Method of designing and manufacturing prosthetic socket

Abstract

The subject of the invention is a method of designing and manufacturing a prosthetic socket, comprising a step of creating a test socket (1) based on an initial digital model of the test socket (1), a step of adjusting the test socket (1), a step of scanning the adjusted test socket (1) to create a digital model of the adjusted test socket (1), a step of creating a digital model of the final prosthetic socket based on the digital model of the adjusted test socket (1), and a step of manufacturing the prosthetic socket based on the digital model of the final prosthetic socket. The step of adjusting the test socket (1) comprises performing at least one physical shape change (2) of the test socket or marking the required shape change (2) of the test socket on the outer surface area (3) of the test socket, the step of scanning the adjusted test socket (1) comprises the step of scanning the outer surface area (4) of the adjusted test socket, and the step of creating the digital model of the final prosthetic socket comprises determining at least part of the inner surface area of the digital model of the final prosthetic socket based on the outer surface area (4) of the digital model of the adjusted test socket.

Description

[0001] Method of designing and manufacturing prosthetic socket

[0002] Field of the Invention

[0003] The invention relates to a method of designing and manufacturing a prosthetic socket based on a 3D scan of a test prosthetic socket to create a custom-made definitive prosthetic socket.

[0004] Background of the Invention

[0005] In the field of designing and manufacturing prosthetic socket, there are a number of technologies and methods that seek to optimise the adaptation of sockets to the individual needs of patients and to increase efficiency and simplify the entire method for the patient, the clinical specialist and the person designing the prosthetic socket.

[0006] One solution is the method published in document US9480581 B2, beginning with the step of creating a modified digital model of a stump, based on which a test socket is subsequently created. The test socket is then seated in an alignment jig and aligned by the clinical specialist or connected to the rest of the prosthesis for axial alignment. Together with the finally set axial position, the test socket is then scanned to obtain a model of the inner wall, including the captured final axial position. The final axial position is further transferred to the previously created modified digital model of the stump (the original model without axial position is aligned according to the captured axial position of the test socket) to create the final modified digital model of the socket with the given axial position, based on which the definitive prosthetic socket is created.

[0007] The advantage of this method is the possibility of performing the axial positioning directly on the physical test socket, which clarifies and facilitates the entire method for the clinical specialist and allows for more accurate alignment in conjunction with other components of the prosthesis. However, the published method requires separate tools for performing shape and volume changes to the model, which are performed in prosthetic CAD software, and for axial positioning, which is performed physically on the test socket. The combination of digital shape and volume adjustments to the socket model and physical axial alignment of the test socket is therefore time-consuming, complicated, as all adjustments and axial position must be in synergy, and requires clinical specialists to have a wide range of knowledge and know-how, including modelling in CAD software.

[0008] According to existing methods, test sockets are especially scanned from the inside, as described, for example, in document WO202488613 A1 . In such solutions, the scanning device is firmly attached and inserted inside the socket, wherein both the inner surface area of the test socket and its axial position relative to the known position and orientation of the scanning device are captured. The method comprising scanning the inner surface area of the socket can be complicated and inconsistent for some types of test sockets, such as those that are too narrow or too long, or it can be very demanding in terms of equipment or even impossible. The resulting model from such scanning is often of poor quality and inaccurate. Furthermore, these methods require the stump to be removed from the test socket for scanning, which can also lead to errors caused by handling the socket between removal and scanning.

[0009] The techniques described in the existing literature, such as documents US9480581 B2 or WO202488613 A1 , therefore do not represent a solution of fully integrated and simple procedure of designing and manufacturing a prosthetic socket that would allow a clinical specialist to personally and physically adapt both the axial position of the test socket as well as its shape, volume and trim edges without the need to digitally adjust the models in modelling software or otherwise communicate these changes in a complicated manner. Summary of the Invention

[0010] The above-mentioned disadvantages of known methods are addressed by the method of designing and manufacturing a prosthetic socket according to the present invention, comprising: a) a step of creating a test socket based on an initial digital model of the test socket; b) a step of adjusting the test socket; c) a step of scanning the adjusted test socket to create a digital model of the adjusted test socket; d) a step of creating a digital model of the final prosthetic socket based on the digital model of the adjusted test socket, and e) a step of manufacturing the prosthetic socket based on the digital model of the final prosthetic socket.

[0011] The step of adjusting the test socket comprises performing at least one physical shape change of the test socket or marking the required shape change of the test socket on the outer surface area of the test socket, the step of scanning the adjusted test socket comprises the step of scanning the outer surface area of the adjusted test socket, and the step of creating the digital model of the final prosthetic socket comprises determining at least part of the inner surface area of the digital model of the final prosthetic socket based on the outer surface area of the digital model of the adjusted test socket.

[0012] The method of designing and manufacturing the prosthetic socket according to the invention allows the clinical specialist to easily adjust both the axial position of the test socket and its shape and trim edges, and all that without the need for complex digital modelling tools or complicated communication of requirements further to manufacturing. The present invention combines the methods of shape adjustments and axial alignment, making the method simpler, more efficient and minimising the risk of errors when combining digital information and requirements for shape adjustments. In addition, the method enables efficient and accurate scanning of the socket without the need to remove the socket from the stump. The invention also enables consistent scanning even for complicated types of sockets, such as narrow or long sockets, and ensures high-quality and accurate results, which significantly increases the efficiency and accuracy of the entire method. All this leads to an easier and faster method of designing and manufacturing prosthetic sockets that better meet the needs of patients.

[0013] The step of creating the test socket comprises the physical creation of the test socket, which comprises the inner surface area of the test socket adapted to the outer shape of the stump of the user for whom the final prosthetic socket is intended. The test socket refers to a test prosthetic socket. This step therefore preferably begins with obtaining a digital representation of the outer shape of the stump, which can be obtained by any known technique. The outer shape of the stump or the outer surface of a manually adjusted plaster model of the stump can, for example, be scanned with a 3D scanner, wherein a digital representation of the inner surface area of the test socket is subsequently created based on the digital representation of the outer shape of the stump of the user. The digital model of the entire test socket is subsequently created from the digital representation of the inner surface area of the test socket by digitally designing the rest of the structure of the test socket. The test socket itself is then created based on this initial digital model of the entire test socket, for example by 3D printing or a similar technique enabling efficient manufacturing based on a unique digital model.

[0014] In another possible embodiment of the step of creating the test socket based on a scan of the outer surface of the stump of the user or a scan of the outer surface of the manually adjusted plaster model of the stump, i.e. its digital representation, a mould can be created, i.e. a physical representation of the modified outer surface area of the stump of the user, onto which a plastic material is stretched, which adapts its shape to the outer shape of this mould. The test socket is created based on this specifically shaped plastic material. The initial digital model of the test socket in this embodiment is therefore a digital representation of the stump of the user, wherein for some embodiments described below, it may be necessary to create an initial digital model of the entire test socket. The initial digital model of the entire test socket also comprises information about the outer shape of the test socket, and therefore the thickness of the walls across the test socket can also be set. Therefore, it may be necessary to additionally scan the outer surface area of the test socket within the procedure of creating the test socket described herein. This provides a digital representation of the outer surface area of the test socket, wherein by combining the digital representation of the modified stump of the user and the digital representation of the outer surface area of the test socket, an initial digital model of the entire test socket is created.

[0015] In an alternative embodiment of the step of creating the test socket, the initial digital model of the test socket is created based on an already fabricated prosthetic socket (preparatory prosthetic socket), e.g. the prosthetic socket currently used by the user. Such a socket is first scanned to obtain a digital model of the preparatory prosthetic socket, based on which an initial digital model of the test socket is then created, which can, for example, be further digitally adjusted for the manufacturing of the test socket better adapted to the subsequent steps of the method according to the present invention. Alternatively, a cast of the inner surface area of the preparatory prosthetic socket can be performed first, wherein the initial digital model of the test socket is created based on a scan of this cast.

[0016] The initial digital model of the test socket refers to any digital model based on which the test socket is created. The initial digital model of the test socket may be the digital model of the inner surface area of the test socket, i.e. the shape of its inner interface with the stump of the user, and / or the digital model of the outer surface area of the test socket capturing the outer shape of the prosthetic socket. Preferably, the initial digital model of the test socket is the initial digital model of the entire test socket, which comprises the digital model of the inner surface area of the test socket and the digital model of the outer surface area of the test socket, and therefore also information about the thickness of the walls across the entire test socket. Analogously, these facts also apply to the digital model of the adjusted test socket, wherein in the present invention, a digital model of the outer surface area of the adjusted test socket is preferably created in the step of scanning the test socket, and a digital model of the inner surface area of the adjusted test socket is subsequently created on the basis thereof. Based on the inner and outer surface areas of the adjusted test socket, a digital model of essentially the entire adjusted test socket can be subsequently created.

