IMPROVED METHOD FOR AID IN THE MANUFACTURE OF A LIMBS PROSTHESIS SOCKET FROM A PROVISIONAL PROSTHESIS AND SYSTEM EXECUTING THE METHOD.

Abstract

The invention relates to an improved method for manufacturing a so-called final socket (2') from a provisional socket (2), for fitting a residual limb of an amputee. The method comprises 3D modeling of the inner surface of the provisional socket (2), including a 3D model (44) of said surface in a spatial reference frame (11), and automatic modification of said 3D model (44) to optimize the arrangement of an artificial limb (3) on the final socket (2). The method further comprises optimizing a digitization step by determining an improved position for a distance measuring tool (42) within the provisional socket (2) during modeling. The invention also relates to a manufacturing aid system for a final socket configured to implement the method of the invention. Fig. 8

Description

Title of the invention: IMPROVED METHOD FOR AID IN THE MANUFACTURE OF A PROSTHETIC SOCKET LIMBER FROM A PROVISIONAL PROSTHESIS AND SYSTEM EXECUTING THE PROCESS. technical field

[0001] The present invention relates to an improved method for manufacturing a prosthetic limb socket. At least one embodiment relates to the definition of one or more attachment surfaces between a socket printed according to a 3D printing method and an artificial limb; and at least one embodiment relates to an improved method for obtaining a digital model of a temporary prosthetic socket. PREVIOUS STATE OF THE ART

[0002] The manufacture of a prosthetic limb comprises the creation of a temporary socket, molded according to the shape of a residual limb, and then, after a trial phase on the person for whom the prosthesis is intended, the manufacture of a so-called "final" socket from the temporary socket. A socket is a part of a prosthetic limb into which the remaining part of an amputated limb is inserted. The trials carried out with the temporary socket aim to adjust or reshape the inner surface of the temporary socket to minimize friction surfaces that could cause discomfort or even injury to the user wearing the prosthesis, and to establish a reference adjustment of the prosthesis joints, thus enabling the best possible comfort of use and also, as far as possible, ensuring that the wearer's posture is well-correlated with their morphology.For example, in the case of a tibial prosthesis, fitting the prosthesis to a wearer requires adjusting the joint along two or three axes between an artificial connecting element (e.g., an artificial tibia) and an artificial end piece (e.g., an artificial foot). This determines the spatial position of the inner surface of the temporary socket relative to the aforementioned reference adjustment, and is somewhat akin to a static adjustment of an artificial joint or connection (e.g., an ankle). In such a context, and when fabricating a final socket for a tibial prosthesis, for example, it may be necessary to adjust the fixation points of the artificial "tibia" to achieve the best possible adjustment range at the ankle joint and to obtain proper positioning. The vertical or near-vertical orientation of the connecting element (tibia) improves the transfer of mechanical stresses to the prosthesis structure during use. It should be noted that the same principle applies to upper limb prostheses (forearm or arm, for example) or other types of prostheses (for example, a leg).

[0003] During the manufacture of the final socket, it is very important to work while maintaining the positioning of the inner surface of the socket in a predefined spatial reference frame so as not to lose the reference settings previously made during a testing phase involving the wearing of the provisional prosthesis by the user.

[0004] Prosthetic manufacturers most often work with equipment used to aid in the fabrication of a final prosthesis. This equipment includes a rigid support structure, which comprises a temporary socket support that is adjustable and lockable in position along three orthogonal directions of movement, allowing a reference position to be found after a positive mold of the inner surface of the temporary socket has been made. The use of this type of three-dimensional support structure requires marking the structure to "memorize" reference positions during the fabrication of a final socket.The final socket is then created by applying materials (notably fibers and resin) to the positive mold, and the final socket and the artificial limb intended for it are assembled using positioning references provided by markings previously made on the rigid support structure. This method is effective but has a major drawback. In case of inattention, and due to incorrect adjustment or marking, the initial reference settings are lost, and all manufacturing steps subsequent to the fitting of the temporary socket to the wearer must be repeated.

[0005] The situation can be improved. Description of the invention

[0006] An object of the present invention is to propose a method for manufacturing a so-called "final" or "definitive" socket for a limb prosthesis, the method comprising automated steps aimed at reducing the risk of errors and significantly facilitating operations, with the aim of reducing manufacturing time.

