METHOD FOR MANUFACTURING PORTIONS OF A PROSTHETIC SOCKET AND KIT

Abstract

The present invention relates to a method for manufacturing or for planning the manufacturing of a prosthetic shaft, of an inner shaft of an 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. In addition, the present invention relates to a prosthetic shaft and a kit. Furthermore, a computing system, a digital storage medium, a computer program product as well as 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, encompassing the steps: determining geometric data or providing geometric data, wherein the geometric data will co-determine the shape of the limb stump at least at a first wearing timepoint of the prosthetic shaft, the inner shaft, the outer shaft, or of the extension; and either creating, based on the determined geometric data, the prosthetic shaft, the inner shaft 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, the outer shaft or the extension, wherein said creating takes place at a creation timepoint prior to the first wearing timepoint, and wherein the geometric data is not data measured on the patient.

2. The method according to claim 1, further encompassing the step of reading a pedometer or mobility sensor which records the steps or mobility of the patient.

3. The method according to claim 1, wherein the geometric data is predicted data, data of variable dimensions of the limb stump-fKSi, 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 timepoint of determining data or at the creation timepoint, and/or wherein the geometric data is not actual data and/or measured data of the patient.

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

5. The method according to claim 1, wherein the geometric data is or was collected by or using a device on a collective of patients, wherein the device is suitable and/or provided for use in manufacturing a plaster impression or creating a data model of the limb stump and comprises a pressure container with a pressure chamber for receiving pressurized fluid, preferably a liquid, wherein the pressure container comprises a wall made of a first material and a fluid-tight membrane made of a second material.

6. 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.

7. 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 timepoint and the first wearing timepoint.

8. 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 least at a second wearing timepoint which is after the first wearing timepoint, 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 timepoint and the second wearing timepoint.

9. 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 timepoint.

10. 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.

11. 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.

12. 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 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.

13. (canceled)

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

15. The kit according to claim 14, wherein at least a first element of the group was created based on the 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 the geometric data which co-determines the shape of the limb stump at the second time.

16. The kit according to claim 14, further comprising at least one further element of the group which consists of prosthetic shaft, inner shaft, outer shaft or at least one extension, wherein said further element is generated based on actual data and/or measured data which co-determines the shape of the limb stump at the timepoint of creation.

17. (canceled)

18. (canceled)

19. (canceled)

20. (canceled)

21. A method for creating a data collection, encompassing the following steps: providing a device for use in manufacturing a plaster impression or creating a data model of a limb stump-fKSi, comprising a container or pressure container having a pressure chamber for receiving pressurized fluid, preferably a liquid, wherein the pressure container comprises a wall made of a first material and a fluid-tight membrane made of a second material; providing a pressurization device and/or a pressurization control device for setting a pressure to prevail within the pressure chamber; measuring actual data of the limb stumps of a plurality of patients respectively at least at one measurement timepoint by or using the device; measuring actual data of the limb stumps respectively at least at one second measurement timepoint, which lies after the first measurement timepoint, by or using the device; associating patient data to both the actual data which was measured at the first measurement timepoint as well as to the actual data which was measured at least at the second measurement timepoint; classifying the actual data measured at the first measurement timepoint and the actual data measured at the second measurement timepoint based on the patient data associated therewith; saving and/or evaluating and/or further processing of the classified actual data, based on the classification thereof, in a suitable storage medium, for instance a database.

22. (canceled)

23. (canceled)

24. A set comprising a computing system programmed to carry out the method according to claim 1 ; and a device for use in manufacturing a plaster impression, or creating a data model, of the limb stump-fKSi, which comprises a container or a pressure container having a pressure chamber for receiving pressurized fluid, preferably a liquid, wherein the pressure container comprises a wall made of a first material and a fluid-tight membrane made of a second material.

25. The set according to claim 24, further comprising a pedometer or mobility sensor.

26. The set according to claim 24, wherein the computing system and the device are in signal communication with each other in order to transmit the actual data measured or collected by the device to the computing system, or are prepared, configured and/or programmed for this.

