IMPROVED METHOD FOR AID IN THE MANUFACTURE OF A LIMBS PROSTHESIS USING A POSITIVE SOCKET MOLD, AND ASSEMBLY FOR PLACEMENT OF AN ATTACHMENT BETWEEN A SOCKET AND A PROSTHETIC CONNECTING ELEMENT.

Abstract

The invention relates to an improved method for manufacturing a prosthesis (1') from a positive mold (110) for fitting a residual limb of an amputee. The method comprises 3D modeling of the inner surface of an existing socket (2), including a 3D model (44) of said surface in a spatial reference frame (10), and automatic modification of said 3D model (44) to optimize the arrangement of an artificial limb (3) within the socket (2') to be manufactured. The method further comprises determining the position of a fastener (116) in said spatial reference frame (10) using a positioning guide (112) for the fastener (116). The invention also relates to a manufacturing aid assembly (100) configured to operate a manufacturing aid for a socket according to the process of the invention and comprising a positive mold (110) and the placement guide (112). Fig. 9

Description

Title of the invention: IMPROVED METHOD FOR AID IN THE MANUFACTURE OF A LIMBS PROSTHESIS USING A POSITIVE SOCKET MOLD, AND ASSEMBLY FOR PLACEMENT OF AN ATTACHMENT BETWEEN A SOCKET AND A PROSTHESIS CONNECTING ELEMENT. technical field

[0001] The present invention relates to an improved method for manufacturing a prosthetic limb from a positive mold obtained from a digital model. At least one embodiment relates to determining one or more attachment points for a fastener on an attachment surface between a hand-shaped prosthetic socket and an artificial limb of that prosthesis; and at least one embodiment relates to a method for obtaining a fastener placement guide obtained from a digital model of a socket surface. The invention also relates to a prosthetic attachment placement guide. PREVIOUS STATE OF THE ART

[0002] The manufacture of a prosthetic limb, as illustrated by an example in [Fig. 1], involves creating a temporary prosthetic socket into which a residual limb is inserted. This temporary socket is molded to the shape of the residual limb and fitted as closely as possible to the limb for which it is intended. Recent technologies and techniques allow prosthetists to create a three-dimensional model of the inner surface of a temporary socket previously molded manually on a residual limb. They can then digitally adapt or refine this 3D model to optimize its shape, as illustrated by an example in [Fig. 2], particularly to increase the wearer's comfort and optimize the fixation of the artificial limb connected to the socket. A final socket can then be 3D printed or machined from the 3D model obtained and subsequently modified digitally.Unfortunately, not all prosthetic practitioners have the technical means to perform 3D modeling and / or adjustments based on a 3D model, as well as 3D printing of a prosthetic socket, and this situation can be improved. Furthermore, although some practitioners may have the necessary equipment to work from a 3D model, the materials and components required may still be too expensive. Description of the invention

[0003] One object of the present invention is to provide a method to assist in the manual fabrication of a temporary socket or a so-called "final" or "definitive" socket for a limb prosthesis, by giving prosthetists access to advantages inherent in 3D modeling, on which the most recent techniques are based, even if these practitioners do not have access to 3D modeling tools and the processing of 3D models obtained by 3D modeling, or if their use proves too costly. In particular, a placement guide is proposed that allows the precise positioning of a mechanical attachment of an artificial limb to be determined on a socket to be made on a positive mold representing the inner surface of a limb socket.

[0004] To this end, a set of aids for the manufacture of a prosthetic limb is proposed, the set comprising: - a positive mold having a surface shape that is complementary or substantially complementary to an internal surface of a first prosthetic limb socket and having at least one first visual reference point, - a placement guide comprising at least one arm and one end of which has a second reference mark, intended to coincide with said first visual reference mark or with a position of the positive mold established in reference to the first visual reference mark said arm of said guide further carrying a retaining and positioning element in space of a mechanical attachment configured to allow the fixing of an artificial limb on a surface of a material applied to said positive mold in order to form a second socket of said prosthetic limb.

[0005] According to one embodiment, the assembly for manufacturing a prosthetic limb comprises at least four branches between which the support and positioning element is arranged and of which one or more branch ends present the support and positioning element, and the second reference being a visual reference.

[0006] According to one embodiment, the assembly for manufacturing a prosthetic limb further includes a ring configured to hold in position and stabilize the placement guide against the positive mold.

[0007] Another object of the invention is a method for manufacturing a prosthetic limb, the method comprising the use of a prosthetic limb manufacturing aid assembly as previously described and comprising the steps: - placing the positive mold of the manufacturing aid assembly on an ideally flat reference work surface, - Position the installation guide of the manufacturing aid assembly so that the part of the mold with the first visual mark is in contact with the part of the guide with the second visual mark, the first and second visual marks being arranged opposite each other or coinciding with each other, - assemble a fastener onto the retaining and positioning element within the space of said installation guide, - to seal the attachment and a surface of the positive mold or an envelope positioned on the positive mold, arranged opposite the attachment.

[0008] Another object of the invention is a method for manufacturing a prosthetic limb as described above and further comprising a deposit of a layer of material around the positive mold, on a surface of the positive mold or on an envelope positioned on the positive mold, the deposited material sealing or permanently encircling the attachment to form the second prosthesis socket equipped with an attachment then configured for the fixation of an artificial limb.

[0009] Another object of the invention is a method for manufacturing a prosthetic limb as mentioned above and further comprising a preliminary manufacturing step by 3D printing, machining or laser cutting of the positive mold from a 3D digital model obtained by modeling an inner surface of said first prosthesis socket.

[0010] The invention also relates to a method for manufacturing a prosthetic limb comprising further a preliminary manufacturing by 3D printing, machining or laser cutting of the placement guide from a 3D digital model obtained by modeling an inner surface of the first prosthesis socket.

[0011] The invention further relates to a method for manufacturing a prosthetic limb comprising further a prior manufacturing by 3D printing, machining or laser cutting of the positive mold and the placement guide from a 3D digital model obtained by modeling an inner surface of the first prosthesis socket, the positive mold and the placement guide being manufactured in the same element (or part) and being separable by means of pre-cuts or breakable parts arranged during the manufacture of this single element (or single part).

