Novel spine correction brace

Abstract

The invention relates to the technical field of medical rehabilitation equipment, and discloses a novel spine correction brace which comprises a spine stress loading device, a pressure sensing system and an X-ray detection system, and the pressure sensing system and the X-ray detection system are arranged on the spine stress loading device. The spine stress loading device comprises an adjustable lifting frame, a loading support, a pressure sensor, a left pushing device and a right pushing device, the loading support is installed on the adjustable lifting frame, the pressure sensor is arranged in the loading support, and the left pushing device and the right pushing device are symmetrically arranged on the left side and the right side of the loading support respectively. The two are connected with the loading bracket; the loading support is provided with a pressurization loading device, the pressurization loading device comprises a cross beam, a lower base and a stand column, the stand column is vertically connected between the loading support and the cross beam, and the lower base is arranged on the side, facing the human body, of the loading support. According to the invention, the precise and individualized orthopedic effect which is difficult to achieve by a traditional brace is realized.

Description

Technical Field

[0001] This invention relates to the field of medical rehabilitation equipment technology, specifically to a novel spinal deformity correction brace. Background Technology

[0002] In the clinical treatment and rehabilitation of spinal deformities (such as adolescent idiopathic scoliosis), bracing is an important non-surgical intervention. Its core objective is to guide the spine to gradually restore its normal physiological curvature and slow the progression of the deformity by applying controllable external force. However, the design and fabrication of traditional spinal braces face two major technical bottlenecks that hinder the achievement of precise and individualized corrective effects. The specific problems are as follows:

[0003] On the one hand, traditional brace fabrication lacks real-time monitoring and quantitative analysis of the "in vivo biomechanical response of the spine." Spinal biomechanical studies show significant individual differences in the body's response to external pushing loads. For example, different patients have different spinal stiffness, muscle compensation capabilities, and vertebral stability. Under the same pushing force, the changes in spinal curvature in the sagittal and coronal planes, as well as the changes in the relative angles between vertebrae, vary considerably. However, in current technologies, the setting of brace forces largely relies on the doctor's clinical experience or universal standard parameters, failing to capture the biomechanical feedback of the patient in a standing and active state (where spinal forces are closer to everyday physiological scenarios). This leads to the possibility of the applied corrective force being "too strong" or "insufficient"—too strong forces can easily cause skin compression damage and muscle spasms, while insufficient forces cannot achieve the expected corrective effect, affecting treatment efficiency.

[0004] On the other hand, traditional braces lack sufficient precision in "force-shape matching," making it difficult to balance corrective effect and comfort. The core logic of brace correction is to use pushing force in specific areas to reposition the spine towards a normal shape. However, current technology cannot accurately determine the "minimum pushing force combination corresponding to the best corrective effect" before brace fabrication. For example, in correcting scoliosis in the apical region, the ratio of horizontal pushing force to axial derotation force, the distribution of application points, and the pushing contact area lack dynamic adjustment based on the patient's real-time spinal morphology (such as total spinal curvature and relative vertebral angles). Furthermore, after traditional braces are fabricated, it is impossible to monitor the actual force applied to the patient's skin in real time, making it difficult to further optimize the force distribution based on individual fit. This leads to reduced compliance in some patients due to localized pressure discomfort, indirectly affecting the corrective effect. Summary of the Invention

[0005] To address the aforementioned shortcomings in existing technologies, this invention provides a novel spinal correction brace that enables real-time biomechanical monitoring, dynamic stress loading, and quantitative analysis of spinal morphology during spinal correction.

[0006] To achieve the above-mentioned objectives, the technical solution adopted by the present invention is as follows: a novel spinal correction brace, comprising a spinal stress loading device, a pressure sensing system and an X-ray detection system disposed on the spinal stress loading device;

[0007] The spinal stress loading device includes an adjustable lifting frame, a loading bracket, a pressure sensor, a left pushing device, and a right pushing device. The loading bracket is installed on the adjustable lifting frame, the pressure sensor is built into the loading bracket, and the left pushing device and the right pushing device are symmetrically arranged on the left and right sides of the loading bracket, respectively, and both are connected to the loading bracket.

[0008] The loading bracket is equipped with a pressure loading device, which includes a crossbeam, a lower base, and a column. The column is vertically connected between the loading bracket and the crossbeam, and the lower base is located on the side of the loading bracket facing the human body.

[0009] Furthermore, the aforementioned novel spinal correction brace also includes a computer terminal processing system, a pressure sensing system that is connected to the computer terminal processing system via wires, and an X-ray detection system; the computer terminal processing system, the spinal stress loading device, and the X-ray detection system each form a signal receiving link.