27. The set according to claim 24, wherein the computing system and the pedometer or mobility sensor are in signal communication with each other in order to transmit the data measured or collected by the pedometer or mobility sensor to the computing system, or are prepared, configured and/or programmed to be for this.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0219] 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:

[0220] 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;

[0221] FIG. 2 shows a cross-section of the thigh prosthesis of FIG. 1;

[0222] FIG. 3 shows an inner shaft according to the present invention as part of a thigh prosthesis in a longitudinal section, in which the thigh prosthesis is only partially shown;

[0223] FIG. 4 shows a cross-section of the thigh prosthesis of FIG. 3;

[0224] FIG. 5 shows an exemplary embodiment of the computing system according to the present invention;

[0225] FIG. 6 shows schematically a reference source for use in the method according to the present invention;

[0226] FIG. 7 shows a first embodiment from the side of a section of a longitudinally cut device or impression device used according to the present invention having a pressurization control device;

[0227] FIG. 8 shows a method according to the present invention 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, schematically simplified in an exemplary embodiment; and

[0228] FIG. 9 shows a method according to the present invention for creating a data collection, schematically simplified in an exemplary embodiment.

DETAILED DESCRIPTION

[0229] 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.

[0230] 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).

[0231] 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.

[0232] 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.

[0233] 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.

[0234] 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.

[0235] 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 manufacturing (that is, for example, at the creation timepoint).

[0236] It was not necessary to use of the extensions 12, 14, 20 on day of handing over the prosthesis with the outer shaft 4, nor would they 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 handing over (e.g., at the timepoint 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 timepoint). Up to a day, referred to herein as the first wearing timepoint, 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 their limb stump and the unchangeable shape of the outer shaft 4 of their prosthesis by inserting the extensions 12, 14, 20, which were determined for them while taking into account the changes of the shape (according to geometric data) of their limb stump expected in their case. In the present example, the patient has only to insert the extensions 12, 14 and 20 as already envisaged by the orthopedic technician at the determining timepoint and, if necessary, secure them against slipping within the prosthetic shaft 2. In this way, the patient can restore the desired accuracy of fit for their prosthesis without having to visit the orthopedic technician again and without expert knowledge.

[0237] FIG. 3 shows a second embodiment of the prosthetic shaft 2 in longitudinal section. FIG. 4 in turn shows a cross-section thereof.

[0238] Unlike what is shown in FIG. 1, the prosthetic shaft 2 comprises 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.

[0239] At the sites at which in the embodiment of FIGS. 1 and 2 extensions 12 and 14 were exemplarily 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 rigid 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 in FIG. 3 allows it to remain form-stable while still exerting the desired pressure on the thigh stump.

[0240] In this, the inner shaft 6a is, so to speak, a shaft from the retort: Its dimensions are not based on the actual dimensions or on dimensions that the orthopedic technician measured on the limb stump of the patient P in order to provide said patient P with a prosthesis. Rather, its dimensions are based on data predicted into the future or on geometric data with the expectation at the timepoint of the fitting that the limb stump would assume or adopt said predicted data or geometric data later and, hence, were determined before or at the creation timepoint.

[0241] In or according to the embodiment shown in FIGS. 3 and 4, it is thus 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 at, or starting from, the first wearing timepoint. It is assumed that the orthopedic technician fitted the patient with an inner shaft, not shown in the figures - which may likewise be part of the kit according to the present invention -, 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, at the first or at a later wearing time, by the inner shaft 6a, shown in FIGS. 3 and 4, while retaining the original outer shaft 4.

[0242] FIG. 5 shows a computing system 200 according to the present invention.

[0243] The computing system 200 optionally comprises a calculation device 210, a reference source 220 (for instance a database), an input device 230, an output device 240, a manufacturing machine 250 and/or a step counter or mobility sensor 260, respectively. The aforementioned units 220, 230, 240, 250 and 260 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.

[0244] 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 creation timepoint, optionally supplemented by other data or patient data such as the age, weight, mobility classification (1 to 4), physical activity, etc. of the patient P, which may optionally be entered via the input device 230, by simply associating this data with empirical values of already provided geometric data, which the limb stump KS of the patient is likely to assume at certain times in the future (referred to herein as wearing timepoints) may be output. The output may be done via 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 sections or parts thereof, can be produced or manufactured 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.

[0245] FIG. 6 shows an example of how measured actual data (optionally in connection with patient data) of a collective is used to determine geometric data of the specific patient P.

