EP4114323A1

EP4114323A1 - Method for manufacturing portions of a prosthetic socket and kit

Info

Publication number: EP4114323A1
Application number: EP21710452.0A
Authority: EP
Inventors: Andreas Radspieler
Original assignee: Romedis GmbH
Current assignee: Romedis GmbH
Priority date: 2020-03-05
Filing date: 2021-03-05
Publication date: 2023-01-11
Also published as: WO2021176063A1; US20230320872A1; DE102020106057A1

Abstract

The invention relates to a method for manufacturing or planning the manufacture of 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, to a digital storage medium, to a computer program product and a computer program.

Description

description

Method for making sections of a prosthetic socket and kit

The present invention relates to a method for manufacturing a prosthesis socket or for planning the production of a prosthesis socket according to claim 1. Furthermore, the present invention relates to a prosthesis socket, inner socket, outer socket or extension for the prosthesis socket according to claim 13 and a kit according to claim 14 a computer system according to claim 17, a digital storage medium according to claim 18, a computer program product according to claim 19 and a computer program according to claim 20 are proposed. The present invention also relates to a method for creating a data collection according to claim 21 and a set according to claim 24 or according to the preamble or generic terms of these claims.

Leg amputees can regain their mobility with prosthetic legs. Modern leg prostheses include various modules (prosthesis socket, knee, lower leg and foot modules) which can be combined in order to meet the various needs of the prosthesis wearer (hereinafter also referred to as wearer) with regard to basic mobility, sporting activity and aesthetic ideas.

The present invention relates to a method which is preferably used to manufacture or plan the manufacture or creation of a prosthetic socket of a prosthesis for e.g. B. the lower extremities, for example a prosthetic leg, serves. The prosthesis socket is that module of the prosthesis which establishes the connection between the mechanical replacement of the extremity and the remaining limb stump (hereinafter also referred to as stump for short) of the prosthesis wearer, for example a thigh stump.

The prosthesis shaft is at its 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 above-knee amputee or a modular lower leg-foot device for the lower leg amputees, connected. The stump is inserted into the prosthesis socket at its proximal end (the end facing the prosthesis wearer). The prosthesis socket should sit tightly and as positively as possible on the stump. The precise connection with the limb stump determines how securely the prosthesis holds on the stump.

In order to transfer 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, standing up, running, etc., the prosthesis shaft needs a high degree of strength or rigidity. This is ensured by a correspondingly stiff outer section of the prosthesis socket, the so-called outer socket. However, since its stiffness causes pressure on the stump, which is regularly perceived as uncomfortable or even painful and can lead to pressure points, the inner socket is supplemented by a so-called inner socket (also known as a sleeve) to increase wearing comfort. The inner shaft mostly has an elastic material. He can in Shape of an elastic cover (liner) consist of it or be padded with it.

The object of the present invention can be to optimize the production of a prosthesis socket or its planning. Furthermore, a prosthesis socket and a kit, a computer system, a digital storage medium, a computer program product and a computer program are to be proposed. A further object of the present invention is to propose a method for creating a data collection or for collecting measured values. A set should also contribute to solving the task.

The object according to 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 and the like with the features of claim 13 and by a kit with the features of claim 14. Furthermore, a computer system with the features of claim 17, a digital storage medium with the features of claim 18, a computer program product with the features of claim 19 and a computer program with the features of claim 20 contribute to solving the problem according to the invention. A method for creating a data collection with the features of claim 21 and a set with the features of claim 24 also serve to achieve the object according to the invention.

According to the invention, a method for manufacturing or for planning the manufacturing of a prosthesis socket, an inner and / or an outer socket and / or an extension of the prosthesis socket is therefore proposed in very general terms. The prosthesis socket is intended to receive 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, at an early point in time, e.g. B. a creation time of the prosthesis socket, inner and / or outer socket and / or the one or more extension (s). In this case, such data, in particular geometric data, are preferably determined which the shape of the limb stump, e.g. B. based on experience, assumption,

Prediction, calculation using models, algorithms, artificial neural networks, artificial intelligence, comparison with a collective and / or machine learning, for at least one point in time, located in the future, describing, determining, mapping or - because they can hardly ever be complete - (the above terms can be interchanged here). In this case, data or geometric data are preferably determined which, at least at the first later point in time, referred to here as the time of wearing, describe, describe, map the shape of the prosthesis socket, the inner or outer socket or the extension (or the shape that these should then have) should co-determine or determine. The data or geometric data can be forecast values or dimensions, estimated values or expected values, in particular about future shapes. The data or geometric data can have been obtained by means of the method according to the invention for creating a data collection or can be based thereon. They can be in a storage medium such as a database.

The method optionally further comprises either the creation of the prosthesis socket or of sections thereof. this takes place based on the determined data and / or geometric data. As an alternative or in addition to the aforementioned creation of the prosthesis socket or sections thereof, the method includes 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 manufacturing machine (e.g. direct or indirect) steps to create the prosthesis socket, of the inner or outer shaft or the extension and / or can create at least one of the aforementioned devices or parts thereof.

In this case, the time of creation (also: creation time) is preferably before the first wearing time.

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

The prosthesis socket according to the invention, the inner or outer socket or the extension according to the invention for the prosthesis socket are preferably 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 prosthesis socket, an inner socket, an outer socket and at least one extension for the prosthesis socket. In this case, at least one element, two or all elements of the groups are created based on the method according to the invention, so z. B. manufactured or produced, or have the properties of such elements. According to the invention, a computer system is proposed which is programmed to carry out or initiate each method according to the invention or the arithmetic or computer steps thereof, in particular in cooperation with the devices required for this purpose, in particular as disclosed herein. For this purpose it can comprise a programmable data processing device.

An inventive, in particular digital, in particular non-volatile, storage medium (also referred to here as a carrier), in particular in the form of a diskette, RAM, ROM, CD, hard drive, DVD, USB stick, flash card, SD card, FeRAM or EPROM, in particular with electronically or optically readable control signals, can be configured in such a way to configure a control device (here alternatively: regulating device) to a control device with which each method according to the invention described herein can be effected, or to configure a computer system to a computer system according to the invention, or causing a control device or computer system to perform any of the methods described herein.

In this case, all, some or some of the steps of this method that can be carried out by machine can preferably be initiated.

A computer program product according to the invention has a volatile, volatile program code or program code stored on a machine-readable carrier, by means of which a control device is configured in such a way that any method according to the invention described herein can be carried out, or in order to configure a computer system to form a computer system according to the invention, or for Causing a control device or a computer system to execute any of the methods described herein.

In this case, all, some or some of the steps of this method that can be carried out by machine can again be initiated.

In certain embodiments of the present invention, the term "machine-readable carrier" as used herein denotes a carrier that contains data or information that can be interpreted by software and / or hardware. 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, a computer program stored on a carrier, 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, runs, is stored, executed or developed.

A computer program according to the invention has a program code by means of which a control device is configured in such a way that any method according to the invention described herein can be effected with it, or to configure a computer system to form a computer system according to the invention, or to cause a control device or a computer system to execute any procedures described herein. In this case, all, some or some of the steps of this method that can be carried out by machine can preferably be initiated.

According to the invention, a computer program can be understood to mean, for example, a physical, marketable software product which has a program.

Furthermore, a computer-implemented method is proposed according to the invention, comprising the steps of any method mentioned herein.

Furthermore, according to the invention, a device / a system for data processing is proposed, comprising means for carrying out the steps mentioned herein of any method mentioned herein.

Furthermore, a computer program product is proposed according to the invention, comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of any method mentioned herein.

Furthermore, according to the invention, a computer-readable (storage) medium is proposed, comprising instructions which, when executed by a computer, cause the computer to carry out the steps of any method mentioned herein.

The method according to the invention for creating a data collection comprises the step of providing a device (also herein: impression device) for use in making a plaster cast or a data model of a limb stump. The device has a container or pressure vessel with a pressure chamber for receiving pressurized fluid, preferably a liquid. The pressure vessel has a wall made of a first material and a fluid-tight membrane made of a second material.

As a further step, the method according to the invention comprises providing a pressurization device and / or a pressurization control device for setting, causing and / or maintaining a pressure prevailing within the pressure chamber.

A further step of the method according to the invention is a measurement of actual data from limb stumps, preferably always at the same, predetermined positions or locations of the limb stumps, a multiplicity of patients or a collective of patients. The measurement takes place at least at a first measurement point in time by means of the device mentioned.

The measurement of actual data of the limb stumps in each case at at least one second measurement time, which, for. B. days, weeks or months after the first measurement time is included as a further step of the method according to the invention. The measurement is also carried out here by means of the device and preferably at the same positions or locations on the limb stump as the measurement at the first measurement time.

To measure z. B. a measuring device, such as the device, can be used.

The actual data of the limb stumps can be stored in a data collection, e.g. B. in a suitable Storage medium, such as a database, e.g. B. one mentioned herein.

As a further step, the method optionally includes an assignment of patient data (e.g. a state of health or an assignment of the patient to this) to the measured actual data, which was measured at the first measurement time, as well as to at least the measured actual data, which were measured at the second measurement time. The measured actual data, which were measured at the at least two measurement times, are thus each assigned the same patient data (or the same health status).

To assign z. B. an allocation device can be used.

A subsequent optional classification, assignment and / or evaluation of the actual data measured at the first measurement time and the actual data measured at the second measurement time using the patient data assigned to them is also included as a further step of the method according to the invention.

To classify z. B. a classification device can be used.

The classified actual data are optionally stored in a further step of the method according to the invention for creating a data collection based on its classification etc. in a suitable storage medium, such as a database, e.g. B. the above or another disclosed herein, deposited or stored, for example in order to access them in the context of the method according to the invention for manufacturing or planning the production of a prosthesis socket, inner socket, outer socket and / or an extension, which is also provided in some embodiments according to the invention, for example when determining or providing the geometric data. Alternatively or in addition, the data can be evaluated and / or further processed by suitable devices.

The set according to the invention has a computer system according to the invention. Alternatively or in addition, it has a computer system which is provided and programmed to carry out the method according to the invention for creating a data collection, in particular by means of a device provided or after it has been provided. In addition, the set according to the invention has a device for use in making a plaster cast or a data model of the limb stump, which in turn comprises a container or pressure vessel with a pressure chamber for receiving pressurized fluid, preferably a liquid. The pressure vessel here has a wall made of a first material and a fluid-tight membrane made of a second material.

In all of the following statements, the use of the expression “can be” or “can have” etc. is to be understood as synonymous with “is preferably” or “preferably” etc. and is intended to explain embodiments according to the invention.

