An external fixation device for clavicular fractures

Abstract

The application relates to the field of medical devices, in particular to an external fixing device for clavicle fracture, which comprises a clavicle belt, a pressure pad is arranged on the clavicle belt, a covering groove is arranged on the side close to the clavicle of the pressure pad, and an isobaric fitting assembly is symmetrically arranged on the two sides of the covering groove and used for isobaric force fitting with the clavicle based on the clavicle shape. The application can be self-adaptively adjusted and fitted according to the individualized clavicle shape of a patient, so that personalized fixation is realized, and the fracture healing is better promoted.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to an external fixation device for clavicle fractures. Background Technology

[0002] Clavicle fractures are common clinical injuries, accounting for approximately 2.6%-4% of all fractures. For most uncomplicated fractures without significant displacement or comminutedness, traditional conservative treatment has been the mainstream approach. This approach primarily relies on elastic fixation devices such as figure-of-eight bandages or clavicle straps. The core principle is to force the patient to maintain a continuously extended and elevated shoulder posture, utilizing the inherent alignment and traction of soft tissues to indirectly maintain the gross alignment of the fracture ends, thereby creating a relatively stable biomechanical environment for natural bone healing. In addition, there are also some relatively simple rigid external fixation devices on the market designed to provide stronger rigid support to the fracture site than bandages.

[0003] However, the human clavicle is not a straight long bone, but a hyperboloidal three-dimensional bone with a unique "S"-shaped curve, exhibiting significant individual differences in its shape, length, and curvature. In contrast, the long bones in other parts of the body (such as the limbs) are generally straight in their shafts, which allows for relatively standardized external fixation devices. Existing rigid clavicle braces mostly use prefabricated one-piece or simple hinged structures, making it difficult to accurately match the different anatomical characteristics of the clavicle in different patients. This results in poor fixation, uneven pressure distribution, and an inability to maintain stable fracture reduction, posing a risk of secondary displacement and thus affecting fracture healing.

[0004] Given the shortcomings of existing technologies, there is an urgent need for an external fixation device that can adaptively adjust and fit according to the patient's unique clavicle morphology in order to achieve precise and reliable personalized fixation, thereby better promoting fracture healing. Summary of the Invention

[0005] To address the aforementioned issues, this invention provides an external fixation device for clavicle fractures, which adaptively adjusts and conforms to the individualized clavicle morphology of the patient to achieve personalized fixation, thereby better promoting fracture healing.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: an external fixation device for clavicle fracture, comprising a clavicle belt, a pressure pad provided on the clavicle belt, a covering groove provided on the side of the pressure pad near the clavicle, and isobaric fitting components symmetrically arranged on both sides of the covering groove, the isobaric fitting components being used to perform isobaric fitting with the clavicle based on the clavicle shape.

[0007] The technical principles of the above solution are as follows:

[0008] The clavicle strap is worn across the patient's shoulders and armpits, crossing and wrapping around the shoulders and back on both sides to apply vertical pressure and posterior traction to the clavicle, forming a basic fixation framework. Pressure pads are positioned at the corresponding fracture ends of the clavicle strap, their covering grooves accommodating the fracture site and avoiding direct pressure that could cause discomfort. Symmetrically arranged isobaric fitting components on both sides of the covering grooves automatically deform based on the clavicle's "S"-shaped curvature and three-dimensional structure, achieving a close fit to the upper and lower surfaces of the clavicle. These isobaric fitting components ensure uniform pressure across every area of ​​the clavicle, achieving precise compression fixation of the fracture ends. This isobaric design allows the device to adapt to differences in clavicle curvature and morphology among patients, maintaining stable alignment of the fracture ends and providing a continuous and reliable biomechanical environment for bone healing.

[0009] The above approach has the following beneficial effects:

[0010] 1. This solution, through the isobaric fitting component, can automatically adjust its shape according to the patient's unique "S"-shaped curvature of the clavicle and individual anatomical characteristics, achieving precise fitting. This overcomes the shortcomings of traditional rigid braces that are pre-formed and difficult to match individual differences, reducing the risk of insecure fixation or displacement.

[0011] 2. This solution, through an isobaric bonding mechanism, ensures that each area on the supraclavicular and infraclavicular surfaces receives the same pressure, avoiding skin pressure sores, soft tissue damage, or blood supply disorders caused by localized pressure concentration, while also improving fixation stability.

