MODULAR TIBIAL PROSTHESIS AND CORRESPONDING ASSEMBLY METHOD

Abstract

A modular tibial prosthesis comprising at least: - a main stem (2) having a proximal end intended to be attached to the patient and a distal end opposite the proximal end, - a seat block (5) in which the distal end of the main stem is housed, the seat block having at least one first layer, a free end of said first layer extending forward of the main stem to form, in use, at least one ground support area, - connecting means comprising at least one link (27) extending from an upper portion of the main stem to a first portion of the seat block, passing around and / or through the free end of the first layer to participate in the temporary attachment of the stem to the seat block. Figure from the abstract: [Fig. 4]

Description

Title of the invention: MODULAR TIBIAL PROSTHESIS AND CORRESPONDING ASSEMBLY METHOD

[0001] The invention relates to a modular tibial prosthesis having in particular means of connection between a stem and a seat block of the prosthesis.

[0002] It is recalled here that a tibial prosthesis makes it possible to replace the limb of a patient who has undergone a leg amputation (i.e., the part of the body from the foot to the knee). Generally, the patient fitted with such a prosthesis therefore still has their knee.

[0003] The invention also relates to a method of assembling such a modular tibial prosthesis.

[0004] BACKGROUND OF THE INVENTION

[0005] Current tibial prostheses generally have a prosthetic foot extended by a simple tube which is attached to the patient's knee.

[0006] It turns out that such tibial prostheses are one piece, the different elements of the same prosthesis all being fixed together for example by welding.

[0007] Consequently, as soon as an element of the prosthesis is damaged, the entire prosthesis should be changed.

[0008] This is problematic in the current environmental context. Furthermore, a prosthesis proves to be very expensive to replace.

[0009] SUBJECT OF THE INVENTION

[0010] The invention is intended in particular to address at least one of the aforementioned problems. Summary of the invention

[0011] To this end, the invention provides a modular tibial prosthesis comprising at least:

[0012] - a main stem comprising a proximal end intended to be associated with the patient and a distal end opposite to the proximal end,

[0013] - a seat block in which the distal end of the main stem is housed, the block the base being provided with at least one first layer, a free end of said first layer extending in front of the main stem to form in service at least one ground support area,

[0014] - means of connection comprising at least one link extending from a part from the top of the main stem to a first portion of the base block by passing around and / or through the free end of the first layer to participate in the temporary bonding of the stem to the base block.

[0015] Thus, the seat block and the main stem are two independent parts which are temporarily joined together first by inserting the main stem into the seat block and then by putting in place the link.

[0016] In this way, it becomes possible to replace only part of the tibial prosthesis, if necessary, since the prosthesis is easily removable and re-mountable.

[0017] It is also possible to adapt the tibial prosthesis to a patient thanks to its modularity.

[0018] The invention is thus more readily accessible and also more easily adaptable.

[0019] It should be noted that the term "proximal" refers, in the medical field, to the part of an element closest to the patient's trunk, and the term "distal" to the part of the element furthest from the patient's trunk. The terms "proximal" and "distal" should therefore be understood according to this interpretation in the present application.

[0020] Similarly, the terms "front" and "rear" are defined with respect to a frontal cross-sectional 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, in the medical field, the terms "upper" and "lower" are defined with respect to a transverse 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" should therefore be understood in 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 includes a secondary stem arranged behind the main stem, the secondary stem comprising a distal end received in the seat block.

[0024] Optionally, the secondary rod is bent.

[0025] Optionally, the link also passes along the secondary stem and / or through the secondary stem.

[0026] Optionally, the main stem is straight.

[0027] Optionally, the first layer is formed by a blade.

[0028] Optionally, the seat block includes at least a second heel-forming layer, the first layer being arranged on the second layer at its attachment end to the seat block.

[0029] Optionally, the bond also passes around and / or through the second layer.

[0030] Optionally, the second layer is made of a less elastically de- formable than that of the first layer.

[0031] Optionally, the seat block includes a shell forming an upper layer of the seat block, the shell being arranged on the first layer at the level of an attachment end of the first layer to the seat block, the shell being made of a material less elastically deformable than that of the first layer.

[0032] Optionally, the shell is made of a material that is the least elastically deformable of the materials forming the layers of the seat 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 seat block.

[0035] Optionally, the prosthesis includes 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 seat 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 stem in the seat block and then securing said stem to said block by means of the link.

