Cover shell for a prosthesis

Description

TECHNICAL FIELD AND PRIOR TECHNOLOGY

[0001] The present invention relates to a prosthesis covering.

[0002] Following a limb amputation, to regain mobility, a patient is usually fitted with a prosthesis that partially replaces the function of the lost limb. The physical form of such a prosthesis is determined by the constraints imposed by its function. For example, to obtain a leg replacement prosthesis, the prosthesis includes a bar ending in a mechanical joint to assume leg functionality as closely as possible. The physical appearance of the prosthesis is of secondary importance.

[0003] To achieve an aesthetic similarity to the missing limb, a prosthesis can be fitted with a covering. An example of such a covering is described in document EP 2 944 290 A1. To obtain a natural appearance, the covering described in the cited document is shaped like a leg. Furthermore, openings are provided to allow ventilation and to reduce the weight of the covering.

[0004] WO 2017 / 012888 describes an exoskeletal structure according to the preamble of claim 1.

[0005] The envelopes known in the prior art only imperfectly reproduce a replaced limb. DESCRIPTION OF THE INVENTION

[0006] The aim of the present invention is therefore to offer a prosthetic cover for a given limb that more realistically reproduces the replaced limb.

[0007] The stated objective is achieved by a sheath that, to the touch, resembles the replaced limb. The sheath of the present invention resembles, in its flexibility, the various parts felt when touching the replaced limb. Such a sheath is described in claims 1-8.

[0008] Also described is a set of a dressing envelope, as mentioned above, for a leg prosthesis and a dressing envelope for a foot prosthesis, according to claims 9-13.

[0009] A method for manufacturing such an envelope according to the invention is described in claims 14 and 15. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The present invention will be better understood on the basis of the following description and the accompanying drawings, in which: [ Fig. 1 ] shows an example of a prosthesis covering according to a first view, [ Fig. 2] shows an anatomy of a given limb from a first view, [ Fig. 3 ] shows an example of a prosthesis covering from a second view, [ Fig. 4 ] shows an anatomy of a given limb from a second view, [ Fig. 5 ] shows a longitudinal cross-sectional view of a prosthesis casing and a prosthesis, [ Fig. 6 ] shows a perspective view of another example of a prosthetic cover and a prosthetic foot cover, [ Fig. 7 ] shows an example of a prosthetic foot shell and a ring including lugs, [ Fig. 8 [ ] shows a detailed view of the prosthesis dressing envelope of the figure 6 including lugs at one end for connection to the prosthetic foot shell, [ Fig. 9 ] shows an enlarged view of the dressing cover placed on the prosthetic foot cover, [ Fig. 10 ] shows the outer casing of the figure 9separated from the prosthetic foot casing. DETAILED DESCRIPTION OF SPECIFIC METHODS OF IMPLEMENTATION

[0011] An example of how to make a prosthesis cover is illustrated in Figures 1 , 3 , 5, 6 And 8 à 10 .

[0012] THE figures 2 And 4 They show the anatomy of a given limb. In this example, it is the lower part of a leg. More precisely, it is the tibial part of a human leg.

[0013] In the said figures, parts of the leg with different hardnesses are identified (7, 8).

[0014] Between the knee (30) and the ankle (31) extends the tibia (13), which is one of the most important bones of this lower limb. Also visible is the tibialis anterior (14), which is one of the muscles (15) of the tibial part of the human leg.

[0015] The tibia (13) is located under the skin (not shown) of the leg. This bone extends almost in a straight line from the knee to the ankle. Between the tibia and the skin lies the tibialis anterior (14). This muscle extends, under the skin, from the outer side (32) of the knee to the inner side (33) of the ankle and passes through the tibia. Thus, one can identify a section where the tibia lies directly under the skin and a section where the tibialis anterior lies directly under the skin, between the skin and the tibia.

[0016] By touching the skin of the leg, one can thus distinguish a first part of hardness (7) and a second part of hardness (8), that is to say, parts of the limb having different hardnesses.

