PROSTHETIC COVER

Abstract

A covering (1) for a prosthesis (12) of a given limb (2), the covering comprising at least two zones (5.1, 5.2, 6.1, 6.2) of different flexibilities (3.1, 3.2, 3.3, 9.1, 9.2), the arrangement of said zones in relation to each other corresponding to the arrangement of parts of the given limb having different hardnesses (7, 8). Figure for the abbreviation: Figure 1.

Description

Title of the invention: PROSTHESIS COVERING ENVELOPE

[0001] TECHNICAL FIELD AND STATE OF THE PRIOR ART

[0002] The present invention relates to a covering envelope for a prosthesis.

[0003] Following a limb amputation, to regain mobility, a patient is usually fitted with a prosthesis that will partially replace the functionality 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 in order to assume as much leg functionality as possible. The physical aspect of the prosthesis remains of secondary importance.

[0004] In order to provide a similar aesthetic to the lost limb, a prosthesis may be adorned with a covering envelope. An example of such an envelope is described by document EP 2 944 290 AL To obtain a natural appearance, the envelope described by the cited document takes the shape of a leg. In addition, openings are provided to allow ventilation and to reduce the weight of the envelope.

[0005] The envelopes known in the prior art only imperfectly reproduce a replaced member. Statement of the invention

[0006] The aim of the present invention is then to provide a covering envelope for a prosthesis of a given limb which reproduces the replaced limb more realistically.

[0007] The above-stated object is achieved by a cover which resembles, to the touch, the replaced limb. The cover of the present invention resembles in its flexibility the different parts felt when touching the replaced limb.

[0008] In the preferred example, the prosthesis dressing envelope for a given limb comprises:

[0009] at least two different flexibility zones,

[0010] the arrangement of said zones between them corresponding to the arrangement of parts of the given member having different hardnesses.

[0011] The envelope may also comprise a first zone which differs from a second zone with respect to:

[0012] - a thickness and / or

[0013] - a material and / or

[0014] - a three-dimensional pattern,

[0015] in order to obtain a first zone having a flexibility different from a second zone.

[0016] The envelope advantageously comprises

[0017] - a first zone has less flexibility than a second zone, the first area being arranged to coincide with a hard part of the limb, and / or

[0018] - a second zone has greater flexibility (9.1, 9.2) than a first area, the second area being arranged to coincide with a soft part of the limb.

[0019] Preferably,

[0020] - the first zone and the second zone have different thicknesses, and

[0021] - the first zone and the second zone are obtained by a rib or by a notch.

[0022] The envelope may also have a tubular shape capable of receiving said prosthesis inside the tubular shape.

[0023] Preferably,

[0024] - a flexibility of the envelope remains mostly constant along a length of the tubular shape, and / or

[0025] - the flexibility of the envelope changes mainly along a circumference of the tubular shape.

[0026] The envelope may also be provided for a leg prosthesis, preferably for a tibia prosthesis or for an arm prosthesis.

[0027] Advantageously, the envelope can have:

[0028] - an area having a thickness greater than an average thickness of the envelope, the area being located on the envelope as the tibia is located under a skin of a leg and / or

[0029] - an area having a thickness less than an average thickness of the envelope, the area being located on the envelope like a muscle or tendon is located under the skin of a leg,

[0030] the muscle or tendon preferably being the soleus, the tibialis anterior, the long fibular, the long extensor of the toes, the gastrocnemius or the Achilles tendon.

[0031] Said envelope may comprise a predominantly smooth outer surface, the thickness changes being located at an inner surface of the envelope.

[0032] Said envelope may also comprise:

[0033] - a material comprising a thermoplastic polyurethane (TPU) and / or

[0034] - a material comprising a polyamide.

[0035] Also described is an assembly of a dressing envelope, as mentioned above, for a leg prosthesis and a dressing envelope for a foot prosthesis,

[0036] the covering envelope of the leg prosthesis being made in one piece with the covering envelope of the foot prosthesis.