[0010] Furthermore, the aforementioned novel spinal correction brace and spinal stress loading device also include bilateral pelvic, bilateral axillary, and convex vertebral push devices to apply stress to the spine, simulate brace orthopedic correction, and ultimately obtain the optimal application method and personalized brace lining.

[0011] Furthermore, in the aforementioned novel spinal correction brace, one part of the detection end of the pressure sensing system is located on the support surface under the subject's feet to detect the pressure of the subject's feet on the ground. The other part of the detection end, along with the left and right pushing devices, is placed between the pad and the pushing devices on the side facing the human body to detect the pushing pressure applied by the left and right pushing devices. The signal output end of the pressure sensing system is connected to the computer terminal processing system through a wire to convert the detected pressure into an electrical signal and transmit it to the computer terminal processing system.

[0012] Furthermore, the aforementioned novel spinal correction brace has an X-ray detection system that covers the entire spine of the subject. It can measure the physiological curvature of the entire spine in the sagittal and coronal planes and the relative angle changes of adjacent vertebrae under different loads, and transmit the measured angle signals to the computer terminal processing system via wireless Bluetooth.

[0013] The beneficial effects of the present invention are as follows: The spinal correction brace of the present invention, by integrating a spinal stress loading device, a pressure sensing system, an X-ray detection system and a computer terminal processing system, achieves a precise and individualized orthopedic effect that is difficult to achieve with traditional braces.

[0014] In use, the outline of the human torso is obtained through 3D scanning. Based on the obtained torso outline, a hollow model of the brace is designed. The personalized lining obtained earlier is added to the inside of the brace. Wireless pressure sensing elements are added between the lining and the brace, and an airbag is installed between the brace and the lining. The pressure of the lining is roughly adjusted by the buckles on the outside of the brace, and the pressure is further finely adjusted in real time by the airbag.

[0015] This corrective brace can capture and quantify the biomechanical response of the spine in real time. The spinal stress loading device can be adjusted in height according to the subject's height via an adjustable lifting frame. The contact surface of the lower pushing device conforms to the armpit, pelvis, and deformed apical vertebrae. The left and right pushing devices can apply stress horizontally and can also apply axial derotation force to the apical vertebrae. At the same time, the pressure sensing system detects the pressure of the subject's feet on the ground to reflect the body's force balance, and detects the pushing force on the skin by the left and right pushing devices. The X-ray detection system covers the entire spine, measuring the physiological curvature of the sagittal and coronal planes and the relative angle changes of adjacent vertebrae under different loads. These pressure and morphological data are transmitted to the computer terminal processing system via wires and wireless Bluetooth, replacing the traditional method of relying on doctors' experience to set the corrective force. This allows the "force-shape" correspondence during the correction process to be tracked and quantified in real time, avoiding problems such as skin damage or muscle spasms due to excessive force, or failure to achieve the corrective effect due to insufficient force.

[0016] This brace significantly improves the accuracy of "force-shape matching," balancing corrective effect with wearing comfort. Before brace fabrication, stress loading tests are conducted to simulate the patient's standing and active state (closer to daily physiological scenarios). The computer terminal processing system can output a linear graph with stress magnitude as the independent variable and spinal curvature and vertebral angle as dependent variables. This helps determine the "minimum pushing force combination corresponding to the best corrective effect," clarifying the optimal ratio and point of application of horizontal pushing force and axial derotation force, ultimately obtaining the best liner and reducing repeated adjustments after brace fabrication from the source. After fabrication, pressure sensors and airbags can be added to the brace liner to monitor the skin pressure on the patient in real time and adjust the pressure according to the airbags. This facilitates further optimization of force distribution based on individual fit, reduces local pressure discomfort, and improves long-term patient compliance. Good compliance is key to ensuring the corrective effect of spinal deformity. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the structure of this orthopedic brace;

[0018] Figure 2 Schematic diagram of coronal plane stress and Cobb angle variation under different loads;

[0019] Figure 3 A diagram showing the sagittal stress on the lower main bending segments T6-T10 under different loads and the corresponding changes in the kyphosis angle of the thoracic vertebrae.

[0020] Figure 4 Schematic diagram of the stress on the superior endplate of the T6 vertebral body under different loading methods;

[0021] Figure 5 Schematic diagram of the stress on the upper endplate of the T7 vertebra under different loads;

[0022] Figure 6 Schematic diagram of the stress on the upper endplate of the T8 vertebra under different loads;

[0023] Figure 7 This is a schematic diagram of the stress on the upper endplate of the T9 vertebra under different loading methods.