[0017] The step of creating the test socket further comprises the step of manufacturing the test socket, which comprises operations related to the manufacture of the socket based on the initial digital model of the test socket, which is processed into manufacturing instructions or directly represents the final instructions for manufacturing, wherein the manufacturing instructions / data are sent to the manufacturing device. The manufacture of the test socket may be carried out by 3D printing, for example using FDM, FGF, FFF, MEX, MJF, SLS, SLA or DLP technology. The manufacture of auxiliary manufacturing model for the CAD / CAM procedure can be produced based on the initial digital model of the test socket on a CNC machine, milling machine, lathe or robot based on CAM (computer-aided manufacturing) technologies. The test socket is preferably made of polymer material.

[0018] The step of adjusting the test socket comprises all operations, which are performed on the test socket prior to the step of scanning the adjusted test socket to create the digital model of the adjusted test socket. In the present invention, these are especially physical shape changes of the test socket or marking the required changes of shape of the socket on the outer surface area of the test socket. Marking the required changes may comprise fastening shape elements to specific regions of the test socket to accurately delimit the region of the required shape adjustments and their further specification. Furthermore, these may comprise, for example, steps to improve the quality of the digital model of the adjusted test socket, which is the result of the method of scanning, especially adjustments of the surface of the test socket, for example with various marks to highlight its curves. Furthermore, these operations may comprise axial positioning of the test socket by connecting it to other prosthetic components or an alignment jig. Furthermore, in this step, the outer surface area of the test socket may be provided with orientation elements to indicate characteristic points, according to which the digital model of the adjusted test socket can subsequently be aligned in digital space within the step of creating the digital model of the final prosthetic socket. This step is preferably performed physically by a clinical specialist who is familiar with the anatomy of the stump of the user and knows how the resulting prosthetic socket should be designed to ensure its functionality and comfort for the patient, and how to properly prepare the test socket for the step of scanning.

[0019] In the present invention, physical shape changes consist preferably especially in adjusting the proximal edge of the test socket or adjusting the side walls of the test socket. The side walls refer to the walls of the prosthetic socket that abut the outer surface area of the stump, i.e. the anterior, posterior, medial and lateral sides of the stump. The side walls of the prosthetic socket can also be referred to as peripheral walls, since these are understood to mean the walls of the prosthetic socket that are in contact with the stump of the user around the perimeter of the stump. Preferably, the prosthetic socket surrounds the stump around its entire perimeter. The proximal edge forms the proximal margin of the test socket. The distal part of the socket then refers to a part of the socket abutting the distal part of the stump, which connects the individual side walls of the socket at their distal end and ensures connection with other prosthetic components. Adjustments to the side walls consist especially in depression or elevation of the inner surface area of the test socket, i.e. the surface area that forms the interface with the stump of the user. The elevation is performed by pressing from the inside against the inner surface area of the test socket towards the wall of the test socket, whereas the depression, on the contrary, is performed by pressing from the outside against the outer surface area of the test socket inwards. Preferably, the physical shape change on the lateral sides of the test socket is preceded by heat treatment of the given adjusted region, whereby the polymer material in this region becomes more plastic and can be easily adjusted to the required shape, wherein it regains its original rigidity and hardness after cooling. Adjustments of the proximal edge of the test socket consist in the removal or the addition of material to adjust its shape; adjustments of the proximal edge of the test socket are therefore performed mechanically. In some embodiments of the invention, these required physical adjustments of the test socket (its lateral sides or proximal edge) may only be marked on the corresponding regions of the outer surface area of the test socket, where these markings preferably comprise the delimitation of the region to which the change relates and another indicator more closely characterising the required change. The marking may be performed with a pen, marker or other colouring tool, or by fastening a shape element, such as a sticker or flat insert made of foam polymer material.

[0020] The step of scanning the adjusted test socket to create the digital model of the adjusted test socket may be performed by a 3D scanner, a photogrammetric process, or other technology capable of creating the digital model based on an object. In some embodiments, it may be advantageous to use scanning technology capable of distinguishing colour or at least shades of grey. The created digital model of the adjusted test socket or the data based on which the digital model of the adjusted test socket can be created are sent from the scanning device (3D scanner, digital camera, mobile phone, etc.) to a computer device that mediates further processing of the model.

[0021] The step of creating the digital model of the final prosthetic socket based on the digital model of the adjusted test socket comprises all the operations that are performed on the digital model of the adjusted test socket, i.e. the initial scan of the adjusted test socket, to create the digital model of the final prosthetic socket, which forms the basis for the structure of the final prosthetic socket. These include adjustments of the shape, thickness, and volume of the digital model, the addition of various supplementary elements of the prosthetic socket, such as adjustments or reconstruction of the distal part of the prosthetic socket, integration of the suspension systems of the prosthetic socket, implementation of electronic components into the socket, openings, integration of additional articulated braces, implementation of flexible and rigid regions, strength optimisation of the structure, etc. Preferably, in the step of creating the test socket or in the step of creating the digital model of the final prosthetic socket, the digital model of the inner surface area is volumetrically decreased by 0.1 % to 10% of its original size. The volume decrease of the inner surface area of the test or final prosthetic socket is advantageous for ensuring sufficient fastening of the socket to the stump of the user, wherein the value of the volume decrease should correspond to the appropriate value of compression of the given region of the user's body.

[0022] This step further comprises designing the proximal curve of the digital model of the final prosthetic socket, wherein preferably it is determined based on the proximal contour curve of the digital model of the adjusted test socket. The clinical specialist can thus mechanically adjust the proximal contour edge of the test socket according to the user's needs within the step of adjusting the test socket, wherein these changes can then form the basis for creating the proximal contour curve of the final prosthetic socket.

[0023] The step of creating the digital model of the final prosthetic socket is performed by a computer device with adapted software, which is used to create the digital model of the final prosthetic socket from the digital model of the adjusted test socket automatically or in combination with manual instructions from an authorised specialist, such as a clinical specialist or modelling software specialist. The digital model of the final prosthetic socket represents a 3D model of the basic structure of the final prosthetic socket, which is further processed into manufacturing data (e.g. G-code) and sent to the manufacturing device.

[0024] The step of manufacturing the prosthetic socket comprises operations related to the manufacture of the final prosthetic socket based on the digital model of the final prosthetic socket, which is processed into manufacturing instructions or directly represents the final instructions for manufacturing, wherein the manufacturing instructions / data are sent to the manufacturing device. Based on the digital model of the final prosthetic socket, the entire prosthetic socket or only a part thereof derived from the digital model of the adjusted test socket can be created using the procedure described herein. The manufacture of the final prosthetic socket may be carried out by 3D printing, for example using FDM, FGF (Fused Granulate Fabrication), FFF, MEX, MJF, SLS, SLA or DLP technology. The manufacture of auxiliary manufacturing model for the CAD / CAM procedure can be produced based on the digital model of the final prosthetic socket on a CNC machine, milling machine, lathe or robot using CAM (computer-aided manufacturing) technologies.

[0025] The first aspect of the present invention is the implementation of the possibility to perform physical shape changes on the test socket, based on which the digital model of the final prosthetic socket will be created, into the method of designing and manufacturing the prosthetic socket. The present description of the summary of the invention further describes several methods, wherein in all of the described methods the step of scanning the adjusted test socket comprises the step of scanning the outer surface area of the adjusted test socket, and the step of creating the digital model of the final prosthetic socket comprises at least partial processing of the digitised outer surface area of the adjusted test socket into the inner surface area of the digital model of the final prosthetic socket.

[0026] The first method is based on the constant thickness of the walls of the test socket. Physical shape changes in the step of adjusting the test socket are also reflected in the shape of the outer surface area of the adjusted test socket due to the constant thickness of the walls, wherein knowing the value of this constant thickness, the inner surface area of the adjusted test socket can also be set based on the shape of the outer surface area of the adjusted test socket. Within the step of creating the digital model of the final prosthetic socket, the inner surface area of the adjusted test socket is therefore set based on the shape of the outer surface area of the adjusted test socket and the value of the constant thickness of the walls of the test socket. In these embodiments, it is required that the test socket has a constant thickness of the wall and that the value of the thickness is known to the professional who performs the step of creating the digital model of the final prosthetic socket using modelling software, or comprised in the software, in which a parameter of the constant thickness is entered within the presetting or during the step of creating the digital model of the final prosthetic socket. Preferably, all side walls of the test socket have a constant thickness.

