Adjustable modular scoliosis orthosis fabrication method and system

By disassembling the orthosis into modular brace pressure plates and using robotic arms and ultrasonic image feedback for fine-tuning, the problems of low fit rate and long manufacturing cycle of existing orthotics are solved, achieving an efficient orthotic fit and economical adjustment solution.

CN117796978BActive Publication Date: 2026-07-03WUHAN KLARITY MEDICAL TECH CO LTD +1

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
WUHAN KLARITY MEDICAL TECH CO LTD
Filing Date
2023-12-11
Publication Date
2026-07-03

AI Technical Summary

Technical Problem

In the current process of personalized design and manufacturing of orthotics, limited data references lead to low fit rates, strong reliance on professional skills, long production cycles, and frequent adjustments or replacements due to changes in the patient's body shape, increasing economic burden.

Method used

The orthosis is disassembled into modular brace pressure plates. The application position and thrust parameters are determined by a robotic arm, and fine-tuning is performed in conjunction with ultrasound image feedback to form an adjustable modular orthosis. The orthosis is then assembled on-site and adjusted or replaced according to changes in the patient.

Benefits of technology

It has improved the fit rate of orthotics, shortened the design and manufacturing cycle, reduced the dependence on professional expertise, reduced the economic burden on families, and met the needs of patients with changes in body shape and spine.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to a kind of adjustable modular scoliosis orthosis manufacturing method and system, split into multiple modularized brace pressure pieces, to realize the orthotic function to user with the joint action of modularized brace pressure piece, and the whole process is completed in situ assembly, reduce the dependence on the professional degree of orthosis designer, improve the fitting rate of orthosis and shorten the design and production cycle of orthosis;And after the general time of patient wearing, can be according to the change of patient's posture and the change of spine, by modularized manufacturing equipment reconfirming correction parameter, then adjusting or replacing component to patient modularized orthosis, meet the change of patient's spine and the change of posture, reduce the economic pressure of family.
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Description

Technical Field

[0001] This invention relates to the field of orthotics, and in particular to a method and system for manufacturing an adjustable modular scoliosis orthotics. Background Technology

[0002] The main treatments for adolescent idiopathic scoliosis include conservative treatment and surgical treatment. Conservative treatment mainly includes gymnastics training and orthotic treatment.

[0003] When designing and fabricating personalized orthotics, methods include traditional plaster casting and modern computer-aided design. The plaster casting method involves first creating a negative plaster mold on the patient, then pouring plaster into the mold to obtain a positive mold. The orthotist then refines the positive mold based on the patient's posture, anteroposterior and lateral X-ray images, and correction needs. Finally, thermoplastic molding material is applied to the positive mold to create the orthotics. The modern computer-aided design method requires the orthotist to first obtain a 3D body surface model of the patient. Then, referring to the patient's X-ray images and scanned 3D body surface data, the model is refined in computer software to obtain the orthotics model. This model is then directly 3D printed or machined using a machine tool based on the model to generate the positive mold. Finally, thermoplastic molding material is applied to the positive mold to create the orthotics.

[0004] Regardless of the method used, due to limited reference data—the patient's surface scan data, X-ray images, and orthotic design are not completed by a single person—subjective human judgment is introduced, resulting in a lower fit rate. Furthermore, the mold-making process heavily relies on individual professional skills, requiring the integration of multiple professional knowledge bases to synthesize comprehensive information, leading to varying corrective effects between orthotics made by different medical personnel. Additionally, it generally takes about a month from data acquisition to complete fitting for the patient, during which time the patient's degree of orthotics may continue to increase. Current orthotics are designed as a single unit; adolescents are in their developmental stage, and orthotics generally require follow-up examinations approximately every six months. If the orthotics no longer fits due to developmental changes, additional pads or even replacement of the orthotics may be necessary. Moreover, orthotics need to be worn until the patient's bones mature, potentially requiring multiple adjustments or even remaking the orthotics, increasing the financial burden on parents. Summary of the Invention

[0005] The purpose of this invention is to at least address one of the shortcomings of the prior art by providing a method and system for manufacturing an adjustable modular scoliosis orthosis.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] Specifically, a method for manufacturing an adjustable modular scoliosis orthosis is proposed, including the following:

[0008] Step 110: Determine multiple action positions of the robotic arm based on the user's treatment parameters;

[0009] Step 120: Control the robot arm to move to each determined action position, control the robot arm to apply thrust at any action position and determine the optimal thrust parameters based on feedback information, obtain each action position and its associated optimal thrust parameters, and make the corresponding support pressure plate based on the action position and its optimal thrust parameters.

