DE102021130707A1 - Process for producing production data and for producing a prosthesis liner - Google Patents

Abstract

The invention relates to a method for producing production data for producing a prosthesis liner, the prosthesis liner having an inner surface (12) for contact with an amputation stump (2) and an outer surface (14) for contact with a prosthesis socket (10), the method being as follows Having steps: providing inner data describing the inner surface (12), the inner surface (12) being adapted to a surface of the amputation stump (2), providing outer data describing the outer surface (14), the Outer surface (14) is adapted to an inner wall of the prosthesis socket (10), calculating 3D data of the prosthesis liner from the inner data and the outer data and creating production data from the calculated 3D data.

Description

The invention relates to a method for producing production data for producing a prosthetic liner. The invention also relates to a method for producing a prosthetic liner.

Prosthetic liners have been known from the prior art for a long time and are preferably, but not exclusively, used for leg prostheses and arm prostheses. The prosthesis liner is first arranged on the amputation stump, preferably rolled onto it and lies tightly against the amputation stump. The prosthesis liner is preferably made of an elastic material and adapts to the shape of the amputation stump. The amputation stump with the prosthesis liner arranged thereon is then inserted into the prosthesis socket. The prosthesis socket is then attached to the liner and/or to the amputation stump, for which various methods are known from the prior art.

The prosthetic socket represents the connection to the rest of the prosthesis, for example a prosthetic knee joint or a prosthetic foot, and is preferably made of carbon fiber composite material. In the case of leg prostheses in particular, the prosthesis shaft is exposed to strong mechanical loads, which also applies to the amputation stump. In order to avoid pressure points and pain here, it makes sense and is important to adapt the prosthesis socket individually to the amputation stump. As a rule, a prosthesis socket is therefore a one-off piece that has been manufactured individually for the respective patient. The prosthesis liner, on the other hand, is used as a standard product in many cases, since it does not have to be manufactured as precisely and individually due to its elastic properties and adapts to the shape of the amputation stump. Optionally, inserts and padding are used, which can be placed on the inner surface or the outer surface of the prosthetic liner.

The prosthesis liner has an inner surface that is in contact with the amputation stump when it is in place and is therefore designed to be placed on this amputation stump. When the liner is in place, the inner surface of the liner ideally corresponds to the outer surface of the amputation stump. The outer surface of the prosthesis liner opposite the inner surface comes into contact with the prosthesis socket when it is in place.

An amputation stump is subject to changes over the years, which are particularly pronounced in the first few years, for example after an amputation caused by an accident. In particular, there is a weight loss of the amputation stump and a regression of the muscle tissue. Both lead to the volume of the amputation stump shrinking in particular. In this case, the prosthesis socket is no longer optimally adapted to the amputation stump.

The object of the invention is to remedy this situation.

• - Bereitstellen von Innendaten, durch die die Innenfläche beschrieben wird, wobei die Innenfläche an die Oberfläche des Amputationsstumpfes angepasst ist,
• - Bereitstellen von Außendaten, durch die die Außenfläche beschrieben wird, wobei die Außenfläche an eine Innenwandung des Prothesenschaftes angepasst ist,
• - Berechnen von 3-D-Daten des Prothesenliners aus den Innendaten und den Außendaten und
• - Erstellen von Produktionsdaten aus den berechneten 3-D-Daten.

The invention solves the problem set by a method for producing production data for producing a prosthesis liner, the prosthesis liner having an inner surface for contact with an amputation stump and an outer surface for contact with a prosthesis socket, the method having the following steps:

• - Provision of internal data describing the internal surface, the internal surface being adapted to the surface of the amputation stump,
• - Providing external data that describes the outer surface, the outer surface being adapted to an inner wall of the prosthesis socket,
• - Calculation of 3-D data of the prosthesis liner from the inside data and the outside data and
• - Creation of production data from the calculated 3D data.