Whenever numerical words are mentioned here, the person skilled in the art understands them to indicate a numerically lower limit. If this does not lead to a contradiction that is recognizable to the person skilled in the art, the person skilled in the art therefore always reads “at least one” or “at least one” with the statement “a” or “an”. This understanding is also of the The present invention also includes 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 encompassed by the present invention and apply to all numerical words used herein.

When "programmed" or "configured" is used herein, it is also disclosed that these terms can be interchanged with one another.

Whenever a suitability or a method step is mentioned herein, the present invention also includes, in addition to this, a corresponding programming or configuration of a suitable device or a section thereof - e.g. B. a computer system and / or its components such as storage medium or storage device for data, z. B. the collective, computing device, device for providing geometric data, device for creating a control file, etc. - as well as devices programmed in this way. The devices, which can be part of the computer system or are in signal connection with it, can each be named according to the method step carried out by them.

If it is disclosed herein that the object according to the invention has one or more features in a certain embodiment, it is also disclosed herein that the object according to the invention specifically does not have this or these features in other embodiments according to the invention, e.g. B. in the sense of a disclaimer. For each embodiment mentioned herein, the opposite embodiment, formulated as negation, for example, is also disclosed.

Advantageous further developments of the present invention are each the subject matter of subclaims and embodiments.

If an embodiment is mentioned here, this represents an exemplary embodiment according to the invention.

Embodiments according to the invention can have one or more of the features and / or method steps mentioned below in any combination, provided that a specific combination is not recognizable as obviously technically impossible for the person skilled in the art. The subjects of the subclaims also each specify embodiments according to the invention.

When a creation is mentioned here, when it relates to physical objects such as the prosthesis socket, the inner socket, etc., this can be understood as a production, manufacture, manufacture or production of the same. The creation time is then the time of finishing, manufacturing, manufacturing or generating.

In some embodiments, the data is not geometric data, although it may be referred to as such herein.

In some embodiments, the data are topographical data of the limb stump, data which the tissue composition, in particular the water content, the Reflect the percentage of muscle, the percentage of adipose tissue or the blood flow.

If a first, second or further time of wearing is mentioned here, in some embodiments this is a date that can be determined according to the calendar, for example on March 1, in 30 days, 60 days after event X, etc. Alternatively or In addition, when a first, second or further time of wearing is mentioned, this can be a time at which a condition is met, for example a time at which the prosthesis wearer has meanwhile walked 5,000 steps, 10,000 steps or more, which can be counted is, for example by means of a pedometer, or has fulfilled another measure of mobility. Wearing times can also be combinations in which they z. B. occur, for example when z. B. 10,000 steps have been taken, or if 30 days have passed, or as soon as the first or the second of these conditions (and / or further conditions) is met, e.g. B. when at least 30 days have passed and a total of 10,000 steps have been counted, etc.

Measurement times can also be determined using steps taken (or using an interval ranging from X steps to Y steps, etc.).

In some embodiments, the invention or the method further comprises reading out a pedometer or mobility sensor which indicates the steps or mobility of the patient or the patient while he is e.g. B. wears his prosthesis, records.

The pedometer or mobility sensor can be inserted into the prosthesis, e.g. B. be integrated into the prosthesis according to the invention. Of the Prosthesis socket according to the invention, inner or outer socket or the extension according to the invention for the prosthesis socket can thus have a step counter or mobility sensor.

The pedometer or mobility sensor can be carried by the patient, e.g. B. in the form of a bracelet, a chip, a wearable, an app on his cell phone, smartphone or other electronic device.

The pedometer or mobility sensor can be part of a GPS system or a positioning system, etc.

The pedometer or mobility sensor can be connected to a computer, a server, a cloud, a smartphone, etc. by means of a signal transmitter. It can be connected to a computer of the orthopedic technician supervising him or a computer in a workshop for the construction of prostheses or shafts, an end mill or the like, or be in signal connection.

A signal receiver can be prepared in order to evaluate, read out, or the like, the signals from the signal transmitter. Received signals can be evaluated to the effect that it is determined on the basis of their information content or their design when, for. B. a first, second or further wearing time has been reached or will presumably be. It can thus z. B. can be determined by means of the computer system that the next wearing time, the z. B. should be reached with the current prosthesis socket, inner socket, outer socket or extension run 10,000 steps, approaches. A prosthesis socket, inner socket, outer socket or an extension as described herein can thus be timely are created, or a control file for their creation, so that the next required (replacement) prosthesis socket, inner socket, outer socket or extension can be created for the patient without re-measuring his limb stump, which he z. B. can be picked up after notification or can be delivered by post, which is also all covered by the present invention.

In some embodiments, the data or geometric data determined in the method according to the invention, especially for manufacturing or planning the manufacturing, are predicted data. There are then no actual data and / or measured data that represent or co-determine the shape of the limb stump at the time the data is determined or at the time the prosthesis socket or control signals are created. A prosthesis socket manufactured on the basis of such data would not suit the patient as best as possible at the time of creation, but only later, at the time designated here as the first wearing time. Such measured data may, however, have been used for the prognosis. 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. An example is the circumference or the water content (edema) of the limb of the limb. The prognosticated data can already show changes in the limb stump since the creation of the prosthesis socket, inner socket, etc. In other words, by comparing the data or dimensions of the limb stump that it actually has at the time of creation ("actual data") with the data that it has after the time has elapsed between the time of creation and the first or shows or will show, according to experience, a change in shape that has taken place in the meantime can be read off.

In some embodiments of the method according to the invention, the determination (which in any embodiment can be understood in the sense of use) of the data and / or geometric data, which are data forecast for the specific patient P, takes into account patient data which, in particular, is current, health-related Reflect the patient's condition. Predicted data and patient data can be or will be assigned to one another.

“Patient data”, as used herein, can include or consist of the state of health, for example at the moment of determination or creation, the patient's age and other medical characteristics or special features mentioned herein, also in any combination with one another In addition or as an alternative, make statements about medical characteristics before or at the time of the determination or creation, such as previous illnesses. Such patient data can be measured and / or anamnestic or clinical, etc.

Examples of this patient data can be:

- the age or an age group of the patient,

- information about the time elapsed since the amputation,

- whether the provision of the patient with a prosthesis is a first or a subsequent prosthesis, - whether the patient is obese (measurable for example via the body mass index (BMI) or bioimpedance, e.g. using an electronic scale, body composition monitor, and the like),

- the genesis or cause of the amputation (for example, as a result of a 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 a PAD / AVK,

- data on cardiac output (e.g. whether there is heart failure),

- whether the patient has a protein deficiency,

- whether the patient suffers from diabetes (mellitus),

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

- How the patient's vein situation looks (e.g. the presence of a deep vein thrombosis (DVT) or other thromboses and / or existing varicose veins (varices) and / or whether the patient has already had to undergo variceal surgery, for example),

- Operations that have already been carried out (especially in the area of the extremity affected by the amputation, for example in the groin due to a cardiac catheter procedure),

- heart failure,

- metabolic diseases,

- Movement behavior of the patient (athletes, strollers, office workers without sporting compensation, etc.),

- how many steps the patient takes in a unit of time (hours, days, weeks, etc.), - step size or length,

- walking or running speed, e.g. B. mean, maximum, movement profile distributed over the day, etc.,

- Mobility, measured in a way other than a pedometer,

- composition of body tissue, e.g. B. of the limb stump, about the fluid, fat and / or muscle percentage (for example by a bioimpedance measurement, for example measured by means of a body composition monitor) or information about a content thereof (in absolute values), information about the blood flow, information about the Distance over which the limb stump passes over bony structures (e.g. femur), e.g. B. in the longitudinal direction, protrudes,

- body mass index,

- Relationship between body surface area of a defined area of the limb stump and body weight of the patient;

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

Patient data can be used herein e.g. B. a health condition or an assignment of the patient to one or more health conditions, to which the age of the patient but also his medication, physical activity, number of steps taken, etc. can be mentioned here.

These patient data preferably do not already include the fact that the patient is missing at least one limb or parts of an extremity.

In some embodiments, geometric data are therefore optionally also associated with patient data in addition to a geometric statement or are preferably assigned to them at least in a stored state of the data, for example the information about a previous illness or underlying illness (see above examples for patient data) and / or they are categorized, classified or cataloged on the basis of the assigned patient data.

So z. B. for a patient P to be cared for, who is 40 years old and diabetic, data from a collective of patients who were also 40 years old and diabetic when data relating to their limb stump were collected on them.

In some embodiments, however, geometrical and / or forecast data are not reference data which e.g. B. be present in a data collection or library, which include pattern designs for prostheses or sections thereof, for example subdivided with regard to the skeletal structure of the cross-section (i.e., for example, the question of how far a bony structure is from a skin surface of the limb stump), with regard to the residual limb length and the tissue mass, especially if these reference data are not further categorized or classified with regard to further patient data (see e.g. above). In some embodiments, such reference data are not taken into account, in particular, if they are to be used to create a prosthetic socket, inner socket, outer socket, extension, etc. that fits or is best suited at the time of creation, which is for immediate use (and not for later use) Wear time) should fit or should fit as well as possible, used or taken into account.

The data, such as patient data, can be used individually or in groups in any combination for the prognosis of the Change in the shape of the limb stump over time (e.g. between the time it was created and the time it was first worn) and can therefore be used, used and / or processed when determining the geometric data, e.g. B. in the presence of diabetes and obesity and / or in connection with a certain age or age group. In particular, can also

Findings gradations or staging of the aforementioned findings and other previous illnesses, e.g. B. as patient data, taken into account and included in the prognosis.

An option or a measure with which such patient data can be included in the determination of the geometric data can be an indication in percent, centimeters, or in another way or - purely optionally - in other units. This level can lead to a change in the z. B. prognostic data determined from a collective of patients, as z. B. are shown by way of example in Fig. 6, lead or flow into this, for example by subtracting empirical values, which are derived from the observation of diabetics or patients with other medical conditions relevant to the future change in the shape of the limb stump (such as, for example, are mentioned above) are known. Likewise, such a measure can be purely optional to be added to the data of the collective for some medical conditions. The invention also encompasses a percentage factor (or its use) by which the empirical data can be multiplied for the collective of patients whose patients do not have the specific medical condition.

According to the invention, the collective data can have been collected on patients who have a specific medical condition are not affected. This data can be as stated above, e.g. B. by means of the above measure, can be adapted to the specific patient in whom the specific medical condition is present.

In some embodiments, however, the collective data have already been collected on patients in whom one and / or the other of the above. medical conditions (patient data) or another medical condition is present, or any combination of two or more such medical conditions is present. In this case, no adjustment is required. The data collected on the group as prognosis data for the patient P who is waiting for care then generally do not require any adjustment to the medical condition, since this was also available in the group. It can be sufficient here if the collective data are classified or categorized according to their patient data. However, an adjustment may still be made optionally, either because it may be necessary or advantageous. It can thus be advantageous to optionally take into account the degree to which the medical condition is present or was present (staging, stage, degree, classification, NYHA, age, etc.) for a fine adjustment.