[0010] Step 130: Replace the robotic arm with a modular support pressure plate, control the support pressure plate to move to a working position, and apply it with the optimal thrust parameters associated with that working position;

[0011] Step 140: Obtain the user's ultrasound image at this time, obtain the scoliosis angle based on the user's ultrasound image and feed it back to the orthodontist, obtain the orthodontist's adjustment opinions, and make fine adjustments to the brace pressure plate based on the adjustment opinions.

[0012] Step 150: Repeat steps 130 to 140 to obtain the brace pressure plates after fine-tuning all the positions of action;

[0013] Step 160: Connect all the brace pressure plates into a whole through the fixing and supporting components of the brace pressure plates, and install an adjustable tension band on the brace pressure plates to form the user's brace;

[0014] Step 170: Obtain the user's brace pressure pad replacement request, determine the brace pressure pad to be replaced according to the brace pressure pad replacement request, and read its fine-tuned position. Repeat steps 120 to 160 to obtain the adjusted user's brace.

[0015] Furthermore, specifically, the user's treatment parameters include,

[0016] Height, weight, and X-ray information, including information on the user's scoliosis type, apical vertebra, end vertebra, vertebral rotation, and pelvic tilt obtained through image recognition based on the X-ray images.

[0017] Furthermore, specifically, the process of obtaining the brace pressure pads at the corresponding application positions includes,

[0018] Control the robotic arm to move to any desired position.

[0019] After the user is in the preset correction position and the robotic arm is in the action position and in contact with the user, the current position information and thrust are obtained;

[0020] The thrust is continuously increased in preset steps, and the position information of the manipulator, the magnitude of the thrust, and the three-dimensional image of the user's spine are obtained after each increase in thrust.

[0021] When the thrust reaches the preset condition, stop adjusting the thrust and record the position information of the robot arm, the magnitude of the thrust (i.e., the optimal thrust parameters), and the three-dimensional image of the user's spine.

[0022] Based on the position information of the manipulator when the thrust reaches the preset condition, the magnitude of the thrust, and the three-dimensional image of the user's spine, the correction parameters are obtained by parameter conversion, and the brace pressure pad at the current position is obtained based on the correction parameters.

[0023] Repeat the above operation for all positions to obtain the brace pressure pads for all positions.

[0024] Furthermore, specifically, during the process of the robotic arm moving to the working position, it will also receive a mode switching command. If it receives a command to switch to the teaching mode, it will stop the original movement and be pulled and fixed to the working position by the orthotist.

[0025] Furthermore, specifically, correction parameters are obtained by converting parameters based on the position information of the robotic arm when the thrust reaches the preset conditions, the magnitude of the thrust (i.e., the optimal thrust parameter), and the three-dimensional image of the user's spine. These parameters include:

[0026] The location of the force application area (x, y, z, α, β, θ) is determined based on the position information of the robotic arm, where x, y, z, α, β, θ are the coordinates of the robotic arm on the X-axis, Y-axis, and Z-axis, respectively, and the corresponding rotation angles α, β, θ on the X-axis, Y-axis, and Z-axis. A reference range [S*(1-a), S*(1+b)] is defined for the size of the force application area, where S, a, and b vary with human body size and anatomical position.

[0027] Where S represents the pushing area of ​​the robotic arm providing correction parameters. The calculation process for S involves determining the pressure tolerance range [Pd, Pu] corresponding to the force application area based on the relationship between the preset region and the pressure tolerance range, where Pd is the minimum pressure tolerance pressure and Pu is the maximum pressure tolerance pressure; Pd and Pu are obtained from clinical trial measurements and biomedical simulations.