[0017] To the touch, an area will feel soft if a muscle or tendon is directly under the skin. An area will feel hard if a bone is directly under the skin.

[0018] In this example, the part of the leg where the tibia lies directly under the skin feels hard, while the part where the tibialis anterior lies directly under the skin feels soft. This identifies two parts of the leg with different levels of firmness.

[0019] With more careful touch, one can differentiate even more than two areas of varying hardness. For example, an area with more muscle tissue between the skin and the shinbone will feel harder than an area with less muscle tissue. An area containing a tendon will feel harder than an area containing a muscle, but softer than an area containing bone.

[0020] Other soft and hard parts of the leg are formed by the position of other bones, muscles and tendons on the leg, such as the peroneus longus (17), the extensor digitorum longus (18), the gastrocnemius (19) or the Achilles tendon (20). Thus, a plurality of parts of the leg with different hardnesses can be identified.

[0021] Parts of a limb with different hardnesses have been exemplified for a lower leg, but they can also be found on the upper leg, arm, and other parts of the body.

[0022] The arrangement of the limb's parts with varying degrees of hardness—that is, the delineation of a hard or soft zone and the relative position of a hard zone in relation to a soft zone—depends on the anatomy of the chosen limb. This arrangement is a characteristic of the given limb that is replaced by the prosthesis.

[0023] The present embodiment relates to a casing for a leg prosthesis, but the invention also applies to other parts of the body with different hardnesses.

[0024] THE Figures 1 , 3 And 5 show a covering (1) for a prosthetic leg (12). On the Figures 1 , 3 And 5 We identify a tubular-shaped covering (23) and a covering for a prosthetic foot (25). The prosthesis is fixed by means of a prosthetic socket (29) onto a user's residual limb ( figure 5 ).

[0025] There figure 5 shows an inner surface (22) and an outer surface (21) of the envelope. The thickness of the envelope is a quantity of material between said inner surface and outer surface of the envelope. We identify on the Figures 1 And 3also a first thickness (3.1, 3.2, 3.3) of the envelope, a second thickness (9.1, 9.2) and a change in thickness (4.1, 4.2) located between the first (3.1, 3.2, 3.3) and the second (9.1, 9.2) thickness.

[0026] A tubular shape is understood to be a cylindrical form that can have cross-sections of varying shapes and sizes. The tubular shape can also be curved and thus predominantly follow a non-straight axis. The envelope shown in the figure 5 This presents a cross-section of different shapes and sizes at the calf and ankle. This tubular-shaped envelope could also be curved to follow a socket (29) that is angled relative to the prosthesis (12). An envelope shaped like a leg or arm thus has a tubular form.

[0027] The change in thickness thus delimits a first zone (5.1, 5.2) having the first thickness (3.1, 3.2, 3.3) from a second zone (6.1, 6.2) having the second thickness (9.1, 9.2).

[0028] The envelope exhibits flexibility dependent on its thickness. Thus, if the first zone (5.1, 5.2) has a greater thickness than the second zone (6.1, 6.2), the first zone (5.1, 5.2) will have less flexibility than the second zone (6.1, 6.2).

[0029] In other words, if the first zone (5.1, 5.2) has a greater thickness than an average thickness of the envelope and if the second zone (6.1, 6.2) has a lesser thickness than an average thickness of the envelope, the first zone (5.1, 5.2) will have less flexibility than the second zone (6.1, 6.2).

[0030] Different zones of flexibility can also be achieved by using different materials. One zone can be made of one material, and a second zone of another. The first material may be less flexible than the second, resulting in two different zones of flexibility.

[0031] A difference in material can be understood as a difference in the chemical composition of the material. Thus, a polymer used may be more flexible if it includes an added chemical component, for example, if it includes a plasticizer.