[0027] The particular value of the constant thickness of the walls of the test socket depends on the parameters of the user (height, weight, activity level, etc.), the material and other structural parameters of the test socket, wherein it can range from 3 mm to 20 mm, more preferably 5 mm to 8 mm.

[0028] Preferably, determining at least a part of the inner surface area of the digital model of the final prosthetic socket comprises modifying at least a part of the digital model of the adjusted test socket based on the thickness of the wall of the test socket. Determining the inner surface area of the digital model of the final prosthetic socket in these embodiments may comprise modifying the outer surface area of the adjusted test socket consisting in the translation of the outer surface area of the adjusted test socket based on the constant thickness of the wall of the test socket with a simultaneous proportional decrease. Alternatively, the outer surface area of the adjusted test socket may be duplicated and subsequently this duplicate decreased towards the centre of the original surface area so that the distance between these two shape-corresponding surface areas corresponds to the constant thickness of the test socket. Determining the inner surface area of the digital model of the final prosthetic socket therefore comprises modifying the outer surface area of the adjusted test socket consisting in decreasing the duplicate based on the constant thickness of the walls of the test socket. Within the modelling software, the inner surface area of the adjusted test socket can be set based on the outer surface area of the adjusted test socket using various other methods, such as offsetting a polygon mesh (mesh offset), analytical approach (surface area equation), finite element method (FEM simulation), machine learning algorithms, etc. In the sense of the present invention, all these methods comprise modification of the outer surface area, essentially consisting in its translation based on the thickness of the test socket, since it is always essentially an imaginary shift of the outer surface area based on its distance from the inner surface area.

[0029] In embodiments according to the first method, only part of the test socket may have a constant thickness, wherein only part of the inner surface area of the final test socket corresponding to the part of the adjusted test socket with a constant thickness of the wall is designed based on the outer surface area of the adjusted test socket. Determining the inner surface area of the digital model of the final prosthetic socket in these embodiments may comprise modifying only part of the digital representation of the outer surface area of the adjusted test socket, consisting in modifying only this part of the outer surface area based on the constant thickness of this part of the test socket. In these embodiments, it is also necessary that the delimitation of the part of the test socket with a constant thickness of the wall be known to the professional who performs the step of creating the digital model of the final prosthetic socket using modelling software, or comprised in the software, into which the delimitation of this part is entered within the presetting or during the step of creating the digital model of the final prosthetic socket.

[0030] Preferably, the test socket has an essentially constant thickness of the wall over most of its height in the direction from its proximal end. More preferably, the test socket has an essentially constant thickness of the walls over at least 70% of its height in the direction from its proximal end, even more preferably over at least 80% of its height. Preferably, the anterior, posterior, medial and lateral walls of the test socket have a constant thickness.

[0031] Preferably, in the step of creating the test socket, the test socket is created by 3D printing, wherein the test socket is manufactured using a 3D printer by extruding plastic material at least partially in vase-mode printing. Such a manufacturing method is particularly advantageous if the test socket has a constant thickness at least over most of its height in the direction from its proximal end. Continuous 3D printing of the test socket is advantageous in terms of production speed, strength, stability and uniformity of the structure of the test socket. Preferably, the width of extrusion from the print head of the 3D printer corresponds to the constant thickness of the wall of the test socket. The second method, by which physical shape changes of the test socket can be implemented in the digital model of the final prosthetic socket within the present method of designing and manufacturing the prosthetic socket, is based on the initial digital model of the entire test socket. The advantage of these embodiments consists in the fact that they do not require the test socket with a constant thickness.

[0032] In the embodiments according to the second method, the inner surface area of the final prosthetic socket is determined in the step of creating the digital model of the final prosthetic socket based on the initial digital model of the entire test socket and the outer surface area of the adjusted test socket. The adjusted test socket has a changed shape of its inner and outer surface areas, but the thickness of the wall of the test socket preferably remains essentially unchanged within the step of adjusting the test socket. The step of creating the digital model of the final prosthetic socket comprises the step of aligning the models of the initial digital model of the entire test socket and the outer surface area of the adjusted test socket. Based on the known thickness of the entire test socket, the inner surface area of the adjusted test socket can be further set from the outer surface area of the adjusted test socket, for example, by translating the points of the outer surface area of the adjusted test socket along the normal to the outer surface area of the adjusted test socket at a given point by a distance corresponding to the thickness of the initial model of the test socket at the corresponding point (by offsetting the outer surface area of the test socket). The second option is to translate the points of the outer surface area of the adjusted test socket in a plane perpendicular to the longitudinal centre (neutral) axis of the adjusted test socket along the normal to this surface area towards the longitudinal centre axis of the adjusted test socket by a distance corresponding to the thickness of the initial model of the test socket in this plane (translation of points of the outer surface area of the adjusted test socket in horizontal planes towards the central axis of this socket). This second option for determining the inner surface area is particularly advantageous for the embodiments of the test sockets that have a gradually varying thickness in the direction of their longitudinal central axis. The detected inner surface area of the adjusted test socket then forms the basis for creating the inner surface area of the final prosthetic socket. In further embodiments, only part of the inner wall of the adjusted test socket can be set in this way. Within the modelling software, the inner surface area of the adjusted test socket can be set based on the initial digital model of the test socket using various other methods, such as offsetting a polygon mesh (mesh offset), analytical approach (surface area equation), finite element method (FEM simulation), machine learning algorithms, etc. In the sense of the present invention, all these methods comprise modification of the outer surface area, essentially consisting in its translation based on the thickness of the test socket, since it is always essentially an imaginary shift of the outer surface area based on its distance from the inner surface area.

[0033] The particular value of the thickness of the walls in different regions of the test socket depends on the parameters of the user (height, weight, activity level, stump anatomy, etc.), the material and other structural parameters of the test socket, wherein it can range from 3 mm to 30 mm, preferably 4 to 10 mm.

[0034] Preferably, the initial digital model of the test socket is therefore a 3D model comprising information about the shape of the test socket and the thickness of the walls.

[0035] The third method, by which physical shape changes of the test socket can be implemented in the digital model of the final prosthetic socket within the present method of designing and manufacturing the prosthetic socket, is based on a comparison of the initial digital model of the test socket and the digital model of the adjusted test socket. This method allows for the greatest control over shape changes within the step of creating the digital model of the final prosthetic socket, as shape changes can be accurately detected and, if necessary, further adapted and changed.

[0036] The step of creating the digital model of the final prosthetic socket in the embodiments according to the third method comprises the step of aligning the models of the initial digital model of the test socket and the digital model of the adjusted test socket. The step of creating the digital model of the final prosthetic socket further comprises comparing the digital model of the adjusted test socket and the initial digital model of the test socket, comprising determining local shape changes between the digital model of the adjusted test socket and the initial digital model of the test socket. This comparison comprises comparing the outer surface area of the test socket (i.e., the outer surface area of the initial digital model of the test socket) and the outer surface area of the adjusted test socket (i.e. , the outer surface area of the digital model of the adjusted test socket), within which the physical shape changes performed in the step of adjusting the test socket are detected. These detected local shape changes preferably comprise information about the position of the shape change, the region of the outer surface area to which the change relates, and the size and shape of the shape change. The regions of shape changes can be set based on the intersection of the two compared surface areas. With these local shape changes can then be further projected in various ways into the shape of the inner surface area of the final prosthetic socket within the step of creating the digital model of the final prosthetic socket. For example, part of the inner surface area of the initial digital model of the test socket can be replaced by the corresponding part of the outer surface area of the adjusted test socket delimited by a certain local shape change by translating the given part of the outer surface area by a distance set based on the thickness of the wall of the test socket at the corresponding location. Determining at least part of the inner surface area of the digital model of the final prosthetic socket thus comprises local shape modifications of the inner surface area of the initial digital model based on detected local shape changes.

