Intelligent six-axis external bone fixation system for monitoring load and power promoting healing

Abstract

The application discloses a kind of intelligent six-axis bone external fixation system for monitoring load and power promoting healing, it includes upper fixed ring, lower fixed ring, 6 intelligent support rods.Control the angle of the support rod setting part of upper fixed ring and lower fixed ring adaptation.Intelligent support rod includes hollow sleeve, first universal joint, tension-compression sensor, motor structure, planetary reducer, partial telescopic structure are sequentially arranged from the first end to the second end of hollow sleeve, and the longitudinal axis of all structures in hollow sleeve is consistent;Motor structure is driven telescopic structure to rotate telescopic by planetary reducer transmission, and can intelligently control telescopic structure can occur 1-2mm micro-motion.The above six-axis bone external fixation system intelligently detects the value of each tension-compression sensor, calculates the axial load stress value of fracture end, and then evaluates the fracture healing, ensures treatment effect, and controls support rod timely micro-motion stimulation according to six rods and overall system stress value, reduces harmful stress, promotes bone healing.

Description

Technical Field

[0001] This invention relates to the field of external fixation devices for fractures, and more particularly to devices for fracture reduction and rehabilitation. Specifically, this invention also relates to an intelligent six-axis external fixation system that monitors load and uses kinetic energy to promote healing. Background Technology

[0002] Various external fixators exist in clinical practice, but most current external fixators consist of fixed support rods. For limb positioning, the support rods in a 6-DOF adjustable external fixator, composed of two end fixation rings and six support rods, are often threaded and adjusted by relative rotation. While this type of support rod is adjustable, it relies heavily on postoperative calculations and manual, passive adjustments based on the planned dimensions according to the fracture deformity. Once adjusted, the support rods are typically not changed during subsequent treatment, serving only a supporting and fixing function. Current Taylor frames only provide support, and their fabrication requires manual setting of each support rod individually, a time-consuming and inaccurate process. Even with pressure-sensing units on the support rods, intended to assess axial load during fracture healing and thus determine healing progress, the entire adjustment process still relies on manual intervention.

[0003] Existing technology 202010421526.2 describes a wearable integrated robot for fracture reduction and rehabilitation, which is an electrically controlled Taylor frame. The support rod involves an external motor structure attached to an existing support rod, connected to the motor structure via Hooke hinges. The rotation of the motor mechanism is transferred to the telescopic support rod through the transmission of the Hooke hinges, thus adjusting the length of the telescopic support rod. This is a technical solution where the motor, fixed to an external fixator, drives the traditional telescopic rod's extension and retraction by rotating the Hooke hinges. While this type of Taylor frame allows for visual observation of the synchronous rotation of the six Hooke hinges during adjustment, the external motor structure results in a large overall size and a shifted center of gravity. The external motor also makes the support rod design difficult. Furthermore, the rotation of the Hooke hinges can create a strong visual impact on the patient, and the large rotation amplitude can cause tension and discomfort, affecting treatment compliance. Additionally, the external motor is susceptible to corrosion from sweat and disinfectants, leading to poor long-term stability. Summary of the Invention

[0004] The core problem with existing Taylor frames using support rods is that most existing support rods are not intelligent. Even when a motor is installed, it is directly connected to the existing support rod. However, because the motor and support rod cannot be effectively integrated, the existing solution uses a Hooke hinge to achieve rotational transmission, ensuring that the motor drives the extension and retraction of the support rod. However, this method requires a large motor power to drive the Hooke hinge. A large motor fixed to an external fixator requires a specially designed fixator to complete the existing support rod setup with an external motor. As a result, when converting to an electrically controlled system for temporary fixation of fracture sites using traditional Taylor frames in local hospitals, the entire Taylor frame needs to be dismantled and reinstalled. Even if it is not reinstalled, a complex intermediate connection structure is required for replacement.

[0005] The aforementioned problem arises because the motor is directly connected to the existing support rod, making it an external structure. Therefore, to achieve intelligent monitoring and adjustment, this application specifically designs an intelligent support rod and adapts its connecting part to the existing Taylor frame, ensuring that the switch from traditional to intelligent operation is achieved simply by removing the traditional support rod and replacing it with the intelligent one. Specifically, a support rod with the motor's longitudinal axis aligned with the support rod's longitudinal axis is designed, and a tension / compression sensor is mounted on the support rod. Connecting rods at both ends of the support rod connect to universal joints, and these connecting rods are adapted to the holes on the existing Taylor frame's support rod. To ensure the motor's longitudinal axis aligns with the support rod's longitudinal axis, the support rod comprises a hollow sleeve, tension / compression sensors, a motor structure, a planetary reducer, and a telescopic structure, sequentially arranged within the hollow sleeve. The planetary reducer controls the extension and retraction of the telescopic structure using a low-power motor, thus ensuring the motor structure is internally housed within the hollow sleeve. The connecting rods at both ends are located on the outside of the hollow sleeve and connect to the structure inside, ensuring that force is transmitted to the tension / compression sensors, guaranteeing accurate force monitoring, and thereby achieving intelligent adjustment. Six intelligent support rods are installed on the Taylor frame to enable intelligent adjustment and monitoring.

[0006] The specific technical solution is as follows: This application discloses an intelligent six-axis external fixation system for monitoring load and promoting healing through dynamics, which includes an upper fixation ring, a lower fixation ring, and 6 intelligent support rods.

[0007] The upper fixation ring includes a fixation ring portion and a support rod setting portion. The fixation ring portion is provided with a fixation hole for fixing the fixation nail connected to the fracture site to the upper fixation ring. The support rod setting portion extends outward from the fixation ring portion and is provided with 3 support rod setting portions along the fixation ring portion. Each support rod setting portion is provided with 2 connecting rod holes for fixing two support rods to the upper fixation ring.

