WO2020202209A1

WO2020202209A1 - A system and a method for manufacturing of prosthetics and orthotic systems

Info

Publication number: WO2020202209A1
Application number: PCT/IN2020/050315
Authority: WO
Inventors: Arun Joshua CHERIAN
Original assignee: Cherian Arun Joshua
Priority date: 2019-04-01
Filing date: 2020-04-01
Publication date: 2020-10-08

Abstract

The various embodiments of the present invention disclose an integrated facility for enabling a semi-automated and self-powered method for manufacturing prosthetics and orthotic systems. The present invention also provides a portable and self-contained facility for enabling manufacturing of prosthetics and orthotic systems. Although modern technologies such as 3D-scanning and specialized software assist in standardizing the process, currently each of these processes are stand-alone support systems. The present invention comprises a scanning module, a CNC module, a digital modification module, a power unit, a prosthetic oven and a smart assembly/fabrication station. The method comprises preparation of the patient, scanning with the help of a handheld computing device, digital modification of the scanned data, fabrication of the mold, fabrication of socket and automated packaging and shipping of the prosthetic. The present invention is configured to be housed in a portable facility that is easily installed in any geographical location.

Description

A SYSTEM AND A METHOD FOR MANUFACTURING OF

PROSTHETICS AND ORTHOTIC SYSTEMS

A) CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims the priority of the Indian

Provisional Patent Application filed on January 1, 2019 and subsequently post dated by 3 months to April 1, 2019 with the number 201941000047 and titled, "A LOW RESOURCE SPECIFIC SMART CELL MANUFACTURING OF PROSTHETICS AND ORTHOTIC SYSTEMS", the contents of which are incorporated herein by the way of reference.

B) TECHNICAL FIELD

[0002] The present invention is generally related to a method for manufacturing prosthetics and orthotic systems. The present invention is particularly related to a low-resource-specific and semi-automated method for manufacturing prosthetics and orthotic systems. The present invention is more particularly related to a portable and self-contained facility for enabling a semi- automated and self-powered method for manufacturing prosthetics and orthotic systems.

C) BACKGROUND OF THE INVENTION

[0003] The processes of manufacturing prosthetics have been prevalent for quite a long time. The conventional casting techniques use Plaster of Paris

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SUBSTITUTE SHEETS (RULE 26) bandage, which is fragile, cumbersome and is qualitatively carved by a prosthetist. In case of a need for a correction to the cast, the process is restarted from the beginning, which is expensive, time consuming and burdensome to the patient and their care-givers.

[0004] Traditional socket design for prosthetics relies on the skill of the prosthetist to understand the anatomy and intended use of the prosthesis. Traditional manufacturing techniques are labor-intensive and requires skilled technicians. Although modem technologies such as 3D-scanning, 3D printing and specialized software assist in standardizing, facilitating and accelerating the process, currently each of these processes are stand-alone support systems. Due to geographical separation and lack of an integrated approach, the time taken and resources necessary for manufacturing prosthesis using these modern techniques is quite high.

[0005] Hence, there is a need for developing an integrated facility for enabling a semi -automated and self-powered method for manufacturing prosthetics and orthotic systems. There is also a need for a portable and self- contained facility for enabling manufacturing of prosthetics and orthotic systems. There is also a need for enabling remotely controlling the plurality of methods and processes enabling the manufacturing of prosthetics and orthotic systems.

[0006] The abovementioned shortcomings, disadvantages and problems are addressed herein, which will be understood by reading and studying the following specification.

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SUBSTITUTE SHEETS (RULE 26) D) OBJECT OF THE INVENTION

[0007] The primary object of the present invention is to provide a low- resource-specific and semi-automated method for manufacturing prosthetics and orthotic systems.

[0008] Another object of the present invention is to provide a portable and self-contained facility for enabling a semi-automated and self-powered method for manufacturing prosthetics and orthotic systems.

[0009] Yet another object of the present invention is to enable remotely controlling the plurality of methods and processes enabling the manufacturing of prosthetics and orthotic systems.

[0010] Yet another object of the present invention is to provide a standardized process, that allows to scan patients in a plurality of remote locations and send the digital scans to a clinic where professionals perform the digital modification on the scan.

[0011] Yet another object of the present invention is to provide a digital fabrication process for prosthetics using a modified mobile computing device scanner, which leverages local infrastructure to fabricate a prosthetic leg in a highly quantitative process.

[0012] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

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SUBSTITUTE SHEETS (RULE 26) E) SUMMARY OF THE INVENTION

[0013] The various embodiments of the present invention provide a low- resource-specific and semi-automated method for manufacturing prosthetics and orthotic systems. The embodiments also provide a portable and self-contained facility for enabling a semi -automated and self-powered method for manufacturing prosthetics and orthotic systems.