[0039] Other features and advantages of the invention will become apparent from the following description. This description presents various specific, but not limiting, embodiments of the invention. Brief description of the drawings

[0040] Reference will be made to the attached drawings, among which:

[0041] [Fig-1] is a perspective view of a tibial prosthesis according to a first embodiment of the invention;

[0042] [Fig.2] is an exploded view of the tibial prosthesis shown in [Fig.1], the link not being visible;

[0043] [Fig.3] is an enlarged exploded view of a part of the tibial prosthesis shown in [Fig.1];

[0044] [Fig.4] is a perspective view of a tibial prosthesis according to a second embodiment of the invention;

[0045] [Fig.5] is an exploded view of the tibial prosthesis shown in [Fig.4], the link not being visible;

[0046] [Fig.6] is a longitudinal cross-sectional view of the prosthesis shown in [Fig.4];

[0047] [Fig.7] is a cross-sectional view of the prosthesis shown in [Fig.4], the cut passing through an attachment pin of said prosthesis;

[0048] [Fig.8] is an enlarged exploded view of a part of the tibial prosthesis shown in [Fig.4];

[0049] [Fig.9a] is a top view representing different versions of the same layer of a base block of a prosthesis shown in [Fig.1] or of a prosthesis shown in [Fig.4];

[0050] [Fig.9b] is a side view representing different versions of the same layer of a base block of a prosthesis shown in [Fig.1] or of a prosthesis shown in [Fig.4];

[0051] [Fig. 10a] is a side view of a prosthesis shown in [Fig.1] or of a prosthesis shown in [Fig.4] according to a first step of a walking step;

[0052] [Fig. 10b] is a side view of the prosthesis shown in [Fig. 10a] according to a second step of a walking step;

[0053] [Fig. 10c] is a side view of the prosthesis shown in [Fig. 10c] according to a third step of a walking step. DETAILED DESCRIPTION OF THE INVENTION

[0054] With reference to figures 1 to 3, a modular tibial prosthesis 1 is shown according to a first embodiment.

[0055] The prosthesis 1 thus comprises a main stem 2 extending longitudinally along a first axis X. The main stem 2 extends here rectilinearly along the first axis X. For example, the first axis X extends vertically when the prosthesis 1 rests on a flat surface.

[0056] The main rod 2 is, for example, formed from a hollow tube. The hollow tube is, for example, of oblong or circular cross-section.

[0057] A proximal end 2a of the main stem 2 is intended to be associated with a patient, for example via an anterior art fixation device.

[0058] 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).

[0059] The main rod 2 is for example manufactured by extrusion.

[0060] Such a main stem 2 fulfills one or more of the following roles: - It allows the entire prosthesis 1 to be supported, - It allows one to symbolize a real tibia and / or to at least partially fill a or several functions of a real tibia, - It is interchangeable with the rest of the modular assembly. prosthesis 1.

[0061] Preferably, the prosthesis 1 comprises a secondary stem 3 extending behind the main stem 2.

[0062] The secondary rod 3 is, for example, formed from a hollow tube. The hollow tube is, for example, of oblong or circular cross-section.

[0063] The secondary stem 3 is, for example, angled. The angled area 4 of the secondary stem 3 is, for example, shaped by fillets so as not to present a protruding edge. The secondary stem 3 is preferably curved towards the rear of the prosthesis 1.

[0064] 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.

[0065] The secondary rod 3 is for example manufactured by extrusion or by bending.

[0066] Such a secondary stem 3 fulfills one or more of the following roles: - It allows for the symbolization of a real fibula and / or for fulfilling at least partially one or more functions of a real fibula. - It allows for the structural reinforcement of prosthesis 1, - It allows the passage of a link (described below) which will be an element of maintenance and connection of the different elements to each other, - It allows for a better distribution of forces within the prosthesis 1, - It plays a role in cushioning and restoring energy when a patient takes a step, - It is interchangeable due to its modular assembly with the rest of prosthesis 1.

[0067] The prosthesis 1 also includes a seat block 5 of the prosthesis 1, seat block 5 forming the base of the prosthesis 1.

[0068] As we shall 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.

[0069] 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.

[0070] Optionally, the secondary stem 3 comprises: - a first section 6 extending straight along an axis A from its distal end 3b to its angled area 4, i.e. towards the rear of the prosthesis 1, and - a second section 7 succeeding the first section 6 and extending straight along an axis B, which is inclined with respect to the axis A, from its angled zone 4 to its proximal end 3a, i.e. in the direction of the stem main 2.

[0071] The proximal end 3a of the secondary stem 3 thus extends opposite the main stem 2 and lower than the proximal end 2a of the main stem 2 when the prosthesis 1 rests on the ground. The proximal end 3a of the secondary stem 3 therefore extends above the seat block 5. The angled area 4 extends out of the seat block 5 behind the prosthesis 1.

[0072] The base block 5 also comprises several successive layers which will now be described.