[0007] To this end, a method is proposed for manufacturing a final socket for a limb prosthesis from a provisional prosthesis, the provisional prosthesis comprising a provisional socket configured to be threaded onto a residual limb, and an artificial limb, the artificial limb comprising an artificial terminal part and a connecting element (for example, tibial) between the artificial terminal part. the artificial and the temporary socket, as well as a first set of fixation called the "distal fixation", adjustable, lockable in position, between the artificial terminal part and the connecting element, and a second set of fixation called the "proximal fixation" between said connecting element and the temporary socket, to jointly adjust and lock in position the artificial terminal part and the connecting element, the method comprising the steps:

[0008] - define a reference setting of the distal fixation defining a relative position of the inner surface of the temporary socket relative to a first reference point of the artificial terminal part when the artificial terminal part is positioned in a predetermined reference position, in a first reference space defined along three directions orthogonal to each other,

[0009] - position and fix said socket, coupled to the connecting element, in a second reference space defined with respect to said three directions and with respect to a second representative reference point, in the second reference space, of said first reference point of the first reference space such that the position of the socket with respect to the first reference point in said first reference space coincides with the position of the socket with respect to the second reference point in said second reference space,

[0010] - determine, by means of a control unit and a distance measuring device operating in the second reference space, a three-dimensional model representing the inner surface of the temporary socket, and each point of which is defined by coordinates in the second reference space, the three-dimensional model being recorded as a set of information, according to a predetermined format,

[0011] - manufacture a second socket called the "final socket" from said model determined three-dimensional.

[0012] The method according to the invention may further include the following additional features, considered alone or in combination: - The process includes, between the steps aimed respectively at determining said three-dimensional model and manufacturing said final socket from said three-dimensional model, a modification of the three-dimensional model by inserting support surfaces for fixing the connecting element, arranged to allow fixing in a predetermined position of the connecting element on the final socket when the reference setting is reproduced in a prosthesis comprising the final socket.

[0013] - The positions of the bearing surfaces are determined and configured on the socket final to allow a maximum amplitude adjustment excursion in two opposite directions of each of the adjustment directions, from the reference setting.

[0014] - The distal fixation comprises two parts inserted one into the other, one of which is one part is integral with the artificial terminal portion and the other is integral with the connecting element, and each includes means for locking in position and, operating in combination with means for locking in position of the other between the two parts of the distal fixation, to jointly operate an adjustment and locking in position of the terminal portion and the connecting element.

[0015] - The artificial terminal part has the shape of a foot, a leg, an arm or one hand.

[0016] - Determine a representative three-dimensional model of the inner surface of The temporary socket includes: positioning a support for holding the distance measuring device along an axis substantially parallel to a longitudinal axis of the temporary socket and then determining a position of said axis, in said second reference space, according to which said support for holding is positioned.

[0017] The invention also relates to a system for assisting in the manufacture of a prosthetic limb socket from a provisional prosthesis, the provisional prosthesis comprising a provisional socket configured to be threaded onto a residual limb, and an artificial limb, the artificial limb comprising an artificial end piece and a connecting element between the artificial end piece and the provisional socket, as well as a first fastening assembly called the "distal fixation," for jointly adjusting and locking the artificial end piece and the connecting element into position, the system comprising mechanical and electromechanical means as well as electronic circuits configured for,after a reference setting of the distal fixation is defined, defining a relative position of the inner surface of the provisional socket with respect to a first reference point of the artificial terminal part when the artificial terminal part is positioned in a predetermined reference position, in a first reference space defined along three directions orthogonal to each other: ,

[0018] - position said socket, coupled to the connecting element, in a second reference space defined with respect to said three directions and with respect to a second representative reference point, in the second reference space, of said first reference point of the first reference space such that the position of the socket with respect to the first reference point in said first reference space coincides with the position of the socket with respect to the second reference point in said second reference space,

[0019] - determine, by means of a control unit and a distance measuring device operating in the second reference space, a three-dimensional model representing the inner surface of the temporary socket, and each point of which is defined by coordinates in the second reference space, the three-dimensional model being recorded as a set of information, according to a predetermined format,

[0020] - manufacture a second socket called the "final socket" from said model determined three-dimensional.

[0021] The system according to the invention may further have the following characteristics, considered alone or in combination:

[0022] - The system includes electronic circuits configured to operate a modi three-dimensional model fiction by insertion of support surfaces for fixing the connecting element, arranged to allow fixing in a predetermined position of said connecting element on the final socket when said reference setting is reproduced in a prosthesis including said final socket.

