Modular tibial prosthesis and corresponding mounting method
The modular tibial prosthesis addresses the inefficiency of single-piece prostheses by allowing for the replacement of only damaged parts, enhancing adaptability and reducing costs through its innovative design featuring a main rod, base block, and connecting link.
Patent Information
- Application Number
- PCT/EP2024/085104
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-11
- Filing Date
- 2024-12-06
- Publication Date
- 2025-06-19
AI Technical Summary
Current tibial prostheses are made of a single piece, making it necessary to replace the entire prosthesis if any part is damaged, which is costly and inefficient.
A modular tibial prosthesis design featuring a main rod, a base block with multiple layers, and connecting means such as a link that allows the prosthesis to be easily disassembled and reassembled, enabling the replacement of only damaged parts.
The modular design allows for the adaptation and modification of the prosthesis to better fit individual patients, reducing costs and improving accessibility by enabling the replacement of only necessary components.
Smart Images

Figure EP2024085104_19062025_PF_FP_ABST
Abstract
Description
[0001] MODULAR TIBIAL PROSTHESIS AND CORRESPONDING MOUNTING METHOD
[0002] The invention relates to a modular tibial prosthesis having in particular means of connection between a rod and a base block of the prosthesis.
[0003] It is recalled here that a tibial prosthesis can replace the limb of a patient who has undergone a leg amputation (i.e. the part of the body going from the foot to the knee). Generally, the patient equipped with such a prosthesis therefore still has their knee at their disposal.
[0004] The invention also relates to a method of mounting such a modular tibial prosthesis.
[0005] BACKGROUND OF THE INVENTION
[0006] Current tibial prostheses generally feature a prosthetic foot extended by a simple tube that is attached to the patient's knee.
[0007] It turns out that such tibial prostheses are made of a single piece, the different elements of the same prosthesis being all fixed together, for example by welding.
[0008] Consequently, as soon as one element of the prosthesis is damaged, the entire prosthesis must be changed.
[0009] This is problematic in the current environmental context. In addition, a prosthesis is very expensive to replace.
[0010] SUBJECT OF THE INVENTION
[0011] The invention aims in particular to respond at least in part to at least one of the aforementioned problems.
[0012] SUMMARY OF THE INVENTION
[0013] To this end, according to the invention, a modular tibial prosthesis is provided comprising at least: - a main rod comprising a proximal end intended to be associated with the patient and a distal end opposite the proximal end,
[0014] - a seat block in which the distal end of the main rod is housed, the seat block being provided with at least a first layer, a free end of said first layer extending in front of the main rod to form in service at least one ground support zone,
[0015] - connecting means comprising at least one link extending from an upper part of the main rod to a first portion of the base block, passing around and / or through the free end of the first layer to participate in the temporary securing of the rod to the base block.
[0016] Thus, the seat block and the main rod are two independent parts which are temporarily secured to each other first by inserting the main rod into the seat block and then by putting the link in place.
[0017] In this way, it is possible to replace only part of the tibial prosthesis, if necessary, since the prosthesis is easily disassembled and reassembled. It is also possible to adapt the tibial prosthesis to a patient thanks to its modularity.
[0018] The invention is thus more easily accessible and also more easily adaptable.
[0019] It is recalled that the term "proximal" designates, in the medical field, the part of an element closest to the patient's trunk and the term "distal" the part of the element furthest from the patient's trunk. The terms "proximal" and "distal" must therefore be understood according to this interpretation in the present application.
[0020] Similarly, the terms "front" and "rear" are defined in relation to a frontal section plane separating the body into a ventral part ("front" part) and a dorsal part ("rear" part). The terms "front" and "rear" must therefore be understood according to this interpretation in the present application.
[0021] Similarly, the terms "upper" and "lower" in the medical field are defined in relation to a transverse sectional plane dividing the body into a part extending from the waist to the skull ("upper" part) and a part extending from the foot to the waist ("lower" part). The terms "upper" and "lower" must therefore be understood according to this interpretation in the present application.
[0022] It is recalled that the definitions given above are understood within the framework of the anatomical position of the human body.
[0023] Optionally, the prosthesis comprises a secondary rod arranged behind the main rod, the secondary rod comprising a distal end received in the seating block.
[0024] Optionally, the secondary rod is bent.
[0025] Optionally, the link also passes along the secondary rod and / or through the secondary rod.
[0026] Optionally, the main stem is straight.
[0027] Optionally, the first layer is formed by a blade.
[0028] Optionally, the seat block comprises at least a second layer forming a heel, the first layer being arranged on the second layer at its end of attachment to the seat block.
[0029] Optionally, the link also passes around and / or through the second layer.
[0030] Optionally, the second layer is made of a material that is less elastically deformable than that of the first layer.
[0031] Optionally, the base block comprises a shell forming an upper layer of the base block, the shell thus being arranged on the first layer at an attachment end of the first layer to the base block, the shell being made of a less elastically deformable material than that of the first layer.
[0032] Optionally, the shell is made of the least elastically deformable material of the materials forming the layers of the base block.
[0033] Optionally, a first end of the link is fixed to an upper face of the hull.
[0034] Optionally, the connecting means include a pin for temporary fixing of the link to the base block.
[0035] Optionally, the prosthesis comprises at least one additional layer arranged between the shell and the first layer, the additional layer being made of a material less elastically deformable than that of the first layer and / or more elastically deformable than the shell.
[0036] Optionally, the additional layer is shaped so that the shell and the first layer are separated by air over at least a portion of the base block.
[0037] Optionally, the prosthesis also includes a secondary stem arranged behind the main stem, the secondary stem comprising a distal end housed in the seating block.