[0012] Another object of the invention is a method for manufacturing a manufacturing aid assembly as previously described, said method comprising the steps of: - obtaining a first 3D digital model, representative of the inner surface of the first socket, by digitizing the inner surface of the first socket, with reference to a spatial reference frame including at least one reference point, - determination of a second 3D digital model, representative of the shape of the positive mold of the second socket, from the first 3D digital model, - determination of a third 3D digital model, representative of the shape of said installation guide, from the second 3D digital model, and, - manufacturing by 3D printing, machining, or laser cutting of said positive mold and / or said positioning guide.

[0013] According to one variant, the aforementioned manufacturing process for a manufacturing aid assembly further includes a step of determining a fourth 3D digital model, representative of the shape of the band.

[0014] Finally, the invention also relates to a computer program product comprising program code instructions for executing the steps of a manufacturing process for a set of manufacturing aids as previously described when this program is executed by a processor of an information processing unit and an information storage medium comprising such a computer program product. Brief description of the drawings

[0015] The features of the invention mentioned above, as well as others, will become clearer upon reading the following description of an exemplary embodiment, said description being made in relation to the accompanying drawings:

[0016] [Fig.1] schematically illustrates an example of a prosthesis, adapted to a lower limb, and whose adjustable elements have been adjusted to be adapted to a wearer of the prosthesis;

[0017] [Fig.2] schematically illustrates an internal surface modeling system of a prosthesis configured for the generation of a 3D digital model of the inner surface of a prosthesis;

[0018] [Fig.3] schematically illustrates a so-called final prosthesis made from the provisional prosthesis shown in [Fig.1] and whose characteristics have been optimized thanks to 3D modeling carried out using the modeling system illustrated in [Fig.2];

[0019] [Fig.4] schematically illustrates a determination of the optimized positioning of a mechanical attachment in relation to a model of the inner surface of a prosthetic limb socket, operated by a digital system after digitization of the inner surface of the socket;

[0020] [Fig.5] schematically illustrates a 3D printing system configured to print a positive mold of complementary or substantially complementary shape to the shape of the modeled inner surface of a socket;

[0021] [Fig.6] schematically illustrates a set of aids for the manufacture of a prosthetic limb according to an embodiment;

[0022] [Fig.7] illustrates details of positioning a mechanical attachment using the prosthesis manufacturing aid assembly already shown in [Fig.6], according to one embodiment;

[0023] [Fig.8] illustrates the assembly of aids for the manufacture of a prosthetic limb already shown in [Fig.7], before assembly, according to one embodiment;

[0024] [Fig.9] is a diagram illustrating steps of a process for assisting in the manufacture of a prosthetic limb using a set of aids for the manufacture of a prosthetic limb, according to an embodiment;

[0025] [Fig. 10] schematically illustrates an example of the architecture of a controller configured for the design of a set of aids for the manufacture of a prosthetic limb from a 3D digital model of an internal surface of a prosthetic limb;

[0026] [Fig. 11] is a flowchart illustrating steps in a process for designing and manufacturing a manufacturing aid assembly according to an embodiment; and,

[0027] [Fig. 12] schematically illustrates details of positioning a mechanical attachment using a prosthesis manufacturing aid assembly, according to an embodiment variant using an articulated arm or a robot as a placement guide.

[0028] DETAILED STATEMENT OF IMPROVEMENTS

[0029] Figs. 1, 2 and 3 illustrate existing techniques for manufacturing prosthetic limbs using 3D modeling means of a provisional socket 2 of a prosthetic limb formed on the residual limb of a user (or wearer, or patient) and a 3D three-dimensional model 44 of the inner surface of the provisional socket 2, which can be digitally modified and retouched.

[0030] Figure 1 is a schematic representation of an example of a limb prosthesis 1. According to this example, the limb prosthesis 1 is a temporary lower limb prosthesis, also called a temporary tibial prosthesis, comprising an artificial terminal part 4, hereinafter referred to as the "artificial foot." However, the prosthesis 1 could be a non-temporary prosthesis, called a "definitive prosthesis," to be reproduced. The temporary prosthesis 1 is called temporary because it includes a temporary socket 2, manually shaped by a practitioner to be progressively adapted to the morphology of the wearer of the temporary prosthesis, who will subsequently receive a so-called "final" prosthesis, optimized and manufactured from the temporary prosthesis 1. The temporary socket 2 is configured to be fitted onto a residual limb of the wearer. The temporary prosthesis 1 comprises an artificial limb 3.Artificial limb 3 includes artificial foot 4 and a connecting element. 5 (an artificial tibia as described here) allows the artificial foot 4 to be mechanically connected to the temporary socket 2. The artificial limb 3 comprises a first set of fixation called the "distal fixation" 6, adjustable, of the ball-and-socket type and lockable in position, between the artificial foot 4 and the connecting element 5, and a second set of fixation called the "proximal fixation" 7, between the connecting element 5 and the temporary socket 2. The distal fixation 6 comprises two complementary parts 6a and 6b, which are inserted one inside the other (parts 6a and 6b of the distal fixation assembly 6 are not detailed in [Fig. 1]). Parts 6a and 6b constitute an assembly commonly known as a "pyramid" used in the field of limb prostheses. Part 6a is attached to the artificial foot 4. Part 6b is attached to the connecting element 5.Each of parts 6a and 6b includes means for adjusting and locking (blocking) in position, operating in combination with means for adjusting and locking in position of the other of the two parts 6a and 6b of the distal fixation 6. Thus, the distal fixation 6 is configured to adjust and lock in position the foot 4 and the connecting element 5, thanks to the combined effect of parts 6a and 6b. Figure 1 illustrates that, according to the reference settings made when the temporary prosthesis 1 is worn by the intended wearer, the best setting, illustrated in Figure 1, is such that the connecting element 5 has a longitudinal axis 50 inclined in a space referenced by an orthonormal frame 10 comprising directions X, Y, and Z.The X, Y, and Z directions are pairwise perpendicular to each other, such that a plane defined along the X and Y directions is horizontal, and a plane defined along the X and Z directions, or even along the Y and Z directions, is vertical. The entire temporary prosthesis 1, in its position best suited to the patient, or at least considered as such, is referenced and located in space with respect to a first predefined reference point 401 of the artificial foot 4 when the artificial foot is positioned in a predetermined reference position, for example, when the artificial foot 4 is placed on a reference surface 101 parallel to a plane defined along the X and Y directions (a horizontal plane).

