EP3880131A1

EP3880131A1 - Method for manufacturing portions of a prosthetic socket and kit

Info

Publication number: EP3880131A1
Application number: EP19805200.3A
Authority: EP
Inventors: Andreas Radspieler
Original assignee: Romedis GmbH
Current assignee: Romedis GmbH
Priority date: 2018-11-12
Filing date: 2019-11-12
Publication date: 2021-09-22
Also published as: CA3118022A1; US20220047404A1; WO2020099435A1

Abstract

The invention relates to a method for manufacturing or planning the manufacture of portions of a prosthetic socket, of an inner or outer socket and/or of an extension of the prosthetic socket, the prosthetic socket being intended for receiving a limb stump of a patient P. The invention also relates to a prosthetic socket and to a kit. The invention further relates to a computer system, a digital storage medium, a computer program product and a computer program.

Description

Process for making sections of a prosthetic socket and kit

The present invention relates to a method for manufacturing a prosthesis socket or to plan the production of a prosthesis socket. Furthermore, the present invention relates to a prosthesis socket according to claim 11 and a kit according to claim 12

Computer system according to claim 14, a digital

Storage medium according to claim 15, a computer program product according to claim 16 and a computer program according to claim 17 proposed.

Leg amputees can use their mobility

Recover leg prostheses. Modern leg prostheses include various modules (prosthesis socket, knee, lower leg, and foot modules), which can be combined to meet the different needs of the prosthesis wearer

Hereinafter also referred to briefly as carrier) with regard to

Basic mobility, exercise and aesthetic

To fulfill ideas.

The present invention relates to a method for manufacturing or planning the manufacture or creation of a

Prosthetic stem of a prosthesis for e.g. B. the lower ones

Extremities, for example a prosthetic leg. The

The prosthesis socket is the module of the prosthesis that establishes the connection between the mechanical replacement of the limb and the remaining limb of the limb (hereinafter also referred to as the stump) of the prosthesis wearer,

for example, a thigh stump. The prosthesis socket is attached to the distal end (the end facing away from the prosthesis wearer) with a

mechanical replacement of the extremity, in the case of the lower extremity, for example, a modular knee joint-lower leg foot device for the thigh amputee or a modular lower leg foot device for the lower leg amputee. At its proximal end (the end facing the prosthesis wearer), the stump is inserted into the prosthesis socket. The

The prosthesis socket should sit on the stump tightly and as positively as possible. The perfect connection with the

Limb stump determines how securely the prosthesis holds the stump.

For transferring the sometimes considerable forces between the body or stump of the wearer on the one hand and the prosthesis

on the other hand, which occur when standing, walking, getting up, running, etc., the prosthesis socket is required to have a high level of strength or rigidity. This is ensured by a correspondingly rigid outer section of the prosthesis socket, the so-called outer socket. Since its stiffness, however, puts pressure on the stump, which is regularly perceived as unpleasant or even painful and increases

Pressure points, the outer shaft is supplemented by a so-called inner shaft (also known as a sleeve) to increase the comfort inside. The inner shaft usually has an elastic material. He can in

Form of an elastic sleeve (liner) consist of it or be padded with it.

The object of the present invention can be that

To optimize the manufacture of a prosthetic socket or its planning. Furthermore, a prosthesis socket and a kit a computer system, a digital storage medium

Computer program product as well as a computer program

be proposed.

The object of the invention can be achieved by a method for manufacturing or planning a prosthesis socket with the features of claim 1. Furthermore, the object can be achieved by a prosthesis socket according to claim 11 and a kit according to claim 12. Also register

Computer system with the features of claim 14, a

digital storage medium with the features of claim 15, a computer program product with the features of

Claim 16 and a computer program with the features of claim 17 to achieve the object of the invention.

According to the invention, a method for manufacturing or for planning the manufacture of a is therefore very general

Prosthesis socket, an inner and / or an outer socket and / or an extension of the prosthesis socket

suggested. The prosthesis socket is provided for receiving a limb stump.

The method according to the invention comprises the determination of data, in particular geometric data, or the

Provision of data, in particular geometric data. In this case, preferably those data, in particular geometric data, are determined which correspond to the shape of the

Body limb stump at at least one time, in the future, determine or co-determine.

In this case, data are preferably determined which

the shape of the

Prosthetic socket, the inner or outer socket or the

Co-determination or should determine extension (or the form that they should then have). The dates or Geometric data can be estimated values or expected values.

The method optionally further includes either creating the prosthetic socket or portions thereof. This is done based on the determined data and / or

geometric data. Alternatively or in addition to

aforementioned creation of the prosthetic socket or

Sections of this, the method comprises the creation of at least one control signal, in particular the creation of a control file with control signals, on the basis of which a production machine (for example, directly or indirectly) takes steps to create the prosthesis socket, the inner or

Can perform outer shaft or extension and / or can create at least one of the aforementioned devices or parts thereof.

Here is the time of creation (also:

Creation time) before the first time of wearing.