[0037] In an assembly of a covering envelope for a prosthesis and a covering for a prosthetic foot, the covering envelope may have a tubular shape and comprise at least one lug on a lower edge of the tubular shape, the lug being capable of reversibly fitting into the covering of the prosthetic foot, so as to fix it in a removable manner to the tubular shape.

[0038] The assembly may comprise a ring with a first surface and a second surface, the first surface of the ring comprising the lug, the second surface of the ring being fixed, preferably glued, to the lower edge of the tubular shape.

[0039] The envelope or assembly may comprise a clamping collar, said collar being capable of fixing an upper portion of the tubular form to a prosthesis socket so as to allow sliding between the tubular form and the socket.

[0040] Advantageously, a set of a covering envelope for an arm prosthesis and a covering envelope for a hand prosthesis comprises the covering envelope described above,

[0041] the covering envelope of the arm prosthesis being made in one piece with the covering envelope of the hand prosthesis or

[0042] the covering envelope of the hand prosthesis being detachably attached to the covering envelope of the arm prosthesis.

[0043] A method of manufacturing such an envelope may advantageously comprise the following steps:

[0044] - obtain a three-dimensional image of a member,

[0045] - identify on the image the parts of the member having different hardnesses,

[0046] - define different flexibility zones on a digital model of the envelope so as to correspond to the arrangement of said parts identified on said image,

[0047] - production of the envelope from the digital model.

[0048] The manufacturing method may also provide that

[0049] - the three-dimensional image is obtained from a complete leg with its foot or from a full arm with his hand or

[0050] - the envelope comprises the envelope of the leg prosthesis and the envelope of the foot prosthesis or the arm prosthesis cover and the hand prosthesis cover.

[0051] Advantageously, the method also comprises the following steps:

[0052] - identify the shape of the member on the image,

[0053] - define the digital model of the envelope so that the shape of the envelope corresponds to the shape of the member as identified in the image.

[0054] The step of carrying out the method described above is advantageously a step of 3D printing, preferably by powder fusion, of the envelope from said digital model. Brief description of the drawings

[0055] The present invention will be better understood on the basis of the description which follows and the appended drawings in which:

[0056] [Fig-1] shows an example of a prosthesis dressing envelope according to a first sight,

[0057] [Fig.2] shows an anatomy of a given limb according to a first view,

[0058] [Fig.3] shows an example of a prosthesis dressing envelope according to a second view,

[0059] [Fig.4] shows an anatomy of a given limb according to a second view,

[0060] [Fig.5] shows a longitudinal sectional view of a prosthesis dressing envelope and a prosthesis,

[0061] [Fig.6] shows a perspective view of another example of a prosthesis dressing cover and a prosthetic foot cover,

[0062] [Fig.7] shows an example of a prosthetic foot shell and a ring comprising lugs,

[0063] [Fig.8] shows a detail view of the prosthesis covering envelope of [Fig.6] including lugs at one end for connection to the prosthetic foot envelope,

[0064] [Fig.9] shows an enlarged view of the dressing envelope placed on the prosthetic foot envelope,

[0065] [Fig. 10] shows the dressing envelope of [Fig.9] separated from the prosthetic foot envelope.

[0066] DETAILED DESCRIPTION OF PARTICULAR EMBODIMENTS

[0067] An example of an embodiment of a prosthesis dressing envelope is illustrated in figures 1, 3, 5, 6 and 8 to 10.

[0068] Figures 2 and 4 show an anatomy of a given limb. In the present example, it is the lower part of a leg. More precisely, it is a tibial part of a human leg.

[0069] In said figures, parts of the leg having different hardnesses (7, 8) are identified.

[0070] Between the knee (30) and the ankle (31) extends the tibia (13), which is one of the most important bones of this lower limb. We also observe the anterior tibial (14), which is one of the muscles (15) of the tibial part of the human leg.

[0071] The tibia (13) is located under a skin (not shown) of the leg. This bone extends almost in a straight line between the knee and the ankle. Between the tibia and the skin is the tibialis anterior (14). This muscle extends, under the skin, from an outer side (32) of the knee to an inner side (33) of the ankle and crosses the tibia. We can thus identify a part where the tibia is directly under the skin and a part where the tibialis anterior is directly under the skin, between the skin and the tibia.

