WO2024115647A1 - Procédé et dispositif destiné à générer des données de fabrication, et procédé destiné à fabriquer un manchon orthopédique - Google Patents

Procédé et dispositif destiné à générer des données de fabrication, et procédé destiné à fabriquer un manchon orthopédique Download PDF

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Publication number
WO2024115647A1
WO2024115647A1 PCT/EP2023/083710 EP2023083710W WO2024115647A1 WO 2024115647 A1 WO2024115647 A1 WO 2024115647A1 EP 2023083710 W EP2023083710 W EP 2023083710W WO 2024115647 A1 WO2024115647 A1 WO 2024115647A1
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WO
WIPO (PCT)
Prior art keywords
liner
model
manufacturing
individualized
electronic computing
Prior art date
Application number
PCT/EP2023/083710
Other languages
German (de)
English (en)
Inventor
Heiko GLINDEMANN
Leonard Vier
Florian Wolf
Olaf Kroll-Orywahl
Andreas Leiniger
Christoph SCHWAB
Sason VON DER HEYDE
Original Assignee
Ottobock Se & Co. Kgaa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ottobock Se & Co. Kgaa filed Critical Ottobock Se & Co. Kgaa
Publication of WO2024115647A1 publication Critical patent/WO2024115647A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/78Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/7812Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/5044Designing or manufacturing processes
    • A61F2/5046Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques

Definitions

  • the invention relates to a method for creating production data for the production of an individualized liner for a body part of a patient that is to be provided with an orthopedic product.
  • the invention also relates to a device and a computer program for this purpose.
  • the invention also relates to a method for producing an orthopedic liner for a body part of a patient which is to be provided with an orthopedic product.
  • Orthopaedic products such as orthoses or prostheses or even exoskeletons, must be developed and adapted precisely and accurately to the prevailing conditions of the handicapped person or the person to be supported in order to be able to provide the best possible care for the handicapped person's body parts. Even today, a large number of manual and hand-held work steps are necessary to produce such an orthopaedic product.
  • Prostheses replace limbs that are not or no longer present in terms of form and/or functionality.
  • Prostheses are used in particular on the upper and lower extremities and include, for example, prosthetic hands or prosthetic feet that are attached to a limb stump via one or more joints. If the lower leg is only partially present, a prosthetic foot is attached to the lower leg stump via a lower leg shaft, if necessary with a prosthetic ankle joint and, if necessary, a lower leg tube.
  • Prosthetic legs with a prosthetic knee joint are attached to a thigh stump via a thigh shaft.
  • the prosthetic component is attached via a forearm shaft or an upper arm shaft.
  • the prosthetic shafts to which the other distal prosthetic components are attached are predominantly cup-shaped and have a proximal entry opening into which the limb stump is inserted.
  • the fixation of the prosthetic shaft which usually has a circumferential shaft wall, can be based on different principles.
  • a liner (prosthetic liner) is then often arranged between the prosthetic shaft and the limb.
  • This liner has an elastomer material to cushion the limb against the hard shaft wall of the prosthetic shaft.
  • the adhesive and sealing properties of the material of the prosthetic liner are used to adhere to the surface of the skin and/or to implement suction shaft technology by creating a negative pressure between the shaft and liner, whereby the volume is usually sealed by means of a sealing lip arranged on the liner.
  • the prosthetic liner which can be sleeve-shaped and optionally with a closed distal cap, represents the intermediate piece or interface between the limb and the prosthetic shaft.
  • Liners of this type are known in numerous designs. They are usually made of an elastic plastic material, such as polyurethane or silicone, and are designed with a wall thickness that creates a cushioning effect. Due to their elasticity, the liners should fit tightly to the body part to be treated (e.g. the hip).
  • amputation stump and thus form a cushioning intermediate layer between the liner and a prosthetic shaft to which a prosthesis for an amputated limb can be attached and to exert a compression effect on the stump.
