Intelligent orthopedic implant and monitoring system and state judgment method thereof

Abstract

The invention discloses an intelligent orthopedic implant and a monitoring system and a state judgment method thereof. A plurality of flexible sensing devices and a sensing-communication integrated module are integrated in the implant body, and real-time stress monitoring is achieved by means of electric signal changes caused by implant deformation. The implant is provided with a soft coating layer and a bionic rigidity-variable supporting structure, a magnetic induction / thermoelectric self-energized device is arranged in the implant, and energy can be automatically obtained under the action of movement or body temperature of a patient. The monitoring system transmits data to the in-vitro terminal through a wireless unit arranged in the interface sealing cap, the in-vitro terminal carries out fusion analysis on the data through an artificial intelligence algorithm, the stress state and the fixing stability of the implant are accurately judged, and once the abnormal trend such as looseness or overload is detected, early warning prompts are sent to a patient and a doctor in time. According to the invention, the sensitivity, the stability and the intelligent level of implant state monitoring are obviously improved, postoperative rehabilitation management is facilitated, and implant failure is prevented.

Description

Technical Field

[0001] The present invention relates to the technical field of orthopedic implant medical devices, and particularly to an intelligent orthopedic implant, its monitoring system, and a method for judging the state. Background Art

[0002] Orthopedic implants (such as bone screws, bone plates, intramedullary nails, joint prostheses, etc.) play a key role in supporting bone tissue healing and long-term mechanical support. However, problems such as loosening, excessive stress, displacement, and even fracture may occur in the implants after surgery. If not detected and treated in time, serious consequences will result. Currently, conventional postoperative monitoring mainly relies on patients' regular follow-up visits to take medical images such as X-rays / CTs, and doctors judge whether the implants are normal based on experience. This method has obvious deficiencies: it cannot continuously and real-time monitor, can only obtain limited information during the review, there are monitoring blind spots, and early failure signs of the implants may be missed; there is a lack of early warning and intervention, and the current methods are difficult to detect the loosening or fatigue accumulation process in time, and often wait until obvious failure to deal with, missing the best intervention opportunity; the judgment accuracy is limited, relying on indirect inference from images, it is difficult to distinguish early minute deformations, the misjudgment rate is high, and it depends on doctors' subjective experience. In addition, X-ray / CT examinations have radiation risks and are not suitable for frequent use; it is inconvenient for patients to monitor at any time, they need to travel back and forth to the hospital, consuming time and costs, and it is impossible to achieve self-remote monitoring of the implants.

[0003] To overcome the above deficiencies, in recent years, some "intelligent implant" solutions with embedded sensors have emerged. For example, Chinese Patent CN115607250A discloses an intelligent orthopedic implant, its monitoring system, and a method for judging the state. This solution integrates multiple capacitor plates inside the implant body, and uses the change in capacitance between adjacent plates caused by the deformation of the implant to monitor the stress change. The implant is internally provided with a MEMS sensing unit and a communication unit, which can collect each capacitance data in real time and wirelessly send it to an external terminal, realizing real-time judgment and early warning of the implant state. This technology can continuously monitor the stress condition of the implant and improve the use safety. However, there is still room for improvement in the structure and performance of this existing solution:

[0004] 1. Limitations of the capacitor plate sensing structure: The existing design uses rigid capacitor plates fixed to the inner wall of the implant. This structure has limited sensitivity to minute deformations, and the capacitance signal is easily interfered by factors such as changes in the dielectric properties of body fluids, resulting in drift and instability. The fixed rigid electrodes may also loosen or peel off under repeated loads, affecting the measurement accuracy and reliability.

[0005] 2. Stress concentration in the fixed connection structure: The sensing component and the implant body are usually rigidly fixed, lacking mechanical buffering. When the implant bears dynamic loads, stress concentration may occur at the interface of the sensing element, leading to structural fatigue or damage. In addition, the overall stiffness of the implant is quite different from that of bone tissue, which is prone to the "stress shielding" effect and affects bone healing.

[0006] 3. Bottlenecks in energy supply and signal transmission: Implantable sensing systems need to operate stably for a long time, but existing solutions rely on small in-vivo batteries or external power supplies, and endurance and encapsulation are difficult points. Wireless communication has obvious signal attenuation in the closed environment of metal implants, and the stability of data transmission needs to be improved.

[0007] 4. Insufficient intelligence in data analysis: Existing monitoring systems are mainly based on simple threshold judgments, and it is difficult to distinguish complex state characteristics such as normal load and abnormal loosening in a timely and accurate manner. Lack of fusion analysis of multi-source sensing data and support from machine learning models, and the accuracy and effectiveness of early warning are still limited.