[0024] The components include: 1. Spinal stress loading device, 2. Pressure sensing system, 3. X-ray detection system, 4. Adjustable lifting frame, 5. Loading bracket, 6. Pressure sensor, 7. Left pushing device, 8. Right pushing device, 9. Pressurization loading device, 10. Crossbeam, 11. Lower base, 12. Column, and 13. Conductor. Detailed Implementation

[0025] Down Figure 1 As shown, this embodiment provides a novel spinal correction brace, including a spinal stress loading device 1, a pressure sensing system 2, an X-ray detection system 3, and a computer terminal processing system (plus a three-dimensional scanning method to obtain the outline of the human torso to create the brace). The various systems work together through electrical signals and wireless transmission to jointly complete the real-time monitoring and mechanical correction of the spinal correction process.

[0026] The spinal stress loading device 1, serving as the actuator of the entire system, is centered around a height-adjustable lifting frame 4. This frame can be flexibly adjusted according to the subject's height to ensure the loading support 5 is at the optimal height corresponding to the human spine. A high-precision pressure sensor 6 is embedded within the loading support 5 to monitor real-time pressure changes when the pushing device contacts the human body. A left-side pushing device 7 and a right-side pushing device 8 are symmetrically arranged on both sides of the frame. The crossbeam 10 is connected to the loading support 5 via the column 12, ensuring a stable structure. The lower base 11 is designed to conform to the curves of the human shoulders and back, and is made of flexible material, ensuring effective force transmission while also improving the subject's comfort.

[0027] The pressure sensing system 2 consists of two detection parts: one part is placed on the support surface under the subject's feet to monitor the pressure distribution of the human body on the ground while standing, reflecting the body's balance; the other part is closely attached to the inside of the left and right pushing devices to detect the pressure of the pushing force acting on the skin surface in real time. All pressure data is transmitted to the computer terminal processing system via wire 13 for real-time display and recording.

[0028] The X-ray detection system 3 has a detection range covering the entire spine. It can acquire the physiological curvature changes of the spine in the sagittal and coronal planes in real time when the subject is standing and subjected to stress loading in different directions, and accurately measure the relative angle between adjacent vertebrae.

[0029] The computer terminal processing system, as the central hub of the entire device, is responsible for receiving and integrating multimodal data from the pressure sensing system 2 and the X-ray detection system 3. The system software can generate data curves and Excel spreadsheets in real time, with stress magnitude as the independent variable and spinal curvature and intervertebral angle as the dependent variables. This helps doctors or technicians to intuitively analyze the morphological response of the spine under different combinations of pushing forces, thereby determining the minimum pushing force combination required to achieve the best corrective effect.

[0030] In the experimental phase, a highly realistic finite element model was constructed to simulate the orthopedic effect of the brace under different combinations of pushing force and contact area. A total of 16 working conditions were designed for the experiment, corresponding to four pushing forces of 20N, 30N, 40N, and 50N applied to the convex side of the apical region, and four chest wall contact areas of 85%, 65%, 45%, and 25% were set under each force condition.

[0031] like Figure 2 As shown, the experimental results indicate that the best corrective effect on the spine in the coronal plane and the most significant change in the Cobb angle are achieved with a 25% contact area and a 50N pushing force. This demonstrates that a larger pushing force or a larger contact area does not necessarily lead to a better corrective effect; rather, the matching relationship between force and area has a decisive influence on the corrective effect.

[0032] like Figure 3 As shown, under the same contact area, the greater the pushing force, the more significant the reduction in the thoracic kyphosis angle; and under the same pushing force, the larger the contact area, the more significant the kyphosis reduction effect. This reveals the quantitative relationship between the change in sagittal curvature and pushing parameters during brace orthopedic treatment, providing a theoretical basis for the optimal configuration of pushing force and padding area in brace design.

[0033] At the vertebral level, the experiment conducted a detailed analysis of the stress distribution of the superior endplates of the T6, T7, T8, and T9 vertebrae under different pushing conditions. The results are shown in Tables 1 and 2. Table 1 shows the pressure changes of the superior endplates of different vertebrae under different experimental conditions, while Table 2 shows the pressure ratio changes of the anterior or posterior side, and convex or concave side of the superior endplates of different vertebrae.

[0034] Table 1:

[0035]

[0036] Table 2:

[0037]

[0038] The area of ​​maximum stress from the brace is not always located on the convex side; its position shifts depending on the type of compression. Generally, the stress on the concave side is less than that on the convex side, and the stress on the posterior side is greater than that on the anterior side. This indicates that while simple lateral compression can improve coronal deformities, it exacerbates the asymmetry of stress between the anterior and posterior sides of the vertebral body, leading to a reduction in thoracic kyphosis. This may be an important reason for the loss of kyphosis in traditional brace treatment.