[0012] 3. This treatment method, with its uniform pressure distribution and adaptive fit, keeps the fracture ends in a relatively stable alignment, effectively preventing secondary displacement common in conservative treatment, creating superior conditions for fracture healing, and shortening the healing time.

[0013] 4. This treatment plan can flexibly adapt to the different clavicle morphology variations of different patients, achieve truly personalized fixation, improve treatment accuracy and patient comfort, and reduce complications caused by fixation discomfort.

[0014] Furthermore, the isobaric bonding component includes a pressing rod, which is arranged along the length of the clavicle. Both ends of the pressing rod are slidably connected to the covering groove. One end of the pressing rod is provided with a spacing adjustment mechanism for adjusting the distance between adjacent pressing rods. Several pressure chambers are arrayed on the side wall of the pressing rod near the clavicle. A pressure relief mechanism is connected in sequence between adjacent pressure chambers. A pressure applying block is slidably connected in each pressure chamber. The first pressure chamber is connected to a circulation mechanism. The pressure relief mechanism is used to connect the previous pressure chamber with the adjacent pressure chamber when the pressure in the previous pressure chamber reaches a preset value. The circulation mechanism is used to control the flow of fluid in the pressure chamber.

[0015] Beneficial effects: The pressing rods on both sides are brought closer together towards the clavicle via the spacing adjustment mechanism. Then, fluid (such as liquid or gas) is injected into the first pressure chamber through the circulation mechanism, pushing the pressure block inside to slide outward, contacting and pressing the clavicle surface. Due to the unevenness of the clavicle surface, each pressure block displaces a different distance outward. The first pressure block stops moving after contact, causing the pressure in its pressure chamber to accumulate and increase. Once the pressure reaches the preset value of the pressure relief mechanism, the mechanism will open, directing the fluid to the next adjacent pressure chamber, pushing the next pressure block out. After a preset time, this process is repeated until the pressure in all pressure chambers is equal, at which point the pressure applied to the clavicle by all the pressure blocks will tend to be consistent.

[0016] This solution no longer relies on pre-fabricated shapes to match the clavicle. Instead, it uses a pressure feedback mechanism to allow the device to actively adapt to the unique shape of the clavicle. It precisely and evenly distributes the total fixation pressure to each individual pressure unit, eliminating pressure concentration points and fixation dead zones, achieving a uniform fixation effect. Due to the uniform pressure distribution, the contact area between the device and the body surface is maximized and the force is balanced, greatly enhancing the overall stability of the fixation, effectively suppressing micro-movements, and preventing secondary displacement.

[0017] Furthermore, the spacing adjustment mechanism includes symmetrically opened slides on both sides of the covering groove, with several sliders slidably fitted in each slide, and each slider being fixedly connected to one end of the pressing rod; a first driving member is provided in any slide, and a lead screw is coaxially fixedly connected to the output shaft of the first driving member. The first driving member is used to drive the lead screw to rotate, and the other end of the lead screw is rotatably connected to the inner wall of the slide. Several nut seats are threaded on the lead screw, and each nut seat is fixedly connected to the slider in the current slide. When the lead screw rotates in a preset direction, the nut seats move towards each other.

[0018] Beneficial effects: When the fitting range needs adjustment, the first drive unit installed in a certain groove is activated. The first drive unit begins to rotate in a preset direction, driving the lead screw, which is coaxially fixed with its output shaft, to rotate together. The rotation of the lead screw drives all the nut seats threaded onto it to produce linear motion. Depending on the design of the lead screw thread (e.g., using a reverse thread section), when the lead screw rotates in the preset direction, these nut seats will move in pairs, synchronously, towards each other or away from each other.

[0019] Since each nut seat is fixedly connected to a slider, and the slider is fixedly connected to the end of a pressing rod, the linear motion of the nut seat is directly converted into the sliding of the slider in the groove, thereby causing the ends of all the pressing rods to move closer or further apart synchronously. By controlling the rotation of the first driving component, the two rows of pressing rods arranged on the upper and lower surfaces of the clavicle are easily adjusted as a whole to the position that best matches the width of the patient's clavicle, completing the initial positioning before fitting.

