Local fine-tuning scoliosis orthosis based on unit design and manufacturing method

Abstract

The invention belongs to the technical field of orthopedic equipment, and relates to a personalized scoliosis orthosis design and manufacturing method, and the design adapts to the requirement change of different orthopedic stages on the local rigidity of the orthosis through dynamic adjustment of the local rigidity. The problems that a traditional orthosis is single in mode, poor in comfort, difficult to adjust and incapable of meeting the dynamic rehabilitation requirement are solved. A main body of the personalized scoliosis orthosis consists of a plurality of basic units, and the rigidity of a local area is improved and reduced through local deformation of one or more basic units, so that the overall orthosis functional adjustment of the orthosis is realized. According to the invention, in the correction process, the bone form of the patient is allowed to be subjected to real-time correction of the correction strategy along with the continuous change of the correction process, the mold is not required to be taken again and a new orthosis is not required to be prepared, the real-time local personalized correction can be realized, and compared with the traditional orthosis, the wearing comfort of the orthosis is greatly improved.

Description

Technical Field

[0001] This invention belongs to the field of orthopedic equipment technology, and relates to a personalized scoliosis orthosis based on a dynamic adjustment mechanism and its manufacturing method. Background Technology

[0002] Scoliosis is a common spinal deformity. Scoliosis orthotics can correct scoliosis. Traditional orthotics are mainly divided into two categories: rigid and flexible. Rigid orthotics (such as plaster casts or 3D-printed one-piece orthotics) can provide stable corrective force, but traditional plaster casts or 3D-printed one-piece orthotics often have poor surface fit after wearing, often requiring secondary processing to fine-tune the internal shape of the orthotics. At the same time, as the correction progresses, the curvature of the patient's spine gradually changes, often requiring new molding and processing, which greatly wastes the patient's time and money. Flexible orthotics, while more comfortable, have insufficient corrective force, resulting in unstable corrective effects. In addition, traditional orthotics require new molding and fabrication based on the patient's spinal shape, which is time-consuming and material-intensive, and cannot be locally adjusted. Furthermore, traditional orthotics are heavy, have low wearing comfort, and pose potential risks to patients with long-term wear.

[0003] Therefore, there is an urgent need for a scoliosis correction device that combines dynamic adjustment capabilities with comfort. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention proposes a locally adjustable scoliosis orthosis based on unit design and its manufacturing method. As rehabilitation progresses and the patient's subjective experience changes, the shape of the orthosis can be adjusted locally or as a whole to adapt to the body surface and orthotic needs, thus solving the problems of poor comfort, difficulty in adjustment, and inability to adapt to dynamic rehabilitation needs of traditional orthosis.

[0005] The technical solution of the present invention to solve the above problems is:

[0006] On the one hand, this invention proposes a personalized scoliosis orthosis based on a dynamic adjustment mechanism, which is unique in that:

[0007] It consists of multiple basic units, which are connected by a connecting mechanism. The shape and function of the orthosis are controlled by a dynamic adjustment mechanism. Based on a phased adjustment process, the orthosis can be adjusted in stages according to the rehabilitation process.

[0008] Furthermore, the basic unit has a polygonal sheet geometry; the connecting mechanism can be either a rigid connection or a flexible connection; the connecting mechanism includes a pull wire and a connector, the connector is located on the side of the polygonal sheet, the pull wire has a connector head, and the connector head and connector are connected by an interference fit.

[0009] Furthermore, when the connecting mechanism adopts a rigid connection method, the pull wire is a rigid rod, and the rigid connector plays an overall supporting role, thereby improving the strength of the orthosis;

[0010] When the connecting mechanism adopts a flexible connection method, the pull wire is made of heat-shrinkable material, and the orthosis achieves local tension through the heat-shrinkable material.

[0011] Furthermore, by adjusting the shape and arrangement of the basic units, the stiffness of the local area of ​​the orthosis can be increased or decreased; the orthosis, through a dynamic adjustment mechanism, controls the orthotic force applied to the patient's body by adjusting the shape of the local units, the connection method of adjacent units, and the replacement of units of different materials, thereby regulating the magnitude and direction of the overall orthotic force.

[0012] Furthermore, through the above design, the individualized needs of patients with different body types, degrees of scoliosis, and orthodontic progress can be met by adjusting the local morphology. Simultaneously, the orthodontic device proposed in this invention allows for timely modification of the orthodontic strategy as the patient's skeletal morphology changes during the correction process. The combination of multiple units enables mass production of this invention through batch manufacturing of basic units, significantly reducing the time and economic costs for patients waiting for orthodontic treatment.