[0037] In solutions according to the third embodiment of the method according to the first aspect of the invention, it may be advantageous in the step of determining at least part of the inner surface area based on the thickness of the wall of the test socket to use different multiples of the thickness of the wall for different regions of the digital model of the adjusted test socket. By changing the physical shape of the inner and outer surface areas of the test socket, these surface areas can be increased in the region of the shape change, wherein the thickness between them will be smaller than the thickness that the test socket had in the same region before this physical adjustment. Outside the regions of detected shape changes, the inner surface area of the adjusted test socket is preferably set based on 100% of the value of the thickness of the wall of the test socket. In regions of detected shape changes, the inner surface area of the adjusted test socket is preferably set based on a multiple of the thickness of the wall of the test socket at the given location, which is less than 1 . Preferably, the inner surface area of the adjusted test socket corresponding to the centre of the given local shape change is determined based on 0.5 to 0.9 times the thickness of the wall, and the inner surface area of the adjusted test socket corresponding to the margin of the given local shape change is determined based on 0.6 to 0.99 times the thickness of the wall.

[0038] The second aspect of the present invention is the implementation of the possibility to mark the required shape changes of the test socket on its outer surface area (outer surface) on the test socket, based on which the digital model of the final prosthetic socket will be created, into the method of designing and manufacturing the prosthetic socket. The indicated changes may represent physical shape adjustments of the side walls of the prosthetic socket or the proximal edges of the prosthetic socket. Marking the required changes preferably consists in delimiting the region of the outer surface of the test socket to which the required change relates and specifying the required change.

[0039] Preferably, marking the required shape change of the test socket comprises delimiting the region of the outer surface area of the test socket to which the required shape change relates. Delimitation of the region of the required change may be performed, for example, by a sticker or other shape element, where the margin of the shape element delimits the region of the required change, or by drawing the margin of the region with a pen, marker, brush or similar colouring tool.

[0040] Furthermore, the marking of the required shape change of the test socket preferably comprises an identifier specifying the required shape change. The identifier refers to a marking characteristic that is apparent on the digital model of the adjusted test socket and represents information that further specifies the required shape adjustments within the step of creating the digital model of the final prosthetic socket. The specification of the required change may then consist in a specific identifier of the shape element, such as its specific shape, position, colour, thickness or mark on its outer surface. The identifier of the shape element can also be referred to as its unique characteristic or mark. A specific shape may be, for example, a characteristic shape of the margin, a protrusion on the outer surface area, the structure of the outer surface, or the degree of rounding of its edges. The position of the shape element may correspond to a characteristic anatomical region on the user's body, wherein, for example, within the software preset this placement may affect the modification using the given shape element. The colour may be, for example, the colour or a different shade of the entire shape element or part thereof. The thickness may be a certain value of the detected thickness or a characteristic change in thickness, wherein the thickness is detected preferably from the side walls of the shape element. The mark on the outer surface area of the shape element may be, for example, a graphic mark, number or letter created by pen or engraving. In the case of an embodiment without a shape element, where the required change is marked with a pen, marker, etc., the specification of the shape change can be performed by an identifier in the form of a number, a symbol inscribed inside the delimited region, or the colour of the indication itself of the curve delimiting the region of the required change. The position and shape of this curve delimiting the region of the required change can also be considered an identifier, as the curve setting the required proximal contour curve can be easily recognised by its placement at the proximal margin or, for example, by the fact that it ends at the proximal margin of the digital model.

[0041] The identifier can then represent various characteristics of the required shape change, such as its shape, degree of change, direction of change (elevation, depression), type of change (trim, hole, shape change, etc.). Which accurate specification the given identifier represents may be set by a given parameter, which may be a software preset, a template, a set of instructions, or the like, or the identifier itself may sufficiently describe the specification of the required shape change.

[0042] Furthermore, in solutions comprising the marking of the required shape change of the test socket on the outer surface area of the test socket may be proceeded according to the solution according to the first aspect of the present invention. The required changes can first be performed on the outer surface area of the digital model of the adjusted test socket and then, based on a constant thickness (according to the first method), based on the initial digital model (according to the second method), or based on a comparison of the digital models of the test socket before and after the step of adjusting (according to the third method). In other embodiments, it may be advantageous to first set the inner surface area of the adjusted test socket and perform the required shape changes marked on the outer surface area of the adjusted test socket directly in the corresponding regions of the inner surface area.

[0043] Preferably, the methods according to the first and second aspects of the present invention may be combined. From the point of view of physical shape adjustments according to the first aspect of the invention, it is more advantageous to perform shape changes consisting in the elevation of the inner surface area of the test socket, i.e. the creation of a larger space inside the socket in a given anatomical region. The physical implementation of the elevation of the inner surface area of the test socket is more appropriate for the clinical specialist, as they have full control over which region of the inner surface area of the test socket they manually adjust, wherein they can immediately perceive the physical change directly during the adjustment. In the event of an error, the change can be corrected by pressing from the outer surface area of the test socket in the given region, by removing material from the outer surface area of the test socket or by adding an insert to the inner surface area of the socket to achieve the correct shape. Marking the required changes, on the contrary, is advantageous for the required shape changes consisting in a depression of the inner surface area of the test socket, i.e. creating a smaller space inside the socket and a tighter attachment of the stump with the prosthetic socket in the given region. In the case of physical changes of the type of depression of the inner surface area, the clinical specialist does not have complete control over how the inner surface area will change when pressure is applied to the outer surface area of the test socket, and possible errors may render the test socket unusable and necessitate the manufacture of a new test socket. Shape changes of the type of depression can also be simulated by adhering the respective shape elements (inserts) in place, that can physically represent these shape changes indicated on the outer surface area of the test socket, wherein the user can test the effect of these marked changes using the inserts. Appropriate shape elements that correctly characterise the required changes can be traced on the outer surface area of the test socket. In other embodiments, such an appropriately selected shape element embodying the required shape change of the inner surface area of the test socket may be adhered to the corresponding region of the outer surface area of the test socket with an identifier specifying how the shape element characterises the change of the inner surface area of the test socket.

[0044] Preferably, the step of adjusting the test socket comprises the step of axial positioning of the test socket in space using a test prosthesis, wherein in the step of scanning the adjusted test socket is captured the axial position of the test socket, and the step of creating the digital model of the final prosthetic socket comprises the step of axial positioning based on the digital model of the adjusted test socket. Preferably, in the step of creating the test socket, the test socket is created in a neutral axial position or in a certain default axial position with default values for flexion / extension and abduction / adduction. In the step of adjusting the test socket, it is further preferably, the test socket is set to the final axial position using the angulations and translations of the test socket. In addition to the test socket, the test prosthesis may be other components of the prosthesis and / or a special alignment jig. The final axial position is then captured in the step of scanning the adjusted test socket, and in the step of creating the digital model of the final prosthetic socket, the final prosthetic socket is axially positioned based on the captured final axial position of the adjusted test socket. In some embodiments, the adjusted test socket may be scanned including the other prosthetic components. The scan of the entire assembly of the test socket and test prosthesis is apparent the axial position of the adjusted test socket relative to the other prosthetic components, wherein based on them, the final prosthetic socket can be axially positioned. In other embodiments, the test socket may be provided with reference marks or lines representing the required axial position in the step of adjusting the test socket. These marks or lines are then captured on the scan in the step of scanning the adjusted test socket, wherein based on them, the final prosthetic socket is also axially positioned in relation to the rest of the prosthetic components. In other embodiments, within the step of adjusting the test socket, the test socket may be established to the final axial position, wherein the values of angulation and translation that were performed relative to the initial axial position of the test socket are captured. These values are then entered into the modelling software, wherein based on them, the final prosthetic socket is also axially positioned from the initial axial position.

[0045] Particularly in embodiments based on the second or third method according to the first aspect of the present invention, it is a necessary step of aligning the models characterising the test socket and the adjusted test socket within the step of creating the digital model of the final prosthetic socket. In solutions according to the first method, it is necessary to align the initial digital model of the test socket and the digital model of the adjusted test socket. In solutions according to the second method, it is necessary to align the initial digital model of the entire test socket and the digital model of the adjusted test socket. The step of aligning can be carried out using various methods, for example, based on similarity, by manual alignment by a modelling software professional within the modelling software, or using auxiliary marks or orientation elements on the test socket. In some embodiments, the initial digital model of the test socket may comprise at least three projections distributed on different sides of the outer surface area of the test socket, which are retained within the step of adjusting the test socket. Both the initial digital model of the test socket and the digital model of the adjusted test socket comprise these same at least three projections, wherein these models can be accurately aligned based on the projections in the step of creating the digital model of the final prosthetic socket. The projections are located in regions of the test socket where no shape changes will be performed within the step of adjusting the test socket, or rather, the projections are designed for locations where no changes of the outer shape of the test socket are required. This does not apply to the embodiment according to the second aspect of the invention, as there are no physical shape changes to the test socket, wherein the projections can be placed in almost any region. Another option is to use the structure of test socket itself for the step of aligning. The initial digital model of the test socket may comprise a single reference mark on the side wall of the socket, which is again retained within the step of adjusting, and thus the digital model of the adjusted test socket also comprises this reference mark in the corresponding location, wherein in the step of creating the digital model of the final prosthetic socket, the models are first aligned based on the distal part of the test socket, or based on the lower cylindrical or conical surface area of the test socket, and subsequently rotationally aligned around the longitudinal axis of the test socket based on the reference mark.