[0008] In summary, it is still necessary to improve the structure and technical solutions of existing intelligent orthopedic implants, and develop a next-generation intelligent orthopedic implant and system with higher sensitivity, better biomechanical compatibility, self-powered supply and intelligent analysis capabilities. Summary of the Invention

[0009] Technical objective: Aiming at the problems of insufficient sensitivity and stability of the capacitive implant sensing structure in the prior art, rigid mismatch of implants, limited energy supply and lack of intelligent analysis, the present invention discloses an intelligent orthopedic implant and its monitoring system and state judgment method, realizing high-precision real-time monitoring of the deformation state of the implant, as well as intelligent judgment and early warning of the safety state of the implant, thereby greatly improving the safety and effectiveness of orthopedic implants.

[0010] Technical solution: To achieve the above technical objective, the present invention adopts the following technical solution:

[0011] An intelligent orthopedic implant includes an implant body. The implant body is a modular shell structure, including an outer shell and a detachable interface cap. The outer shell has a threaded surface for bone fixation, and its outer surface is covered with a layer of compliant coating. It has a nested cavity inside, and a sensing module and a processing and communication module are installed in the nested cavity;

[0012] The sensing module includes a MEMS sensing unit and several sensor components, which are used to sense the deformation state of the implant body and output corresponding electrical signals; the processing and communication module includes a microprocessing unit and a wireless communication unit. The microprocessing unit is electrically connected to the MEMS sensing unit to obtain deformation monitoring data, and sends the data to an external terminal through the wireless communication unit;

[0013] The implant body is internally integrated with a bionic variable stiffness structure and an energy self - supply unit. The bionic variable stiffness structure enables the implant body to exhibit different elastic stiffness under different force conditions, and the energy self - supply unit is used to supply power to the processing and communication module through magnetic induction conversion.

[0014] Preferably, the several sensor devices are a flexible capacitive sensor array arranged inside the implant body. The flexible capacitive sensor array is composed of multiple flexible capacitive plates, which are attached to the inner wall of the implant body and arranged at intervals along a specific direction. The capacitance value between adjacent capacitive plates will change with the deformation of the implant body; the MEMS sensing unit is electrically connected to each capacitive plate and is used to measure the capacitance data between adjacent capacitive plates in real time, and the micro - processing unit filters and converts the capacitance data to obtain a digital signal reflecting the strain of the implant body.

[0015] Preferably, the bionic variable stiffness structure includes an elastic support element arranged inside the implant body; one end of the elastic support element is fixedly connected to the implant body, and the other end is connected to the energy self - supply unit. The elastic support element provides flexible support under normal loads and deforms to absorb energy when the load increases to a predetermined threshold, thereby improving the mechanical compatibility and shock resistance of the implant body.

[0016] Preferably, the energy self - supply unit includes a magnetic induction power generation device. The magnetic induction power generation device includes a coil and a permanent magnet. The permanent magnet is suspended and installed in the nested cavity of the implant body through an elastic support element, and the coil is fixed around the permanent magnet; when the implant body is vibrated due to activity, the permanent magnet vibrates relative to the coil to cut the magnetic field lines, inducing a current at both ends of the coil, which is rectified and regulated to supply power to the internal electronic components of the implant body.

[0017] Preferably, the elastic support element is a rotary spring; the energy self - supply unit further includes a thermoelectric conversion device, which uses the temperature difference between the intelligent orthopedic implant and the surrounding tissues to generate electrical energy to assist or replace the vibration power generation method.

[0018] Preferably, the compliant coating layer on the outer surface of the implant body is made of a biocompatible elastic material, and the material is selected from any one of silicone, polyurethane, and PEEK; the flexible coating layer covers the main area where the implant body contacts the bone, and its Shore hardness is in the range of 50A - 80A to provide a transitional hardness between the rigid implant and the flexible bone tissue.

[0019] Preferably, the implant body is a bone fixation screw, which includes a threaded rod and a screw head. The two are hollow and communicate with each other to form the nested cavity structure. A cylindrical through-hole is provided along the axial direction inside the screw rod, and the inner wall of the through-hole is attached with the flexible capacitive sensor array. Each sensing electrode is evenly distributed on the inner wall of the through-hole; an enlarged chamber is formed inside the screw head for accommodating the wide-diameter section of the sensing-energy integration module and the processing and communication module; an interface cap is provided at the top opening of the screw head, and the cap seals the module inside the screw and serves as a wireless signal interface.

[0020] The present invention also provides an intelligent orthopedic implant monitoring system, which includes the intelligent orthopedic implant as described above and an external monitoring terminal wirelessly connected to it. The external monitoring terminal includes a data receiving module, a data processing and status judgment module, and a prompt output module;

[0021] The data receiving module is used to obtain the sensing data from the intelligent orthopedic implant and optionally send energy or instructions to the intelligent orthopedic implant;

[0022] The data processing and status judgment module analyzes the sensing data of the received intelligent orthopedic implant, and uses a pre-trained artificial intelligence model to identify the status information of the intelligent orthopedic implant, including normal force, biomechanical stability, and abnormal states such as loosening or overload;

[0023] The prompt output module generates corresponding prompt signals or alarms according to the status information and displays them through the interface of the external monitoring terminal.