[0008] The lower fixing ring is set in the same way as the upper fixing ring, controlling the angle of the support rod setting part of the upper and lower fixing rings to ensure that the 6 intelligent support rods are set between the upper and lower fixing rings.

[0009] The intelligent support rod includes a hollow sleeve, a tension / compression sensor, a motor structure, a planetary reducer, a telescopic structure, a first universal joint with a first connecting rod, and a second universal joint with a second connecting rod. From the first end to the second end of the hollow sleeve, a portion of the first universal joint, the tension / compression sensor, the motor structure, the planetary reducer, and a portion of the telescopic structure are sequentially arranged, with all structures within the hollow sleeve having the same longitudinal axis. When the telescopic structure is fully extended, the length of the telescopic section extending beyond the second end of the hollow sleeve is greater than or equal to the length of the threaded pipe. The motor structure drives the planetary reducer to rotate, which in turn drives the telescopic structure to rotate, thus extending and retracting the telescopic structure.

[0010] Furthermore, the system also includes a control structure that receives the pressure values ​​from the tension and compression sensors of each smart support rod. Based on the pressure values, the control structure individually controls each smart support rod or simultaneously controls several smart support rods to perform telescopic movements, so as to ensure that one or several smart support rods can be adjusted when stress blockage occurs.

[0011] Furthermore, the overall control structure controls the extension and retraction of the six intelligent support rods at a certain frequency. The extension and retraction amplitude of each rod is 1-2mm in a single operation, thereby achieving micro-motion mechanical stimulation of the fracture site through the micro-motion of the Taylor frame.

[0012] Furthermore, the control structure is modular, and is set on the upper or lower fixed ring. The control structure includes a built-in lithium-ion battery and a microcontroller (MCU) with built-in control programs for all intelligent support rods. The control structure also includes a wireless signal transmission structure to transmit the received pressure data to a computer or mobile terminal.

[0013] Furthermore, the dimensions of the first and second connecting rods are adapted to the connecting rod holes on the traditional Taylor frame; this ensures that when replacing the traditional support rod with the intelligent support rod, only the original support rod needs to be removed and replaced with the intelligent support rod, making the replacement simple and convenient.

[0014] Furthermore, the upper and lower fixation rings are circular with a thickness ranging from 5 to 8 mm; the materials of the upper and lower fixation rings are medical-grade titanium alloy or high-strength aluminum alloy, taking into account both lightweight and biocompatibility.

[0015] Furthermore, the hollow sleeve is integrally formed from medical-grade titanium alloy, and the inner wall is polished at the nanoscale to ensure that the intelligent drive unit has no wear and zero lag during long-term reciprocating motion.

[0016] Furthermore, the six intelligent support rods are arranged in pairs. The first connecting rod of the two support rods in each pair is set in a support rod setting part of the lower fixing ring, and the two intelligent support rods of the corresponding pair are set in two adjacent connecting rod holes in two adjacent support rod setting parts of the upper fixing ring. In this way, a six-bar parallel constraint structure is formed. The control structure controls all the intelligent support rods to extend or retract at the same time to achieve stable micro-motion adjustment, while supporting group differential adjustment to accurately correct minor misalignments of the fracture ends.

[0017] Furthermore, the telescopic structure includes a telescopic section and a rotating section; the rotation of the rotating section drives the telescopic section to extend and retract; the telescopic section has a threaded tube section, and the rotating section has a threaded section, which cooperates with the threaded tube. The rotation of the threaded section drives the threaded tube to extend and retract along the longitudinal axis of the telescopic structure; a moving groove is provided inside the hollow sleeve, and a protruding slider is provided on the outside of the telescopic section that extends into the moving groove, so that the telescopic section moves smoothly along the axial direction of the hollow sleeve without radial swaying; ensuring that the telescopic section does not rotate with the rotating section.

[0018] Furthermore, the rotating section is combined with a planetary reducer. After combination, the planetary reducer drives the rotating section to rotate, but the longitudinal axis positions of the rotating section and the planetary reducer are relatively fixed. Similarly, the motor structure is combined with the planetary reducer. After combination, the motor structure drives the planetary reducer to rotate, but the longitudinal axis positions of the motor structure and the planetary reducer are relatively fixed. This arrangement integrates the motor mechanism, planetary reducer, and telescopic structure into a single unit, enabling effective force transmission when placed above the tension / compression sensor.

[0019] Furthermore, the first end of the hollow sleeve is provided with an outlet smaller than the inner diameter of the hollow sleeve body. The first universal joint includes a cylindrical section confined within the inner cavity of the first end of the hollow sleeve. The cylindrical section extends to form a joint section one, which extends out from the outlet. This arrangement can confine the various structures within the hollow sleeve and prevent them from detaching from the first end.

[0020] Furthermore, the cylindrical segment is fixed to the first end of the hollow sleeve by gluing, and the tension / compression sensor is fixedly connected to the cylindrical segment; the motor structure, planetary reducer and telescopic structure all include a matching segment with an outer diameter consistent with the inner diameter of the hollow sleeve; the outer wall of the matching segment is smooth with the inner wall of the hollow sleeve segment; and the matching segment of each structure moves relative to the hollow sleeve in the longitudinal direction. The second end of the motor structure is combined with the tension / compression sensor, so that the tension and pressure can be transmitted to the tension / compression sensor through the motor structure.

[0021] Furthermore, an axial limiting protrusion is provided on the housing of the motor structure or planetary reducer, and an axial limiting groove that cooperates with the limiting protrusion is provided on the inner wall of the hollow sleeve. The length of the axial limiting groove is 1-3mm, so as to limit the maximum displacement of the whole along the longitudinal axis, ensuring that the tension and compression sensor is always within its calibrated working range, and avoiding measurement inaccuracies or structural interference caused by overtravel.

