Improved method for assisting with the manufacture of a prosthetic limb 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 equipping a residual limb of an amputee. The method comprises 3D modelling of the inner surface of the provisional socket (2), comprising a 3D model (44) of said surface in a spatial reference frame (11), and automatically modifying said 3D model (44) to optimise the arrangement of an artificial limb (3) on the final socket (2). The method further comprises optimising a digitisation step by determining an improved position of a distance measurement tool (42) in the provisional socket (2) during the modelling. The invention also relates to a system for assisting with the manufacture of a final socket, which system is configured to implement the method according to the invention.

Description

[0001] IMPROVED METHOD FOR ASSISTING IN THE MANUFACTURE OF A LIMB PROSTHETIC SOCKET FROM A TEMPORARY PROSTHESIS AND SYSTEM CARRYING OUT THE METHOD.

[0002] TECHNICAL FIELD

[0003] The present invention relates to an improved method for manufacturing a prosthetic limb socket. At least one embodiment relates to defining 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.

[0004] STATE OF THE PRIOR ART

[0005] The manufacture of a limb prosthesis involves the creation of a temporary socket, modeled according to the shape of a residual limb, then after a testing 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 limb prosthesis into which the remaining part of an amputated limb is inserted. The tests carried out with the temporary socket aim to retouch or reshape the interior surface of the temporary socket to minimize friction surfaces likely to cause discomfort or even injury to the user wearing the prosthesis, and to carry out a reference adjustment of the joints of the prosthesis, thus making it possible to obtain the best possible comfort of use and also making it possible to obtain, as far as possible, postures of the wearer of the prosthesis in good correlation with his morphology.For example, in the case of a tibial prosthesis, providing the tibial prosthesis to a wearer requires adjusting a joint setting along two or three axes between an artificial connecting element (e.g. an artificial tibia) and an artificial terminal part (e.g. an artificial foot), which then determines a position in space of the inner surface of the temporary socket with respect to the aforementioned reference setting, and which is similar, in some way, to a static adjustment of an artificial connection or joint (e.g. an ankle).In such a context, and when producing a final socket for a tibial prosthesis, for example, it may be necessary to adjust the attachment points of the artificial "tibia" to obtain the best possible adjustment travel at the ankle joint and to be able to obtain a vertical or almost vertical positioning of the connecting element (tibia), thus improving the absorption of mechanical forces on the structure of the prosthesis, during its 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).When manufacturing 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 so as not to lose the reference settings previously made during a testing phase involving the wearing of the temporary prosthesis by the wearer.

[0006] Prosthetic practitioners most often work with equipment to assist in the manufacture of a final prosthesis with a rigid support structure, which includes a temporary socket support that is adjustable and lockable in position in three orthogonal directions of movement, and allows a reference position to be found after the production of a positive mold of the interior surface of the temporary socket. The use of this type of three-dimensional support structure involves making markings on the structure to "memorize" reference positions during the manufacturing work of a final socket.The final socket is then made by applying materials (particularly fibers and resin) to the positive mold and the assembly of the final socket and the artificial limb intended for it is carried out with positioning references provided by the markings previously made on the rigid support structure. Such a method is effective but has a major drawback. In the event of inattention and in the event of poor adjustment or poor marking, the initial reference settings are lost and all the manufacturing steps subsequent to the adjustment of the temporary socket on the wearer must be repeated.

[0007] The situation can be improved.

[0008] STATEMENT OF THE INVENTION

[0009] An object of the present invention is to provide 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.

[0010] To this end, a method is proposed for manufacturing a final socket for a limb prosthesis from a temporary prosthesis, the temporary prosthesis comprising a temporary socket configured to be slipped onto a residual limb, and an artificial limb, the artificial limb comprising an artificial end portion and a connecting element (for example tibial) between the artificial end portion and the temporary socket as well as a first fixing assembly called "distal fixing", adjustable, lockable in position, between the artificial end portion and the connecting element, and a second fixing assembly called "proximal fixing" between said connecting element and the temporary socket, to jointly operate an adjustment and a locking in position of the artificial end portion and the connecting element,the method comprising the steps of: defining a reference setting of the distal fixation defining a relative position of the inner surface of the temporary 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 in three mutually orthogonal directions, positioning and fixing 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 so that the position of the socket relative to the first reference point in said first reference space coincides with the position of the socket relative to the second reference point in said second reference space, determining, by a control unit and a distance measuring device operating in the second reference space, a three-dimensional model representative of the interior 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 in the form of a set of information, according to a predetermined format, manufacturing a second socket called "final socket" from said determined three-dimensional model.,

[0011] The method according to the invention may further comprise the additional characteristics, considered alone or in combination:

[0012] The method comprises, between the steps of respectively determining said three-dimensional model and manufacturing said final socket from said three-dimensional model, a modification of the three-dimensional model by inserting bearing 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. The positions of the bearing surfaces are determined and configured on the final socket to allow a maximum amplitude adjustment excursion in two opposite directions of each of the adjustment directions, from the reference setting.