[0073] The lower layer of the seat block 5 is intended to rest on the ground when the prosthesis 1 is worn.

[0074] 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 between 60 and 80 Shore A, and preferably between 65 and 75 Shore A, and is preferably 65 Shore A.

[0075] The lower layer is for example manufactured by injection.

[0076] The lower layer is preferably shaped into a heel 8 and will be referred to as such hereafter.

[0077] The thickness of the heel 8 (considered along the first axis X) thus decreases towards the front of the prosthesis 1.

[0078] The underside of the heel 8, intended to rest on the ground, may be flat or may be convex. The heel 8 thus rests on the ground via a protrusion 9 (as with a real heel).

[0079] Optionally the back of the heel 8 is not flat but is curved towards the back of the prosthesis 1. The heel 8 therefore also forms a protrusion 10 at the back of the prosthesis 1 (in the same way that the back of a real foot forms a protrusion with a real leg).

[0080] Such a heel 8 fulfills one or more of the following roles: - It allows for the symbolic representation of a real stock and / or for fulfilling at least partially one or more functions of a real stock. - It is interchangeable with the rest of prosthesis 1 due to its modular assembly. - It acts as a cushioning agent when the patient takes a step.

[0081] The heel 8 is covered by a first layer.

[0082] The first layer is also intended to rest on the ground when the prosthesis 1 is worn.

[0083] To this end, the first layer is formed into a sole 11 comprising a The rear part is attached to the seat block 5 and the front part is free to rest on the ground. The first layer will therefore be called "sole 11" hereafter.

[0084] 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. To this end, the upper face of the heel 8 extends parallel to the second axis Y in the direction of the ground.

[0085] Preferably, the free front end 12 of the sole 11 extends at an angle relative to the rest of the sole. Said end 12 thus extends parallel to the ground when the prosthesis 1 is placed on it.

[0086] It is noted that the junction between the front end 12 of the sole 11 and the rest of the sole 11 makes it possible to symbolize and / or to fulfill at least in part at least one of the functions of a boundary between metatarsals and the rest of a real foot.

[0087] The thickness of the sole 11 (considered along the first X axis) is substantially the same along the entire length of the sole 11 (the length being considered along the second Y axis).

[0088] The sole 11 is made of a second material which has a less elastic deformability than that of the first material.

[0089] The second material is thus harder than the first material. The second material is, for example, made of or based on carbon.

[0090] The sole 11 is preferably shaped into a blade. The sole 11 is therefore flexible.

[0091] Such a sole 11 fulfills one or more of the following roles: - It allows for the symbolization of a real forefoot and / or for fulfilling at least partially one or more functions of a real forefoot, - It is interchangeable with the rest of prosthesis 1 due to its modular assembly. - It facilitates a rebound for the patient when they take a step.

[0092] It is noted that: - the front end of the prosthesis 1 is formed by the free front end 12 of the sole 11, and / or - the rear end of the prosthesis 1 is formed by the angled area 4 of the secondary stem 3, and / or - the upper end of the prosthesis 1 is formed by the proximal end 2a of the main stem 2, and / or - the lower end of the prosthesis 1 is formed by the lower face of the heel 8.

[0093] The sole 11 is also 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 referred to as such hereafter.

[0094] The shell 13 has at least one housing 14 in which the distal end 2b of the main stem 2 is housed. The housing 14 is here not opening into the lower part of the shell 13.

[0095] 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.

[0096] The shell 13 is made of a third material which has a lower elastic deformability than that of the first material and that of the second material.

[0097] The third material is, for example, the hardest material of the different layers of the base block 5.

[0098] The third material is, for example, made of or based on a polymer, such as a thermoplastic polymer. Preferably, the third material is made of ABS (Acrylonitrile Butadiene Styrene).

[0099] The shell 13 is for example manufactured by injection.

[0100] Such a hull 13 fulfills one or more of the following roles: - It allows for the symbolization of a real ankle and / or for fulfilling at least partially one or more functions of a real ankle. - It is interchangeable with the rest of prosthesis 1 due to its modular assembly. - It helps to reinforce the structure of prosthesis 1.

[0101] Preferably, the shell is not positioned directly on the sole 11.

[0102] The seat block 5 therefore preferably comprises at least one intermediate layer 15 in at least one island which is arranged between the shell 13 and the base 11.

[0103] For example, in this first embodiment, the shell 13 is arranged on an intermediate layer 15 in two islands which itself rests on the base 11.

[0104] The intermediate layer 15 thus comprises a rear island 16.

[0105] 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 between 20 and 35 Shore A, and preferably between 25 and 30 Shore A, and is preferably 25 Shore A.

[0106] The fourth material exhibits a lower elastic deformability than that of the first material and that of the second material and that of the third material.