[0072] By touching the skin of the leg, it is thus possible to 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.

[0073] To the touch, a part will feel soft if a muscle or tendon is directly under the skin. A part will feel hard if a bone is directly under the skin.

[0074] In the present example, the part of the leg where the tibia is directly under the skin is a part felt as hard, the part of the leg where the anterior tibial is directly under the skin is a part felt as soft. We thus identify two parts of the leg having different hardnesses.

[0075] Touched more carefully, one can differentiate even more than two parts of different hardness. For example, a part with more muscle tissue between the skin and the shin will be harder than a part with less muscle tissue between the skin and the shin. A part where a tendon is located will feel harder than a part where a muscle is located, but less hard than a part where a bone is located.

[0076] 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 long fibular (17), the long extensor of the toes (18), the gastrocnemius (19) or the Achilles tendon (20). A plurality of parts of the leg with different hardnesses are thus identified.

[0077] Parts of a limb having different hardnesses have been exemplified for a lower leg, but they can also be found on the upper leg, on the arm and at other places on the body.

[0078] The arrangement of the parts of the limb having different hardnesses, i.e. the delimitation of a hard or soft zone and the relative position of a hard zone with respect to a soft zone depend on the anatomy of the chosen limb. This arrangement is a characteristic of the given limb which is replaced by the prosthesis.

[0079] The present exemplary embodiment relates to an envelope for a leg prosthesis, but the invention also applies to other parts of the body having different hardnesses.

[0080] Figures 1, 3 and 5 show a covering envelope (1) for a leg prosthesis (12). In Figures 1, 3 and 5, a covering envelope having a tubular shape (23) and an envelope for a prosthetic foot (25) are identified. The prosthesis is fixed by a prosthesis socket (29) on a stump of a user ([Fig.5]).

[0081] [Fig.5] shows an inner surface (22) and an outer surface (21) of the casing. The thickness of the casing is a quantity of material between said inner surface and outer surface of the casing. Figures 1 and 3 also identify a first thickness (3.1, 3.2, 3.3) of the casing, 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.

[0082] By tubular shape is meant a cylindrical shape which can have sections having a variable shape and size. The tubular shape can also be curved and thus mainly follow a non-straight axis. The envelope shown in [Fig.5] thus has a section of shape and size which is different at a level of the calf and at a level of the ankle. This tubular shaped envelope could also be curved and thus follow a socket (29) which has an angle relative to the prosthesis (12). An envelope which has a leg or arm shape thus has a tubular shape.

[0083] 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).

[0084] The envelope has flexibility depending 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).

[0085] In other words, if the first zone (5.1, 5.2) has a thickness greater than an average thickness of the envelope and if the second zone (6.1, 6.2) has a thickness less 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).

[0086] Different flexibility zones can also be obtained by a difference in material. A first zone can be made of a first material, a second zone can be made of a second material. The first material can be less flexible than the second material. Two different flexibility zones are thus obtained.

[0087] 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.

[0088] A difference in material can also be understood as a difference in macroscopic composition. Thus, a second zone may comprise a thermoplastic polyurethane. A first zone may comprise the thermoplastic polyurethane and also carbon fibers. This results in two different zones of flexibility, the first zone having less flexibility than the second zone due to the properties of the carbon fibers.

[0089] It is also possible to obtain zones of different flexibility by a difference in three-dimensional pattern impregnated on the zone. For example, a second zone may comprise a thermoplastic polyurethane. A first zone may comprise the thermoplastic urethane impregnated with a three-dimensional deformation making said zone less flexible.

[0090] When touching the envelope, 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.

[0091] The covering envelope may also comprise a plurality of zones having different flexibilities. Two, three, four or more zones may be provided, all of the zones having two, three or more different flexibilities. For example, five zones may be provided, all five zones having three different flexibilities.

[0092] In this way, it is possible to obtain a plurality of different flexibilities. It is thus possible to obtain a covering envelope which feels, to the touch, a plurality of different hardnesses. In this way, the covering envelope can even more precisely resemble a touch of a limb anatomy because, when touched more carefully, more than two parts of different hardnesses can be differentiated on the limb anatomy. It is also possible to vary a combination of a thickness, a material and / or a three-dimensional structure to obtain different flexibility zones.