[0038] The invention also relates to a method of mounting such a tibial prosthesis comprising the steps of housing the distal end of the main rod in the seating block and then securing said rod to said block via the link.
[0039] Other characteristics and advantages of the invention will emerge from reading the following description. This description presents various particular and non-limiting embodiments of the invention.
[0040] BRIEF DESCRIPTION OF THE DRAWINGS
[0041] Reference will be made to the attached drawings, including:
[0042] [Fig. 1] is a perspective view of a tibial prosthesis according to a first embodiment of the invention;
[0043] [Fig. 2] is an exploded view of the tibial prosthesis shown in Figure 1, with the link not visible;
[0044] [Fig. 3] is an enlarged exploded view of a portion of the tibial prosthesis shown in Figure 1;
[0045] [Fig. 4] is a perspective view of a tibial prosthesis according to a second embodiment of the invention;
[0046] [Fig. 5] is an exploded view of the tibial prosthesis shown in Figure 4, the link not being visible;
[0047] [Fig. 6] is a longitudinal sectional view of the prosthesis shown in Figure 4;
[0048] [Fig. 7] is a cross-sectional view of the prosthesis shown in Figure 4, the section passing through an attachment pin of said prosthesis;
[0049] [Fig. 8] is an enlarged exploded view of a portion of the tibial prosthesis shown in Figure 4; [Fig. 9a] is a top view showing different versions of the same layer of a seating block of a prosthesis shown in Figure 1 or of a prosthesis shown in Figure 4;
[0050] [Fig. 9b] is a side view showing different versions of the same layer of a seating block of a prosthesis shown in Figure 1 or a prosthesis shown in Figure 4;
[0051] [Fig. 10a] is a side view of a prosthesis shown in Figure 1 or a prosthesis shown in Figure 4 in a first step of a walking step;
[0052] [Fig. 10b] is a side view of the prosthesis shown in Fig. 10a in a second stage of a walking step;
[0053] [Fig. 10c] is a side view of the prosthesis shown in Figure 10c in a third stage of a walking step.
[0054] DETAILED DESCRIPTION OF THE INVENTION
[0055] Referring to figures 1 to 3, a modular tibial prosthesis 1 is shown according to a first embodiment.
[0056] The prosthesis 1 thus comprises a main rod 2 extending longitudinally along a first axis X. The main rod 2 here extends rectilinearly along the first axis X. For example, the first axis X extends vertically when the prosthesis 1 rests on a flat surface.
[0057] The main rod 2 is for example formed of a hollow tube. The hollow tube is for example of oblong or circular cross-section.
[0058] A proximal end 2a of the main rod 2 is intended to be associated with a patient, for example by means of a fixing device of the prior art.
[0059] The main rod 2 is for example made of or based on a metallic material (and for example made of or based on steel and / or aluminum).
[0060] The main rod 2 is for example manufactured by extrusion.
[0061] Such a main stem 2 fulfills one or more of the following roles:
[0062] It allows the entire prosthesis 1 to be supported, It allows a real tibia to be symbolized and / or at least partially to fulfill one or more functions of a real tibia,
[0063] It is interchangeable due to its modular assembly with the rest of the prosthesis 1.
[0064] Preferably, the prosthesis 1 comprises a secondary stem
[0065] 3 extending to the rear of the main stem 2.
[0066] The secondary rod 3 is for example formed of a hollow tube. The hollow tube is for example of oblong or circular cross-section.
[0067] The secondary rod 3 is for example bent. The bent area
[0068] 4 of the secondary stem 3 is for example designed by fillets so as not to have a protruding edge. The secondary stem 3 is preferably curved towards the rear of the prosthesis 1.
[0069] The secondary rod 3 is for example made of or based on a metallic material (and for example made of or based on steel and / or aluminum). The secondary rod 3 is made of the same material or a different material than the secondary rod 3. The secondary rod 3 is for example manufactured by extrusion or by bending.
[0070] Such a secondary stem 3 fulfills one or more of the following roles:
[0071] - It allows to symbolize a real fibula and / or to fulfill at least in part one or more functions of a real fibula,
[0072] - It allows the prosthesis to be structurally reinforced 1,
[0073] - It allows the passage of a link (described below) which will be an element of maintenance and connections of the different elements between them,
[0074] - It allows for better distribution of forces inside the prosthesis 1,
[0075] - It plays a role in cushioning and restoring energy when a patient takes a step,
[0076] - It is interchangeable due to its modular assembly with the rest of the prosthesis 1.
[0077] The prosthesis 1 also comprises a base block 5 of the prosthesis 1, the base block 5 forming the base of the prosthesis 1.
[0078] As we will see later, such a base makes it possible to symbolize a real foot + ankle set and / or to fulfill at least in part one or more functions of said set.
[0079] Thus the distal end 2b of the main rod 2 (opposite the proximal end 2a of the main rod 2) and a distal end 3b of the secondary rod 3 are both housed in the seat block 5. Optionally, the secondary rod 3 comprises:
[0080] - a first section 6 extending rectilinearly along an axis A from its distal end 3b to its bent zone 4, i.e. in the direction of the rear of the prosthesis
[0081] 1, and
[0082] - a second section 7 following the first section 6 and extending rectilinearly along an axis B, which is inclined with respect to the axis A, from its bent zone 4 to its proximal end 3a, i.e. in the direction of the main rod 2.
[0083] The proximal end 3a of the secondary rod 3 thus extends opposite the main rod 2 and lower than the proximal end 2a of the main rod 2 when the prosthesis 1 rests on the ground. The proximal end 3a of the secondary rod 3 therefore extends above the seating block 5. The bent zone 4 extends outside the seating block 5 behind the prosthesis 1.