The invention is based on the finding that if the fit between the amputation stump and the prosthesis socket is no longer optimal, it does not have to be necessary to produce a new, costly prosthesis socket in a time-consuming manner, but that it may be sufficient to produce a prosthesis liner that is individually manufactured and adapted to the changed geometric situation . This is produced on the basis of production data, which can be designed differently depending on the production process and can contain different information. Irrespective of this, each manufacturing process requires production data in one form or another.

In the method according to the present invention, inside data and outside data are provided. This can happen simultaneously or sequentially. The inner data are suitable for describing the inner surface of the prosthetic liner to be manufactured. The external data, on the other hand, are suitable for describing the outer surface of the prosthesis liner. To describe the inner surface or the outer surface, the respective inner data or outer data can contain a parameterization of the respective surface. This can be in the form of a functional representation of the area, for example che or in the form of a point cloud. In a point cloud, the corresponding coordinates are assigned to as many points as possible in the respective area in a previously defined coordinate system. The surface itself can then be restored by interpolation or, in the simplest case, by simply connecting the various points with a straight line. The thickness of the liner at the respective point also results from the inner surface and the outer surface. In order to relate the inside data to the outside data and, for example, to position and/or orient them relative to one another, at least one reference point is preferably used. Multiple reference points are particularly preferably used. A reference point is preferably understood to mean a point that is contained both in the internal data and in the external data. It does not have to be a part of the liner. A reference point is preferably outside the liner.

The inner data describe the inner surface of the prosthetic liner to be manufactured. According to the invention, they are adapted to the surface of the amputation stump. This means that the inner surface of the prosthesis liner is designed in such a way that when the prosthesis liner is in place, at least 80%, preferably at least 90%, particularly preferably at least 95% of the inner surface of the prosthesis liner is in contact with the amputation stump of the wearer of the prosthesis. In the ideal case, 100% of the inner surface of the prosthesis liner is in contact with the surface of the amputation stump, i.e. in particular with the skin of the wearer. In the case of standard liners that are not individually adapted, there are deviations, especially in the case of special amputation stumps, for example with extensive scar tissue, ie for example areas in which the inner surface of such a standard liner is not in contact with the surface of the stump. In this case, these areas are reduced or even completely avoided by the individually shaped inner surface according to the invention.

The outer data describe the outer surface of the prosthetic liner to be manufactured. This means that the outer surface of the prosthesis liner is designed in such a way that when the prosthesis socket is in place, at least 80%, preferably at least 90%, particularly preferably at least 95% of the outer surface of the prosthesis liner, which is inside the prosthesis socket, is on the inner wall of the prosthesis socket wearer of the prosthesis. In a preferred case, 100% of this outer surface of the prosthesis liner is in contact with the inner wall of the prosthesis socket. As a rule, a liner protrudes proximally beyond the prosthesis socket. This part of the liner is not meant and not taken into account in the percentages given here. This is the part of the liner that is inside the prosthesis socket when the prosthesis is in place, i.e. between the amputation stump and the prosthesis socket.

In the method according to the invention, a set of 3D data is calculated from the internal data and the external data, which can preferably be used to describe the prosthetic liner. In a particularly simple embodiment, the interior data and the exterior data are in the form of parameters of different points that describe the respective interior surface or exterior surface, the parameters for both surfaces being in the same coordinate system. This can be achieved, for example, in that both the interior data and the exterior data have a common element, for example a common point, relative to which all other points and coordinates can be expressed. As a result, the two possibly different coordinates for systems of the interior data and the exterior data can be converted into a common coordinate system. Once this is done, the area between the interior surface described by the interior data and the exterior surface described by the exterior data is parameterized. In this way, a particularly simple form of 3D data can be achieved.

The interior data and the exterior data can also be merged into the 3D data by recognizing prominent points and/or areas and then overlapping them. The inner wall of the prosthesis socket is usually adapted or at least has been adapted to the amputation stump. In particular, special areas where there are, for example, prominent bony protrusions, particularly firm scar tissue or other prominent points or areas on the amputation stump have a correspondence in this case on the inner wall of the prosthesis socket and thus also in the external data. Such elements may be referred to as "distinctive points", although they may be extended areas and not points in the mathematical sense.