[0023] - The system includes circuits configured to determine and configure the positions of the bearing surfaces of said final socket to allow maximum amplitude adjustment in the two opposite directions of each of the adjustment directions from the reference setting.

[0024] - The system comprises mechanical means or modules and electrical circuits tronics configured to position a support for holding the distance measuring device along an axis substantially parallel to a longitudinal axis of the temporary socket and to determine a position of the axis along which the distance measuring device is positioned in the second reference space.

[0025] The invention also relates to a computer program product comprising program code instructions to execute the steps of the process previously described when said program is executed by a processor, as well as an information storage medium comprising such a computer program product. Brief description of the drawings

[0026] 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:

[0027] [Fig.1] schematically illustrates an example of a temporary prosthesis, adapted to a lower limb, and whose adjustable elements have been adjusted to be adapted to a wearer of the prosthesis;

[0028] [Fig.2] schematically illustrates a so-called final prosthesis made from the provisional prosthesis shown in [Fig.1] and whose parameters have been optimized;

[0029] [Fig.3] schematically illustrates a so-called "distal" fixation assembly, usually called a "pyramid", of a provisional or final prosthesis, according to one embodiment;

[0030] [Fig.4] schematically illustrates a three-dimensional system for modeling the inner surface of a temporary prosthesis, according to one embodiment;

[0031] [Fig.5] schematically illustrates a three-dimensional model of the surface in external of a temporary socket as determined by the system shown in [Fig.4];

[0032] [Fig.6] schematically illustrates the three-dimensional modeling of the inner surface of a provisional socket already shown on [Fig.5] after automatic modifications, according to one embodiment;

[0033] [Fig.7] schematically illustrates a 3D printing manufacturing system for a final socket of a limb prosthesis, according to one embodiment;

[0034] [Fig.8] schematically illustrates details of the modeling system already shown in [Fig.4];

[0035] [Fig.9] schematically illustrates a use of the modeling system already represented on [Fig.8], according to one embodiment;

[0036] [Fig. 10] schematically represents an internal architecture of the system for assisting in the manufacture of a prosthetic limb;

[0037] [Fig. 11] is a diagram illustrating an improved method for assisting in the manufacture of a final socket and thus a final limb prosthesis from a provisional prosthesis, according to an embodiment of the invention; and,

[0038] [Fig. 12] schematically illustrates a three-dimensional modeling system for the inner surface of a temporary prosthesis, according to one embodiment variant.

[0039] DETAILED STATEMENT OF IMPROVEMENTS

[0040] Figure 1 is a schematic representation of a limb prosthesis 1. According to the non-limiting example shown in Figure 1, the limb prosthesis 1 is a temporary lower limb prosthesis, also called a temporary tibial prosthesis, comprising an artificial terminal part 4, referred to herein as the "artificial foot." 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.The artificial limb 3 comprises the artificial foot 4 and a connecting element 5 (an artificial tibia according to the example described here) allowing 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 type of ball joint 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 parts 6a and 6b which are complementary to each other and are inserted one into the other (parts 6a and 6b of the distal fixation assembly 6 are not detailed in [Fig. 1] but are shown. presented in [Fig. 3]. According to one embodiment, parts 6a and 6b constitute an assembly commonly known as a "pyramid" used in the field of limb prostheses. Part 6a is integral with the artificial foot 4. Part 6b is integral with 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. [Fig. 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 [Fig. 1], is the optimal setting for the prosthesis.[l] is such that the fixation element 5 has a longitudinal axis 50 inclined in a space referenced by an orthonormal frame 10 comprising directions X, Y and Z. The directions X, Y and Z are pairwise perpendicular to each other and such that a plane defined along the directions X and Y is horizontal and a plane defined along the directions X and Z, or even along the directions Y and Z, 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 directions X and Y (a horizontal plane).

[0041] According to one embodiment, the adjustable distal fixation is 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 lockable in position.

[0042] According to yet another embodiment, the adjustable distal fixation is 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.

[0043] 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 that make up the prosthesis, depends on the type of prosthesis and in particular on the type of the artificial end piece 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 piece is an arm; a reference position with respect to the arm can be determined when the artificial end piece 4 is a hand, and so on.

[0044] It should also be noted that, 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 parts of 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.

