METHOD FOR MANUFACTURING PORTIONS OF A PROSTHETIC SHAFT AND KIT

Abstract

The present invention relates to a method for manufacturing or planning the manufacturing of a prosthetic shaft, an inner or outer shaft and/or of an extension of the prosthetic shaft, wherein the prosthetic shaft is provided for receiving a limb stump of a patient P. The present invention further relates to prosthetic shaft and a kit. Furthermore, a computer system, a digital storage medium, a computer program product and a computer program are proposed.

Claims

1. A method for manufacturing or for planning the manufacturing of a prosthetic shaft, an inner shaft, an outer shaft and/or an extension of the prosthetic shaft, wherein the prosthetic shaft is provided for receiving a limb stump of a patient P, encompassing the steps: determining geometric data or providing geometric data, wherein the geometric data helps determine the shape of the limb stump at at least a first wearing time of the prosthetic shaft, inner shaft, outer shaft, or of the extension; and either creating, based on the determined geometric data, the prosthetic shaft, the inner or outer shaft, or the extension, or creating sections thereof, based on the geometric data, or creating a control file having control signals upon which a manufacturing machine may execute steps for creating the prosthetic shaft, the inner shaft, outer shaft or the extension, wherein said creating takes place at a time of creating prior to the first wearing time, and wherein the geometric data is not data measured on the patient P.

2. The method according to claim 1, wherein the geometric data is predicted data, data of variable dimensions of the limb stump, data which is subject to, or caused by, post-operative changes over time and changes caused by a previous surgical operation, and/or data which does not represent or reflect the shape of the limb stump at the time of determining the data or at the time of creating, and/or it is not actual data and/or measured data of the patient P.

3. The method according to claim 1, wherein the determining of the geometric data, which is predicted data, takes into account patient data which reflects the, or at least one, in particular momentary, health condition or finding of the patient P at the time of the determining and/or at a past time or takes into account patient data which was collected from a collective of patients having this health condition or finding.

4. The method according to claim 1, wherein the geometric data is or encompasses the result of an estimation, a readout from a reference source and/or a calculation based on an algorithm.

5. The method according to claim 1, wherein at least 3 days, preferably at least 10, 20, 30, 60, 90 days, in particular at least 180 days, 12 months or 24 months lie between the creation time and the first wearing time.

6. The method according to claim 1, wherein the geometric data additionally also encompasses data which will co-determine the shape of the limb stump at at least a second wearing time which is after the first wearing time, wherein at least 3 days, preferably at least 10, 20, 30, 60, 90 days, in particular at least 180 days, 12 months or 24 months lie between the first wearing time and the second wearing time.

7. The method according to claim 1, wherein in the step of creating, a prosthetic shaft, an inner shaft, an outer shaft and/or at least one extension or a corresponding control file for the manufacturing machine is also created based on the geometric data which will co-determine the shape of the limb stump at least at the second wearing time.

8. The method according to claim 1, wherein the inner shaft serves to receive at least portions of the limb stump and in turn is provided to be at least partially received in an interior of the outer shaft.

9. The method according to claim 1, wherein the extension is an inlay, a pad, a pressure insert, a compression insert, a stocking with different wall thicknesses or a double-walled stocking with at least one insert inserted between its layers.

10. The method according to claim 1, wherein the manufacturing machine is a printer, a 3D printer, a casting device, a milling machine, a rapid prototyping device, a CNC milling machine, a CAD milling machine, a thermoforming device, or nowadays also an injection device, configured to create the prosthetic shaft, the inner shaft, the outer shaft or the extension or sections thereof based on the control signals.

11. A prosthetic shaft, an inner shaft, an outer shaft and/or an extension for the prosthetic shaft, manufactured by the method according to claim 1.

12. A kit with at least two elements from a group consisting of prosthetic shaft, inner shaft, outer shaft or at least of one extension, each manufactured according to the method of claim 1.