[0014] According to one embodiment of the present invention, a low- resource-specific and semi-automated method for manufacturing prosthetics and orthotic systems is provided. The invention provides a standardized process, that allows to scan patients in a plurality of remote locations, send the digital scans to a clinic where professionals perform the digital modification on the scan. A mold is then produced from the modified leg geometry and a prosthetic socket is fabricated. The process includes a plurality of steps and integrates a plurality of remote and geographically separated modules.

[0015] According to one embodiment of the present invention, a process for manufacturing prosthetics and orthotic systems is provided. The digital fabrication process for prosthetics uses a modified mobile computing device scanner and leverages local infrastructure to fabricate a prosthetic leg in a highly quantitative process. Even unskilled personnel are enabled to scan the patient remotely and upload the data to a cloud module. The scan data is provided for a CNC-based carving of a prosthetic mold with sub-millimeter accuracy on foam blanks and environmentally friendly blanks. The digital model is modified, by centrally located prosthetists, to accommodate changes specific to a patient. The

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SUBSTITUTE SHEETS (RULE 26) entire process is completed in less than one hour, which allows for scaling-up production of prosthetics.

[0016] According to one embodiment of the present invention, a facility for manufacturing prosthetics and orthotic systems is provided. The facility comprises a scanning module, a CNC module, a digital modification module, a power unit, a prosthetic oven and a smart assembly/fabrication station.

[0017] According to one embodiment of the present invention, a method for 3D scanning is provided for scanning patient’s limbs where a prosthetic is to be fixed. A patient is prepared and placed into a position for enabling the scanning. The scanning is done through an application on a handheld computing device, where the computing device is enabled for capturing a full, smooth mesh and a sharp, clear texture. For a closed, smooth mesh, it is essential, that the stump is scanned from all sides. Areas that are more difficult to access by light require more time for scanning. The main factor determining the quality of the mesh is the position in which the patient lays during the scanning procedure. Movement or trembling causes displacement of the scan and artifacts in the mesh.

[0018] According to one embodiment of the present invention, a method for fabrication of prosthetic mold is provided. The method comprises the following steps: preparation of the patient who is to be fitted with the prosthetic; scanning with the help of a handheld computing device and patient positioning with help of jigs; digital modification of the scanned data; fabrication of the mold through polyurethane foam fabrication and carving of leg geometries;

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SUBSTITUTE SHEETS (RULE 26) fabrication of socket with processes such as vacuum forming, compression testing and air extraction; and, automated packaging and shipping of the prosthetic.

[0019] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating the preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

F) BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

[0021] FIG. 1 illustrates a portable and self-contained facility for enabling a semi -automated and self-powered method for manufacturing prosthetics and orthotic systems, according to one embodiment of the present invention.

[0022] FIG. 2 a flow diagram of a low-resource-specific and semi- automated method for manufacturing prosthetics and orthotic systems, according to one embodiment of the present invention.

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SUBSTITUTE SHEETS (RULE 26) [0023] FIG. 3a illustrates an actual image of the stump of an amputee captured by the scanning module of the present invention, according to one embodiment of the present invention.

[0024] FIG. 3b illustrates a digitally modified image of the stump of an amputee, according to one embodiment of the present invention.

[0025] FIG. 4a - 4d illustrate a plurality of jigs that hold the position of an amputee in place to enable the scanning process, according to one embodiment of the present invention.

[0026] Although the specific features of the present invention are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the present invention.

G) DETAILED DESCRIPTION OF THE INVENTION

[0027] In the following detailed description, a reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.

[0028] The various embodiments of the present invention provide a low- resource-specific and semi-automated method for manufacturing prosthetics and

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SUBSTITUTE SHEETS (RULE 26) orthotic systems. The embodiments also provide a portable and self-contained facility for enabling a semi -automated and self-powered method for manufacturing prosthetics and orthotic systems.

[0029] According to one embodiment of the present invention, a low- resource-specific and semi-automated method for manufacturing prosthetics and orthotic systems is provided. The invention provides a standardized process, that allows to scan patients in a plurality of remote locations, send the digital scans to a clinic where professionals perform the digital modification on the scan. A mold is then produced from the modified leg geometry and a prosthetic socket is fabricated. The process includes a plurality of steps and integrates a plurality of remote and geographically separated modules.

[0030] According to one embodiment of the present invention, a process for manufacturing prosthetics and orthotic systems is provided. The digital fabrication process for prosthetics uses a modified mobile computing device scanner and leverages local infrastructure to fabricate a prosthetic leg in a highly quantitative process. Even unskilled personnel are enabled to scan the patient remotely and upload the data to a cloud module. The scan data is provided for a CNC-based carving of a prosthetic mold with sub-millimeter accuracy on foam blanks and environmentally friendly blanks. The digital model is modified, by centrally located prosthetists, to accommodate changes specific to a patient. The entire process is completed in less than one hour, which allows for scaling-up production of prosthetics.