[0022] Technical effect By placing each structure within a hollow sleeve, with all structures aligned along their longitudinal axes, and utilizing a planetary reducer, a smaller motor can control the telescopic structure's extension and retraction. This results in a compact intelligent support rod, which appears as a very simple rod. When positioned between the upper and lower fixing rings, the overall design remains clean and avoids negative psychological impact on the patient. The Taylor frame's six intelligent support rods can be quickly positioned between the upper and lower fixing rings. Once positioned, each rod can be controlled individually, simultaneously, or all at once, allowing for intelligent adjustment of the fixing angle and distance between the upper and lower fixing rings. The entire device is simple to set up and rationally controlled, automating the adjustment of the angle and position between the upper and lower fixing rings. The adjustment process relies on data from the tension and compression sensors on each intelligent support rod to adjust its extension and retraction.

[0023] By controlling the structure to receive pressure values ​​from tension and compression sensors, the extension and retraction of each intelligent support rod are automatically adjusted to ensure that each intelligent support rod is in a normal state. This allows for monitoring of the treatment process and guarantees treatment effectiveness, solving the problem of traditional Taylor frames being unable to be adjusted or having very cumbersome adjustments after fixation. Compared with the existing technology of constantly rotating Hooke hinges, this avoids negative interference to the patient. Furthermore, the rotation of Hooke hinges can easily cause entanglement of objects around the patient, thus affecting rotation. Therefore, the existing Hooke hinge method cannot achieve continuous micro-motion extension and retraction at different frequencies. In contrast, the intelligent support rod motors in this Taylor frame are built-in, and the entire extension and retraction adjustment is only observable through the extension and retraction structure itself. Therefore, continuous small-amplitude adjustments will not affect the patient or their family, allowing for continuous micro-motion stimulation of 1-2 mm to promote bone healing. Of course, the specific micro-motion can be performed at appropriate times and for appropriate durations as needed to ensure the best healing effect.

[0024] By placing the connecting rods at both ends, the combination of the support rod and the external fixator can be easily achieved. During combination, it is only necessary to adjust the telescopic rod to the appropriate position for clinical application and place the connecting rod into the corresponding hole of the external fixator. The entire support rod setup is also very simple and convenient.

[0025] By fixing the tension / compression sensor to the hollow sleeve, and ensuring that the motor structure, planetary reducer, and telescopic structure all include a matching section, the supporting force can be effectively transmitted to the tension / compression sensor by allowing it to move relative to the hollow sleeve along the longitudinal axis. The fact that both the outer wall of the matching section and the inner wall of the hollow sleeve are smooth also reduces the interference of friction on force transmission, ensuring the effectiveness of force transmission.

[0026] The motor structure, planetary reducer, and telescopic structure are integrated into a single movable structure. An axial limiting protrusion is provided on the outer shell of the motor structure or planetary reducer, and an axial limiting groove that matches the limiting protrusion is provided on the inner wall of the hollow sleeve. This configuration ensures that each structure is effectively confined within the hollow sleeve, guaranteeing the stability of the overall structure. Attached Figure Description

[0027] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings: Figure 1 This is a schematic diagram of the overall structure of the six-axis external fixation system of the present invention; Figure 2 This is a schematic diagram of the upper and lower fixation ring structure of the six-axis external fixation system of the present invention; Figure 3 This is a schematic diagram of the combined state of the fixed ring and the control structure under the present invention; Figure 4 This is a schematic diagram of the control structure of the present invention; Figure 5 A schematic diagram of the bottom surface of the control structure without a bottom cover; Figure 6 This is a schematic diagram of the structure of the six intelligent support rods between the upper and lower fixation rings of the six-axis external fixation system of the present invention; Figure 7 This is a schematic diagram of the longitudinal cross-sectional structure of a single intelligent support rod of the present invention; Figure 8 For the present invention Figure 7 A magnified view of the structure of part A in the middle circle; Figure 9 For the present invention Figure 7 A magnified schematic diagram of a portion of the middle circle, B; Figure 10 For the present invention Figure 7 A magnified schematic diagram of a portion of the central circle C section; Figure 11 For the present invention Figure 7 A magnified schematic diagram of a portion of the central circle, D section; Figure 12 This is a partially enlarged schematic diagram of the connection point between the motor structure and the planetary reducer of the present invention; Label Explanation 1. Intelligent support rod; 11. Hollow sleeve; 111. Moving groove; 12. Motor structure; 13. Planetary reducer; 14. Telescopic structure; 141. Telescopic section; 1411. Threaded pipe; 1412. Protruding slider; 142. Rotating section; 1421. Threaded section; 143. Locking nut; 15. Tension / compression sensor; 161. First connecting rod; 162. Second connecting rod; 163. Limiting ring; 171. First universal joint; 1711. Cylindrical section; 1712. Joint section one; 172. Second universal joint; 81. Rotary mating section; 182. Boss; 191. Longitudinal protrusion; 192. Longitudinal groove; 193. Limiting protrusion; 194. Axial limiting groove; 21. Upper fixing ring; 211. Fixing ring part; 2111. Fixing hole; 212. Support rod setting part; 2121. Connecting rod hole; 22. Lower fixing ring; 3. Control structure; 31. Lithium-ion battery; 32. Microcontroller; 33. Wireless signal transmission structure; 34. Connecting fixing part; 35. Housing; 36. Setting cavity; 37. Combination hole; 38. Wire connection hole. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0029] In this document, “illustrative” means “serving as an example, illustration or description”, and any illustration or implementation described herein as “illustrative” should not be construed as a more preferred or advantageous technical solution.

[0030] To keep the drawings concise, only the parts relevant to this application are shown schematically in each drawing, and they do not represent the actual structure of the product. In addition, to make the drawings concise and easy to understand, in some drawings, only one of the components with the same structure or function is shown schematically, or only one of them is labeled.

