the prepregs via the resin from the prepregs.
- the free space 22 on the back of the prosthesis socket 10 is completely covered by the textile 30, so that the prosthesis socket 11 completely envelops the stump when the prosthesis socket 10 is applied.
- FIG. 3 the connection of a textile 30 to the frame 20 is shown in a schematic sectional illustration.
- a further material or a further material layer is arranged as an intermediate material 40 on the frame 20, in the illustrated embodiment at the left end on the side of the frame 20 facing away from the textile 30 and at the right end between the frame 20 and the textile 30 .
- the frame 20 made of a fiber-reinforced plastic, for example made of prepregs, has a sticky surface in its processable state, which, as described above, is due to the excess resin. The stickiness will disappear in a subsequent processing process through curing and crosslinking at elevated temperatures under vacuum.
- the textile 30 is placed on a surface of the frame 20 and is permanently and directly fixed to the frame 20 by the resin in a transition area 25 during curing or baking.
- the intermediate material 40 is placed firmly on the frame 20 on the side of the frame 20 facing away from the textile 30; here, too, the setting takes place via the resin on the prepregs and the hardening or baking during further processing.
- the intermediate material 40 can also be arranged between the textile 30 and the frame 20, as is shown at the right-hand end of FIG.
- the resin then penetrates the inter mediate material 40 completely and also connects to part of the textile 30, for example to the side of the goods facing the frame 20.
- the textile 30 is thus fixed to the frame 20 via the intermediate material 40.
- the resin preferably does not penetrate completely through the textile 30, in order to avoid that hardened resin is present on the inner surface of the prosthesis socket 10.
- cushioning material 41 is arranged on the edge of the prosthesis shaft, which was baked together with the prepregs.
- the cushioning material can be the same material as the material of the intermediate layer 40 and can consist of or comprise an elastomer which is cured in the end state.
- FIG. Figure 4 is a variant of the embodiment according to Figure 3 and also shows a see- matic sectional view through a proximal area of a prosthesis shaft.
- a textile 30 is positioned from the inside of the prosthesis socket and is connected to the dimensionally stable frame 20 of the prosthesis socket via a resin layer in the transition area 25.
- the resin layer penetrates both the textile 30 and the frame 20 in the transition region 25, because the resin from the material of the frame 20 is provided during the manufacture of the prosthesis socket. Excess resin from the starting materials penetrates at least partially into the textile 30 and causes a permanent and secure connection of the textile 30 to the hardened frame 20.
- a window 50 or a recess is arranged, into which, for example, an electrode Sensor, an actuator or the like can be introduced.
- another material 40 is arranged around the opening or the window 50, which in the final state consists of a cured elastomer or contains a cured elastomer.
- This further material layer is attached as a surface layer 40 on the outside of the frame 40 and forms the top layer, that is, the layer furthest away from the skin.
- the surface layer 40 can be applied before or after the introduction of the window 50, it serves to make the window 50 easier to insert in order to position electrodes or other devices in the prosthesis socket Hole as well as in the definition of the electrode or the further component within the opening.
- the surface length 40 can also be designed closed or have an opening smaller than the window 50 or surround the edge of the opening.
- the further material 40 is designed as a combined cushion and surface layer 40.
- a layer or an area of the additional material made of cured elastomer or cured elastomer is applied around the edge area of the respective material Frame 20 and the textile 30 to protect.
- a lip or a pad is formed on the front side, which protects against the hard edge of the frame 20 when the limb is inserted.
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE102019132290.1A DE102019132290A1 (en) | 2019-11-28 | 2019-11-28 | Prosthetic socket and process for its manufacture |
PCT/EP2020/083616 WO2021105346A1 (en) | 2019-11-28 | 2020-11-27 | Prosthesis socket and method for producing same |
Publications (1)
Publication Number | Publication Date |
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EP4065053A1 true EP4065053A1 (en) | 2022-10-05 |
Family
ID=73646322
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP20816446.7A Pending EP4065053A1 (en) | 2019-11-28 | 2020-11-27 | Prosthesis socket and method for producing same |
Country Status (4)
Country | Link |
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US (1) | US20220409407A1 (en) |
EP (1) | EP4065053A1 (en) |
DE (1) | DE102019132290A1 (en) |
WO (1) | WO2021105346A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
NL1044517B1 (en) | 2023-01-06 | 2024-07-16 | Genistarus Bvba | Connection assembly for connecting together two pipe sections |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7488349B2 (en) * | 2006-03-24 | 2009-02-10 | Ossur Hf | Ventilated prosthesis system |
DE102006045517A1 (en) * | 2006-09-27 | 2008-04-03 | Stefan Ostendorff | Sleeve or beaker-like prosthetic shaft for arms or legs comprises an inner chamber for holding a sliding body stump and a wall with a window surrounding the hollow chamber |
DE102006046927A1 (en) * | 2006-09-29 | 2008-04-03 | Otto Bock Healthcare Ip Gmbh & Co. Kg | Prosthesis with shaft for accommodating amputation stump has inner shaft with fitting(s) for locking in corresponding opening in outer shaft to prevent axial extraction movement and relative rotation |
US8323353B1 (en) * | 2008-03-04 | 2012-12-04 | Randall D. Alley | Method for use of a compression stabilized prosthetic socket interface |
WO2012021823A1 (en) * | 2010-08-12 | 2012-02-16 | Cj Socket Technologies | Adjustable prosthetic limb socket |
DE102011117801A1 (en) * | 2011-11-03 | 2013-05-08 | Otto Bock Healthcare Gmbh | prosthetic socket |
FR3011176B1 (en) * | 2013-10-01 | 2017-05-19 | Pommier Orthopedie | PROTHETIC EMBODY, METHOD FOR MANUFACTURING SUCH BOOM |
DE102015112028A1 (en) * | 2015-07-23 | 2017-01-26 | Otto Bock Healthcare Products Gmbh | Method for producing a prosthesis socket and prosthesis socket |
US10172728B2 (en) * | 2015-11-25 | 2019-01-08 | Lim Innovations, Inc. | Transtibial prosthetic socket with textile jacket |
US10004614B1 (en) * | 2016-11-02 | 2018-06-26 | Joe Johnson | Disarticulated compression socket |
US10806607B2 (en) * | 2017-02-06 | 2020-10-20 | Ossur Iceland Ehf | Adjustable socket system |
-
2019
- 2019-11-28 DE DE102019132290.1A patent/DE102019132290A1/en active Pending
-
2020
- 2020-11-27 EP EP20816446.7A patent/EP4065053A1/en active Pending
- 2020-11-27 WO PCT/EP2020/083616 patent/WO2021105346A1/en unknown
- 2020-11-27 US US17/780,008 patent/US20220409407A1/en active Pending
Also Published As
Publication number | Publication date |
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DE102019132290A1 (en) | 2021-06-02 |
US20220409407A1 (en) | 2022-12-29 |
WO2021105346A1 (en) | 2021-06-03 |
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