13. The kit according to claim 12, wherein at least a first element of the group was created based on geometric data which co-determines the shape of the limb stump at the first wearing time, and wherein at least a second element of the group was created based on geometric data which co-determines the shape of the limb stump at the second wearing time.

14. A computer system programmed to carry out the method according to claim 1.

15. A digital storage medium, in particular a floppy disk, CD or DVD or EPROM, with electronically readable instructions, configured in order to configure a control device and/or a closed-loop control device into a control device and/or a closed-loop control device with which the method according to claim 1 may be executed.

16. A computer program product with a program code stored on a machine-readable carrier, configured in order to configure a control device and/or a closed-loop control device into a control device and/or a closed-loop control device with which the method according to claim 1 may be executed.

17. A computer program with a program code for configuring a control device and/or a closed-loop control device into a control device and/or a closed-loop control device with which the method according to claim 1 may be executed.

Description

[0110] The present invention is in the following exemplarily explained based on the accompanying drawings, in which identical reference numerals denote the same or similar components. The following applies in the partially highly simplified figures:

[0111] FIG. 1 shows a prosthetic shaft as part of a thigh prosthesis being only partially shown with several extensions according to the present invention in a longitudinal section;

[0112] FIG. 2 shows a cross-section of the thigh prosthesis of FIG. 1;

[0113] FIG. 3 shows an inner shaft according to the present invention as part of a thigh prosthesis, which is only partially shown in a longitudinal section;

[0114] FIG. 4 shows a cross-section of the thigh prosthesis of FIG. 3;

[0115] FIG. 5 shows an exemplary embodiment of the computer system according to the present invention; and

[0116] FIG. 6 shows, schematically, a reference source for use in the method according to the present invention.

[0117] FIG. 1 shows an outer shaft 4 as part of a prosthetic shaft 2 of a thigh prosthesis being only partially shown. The relatively stiff, shell-shaped outer shaft 4 receives in its interior a preferably comparatively flexible inner shaft 6 which is inserted removably and which is individually adapted to the limb stump of the patient P.

[0118] The optionally closed distal end 8 of the outer shaft 4 is followed by a column-like component 10 leading to the mechanical knee joint (not shown in FIG. 1).

[0119] Unlike prostheses of this type as known from the prior art, here—e.g. between the longitudinally extending walls of the outer shaft 4 and the inner shaft 6—e.g. two extensions 12 and 14 according to the present invention are arranged, which may each press the wall 18 of the inner shaft 6 inwards by their inner wall in the relevant areas in order to achieve a local reduction in the internal volume of the shaft.

[0120] An optional, further such extension 20 according to the present invention is located on the outside of the inner shaft 6 at its distal end.

[0121] More precisely, the extensions 12 and 14 are optionally arranged here in the dorso-lateral area following an edge 22 of the thighbone (femur) 24 (indicated by dashed lines) or in the medial-distal area. In this, the extension 12, extending from proximal to distal, optionally has an elongated shape, whereas the extension 14 optionally has a rather round shape.

[0122] As indicated by the arrows in the cross-section through the prosthetic shaft 2 of FIG. 1 shown in FIG. 2, the femur 24 intentionally undergoes a more or less strong adduction as a result of the extension 12. This allows the abduction, that usually occurs in transfemoral amputees some time after the amputation, to be corrected. In addition, the extensions 12 and 14 allow the shaft volume to be reduced and provide the residual limb with increased surface adhesion in the shaft, here: in the inner shaft 6. This surface adhesion in turn makes it possible, with the aid of the optional extension 20, to restore a desired residual limb end contact after swelling has subsided and, if necessary, after atrophy processes.

[0123] The extensions 12, 14 and 20 have been given together with the outer shaft 4 to the patient P, on whose limb stump the outer shaft 4 was adapted on the day of its manufacture (that is, for example, at the time of creation).