[0031] In this document, unless otherwise expressly specified and limited, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance; unless otherwise specified or stated, the term "multiple" refers to two or more; the terms "connected," "fixed," etc., should be interpreted broadly. For example, "connected" can be a fixed connection, a detachable connection, an integral connection, or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0032] Example 1: An intelligent six-axis external fixation system that monitors load and dynamizes healing First, it's important to understand that in the process of fracture healing using external fixation, the optimal balance between the mechanical environment and biological factors is crucial for safe fracture healing, as both synergistically influence the bone regeneration process. Mechanical stimulation plays a vital role in fracture healing, acting as a catalyst to initiate a cascade of growth factor secretion, macrophage recruitment and migration, and osteoblast proliferation and differentiation, ultimately completing the overall bone regeneration process. Local strain during fracture healing is determined by mechanical factors; small fracture gaps can accelerate the healing process, while large gaps may lead to delayed healing. Dynamic fixation during fracture healing refers to treatment techniques that stimulate biological responses at the fracture ends through controlled micromotion or dynamic fixation, thereby accelerating healing. This can activate the osteogenic potential of mesenchymal cells, and the biological effects of pressure can improve cell function, increase blood supply, and enhance osteoblast activity. Fracture healing is a mechanically sensitive process, with corresponding optimal stress states at different stages. Early treatment requires rigid fixation of the fracture ends, but this rigid fixation can create stress shielding at the bone mineralization zone and joint point in the later stages, affecting fracture healing. At this point, moderate axial micromotion can upregulate the expression of osteogenic factors. For Taylor ring fixation, there is also a need for a fixation system that can be intelligently adjusted and effectively micro-moved. The following implementation is an intelligent six-axis external fixation system that monitors load and dynamically promotes healing.

[0033] refer to Figure 1-3 A smart six-axis external fixation system for monitoring load and kineticizing healing includes an upper fixation ring 21, a lower fixation ring 22, and six smart support rods 1.

[0034] The upper fixation ring 21 includes a fixation ring portion and a support rod setting portion 212. The fixation ring portion is provided with a fixation hole 2111 for fixing the fixation nail connected to the fracture site to the upper fixation ring 21. The support rod setting portion 212 extends outward from the fixation ring portion and is provided with 3 support rod setting portions 212 along the fixation ring portion. Each support rod setting portion 212 is provided with 2 connecting rod holes 2121 for fixing two support rods to the upper fixation ring 21.

[0035] The lower fixing ring 22 is set in the same way as the upper fixing ring 21, and the angle of the support rod setting part 212 of the upper fixing ring 21 and the lower fixing ring 22 is adapted to ensure that the six intelligent support rods 1 are set between the upper and lower fixing rings 22.

[0036] refer to Figure 4-9 The intelligent support rod 1 includes a hollow sleeve 11, a motor structure 12, a planetary reducer 13, a telescopic structure 14, universal joints at both ends, and connecting rods.

[0037] The telescopic structure 14, which adjusts the overall length of the support rod through its telescopic movement, includes a telescopic section 141 and a rotating section 142. The rotation of the rotating section 142 drives the telescopic section 141 to extend or retract. The telescopic section 141 has a threaded tube 1411, and the rotating section 142 has a threaded section 1421. The threaded section 1421 engages with the threaded tube 1411, and its rotation causes the threaded tube 1411 to extend or retract along the longitudinal axis of the telescopic structure 14. The pitch of the rotating section 142 is 1mm, and for every revolution of the rotating section 142, the telescopic section 141 moves 1mm. Thus, by controlling the rotating section 142 to rotate 1-2 revolutions repeatedly via the motor structure 12, a telescopic vibration of 1-2mm can be achieved, making the entire control process simple and controllable.

[0038] The motor structure 12 is used to provide rotational force to the rotating section 142; the motor type is a 12mm diameter micro motor; the rated power is 1-3W.

[0039] The planetary reducer 13 is used to control the rotation of the rotating section 142 while reducing the power of the motor structure 12; the first end of the planetary reducer 13 is combined with the rotating shaft of the motor structure 12, and the second end is combined with the rotating section 142. The motor structure 12 drives the planetary reducer 13 to rotate, and then the planetary reducer 13 drives the rotating section 142 to rotate; the reduction ratio of the planetary reducer is 256:1.

[0040] The tension / compression sensor 15 is used to monitor the tension or compression force borne by the support rod. The range of the tension / compression sensor 15 is 0 to 80 kg, with a resolution of 0.1 kg.

[0041] The support rod is provided with a first connecting rod 161 and a second connecting rod 162 at both ends for fixing the support rod to the external fixing frame. The first connecting rod 161 is connected to the first universal joint 171, and the second connecting rod 162 is connected to the second universal joint 172. This ensures that when the length of the telescopic rod is adjusted, the support rod is stably maintained on the external fixing frame by changing the angle. The second end of the telescopic section 141 includes part or all of the second universal joint 172.

[0042] The hollow sleeve 11 has a first universal joint 171, a tension / compression sensor 15, a motor structure 12, a planetary reducer 13, a rotating section 142, and a partial telescopic section 141 arranged sequentially from the first end to the second end of the hollow sleeve 11. The longitudinal axis of all structures inside the hollow sleeve 11 is consistent. When the telescopic section 141 is fully extended, the length of the telescopic section 141 extending beyond the second end of the hollow sleeve 11 is greater than or equal to the length of the threaded pipe 1411.

