Needle threading external fixation device and method for evaluating fracture healing based on mechanical inversion

Abstract

The invention provides a needle-threading external fixation device and method for evaluating fracture healing based on mechanical inversion, and relates to the technical field of medical instruments. According to the device, the fracture of a patient is fixed through the fixing module, the device is high in integration level, easy and convenient to operate and wider in clinical applicability, stress data borne by the fixing module when the patient bears the weight is obtained through the monitoring module, objective and quantitative fracture healing evaluation indexes are provided, excessive dependence on experience and iconography is reduced, and the fracture healing effect is improved. The measurement principle is more direct, the accuracy and credibility of an evaluation result are improved, finally, through a data processing and transmission module, collected stress data are preliminarily calculated and transmitted to a computer end for mechanical inversion, the equivalent stiffness of the healing tissue of the fracture broken end is calculated, and the accuracy and credibility of the evaluation result are improved. The qualitative change of fracture healing evaluation from imaging evaluation to mechanical property evaluation is realized.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a pin-fixation device and method for evaluating fracture healing based on mechanical inversion. Background Technology

[0002] In the field of traditional Chinese medicine orthopedics, external fixation with pins is a classic and effective treatment for fractures. This method involves implanting several fixation pins into the bone on both sides of the fracture site and connecting and locking these pins externally through a rigid or semi-rigid connecting frame. This provides a stable biomechanical environment for the fracture site, promoting bone healing. Compared to open internal fixation, external fixation with pins offers advantages such as less trauma, lower risk of infection, easier wound observation, and the ability to make secondary adjustments. It holds an irreplaceable position in treating open, comminuted fractures, or cases accompanied by severe soft tissue injuries.

[0003] External fixation devices widely used in clinical practice have evolved to utilize more biocompatible metallic materials such as carbon fiber, aluminum-zinc alloy, and titanium alloy. Their structures have also diversified, including single-sided, double-sided, ring-shaped, and combined designs, to meet the fixation needs of fractures at different locations and of different types. However, the core function of current technology remains primarily focused on providing static mechanical support. When installing these devices, physicians mainly rely on clinical experience to determine the tightness of the fixation and the force of distraction. During the subsequent healing period, it is impossible to objectively and quantitatively understand the mechanical environment acting on the fracture ends and its changes as the fracture heals. Summary of the Invention

[0004] To address the problems in the existing technology, this invention provides a pinned external fixation device and method for assessing fracture healing based on mechanical inversion. Firstly, the fixation module achieves fracture fixation, offering high integration, ease of operation, and wider clinical applicability. Secondly, the monitoring module acquires force data on the fixation module under patient weight-bearing, providing objective and quantitative indicators for fracture healing assessment. This reduces over-reliance on experience and imaging, and the measurement principle is more direct, improving the accuracy and reliability of the assessment results. Finally, the data processing and transmission module performs preliminary calculations on the collected force data and transmits it to a computer for mechanical inversion, estimating the equivalent stiffness of the healing tissue at the fracture ends. This represents a qualitative leap in fracture healing assessment, moving from "imaging assessment" to "mechanical performance assessment." To achieve the above objectives, the technical solution is as follows: On one hand, the present invention provides a pinning external fixation device for evaluating fracture healing based on biomechanical inversion, the device comprising: The fixation module is the main structure that provides mechanical support for the fractured limb and the device. The monitoring module is responsible for monitoring and collecting mechanical data; The data processing and transmission module is used to transmit and process the mechanical data.

[0005] Optionally, the fixing module includes: A semi-circular external fixator is used as a load-bearing frame for the fractured limb and the device, and the curvature of the semi-circular external fixator is matched to that of the human limb. A bone aspiration needle is used to penetrate the skin and muscle and be directly implanted into the healthy bone on both sides of the fracture site. The bone aspiration needle is a bridge connecting the bone to the semi-circular external fixator. Support rods are used to connect and fix the semi-circular outer fixing frame to form a stable three-dimensional structure; A locking device is used to secure the bone-piercing needle to the semi-circular external fixator. The locking nut is used to lock the locking pin. Support rod nut, used to lock the support rod and the semi-circular outer fixing bracket.