[0013] - The distal attachment comprises two parts inserted into each other, one of which is integral with the artificial terminal part and the other of which is integral with the connecting element, and each comprising means for locking in position and, operating in combination with means for locking in position of the other of the two parts of the distal attachment, to jointly operate an adjustment and a locking in position of the terminal part and of the connecting element.

[0014] - The artificial terminal part has the shape of a foot, a leg, an arm or a hand.

[0015] - Determining a three-dimensional model representative of the interior surface of the temporary socket comprises: 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.

[0016] The invention also relates to a system for assisting in the manufacture of a limb prosthesis socket from a temporary prosthesis, the temporary prosthesis comprising a temporary socket configured to be slipped onto a residual limb, and an artificial limb, the artificial limb comprising an artificial terminal part and a connecting element between the artificial terminal part and the temporary socket as well as a first fixing assembly called "distal fixing", to jointly operate an adjustment and a locking in position of the artificial terminal part and the connecting element, the system comprising mechanical, electromechanical means as well as electronic circuits configured to,after defining a reference setting of the distal fixation defining a relative position of the inner surface of the temporary 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 in three mutually orthogonal directions: positioning 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 reference point representative, in the second reference space, of said first reference point of the first reference space so 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, determining,by a control unit and a distance measuring device operating in the second reference space, a three-dimensional model representative of the interior 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 in the form of a set of information, according to a predetermined format, manufacturing a second socket called the “final socket” from said determined three-dimensional model.,

[0017] The system according to the invention may further have the following characteristics, considered alone or in combination:

[0018] - The system comprises electronic circuits configured to carry out 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 said connecting element on the final socket when said reference setting is reproduced in a prosthesis comprising said final socket.

[0019] - The system comprises 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 adjustment.

[0020] - The system comprises mechanical means or modules and electronic circuits 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 determine a position of Tax according to which the distance measuring device is positioned in the second reference space.

[0021] The invention also relates to a computer program product comprising program code instructions for executing the steps of the method described above when said program is executed by a processor, as well as an information storage medium comprising such a computer program product.

[0022] BRIEF DESCRIPTION OF THE DRAWINGS The above-mentioned and other features of the invention will become more apparent from the following description of an exemplary embodiment, said description being made in conjunction with the accompanying drawings:

[0023] [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;

[0024] [Fig. 2] schematically illustrates a so-called final prosthesis made from the provisional prosthesis shown in Fig. 1 and whose parameters have been optimized;

[0025] [Fig. 3] schematically illustrates a so-called “distal” fixing assembly usually called “pyramid” of a temporary or final prosthesis, according to one embodiment;

[0026] [Fig. 4] schematically illustrates a three-dimensional system for modeling the interior surface of a temporary prosthesis, according to one embodiment;

[0027] [Fig. 5] schematically illustrates a three-dimensional modeling of the interior surface of a temporary socket as determined by the system shown in Fig. 4;

[0028] [Fig. 6] schematically illustrates the three-dimensional modeling of the interior surface of a temporary socket already shown in Fig. 5 after automatic modifications, according to one embodiment;

[0029] [Fig. 7] schematically illustrates a system for manufacturing by 3D printing a final limb prosthesis socket, according to one embodiment;

[0030] [Fig. 8] schematically illustrates details of the modeling system already shown in Fig. 4;

[0031] [Fig. 9] schematically illustrates a use of the modeling system already shown in Fig. 8, according to one embodiment;

[0032] [Fig. 10] schematically represents an internal architecture of the system for assisting in the manufacture of a limb prosthesis;

[0033] [Fig. 11] is a diagram illustrating an improved method of assisting in the manufacture of a final socket and thus a final limb prosthesis from a provisional prosthesis, according to one embodiment of the invention; and,

[0034] [Fig. 12] schematically illustrates a three-dimensional modeling system for the interior surface of a temporary prosthesis, according to an alternative embodiment.