[0043] The fixation frame also includes a control structure 3. The control structure 3 receives the pressure values ​​from the tension / compression sensors 15 of each intelligent support rod 1. Based on the pressure values, it individually controls each intelligent support rod 1 or simultaneously controls several intelligent support rods 1 to extend and retract, ensuring adjustment of one or more intelligent support rods 1 in case of stress shielding; or it controls the extension and retraction of all six intelligent support rods 1 at a certain frequency, with each rod extending or retracting by 1-2 mm at a time, achieving micro-motion mechanical stimulation of the fracture site through the micro-motion of the Taylor frame. By receiving the pressure values ​​from the tension / compression sensors 15 through the control structure 3, the extension and retraction degree of each intelligent support rod 1 is automatically adjusted to ensure that each intelligent support rod 1 is in a normal state, thereby monitoring the treatment process and ensuring treatment effectiveness. This solves the problem that traditional Taylor frames are either impossible to adjust or have very cumbersome adjustment mechanisms after fixation. Compared to existing technologies that involve continuous rotation of the Hooke hinge, which avoids negative interference with the patient, the rotation of the Hooke hinge can easily cause entanglement with surrounding objects, thus affecting the rotation. Therefore, existing technologies using the Hooke hinge cannot achieve continuous micro-motion extension and retraction at different frequencies. In contrast, the intelligent support rod 1 in the Taylor frame has a built-in motor, and the entire extension and retraction adjustment is only observable through the extension and retraction structure 14. Therefore, continuous small-amplitude adjustments will not affect the patient or their family, allowing for continuous micro-motion stimulation of 1-2 mm at a controlled frequency of 30-50 times. This promotes bone healing. Of course, the specific duration of micro-motion stimulation should be selected according to the needs to ensure the best effect on promoting healing.

[0044] The control structure 3 is modular and is mounted on either the upper or lower fixed ring. It includes a built-in lithium-ion battery 31 and a microcontroller 32 (MCU) with built-in control programs for all intelligent support rods. The control structure 3 also includes a wireless signal transmission structure 33 (Bluetooth module) to transmit received pressure data to a computer or mobile terminal. During use, it receives pressure signals from each intelligent support rod and analyzes them through the control program of the control structure 3. When stress blockage occurs, the control program analyzes the data to obtain adjustment data for each intelligent support rod and controls the corresponding support rod to adjust simultaneously. This setup allows data to be received and processed automatically via the control structure 3 mounted on the fixed ring, making the entire device very convenient to use and adjust. Furthermore, the wireless transmission method allows data to be transmitted to a computer or mobile terminal, ensuring that medical staff can monitor the patient's recovery progress and make overall adjustments based on the patient's recovery status.

[0045] More specifically, the control structure 3 includes a fixing part 34 that engages with the fixing ring, and a housing 35 with a mounting cavity 36. The housing 35 is located on the periphery of the fixing ring and is integrally connected to the fixing part 34. The lithium-ion battery 31, the microcontroller 32, and the wireless signal transmission structure 33 are all housed within the mounting cavity 36, and the housing 35 has an arc-shaped structure similar to the fixing ring. The fixing ring has combination holes 37 corresponding to the fixing holes, and the fixing holes and combination holes 37 are locked together by screws to complete the engagement of the control structure 3 and the fixing ring. The arc of the fixing ring is less than or equal to 90 degrees to ensure that the fixing part 34 is fixed between the support rod mounting parts, and the position is adjusted according to the selection of the human body fixing nail of the fixing ring. A wire connection hole 38 is provided on the housing 35 to connect the intelligent support rod to the control structure 3. The lithium-ion battery 31 occupies more than 70% of the space in the mounting cavity 36 to ensure that all intelligent support rods are powered by the lithium-ion battery 31. Of course, in actual implementation, two interconnected control structures 3 can be set up symmetrically to ensure that space and power supply are sufficient.

[0046] By setting up the planetary reducer 13, a small motor mechanism coaxial with the planetary reducer 13 can be installed together with the planetary reducer 13 inside the hollow sleeve. The planetary reducer 13 is connected to the rotating section 142 of the telescopic structure 14 to achieve low-power motor control of the telescopic rod's extension and retraction. This results in all structures being confined to a single longitudinal axis. During the process, the rotation of the motor and various structures are confined within a relatively thin hollow sleeve. When in use, the patient and their family only observe a wire and a support rod. When controlling the extension and retraction, only the movement of the telescopic section 141 relative to the hollow sleeve 11 can be observed. The entire process will not affect the patient. In addition, only a 1-2 mm micro-displacement occurs during micro-adjustment, and the patient has no obvious foreign body sensation or discomfort feedback. Moreover, the micro-displacement amplitude has been biomechanically verified to be within the range corresponding to the bone tissue stress adaptation window (0.1–0.3 MPa), which can effectively activate osteoblast activity and inhibit osteoclast overexpression. Furthermore, placing the connecting rods at both ends ensures convenient assembly of the support rod and the external fixing frame. Assembly simply requires adjusting the telescopic rod to its shortest length and inserting the connecting rod into the corresponding hole in the external fixing frame; the entire support rod setup is very simple and convenient. Moreover, the entire support rod is a single, integrated rod with a simple structural design, making it very convenient to handle and transport.

[0047] A more preferred embodiment is that the dimensions of the first connecting rod 161 and the second connecting rod 162 are adapted to the connecting rod hole 2121 on the conventional Taylor frame; this ensures that when replacing the conventional support rod with the intelligent support rod 1, only the original support rod needs to be removed and replaced with the intelligent support rod 1, making the replacement simple and convenient.

[0048] The upper fixing ring 21 and the lower fixing ring 22 are circular rings with a thickness ranging from 5 to 8 mm. The materials of the upper fixing ring 21 and the lower fixing ring 22 are medical-grade titanium alloy or high-strength aluminum alloy, taking into account both lightweight and biocompatibility. The hollow sleeve 11 is integrally formed from medical-grade titanium alloy, and the inner wall is polished at the nanoscale to ensure that the intelligent drive unit has no wear and zero hysteresis during long-term reciprocating motion.

[0049] The six intelligent support rods 1 are arranged in pairs. The first connecting rod 161 of the two support rods in one pair is set in a support rod setting part 212 of the lower fixing ring 22. The two intelligent support rods 1 of the corresponding pair are set in two adjacent connecting rod holes 2121 of two adjacent support rod setting parts 212 of the upper fixing ring 21. In this way, a six-bar parallel constraint structure is formed. By controlling all the intelligent support rods 1 to extend or retract at the same time, stable micro-motion adjustment can be achieved. At the same time, it supports group differential adjustment to accurately correct minor misalignments of the fracture ends.