[0013] On the other hand, a method for applying the above-mentioned orthosis is characterized by controlling the shape and function of the orthosis through a dynamic adjustment mechanism. Based on a phased adjustment process, the orthosis can be adjusted in stages according to the rehabilitation process.

[0014] Furthermore, the dynamic adjustment mechanism specifically includes:

[0015] 1. Addition and reduction of basic units and shape adjustment: At the apex of scoliosis or in areas where the corrective force needs to be enhanced, increase the bonding force between basic units to form high-strength support; in sensitive areas where pressure needs to be released, reduce the number of basic units to reduce local compression.

[0016] 2. Alignment direction optimization: By changing the tightness and arrangement of the basic units (such as changing the horizontal arrangement to a diagonal staggered arrangement), the direction of orthopedic force distribution is optimized.

[0017] 3. Modular replacement: For different rehabilitation stages (such as the transition from the correction period to the maintenance period), some basic units are replaced with low-rigidity or flexible materials to gradually reduce the orthodontic intensity and achieve progressive rehabilitation.

[0018] Furthermore, the dynamic adjustment mechanism precisely controls the magnitude and direction of the orthopedic force by adjusting the shape and arrangement of the basic units, ensuring that orthotics can be fabricated quickly and efficiently for patients with different types and degrees of scoliosis. Traditional plaster casts or orthotics made by one-piece printing often suffer from inaccurate mold taking, resulting in inaccurate application of orthopedic force. Based on the dynamic adjustment mechanism, the mold taking process can be eliminated by adjusting the basic units, correcting errors caused by mold taking and improving the orthopedic effect.

[0019] Compared to traditional personalized scoliosis orthotics that require molding and other procedures, the orthotics described in this invention only requires adjustments to the size, shape, and material of local units based on molding for different patients.

[0020] Furthermore, the phased adjustment process includes the following steps:

[0021] 1. Shaping stage: This invention does not require mold taking. After the patient wears it, local heating is applied and it is directly attached to the body. Local details are adjusted according to the patient's CT images and wearing experience.

[0022] 2. Adjustment Phase: As rehabilitation progresses, some rigid units can be replaced with flexible units based on patient feedback. Wire tension can be adjusted to balance orthopedic force and comfort. The number of basic units can be reduced and the spacing increased, retaining only key support areas to promote the recovery of spinal stability. Multiple adjustments can be made according to the patient's different recovery stages.

[0023] On the other hand, this invention proposes a method for manufacturing a personalized scoliosis orthosis based on a dynamic adjustment mechanism, comprising the following steps:

[0024] a. Determine the corrective area based on the patient's CT data;

[0025] b. Use 3D printing or injection molding to form the basic units of the orthodontic device;

[0026] c. Personalized orthotics are assembled based on CT data. Low-temperature thermoplastic materials support the shaping of the orthotics by heating, thereby conforming to the human body.

[0027] Furthermore, the aforementioned 3D printing methods include selective laser sintering (SLS), photopolymerization, or fused deposition modeling (FDM).

[0028] Advantages of this invention:

[0029] 1. Comfort and dynamic adaptability: The orthosis can be locally adjusted according to the rehabilitation process. Through a dynamic adjustment mechanism, the local stiffness can be increased or decreased by using the arrangement and combination of one or more basic units to adapt to various types and degrees of scoliosis, as well as the needs of patients of different body types and ages, greatly improving the patient's comfort.

[0030] 2. Precise Orthopedic Force Mapping: The arrangement of basic units and the synergistic effect of force lines ensure that the distribution of orthopedic force matches the biomechanical characteristics of the spine, avoiding stress concentration. As the orthodontic process progresses, only local units need to be adjusted to achieve dynamic adjustment of the orthosis.

[0031] 3. Cost-effective: 3D printed basic units can be manufactured separately, reducing material and time costs. Damaged units can be replaced individually. Mass production of orthotics can be achieved by mass-producing basic units. Attached Figure Description

[0032] Figure 1 This is a model diagram of an orthotic device according to an example of the present invention;

[0033] Figure 2 This is a schematic diagram of the region division in an example of the present invention;

[0034] Figure 3 This is a schematic diagram of the basic unit of an example of the present invention;

[0035] Figure 4 This is a schematic diagram illustrating the connection method of an example of the present invention.

[0036] Among them: 101, basic unit; 102, wire; 201, concentrated force region; 202, unloading region; 301, biomimetic surface unit; 401, connecting hole; 402, connector. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention.

[0038] This invention proposes a personalized scoliosis orthosis based on a dynamic adjustment mechanism, comprising multiple basic units 101, which are connected by a connecting mechanism. The length of the connecting mechanism is adjustable, enabling the orthosis to be adjusted in stages according to the rehabilitation process.