[0006] Optionally, the monitoring module includes: The pressure monitoring unit is used to collect the pressure exerted by the patient on the support rod when bearing weight; The load monitoring unit is used to measure the patient's total load value when bearing weight; Fracture end force sensor, used to measure the pressure at the fracture ends; Fracture end displacement sensor, used to measure the displacement of fracture ends.

[0007] Optionally, the pressure monitoring unit includes: Tension and compression sensors are used to measure the axial tensile or compressive force borne by the support rod; A signal amplifier is used to amplify the electrical signal output by the tension / compression sensor. A metal housing is used to encapsulate the tension / compression sensor and the signal amplifier together inside.

[0008] Optionally, the three support rods are fixedly connected to the two semi-circular external fixation frames by the support rod nuts. The three support rods are evenly distributed on the semi-circular external fixation frames. The pressure monitoring unit is arranged on the support rods. The two ends of the bone puncture needle are respectively fixed on the semi-circular external fixation frame by the needle locking device. The needle locking device nut matches the needle locking device to lock the bone puncture needle. The data processing and transmission module is fixedly installed on the semi-circular external fixation frame.

[0009] Optionally, the weight-bearing monitoring unit is a separate plantar force plate located under the patient's foot.

[0010] Alternatively, the bone aspiration needles are two in number and installed in a cross configuration.

[0011] On the other hand, the present invention provides a method for pinning external fixation based on biomechanical inversion to assess fracture healing. This method is implemented using a pinning external fixation device based on biomechanical inversion to assess fracture healing. The method includes: S1. Based on the patient wearing the external fixation device for needle insertion, obtain the force data of the support rod of the external fixation device for needle insertion through the pressure monitoring unit; S2. Based on the force data of the support rod of the needle-threading external fixation device, the total force of the needle-threading external fixation device is obtained through calculation. S3. The total force on the fractured limb of the patient is obtained based on the load monitoring unit of the external fixation device. S4. Based on the total force of the external fixation device and the total force of the fractured limb of the patient, the force at the fracture ends is obtained. S5. Based on the total force of the external fixation device, the equivalent displacement of the fracture ends is obtained through the calibrated force displacement parameters of the external fixator. S6. Based on the force on the fracture ends and the equivalent displacement of the fracture ends, obtain the equivalent stiffness parameters of the fracture ends. S7. Based on the equivalent stiffness parameters of the fracture ends, the patient's healing stage is determined.

[0012] Optionally, the calibration process for the force-displacement parameters of the external fixation frame includes: S51. The external fixation device is installed on the artificial synthetic bone of the tibia simulating a transverse fracture. Springs with different stiffnesses are filled into the fracture ends of the artificial synthetic bone of the tibia to simulate the stiffness growth process of the healing tissue at the fracture ends. S52. Based on the stiffness growth process of the fracture healing tissue, the total force on the external fixation device and the displacement of the fracture ends at each stiffness stage are obtained. S53. Based on the total force on the external fixation device during each stiffness period and the displacement of the fracture ends, the force-displacement parameters of the external fixator are obtained using formula (1). K u = F 模拟 / △u (1) In the formula, K u Here are the force-displacement parameters of the external fixator, where Δu is the displacement of the fracture ends at various stiffness periods of the healing tissue, and F is the force-displacement parameter. 模拟 This represents the total force on the external fixation device for each stiffness period.

[0013] Optionally, in S6, the equivalent stiffness parameters of the fracture ends are obtained based on the forces acting on the fracture ends and the equivalent displacements of the fracture ends, including: K f = F 断 / u = ( F总 –F 架 ) / ( F 架 / K u (2) In the formula, K f F is the equivalent stiffness parameter of the fracture ends. 断 Let F be the force on the fracture ends, u be the equivalent displacement of the fracture ends, and F be the force. 总 F represents the total force on the fractured limb of the patient. 架 K represents the total force on the external fixation device for threading the needle. u These are the force-displacement parameters of the external fixed frame.