[0050] More specifically, see reference Figure 4 and 5A movable groove 111 is provided inside the hollow sleeve 11, and a protruding slider 1412 extending into the movable groove 111 is provided on the outside of the telescopic section 141, so that the telescopic section 141 can move smoothly along the axial direction of the hollow sleeve 11 without radial shaking, ensuring that the telescopic section 141 does not rotate with the rotating section 142.

[0051] A more preferred embodiment is that the first end of the hollow sleeve 11 has an outlet smaller than the inner diameter of the main body of the hollow sleeve 11, and the first universal joint 171 includes a cylindrical section 1711 confined in the inner cavity of the first end of the hollow sleeve 11, and a joint section 1712 extends from the outlet. This arrangement confines each structure within the hollow sleeve 11, preventing it from detaching from the first end.

[0052] More specifically: Reference Figure 4 Both the first universal joint 171 and the second universal joint 172 include a ball-and-socket structure and a ball-and-head structure. The ball-and-socket of the first universal joint 171 is located on joint segment 1712, and the first connecting rod 161 is integrally connected to the ball-and-head structure. The telescopic segment 141 includes joint segment 2, and the ball-and-socket of the second universal joint 172 is located on joint segment 2. The second connecting rod 162 is integrally connected to the ball-and-head structure. The ball-and-head structure is embedded in the corresponding ball-and-socket, forming a spherical pair that can rotate freely around any axis. Through the above configuration, it is possible to combine the support rod with various types of external fixation frames to form a certain support angle. The ends of the first connecting rod 161 and the second connecting rod 162 are provided with threaded sections 1421, and both the first connecting rod 161 and the second connecting rod 162 are provided with limiting rings 163 to prevent the universal joint from contacting the combination hole of the external fixation frame, thus affecting the degree of freedom of the universal joint during initial setup. The above settings ensure that after the nut is tightened, the limiting ring 163 and the surface of the outer fixing frame form a reliable limit, which not only guarantees the full degree of freedom adjustment space during the initial installation of the universal joint, but also suppresses loosening of the connection during subsequent micro-movements.

[0053] A more preferred embodiment is, referring to Figure 4 and Figure 8The cylindrical segment 1711 is fixed to the first end of the hollow sleeve 11 by gluing, and the tension / compression sensor 15 is fixedly connected to the cylindrical segment 1711; the motor structure 12, the planetary reducer 13 and the telescopic structure 14 each include a matching segment whose outer diameter is the same as the inner diameter of the hollow sleeve 11; the outer wall of the matching segment is in smooth contact with the inner wall of the hollow sleeve 11; and the matching segment of each structure moves relative to the longitudinal axis of the hollow sleeve 11. The second end of the motor structure 12 is combined with the tension / compression sensor 15, so that the tension and pressure can be transmitted to the tension / compression sensor 15 through the motor structure 12. The above configuration ensures the positional relationship between the cylindrical section 1711, the tension / compression sensor 15, and the hollow sleeve 11. The variable relative positions of the motor structure 12, the planetary reducer 13, and the telescopic structure 14 to the longitudinal axis of the hollow sleeve 11 ensures that the force applied to the longitudinal axis of the support rod in a static state is effectively applied to the tension / compression sensor 15 through the motor structure 12, and ensures the accuracy of force transmission, unaffected by the contact between the mating section and the hollow sleeve 11.

[0054] A more preferred embodiment is described in reference. Figure 6 and Figure 9 The motor structure 12 is combined with the planetary reducer 13, and their relative positional relationship along the longitudinal axis is fixed after combination. The planetary reducer 13 is combined with the rotating section 142, and their relative positional relationship along the longitudinal axis is fixed after combination. The motor structure 12, the planetary reducer 13, and the telescopic structure 14 are constructed as a whole with a fixed relative positional relationship along the longitudinal axis. Only rotational transmission occurs between the structures, and no relative axial displacement occurs. Specifically, a rotating shaft extends from the motor structure 12, and a connecting pipe extends from below the planetary reducer 13. Multiple longitudinal protrusions 191 and longitudinal grooves 192 are provided on the connecting pipe and the rotating shaft to ensure the two sets of engagement. After combination, the combination relationship is fixed by gluing. The planetary reducer 13 and the rotating section 142 also adopt the above combination and fixing method. This configuration ensures that the torque output by the motor is transmitted to the rotating section 142 only through the planetary reducer 13, and then converted into a precise linear displacement along the longitudinal axis via the telescopic structure 14. This linear displacement is coupled to the external fixator via the second universal joint 172, ultimately generating periodic micro-motion stimulation with controllable amplitude (1–2 mm) and stable direction at the fracture site. Constructing the motor structure 12, planetary reducer 13, and telescopic structure 14 into a structure with a fixed longitudinal axis position ensures the stability of the support rod structure and avoids the risk of separation of the various structures during use. In conjunction with the protruding slider 1412 of the telescopic section 141 and the moving groove 111 of the hollow sleeve 11, the various structures can be stably confined within the hollow sleeve, avoiding the risk of structural separation.