[0246] Shown on the left in FIG. 6, a limb stump KS, of the patient P, only partially represented, may, when measured, have the measurement results shown in the table on the right in FIG. 6. Column B shows the measurement results determined on the limb stump KS of patient P and indicates the respective measured circumference (in cm) at a distance of e.g. 6 cm, 9 cm and 12 cm from a predetermined reference point or reference cross-section (column A). The values of column B are also considered herein to be actual data of patient P. They were measured at the positions of the limb stump KS indicated in column A prior to manufacturing the prosthetic shaft 2, preferably with the herein disclosed impression device or device 100, as shown for example in FIG. 7 or disclosed herein.

[0247] When examining a plurality of patients of a collective with comparable limb stumps and/or comparable patient data, e.g. before the start of the method according to the present invention for creating and/or in the course of the method for creating a data collection, there were values measured, i.e. actual data was determined on the collective, which - here exemplarily - indicates the cross-sections of the limb stump, e.g. 6 cm, 9 cm and 12 cm, at later, defined wearing timepoints, at which preferably measurements were taken again by the impression device - or by an identically constructed type of device. They are indications or clues of what the limb stump KS of patient P will probably look like at the reference points or reference cross sections mentioned in column A at later wearing timepoints. Thus, the numerical values in column C, for example, indicate which circumference values will be present at the positions named in column A at a first wearing timepoint, for example 3 months after the timepoint of creation of the prosthesis, since there were similar values present in the collective; if necessary, they are actual data determined on the collective, alternatively related to the limb stump KS of the patient P. Thus, said numerical values in column C preferably indicate which measured values the limb stump KS of patient P would presumably assume, since these measured values have already applied to a sufficiently large collective, for instance by reflecting the changes of the measured values over three months - preferably each determined by or using the impression device - being observed in the collective and, if necessary, have already been determined after having been mathematically adjusted to the measured actual data of patient P.

[0248] 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 timepoint, for example after about 6 months.

[0249] FIG. 6 shows, in other words, 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 timepoint of determination) has the values of column B at the positions specified in column A, will according to assumption or experience have at the, herein exemplarily considered, first and second wearing timepoints, namely the values of columns C and D. Reading them out may represent a determination in the sense of the present invention.

[0250] If patient P is a diabetic (as an example for the patient data), the values in columns C and D could already be determined from a collective that also consisted of diabetics. According to the inventor’s experience, their limb stumps regularly change more slowly between different measurement timepoints than it is the case in patients who, have lost e.g. their lower leg in an accident. If patient P were an athlete, columns C and D might show different values.

[0251] 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 different, in particular greater.

[0252] FIG. 6 serves as an example. The present invention is not limited to considering the circumference as a measured or determined geometric datum. The use of other actual data and patient data is, additionally or alternatively, in combination with each other or alone, likewise encompassed by the present invention.

[0253] Instead of taking them from a reference source, geometric data may, according to the present invention, be determined based on a provided set of data at the moment of determination.

[0254] 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 present 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.

[0255] FIG. 7 shows an impression device or device 100 (both terms may designate the same device, i.e. they are interchangeable herein) cut longitudinally or in the longitudinal direction (i.e. with reference to FIG. 7 from top to bottom), which device 100 may be used according to the present invention, wherein said device 100 is shown in an exemplary embodiment e.g. of the method for manufacturing or for the planning of manufacturing and/or in an exemplary embodiment of the method for creating a data collection.

[0256] The device 100 comprises at least one pressure container 31, which in turn comprises or, consists of, a wall 33 and a membrane 35.

[0257] The pressure container 31, which may be purely optionally cylindrical as shown in FIG. 7, optionally comprises a first end face 32 (top in FIG. 7) and a second end face 34 (bottom in FIG. 7). In the exemplary embodiment of FIG. 7, the second end face 34 is fluid-tight sealed from an exterior Ä by a bottom plate or bottom surface 34a. The bottom surface 34a may be made of the same material as the wall 33.

[0258] The membrane 35 separates a fluid chamber or pressure chamber DK of the pressure container 31 fluid-tight from an exterior of the fluid chamber or pressure chamber DK, or for example from the exterior Ä, i.e. an environment of the pressure container 31, or, as shown in FIG. 7, from a limb stump KS introduced in or surrounded by the membrane 35.