[0031] According to another example, the adjustable distal fixation can be implemented without using a “pyramid” system as previously described, but by means of one or more pivot links, or even a ball joint of any type that can be locked in position.

[0032] According to yet another example, the adjustable distal fixation can be implemented using a connecting element made of a deformable material when a force greater than a predetermined threshold is applied to it; for example a metal bar deformable by means of specific tools dedicated to making such an adjustment.

[0033] It should be noted that the determination of a predetermined reference position, and therefore of a reference setting in relative position, with respect to each other, of the arrangement of all the elements which make up the prosthesis, depends on the type of prosthesis and in particular on the type of the artificial end part 4 to be assembled to the connecting element 5. Thus, for example, a reference position along the torso of a wearer can be determined when the artificial end part is an arm; a reference position with respect to the arm can be determined when the artificial end part 4 is a hand, and so on.

[0034] Depending on the type of artificial terminal part 4 assembled on the prosthesis, the connecting element 5 can have many different shapes so as to provide structural characteristics implementing all or part of the functions of shoulder, hip, knee, ankle, for example, but also more generally to operate a solid connection between a socket adapted to a residual portion of the body, on the one hand, and to an artificial limb, on the other hand.

[0035] Figure 2 illustrates the positioning of the provisional prosthesis 1 in a modeling system 400 of the inner surface of the provisional socket 2. The system 400 includes a second reference space 40 defined by directions X', Y' and Z' respectively parallel to the directions X, Y and Z of the first reference space 10, as well as a support including the reference point 201. Cleverly, the reference point 201 is included in a distal fixation assembly identical to the distal fixation assembly of the provisional prosthesis 1. According to the described embodiment, the reference point 201 is implemented by the intersection of the adjustment axes of a so-called "pyramid" linkage assembly such as the distal fixation assembly 6 illustrated in Figure 3 and composed of elements 6a and 6b.Using a pyramid as the reference point 201 of the system 400 for modeling the inner surface of the temporary socket 2 advantageously allows for the fixing of the connecting element 5 to which the temporary socket 2 is attached, while maintaining the positional adjustment of the connecting element 5 relative to the spatial reference frame 10 (reference adjustment). Indeed, if the decoupling of the fixing element 5 and the artificial foot 4 is achieved by loosening only two adjacent screws among the four screws of the pyramid system 6, and then the connecting element 5 is re-coupled to an element similar to element 6a of the distal fixation 6, including the reference point 201, by tightening the two previously loosened screws, the relative positioning of the assembly composed of the connecting element 5 and the temporary socket 2 with respect to the spatial reference frame 10 is maintained.This obviously implies that the pyramid element used for fixing and including the reference point 201 is fixed in the fixing assembly in a position such that the respective orientation directions of the settings in the second reference space 40 are. parallel to the X, Y and Z directions of reference space 10. Obviously, the reference point could be another point of the provisional prosthesis, provided that it is possible to define a relative position between the position of the provisional prosthesis in the second reference space 40 with respect to the first reference space 10.

[0036] The modeling system 400 includes a distance measuring device 42 connected to a control unit 41 via a bidirectional communication link 43. According to one embodiment, the distance measuring system 42 is mobile and can be moved along the X', Y' and Z' directions of an orthonormal frame (spatial reference frame) 11, in the reference space 40. The movements of the distance measuring device 42 in the reference space 40 can be operated manually or automatically.That is to say, the distance measuring device 42 can be guided manually by an operator or guided along the X', Y', and Z' directions by actuators, such as stepper motors, for example, under the control of the control unit 41 executing software routines designed for this purpose, and comprising a user interface accessible via the control unit 4L. In all cases, the modeling system 400 includes means for determining the precise position in the second reference space 40, thanks to a set of position sensors. Advantageously, and according to one embodiment of the invention, the distance measuring device 42 comprises a rotating arm (or shaft) 421 at the end of which is fixed a measuring head 422 (these elements are not shown in [Fig. 4] to improve readability).In one embodiment, the measuring head 422 of the measuring device 42 includes a light wave transmitting and receiving module configured to determine the distance between the transmitting and receiving module and an interface positioned opposite it, using a "time-of-flight" method. In one embodiment, the light wave is a laser beam. This configuration advantageously allows the distance between the measuring head and a point on the inner surface of the temporary socket 2, located opposite the measuring head 422, to be determined when all or part of the arm 421 and the measuring head 422 are inserted into the temporary socket 2.Thus, thanks to the modeling system 400, it is possible to determine a model 44 representing the inner surface of the provisional socket 2 in the reference space 40, and therefore, consequently, in the reference space 10, since the distance between the reference points 401 of the artificial foot 4 of the provisional prosthesis 1 and the fixation and reference point 201 is known, and can be expressed in terms of coordinates along the X, Y and Z directions of the reference space 10 or along the X', Y' and Z' directions of the reference space 40. In [Fig. 4], the 3D model 44 representing the space of . The inner surface of the temporary socket 2 is displayed on the screen of the control unit 41 for the purpose of fully illustrating the modeling system 400. Naturally, the information representing each of the measurement points, which together constitute modeling points of the inner surface of the socket, can be stored in the working memory of the control unit 41 or in external memory accessible from the control unit 41. The control unit 41 is generally configured to perform changes of coordinate systems or reference spaces, allowing it to convert the first coordinates of one or more points of an object in a first coordinate system or spatial reference frame into the second coordinates of these same points in a second coordinate system or spatial reference frame, and vice versa.As a result, after scanning an object in a first spatial coordinate system, the control unit can determine three-dimensional models of parts with complementary shapes to be positioned in another spatial coordinate system. Obviously, the scanning method described here is not exhaustive, and other 3D scanning methods can be used to model the inner or outer surface of a socket. For example, a handheld 3D scanner of the Einstar type (registered trademark) from the supplier Shining 3D (registered trademark) can be used when the socket whose inner surface is to be scanned is positioned on a calibration support equipped with a distal fixation system similar to distal fixation assembly 6, for example, a plate with a pyramid and visual markers providing a three-dimensional reference space (or 3D coordinate system).