[0028] Since S=F / P, F is the magnitude of the thrust, which can be directly read, and P is located in the pressure tolerance range [Pd, Pu], the range of values ​​for S can be calculated, and thus the reference range of the area size can be determined.

[0029] Furthermore, based on the pressure tolerance range [Pd, Pu], the theoretical sinking or floating stroke L1 of the manipulator in the force application area can be determined. Then, based on the stroke L2 of the manipulator after the thrust reaches the preset condition, the actual set stroke L=c*L1+d*L2 of the manipulator can be calculated, where c and d are determined by pre-test fitting.

[0030] The correction parameters are the location of the force application area (x,y,z, α, β, θ), the reference range of the area size of the force application area [S*(1-a), S*(1+b)], and the actual set stroke of the robot L=c*L1+d*L2.

[0031] This invention also proposes an adjustable modular scoliosis orthosis fabrication system, comprising:

[0032] The action position determination module is used to determine multiple action positions of the robotic arm based on the user's treatment parameters;

[0033] The brace pressure plate manufacturing module is used to control the robot arm to move to each determined action position, control the robot arm to apply thrust at any action position and determine the optimal thrust parameters based on feedback information, obtain each action position and its associated optimal thrust parameters, and manufacture the corresponding brace pressure plate based on the action position and its optimal thrust parameters.

[0034] The support pressure plate replacement module is used to replace the robot with modular support pressure plates, control the support pressure plates to move to a working position, and apply the optimal thrust parameters associated with that working position.

[0035] The brace pressure plate fine-tuning module is used to acquire the user's ultrasound image at this time, obtain the current scoliosis angle based on the user's ultrasound image and feed it back to the orthodontist, obtain the orthodontist's adjustment opinions, and fine-tune the brace pressure plate based on the adjustment opinions;

[0036] The brace pressure plate determination module is used to repeatedly run the brace pressure plate replacement module and the brace pressure plate fine-tuning module to obtain the brace pressure plates after fine-tuning at all working positions.

[0037] The brace fabrication module is used to connect all the brace pressure plates into a whole through the fixing and supporting components of the brace pressure plates, and to install an adjustable tension band on the brace pressure plates to form a brace for the user.

[0038] The brace adjustment module is used to obtain the user's brace pressure pad replacement request, determine the brace pressure pad to be replaced according to the request, and read its fine-tuned position. The module repeatedly runs the brace pressure pad manufacturing module, the brace pressure pad replacement module, the brace pressure pad fine-tuning module, the brace pressure pad determination module, and the brace manufacturing module to obtain the adjusted brace for the user.

[0039] Furthermore, specifically, it also includes a mode switching module, which is used to obtain a mode switching command during the process of the robotic arm moving to the working position. If a command to switch to the teaching mode is obtained, the original movement is stopped and the orthotist pulls and fixes it to the working position.

[0040] The beneficial effects of this invention are as follows:

[0041] This invention proposes an adjustable modular scoliosis orthosis manufacturing method and system. The orthosis is disassembled into multiple modular brace pressure plates, which work together to achieve the orthotic function for the user. The entire process is completed on-site, reducing reliance on the professional expertise of the orthosis designer, improving the orthosis's fit rate, and shortening the design and manufacturing cycle. Furthermore, after the patient has worn the orthosis for a period of time, the orthotic parameters can be reconfirmed based on changes in the patient's posture and spine using modular manufacturing equipment. The modular orthosis can then be adjusted or components replaced to meet the patient's changing spinal and postural needs, reducing the financial burden on families. Attached Figure Description

[0042] The above and other features of this disclosure will become more apparent from the detailed description of the embodiments illustrated in conjunction with the accompanying drawings. In the accompanying drawings, the same reference numerals denote the same or similar elements. Obviously, the drawings described below are merely some embodiments of this disclosure. For those skilled in the art, other drawings can be obtained from these drawings without any creative effort. In the drawings:

[0043] Figure 1 The diagram shows a flowchart of a method for manufacturing an adjustable modular scoliosis orthosis according to the present invention. Detailed Implementation

[0044] The following will provide a clear and complete description of the concept, specific structure, and technical effects of the present invention in conjunction with embodiments and accompanying drawings, so as to fully understand the purpose, solution, and effects of the present invention. It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The same reference numerals used throughout the accompanying drawings indicate the same or similar parts.