[0259] The membrane 35 may be fluid-tight connected to the pressure container 31 at an upper edge 37 of the wall 33 which is often ring-shaped, rectangular, square or differently circumferential, or at another site.

[0260] The upper edge 37 lies here exemplarily in a plane in which an insertion opening 39 of the pressure container 31 lies, or delimits this on its circumference. The insertion opening 39 lies in the plane indicated by the dashed line.

[0261] The insertion opening 39 serves for inserting the limb stump KS, which is wrapped in a moist plaster bandage, into an interior I of the pressure container 31.

[0262] The interior I is the volume of the pressure container 31 delimited by the wall 33. It extends from the second end face 34, which is sealed fluid-tight with the bottom surface 34a, to the insertion opening, designated with reference numeral 39 and indicated by a dashed line.

[0263] The pressure chamber DK is filled with a fluid, here exemplarily with a liquid F indicated by dots. A filling with gas is also contemplated by the present invention.

[0264] In FIG. 7, the device 100 is shown in a state in which the extremely schematically indicated limb stump KS of the standing patient is inserted into the interior I such that it is, at least in its distal section, surrounded by the membrane 35. The membrane 35 rests against the plaster bandage on the limb stump KS like a second skin, wherein further layers such as liners or similar may be provided between the plaster bandage and the membrane 35.

[0265] The limb stump KS is preferably loaded with the full body weight of the standing patient. Knowing the volume of the interior I or of the pressure container 31, the amount of liquid F is preferably dimensioned such that the limb stump KS may enter the pressure container 31 through the insertion opening 39 at least to such a depth that the entire surface of the plaster bandage, however though as far as it is relevant for the impression, is in contact with the membrane 35. At the same time, the amount of liquid F is dimensioned such that the distal end of the limb stump KS (bottom of FIG. 7) preferably does not touch or rest on the bottom of the pressure container 31. This ensures that it is the pressure of the fluid on which the patient rests with the inserted limb and that the plaster bandage experiences the same pressure at every point by the membrane 35.

[0266] It can be seen from FIG. 7 that when no limb stump KS is inserted into the pressure container 31, the membrane 35 floats or raises due to the pressure of the fluid, here the liquid, and a liquid level, not shown in FIG. 7, is reached. The shape of the membrane 35 shown in FIG. 7 thus represents that shape which the membrane 35 assumes under load when it rests against the inserted limb stump KS and is “carried along” by the latter - in the example of FIG. 7 - into the depth of the interior I in the direction of the bottom surface 4a.

[0267] It can also be seen from the figure that by preventing fluid exchange between the pressure chamber DK and the exterior Ä or by preventing fluid from escaping from the pressure chamber DK, the wall 33 and the membrane 35 enable the desired pressure builds up within the pressure chamber DK of the pressure container 31, but cannot escape from it or degrade or decrease.

[0268] As can be seen in FIG. 7, the pressure chamber DK is thus formed by the membrane 35 and by at least parts of the wall 33, to which here the bottom surface 34a of the end face 34 is also included.

[0269] In embodiments of the present invention other than the exemplary embodiment shown in FIG. 7, the pressure chamber DK may consist of or comprise a membrane closed all around, which may similar to a balloon or bladder lie in the interior I of the pressure container 31.

[0270] The same applies for the pressure container 31 shown in FIG. 7 or in one of the following figures as well as for the pressure container of any other embodiment according to the present invention, that it may comprise a non-circular, preferably an angular, cross-section instead of a circular cross-section. The cross-section may be e.g. rectangular, polygonal or square. The latter cross-sections may advantageously avoid or reduce artifacts that may be caused by the curved circumferential surface, in particular when measuring the limb stump KS inserted into the device 100 automatically, using a camera or similar as described herein.

[0271] The membrane 35 is optionally force-fit connected to a section 351 of the wall 33 or the end face 34, preferably in its distal middle or central section or area. In the embodiment shown in FIG. 7, the force-fit connection is effected by an optional connector 353, which extends from a distal end of the membrane 35 to the section 351, here purely optionally the bottom surface 34a of the pressure chamber DK.