[0035] DETAILED DESCRIPTION OF EMBODIMENTS Fig. 1 is a schematic representation of a limb prosthesis 1. According to the non-limiting example shown in Fig. 1, the limb prosthesis 1 is a temporary lower limb prosthesis, also called a temporary tibial prosthesis comprising an artificial terminal part 4 also called here “artificial foot”. The temporary prosthesis 1 is called temporary insofar as it comprises a temporary socket 2 shaped manually by a practitioner to be progressively adapted to the morphology of the wearer of the temporary prosthesis, who must subsequently receive a so-called “final” prosthesis optimized and manufactured from the temporary prosthesis 1. The temporary socket 2 is configured to be slipped 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) making it possible to mechanically connect the artificial foot 4 to the temporary socket 2. The artificial limb 3 comprises a first fixing assembly called "distal fixing" 6, adjustable, of the ball joint type and lockable in position, between the artificial foot 4 and the connecting element 5, and a second fixing assembly called "proximal fixing" 7, between the connecting element 5 and the temporary socket 2. The distal fixing 6 comprises two parts 6a and 6b complementary to each other and uses them inserted into each other (the parts 6a and 6b of the distal fixing assembly 6 are not detailed in Fig. 1 but are shown in Fig. 3). According to one embodiment, parts 6a and 6b constitute an assembly usually known as a “pyramid” used in the field of limb prostheses.The part 6a is integral with the artificial foot 4. The part 6b is integral with the connecting element 5. Each of the parts 6a and 6b comprises 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 attachment 6. Thus the distal attachment 6 is configured to operate an adjustment and locking in position of the foot 4 and the connecting element 5, thanks to the joint effect of the parts 6a and 6b. Fig. 1 illustrates that, according to the reference adjustments made when the temporary prosthesis 1 is worn by the wearer for whom it is intended, the best adjustment, illustrated in Fig. 1, is such that the fixing element 5 has a longitudinal axis 50 inclined in a space referenced by an orthonormal reference frame 10 comprising directions X, Y and Z.The X, Y and Z directions are perpendicular to each other in pairs and such that a plane defined according to the X and Y directions is horizontal and a plane defined according to the X and Z directions, or according to the Y and Z directions, is vertical.

[0036] 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 relative 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 according to the X and Y directions (a horizontal plane).

[0037] According to an alternative embodiment, the adjustable distal fixation is implemented without using a “pyramid” system as previously described, but using one or more pivot links, or even a ball joint of any type that can be locked in position.

[0038] According to yet another embodiment variant, the adjustable distal fixation is implemented using a connecting element made of a material that is deformable when a force greater than a predetermined threshold is applied to it; for example, a metal bar that is deformable using specific tools dedicated to carrying out such an adjustment.

[0039] It should be noted that the determination of a predetermined reference position, and therefore of a reference adjustment in relative position, with respect to each other, of the arrangement of all elements which make up the prosthesis, depends on the type of prosthesis and in particular on the type of the artificial terminal part 4 to be assembled to the connecting element 5. Thus, for example, a reference position along the bust of a wearer can be determined when the artificial terminal part is an arm; a reference position relative to the arm can be determined when the artificial terminal part 4 is a hand, and so on.

[0040] It should further be noted that depending on the type of artificial end part 4 assembled on the prosthesis, the connecting element 5 can have many varied shapes so as to provide structural characteristics implementing all or part of shoulder, hip, knee, ankle functions, 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.

[0041] Fig. 2 represents a final prosthesis 1', the manufacture of which is advantageously optimized thanks to the improved method according to the invention and thanks to a manufacturing assistance system carrying out this optimized method. The final prosthesis 1' comprises the same elements as the provisional prosthesis 1 except for the socket and the proximal fixation 7 replaced by a final proximal fixation 7'. In the final prosthesis 1', the provisional socket 2 is replaced by a final socket 2'. The fixation parameters, and the settings of the distal 6 and proximal 7' fixation assemblies are however different from those of the distal 6 and proximal 7 fixation implemented for the provisional prosthesis 1. Fig. 2 is intended to illustrate one of the advantages of using the so-called final prosthesis 1' comprising 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 here to obtain a vertical or substantially vertical positioning of the longitudinal axis 50 of the fixing element 5, which allows, in the example of prosthesis (tibial) described here, to advantageously operate an optimized recovery of the mechanical support forces present during the use of the final prosthesis 1' by its wearer. In addition, an adjustment of the shape of the final socket 2' at the proximal fixation 7', relative to the shape of the temporary socket 2, near the proximal fixation 7, makes it possible not only to obtain a vertical or quasi-vertical positioning capacity of the fixing element 5 but also to obtain an adjustment of the distal fixation 6 having an adjustment stroke (or excursion) more equally distributed in two opposite directions of the same adjustment direction.In other words, the adjustment 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 temporary socket 2. The adjustment excursions of the distal fixation 6, resulting from the reference adjustment carried out during repeated tests with the wearer, are then compensated by an adjustment of the shape of the final socket 2' at the proximal fixation 7' ​​and by the configuration of the proximal fixation 7' ​​which results therefrom, considered as a whole.