[0045] Figure 2 represents a final prosthesis 1', the manufacture of which is advantageously optimized by means of the improved process according to the invention and by means of a manufacturing aid system executing this optimized process. 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 2 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, the optimized weight, and the 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 advantageous and optimized transfer 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', relative to the shape of the provisional socket 2, near the proximal fixation 7, not only allows for a vertical or near-vertical positioning of the fixation element 5 but also for an adjustment of the distal fixation 6 with a more evenly distributed adjustment range (or excursion) along two opposite directions of the same adjustment direction.In other words, the setting of the distal fixation 6 can be repositioned "to neutral" due to an adjustment of 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 setting 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.

[0046] These improvements to the final prosthesis 1' comprising the final socket 2', compared to the provisional prosthesis 1 comprising the provisional socket 2, are astu beautifully obtained through the process, according to the invention illustrated in relation to [Fig.11], and which notably includes the following successive steps, carried out after an initial step SO of preparing the necessary elements and means:

[0047] - determine, during an SI step in which the provisional socket 2 is worn by the user, a reference setting of the distal fixation 6 defining a relative position of the inner surface of the temporary socket 2 with respect to a first reference point 401 of the artificial foot 4 when the artificial foot 4 is placed on the reference surface 101, in a first space referenced according to the reference frame 10, also called space 10, defined according to the three directions X, Y and Z orthogonal to each other, then,

[0048] - position, during a step S2, the temporary socket 2, coupled to the element of link 5, in a second reference space 40 of a digitizing system of the inner surface of the provisional socket 2, defined and located with respect to three directions X', Y' and Z' of a spatial reference frame 11, respectively parallel to the three directions X, Y and Z of the spatial reference frame 10, and with respect to a second representative reference point 201, in the second reference space 40 of the digitizing system, of the first reference point 401 of the first reference space 10, such that the position of the socket 2 with respect to the first reference point 401 in the first reference space 10 coincides with the position of the socket 2 with respect to the second reference point 201 in the second reference space 40 of the digitizing system of the inner surface of the socket 2, and,

[0049] - determine, during a step S3, by a control unit of a measuring device a three-dimensional model representing the inner surface of the temporary socket 2, operating in the second reference space 40, and each point of which is defined by coordinates in the second reference space 40, the three-dimensional model being recorded as a set of information, according to a predetermined format, in the digitization system of the inner surface of the temporary socket 2, and finally,

[0050] - manufacture, during a step S4, for example by printing according to a mode 3D printing, the second socket 2' called "final socket" from the determined (digitized) three-dimensional model possibly modified.

[0051] According to one embodiment, during the manufacturing step S4, the final socket is manufactured using a milling method, the milling tool used being digitally controlled by a control unit from the three-dimensional model representing the internal surface of the socket, which is digitally modified.

[0052] According to this example, a milling tool shapes a block of material held in a reference position, thanks to supports, and operates a progressive removal of material until the final socket 2 determined is obtained.

[0053] According to another embodiment, 3D printing and milling operations are combined to manufacture the final socket 2 determined from the three-dimensional model determined and then digitally modified.

[0054] In the present description, the terms "digitization" and "modeling" are used interchangeably to describe measurement operations carried out on the provisional socket 2 in a reference space and aimed at obtaining representative information of a very large number n of points (point mesh) whose respective coordinates Xn, Yn and Zn are determined in the X, Y, Z 10 reference frame and recorded to define a digitized three-dimensional model (or 3D model) of the inner surface of the provisional socket 2.

[0055] According to one embodiment, the method cleverly and advantageously includes, between steps S2 and S3, a calibrated positioning step of the distance measuring device or of an arm of this device carrying a measuring head, so as to be able to insert the distance measuring head of the distance measuring device facing any point of the inner surface of the temporary socket 2. To do this, the distance measuring device is for example cleverly arranged on a ball joint with a three-dimensional structure which carries it, and sensors configured to operate rotation measurements along the 3 axes of rotation X', Y' and Z' allow to determine coordinates of distance measurement points in the second according to the spatial reference frame X', Y', Z', and therefore according to the reference frame X, Y and Z.