[0093] Different thicknesses of the envelope can be manufactured by varying a thickness of a material used for manufacturing the envelope. It is also possible to use a material comprising several layers and to vary from one place to another place the number of layers to arrive at the different thickness of the envelope. It is also possible to use layers made of different materials.

[0094] By comparing the envelope of [Fig.l] with the anatomy of [Fig.2] we observe that the arrangement of the zones of different flexibility (5.1, 5.2, 6.1, 6.2) between them corresponds to the arrangement of the parts of the member having different hardnesses (13, 14, 17).

[0095] It can be seen in [Fig. 1] that the second zone (6.1) is arranged in a predominantly longitudinal manner, curving downwards. The first zone (5.1) is arranged so as to widen from top to bottom.

[0096] The first zone (5.1) is thus arranged relative to the second zone (6.1) on the envelope as the tibia (13) is arranged relative to the anterior tibial (14).

[0097] The arrangement of the zones varies from one patient to another, just as the position of the bones, muscles and tendons varies from one patient to another.

[0098] In the present example, the first zone (5.1) has a greater thickness than the second zone (6.1). Said first zone thus gives the impression of being harder to the touch than the second zone. The second zone gives the impression of being softer than the first zone.

[0099] By touching the envelope, the user thus receives a sensation similar to touching a lower part of a human leg. The first zone (5.1) will be felt as if touching the tibia and the second zone as if touching the anterior tibial 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 thickness of the envelope, is felt as a change in firmness, between a soft part and a hard part of a human leg.

[0100] Similarly, it can be seen in Figures 3 and 4 that a second zone (6.2) having a lesser thickness is arranged on the envelope like the long fibular (17) on the tibial part of a leg.

[0101] A change in thickness to delimit zones of different flexibility can also be obtained by a rib or by a notch on the covering envelope.

[0102] [Fig.3] shows a rib (10) on the trim shell to provide less flexibility at the location of the rib. [Fig.3] also shows a notch (11) to provide increased flexibility at the location of the notch.

[0103] A rib where a notch has a change in thickness of the envelope. A envelope having a rib comprises a first zone and a second zone having different thicknesses. For example, the zone of the rib itself can be identified as the first zone of greater thickness. The second zone of lesser thickness relative to the first zone is, in this case, the zone which is outside the location of the rib.

[0104] The use of ribs or notches allows for a particularly fine arrangement of different flexibility zones.

[0105] Advantageously, the envelope comprises a thermoplastic polyurethane (thermoplastic polyurethane, TPU) and / or a polyamide.

[0106] Thermoplastic polyurethane has advantages for the manufacture of a prosthesis shell. It allows a good imitation of a contralateral limb, this material can go in water and can be washed easily. Under impact, the shell comprising this material deforms and does not make noise. Due to its properties of elasticity and flexibility, TPU is particularly well suited for the manufacture of different flexibility zones to imitate a physiological touch. A shell comprising this material is light and does not add too much weight to the prosthesis.

[0107] The envelope may be manufactured by a 3D printing process, for example by powder fusion.

[0108] The first zone (5.1, 5.2) and the second zone (6.1, 6.2) may have a longitudinal shape ([Fig.l], 2) on the covering envelope, the longitudinal shape extending along an extension of the member.

[0109] In the embodiment shown in Figures 1, 3 and 5, the covering envelope has a tubular shape. The first thickness (3.1, 3.2, 3.3) and the second thickness (9.1, 9.2) remain predominantly constant along a length of the envelope. The thickness exhibits a change predominantly along a circumference of the tubular shape of the envelope.

[0110] In the particular case of ribs or notches, said ribs and notches extend mainly along a length of the tubular shape.

[0111] An arrangement as described above is particularly suitable for the manufacture of a prosthesis casing for an arm or for a leg.