[0032] A difference in material can also be understood as a difference in macroscopic composition. For example, a second zone might contain thermoplastic polyurethane. A first zone might contain thermoplastic polyurethane and also carbon fibers. This results in two zones with different levels of flexibility, the first zone having less flexibility than the second due to the properties of the carbon fibers.

[0033] It is also possible to obtain different zones of flexibility by varying the three-dimensional pattern impregnated onto the area. For example, a second zone might consist of thermoplastic polyurethane. A first zone might consist of thermoplastic urethane impregnated with a three-dimensional pattern, making that zone less flexible.

[0034] When touching the outer layer, the area of ​​greater flexibility gives the impression of touching a soft part of a limb, while the area of ​​less flexibility gives the impression of touching a hard part of a limb.

[0035] The cladding envelope can also include multiple zones with varying degrees of flexibility. Two, three, four, or more zones can be included, each with two, three, or more different flexibilities. For example, five zones could be included, each with three different flexibilities.

[0036] In this way, it is possible to obtain a variety of different flexibilities. This allows for a garment that, to the touch, offers a range of different hardnesses. In this way, the garment can more accurately resemble the feel of a limb's anatomy because, upon closer examination, one can distinguish more than two areas of varying hardness within the anatomy of a limb. It is also possible to vary a combination of thickness, material, and / or three-dimensional structure to achieve different zones of flexibility.

[0037] Different envelope thicknesses can be achieved by varying the thickness of the material used in its construction. It is also possible to use a multi-layered material and vary the number of layers in different areas to achieve the desired envelope thickness. Alternatively, the layers can be made of different materials.

[0038] By comparing the envelope of the figure 1 with the anatomy of the figure 2 We observe that the arrangement of the different flexibility zones (5.1, 5.2, 6.1, 6.2) with each other corresponds to the arrangement of the parts of the limb having different hardnesses (13, 14, 17).

[0039] We observe on the figure 1 that the second zone (6.1) is arranged predominantly longitudinally, curving downwards. The first zone (5.1) is arranged so as to widen from top to bottom.

[0040] The first zone (5.1) is thus arranged in relation to the second zone (6.1) on the envelope as the tibia (13) is arranged in relation to the anterior tibial (14).

[0041] The arrangement of the zones varies from patient to patient, just as the position of bones, muscles, and tendons varies from patient to patient.

[0042] In this example, the first zone (5.1) is thicker than the second zone (6.1). The first zone therefore feels harder to the touch than the second zone. The second zone feels softer than the first zone.

[0043] By touching the casing, the user receives a sensation similar to touching the lower part of a human leg. The first zone (5.1) will feel like touching the shinbone, and the second zone like touching the tibialis anterior muscle. By sliding a finger between the first zone (5.1) and the second zone (6.1), the change in flexibility, caused by the change in the casing's thickness, is felt like a change in firmness, between a soft and a hard part of a human leg.

[0044] Similarly, we observe on the figures 3 and 4 that a second zone (6.2) having a lesser thickness is arranged on the envelope like the long fibularis (17) on the tibial part of a leg.

[0045] A change in thickness to delimit areas of different flexibility can also be achieved by a rib or a notch on the covering envelope.

[0046] There figure 3shows a rib (10) on the outer casing to achieve less flexibility at the location of the rib. figure 3 also shows a notch (11) to obtain increased flexibility at the location of the notch.

[0047] A rib or notch represents a change in the thickness of the outer layer. An outer layer with a rib comprises a first zone and a second zone of different thicknesses. For example, the first zone, which is thicker, can be identified as the area of ​​the rib itself. The second zone, which is thinner than the first, is, in this case, the area outside the rib's location.

[0048] The use of ribs or notches allows for a particularly fine arrangement of different areas of flexibility.

[0049] Advantageously, the casing comprises a thermoplastic polyurethane (TPU) and / or a polyamide.