The elements on the amputation stump that have led to the prominent points on the inner wall of the prosthesis socket are preferably such that they are subject to little, particularly preferably no, significant change over time. Bony prominences or scarred tissue in particular will not change in size or position. This means that these elements also lead to prominent points in the interior data. To now the To bring indoor data and outdoor data together to form the 3D data, the prominent points in the indoor data and the prominent points in the outdoor data can be recognized and identified. They are then overlapped in such a way that the distinctive points of the interior data are opposite the distinctive points of the exterior data in the 3D data. So they are only separated from each other by the distance of the wall thickness in this area. There are preferably several, particularly preferably more than three, distinctive points that are present both in the interior data and in the exterior data.

The 3-D data contains in particular information about how the prosthesis liner is structured, for example which wall thickness is present at which point, which material should be used, whether and if so which additives and supplements are present, whether and if so which reinforcing elements, such as fibers, are to be used and/or whether other elements, for example electrically conductive elements in the form of electrical conductors and/or electrodes, are to be built into the liner.

On the basis of this 3D data, the production data are then produced, which are preferably suitable for controlling a production system on which the prosthetic liner is to be produced, or are at least able to provide the necessary operating parameters for this.

In a preferred embodiment of the method, the surface of the amputation stump is scanned and the internal data are generated from the internal scan data generated in the process. This can be done with a stationary scanner or with a mobile hand-held scanner. For example, the surface is irradiated with scanning radiation, for example visible light or UV light, and the reflected radiation is captured by the scanner. Other scanning methods are known to those skilled in the art and can be used here. Typically, the interior perimeter, which can be calculated and determined from the interior scan data, is reduced to generate the interior data. In this way it is ensured that the liner has to be elastically widened when it is placed on the amputation stump and thus develops the desired compression effect on the amputation stump.

In a preferred embodiment of the method, an inner wall or an outer wall of the prosthesis socket is scanned and the external data are generated from the external scan data generated in the process. This can also be done with a stationary scanner or with a mobile hand-held scanner. The scanning of the outer wall of the prosthesis socket is preferably sufficient if the thickness of the prosthesis socket is known, so that the inner wall of the prosthesis socket can be deduced from the outer wall.

There are preferably predetermined points at which the inner surface is not adapted to the surface of the amputation stump and/or the outer surface is not adapted to the inner wall of the prosthesis socket. These points can be relief points, for example, where contact between the amputation stump and the prosthesis socket is to be avoided, for example due to a particular sensitivity of the amputation stump at this point. As an alternative to this, the points can also be contact pressure points at which a particularly large load is to be transferred from the amputation stump to the prosthesis socket. These points are preferably marked in the internal data and/or the external data. Pressure points can also be referred to as load application points.

As already explained, individually manufactured prosthesis liners are used and required, for example, when an individually adapted prosthesis socket no longer fits precisely due to changes in the volume of the amputation stump. In this case, in particular, there is consequently a previous example of the prosthesis liner, which can be manufactured individually or can be a standard product. 3-D data and/or production data of this previous example are preferably known and are stored and stored, for example, in an electronic data storage device that can be accessed by an electrical controller, in particular an electronic data processing device. The prosthetic liner is preferably a replacement for a previous example and the 3D data is at least also calculated from the 3D data and/or the production data of the previous example.

The external data provided is particularly preferably the external data of the previous example. In this case, it is no longer necessary to scan the prosthesis socket and its inside, which saves a possibly time-consuming work step.

When calculating the 3D data, a difference between the interior data provided and the interior data of the previous example is advantageously calculated.