  • the system of prosthetic shaft and liner thus serves to attach a prosthesis to the body part to be treated. This attachment can be supported in a known technique by creating a vacuum between the liner and the amputation stump and/or between the liner and the prosthetic shaft, which increases the respective friction pairing.
  • the liner can be mechanically connected to the shaft via a pin at the distal end.
  • a prosthesis liner is known which is used to make the respective pressure situation of the prosthesis shaft visible in the applied state, so that by changing the prosthesis shaft it can be ensured that no pressure peaks or cavities occur during wear in order to ensure an even load and stress on the stump.
  • DE 10 2019 109 781 A1 discloses a method for creating production data for the automatic manufacture of an orthopedic device using an automated production system, in which a digital functional form is first provided. Based on the digital functional form, a volume model of the orthopedic device to be manufactured is created using a data processing system, whereby the production data for the automated production system is then generated based on the digital volume model.
  • DE 102020 126 435 A1 discloses a method for creating manufacturing data for the manufacture of an orthopedic device, whereby the orthopedic device is then manufactured using the created manufacturing data in an automated manufacturing process.
  • a 3D body part model of a body part of the patient to be treated is provided, as well as several digital functional component models of orthopedic functional components that are to be integrated into the orthopedic device.
  • a digital component interface is then generated using a data processing system in order to then create a corresponding digital orthopedic model on the basis of which the orthopedic device can then be manufactured.
  • EP 1 588 244 B1 discloses a method for producing a liner for a prosthesis, in which a 3D model of the body part to be treated is first recorded. Then, based on the recorded 3D model, a three-dimensional digital model of a liner is created, on the basis of which the liner is then produced.
  • a method for creating manufacturing data for manufacturing an individualized liner for a body part of a patient which is to be provided with an orthopedic product comprising the following steps:
  • Liner base model in particular in the form of a 3D liner base model, which fits the patient's body part to be treated. According to one embodiment, it can be provided that such a liner base model is selected from a large number of possible models and provided accordingly.
  • the liner base model provided in this way is then individualized by automatically changing at least one liner property, for example the shape or size of the liner, by the electronic computing device based on digital input data.
  • the digital input data is or was entered into an input device of the electronic computing device by a user, for example an orthopedic technician.
  • the boundary conditions and properties of the liner are specified so that the liner base model provided is changed so that it meets the boundary conditions and properties of the liner represented by the digital input data.
  • the input data is not measurement data of the body part to be treated, which results, for example, from a scan of the body part, but rather manual inputs in particular, which are intended to change one or more properties of the liner base model.
  • the electronic computing device then automatically creates the manufacturing data for producing the customized liner based on the customized 3D liner model, which can then be used to produce a liner in an automated manufacturing process.
  • the sealing lip cannot be positioned as far proximally as desired, as the liner must be suitable for different stump lengths and shafts. It is also often shortened for the respective user. If, on the other hand, the sealing lip position is individually adapted, it can be moved as far distally as possible.
  • the present method can also be used to produce liners that are individually adapted to certain, already existing prosthetic shafts, for example in such a way that a plurality of sealing lips are provided in order to best support the application of suction shaft technology.
  • a further advantage of the present invention is the avoidance of a 3D body part scan, which avoids errors when scanning or capturing the body part to be treated.
  • the process is therefore safer and much simpler and can cover a high degree of individualization, such as the local functional integration (e.g. wounds, breathing, adjustment of the angle range to the correct position of the knee, etc.).
  • Such a liner basic model is a sleeve-shaped volume model, possibly with a closed distal cap, in which the volume geometry is formed by a wall with a predetermined wall thickness that may vary across the entire liner.
  • the inner wall of the individualized 3D liner model is or will be adapted to the outer contour of the body part to be treated, provided that a corresponding 3D body part model is provided.
  • a 3D body part model can be created, for example, by scanning the body part to be treated, which can be created from the outside using a 3D scanner, for example.