The data collected on the collective and used as prognosis data for the patient P due for care can, of course, take into account the time interval z. B. be classified between the amputation or the creation time on the one hand and the first wearing time on the other hand. As an alternative or in addition, for a specific patient P who is 40 years old and a diabetic, in some embodiments it is possible to predict how things will be on the basis of the collective data relating to 40-year-old diabetics The limb stump will change between the time it was created and the time it was first worn (e.g. in a week, two weeks or 3 months, etc.). With a view to the patients of the collective and the data collected on them over a sufficiently long period of time, for the specific patient P, for example, at the time of creation. B. be said that his limb stump presumably z. B. will lose 4 cm in circumference, experience a decrease in volume of, for example, 5%, or the like.

The actual data of the collective can be stored, taking into account the associated patient data of the patients measured, e.g. B. in one of the devices according to the invention, or at a location where the devices according to the invention such. B. the computer system can access them, for example in a database, a storage device, the computer system itself, etc. The devices according to the invention can be configured to (back) access such stored data. Alternatively, these data can be entered by the user of the devices according to the invention 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 run automatically, for example once, several times and / or regularly.

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

When used herein by mathematical arithmetic operations, such as. B. addition, subtraction, division or multiplication, the speech is, then all other known mathematical arithmetic operations are also included according to the invention. The ways mentioned above and below for determining the prognosis data or for determining or adapting the geometric data, in particular due to medical conditions, are purely exemplary.

In some embodiments, the actual data of the collective, which is or has been stored, is or has been collected using a device which is used for the production of a plaster cast or a data model of the limb stump. Such a device, which is also referred to herein as an impression device, can have a pressure vessel with a pressure chamber for receiving pressurized fluid, preferably a liquid. The pressure vessel can have a wall made of a first material. The wall delimits an interior of the pressure vessel from an exterior. The pressure vessel can have an insertion opening for introducing the limb stump into the interior of the pressure vessel. Such a device can have a fluid-tight membrane made of a second material, which is arranged to form or delimit the fluid chamber or the pressure chamber. The pressure vessel can have a device for adjusting the pressure prevailing in the pressure chamber.

In some embodiments, the actual data of the patients are or were advantageously collected by means of such an impression device, since in this way they can be collected, so to speak, by machine or at least using a machine and thus reproducibly. In this way, it is advantageously possible to measure a number, possibly also a smaller number, of patients or their limb stumps, and in doing so for results that are clearly comparable with one another (Actual data or measured values) to come. Deviations, or at least relevant deviations, between the procedure when collecting actual data on the limb stump on a first patient A of the group on the one hand and the procedure when collecting actual data on the limb stump of a second patient B of the group on the other hand are not to be expected according to the invention, because the manual procedure, which can depend on the orthopedic technician in charge and, moreover, on his experience, is replaced by the use of the device or at least significantly supported and standardized.

Likewise, for the same reason, deviations, or at least relevant deviations, between the procedure when collecting actual data on the limb stump on the first patient A of the collective at a first point in time on the one hand and on the same patient A at a second point in time on the other hand, are not to be expected according to the invention.

In some embodiments, the actual data determined in the method according to the invention or for the method according to the invention are or comprise measured values am

Limb stumps of different patients in the collective, which were recorded for the observed patients in the collective at different measurement times, e.g. B. several times at constant intervals (z. B. every four weeks) or at different intervals, z. B. with increasing distance between successive points in time.

In some embodiments, the aforementioned actual data of the collective are or have been collected when the pressure on the limb stump increases over the course of the number of collection times. Thus, when the above impression device is used, the Pressure that prevails in the pressure chamber during the elevation, is set by the machine or is or has been applied to the limb stump at least once between a first measurement or elevation time and a subsequent measurement time. The other settings on the impression device can remain unchanged. The observation of the inventor of the present invention has shown that in order to manufacture a prosthesis shaft that optimally fits at the time of the survey or measurement, with increasing distance z. B. for the first care of this patient after amputation, at least in the following weeks or months to determine the dimensions of a prosthesis that optimally fits at this point in time, an increasing pressure is to be applied to the limb of the limb.

The aforementioned printing device for collecting the actual data of the patients in the collective can be designed as described in WO 2016/135320 A1, WO 2018/065362 A1, or in WO 2018/234486 A1. Reference is hereby made in full to their disclosures.

In some embodiments, the data, in particular the geometric data, describe the shape of the limb KS of the specific patient P treated by the method according to the invention at a point in time in the future ("future data") and differ from those data which describe the limb KS of this patient P at the time of creation (“actual data”). A prosthesis socket, inner socket, outer socket or extension created with the "future data" would not yet fit the patient at the time of creation and / or would not be made to the data or dimensions available at the time of creation (and should be provided to the patient at the time of creation The time of creation does not yet fit, but it will fit at a later time of wearing), as the limb stump will change its shape between the time of creation and the time of wearing.

In some embodiments, the data or geometric data determined in the method according to the invention are or include the result of an estimation.

Alternatively or in addition, they are read from a lookup source. Such a look-up source can be, for example, a table of values and / or a database.

Estimation and / or reading out and / or calculation can take place by means of a device, computing device, or the like programmed for this purpose.

In some embodiments, the actual data that are or have been collected on the collective of patients and are used according to the invention as geometric data for the specific patient P would or are collected by means of or using a device or impression device that is used in the production of a Plaster cast or a data model of the limb stump is used. Such a device has a pressure vessel with a pressure chamber for receiving pressurized fluid, preferably a liquid. The pressure vessel has a wall made of a first material and a fluid-tight membrane made of a second material. The device is used to at least partially receive the limb stump of the patient to be fitted with a prosthesis in order to determine the shape of the limb stump, as far as this is helpful for the adaptation of a prosthesis. In some embodiments, the geometric data is or includes the result of a calculation based on an algorithm. This algorithm can in turn be created using an expert system and / or can be based on a large number of comparison data. Measured actual data can be used and / or data that has already been processed, for example data that has already been classified or assigned to patient data, can be further processed.

Both the lookup source and the algorithm can be the result of the use of artificial intelligence or constitute it. For example, machine learning tools, e.g. B. based on artificial neural networks, for determining or processing the geometric data based on the provided actual and / or patient data can be used or come, in one of the ways known to a person skilled in the art.

The geometric data can be obtained by evaluating measurement results on limb stumps of a large number of patients, the number of patients or the collective being preferably 10, 50, 100 or more, preferably per class or category. To obtain the geometric data, e.g. B. the actual data of the respective limb stump of the individual patient have been measured from the plurality of patients, 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 be compared (as actual data) with the measurement results obtained from the same patient at later or later times of wearing, for example after 3 months and after 6 months. This is the course of the change in the shape of the limb of these patients over the different measurement times known, so z. B. at t = 0, i.e. for example immediately after amputation, i.e. as part of an initial treatment of the respective patient with a prosthesis, at the first wearing time or at another measurement time of the respective patient after perhaps one month, at a second wearing time or measurement time after perhaps another month, at a third wearing time after perhaps another four weeks, i.e. after a total of three months, etc.). The actual data and measurements obtained in this way can be collected and / or evaluated as a function of further patient data, for example in a reference source. If you now know the actual data of the patient P to be specifically treated by the orthopedic technician or of his limb KS, then the reference source or another storage location can be taken from or determined from this, such as based on the experience that results from the measured values / actual Data on the limb stumps of the large number of patients in the collective have shown that the geometric data of the limb stump KS of this patient P at one or more later wear times (e.g. after 1, 2, 3, 4, 5 and / or after 6 months) probably because the collective can be used to estimate how the limb stump KS will change, since it is known how the limb stumps of the patients in the collective have changed over time (e.g. after 1, 2, 3, 4 , 5 and / or after 6 months). The empirical values on the

Collected patients were collected, so they can 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 wearing times, in particular at the reference points considered, z. B. measuring points, will probably be. Intra- and extrapolations can be helpful here. Optionally, the mentioned look-up source and / or the above-mentioned algorithm are based on actual data or measured data and often provide data that differ from this in terms of size. B. available as geometric data or output them.

In some embodiments of the method according to the invention, there are at least 30 days, preferably at least 90 days, in particular at least 180 days, between the creation time of the prosthesis socket or the creation time of the control file for its production on the one hand and the first time the prosthesis socket is worn on the other.

It does not matter in certain embodiments whether z. B. a prosthesis socket created according to the invention is actually worn at the first time it is worn. What is more important is that it was manufactured so that it can be worn the first time it is worn, in particular, of course, with the greatest possible comfort on that day. This increased wearing comfort can be the aim of the method according to the invention.

In some embodiments of the method according to the invention, the geometric data additionally also include data which determine the shape of the limb stump (e.g. based on experience, assumption, prediction, calculation using models, algorithms, artificial neural networks, artificial intelligence, comparison with a collective and / or machine learning) at least at a second point in time, referred to herein as the second time of wearing, or - because they can hardly ever be complete - co-determine (here also only: co-determine for short). These dates can take into account a change in the limb stump over time, for example the change in its dimensions (e.g. due to swelling or swelling). The second wearing time is later than the first wearing time, 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 wearing times.

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 creation step. As an alternative or in addition, a control file with control data can also be created. In this embodiment, the prosthesis socket and / or the corresponding control file are based on the geometric data that were determined, measured and / or calculated using the method according to the invention and that will help determine the shape of the limb stump at at least one second time of wearing as described above.

According to the invention it can be provided that both geometric data for the first time of wearing and, preferably at the same time, that is z. 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 geometric data for a second wearing time and / or further wearing times and / or prosthesis socket, inner or outer socket or extension for the first wearing time and to create the further wearing time (s).

In certain embodiments, an extension is a supplement for the prosthesis socket, an accessory, a built-in element, an inner socket, or the like. In some embodiments, the extension is provided to be generally arranged in the interior of the outer socket, the inner socket or the prosthesis socket, e.g. B. at or from the first or further time of wearing. It can preferably be given to the patient P to take it home with him on the day it was created, whereby the day of creation can correspond to the day of determination.

In some embodiments, e.g. B. the method or kit according to the invention, the inner socket is used to accommodate the limb stump or at least sections thereof. It is provided for its part to be received in an interior of the outer shaft, at least in sections thereof.

In some embodiments, e.g. B. 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 is inserted between its layers.

The extension is not adjustable in some embodiments. It may optionally be compressible, it may optionally be elastic. In some embodiments it is not adjustable; so it can optionally z. B. not be inflatable, not be or will not be connected to a pump, have no lines or be connected to them and / or cannot be varied by the patient.