[0050] Thermoplastic polyurethane (TPU) offers several advantages for manufacturing prosthetic shells. It allows for a good imitation of a contralateral limb, is waterproof, and is easy to clean. Under impact, a shell made of this material deforms silently. Due to its elasticity and flexibility, TPU is particularly well-suited for creating zones of varying flexibility to mimic a physiological feel. A shell made of this material is lightweight and does not add excessive weight to the prosthesis.

[0051] The casing can be manufactured using a 3D printing process, for example by powder fusion.

[0052] The first zone (5.1, 5.2) and the second zone (6.1, 6.2) may have a longitudinal shape ( figure 1, 2 ) on the dressing envelope, the longitudinal shape extending along an extension of the limb.

[0053] In the example implementation shown to Figures 1 , 3 And 5 The cladding envelope has a tubular shape. The first thickness (3.1, 3.2, 3.3) and the second thickness (9.1, 9.2) remain mostly constant along one length of the envelope. The thickness changes mainly along a circumference of the tubular shape of the envelope.

[0054] In the particular case of ribs or notches, said ribs and notches extend predominantly along a length of the tubular shape.

[0055] An arrangement such as the one described above is particularly well suited for the manufacture of a prosthetic casing for an arm or a leg.

[0056] The muscles, tendons, and bones of the arm and leg are mostly elongated along the length of the arm or leg. For this reason, when touching an arm or leg, one feels little change in hardness as one moves along the limb. A rib or notch along the length of the tubular form causes a change in hardness to be felt if a user runs their finger along the circumference of the casing, the hardness remaining constant along the length of the tubular form. To the touch, the casing thus replicates the behavior of a leg or arm.

[0057] There figure 5The illustration shows the outer casing (1) for a tibia and an outer casing for a prosthetic foot (25). A lower limb prosthesis (12), more specifically a tibia, comprising a prosthetic socket (29) is also shown. In the example shown, the connection between the socket and the foot prosthesis is ensured by an internal element (12), for example, a stem or a bar.

[0058] Similarly (image not shown), a rigid cage can be used to connect the socket to the prosthetic foot. In this case, the cage replaces the tube mentioned above. The cage provides stability and transmits force between the prosthetic foot and the socket. In this case, the outer shell houses the cage inside, thus encasing it.

[0059] The use of a cage is particularly well-suited for implementing an arm prosthesis. The cage connects the socket to a hand prosthesis. The prosthesis itself is a rigid cage, attached at one end to a prosthetic socket. The hand prosthesis is attached to the other end of the cage. A prosthetic hand cover is then attached to the cage. A prosthetic hand cover can be attached to the prosthetic hand. The cage can be made of carbon fiber or thermoplastic polyamide, for example, PA12. The cover for the arm prosthesis and the cover for the hand prosthesis can be made in two parts. They can also be made from a single piece of material, thus covering both the arm and hand prostheses in a single continuous piece.

[0060] The casing has a tubular shape (3) comprising an inner surface (22) and an outer surface (21). The casing houses the prosthesis inside and thus encloses the prosthesis. The casing is placed with its lower edge (36) onto the prosthetic foot casing (25).

[0061] Advantageously, the outer surface (21) of the envelope is mostly smooth compared to the changes (4.1, 4.2) delimiting different flexibility zones.

[0062] The expansion or contraction of the material that forms a greater thickness (e.g., a rib) or a lesser thickness (e.g., a notch) takes place towards the interior of the envelope ( figure 5 ), towards the prosthesis. The surface thus remains smooth.

[0063] More precisely, the inner surface (22) moves away from or towards the outer surface (21) to cause a change in thickness. The entire outer and inner surfaces, forming a wall of the envelope, can conform to a shape resembling the anatomy of a limb. For example, on the figure 5 The wall between the outer surface (21) and the inner surface (22) curves downwards, making the casing, at that point, resemble a calf. A smooth outer surface means that the inner surface, while following the shape of the outer surface, moves away from and towards the outer surface to form areas of varying thickness. In the specific case of ribs (10) and / or notches (11), predominantly smooth means that the rib and / or notch is located on the inside of the casing.