[0039] Each basic unit can have a uniform configuration or be designed non-uniformly according to the different body shapes of patients. It uses thermoplastic materials as raw materials, and the surfaces are connected by a connecting mechanism, supporting free combination and disassembly in the horizontal, vertical, and diagonal directions. The interior of the basic unit is made of thermoplastic materials (polyethylene, polypropylene, etc.) through 3D printing or injection molding, allowing for a complete fit to the body's surface curvature, reducing skin pressure while providing support.

[0040] The connecting mechanism can employ either a rigid or flexible connection. A flexible connection uses heat-shrinkable materials, and adjacent planar basic units are joined by heating after connection. A rigid connection uses rigid connecting rods, primarily to increase the overall stiffness and support capacity of the orthosis. As the patient's recovery progresses, the orthotic force can be adjusted by changing the connection method.

[0041] The orthotic device described in this invention eliminates the need for a molding process during manufacturing, thus avoiding deviations that may occur during molding or mold repair. Furthermore, the direct molding method using thermoplastic materials allows for a better fit to the patient's body surface, significantly improving patient comfort when wearing the device.

[0042] Specifically, the orthotics such as Figure 1 and Figure 4 As shown, the device includes a basic unit 101 and a connecting mechanism, the connecting mechanism being a pull wire 102. The basic unit 101 is a polygonal sheet with connecting holes 401 on its side. The pull wire 102 includes a connector 402. The inner diameter of the connecting hole 401 is larger than the outer diameter, and the inner cavity is used to fix the connector 402. The pull wire 102 connects the polygonal sheets. After determining the orthopedic area and the magnitude of the orthopedic force, the pull wire 102 is used through the connecting holes 401. By controlling the pull wire connector 402, the tightening and loosening of local areas are achieved, thus realizing the orthopedic effect.

[0043] When the connecting mechanism requires a rigid connection, the pull wire 102 is made of heat-shrinkable material, which is heated and tightened to adjust the magnitude of the straightening force; when the connecting mechanism requires a rigid connection, the pull wire 102 is a rigid connecting rod.

[0044] like Figure 1 The orthotics styles can include men's vests and women's tube tops to accommodate a wider range of people. Due to their better surface fit and comfort, they can accommodate more types of scoliosis and different degrees of curvature.

[0045] The thickness of the basic unit ranges from 2 to 8 mm. If it is too thick, it will cause discomfort and excessive weight; if it is too thin, it will break due to exceeding the material strength range and failing to provide stable orthopedic force. The diameter of the connecting hole 401 does not exceed 1 / 2 of the thickness of the sheet, allowing the pull cord 102 to enter. By adjusting the position and tension of the pull cord 102, the orthopedic area and the magnitude of the orthopedic force can be controlled.

[0046] like Figure 2 As shown, the orthosis is divided into a force concentration area 201 and an unloading area 202. The orthosis is generally corrected using the three-point force method. During the correction process, clamping force is provided in the direction where the three-point force is required. At the same time, a part of the unit needs to be removed on the opposite side of the force concentration area as an unloading area to release stress and improve the patient's comfort when wearing it.

[0047] like Figure 3 As shown, the basic unit 101 of the orthosis is designed as a biomimetic curved surface unit 301, which can simulate the human body surface. Using the basic unit can reduce the adjustment time when wearing it for the first time, and only local adjustments are needed to complete the overall wearing.

[0048] The basic shape of the basic unit may include various forms, such as Figure 3 The shapes shown include triangles, squares, rectangles, and hexagons, to accommodate more skin shapes and personalized needs. Combinations of various shapes also allow for more flexible adjustment of orthopedic force.

[0049] The orthotics can be manufactured using methods such as 3D printing, injection molding, and extrusion molding to meet the needs of mass production. The materials used in the orthotics include thermoplastic materials such as polymers and ceramics, which can easily accommodate adjustments to local forces as the recovery process progresses.

[0050] As rehabilitation progresses, the tension of the local sutures and the shape of the basic units can be adjusted. Traditional orthotics often require local fine-tuning when worn. Using the above method can significantly reduce the time and manpower wasted on reshaping. Only minor adjustments are needed on some structures. By adjusting the connection between units, the local orthopedic force can be finely adjusted.

[0051] Meanwhile, as patients gradually recover, some of the less stress-bearing parts can be replaced with flexible materials to improve patient comfort and wearing experience, thereby achieving a positive cycle of recovery.

[0052] The above embodiments are merely examples for reference only. In actual situations, the situation is not limited to the above. Other structures or composite structures combining several structures can be selected according to the actual situation and are all within the protection scope of this invention.