[0056] The sensors used are, for example, potentiometers or optical sensors, configured to each perform an angular measurement to the tenth of an angular degree. The angular measurement information obtained by each of the sensors along three axes of rotation then makes it possible to perform a 3D change of reference frame, that is to say, to convert the coordinates xl, yl, zl of a point M in space referenced according to a first orthonormal frame XI, Yl, Zl (or O, i, j, k, for example) into coordinates x2, y2, z2 of the same point M referenced according to a second orthonormal frame X2, Y2, Z2 (or P, u, v, w).Ingeniously, it is thus possible to modify the position of the tool carrying the distance measurement sensor, prior to defining the three-dimensional model through distance measurements, or even during the performance of these measurements, since any point in space can be referenced in a new spatial coordinate system defined by modifying the position of the manually orientable distance measurement sensor, thanks to the angular measurement sensors combined with the ball joint supporting the distance measurement sensor. In an alternative embodiment, the position of the distance measurement sensor can be controlled digitally (robotic version of the distance measurement tool), and the changes in spatial coordinate system are performed according to the same coordinate transformation principle.

[0057] The details of mathematical methods classically implemented to perform a change of coordinates of a point P referenced in a first orthonormal frame (O, i, j, k) into coordinates of the same point P referenced in a second orthonormal frame (P, u, v, w) whose axes u, v, w form respectively angles a, [3, y with the axes i, j, k, and where P is at coordinates (X, Y, Z) with respect to O, are not developed here insofar as they do not contribute to a good understanding of the invention and since a person skilled in mechanical and / or robotic systems knows how to perform such a change of coordinates for a given point P, and by extension for any point referenced by first coordinates in a first orthonormal frame into second coordinates in a second orthonormal frame.

[0058] Figure 4 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 the second reference space 40 defined by the 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 serving as a 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 the reference space 10. The modeling system 400 includes a distance measuring device 42 connected to a control unit 41 via a bidirectional communication link 412. According to one embodiment, the distance measuring system 42 is mobile and can be moved according to the . directions X', Y', and Z' of an orthonormal coordinate system (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, 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 including a user interface accessible via the control unit 41. In all cases, the modeling system 400 includes means for determining the precise position in the second reference space 40, by means of 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 increase the readability of [Fig. 4] but are visible in [Fig. 8]). In one embodiment, the measuring head 422 of the measuring device 42 comprises a light wave transmitting-receiving module configured to determine the distance between the transmitting-receiving module and a surface positioned opposite it, according to a "time-of-flight" method. In one embodiment, the light wave is a laser beam.Such a configuration advantageously allows determining a distance between the measuring head and a point on the inner surface of the provisional socket 2, located opposite the measuring head 422, when all or part of the arm 421 and the measuring head 422 are inserted into the provisional 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. On the [Fig.[4], the 3D model 44 representing in space the inner surface of the provisional socket 2 is displayed on the screen of the control unit 41, for the purpose of fully illustrating the modeling system 400. Obviously, the information representing each of the measurement points, which together constitute modeling points of the inner surface of the socket, can be recorded in a working memory of the control unit 41 or in an external memory accessible from the control unit 41.

[0059] Figure 5 is an enlarged view of the three-dimensional model 44 representing the inner surface of the provisional socket 2. A lower part 44e is represented The surface of the bottom of the temporary socket 2 (or lower part of the temporary socket 2) is defined. Advantageously, it is possible to automatically define, through modeling, an external surface of a socket to be manufactured that reproduces the internal surface of the socket 2. In one embodiment, the control unit 41 executes an algorithm to define a volume corresponding to a thickness around the modeled internal surface 44 and can determine a volume shape to meet specific criteria or given constraints. Thus, the control unit 41 defines the bearing and fixing surfaces of the connecting element 5, taking into account the positioning of the internal surface 44 relative 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 using the detection device 42. [Fig.6] represents a model 440 of the final socket 2' to be produced, obtained from the three-dimensional model 44 of the inner surface of the temporary socket 2.Lateral support and fixing surfaces 441a and 441b of a lower part 441 of a determined volume of the final socket 2' were automatically determined from the orientation in space, and the precise position in space of the inner surface of the socket 2, that is to say in other words according to the position of a limb inserted in the provisional socket 2 with respect to the reference point 201, and therefore finally with respect to the reference point 401 of the artificial foot 4 used during the testing phase of the provisional socket 2, as well as with respect to the reference surface 101 on which the artificial foot 4 rests during at least part of the tests carried out.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 resumption of mechanical stresses 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.