[0064] The smooth exterior of the casing gives it an even more physiological feel, corresponding to smooth skin with different hardnesses to the touch.

[0065] It is also possible to design a mostly smooth interior surface and to locate the changes (4.1, 4.2) on an exterior surface. Thus, the ribs and / or notches can be oriented towards an exterior surface.

[0066] Also, changes (4.1, 4.2) can be located on the outer surface and on the inner surface.

[0067] There figure 6 The figure shows the covering (1) for a prosthetic leg, the covering having a tubular shape and including an articulation area (24). Also shown is the covering for a prosthetic foot (25) which can be made of polyurethane foam.

[0068] The dressing cover (1) is placed over the prosthetic foot cover. Inside the dressing cover is positioned the prosthesis (12) also shown on the figure 5 .

[0069] In the example shown, the joint area (24) is provided at the level of an ankle, but it could also be at the level of a knee if the casing is intended for another type of prosthesis, such as a prosthesis for a whole leg.

[0070] In this example, the joint area (24) has openings in the prosthesis shell. More specifically, in this example, these are diamond-shaped openings located at the ankle. Other shapes of openings can be used, for example, circles or rectangles. Due to the absence of material in the openings, the shell is more flexible at the openings than elsewhere. The shell can therefore easily deform at the ankle to follow the movement of a prosthesis during walking.

[0071] The diamond-shaped openings also allow access to the prosthesis located inside the outer casing. In the example shown ( figure 6), it is possible to access the prosthesis through diamond-shaped openings. This allows the prosthetic foot to be disconnected from the other parts of the prosthesis without having to modify the prosthesis shell. Maintenance procedures are also possible without removing the outer shell. Other openings, for example at the calf, above the joint area (24) (see figure 6 These openings may be designed to allow access to other prosthesis adjustment components (e.g., a valve, a locating device). The distribution of these openings is specific to each prosthesis and depends on the needs of each patient.

[0072] THE figures 7 to 10 They show the dressing shell (1) having the articulation area (24) and the prosthetic foot shell (25). The foot shell has recesses (34) on an open side.

[0073] There figure 8also shows lugs (27) on a lower edge of the envelope (36), but in some cases a single lug might be sufficient to ensure a stable connection.

[0074] According to a first embodiment, the lug (27) and the cover (1) are formed in one piece. The lugs are made from the same material as the cover.

[0075] There figure 7 shows a ring (26) having a first surface and a second surface. The second surface is provided with lugs (27). According to a second embodiment, the first surface of the ring (26) is fixed, preferably glued, to the lower edge of the prosthesis casing.

[0076] The covering envelope thus includes at least one lug (27) on a lower edge (36).

[0077] This lower edge will be opposite the prosthetic foot casing ( Figure 9, 10 ).

[0078] The lugs (27) are thus oriented outwards, towards the foot casing ( Figure 10 ). The covering (1) can be attached to the foot cover (25) to form a complete covering for a prosthesis. During assembly, the lugs of the ring fit reversibly into the holes (34) provided on the open side of the prosthetic foot cover ( Figure 9, 10 Since the assembly is reversible, the outer shell can be separated from the foot shell by gently pulling on either piece. The tibial prosthesis can thus be easily disassembled without the need to modify the outer shell, such as by cutting or deforming it.

[0079] Through openings in the articulation area, the prosthesis located inside the outer shell can be accessed, if necessary with a tool. Other openings may be present to access different adjustment elements of the prosthesis, such as a valve or a keying device.

[0080] This allows us to detach the prosthetic foot from the rest of the prosthesis. Next, we remove the prosthetic foot from the rest of the prosthesis by separating the outer casing from the prosthetic foot casing by disengaging the tabs from the holes (34).

[0081] In another embodiment, the covering can be made from the same material as the prosthetic foot cover. According to this embodiment, the covering forms a continuous element of material with the prosthetic foot.