[0046] Preferably, the step of creating the test socket and / or the step of creating the digital model of the final prosthetic socket may comprise digital reconstruction of the distal part of the initial digital model of the test socket or the digital model of the adjusted test socket based on the sleeve used, or liner. In situations where a liner is worn on the stump between the prosthetic socket and the stump, this liner often comprises a specifically shaped distal part that corresponds in shape to the mechanism for fastening it in the socket. The structure of the inner shape of the prosthetic socket in the region of the distal part of the stump is not performed based on a scan of the stump but based on the outer shape of the distal part of the liner. Preferably, the sleeve is therefore fitted directly onto the stump during scanning, or the computer device comprise a model of this distal part of the sleeve, which is implemented in the steps of creating the test socket and / or creating the digital model of the final prosthetic socket. Description of the Drawings

[0047] The summary of the invention is further explained by exemplary embodiments which are described with reference to the accompanying drawings, in which:

[0048] Fig. 1 shows an initial digital model of a test socket according to the first exemplary embodiment,

[0049] Fig. 2 shows a section A-A of the initial digital model of the test socket according to the first exemplary embodiment,

[0050] Fig. 3 shows the test socket, including other components of the test prosthesis according to the first exemplary embodiment from the front side,

[0051] Fig. 4 shows the test socket including other components of the test prosthesis according to the first exemplary embodiment from the lateral side,

[0052] Fig. 5 shows the adjusted test socket according to the first and second exemplary embodiments from the front side,

[0053] Fig. 6 shows the adjusted test socket according to the first and second exemplary embodiments from the lateral side,

[0054] Fig. 7 shows a section B-B of the adjusted test socket according to the first exemplary embodiment,

[0055] Fig. 8 shows a section D-D of the adjusted test socket according to the first exemplary embodiment,

[0056] Fig. 9 shows a section C-C of the adjusted test socket according to the first exemplary embodiment,

[0057] Fig. 10 shows a section E-E of the adjusted test socket according to the first exemplary embodiment,

[0058] Fig. 1 1 shows an axially positioned adjusted test socket, including other components of the test prosthesis according to the first exemplary embodiment, from the front side,

[0059] Fig. 12 shows the axially positioned adjusted test socket, including other components of the test prosthesis according to the first exemplary embodiment, from the lateral side,

[0060] Fig. 13 shows a step of determining an inner surface area of the digital model of the final prosthetic socket according to the first exemplary embodiment from the front side, where (a) is the outer surface area of the adjusted test socket, (b) is the translation of the outer surface area of the adjusted test socket, and (c) is the inner surface area of the adjusted test socket,

[0061] Fig. 14 shows the step of determining the inner surface area of the digital model of the final prosthetic socket according to the first exemplary embodiment from the lateral side, where (a) is the outer surface area of the adjusted test socket, (b) is the translation of the outer surface area of the adjusted test socket, and (c) is the inner surface area of the adjusted test socket,

[0062] Fig. 15 shows the step of translating the outer surface area of the adjusted test socket according to the first exemplary embodiment from the front side,

[0063] Fig. 16 shows the step of translating the outer surface area of the adjusted test socket according to the first exemplary embodiment from the lateral side,

[0064] Fig. 17 shows a F-F section in the step of translating the outer surface area of the adjusted test socket according to the first exemplary embodiment,

[0065] Fig. 18 shows a section H-H in the step of translating the outer surface area of the adjusted test socket according to the first exemplary embodiment,

[0066] Fig. 19 shows a section G-G in the step of translating the outer surface area of the adjusted test socket according to the first exemplary embodiment,

[0067] Fig. 20 shows a section l-l in the step of translating the outer surface area of the adjusted test socket according to the first exemplary embodiment,

[0068] Fig. 21 shows a section B-B of the adjusted test socket according to the second exemplary embodiment,

[0069] Fig. 22 shows a section D-D of the adjusted test socket according to the second exemplary embodiment,

[0070] Fig. 23 shows a section C-C of the adjusted test socket according to the second exemplary embodiment,

[0071] Fig. 24 shows a section E-E of the adjusted test socket according to the second exemplary embodiment,

[0072] Fig. 25 shows the step of translating the outer surface area of the adjusted test socket according to the second exemplary embodiment from the front side,

[0073] Fig. 26 shows the step of translating the outer surface area of the adjusted test socket according to the second exemplary embodiment from the lateral side,

[0074] Fig. 27 shows a section J-J in the step of translating the outer surface area of the adjusted test socket according to the second exemplary embodiment, Fig. 28 shows a section L-L in the step of translating the outer surface area of the adjusted test socket according to the second exemplary embodiment,

[0075] Fig. 29 shows a section K-K in the step of translating the outer surface area of the adjusted test socket according to the second exemplary embodiment,

[0076] Fig. 30 shows a section M-M in the step of translating the outer surface area of the adjusted test socket according to the second exemplary embodiment,

[0077] Fig. 31 shows the adjusted test socket according to the third and fourth exemplary embodiments from the lateral side,

[0078] Fig. 32 shows the adjusted test socket according to the third and fourth exemplary embodiments from the front side,

[0079] Fig. 33 shows a section N-N of the adjusted test socket according to the third exemplary embodiment,

[0080] Fig. 34 shows a section 0-0 of the adjusted test socket according to the third exemplary embodiment,

[0081] Fig. 35 shows a section N-N of the adjusted test socket according to the fourth exemplary embodiment,

[0082] Fig. 36 shows a section 0-0 of the adjusted test socket according to the fourth exemplary embodiment

[0083] Exemplary Embodiments of the Invention

[0084] The invention will be further explained by exemplary embodiments with reference to the relevant drawings.

[0085] A method of designing and manufacturing a prosthetic socket according to the first exemplary embodiment of the invention is the method of designing and manufacturing a transtibial prosthetic socket for transtibial amputation of the left leg and is illustrated in Figs. 1 to 20.

[0086] In a step of creating a test socket 1_, the test socket 1_ is created according to the first exemplary embodiment shown in Fig. 1 based on a scan of the outer shape of the stump of the user. Based on a digital representation of the outer surface area of the stump of the user a digital model of the entire test socket 1_ is created. Based on the digital representation of the outer surface area of the stump of the user, the inner surface area of the test socket 1. is first created, which in this embodiment represents an initial digital model of the test socket 1. and its shape fully corresponds to the digital representation of the outer surface area of the stump, wherein it is subsequently volumetrically decreased by 2% to ensure slight compression of the soft tissues. Furthermore, a reconstruction of the distal part of the inner surface area of the test socket 1. is performed based on a model of the liner so that its shape fully corresponds to the distal part of the liner used (sleeve for the stump). The inner surface area of test socket 1. thus has side walls created based on the outer shape of the stump of the user and a distal part created based on the outer shape of the distal part of the liner. Subsequently, based on the inner surface area of the test socket 1_, the outer surface area 3 of the test socket is designed, which essentially corresponds in shape to the inner surface area of the test socket 1_, wherein it is offset from the inner surface area of test socket 1. so that there is a constant distance of 6 mm between them in all side or perimeter walls of test socket 1_. Furthermore, the distal part of the outer surface area 3 of the test socket is adjusted so that it is correctly adapted for connection to other prosthetic components. Based on the initial digital model of the entire test socket 1_ created in this way, comprising digital models of the inner surface area and outer surface area 3 of the test socket, a test socket 1. made of thermoplastic polymer material is subsequently created using a 3D printer based on FDM (Fused Deposition Modelling) technology. The 3D printing of test socket 1_ is carried out partly in vase mode, wherein the distal part of test socket 1_ is first printed in standard printing mode, i.e. the first 10 mm of the height of test socket 1. from its base, and subsequently all its side walls, or the rest of test socket 1_, are printed in vase mode, where the extrusion width corresponds to the thickness of these walls (constant 6 mm). Test socket 1 according to the first exemplary embodiment is shown in Figs. 1 and 2, where the inner wall of test socket 1. is indicated in dashed lines, wherein the constant thickness of its side walls is apparent.