[0024] Preferably, the external monitoring terminal is a portable device or a wearable device, including a receiving coil or antenna attached to the patient's skin surface, which is used to improve the receiving efficiency of the communication signal of the intelligent orthopedic implant and can transmit energy to the intelligent orthopedic implant through electromagnetic induction to maintain its operation;

[0025] The artificial intelligence model adopts a multi-source data fusion algorithm, which combines the sensing data of the intelligent orthopedic implant with the user's activity status data to improve the accuracy of status judgment;

[0026] The prompt output module includes a mobile application programming interface, so that the monitoring results can remind the user in the form of graphics or alarms through the smartphone App, and supports uploading the data to the cloud for viewing.

[0027] The present invention also provides a method for judging the status of an intelligent orthopedic implant, which is applicable to an intelligent orthopedic implant monitoring system as described above, and includes the following steps:

[0028] S1. Under the continuous action of the internal sensor module of the intelligent orthopedic implant, the multi-channel raw data of the force and deformation of the intelligent orthopedic implant is collected, and the data is wirelessly sent to the external monitoring terminal after being processed internally by the intelligent orthopedic implant and preliminarily pre-processed by the communication module;

[0029] S2. The in vitro monitoring terminal receives multi-channel raw data and inputs it into a pre-established intelligent orthopedic implant state evaluation model for real-time analysis. The evaluation model is constructed using a machine learning algorithm and can extract multi-dimensional features from the input data and determine the current mechanical state of the intelligent orthopedic implant.

[0030] S3. If the evaluation model determines that the intelligent orthopedic implant is in normal condition, the current data features are recorded and the model threshold is updated, and the monitoring continues for the next cycle; if an abnormal trend or failure sign is detected, the process proceeds to step S4;

[0031] S4. The in vitro monitoring terminal triggers an early warning prompt, reminding the user to pay attention to the status of the intelligent orthopedic implant through sound and light alarms, SMS notifications or network push notifications.

[0032] Beneficial effects: The intelligent orthopedic implant and its monitoring system and state judgment method provided by the present invention have the following beneficial effects:

[0033] 1. The present invention uses a flexible capacitive sensor array and a bionic variable stiffness structure to enable the implant to capture multi-axis strain signals in real time when it is subjected to slight deformation. The flexible sensor array is evenly arranged along the inner wall of the implant, and can collect strain data in different directions, greatly improving the accuracy and stability of monitoring. At the same time, the bionic variable stiffness structure can automatically adjust its mechanical response under normal load and abnormal stress conditions, ensuring that the sensor data is not easily disturbed by noise and drift in the complex environment of the body, thereby more accurately reflecting the real-time status of the implant, identifying abnormal conditions such as looseness, overload or early fatigue in advance, and helping to reduce the risk of surgical failure due to delayed discovery of problems.

[0034] 2. By integrating energy self-supply technologies such as magnetic induction power generation or thermoelectric conversion, the implant of the present invention can continuously collect vibration or temperature difference energy in the body during the patient's daily activities and convert it into electrical energy to power internal sensing, data processing and wireless communication modules. This self-powered system frees the implant from the limitation of relying on external batteries, enables long-term, continuous monitoring and data collection, reduces the risk of system interruption caused by insufficient power supply, improves the reliability and stability of the overall system, and reduces the risk of secondary surgery for patients due to frequent battery replacement.

[0035] 3. The present invention incorporates a microprocessor and a data memory, and is equipped with a wireless communication unit. It performs real-time fusion analysis on multi-channel data collected by sensors through advanced artificial intelligence algorithms. This system can automatically distinguish normal physiological stress from abnormal deformation patterns. Once it detects loosening, overload, or other abnormal changes in the implant, it will transmit warning information to the external monitoring terminal (such as a smartphone or cloud platform) in a timely manner through wireless communication. This intelligent remote monitoring and warning function not only facilitates doctors to understand the status of the implant in real time and formulate personalized intervention plans, but also significantly reduces the complications and the risk of secondary surgery caused by implant failure, thereby improving the overall safety and rehabilitation effect of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or in the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art.

[0037] Figure 1 Structural schematic diagram of the intelligent orthopedic implant of the present invention;

[0038] Figure 2 Exploded schematic diagram of the intelligent orthopedic implant of the present invention and its internal modules;

[0039] Figure 3 Functional framework schematic diagram of the intelligent orthopedic implant monitoring system of the present invention;

[0040] Figure 4 Flowchart of the method for judging the status of the intelligent orthopedic implant of the present invention.