The method in its general or most general configuration optionally does not have any further features.

The prosthesis socket according to the invention, inner or outer socket or the extension according to the invention for the prosthesis socket are manufactured by means of the method according to the invention or using the same.

According to the invention, a kit is also proposed with

at least two elements of a group. The group consists of a prosthetic socket, an inner socket, an

Outer shaft and at least one extension for the

Prosthesis socket. All the elements of the groups created based on the inventive method, so z. B. manufactured or produced.

According to the invention, a computer system is proposed which is programmed, the method according to the invention

perform. For this it can be a programmable

Computing device include.

An inventive, in particular digital, in particular non-volatile, storage medium (also referred to here as a carrier), in particular in the form of floppy disk, RAM, ROM, CD, hard disk, DVD, USB stick, flash card, SD card, FeRAM or EPROM, in particular with electronically or optically readable control signals, can be configured to a

Control device to a control device

configure with which the described herein

The inventive method can be effected.

All, some or some of the machines can do this

feasible steps of this procedure are initiated.

A computer program product according to the invention has a volatile, volatile or program code stored on a machine-readable medium, through which one

Control device is configured such that the inventive method described herein can be effected.

In turn, all, some or some of the mechanically feasible steps of this method can be initiated.

The term "machine-readable carrier" as used herein

is used in certain embodiments of the present invention refers to a carrier, the data or information interpretable by software and / or hardware contains. The carrier can be a data carrier such as a floppy disk, a CD, DVD, a USB stick, a flash card, an SD card, FeRAM, an EPROM and the like.

According to the invention, a computer program product can be, for example, one stored on a carrier

Computer program, an embedded system as a comprehensive system with a computer program (e.g. an electronic device with a computer program), a network of

computer-implemented computer programs (e.g.

Client / server system, cloud computing system, etc.) or a computer on which a computer program is loaded, running, stored, executed or developed is understood.

A computer program according to the invention has one

Program code by which a control device is configured in such a way that it describes what is described herein

The inventive method can be effected.

All, some or some of the machines can do this

feasible steps of this procedure are initiated.

According to the invention, under a computer program

for example, a physical, marketable software product can be understood that has a program.

In all of the following versions, the use of the

The expression “may be” or “may have” etc. should be understood as synonymous with “is preferred” or “preferably” etc. and is intended to explain embodiments of the invention.

Whenever numerical words are mentioned herein, the person skilled in the art understands them as indicating a lower numerical limit. If this does not lead to a contradiction recognizable to the person skilled in the art, the person skilled in the art therefore always reads “at least one” or “at least one” when specifying “a” or “a”. This understanding is as much encompassed by the present invention as the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one" wherever this is technically possible for the person skilled in the art. Both are from

The present invention encompasses and applies to all numerical words used herein.

If “programmed” or “configured” is mentioned here, it is also disclosed to exchange these terms with one another.

Whenever a suitability or a method step is mentioned herein, the present invention also includes corresponding programming or

Configure a suitable device or

Section of this - e.g. B. a computer system - and such programmed devices. The devices can each be named after the process step they have carried out.

Advantageous further developments of the present invention are the subject of subclaims and

Embodiments.

When an embodiment is mentioned here, it represents an exemplary embodiment according to the invention.

Embodiments according to the invention can have one or more of the features mentioned below in any combination if a specific combination is not technically recognizable to the person skilled in the art. The subjects of the subclaims also give in each case

Embodiments of the invention.

When referring to a creation herein, when referring to physical objects such as the prosthetic socket, the inner socket, etc., it can be understood as a manufacture, manufacture, manufacture or manufacture of the same. The time of creation is then the time of manufacture, manufacture, manufacture or production.

In some embodiments, the data is not

geometric data, although perhaps referred to herein as such.

In some embodiments, the data is topographic data of the limb stump.

In some embodiments, the data or geometric data determined in the method according to the invention

forecast data. It is then not actual data and / or measured data that reflect the shape of the limb at the time the data was determined or

Display the creation time of the prosthesis socket or control signals. Such measured data can, however, have been used for the forecast. The predicted data can be or include variable dimensions of the limb stump and / or data which are subject to changes over time, for example post-operatively or as a result of a previous surgical operation. As an example, here is the extent or the water content (edema) of the

Called limb stump. In some embodiments of the method according to the invention, the determination of the data and / or geometric data, which are predicted data, takes into account patient data which reflect the, in particular current, health status of the patient. The patient data can

state of health at the moment of detection or

Play creating. In addition or as an alternative, you can make a statement about a medical peculiarity before or at the time of the determination, such as

Pre-existing illness. The patient data can be measured and / or anamnestic or clinical, etc.