[0045] Example 1: This invention proposes a method for manufacturing an adjustable modular scoliosis orthosis, comprising the following:

[0046] Step 110: Determine multiple action positions of the robotic arm based on the user's treatment parameters;

[0047] Step 120: Control the robot arm to move to each determined action position, control the robot arm to apply thrust at any action position and determine the optimal thrust parameters based on feedback information, obtain each action position and its associated optimal thrust parameters, and make the corresponding support pressure plate based on the action position and its optimal thrust parameters.

[0048] Step 130: Replace the robotic arm with a modular support pressure plate, control the support pressure plate to move to a working position, and apply it with the optimal thrust parameters associated with that working position;

[0049] Step 140: Obtain the user's ultrasound image at this time, obtain the scoliosis angle based on the user's ultrasound image and feed it back to the orthodontist, obtain the orthodontist's adjustment opinions, and make fine adjustments to the brace pressure plate based on the adjustment opinions.

[0050] Step 150: Repeat steps 130 to 140 to obtain the brace pressure plates after fine-tuning all the positions of action;

[0051] Step 160: Connect all the brace pressure plates into a whole through the fixing and supporting components of the brace pressure plates, and install an adjustable tension band on the brace pressure plates to form the user's brace;

[0052] Step 170: Obtain the user's brace pressure pad replacement request, determine the brace pressure pad to be replaced according to the brace pressure pad replacement request, and read its fine-tuned position. Repeat steps 120 to 160 to obtain the adjusted user's brace.

[0053] In this embodiment 1, the orthosis is disassembled into multiple modular brace pressure plates. The combined action of these modular brace pressure plates achieves the orthotic function for the user. The entire assembly process is completed on-site, reducing reliance on the professional expertise of the orthosis designer, improving the orthosis's fit rate, and shortening the orthosis's design and manufacturing cycle. Furthermore, after the patient has worn the orthosis for a period of time, the correction parameters can be reconfirmed based on changes in the patient's posture and spine using modular manufacturing equipment. Then, the modular orthosis can be adjusted or components replaced to meet the patient's changes in spine and posture, reducing the financial burden on the family.

[0054] In a preferred embodiment of the present invention, the user's treatment parameters specifically include:

[0055] Height, weight, and X-ray information, including information on the user's scoliosis type, apical vertebra, end vertebra, vertebral rotation, and pelvic tilt obtained through image recognition based on the X-ray images.

[0056] In a preferred embodiment of the present invention, the process of obtaining the brace pressure plate at the corresponding position includes:

[0057] Control the robotic arm to move to any desired position.

[0058] After the user is in the preset correction position and the robotic arm is in the action position and in contact with the user, the current position information and thrust are obtained;

[0059] The thrust is continuously increased in preset steps, and the position information of the manipulator, the magnitude of the thrust, and the three-dimensional image of the user's spine are obtained after each increase in thrust.

[0060] When the thrust reaches the preset condition, stop adjusting the thrust and record the position information of the robot arm, the magnitude of the thrust (i.e., the optimal thrust parameters), and the three-dimensional image of the user's spine.

[0061] Based on the position information of the manipulator when the thrust reaches the preset condition, the magnitude of the thrust, and the three-dimensional image of the user's spine, the correction parameters are obtained by parameter conversion, and the brace pressure pad at the current position is obtained based on the correction parameters.

[0062] Repeat the above operation for all positions to obtain the brace pressure pads for all positions.

[0063] In a preferred embodiment of the present invention, the robotic arm will receive a mode switching command during the movement to the working position. If a command to switch to the teaching mode is received, the original movement will stop and the orthotist will pull and fix it to the working position.

[0064] In a preferred embodiment of the present invention, specifically, correction parameters are obtained by parameter conversion based on the position information of the manipulator when the thrust reaches a preset condition, the magnitude of the thrust (i.e., the optimal thrust parameter), and the three-dimensional image of the user's spine. These parameters include...