[0041] In the figure: 1. Outer shell; 2. Capacitor plate; 3. Processing and communication module; 4. Coil; 5. Permanent magnet; 6. Compliant coating layer; 7. Interface cap; 8. Rotary spring. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0042] The following will more clearly and completely illustrate the present invention by way of a preferred embodiment in conjunction with the drawings, but the present invention is not limited to the scope of the described embodiments.

[0043] As Figure 1As shown, the present invention discloses an intelligent orthopedic implant, which includes an implant body. The implant body is a modular shell structure, including an outer shell 1 and a detachable interface cap 7. The outer shell 1 has a threaded surface for bone fixation, and its outer surface is covered with a compliant coating layer 6. The thickness of the compliant coating layer 6 is about 0.5 - 1 mm, and the material can be a biocompatible medical elastomer, such as silicone, polyurethane, PEEK, etc.; the flexible coating layer 6 covers the main area where the implant body contacts the bone, and its Shore hardness is in the range of 50A - 80A. Through this compliant coating layer 6, the micromotion at the interface between the implant body and the bone is buffered, reducing the stress concentration caused by the hard interface, and promoting the ingrowth of bone tissue along the surface of the coating layer to achieve a more firm biological fixation. At the same time, the compliant coating layer 6 can embed antibacterial drug or growth factor microcapsules to endow the implant with additional functions of anti-infection or promoting healing.

[0044] The interior of the outer shell 1 is hollow, forming a nested cavity. The nested cavity includes a thinner lower cavity section and a wider upper cavity section, and both ends form part of the modular shell structure for accommodating an internal sensing module and a processing and communication module;

[0045] The sensing module includes a MEMS sensing unit and several sensor devices for sensing the deformation state of the implant body and outputting corresponding electrical signals; the processing and communication module includes a microprocessing unit and a wireless communication unit. The microprocessing unit is electrically connected to the MEMS sensing unit to obtain deformation monitoring data and sends the data to an external terminal through the wireless communication unit;

[0046] The implant body is internally integrated with a bionic variable stiffness structure and an energy self - supply unit. The bionic variable stiffness structure enables the implant body to exhibit different elastic stiffnesses under different loading conditions, and the energy self - supply unit is used to supply power to the processing and communication module through magnetic induction conversion.

[0047] Among them, the sensing module and the energy self - supply unit constitute a sensing - energy integration module. This module is an overall cylindrical component, including a narrow - diameter section at the lower part and a wide - diameter section at the upper part to match the nested structure of the cavity. The lower part of the sensing - energy integration module mainly accommodates the energy self - supply unit. The energy self - supply unit includes a magnetic induction power generation device, which is composed of a coil 4 fixed on the inner wall of the outer shell 1 and a permanent magnet 5 suspended through the bionic variable stiffness structure. The bionic variable stiffness structure includes an elastic support element arranged inside the implant body; preferably, the elastic support element is a rotary spring 8; one end of the rotary spring 8 is fixedly connected to the implant body, and the other end is connected to the permanent magnet 5. The rotary spring 8 provides flexible support under normal loads and deforms to absorb energy when the load increases to a predetermined threshold, thereby improving the mechanical compatibility and impact resistance of the implant body.

[0048] Figure 1 The orange area represents the toroidal coil 4, which is wound around the outside of the sensing-energy integration module and together with the green permanent magnet 5 forms a magnetic induction power generation device. When the implant body is vibrated by human movement, the permanent magnet 5 oscillates relative to the coil 4 under the action of the rotary spring 8, generating an induced current to achieve self-power supply. The rotary spring 8 itself also acts as a variable stiffness support element, maintaining a certain flexibility under normal loads, giving the implant body a bionic elasticity, and compressing the rotary spring 8 to provide additional support during overload to prevent excessive deformation of the structure. The upper wide-diameter section of the sensing-energy integration module is located inside the nail head, accommodating the MEMS sensing unit and the processing and communication module 3, including high-precision microelectromechanical sensors (such as triaxial accelerometers, thermometers, etc.) and microprocessors, circuit boards, etc.

[0049] Several sensor components of the sensing module are a flexible capacitive sensor array arranged inside the implant body. The flexible capacitive sensor array is composed of multiple flexible capacitive plates 2, attached to the inner wall of the implant body and arranged at intervals along a specific direction. The capacitance value between adjacent capacitive plates 2 will change with the deformation of the implant body; the MEMS sensing unit is electrically connected to each capacitive plate, used to measure the capacitance data between adjacent capacitive plates 2 in real time and the microprocessing unit filters and converts the capacitance data to obtain a digital signal reflecting the strain of the implant body.