In some embodiments, the prosthesis or the prosthesis shaft do not have a device for actuating the extension, for example a mechanical device provided for this purpose Device such as an actuator, a pump, a fluid reservoir and / or lines provided for actuating the extension.

In some embodiments, the computing system is configured to be in signal communication with or in signal communication with a manufacturing machine.

When a signal or communication connection between two components is mentioned here, this can be understood to mean a connection that is in use. This can also mean that there is preparation for such (wired, wireless or otherwise implemented) signal communication, for example by coupling the two components, for example by means of pairing, etc.

Pairing is a process that takes place in connection with computer networks in order to establish an initial link between computer units for the purpose of communication. The best-known example of this is the establishment of a Bluetooth connection, by means of which various devices (e.g. smartphone, headphones) are connected to one another. Pairing is sometimes referred to as bonding.

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 production 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 an injection device. Here, the production machine is optionally configured to create the prosthesis socket, the inner or outer socket or the extension (or sections thereof) based on control signals. These control signals can in turn have been created by the method according to the invention.

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

The inner shaft can be dimensionally stable. It cannot be elastic. Its shape can, without wanting or having to destroy it, in any case under normal conditions of use for it or for the prosthesis socket according to the invention, be dimensionally stable or solid. The inner shaft can consist of or have carbon fibers.

The inner shaft can consist of the same material as the outer shaft or 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 circumferential contour of the outer shaft.

The outer shaft can have a first strength or elasticity (for example expressed as total strength or total elasticity or as average total strength or total elasticity, for example in the direction of the greatest extent of the circumferential section). The inner shaft can have a second strength or elasticity which is higher than the first or equal to that, i.e. than that of the outer shaft, with the same procedure when measuring the strength or elasticity.

In some embodiments, the outer shaft only surrounds the inner shaft in sections, while in others it surrounds it completely.

In certain embodiments, the inner shaft is preferably at least one of: one-piece, closed circumferential, seamlessly circumferential, without doubling in the sense of wrinkling, without step, without gap and / or slot, 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 comprise or consist of at least one Velcro connection, an adhesive connection and / or a screw connection.

In some embodiments, the extension is not or does not have a pumping system.

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 do not have a lacing system or a tensioning system that would allow the change of the one surrounded by the respective shaft Volume or to change the diameter of the respective shaft or shaft section would be used.

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

Optionally, at least any element of this group was created at the time of creation, based on available actual data of the specific patient P, which reproduce or co-determine the shape of the limb of this patient at the time of creation. Such actual data can e.g. B. be measured directly on the limb stump or be, for example by means of the impression device disclosed herein for use in the preparation of a data model or a plaster cast. As a rule, they do not correspond to the determined data or geometric data.

In some embodiments, the step of determining the geometric data does not include any of the steps (or does not correspond to any) that lead to the acquisition of measurement data on the specific patient P that can be obtained when measuring the limb stump or that would have been measured on his limb stump, at least not, in order to already use the one to be used at the first time of wearing and created for this purpose according to the invention based on this To create prosthesis socket, outer socket, inner socket or extension or control signals. Steps that lead to the receipt of measurement data lead, in particular, to data obtained by means of measurement by means of a tape measure, by means of scanning, by means of laser measurement or scanning, by means of

Ultrasonic measurement or scanning, by determining the proportions of solid tissue (bone) in relation to the proportions of soft tissue (fat, edema, connective tissue, muscles).

In some embodiments, the step of determining also includes taking into account actual data or measured data, referred to herein as measurement data. Receiving the measurement data (as actual data) on the specific patient P, on the other hand, is optionally not part of the method.

By means of such actual data, at least one element of the group, which consists of the prosthesis socket, inner socket, outer socket or at least one extension, can be generated or have been generated. This means that at the time of creation, the patient can be given one element of this group that already suits him initially (based on his actual data), and at least one further element of this group that is only weeks in the future for him at the time of the first wearing time, which is intended to be weeks can, will fit (based on the determined geometric data).

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

In some embodiments, determining is reading, estimating, forecasting and / or determining geometric data for one in the future Understood lying wearing time, but preferably no measurement on the specific patient P at this wearing time.

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 taking into account what is known as a reduction measure (RM) or, as a supplement, it does. One speaks of a reduction measure when the orthopedic technician z. B. from the thigh circumference and one

Constriction measurement defines a measure by which the dimensions of the shaft to be manufactured by the orthopedic technician must deviate from the actual data measured on site on the patient P so that the shaft manufactured by the orthopedic technician can be used by the patient P in the immediately following use and when exposed to the body weight of the Patient P gives sufficient support. The reduction dimension is therefore taken into account by the orthopedic technician for the dimensioning and construction of the stem of the prosthesis, with the aim of adapting the prosthesis stem as optimally as possible to the measured limb stump and its properties for the time of its first use (time of creation). Taking into account a reduction dimension thus serves to compensate for inadequacies that occur in connection with the measurement of the limb stump before the patient uses the prosthesis for the first time.

In some embodiments, the method also includes the creation of control signals or of a control file with control signals, in each case for creating a prosthesis socket, although this is not based on the determined geometric data, but based on measured data Actual data. The actual data reflect the shape of the limb stump at the time of creation, while the data or geometric data describe or approximate the shape of the limb stump at one or more wearing time (s) lying more or less far after the time of creation.

In some embodiments, the geometric data is approximated data derived from data obtained from the

Creation time or at a specific time when the patient P was worn or were measured would have been measurable.

In some embodiments, the geometric data are not data on the specific patient P and are not data collected on him, but data collected on a collective of patients or by means of a collective of patients, or data calculated based thereon.

When it is said here that the geometric data will help to determine the shape of the limb stump at a point in time when it is worn in the future, this means in some embodiments that there is a reasonable assumption that this will be the case. This assumption can be based on empirical values. It can be based on the fact that based on the specific shape of the stump at the time of creation and the z. B. values determined from patient collectives, it can be assumed that the limb stump with sufficient experience at the intended wearing time will show the geometric data, such as a predicted circumference at a predetermined height, for example measured at a predetermined distance of z. B. an immobile bony structure. It is not certain whether this will happen. If measurements are to be made at further measurement times, the pressure is preferably increased several times or always between two successive measurement times.

Preferably, all of the actual data mentioned herein are or are measured, optionally at any point in time, in particular for both the specific patient P and the patients of the collective, by means of the same imprint device or sensor arrangement (or with identical imprint devices or sensor arrangements), or during the respective , to be measured limb stump was arranged in each case in the impression device filled with water. There is preferably or was pressure on the limb stump of the patients in the collective, which was always calculated and / or set in the same way, with the pressure or how it was determined and / or set - across the collective - differing from the point in time at which it was created Moment of first aid, which can differentiate between different wearing times or measurement times, but preferably not between the individual patients of the collective at the same wearing time (e.g. always after 1 month, or always after 2 months, or ...), creation time, Time of measurement, moment of first aid, etc. This can result in extremely valuable reproducibility, which can also correspond to the pressure exerted on the prosthesis by the patient's weight at the time of wearing.

Is z. For example, in the case of the specific patient P at the time of creation, a pressure is set in the device in a manner x (e.g. calculated using the same formula, always always at a constant value y for the pressure, etc.), so is provided in some embodiments that to manufacture or for planning the manufacture of his prosthesis socket, etc. data or geometric data, the geometric data being determined or provided which were collected from a collective of patients whose limb stumps were also subjected to a pressure in the device at the time they were created or at the time of initial care which was set in the same way x (e.g. calculated using the same formula, always always with a constant value y for the pressure, etc.). The patients selected in this way, who can also be brought into congruence with the specific patient in terms of their patient data (same age, same illness, etc.), can be those whose later measurements are used as the basis for the geometric data for the first time of wearing second wearing time etc. are considered when manufacturing or planning the production of the prosthesis socket etc. of the specific patient P.

Measurement times, as used herein, preferably do not fall on a day determined by date or calendar, but depend on a predetermined event, for example on the day of the amputation of the limb that left the limb stump, or on the day on which the freshly amputated patient left the bed for the first time, or from the day on which the patient's limb stump was first measured to manufacture a prosthesis (creation time), etc. B. between 3 to 10 days after amputation, etc. includes. In this way, the measurement times can all depend on one and the same event, but in the life of different patients in the collective, or can be calculated on the basis of this. Will they z. B. calculated from the day of the amputation, so the first measurement time z. B. be one month after amputation, the second measurement time z. B. two months after amputation, etc. This means that z. B. the first measurement time does not fall on the same day in the calendar for all patients, but has the same time interval for patient A from his amputation day as for patient B or at least for A and B falls within a period of a predetermined width.

If (first, second, etc.) wearing times are now specified for the specific patient P in order to determine the associated geometric data of the collective of patients associated with these wearing times, the actual data measured on the collective at the first, second, etc. measurement time are used for this . If you are interested e.g. B. for data that the limb KS will have at a first wearing time, which z. B. is one month after the amputation or after the time of creation, the orientation is based on geometric data that were measured in the collective one month after the comparable event (amputation, time of creation, etc.) as actual data templates or measured.

A "measurement time" as used herein can be identical to a "wear time". If the time of wearing (for a specific patient) is, for example, 30 days after amputation, data can be used that were collected at a measurement time which was also 30 days after amputation (in the collective).

The terms “time of measurement” and “time of wearing” can therefore be exchanged for one another in some embodiments. In some embodiments of the method for creating a data collection, for the purpose of measuring the actual data, the pressure prevailing in the pressure chamber when measuring at the first measuring time is set and / or maintained lower than when measuring at the second measuring time on the device by means of the pressurization control device.

In some embodiments, the first measurement time is the time of initial supply or creation.

In some embodiments, the pressure that should prevail in the pressure chamber during a measurement time is determined using a look-up table or using a simple or simplified formula.

Such a formula can

P = (m * 9.81 * 4 * P) / U ² , with

P as the target pressure to be set by the pressurization control device or set pressure, m as the mass of the (possibly weighted down)

Patients

P as a circle number and

U as the circumference of the limb stump, e.g. B. in the field of

The entry opening or the entry plane of the prosthesis shaft and / the most distal (with the patient standing in the starting position according to the neutral-zero method) horizontal cross-section of the limb stump, also known as the insertion plane. 0. g. The value 9.81 can be understood here as a spatial factor and / or can be exchanged for this and have the dimension m / s ² .

As a first approximation, this formula leads to sufficiently good results. However, it can be modified. Other sizes mentioned herein can also be used.