The invention also solves the problem set by a device for carrying out a method described here for producing production data for producing a prosthesis senliners. This device has an electronic data processing device which has a calculation unit in which the 3-D data are calculated from the interior data provided and the exterior data. It also has a production unit that is set up to produce the production data from the calculated 3D data. The electronic data processing device is preferably connected to an electronic data memory in such a way that it can access data stored in the data memory. The internal data and/or the external data are particularly preferably stored in the electronic data memory and queried by the electronic data processing device, in particular the calculation unit, if required. In addition or as an alternative to this, the device has an input module via which internal data and/or external data can be made available to the electronic data processing unit of the device. This can be a drive for a data carrier, an interface for communication with another device, for example a USB interface, a wireless communication interface such as WLAN or Bluetooth, or an input device with which a user can enter data and information.

• - Erstellen von Produktionsdaten nach einem Verfahren der hier beschriebenen Art,
• - Herstellen des Prothesenliners mittels der hergestellten Produktionsdaten.

The invention also achieves the object set by a method for producing a prosthesis liner, the prosthesis liner having an inner surface for contact with an amputation stump and an outer surface for contact with a prosthesis socket, the method having the following steps:

• - Creation of production data using a method of the type described here,
• - Manufacture of the prosthesis liner using the manufactured production data.

The prosthetic liner is preferably produced at least partially in an additive manufacturing process using at least one additive manufacturing system, for example a 3D printer. The production data preferably also contain at least the operating parameters of the at least one additive manufacturing system.

The production data preferably contain further information which, for example, contain the materials to be used. Different materials, different additives, different reinforcements and/or different electrical or electronic components can be used at different points and/or in different areas of the prosthesis liner. All of this information is preferably contained in the production data. The production data has particularly preferably already been produced in a format that makes it possible to read the production data directly into an electronic data memory of the production facility and to use them to produce the prosthetic liner without post-processing or formatting of the data being necessary.

• 1 - die schematische Darstellung eines versorgten Amputationsstumpfes,
• 2 - die schematische Darstellung eines sich verändernden Amputationsstumpfes,
• 3 - die schematische Darstellung eines alten Liners,
• 4 - die schematische Darstellung eines Prothesenschaftes und
• 5 - die schematische Darstellung des veränderten versorgten Amputationsstumpfes.

An exemplary embodiment of the present invention is explained in more detail below with the aid of the attached figures. Show it:

• 1 - the schematic representation of a treated amputation stump,
• 2 - the schematic representation of a changing amputation stump,
• 3 - the schematic representation of an old liner,
• 4 - the schematic representation of a prosthetic socket and
• 5 - the schematic representation of the modified treated amputation stump.

1 shows schematically a supplied amputation stump 2, which has an indentation 4. There is a liner 6 around the amputation stump 2, which is shown as a dashed line. It encloses the amputation stump 2 and has a thickening 8 at its indentation 4, where the liner 6 has a particularly thick wall. The amputation stump 2 with the liner 6 arranged thereon is arranged in a prosthesis socket 10, which is represented by the thin solid line. It can be seen that the liner 6 fills the gap between the amputation stump 2 and the prosthesis socket 6 and an inner surface 12 is adapted to the surface of the amputation stump 4 and an outer surface 14 to the inner wall of the prosthesis socket 10 . This is different at 2 contact pressure points 16 . There the liner 6 is squeezed through the inwardly projecting wall of the prosthesis socket 10 . There is stronger contact and higher pressure on the amputation stump 2 so that forces are transmitted particularly strongly from the amputation stump 2 to the prosthesis socket 10 at these points.