[0020] Furthermore, the pressure relief mechanism includes a lifting groove connected to the end of the pressure chamber away from the clavicle, with an outlet connected to one side of the lifting groove; a piston block and a plunger block are slidably fitted inside the lifting groove, the piston block and the plunger block are coaxially and fixedly connected, a spring is provided at the end of the plunger block away from the pressure block, and the two ends of the spring are fixedly connected to the inner wall of the lifting groove and the plunger block respectively; a spiral groove is opened on the outer side of the plunger block, the spiral groove is located between the piston block and the plunger block, the spiral groove is connected to a through groove, the through groove connects the spiral groove to the pressure chamber, and when the edge of the spiral groove crosses the outlet, the spiral groove connects to the outlet.

[0021] Beneficial effect: Before the preset pressure is reached, the spring is in a natural or slightly compressed state, pushing the plunger block and the piston block fixed thereto, causing the spiral groove to be misaligned with the outlet. At this time, the pressure chamber of this stage is in a closed state.

[0022] When the circulation mechanism injects fluid into the pressure chamber, pushing the pressure block outward, if the pressure block is obstructed by contact with the clavicle surface, the pressure inside the chamber begins to rise. This pressure is transmitted to the end face of the piston block through the fluid. When the thrust generated by the fluid on the piston block is sufficient to overcome the preload of the spring, the piston block and plunger block as a whole begin to slide in the direction of compressing the spring.

[0023] As the plunger block moves, the spiral groove on its outer side translates accordingly. When the edge of the spiral groove slides past the edge of the outlet, a connecting channel is opened. At this point, fluid in the pressure chamber containing the plunger block can flow into the spiral groove through the through-slot, and then flow out of the outlet through this newly opened channel into the next adjacent pressure chamber. Once the depressurization process begins, the pressure in the current pressure chamber is maintained at the threshold level set by the spring preload. The system continuously pumps in excess fluid and transmits pressure to subsequent chambers through this open path until the pressure in all pressure chambers reaches dynamic equilibrium.

[0024] Furthermore, the circulation mechanism includes a base pad, which is fixedly connected to the clavicle strap. Several air storage chambers are provided inside the base pad, and each air storage chamber corresponds to a pressing rod. The air storage chambers are connected to the pressure chambers inside the corresponding pressing rods. A piston plate is slidably fitted inside each air storage chamber, and an electric push rod is provided on one side of each piston plate.

[0025] Beneficial effects: Each pressure chamber corresponding to the pressing lever is connected to an independent air storage chamber. Initially, the electric actuator retracts, causing the piston plate to be in its initial position within the air storage chamber. When the system starts working, the electric actuator extends according to control commands, pushing the piston plate to move within the air storage chamber, thereby forcing the gas (or liquid) in the chamber into the connected pressure chamber. After the fluid enters the pressure chamber, it pushes the pressure block towards the clavicle surface.

[0026] Furthermore, it also includes a pressure regulating mechanism, which includes several transmission wheels rotatably connected in the lifting groove. Each transmission wheel has a belt tensioned on its outer side, and an adjusting wheel is tensioned on its inner side. A transmission disc is also provided between the plunger block and the spring. The transmission disc is coaxially and fixedly connected to the plunger block, abuts against the spring, and is fixedly connected to the inner spline of the transmission wheel.

[0027] Beneficial effects: When a change in fixed pressure is required, the adjusting wheel is rotated via a drive source (such as an electric or manual knob). The rotation of the adjusting wheel moves the belt tensioned on it. Since the belt is simultaneously tensioned on the outside of all drive pulleys, its movement causes all drive pulleys to rotate synchronously and in the same direction. Each drive pulley is connected to a drive disc via a spline on its inner side. The rotation of the drive pulley then drives all drive discs to rotate synchronously. Because the drive discs are coaxially fixed to the plunger block, the plunger block also rotates. The rotation of the plunger block causes the spiral groove on its outer side to rotate as well. This changes the relative circumferential position between the groove wall edge and the outlet opening. Because the depth of the groove varies, the "aperture distance" between its edge and the outlet (i.e., how much linear travel the plunger block needs to move to align the groove with the outlet) also changes. This distance directly determines how much spring compression is required to open the outlet channel, and the spring compression is proportional to its pressure. Therefore, the trigger pressure threshold for pressure relief can be set linearly and precisely by rotation.