[0037] Figure 3 represents a final prosthesis 1', the fabrication of which is simplified by the manufacturing aid system described. The final prosthesis 1' comprises the same elements as the provisional prosthesis 1, except for the socket and the proximal fixation 7, which is replaced by a final proximal fixation 7'. In the final prosthesis 1', the provisional socket 2 is replaced by a final socket 2'. However, the fixation parameters and the settings of the distal fixation assemblies 6 and proximal fixation 7' ​​are different from those of the distal fixation 6 and proximal fixation 7 implemented for the provisional prosthesis 1. Figure 3 is intended to illustrate one of the advantages of using the so-called final prosthesis 1', which includes the so-called final socket 2'.Indeed, in addition to the strength of the materials, optimized weight, and robustness, for example, the assembly of the elements of the final prosthesis 1' aims to achieve a vertical or nearly vertical positioning of the longitudinal axis 50 of the fixation element 5. This allows, in the example of the (tibial) prosthesis described here, for an optimized absorption of the mechanical weight-bearing forces present during the use of the final prosthesis 1' by its wearer. Furthermore, an adjustment of the shape of the final socket 2' at the level of the proximal fixation 7' ​​is made relative to the shape of the socket. The provisional 2, located near the proximal fixation 7, not only allows for vertical or near-vertical positioning of the fixation element 5 but also enables the distal fixation 6 to be adjusted with an adjustment range (or excursion) evenly distributed in two opposite directions of the same adjustment direction. In other words, the distal fixation 6 can be repositioned "to neutral" by adjusting the shape of the final socket 2', at and near the proximal fixation 7', relative to the shape of the provisional socket 2. The adjustment excursions of the distal fixation 6, resulting from the reference adjustment made during repeated trials with the wearer, are then compensated by an adjustment of the shape of the final socket 2' at the level of the proximal fixation 7' ​​and by the resulting configuration of the proximal fixation 7', considered as a whole.

[0038] These characteristics of the final prosthesis 1' comprising the final socket 2', in relation to the provisional prosthesis 1 comprising the provisional socket 2, are obtained through digitization means which make it possible to manufacture, for example by machining or 3D printing, the second socket 2' called "final socket" from the determined (digitized) three-dimensional model possibly modified.

[0039] Figure 4 is an enlarged view of the three-dimensional model 44 representing the inner surface of the provisional socket 2. A lower portion 44e represents the surface of the bottom of the provisional socket 2 (or lower or bottom part of the provisional socket 2). Advantageously, it is possible to automatically define, through modeling, an outer surface of a socket to be produced that reproduces the inner surface of the socket 2. According to one embodiment, the control unit 41 executes an algorithm for defining a volume corresponding to a thickness around the modeled inner surface 44 and can determine a volume shape to meet specific criteria or given constraints.Thus, the control unit 41 defines the support and fixing surfaces of the connecting element 5 by taking into account the positioning of the inner surface modeled by the three-dimensional model 44 with respect to the reference point 401 of the artificial foot 4. This is made possible thanks to the different spatial references used and in particular thanks to the use of the fixing pyramid to fix the connecting element 5 coupled to the temporary socket 2 in the reference space 40, before digitizing the inner surface of the temporary socket 2 by means of the detection device 42.

[0040] The bearing and fixation surfaces determined by the control unit 41 can vary and obviously depend on the type of artificial limb to be fixed to the socket. According to the prosthesis example described, the control unit 41 advantageously allows a reference point PI to be defined in the reference space 10 (determined by the X, Y, and Z directions) to be used to define the attachment point of an artificial limb attachment 116. Attachment 116 is a component of the proximal fixation of the tibial prosthesis illustrated in an example embodiment.

[0041] Modifications made to the 3D model 44 aimed at optimizing the comfort of the prosthesis wearer and / or the mechanical characteristics of fixation and load transfer, for example, can be carried out automatically, using dedicated calculation modules of the control unit 41 executing algorithms adapted for this purpose, but also carried out under the control of an operator such as a prosthetist, who is able to modify the stored three-dimensional model by entering or modifying shape and position parameters (local thicknesses, reliefs, cavities, etc.) of the socket via a human-machine interface operating in connection with the control unit 4L. Obviously, the modification of a three-dimensional surface or volume model of a prosthesis socket can combine automated modifications and modifications carried out by entering or modifying parameters under the control of an operator.

[0042] Cleverly and advantageously, the control unit is further used to define a positioning guide device or system, based on point PI, of the three-dimensional model 44 of the socket's inner surface and the shape of the attachment 116, the dimensions of which are predetermined. The term "positioning guide" here refers to a limb attachment positioning guide for a socket to be manufactured. The aim is to position the attachment 116, also referred to here as the mechanical attachment 116, at a precise location (PI, or another point defined with reference to point PI), thus optimizing the comfort and / or mechanical function of the prosthesis to be manufactured, as illustrated previously in relation to [Fig. 1], [Fig. 2], and [Fig. 3].

[0043] Since the prosthesis is to be made manually by modeling on a positive mold, the use of a placement guide device or system advantageously allows the attachment 116 to be positioned and held in position while the attachment 116 is sealed onto a surface positioned on the positive mold 110, for example by gluing, before material is applied to the positive mold 110 to form the socket around this positive mold and at least partially around the attachment 116. The term "positive mold" here refers to a mold whose outer surface has a shape that is complementary or substantially complementary to the inner surface of a prosthesis socket.The term "substantially complementary" here refers to a complementary form possibly modified marginally to make local adjustments to improve the wearer's comfort, or to an anchoring or mechanical attachment position of an element to a socket made from the mold.