[0112] The muscles, tendons and bones of the arm and leg are elongated predominantly along a length of the arm or leg. For this reason, when touching an arm or leg, little change in hardness is felt when walking along the limb. A rib or indentation provided along a length of the tubular shape causes a change in hardness to be felt if a user walks their finger around the circumference of the casing, with the hardness remaining constant along the length of the tubular shape. When touched, the casing thus reproduces a behavior similar to a leg or an arm.

[0113] [Fig. 5] shows the covering envelope (1) for a tibia prosthesis and a prosthetic foot envelope (25). A lower limb prosthesis (12), more particularly a tibia prosthesis, comprising a prosthesis socket (29) is also shown. In the example shown, the connection between the socket and the foot prosthesis is provided by an inner element (12), for example a rod or a bar.

[0114] Similarly (image not shown), a rigid cage can be provided to provide a connection between the socket and the foot prosthesis. In this case, the cage replaces the tube mentioned above. The cage provides stability and transmission of force between the prosthetic foot and the socket. In this case, the covering envelope houses the cage inside and thus envelops the cage.

[0115] The use of a cage is particularly well suited for the implementation of an arm prosthesis. The cage ensures the connection between the socket and a hand prosthesis. The prosthesis itself is in the form of a cage made of rigid material, said cage being fixed by one end to a prosthesis socket. The hand prosthesis is fixed to the other end of the cage. The covering envelope is fixed to the cage. A prosthetic hand envelope can be fixed to the prosthetic hand. The cage can be made of carbon fiber or thermoplastic polyamide, for example PA12. The covering envelope for the arm prosthesis and the covering envelope for the hand prosthesis can be manufactured in two parts. They can also be manufactured in one piece with each other and in this way cover in a single element of continuous material the arm prosthesis and the hand prosthesis.

[0116] The envelope has a tubular shape (3) comprising an inner surface (22) and an outer surface (21). The envelope houses the prosthesis inside and thus envelops the prosthesis. The dressing envelope is placed with its lower edge (36) on the prosthetic foot envelope (25).

[0117] Advantageously, the outer surface (21) of the envelope is mostly smooth relative to the changes (4.1, 4.2) delimiting zones of different flexibility.

[0118] The expansion or retraction of the material which forms a greater thickness (for example a rib) or lesser thickness (for example a notch) takes place towards an interior of the envelope ([Fig.5]), in the direction of the prosthesis. The surface remains, in this way, smooth.

[0119] More specifically, the inner surface (22) moves away from or towards the outer surface (21) to cause a change in thickness. The entire outer surface and inner surface, forming a wall of the envelope, can take on a shape resembling the anatomy of a limb. It can be seen, for example in [Fig.5], that the wall between the outer surface (21) and the inner surface (22) curves from top to bottom to make the envelope resemble, at this point, 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 different thickness. In the particular case of ribs (10) and / or notches (11), mostly smooth means that the rib and / or notch is located inside the envelope.

[0120] The envelope provides, with its smooth exterior, an even more physiological feel, corresponding to smooth skin with different hardnesses to the touch.

[0121] It is also possible to provide a predominantly smooth inner surface and to locate the changes (4.1, 4.2) on an outer surface. Thus, the ribs and / or notches can be oriented towards an outer surface.

[0122] Also, the changes (4.1, 4.2) can be located on the outer surface and on the inner surface.

[0123] [Fig.6] shows the covering envelope (1) for a leg prosthesis, the envelope having a tubular shape and comprising an articulation zone (24). Also shown is the prosthetic foot envelope (25) which can be made of polyurethane foam.

[0124] The dressing envelope (1) is placed on the prosthetic foot envelope. Inside the dressing envelope is positioned the prosthesis (12) also shown in [Fig.5].

[0125] In the example shown, the articulation zone (24) is provided at the level of an ankle, but it could also be located at a knee level if the envelope is provided for another type of prosthesis, such as a prosthesis for a whole leg.

[0126] In the present example, the articulation zone (24) has openings in the covering envelope. More precisely, in the present example these are openings having a diamond shape, located at a level of the ankle. Other shapes of openings can be used, for example in the form of a circle or a rectangle. Due to the missing material in the openings, the envelope is more flexible at the location of the openings than elsewhere. The envelope can thus easily deform at the ankle to follow the movement of a prosthesis during walking.