Examples of this patient data can be:

- the age of the patient,

- Information about the time elapsed since the amputation,

- whether it is in the care of the patient with a prosthesis by means of primary or

Subsequent prosthesis

- whether the patient is obese (obesity)

is present (measurable, for example, via the body mass index (BMI) or bioimpedance, e.g. using an electronic balance, body composition monitor, and the like),

- The genesis or cause of the amputation (e.g. as a result of peripheral arterial

Occlusive disease (PAD / AVK), trauma or inflammation and / or the presence of a tumor, inflammation and / or the like),

- whether the patient has pAD / AVK,

- Cardiac output data (e.g. whether a

Heart failure),

- whether the patient is deficient in protein,

- whether the patient has diabetes, - whether there is an insufficiency of the patient's lymphatic system (e.g. preoperative or postoperative lymphedema),

- how the patient's vein situation presents itself

(for example the presence of a deep

Venous thrombosis (DVT) or other thromboses and / or existing varicose veins (varices) and / or whether the patient is z. B. already had to undergo varicose surgery),

- Operations already carried out (especially in the

Area of the limb affected by the amputation, e.g. in the groin due to cardiac catheter surgery),

- heart failure,

- metabolic diseases,

- Movement behavior of the patient (athletes,

Strollers, office workers without sporty

Compensation, etc.),

- Composition of body tissues, e.g. B. of

Limb stump, over the fluid, fat and / or muscle portion (e.g. by a

Bioimpedance measurement, for example measured using a body composition monitor) or information about a content thereof (in absolute values), information about the

Circulation, information about the distance over which the limb stump over bony structures (e.g.

Femur), e.g. B. in its longitudinal direction,

- Medication of the patient, especially long-term medication.

The data can be used individually or in combination in any combination to predict the change in the shape of the data

Limb stump used with time (e.g. between the time of creation and the first time of wearing) and thus when determining the geometric data and / or

are processed. In particular, here too Findings gradations or stage divisions of the aforementioned findings and other pre-existing diseases are observed and included in the

Forecast to be included.

The extent to which such patient data is included in the

Ascertaining the geometric data can be an indication in percent, centimeters, or in another way or - purely optional - in other units. This measure can lead to a change in the z. B. from a collective of patients determined prognosis data such as z. B. in FIG. 6

are shown as examples, lead or flow into them, for example by subtracting empirical values that result from the observation of diabetics or patients with others for the future change in the shape of the limb stump

relevant medical conditions (as mentioned above, for example) are known. Such a measure can also be added to the data of the collective for some medical conditions purely as an option. The invention also encompasses a percentage factor (or its use) by which the empirical data that can be multiplied for the collective of patients whose patients have no specific medical condition.

According to the invention, the collective data can be collected from patients who are not affected by the specific medical condition. This data can be as set out above, e.g. B. by means of the above measure on the

concrete patient, in which the concrete medical

Condition is present, to be adjusted.

In some embodiments, however, the collective data have already been collected from patients who have one or the other of the aforementioned medical conditions or another medical condition, or any combination of two or more such medical conditions. In this case no adjustment is required; the forecast data collected on the collective then generally do not need to be adapted to the medical condition, since this was also present in the collective. However, an adjustment may still be made optionally, either because it may be necessary or advantageous. For example, it may be advantageous to take the degree in which the medical condition is or was present (staging, stage, degree, classification, NYHA, age, etc.) into account for a fine adjustment.

The patient data can be stored, e.g. B. in one of the devices according to the invention, or at a location where the devices according to the invention can access them, for example in a database, etc. The devices according to the invention can be configured to access (stored) such stored data. Alternatively, this data can be obtained from the user of the invention

Devices can be entered by means of an input device provided and / or configured for this purpose. The optionally required comparisons between patient data of the specific patient and a collective, if provided, can optionally take place automatically, for example once, several times and / or regularly.

In some embodiments of the method according to the invention, the patient data are determined when determining the data or geometric data, e.g. B. by mathematical

Operations, taken into account.

If herein mathematical arithmetic operations such as e.g. B. addition, subtraction, division or multiplication is mentioned, so are all other known mathematical

Computing operations according to the invention includes. The above and The ways mentioned below for determining the forecast data or for determining or adapting the geometric data, in particular due to medical conditions, are pure

exemplary.

In some embodiments, the data or determined in the method according to the invention are or include

geometric data the result of an estimation.

Alternatively or in addition, they become one

Lookup source read out. Such a lookup source can be, for example, a table of values and / or a database.

In some embodiments, this data is or includes the result of a calculation based on a

Algorithm. This algorithm can in turn

Expert systems can be created and / or on a

A large number of comparison data are based. Measured data can be used and / or already calculated data

be processed further.

Both the lookup source and the algorithm can be the result of using artificial intelligence. So machine learning tools, e.g. B. based on

artificial neural networks to generate the

provided geometric data have been used in one of the ways known to those skilled in the art.

The geometric data can be evaluated by

Measurement results on limb stumps of a large number of patients. For this purpose, e.g. B. the actual values of the respective limb stump have been measured, such as the cross sections of the limb stump at a distance of z. B. 6 cm, 9 cm and 12 cm to a reference point or cross section. These measurement results can

measurement results obtained later or later, e.g. after 3 months and after 6 months, are compared to the same patient. If you now know actual data of the patient to be treated by the orthopedic technician or his limb stump, the reference source can be found, like that

geometric data at later times of wear (e.g. after 3 months or after 6 months) will be. The

Empirical values, which were collected from a patient collective, can thus be used to predict how the shape of the limb stump of the concrete, at the time of creation z. B. supplied with a prosthesis, patient P at later times, especially on the considered

Reference points, e.g. B. measuring points, will be.