[0084] The base block 5 also comprises several successive layers which will now be described.
[0085] The lower layer of the seat block 5 is intended to rest on the ground when the prosthesis 1 is worn. The lower layer is made of a first material which is for example made of or based on at least one polymer. The first material is preferably made of or based on at least one elastomer. The first material is for example made of or based on rubber. The first material is for example made of or based on rubber having a hardness of between 60 and 80 Shore and preferably between 65 and 75 Shore and is preferably 65 Shore.
[0086] The lower layer is for example manufactured by injection.
[0087] The lower layer is preferably shaped into a heel 8 and will be referred to as such hereinafter. The thickness of the heel 8 (considered along the first axis X) thus decreases towards the front of the prosthesis 1.
[0088] The lower face of the heel 8 intended to rest on the ground may be flat or may be curved. The heel 8 thus rests on the ground via a protuberance 9 (as for a real heel).
[0089] Optionally, the rear of the heel 8 is not flat but is curved towards the rear of the prosthesis 1. The heel 8 therefore also forms a protuberance 10 at the rear of the prosthesis 1 (in the same way that the rear of a real foot forms a protuberance with a real leg). Such a heel 8 fulfills one or more of the following roles:
[0090] It allows to symbolize a real heel and / or to fulfill at least in part one or more functions of a real heel,
[0091] It is interchangeable due to its modular assembly with the rest of the prosthesis 1,
[0092] It acts as a cushion when the patient takes a step.
[0093] Heel 8 is covered by a first layer.
[0094] The first layer is also intended to rest on the ground when the prosthesis 1 is worn.
[0095] For this purpose, the first layer is shaped into a sole 11 comprising a rear part for attachment to the base block 5 and a front part free for laying on the ground. The first layer will therefore be called “sole 11” hereinafter.
[0096] The heel 8 and the sole 11 are further shaped so that when the sole 11 rests on the heel 8, it does not extend longitudinally orthogonally to the first axis X. The sole 11 thus generally extends along a second axis Y which is inclined relative to the first axis X and which is inclined towards the ground. For this purpose, the upper face of the heel 8 extends parallel to the second axis Y towards the ground.
[0097] Preferably, the front of the free end 12 of the sole 11 extends in an inclined manner relative to the rest of the free end 12. Said front zone thus extends parallel to the ground when the prosthesis 1 is placed on it.
[0098] It is thus noted that the junction between the front zone of the sole 11 and the rest of the sole 11 makes it possible to symbolize and / or fulfill at least in part at least one of the functions of a boundary between metatarsals and the rest of a real foot.
[0099] The thickness of the sole 11 (considered along the first axis X) is substantially the same along the entire length of the sole 11 (the length being considered along the second axis Y).
[0100] The sole 11 is made of a second material which has less elastic deformability than that of the first material.
[0101] The second material is therefore harder than the first material. The second material is for example made of or carbon-based.
[0102] The sole 11 is preferably shaped like a blade. The sole 11 is therefore flexible.
[0103] Such a sole 11 fulfills one or more of the following roles:
[0104] - It makes it possible to symbolize a real forefoot and / or to fulfill at least in part one or more functions of a real forefoot, - It is interchangeable due to its modular assembly with the rest of the prosthesis 1,
[0105] - It facilitates a rebound of the patient when he takes a step.
[0106] We note that:
[0107] - the front end of the prosthesis 1 is formed by the front zone of the free end 12 of the sole 11, and / or
[0108] - the rear end of the prosthesis 1 is formed by the bent zone 4 of the secondary rod 3, and / or
[0109] - the upper end of the prosthesis 1 is formed by the proximal end 2a of the main stem 2, and / or
[0110] - the lower end of the prosthesis 1 is formed by the lower face of the heel 8.
[0111] The sole 11 is furthermore covered by at least one other layer forming the upper layer of the base block 5. Said upper layer is formed by a shell 13 and will be called as such hereinafter.
[0112] The shell 13 has at least one housing 14 in which the distal end 2b of the main rod 2 is housed. The housing 14 here does not open into the lower part of the shell 13.
[0113] The shell 13 is preferably curved in order to follow the curvature of the sole 11 and / or the upper face of the heel 8.
[0114] The shell 13 is made of a third material which has less elastic deformability than that of the first material and that of the second material.
[0115] The third material is for example the hardest material of the different layers of the base block 5.
[0116] The third material is for example made of or based on a polymer such as a thermoplastic polymer. Preferably, the third material is ABS (for Acrylonitrile Butadiene Styrene).
[0117] The hull 13 is for example manufactured by injection.
[0118] Such a shell 13 fulfills one or more of the following roles:
[0119] - It allows to symbolize a real ankle and / or to fulfill at least in part one or more functions of a real ankle,
[0120] - It is interchangeable due to its modular assembly with the rest of the prosthesis 1,
[0121] - It allows the structure of the prosthesis 1 to be reinforced. Preferably, the shell is not positioned directly on the sole 11.
[0122] The seat block 5 thus preferably comprises at least one intermediate layer 15 in at least one island which is arranged between the shell 13 and the sole 11.
[0123] For example, in this first embodiment, the shell 13 is arranged on an intermediate layer 15 in two islands which itself rests on the sole 11.
[0124] The intermediate layer 15 thus comprises a rear island 16.
[0125] The rear island 16 is made of a fourth material which is for example made of or based on at least one polymer. The fourth material is preferably made of or based on at least one elastomer. The fourth material is for example made of or based on an elastomer having a hardness of between 20 and 35 Shore and preferably between 25 and 30 Shore and is preferably 25 Shore.
