A method for manufacturing and using a spinal soft brace

Abstract

This invention relates to the field of medical device technology, specifically a method for manufacturing and using a spinal soft brace. The method first acquires spinal data from the patient through 3D scanning and pressure distribution measurement. Then, a personalized 3D model of the soft brace is designed, and suitable materials are selected for manufacturing. Finally, the brace is adjusted and optimized. The usage method includes steps such as pre-wearing preparation, correct wearing, wearing time and activity guidance, and regular inspection and maintenance. The spinal soft brace manufactured by this invention has advantages such as good support, high comfort, and high correction accuracy. Its scientific and standardized usage method helps improve the treatment effect and quality of life for patients with spinal diseases.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a method for manufacturing and using a spinal soft brace. Background Technology

[0002] Spinal diseases are common clinical conditions that severely impact patients' quality of life. Spinal braces, as important adjunctive therapeutic devices, effectively restrict abnormal spinal movement, provide support, reduce spinal burden, and promote spinal rehabilitation and correction. However, traditional rigid spinal braces suffer from drawbacks such as heavy weight, poor breathability, and limited fit, while existing soft spinal braces still need improvement in terms of support strength, fit, and corrective effect, and lack standardized usage guidelines. Therefore, developing a novel method for manufacturing and using soft spinal braces is of significant practical importance. Summary of the Invention

[0003] The purpose of this invention is to provide a method for manufacturing and using a spinal soft brace, addressing the problems of insufficient support strength, poor fit, unsatisfactory corrective effect, and lack of standardized usage guidance in existing spinal soft brace manufacturing methods. The manufacturing method of this invention can produce a spinal soft brace that is comfortable to wear, provides good support, and has a significant corrective effect, and provides a scientific method for its use, thereby improving the treatment effect and quality of life for patients with spinal diseases.

[0004] To achieve the above-mentioned objectives, the technical solution adopted by this invention is as follows: A method for manufacturing a spinal soft brace, characterized by comprising the following steps: Step 1: Patient spinal data acquisition. A 3D scanner is used to perform a comprehensive scan of the patient's spine to obtain 3D morphological data of the patient's spine. A pressure sensor pad is used to measure the pressure distribution of the patient's spine in different postures such as natural standing and sitting, and the pressure values ​​borne by each part of the spine are recorded. The acquired data is then transmitted to the computer-aided design system. Step Two: 3D Model Design of the Brace. Using a computer-aided design system, based on the patient's spinal data and considering ergonomic principles and spinal biomechanical characteristics, a 3D model of the spinal soft brace is designed. Reinforcing support structures are incorporated into key support areas of the brace. To improve breathability and comfort, multiple ventilation holes and channels are designed into the brace model. Finite element analysis is used to simulate and analyze the brace's support performance and stress distribution, and the brace's structure is optimized. Step 3: Material selection and preparation. The main body of the brace is made of polymer material; the reinforcing support structure is made of composite material; and the breathable layer is made of skin-friendly and breathable fabric. According to the size and shape of the three-dimensional model of the brace, the selected materials are cut and pre-processed. Step 4: Bracket fabrication. The main body of the bracket is fabricated using a hot-press molding process. The reinforcing support structure is fixed to the key support parts of the main body of the bracket using adhesives or mechanical connections. The breathable layer is fixed to the inner surface of the main body of the bracket by sewing or gluing. Step 5: Bracing adjustment and optimization. The completed spinal soft brace is delivered to the patient for trial wear. Based on the problems found during the trial wear and the measurement results of pressure distribution, the brace is adjusted and optimized in a targeted manner.

[0005] Furthermore, in the patient's spinal data acquisition step, the scanning accuracy of the 3D scanner is not less than 0.1 mm, and the measurement accuracy of the pressure sensor pad is not less than 0.1 N.

[0006] Furthermore, in the brace 3D model design step, the reinforcing support structure is made of carbon fiber reinforced plastic, and its shape and size are optimized according to the pressure distribution and support requirements of the spine; the distribution and size of the ventilation holes and ventilation channels are rationally planned according to the heat dissipation and perspiration requirements of human skin.

[0007] Furthermore, in the material selection and preparation steps, the main body material of the brace is thermoplastic polyurethane elastomer with a Shore hardness of 70A-90A; the reinforcing support structure material is carbon fiber reinforced plastic with a tensile strength of not less than 1000MPa and a flexural strength of not less than 800MPa; and the breathable layer material is cotton or modal fabric.

[0008] Furthermore, in the brace manufacturing step, the temperature of the hot pressing process is controlled at 180℃-220℃, the pressure is controlled at 5MPa-10MPa, and the molding time is 3min-5min.