Optionally go here the mentioned lookup source

and / or the above-mentioned algorithm from actual data or measured data, and their size often represents data which deviate therefrom z. B. available as geometric data or output them.

In some embodiments of the method according to the invention lie between the time of creation of the prosthesis socket or the time of creation of the control file

Manufacturing on the one hand and the first time of wearing the

Prosthesis stem, on the other hand, at least 30 days,

preferably at least 90 days, especially at least 180 days.

In certain embodiments, it does not matter whether e.g. B. an inventive prosthesis socket is actually worn at the first time of wearing. Rather, what matters is that it was made to be on the first To be able to be worn at the time, especially of course with the highest possible comfort on that day.

This increased wearing comfort can be the goal of the method according to the invention.

In some embodiments of the method according to the invention, the geometric data additionally include data which will also determine the shape of the limb stump at at least a second time of wearing. This data can take into account a change in the limb stump over time, for example the change in it

Dimensions (e.g. due to swelling or swelling). The second wearing time is after the first

Time of wear, with at least 3 days, preferably at least 10, 20, 30, 60, 90 days, in particular at least 180 days, 12 months or 24 months, between the two times of wear.

In some embodiments of the method according to the invention, a prosthesis socket, an inner or outer socket and / or at least one extension is also created in the step of creating. Alternatively or in addition, one

Tax file with tax data can be created. The

In this embodiment, the prosthesis socket and / or the corresponding control file are based on the geometric data which were measured and / or calculated using the method according to the invention and which reflect the shape of the

Body limb stumps are determined at least at a second time as described above.

According to the invention, it can therefore be provided both data for the first time of wear and, preferably at the same time, that is to say, for. B. on the same day, in the same session, during the same visit of the patient to the orthopedic technician (or vice versa) to determine data for a second time of wear and / or further times of wear and / or

Prosthetic socket, inner or outer socket or extension for the first time of wearing and the other one or more

To create times of wear.

In certain embodiments, an extension is a supplement to the prosthetic socket, an accessory

Installation element, an inner shaft, or the like.

In some embodiments, the extension is intended to be generally located inside the outer socket, inner socket or prosthesis socket, e.g. B. on or from the first or further wearing time. It can preferably be given to the patient P at home on the day of its creation, the date of creation being the

Can correspond to the determination date.

In some embodiments of the method according to the invention, the inner socket serves to accommodate the limb stump or at least sections thereof. He is there

provided, in turn, to be received, at least in sections thereof, in an interior of the outer shaft.

In some embodiments of the method according to the invention, the extension of the prosthesis socket 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 that lies between its layers

is introduced.

The extension is not adjustable in some embodiments. It may optionally be able to be pressed in, it may optionally be elastic. It is in some embodiments not adjustable; so it can optionally z. B. not

be inflatable, not be connected to a pump, have no lines or be connected to it and / or cannot be varied by the patient.

In some embodiments, the prosthesis or the prosthetic socket have no device for actuating the

Expansion to, for example, a mechanical device provided for this purpose, such as an actuator, a pump

Fluid reservoir and / or lines provided for actuating the extension.

In some embodiments, the computing system is

configured to work in with a manufacturing machine

Signal connection to be or it is in with this

_Getting Connected signal.

In some embodiments, the computer system is part of a manufacturing machine or vice versa.

In some embodiments, e.g. B. the method according to the invention, the manufacturing machine for creating the prosthesis socket or sections thereof 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 deep-drawing device or one

Sprayer. Here is the manufacturing machine

optionally configured to control the prosthetic socket, the inner socket or the outer socket or based on control signals

To create an extension (or sections thereof). These control signals can in turn by the

method according to the invention have been created. In some embodiments, the inner shaft and outer shaft are connected to one another, for example by means of joining methods such as gluing, riveting and the like.

The inner socket can be dimensionally stable. It cannot be elastic. Its shape can, without wanting to or having to destroy it, at least under normal conditions of use for it or for the prosthesis socket according to the invention

be dimensionally stable or firm. The inner shaft can be made

Carbon fibers exist or have such.

The inner shaft can consist of the same material as the outer shaft or can have the same material as the

Outer shaft.

The inner shaft can have an individualized circumferential shape. The individualization can consist in adapting its shape to a peripheral contour of the outer shaft.

The outer shaft can have a first strength or elasticity (for example as total strength or total elasticity or as average total strength or

Expressed total elasticity, for example in the direction of the greatest extent of the peripheral portion). The inner shaft can have a second strength or elasticity which is higher than or equal to the first, that is to say that of the outer shaft, with the same procedure for measuring the strength or elasticity.