[0050] As Figure 1 Shown in red, several flexible capacitive plates 2 are attached to the inner wall of the nested cavity. Adjacent capacitive plates 2 form a capacitance pair. When the outer shell 1 is bent or stretched and deformed, the inner wall spacing or overlapping area changes, causing the capacitance value to change. The processing and communication module 3 collects the values of each capacitive plate 2 in real time and performs preliminary filtering and feature extraction. A wireless communication unit (such as a radio frequency antenna) is also arranged inside the implant, and data communication with an external device is achieved through the interface cap 7 located at the top of the intelligent orthopedic implant. The interface cap 7 is made of a biocompatible material (such as PEEK polymer), wave-transparent and sealed, used to seal the cavity and act as a wireless signal interface. The entire sensing-energy integration module is fixed in the outer shell cavity by sealant or mechanical fasteners, and the upper part is tightly connected to the interface cap 7 to form an independent and sealed electronic compartment. This modular design facilitates manufacturing and assembly, and also allows the sensing unit to be replaced or upgraded when necessary without replacing the entire intelligent orthopedic implant.

[0051] In one embodiment, the energy self-supply unit further includes a thermoelectric conversion device, which uses the temperature difference between the intelligent orthopedic implant and the surrounding tissue to generate electrical energy to assist or replace the vibration power generation method.

[0052] In one embodiment, the bionic variable stiffness structure includes a gradient porous structure, which is disposed at a specific part of the implant body, such that the porosity gradually changes along the thickness direction of this part, achieving a stiffness transition from soft to rigid, simulating the gradient structure of human bone tissue and reducing the stress shielding effect.

[0053] In an embodiment, the implant body can be made into various forms according to needs, such as bone fixation screws, bone plates, intramedullary nails, joint prostheses, etc.

[0054] When the implant body is a bone fixation screw, the bone fixation screw includes a threaded rod and a screw head, and the two are hollow and communicated to form the nested cavity structure. A cylindrical through-hole is provided along the axial direction inside the screw rod, and the inner wall of the through-hole is attached with the flexible capacitive sensor array, and each sensing electrode is equally spaced on the inner wall of the through-hole; an enlarged chamber is formed inside the screw head for accommodating the wide-diameter section of the sensing-energy integration module and the processing and communication module 3; an interface cap 7 is provided at the opening at the top of the screw head, and the interface cap 7 seals the modules inside the screw and serves as a wireless signal interface.

[0055] When the implant body is a bone plate, the bone plate body is in a long strip shape, and a plurality of capacitor plates are buried inside the bone plate on both sides of at least one fixing screw hole. The plurality of capacitor plates are respectively arranged in an array structure along the length direction of the bone plate for sensing the bending deformation of the bone plate during the fracture healing process. A through slot or cavity is provided in the thickness direction of the bone plate to accommodate the sensing module and the processing and communication module 3, and the interface cap 7 is provided at one end or an appropriate position on the surface of the bone plate, allowing wireless data transmission without affecting the installation and mechanical properties of the bone plate. By integrating sensing and electronic modules at key parts of the bone plate, real-time monitoring of the stress of the bone plate and the degree of bone union is achieved.

[0056] When the implant body is an intramedullary nail, the intramedullary nail includes a hollow nail body and an end locking structure. A long cavity is provided along the axial direction inside the nail body, and the sensing-energy integration module is disposed in the cavity. The flexible sensor elements are distributed along the inner wall of the intramedullary nail cavity for detecting the axial compression and bending deformation of the nail body; a detachable interface cap 7 is provided at the proximal end of the nail body, and the processing and communication module 3 is located in the proximal inner cavity of the intramedullary nail, and wireless signals are transmitted out of the body through the interface cap 7. During the bone healing process carried by the intramedullary nail, the internal sensing module continuously monitors the stress state of the nail body, and combines with the structure to provide variable support stiffness and energy supply, thereby improving the intelligent level of intramedullary fixation.

[0057] This embodiment is illustrated by taking a bone fixation screw with threads as an example. Similar functions can be achieved by making corresponding adjustments in other forms. For example, if it is a bone plate, internal cavities and flexible sensors can be provided in specific stress concentration areas of the plate body (such as around the screw holes), and a flexible coating can be covered on the outside; if it is an intramedullary nail, a long cavity can be provided along the axis in the middle of the nail rod and a sensing module can be placed, and a sealing cap can be installed at the nail end as a communication interface. Through the above structural design, the implant of the present invention successfully integrates high-sensitivity multi-point sensors, a robust energy supply and signal transmission path without affecting the original mechanical properties. After the implant is implanted into the patient's bone, it can continuously monitor and record the stress changes received by the implant; when abnormal micro-movement or fixation loosening occurs at the fracture end, the flexible sensing array will capture unusual deformation patterns, and the internal processing unit will send these data out through the interface cap 7.