[0060] It is then possible to manufacture the final socket 2' using a 3D printing technique, for example, from the three-dimensional model 440 of the final socket 2', derived from the three-dimensional model 44 of the inner surface of the socket provisional 2, according to the described process. Obviously, the manufacture of the provisional socket can be carried out using another manufacturing technique, from the three-dimensional model 440, for example by milling material using a numerically controlled milling tool.

[0061] Figure 7 illustrates a 3D printing manufacturing system configured for three-dimensional printing of the final socket 2'. The system consists of the control unit 41, used in the modeling system 400, or any similar system, into which the three-dimensional model 440, derived by modifications from the three-dimensional model 44, has been transferred, connected to a 3D printer 45. A bidirectional link 415 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 final socket 2' from the three-dimensional model 440, and thus from the modified three-dimensional model 44, by one or more dedicated applications executed by the control unit 41.

[0062] Fig. 8 illustrates the cleverly optimized system for assisting in the manufacture of a final prosthesis 1' from a provisional prosthesis 1.

[0063] According to a preferred embodiment, the distance measuring device 42 is mounted on a ball joint 425 so that it can be freely directed along six axes of freedom. Thus, the distance measuring device 42 can be moved in rotation and translation around and along each of the three directions X', Y', and Z'. Cleverly, motion sensors allow the movements around the directions X', Y', and Z' to be measured, and the translation along these directions, so as to be able to perform measurements in a new spatial frame 12, along reference directions X”, Y”, and Z”, or to transpose the distance measurement results carried out in the reference space 40 and therefore in the reference space 10, while ensuring that the measuring head can access any point on the inner surface of the temporary socket 2.This is particularly advantageous because, in the absence of such a ball joint 425 equipped with motion sensors designed to measure, in particular, rotational movements of the measuring device 42 along each of the three directions X', Y', and Z', certain reference adjustment configurations of the temporary socket 2 do not allow the measuring head 422 to access all points on the inner surface of the temporary socket 2, or more precisely, to be positioned opposite any point on this inner surface. This is particularly the case when the temporary socket 2 is oriented at an angle to the vertical along the X and / or Y direction.

[0064] Figure 9 schematically illustrates the advantageous positioning of the distance measuring device 42 in the provisional socket 2 of the provisional prosthesis 1 thanks to The use of a ball joint 425 between the distance measuring device 42 and the support structure that carries it. Thanks to the use of rotation sensors integrated into the ball joint 425 and configured to measure rotations of the distance measuring device 42 with respect to the spatial reference frame 11, it is possible to operate measurements according to a new spatial reference frame 12 (X”, Y” and Z”) and to convert these measurements into measurements according to the spatial reference frame 11 or according to the spatial reference frame 10.

[0065] Figure 12 illustrates an alternative embodiment of the modeling system 400 of the inner surface of the temporary socket 2 in which the distance measuring device 42 is not articulated on a ball joint (as illustrated in Figures 8 and 9, with the ball joint 425), but in which the reference point 201 is predefined on an articulated support 235 configured to be able to be moved in translation along the two directions X' and Y' of the spatial reference frame 11, and in rotation about at least two axes, one of which is oriented parallel to the direction Z' of the spatial reference frame 11 and the other is oriented parallel to the direction X' of the spatial reference frame 11. According to this embodiment, the distance measuring device 42 is assembled by means of a sliding joint equipped with position sensors and can be moved into position,along an axis parallel to the Z' direction of the spatial reference frame 11. All the elements holding the distance measuring device 42 and the articulated support 235 are assembled on a frame 410. In this configuration, the arm of the distance measuring device 42 maintains a fixed position relative to the Z' direction of the spatial reference frame 11, and it is the support 235 that can be rotated around an axis along the Z' direction and around an axis along the X' direction by means of pivot-type mechanical linkages, each comprising position sensors configured to measure the angles of displacement of the pivot links. To achieve this, the support 235 is assembled on an intermediate support 200, which is fixedly mounted by two lateral pivot links 215 and 225. According to this embodiment as well, the distance measuring device 42 can be guided manually by an operator or guided along the X' directions.Y' and Z' by actuators, such as stepper motors, for example, under the control of the control unit 41 executing software routines provided for this purpose, and including a user interface accessible via the control unit 4L. In all cases, here again, the modeling system 400 includes means for determining the precise position in the second reference space 40 located by the spatial reference frame 11, thanks to a set of position sensors and sensors configured to measure the displacements of the sliding joint carrying the distance measuring device 42 and the angles of displacements operated in the pivot joints 215 and / or 225 as well as in the pivot joint of the support 235 make it possible to recalculate the coordinates of all the points of the three-dimensional model 44 in any one of the spatial reference frames 10, 11 or 12, corresponding respectively, to the orthonormal coordinate systems X, Y, Z; X', Y', Z' and X”, Y” and Z”. Cleverly, and as in the case of the use of the ball joint 425 previously described in relation to [Fig.8] and [Fig.9], it is thus possible to operate measurements according to a new spatial reference 12 (X”, Y” and Z”) and to convert these measurements into measurements according to the spatial reference 11 or according to the spatial reference 10, which makes it possible to guarantee that the measuring device can operate a measurement at any point of the inner surface of the provisional socket 2, which is usable for a 3D modeling, regardless of the configuration of the provisional prosthesis 1, after the initial reference adjustment.