  • the outer wall of the individualized 3D liner model is adapted to the inner contour of a prosthetic shaft, provided that a corresponding 3D prosthetic shaft model is provided.
  • the manufacturing data created according to the present invention are intended exclusively for automatically producing an individualized liner using an automated manufacturing system. After the manufacturing data have been created, they are therefore used to produce an individualized liner using a manufacturing system. According to one embodiment, it is provided that the created production data are transmitted by means of the electronic computing device to a production system for the automated production of the individualized liner.
  • Such a production facility can be designed to produce such a liner, for example using a 3D printing process.
  • the production data serves as input data for controlling the production facilities.
  • the digital liner base model is provided by selecting a liner base model from a plurality of liner base models stored in a digital data memory.
  • the selection of such a liner base model can be carried out automatically by the electronic computing device. However, it is also conceivable that the selection of such a liner base model is carried out manually by a user of the electronic computing device, for example an orthopedic technician.
  • Such patient data of the patient to be cared for can, for example, include data relating to the body part to be cared for, such as the size or shape of the amputation stump.
  • Data relating to body fat percentage, state of health, activity level or similar, which has an influence on the fit of the liner on the body part to be cared for, can also be taken into account when selecting the basic liner model. It is conceivable that relevant patient data is entered into the electronic computing device or that this is made available, with the electronic computing device then automatically selecting a corresponding basic liner model depending on the relevant patient data.
  • the digital liner basic model is provided by first providing a digital 3D body part model of the relevant body part for which the orthopedic product is intended to the electronic computing device, wherein a 3D liner basic model is then created by means of the electronic computing unit as a function of the digital 3D body part model.
  • a liner base model is created based on the 3D body part model that was provided to the electronic computing device, which is then customized based on the digital input data to create a customized 3D liner model. This makes it possible to adapt the inner wall of the liner base model to the outer contour of the amputation stump and then to further customize a liner base model that has been adapted in this way using additional digital input data, such as the selection of the material or the wall thickness.
  • a manufacturing process is automatically selected from a list of different manufacturing processes by the electronic computing unit and the manufacturing data are further created depending on the selected manufacturing process.
  • the computing unit can check whether whether a suitable print path is possible to create the desired liner.
  • an alternative method can be chosen, such as creating a mold.
  • At least one liner property of the individualized 3D liner model is adapted as a function of at least one second manufacturing method that is an alternative to the selected manufacturing method in such a way that the adapted individualized 3D liner model can be produced using the alternative second manufacturing method.
  • the already customized 3D liner model is modified automatically or manually based on suggestions so that the customized 3D liner model can be manufactured in the adjusted state using an alternative second manufacturing process, which may be cheaper in terms of production costs.
  • the electronic computing device determines changes or areas of changes in at least one liner property that do not lead to any fundamental deviation in terms of comfort or fit, but do lead to the possibility of using a second manufacturing process. For example, the wall thickness can be reduced or increased, which means that such a liner can be manufactured using an alternative manufacturing process.
  • the manufacturing process is an additive manufacturing process, in particular a rapid liquid printing process, or a mold casting process.
  • the object of the present invention is also achieved with the computer program according to claim 10, wherein the computer program has program code means configured to carry out the method described above when the computer program is executed on a data processing system.
  • the object of the present invention is also achieved according to the invention with the device according to claim 11 for carrying out the method described above.
  • the object is also achieved according to the invention with a method for producing an individualized liner according to claim 12, with the steps:
  • Figure 1 a Prosthetic liner according to the state of the art
  • FIG. 1 Schematic representation of the method according to the invention
  • Figure 5 3D liner model with modified flexion angle
  • Figure 7 3D liner model with modified sealing lip geometry.
  • FIG 1a shows a schematically highly simplified representation of a prosthetic liner 10, as is known from the prior art.
  • the prosthetic liner 10 has a substantially sleeve-shaped geometry that tapers slightly downwards, with an end cap being provided at a distal end of the prosthetic liner 10.