[0124] The use of the extensions 12, 14, 20 was not necessary on the day of transferring the prosthesis with the outer shaft 4, nor would it have provided the patient P with increased wearing comfort. According to the present invention, however, it had already been determined on or before the day of transfer (e.g., at the time of determination) how some of the data or geometric data of the limb stump would in all likelihood change in the foreseeable future (i.e., at the first wearing time). Up to a day, referred to herein as the first wearing time, the limb stump had changed due to muscular remodeling and possibly a reduction in swelling such that the outer shaft 4 produced at that time could no longer fit optimally. Patient P can independently correct the deviation between the changed shape of his limb stump and the unchangeable shape of the outer shaft 4 of his prosthesis by inserting the change in the shape (geometric data) of his limb stump that is expected in his case. In the present example, he only has to insert or use the extensions 12, 14 and 20 as already envisaged by the orthopedic technician at the time of determination and, if necessary, secure them against slipping within the prosthetic shaft 2. In this way, he can restore the desired accuracy of fit for his prosthesis without having to visit the orthopedic technician again and without expert knowledge.

[0125] FIG. 3 shows a second embodiment of the prosthetic shaft 2 in longitudinal section. FIG. 4 in turn shows a cross-section thereof.

[0126] Unlike what is shown in FIG. 1, the prosthetic shaft 2 has no extensions 12, 14 or 20. The muscular remodeling and also the decrease in possible post-operative edema are compensated for by the special design of the inner shaft 6a, which differs fundamentally from the inner shaft 6 of FIG. 1 and FIG. 2.

[0127] At the points at which in the embodiment of FIGS. 1 and 2 exemplary extensions 12 and 14 were provided to compensate for muscular remodeling with the aim of exerting pressure on the femur 24 in the direction of the arrow, in the embodiment shown in FIG. 3 and FIG. 4, the stiff inner shaft 6a shaped in a special way takes over or adopts this function. Its rigidity results in the formation of empty spaces 26 and 28. They have the shape of the extensions 14 and 12 of FIGS. 1 and 2, respectively. The rigidity of the inner shaft 6a of FIG. 3 allows it to remain form-stable while still exerting the desired pressure on the thigh stump.

[0128] The inner shaft 6a is, so to speak, a shaft from the retort: Its dimensions are not based on the dimensions that the orthopedic technician measured on the limb stump in order to fit the patient P with a prosthesis. Rather, its dimensions are based on data predicted into the future or geometric data, of or based on which it was assumed at the time of the fitting that the limb stump would assume or adopt them later and which were thus determined before or at the time of creation.

[0129] In the embodiment shown in FIGS. 3 and 4, it is therefore assumed in the present example that the inner shaft 6a is already the second inner shaft, i.e. an inner shaft that was intended to be worn only or starting from the first wearing time. It is assumed that the patient was fitted by the orthopedic technician with an inner shaft (not shown in the figures) which was placed inside the outer shaft 4 with continuous contact to the inside thereof. It is further assumed that this original inner shaft no longer fitted optimally at a first wearing time, e.g. weeks or months after being provided by the orthopedic technician, which is why it was replaced by the inner shaft 6a, shown in FIGS. 3 and 4, while retaining the original outer shaft 4.

[0130] FIG. 5 shows a computer system 200 according to the present invention.

[0131] The computer system 200 optionally comprises a calculation device 210, a reference source 220, an input device 230, an output device 240, and/or a manufacturing machine 250, respectively. The aforementioned units 220, 230, 240, and 250 are each optional and may be connected to or integrated with the calculation device 210. They may be in one-way or two-way signal communication with the calculation device 210. They may be interconnected in any manner. Each of these connections may be wired or wireless.

[0132] The calculation device 210 may serve to determine the geometric data. For this purpose, it may make use of an optional reference source 220 in which reference data may be stored. For example, by specifying the actual dimensions measured at the time of creation, optionally supplemented by other data such as the age, weight, mobility classification (1 to 4), physical activity, etc. of the patient P, which may optionally be entered by the input device 230, by simply associating this data with empirical values of already existing geometric data, which the limb stump is likely to assume at certain times in the future (referred to herein as wearing times) may be output. The output may be done by the output device 240, e.g. in the form of a notification on a display or as a printout for the orthopedic technician. In addition to or instead of an output, control signals (individually or as part of a control file) may be transmitted to the manufacturing machine 250. The desired component, for example the inner shaft or the extension, or a section or parts thereof, can be produced on it, optionally automatically. The indication and/or control signals may encompass information as to where, for example, produced extensions 12, 14, 20 are to be placed in the prosthetic shaft 2.