[0066] Figure 10 schematically illustrates an example of the internal architecture of the control unit 41. For illustrative purposes, Figure 10 illustrates an internal arrangement of the control unit 41. 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 Figure 10, the internal architecture of the control unit 41 is shown in Figure 10.

[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.

[0067] 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.

[0068] 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 this process.

[0069] 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”) The control unit 41 is a digital core operating as a control unit and its peripherals, such as a processor (in English) or a microcontroller, or it may be implemented in hardware by a dedicated machine or component, for example, an FPGA (Field-Programmable Gate Array) 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. Naturally, the control unit 41 also includes all the elements typically found in a system comprising a digital core performing 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, and bus drivers, although this list is not exhaustive.

[0070] The invention is not limited to the embodiments and examples described above, and relates more broadly to a method for manufacturing a so-called final prosthesis comprising a so-called final socket made from a provisional socket, the prosthesis comprising a connecting element between the socket and an end portion, a proximal fixation, and an adjustable distal fixation. For example, the socket can be designed and configured to adapt to the morphology of a shoulder, arm, forearm, hip, thigh, or calf and to be positioned on the body part in question. In addition, the terminal part connected by means of a linking element present between a proximal and a distal fixation can be a hand, a whole arm with a hand, a forearm with a hand, a leg with a knee, a calf and a foot, a calf with a foot, these examples not being limiting.

Claims

Demands

1. A method for manufacturing a prosthetic limb socket (2') from a provisional prosthesis (1), the provisional prosthesis (1) comprising a provisional socket (2) configured to be threaded onto a residual limb, and an artificial limb (3), the artificial limb (3) comprising an artificial end piece (4) and a connecting element (5) between the artificial end piece (4) and the provisional socket (2), as well as a first set of fixings called the "distal fixation" (6), adjustable and lockable in position, between the artificial end piece (4) and the connecting element (5), and a second set of fixings called the "proximal fixation" (7), between said connecting element (5) and the provisional socket (2), for jointly adjusting and locking in position the artificial end piece (4) and the connecting element (5), the method comprising the steps: - determine (SI) a reference setting of the distal fixation (6) defining a relative position of the inner surface of the provisional socket (2) with respect to a first reference point (401) of the artificial part (4) when the artificial part (4) is positioned in a predetermined reference position (101), in a first reference space (10) defined along three directions (X, Y, Z) orthogonal to each other, - to position and fix (S2) said socket (2), coupled to the connecting element (5), in a second reference space (40) defined with respect to said three directions (X, Y, Z) and with respect to a second reference point (201) representative, in the second reference space (40), of said first reference point (401) of the first reference space (10) such that the position of the socket (2) with respect to the first reference point (401) in said first reference space (10) coincides with the position of the socket (2) with respect to the second reference point (201) in said second reference space (40), - to determine (S3), by a control unit (41) and a distance measuring device (42) operating in the second reference space (40), a three-dimensional model (44) representative of the inner surface of the provisional socket, and each point of which is defined by coordinates in the second space reference (40),the three-dimensional model (44) being recorded as a set of information, according to a predetermined format, - manufacture (S4) a second socket (2') called "final socket" from said determined three-dimensional model (44).