2 shows amputation stump 2 on the left 1 . In the right part of 2 the situation is shown that the amputation stump 2 has changed over time. It has lost volume, especially in the distal area, and further deviations in shape can be seen. This can lead to the amputation stump 2 no longer being optimally positioned in the prosthesis socket 10 and the prosthesis socket 10 slipping too far proximally, for example. thereby become the contact pressure points 16 are no longer optimally positioned on the amputation stump 2 either

A new liner 6 is to be manufactured. According to the invention, internal data describing the inner surface 12 must be provided for this. In addition, exterior data describing the exterior surface 14 must be provided. In 3 the liner 6 is off 1 shown. In 4 the prosthetic socket 10 is off 1 shown with the marked contact pressure points 16. To provide the internal data, for example, the amputation stump 2 in its new modified form, as shown in the right part of the 2 is shown to be scanned. Is also the amputation stump 2 in its original form, as shown in the left part of the 2 is shown, has been scanned, the interior data can be provided from the differences between the two scanned data. As an alternative or in addition, the amputation stump 2 in its newly modified form and the inner surface 12 of the liner 6 can also be measured, for example scanned. However, it must be taken into account that the inner surface 12 of the liner 6 corresponds to the surface of the amputation stump 2 in its original form when it is in place.

In order to provide the external data, it is possible, for example, to position the outer surface 14 of the liner 6 or the inner wall of the prosthesis socket 10 . In the latter case, the positions of the contact pressure points 6 are preferably also recorded.

According to the invention, 3D data of the prosthesis liner are then calculated from the internal data and the external data and the production data are then created from these. 5 shows the result. The new liner 6 with the inner surface 12 and the outer surface 6 is shown in the right part. You can see when comparing the 3 and 5 that the new liner 6 out 5 in particular has a significantly modified inner surface 12 in order to take the modified volume of the amputation stump 2 into account. It should be noted, however, that the changes and the individual structural elements and features of the amputation stump 2, liner 6 and prosthesis socket 10 are shown in the figures shown here in a greatly exaggerated manner for reasons of better clarity.

In the left part of the 5 is like in 1 the provided amputation stump 2 with the indentation 4 can be seen, which is positioned in the liner 6 with the thickening 8 . The prosthesis socket 10 again has the two contact points 16.

Reference List

2

amputation stump

4

indentation

6

liners

8th

thickening

10

prosthetic socket

12

Inner surface

14

outer surface

16

contact point

Claims (10)

Method for producing production data for producing a prosthesis liner, the prosthesis liner having an inner surface (12) for contact with an amputation stump (2) and an outer surface (14) for contact with a prosthesis socket (10), the method having the following steps: - providing internal data that describes the inner surface (12), the inner surface (12) being adapted to a surface of the amputation stump (2), - Providing external data that describes the outer surface (14), the outer surface (14) being adapted to an inner wall of the prosthesis socket (10), - Calculation of 3D data of the prosthesis liner from the inside data and the outside data and - Creation of production data from the calculated 3D data. procedure after claim 1 , characterized in that the surface of the amputation stump (2) is scanned and the internal data are generated from the internal scan data generated in the process. procedure after claim 1 or 2 , characterized in that an inner wall or an outer wall of the prosthesis socket (10) is scanned and the external data are generated from the external scan data generated in the process. Method according to one of the preceding claims, characterized in that at predetermined points the inner surface (12) is not adapted to the surface of the amputation stump (2) and/or the outer surface (14) is not adapted to the inner wall of the prosthesis socket (10). Method according to one of the preceding claims, characterized in that the prosthesis liner is a replacement for a previous example and the 3D data also consists of 3D data and/or Production data of the previous copy are calculated. procedure after claim 4 , characterized in that the provided external data are the external data of the previous example. procedure after claim 4 or 5 , characterized in that when calculating a difference between the provided internal data and internal data of the previous example is calculated. Method for producing a prosthesis liner, wherein the prosthesis liner has an inner surface (12) for contact with an amputation stump (2) and an outer surface (14) for contact with a prosthesis socket (10), the method having the following steps: - Creation of production data according to one of the preceding claims - Manufacture of the prosthesis liner using the manufactured production data. procedure after claim 7 , characterized in that the prosthetic liner is at least partially manufactured in an additive manufacturing process using at least one additive manufacturing system and the production data at least also contain operating parameters of the at least one additive manufacturing system. procedure after claim 7 or 8th , characterized in that the production data contain information about materials to be used, with different materials preferably being used.

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