In some embodiments, the outer shaft surrounds the

Inner shaft only in sections, in others, however

Completely . In certain embodiments, the inner shaft

preferably at least one of: in one piece, closed all the way around, without gaps all the way around, without doubling in the sense of wrinkling, without step, without gap and / or slit, no elastic liner. In some embodiments, this also applies to the outer shaft.

In some embodiments, the outer shaft, the inner shaft and / or the extension (s) have at least one connecting device, by means of which at least two of the aforementioned components can be connected to one another.

The connecting device can have at least one

Velcro connection, an adhesive connection and / or a

Include or consist of screw connection.

In some embodiments, the extension is not

Pump system or has no such.

In some embodiments, the outer shaft and / or the inner shaft are not flexible.

In some embodiments, the outer shaft and / or the inner shaft have no lacing system or no tension system which would serve to change the volume surrounded by the respective shaft or to change the diameter of the respective shaft or shaft section.

In some embodiments of the kit according to the invention, a first element of the group consisting of a

Prosthesis socket, an inner or outer socket or

at least one extension of the prosthesis socket, based on data or geometric data, which preferably the Shape of the limb at the first time of wearing

co-determine, created. In addition, a second element of the group was created based on data or geometric data, which preferably also determine the shape of the limb at the second time of wearing.

At least any element of this became optional

Group created at the time of creation, based on existing actual data of the patient P, which reproduce or co-determine the shape of the limb of this patient's limb at the time of creation. Such actual data can e.g. B. be measured or be directly on the limb. They do not correspond to the determined data or geometrical data.

In some embodiments, the step of

Ascertaining the geometric data does not (or does not correspond to) any of the steps that lead to the obtaining of measurement data that can be achieved when measuring the limb stump, at least not in order to base on this the one that is to be used at the first time of wearing and for this

prosthesis socket, outer socket, inner socket or extension or control signals created according to the invention. Steps leading to the receipt of measurement data

in particular for data which are measured by means of measuring tape, by means of scanning, by means of laser measurement or scanning, by means of ultrasonic measurement or scanning, by means of

Determination of the proportions of solid tissue (bone) in relation to the proportions of soft tissue (fat, edema, connective tissue, muscles) can be obtained.

In some embodiments, the step of

Determining also taking into account actual data or measured data, referred to herein as measurement data. The However, obtaining the measurement data is optionally not part of the process.

In some embodiments, the method according to the invention in particular does not include an ultrasound measurement.

In some embodiments, ascertaining is understood to be reading out, estimating, forecasting and / or defining.

In some embodiments, the method according to the invention does not include a scanning step, no sonographic step and / or no creation of a bone model.

In some embodiments, the method according to the invention does not include the consideration of a so-called

Reduction measure (RM). One speaks of a reduction measure if the orthopedic technician z. B. determined from the thigh circumference and a constriction measurement by which the dimensions of the shaft to be manufactured by the orthopedic technician must deviate from the dimensions determined on site on the patient P, so that the shaft manufactured by the orthopedic technician the patient P in use and when loaded with the

Body weight of the patient gives sufficient support. The

Reduction measure is therefore taken into account by the orthopedic technician for dimensioning and designing the stem of the prosthesis, with the aim that the prosthesis stem should be optimally matched to the measured one at the time of its first use

Limb stump and its properties are adapted. The consideration of a reduction measure thus serves to compensate for shortcomings which occur in connection with the measurement of the limb stump even before the patient uses the prosthesis for the first time. In some embodiments, the method also includes creating control signals or a control file with control signals, each for creating a prosthesis socket, although this is not based on the determined geometric data, but rather on the basis of measured actual data. The actual data reflect the form of the

Limb stump is reflected at the time of creation, while the data or geometric data reflects the shape of the

Limb stump at one or more more or less far after the time of creation

Describe or approximate wearing time (s).

In some embodiments, the geometric data is approximated data from data related to the

Creation time or at a certain time of wear on patient P would have been measurable or were measured.

In some embodiments, the geometric data are not data of the specific patient P and no data collected on him, but rather on a patient collective or data collected by means of a patient collective or data calculated based on this.

In this case, if it is mentioned here that the geometric data will also determine the shape of the limb stump at a point in time in the future, in some embodiments this means that the reasoned

The assumption is that this will be the case. This assumption can be based on empirical values. It can be based on the fact that, on the basis of the concrete shape of the stump

Creation time and the z. B. from patient collectives, it can be assumed that the limb stump has sufficient experience to target Wear time will show the geometric data, such as a predicted extent at a predetermined height, such as measured at a predetermined distance of z. B. an immobile bony structure. It is not certain whether this will happen.

By means of some or all of the invention

Embodiments can achieve one or more of the advantages mentioned above or below.

The limb stump is subject to volume fluctuations on a daily basis, as well as sometimes considerable volume changes in the months after the amputation, initially due to postoperative edema and scarring and later due to muscular atrophy.