According to the invention, P = F / A is optionally used as an alternative formula, with

P as target pressure or set pressure,

F as a force acting on the membrane, e.g. B. as

Patient weight (possibly weighted or not), and

A as the surface of the pressure P applied

Limb stump during the measurement within the impression device.

If A increases with time since z. B. the amputation at z. B. stable patient weight G over z. B. successive measurement times, then P is to be increased in order to bring about a constant force which acts on the limb stump during measurement.

According to the invention, P = G / Q is optionally used as a further formula, with

P as target pressure or set pressure,

G patient weight (possibly weighted down or not), and

Q as the cross-sectional area of a cross-section of the

Limb stump; the cross-sectional area can be that of the most distal (in the case of the standing Patients should be in the starting position according to the neutral-zero method (horizontal) cross-section of the limb, also known as the insertion plane.

Has Q increased with increasing time since e.g. B. the amputation at z. B. stable patient weight G from, then P is to be increased in order to bring about a constant force which acts on the limb stump during measurement.

In some embodiments, therefore, over some or all of the successive measurement times, a constant value range or a value range that does not differ from a predetermined value range (e.g. stated in percent, for example a maximum of +/- 2%, 3%, 5%, 10% or 15%) moving out product of P * Q or P * A aimed or effected by pressure adjustments by means of the pressurizing device or the pressurizing control device.

In a simple case, the aim can be to achieve a constant value range or a value range that does not differ from a predetermined value range (e.g. stated in percent, e.g. a maximum of +/- 2%, 3%, 5%, 10% or 15%) to strive for moving out product of P * U ² or to effect it through pressure adjustments by means of the pressurizing device or the pressurizing control device.

In some embodiments, for the purpose of measuring the actual data, e.g. B. pertaining to the specific patient at the time of creation and / or pertaining to the collective of patients (preferably all patients and at all measuring times) at the measurement times, the product of the pressure prevailing in the pressure chamber during measurement on the one hand and the circumference, the square of a circumference or the cross-sectional area of the limb stump, preferably in the insertion plane, kept constant or within a predetermined value range when measuring at the first and when measuring at the second measuring time and / or at further measuring times. This product can optionally vary from patient to patient. It should preferably be constant for the individual patient.

The circumference, square of a circumference or cross-sectional area of the limb stump can be e.g. B. to the heights shown in Fig. 6 at 12 cm or 15 cm (not shown, see column A in Fig. 6).

In some embodiments, none of the methods according to the invention include user interaction with a 3D socket or stump model in order to modify it. In some embodiments, none of the inventive devices is configured to enable such user interaction.

In some embodiments, the computer system and / or imprint device have transmitting or receiving devices in order to be able to be in signal communication with one another via them. The transmitting or receiving devices can be prepared, configured and / or programmed for this. Actual data measured or collected by the printing device can thus be transmitted to the computer system, preferably automatically, for example in a wired or wireless manner, e.g. B. by means of a network of computer-implemented computer programs (e.g. client / server system, cloud computing system, etc.). In certain embodiments, the impression device and / or the set has a stocking, adhesive stocking or another sensor arrangement for being pulled over the

Limb stump, the stocking, the adhesive stocking or the sensor arrangement having sensors for producing a data model or for transmitting position data.

In some embodiments, the measurement of actual data when creating the data collection comprises the use of a stocking, adhesive stocking with sensors or another sensor arrangement for pulling over the limb stump, the stocking, adhesive stocking or sensor arrangement sensors for producing the data model or for transmitting Has position data.

The sensors can be arranged in a distal section resting on the body stump at a smaller distance from one another than in a section located proximally thereto. The distance can relate to the circumferential direction and / or the longitudinal direction of the limb stump.

In some embodiments according to the invention, the device has at least one, preferably two or more cameras, image recording systems, surface scanners, magnets or laser scanners, 3D scanners, infrared scanners or other types of scanners, ultrasound devices or other devices which are suitable and / or configured, the adhesive stocking or to detect or measure the sensor arrangement into which the limb stump is inserted and / or to measure its volume and / or geometry (e.g. length, width, surface, outer contour, radii, curvatures, dents, Edges, angles and the like), or the stump of the limb. Based on these measurements, recordings, scans and the like, it may be possible to produce a socket for the limb stump without having made a plaster cast for this purpose. With this procedure according to the invention, there is advantageously no need to make a plaster cast. In certain embodiments according to the invention, the detection or measurement is a scanning and / or a surface scanning of the limb stump.

In some embodiments according to the invention, the surface of the limb stump is scanned with at least one sensor, advantageously with at least one line structure of sensors, e.g. B. with sensors arranged in a line or row, which are arranged approximately along one or more straight lines.

In some embodiments of the invention, the sensors are on a surface, e.g. B. the adhesive stocking or the sensor arrangement arranged. The surface is optionally designed so that it can adapt to measuring the surface area of the limb stump.

In some embodiments according to the invention, the surface can consist of or have strip-shaped sections. The band-shaped sections can intersect or overlap, for example at a center point. The center point can be the same or substantially the same distance from the free ends of the band-shaped sections that meet in the center point.

The space (alternatively: gap) between two band-shaped sections meeting and / or adjacent at a center point or close to it can be free, that is to say especially free of material. The space (or gap) can increase in width towards the free end or towards the proximal or upper end of the band-shaped sections in use.

In this way, wrinkles in the sensor arrangement or in the adhesive stocking can advantageously be counteracted in the case of a slender limb stump, or wrinkles can even be completely avoided.

In some embodiments according to the invention, the surface consists of a preferably even number, for example six, eight or ten, band-shaped sections or has these. Any two of them can optionally merge into one another in one piece in the area of the center point.

In some embodiments according to the invention, the width of the band-shaped sections is 1 cm to 5 cm, preferably exactly or about 2 cm.

In some embodiments according to the invention, the band-shaped sections are not elastic.

In some embodiments according to the invention, some or all of the band-like sections, in particular band-like sections that are adjacent to one another, are connected to one another by further, preferably elastic, band-like sections or other, again preferably elastic, structures.

In some embodiments according to the invention, the band-shaped sections are releasably connected to the further band-shaped sections or other structures.

In some embodiments according to the invention, the connection between the band-shaped sections and the further band-shaped sections or other structures on or consists of a Velcro bandage.

In some embodiments according to the invention, the band-shaped sections or the other structures are inextricably connected to the further band-shaped sections.

In some embodiments according to the invention, the band-shaped sections or other structures are glued to the further band-shaped sections.

In some embodiments according to the invention, the band-shaped sections are riveted to the further band-shaped sections or other structures.

In some embodiments according to the invention, the band-shaped sections with the further band-shaped sections or other structures are at an angle to one another which is between 70 ° and 110 °, preferably at a right angle, for example measured during intended use.

In some embodiments according to the invention, when the sensor arrangement is used as intended, the band-shaped sections preferably run completely or essentially along the longitudinal axis of the limb stump or in a projection thereon and / or along the outer contour of the limb stump in a direction from distal to proximal.

In some embodiments according to the invention, all or some of the sensors are iron cores, preferably with magnetic coils, or have iron cores, preferably with magnetic coils. In some embodiments according to the invention, the sensors and / or the transmitting device and / or the receiving device are not based on an optical system or a laser-based system.

In some embodiments according to the invention, the device or the set has a transmitting device and / or a receiving device for transmitting and / or receiving signals from the sensors of the adhesive stocking or the sensor arrangement.

In some embodiments according to the invention, the sensor arrangement, the sensors, the transmitting device and / or the receiving device are designed and / or used as disclosed in WO 2018234486 A1, the disclosure of which is hereby incorporated in its entirety.

Methods disclosed herein may be a common method. Any combination of your steps can be performed in a common procedure.

In some embodiments, the impression device or its pressure container has a wall with or made of metal. In some embodiments, the membrane has silicone.

In certain embodiments, the membrane is screwed directly or indirectly to the pressure vessel or clamped using one or more screws.

By means of some or all of the invention

Embodiments may include one or more of the above or im

The following advantages can be achieved. The limb stump is subject to daily volume fluctuations, as well as to 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 prosthesis stem both at the time of its creation or adjustment (the

Creation time) as well as at later times (the observed wearing times) as if freshly adapted to the limb and still guarantees the required stability even after muscular atrophy, especially when standing and walking. It is obvious that e.g. B. a prosthesis outer socket, which must bring considerable stability to fulfill its task, cannot adapt to such a cross-sectional change in the limb of the limb due to its strength.

The present invention is used advantageously for the rapid adaptation or adaptability of the prosthesis socket to a change in shape of the limb stump. The wearer himself can easily adjust the fit by changing the accuracy of fit of his prosthesis in just a few simple steps.

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

Clicking in, gluing, etc.), which based on the determined data for later use, namely for use at the first (or a further) time of wearing, can already have been made prematurely at the time of creation.

Since the adaptation of, for. B. manufactured on the day of creation, prosthesis socket to a change in shape of the limb stump by the wearer himself can be done comfortably by using a few simple steps the accuracy of his z. B. given at the time of creation prosthesis z. B. by inserting the extension at the time of first wearing, it is possible and also desirable that the prosthesis socket fits as best as possible on the day of its creation from a technical point of view. The prosthesis socket can thus be manufactured in order to optimally fit the residual limb geometry present at this point in time from the first minute of wearing (e.g. already at the time of creation and thus well before the first wearing time). A worsening of the "fit" over time (e.g. over the next few weeks) due to changes in the shape of the limb stump is not problematic in the light of the present invention, since the patient does not need to visit the orthopedic technician again to find the optimum from the technical point of view Restoring the fit of the prosthesis socket yourself, e.g. by inserting the second inner socket given to it at an early stage (e.g. at the time of creation) or by inserting the extension given to it at an early stage, which is already matched to the change in shape of the limb stump expected up to the first time of wear However, since this is so easy for him to do, and since his prosthesis socket fits perfectly from the first minute of wearing, i.e. at the time of creation, he also wears it as intended from the first minute of wearing, and in particular it puts a lot of strain on him. The latter contributes to this at that the body gli edstump is loaded from the first minute of wearing as medically desired and that the prosthetic stump is in optimal mechanical interaction with the limb from the first minute of wearing, so that the limb is preferably not optimally through a not already optimal from the first minute of wearing matching prosthesis socket z. B. pressure points, scarring, wound healing disorders, cornifications, etc. developed. Such developments of the limb stump, which regularly become chronic, can advantageously be avoided by means of the present invention or the probability or severity of their occurrence can be reduced. Since the prosthesis socket created at the time of creation fits the patient as best as possible from the first minute of wearing, it is advantageously possible to mobilize the patient sufficiently early and comprehensively, which is advantageous because otherwise there will be no sufficiently rapid recovery, for example with regard to the healing of amputation wounds on the limb of the limb , takes place.