[0028] Doctors can adjust the pressure of the entire device, like adjusting a dial, based on the type and severity of the fracture, the stage of healing, and the patient's individual tolerance. This makes the treatment process standardized and precise, moving away from experience-based approaches. In the early stages of healing, a higher pressure threshold can be set to achieve strong fixation; in the middle and later stages of healing, the pressure can be gradually reduced to maintain necessary stability while promoting local blood circulation and functional activity, achieving dynamic fixation, which aligns with the modern BO (Bio-Osteosynthesis) concept in fracture treatment.

[0029] The trigger thresholds of all pressure relief units can be adjusted synchronously using a single adjustment wheel, ensuring that every point along the entire length of the clavicle operates under the exact same new pressure standard. This avoids the tediousness and inaccuracy of adjusting each unit individually, guaranteeing the uniformity and symmetry of pressure distribution, making operation extremely simple and efficient.

[0030] Furthermore, each pressing lever has a pneumatic switch connected to its last outlet, which is electrically connected to the electric actuator.

[0031] Beneficial effects: The electric actuator and the pneumatic switch, together, ensure that the pressure building process automatically stops when the optimal treatment pressure is reached, achieving precise automated control and completely eliminating errors that may be caused by human estimation or timing control.

[0032] Furthermore, each pressure block is equipped with an impedance sensor, which is used to collect impedance change information in the fracture area; the impedance sensor is electrically connected to a control unit, which is electrically connected to a communication unit; the control unit is used to determine the degree of clavicle healing of the patient based on the impedance change information and generate a test report; the communication unit is used to send the test report to the user terminal.

[0033] Beneficial effects: Each pressure block integrates a miniature impedance sensor at its end. When the pressure block is in close contact with the clavicle skin surface, these sensors continuously or periodically emit weak, safe alternating current signals into the fracture area below and detect the feedback impedance signal. Fracture healing is a dynamic process of changes in tissue composition and structural density (such as hematoma, fibrocartilage, callus formation, and calcification). These different tissues have different electrical conductivity and dielectric properties, resulting in a regular change in their overall impedance value.

[0034] All raw data collected by impedance sensors are transmitted to the control unit in real time. The control unit contains a fracture healing model and algorithm based on a large amount of clinical data. The algorithm filters, fuses, and analyzes the received multi-channel impedance data, and quantitatively assesses the quality and maturity of callus formation and the biomechanical connection strength of the fracture line by monitoring the magnitude of the impedance value, frequency response characteristics, and their changes over time.

[0035] Based on the analysis results, the control unit automatically determines the patient's clavicle healing stage (e.g., it can be divided into fibrous healing stage, callus formation stage, clinical healing stage, etc.) and generates a structured test report. This report can be automatically sent to the doctor's or patient's user terminal (such as a mobile APP or computer) via a wireless communication unit, realizing remote digital management of the treatment process.

[0036] Furthermore, a second driving component is coaxially fixedly connected to the adjusting wheel. The second driving component is used to drive the adjusting wheel to rotate, and the second driving wheel is electrically connected to the control unit. The control unit is also used to control the operation of the second driving component and the electric push rod based on the degree of clavicle healing.

[0037] Beneficial Effects: The device can automatically and dynamically adjust the fixation stiffness and pressure based on each patient's real-time physiological healing response, perfectly simulating the phased adjustments made by orthopedic surgeons under ideal conditions, thus achieving personalized and adaptive rehabilitation treatment. Different healing stages require different biomechanical environments for fixation. By providing high-strength stable fixation in the early stages and gradually and controllably reducing stiffness in the middle and later stages, this system perfectly matches the biological laws of fracture healing. It effectively prevents early displacement and avoids bone atrophy caused by stress shielding in the later stages, thereby optimally promoting the quality and speed of healing.

[0038] Furthermore, each pressing rod is equipped with an elastic layer, which covers all the pressure blocks.

[0039] Beneficial effects: The elastic layer, as a complete and flexible encapsulation film, completely covers the end faces of all the pressure blocks arranged in the array and the gaps between them, forming a continuous, smooth and elastic contact interface.

[0040] When the device is in operation, each pressure block extends independently under the drive of the pressure chamber, pushing against the internal elastic layer and causing it to deform locally, thereby precisely conforming to the concave and convex contours of the clavicle surface. The elastic layer transmits the discrete point pressure of each pressure block through its own deformation and transforms it into a softer, more continuous surface pressure.