[0042] These improvements of the final prosthesis 1' comprising the final socket 2', compared to the temporary prosthesis 1 comprising the temporary socket 2, are cleverly obtained thanks to the method, according to the invention illustrated in relation to Fig. 11, and which notably comprises the following successive steps, executed after an initial step S0 of preparation of the necessary elements and means: determining, during a step S1 during which the temporary socket 2 is worn by the user wearer, a reference setting of the distal fixation 6 defining a relative position of the inner surface of the temporary socket 2 relative 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 system 10, also called space 10, defined according to the three directions X, Y and Z orthogonal to each other, then, positioning, during a step S2,the temporary socket 2, coupled to the connecting element 5, in a second reference space 40 of a system for digitizing the inner surface of the temporary 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 reference point 201 representative, in the second reference space 40 of the digitizing system, of the first reference point 401 of the first reference space 10, so 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 system for digitizing the inner surface of the socket 2, and, determining, during a step S3,by a control unit of a distance measuring device operating in the second reference space 40, a three-dimensional model representative of the inner surface of the temporary socket 2, and each point of which is defined by coordinates in the second reference space 40, the three-dimensional model being recorded in the form of a set of information, according to a predetermined format, in the system for digitizing the inner surface of the temporary socket 2, and finally, manufacturing, during a step S4, for example by printing according to a 3D printing mode, the second socket 2' called "final socket" from the determined (digitized) three-dimensional model, possibly modified.,

[0043] According to one embodiment, during 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 representative of the internal surface of the socket, digitally modified.

[0044] In this example, a milling tool shapes a block of material held in a reference position, using supports, and carries out a progressive removal of material until the final socket 2 is determined.

[0045] 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.

[0046] In the present description, the terms “digitization” and “modeling” are used interchangeably to describe measurement operations carried out on the temporary socket 2 in a reference space and aimed at obtaining information representative of a very large number n of points (mesh of points) whose respective coordinates Xn, Yn and Zn are determined in the X, Y, Z reference system 10 and recorded to define a digitized three-dimensional model (or 3D model) of the interior surface of the temporary socket 2.

[0047] According to one embodiment, the method cleverly and advantageously comprises, between steps S2 and S3, a step of calibrated positioning 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 carry out rotation measurements along the 3 axes of rotation X', Y' and Z' make it possible to determine coordinates of distance measuring points in the second according to the spatial reference frame X', Y', Z', and therefore according to the reference frame X, Y and Z.

[0048] The sensors used are, for example, potentiometers or optical sensors, each configured to 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 change of 3D reference frame, that is to say to convert coordinates xl, yl, zl, of a point M in space referenced according to a first orthonormal reference frame XI, Yl, ZI (or O, i, j, k, for example) into coordinates x2, y2, z2 of the same point M referenced according to a second orthonormal reference frame X2, Y2, Z2 (or P, u, v, w).Cleverly, it is thus possible to modify the position of the tool carrying the distance measuring sensor, prior to the definition of the three-dimensional model by distance measurements, or even during the performance of these measurements, since any point in space can be referenced in a new spatial reference frame defined by modifying the position of the distance measuring sensor, manually orientable, thanks to the angular measurement sensors combined with the ball joint carrying the distance measuring sensor support. According to an alternative embodiment, the position of the distance measuring sensor can be controlled digitally (robotic version of the distance measuring tool) and the changes of spatial reference frame are carried out according to the same principle of change of coordinates.

[0049] The details of mathematical methods conventionally implemented to operate 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 respectively form angles a, P, y with the axes i, j, k, and where P is at the coordinates (X, Y, Z) relative to O, are not developed here insofar as they do not contribute to a good understanding of the invention and where the person skilled in the art of mechanical and / or robotic systems knows how to operate 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.