[0126] The fourth material has a lower elastic deformability than the first material and the second material and the third material. The fourth material is, for example, the least hard material of the different layers of the base block 5.
[0127] The rear island 16 is for example manufactured by injection.
[0128] The rear island 16 is here positioned so as to extend above the heel 8 and the rear of the sole 11.
[0129] In order to facilitate the positioning of the rear island 16, the rear island 16 and the sole 11 here comprise at least one male member / female member pair cooperating together. For example, the male member is a pin 17 cooperating with a groove 18 forming a female member for positioning the rear island 16 in the sole 11. In the present case, the rear island 16 comprises the pin 17 and the sole 11 the groove 18.
[0130] The rear island 16 has at least one orifice 19 through which the first section 6 of the secondary rod 3 extends. Preferably, the rear of the sole 11 has a corresponding orifice 20 through which said first section 6 of the secondary rod 3 extends. Preferably, the heel 8 has a housing 21 in which the distal end 3b of the secondary rod 3 is housed. The housing 21 here does not open onto the lower face of the heel 8.
[0131] It is therefore understood that the secondary rod 3 makes it possible to temporarily link the rear island 16, the sole 11 and the heel 8 together.
[0132] The rear island 16 is preferably curved in order to follow the curvature of the hull 13 and / or the curvature of the upper face of the sole 11.
[0133] The rear island 16 here has a groove 22 open at its front end allowing the rear end of the shell 13 to be housed. The shell 13 and the rear island 16 thus extend successively one after the other along the second axis Y. The shell 13 and the rear island 16 are in particular juxtaposed along the second axis Y.
[0134] In this way, when the rear island 16 is directly placed on the sole 11, the shell 13 is attached to the rear island 16.
[0135] Such a rear island 16 fulfills one or more of the following roles:
[0136] - It is interchangeable due to its modular assembly with the rest of the prosthesis 1,
[0137] - It plays a cushioning role when the patient takes a step.
[0138] The intermediate layer 15 also includes a front island 23 here.
[0139] The front island 23 is made of a fifth material which is for example made of or based on at least one polymer. The fifth material is preferably made of or based on at least one elastomer. The fifth material is for example made of or based on an elastomer having a hardness of between 20 and 35 Shore and preferably between 25 and 30 Shore and is preferably 25 Shore.
[0140] The fifth material has less elastic deformability than the first material and the second material. The fifth material has greater elastic deformability than the third material.
[0141] The fifth material is for example identical to the fourth material.
[0142] The front island 23 is for example manufactured by injection. The front island 23 is for example shaped into an elongated block along an axis C optionally extending parallel to the axis Y.
[0143] The front island 23 is here positioned so as to be positioned between the sole 11 and the hull 13 and so as to be positioned elsewhere in front of the rear island 16.
[0144] The front island 23 is for example positioned at the level of the center of gravity of the seat block 5.
[0145] Preferably, the shell 13 has a housing 24 for housing the rear island 23 in the shell 13. Unlike the housing 14 of the main rod 2 which opened onto the upper face of the shell 13, the housing 24 opens onto the lower face of the shell 13. The two housings 14, 24 therefore do not open into each other here. The housing 14 does not open onto the lower face of the shell 13 and the housing 24 does not open onto the upper face of the shell 14.
[0146] In order to facilitate the positioning of the front island 23, the front island 23 and the shell 13 comprise at least one male member / female member pair cooperating together. For example, the male member is a pin 25 cooperating with a groove 26 forming a female member to position the front island 23 in the shell 13. In the present case, the front island 23 comprises the groove 26 and the shell 13 the pin 25. The pin 25 extends from the top of the housing 24 towards the front island 23.
[0147] The front island 23 and the shell 13 are here shaped so that the shell 13 does not rest on the sole 11: a layer of air separates the shell 13 from the sole 11 due to the fact that the front island 23 raises the shell 13 with respect to the sole 11. The shell 13 is thus offset from the sole 11 by a height of between 1 and 11 millimeters and for example between 3 and 9 millimeters.
[0148] In this way, the shell 13 is movable relative to the sole 11 along at least one axis of rotation and for example a third axis of rotation Z orthogonal to the axes X and Y. In particular, the relative movement between the shell 13 and the sole 11 allows angular movement of the prosthesis 1. This movement is similar to that allowed by a real ankle.
[0149] Therefore, prosthesis 1 has greater flexibility. In addition, prosthesis 1 is less fragile because it can adapt more easily to uneven floors when the patient moves.
[0150] It is noted that the cooperation of the groove 22 of the rear island 16 with the shell 13 limits the angular movement of the latter relative to the sole 11.
[0151] The front island 23 is preferably curved in order to follow the curvature of the hull 13 and / or the upper face of the heel 8 on the other hand.
[0152] Such an island before 23 fulfills one or more of the following roles:
[0153] It is interchangeable due to its modular assembly with the rest of the prosthesis 1,
[0154] It allows lateral flexion of the prosthesis 1,
[0155] It acts as a cushion when the patient takes a step.
[0156] The seat block 5 thus described is therefore present successively from top to bottom:
[0157] The shell 13, The intermediate layer 15 formed by the rear islands 16 and front 23, The sole 11, The heel 8.
[0158] Furthermore, the prosthesis 1 comprises connecting means for temporarily connecting the different elements of the prosthesis 1 described above and in particular for connecting the main 2 and secondary 3 rods to the seat block 5.
[0159] For this purpose, the connecting means comprise a link 27 fixed (temporarily) at a first end 27a to the main rod 2 and at a second end 27b to the seat block 5.
[0160] For example, the first end 27a of the link 27 is pierced with an orifice (optionally reinforced by an eyelet). The orifice is passed through the proximal end 2a of the main rod 2. The latter comprises, for example, a shoulder 28 on which the first end 27a of the link 27 rests in order to prevent the link 27 from being able to slide along the main rod 2.