[0009] Furthermore, in the brace adjustment and optimization steps, if it is found that the brace is causing pressure on the skin in a certain area, the shape of the brace in that area can be adjusted appropriately and cushioning material can be added; if the support force of the brace is insufficient, the shape or material thickness of the support structure can be further optimized and strengthened.

[0010] A method of using a spinal soft brace, characterized in that the spinal soft brace, manufactured based on the manufacturing method according to any one of claims 1 to 6, is used as follows: Preparation before wearing: The patient should keep the skin clean and dry; check whether the spinal brace is intact, whether the connection of each component is firm, and whether the breathable layer is clean and tidy; Correct wearing: The patient should stand or sit and place the spinal brace against the body. Adjust the position of the brace so that the key support parts of the brace accurately correspond to the corresponding parts of the spine. Adjust the tightness of the brace appropriately using the adjustment device on the brace. Wearing time and activity guidance: When first wearing the spinal brace, patients should start by wearing it for 2-3 hours a day, and gradually increase the wearing time until they can wear it continuously for 8-12 hours a day. During the wearing period, patients should avoid strenuous exercise and heavy physical labor, but can do appropriate light rehabilitation exercises. Regular check-ups and maintenance: Patients should have regular check-ups at the hospital or a professional institution, and the doctor will adjust the brace according to the check-up results. Patients should clean the breathable layer regularly and avoid the brace from contacting sharp objects or high-temperature environments. If wear or deformation is found in the brace, contact a professional for repair or replacement in a timely manner.

[0011] Furthermore, during the correct wearing procedure, when adjusting the position of the brace, it is essential to ensure that the brace provides effective support for the spine; when adjusting the tightness of the brace, it is advisable to do so in a way that the patient feels comfortable and the brace can exert a certain restraining force on the spine.

[0012] Furthermore, in the routine inspection and maintenance steps, the patient should clean the breathable layer every so often, using a mild detergent and avoiding cleaning agents containing bleach or strong alkaline ingredients. After cleaning, the breathable layer should be allowed to air dry naturally.

[0013] As an improvement, the beneficial effects of the present invention are as follows: 1. Production method 1.1 By accurately collecting three-dimensional morphological data and pressure distribution data of the patient's spine, and designing a three-dimensional model of the brace based on these data, it is possible to produce a personalized soft brace that closely fits the patient's spine, effectively improving the support effect and correction accuracy of the brace.

[0014] 1.2 By setting up reinforced support structures at key support points of the brace and selecting appropriate materials, the brace is ensured to have sufficient support strength without affecting the patient's daily activities due to excessive weight, while also improving the durability of the brace.

[0015] 1.3 The ventilation design of the brace was optimized by setting multiple ventilation holes and channels and using skin-friendly and breathable layer materials, which greatly improved the breathability and comfort of the brace and reduced skin problems caused by prolonged brace use.

[0016] 1.4 During the manufacturing process, rigorous adjustments and optimizations are carried out to ensure that the brace can perfectly fit the patient's spine and provide appropriate support, thereby further improving the quality and effectiveness of the brace.

[0017] 2. Usage method 2.1 It provides detailed instructions on pre-wearing preparation, correct wearing, wearing time and activities, as well as regular inspection and maintenance, providing patients with scientific and standardized usage methods, which helps patients use spinal braces correctly and improve treatment outcomes.

[0018] 2.2 Specific solutions are provided for potential problems during the wearing process, such as skin pressure and exercise guidance, which enhances the safety and comfort of patients using the brace.

[0019] 2.3 Emphasizing the importance of regular inspection and maintenance, it is possible to promptly identify and resolve problems that arise during the use of the brace, extend the service life of the brace, and adjust the brace usage plan according to the patient's recovery progress to ensure the continuity and effectiveness of treatment. Detailed Implementation

[0020] To make the content of this invention easier to understand, the technical solutions in the embodiments of this invention will be clearly and completely described below in conjunction with the embodiments of this invention.

[0021] Example 1: Fabrication of Spinal Soft Braces Patient spinal data collection 1. 3D Scan: A comprehensive scan of the patient's spine is performed using a HandySCAN 3D series 3D scanner (with an accuracy of 0.05mm). The patient maintains a natural standing posture, and the scanner slowly moves around the patient's spine to acquire three-dimensional morphological data of the spine, including the curvature, length, width, and positional information of each vertebra.

[0022] 2. Pressure Distribution Measurement: The Tekscan pressure measurement system (accuracy 0.01N) was used to measure the pressure distribution of the patient's spine in different postures, such as natural standing and sitting. The pressure sensor pad was placed between the patient's spine and back, and the pressure values ​​borne by each part of the spine were recorded.