It is desirable that the prosthetic socket both at the moment of its creation or adaptation (the

Creation time) as well as at later times (the considered times of wear) as fresh on the

Adjusted limb stump and still has the required stability even after muscular atrophy

guaranteed, especially when standing and walking. It is obvious that e.g. B. a prosthesis outer shaft, which must bring considerable stability to fulfill its task, can not adapt to such a cross-sectional change of the limb stump due to its strength.

The present invention advantageously serves the rapid

Adaptation or adaptability of the prosthetic socket to a change in shape of the limb stump. The adjustment can be carried out comfortably by the wearer himself, using only a few

Hand movements changed the fit of his prosthesis.

For this purpose, the wearer alone has to insert the extension or the inner socket into the prosthesis socket and to fix there, if provided (screwing,

Click, glue, etc.) based on the

determined data for later use, namely for use at the first (or another) time of wear, may have been produced prematurely at the time of creation.

The present invention is explained below by way of example with reference to the accompanying drawings, in which identical reference symbols denote identical or similar components. In the sometimes very simplified figures:

Fig. 1 shows a prosthesis shaft as part of a just for

Partly shown thigh prosthesis with

several extensions according to the invention in longitudinal section;

FIG. 2 shows a cross section of the thigh prosthesis from FIG. 1;

Fig. 3 shows an inner shaft according to the invention as part of a part shown only

Longitudinal femoral prosthesis;

FIG. 4 shows a cross section of the thigh prosthesis from FIG. 3;

5 shows an exemplary embodiment of the

computer system according to the invention; and

6 schematically shows a lookup source for

Use in the method according to the invention. Fig. 1 shows an outer shaft 4 as part of an

Prosthetic stem 2 only partially shown

Thigh prosthesis. The relatively stiff

shell-shaped outer shaft 4 takes a removable inside, preferably adapted to the body limb stump of the patient P inserted therein

comparatively flexible inner shaft 6.

At the optionally closed distal end 8 of the

Outer shaft 4 is followed by a columnar component 10 leading to the mechanical knee joint (not shown in FIG. 1).

Unlike prostheses of this type, as are known from the prior art, here - z. B. between the longitudinal walls of the outer shaft 4 and the

Inner shaft 6 - for example two according to the invention

Extensions 12 and 14 arranged with their

inner wall can in each case press the wall 18 of the inner shaft 6 inwards in the relevant areas, so as to locally reduce the inner volume of the shaft

achieve.

An optional, further such according to the invention

Extension 20 is located on the outside of the inner shaft 6 at its distal end.

To be more precise, the extensions 12 and 14 are optionally arranged here in the dorso-lateral region following an edge 22 of the femur 24 (indicated by dashed lines) or in the medial-distal region. The extension 12, which extends from proximal to distal, optionally has an elongated shape, but the extension 14 optionally has a rather round shape. As indicated by the arrows in the cross section shown in FIG. 2 through the prosthetic socket 2 of FIG. 1, the thigh bone 24 is intentionally subjected to a more or less strong adduction by the enlargement 12.

It can be used to correct the abduction that usually occurs in thigh amputees after the amputation. In addition, extensions 12 and 14 allow the shaft volume to be reduced and the stump in the shaft, here: in the inner shaft 6, to be given increased surface adhesion. This surface liability in turn allows, with the help of the optional extension 20, a desired one

Restore butt end contact after swelling has decreased and, if necessary, after atrophy processes.

The extensions 12, 14 and 20 have been given together with the outer shaft 4 to the patient P, on the limb of which the outer shaft 4 was adjusted on the day of its manufacture (that is to say, for example, at the time of manufacture).

The use of extensions 12, 14, 20 were on the day of

Handover of the prosthesis with the outer shaft 4 does not

required and would not have offered the patient P any increased wearing comfort. According to the invention, however, was already on or before the date of handover (e.g. on

It was determined how some of the data or geometric data of the limb stump would change in the foreseeable future (e.g. at the first time of wearing). Up to a day referred to herein as the first time of wearing, the

Limb stump through muscular remodeling and possibly

The swelling decrease changed in such a way that the outer shaft 4 produced at that time could no longer fit optimally. The patient P can see the difference between the in the meantime, change the shape of his limb stump and the non-changeable shape of the outer socket 4 of his prosthesis by inserting the shape of his limb stump that is expected for him and with a view to the change in shape (geometric data) expected in his case. In the present example, he only has to use the extensions 12, 14 and 20 as already intended by the orthopedic technician at the time of the determination and, if necessary, to secure them against slipping within the prosthesis socket 2. In this way, he can visit the orthopedic technician without visiting again

Expertise to restore the desired fit of his prosthesis.

Fig. 3 shows a second embodiment of the

Prosthetic stem 2 in longitudinal section. 4 again shows a cross section thereof.

Unlike shown in FIG. 1, the prosthesis socket 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 FIGS. 1 and 2.