[0127] The diamond-shaped openings also provide access to the prosthesis located inside the covering envelope. In the example shown ([Fig.6]), it is possible to access the prosthesis through diamond-shaped openings. This allows the foot of the prosthesis to be disconnected from other parts of the prosthesis without having to modify the covering envelope of the prosthesis. Also, maintenance procedures are possible without the need to remove the covering envelope. Other openings, for example at a level of the calf, above the articulation zone (24) (see [Fig.6]), may be provided to provide access to other adjustment elements of the prosthesis (for example a valve, a keying device). The distribution of these openings is specific to each prosthesis and depends on the needs of each patient.

[0128] Figures 7 to 10 show the dressing cover (1) having the articulation zone (24) and the prosthetic foot cover (25). The foot cover has recesses (34) on one open side.

[0129] [Fig.8] also shows lugs (27) on a lower edge of the casing (36), but in some cases a single lug might be sufficient to ensure a stable connection.

[0130] According to a first embodiment, the lug (27) and the covering envelope (1) are formed in a single piece. The lugs are integral with the covering envelope.

[0131] [Fig.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 shell.

[0132] The covering envelope thus comprises at least one lug (27) on a lower edge (36).

[0133] This lower edge will be facing the prosthetic foot envelope ([Fig.9], 10).

[0134] The lugs (27) are in this way oriented outwards, in the direction of the foot shell ([Fig. 10]). The covering shell (1) can be attached to the foot shell (25) to form a complete covering for a prosthesis. During assembly, the lugs of the ring engage reversibly in the holes (34) provided on the open side of the prosthetic foot shell ([Fig.9], 10). Since the assembly is reversible, the covering shell can be separated from the foot shell by gently pulling on one of the two parts. The tibial prosthesis can thus be easily dismantled without the need to modify, such as by cutting or deforming, the covering shell.

[0135] Through openings in the articulation zone, access is provided, if necessary with a tool, to the prosthesis located inside the covering envelope. Other openings may be present to access different adjustment elements of the prosthesis, such as a valve or a key.

[0136] This allows the prosthetic foot to be dismantled from the rest of the prosthesis. The prosthetic foot is then removed from the rest of the prosthesis by separating the covering envelope from the prosthetic foot envelope by uncoupling the lugs from the holes (34).

[0137] According to another embodiment, the covering envelope may be made of a single material with the envelope of the prosthetic foot. According to this embodiment, the covering envelope forms a continuous material element with the prosthetic foot.

[0138] Figures 5 and 6 also show a clamping collar (28) on an upper part (35) of the covering envelope.

[0139] The clamping collar fixes the envelope (1) on the prosthesis socket (29). The collar is arranged so as to allow a slight sliding between the envelope and the socket so that the aesthetics are not constrained when walking with the prosthesis comprising the envelope.

[0140] The envelope described above can be advantageously manufactured by the method described below.

[0141] In a first step, a three-dimensional image of a member is obtained.

[0142] For example, a non-amputated limb of the patient is scanned using a 3D scanner to obtain said image. From said image, a representation of the surface of this limb is obtained, that is to say, a three-dimensional digital representation of the limb is obtained. The digital representation of the limb is a three-dimensional surface.

[0143] Alternatively, a three-dimensional image output from a data library could be used. In this case, said image is obtained from a library of morphotypes based on the patient's height and weight.

[0144] A scanned image of the patient's limb taken before the limb was amputated could also be used.

[0145] In the present example, a digital representation of a tibial part of a leg is obtained, that is to say a digital representation of a lower part of the leg as shown in figures 2 and 4.

[0146] 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.

[0147] Similarly, one can also obtain a digital representation of a leg with its foot, using a 3D scanner or by retrieving an image from an image library.

[0148] Similarly, one can also obtain a digital representation of a hand, an arm with its hand or an arm and a hand separately.

[0149] In a second step, the parts of the limb having 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 done on the complete digital representation or only on a part of the digital representation. In the example of a digital representation of a leg with its foot, this identification can be done, for example, only on the part of the leg excluding the foot. Following this step, a delimitation of the parts having different hardnesses can be drawn on the representation of the limb. In other words, an arrangement of the parts of different hardnesses can be drawn on the representation of the limb.