[0082] THE figures 5 and 6 also show a clamping collar (28) on an upper part (35) of the covering envelope.

[0083] The clamping collar secures the shell (1) onto the prosthesis socket (29). The collar is arranged to allow slight sliding between the shell and the socket so that the aesthetics are not compromised when walking with the prosthesis including the shell.

[0084] The envelope described above can be advantageously manufactured by the process described below.

[0085] In the first step, a three-dimensional image of a limb is obtained.

[0086] For example, a patient's non-amputated limb is scanned using a 3D scanner to obtain the image. This image provides a representation of the limb's surface; that is, a three-dimensional digital representation of the limb. The digital representation of the limb is a three-dimensional surface.

[0087] Alternatively, a three-dimensional image from a data library could be used. In this case, the image is obtained from a library of morphotypes based on the patient's height and weight.

[0088] We could also use a scanned image of the patient's limb taken before the limb amputation.

[0089] In the present example, we obtain a digital representation of a tibial part of a leg, that is to say, a digital representation of a lower part of the leg as shown in the figures 2 And 4 .

[0090] Similarly, a digital representation of a foot can also be obtained. As described above, it is possible to use a 3D scanner or retrieve an image from an image library.

[0091] Similarly, a digital representation of a leg with its foot can also be obtained, using a 3D scanner or by retrieving an image from an image library.

[0092] Similarly, one can also obtain a digital representation of a hand, of an arm with its hand, or of an arm and a hand separately.

[0093] In a second step, the parts of the limb with different hardnesses (7, 8) are identified on the digital representation of the limb. This identification can be done automatically, manually by an operator, or by an operator assisted by an algorithm. This identification can be performed on the entire digital representation or only on a portion of it. In the example of a digital representation of a leg with its foot, this identification can be done, for instance, only on the leg portion, excluding the foot. Following this step, a boundary between the parts with different hardnesses can be drawn on the representation of the limb. In other words, an arrangement of the parts with different hardnesses can be drawn on the representation of the limb.

[0094] For example, on a digital representation of the tibial portion of a leg, the part corresponding to the tibia and the part corresponding to the tibialis anterior are identified. Then, a line is drawn on the digital representation to delineate an extension of the tibia and tibialis anterior under the skin.

[0095] In a third step, the aesthetics are designed. The second and third steps can be carried out using computer-aided design (CAD) software.

[0096] On a digital model of the envelope, a zone is defined by defining its shape. A zone shape is then drawn on the envelope's surface. Next, the flexibility of this zone is defined. For example, the thickness of the envelope material within this zone is specified. At the end of this step, an arrangement of zones with varying degrees of flexibility, obtained for example by different thicknesses, is defined on the envelope.

[0097] The shape and flexibility of the zones are defined so as to correspond to the arrangement of parts of the limb having different hardnesses.

[0098] In an example using different thicknesses, on the envelope, a first zone with a greater thickness will be located relative to a second zone with a lesser thickness, just as a harder part of the limb is located relative to a less hard part on the digital representation of the limb, said parts being identified previously as described above.

[0099] To check the arrangement of said zones in relation to each other and the correspondence to the arrangement of the parts of the limb, the digital representation of the prosthesis envelope can be projected onto the digital representation of the limb.

[0100] In this way, an area with a greater than average thickness is arranged to coincide with a hard part of the limb and / or an area with a less than average thickness is arranged to coincide with a soft part of the limb.

[0101] For example, we trace on a digital model of the envelope as seen in the figure 1 a first zone (5.1) corresponding by its shape to part (13) of the tibia. The part of the tibia was previously identified on the digital representation of the leg.

[0102] Next, a second zone (6.1) is drawn on the digital model of the envelope corresponding by its shape to the part (14) of the anterior tibial, as identified on the digital representation of the leg previously.

[0103] Next, a greater thickness is associated with the first zone and a lesser thickness with the second zone.