[0161] For example, the second end 2b of the link 27 is held in place against the seat block 5 by a clamp 29. The clamp 29 is, for example, a bicycle seat post clamp or the like. The clamp 29 presses, for example, the second end 27b of the link 27 against the shell 13 and, for example, against the upper face of the shell 13. For example, a groove 30 is provided on the upper face of the shell 13 so that the clamp 29 can extend into this groove 30 when it clamps the link 27 against the shell 13. Typically, the second end 27b of the link 27 extends substantially orthogonally to the groove 30 when the link 27 is clamped by the clamp 29.
[0162] The shell 13 may optionally comprise a well arranged near the groove 30 or opening into the groove 30 to contain a portion of the second end 27b of the link 27.
[0163] The clamping collet 29 is for example made of or based on metal such as steel or cast iron.
[0164] Alternatively or additionally, the shell 13 comprises a hole and the second end 27b of the link 27 is pierced by an orifice (optionally reinforced by an eyelet): a portion of the clamping pliers 29 thus comes to be pushed through the orifice of the link then into the hole of the shell 13 to secure the link 27 to the shell 13.
[0165] In both cases, the clamping clamp 29 can be simply folded down or can be screwed to a portion of the shell 13.
[0166] Alternatively or additionally, the second end 27b of the link 27 is provided with a hole (optionally reinforced by an eyelet) which is inserted into a corresponding pin of the shell 13 - just as at the first end 27a.
[0167] The route of link 27 is as follows:
[0168] The link 27 extends along a first section from the proximal end 2a of the main rod 2 to the secondary rod 3.
[0169] It then extends, along a second section successive to the first section, inside the second section 7 of the secondary rod 3. It then extends, along a third section successive to the second section, partially inside the first section 6 of the secondary rod 3, opening out through a hole provided at the rear of the secondary rod 3. The secondary rod 3 is shaped so that the link opens out in the lower part of the first section 6 and above the seating block 5. As can be seen in Figure 10b, when the prosthesis 1 rests flat on the ground, the link 27 thus extends through the hole provided at the rear of the secondary rod 3 towards the rear of the seating block 5 along an axis D which is directed towards the rear of the prosthesis 1 and which extends in an inclined manner with respect to the first axis X and the first section 6 of the secondary rod 3.
[0170] Then the link extends, according to a fourth section successive to the third section, along the rear of the seat block 5, i.e. successively at the rear of the rear island 19, the sole 18 and the heel 8. As more visible in Figure 3, the rear of the seat block has a slide 31 inside which the link 27 extends. The slide 31 is here formed by grooves arranged successively in the three aforementioned layers. This makes it possible to guide the link 27 well around the prosthesis 1 and to prevent it from sliding laterally relative to it.
[0171] The link 27 then passes under the heel 8 along a fifth section following the fourth section. The heel 8 also has a slide provided on its lower face for this purpose to guide the link.
[0172] Alternatively, on this fifth section, the link passes through the heel 8 thanks to a channel provided in the heel 8. The link 27 then extends, along a sixth section successive to the fifth section, from the heel 8 to the front end of the sole 11.
[0173] Preferably, the sole 11 is provided with a hole 32 passing through it.
[0174] Preferably, said hole 32 is arranged at the junction between the front zone of the free end of the sole 11 and the rest of the free end 12.
[0175] The link 27 thus passes through the sole 11 via said hole 32 to then extend, along a seventh section successive to the sixth section, from the upper face of the sole 11 to the shell 13 and optionally to the groove 30 of the shell 13.
[0176] The positioning of link 27 allows all the elements of the prosthesis to be linked together.
[0177] Link 27 is for example a rope or a strap.
[0178] The link 27 is made of a woven material and preferably a reinforced woven material. For example, the link 27 is made of or based on nylon and preferably coated nylon. For example, the link 27 is made of the same material as a car seat belt.
[0179] The link 27 thus proves to be both strong and flexible. It is understood that the link 27 must be able to be put under tension and must therefore not have an elastically deformable character in tension / compression.
[0180] Link 27 thus fulfills at least in part at least one of the roles of a tendon complex of a real leg.
[0181] The method of mounting prosthesis 1 will now be described.
[0182] The seat block 5 is first assembled. For example, the heel 8 is positioned, then the sole 11 is placed on the heel 8, then the rear island 19 is positioned on the sole 11 using the male member / female member pair. The secondary rod 3 is then inserted through the rear island 19 and the sole 11 to fit into the heel 8.
[0183] The front island 23 is also positioned in the shell 13 and the assembly is mounted on the sole 11 with the aid of the cooperation between the groove 22 of the rear island 19 and the shell 13.
[0184] The main rod 2 is also inserted into the shell 13.
[0185] The tie 27 is then attached at one of its ends and then stretched along the path indicated above until its other end is also secured. As seen in Figure 10b, the tie 27 is then stretched between its two ends 27a and 27b.
[0186] Preferably, we start by fixing the first end 27a of the link 27.
[0187] The link 27 is then passed through the secondary rod 3 then through the heel 8 and finally through the hole 32 of the sole 11.
[0188] The second end 27b is arranged in the groove 30 of the shell 13 and / or the orifice of the second end 27b is placed in line with the hole of the shell 13.
[0189] The clamp is then actuated to secure the second end 27b of the link 27 to the shell 13.
[0190] To separate the different elements of the prosthesis 1, simply perform the reverse steps.
[0191] The assembly and disassembly of the prosthesis 1 thus described proves to be simple and rapid.