[0065] The location of the force application area (x, y, z, α, β, θ) is determined based on the position information of the robotic arm, where x, y, z, α, β, θ are the coordinates of the robotic arm on the X-axis, Y-axis, and Z-axis, respectively, and the corresponding rotation angles α, β, θ on the X-axis, Y-axis, and Z-axis. A reference range [S*(1-a), S*(1+b)] is defined for the size of the force application area, where S, a, and b vary with human body size and anatomical position.

[0066] Where S represents the pushing area of ​​the robotic arm providing correction parameters. The calculation process for S involves determining the pressure tolerance range [Pd, Pu] corresponding to the force application area based on the relationship between the preset region and the pressure tolerance range, where Pd is the minimum pressure tolerance pressure and Pu is the maximum pressure tolerance pressure; Pd and Pu are obtained from clinical trial measurements and biomedical simulations.

[0067] Since S=F / P, F is the magnitude of the thrust, which can be directly read, and P is located in the pressure tolerance range [Pd, Pu], the range of values ​​for S can be calculated, and thus the reference range of the area size can be determined.

[0068] Furthermore, based on the pressure tolerance range [Pd, Pu], the theoretical sinking or floating stroke L1 of the manipulator in the force application area can be determined. Then, based on the stroke L2 of the manipulator after the thrust reaches the preset condition, the actual set stroke L=c*L1+d*L2 of the manipulator can be calculated, where c and d are determined by pre-test fitting.

[0069] The correction parameters are the location of the force application area (x,y,z, α, β, θ), the reference range of the area size of the force application area [S*(1-a), S*(1+b)], and the actual set stroke of the robot L=c*L1+d*L2.

[0070] In this preferred embodiment, the obtained correction parameters (position parameters of the robotic arm, correction force, real-time image of the spine, and pushing area of ​​the robotic arm) and their changes are imported into the orthotic design software. The orthotic parameters allow for automatic adjustment of the human model within the design software. For example, through position registration, the position parameters in the correction parameters determine the specific area on the model as the force application area (x, y, z, α, β, θ). The pushing area S of the robotic arm, which provides the correction parameters, serves as a reference range for the size of the force application area [S*(1-a), S*(1+b)]. Based on patient information and literature, the pressure tolerance range [Pd, Pu] of the corresponding area is obtained by looking up a table. Using the relationship between force F, pressure P, and area S (F=P*S), S=F / P is calculated. S serves as the actual size of the force application area in the model and satisfies the aforementioned reference range requirements for area and pressure. Based on the relationship between the pressure of the corresponding area and the settlement of the model area, the theoretical sinking or floating stroke L1 of the force application area can be determined. Simultaneously, utilizing the robotic arm's stroke L2 after the force exceeds a specific threshold (F>T), the actual stroke L is set as L=c*L1+d*L2, where c and d are determined through experimental fitting. In this way, by matching the corrective force parameter information to a mathematical model, the protrusions or depressions in specific areas of the model can be determined. Data can be used to deduce the size, intensity, and direction of the undulations in specific areas of the model surface, helping orthodontists control the model design and achieving automated model optimization. Secondly, using real-time spinal image data, the design software can analyze the patient's actual posture, scoliosis angle, and the difference in body shape before and after the application of corrective force, achieving a model that conforms to the actual human body. Furthermore, the direction of force application on the body can be determined by reference angles, improving the orthodontist's design efficiency and providing reliable parameter verification.

[0071] This invention also proposes an adjustable modular scoliosis orthosis fabrication system, comprising:

[0072] The action position determination module is used to determine multiple action positions of the robotic arm based on the user's treatment parameters;

[0073] The brace pressure plate manufacturing module is used to control the robot arm to move to each determined action position, control the robot arm to apply thrust at any action position and determine the optimal thrust parameters based on feedback information, obtain each action position and its associated optimal thrust parameters, and manufacture the corresponding brace pressure plate based on the action position and its optimal thrust parameters.

[0074] The support pressure plate replacement module is used to replace the robot with modular support pressure plates, control the support pressure plates to move to a working position, and apply the optimal thrust parameters associated with that working position.