[0104] The resulting shell will be less flexible in the first zone than in the second, just as a leg is firmer in the area corresponding to the tibia and softer in the area corresponding to the anterior tibial. In this way, the shell provides a physiological feel to the user.

[0105] It is also possible to give the envelope the shape of the limb as deduced from the digital representation of the original limb. In this way, the envelope adopts the shape of the limb. The envelope can thus adopt the three-dimensional shape of the leg, for example, the tibia, the arm, the foot, or the hand. The envelope can also adopt the shape of the leg with its foot or the arm with its hand, and thus reproduce a complete limb shape.

[0106] An envelope that conforms to the shape of the limb and simultaneously provides a physiological feel is particularly well suited to provide a user with a natural feeling when wearing their prosthesis.

[0107] The manufacturing process may also include a 3D scanning step of the prosthesis (12) that is to be covered by the envelope, in order to adapt the envelope to the prosthesis during the computer-aided design process.

[0108] The casing can then be manufactured using a 3D printing process from the digital model. More specifically, powder sintering 3D printing can be used, for example with TPU.

[0109] It is therefore possible to manufacture a covering for a leg prosthesis or for an arm prosthesis.

[0110] In the case of a leg prosthesis, the outer casing can be manufactured from a digital representation of a complete leg and foot, using the process described above. In this case, it is possible to manufacture a complete casing for both the foot and the leg prosthesis. The casing for the leg and the casing for the foot prosthesis can be manufactured as two separate parts. Alternatively, the casing for the leg and the casing for the foot prosthesis can be manufactured from a single piece of material. In the latter case, a prosthesis casing is obtained that can cover both the foot and the leg prosthesis in a single continuous piece of material. In other words, from a digital representation of a complete leg and foot, a casing can be manufactured that covers both the leg and foot prostheses with a single continuous piece of material.This covering can be given the shape defined by the digital representation. In other words, the covering of the leg prosthesis reproduces the shape of the leg according to the digital representation, and the covering of the foot prosthesis reproduces the shape of the foot according to the digital representation. In summary, from a representation of a complete leg with its foot, a covering for a complete prosthesis, including a tibial prosthesis with a foot prosthesis, can be obtained. This covering can have the shape of the complete leg with its foot and provide, in certain areas or completely, a physiological feel.

[0111] Similarly, a casing can be created for an upper limb prosthesis, such as an arm. In the case of an arm prosthesis, the casing can also be manufactured from a digital representation of a complete arm with its hand, using the process described above. The casing for the arm prosthesis and the casing for the hand prosthesis can be manufactured as two separate parts or as a single piece of material. In other words, it is possible to create, from a digital representation of the complete arm with its hand, a casing that covers both the arm and hand prostheses with a single continuous piece of material. The casing can take the shape defined by the digital representation of the arm, with or without its hand.

Claims

1. Covering shell (1) for a prosthesis (12) of a given limb (2), the shell comprising at least two zones (5.1, 5.2, 6.1, 6.2) of different flexibility (3.1, 3.2, 3.3, 9.1, 9.2), Characterise din that : the arrangement of said zones in relation to one another correspond to the arrangement of the parts of the given limb having different hardnesses (7, 8).

2. Shell according to claim 1, wherein a first zone (5.1, 5.2) differs from a second zone (6.1, 6.2) in relation to: - a thickness and / or - a material and / or - a three-dimensional pattern in order to obtain a first zone having a different flexibility from a second zone.

3. Shell according to claim 1 or 2, wherein: - a first zone has a lesser flexibility (3.1, 3.2, 3.3) than a second zone, the first zone being arranged to coincide with a hard part (7) of the limb, and / or - a second zone has a greater flexibility (9.1, 9.2) than a first zone, the second zone being arranged to coincide with a soft part (8) of the limb, preferably wherein: - the first zone (5.1., 5.2) and the second zone (6.1, 6.2) have different thicknesses, and - the first zone and the second zone are a rib (10) or a recess (11).