  • the prosthetic liner 10 shown in Figure 1a represents a type of standard liner that is not adapted to any individual needs of the patient. Such a standardized prosthetic liner 10 is therefore mass-produced without deviation.
  • Figure 1 b shows a selection of different customized prosthetic liners 20, all of which have been modified with respect to at least one liner property compared to the standard liner known from Figure 1a. These changes concern, for example, the size, the flexion angle, the position of the flexion angle and the number of sealing lips.
  • the prosthetic liners 20 shown in Figure 1 b can be produced according to the present inventive method.
  • FIG. 2 shows the method sequence according to the invention in a schematically simplified representation.
  • An electronic computing device 30 is initially provided with a plurality of digital 3D liner basic models, which are stored in a database 31. Furthermore, the electronic computing device connected to an input device 32, via which a user, for example an orthopedic technician, can enter digital input data for changing a 3D liner basic model.
  • the electronic computing device 30 now determines a 3D liner base model, for example based on patient data or by manual input, and makes the corresponding changes to the provided 3D liner base model based on the digital input data in order to create an individualized 3D liner model.
  • the individualized 3D liner model resulting from the change can then be displayed on a display device of the input device 32 so that the user receives immediate feedback on how the changes affect the liner model.
  • the manufacturing data 33 based on the individualized 3D liner model and a selected manufacturing process are automatically created by the electronic computing device 30 upon activation by the user, for example.
  • a digital 3D body part model of the patient's body part in question is stored in the database 31 and is made available to the electronic computing device 30. Based on this 3D body part model and the digital input data from the input device 32, an individualized 3D liner model is now generated, on the basis of which the production data 33 is then created.
  • Figure 3 shows on the left the lower end of a 3D liner base model 40 with a distal end cap.
  • the user for example the technician, has changed the distal circumference in the area of the end cap of the 3D liner base model 40 and in doing so has increased the size of the circumference, thereby creating an individualized 3D liner model 41.
  • This individualized 3D liner model 41 is shown on the right side of Figure 3.
  • the increased circumference in the area of the distal end cap compared to the 3D liner base model 40 on the left is clearly visible.
  • Such an adjustment is useful, for example, if the amputation stump has an above-average circumference or diameter in the area of its distal end, so that the liner can be adjusted to this.
  • Figure 4 shows a 3D liner basic model 50 on the left. On the right, a 3D liner model 51 is shown in which the overall length has been increased compared to the 3D liner basic model 50, making the entire liner longer. This allows the liner to be adapted to particularly tall people.
  • Figure 5 shows on the left side a section of a 3D liner base model 60, while on the right side a section of an individualized 3D liner model 61 is shown, in which a flexion angle 62 was set compared to the 3D liner base model 60.
  • Figure 6 shows on the left side a section of a 3D liner basic model 70, while on the right side a section of an individualized 3D liner model 71 is shown, in which the number of sealing lips 72 has been increased compared to the 3D liner basic model 70.
  • the 3D liner basic model 70 has one sealing lip, while the individualized 3D liner model has a total of 3 sealing lips 72.
  • Figure 7 shows on the left side a section of a 3D liner basic model 80, while on the right side a section of an individualized 3D liner model 81 is shown, in which the shape and size of the sealing lips 82 have been changed compared to the 3D liner basic model 70.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un procédé destiné à générer des données de fabrication pour la fabrication d'un manchon individualisé pour une partie du corps d'un patient devant être équipé d'un produit orthopédique, le procédé comprenant les étapes suivantes consistant à fournir une unité informatique électronique avec un modèle de manchon de base numérique correspondant à la partie du corps du patient, et générer un modèle de manchon 3D personnalisé à l'aide de l'unité informatique électronique, de façon qu'au moins une caractéristique de manchon du modèle de manchon de base fourni soit modifiée par l'unité informatique électronique sur la base de données d'entrée numériques fournies par un dispositif d'entrée de l'unité informatique électronique ; et générer automatiquement, au moyen de l'unité informatique électronique, des données de fabrication pour la fabrication du manchon personnalisé, sur la base du modèle de manchon 3D personnalisé et d'un procédé de fabrication sélectionné.