[0055] A more preferred embodiment is described in reference. Figure 7To prevent excessive movement of the integrated structure of motor structure 12, planetary reducer 13, and telescopic structure 14, which could affect the measurement of tension / compression sensor 15, an axial limiting protrusion is provided on the housing of motor structure 12 or planetary reducer 13. Correspondingly, an axial limiting groove 194 is provided on the inner wall of hollow sleeve 11 to cooperate with the limiting protrusion. The length of the axial limiting groove 194 is 1-3 mm to limit the maximum displacement of the entire structure along the longitudinal axis, ensuring that the tension / compression sensor 15 is always within its calibrated working range and avoiding measurement inaccuracies or structural interference due to overtravel. Alternatively, refer to... Figure 8 The inner diameter of the portion of the hollow sleeve 11 that encloses the rotating section 142 and the telescopic section 141 is smaller than the inner diameter of other positions. However, the rotating section 142 includes a rotating mating section 181 whose size matches the larger portion of the hollow sleeve 11, forming a boss 182 at the two dimensional change positions. In the vertically placed state, the distance between the mating section on the rotating section 142 and the bottom of the boss 182 is controlled within the range of 1 to 3 mm. The above setting can ensure the stability of the moving groove 111. In addition, through this dimensional change, when all structures are set in the hollow sleeve 11, this dimensional change can form a natural barrier, which can confine the motor structure 12, the planetary reducer 13 and the telescopic structure 14 within the hollow sleeve 11, preventing the risk of any structure coming off the hollow sleeve 11. In addition, it also ensures that the structure under the boss 182 has a certain amount of room to move, so as to ensure that the tension and compression sensor 15 is pulled within a safe range.

[0056] When implementing, refer to Figure 7 Both the hollow sleeve 11 and the telescopic section 14 have a threaded section on their outer sides, and a locking nut 143 is provided on the corresponding outer side. The inner thread of the first end of the locking nut 143 corresponds to the thread on the outer side of the telescopic section 14, and the inner thread of the second end of the locking nut 143 corresponds to the thread on the outer side of the hollow sleeve 11. The locking nut 143 locks the positional relationship between the hollow sleeve and the telescopic section before use. During use, rotating the locking nut separates the inner thread of the locking nut from the threads of the hollow sleeve and the telescopic section, releasing the locking effect and allowing the entire intelligent support rod to effectively perform its supporting function.

[0057] In a more preferred embodiment, the hollow sleeve 11 has an outer diameter ranging from 10 to 15 mm, a wall thickness ranging from 1.5 to 2.5 mm, and an inner diameter ranging from 8.5 to 12.5 mm; this size satisfies the overall structural strength and clinical installation space constraints. This results in a structure with sufficient strength yet a relatively simple overall design, eliminating any negative impact on patient observation during use.

[0058] In a more preferred embodiment, the hollow sleeve 11 is symmetrically assembled from two identical halves, and the joint is protected by both airtightness and structural rigidity through laser welding or micron-level interference fit. This arrangement effectively confines each structure within the hollow sleeve 11 before assembly, ensuring convenient assembly.

[0059] In a more preferred embodiment, a miniature battery is provided inside the hollow sleeve 11 to power the tension / compression sensor 15. This battery allows for real-time display of the current force value of the tension / compression sensor 15 before the motor power is turned on, ensuring that pre-motion calibration and intraoperative monitoring are performed simultaneously. The mechanical sensitivity of the tension / compression sensor 15 is 0.1 kg, ensuring the accuracy of monitoring. (See attached figures.)

[0060] Each motor structure 12 extends a wire. When a single external mounting bracket requires multiple support rods, the wires of each motor structure 12 are connected in parallel to the power supply, and a control structure is provided to control the rotation direction, rotation speed, and rotation duration of the motor structure 12 to ensure that the support rods are mounted on the external mounting bracket. After the support rods are assembled with the external mounting bracket, the control structure controls the frequency of forward and reverse rotation of the motor structure 12 and the rotation speed within a single cycle to ensure that the rotating section 142 rotates 1-2 revolutions within a single cycle, causing the telescopic section 141 to undergo a micro-motion of 1-2 mm.

[0061] A method for setting up and using an intelligent six-axis external fixation system that monitors load and promotes healing via kinetics: First, multiple fixation pins are inserted into both sides of the bone segment to be reduced and rehabilitated. Then, a connecting structure is fixedly set on the multiple fixation pins inserted at the fracture site. The upper fixation ring 21 and the lower fixation ring 22 are set up by inserting the connecting structure into the 360-degree ring of the upper and lower fixation rings 22. After setting the upper fixing ring 21 and the lower fixing ring 22, adjust the six intelligent support rods 1 to a suitable length to ensure that the first connecting rod 161 and the second connecting rod 162 can extend into the connecting rod hole 2121. After setting the length of the six intelligent support rods 1, set the six intelligent support rods 1 to the corresponding support rod setting part 212, so that the limiting ring 163 of the first connecting rod 161 and the second connecting rod 162 contacts the upper fixing ring 21 and the lower fixing ring 22. Set the nuts on the outside of the upper fixing ring 21 and the lower fixing ring 22, and use the nuts to lock the relationship between the first connecting rod 161 and the second connecting rod 162 and the upper fixing ring 21 and the lower fixing ring 22. After completing the setting of the six intelligent support rods 1, adjust the length of the support rods again according to the obtained values ​​of the tension and compression sensors 15. When the tension and compression sensors 15 of each intelligent support rod 1 return accurate pressure values, the setting of the fixing frame is completed. If, during use, the value of the tension / compression sensor 15 of one of the smart support rods 1 is found to be inappropriate, it indicates stress blockage. This is then eliminated through gradual fine-tuning, ensuring that the values ​​of all tension / compression sensors 15 are within the appropriate range. Once all the values ​​of the tension / compression sensors 15 are within the appropriate range, the six smart support rods 1 are simultaneously extended and retracted, with the extension and retraction amplitude controlled within 1-2 mm. This provides micro-mechanical stimulation to the fracture site, promoting bone healing.