[0014] Compared with the prior art, the technical solution of the present invention has at least the following beneficial effects: The above-mentioned solution achieves fixation of the patient's fracture through a fixation module, which is highly integrated, easy to operate, and has wider clinical applicability. Secondly, it acquires the patient's force data through a monitoring module, providing objective and quantitative healing assessment indicators, reducing over-reliance on experience and imaging, and making the measurement principle more direct, thus improving the accuracy and reliability of the assessment results. Thirdly, through a unique calibration method and parameter calculation method, the equivalent stiffness parameters of the fracture ends are inversely deduced from the force displacement parameters of the external fixation device and the force data collected during in vivo fixation, realizing a qualitative change from "mechanical monitoring" to "healing assessment". It can directly assess the mechanical properties of the healing tissue at the fracture ends, calculate the fracture healing truncation, and significantly enhance the diagnostic function. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a block diagram of an embodiment of the pinning external fixation device for evaluating fracture healing based on mechanical inversion according to the present invention; Figure 2 This is a schematic diagram of an embodiment of the pinning external fixation device for evaluating fracture healing based on mechanical inversion according to the present invention; Figure 3 This is a flowchart of an embodiment of the pinning external fixation method for evaluating fracture healing based on mechanical inversion according to the present invention; Figure 4 This is a flowchart illustrating the calibration process of the force displacement parameters of the external fixator in an embodiment of the pinning external fixation method for evaluating fracture healing based on mechanical inversion according to the present invention.

[0017] The markings in the diagram are as follows: 1. Bone aspiration needle; 2. Support rod nut; 3. Locking needle device; 4. Support rod; 5. Semi-circular external fixator; 6. Pressure monitoring unit; 7. Data processing and transmission module; 8. Load monitoring unit; 9. Detailed Implementation

[0018] The technical solution of the present invention will now be described with reference to the accompanying drawings.

[0019] In embodiments of the present invention, words such as "exemplarily," "for example," etc., are used to indicate that something is an example, illustration, or description. Any embodiment or design described as "exemplary" in the present invention should not be construed as being more preferred or advantageous than other embodiments or designs. Specifically, the use of the word "exemplary" is intended to present the concept in a concrete manner. Furthermore, in embodiments of the present invention, the meaning expressed by "and / or" can be both, or either one.

[0020] To make the technical problems, technical solutions and advantages of the present invention clearer, a detailed description will be given below in conjunction with the accompanying drawings and specific embodiments.

[0021] like Figure 1 The diagram shown is a block diagram of an embodiment of the pinning external fixation device for evaluating fracture healing based on biomechanical inversion according to the present invention, and as shown below... Figure 2 The diagram shown is a structural schematic of an embodiment of the external fixation device for assessing fracture healing based on mechanical inversion according to the present invention. The present invention provides an external fixation device for assessing fracture healing based on mechanical inversion. This device can realize an external fixation method for assessing fracture healing based on mechanical inversion. The system includes: a fixation module, a monitoring module, and a data processing and transmission module. A fixed module, which is the main structure that provides mechanical support for the device; Specifically, the fixed module includes: A semi-circular external fixator 6 is used as a load-bearing frame for the device, and the curvature of the semi-circular external fixator 6 is matched with that of a human limb. Bone aspiration needle 1 is used to penetrate the skin and muscle and be directly implanted into the healthy bones on both sides of the fractured bone ends. Bone aspiration needle 1 is a bridge connecting the bone and the semi-circular external fixator 6. Furthermore, the bone aspiration needle 1 consists of two needles installed in a cross configuration.

[0022] Support rod 5 is used to connect and fix the semi-circular outer fixing frame 6 to form a stable three-dimensional structure; The locking device 3 is used to fix the bone needle 1 and the semi-circular external fixator 6; The locking nut 4 is used to lock the locking needle 3; Support rod nut 2 is used to lock the support rod 5 and the semi-circular outer fixing bracket 6.