The use of the same impression device or device of the same construction for this purpose when measuring on the collective and on the specific patient, as suggested in some embodiments, can significantly increase the reproducibility of the data obtained and the value of the data obtained on the collective for the specific patient, also because this results in the Influence and the individual experience of orthopedic technicians, which can in each case lead to different measurement results, can be replaced by objective procedures. A further contribution to this is if the pressure in the impression device during measurement, as disclosed herein, is or was always set in an identical manner at certain measurement or wear times.

The present invention is explained below by way of example with reference to the accompanying drawings, in which identical reference symbols designate identical or similar components. In the partially simplified figures, the following applies: 1 shows a prosthesis shaft as part of a thigh prosthesis, which is only partially shown, with several extensions according to the invention in a longitudinal section;

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

3 shows an inner socket according to the invention as part of a thigh prosthesis, which is only partially shown, in a longitudinal section;

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;

Fig. 6 shows schematically a reference source for use in the method according to the invention;

7 shows a longitudinally sectioned device or impression device used according to the invention in section with a pressure application control device in a first embodiment from the side;

8 shows a method according to the invention for manufacturing or planning the manufacture of a prosthesis socket, an inner socket, an outer socket and / or an extension of the prosthesis socket in a schematically simplified manner in an exemplary embodiment; and 9 shows a method according to the invention for creating a data collection in a schematically simplified manner in an exemplary embodiment.

1 shows an outer socket 4 as part of a prosthesis socket 2 of a thigh prosthesis, which is only partially shown. The relatively stiff, shell-shaped outer shaft 4 accommodates 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.

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).

Unlike prostheses of this type, as they 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 expansions 12 and 14 according to the invention, which can each press the wall 18 of the inner shaft 6 in the relevant areas with their inner wall, so as to reduce the local temperature To achieve internal shaft volume.

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

More precisely, the widenings 12 and 14 are here optionally in the dorso-lateral area following an edge 22 of the thigh bone (femur) 24 (indicated by dashed lines) or arranged in the medial-distal area. The enlargement 12, extending from proximal to distal, optionally has an elongated shape, whereas the enlargement 14 optionally has a rather round shape.

As indicated by means of the arrows in the cross section through the prosthesis shaft 2 of FIG. 1 shown in FIG. 2, the thighbone 24 experiences a more or less strong adduction in a deliberate manner as a result of the enlargement 12.

They can be used to correct the abduction that usually occurs in transfemoral amputees for a certain period of time after the amputation. In addition, the extensions 12 and 14 allow the socket volume to be reduced and the stump in the socket, here: in the inner socket 6, to be given increased surface adhesion. This surface adhesion in turn makes it possible, with the aid of the optional extension 20, to restore a desired stump end contact after the swelling has decreased and, if necessary, after atrophy processes.

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

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

It is not necessary to hand over the prosthesis with the outer socket 4 and would not have offered the patient P any increased wearing comfort. According to the invention, however, was already on or before the day of the handover (e.g. on

Determination time) it has been determined how some of the data or geometric data of the limb stump would in all probability change in the foreseeable future (e.g. at the first wearing time). The The stump of the limb was changed by muscular remodeling and possibly a reduction in swelling in such a way that the outer socket 4 made at the time could no longer fit optimally. The patient P can independently correct the discrepancy between the shape of his limb stump, which has changed in the meantime, and the unchangeable shape of the outer socket 4 of his prosthesis by inserting the change in the shape of his limb stump that is expected in his case (according to the geometric data) . In the present example it only has the extensions 12, 14 and 20 as from the orthopedic technician on

Use the determination time already considered and, if necessary, secure it against slipping within the prosthesis socket 2. In this way, he can restore the desired accuracy of fit of his prosthesis without having to visit the orthopedic technician again and without specialist knowledge.

Fig. 3 shows a second embodiment of the prosthesis shaft 2 in longitudinal section. Fig. 4 again shows a cross section thereof.

In contrast to what is shown in FIG. 1, the prosthesis shaft 2 does not have any 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 socket 6a, which differs fundamentally from the inner socket 6 in FIGS. 1 and 2.

At the points at which, in the embodiment of FIGS. 1 and 2, the widenings 12 and 14 were intended to compensate for the muscular remodeling with the aim of exerting pressure on the femur 24 in the direction of the arrow, the process shown in FIG. 3 and 4 of the rigid and specially shaped Inner shaft 6a this function. Its rigidity 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 rigidity of the inner shaft 6a from FIG. 3 allows it to remain dimensionally stable and still apply the desired pressure exercise the thigh stump.

The inner shaft 6a is, so to speak, a shaft from the retort: its dimensions are not based on the actual data or dimensions that the orthopedic technician measured on the patient's stump to provide the patient P with a prosthesis. Rather, its dimensions are based on data forecasted into the future or geometric data, of which it was assumed at the time of the treatment that the limb stump would accept them later 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 upper 6a is already the second inner upper, that is, an inner upper which, from the start, was only intended to be worn from the first time of wearing. It is assumed that the patient was provided with an inner socket (not shown in the figures, which can also be part of the kit according to the invention) by the orthopedic technician, who placed the outer socket 4 with continuous contact on its inside. It is also assumed that this original inner upper is worn at a first point in time, that is to say e.g. B. weeks or months after the care at the orthopedic technician, no longer fit optimally, which is why he through the inner socket 6a shown in FIGS. 3 and 4 while maintaining the original Outer socket 4 was replaced at the first or further time of wearing.

5 shows a computer system 200 according to the invention.

The computer system 200 each optionally comprises a computing device 210, a look-up source 220 (such as a database), an input device 230, an output device 240, a manufacturing machine 250 and / or a step counter or mobility sensor 260. The aforementioned units 220, 230, 240, 250 and 260 are each optional and can be connected to or integrated into computing device 210. They can be in one-way or two-way signal communication with the computing device 210. They can be connected to each other in any way. Each of these connections can be wired or wireless.

The computing device 210 can serve to determine the geometric data. For this purpose, it can use an optional look-up 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 information or patient data such as age, weight, mobility classification (1 to 4), physical activity, etc. of patient P, which are optionally entered using input device 230 can output, by simply assigning these data to empirical values of already existing geometric data, which the limb stump KS of the patient P will presumably assume at certain times in the future (referred to herein as wearing times). The output can take place by means of the output device 240, e.g. B. in the form of an indication 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 transmitted to the production machine 250. The desired component, for example the inner shaft or the extension, or section or parts thereof, can be produced on it, optionally automatically. The indication and / or the control signals may include information where e.g. B. generated extensions 12, 14, 20 are to be placed in the prosthesis socket 2.

Fig. 6 shows an example of how measured actual data (optionally in connection with patient data) of a collective are used to determine geometric data of the specific patient P.

A limb stump KS, shown on the left in FIG. 6, of the patient P, which is only partially shown, can have the measurement results shown in the table shown on the right in FIG. 6 when it is measured. Column B shows the measurement results obtained on the limb KS of the patient P and gives the respective measured circumference (in cm) at a distance of z. B. 6 cm, 9 cm and 12 cm to a predetermined reference point or cross-section (column A). The values in column B also apply here as actual data for patient P. They were measured at the positions of the limb stump KS mentioned in column A before the prosthesis socket 2 was created, preferably with the impression device or device 100 disclosed herein, as it is e.g. As shown in Fig. 7 or disclosed herein.

When examining a large number of patients in a collective with comparable limb stumps and / or comparable patient data, z. B. before the start of the inventive method for manufacturing and / or in Course of the process for creating a data collection, measured values, ie actual data collected on the collective, which - here as an example - the cross-sections of the limb stump z. B. 6 cm, 9 cm and 12 cm at later, defined wearing times, at which preferably again by means of the impression device - or a model of the same construction - has been measured. They provide clues as to how the limb KS of patient P will probably look at the reference points or cross-sections mentioned in column A at later times of wearing. For example, the numerical values in column C indicate which circumferential values will be available at the positions mentioned in column A at the first time of wearing, approximately 3 months after the prosthesis has been created, since they were similar values in the collective, and if necessary, they are recorded in the collective Actual data, alternatively related to the limb KS of the patient P. They thus preferably indicate which measured values the limb KS of the patient P would presumably assume, since these measured values have already been applied to a sufficiently large collective, for example by monitoring the changes observed in the collective in the measured values - preferably each recorded by means of the impression device - over three Reflect months and, if necessary, have already been determined mathematically adapted to the measured actual data of patient P.

Column D indicates circumferential values from which one can assume, based on the earlier measurements on the above-mentioned patient collective, that the specific limb stump KS shown on the left in FIG will assume the positions mentioned in column A. In other words, Fig. 6 shows a look-up source on the right. Your columns C and D can be seen which geometric data a

Body limb stump KS, which at the time of first fitting with a prosthesis (e.g. at the time of determination) at the positions named in column A shows the values of column B, at the first and second wearing times considered here as an example, will show all assumptions or experience, namely the values of columns C and D. Reading them out can represent a determination in the sense of the present invention.

If the 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 which also consisted of diabetics. According to the inventor's experience, their limb stumps change regularly more slowly between different measurement times than is the case with patients who, for. B. have lost their lower leg in an accident. If patient P were an athlete, columns C and D would possibly show different values.

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 data than those noted in column B, the values C and D could also have turned out different, in particular larger.

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

Instead of taking them from a look-up source, geometrical data can be determined according to the invention on the basis of an available data volume at the moment of determination.

Although the present invention is described or discussed 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), the invention is in no way limited to the treatment of a limb stump of the lower extremity. According to the invention, what is stated herein applies analogously without restriction to the supply of the upper extremity (upper arm, forearm, hand) and to the products proposed for supply such as prosthesis socket, inner socket, outer socket and extensions.

FIG. 7 shows an impression device or device 100 cut lengthways or in the longitudinal direction (i.e. from top to bottom in relation to FIG Design z. B. the method for manufacturing or for planning the manufacturing and / or the method for creating a data collection.

The device 100 has at least one pressure vessel 31, which in turn has a wall 33 and a membrane 35 or consists of these.

The pressure vessel 31, which can purely optionally be cylindrical as shown in FIG. 7, optionally has a first End face 32 (above in FIG. 7) and a second end face 34 (below in FIG. 7). In the exemplary embodiment in FIG. 7, the second end face 34 is closed in a fluid-tight manner with respect to an outside with a base plate or base surface 34a. The bottom surface 34a can be made of the same material as the wall 33.

The membrane 35 separates a fluid chamber or pressure chamber DK of the pressure vessel 31 in a fluid-tight manner from an exterior of the fluid chamber or pressure chamber DK, or, for example, from the exterior, i.e. the surroundings of the pressure vessel 31, or, as shown in FIG. 7, from one in the diaphragm 35 introduced or surrounded by this limb stump KS.