[0053] like Figure 4As shown, a connecting device can be used to connect two adjacent biomimetic curved surface units 301. The pull wire 102 is made of heat-shrinkable material. After connection, the pull wire is heated to shrink it, thereby adjusting the local orthopedic force. The pull wire 102 includes a connector 402, which connects to the connector 401. The interference fit design ensures that adjacent basic units are tightly bonded.

[0054] The connectors include various forms such as double-headed, triple-headed, and quad-headed connectors to adapt to basic units of different shapes. Multiple connectors can also achieve the application of orthopedic forces in different directions.

[0055] Preferably, to further reduce patient discomfort during use, a cushioning pad, made of sponge or silicone, can be added between the orthosis 1 and the body surface. The orthosis is designed in multiple sizes such as S, L, and XL to accommodate wearers of different body types.

[0056] On the other hand, the present invention proposes an application method for the above-mentioned orthosis, which controls the shape and function of the orthosis through a dynamic adjustment mechanism. Based on a phased adjustment process, the orthosis can be adjusted in stages according to the rehabilitation process.

[0057] Specifically, the dynamic adjustment mechanism is as follows:

[0058] 1. Addition and reduction of basic units and shape adjustment: At the apex of scoliosis or in areas where the corrective force needs to be enhanced, increase the bonding force between basic units to form high-strength support; in sensitive areas where pressure needs to be released, reduce the number of basic units to reduce local compression.

[0059] 2. Alignment direction optimization: By changing the tightness and arrangement of the basic units (such as changing the horizontal arrangement to a diagonal staggered arrangement), the direction of orthopedic force distribution is optimized.

[0060] 3. Modular replacement: For different rehabilitation stages (such as the transition from the correction period to the maintenance period), some basic units are replaced with low-rigidity or flexible materials to gradually reduce the orthodontic intensity and achieve progressive rehabilitation.

[0061] The dynamic adjustment mechanism precisely controls the magnitude and direction of the orthopedic force by adjusting the shape and arrangement of the basic units, ensuring that orthotics can be fabricated quickly and efficiently for patients with different types and degrees of scoliosis. Traditional plaster casts or orthotics made with one-piece printing often suffer from inaccurate mold taking, leading to inaccurate application of orthopedic force. Based on the dynamic adjustment mechanism, the mold taking process can be eliminated by adjusting the basic units, correcting errors caused by mold taking and improving the orthopedic effect.

[0062] Compared to traditional personalized scoliosis orthotics that require molding and other procedures, the orthotics described in this invention only requires adjustments to the size, shape, and material of local units based on molding for different patients.

[0063] Specifically, the phased adjustment process includes the following steps:

[0064] 1. Shaping stage: This invention does not require mold taking. After the patient wears it, local heating is applied and it is directly attached to the body. Local details are adjusted according to the patient's CT images and wearing experience.

[0065] 2. Adjustment Phase: As rehabilitation progresses, some rigid units can be replaced with flexible units based on patient feedback. Wire tension can be adjusted to balance orthopedic force and comfort. The number of basic units can be reduced and the spacing increased, retaining only key support areas to promote the recovery of spinal stability. Multiple adjustments can be made according to the patient's different recovery stages.

[0066] On the other hand, the present invention proposes a method for manufacturing the aforementioned personalized scoliosis orthosis based on a dynamic adjustment mechanism, comprising the following steps:

[0067] a. Determine the corrective area and corrective points based on the patient's CT data;

[0068] b. Use 3D printing or injection molding to form the orthotics' biomimetic curved surface unit;

[0069] c. Personalized orthotics are assembled based on CT data. Low-temperature thermoplastic materials support the shaping of the orthotics by heating, thereby conforming to the human body.

[0070] When in use, the orthopedic position is obtained based on the three-dimensional data, the orthopedic position is tightened, the overall unit is compressed, and the required three or more points are fixed.

[0071] The 3D printing materials are selected from materials such as PLA, PEEK, or PETG; the shape memory materials include shape memory alloys, hydrogels, or polymers. The 3D printing methods include selective laser sintering (SLS), photopolymerization, or fused deposition modeling (FDM).

[0072] In summary, the orthosis proposed in this invention, using 3D printing, can reduce the waste of materials and time costs. Existing 3D-printed one-piece orthotics are printed as a single unit, requiring extensive support, and local adjustments are always impossible during the printing process. This invention, however, constructs a whole by connecting basic units, simplifying the printing process and eliminating the need for complex placement and extensive support, significantly reducing printing time. Furthermore, because traditional one-piece printed orthotics are too large and have strict requirements on printer size, this invention can significantly reduce the printing area and scope by disassembling the orthotics, thus reducing the waste of materials and time costs.