[0075] The brace pressure plate fine-tuning module is used to acquire the user's ultrasound image at this time, obtain the current scoliosis angle based on the user's ultrasound image and feed it back to the orthodontist, obtain the orthodontist's adjustment opinions, and fine-tune the brace pressure plate based on the adjustment opinions;

[0076] The brace pressure plate determination module is used to repeatedly run the brace pressure plate replacement module and the brace pressure plate fine-tuning module to obtain the brace pressure plates after fine-tuning at all working positions.

[0077] The brace fabrication module is used to connect all the brace pressure plates into a whole through the fixing and supporting components of the brace pressure plates, and to install an adjustable tension band on the brace pressure plates to form a brace for the user.

[0078] The brace adjustment module is used to obtain the user's brace pressure pad replacement request, determine the brace pressure pad to be replaced according to the request, and read its fine-tuned position. The module repeatedly runs the brace pressure pad manufacturing module, the brace pressure pad replacement module, the brace pressure pad fine-tuning module, the brace pressure pad determination module, and the brace manufacturing module to obtain the adjusted brace for the user.

[0079] In this embodiment, the modular orthotic fabrication equipment has a three-dimensionally adjustable robotic arm, a real-time thrust feedback system, and a correction parameter storage function. Before fabricating the orthotic for the patient, the corrective parameters acceptable to the patient can be confirmed, the corrective effect of the patient's fit can be evaluated, and the orthotic parameters and effect pre-evaluation can be provided for the fabrication of the modular orthotic.

[0080] Modular orthotics involves disassembling the patient's orthotics into multiple prefabricated components to form prefabricated pressure plates, which facilitates on-site orthotics fabrication and subsequent adjustments based on changes in the patient's body shape and orthotics results.

[0081] The combined implementation plan involves: using a modular orthotic fabrication device with a three-dimensional force manipulator to determine the application position of the manipulator based on the patient's X-ray, adjusting the magnitude of the three-dimensional force according to the patient's tolerance, allowing the patient to adapt to the pressure and position on the manipulator, and evaluating the corrective effect through ultrasound scanning of the patient's spine. Once the corrective effect requirements are met, the position and thrust parameters of the manipulator are saved. The manipulator is then replaced with a pre-fabricated pressure plate or a pre-fabricated pressure plate is placed at the end of the manipulator and adjusted to the corresponding position for patient adaptation of the corrective parameters. Fine adjustments are made based on patient comfort and fit. After adjustment to the appropriate position, the orthotic pressure plate is connected into a whole using the fixing and supporting components of the modular brace, and tension straps and other adjustment and fixing components are installed on the patient's adjustable modular orthotic to form the patient's orthotic device.

[0082] The pressure plate material can be thermoplastic board or carbon fiber material, and the surface in contact with the human body is protected by a soft material. The connecting and supporting parts are made of carbon fiber or aluminum alloy, and the fixing parts are made of aluminum alloy.

[0083] The pressure plates, connectors, and support components are prefabricated. Prefabricated pressure plates and connectors for key areas (such as the armpits, iliac spines, lumbar region, and abdomen) can be manufactured according to the body shape of different age groups. Pre-drilled holes or slots are provided in the connectors to facilitate subsequent multi-level or stepless adjustment.

[0084] Some pressure pads with special requirements can be designed based on X-ray images and correction parameters obtained through modular manufacturing equipment, and then printed on-site using 3D printing equipment.

[0085] The pressure pads can conform to the shape of the human body and can also be directly coupled to a robot's manipulator through installation.

[0086] In a preferred embodiment of the present invention, a mode switching module is further included, which is used to obtain a mode switching command during the process of the robotic arm moving to the working position. If a command to switch to the teaching mode is obtained, the original movement is stopped and the orthotist pulls and fixes the robotic arm to the working position.

[0087] The modules described as separate components may or may not be physically separate. The components shown as modules may or may not be physical modules; that is, they may be located in one place or distributed across multiple network modules. Some or all of the modules can be selected to achieve the purpose of the solution in this embodiment, depending on actual needs.

[0088] Furthermore, the functional modules in the various embodiments of the present invention can be integrated into one processing module, or each module can exist physically separately, or two or more modules can be integrated into one module. The integrated modules described above can be implemented in hardware or as software functional modules.