[0041] The elastic layer provides a soft, smooth, and complete contact surface, completely avoiding direct friction between the hard pressure block edges or mechanical gaps and the skin, significantly improving skin comfort and making it easier for patients to accept long-term wear.

[0042] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0043] Figure 1 This is a three-dimensional structural schematic diagram of the external fixation device for clavicle fractures according to the present invention;

[0044] Figure 2 This is a schematic diagram of the internal structure of the pressure pad in the external fixation device for clavicle fractures of the present invention;

[0045] Figure 3 This is a schematic diagram of the internal structure of the base pad in the external fixation device for clavicle fractures of the present invention;

[0046] Figure 4 for Figure 2 Enlarged view of a portion of point M in the middle;

[0047] Figure 5 for Figure 4 A magnified view of a portion of point N in the middle.

[0048] The reference numerals in the accompanying drawings of the instruction manual include: 1. Clavicle strap; 2. Base pad; 3. Pressure pad; 201. Air storage chamber; 202. Piston plate; 203. Electric actuator; 301. Covering groove; 302. Slide groove; 303. Lead screw; 304. Nut seat; 305. Micro servo motor; 306. Slider; 307. Pressing rod; 308. Pressure block; 309. Elastic layer; 310. Pressure chamber; 311. Transfer channel; 312. Air pipe; 313. Piston block; 314. Plunger block; 315. Spring; 316. Transmission wheel; 317. Belt; 318. Transmission disc; 319. Adjusting wheel; 320. Spiral inclined groove; 321. Through groove; 322. Outlet. Detailed Implementation

[0049] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0050] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0051] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0052] The following detailed description illustrates the specific implementation method:

[0053] Example:

[0054] As attached Figure 1 - Appendix Figure 5As shown: An external fixation device for clavicle fractures includes a clavicle band 1, which has an "8"-shaped structure. Preferably, a base pad 2 is bonded and fixed at the intersection of the clavicle band 1. A pressure pad 3 is bonded and fixed to the clavicle band 1, located in the area of ​​the patient's clavicle fracture. A covering groove 301 is provided on the side of the pressure pad 3 near the clavicle. Isopressure fitting components are symmetrically arranged on both sides of the covering groove 301. When the patient wears this device, the clavicle is located between the isopressure fitting components, which are used to apply isopressure to the clavicle based on its shape.

[0055] Specifically, in conjunction with the appendix Figure 2 and attached Figure 4 As shown, the isobaric bonding assembly includes a pressing rod 307, which is arranged along the length of the clavicle. Both ends of the pressing rod 307 are slidably connected to the covering groove 301. One end of the pressing rod 307 is provided with a spacing adjustment mechanism for adjusting the distance between adjacent pressing rods 307. Preferably, the spacing adjustment mechanism includes symmetrically arranged grooves 302 on both sides of the covering groove 301. Several sliders 306 are slidably fitted within each groove 302. In this embodiment, there are four sliders 306. Each slider 306 is welded and fixed to one end of the pressing rod 307. A first driving component is provided in any groove 302. In this embodiment, the first driving component is a micro servo motor 305. The output shaft of the first driving component is coaxially fixedly connected to a lead screw 303 via a coupling. The first driving component is used to drive the lead screw 303 to rotate. The other end of the lead screw 303 is rotatably connected to the inner wall of the slide groove 302. Several nut seats 304 are threaded on the lead screw 303. In this embodiment, there are two nut seats 304. Each nut seat 304 is welded and fixed to the slider 306 in the current slide groove 302. When the lead screw 303 rotates in a preset direction, the two nut seats 304 move towards each other, that is, the two nut seats 304 move in opposite directions. In this embodiment, the lead screw 303 is provided with two reverse thread sections to realize the opposite and backward movement of the nut seats 304.

[0056] The pressure rod 307 has a linear array of pressure chambers 310 on its side wall near the clavicle. Adjacent pressure chambers 310 are sequentially connected by pressure relief mechanisms. Each pressure chamber 310 has a sliding pressure block 308. Preferably, each pressure block 308 is also equipped with an impedance sensor, which collects impedance change information from the fracture area. The impedance sensor is electrically connected to a control unit. The control unit is electrically connected to a communication unit, which determines the degree of clavicle healing based on impedance change information and generates a test report. The communication unit sends the test report to a user terminal. The first pressure chamber 310 is connected to a circulation mechanism. The pressure relief mechanism connects the previous pressure chamber 310 to the adjacent pressure chamber 310 when the pressure in the previous pressure chamber 310 reaches a preset value. The circulation mechanism controls the flow of fluid within the pressure chambers 310.