4. Shell according to one of claims 1 to 3, wherein the shell has a tubular shape capable of receiving said prosthesis (12) inside the tubular shape, preferably wherein : - a flexibility of the shell remains mostly constant along a length of the tubular shape, and / or - the flexibility of the shell mostly changes along a circumference of the tubular shape.

5. Shell according one of the preceding claims, the shell being adapted for housing a leg prosthesis, preferably a tibia prosthesis or an arm prosthesis, therein.

6. Shell according to claims 2 and 5 wherein: - a zone having a greater thickness (3.1, 3.2, 3.3) than a mean thickness of the shell, the zone being located on the shell like the tibia (13) is located under a leg's skin and / or - a zone having a lesser thickness (6.1, 6.2) than a mean thickness of the shell is located on the shell like a muscle (15) or a tendon (16) is located under a leg's skin, the muscle or the tendon being preferably the soleus (30), the tibialis anterior (14), the fibularis longus (17), the extensor digitorum longus (18), the gastrocnemius (19) or Achille's tendon (20).

7. Shell according to one of the preceding claims in combination with claim 2, wherein an outer surface (21) of the shell is mostly smooth and the changes in thickness are located on an inner surface (22) of the shell.

8. Shell according to one of the preceding claims, wherein: - a material of the shell comprises a thermoplastic polyurethane (TPU) and / or - a material of the shell comprises a polyamide.

9. Assembly of a covering shell for a leg prosthesis and a covering shell for a foot prosthesis, the covering shell being according to one of claims 1 to 8, the covering shell of the leg prosthesis being integral with the covering shell of the foot prosthesis.

10. Assembly of a covering shell for a prosthesis according to one of claims 1 to 8 and a covering shell for a prosthetic foot (25), the covering shell having a tubular shape (23) and comprising at least one lug (27) on a bottom edge (36) of the tubular shape, the lug being capable of interlocking reversibly in the shell of the prosthetic foot (25), so as attach it removably to the tubular shape, preferably comprising a ring (26) with a first surface and a second surface, the first surface of the ring comprising the lug (27), the second surface of the ring being attached, preferably bonded, to the bottom edge (36) of the tubular shape.

11. Shell according to one of claims 1 to 8, wherein the shell comprises a gripping collet (28), said collet being capable of attaching an upper part of the tubular shape to a prosthesis socket (29) so as to enable sliding between the tubular shape and the socket.

12. Assembly according to one of claims 9 or 10, wherein the shell comprises a gripping collet (28), said collet being capable of attaching an upper part of the tubular shape to a prosthesis socket (29) so as to enable sliding between the tubular shape and the socket.

13. Assembly of a covering shell for an arm prosthesis and a covering shell for a hand prosthesis, the covering shell being according to one of claims 1 to 8, the covering shell of the arm prosthesis being integral with the covering shell of the hand prosthesis or the covering shell of the hand prosthesis being removably attached to the covering shell of the arm prosthesis.

14. Method for manufacturing a shell according to one of claims 1 to 13, the method comprising the following steps: - obtaining a three-dimensional image of a limb, - identifying in the image the parts of the limb having different hardnesses (7, 8), - defining on a digital model of the shell zones of different flexibility (5.1, 5.2, 6.1, 6.2) so as to correspond to the arrangement of said parts identified in said image, - producing the shell from the digital model, preferably wherein - the three-dimensional image is obtained from a complete leg with its foot or from a complete arm with its hand, - the shell comprises the shell of the leg prosthesis and the shell of the foot prosthesis or the shell of the arm prosthesis and the shell of the hand prosthesis, the method preferably comprising the following step: - identifying in the image the shape of the leg - defining the digital model of the shell such that the shape of the shell corresponds to the shape of the limb as identified in the image.

15. Method according to claim 14, wherein the production step is a step of 3D printing, preferably using powder melting, of the shell from said digital model.