[0192] The prosthesis 1 is also very modular. It is therefore easy to modify only one element of the prosthesis 1 to replace it, for example, if it is worn or if it needs to be adapted to a new user or if it needs to be adapted to a new user need.
[0193] Indeed, it is easy to adapt the prosthesis 1 to the patient.
[0194] Thus, as visible in figure 9a, it is possible to offer different lengths of soles 11 for the same prosthesis 1.
[0195] The prosthesis 1 can therefore be used by a large number of people. The prosthesis 1 can also follow the development of the same person, for example a growing child. Furthermore, and as visible in Figure 9b, it is possible to offer different heel heights 8 for the same prosthesis and / or different types of textures (for example to have better grip on the ground). Furthermore, one or more layers of the seat block 5 can be chosen with a specific hardness according to the needs and / or physical characteristics of a patient. The prosthesis 1 thus proves to be particularly adaptable between two different patients and for the same patient.
[0196] In use, when the patient takes a step, as seen in Figure 10a, the patient places heel 8 on the ground. Heel 8 then becomes a pivot point.
[0197] The heel 8 exerts forces on the sole 11 which in turn exerts forces on the intermediate layer 15.
[0198] The seat block 5 then collapses under the force exerted on the seat block 5.
[0199] This has the effect of causing a release of the link 27 at its third section (i.e. the one extending from the first section 6 of the secondary rod 3 to the seat block 5). This also has the effect of pushing the secondary rod 3 upwards as would be the case in a real leg.
[0200] The elastically deformable layers of the seat block 5 will naturally want to return to their original positions which are those of the prosthesis 1 on the ground as visible in figure 10b. In the same way, the link 27 more in tension at the front of the prosthesis 1 (due to its rear relaxation) tends to bring the prosthesis 1 back to its initial position.
[0201] The patient then presses the front end of the sole 11 onto the ground, causing the sole 11 to flex relative to the rest of the sole 11. The front of the sole 11 then becomes a pivot point.
[0202] The flexion of the front of the sole 11 causes a release of the link on its sixth section and on its third section.
[0203] This naturally causes the heel 8 to tilt upwards.
[0204] The sole 11 will therefore want to return to its original position visible in figure 10b.
[0205] It is therefore understood that not only does the link 27 allow the different elements of the prosthesis 1 to be held together, but it also allows the patient's walking movement to be promoted. Furthermore, the elasticity of the layers of the seat block 5 also promotes the patient's walking movement.
[0206] Prosthesis 1 is therefore particularly ergonomic and effective.
[0207] A second embodiment will now be described with reference to Figures 4 to 8.
[0208] First of all, the link 27 is not temporarily secured to the rest of the prosthesis 1 in the same way as in the first embodiment.
[0209] In fact, the connecting means do not here comprise a clamping clamp but a pin 40 to ensure the fixing of the second end 27b of the link 27 on the shell 13. The pin 40 comprises for example a rod, a screw, a rivet, etc.
[0210] For this purpose, at least one of the layers of the base block 5 is provided with an orifice 43 through which the pin 40 extends. In the present case, the orifice 43 extends through all the layers of the base block 5 (here the shell 13, the intermediate layer 15, the sole 11 and the heel 8) so as to open at a first end onto the upper face of the shell 13 and to open at a second end onto the lower face of the heel 8.
[0211] Preferably, the orifice 43 opens onto an area of the heel 8 not resting on the ground when the prosthesis 1 is placed on the ground.
[0212] The orifice 43 preferably extends along an axis E which is inclined relative to the first axis X and / or the second axis Y and / or the third axis Z. The orifice 43 therefore extends neither horizontally nor vertically.
[0213] Thus in service, the orifice of the second end 27b of the link 27 is placed directly above the orifice 43 then the pin 40 is inserted through said two orifices.
[0214] A bolt of the connecting means optionally allows the assembly to be temporarily sealed. Alternatively, the orifice 43 is at least partly threaded and the pin 40 is directly screwed into the orifice 43 to temporarily secure the assembly.
[0215] The first end 27a of the link 27 can be secured to the rest of the prosthesis 1 in the same way as in the first embodiment. Alternatively, the first end 27a of the link 27 can be fixed to a rotating part of a reel whose frame is itself fixed to the main rod 2. In this way, the reel makes it possible to tighten the link 27 more or less. This variant is of course also applicable to the first embodiment.
[0216] Furthermore, unlike the first embodiment, the secondary rod 3 is not hollow. It is shaped into a blade. The link 27 thus extends along the secondary rod 3 and not inside it. For example, the secondary rod 3 is manufactured from a sheet metal and for example by stamping said sheet metal.
[0217] Preferably at least the proximal end 3a of the secondary rod 3 forms a slide for the link 27.
[0218] Preferably, the secondary rod 3 is shaped so that its first section 41 extends rectilinearly along an axis F inclined or orthogonal to the axis X and so that its second section 42 extends along an axis G inclined or orthogonal to the axis F. The bent zone 44 of the secondary rod 3 is for example drawn by fillets so as not to have a protruding edge.
[0219] Preferably, the secondary upper 3 is shaped so that the bent zone 44 extends at the level of the heel 8 and more preferably at the level of the rear curved zone of the heel. The bent zone 44 is shaped so as to rest at least partly against the heel 8. The bent zone 44 is shaped so as to be glued at least partly against the heel 8.
[0220] The first section 41 thus extends inside the seat block 5 between two layers thereof and / or inside at least one layer thereof. For example, the first section 41 extends inside the heel 8. Preferably, the first section 41 extends from the rear of the heel 8 to at least the orifice 43. Preferably, the first section 41 is itself pierced with a hole forming part of said orifice 43 so that the pin 40 can pass through the first section 41 when the prosthesis 1 is assembled. This makes it possible to simply fix the secondary rod 3 to the seat block 5 and this temporarily. For example, the first section 41 extends from the rear of the heel 8 to the front of the heel 8.