PCT/EP2023/083710 2022-11-30 2023-11-30 Procédé et dispositif destiné à générer des données de fabrication, et procédé destiné à fabriquer un manchon orthopédique WO2024115647A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102022131756.0A DE102022131756A1 (de) 2022-11-30 2022-11-30 Verfahren und Vorrichtung zur Erstellung von Fertigungsdaten sowie Verfahren zur Fertigung eines orthopädietechnischen Liners
DE102022131756.0 2022-11-30

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WO2024115647A1 true WO2024115647A1 (fr) 2024-06-06

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100161076A1 (en) * 2008-12-11 2010-06-24 Materialise N.V. Orthotic or prosthetic cushioned device and method of making the same
WO2013134268A1 (fr) 2012-03-05 2013-09-12 Otto Bock Healthcare Gmbh Revêtement d'indication de pression et procédé d'utilisation
US20140163697A1 (en) * 2012-05-04 2014-06-12 University Of Washington Through Its Center For Commercialization Systems and Methods for Modifying Prosthetic Sockets
EP1588244B1 (fr) 2003-11-28 2016-09-28 Ohio Willow Wood Company Système et procédé de fabrication d'une garniture prothétique personnalisée
WO2017136405A1 (fr) * 2016-02-02 2017-08-10 Hanger, Inc. Système et procédé numériques servant à la fabrication de dispositif orthopédique et prothétique définitif
DE102019109781A1 (de) 2019-04-12 2020-10-15 plus medica OT GmbH Verfahren zum Erstellen von Fertigungsdaten und Computerprogramm sowie Verfahren zur Fertigung einer orthopädietechnischen Einrichtung
US20220031480A1 (en) * 2018-10-04 2022-02-03 Ottobock Se & Co. Kgaa Method for producing an orthopedic device and orthopedic device
DE102020126435A1 (de) 2020-10-08 2022-04-14 Ottobock Se & Co. Kgaa Verfahren und Computerprogramm zum Erstellen von Fertigungsdaten sowie Verfahren zur Fertigung einer orthopädietechnischen Einrichtung

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1588244B1 (fr) 2003-11-28 2016-09-28 Ohio Willow Wood Company Système et procédé de fabrication d'une garniture prothétique personnalisée
US20100161076A1 (en) * 2008-12-11 2010-06-24 Materialise N.V. Orthotic or prosthetic cushioned device and method of making the same
WO2013134268A1 (fr) 2012-03-05 2013-09-12 Otto Bock Healthcare Gmbh Revêtement d'indication de pression et procédé d'utilisation
US20140163697A1 (en) * 2012-05-04 2014-06-12 University Of Washington Through Its Center For Commercialization Systems and Methods for Modifying Prosthetic Sockets
WO2017136405A1 (fr) * 2016-02-02 2017-08-10 Hanger, Inc. Système et procédé numériques servant à la fabrication de dispositif orthopédique et prothétique définitif
US20220031480A1 (en) * 2018-10-04 2022-02-03 Ottobock Se & Co. Kgaa Method for producing an orthopedic device and orthopedic device
DE102019109781A1 (de) 2019-04-12 2020-10-15 plus medica OT GmbH Verfahren zum Erstellen von Fertigungsdaten und Computerprogramm sowie Verfahren zur Fertigung einer orthopädietechnischen Einrichtung
DE102020126435A1 (de) 2020-10-08 2022-04-14 Ottobock Se & Co. Kgaa Verfahren und Computerprogramm zum Erstellen von Fertigungsdaten sowie Verfahren zur Fertigung einer orthopädietechnischen Einrichtung

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