[0057] Preferably, an elastic layer 309 is bonded and fixed to each pressing rod 307, and the elastic layer 309 covers all the pressing blocks 308.

[0058] Preferred, combined with appendix Figure 4 and attached Figure 5 As shown, the pressure relief mechanism includes a lifting groove connected to the end of the pressure chamber 310 away from the clavicle, and an outlet 322 is connected to one side of each lifting groove; a piston block 313 and a plunger block 314 are slidably fitted in each lifting groove, and the piston block 313 and the plunger block 314 are coaxially and fixedly connected. In this embodiment, the piston block 313 and the plunger block 314 are integrated. A spring 315 is provided at the end of the plunger block 314 away from the pressure block 308. Preferably, a transmission disc is also provided between the plunger block 314 and the spring 315. 318, the transmission disc 318 is coaxially welded and fixed to the plunger block 314, and the transmission disc 318 abuts against the spring 315; the outer side of the plunger block 314 is provided with a spiral groove 320, the spiral groove 320 is located between the piston block 313 and the plunger block 314, the spiral groove 320 is connected to the through groove 321, the through groove 321 connects the spiral groove 320 to the pressure chamber 310, when the edge of the spiral groove 320 crosses the outlet 322, the spiral groove 320 is connected to the outlet 322.

[0059] Preferably, the system further includes a pressure regulating mechanism, which comprises several transmission wheels 316 rotatably connected within a lifting groove. Each transmission wheel 316 has a belt 317 tensioned on its outer side, and an adjusting wheel 319 is tensioned on the inner side of each belt 317. Preferably, the belt is a toothed belt, which sequentially passes around the adjusting wheel 319 and all the transmission wheels 316 before returning to the adjusting wheel 319, forming a loop. The adjusting wheel 319 is rotatably connected within a corresponding slider 306. A second driving component is coaxially fixedly connected to the adjusting wheel 319. In this embodiment, the second driving component is a micro stepper motor, and the output shaft of the micro stepper motor is coaxially keyed and fixed to the adjusting wheel 319. The second driving component drives the adjusting wheel 319 to rotate. A transmission disc 318 is splinedly connected and fixed to the inner side of the transmission wheel 316.

[0060] Specifically, in conjunction with the appendix Figure 3As shown, the circulation mechanism includes several air storage chambers 201 formed within the base pad 2. Each air storage chamber 201 corresponds to a pressing rod 307. In this embodiment, there are two air storage chambers 201. Each air storage chamber 201 is connected to a pressure chamber 310 within the corresponding pressing rod 307 via an air pipe 312. A transfer channel 311 is also provided within the corresponding slider 306. The transfer channel 311 connects the air pipe 312 to the first pressure chamber 310 (the pressure chamber 310 closest to the transfer channel 311 is designated as the first, and the pressure chamber 310 furthest from the transfer channel 311 is designated as the last). A piston plate 202 is slidably fitted within each air storage chamber 201. An electric actuator 203 is mounted on one side of each piston plate 202. The output end of the electric actuator 203 is fixedly connected to the piston plate 202 via a flange. Preferably, the control unit is also used to control the operation of the second drive component and the electric actuator 203 based on the degree of clavicle healing.

[0061] Preferably, each pressing rod 307 has a pneumatic switch connected to its last outlet 322, and the pneumatic switch is electrically connected to the corresponding electric push rod 203.

[0062] The specific implementation process is as follows:

[0063] The patient secures the device by passing it over both shoulders and under the armpits, similar to wearing a traditional figure-eight bandage, ensuring that the intersection of the clavicle strap 1 is in the center of the back and the base pad 2 fits firmly. Adjust the tightness of the clavicle strap 1 so that the pressure pad 3 roughly covers the area above the clavicle fracture.

[0064] The first driving component (micro servo motor 305) is activated to drive the lead screw 303 to rotate. Since the lead screw 303 has a reverse thread, the two nut seats 304 drive the connected sliders 306 to slide in opposite directions in the slide groove 302, thereby adjusting the pressing rods 307 on both sides as a whole to a position that adapts to the width of the patient's clavicle, completing the initial contour matching.