[0089] If the integrated module is implemented as a software functional module and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, all or part of the processes in the methods of the above embodiments of the present invention can also be implemented by a computer program instructing related hardware. The computer program can be stored in a computer-readable storage medium, and when executed by a processor, it can implement the steps of the various method embodiments described above. The computer program includes computer program code, which can be in the form of source code, object code, executable files, or certain intermediate forms. The computer-readable medium can include: any entity or device capable of carrying the computer program code, recording media, USB flash drives, portable hard drives, magnetic disks, optical disks, computer memory, read-only memory (ROM), random access memory (RAM), electrical carrier signals, telecommunication signals, and software distribution media, etc.

[0090] Although the description of the invention has been quite detailed and particularly of several described embodiments, it is not intended to limit it to any of these details or embodiments or any particular embodiment, but should be considered as providing a broad possible interpretation of the claims by referring to the appended claims and taking into account the prior art, thereby effectively covering the intended scope of the invention. Furthermore, the invention has been described above with respect to embodiments foreseeable by the inventors in order to provide a useful description, and non-substantial modifications to the invention that have not yet been foreseen may still represent equivalent modifications.

[0091] The above description is merely a preferred embodiment of the present invention. The present invention is not limited to the above-described embodiments. Any embodiment that achieves the technical effects of the present invention using the same means should fall within the protection scope of the present invention. Within the protection scope of the present invention, various modifications and variations can be made to the technical solutions and / or implementation methods.

Claims

1. A method for manufacturing an adjustable modular scoliosis orthosis, characterized in that, Including the following: Step 110: Determine multiple action positions of the robotic arm based on the user's treatment parameters; Step 120: Control the robotic arm to move to each determined action position, and control the robotic arm to apply thrust at any action position. When the thrust reaches the preset condition, stop the thrust adjustment. Record the position information of the robotic arm, the thrust magnitude (i.e., the optimal thrust parameter), and the three-dimensional image of the user's spine at this time. Based on the action position, the optimal thrust parameter, and the three-dimensional image of the user's spine, perform parameter conversion to obtain the correction parameter. Based on the correction parameter, obtain the brace pressure pad for the corresponding action position. Step 130: Replace the robotic arm with a modular support pressure plate, control the support pressure plate to move to a working position, and apply it with the optimal thrust parameters associated with that working position; Step 140: Obtain the user's ultrasound image at this time, obtain the scoliosis angle based on the user's ultrasound image and feed it back to the orthodontist, obtain the orthodontist's adjustment opinions, and make fine adjustments to the brace pressure plate based on the adjustment opinions. Step 150: Repeat steps 130 to 140 to obtain the brace pressure plates after fine-tuning all the positions of action; Step 160: Connect all the brace pressure plates into a whole through the fixing and supporting components of the brace pressure plates, and install an adjustable tension band on the brace pressure plates to form the user's brace; Step 170: Obtain the user's brace pressure pad replacement request, determine the brace pressure pad to be replaced according to the brace pressure pad replacement request, and read its fine-tuned position. Repeat steps 120 to 160 to obtain the adjusted user's brace. The correction parameters are obtained through parameter transformation, including: The location of the force application area (x, y, z, α, β, θ) is determined based on the position information of the robotic arm, where x, y, z, α, β, θ are the coordinates of the robotic arm on the X-axis, Y-axis, and Z-axis, respectively, and the corresponding rotation angles α, β, θ on the X-axis, Y-axis, and Z-axis. A reference range [S*(1-a), S*(1+b)] is defined for the size of the force application area, where S, a, and b vary with human body size and anatomical position. Where S represents the pushing area of ​​the robotic arm providing correction parameters. The calculation process for S involves determining the pressure tolerance range [Pd, Pu] corresponding to the force application area based on the relationship between the preset region and the pressure tolerance range, where Pd is the minimum pressure tolerance pressure and Pu is the maximum pressure tolerance pressure; Pd and Pu are obtained from clinical trial measurements and biomedical simulations. Since S=F / P, F is the magnitude of the thrust, which can be directly read, and P is located in the pressure tolerance range [Pd, Pu], the range of values ​​for S can be calculated, and thus the reference range of the area size can be determined. Furthermore, based on the pressure tolerance range [Pd, Pu], the theoretical sinking or floating stroke L1 of the manipulator in the force application area can be determined. Then, based on the stroke L2 of the manipulator after the thrust reaches the preset condition, the actual set stroke L=c*L1+d*L2 of the manipulator can be calculated, where c and d are determined by pre-test fitting. The correction parameters are the location of the force application area (x,y,z, α, β, θ), the reference range of the area size of the force application area [S*(1-a), S*(1+b)], and the actual set stroke of the robot L=c*L1+d*L2.