[0044] It is thus advantageously possible to reposition the proximal fixation 7' ​​relative to the axis 50 of the connecting element 5, so as to obtain an assembly of the final socket 2' and the connecting element 5 which allows the most vertical possible position, or substantially vertical, of the connecting element 5, when the final prosthesis 1' is worn by a wearer, while best meeting the comfort conditions tested and obtained during the preliminary testing phase of the provisional prosthesis 1. As a result, the final prosthesis 1' will be as comfortable as possible, while presenting an optimized configuration for the absorption of mechanical forces during use and while offering well-distributed adjustment possibilities (substantially equal excursions) in both directions of the same direction for the adjustment of the distal fixation 6.

[0045] That being said, not all prosthetists have automated tools capable of operating a machining or 3D printing from a digital model or even capable of operating by combining these two techniques, which is why the placement guide device or system according to the invention and its use for the manufacture of a prosthesis cleverly and advantageously allows prosthetist practitioners to manually manufacture a limb prosthesis from a 3D model generated via the aforementioned tools and taking advantage of the described advantages allowing to optimize the characteristics of this prosthesis.

[0046] Figure 5 illustrates a 3D printing manufacturing system configured for three-dimensional printing of a positive mold 110 representative of the internal shape of the final socket 2'. According to one embodiment, this system comprises a 3D printer 45. The system consists of the control unit 41, used in the modeling system 400, or any similar system, into which a three-dimensional model derived with or without modifications of the three-dimensional model 44 has been transferred, connected to the 3D printer 45.A bidirectional link 43 between the control unit 41 and the 3D printer 45 allows the control unit 41, operating under the control of dedicated software routines, to three-dimensionally print the prosthesis manufacturing aid assembly 100 from the three-dimensional model 44, possibly modified by one or more dedicated applications executed by the control unit 41 (an example of whose architecture is illustrated in [Fig. 10]). According to one embodiment, the prosthesis manufacturing aid assembly 100 comprises the positive mold 110 and a placement guide 112 allowing for precise positioning of the attachment 116 in relation to the positive mold 110.

[0047] The 3D printing system using the 3D printer 45 advantageously allows printing of the positive mold 110 but also a guide for positioning a mechanical fastener, under the control of the control unit 4L

[0048] Indeed, the control unit 41 is configured to determine any object or volume from a set of points determined in a spatial frame (or reference space) in which a set of points representative of the digitized inner surface of a socket is determined.

[0049] According to one embodiment, the positive mold 110 and the positioning guide 112 are manufactured as two separate objects or assemblies. According to another embodiment, the positive mold 110 and the positioning guide are manufactured as a single object but which has predefined points of weakness, also called "breakable parts", which makes it possible to separate the positive mold 110 from one or more other elements forming the positioning guide 112 or intended to form the positioning guide 112 after an assembly step.

[0050] Obviously, the manufacturing methods described above are not limiting, and other manufacturing methods for the positive mold 110 and the positioning guide 112 may be used. By way of example, the positive mold 110 could be produced by machining operations (milling, for example), and the positioning guide 112 could be produced by milling or by cutting with a laser cutting tool. The different manufacturing methods, such as machining, material addition, or laser cutting, can of course be combined.

[0051] It should be noted that the outer surface of the positive mold 110 is very important insofar as it serves to define an inner surface of a socket to be made, which will be worn by the wearer of the prosthesis to be manufactured, based on a digitization of the inner surface of a previous socket (temporary or otherwise), modified or not. This does not, however, preclude the creation of a cavity or any other shape inside the positive mold 110, particularly for the purpose of fixing the positive mold 110 to a working support in order to apply a material to it for manufacturing a prosthesis socket. More generally, the interior of the positive mold 110 can be arranged to meet various constraints, for example, to save material or to insert one or more fixing elements, provided that the positive mold 110 is sufficiently robust and practical to meet the manufacturing requirements of a prosthesis using this positive mold 110.

[0052] Fig. 6 schematically illustrates, in perspective, a prosthesis manufacturing aid 100 comprising the positive mold 110 and a placement guide 112.

[0053] According to the example shown, the positive mold 110 is a separate element from the positioning guide 112, and a calibrated clamping ring 114 ensures stable retention of the positive mold 110 and the positioning guide 112 in the correct relative position, without any movement. The clamping ring 114 is first determined by the control unit 41, in the form of a 3D digital model, from a 3D digital model of the positioning guide 112. which 3D digital model of the positioning guide 112 is determined from the 3D digital model of the positive mold 110.

[0054] Cleverly, at least one arm of the positioning guide 112 includes a visual marker 112n designed to coincide with a visual marker 110 of the positive mold 110 when the positioning guide 112 is positioned in contact with the positive mold 110 or when a single arm is securely fixed to a common base (a common support) with the positive mold 110 which includes a marker 11. According to one embodiment, the positioning guide 112 includes a plurality of arms and at least two of these arms then include a predetermined visual marker 112n designed to coincide with a dedicated visual marker 110 of the positive mold 110. According to the embodiment described in relation to [Fig. 6], a second visual marker 112n' of one arm of the positioning guide 112 is determined to be positioned opposite a second visual marker 110 of the positive mold 110.

[0055] It should be noted that the term "visual markers" here refers to any marker that can be perceived visually. Thus, it may be a simple marking, but also a first predetermined mechanical shape designed to complement a second mechanical shape, so as to allow one to be fitted into the other. For example, a first marker may be a cylindrical mechanical shape (a pin or a cylindrical lug) designed to be inserted into a bore of complementary shape. According to yet another example, a first marker may have a square protrusion designed to be inserted into a square cavity, etc. Thus, a visual marker designed to coincide with another visual marker can be defined as two complementary surfaces configured to achieve precise relative positioning between two parts or elements (here, the positioning guide 112 with respect to the positive mold 110).The complementary shapes used can then be any shapes as long as, in pairs, they allow for error correction in position and precise positioning of the placement guide 112 relative to the positive mold 110.