[0065] According to the preset initial treatment plan, the control unit drives the adjustment wheel 319 to rotate through the second drive unit (micro stepper motor), and drives all transmission discs 318 and plunger blocks 314 to rotate synchronously through belt 317 and transmission wheel 316, thereby setting the trigger pressure threshold of all pressure relief mechanisms.

[0066] Subsequently, the control unit activates each electric actuator 203. The electric actuator 203 pushes the piston plate 202 to move within the gas storage chamber 201, forcing gas through the gas pipe 312 and the transfer channel 311 into the corresponding first pressure chamber 310.

[0067] Gas pushes the first pressure block 308 out, pushing the elastic layer 309 to contact the clavicle surface. When the first pressure block 308 is obstructed due to contact, the pressure in its pressure chamber 310 increases. When the pressure reaches a preset threshold, it pushes the piston block 313 and plunger block 314 to compress the spring 315 backward until the spiral groove 320 is aligned with the outlet 322. Gas then enters the next pressure chamber 310 through the through groove 321, the spiral groove 320, and the outlet 322.

[0068] This process is repeated sequentially until all pressure chambers 310 on the pressing rod 307 are filled and all pressure blocks 308 are in contact with the clavicle surface under equal pressure. When the pressure of the last pressure chamber 310 reaches the target, the pneumatic switch at its outlet 322 is triggered, sending a signal to immediately stop the corresponding electric actuator 203, ensuring accurate pressure and preventing overpressure.

[0069] The above process is carried out simultaneously on the pressing rods 307 on both sides above and below the clavicle, ultimately achieving three-dimensional, uniform, and stable adaptive wrapping and fixation of the fracture area.

[0070] During the fixation period, the impedance sensors on each pressure block 308 work continuously, periodically collecting electrical impedance data of the fracture area and sending it to the control unit.

[0071] The algorithm within the control unit analyzes the data and determines the degree of fracture healing in real time (e.g., inflammatory phase, fibrous connection phase, callus formation phase, and callus remodeling phase).

[0072] Based on the degree of healing, the control unit automatically executes a preset "pressure-healing phase" strategy:

[0073] In the early stage of healing: the second drive component is set to a higher pressure relief threshold, and the electric actuator 203 is instructed to provide sufficient support force to achieve strong fixation.

[0074] In the mid-to-late stage of healing: As callus grows and healing strength increases, the control unit controls the second drive to lower the pressure relief threshold, rotates the plunger block 314 until the through groove 321 is directly connected to the outlet 322, and then drives the electric push rod 203 to retract, slowly drawing the gas back into the gas storage chamber 201, and then triggers the pressure threshold again with a new preset value, and repeats the gas injection process of each pressure chamber 310.

[0075] The control unit periodically generates monitoring reports, which are wirelessly transmitted to the user terminals of doctors and patients via the communication unit, enabling remote, digital monitoring of the treatment process. The system can issue early warnings if abnormal trends such as slow healing are detected.

[0076] When the device needs to be removed, the control unit can reverse the electric push rod 203 and simultaneously control the second drive to rotate the plunger block 314 until the through groove 321 is directly connected to the outlet 322, retract the piston plate 202, depressurize the system, and reset the pressure block 308 under external pressure. Then, the device can be easily removed by unfastening the clavicle strap 1.