[0062] The above description is merely a specific embodiment of this application. Under the guidance of the above teachings, those skilled in the art can make other improvements or modifications based on the above embodiments. Those skilled in the art should understand that the above specific description is only to better explain the purpose of this application, and the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A smart six-axis external fixation system for monitoring load and kinetically promoting healing, comprising an upper fixation ring, a lower fixation ring, and six smart support rods; characterized in that, The upper fixation ring includes a fixation ring part and a support rod setting part. The fixation ring part is provided with a fixation hole for fixing the fixation nail connected to the fracture site to the upper fixation ring. The support rod setting part extends outward from the fixation ring part and is provided with 3 support rod setting parts along the fixation ring part. Each support rod setting part is provided with 2 connecting rod holes for fixing two support rods to the upper fixation ring. The lower fixed ring and the upper fixed ring are set in the same way. The angle of the support rod setting part of the upper fixed ring and the lower fixed ring is adapted to ensure that the six intelligent support rods are set between the upper and lower fixed rings. The intelligent support rod includes a hollow sleeve, a tension / compression sensor, a motor structure, a planetary reducer, a telescopic structure, a first universal joint with a first connecting rod, and a second universal joint with a second connecting rod; from the first end to the second end of the hollow sleeve, a portion of the first universal joint, the tension / compression sensor, the motor structure, the planetary reducer, and a portion of the telescopic structure are arranged sequentially, and the longitudinal axis of all structures inside the hollow sleeve is consistent. When the telescopic structure is fully extended, the length of the telescopic section extending beyond the second end of the hollow sleeve is greater than or equal to the length of the threaded pipe; the planetary reducer is driven to rotate by the motor structure, and then the planetary reducer drives the telescopic structure to rotate, thereby causing the telescopic structure to extend and retract.

2. The six-axis external fixation system according to claim 1, characterized in that, The six-axis external fixation system also includes a control structure. This control structure receives the pressure values ​​from the tension and compression sensors of each smart support rod. Based on the pressure values, it controls the extension and retraction of each smart support rod individually or simultaneously, ensuring adjustment of one or several smart support rods in case of stress shielding; or it controls the extension and retraction of all six smart support rods at a certain frequency to achieve uniform stress release and avoid stress shielding. At the same time, the extension and retraction amplitude of each rod is 1-2 mm at a time, realizing dynamic micro-motion mechanical stimulation of the fracture site through the micro-motion of the Taylor frame.

3. The six-axis external fixation system according to claim 2, characterized in that, The control structure is modular and is set on the upper or lower fixed ring. The control structure includes a built-in lithium-ion battery and a microcontroller (MCU) with built-in control programs for all intelligent support rods. The control structure also includes a wireless signal transmission structure to transmit the received pressure data to a computer or mobile terminal.

4. The six-axis external fixation system according to claim 3, characterized in that, The control structure includes a coupling and fixing part that engages with a fixing ring, and a housing with a cavity. The housing is disposed around the fixing ring and is integrally connected with the coupling and fixing part. Preferably, the lithium-ion battery, microcontroller, and wireless signal transmission structure are all housed within the cavity, and the housing has an arc-shaped structure similar to the fixing ring. The fixing ring has combination holes corresponding to the fixing holes, and the fixing holes and combination holes are locked together by screws to complete the connection between the control structure and the fixing ring. Preferably, the curvature of the retaining ring is less than or equal to 90 degrees; wire connection holes are provided on the housing to connect the smart support rod to the control structure; the lithium-ion battery occupies more than 70% of the space in the housing cavity.

5. The six-axis external fixation system according to claim 1, characterized in that, The dimensions of the first and second connecting rods are adapted to the connecting rod holes on the traditional Taylor frame; this ensures that when replacing the traditional support rod with the smart support rod, only the original support rod needs to be removed and replaced with the smart support rod.

6. The six-axis external fixation system according to claim 1, characterized in that, The upper and lower fixation rings are circular with a thickness ranging from 5 to 8 mm. The materials of the upper and lower fixation rings are medical-grade titanium alloy or high-strength aluminum alloy, taking into account both lightweight and biocompatibility.

7. The six-axis external fixation system according to claim 1, characterized in that, The hollow sleeve is made of medical-grade titanium alloy in one piece, and the inner wall is polished at the nano level.

8. The six-axis external fixation system according to claim 1, characterized in that, The six intelligent support rods are arranged in pairs. The first connecting rod of the two support rods in each pair is set in a support rod setting part of the lower fixing ring. The two intelligent support rods of the corresponding pair are set in two adjacent connecting rod holes in two adjacent support rod setting parts of the upper fixing ring.

9. The six-axis external fixation system according to claim 8, characterized in that, The telescopic structure includes a telescopic section and a rotating section; the rotation of the rotating section drives the telescopic section to extend and retract; the telescopic section has a threaded tube, and the rotating section has a threaded section. The threaded section and the threaded tube cooperate with each other, and the rotation of the threaded section drives the threaded tube to extend and retract along the longitudinal axis of the telescopic structure; a moving groove is set inside the hollow sleeve, and a protruding slider is set on the outside of the telescopic section that extends into the moving groove, so that the telescopic section can move smoothly along the axial direction of the hollow sleeve without radial swaying. Preferably, the rotating section is combined with a planetary reducer, and after the combination, the planetary reducer drives the rotating section to rotate, but the longitudinal axis positions of the rotating section and the planetary reducer are relatively fixed; the motor structure is combined with the planetary reducer, and after the combination, the motor structure drives the planetary reducer to rotate, but the longitudinal axis positions of the motor structure and the planetary reducer are relatively fixed.

10. The six-axis external fixation system according to claim 8, characterized in that, The first universal joint is fixed to the first end of the hollow sleeve by adhesive bonding, and the tension / compression sensor is fixedly connected to the first universal joint. The motor structure, planetary reducer, and telescopic structure all include a matching section with an outer diameter that matches the inner diameter of the hollow sleeve. The outer wall of the matching section is smooth with the inner wall of the hollow sleeve section. The matching sections of each structure move relative to the longitudinal axis of the hollow sleeve. The second end of the motor structure is combined with the tension / compression sensor, so that both tension and pressure can be transmitted to the tension / compression sensor through the motor structure. Preferably, an axial limiting protrusion is provided on the housing of the motor structure or planetary reducer, and an axial limiting groove that cooperates with the limiting protrusion is provided on the inner wall of the hollow sleeve, with the length of the axial limiting groove being 1-3mm.

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