At the points where, in the embodiment of FIGS. 1 and 2, the extensions 12 and 14 are exemplary

Compensation of the muscular remodeling with the aim of exerting pressure in the direction of the arrow on the femur 24 was provided in the one shown in FIGS. 3 and 4

Embodiment of the rigid and specially shaped inner shaft 6a this function. Its stiffness leads to the formation of empty spaces 26 and 28. They have the shape of the extensions 14 and 12 of FIGS. 1 and 2. The stiffness of the inner shaft 6a from FIG. 3 allows it to remain dimensionally stable and still exert the desired pressure on the thigh stump.

The inner socket 6a is, so to speak, a shaft from the retort: its dimensions are not based on the dimensions that the orthopedic technician used to supply the

Patient P with a prosthesis on the limb stump. Rather, its dimensions are based on future predicted data or geometric data, which was assumed at the time of supply that the

Limb stump they would later accept and which were thus determined before or at the time of creation.

In the embodiment of FIGS. 3 and 4, it is therefore assumed in the present example that the

Inner shaft 6a is already the second inner shaft, that is, an inner shaft that was intended to be worn from the beginning only from the first time of wearing. It will

It is assumed that the patient was provided with an inner shaft, not shown in the figures, by the orthopedic technician, who placed the outer shaft 4 on the inside thereof with constant contact. It is also assumed that this original inner shaft at the first time of wearing, e.g. B. weeks or months after the care at

Orthopedic technician, no longer sat optimally, which is why he by the inner shaft 6a shown in FIGS. 3 and 4 below

Maintaining the original outer shaft 4 has been replaced.

5 shows a computer system 200 according to the invention.

The computer system 200 optionally includes one

Computing device 210, a lookup source 220, a

Input device 230, an output device 240 and / or a production machine 250. The aforementioned units 220, 230, 240 and 250 are each optional and can be connected to or integrated into the computing device 210. You can choose one or two sided

Signal communication with the computing device 210 are available. They can be interconnected as required. Each of these connections can be wired or wireless.

The computing device 210 may determine the

serve geometric data. For this purpose, it can use an optional lookup source 220 in which reference data can be stored. For example, by specifying the actual dimensions measured at the time of creation, possibly supplemented by further details such as age, weight,

Mobility classification (1 to 4), physical activity, etc. of the patient P, which is optional using the

Input device 230 can be input by simply assigning this data to empirical values of already existing geometric data that the limb stump has at certain times in the future (herein as

Wearing times) will presumably assume

output. The output can take place by means of the output device 240, e.g. B. in the form of a display 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) can be sent to the production machine 250

be transmitted. Optionally, the desired component, such as the inner shaft or the

Extension, or section or parts thereof. The specification and / or the control signals can

Include information where e.g. B. extensions 12, 14,

20 are to be placed in the prosthesis socket 2. Fig. 6 shows an example of how data provided or geometric data are used.

A limb stump of the patient P, which is only partially shown, shown on the left in FIG. 6, can have the measurement results shown in the table shown on the left in FIG. 6 when it is measured. Column B shows the measurement results obtained on the stump and gives the measured circumference (in cm) at a distance of z. B. 6 cm, 9 cm and 12 cm to a reference point or cross-section (column A). The values in column B also apply here as actual values. They were measured at the positions of the limb stump mentioned in column A before the prosthetic socket 2 was created.

When examining a variety of patients with

comparable limb stumps were the

The method according to the invention measured in advance values which the cross sections of the limb stump z. B. 6 cm, 9 cm and 12 cm to later, defined

Specify times of wear. So give the numerical values in

Column C, for example, shows which circumferential values at the positions mentioned in column A at the first time of wearing, approximately 3 months after the prosthesis was created, were collectively, possibly based on or related to actual values. At the same time, they indicate which measurements 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 measurements observed over 3 months.

Column D gives circumferential values, of which one can be based on the previous measurements on the above. The patient group may go out that the concrete one shown on the left in FIG. 6

Limb stump at the second wear point, approximately after 6 Months, this (or at least very similar) will assume the positions listed in column A.

6 shows a lookup source on the right. Columns C and D show which geometrical data a limb stump has at the positions specified in column A the values in column B at the time of the initial treatment with a prosthesis (e.g. at the time of investigation)

has, at the first and second wearing times considered here by way of example, will presumably have, namely the values of the columns C and D. Reading them out can represent a determination in the sense of the present invention.

If patient P is a diabetic, the values of columns C and D can be determined from a collective that also consisted of diabetics.

Furthermore, the values of columns C and D can already

take into account how big the values in column B are. If the specific patient P had shown larger actual values than those noted in column B, the values C and D could also have been larger.

6 serves as an example. The present invention is not limited to considering the scope as a geometric datum. The use of other data, in addition or alternatively, in combination with one another or alone, is likewise encompassed by the present invention.

Instead of a lookup source, geometric data can be determined on the basis of an existing amount of data at the time of the determination. Although the present invention is described herein in a number of passages and in particular with reference to the exemplary figures using the example of the limb stump of a lower extremity (thigh, lower leg, foot)

is discussed, the invention is in no way on the

Limited limb stump care limited. According to the invention, what is stated here applies without restriction to the treatment of the upper extremity (upper arm, forearm, hand) as well as to the products proposed for care, such as prosthesis socket, inner socket, outer socket and extensions.