[0272] The connector 353 may be a thread, as exemplarily shown in FIG. 7. Any other suitable connector, such as a tape, Velcro or similar, is also encompassed by the present invention.

[0273] The connector 353 holds the membrane 35 in a force-fit and/or form-fit and/or material-bond connection to the pressure container 31 or to the bottom surface 34a, preferably in the region of the second end face 34 of the pressure container 31, in particular in the region of the bottom surface 34a and preferably in the middle or center thereof.

[0274] It is preferred that the connector 353, at least when the device 100 is in use, i.e. with the limb stump KS inserted into the pressure chamber DK, allows flow around the distal end of the limb stump KS completely or substantially completely. A flow around the limb stump KS is thus advantageously still possible in FIG. 7 except for the area corresponding to the cross-section of the connector 353. In this way, buoyancy or the pressurization of the distal section of the limb stump KS, which is very important for readjusting or recreating the subsequent load situation in the finished shaft, may also take place by the fluid in an unchanged manner.

[0275] In addition to the optional connector 353 shown in FIG. 7, several or additional connectors may be provided. These may be connected to the bottom surface 34a like the connector 353. They may alternatively or additionally be connected to the pressure chamber DK or the pressure container 31 at a section of the wall 33 being different than the end face or bottom surface 34a. This also applies to the connector 353 shown in FIG. 7.

[0276] The connection between connector 353 on the one hand and wall 33 or bottom surface 34a on the other hand may - such as, independently therefrom, the connection between connector 353 on the one hand and membrane 35 on the other hand - be an adhesive connection, a screw connection, a plug-in connection, a snap-in connection, a latching connection or similar. It may be releasable or non-releasable.

[0277] The connector shown in FIG. 7 is preferably not elastically stretchable. It is preferably not stretchable.

[0278] The membrane 35 shown in FIG. 7 is also preferably non-stretchable and/or non-elastic in the longitudinal direction L.

[0279] In certain embodiments, “non-stretchable” or “non-elastic” means that the Young’s modulus of the relevant component (connector, membrane, fibers, etc.) is at least above 700 N/mm.sup.2, preferably above 1000 N/mm.sup.2, more preferably above 2000 N/mm.sup.2.

[0280] In some embodiments, “non-stretchable” or “non-elastic” means that an elongation of the relevant component (connector, membrane, fibers, etc.) may not exceed 20%, preferably not more than 10%, preferably not more than 5%, more preferably not more than 2% of its length before the component tears or breaks.

[0281] The medical device 100 is preferably connected to a pressurization control device 410. The pressurization control device 410 is hereinafter abbreviated as the control device 410. It may be designed to regulate the pressure.

[0282] The control device 410 comprises a pressure reservoir connector 413, which may be designed as a connection to a pressure source, e.g. to a water line. Furthermore, in the embodiment shown here, the control device 410 comprises a separate discharge connector 415 for emptying the fluid from the pressure chamber DK. The discharge could alternatively take place e.g. via a multi-way valve which may be connected to the pressure reservoir connector 413.

[0283] The control device 410 of FIG. 37 further comprises an optional pressure-control valve arranged within the control device 401 (not shown in FIG. 7). The pressure-control valve may limit the pressure prevailing in the pressure reservoir connector 413, so that the pressure applied downstream of the pressure-control valve does not exceed a predeterminable value or a value optionally adjustable by the user. As a result, an excessively high pressure in the pressure chamber DK may advantageously be avoided or prevented, which, for example, might cause an excessive pressure load on the limb stump KS, and thus could cause damage and/or pain, as well as a distortion of the plaster impression. The pressure-control valve may purely exemplarily limit the pressure to max. 0.8 bar (800 hPa).

[0284] The control device 410 optionally further comprises a pressure chamber connection 417, which is connected to, or comprises, e.g. a regulating valve 419 for increasing the pressure in the pressure chamber DK. When the regulating valve 419 is actuated, e.g. manually, it can increase the pressure in the pressure chamber DK, e.g. gradually, up to a desired pressure or to the maximum pressure which is limited by the pressure-control valve.