[0087] Furthermore, Fig. 3 shows an anterior view and Fig. 4 shows a lateral view of the created test socket 1. together with the rest of the test prosthesis 7 for axial positioning in the initial state for further steps of the method according to the first exemplary embodiment of the invention. In a step of adjusting the test socket 1_, the clinical specialist further physically adjusts the test socket 1_ by performing four shape changes 2. The proximal contour curve 6 (edge) of the test socket runs on the front side above the centre of the patellar tendon, on the medial and lateral sides it defines two rounded protrusions extending up to the level of the knee, and it is at a defined height from the centre of the patellar tendon, and on the rear side it runs at defined heights relative to the orientation points of the hamstring insertions. The proximal contour curve 6 of the test socket is mechanically adjusted in the region of the patellar tendon, where part of the edge has been deepened so that in this region the proximal contour curve 6 runs closer to the distal end of the test socket 1. (see Figs. 5, 6 and 7). The side walls are shape-adjusted in the regions of the centre of the patellar tendon, the distal end of the tibia and the region of the head of the fibula (calf bone), wherein the shape changes 2 of the side walls of the test socket 1. according to the first exemplary embodiment are always preceded by heat treatment of the given region so that its ductility is increased without permanently damaging the properties of the given thermoplastic polymer. In the region of the centre of the patellar tendon, a slight depression of the inner surface area of the test socket 1. is performed by pressing on the outer surface area 3 of the test socket in the region of the centre of the patellar tendon (see Figs. 6 and 7). In the region of the distal end of the tibia, elevation of the inner surface area of the test socket 1. is performed by pressing on the inner surface area 3 of the test socket in the region of the distal end of the tibia (see Figs. 5, 6, 7 and 9), and in the region of the head of the fibula, elevation of the inner surface area of test socket 1_ is performed by pressing on the inner surface area of test socket 1. in the region of the head of the fibula (see Figs. 5, 6, 8 and 10).

[0088] Figs. 5 to 10 show in detail physical shape changes 2 performed in the step of adjusting the test socket 1_ according to the first exemplary embodiment, where the solid line depicts the inner surface area 5 and outer surface area 4 of the adjusted test socket, and the dashed line depicts the inner surface area and outer surface area 3 of the test socket, or rather the original test socket 1. before adjustment, in regions where their shapes differ.

[0089] In the step of adjusting the test socket 1_ according to the first exemplary embodiment, the axial positioning of the test socket 1. is further performed using test prosthesis 7. The shape-adjusted test socket 1_ is connected to other components of test prosthesis 7. The test prosthesis 7 comprises a socket attachment adapter, a tubular adapter (pylon) and a prosthetic foot, wherein the socket attachment adapter is connected to the distal part of the adjusted test socket 1_, and the tubular adapter interconnects the socket attachment adapter and the prosthetic foot. The prosthetic foot has a tread surface area that represents the base plane against which the test prosthesis 7 or test socket 1. is axially positioned. The adjusted test socket 1. established in the final axial position is provided with reference marks 8 for its capturing. As can be seen in Figs. 11 and 12, the test socket 1. is provided with two pairs of reference marks 8. The reference marks 8 are circular stickers of red colour with a diameter of 10 mm. The first pair is placed on test socket 1. from its front side at two different locations so that these reference marks 8 represent points which, from the front view, are on one vertical axis perpendicular to the base plane and passing through the reference point of the foot (see Fig. 11 ). The second pair is placed on the test socket 1. from its lateral side at two different locations so that these reference marks 8 represent points which, from a lateral view, are on a single vertical axis perpendicular to the base plane and passing through the reference point of the foot (see Fig. 12). The reference points of the foot through which the vertical axis passes are indicated by two reference marks 8 on the front and lateral sides of the upper edge of the prosthetic foot (see Figs. 11 and 12).

[0090] Subsequently, in the step, the outer surface area 4 of the adjusted test socket is scanned by a scanning device in the form of a colour 3D scanner. The captured colour 3D model is sent wirelessly from the scanning device to a computer device adapted to perform a step of creating a digital model of the final prosthetic socket.

[0091] The step of creating the digital model of the final prosthetic socket is performed on a computer device with modelling software installed. A step of determining at least part of the inner surface area of the digital model of the final prosthetic socket comprises determining the digital model of the inner surface area 5 of the adjusted test socket based on the digital model of the outer surface area 4 of the adjusted test socket. The step of determining the inner surface area 5 of the adjusted test socket is shown in Figs. 13 and 14, where Fig. 13 (a) and Fig. 14 (b) show the outer surface area 4 of the adjusted test socket in two different views. The inner surface area 5 of the adjusted test socket is determined by proportionally modifying the outer surface area 4 of the adjusted test socket. This modification comprises translating the entire outer surface area 4 of the adjusted test socket based on the thickness of the walls of the test socket 1_. The translation is performed by decreasing the outer surface area 4 of the adjusted test socket towards the central longitudinal axis of the test socket 1. in planes perpendicular to this axis so that that the distance between the decreased surface area and the original model of the outer surface area 4 of the adjusted test socket in regions of side walls corresponds to the thickness of the test socket 1_, i.e. 6 mm. This method is illustrated in Fig. 13 (b) and Fig. 14 (b), where the original outer surface area 4 of the adjusted test socket is indicated in dashed lines and the decreased model is indicated in solid lines in two different views, based on which the inner surface area 5 of the adjusted test socket is designed, shown in two views in Fig. 13 (c) and Fig. 14 (c). A step of translating is further illustrated in Figs. 15 to 20, where the translation of the outer surface area 4 of the digital model of the adjusted test socket can be observed in sections F-F, H-H, G-G and l-l in the step of determining the inner surface area 5 of the adjusted test socket according to the first exemplary embodiment. In the case of the thus designed inner surface area 5 of the adjusted test socket, reconstruction of its distal part is further carried out, which is adjusted based on the distal part of the liner of the user that is used and the liner connection mechanism (lock). By connecting and further processing the thus designed inner surface area 5 of the adjusted test socket and its outer surface area 4, the digital model of the entire adjusted test socket 1. is designed.

[0092] Subsequently, in the step of creating the digital model of the final prosthetic socket, the axial positioning of the digital model of the entire adjusted test socket 1. is performed based on the captured reference marks 8 on the outer surface area 4 of the adjusted test socket. The digital model of the entire adjusted test socket 1_ is rotated in 3D space relative to the vertical base axis of the prosthesis so that the pair of reference marks 8 from the front view and the pair of reference marks 8 from the lateral view are aligned with respect to the vertical axis of the prosthesis, as shown in Fig. 11 and Fig. 12.

[0093] In the step of creating the digital model of the final prosthetic socket, the digital model of the final prosthetic socket is created based on the digital model of the entire adjusted test socket 1. and the established axial position, which is structurally adapted for connection to other prosthetic components of the final prosthesis. Within this step, the digital model of the entire adjusted test socket 1_ is processed, optimised and smoothed, wherein the missing parts of the model are designed (holes at the boundary between the inner and outer surface areas of the adjusted test socket 1_), excessively sharp edges and irregularities are smoothed, and the model is adapted for the implementation of other elements of the prosthetic socket, such as a ventilation system, a liner connection mechanism, sensors and other electronics on the sockets.

[0094] Within the step of manufacturing the prosthetic socket, a G code representing instructions for manufacture for a 3D printer is created from the digital model of the final prosthetic model, and the final prosthetic socket is subsequently printed using a 3D printer. The final prosthesis for transtibial amputation is produced by assembling the final prosthetic socket with other prosthetic components and implementing other elements of the prosthetic socket.

[0095] In alternative embodiments according to the first exemplary embodiment of the invention, in a step of creating a digital model of the final prosthetic socket, the digital model of the final prosthetic socket may be created based only on the inner surface area 5 of the adjusted test socket and the captured axial position of the adjusted test socket 1_.