[0023] The monitoring module is responsible for monitoring and collecting mechanical data; Specifically, the monitoring module includes: Pressure monitoring unit 7 is used to collect the pressure of the support rod; Weight monitoring unit 9 is used to measure the patient's total load value; Fracture end force sensor, used to measure the pressure at the fracture ends; Fracture end displacement sensor, used to measure the displacement of fracture ends.

[0024] Furthermore, the pressure monitoring unit 7 includes: Tension and compression sensors are used to measure the axial tensile or compressive force borne by the support rod; A signal amplifier is used to amplify the electrical signal output by the tension / compression sensor. A metal housing is used to encapsulate the tension / compression sensor and the signal amplifier together inside.

[0025] The data processing and transmission module 8 is used to transmit and process the mechanical data.

[0026] Specifically, the three support rods 5 are fixedly connected to the two semi-circular external fixation frames 6 by the support rod nuts 2. The three support rods 5 are evenly distributed on the semi-circular external fixation frames 6. The pressure monitoring unit 7 is arranged on the support rods 5. The two ends of the bone needle 1 are fixed on the semi-circular external fixation frame 6 by the needle locking device 3. The needle locking device nut 4 matches and locks the bone needle 1 with the needle locking device 3. The data processing and transmission module 8 is fixedly installed on the semi-circular external fixation frame 6.

[0027] Specifically, the weight-bearing monitoring unit 9 is an independent plantar force plate located under the patient's foot.

[0028] like Figure 3 The flowchart shown is an embodiment of the pinning external fixation method for assessing fracture healing based on biomechanical inversion according to the present invention. The present invention provides a pinning external fixation method for assessing fracture healing based on biomechanical inversion, which is implemented by a pinning external fixation device for assessing fracture healing based on biomechanical inversion. The method includes: S1. Based on the patient wearing the external fixation device for needle insertion, obtain the force data of the external fixation device for needle insertion through the pressure monitoring unit; S2. Based on the force data of the external fixation device for the needle insertion, the total force of the external fixation device for the needle insertion is obtained through calculation; Furthermore, the method for calculating the total force of the needle-threading external fixation device includes: F 架 = F1 + F2 + F3 (3) In the formula, F架 F1 represents the total force on the needle-threading external fixing device, F2 represents the force on the first support rod, F3 represents the force on the second support rod, and F4 represents the force on the third support rod.

[0029] S3. The total force on the patient is obtained based on the load monitoring unit of the external fixation device. S4. Based on the total force of the external fixation device and the total force of the patient, the force on the fracture ends is obtained; Specifically, the method for calculating the forces acting on the fracture ends includes: F 断 = F 总 - F 架 (4) In the formula, F 断 For the force on the fracture ends, F 总 For the total force on the patient, F 架 This represents the total force on the external fixation device for threading the needle.

[0030] S5. Based on the total force of the external fixation device, the equivalent displacement of the fracture ends is obtained through the calibrated force displacement parameters of the external fixator. Specifically, such as Figure 4 The flowchart shown is a record of the calibration process for the force-displacement parameters of the external fixator in an embodiment of the pinning external fixation method for evaluating fracture healing based on mechanical inversion of the present invention. The calibration process for the force-displacement parameters of the external fixator includes: S51. The external fixation device is installed on the artificial synthetic bone of the tibia simulating a transverse fracture. Springs with different stiffnesses are filled into the fracture ends of the artificial synthetic bone of the tibia to simulate the stiffness growth process of the healing tissue at the fracture ends. S52. Based on the stiffness growth process of the fracture healing tissue, the total force on the external fixation device and the displacement of the fracture ends at each stiffness stage are obtained. S53. Based on the total force on the external fixation device during each stiffness period and the displacement of the fracture ends, the force-displacement parameters of the external fixator are obtained using formula (1). K u = F 模拟 / △u (1) In the formula, K u Here are the force-displacement parameters of the external fixator, where Δu is the displacement of the fracture ends at various stiffness periods of the healing tissue, and F is the force-displacement parameter. 模拟 This represents the total force on the external fixation device for each stiffness period.