[0056] Figure 7 schematically illustrates the positioning of a portion 112m of the positioning guide 112 configured to operate and functioning as a mechanical attachment support for a prosthetic artificial limb. This mechanical attachment support performs the functions of holding and positioning a mechanical attachment for the artificial limb in space. The prosthesis manufacturing aid assembly 100, shown in Figure 7, comprises the positive mold 110, the positioning guide 112, and the band 114. The positioning guide 112 comprises four arms 112a, 112b, 112c, and 112d, each arranged overall in an "L" shape and converging towards the central portion 112m. In one embodiment, the central portion 112m comprises one or more bores or threads configured for the temporary attachment of the bracket 116 to the The positioning guide 112, with reference to the reference point PI, precisely defines the position and orientation of the attachment 116 in combination with the central part 112m of the positioning guide 112, the shape of which is determined under the control of the control unit 41, and 3D modeling. Such an arrangement advantageously allows the artificial limb attachment 116 to be positioned and fixed to the positioning guide 112, in a predetermined position of the reference space (spatial frame) used, before sealing the attachment 116 to a surface affixed to the positive mold 110, prior to the molding of the prosthetic socket to be manufactured by a prosthetist or by an operator working under the supervision of a prosthetist.

[0057] The socket manufacturing steps described herein are intentionally simplified to enhance the readability of this description, as they do not directly contribute to understanding the invention. A person skilled in the art, specializing in prosthetics, will be able to determine the prerequisites and steps for manufacturing a socket from a positive mold and a limb attachment positioned at a precise point relative to this mold, according to at least one embodiment and with the aid of an attachment placement guide. Thus, for example, a first pocket of PVA or PVC material can be applied (threaded) by an operator onto the surface of the positive mold, onto which a layer of re-impregnated fibers will be applied, the whole then being covered by a second pocket threaded over the assembly, the space between the two pockets then being filled with a material such as, for example, resin.Thus, when it is stated previously that the fastener 116 is sealed onto the mold, it is actually positioned against the mold, flush with it or close to it, but is isolated by the first pocket acting as an insulating interface. The fastener 116 is actually sealed in the socket made on the positive mold, and close to or against the positive mold.

[0058] Figure 8 illustrates an embodiment of the prosthetic limb manufacturing aid assembly 100, in which the positive mold 110 and the positioning guide 112 are manufactured and supplied as separate components. According to the embodiment described, the positioning guide 112 is supplied in the form of four arms 112a, 112b, 112c, and 112d, also supplied as separate components. In this embodiment, the ends of the arms then form the central part 112m of the positioning guide 112 when brought together during an assembly operation. According to this example, the assembly includes the fastener 116, and the band 114, as well as a set 116s of screws provided and configured to achieve positioning and fixing of the fastener 116 against the central part 112m of the positioning guide 112, precisely between the central part 112m and the positive mold 110.According to the example of the realization of assembly 110 shown in [Fig.8], the visual references allow for a good relative positioning of the laying guide and the assembly. 100 are complementary shapes allowing the insertion of a foot arranged at the base of each of the branches of the positioning guide into a cavity of complementary shape to the foot arranged at the base of the positive mold 110.

[0059] Advantageously, when the positioning guide 112 is assembled against or near the positive mold 110 and positioned according to the predetermined reference position from the 3D modeling, and the attachment 116 is fixed to the central part of the positioning guide 112, a practitioner or operator can proceed to cement the attachment 116 to a prosthesis fabricated on the positive mold 110. This cementing can be achieved using an adhesive, cement, or any other product, element, or assembly of fasteners. Once the attachment 116 has been cemented to the positive mold 110 (or to an interface envelope affixed to the positive mold), the dental technician or operator can disassemble the attachment 116 from the positioning guide 112 and apply to the positive mold 110 the material used to continue fabricating the socket of the prosthesis.This material is then deposited in the form of a layer covering the positive mold 110 and enclosing the attachment 116 intended to receive an end of an artificial limb or an intermediate fixing element of an artificial limb configured to be assembled onto the attachment 116.

[0060] Advantageously, the presentation of the set 100 in the form of a kit makes it easier to transport.

[0061] According to one embodiment, the positive mold 110 and the placement guide 112 of the attachment 116 are supplied in the form of digital files comprising data respectively representative of the shapes (or profiles, or volumes, in reference to an orthonormal reference frame) of each and allowing a prosthetist or operator to manufacture them himself with equipment programmed from these digital files, before using them for the manufacture of a prosthesis.

[0062] According to one embodiment, the positive mold is supplied in the form of a digital file comprising data representative of its shape (or profile, or volume with reference to a reference orthonormal frame) and the positioning guide 112 of the attachment 116 is supplied in the form of a digital file comprising data established for the configuration of a robot or an articulated arm, according to a predetermined position, with reference to the reference orthonormal frame used for the manufacture of the positive mold, allowing, in the end, the use of this robot or this articulated arm, provided with a gripping element of the attachment 116, to serve as a positioning guide equivalent to the positioning guide made of a material and comprising one or more arms, at least one of which carries a visual reference.

[0063] Figure 9 is a diagram illustrating a method for assisting in the manufacture of a prosthetic limb according to one embodiment, which is presented more specifically in the form of a process to aid in the manufacture of a prosthetic limb socket. A step SO is an initial preparation step of the socket manufacturing aid process, at the end of which all the elements used are made available to a prosthetist or an operator working under the supervision of a prosthetist. Thus, at the end of the initial step SO, the positive mold 110 was designed and manufactured (e.g., 3D printed or machined, or both) from the digitally modified three-dimensional model 44 under the control of the control unit 41. Similarly, the positioning guide 112 was automatically designed from a three-dimensional digital model of the positive mold 110, determining the number and dimensions of the arm(s) of the positioning guide 112, as well as their precise shape, based in particular on the attachment model 116 designed for the occasion or selected from a catalog of prosthetic attachment parts.Thus, at the end of the initial preparatory step SO, the dental technician or operator has the fabrication aid set 100, designed from a digital model of the inside of a temporary or anterior prosthesis of the wearer, and which has been provided to them (for example, by delivery to their practice). During a step SI, the positive mold 100 is then placed on a reference plane or base, allowing for stable and precise positioning in space, on which the positioning guide 112 can also be based to provide a common spatial reference frame (or common reference space). The positioning guide is then positioned along or around the positive mold 110, during a step S2, so as to align the visual marker(s) arranged on the positive mold 110 and on the positioning guide 112.In step S3, the fastener 116 is positioned and fixed against the central part 112m of the positioning guide 112, so as to place this fastener between the central part 112m and the top of the positive mold 110, at a predetermined distance, or possibly tangentially flush with the surface of the positive mold 110 or against the positive mold. In one embodiment, the fastening is achieved using a screw or a bolt, or a set of screws or bolts. A step S4 then takes place, for example, using a strong adhesive or cement, to seal the fastener 116 to the positive mold, or to an envelope applied to the positive mold 110.According to one embodiment, the process then comprises, after the attachment 116 is sealed to the positive mold 110, a drying step of the adhesive or cement, followed by a disassembly step of the attachment 116 and the central or terminal part of the positioning guide 112, for example by removing the screws used, if any. The mold to which the attachment 116 is then fixed is ready to be coated with a material that will dry to create a prosthetic socket for which the attachment point of an artificial limb is optimized, although the socket is manufactured manually in this case.