[0096] The second exemplary embodiment of the method of designing and manufacturing the prosthetic socket according to the invention for transtibial amputation of the left leg is shown in Figs. 21 to 30. A step of creating the test socket 1 comprises a step of creating the transtibial test socket 1. based on an initial model of the entire test socket 1. designed based on a scan of the outer shape of the stump of the user. In this embodiment, test socket 1. has a gradually increasing thickness of the peripheral side walls in the direction of the longitudinal centre axis of test socket 1_ from the distal part of test socket 1_, where the side walls have a thickness of 10 mm around the perimeter, to the proximal peripheral edge of the test socket 1_, where the side walls have a thickness of 5 mm around the perimeter. The cross-sections of the test socket 1 in horizontal planes perpendicular to the longitudinal centre axis of the test socket 1. have the same thickness around the entire perimeter, as can be seen in the horizontal cross-sections of the adjusted test socket 1. according to the second exemplary embodiment, see Figs. 23 and 24. The initial digital model of test socket 1_,_and therefore also the created test socket 1_, includes three projections distributed on different sides of the outer surface area 3 of the test socket, the projections are located at different heights, one on the front side, the second on the medial side and the third on the lateral side of test socket 1. (not shown in the figures).

[0097] In a step of adjusting the test socket 1. according to the second exemplary embodiment, the same shape changes 2 are made as in the first exemplary embodiment shown in Figs. 21 to 30, and the test socket 1_ is also axially positioned analogously to the first exemplary embodiment according to Figs. 11 and 12. Within the step of adjusting the test socket 1_, the outer shape of the test socket 1. is not physically adjusted in the regions of the projections.

[0098] In a step of scanning the adjusted test socket 1_ according to the second exemplary embodiment of the invention, the outer surface area 4 of the adjusted test socket is scanned by a colour 3D scanner, wherein a colour digital model of the outer surface area 4 of the adjusted test socket is created, which captures the projections and reference marks 8. This is sent to a computer device for further processing.

[0099] In a step of creating a digital model of the final prosthetic socket, the digital model of the outer surface area 4 of the adjusted test socket and the initial digital model of the entire test socket 1. are first aligned in space using projections so that their mutual shape differences can be identified. These two models are thus aligned so that the projections of the digital model of the outer surface area 4 of the adjusted test socket and the projections of the initial digital model of the entire test socket 1_ correspond completely, wherein the regions of the outer surface areas of the models where no physical shape changes 2 were performed in the step of adjusting the test socket 1. also essentially correspond. In the step of determining the inner surface area of the final prosthetic socket, the translation of the outer surface area 4 of the adjusted test socket is further performed based on the thickness of the wall of the aligned initial digital model of the entire test socket 1. in the corresponding regions. The step of translating according to the second exemplary embodiment is shown in Figs. 25 to 30, where the translation of the digital model of the outer surface area 4 of the adjusted test socket can be observed in sections J— J, K-K, L-L and M-M in the step of determining the inner surface area 5 of the adjusted test socket. In planes perpendicular to the longitudinal centre axis of the test socket, the points of the outer surface area 4 of the adjusted test socket are transferred towards the longitudinal centre axis of the adjusted test socket 1. along the normal to the outer surface area 4 of the adjusted test socket at a given point by a distance corresponding to the thickness of the initial model of the entire test socket 1. in the given plane. In other words, the translation of the points of the outer surface area 4 of the adjusted test socket is carried out in horizontal planes along the normals towards the central axis of the test socket 1 by a distance corresponding to the thickness of the initial model of the entire test socket 1 at the given location. On the distal side of the test socket 1_, translation therefore occurs by the greatest distance (see Fig. 29), and on the proximal side of the test socket 1_, translation occurs by a smaller distance (see Fig. 30), since the thickness of the test socket 1_ in horizontal planes gradually decreases from the distal part to the proximal end of the test socket 1_. For the designed inner surface area 5 of the adjusted test socket, reconstruction of its distal part is further carried out, which is adjusted based on the distal part of the liner of the user that is used. By connecting and further processing the thus designed inner surface area 5 of the adjusted test socket and its outer surface area 4, the digital model of the entire adjusted test socket 1. is designed, which is subsequently aligned based on the reference marks 8 according to the first exemplary embodiment.

[0100] Furthermore, the method according to the second exemplary embodiment proceeds analogously to the first exemplary embodiment.

[0101] The method of designing and manufacturing the prosthetic socket according to the third exemplary embodiment of the invention for transfemoral amputation of the left leg is shown in Fig. 31 to 34. This method proceeds analogously to the first exemplary embodiment of the invention, with the differences specified below.

[0102] In a step of creating the test socket 1_, a transfemoral test socket 1_ is first created based on an initial digital model of the entire test socket 1., which is created based on a scan of the outer shape of the stump of the user. First, the inner surface area of the initial digital model of the test socket 1. is created based on the scan of the stump. Subsequently, a digital model of the outer surface area 3 of the initial digital model of the test socket is designed, which essentially corresponds in its shape to the inner surface area of the test socket 1_, wherein it is offset from the inner surface area of the test socket 1. with a simultaneous increase so that there is a constant distance of 8 mm between them in all walls of the test socket 1_, including its distal part.

[0103] In a step of adjusting the test socket 1_, the clinical specialist physically adjusts test socket 1. by making five physical shape changes 4. The front part of the proximal contour curve 6 (edge) of the test socket is mechanically adjusted in the region of front side of the thigh, where part of the edge is deepened so that in this region the proximal contour curve 6 runs closer to the distal end of the test socket 1. (see Figs. 32 and 34). The side walls are shape-adjusted in three regions on the lateral side and in one region on the front side of the test socket 1_. On the lateral side of the test socket 1_, elevation of the inner surface area of the test socket 1_ is performed in two regions (trochanter and distal end of the femur) by pressing on the inner surface area of the test socket 1, and in one region (region behind the trochanter), depression of the inner surface area of test socket 1. is performed by pressing on the outer surface area 3 of the test socket (see Figs. 31 and 33); these shape changes 2 are essentially circular in shape. On the front side of the test socket 1. in the Scarpa triangle region, extensive depression of the inner surface area of the test socket 1. is performed by pressing on the outer surface area 3 of the test socket (see Figs. 32 and 34).

[0104] In a step of creating the digital model of the final test socket, the digital model of the outer surface area 4 of the adjusted test socket and the outer surface area 3 of the initial digital model of the test socket are first aligned based on similarity, wherein these models are then compared. Based on the intersections of these models, regions of partial shape changes 2 are delimited on the outer surface area 4 of the digital model of the adjusted test socket, and based on the orientation of these regions above or below the outer surface area 4 of the digital model of the adjusted test socket, the type of shape change 2 (depression / elevation) is set. In the direction of the normal to the outer surface area 3 of the initial digital model of the test socket, the partial models representing these local shape changes 2 are then shifted towards the vertical centre axis of the test socket 1 by a distance of 8 mm. By the subsequent implementation of these local shape changes 2 into the inner surface area of the initial model of the test socket 1. is the inner surface area 5 of the adjusted test socket determined. This modification of the inner surface area of the initial model of the test socket 1_ is carried out again based on the points of intersection between the shifted partial models representing these local shape changes 2 and the inner surface area of the initial model of the test socket 1_, wherein inside these regions of intersection of the models, the inner surface area of the initial digital model of test socket 1. is deleted and replaced with a new partial model representing the required shape change obtained from the outer surface area 4 of the adjusted test socket.

[0105] The method of designing and manufacturing the transfemoral prosthetic socket according to the fourth exemplary embodiment of the invention is illustrated in Figs. 31 , 32, 35 and 36. This method proceeds analogously to the second and third exemplary embodiments of the invention. A step of adjusting the test socket 1. is carried out by performing the same shape changes 2 as in the third exemplary embodiment, with the difference that the transfemoral test socket 1. according to the fourth exemplary embodiment has a variable thickness of the wall. A step of creating a digital model of the final prosthetic socket, including a step of determining the inner surface area 5 of the adjusted test socket based on the outer surface area 4 of the adjusted test socket, proceeds analogously to the second exemplary embodiment.