[0031] S6. Based on the force on the fracture ends and the equivalent displacement of the fracture ends, obtain the equivalent stiffness parameters of the fracture ends. Specifically, in S6, the equivalent stiffness parameters of the fracture ends are obtained based on the forces acting on the fracture ends and the equivalent displacements of the fracture ends, including: K f = F 断 / u = ( F 总 –F 架 ) / ( F 架 / K u (2) In the formula, K f F is the equivalent stiffness parameter of the fracture ends. 断 Let F be the force on the fracture ends, u be the equivalent displacement of the fracture ends, and F be the force. 总 F represents the total force on the fractured limb of the patient. 架 K represents the total force on the external fixation device for threading the needle. u These are the force-displacement parameters of the external fixed frame.

[0032] S7. Based on the equivalent stiffness parameters of the fracture ends, the patient's healing stage is determined.

[0033] Specifically, based on the range of the equivalent stiffness parameters of the fracture ends, the healing stage of the fracture can be determined as the hematoma stage, fibrous callus stage, or bony callus stage.

[0034] This invention provides a pinned external fixation device and method for assessing fracture healing based on mechanical inversion. Firstly, the fixation module achieves fracture fixation, offering high integration, ease of operation, and wider clinical applicability. Secondly, the monitoring module acquires force data on the fixation module under patient weight-bearing, providing objective and quantitative indicators for fracture healing assessment. This reduces over-reliance on experience and imaging, and the measurement principle is more direct, improving the accuracy and reliability of the assessment results. Finally, the data processing and transmission module performs preliminary calculations on the collected force data and transmits it to a computer for mechanical inversion, estimating the equivalent stiffness of the healing tissue at the fracture ends. This represents a qualitative leap in fracture healing assessment, moving from "imaging assessment" to "mechanical performance assessment."

[0035] It is understood that the present invention has been described through the above embodiments and should not be construed as limiting the implementation and scope of the present invention. Those skilled in the art will recognize that various changes or equivalent substitutions can be made to these features and embodiments without departing from the spirit and scope of the present invention. Furthermore, under the teachings of the present invention, these features and embodiments can be modified to adapt to specific situations and materials without departing from the spirit and scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of this application are within the protection scope of the present invention.

Claims

1. A pinned external fixation device for assessing fracture healing based on biomechanical inversion, characterized in that, The device includes: A fixation module, a main structure used to provide mechanical support for the fractured limb and the device; The monitoring module is responsible for monitoring and collecting mechanical data; The data processing and transmission module is used to transmit and process the mechanical data.

2. The pin-fixation device for evaluating fracture healing based on biomechanical inversion according to claim 1, characterized in that, The fixing module includes: A semi-circular external fixator is used as a load-bearing frame for the fractured limb and the device, and the curvature of the semi-circular external fixator is matched with that of the human limb. A bone aspiration needle is used to penetrate the skin and muscles and be directly implanted into the healthy bone on both sides of the fracture site. The bone aspiration needle is a bridge connecting the bone to the semi-circular external fixator. Support rods are used to connect and fix the semi-circular outer fixing frame to form a stable three-dimensional structure; A locking device is used to secure the bone aspiration needle to the semi-circular external fixator; A locking nut is used to lock the locking pin. The support rod nut is used to lock the support rod and the semi-annular outer fixing frame.

3. The pin-fixation device for evaluating fracture healing based on mechanical inversion according to claim 2, characterized in that, The monitoring module includes: The pressure monitoring unit is used to collect the pressure exerted by the patient on the support rod when bearing weight; The load monitoring unit is used to measure the total load value of the patient when bearing weight; Fracture end force sensor, used to measure the pressure at the fracture ends; Fracture end displacement sensor, used to measure the displacement of fracture ends.