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SUBSTITUTE SHEETS (RULE 26) [0031] According to one embodiment of the present invention, a facility for manufacturing prosthetics and orthotic systems is provided. The facility comprises a scanning module, a CNC module, a digital modification module, a power unit, a prosthetic oven and a smart assembly/fabrication station.

[0032] According to one embodiment of the present invention, a method for 3D scanning is provided for scanning patient’s limbs where a prosthetic is to be fixed. A patient is prepared and placed into a position for enabling the scanning. The scanning is done through an application on a handheld computing device, where the computing device is enabled for capturing a full, smooth mesh and a sharp, clear texture. For a closed, smooth mesh, it is essential, that the stump is scanned from all sides. Areas that are more difficult to access by light require more time for scanning. The main factor determining the quality of the mesh is the position in which the patient lays during the scanning procedure. Movement or trembling causes displacement of the scan and artifacts in the mesh.

[0033] According to one embodiment of the present invention, a method for fabrication of prosthetic mold is provided. The method comprises the following steps: preparation of the patient who is to be fitted with the prosthetic; scanning with the help of a handheld computing device and patient positioning with help of jigs; digital modification of the scanned data; fabrication of the mold through polyurethane foam fabrication and carving of leg geometries; fabrication of socket with processes such as vacuum forming, compression

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SUBSTITUTE SHEETS (RULE 26) testing and air extraction; and, automated packaging and shipping of the prosthetic.

[0034] FIG. 1 illustrates a portable and self-contained facility for enabling a semi -automated and self-powered method for manufacturing prosthetics and orthotic systems. The facility includes a scanning module 101, a CNC module 102, a digital modification module 103, a power unit 104, a prosthetic oven 105 and a smart assembly/fabrication station 106.

[0035] FIG. 2 a flow diagram of a low-resource-specific and semi- automated method for manufacturing prosthetics and orthotic systems. The method comprises the following steps: preparation of the patient who is to be fitted with the prosthetic (201); scanning with the help of a handheld computing device and patient positioning with help of jigs (202); digital modification of the scanned data (203); fabrication of the mold through polyurethane foam fabrication and carving of leg geometries (204); fabrication of socket with processes such as vacuum forming, compression testing and air extraction (205); and, automated packaging and shipping of the prosthetic (206).

[0036] FIG. 3a illustrates an actual image of the stump of an amputee captured by the scanning module of the present invention. FIG. 3b illustrates a digitally modified image of the stump of an amputee.

[0037] FIG. 4a - 4d illustrate a plurality of jigs that hold the position of an amputee in place to enable the scanning process. FIG. 4a illustrates a jig that enables the scanning of the amputee in standing position. The amputee is enabled to stand on the surface 403 and hold on the structure 401. The height of the jig is

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SUBSTITUTE SHEETS (RULE 26) adjusted with 402. FIG. 4b illustrates a jig that enables the scanning of the amputee in laying down position. The jig comprises three parts, where 404 comprises grooves to hold 406, while 405 is connected to 404 and 406. The jig enables a plurality of positions for the amputee to lay down.

[0038] Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to practice the embodiments herein with modifications.

H) ADVANTAGES OF THE INVENTION

[0039] The present invention provides an integrated facility for enabling a semi-automated and self-powered method for manufacturing prosthetics and orthotic systems. The present invention also provides a portable and self- contained facility for enabling manufacturing of prosthetics and orthotic systems. The invention enables remotely controlling the plurality of methods and processes enabling the manufacturing of prosthetics and orthotic systems. The present invention is configured to be housed in a portable facility that is easily installed in any geographical location. The present invention is enabled to connect with a plurality of remote nodes to enable an integrated solution for manufacturing prosthetics and orthotic systems.

[0040] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such as specific embodiments without departing from the generic concept, and,

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SUBSTITUTE SHEETS (RULE 26) therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modifications. However, all such modifications are deemed to be within the scope of the claims.

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SUBSTITUTE SHEETS (RULE 26)

Claims

CLAIMS What is claimed is:

1. A portable and self-contained facility for enabling a semi- automated and self-powered manufacturing of prosthetics and orthotic systems, the facility comprising:

a scanning module, wherein the scanning module is an arrangement that enables a handheld computing device to be attached and capture visual data;

a Computer Numeric Control (CNC) module;

a plurality of jigs, wherein the jigs hold the position of an amputee in place to enable the scanning process, and wherein the jigs are designed to provide markings and labeling on the areas to be scanned by the scanning module;

a digital modification module;

a power module;

a prosthetic oven; and,

a smart assembly and fabrication station.