[0107] The fourth material is, for example, the least hard material of the different layers of the base block 5.

[0108] The rear island 16 is for example manufactured by injection.

[0109] The rear island 16 is positioned here so as to extend over the heel 8 and the rear of the sole 11.

[0110] To facilitate the positioning of the rear island 16, the rear island 16 and the base 11 here comprise at least one pair of male / female organs cooperating together. For example, the male organ is a pin 17 cooperating with a groove 18 forming a female organ to position the rear island 16 in the base 11. In the present case, the rear island 16 comprises the pin 17 and the base 11 the groove 18.

[0111] The rear island 16 has at least one opening 19 through which the first section 6 of the secondary stem 3 extends. Preferably, the rear of the sole 11 has a corresponding opening 20 through which said first section 6 of the secondary stem 3 extends. Preferably, the heel 8 has a recess 21 in which the distal end 3b of the secondary stem 3 is housed. The recess 21 here does not open onto the underside of the heel 8.

[0112] It is therefore understood that the secondary stem 3 allows the rear island 16, the sole 11 and the heel 8 to be temporarily linked together.

[0113] 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.

[0114] The rear island 16 here has a groove 22 open at its front end allowing the rear end of the hull 13 to be housed. The hull 13 and the rear island 16 thus extend successively one after the other along the second axis Y. The hull 13 and the rear island 16 are in particular juxtaposed along the second axis Y.

[0115] In this way, when the rear island 16 is placed directly on the base 11, the hull 13 is attached to the rear island 16.

[0116] Such a rear island 16 fulfills one or more of the following roles: - It is interchangeable with the rest of prosthesis 1 due to its modular assembly. - It plays a cushioning role when the patient takes a step.

[0117] The intermediate layer 15 also includes here an island before 23.

[0118] The forward 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 between 20 and 35 Shore A, and preferably between 25 and 30 Shore A, and is preferably 25 Shore A.

[0119] The fifth material exhibits less elastic deformability than both the first and second materials. The fifth material exhibits greater elastic deformability than the third material.

[0120] The fifth material is, for example, identical to the fourth material.

[0121] The front island 23 is for example manufactured by injection.

[0122] The forward island 23 is, for example, shaped into an elongated block along an axis C optionally extending parallel to the Y axis.

[0123] The front island 23 is positioned here so as to be positioned between the sole 11 and the hull 13 and so as to be positioned further in front of the rear island 16.

[0124] The front island 23 is for example positioned at the center of gravity of the seating block 5.

[0125] Preferably, the hull 13 has a housing 24 for the rear island 23 within the hull 13. Unlike the housing 14 of the main rod 2, which opened onto the upper face of the hull 13, the housing 24 opens onto the lower face of the hull 13. Therefore, the two housings 14 and 24 do not open into each other. The housing 14 does not open onto the lower face of the hull 13, and the housing 24 does not open onto the upper face of the hull 14.

[0126] To facilitate the positioning of the front island 23, the front island 23 and the shell 13 each have at least one pair of male / female organs cooperating together. For example, the male organ is a pin 25 cooperating with a groove 26 forming a female organ to position the front island 23 in the shell 13. In this case, the front island 23 has the groove 26 and the shell 13 has the pin 25. The pin 25 extends from the top of the housing 24 towards the front island 23.

[0127] The front island 23 and the hull 13 are here shaped so that the hull 13 does not rest on the base 11: a layer of air separates the hull 13 from the base 11 because the front island 23 raises the hull 13 relative to the base 11. The hull 13 is thus offset from the base 11 by a height of between 1 and 11 millimeters and for example between 3 and 9 millimeters.

[0128] In this way, the shell 13 is mobile relative to the sole 11 along at least one axis of rotation and, for example, a third axis of rotation Z orthogonal to the X and Y axes. In particular, the relative movement between the shell 13 and the sole 11 allows an angular range of motion of the prosthesis 1. This range of motion is similar to that allowed by a real ankle.

[0129] Therefore, prosthesis 1 has better flexibility.

[0130] Furthermore, prosthesis 1 proves to be less fragile because it can adapt more easily to uneven floors during patient movement.

[0131] It is noted that the cooperation of the groove 22 of the rear island 16 with the hull 13 limits the angular deflection of the latter relative to the sole 11.

[0132] The forward island 23 is preferably curved in order to follow the curvature of the hull 13 and / or and of the upper face of the heel 8 on the other hand.

[0133] Such an island before 23 fulfills one or more of the following roles: - Its modular assembly makes it interchangeable with the rest of the prosthesis 1, - It allows lateral flexion of prosthesis 1, - It acts as a cushioning agent when the patient takes a step.