The membrane 35 can be connected to the pressure vessel 31 in a fluid-tight manner at an upper, often ring-shaped, rectangular, square or otherwise circumferential edge 37 of the wall 33, or at another point.

The upper edge 37 lies here by way of example in a plane in which an insertion opening 39 of the pressure vessel 31 lies, or delimits this at its circumference. The insertion opening 39 lies in the plane indicated by a dashed line.

The insertion opening 39 serves to introduce the limb KS wrapped with a moist plaster bandage into an interior I of the pressure vessel 31.

The interior I is the volume of the pressure vessel 31 delimited by the wall 33. It extends from the second end face 34, which is closed in a fluid-tight manner by the bottom surface 34a, to the insertion opening indicated by 39 and indicated by a dashed line. The pressure chamber DK is filled with a fluid, here by way of example with a liquid F indicated by dots. Filling with gas is likewise covered by the present invention.

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

The limb stump KS is preferably loaded with the full body weight of the standing patient. With knowledge of the volume of the interior I or of the pressure vessel 31, the amount of the liquid F is preferably dimensioned such that the limb stump KS can enter the pressure vessel 31 through the insertion opening 39 at least to such an extent that the entire surface of the plaster of paris bandage, but at least so far relevant to the print, with which membrane 35 is in contact. At the same time, the amount of liquid F is such that the distal end of the limb stump KS (at the bottom in FIG. 7) preferably does not touch the bottom of the pressure vessel 31 or is not supported on it. This ensures that it is the pressure of the fluid on which the patient rests with the inserted extremity, and that the plaster of paris bandage experiences the same pressure at every point by means of the membrane 35. It can be seen from FIG. 7 that the membrane 35, when no limb stump KS is inserted into the pressure vessel 31, floats or floats due to the pressure of the fluid, in this case the liquid, and a liquid level (not shown in FIG. 7) is established. 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 KS and through it - in the example of FIG. 7 - in depth of the interior I is "taken along" in the direction of the bottom surface 4a.

It can also be seen from the figure that wall 33 and membrane 35, by preventing an exchange of fluid between the pressure chamber DK and the outside or preventing fluid from escaping from the pressure chamber DK, enable the desired pressure to be achieved within the pressure chamber DK of the pressure vessel 31 builds up, but cannot escape from it or break down.

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

In an embodiment of the present invention other than the exemplary embodiment shown in FIG. 7, the pressure chamber DK can consist of or comprise a membrane which is closed all around and which, like a balloon or a bladder, can lie in the interior I of the pressure vessel 31.

For the pressure vessel 31 shown in FIG. 7 or in one of the following figures, as for the pressure vessel, any other according to the invention applies Embodiment that this instead of a round cross-section can have a non-round, preferably an angular, cross-section. The cross section can, for example, be rectangular, polygonal or square. The last-mentioned cross-sections can advantageously avoid or reduce artifacts, which can arise due to the curved peripheral surface, particularly during the automatic measurement of the limb stump KS introduced into the device 100 by means of a camera or the like, as described herein.

The membrane 35 is optionally connected in a force-locking manner 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 frictional connection is brought about 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.

As shown by way of example in FIG. 7, the connector 353 can be a thread. Any other suitable connector, such as a tape, a Velcro tape or the like, is also encompassed by the present invention.

The connector 353 holds the membrane 35 preferably in the area of the second end face 34 of the pressure vessel 31, in particular in the area of the bottom surface 34a and preferably in its middle or center, positively and / or positively and / or materially connected to the pressure vessel 31 or the bottom surface 34a .

It is preferred that the connector 353 at least when the device 100 is in use, that is to say when in the Limb KS introduced into the pressure chamber DK allows flow around the distal end of the limb KS completely or essentially completely. A flow around the limb stump KS is thus advantageously still possible in FIG. 7 except for the area which corresponds to the cross section of the connector 353. In this way, buoyancy or the pressurization of the distal section of the limb KS by the fluid, which is so important for readjusting or simulating the later loading situation in the finished shaft, can take place.

In addition to the optional connector 353 shown in FIG. 7, several or further connectors can be provided. Like the connector 353, these can be connected to the bottom surface 34a. As an alternative or in addition, they can be connected to the pressure chamber DK or the pressure vessel 31 at a section of the wall 33 other than the end face or bottom face 34a. This also applies to the connector 353 shown in FIG. 7.

The connection between connector 353 on the one hand and wall 33 or bottom surface 34a on the other hand can - as independently of this 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 connection, a snap connection, a latching connection or the like. It can be solvable or unsolvable.

The connector shown in Figure 7 is preferably not elastically extensible. It is preferably not stretchable. The membrane 35 shown in FIG. 7 is likewise preferably non-stretchable and / or non-elastic in the longitudinal direction L.

In certain embodiments, "non-stretchable" or "non-elastic" means that the modulus of elasticity of the component in question (connector, membrane, fibers, etc.) is at least above 700 N / mm ² , preferably above 1000 N / mm ² , particularly preferred above 2000 N / mm ² .

In some embodiments, "non-stretchable" or "non-elastic" means that an extension of the component in question (connector, membrane, fibers, etc.) does not exceed 20%, preferably no more than 10%, preferably no more than 5%, particularly preferably not more than 2% of its length before the component tears or breaks.

The medical device 100 is preferably connected to a pressurization control device 410. The pressurization control device 410 is abbreviated as control device 410 in the following. It can be designed to regulate the pressure.

The control device 410 comprises a pressure reservoir connection 413, which can be designed as a connection to a pressure source, for example to a water pipe. Furthermore, in the embodiment shown here, the control device 410 comprises a separate outflow connection 415 for emptying the fluid from the pressure chamber DK. Alternatively, the outflow could take place, for example, by means of a multi-way valve which can be connected to the pressure reservoir connection 413. The control device 410 of FIG. 7 furthermore comprises an optional pressure limiting valve which is arranged within the control device 410 (not shown in FIG. 7). The pressure limiting valve can limit the pressure prevailing in the pressure reservoir connection 413, so that the pressure present downstream of the pressure limiting valve does not exceed a value that can be predetermined or optionally set by the user. In this way, an excessively high pressure in the pressure chamber DK can advantageously be avoided or prevented, which, for example, could cause an excessively high pressure load on the limb KS, and thus damage and / or pain, and also a distortion of the plaster cast. The pressure relief valve can limit the pressure to a maximum of 0.8 bar, purely as an example.

The control device 410 optionally further comprises a pressure chamber connection 417, which z. B. is connected to a control valve 419 for increasing the pressure in the pressure chamber DK or has one. The control valve 419 can, for example, manual actuation, the pressure in the pressure chamber DK, z. B. gradually, up to a desired or up to the maximum pressure, which is limited by the pressure relief valve, increase.

Furthermore, the control device 410 optionally comprises a pressure chamber return flow connection 421, which is connected to a further regulating valve 423 for reducing the pressure in the pressure chamber DK, or has one. The further control valve 423 can, for example with manual actuation, the pressure in the pressure chamber DK z. B. gradually, as required, reduce. After completing the preparation of the plaster cast, so after z. B. a predetermined drying or curing time, the pressure in the pressure chamber DK can be reduced to such an extent that the The patient can pull the limb stump KS out of the device 100.

In the embodiment shown, the control device 410 further comprises an optional inlet pressure indicator 425 and an also optional emergency stop device 427. The inlet pressure indicator 425 can be referred to as a manometer and as an additional display, for example as a safety indicator or redundancy arrangement for monitoring the Pressure in the pressure chamber DK, be provided. The inlet pressure indicator 425 is arranged, for example, with or in a connecting line in the control device 410 between the regulating valve 419 (for increasing the pressure in the pressure chamber DK) and the pressure chamber connection 417.

Emptying the pressure chamber DK by means of the pressure chamber backflow connection 421 and the drain connection 415, controlled via the further regulating valve 423, can take place in different ways. For example - z. B. downstream of the drain connection 415 - a suction pump can be connected, which sucks fluid F out of the pressure chamber DK when the further control valve 423 is opened and, if necessary, sucks it empty. Likewise - z. B. downstream of the outflow connection 415 - optionally a Venturi nozzle or a Venturi tube for sucking off or emptying the fluid F from the pressure chamber DK can be connected or be. A venturi nozzle can, for example, be connected to an external water connection, for example to a faucet on a wash basin. If the water tap is opened and water flows through the optional Venturi nozzle, a negative pressure is generated in a line connected to the drain connection 415 and fluid F is sucked off with the further control valve 423 open. A venturi nozzle advantageously does not require an electrical connection, as would be necessary, for example, with a suction pump.

The exemplary embodiment of the control device 410 described here advantageously requires no electrical components and thus no power supply and no power connection. Embodiments in which this is otherwise are also encompassed by the present invention.

In other embodiments of the invention than those described herein, the pressurization control device 410 consists of a device for applying pressure to a fluid reservoir, such as a supply container.

For this purpose, it is considered, for example, to provide a mechanical or hydraulic pressing device, by means of which the fluid with the desired, but in any case sufficient pressure from a supply container or the

Pressurization control device 410 can be deployed.

Such a mechanism can have a crank mechanism, a pressing or clamping mechanism with clamping surfaces, a foot actuation device, the structure of which corresponds or is similar to that of a bellows or a bicycle pump, or the like. By means of such a pressurization control device 410, on the one hand, the required pressure can be achieved; on the other hand, the user of the device 100 is not dependent on external pressure sources such as water connections or the like used according to the invention. The pressurization controller 410 can be operated electrically. However, this is not necessary. It can be provided to be able to work without a power supply.

Fig. 8 shows the method according to the invention for manufacturing or planning the manufacture of a prosthesis socket 2, an inner socket 6 and / or an outer socket 4 and / or an extension 12, 14, 20 of the prosthesis socket 2 in a schematically simplified manner in an exemplary embodiment. The prosthesis socket 2 is provided for receiving a limb stump KS (see FIG. 7).

The method according to the invention comprises, as step F1, the determination of data, in particular geometric data, or the provision of data, in particular geometric data. In this case, such data, in particular geometric data, are preferably determined which describe, determine or co-determine the shape of the limb stump KS at at least one point in time, located in the future. In this case, data are preferably determined which, at least at the first time of wearing, should help determine or determine the shape of the prosthesis socket 2, the inner socket 6 or the outer socket 4 or the extension (s) 12, 14, 20 (or the shape that these should then have) . The data or geometric data can be forecast values or dimensions, estimated values or expected values, in particular about future shapes. The data or geometric data can have been created based on measurements on the collective or can be derived therefrom, as disclosed herein. The measurements on the collective can be performed using the device or impression device disclosed herein, see e.g. B. Fig. 7, have been collected. The method optionally further comprises, as step F2, the creation of the prosthesis socket 2 or sections thereof. This is done based on the determined data and / or geometric data.