[0064] According to one embodiment, the positioning guide 112 used is an articulated arm or robot whose position is programmed to implement the positioning guide 112, that is, by aligning its position with the position of the positive mold 110 in order to position the fastener 116 at the predetermined location when the fastener 116 is held by a terminal gripping element of the articulated arm or robot, optionally positioned precisely by an element then acting as a visual alignment guide. The articulated arm, or robot, thus programmed, performs the same positioning guide function as the positioning guide 112 described above. To this end, a work surface S is used that allows conformity to a single spatial reference frame for the robot and for the positioning of the positive mold 110.In this case, any point of a terminal gripping element or tool of the attachment 116, arranged at the end of the articulated arm or robot, operates the function of a reference point, visual or not, whose programmed position is determined with respect to a reference point of the positive mold 110 or to a reference position of the positive mold 110 on the working surface S.

[0065] Fig. 11 illustrates a method for designing and manufacturing the assembly 100 for assisting in the manufacture of a socket according to one embodiment.

[0066] An initial step S0' is an initial preparation step at the end of which the provisional socket or an anterior socket 2 has been digitized using the three-dimensional modeling system illustrated in [Fig. 2] or a similar system. During a step S1', the control unit 41 determines a three-dimensional volume with a shape complementary to the inner surface of the socket 2, inserting modifications as needed to increase wearer comfort and / or the mechanical characteristics of the prosthesis to be produced (range of motion, load transfer, etc.). In addition, the reference point PI for positioning the attachment 116 is also determined with respect to the preliminary settings established as described in relation to [Fig. 1]. This three-dimensional volume is then used by the control unit 41 to determine another volume for defining the positive mold 110, during a step S2'.Then the shape and dimensions of the placement guide 112 are determined during a step S3' by the control unit 41 from the modeled volume of the positive mold 110, the chosen attachment model 116 and possibly the material chosen to make the prosthesis socket since this choice has an impact on the strength of the socket and therefore on its thickness.

[0067] The dimensions of the positioning guide 112 are calculated based on the dimensions of the positive mold 110, the dimensions of the chosen fastener 116, and the desired thickness of the socket, which depends on the required mechanical characteristics. Finally, the positive mold 110 and the positioning guide are manufactured, during a step S4', by a 3D printer, a machining center, or a combination of machining and additive manufacturing using one or more dedicated machines.

[0068] The use of the prosthesis manufacturing aid assembly 100 in a manufacturing process such as that described in relation to [Fig. 9] advantageously allows for very precise alignment and positioning of the artificial limb attachment. 3D printing the internal shape of the prosthesis, defined here as the positive mold 110, and the positioning guide 112 greatly simplifies and accelerates the manufacturing process. Furthermore, the system can be easily modified to adapt to various prosthesis configurations.

[0069] Fig. 10 schematically illustrates an example of the internal architecture of the 4L control unit. For illustrative purposes, Fig. 10 illustrates an internal arrangement of the 4L control unit. It should be noted that the architecture shown could also be used as the internal architecture of the internal systems of the distance measuring device 42 or as the internal architecture of the 3D printing device 45. According to the example of hardware architecture shown in Fig.

[10] , the control unit 41 then comprises, connected by a communication bus 419: a processor or CPU (Central Processing Unit) 411; a RAM (Random Access Memory) 412; a ROM (Read Only Memory) 413; a storage unit such as a hard disk drive (or a storage media reader, such as an SD card reader (Secure Digital) 414); at least one communication interface 415 allowing the control unit 41 to communicate with other devices to which it is connected, such as the distance measuring device 42 or the 3D printing device 45 or internal devices such as a screen, a keyboard, etc.

[0070] According to one embodiment, the communication interface 415 is also configured for the control of a user interface configured for the supervision of the manufacturing operations of a final socket using the system 400 and according to the process described and its variants described.

[0071] The processor 411 is capable of executing instructions loaded into RAM 412 from ROM 413, external memory (not shown), storage media (such as an SD card), or a communication network. When the control unit 41 is powered on, the processor 411 is capable of reading instructions from RAM 412 and executing them. These instructions form a computer program causing the processor 411 to implement all or part of a process described in relation to [Fig. 11] or described variants of that process.

[0072] All or part of the methods described in relation to [Fig. 11] or their described variants can be implemented in software form by executing a set of instructions by a programmable machine, for example a DSP (Digital Signal Processor) or a microcontroller, or be implemented in hardware form by a dedicated machine or component, for example an FPGA (Field- Programmable Gate Array (in English) or an ASIC (Application-Specific Integrated Circuit). In general, the control unit 41 comprises electronic circuitry configured to implement the processes described in relation to itself. Obviously, the control unit 41 also includes all the elements usually present in a system comprising a digital core operating control unit functions and its peripherals, such as a power supply circuit, a power supply monitoring circuit, one or more clock circuits, a reset circuit, input / output ports, interrupt inputs, bus drivers, this list being non-exhaustive.