[0134] The base block 5 thus described is therefore successively present from top to bottom: - Hull 13, - The intermediate layer 15 formed by the rear islands 16 and front islands 23, - Sole number 11, - Heel 8.

[0135] Furthermore, the prosthesis 1 includes means for temporarily linking together the different elements of the prosthesis 1 described above and in particular for linking the main stem 2 and secondary stem 3 to the seat block 5.

[0136] For this purpose, the connecting means comprise a link 27 fixed (temporarily) at a first end 27a to the main rod 12 and at a second end 27b to the seat block 5.

[0137] For example, the first end 27a of the link 27 is pierced with an opening (optionally reinforced by an eyelet). The opening passes through the proximal end 2a of the main rod 2. The latter has, for example, a shoulder 28 on which the first end 27a of the link 27 rests in order to prevent the link 27 from sliding along the main rod 2.

[0138] For example, the second end 2b of the link 27 is held in place against the seat block 5 by a clamping clip 29. The clamping clip 29 is, for example, a bicycle seatpost clamp or similar. The clamping clip 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 clamping clip 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 clamping clip 29.

[0139] The shell 13 may optionally include 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.

[0140] The clamping clamp 29 is for example made of or based on metal such as steel or cast iron.

[0141] As an alternative or in addition, the shell 13 includes 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 clip 29 thus goes through the orifice of the link and then into the hole in the shell 13 to secure the link 27 to the shell 13.

[0142] In both cases, the clamping clip 29 can simply be folded down or can be screwed to a portion of the hull 13.

[0143] As an alternative or in addition, the second end 27b of the link 27 is provided with a hole (optionally reinforced by an eyelet) which fits into a corresponding pin of the hull 13 - just as at the first end 27a.

[0144] The path of link 27 is as follows:

[0145] The link 27 extends along a first segment from the proximal end 2a of the main stem 2 to the secondary stem 3.

[0146] It then extends, along a second section successive to the first section, inside the second section 7 of the secondary stem 3.

[0147] It then extends, along a third section successive to the second section, partially inside the first section 6 of the secondary stem 3, emerging through a hole provided at the rear of the secondary stem 3. The secondary stem 3 is shaped so that the link emerges in the lower part of the first section 6 and above the seat block 5. As can be seen in [Fig. 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 stem 3 towards the rear of the seat block 5 along an axis D which is directed towards the rear of the prosthesis 1 and which extends at an angle to the first axis X and the first section 6 of the secondary stem 3.

[0148] The link then extends, in a fourth section following the third section, along the rear of the seat block 5, that is, successively, along the rear of the rear island 19, the sole 18, and the heel 8. As more clearly seen in [Fig. 3], the rear of the seat block has a groove 31 within which the link 27 extends. The groove 31 is formed here by grooves successively cut into the three aforementioned layers. This allows the link 27 to be properly guided around the prosthesis 1 and prevents it from slipping laterally relative to it.

[0149] The link 27 then passes under the heel 8 in a fifth section successive to the fourth section. The heel 8 also has a guide provided in its underside to ensure the guidance of the link.

[0150] Alternatively, on this fifth section, the link passes through the heel 8 by means of a channel provided in the heel 8.

[0151] 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.

[0152] Preferably, the sole 11 is provided with a hole 32 through it.

[0153] Preferably, said hole 32 is arranged at the junction between the end before 12 of sole 11 and the rest of sole 11.

[0154] The link 27 thus passes through the sole 11 via said hole 32 to then extend, according to 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.

[0155] The positioning of link 27 allows all the elements of the prosthesis to be linked together.

[0156] Link 27 is for example a rope or a strap.

[0157] The link 27 is made of a woven material, preferably a reinforced woven material. For example, the link 27 is made of or based on nylon, preferably coated nylon. For example, the link 27 is made of the same material as a car seatbelt.

[0158] The link 27 is thus both strong and flexible. It is understood that the link 27 must be able to withstand tension and therefore must not exhibit elastic deformability in tension / compression.

[0159] Link 27 thus fulfills at least in part at least one of the roles of a tendon complex of a real leg.

[0160] The method for mounting the prosthesis 1 will now be described.

[0161] The seat block 5 is assembled first. For example, the heel 8 is positioned, then the sole 11 is placed on the heel 8, and then the rear island 19 is positioned on the sole 11 using the male / female organ pair.

[0162] The secondary stem 3 is then inserted through the rear island 19 and the sole 11 to fit into the heel 8.

[0163] The front island 23 is also positioned in the hull 13 and the assembly is mounted on the base 11 with the help of the cooperation between the groove 22 of the rear island 19 and the hull 13.