[0050] Fig. 4 illustrates a positioning of the temporary prosthesis 1 in a modeling system 400 of the inner surface of the temporary socket 2. The system 400 comprises 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 comprising the reference point 201. Cleverly, the reference point 201 is included in a distal fixation assembly identical to the distal fixation assembly of the temporary prosthesis 1. According to the exemplary embodiment described, the reference point 201 is implemented by the crossing of the adjustment axes of a so-called "pyramid" connection assembly such as the distal fixation assembly 6 illustrated in Fig. 3 and composed of the elements 6a and 6b.The use of a pyramid as a reference point 201 of the system 400 for modeling the inner surface of the temporary socket 2 advantageously makes it possible to fix the connecting element 5 to which the temporary socket 2 is fixed 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 unscrewing only two neighboring screws among the four screws of the pyramid system 6, then a new coupling of the connecting element 5 is carried out on an element similar to the element 6a of the distal fixing 6, comprising 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 relative to the spatial reference frame 10 is maintained.This obviously implies that the pyramid element serving as a fixing and comprising the reference point 201 is fixed in the fixing assembly in a position such that the respective directions of orientation of the adjustments in the second reference space 40 are parallel to the X, Y and Z directions of the reference space 10. The modeling system 400 comprises 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 along the X', Y' and Z' directions of an orthonormal reference 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 carried out manually or automatically.That is to say, the distance measuring device 42 can be guided manually by an operator or guided in the directions X', 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 comprising a user interface accessible via the control unit 41. In all cases, the modeling system 400 comprises 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 in order to increase the readability of Fig. 4 but are visible in Fig. 8).According to one embodiment, the measuring head 422 of the measuring device 42 comprises a module for transmitting-receiving a light wave configured to be able to determine a distance between the transmitting-receiving module and a surface positioned opposite the latter, according to a “time of flight” determination method. According to an exemplary embodiment, the light source is a laser beam. Such a configuration advantageously makes it possible to determine a distance between the measuring head and a point on the inner surface of the temporary 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 temporary socket 2.Thus, thanks to the modeling system 400, it is possible to determine a model 44 representing the inner surface of the temporary 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 temporary prosthesis 1 and the fixing and reference point 201 is known, and can be expressed in terms of coordinates according to the X, Y and Z directions of the reference space 10 or according to the X', Y' and Z' directions of the reference space 40. In Fig. 4, the 3D model 44 representing in space the inner surface of the temporary socket 2 is shown on the screen of the control unit 41, for the purpose of complete illustration of the modeling system 400.Obviously, the information representative of each of the measurement points jointly constituting modeling points of the interior surface of the socket, can be recorded in a working memory of the control unit 41 or in a memory external to the control unit 41 and accessible from the latter.

[0051] Fig. 5 is an enlarged view of the three-dimensional model 44 representing the inner surface of the temporary socket 2. A lower part 44e is representative of the surface of the bottom of the temporary socket 2 (or lower or bottom part of the temporary socket 2). Advantageously, it is possible to automatically define by modeling an outer surface of a socket to be produced which 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 support and fixing surfaces of the connecting element 5 taking into account the positioning of the inner 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 interior surface of the temporary socket 2 by means of 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 interior 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 determined automatically 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 as a function of the position of a limb inserted into the temporary socket 2 relative to the reference point 201, and therefore finally relative to the reference point 401 of the artificial foot 4 used during the testing phase of the temporary socket 2, as well as relative 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 attachment 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 makes it possible to obtain the most vertical position possible, or substantially vertical, of the connecting element 5, when wearing the final prosthesis.

[0052] I ' by a wearer, while satisfying as best as possible the comfort conditions tested and obtained during the preliminary testing phase of the provisional prosthesis 1. The result is that the final prosthesis 1' will be as comfortable as possible, while presenting an optimized configuration for taking up mechanical forces during use and while offering possibilities for well-distributed adjustments (substantially equal excursions) in both directions of the same direction for adjusting the distal fixation 6.

[0053] 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 temporary socket 2, according to the method described. Obviously, the manufacture of the temporary 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. Fig. 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 of 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 of the 3D printer 45 by the control unit 41 operating under the control of software routines dedicated to this purpose, to print in three dimensions the final socket 2' from the three-dimensional model 440, and therefore from the three-dimensional model 44 modified by one or more dedicated applications executed by the control unit 4L.