2. A method for manufacturing a prosthesis according to claim 1, comprising between the steps of respectively determining (S3) said three-dimensional model (44) and manufacturing (S4) said final socket (2') from said three-dimensional model (44), a modification of said three-dimensional model (44) by inserting support surfaces for fixing the connecting element (5) arranged to allow fixing in a predetermined position of said connecting element (5) on the final socket (2') when said reference setting is reproduced in a prosthesis comprising said final socket (2').

3. A method of manufacturing a prosthesis according to claim 2, wherein the positions of said bearing surfaces are determined and configured on said final socket (2') to allow maximum amplitude adjustment excursion of the distal fixation in each of the adjustment directions from said reference setting.

4. A method for manufacturing a prosthesis according to any one of claims 1 to 3, wherein said distal fixation (6) comprises two parts (6a, 6b) inserted one into the other, one of which (6a) is integral with the artificial terminal part (4) and the other (6b) is integral with the connecting element (5), and each comprising means for locking in position and, operating in combination with means for locking in position of the other among the two parts (6a, 6b) of the distal fixation (6), to jointly operate an adjustment and locking in position of the terminal part (4) and the connecting element (5).

5. Method of manufacturing a prosthesis, according to any one of claims 1 to 4, wherein said artificial terminal part has the shape of a foot, a leg, an arm or a hand.

6. A method for manufacturing a prosthesis according to any one of the preceding claims, wherein determining (S3) a three-dimensional model (44) representative of the inner surface of the provisional socket (2) comprises: - positioning a support for holding said distance measuring device along an axis substantially parallel to a longitudinal axis of said provisional socket (2) and determining a position of said axis in said second reference space, so as to be able to perform a change of coordinates of any

7. point of said three-dimensional model from said second reference space in coordinates of a third reference space. A system to aid in the manufacture of a prosthetic limb socket (2') from a provisional prosthesis (1), the provisional prosthesis (1) comprising a provisional socket (2) configured to be threaded onto a residual limb, and an artificial limb (3), the artificial limb (3) comprising an artificial terminal portion (4) and a connecting element (5) between the artificial terminal portion (4) and the provisional socket (2), as well as a first set of fixation called the "distal fixation" (6), adjustable and lockable in position, between the artificial terminal portion (4) and the connecting element (5), and a second set of fixation called the "proximal fixation" (7), between said connecting element (5) and the provisional socket (2), for jointly adjusting and locking in position the artificial terminal portion (4) and the connecting element (5), the system comprising mechanical means,electromechanical and electronic circuits configured for, after a reference setting of the distal fixation (6) is determined (SI) defining a relative position of the inner surface of the provisional socket (2) with respect to a first reference point (401) of the artificial terminal part (4) when the artificial terminal part (4) is positioned in a predetermined reference position (101), in a first reference space (10) defined along three directions (X, Y, Z) orthogonal to each other:, - position (S2) said socket (2), coupled to the connecting element (5), in a second reference space (40) defined with respect to said three directions (X, Y, Z) and with respect to a second reference point (201) representative, in the second reference space (40), of said first reference point (401) of the first reference space (10) such that the position of the socket (2) with respect to the first reference point (401) in said first reference space (10) coincides with the position of the socket (2) with respect to the second reference point (201) in said second reference space (40), - determine (S3), by a control unit (41) and a distance measuring device (42) operating in the second reference space (40), a three-dimensional model (44) representing the inner surface of the provisional socket, and of which each point is defined by coordinates in the second reference space (40), the three-dimensional model (44) being recorded in the form of a set of information, according to a predetermined format, - manufacture (S4) a second socket (2') called "final socket" from said determined three-dimensional model (44).

8. System according to claim 7, further comprising electronic circuits configured to operate a modification of said three-dimensional model (44) by inserting support surfaces for the attachment of the linking element (5), arranged to allow attachment in a predetermined position of said linking element (5) on the final socket (2') when said reference setting is reproduced in a prosthesis comprising said final socket (2').

9. System according to claim 8 comprising circuits configured to determine and configure said positions of said bearing surfaces of said final socket to permit maximum amplitude adjustment in each of the adjustment directions from said reference adjustment.

10. System according to any one of claims 7 to 9 further comprising mechanical means, position sensors and electronic circuits configured to: - position a support for holding said distance measuring device along an axis substantially parallel to a longitudinal axis of said temporary socket and determine a position of said axis along which the distance measuring device is positioned in the second reference space.

11. Product computer program comprising program code instructions to execute the steps of the process according to any one of claims 1 to 6 when said program is executed by a processor.

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