[0073] According to an alternative embodiment illustrated in [Fig. 12], the prosthesis manufacturing aid assembly 100 comprises a positive mold 110 having a surface shape complementary or substantially complementary to an internal surface of a limb prosthesis socket and having at least one first visual reference mark 110 allowing precise and reference positioning of the positive mold 110 relative to a reference working surface S on which the positive mold 110 is positioned and held, and the positioning guide 112 is an articulated arm, for example a robot arm forming a branch 112a, positioned in space with reference to said working surface S, and whose actuator operates, in a programmed position, a second reference mark 112n intended to coincide with a determined position of the positive mold 110 established with reference to said first visual reference mark 110,The robot arm, forming the arm 112a of the positioning guide 112, further carries a holding and positioning element 112m within the space of a mechanical attachment 116 configured to allow the fixation of an artificial limb onto a surface of a material applied to the positive mold 110 in order to form a socket for the prosthetic limb. According to the described embodiment, a visual marker SA and a positive mold support 110g are used to define a reference position of the positive mold 110 on the working surface S. According to an embodiment illustrated by way of non-limiting example, the element 110g is a vertical holding axis inserted into a cavity or machining of the positive mold 110, and the markers 110g and SA are used to correctly orient the positive mold 110 around the vertical axis defined by the element 110g. This makes it possible to determine a reference position of the positive mold 110.determined from a 3D model in a spatial reference frame. According to this same embodiment, the reference frame 112n is used to normally position the attachment 116 in a gripper actuator of the articulated arm (for example, a rod intended to be inserted into a bore of the attachment 116). Obviously, this example is not limiting, and the reference frame 112n can be any element participating in the gripping function of the attachment 116 by the articulated arm or robot 112, capable of determining a position. relative of the attachment 116 and the positive mold 110 to operate a placement of the attachment on the prosthesis to be made on the positive mold.

[0074] The invention is not limited to the examples and embodiments described, but more generally to any set of aids for the manual manufacture of a prosthesis from a positive mold using a guide for positioning an attachment of an artificial limb, the positioning guide being designed and then manufactured from a 3D model of the inner surface of a socket or being a robot programmed from this 3D model, as well as to any manufacturing process using a positive mold and such a positioning guide to position such an attachment.

Claims

Demands

1. Assembly (100) for manufacturing a prosthetic limb (1'), said assembly comprising: - a positive mold (110) having a surface shape complementary or substantially complementary to an internal surface of a first socket (2) for a prosthetic limb (1) and having at least one first visual reference mark (HOn), - a positioning guide (112) comprising at least one arm (112a) and having one end having a second reference mark (112n) intended to coincide with said first visual reference mark (1 lOn), or with a position of said positive mold (110) established with reference to said first visual reference mark (1 lOn),said branch (112a) of said guide (112) further carrying a retaining and positioning element in space (112m) of a mechanical attachment (116) configured to allow the fixation of an artificial limb (3) onto a surface of a material applied to said positive mold (110) in order to form a second socket of said prosthetic limb.

2. Assembly (100) for manufacturing a prosthetic limb according to claim 1, said assembly comprising at least four branches (112a, 112b, 112c, 112d) between which is arranged said support and positioning element (112s) and of which one or more disconnected ends (112a, 112b, 112c, 112d) have said support and positioning element (112s), and the second marker (112n) being a visual marker.

3. Assembly (100) of aid for the manufacture of a prosthetic limb according to any one of claims 1 and 2, further comprising a band (114) configured to hold in position and stabilize said guide (112) against said positive mold (110).

4. A method for manufacturing a prosthetic limb (1'), the method being characterized in that it comprises the use of an assembly (100) of aids for manufacturing a prosthetic limb (1') according to any one of claims 1 to 3 and in that it comprises the steps: - place (S1) said positive mold (110) of said assembly (100) on a reference surface, - position (S2) the positioning guide (112) of said assembly (100) so that the part of said mold (110) having said first visual mark (111n) is in contact with the part of said guide (112) having said second visual mark (112n), said first (111n) and second (112n) visual marks (111n, 112n) being arranged opposite each other or coinciding with each other, - assemble (S3) a fastener (116) on said holding and positioning element (112s) in the space of said positioning guide (112), - perform a sealing (S4) of said fastener (116) and of a surface or envelope of said positive mold arranged opposite said fastener (116).

5. Method of manufacturing a prosthetic limb (1') according to claim 4, further comprising depositing a layer of material around said positive mold (110), the deposited material sealing said attachment (116) on said positive mold (110) to form said second socket (2') of prosthesis (1') equipped with an attachment (116) configured for the fixation of an artificial limb (3).

6. Method of manufacturing a prosthetic limb (1') according to any one of claims 4 and 5, the method further comprising a preliminary manufacturing step by 3D printing, machining or laser cutting said positive mold (110) from a 3D digital model obtained by modeling an inner surface of said first socket (2) of prosthesis (1).

7. Method of manufacturing a prosthetic limb (1') according to any one of claims 4 and 5, the method further comprising prior manufacturing by 3D printing, machining or laser cutting of said positioning guide (112) from a 3D digital model (44) obtained by modeling an inner surface of said first prosthetic socket (2).

8. A method for manufacturing a prosthetic limb according to any one of claims 4 and 5, the method further comprising prior fabrication by 3D printing, machining or laser cutting of said positive mold (110) and said positioning guide (112) from a model digital 3D obtained by modeling an inner surface of said first socket (2) of prosthesis (1), said positive mold (110) and placement guide (112) being made in the same element and being separable by means of pre-cuts or breakable parts.

9. A method for manufacturing an assembly (100) of a manufacturing aid according to any one of claims 1 to 3, said method comprising the steps of: - obtaining a first 3D digital model (44), representative of the inner surface of said first socket (2), by digitizing the inner surface of said first socket (2), with reference to a spatial reference frame (10) comprising at least one reference point (PD, - determining a second 3D digital model, representative of the shape of said positive mold (110) of said second socket (2'), from the first 3D digital model (44), - determining a third 3D digital model, representative of the shape of said positioning guide (112), from the second 3D digital model, and, - manufacturing by 3D printing, laser cutting or machining, of the positive mold (110) or of said positioning guide (112).

10. Method of manufacturing an assembly (100) of manufacturing aid according to any one of claims 1 to 3, said method further comprising a step of determining a fourth 3D digital model, representative of the shape of said band (114).

11. Product computer program comprising program code instructions to execute the steps of the process according to any one of claims 9 and 10 when said program is executed by a processor.

12. Information storage medium comprising a computer program product according to claim 11.