[0150] For example, on a digital representation of a tibial part of a leg, we identify the part corresponding to the tibia and the part corresponding to the anterior tibial. Then, a line is drawn on the digital representation to delimit an extension of the tibia and the anterior tibialis under the skin.

[0151] In a third step, the aesthetics are designed. The second and third steps can be carried out using computer-aided design (CAD) software.

[0152] On a digital model of the envelope, a zone is defined by defining its shape. A zone shape is then traced on the surface of the envelope. Then, a flexibility of this zone is defined. For example, the thickness that the material of the envelope will have within this zone is fixed. At the end of this step, an arrangement of zones of different flexibilities, for example obtained by different thicknesses, is defined on the envelope.

[0153] The shape and flexibility of the zones are defined to correspond to the arrangement of the parts of the member having different hardnesses.

[0154] In an example using different thicknesses, on the envelope, a first area having a greater thickness will be located relative to a second area having a lesser thickness as a harder portion of the member is located relative to a less hard portion on the digital representation of the member, said portions being previously identified as described above.

[0155] To check the arrangement of said zones between them and the correspondence to the arrangement of the parts of the member, the digital representation of the prosthesis envelope can be projected onto the digital representation of the member.

[0156] In this way, an area having a thickness greater than an average thickness is arranged to coincide with a hard part of the member and / or an area having a thickness less than an average thickness is arranged to coincide with a soft part of the member.

[0157] For example, a first zone (5.1) corresponding in shape to the part (13) of the tibia is drawn on a digital model of the envelope as seen in [Fig.l]. The part of the tibia has previously been identified on the digital representation of the leg.

[0158] Then, 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.

[0159] Then, a greater thickness is associated with the first zone and a lesser thickness with the second zone.

[0160] The manufactured envelope will thus be less flexible at the first zone than at the second zone, such that a leg is harder at a part corresponding to the tibia and softer at a part corresponding to the anterior tibial. The envelope thus provides a physiological feel to a user.

[0161] It is also possible to give the envelope the shape of the limb as deduced from the digital representation of the original limb. The envelope thus adopts the shape of the limb. The envelope can thus adopt the three-dimensional shape of the leg, for example the tibial part, 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 shape of a limb.

[0162] A cover that adopts the shape of the limb and at the same time provides a physiological touch is particularly well suited to providing a user with a natural feeling when wearing his prosthesis.

[0163] The manufacturing method may also include a step of 3D scanning of the prosthesis (12) that is to be covered by the envelope, to adapt the envelope to the prosthesis during the computer-aided design process.

[0164] The envelope can then be manufactured by a 3D printing process from the digital model. More particularly, 3D printing by powder fusion, for example in TPU, can be used.

[0165] It is thus possible to manufacture a covering envelope for a leg prosthesis or for an arm prosthesis.

[0166] In the case of a leg prosthesis, the covering envelope can be manufactured from a digital representation of a complete leg with its foot, by the method described above. In this case, it is possible to manufacture a complete covering for the foot prosthesis and for the leg prosthesis. The covering for the leg prosthesis and the covering for the foot prosthesis can be manufactured in two separate parts. The covering for the leg prosthesis and the covering for the foot prosthesis can also be manufactured in one piece with each other. In the latter case, a prosthesis covering is obtained which can cover the foot prosthesis and the leg prosthesis in a single continuous piece of material. In other words, from a digital representation of a complete leg with its foot, it is possible to manufacture a covering covering the leg prosthesis and the foot prosthesis with a single continuous piece of material.This covering can be given the shape as 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 of 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 confer, in places or completely, a physiological touch.

[0167] In the same way, a covering for an upper limb prosthesis, for example an arm, can be obtained. In the case of an arm prosthesis, the covering can also be manufactured from a digital representation of a complete arm with its hand, by the method described above. The covering for the arm prosthesis and the covering for the hand prosthesis can be manufactured in two separate parts or made from one piece with the other. In other words, it is possible to manufacture from a digital representation of the complete arm with its hand an envelope covering the arm prosthesis and the hand prosthesis with a single element of continuous material. The covering can adopt the shape as defined by the digital representation of the arm with or without its hand.