[0054] Fig. 8 illustrates the cleverly optimized system for assisting in the manufacture of a final prosthesis 1' from a provisional prosthesis 1.

[0055] 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, movement sensors make it possible to measure the movements around the directions X', Y' and Z', and in translation along these directions, so that measurements can be made in a new spatial reference frame 12, along reference directions X”, Y” and Z”, or even to transpose the results of distance measurements made in the reference space 40 and therefore in the reference space 10, while ensuring that the measuring head can access any point on the interior surface of the temporary socket 2.This is particularly advantageous since, in the absence of such a ball joint 425 equipped with movement sensors intended to measure in particular rotational movements of the measuring device 42 in 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 the points of the interior surface of the temporary socket 2, or more precisely to be positioned opposite any point of this interior surface. This is particularly the case when the temporary socket 2 is oriented at an angle relative to the vertical in the X direction and / or the Y direction.

[0056] Fig. 9 schematically illustrates the advantageous positioning of the distance measuring device 42 in the temporary socket 2 of the temporary prosthesis 1 thanks to the use of a ball joint 425 between the distance measuring device 42 and the support structure which 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 carry out 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.

[0057] Fig. 12 illustrates an alternative embodiment of the modeling system 400 of the inner surface of the temporary socket 2 according to which the distance measuring device 42 is not mounted articulated on a ball joint (as illustrated in Fig. 8 and Fig. 9, with the ball joint 425), but according to which the reference point 201 is predefined on an articulated support 235 configured to be able to be moved in translation in the two directions X' and Y' of the spatial reference frame 11, and in rotation around 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 alternative, the distance measuring device 42 is assembled using a sliding connection equipped with position sensors and can be moved into position,along an axis parallel to the direction Z' of the spatial reference frame 11. All of the elements holding the distance measuring device 42 as well as 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 direction Z' of the spatial reference frame 11 and it is the support 235 which can be oriented in rotation around an axis along the direction Z' and around an axis along the direction X' thanks to pivot-type mechanical connections each comprising position sensors configured to measure the angles of movement of the pivot connections. To do this, the support 235 is assembled on an intermediate support 200, mounted securely on two lateral pivot connections 215 and 225. According to this embodiment variant also, the distance measuring device 42 can be guided manually by an operator or else guided along the directions X',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 comprising a user interface accessible via the control unit 4L In all cases, here again, the modeling system 400 comprises means for determining the precise position in the second reference space 40 identified by the spatial reference frame 11, thanks to a set of position sensors and the sensors configured to measure the displacements of the carrier slide connection of the distance measuring device 42 and the angles of displacements operated in the pivot connections 215 and / or 225 as well as in the pivot connection 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 reference frames 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 carry out 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, which makes it possible to guarantee that the measuring device can carry out a measurement at any point on the interior surface of the temporary socket 2, which can be used for 3D modeling, whatever the configuration of the temporary prosthesis 1, after the initial reference adjustment.,

[0058] Fig. 10 schematically illustrates an example of the internal architecture of the control unit 41. For illustrative purposes, consider that Fig. 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 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 (or a storage media reader, such as an SD (Secure Digital) card reader) 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.

[0059] According to one embodiment, the communication interface 415 is also configured for controlling a user interface configured for supervising the manufacturing operations of a final socket using the system 400 and according to the method described and its variants described.

[0060] The processor 411 is capable of executing instructions loaded into the RAM 412 from the ROM 413, an external memory (not shown), a storage medium (such as an SD card), or a communications network. When the control unit 41 is powered on, the processor 411 is capable of reading instructions from the RAM 412 and executing them. These instructions form a computer program causing the processor 411 to implement all or part of a method described in relation to FIG. 11 or described variants of this method.

[0061] All or part of the methods described in relation to Fig. 11 or their described variants may 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 machine or a dedicated 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 methods described in relation to itself.Obviously, the control unit 41 further comprises 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 supervision circuit, one or more clock circuits, a reset circuit, input-output ports, interrupt inputs, bus drivers, this list being non-exhaustive.

[0062] 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 from a temporary socket, the prosthesis comprising a connecting element between the socket and a terminal part, a proximal attachment and an adjustable or adjustable distal attachment. For example, the socket can be provided and configured to adapt to the morphology of a shoulder, an arm, a forearm, a hip, a thigh or a calf and to position itself on the part of the body in question. Furthermore, the terminal portion connected by means of a connecting element present between a proximal attachment and a distal attachment, may be a hand, a whole arm provided with a hand, a forearm provided with a hand, a leg provided with a knee, a calf and a foot, a calf provided with a foot, these examples not being limiting.