[0073] In addition, by setting different sizes and connection methods, the actual needs of most scoliosis patients can be met. There is no need to design force application areas and force release areas. It is only necessary to fix the required position to achieve fixation and relaxation in various directions and positions, reducing design and personalized manufacturing time. Personalized fitting is sufficient to meet the orthopedic needs.

[0074] The above description is merely an embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention's specification and drawings, or direct or indirect applications in other related system fields, are similarly included within the scope of protection of the present invention.

Claims

1. A personalized scoliosis orthosis based on a dynamic adjustment mechanism, characterized in that: It includes multiple basic units (101), which are connected by a connecting mechanism. The length of the connecting mechanism is adjustable, so as to realize the phased adjustment of the orthosis according to the rehabilitation process.

2. The orthotic device according to claim 1, characterized in that: The basic unit (101) has a polygonal sheet geometry; the connecting mechanism can be either a rigid connection or a flexible connection. The connecting mechanism includes a pull wire (102) and a connector (401). The connector (401) is located on the side of the polygonal sheet. The pull wire (102) is provided with a connector (402). The connector (402) and the connector (401) are connected by an interference fit.

3. The orthotic device according to claim 2, characterized in that: When the connecting mechanism adopts a rigid connection method, the pull wire (102) is a rigid rod, and the rigid connector plays an overall supporting role, thereby improving the strength of the orthosis; When the connecting mechanism adopts a flexible connection method, the pull wire (102) is made of heat-shrinkable material, and the orthosis achieves local tension through the heat-shrinkable material.

4. The orthotic device according to claim 1, characterized in that: By adjusting the shape and arrangement of the basic units, the stiffness of local areas of the orthosis can be increased or decreased. By adjusting the shape and arrangement of the basic units, the orthotic device can be made to resemble a men's vest or a women's strapless top to meet the clinical needs of patients. It is available in sizes S, M, L, and XL according to body shape.

5. The orthotic device according to claim 1, characterized in that: The basic unit (101) supports modular replacement and can be replaced with basic units of low stiffness, flexible materials or different sizes at different stages of rehabilitation to achieve progressive adjustment of orthopedic strength.

6. A method of applying the orthotic device according to any one of claims 1-5, characterized in that, The shape and function of the orthosis are controlled by a dynamic adjustment mechanism. Based on a phased adjustment process, the orthosis can be adjusted in stages according to the rehabilitation process. The dynamic adjustment mechanism includes: 1) Basic unit shape and density adjustment: At the apex of scoliosis or in areas where the corrective force needs to be enhanced, the shape and density of the basic unit are changed to form high-strength support; in sensitive areas where pressure needs to be released, the number of basic units is reduced to reduce local compression. 2) Alignment direction optimization: By changing the arrangement direction of the basic units, the spinal curvature is adapted and the distribution direction of the corrective force is optimized; 3) Modular replacement: For different stages of rehabilitation, some basic units are replaced with low-rigidity or flexible materials to gradually reduce the orthopedic intensity and achieve progressive rehabilitation.

7. The method of applying the orthotic device according to claim 6, characterized in that, The phased adjustment process includes: 1) Shaping stage: No mold is required. After the patient wears it, local heating is applied and it is directly attached. Local details are adjusted according to the patient's CT images and wearing experience. 2) Adjustment stage: As the rehabilitation progresses, some rigid units can be replaced with flexible units based on patient feedback, and the tension of the sutures can be adjusted to balance the orthopedic force and comfort. The number of basic units can be reduced and the spacing can be increased, retaining only the key support areas to promote the recovery of the spine's autonomous stability. Multiple adjustments can be made according to the different recovery processes of the patients.

8. A method for manufacturing an orthosis according to any one of claims 1-5, characterized in that, Includes the following steps: a. Determine the orthopedic area and initial basic unit layout scheme based on the patient's CT data; b. Mass production of standardized basic units, using 3D printing or injection molding processes for one-piece molding; c. Based on the needs of the rehabilitation stage, the basic units are dynamically combined into different forms through connecting mechanisms.

9. The manufacturing method according to claim 8, characterized in that: The basic unit can be mass-produced and assembled in a personalized manner according to the patient's body shape and orthopedic needs. Then, the orthopedic force can be locally controlled by adjusting the shape and arrangement of the local units.

10. The manufacturing method according to claim 8, characterized in that: The basic unit (101) is made of low-temperature thermoplastic material; the pull cord (102) is made of heat-shrinkable material, and the orthopedic force can be adjusted by local heating after connection and wearing.

Images