Reference symbol list

2 prosthesis socket

4 outer shaft

5 entry opening

6 inner shaft 6

7 slot

8 distal end of the outer shaft

10 columnar component

12 extension

14 extension

18 wall

29 extension

22 edge

24 femur

200 computer system

210 computing device

220 reference source

230 input device

240 dispenser

250 manufacturing machine

Claims

Expectations

1. A method for manufacturing or planning the manufacture of a prosthesis socket (2), an inner socket (6), an outer socket (4) and / or an extension (12, 14, 20) of the prosthesis socket (2), the

Prosthetic socket (2) for holding a

The limb stump of a patient P is provided with the steps:

- Determination of geometric data or provision of geometric data, the geometric data relating to the shape of the limb stump at at least a first time of wearing the prosthetic socket (2), the inner socket (6), outer socket (4) or the extension (12, 14, 20) will have a say; and either

- Create based on the determined

geometric data, the prosthesis socket (2), the inner or outer socket (4) or the

Extension (12, 14, 20), or portions thereof, based on the geometric data, or

- creating a control file with control signals,

based on which a manufacturing machine steps to create the prosthesis socket (2), the inner socket (6), outer socket (4) or the

Extension (12, 14, 20) can perform wherein the creation takes place at a point in time before the first time of wearing, and wherein the geometric data are not data measured on the patient P.

2. The method of claim 1, wherein the geometric data predicted data, data of variable dimensions of the limb stump, data, which post-operative and by a previous surgical operation

are subject to or are due to changes in the course of time and / or data that do not represent or reflect the shape of the limb at the time the data was determined or at the time of creation, and / or are not actual data and / or measured data of the patient P are.

3. The method according to claim 1 or 2, wherein the determination of the geometric data, which are predicted data, takes into account patient data that the or at least one, in particular current,

reflect health condition or finding of patient P at the time of the determination and / or at a past time or at a collective of

Patients with this health condition or finding were surveyed.

4. The method according to any one of the preceding claims,

where the geometric data is the result of a

Estimating, reading from a lookup source and / or calculating based on one

Algorithm are or include.

5. The method according to any one of the preceding claims,

whereby between the time of creation and the first Wear time at least 3 days, preferably at least 10, 20, 30, 60, 90 days, in particular at least 180 days, 12 months or 24 months.

6. The method according to any one of the preceding claims,

wherein the geometric data also include data which will also determine the shape of the limb at least at a second time of wear, which is after the first time of wear, with at least 3 days, preferably at least 10, 20, 30, between the first time of wear and the second time of wear. 60, 90 days, especially at least

180 days, 12 months or 24 months.

7. The method according to any one of the preceding claims,

where in the step of creating also a

Prosthesis socket (2), an inner socket (6),

Outer shaft (4) and / or at least one

Extension (12, 14, 20) or equivalent

Control file for the production machine (250) is created based on the geometric data that will determine the shape of the limb stump at least at the second time of wearing.

8. The method according to any one of the preceding claims,

wherein the inner shaft (6, 6a) serves to receive at least sections of the limb stump and in turn is provided for receiving it at least in sections in an interior of the outer shaft (4).

9. The method according to any one of the preceding claims,

the extension (12, 14, 20) an inlay, a pad, a pressure insert, a compression insert, a stocking with different wall thicknesses or a double wall Stocking with at least one insert that is inserted between its layers.

10. The method according to any one of the preceding claims,

wherein the manufacturing machine (250) 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 deep-drawing device, or nowadays also a spraying device, configured to be produced the prosthesis stem (2), the

Inner shaft (6), the outer shaft (4) or the

Extension (12, 14, 20) or portions thereof based on the control signals.

11. prosthesis socket (2), inner socket (6), outer socket (4) or extension (12, 14, 20) for the

Prosthetic socket (2), produced by means of the method according to one of the preceding claims.

12. Kit with at least two elements from a group,

which consists of prosthesis socket (2), inner socket (6),

Outer shaft (4) or at least one extension (12,

14, 20), each manufactured according to the method according to one of claims 1 to 10.

13. The kit of claim 12, wherein at least a first

Element of the group was created based on geometric data, which also determine the shape of the limb stump at the first time of wearing, and at least one second element of the group

was created based on geometric data representing the shape of the limb stump for the second

Determine when to wear it.

14. Computer system, programmed to perform the

Method according to one of claims 1 to 10.

15. Digital storage medium, in particular in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to a

To configure a control and / or regulating device (29) to form a control and / or regulating device (29) with which the method according to one of claims 1 to 10 can be carried out.

16. Computer program product with one on one

machine-readable carrier stored program code to configure a control and / or regulating device (29) to a control and / or regulating device (29) with which the method according to one of claims 1 to 10 can be carried out.

17. Computer program with a program code to a