Claims

CLAIMS 1) Method for manufacturing a limb prosthesis socket (2') from a temporary prosthesis (1), the temporary prosthesis (1) comprising a temporary socket (2) configured to be slipped onto a residual limb, and an artificial limb (3), the artificial limb (3) comprising an artificial end portion (4) and a connecting element (5) between the artificial end portion (4) and the temporary socket (2) as well as a first fixing assembly called "distal fixing" (6), adjustable, lockable in position, between the artificial end portion (4) and the connecting element (5), and a second fixing assembly called "proximal fixing" (7), between said connecting element (5) and the temporary socket (2), to jointly operate an adjustment and a locking in position of the artificial end portion (4) and the connecting element (5),the method comprising the steps of: determining (S 1) a reference setting of the distal attachment (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 part (4) when the artificial part (4) is positioned in a predetermined reference position (101), in a first reference space (10) defined along three mutually orthogonal directions (X, Y, Z), positioning and fixing (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 representative reference point (201), in the second reference space (40),said first reference point (401) of the first reference space (10) so that the position of the socket (2) relative to the first reference point (401) in said first reference space (10) coincides with the position of the socket (2) relative to the second reference point (201) in said second reference space (40), determining (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 temporary socket, and each point of which 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, manufacturing (S4) a second socket (2') called "final socket" from said determined three-dimensional model (44)., 2) Method for manufacturing a prosthesis according to claim 1, comprising between the steps aimed respectively at 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 bearing 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) Method of manufacturing a prosthesis according to claim 2, in which the positions of said bearing surfaces are determined and configured on said final socket (2') to allow a maximum amplitude adjustment excursion of the distal fixation in each of the adjustment directions from said reference adjustment. 4) A method of manufacturing a prosthesis according to one of claims 1 to 3, wherein said distal attachment (6) comprises two parts (6a, 6b) inserted into each 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 of the two parts (6a, 6b) of the distal attachment (6), to jointly operate an adjustment and a locking in position of the terminal part (4) and of the connecting element (5). 5) Method of manufacturing a prosthesis, according to one of claims 1 to 4, in which said artificial terminal part has the shape of a foot, a leg, an arm or a hand. 6) Method for manufacturing a prosthesis according to one of the preceding claims in which determining (S3) a three-dimensional model (44) representative of the interior surface of the temporary socket (2) comprises: positioning a support for holding said distance measuring device along an axis substantially parallel to a longitudinal axis of said temporary socket (2) and determining a position of said axis in said second reference space, so as to be able to operate a change of coordinates of any point of said three-dimensional model from said second reference space into coordinates of a third reference space. 7) System for assisting in the manufacture of a limb prosthesis socket (2') from a temporary prosthesis (1), the temporary prosthesis (1) comprising a temporary socket (2) configured to be slipped onto a residual limb, and an artificial limb (3), the artificial limb (3) comprising an artificial end portion (4) and a connecting element (5) between the artificial end portion (4) and the temporary socket (2) as well as a first fixing assembly called "distal fixing" (6), adjustable, lockable in position, between the artificial end portion (4) and the connecting element (5), and a second fixing assembly called "proximal fixing" (7), between said connecting element (5) and the temporary socket (2), to jointly operate an adjustment and a locking in position of the artificial end portion (4) and the connecting element (5), the system comprising mechanical means,electromechanical as well as electronic circuits configured to, after determining (SI) 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 terminal part (4) when the artificial terminal part (4) is positioned in a predetermined reference position (101), in a first reference space (10) defined in three mutually orthogonal directions (X, Y, Z): 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 representative reference point (201), in the second reference space (40),said first reference point (401) of the first reference space (10) so that the position of the socket (2) relative to the first reference point (401) in said first reference space (10) coincides with the position of the socket (2) relative to the second reference point (201) in said second reference space (40), determining (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 temporary socket, and each point of which 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, manufacturing (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 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'). 9) System according to claim 8 comprising circuits configured to determine and configure said positions of said bearing surfaces of said final socket to allow maximum amplitude adjustment in each of the adjustment directions from said reference adjustment. 10) System according to 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) Computer program product comprising program code instructions for executing the steps of the method according to 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.

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