[0221] Thus, whereas in the first embodiment, the secondary rod 3 entered the heel 8 from above the latter, in the second embodiment, the secondary rod 3 enters the heel 8 from behind the heel 8.
[0222] Preferably, the link 27 extends along the secondary upper 3 over its entire length. Thus, the link 27 extends along the first section 41 but also along the second section 42, and therefore inside the heel 8, before continuing its trajectory to the hole 32 of the sole 11.
[0223] The heel 8, the intermediate layer 15 and the sole 11 are here without a rear groove.
[0224] Furthermore, unlike the first embodiment, in order to facilitate the positioning of the sole 11, the sole 11 and the heel 8 comprise at least one male member / female member pair cooperating together. For example, the male member is an excess thickness 45 cooperating with at least one tab 46 forming a female member to position the sole 11 with respect to the heel 8. In the present case, the heel 8 has an excess thickness 45 which is framed by two tabs 46 of the sole 11. The excess thickness 45 is for example centered in the width of the heel 8 (considered along the third axis Z) and arranged at the rear of the heel 8. The rear end of the sole 11 thus has two tabs 46 which frame the excess thickness 45 on either side.
[0225] Furthermore, unlike the first embodiment, the shell 13 extends to the rear of the seat block 5 (whereas in the first embodiment it only extended to the rear island 16).
[0226] Furthermore, unlike the first embodiment, the intermediate layer 15 and the heel 8 do not comprise at least one male member / female member pair cooperating together.
[0227] Furthermore, unlike the first embodiment, the intermediate layer 15 is in a single island 47. However, as in the first embodiment, it allows the shell 13 to be separated from the sole 11 and the heel 8. However, as in the first embodiment, it allows angular movement of the shell 13 relative to the sole 11.
[0228] For this purpose, and as more visible in Figure 7, on at least one area of the shell 13, the shell 13 is separated from the heel 8 by a layer of air thanks to the intermediate layer 15 which raises it. This makes it possible to ensure lateral flexibility of the prosthesis. For example, the intermediate layer 15 comprises a sub-layer 48 resting on the heel 8 and a protrusion 49 extending from the upper face of the sub-layer 48 in the opposite direction of the heel 8. The protrusion 49 extends for example orthogonally to the sub-layer 48. The protrusion 49 is for example centered in at least one direction on the upper face of the sub-layer 48.
[0229] Preferably, the orifice 43 is shaped so as to pass through said protrusion 49. Preferably, the orifice 43 is centered in at least one direction on the protrusion 49.
[0230] Preferably, the shell 13 has a housing 50 in which the protrusion is received. In particular, the orifice 43 is shaped so as to pass through said housing 50.
[0231] The housing 50 is for example defined by one or more platforms extending from a lower face of the shell 13. For example, the shell 13 comprises two platforms 51 extending on either side of the lower face of the shell 13. The two platforms 51 thus form lower lateral edges of the shell 13. The two platforms 51 delimit between them a slide 52 inside which the protrusion 49 is arranged, slide 52 therefore forming the aforementioned housing 50. The slide 52 is preferably centered in at least one direction on the lower face of the shell 13. For example, the slide 52 extends parallel to the male member of the heel 8. Preferably, the junction between the housing 50 and the orifice 43 is not formed by a straight shoulder. Thus at least one chamfer and / or rounding 53 is provided inside the shell 13 to form a smooth junction between the housing 50 and the orifice 43.
[0232] Apart from what has been stated above, everything stated for the first embodiment is also applicable to the present second embodiment.
[0233] An example of a method for mounting such a prosthesis 1 will now be described.
[0234] The secondary rod 3 is first inserted into the heel 8 until the secondary rod 3 comes into contact with the protrusion 10 of the heel 8.
[0235] The intermediate layer 15 is also inserted into the housing 50 of the shell 16.
[0236] Then the sole 11 is arranged on the assembly formed by the secondary rod 3 and the heel 8, ensuring that the holes intended to receive the bolt 40 coincide. The assembly formed by the intermediate layer 15 and the shell 13 is then placed on the assembly of sole 11 + secondary rod 3 + heel 8, ensuring that the holes intended to receive the bolt 40 coincide.
[0237] The seat block 5 is thus formed.
[0238] Finally, the link 27 is placed by passing it from the main rod 2 to the hole 43, passing it behind the secondary rod 3, through the heel 8 then the hole 32 of the sole 11.
[0239] When the end 27b of the tie is level with the hole 43, the bolt 40 is then arranged to fix the tie 27 to the rest of the prosthesis. The reel is possibly used to ensure that the tie 27 is well tensioned.
[0240] To separate the different elements of the prosthesis 1, simply perform the reverse steps.
[0241] Embodiments have thus been described in which the prosthesis 1 is made up of elements which can be easily assembled and disassembled. In particular, the seat block 5 forms a sandwich of layers with different properties.
[0242] Such a prosthesis 1 proves to be comfortable to wear.
[0243] Such a prosthesis 1 proves to be structurally sound.
[0244] Such a prosthesis 1 further facilitates the patient's walking. For example, the prosthesis 1 promotes propulsion by facilitating the upward extension of the heel 8 (as described with reference to Figure 10c). For example, it cushions the patient's steps.
[0245] Such a prosthesis 1 ensures good support for the body wearing the prosthesis 1.
[0246] It is also noted that prosthesis 1 is of simple construction. In particular, the different elements constituting it are of simple structure.