[0164] The main rod 2 is also inserted into the shell 13.

[0165] The link 27 is then attached at one of its ends and then stretched along the path indicated above until its other end is also fixed. As can be seen in [Fig. 10b], the link 27 is then stretched between its two ends 27a and 27b.

[0166] Preferably, we start by fixing the first end 27a of the link 27.

[0167] The link 27 is then passed through the secondary stem 3, then through the heel 8, and finally through the hole 32 in the sole 11.

[0168] 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 vertically over the hole in the shell 13.

[0169] The clamping clamp is then actuated to fix the second end 27b of the link 27 to the shell 13.

[0170] To separate the different elements of the prosthesis 1, it is sufficient to carry out the reverse steps.

[0171] The assembly and disassembly of the prosthesis 1 thus described proves to be simple and quick.

[0172] Prosthesis 1 also proves to be very modular.

[0173] It is thus easy to modify only one element of the prosthesis 1, for example to replace it if it is worn or if it needs to be adapted to a new user or whether it should be adapted to a new user need.

[0174] Indeed, it is easy to adapt the prosthesis 1 to its patient.

[0175] Thus, as can be seen in [Fig.9a], it is possible to offer different lengths of soles 11 for the same prosthesis 1.

[0176] Prosthesis 1 can therefore be used by a large number of people. Prosthesis 1 can also adapt to the changing needs of the same person, for example, a growing child.

[0177] Furthermore, and as can be seen in [Fig.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).

[0178] Furthermore, one or more layers of the seating block 5 can be chosen with a specific hardness according to the needs and / or physical characteristics of a patient.

[0179] Prosthesis 1 thus proves to be particularly adaptable between two different patients and for the same patient.

[0180] In use, when the patient takes a step, as seen in [Fig. 10a], the patient places the heel 8 on the ground. The heel 8 then becomes a pivot point.

[0181] The heel 8 exerts forces on the sole 11 which in turn exerts forces on the intermediate layer 15.

[0182] The seat block 5 then collapses under the force exerted on the seat block 5.

[0183] 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.

[0184] The elastically deformable layers of the seat block 5 will naturally tend to return to their original positions, which are those of the prosthesis 1 on the ground as seen in [Fig. 10b]. Similarly, the link 27, which is under greater tension at the front of the prosthesis 1 (due to its rearward relaxation), tends to return the prosthesis 1 to its initial position.

[0185] The patient then presses the front end of the sole 11 on 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.

[0186] The bending of the front of the sole 11 causes a loosening of the link on its sixth section and on its third section.

[0187] This naturally causes the heel 8 to tilt upwards.

[0188] The sole 11 will therefore want to return to its original position visible in [Fig.1Ob].

[0189] It is therefore understood that not only does link 27 allow the different elements of the prosthesis 1 to be held together, but that it also helps to promote the patient's walking movement. Furthermore, the elasticity of the layers of the seating block 5 also promotes the patient's walking movement.

[0190] Prosthesis 1 thus proves to be particularly ergonomic and efficient.

[0191] A second embodiment will now be described with reference to Figures 4 to 8.

[0192] First of all, link 27 is not temporarily secured to the rest of the prosthesis 1 in the same way as in the first embodiment.

[0193] Indeed, the connecting means here do not include a clamping clip but a pin 40 to secure the second end 27b of the link 27 to the hull 13. The pin 40 includes, for example, a rod, a screw, a rivet...

[0194] 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 (i.e. here the shell 13, the intermediate layer 15, the base 11 and the heel 8) so as to open at a first end on the upper face of the shell 13 and to open at a second end on the lower face of the heel 8.

[0195] Preferably the orifice 43 is opening onto an area of ​​the heel 8 not resting on the ground when the prosthesis 1 is placed on the ground.

[0196] 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 does not extend horizontally or vertically.

[0197] Thus in service, the orifice of the second end 27b of the link 27 is placed vertically above the orifice 43 and then the pin 40 is inserted through said two orifices.

[0198] A bolt on the connecting means optionally allows the assembly to be temporarily sealed. Alternatively, the orifice 43 is at least partially threaded and the pin 40 is screwed directly into the orifice 43 to temporarily secure the assembly.

[0199] 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 winder whose frame is itself fixed to the main rod 2. In this way, the winder allows the link 27 to be tensioned more or less. This alternative is, of course, also applicable to the first embodiment.

[0200] 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 made from sheet metal, for example by stamping said sheet metal.

[0201] Preferably at least the proximal end 3a of the secondary stem 3 forms a slide for the link 27.

[0202] Preferably, the secondary rod 3 is shaped so that its first section 41 extends straight 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 angled area 44 of the secondary rod 3 is for example drawn by fillets so as not to present a protruding edge.