[0058] Figure 2 is an exploded view of the intelligent orthopedic implant of the present invention and its internal modules. Taking the implant in the form of a bone fixation screw as an example, this figure shows the exploded structure and connection relationship of the main components such as the outer shell 1, the internal integrated module, and the interface cap 7. It can be seen that the implant outer shell 1 is in the shape of a hollow screw, and the internal cavity opens from the top end and is used to accommodate the columnar sensing-energy integration module. A screw head is provided at the tail end of the outer shell 1, and the top opening thereof is encapsulated by the gray interface cap 7. The sensing-energy integration module is marked in orange and is columnar as a whole, and can be inserted into the outer shell cavity from the top of the screw. The upper end of the sensing-energy integration module has a slightly larger diameter and just fits into the internal space of the screw head, and the lower end is thinner and extends into the narrow section of the screw rod cavity. During installation, first align the sensing-energy integration module and slide it into the bottom of the outer shell 1 cavity, and then snap the interface cap 7 onto the opening of the screw head to fix and seal the module in the shell. The black arrow indicates the insertion direction of the sensing-energy integration module and the installation direction of the interface cap 7. Through this modular assembly method, the sensing electronic part and the structural load-bearing part are effectively separated, which is convenient for the separate optimization design and manufacturing of each module. For example, the outer shell 1 can be formed by 3D printing with high-strength metal, having the required shape and porous gradient; while the internal sensing-energy integration module can centrally arrange precision electronic devices, be encapsulated by a special process, and then be integrally embedded in the outer shell. While providing an electromagnetic wave transmission window, the interface cap 7 realizes reliable connection with the outer shell through threads or snaps and ensures the sealing and insulation of the internal cavity. Figure 2 The exploded view clearly shows the corresponding relationship and installation sequence between the components. Through this structure combining the modular shell and the built-in module, the present invention greatly improves the possibility of the integrated function of the implant and the convenience of maintenance.

[0059] The present invention also provides an intelligent orthopedic implant monitoring system, including the intelligent orthopedic implant as described above and an external monitoring terminal wirelessly communicatively connected thereto. The external monitoring terminal includes a data receiving module, a data processing and status judgment module, and a prompt output module;

[0060] The data receiving module is configured to obtain sensing data from the intelligent orthopedic implant and optionally send energy or instructions to the intelligent orthopedic implant;

[0061] The data processing and status judgment module analyzes the received sensing data of the intelligent orthopedic implant and uses a pre-trained artificial intelligence model to identify the status information of the intelligent orthopedic implant, including normal force, biomechanical stability, and abnormal states of loosening or overload;

[0062] The prompt output module generates corresponding prompt signals or alarms according to the status information and displays them through the interface of the external monitoring terminal.

[0063] Preferably, the external monitoring terminal is a portable device or a wearable device, including a receiving coil or antenna attached to the skin surface of the patient, which is used to improve the reception efficiency of the communication signal of the intelligent orthopedic implant and can transmit energy to the intelligent orthopedic implant through electromagnetic induction to maintain its operation;

[0064] The artificial intelligence model adopts a multi-source data fusion algorithm, which combines the sensing data of the intelligent orthopedic implant with the user activity status data to improve the accuracy of status judgment;

[0065] The prompt output module includes a mobile application programming interface, enabling the monitoring results to remind the user in the form of graphics or alarms through a smartphone App and supporting uploading the data to the cloud for viewing.

[0066] Figure 3It is a schematic diagram of the functional framework of the intelligent orthopedic implant monitoring system of the present invention. The light green area on the left represents the internal system of the implant, including parts such as a sensing module, an energy self-supply unit, and a processing and communication unit; the light blue area on the right represents the external monitoring terminal / system, including a data receiving module and an energy supply device, a data processing and status judgment module, and a prompt output module interface, etc. The internal implant continuously collects data such as stress and deformation, and sends it to the external monitoring terminal through wireless data transmission (shown by the black arrow). The external terminal processes and analyzes the received data: First, the data receiving module demodulates the sensing data and supplies the required energy to the implant (auxiliary energy can be provided through inductive coil coupling if necessary); then the built-in data processing and status judgment module performs fusion analysis on the data to judge the current state of the implant, such as normal load-bearing, abnormal loosening, overload risk, etc.; finally, the analysis result is fed back to the user or doctor through the warning prompt interface, such as an alarm popping up on the mobile phone App or a reminder recorded by the hospital monitoring system. The whole system forms a closed-loop working mode: the implant continuously uploads its own state data, and the external system continuously and intelligently evaluates the risks, and immediately issues a warning once an abnormal trend appears. This architecture makes full use of the real-time sensing advantages inside the implant and the computing and display capabilities of the external system, ensuring reliable data transmission and effective interpretation in clinical use. Through software upgrades of the external terminal, the reinforcement learning model can be further optimized or new functions can be added. The monitoring system of the present invention can be implemented by a portable patient terminal (such as a smartphone with a wearable receiving coil) or a hospital centralized monitoring system, with great flexibility and scalability.