[0023] 3. Data transmission: The collected 3D morphological data and pressure distribution data are transmitted to the SolidWorks computer-aided design (CAD) system.

[0024] 3D model design of braces 1. Preliminary Design: In the SolidWorks system, based on the patient's spinal data and combined with ergonomic principles and spinal biomechanical characteristics, a 3D model of the spinal brace is designed. During the design process, the physiological curvature and range of motion of the spine are fully considered to determine the overall shape and size of the brace, as well as the location and shape of key support components.

[0025] 2. Enhanced Support Structure Design: Reinforced support structures are installed at critical support points of the brace, such as the convex side of scoliosis and stress-bearing areas of spinal fractures. These reinforced support structures are made of carbon fiber reinforced plastic (CFRP), and their shape and dimensions are optimized according to the pressure distribution and support requirements of the spine. For example, on the convex side of scoliosis, the thickness and width of the reinforced support structure are appropriately increased to provide stronger support.

[0026] 3. Breathable Design: To improve the breathability and comfort of the brace, multiple ventilation holes and channels are designed on the brace model. The distribution and size of the ventilation holes and channels are rationally planned according to the heat dissipation and perspiration needs of human skin. For example, larger ventilation holes and more ventilation channels are set in areas prone to sweating, such as the back and waist of the brace.

[0027] 4. Finite Element Analysis: ANSYS finite element analysis software was used to simulate and analyze the support performance and stress distribution of the brace. Finite element analysis provides a direct understanding of the deformation and stress concentration areas of the brace under different stress conditions. Based on the analysis results, the structure of the brace was optimized to improve its support effect and service life. For example, the shape and size of the reinforced support structure were optimized to distribute the pressure on the spine more evenly.

[0028] Material selection and preparation 1. Brace Body Material: Thermoplastic polyurethane elastomer (TPU) is selected as the body material of the brace. TPU material has a Shore hardness of 80A, which provides both good elasticity and a certain degree of support.

[0029] 2. Reinforced Support Structure Material: Carbon fiber reinforced plastic (CFRP) was selected as the reinforced support structure material. CFRP has a tensile strength of 1200 MPa and a flexural strength of 1000 MPa, meeting the strength requirements of critical support components of the brace.

[0030] 3. Breathable layer material: Cotton fabric is selected as the breathable layer material. Cotton fabric is skin-friendly and breathable, which can improve the comfort of patients when wearing it and reduce skin irritation.

[0031] 4. Material Cutting and Pre-processing: Based on the dimensions and shape of the brace's 3D model, the selected materials are cut and pre-processed. For example, TPU material is cut into sheets that match the shape of the brace's main body, carbon fiber reinforced plastic is cut into shapes that reinforce the support structure, and cotton fabric is cut into sheets that match the shape of the inner surface of the brace's main body.

[0032] Braces making 1. Bracket Body Fabrication: A thermoforming process is used, where pre-cut TPU material is placed in a pre-designed mold. The mold's shape matches the shape of the bracket body. The mold is then placed in a thermoforming machine, with the temperature set at 200℃, the pressure at 8MPa, and the molding time at 4 minutes. Under heat and pressure, the TPU material softens and conforms to the mold shape. After cooling, the bracket body is obtained.

[0033] 2. Installation of the reinforced support structure: The pre-cut carbon fiber reinforced plastic reinforced support structure is fixed to the key support parts of the support body using a special adhesive. During installation, clamps are used to tightly bond the reinforced support structure to the support body, ensuring no loosening.

[0034] 3. Installation of the breathable layer: The cut cotton breathable layer fabric is sewn onto the inner surface of the main body of the brace. Use a sewing machine to sew the breathable layer to the main body of the brace, ensuring that the breathable layer is flat, firm, and free of wrinkles or looseness.

[0035] Bracket Adjustment and Optimization 1. Trial Wear and Observation: The completed spinal brace is delivered to the patient for trial wear. During the trial, medical staff closely observe the fit between the brace and the patient's spine, checking for any issues such as local pressure, loosening, or discomfort. Simultaneously, pressure sensors are used to remeasure the pressure distribution on the spine after the patient wears the brace, assessing its support effectiveness.

[0036] 2. Adjustment and Optimization: Based on the problems found during the trial fitting and the measurement results of pressure distribution, the brace is adjusted and optimized in a targeted manner. For example, if it is found that the brace is causing pressure on the skin in a certain area, the shape of the brace in that area can be adjusted appropriately and cushioning material can be added; if the support of the brace is insufficient, the shape or material thickness of the support structure can be further optimized and strengthened.