2. The system according to claim 1, wherein the scanning module is designed as a handheld and/or a tabletop mechanical structure, and wherein the distance between the scanning module and a subject to be scanned is one meter for optimal scanning, and wherein an unimpeded

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SUBSTITUTE SHEETS (RULE 26) 360-degree path is provided around the subject for a complete scanning of the subject.

3. The system according to claim 1, wherein the digital modification module enables a modification of the digital images scanned by the scanning module for designing an optimal fit of the prosthetic socket, and wherein the digital modification module removes the non-essential parts from the scanned images and retains only the necessary elements of the scanned images, and wherein the modifications are also performed as per the manually markings on the subject’s limbs.

4. A method for enabling a semi-automated and self-powered manufacturing of prosthetics and orthotic systems in a portable and self- contained facility, the method comprising:

preparing and positioning the subject to be fitted with the prosthetic with the help of jigs;

scanning the amputee with the scanning module;

digitally modifying the scanned data;

fabricating a mold through polyurethane foam fabrication and carving of leg geometries based on the digitally modified scanned data;

fabricating a socket through processes such as vacuum forming, compression testing and air extraction; and,

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SUBSTITUTE SHEETS (RULE 26) automated packaging and shipping of the prosthetic.

5. The method according to claim 4, wherein the subject is an amputee, and wherein preparing and positioning an amputee to be fitted with the prosthetic with the help of jigs includes the assessing of the stump of the limb of the amputee by a trained personnel, and wherein the clothing in the area of the limb to be scanned is removed, and wherein when the subject is a below-the-knee-amputee, a thin stockinette is pulled over the stump of the limb followed by a tight wrapping to compress the muscle and fat tissue, and wherein when the subject is an above-the-knee- amputee, a double stockinette is worn over the stump, and wherein the stump of the amputated limb and the unamputated limb are tightly wrapped for capturing the perineum area during the scanning and prevent loose tissue from being contort due to gravity when laying on the side, and wherein after the wrapping, the trained personnel makes a visible marking on the wrapping on the limbs to indicate relevant anatomic features and measuring points during scanning.

6. The method according to claim 4, wherein scanning the amputee with the scanning module includes capturing the images of the markings on the wrapping on the limbs of the subject and creating a mesh of the captured images using photogrammetry, and wherein the quality of the mesh is affected by the stillness of the subject during the scanning

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SUBSTITUTE SHEETS (RULE 26) process, and wherein the important factors for obtaining a high quality scanning images include capturing a full smooth mesh and a sharp clear texture, and wherein areas with less exposure to light such as the perineum area between legs are scanned for more duration of time compared to other areas, and wherein an optimum scanning of a below- the-knee-amputation includes scanning one side of the stump from top to bottom till the ventral side of the stump is captured, and then moving the scanner all the way up, keeping the scanner in a high position, focused on the stump, and then moving down to capture the distal end and the ventral side of the stump.

7. The method according to claim 4, wherein digitally modifying the scanned data includes modifying the scanned data for above-the-knee- amputees and below-the-knee-amputees, and wherein digitally modifying the scanned data for above-the-knee-amputees includes Contoured

Adducted Trochanteric-Controlled Alignment Method with ischial contention and full contact, and wherein the design focusses on the trim line and the socket brim, and wherein the perineum is a critical area that is not often captured completely and is digitally deconstructed from scanned images, and wherein digitally modifying the scanned data for below-the-knee-amputees trans-tibial sockets are designed according to the patella-tendon bearing principle, and wherein the design is rotationally stable and beneficial when no gel liners are used, and

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SUBSTITUTE SHEETS (RULE 26) wherein when the digital modification is performed, in the regions that tolerate more pressure, the mesh is pulled inside and in the regions that are pressure sensitive, the mesh is bulged out, and wherein for enabling a tight fit, the overall circumference of the scanned model is reduced by 4 millimeters for bony stumps and 10 millimeters for fleshy stumps.

8. The method according to claim 4, wherein fabricating a mold through polyurethane foam fabrication and carving of leg geometries based on the digitally modified scanned data is performed using 3-axis and 4-axis rotary CNC machines.

9. The method according to claim 4, wherein fabricating a socket through processes such as vacuum forming, compression testing and air extraction includes heating polypropylene (PP) sheet to 220° C in a dry heat chamber, then pulled over the modified foam mold and applying vacuum such that the plastic sheet adapts to the shape of the mold, and wherein the excess plastic material is cut off after lamination, followed by cutting and smoothening the trim line.

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SUBSTITUTE SHEETS (RULE 26)