[0077] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An external fixation device for clavicle fractures, comprising a clavicle strap (1), characterized in that, A pressure pad (3) is provided on the clavicle band (1). A covering groove (301) is provided on the side of the pressure pad (3) near the clavicle. An equal pressure bonding component is symmetrically provided on both sides of the covering groove (301). The equal pressure bonding component is used to perform equal pressure bonding with the clavicle based on the shape of the clavicle. The isobaric bonding assembly includes a pressing rod (307) which is arranged along the length of the clavicle. Both ends of the pressing rod (307) are slidably connected to the covering groove (301). One end of the pressing rod (307) is provided with a spacing adjustment mechanism for adjusting the distance between adjacent pressing rods (307). Several pressure chambers (310) are arranged in an array on the side wall of the pressing rod (307) near the clavicle. A pressure relief mechanism is connected between adjacent pressure chambers (310). A pressure applying block (308) is slidably connected in each pressure chamber (310). The first pressure chamber (310) is connected to a circulation mechanism. The pressure relief mechanism is used to connect the previous pressure chamber (310) with the adjacent pressure chamber (310) when the pressure in the previous pressure chamber (310) reaches a preset value. The circulation mechanism is used to control the flow of fluid in the pressure chamber (310). The pressure relief mechanism includes a lifting groove connected to the end of the pressure chamber (310) away from the clavicle, and an outlet (322) connected to one side of the lifting groove; a piston block (313) and a plunger block (314) are slidably fitted inside the lifting groove, the piston block (313) and the plunger block (314) are coaxially fixedly connected, and a spring (315) is provided at the end of the plunger block (314) away from the pressure block (308), and the two ends of the spring (315) are respectively connected to the inner wall of the lifting groove and the plunger block (314). Fixed connection; a spiral groove (320) is provided on the outer side of the plunger block (314). The spiral groove (320) is located between the piston block (313) and the plunger block (314). The spiral groove (320) is connected to a through groove (321). The through groove (321) connects the spiral groove (320) to the pressure chamber (310). When the edge of the spiral groove (320) crosses the outlet (322), the spiral groove (320) is connected to the outlet (322).

2. The external fixation device for clavicle fractures according to claim 1, characterized in that, The spacing adjustment mechanism includes slids (302) symmetrically opened on both sides of the cover groove (301). Several sliders (306) are slidably fitted in each slid groove (302). The sliders (306) are fixedly connected to one end of the pressing rod (307). A first driving member is provided in any slid groove (302). A lead screw (303) is coaxially fixedly connected to the output shaft of the first driving member. The first driving member is used to drive the lead screw (303) to rotate. The other end of the lead screw (303) is rotatably connected to the inner wall of the slid groove (302). Several nut seats (304) are threaded on the lead screw (303). The nut seats (304) are fixedly connected to the sliders (306) in the current slid groove (302). When the lead screw (303) rotates in a preset direction, the nut seats (304) move towards each other.

3. The external fixation device for clavicle fractures according to claim 2, characterized in that, The circulation mechanism includes a base pad (2), which is fixedly connected to the clavicle strap (1). The base pad (2) is provided with several air storage chambers (201). Each air storage chamber (201) corresponds to a pressing rod (307). Each air storage chamber (201) is connected to the pressure chamber (310) in the corresponding pressing rod (307). Each air storage chamber (201) is slidably fitted with a piston plate (202). Each side of the piston plate (202) is provided with an electric push rod (203).

4. The external fixation device for clavicle fractures according to claim 3, characterized in that, It also includes a pressure regulating mechanism, which includes several transmission wheels (316) rotatably connected in the lifting groove. Each transmission wheel (316) has a belt (317) tensioned on its outer side, and an adjusting wheel (319) tensioned on the inner side of the belt (317). A transmission disc (318) is also provided between the plunger block (314) and the spring (315). The transmission disc (318) is coaxially and fixedly connected to the plunger block (314). The transmission disc (318) abuts against the spring (315). The transmission disc (318) is fixedly connected to the inner spline of the transmission wheel (316).

5. The external fixation device for clavicle fractures according to claim 4, characterized in that, Each push rod (307) has a pneumatic switch connected to its last outlet (322), which is electrically connected to the electric push rod (203).

6. The external fixation device for clavicle fractures according to claim 5, characterized in that, Each pressure block (308) is also equipped with an impedance sensor, which is used to collect impedance change information of the fracture area; the impedance sensor is electrically connected to a control unit, which is electrically connected to a communication unit; the control unit is used to determine the degree of healing of the patient's clavicle based on the impedance change information and generate a test report; the communication unit is used to send the test report to the user terminal.

7. The external fixation device for clavicle fractures according to claim 6, characterized in that, A second drive member is coaxially fixedly connected to the adjustment wheel (319). The second drive member is used to drive the adjustment wheel (319) to rotate. The second drive wheel is electrically connected to the control unit. The control unit is also used to control the operation of the second drive member and the electric push rod (203) based on the degree of clavicle healing.

8. The external fixation device for clavicle fractures according to claim 7, characterized in that, Each pressing rod (307) is provided with an elastic layer (309), which covers all the pressing blocks (308).

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