As an alternative or in addition to the aforementioned creation of the prosthesis socket 2 or of sections thereof, the method comprises, as step F3, the creation of at least one control signal, in particular the creation of a control file with control signals, based on which a production machine (e.g. direct or indirect) steps to Creation of the prosthesis socket 2, the inner socket 6, the outer socket 4 or the extension 12, 14, 20 and / or can create at least one of the aforementioned devices or parts thereof.

The time of creation (also: creation time) is before the first time of wearing.

9 shows the method according to the invention for creating a data collection or ascertaining body limb dimensions in a schematically simplified manner in an exemplary embodiment.

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

As an optional step S2, the method according to the invention comprises providing a pressurization device and / or a pressurization control device 410 for setting, causing and / or maintaining a pressure prevailing within the pressure chamber DK.

As step S3 of the method according to the invention is a measurement of actual data of limb stumps KS, preferably always at the same predetermined positions, circumferences or locations of or on the limb stumps, a plurality of patients or a collective of patients. The measurement takes place at least at a first measurement point in time by means of the device 100. The measurement on the collective of patients can take place here by means of the device 100, a measuring device contained therein or connected to it, or by hand. The measurement can be done directly, e.g. B. on the limb of the patient of the collective, and / or indirectly, z. B. on a geometric data obtained by means of the device 100 or with it, respectively created for the patients of the collective, positive or negative models, impressions, plaster casts or prosthetic sockets, etc.

The measurement of actual data of the limb stumps in each case at at least one second measurement time, which is after the first measurement time, is included as a further step S4 of the method according to the invention. The measurement here is preferably also carried out by means of the device 100, or as indicated above, and preferably at the same positions or locations on the limb stump as the measurement at the first measurement time. As step S5, the method optionally includes collecting and / or assigning patient data to the measured actual data of the patient collective, which were measured at the first measurement time or at the second measurement time. The measured actual data, which were measured at the at least two measurement times, are thus assigned the same patient data in each case.

A subsequent classification of the actual data measured at least at the first measurement time and the actual data measured at least at the second measurement time on the basis of the patient data assigned to them is included as a further optional step S6 of the method according to the invention.

The classified actual data are stored or stored in a step S7 of the method according to the invention for creating a data collection based on their classification in a suitable storage medium, such as a database, for example in order to access them in the context of the method according to the invention for manufacturing or planning the production of a Prosthesis socket 2, inner socket 6, outer socket 4 and / or an extension 12, 14, 20 of the prosthesis socket (see FIG. 8) to be able to access (backwards). As an alternative or in addition, these data can be evaluated and / or further processed by suitable devices. List of reference symbols

2 prosthesis socket

4 outer socket

5 inlet opening

6 inner socket 6

7 slot

8 distal end of the outer shaft

10 columnar component

12 extension

14 extension

18 wall

20 extension

22 edge

24 femur

26 empty space

28 empty space

31 pressure vessels

32 first face

33 wall

34 second end face, can optionally be closed with the bottom surface

34a floor space

35 membrane

37 top margin

39 Insertion opening

100 device

200 computer system

210 computing 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,

Pressurizing device

413 pressure reservoir connection

415 drain connection

417 pressure chamber connection

419 control valve

421 Pressure chamber backflow connection

423 another control valve

425 Inlet pressure indicator

427 emergency stop device

Exterior of the pressure vessel

DK pressure chamber of the pressure vessel

F fluid or liquid

I Inside the pressure vessel

KS limb stump

L lengthwise

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 prosthesis socket (2 ) is provided for picking up a limb stump (KS) of a patient (P), with the steps:

- Determination of geometrical data or provision of geometrical data, the geometrical data showing the shape of the limb stump (KS) at at least one first time the prosthesis socket (2), the inner socket (6), outer socket (4) or the extension (12, 14) is worn , 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 sections thereof, based on the geometric data, or

- Creation of a control file with control signals, based on which a production machine steps for creating the prosthesis socket (2), des Inner socket (6), outer socket (4) or the extension (12, 14, 20), the creation taking place at a creation time prior to the first wearing time, and the geometric data not being data measured on the patient (P) .

2. The method of claim 1, further comprising the step

- Reading out a step counter or

Mobility sensor (260) which records the steps or mobility of the patient (P).

3. The method according to claim 1 or 2, wherein the geometric data is predicted data, data of variable dimensions of the limb stump, data which are subject to or due to changes in the course of time post-operative and due to a previous surgical operation, and / or data which do not represent or reflect the shape of the limb stump 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).

4. The method according to any one of the preceding claims, wherein the determination of the geometric data takes into account patient data which reproduce the or at least one, in particular current, health condition or finding of the patient (P) at the time of the determination and / or at a previous point in time and / or being the geometric data from a collective of patients with this health condition or finding.

5. The method according to any one of the preceding claims, wherein the geometric data by means of or using a device (100) are or were collected from a collective of patients, the device (100) for use in making a plaster cast or a data model of the Limb stump (KS) is suitable and / or intended and has a pressure vessel (1) with a pressure chamber (DK) for receiving pressurized fluid (F), preferably a liquid, the pressure vessel (1) having a wall (3) a first material and a fluid-tight membrane (5) made of a second material.

6. The method according to any one of the preceding claims, wherein the geometric data are or include the result of an estimation, a readout from a look-up source and / or a calculation based on an algorithm.

7. The method according to any one of the preceding claims, wherein at least 3 days, preferably at least 10, 20, 30, 60, 90 days, in particular at least 180 days, 12 months or 24 months lie between the creation time and the first wearing time.

8. The method according to any one of the preceding claims, wherein the geometric data also include data that will help determine the shape of the limb stump at at least one second time of wearing, which is after the first time of wearing, whereby 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 time of wearing and the second time of wearing.

9. The method according to any one of the preceding claims, wherein 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 a corresponding control file for the production machine (250) is created based on the geometric data that will help determine the shape of the limb at least at the second time it is worn.

10. The method according to any one of the preceding claims, wherein the inner shaft (6, 6a) serves to receive at least portions of the limb stump and in turn is provided to receive it at least in sections in an interior of the outer shaft (4).

11. The method according to any one of the preceding claims, wherein the extension (12, 14, 20) 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 placed between its layers is is.

12. 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 a Sprayer is configured to create of the prosthesis socket (2), the inner socket (6), the outer socket (4) or the extension (12, 14, 20) or sections thereof based on the control signals.

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

Prosthesis socket (2) manufactured by means of the method according to one of the preceding claims.

14. Kit with at least one element from a group consisting of prosthesis socket (2), inner socket (6), outer socket (4) or at least one extension (12,

14, 20), each manufactured according to the method according to one of claims 1 to 12, consists.

15. Kit according to claim 14, wherein at least a first element of the group was created based on the geometric data which help determine the shape of the limb stump (KS) at the first time of wearing, and wherein at least a second element of the group is based on the geometric Data was created that help determine the shape of the limb stump (KS) at the second time it is worn.

16. Kit according to one of claims 14 and 15, further comprising at least one further element of the group consisting of prosthesis socket (2), inner socket (6), outer socket (4) or at least one extension (12,

14, 20), wherein the further element is generated based on actual data and / or measured data, which the shape of the limb stump (KS) for

Help determine the date of issue.

17. Computer system programmed to carry out the method according to one of claims 1 to 12.

18. Digital storage medium, in particular in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to configure a control and / or regulating device to a control and / or regulating device (29) with which the method according to one of claims 1 to 12, or to configure a computer system to a computer system according to claim 17.

19. Computer program product with a program code stored on a machine-readable carrier in order to configure a control and / or regulating device into a control and / or regulating device (29) with which the method according to one of claims 1 to 12 can be carried out , or to configure a computer system to a computer system according to claim 17.

20. Computer program with a program code to configure a control and / or regulating device to a control and / or regulating device (29) with which the method according to one of claims 1 to 12 can be carried out, or to a computer system Configure the computer system according to claim 17.

21. Procedure for creating a data collection, with the steps: Providing a device (100) for use in making a plaster cast or a data model of a

Limb stump (KS) which has a container or pressure vessel (1) with a pressure chamber (DK) for receiving pressurized fluid (F), preferably a liquid, the pressure vessel (1) having a wall (3) made of a first material and a fluid-tight membrane (5) made of a second material;

Providing a pressurizing device and / or a pressurizing control device (410) for setting a pressure within the pressure chamber (DK);

Measuring actual data of limb stumps of a multiplicity of patients in each case at at least one first measuring time by means of or using the device (100);

Measuring actual data of the limb stumps in each case at at least one second measuring time located after the first measuring time by means of or using the device (100);

Assigning patient data to both the actual data measured at the first measurement time and to the actual data measured at at least the second measurement time;

Classification of the actual data measured at the first measurement time and that of the second Actual data measured at the time of measurement based on the patient data assigned to them;

Storage and / or evaluation and / or further processing of the classified actual data based on their classification in a suitable storage medium, such as a database.

22. The method according to claim 21, wherein, for the purpose of measuring the actual data, the data prevailing in the pressure chamber (DK)

Pressure during measurement at the first measurement time by means of the pressurization control device (410) is set and / or maintained lower than during measurement at the second measurement time on the device (100).

23. The method according to claim 21 or 22, wherein, for the purpose of measuring the actual data, the product of the pressure prevailing in the pressure chamber (DK) when measuring and the square of a circumference of the limb stump, preferably in the insertion plane, when measuring to the first and at Measurement at the second measurement time is constant or lies within a predetermined range of values.

24. Set, having

- A computer system according to claim 17 and / or a computer system programmed to carry out the method according to one of claims 21 to 23; and

- A device (100) for use in the production of a plaster cast or a data model of the limb stump (KS), which has a container or pressure vessel (1) with a pressure chamber (DK) for receiving pressurized fluid (F), preferably a liquid, comprises, wherein the pressure vessel (1) has a wall (3) made of a first material and a fluid-tight one

Has membrane (5) made of a second material.

25. The set of claim 24 further comprising

- a pedometer or mobility sensor (260).

26. Set according to claim 24 or 25, wherein the computer system and the device (100) are in signal communication with one another or are prepared, configured and / or programmed for this in order to send actual data measured or collected by means of the device (100) to the computer system to transfer.

27. Set according to one of claims 24 to 26, wherein the computer system (210) and pedometer and / or mobility sensor (260) are in signal communication with one another or are prepared, configured and / or programmed for this purpose in order to use the

Pedometer or mobility sensor (260) to transmit measured or collected data to the computer system (210).