[0285] Furthermore, the control device 410 optionally comprises a pressure chamber backflow connector 421, which is connected to, or comprises an additional regulating valve 423 for reducing pressure in the pressure chamber DK. When the additional regulating valve 423 is actuated, e.g. manually, it can reduce the pressure in the pressure chamber DK, e.g. gradually, as required. Once the manufacturing of the plaster impression has been completed, i.e. after a predetermined drying or curing time, the pressure in the pressure chamber DK can be reduced to the point where the patient may pull the limb stump KS out of the device 100.

[0286] In the illustrated embodiment, the control device 410 further comprises an optional inlet pressure display 425 and a likewise optional shutdown device 427. The inlet pressure display 425 may be referred to as a manometer and may be provided as an additional display, for example as a safety display or redundancy arrangement for monitoring the pressure in the pressure chamber DK. The inlet pressure display 425 is arranged, e.g., with, or in, a connection line in the control device 410 between the regulating valve 419 (for the pressure increase in the pressure chamber DK) and the pressure chamber connection 417.

[0287] Emptying the pressure chamber DK using the pressure chamber backflow connector 421 and the outlet connection 415, controlled by the additional regulating valve 423, may be effected in various ways. For example, a suction pump may be connected - for example downstream of the discharge connection 415 - which, when the additional regulating valve 423 is opened, sucks fluid F from the pressure chamber DK and, if necessary, until empty. Likewise, an optional venturi nozzle or a Venturi tube for sucking or draining the fluid F from the pressure chamber DK may be connected or is connected, for example, downstream of the discharge connector 415. A Venturi nozzle may, for example, be connected to an external water connection, for example to a water tap on a washbasin. If the water tap is opened and water flows through the optional Venturi nozzle, a vacuum is generated in a line connected to the outlet connection 415, and fluid F, with the additional regulating valve 423 being open, is sucked. A Venturi nozzle advantageously does not require any electrical connection, as would for example be necessary for a suction pump.

[0288] The exemplary embodiment of the control device 410 described here, advantageously does not require any electrical components and thus no power supply and no power connection. Embodiments which differ to this are likewise encompassed by the present invention.

[0289] In embodiments of the present invention other than those described herein, the pressurization control device 410 is a device for applying pressure to a fluid reservoir, for instance a supply reservoir.

[0290] For this purpose, it is contemplated to provide, e.g., a mechanical or hydraulic pressing device by which the fluid may be discharged from a supply reservoir or from the pressurization control device 410 under a desired pressure or in any case a sufficient pressure.

[0291] Such a mechanism may include a crank mechanism, a pressing or clamping mechanism having clamping surfaces, a foot actuating device the construction of which corresponds or is similar to a bellows or to a bicycle pump. Using such a pressurization control device 410, the required pressure may be achieved on the one hand, the user of the device 100 according to the present invention is on the other hand not dependent on external pressure sources, such as water connections or similar.

[0292] The pressurization control device 410 may be operated electrically. However, this is not required. It can be provided to be able to operate without power supply.

[0293] FIG. 8 shows the method according to the present invention for manufacturing or planning the manufacturing of a prosthetic shaft 2, an inner shaft 6 and/or an outer shaft 4 and/or an extension 12, 14, 20 of the prosthetic shaft 2, schematically simplified in an exemplary embodiment. The prosthetic shaft is provided in order to receive a limb stump KS (see FIG. 7).

[0294] The method according to the present invention encompasses determining data, in particular geometric data, or providing data, in particular geometric data. In this, preferably such data is determined, in particular geometric data, which will describe, determine or co-determine the shape of the limb stump KS at least at one timepoint in the future. Preferably, data is hereby determined which, at least at the first wearing timepoint, should co-determine or define the shape of the prosthetic shaft 2, the inner shaft 6 or the outer shaft 4 or of the extension(s) 12, 14, 20 (or the shape which these should then have). The data or geometric data may be predicted values or measurements, estimated values or expected values, in particular about future shapes. The data or geometric data may have been created based on measurements done on the collective or may be derived based thereon as disclosed herein. The measurements on the collective may have been collected using the device or impression device disclosed herein, see e.g. FIG. 7.

[0295] The method optionally further encompasses manufacturing the prosthetic shaft 2 or sections thereof as method step F2. This is done based on the determined data and/or geometric data.