[0203] Preferably, the secondary stem 3 is shaped so that the angled area 44 extends to the level of the heel 8 and preferably also to the level of the rear convex area of ​​the heel. The angled area 44 is shaped so as to rest at least partially against the heel 8. The angled area 44 is shaped so as to be bonded at least partially against the heel 8.

[0204] The first section 41 thus extends inside the base 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 back of the heel 8 to at least the opening 43. Preferably, the first section 41 is itself drilled with a hole forming part of said opening 43 so that the pin 40 can pass through the first section 41 when the prosthesis 1 is assembled. This allows the secondary stem 3 to be fixed to the base block 5 in a simple and temporary manner. For example, the first section 41 extends from the back of the heel 8 to the front of the heel 8.

[0205] Thus, whereas in the first embodiment, the secondary rod 3 entered the heel 8 from the top of it, in the second embodiment, the secondary rod 3 enters the heel 8 from the rear of the heel 8.

[0206] Preferably, the link 27 extends along the secondary stem 3 along 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 path to the hole 32 of the sole 11.

[0207] The heel 8, the intermediate layer 15 and the sole 11 are here without a rear groove.

[0208] 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 pair of male / female organs cooperating together. For example, the male organ is a raised section 45 cooperating with at least one tab 46 forming a female organ to position the sole 11 vis-à-vis the heel 8. In the present case, the heel 8 has a raised section 45 framed by two tabs 46 of the sole 11. The raised section 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 framing the raised section 45 on either side.

[0209] Furthermore, unlike the first embodiment, the hull 13 extends up to the rear of the seating block 5 (whereas in the first embodiment it only extended to the rear island 16).

[0210] Furthermore, unlike the first embodiment, the intermediate layer 15 and the heel 8 do not include at least one pair of male / female organs cooperating together.

[0211] Furthermore, unlike the first embodiment, the intermediate layer 15 is in a single island 47. However, just as in the first embodiment, it allows the shell 13 to be separated from the sole 11 and the heel 8. It also allows, just as in the first embodiment, for angular movement of the shell 13 relative to the sole 11.

[0212] To this end, and as more clearly seen in [Fig. 7], in at least one area of ​​the shell 13, the shell 13 is separated from the heel 8 by an air gap thanks to the intermediate layer 15 which raises it. This ensures lateral flexibility of the prosthesis. For example, the intermediate layer 15 comprises a sub-layer 48 resting on the heel 8 and a projection 49 extending from the upper surface of the sub-layer 48 in the opposite direction from the heel 8. The projection 49 extends, for example, orthogonally to the sub-layer 48. The projection 49 is, for example, centered in at least one direction on the upper surface of the sub-layer 48.

[0213] 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.

[0214] Preferably, the shell 13 has a housing 50 in which the protrusion is received. In a particular case, the orifice 43 is shaped so as to pass through said housing 50.

[0215] 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 has 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 define between themselves a slide 52 within which the protrusion 49 is arranged, the slide 52 thus 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.

[0216] 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 a rounded edge 53 is provided inside the shell 13 to form a smooth junction between the housing 50 and the orifice 43.

[0217] Apart from what has been indicated above, everything that has been indicated for the first This embodiment is also applicable to the present second embodiment.

[0218] An example of a method for mounting such a prosthesis 1 will now be described.

[0219] The secondary stem 3 is first inserted into the heel 8 until the stem secondary 3 arrives at the stop of the protuberance 10 of the heel 8.

[0220] The intermediate layer 15 is also inserted into the housing 50 of the shell 16.

[0221] 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 sole 11 + secondary rod 3 + heel 8 assembly, ensuring that the holes intended to receive the bolt 40 coincide.

[0222] The base block 5 is thus formed.

[0223] Finally, the link 27 is placed by passing it from the main stem 2 to the orifice 43 by passing it behind the secondary stem 3, through the heel 8 and then the hole 32 of the sole 11.

[0224] When the end 27b of the link is level with the opening 43, the bolt 40 is then arranged to fix the link 27 to the rest of the prosthesis. The reel is optionally used to ensure that the link 27 is properly tensioned.

[0225] To separate the different elements of the prosthesis 1, simply follow the reverse steps.

[0226] Embodiments have thus been described in which the prosthesis 1 is made up of elements that can easily be assembled and disassembled. In particular, the seat block 5 forms a sandwich of layers with different properties.

[0227] Such a prosthesis 1 proves to be comfortable to wear.

[0228] Such a prosthesis 1 proves to be structurally sound.

[0229] Such a prosthesis 1 also facilitates the patient's walking. For example, prosthesis 1 It promotes propulsion by facilitating the upward extension of the heel (as described with reference to [Fig. 10c]). For example, it cushions the patient's steps.