2. The method for manufacturing an adjustable modular scoliosis orthosis according to claim 1, characterized in that, Specifically, the user's treatment parameters include: Height, weight, and X-ray information, including information on the user's scoliosis type, apical vertebra, end vertebra, vertebral rotation, and pelvic tilt obtained through image recognition based on the X-ray images.

3. The method for manufacturing an adjustable modular scoliosis orthosis according to claim 2, characterized in that, Specifically, the process of obtaining the brace pressure pads at the corresponding application positions includes, Control the robotic arm to move to any desired position. Once the user is in the preset correction position and the robotic arm is in its initial position and in contact with the user, the current position information and thrust are obtained. The thrust is continuously increased in preset steps, and the position information of the manipulator, the magnitude of the thrust, and the three-dimensional image of the user's spine are obtained after each increase in thrust. When the thrust reaches the preset condition, stop adjusting the thrust and record the position information of the robot arm, the thrust magnitude (i.e., the optimal thrust parameters), and the three-dimensional image of the user's spine. Based on the position information of the manipulator when the thrust reaches the preset condition, the magnitude of the thrust, and the three-dimensional image of the user's spine, the correction parameters are obtained by parameter conversion, and the brace pressure pad at the current position is obtained based on the correction parameters. Repeat the above operation for all positions to obtain the brace pressure pads for all positions.

4. The method for manufacturing an adjustable modular scoliosis orthosis according to claim 3, characterized in that, Specifically, during the process of the robotic arm moving to the working position, it will also receive a mode switching command. If it receives a command to switch to the teaching mode, it will stop the original movement and be pulled and fixed to the working position by the orthotist.

5. An adjustable modular scoliosis orthosis fabrication system, characterized in that, The system comprising the steps of the method according to any one of claims 1-4, wherein the method is applied: The action position determination module is used to determine multiple action positions of the robotic arm based on the user's treatment parameters; The brace pressure plate manufacturing module is used to control the robot arm to move to each determined action position, control the robot arm to apply thrust at any action position and determine the optimal thrust parameters based on feedback information, obtain each action position and its associated optimal thrust parameters, and manufacture the corresponding brace pressure plate based on the action position and its optimal thrust parameters. The support pressure plate replacement module is used to replace the robot with modular support pressure plates, control the support pressure plates to move to a working position, and apply the optimal thrust parameters associated with that working position. The brace pressure plate fine-tuning module is used to acquire the user's ultrasound image at this time, obtain the current scoliosis angle based on the user's ultrasound image and feed it back to the orthodontist, obtain the orthodontist's adjustment opinions, and fine-tune the brace pressure plate based on the adjustment opinions; The brace pressure plate determination module is used to repeatedly run the brace pressure plate replacement module and the brace pressure plate fine-tuning module to obtain the brace pressure plates after fine-tuning at all working positions. The brace fabrication module is used to connect all the brace pressure plates into a whole through the fixing and supporting components of the brace pressure plates, and to install an adjustable tension band on the brace pressure plates to form a brace for the user. The brace adjustment module is used to obtain the user's brace pressure pad replacement request, determine the brace pressure pad to be replaced according to the request, and read its fine-tuned position. The module repeatedly runs the brace pressure pad manufacturing module, the brace pressure pad replacement module, the brace pressure pad fine-tuning module, the brace pressure pad determination module, and the brace manufacturing module to obtain the adjusted brace for the user.

6. The adjustable modular scoliosis orthosis fabrication system according to claim 5, characterized in that, Specifically, it also includes a mode switching module, which is used to obtain a mode switching command during the process of the robotic arm moving to the working position. If a command to switch to the teaching mode is obtained, the original movement is stopped and the orthotist pulls and fixes it to the working position.