[0296] Alternatively or in addition to the aforementioned manufacturing of the prosthetic shaft 2 or sections thereof, the method encompasses as step F3 creating at least one control signal, in particular creating a control file with control signals, based on which a manufacturing machine may (e.g. directly or indirectly) perform steps for manufacturing the prosthetic shaft 2, the inner shaft or outer shaft or the extension 12, 14, 20 and/or create at least one of the aforementioned devices or parts thereof.

[0297] Thereby, the timepoint of creation (also: creation timepoint) is preferably earlier than the first wearing timepoint.

[0298] FIG. 9 shows the method according to the present invention for creating a data collection or for collecting measurements of the limp stump schematically simplified in an exemplary embodiment.

[0299] The method for creating a data collection according to the present invention encompasses as step S1 providing a device 100 for example the impression device disclosed herein for use in manufacturing a plaster impression or creating a data model of a limb stump KS. The device 100 comprises a container or pressure container 31 having a pressure chamber DK for receiving pressurized fluid F, preferably a liquid (see FIG. 7). The pressure container 31 comprises a wall 33 made of a first material and a fluid-tight membrane 35 made of a second material.

[0300] As an optional step S2, the method according to the present invention encompasses providing a pressurization device and/or a pressurization control device 410 for setting, effecting and/or maintaining a pressure prevailing within the pressure chamber DK.

[0301] Step S3 of the method according to the present invention is a measuring of actual data of the limb stumps KS, preferably at always the same, predetermined positions, circumferences or sites of or on the limb stumps, of a plurality of patients or a collective of patients. The measuring is carried out, respectively, at least at one first measurement timepoint by the device 100. Measuring on the collective of patients may hereby be done using the device 100, by a measuring device contained in or connected to said device 100 or by hand. The measurement may be done directly, e.g., on the limb stump of the patients of the collective, and/or indirectly, e.g., on positive or negative models, impressions, plaster impressions, or prosthetic shafts, etc., being respectively created by the device 100 or geometric data obtained therewith for the patients of the collective.

[0302] The measuring of actual data of the limb stumps, respectively, at least at one second measurement timepoint, which lies after the first measurement timepoint, is encompassed as a further step S4 by the method according to the present invention. The measuring is carried out here preferably also by the device 100, or as indicated above, and preferably at the same positions or sites of the limb stump just like the measuring carried out at the first measurement timepoint.

[0303] As step S5, the method optionally encompasses a determination or an association of patient data to the measured actual data of the patient collective which was measured at the first measurement timepoint or at the second measurement timepoint. The measured actual data, which was measured at the at least two measurement timepoints, is thus associated to the same patient data, respectively.

[0304] A subsequent classification of the actual data measured at least at the first measurement timepoint and the actual data measured at least at the second measurement timepoint based on the patient data associated to them is also encompassed as a further optional step S6 by the method according to the present invention.

[0305] In a step S7 of the method according to the present invention for creating a data collection, the classified actual data is stored, based on its classification, in a suitable storage medium, such as a database, e.g. in order to be able to (re)access it within the scope of the method according to the present invention for manufacturing or planning the manufacturing of a prosthetic shaft 2, inner shaft 6, outer shaft 4 and/or of an extension 12, 14, 20 of the prosthetic shaft (see also FIG. 8). Alternatively or additionally, the data can be evaluated and/or further processed by suitable devices.

TABLE-US-00001 List of reference numerals 2 prosthetic shaft 4 outer shaft 5 inlet opening 6 inner shaft 7 slot 8 distal end of the outer shaft 10 column-like or columnar component 12 extension 14 extension 18 wall 20 extension 22 edge 24 femur 26 empty space 28 empty space 31 pressure container 32 first end face 33 wall 34 second end face, may optionally be closed or sealed with the base surface 34a base surface 35 membrane 37 upper edge 39 insertion opening 100 device 200 computing system 210 calculation device 220 reference source 230 input device 240 output device 250 manufacturing machine 260 pedometer or mobility sensor 351 lower section of the wall 353 connector 410 pressurization control device pressurization device 413 pressure reservoir connector 415 discharge connector 417 pressure chamber connector 419 regulating valve 421 pressure chamber backflow connector 423 additional regulating valve 425 inlet pressure display 427 emergency stop device Ä exterior of the pressure container DK pressure chamber of the pressure container F fluid or liquid I interior of the pressure container KS limb stump L longitudinal direction