[0067] As Figure 4 shown, the present invention also provides a method for judging the state of an intelligent orthopedic implant, which is applicable to an intelligent orthopedic implant monitoring system as described above, and includes the following steps:

[0068] S1. Under the continuous action of the internal sensing module of the intelligent orthopedic implant, multi-channel raw data of the stress and deformation of the intelligent orthopedic implant are collected, and after being preliminarily preprocessed by the internal processing and communication module of the intelligent orthopedic implant, they are wirelessly sent to the external monitoring terminal;

[0069] S2. The external monitoring terminal receives the multi-channel raw data, inputs it into a pre-established intelligent orthopedic implant state evaluation model for real-time analysis. The evaluation model is constructed by machine learning algorithms and can extract multi-dimensional features from the input data and judge the current mechanical state of the intelligent orthopedic implant;

[0070] The evaluation model is a deep learning neural network model that has been trained with a large number of data sets containing samples of normal and abnormal working states of implants, and can identify different patterns such as loose fixation, unhealed fractures, and implant overload. The method can adjust parameters according to the specific implant type and patient condition, such as setting the sensitivity of the alarm threshold or the model update strategy, so as to strike a balance between timely warning and avoiding false alarms. When the doctor intervenes, the model parameters of the monitoring system can be reset or corrected to enter the next stage of the monitoring cycle.

[0071] S3. If the evaluation model determines that the intelligent orthopedic implant is in normal condition, the current data features are recorded and the model threshold is updated, and the monitoring continues for the next cycle; if an abnormal trend or failure sign is detected, the process proceeds to step S4;

[0072] S4. The in vitro monitoring terminal triggers an early warning prompt, reminding the user to pay attention to the status of the intelligent orthopedic implant through sound and light alarms, SMS notifications or network push notifications.

[0073] The state judgment method of the present invention can realize early fault discovery and risk management during the use of orthopedic implants, thereby improving the efficacy and safety of implants.

[0074] In the specific application of the present invention, for example, the intelligent implant screw is used for internal fixation of fractures, and the internal sensor monitoring function is activated immediately after surgery. When the user is discharged from the hospital at home, he can wear a small receiving terminal close to the surgical site to collect data sent by the implant screw. The reinforcement learning model in the terminal has been trained based on a large amount of clinical data, and can identify the stress change pattern of the implant during normal bone healing. Once the model determines that the screw has abnormal signs of loosening during a patient's activity (for example, the sensor data shows a violent fluctuation that does not match the model prediction), the terminal interface will pop up a warning and suggest that the patient seek medical attention for review in time. Doctors can also more intuitively understand the load and stability changes of the implant through the historical data curve uploaded by the terminal, thereby assisting more accurate clinical decision-making. If no abnormal situation occurs, the sensor data of the implant will also be regularly stored in the cloud for reference by doctors during follow-up, and can be further used to improve the reinforcement learning algorithm model. In summary, the specific implementation method provided by the present invention can significantly improve the postoperative monitoring level of orthopedic implants, realize true "real-time perception-intelligent early warning", and escort patients' bone healing.

[0075] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. An intelligent orthopedic implant, characterized in that, Comprising an implant body, the implant body being a modular housing structure, including an outer shell and a detachable interface cap. The outer shell has a threaded surface for bone fixation, and its outer surface is covered with a compliant coating layer. Inside, there is a nested cavity where a sensing module and a processing and communication module are installed; The sensing module includes a MEMS sensing unit and a plurality of sensor devices, which are used to sense the deformation state of the implant body and output corresponding electrical signals. The processing and communication module includes a microprocessing unit and a wireless communication unit. The microprocessing unit is electrically connected to the MEMS sensing unit to obtain deformation monitoring data and sends the data to an external terminal through the wireless communication unit; The implant body is internally integrated with a bionic variable stiffness structure and an energy self - supply unit. Among them, the bionic variable stiffness structure enables the implant body to exhibit different elastic stiffness under different loading conditions, and the energy self - supply unit is used to supply power to the processing and communication module through magnetic induction conversion.

2. An intelligent orthopedic implant according to claim 1, characterized in that, The plurality of sensor devices are a flexible capacitive sensor array arranged inside the implant body. The flexible capacitive sensor array is composed of multiple flexible capacitive plates, attached to the inner wall of the implant body and arranged at intervals along a specific direction. The capacitance value between adjacent capacitive plates will change with the deformation of the implant body. The MEMS sensing unit is electrically connected to each capacitive plate, used to measure the capacitance data between adjacent capacitive plates in real time, and the microprocessing unit filters and converts the capacitance data to obtain a digital signal reflecting the strain of the implant body.