[0247] Furthermore, the different elements, although independent, can be fitted into each other and a simple link 27 allows them all to be fixed together. In particular, there is only one fixing point at the level of the seat block 5 (the clamping clamp 29 or the pin 40 in the non-limiting examples described).
[0248] We note that each of the elements has a simple structure and plays a very specific role.
[0249] Thus the shell 13 makes it possible to prestress the various other parts while allowing movement along at least one axis of rotation and preferably at least two axes of rotation of the top of the prosthesis 1 relative to the heel 8.
[0250] The heel 8, and here also the intermediate layer 15, form a complex of elastically deformable materials which sandwich the sole 11.
[0251] Link 27 reproduces the tendon complex of a real foot and leg. Its path is notably guided by secondary rod 3 which is also connected to seat block 5.
[0252] The secondary rod 3 also increases walking comfort. The secondary rod 3 acts as a conductor of the tension and compression dynamics of the prosthesis elements 1.
[0253] Of course, the invention is not limited to the embodiments described but encompasses any variant falling within the scope of the invention as defined by the claims.
[0254] In particular, the two embodiments may be mixed together. For example, the secondary upper may be partly hollow as in the first embodiment and partly shaped like a blade (flat and / or curved) as in the second embodiment. For example, the underlayer and the outgrowth of the intermediate layer forming a single island in the second embodiment may be in two islands (for example, one for the underlayer and one for the outgrowth) as in the first embodiment. Furthermore, the intermediate layer and the heel of the second embodiment may comprise at least one male member / female member pair cooperating together as in the first embodiment. Furthermore, the sole and the heel of the first embodiment may comprise at least one male member / female member pair cooperating together as in the second embodiment.
[0255] The prosthesis may include other elements than those described. The prosthesis may thus include one or more protections arranged in the prosthesis to limit friction of the link against the prosthesis. Figure 2 illustrates for example such a protection housed in a housing made in the sole at the level of the hole in the sole through which the link extends or directly in the hole in the sole. This protects the sole. If necessary, the protection can easily be changed when it is worn (without it being necessary to touch the sole).
[0256] The male and female organs may be different from what has been described and / or be arranged differently from what has been described (for example, for two parts A and B, A and B may indifferently carry one the male organ and the other the female organ).
[0257] The base block may have a different number of layers than described.
[0258] At least one of the layers of the base block may be composed of at least two islands or a greater number of islands. For example, the heel may be in two islands. At least two elements of the prosthesis may have additional (removable) fixing means between them, such as at least one screw-nut assembly. Preferably, the prosthesis will be devoid of such fixing means and only the connecting means will ensure the temporary fixing of the different elements of the prosthesis together.
[0259] Although here the hole passing through the sole (hole crossed in service by the link) is arranged at the front of the free end of said sole, it could be arranged at the rear of said free end. Said hole could thus be arranged more or less close to the base block. Said hole could for example be closer to the base block than to the portion of the sole resting in service on the ground.
Claims
CLAIMS 1. Modular tibial prosthesis comprising at least: - a main rod (2) comprising a proximal end intended to be associated with the patient and a distal end opposite the proximal end, - a seat block (5) in which the distal end of the main rod is housed, the seat block being provided with at least a first layer (11), a free end of said first layer extending in front of the main rod to form in service at least one ground support zone, - connecting means comprising at least one link (27) extending from an upper part of the main rod to a first portion of the base block, passing around and / or through the free end of the first layer to participate in the temporary securing of the rod to the base block.
2. Prosthesis according to claim 1, comprising a secondary rod (3) arranged behind the main rod (2), the secondary rod comprising a distal end received in the seat block (5).
3. Prosthesis according to claim 2, in which the secondary rod (3) is bent.
4. Prosthesis according to one of claims 2 to 3, in which the link (27) also passes along the secondary rod (3) and / or through the secondary rod.
5. Prosthesis according to one of claims 1 to 4, in which the main rod (2) is rectilinear.
6. Prosthesis according to one of the preceding claims, in which the first layer (11) is formed by a blade.
7. Prosthesis according to one of the preceding claims, in which the seat block (5) comprises at least a second layer forming a heel (8), the first layer (11) being arranged on the second layer at its end of attachment to the seat block (5).
8. Prosthesis according to claim 7, wherein the link (27) also passes around and / or through the second layer (8).
9. Prosthesis according to claim 7 or claim 8, in which the second layer (8) is made of a less elastically deformable material than that of the first layer (11).
10. Prosthesis according to one of the preceding claims, in which the seat block (5) comprises a shell (13) forming an upper layer of the seat block, the shell thus being arranged on the first layer (11) at an end of attachment of the first layer to the seat block, the shell being made of a less elastically deformable material than that of the first layer.
11. Prosthesis according to claim 10 and one of claims 7 to 9, in which the shell (13) is made of the least elastically deformable material of the materials forming the layers of the base block.
12. Prosthesis according to one of claims 10 or 11, in which a first end of the link (27) is fixed to an upper face of the shell (13).
13. Prosthesis according to claim 12, in which the connecting means comprise a pin (40) for temporary fixing of the link to the seat block (5).
14. Prosthesis according to one of claims 10 to 13, comprising at least one additional layer (15) arranged between the shell (13) and the first layer (11), the additional layer being in a material less elastically deformable than that of the first layer and / or more elastically deformable than the shell.
15. Prosthesis according to one of the preceding claims, in which the additional layer (15) is shaped so that the shell (13) and the first layer (11) are separated by air over at least a portion of the seating block.
16. Method for mounting a prosthesis according to one of the preceding claims, comprising the steps of housing the distal end of the main rod (2) in the seating block (5) and then securing said rod to said block via the link.
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