[0230] Such a prosthesis 1 ensures good support of the body bearing the prosthesis 1.

[0231] It is also noted that prosthesis 1 is of simple construction. In particular the its constituent elements are of simple structure.

[0232] Furthermore, the various elements, although independent, are nestable within one another 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).

[0233] It is noted that each of the elements has a simple structure and produces a very specific role.

[0234] Thus the shell 13 allows the various other parts to be pre-stressed while permitting 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.

[0235] The heel 8, and here also the intermediate layer 15, form a complex of elastically deformable materials which sandwich the sole 11.

[0236] Link 27 reproduces the tendon complex of a real foot and leg. Its path is guided in particular by the secondary rod 3 which is also connected to the seating block 5.

[0237] The secondary stem 3 also increases walking comfort. The secondary stem 3 acts as a conductor of the tension and compression dynamics of the prosthesis elements 1.

[0238] 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.

[0239] In particular, the two embodiments may be combined. For example, the secondary stem may be partly hollow, as in the first embodiment, and partly shaped into a blade (flat and / or curved), as in the second embodiment. For example, the underlayer and the protrusion 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 protrusion), as in the first embodiment. Furthermore, the intermediate layer and the heel of the second embodiment may comprise at least one pair of male / female organs cooperating together, as in the first embodiment. Moreover, the sole and the heel of the first embodiment may comprise at least one pair of male / female organs cooperating together, as in the second embodiment.

[0240] The prosthesis may include other elements than those described. For example, the prosthesis may include one or more protective elements arranged within it to limit friction between the strap and the prosthesis. Figure 2 illustrates such a protective element housed in a recess in the sole at the level of the hole through which the strap extends, or directly in the hole in the sole. This protects the sole. If necessary, the protective element can easily be replaced when worn (without having to touch the sole).

[0241] The male and female organs may be different from what has been described and / or 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).

[0242] The base block may comprise a different number of layers than described.

[0243] At least one of the layers of the foundation block may be composed of at least two islands or a greater number of islands. For example, the heel may consist of two islands.

[0244] At least two elements of the prosthesis may include additional (removable) means of fastening between them, such as at least one screw-nut assembly. Preferably, the prosthesis will not have such means of fastening, and only the connecting means will ensure the temporary fixation of the different elements of the prosthesis together.

Claims

Demands

1. Modular tibial prosthesis comprising at least: - a main stem (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 stem is housed, the seat block being provided with at least one first layer (11), a free end of said first layer extending forward of the main stem to form in service at least one ground support area, - connecting means comprising at least one link (27) extending from an upper part of the main stem to a first portion of the seat block by passing around and / or through the free end of the first layer to participate in the temporary securing of the stem to the seat block.

2. Prosthesis according to claim 1, comprising a secondary stem (3) arranged behind the main stem (2), the secondary stem comprising a distal end received in the seat block (5).

3. Prosthesis according to claim 2, wherein the secondary stem (3) is bent.

4. Prosthesis according to any one of claims 2 to 3, wherein the link (27) also passes along the secondary stem (3) and / or through the secondary stem.

5. Prosthesis according to any one of claims 1 to 4, wherein the main stem (2) is straight.

6. Prosthesis according to any one of the preceding claims, wherein the first layer (11) is formed by a blade.

7. Prosthesis according to any one of the preceding claims, wherein the seat block (5) comprises at least a second heel-forming layer (8), the first layer (11) being arranged on the second layer at its attachment end 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, wherein the second layer (8) is made of a material less elastically deformable than that of the first layer (11).

10. Prosthesis according to any one of the preceding claims, wherein the seat block (5) includes a shell (13) forming an upper layer of the seat block, the shell being arranged on the first layer (11) at an end of attachment of the first layer to the seat block, the shell being in a material less elastically deformable than that of the first layer.

11. Prosthesis according to claim 10 and any one of claims 7 to 9, wherein the shell (13) is made of a material that is the least elastically deformable of the materials forming the layers of the seat block

12. Prosthesis according to any one of claims 10 or 11, wherein a first end of the link (27) is fixed to an upper face of the shell (13).

13. Prosthesis according to claim 12, wherein the connecting means comprise a pin (40) for temporary attachment of the link to the seat block (5).

14. Prosthesis according to any 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 made of a material less elastically deformable than that of the first layer and / or more elastically deformable than the shell.

15. Prosthesis according to any one of the preceding claims, wherein 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 seat block.

16. Method of mounting a prosthesis according to one of the preceding claims, comprising the steps of housing the distal end of the main stem (2) in the seat block (5) and then securing said stem to said block by means of the link.

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