[0037] 3. Final Determination: After multiple adjustments and optimizations, the brace was finalized until it perfectly conformed to the patient's spine, provided appropriate support, and was comfortable for the patient to wear. At this point, the brace was complete.

[0038] Example 2: Use of Spinal Soft Braces Preparation before wearing 1. Skin Cleansing: Before using a spinal brace, patients should clean their back skin with warm water and mild soap, keeping the skin clean and dry. Avoid using cleansing products containing irritating ingredients to prevent skin irritation.

[0039] 2. Bracing Inspection: Inspect the spinal brace for damage, ensure all components are securely connected, and check the breathable layer for cleanliness. If any damage, looseness, or contamination is found, repair or replacement should be made promptly. For example, if the Velcro straps are loose, they can be sewn together for reinforcement; if stains are found on the breathable layer, they can be gently wiped with a damp cloth.

[0040] Wear correctly 1. Fitting the brace: The patient stands and aligns the opening of the spinal brace with the spine, slowly fitting the brace onto the body. During the fitting process, pay attention to adjusting the position of the brace so that the key support parts of the brace accurately align with the corresponding parts of the spine. For example, align the reinforcing support structure of the brace with the convex side of the scoliosis to ensure effective support for the spine.

[0041] 2. Adjusting the tightness: After putting on the brace, adjust its tightness using the Velcro adjustment mechanism. The adjustment should be made so that the patient feels comfortable and the brace provides sufficient support for the spine. It should not be too tight, which could restrict blood circulation, nor too loose, which would lose its support function. For example, the patient can first tighten the Velcro and then perform simple activities such as bending over or turning to check if the tightness is appropriate. If it feels too tight, loosen the Velcro appropriately; if it feels too loose, tighten the Velcro appropriately.

[0042] Wearing Time and Activity Guidelines 1. Initial Wearing Time: When first wearing the spinal brace, patients should begin with 2 hours of wear per day. Patients can choose to wear the brace for a period of time during the day, such as 1 hour in the morning and 1 hour in the afternoon. Gradually increase the wearing time until the patient can wear it continuously for 10 hours per day. The specific wearing time should be adjusted according to the patient's condition, physical condition, and the doctor's advice. For example, for patients with milder conditions, the wearing time can be appropriately shortened; for patients with more severe conditions, the wearing time can be appropriately extended.

[0043] 2. Activity Restrictions: While wearing a spinal brace, patients should avoid strenuous exercise and heavy physical labor, such as running, jumping, and lifting heavy objects, to prevent excessive pressure on the spine, which could affect the brace's support and spinal rehabilitation. However, some light rehabilitation exercises, such as walking and simple spinal stretching exercises, are permissible. For example, patients can take a 30-minute walk daily to promote blood circulation in the spine and restore muscle strength. When performing spinal stretching exercises, patients should do so under the guidance of a doctor to avoid overstretching and causing spinal injury.

[0044] Regular inspection and maintenance 1. Regular Check-ups: Patients should have monthly check-ups at the hospital or a professional institution. Doctors will use imaging examinations (such as X-rays and CT scans) and clinical assessments to understand the patient's spinal rehabilitation progress and the effectiveness of the brace. Based on the examination results, the doctor may further adjust the brace's wearing time and tightness. For example, if the angle of scoliosis is found to have decreased, the doctor may appropriately reduce the brace's wearing time; if insufficient spinal support is found, the doctor may recommend increasing the brace's tightness.

[0045] 2. Brace Maintenance: Patients should pay attention to the maintenance of their spinal braces in daily life. Clean the breathable layer weekly with a mild detergent, avoiding cleaners containing bleach or strong alkaline ingredients to prevent damage to the breathable fabric. After washing, allow the breathable layer to air dry naturally, avoiding direct sunlight. Avoid contact with sharp objects or high temperatures to prevent damage to the brace materials. If wear or deformation is found, contact a professional for repair or replacement immediately. For example, if cracks are found in the TPU material of the brace, the main body of the brace should be replaced immediately; if the carbon fiber reinforced plastic of the brace is found to be broken, the reinforcing support structure should be replaced immediately.