Claims

Claims

1. Covering envelope (1) for a prosthesis (12) of a given limb (2), the envelope 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) and having a tubular shape capable of receiving said prosthesis (12) inside the tubular shape, the arrangement of said zones between them corresponding to the arrangement of parts of the given limb having different hardnesses (7, 8), a flexibility of the envelope: - remaining predominantly constant along a length of the tubular shape, - and / or changing predominantly along a circumference of the tubular shape.

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

3. An envelope according to claim 1 or 2, wherein: - a first zone has less 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 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.

4. Envelope according to claim 3, in which: - 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 notch (11).

5. Envelope according to one of the preceding claims, the envelope being adapted to house inside it a leg prosthesis, preferably a tibia prosthesis or an arm prosthesis.

6. Envelope according to claims 2 and 5 in which: - an area having a greater thickness (3.1, 3.2, 3.3) than an average thickness of the envelope is located on the envelope such as the tibia (13) is located under a skin of a leg and / or - an area having a lesser thickness (6.1, 6.2) than an average thickness of the envelope is located on the envelope such as a muscle (15) or a tendon (16) is located under a skin of a leg, the muscle or tendon preferably being the soleus (30), the tibialis anterior (14), the long fibular (17), the long extensor of the toes (18), the gastrocnemius (19) or the Achilles tendon (20).

7. An envelope according to one of the preceding claims in combination with claim 2, wherein an outer surface (21) of the envelope is predominantly smooth and the thickness changes are located at an inner surface (22) of the envelope.

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

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

10. Assembly of a dressing envelope for a prosthesis according to one of claims 1 to 8 and of a covering for a prosthetic foot (25), the dressing envelope having a tubular shape (23) and comprising at least one lug (27) on a lower edge (36) of the tubular shape, the lug being capable of fitting reversibly into the covering of the prosthetic foot (25), so as to fix it in a removable manner to the tubular shape.

11. An assembly according to claim 10, 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 fixed, preferably glued, to the lower edge (36) of the tubular shape.

12. Envelope according to one of claims 1 to 8 wherein the casing comprises a clamping collar (28), said collar being capable of fixing an upper part of the tubular form on a prosthesis socket (29) so as to allow sliding between the tubular form and the socket.

13. Assembly according to one of claims 9 to 11, in which the envelope comprises a clamping collar (28), said collar being capable of fixing an upper part of the tubular form on a prosthesis socket (29) so as to allow sliding between the tubular form and the socket.

14. Assembly of a covering envelope for an arm prosthesis and a covering envelope for a hand prosthesis, the covering envelope being according to one of claims 1 to 8, the covering envelope of the arm prosthesis being made in one piece with the covering envelope of the hand prosthesis or the covering envelope of the hand prosthesis being fixed in a removable manner to the covering envelope of the arm prosthesis.

15. Method for manufacturing a covering envelope (1) for a prosthesis (12) of a given limb (2), the envelope 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), the arrangement of said zones between them corresponding to the arrangement of parts of the given limb having different hardnesses (7, 8), the method comprising the following steps: - obtaining a three-dimensional image of a limb, - identifying on the image the parts of the limb having different hardnesses (7, 8), - defining on a digital model of the envelope zones of different flexibility (5.1, 5.2, 6.1, 6.2) so as to correspond to the arrangement of said parts identified on said image, - producing the envelope by 3D printing, preferably by powder fusion, from the digital model.

16. Manufacturing method according to claim 15, wherein - the three-dimensional image is obtained from a complete leg with its foot or from a complete arm with its hand, - the envelope comprises the envelope of the leg prosthesis and the envelope of the foot prosthesis or the envelope of the arm prosthesis and the envelope of the hand prosthesis.

17. Method according to claim 15 or 16 comprising the following step: - identifying on the image the shape of the member - defining the digital model of the envelope so that the shape of the envelope corresponds to the shape of the member as identified on the image.

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