[0133] FIG. 6 shows an example of how provided data or geometric data is used.

[0134] On the left in FIG. 6, a limb stump of patient P, who is only partially shown, may, when being measured, have the measurement results stated in the table on the left in FIG. 6. Column B shows the measurement results obtained on the stump and indicates the respective measured circumference (in cm) at a distance of, for example, 6 cm, 9 cm and 12 cm from a reference point or reference cross-section (column A). The values in column B are also regarded as actual values. They were measured at the positions of the limb stump specified in column A before the prosthetic shaft 2 was created.

[0135] When examining a large number of patients with comparable limb stumps, values were measured in advance of the method according to the invention which indicate the cross-sections of the limb stump, e.g. 6 cm, 9 cm and 12 cm, at later, defined wearing times. For example, the numerical values in column C indicate which circumferential values were determined for the collective at the positions specified in column A at a first wearing time, for instance after 3 months after creation of the prosthesis, possibly based on or related to determined actual values. At the same time, they indicate which measured values the limb stump of patient P would presumably assume, since they have already applied to a sufficiently large collective, for example by reflecting the changes in the measured values observed for the collective over 3 months.

[0136] Column D gives circumferential values, for which one may assume, due to the previous measurements on the above-mentioned patient collective, that the actual limb stump shown on the left in FIG. 6 will also assume these (or very similar) values/dimensions at the positions specified in column A at the second wearing time, after about 6 months.

[0137] FIG. 6 shows a reference source on the right. The columns C and D thereof show which geometric data a limb stump, which at the time of initial fitting with a prosthesis (e.g. at the time of determination) has the values of column B at the positions specified in column A, will in all probability have at the, herein exemplarily considered, first and second wearing times, namely the values of columns C and D. Reading them out may represent a determination in the sense of the present invention.

[0138] If patient P is a diabetic, the values in columns C and D may be determined from a collective that also consisted of diabetics.

[0139] Furthermore, the values in columns C and D can already take into account how large the values in column B are. If the specific patient P had shown greater actual values than those noted in column B, the values C and D could also have been greater.

[0140] FIG. 6 serves as an example. The present invention is not limited to considering the circumference as a geometric datum. The use of other data is supplementary or alternative, in combination with one another or alone, likewise encompassed by the present invention.

[0141] Instead of a reference source, geometric data may be determined based on a present set of data at the moment of determination.

[0142] Although the present invention is described or discussed herein in a number of passages and in particular on the basis of the exemplary figures using the example of the limb stump of a lower extremity (thigh, lower leg, foot), the present invention is by no means limited to the fitting of a limb stump of the lower extremity. According to the invention, what is described herein also applies without restriction to the fitting of the upper extremity (upper arm, lower arm, hand) as well as to the products proposed for fitting, such as prosthetic shaft, inner shaft, outer shaft and extensions.

LIST OF REFERENCE NUMERALS

[0143] 2 prosthetic shaft

[0144] 4 outer shaft

[0145] 5 inlet opening

[0146] 6 inner shaft

[0147] 7 slot or slit

[0148] 8 distal end of the outer shaft

[0149] 10 column-like or columnar component

[0150] 12 Extension or accessoire

[0151] 14 Extension or accessoire

[0152] 18 wall

[0153] 20 extension or accessoire

[0154] 22 edge

[0155] 24 femur

[0156] 200 computer system

[0157] 210 calculation device

[0158] 220 reference source

[0159] 230 input device

[0160] 240 output device

[0161] 250 manufacturing machine