[0046] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A method of making a spinal soft brace, comprising: Includes the following steps: Step 1: Patient spinal data acquisition. A 3D scanner is used to perform a comprehensive scan of the patient's spine to obtain 3D morphological data of the spine. A pressure sensor pad is used to measure the pressure distribution of the patient's spine in different postures such as natural standing and sitting, and the pressure values ​​of each part of the spine are recorded. The acquired data is then transmitted to the computer-aided design system. Step Two: 3D Model Design of the Brace. Using a computer-aided design system, based on the patient's spinal data and considering ergonomic principles and spinal biomechanical characteristics, a 3D model of the spinal soft brace is designed. Reinforcing support structures are installed at key support points of the brace. To improve the brace's breathability and comfort, multiple ventilation holes and channels are designed on the brace model. Finite element analysis is used to simulate and analyze the brace's support performance and stress distribution, and the brace's structure is optimized. Step 3: Material selection and preparation; the main body of the brace is made of polymer material. Composite materials are selected to strengthen the supporting structure; skin-friendly and breathable fabrics are selected for the breathable layer material. The selected materials are cut and pre-treated according to the size and shape of the three-dimensional model of the support. Step 4: Bracing fabrication. The main body of the bracing is fabricated using a hot pressing molding process. The reinforcing support structure is fixed to the key support parts of the support body by adhesive or mechanical connection; the breathable layer is fixed to the inner surface of the support body by sewing or pasting. Step 5: Bracing adjustment and optimization. The completed spinal soft brace is delivered to the patient for trial wear. Based on the problems found during the trial wear and the measurement results of pressure distribution, the brace is adjusted and optimized in a targeted manner.

2. A method of making a soft brace for the spine according to claim 1, wherein, In the patient's spinal data acquisition step, the scanning accuracy of the 3D scanner is not less than 0.1 mm, and the measurement accuracy of the pressure sensor pad is not less than 0.1 N.

3. The method of claim 1, wherein: In the three-dimensional model design step of the brace, the reinforced support structure is made of carbon fiber reinforced plastic, and its shape and size are optimized according to the pressure distribution and support requirements of the spine. The distribution and size of the vents and ventilation channels are rationally planned according to the human skin's needs for heat dissipation and perspiration.

4. A method for manufacturing a spinal soft brace according to claim 1, characterized in that, In the material selection and preparation steps, the main material of the brace is thermoplastic polyurethane elastomer with a Shore hardness of 70A-90A. The supporting structure is made of carbon fiber reinforced plastic with a tensile strength of not less than 1000 MPa and a flexural strength of not less than 800 MPa; the breathable layer is made of cotton or modal fabric.

5. A method for manufacturing a spinal soft brace according to claim 1, characterized in that, In the brace manufacturing process, the temperature of the hot pressing process is controlled at 180℃-220℃, the pressure is controlled at 5MPa-10MPa, and the molding time is 3min-5min.

6. A method for manufacturing a spinal soft brace according to claim 1, characterized in that, During the brace adjustment and optimization process, if it is found that the brace is causing pressure on the skin in a certain area, the shape of the brace in that area can be adjusted appropriately and cushioning material can be added; if the brace's support is insufficient, the shape or material thickness of the support structure can be further optimized and strengthened.

7. A method of using a spinal soft brace, characterized in that, The spinal brace manufactured according to the manufacturing method of any one of claims 1 to 6 is used as follows: Preparation before wearing: The patient should keep the skin clean and dry; check whether the spinal brace is intact, whether the connection of each component is firm, and whether the breathable layer is clean and tidy; Correct wearing: The patient should stand or sit and place the spinal brace against the body. Adjust the position of the brace so that the key support parts of the brace accurately correspond to the corresponding parts of the spine. Adjust the tightness of the brace appropriately using the adjustment device on the brace. Wearing time and activity guidance: When first wearing the spinal brace, patients should start by wearing it for 2-3 hours a day, and gradually increase the wearing time until they can wear it continuously for 8-12 hours a day. During the wearing period, patients should avoid strenuous exercise and heavy physical labor, but can do appropriate light rehabilitation exercises. Regular check-ups and maintenance: Patients should have regular check-ups at the hospital or a professional institution, and the doctor will adjust the brace according to the check-up results. Patients should clean the breathable layer regularly and avoid the brace from contacting sharp objects or high-temperature environments. If wear or deformation is found in the brace, contact a professional for repair or replacement in a timely manner.

8. A method of using a spinal soft brace according to claim 7, characterized in that, When adjusting the position of the brace during the correct wearing procedure, it is important to ensure that the brace can provide effective support for the spine. When adjusting the tightness of the brace, it is advisable to do so in a way that the patient feels comfortable and the brace can exert a certain restraining force on the spine.

9. A method of using a spinal soft brace according to claim 7, characterized in that, During the regular inspection and maintenance process, patients should clean the breathable layer periodically with a mild detergent, avoiding cleaning agents containing bleach or strong alkaline ingredients. After cleaning, allow the breathable layer to air dry naturally.