[0106] In alternative exemplary embodiments of the method according to the invention proceeding analogously to the exemplary embodiments described above, in a step of adjusting the test socket 1_, the required shape changes 3 are marked on the outer surface area 3 of the test socket according to the second aspect of the present invention. In the first such exemplary embodiment, carried out partially based on the first exemplary embodiment of the invention, the required shape changes 2 are indicated using blue colour. The regions of the required shape change 2 on the outer surface area 3 of the side walls of the test socket in the regions of the centre of the patellar tendon, the distal end of the tibia and the region of the head of the fibula (calf bone) are delimited in colour. An appropriate shape element is first adhered to the inner surface area of the test socket 1_, correctly representing the required depression in the region of the centre of the patellar tendon in terms of its shape and properties, wherein on the outer surface area 3 of the test socket, the margin of this shape element is traced in the corresponding region and the letter "D" is indicated in blue colour, representing the shape change 2 of the type of depression and the code of the selected shape element assigned to a digital model representing the selected shape element in the modelling software database in the computer device. Furthermore, the regions of the required shape changes 2 in the regions of the distal end of the tibia and the region of the head of the fibula (calf bone) are delimited in blue colour on the outer surface area 3 of the test socket, wherein the letters "E" representing the shape change 2 of the type of elevation and the code of the required shape change 2 assigned to the digital model representing the required shape change in the modelling software database in the computer device are further delimited into them in blue colour. In the step of creating the digital model of the final prosthetic socket, as in the first exemplary embodiment, the inner surface area 5 of the adjusted test socket is set based on the constant thickness of the test socket 1_, wherein, in this step of determining the inner surface area 5 of the adjusted test socket, together with the shape of the outer surface area 4 of the adjusted test socket, the blue markings of the regions, of the type and code of the required shape changes 2, which represent the identifiers of shape change 2, transferred into the designed inner surface area 4 of the adjusted test socket. Based on the marked regions, types of shape change 2 and codes representing the models of the required changes 2, the inner surface area 5 of the adjusted test socket is further adjusted. The margins of the delimited region of the required shape change 2 then determine the part of the inner surface area 5 of the adjusted test socket to which the shape change 2 relates, the type of change 2 represents the orientation of the shape adjustment 2, i.e. elevation or depression, and the code then identifies the model of the shape change in the database to be implemented in the delimited region in the correct orientation. This is how the final inner surface area 5 of the adjusted test socket is designed, based on which the inner surface area of the final prosthetic socket is designed.

[0107] In other exemplary embodiments of the invention according to the second aspect of the present invention, in a step of adjusting the test socket 1_, the required shape changes 2 are marked in colour so that the colour of the markings represents the type of change 2 (elevation, depression) and the maximum height of the required shape change 2 is further listed in the region delimited in colour. For example, in one region of the outer surface area 4 of the adjusted test socket, the region of the required change 2 is delimited in blue colour in the shape of a circle and the data 3 mm is written inside, and in another region, the region of the required change 2 is delimited in red colour in the shape of an ellipse and the data 2 mm is written inside. Based on preset instructions, for a step of creating a digital model of the final prosthetic socket, it is determined that the blue colour represents a shape change 2 of the type of elevation, the red colour represents a shape change 2 of the type of depression, and that the distance data represents the distance between the apex of the required change 2 placed in its centre and the inner surface area 5 of the test socket (maximum deviation of shape change 2 from the original inner surface area of the test socket 1_). The rest of the shape of the required shape change 2 is then modelled so that it smoothly and continuously connects the designed apex and the margins of the delimited region, wherein the resulting shape adjustment of the inner surface area 5 of the adjusted test socket is further rounded so that it does not contain sharp edges causing discomfort to the user. Based on the thus designed inner surface area 5 of the adjusted test socket, the inner surface area of the final prosthetic socket is designed.

[0108] Industrial applicability

[0109] In addition to transtibial and transfemoral prosthetic sockets, the invention can also be used within the methods of designing and manufacturing other prosthetic or orthotic devices not mentioned here.

[0110] List of the Reference Signs

[0111] 1 test socket

[0112] 2 shape change of the test socket

[0113] 3 outer surface area of the test socket

[0114] 4 outer surface area of the adjusted test socket

[0115] 5 inner surface area of the adjusted prosthetic socket

[0116] 6 proximal contour curve

[0117] 7 test prosthesis

[0118] 8 reference mark

Claims

PATENT CLAIMS1 . A method of designing and manufacturing a prosthetic socket, comprising: a) a step of creating a test socket (1 ) on the basis of an initial digital model of the test socket (1 ); b) a step of adjusting the test socket (1 ); c) a step of scanning the adjusted test socket (1 ) to create a digital model of the adjusted test socket (1 ); d) a step of creating a digital model of the final prosthetic socket on the basis of the digital model of the adjusted test socket (1 ); e) a step of manufacturing the prosthetic socket on the basis of the digital model of the final prosthetic socket, characterised in that the step of adjusting the test socket (1 ) comprises performing at least one physical shape change (2) of the test socket or marking the required shape change (2) of the test socket on the outer surface area (3) of the test socket, the step of scanning the adjusted test socket (1 ) comprises the step of scanning the outer surface area (4) of the adjusted test socket, and the step of creating the digital model of the final prosthetic socket comprises determining at least part of the inner surface area of the digital model of the final prosthetic socket on the basis of the outer surface area (4) of the digital model of the adjusted test socket.

2. The method of designing and manufacturing the prosthetic socket according to claim 1 , characterised in that determining at least part of the inner surface area of the digital model of the final prosthetic socket comprises modification of at least part of the digital model of the adjusted test socket (1 ) on the basis of the thickness of the wall of the test socket (1 ).

3. The method of designing and manufacturing the prosthetic socket according to claim 2, characterised in that the test socket (1 ) has essentially constant thickness of the walls over most of its height in the direction from its proximal end.

4. The method of designing and manufacturing the prosthetic socket according to claims 1 to 3, characterised in that, in the step of creating the test socket (1 ), the test socket (1 ) is created by 3D printing, wherein the test socket (1 ) is manufactured using a 3D printer by extruding plastic materials at least partially in vase-mode printing.

5. The method of designing and manufacturing the prosthetic socket according to claims 2 to 4, characterised in that the initial digital model of the test socket (1 ) is a 3D model comprising information about the shape of the test socket (1 ) and the thickness of its walls.

6. The method of designing and manufacturing the prosthetic socket according to claims 2 to 5, characterised in that the modification of at least part of the digital model of the adjusted test socket (1 ) comprises the translation of at least part of the outer surface area (4) of the digital model of the adjusted test socket by a distance set on the basis of the thickness of the wall of the test socket (1 ) at the corresponding location.

7. The method of designing and manufacturing the prosthetic socket according to claims 1 to 6, characterised in that the step of creating the digital model of the final prosthetic socket further comprises comparing the digital model of the adjusted test socket (1 ) and the initial digital model of the test socket (1 ), comprising determining local shape change (2) between the digital model of the adjusted test socket (1 ) and the initial digital model of the test socket (1 ), wherein determining at least part of the inner surface area of the digital model of the final prosthetic socket further comprises subsequent local shapemodification of the initial digital model of the test socket (1 ) on the basis of the determined local shape change (2).

8. The method of designing and manufacturing the prosthetic socket according to claims 1 to 7, characterised in that the proximal contour curve (6) of the digital model of the final prosthetic socket is determined on the basis of the proximal contour curve (6) of the digital model of the adjusted test socket (1 ).

9. The method of designing and manufacturing the prosthetic socket according to claims 1 to 8, characterised in that at least one physical shape change (2) of the test socket (1 ) comprises adjustment from the group of: adjustment of the proximal edge of the test socket (1 ) and adjustment of the side walls of the test socket (1 ).

10. The method of designing and manufacturing the prosthetic socket according to claims 1 to 9, characterised in that the test socket (1 ) is made of polymer material, wherein at least one physical shape change (2) of the test socket (1 ) is preceded by heat treatment of the given adjusted region, or the physical shape change (2) consists in mechanical adjustment of the test socket (1 ).1 1 . The method of designing and manufacturing the prosthetic socket according to claims 1 to 10, characterised in that marking the required shape change (2) of the test socket comprises delimiting a region of the outer surface area (3) of the test socket to which the required shape change (2) relates.

12. The method of designing and manufacturing the prosthetic socket according to claim 11 , characterised in that marking the required shape change (2) of the test socket further comprises an identifier specifying the required shape change (2).

13. The method of designing and manufacturing the prosthetic socket according to claims 1 to 12, characterised in that the step of adjusting the test socket (1 ) comprises the step of axial positioning of the test socket (1 ) in space using a test prosthesis (7), wherein in the step of scanning the adjusted test socket (1 ),the axial position of the test socket (1 ) is captured, and the step of creating the digital model of the final prosthetic socket comprises the step of axial positioning on the basis of the digital model of the adjusted test socket (1 ).

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