[0039] like Figures 4-7 As shown, the T6 vertebral body generally experiences greater stress on the convex endplate than on the concave side, with the maximum compressive stress occurring on the convex side, reaching 2.48 MPa. The T7 vertebral body, however, exhibits a phenomenon where the stress on the concave side exceeds that on the convex side, suggesting differences in biomechanical responses among vertebral bodies. Under most operating conditions, the T8 and T9 vertebral bodies still experience greater stress on the convex side than on the concave side, but their force transmission capabilities differ. The anterior side of the T9 vertebral body experiences significantly weaker stress, indicating that the transmission efficiency of the pushing force is inconsistent across different segments of the spine.

[0040] The experimental results were directly applied to the design and adjustment of this spinal correction brace. In actual use, the subject stands inside the brace, and the height of the brace is adjusted using an adjustable lifting frame to align it with the individual's spinal anatomy. Symmetrical pushing devices are provided on both sides of the brace, which can apply controllable pushing force to the convex side of the apex vertebra, both sides of the armpit, and both sides of the pelvis based on the optimal pushing force and contact area set according to experimental data.

[0041] The inner lining of the brace is custom-made based on the individual's torso contour obtained through 3D scanning. High-precision pressure sensors are embedded between the lining and the brace to monitor the pressure on the skin surface in real time. Simultaneously, an air bladder structure is located behind the lining. Based on real-time pressure data, the pressure inside the air bladder can be finely adjusted to dynamically control the pushing force, ensuring optimal orthopedic results while avoiding excessive local pressure that could lead to skin damage or muscle discomfort.

[0042] The X-ray imaging system covers the entire spine, enabling real-time capture of spinal curvature changes in the sagittal and coronal planes, and measurement of the relative angles between adjacent vertebrae, while the subject stands and is subjected to varying pushing forces. All pressure and morphological data are transmitted via wired or wireless means to a computer terminal processing system. Based on the experimentally derived force-shape relationship model, the system software automatically generates response curves with pushing force as the independent variable and spinal curvature and vertebral angles as dependent variables, assisting physicians in determining personalized parameter combinations to achieve the best orthopedic effect with minimal pushing force.

[0043] The greatest advantage of this brace lies in its application of the "force-area-corrective effect" relationship revealed by finite element analysis to clinical brace design and control, achieving a shift from experience-based correction to data-driven correction. By conducting simulated loading tests before brace fabrication, optimal pushing parameters can be predetermined. During brace use, real-time monitoring and feedback adjustments further optimize the force distribution and magnitude, thereby significantly improving patient comfort and compliance while ensuring corrective effects, providing new technical support for non-surgical treatment of spinal deformities.

Claims

1. A novel spinal correction brace, characterized in that, It includes a spinal stress loading device (1), a pressure sensing system (2) installed on the spinal stress loading device (1), and an X-ray detection system (3). The spinal stress loading device (1) includes an adjustable lifting frame (4), a loading bracket (5), a pressure sensor (6), a left pushing device (7) and a right pushing device (8). The loading bracket (5) is installed on the adjustable lifting frame (4), the pressure sensor (6) is built into the loading bracket (5), and the left pushing device (7) and the right pushing device (8) are symmetrically arranged on the left and right sides of the loading bracket (5), and both are connected to the loading bracket (5). The loading bracket (5) is equipped with a pressure loading device (9), which includes a crossbeam (10), a lower base (11) and a column (12). The column (12) is vertically connected between the loading bracket (5) and the crossbeam (10). A disassembly pulley (13) is fixedly installed on the crossbeam (10), and the lower base (11) is located on the side of the loading bracket (5) facing the human body.

2. The novel spinal correction brace according to claim 1, characterized in that, The corrective brace also includes a computer terminal processing system. The pressure sensing system (2) is connected to the computer terminal processing system via a wire (13). The computer terminal processing system, the spinal stress loading device (1), and the X-ray detection system (3) form signal receiving links respectively.

3. The novel spinal correction brace according to claim 1, characterized in that, The spinal stress loading device also includes bilateral pelvic, bilateral axillary, and convex vertebral push devices to apply stress to the spine, simulate brace orthopedics, and ultimately obtain the optimal application method and personalized brace lining.

4. A novel spinal correction brace according to claim 1, characterized in that, One part of the pressure sensing system's detection end is located on the support surface under the subject's feet to detect the pressure of the subject's feet on the ground. The other part of the detection end, along with the left and right pushing devices, is placed between the pad and the pushing devices on the side facing the human body to detect the pushing pressure applied by the left and right pushing devices. The signal output end of the pressure sensing system is connected to the computer terminal processing system through wires to convert the detected pressure into an electrical signal and transmit it to the computer terminal processing system.

5. A novel spinal correction brace according to claim 1, characterized in that, The X-ray detection system (3) covers the entire spine of the subject and can measure the physiological curvature of the entire spine in the sagittal and coronal planes and the relative angle changes of adjacent vertebrae under different loads. The measured angle signal is transmitted to the computer terminal processing system via wireless Bluetooth.

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