3. An intelligent orthopedic implant according to claim 1, characterized in that, The bionic variable stiffness structure includes an elastic support element arranged inside the implant body. One end of the elastic support element is fixedly connected to the implant body, and the other end is connected to the energy self - supply unit. The elastic support element provides flexible support under normal loads and deforms to absorb energy when the load increases to a predetermined threshold, thereby improving the mechanical compatibility and impact resistance of the implant body.

4. An intelligent orthopedic implant according to claim 1, characterized in that, The energy self - supply unit includes a magnetic induction power generation device. The magnetic induction power generation device includes a coil and a permanent magnet. The permanent magnet is suspended and installed in the nested cavity of the implant body through an elastic support element, and the coil is fixed around the permanent magnet. When the implant body is vibrated due to activity, the permanent magnet vibrates relative to the coil to cut the magnetic field lines, inducing a current at both ends of the coil, which is rectified and regulated to supply power to the internal electronic components of the implant body.

5. An intelligent orthopedic implant according to claim 5, characterized in that, The elastic support element is a rotary spring. The energy self - supply unit further includes a thermoelectric conversion device, which uses the temperature difference between the intelligent orthopedic implant and the surrounding tissue to generate electrical energy to assist or replace the vibration power generation method.

6. An intelligent orthopedic implant according to claim 1, characterized in that, The compliant coating layer on the outer surface of the implant body is made of a biocompatible elastic material, and the material is selected from any one of silicone, polyurethane, and PEEK. The flexible coating layer covers the main area where the implant body contacts the bone, and its Shore hardness is in the range of 50A - 80A to provide a transitional hardness between the rigid implant and the flexible bone tissue.

7. An intelligent orthopedic implant according to any one of claims 1-6, characterized in that, The implant body is a bone fixation screw, which includes a threaded rod and a screw head. The two are hollow and connected to form the nested cavity structure. A cylindrical through-hole is provided along the axial direction inside the screw rod, and the inner wall of the through-hole is attached with the flexible capacitive sensor array. Each sensing electrode is evenly distributed on the inner wall of the through-hole; an enlarged chamber is formed inside the screw head for accommodating the wide-diameter section of the sensing-energy integration module and the processing and communication module; an interface sealing cap is provided at the top opening of the screw head, and the cap seals the module inside the screw and serves as a wireless signal interface.

8. An intelligent orthopedic implant monitoring system, comprising the intelligent orthopedic implant according to any one of claims 1-7 and an in vitro monitoring terminal wirelessly communicatively connected thereto, characterized in that, The external monitoring terminal includes a data receiving module, a data processing and status judgment module, and a prompt output module; The data receiving module is used to obtain the sensing data from the intelligent orthopedic implant, and optionally send energy or instructions to the intelligent orthopedic implant; The data processing and status judgment module analyzes the sensing data of the received intelligent orthopedic implant, and uses a pre-trained artificial intelligence model to identify the status information of the intelligent orthopedic implant, including normal force, biomechanical stability, and abnormal states such as loosening or overload; The prompt output module generates corresponding prompt signals or alarms according to the status information and displays them through the interface of the external monitoring terminal.

9. The intelligent orthopedic implant monitoring system according to claim 8, characterized in that, The external monitoring terminal is a portable device or a wearable device, including a receiving coil or antenna attached to the patient's skin surface, which is used to improve the receiving efficiency of the communication signal of the intelligent orthopedic implant, and can transmit energy to the intelligent orthopedic implant through electromagnetic induction to maintain its operation; The artificial intelligence model adopts a multi-source data fusion algorithm, which combines the sensing data of the intelligent orthopedic implant with the user's activity status data to improve the accuracy of status judgment; The prompt output module includes a mobile application programming interface, enabling the monitoring results to remind the user in the form of graphics or alarms through a smartphone App, and supporting the upload of data to the cloud for viewing.

10. A method for judging the state of an intelligent orthopedic implant, applicable to an intelligent orthopedic implant monitoring system as described in any one of claims 8-9, characterized in that, Including the following steps: S1. Under the continuous action of the internal sensing module of the intelligent orthopedic implant, multi-channel raw data of the force deformation of the intelligent orthopedic implant is collected, and after preliminary preprocessing by the internal processing and communication module of the intelligent orthopedic implant, it is wirelessly sent to the external monitoring terminal; S2. The external monitoring terminal receives the multi-channel raw data, inputs it into a pre-established intelligent orthopedic implant status evaluation model for real-time analysis. The evaluation model is constructed using machine learning algorithms and can extract multi-dimensional features from the input data and judge the current mechanical state of the intelligent orthopedic implant; S3. If the evaluation model determines that the status of the intelligent orthopedic implant is normal, record the current data characteristics and update the model threshold, and continue to monitor the next cycle; if an abnormal trend or failure sign is detected, go to step S4; S4. The external monitoring terminal triggers a warning prompt to remind the user to pay attention to the status of the intelligent orthopedic implant through audible and visual alarms, SMS notifications, or network pushes.

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