4. The pin-fixation device for evaluating fracture healing based on mechanical inversion according to claim 3, characterized in that, The pressure monitoring unit includes: A tension or compression sensor is used to measure the axial tension or compression force borne by the support rod; A signal amplifier is used to amplify the electrical signal output by the tension / compression sensor; A metal housing is used to encapsulate the tension / compression sensor and the signal amplifier together inside.

5. The pin-fixation device for evaluating fracture healing based on mechanical inversion according to claim 3, characterized in that, The three support rods are fixedly connected to the two semi-circular external fixation frames by the support rod nuts. The three support rods are evenly distributed on the semi-circular external fixation frames. The pressure monitoring unit is arranged on the support rods. The two ends of the bone puncture needle are respectively fixed on the semi-circular external fixation frames by the needle locking device. The needle locking device nut matches the needle locking device to lock the bone puncture needle. The data processing and transmission module is fixedly installed on the semi-circular external fixation frame.

6. The pinning external fixation device for evaluating fracture healing based on mechanical inversion according to claim 3, characterized in that, The weight-bearing monitoring unit is an independent plantar force plate, which is located under the patient's foot.

7. The pin-fixation device for evaluating fracture healing based on mechanical inversion according to claim 2, characterized in that, The bone aspiration needles are two in number and are installed in a cross configuration.

8. A method for external fixation based on biomechanical inversion to assess fracture healing, wherein the method is implemented by the external fixation device for external fixation based on biomechanical inversion to assess fracture healing as described in any one of claims 1-7, characterized in that... The method includes: S1. Based on the patient wearing the external fixation device for needle insertion, obtain the force data of the support rod of the external fixation device for needle insertion through the pressure monitoring unit; S2. Based on the force data of the support rod of the needle-threading external fixation device, the total force of the needle-threading external fixation device is calculated. S3. The total force on the fractured limb of the patient is obtained according to the load monitoring unit of the external fixation device. S4. Based on the total force of the external fixation device and the total force of the fractured limb of the patient, the force at the fracture ends is obtained. S5. Based on the total force of the external fixation device, the equivalent displacement of the fracture ends is obtained through the calibrated force displacement parameters of the external fixator. S6. Based on the force on the fracture ends and the equivalent displacement of the fracture ends, obtain the equivalent stiffness parameters of the fracture ends. S7. Based on the equivalent stiffness parameters of the fracture ends, determine the patient's healing stage.

9. The method for pinning external fixation based on biomechanical inversion to assess fracture healing according to claim 8, characterized in that, The calibration process for the force displacement parameters of the external fixator includes: S51. The external fixation device is installed on the artificial synthetic bone of the tibia simulating a transverse fracture, and springs with different stiffnesses are filled at the fracture ends of the artificial synthetic bone of the tibia to simulate the stiffness growth process of the healing tissue at the fracture ends. S52. Based on the stiffness growth process of the fracture healing tissue, the total force on the external fixation device and the displacement of the fracture ends at each stiffness stage are obtained. S53. Based on the total force on the external fixation device during each stiffness period and the displacement of the fracture ends, the force-displacement parameters of the external fixator are obtained using formula (1). K u = F 模拟 / △u (1) In the formula, K u Here are the force-displacement parameters of the external fixator, where Δu is the displacement of the fracture ends at various stiffness periods of the healing tissue, and F is the force-displacement parameter. 模拟 This represents the total force on the external fixation device for each stiffness period.

10. The method for pinning external fixation based on biomechanical inversion to assess fracture healing according to claim 8, characterized in that, In step S6, the equivalent stiffness parameters of the fracture ends are obtained based on the forces acting on the fracture ends and the equivalent displacements of the fracture ends, including: K f = F 断 / u = ( F 总 –F 架 ) / ( F 架 / K u ) (2) In the formula, K f F is the equivalent stiffness parameter of the fracture ends. 断 Let F be the force on the fracture ends, u be the equivalent displacement of the fracture ends, and F be the force on the fracture ends. 总 F represents the total force on the fractured limb of the patient. 架 K represents the total force on the external fixation device for threading the needle. u These are the force-displacement parameters of the external fixed frame.

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