A local pressure monitoring system and method based on double helix sensing suture

Abstract

The application relates to the technical field of local pressure monitoring, and provides a local pressure monitoring system based on double-helix sensing suture, which comprises the following modules: a suture base material optimization module, which selects polycaprolactone (PCL) fiber as the suture base material; a double-helix sensing array module, which adopts PEDOT:PSS solution to treat the suture base material to obtain functionalized conductive silk threads, weaves the functionalized conductive silk threads into a double-bolt-structure cross-weaving array, and simultaneously protects the double-bolt-structure cross-weaving array through medical silica gel packaging; a wireless energy supply and transmission module, which integrates a suture inductor coil on a degradable Mg-Zn alloy interface screw, combines an LC resonant circuit formed by the suture inductor coil and the degradable Mg-Zn alloy interface screw, realizes wireless energy supply of the double-helix sensing array module and data communication function of the double-helix sensing array module with external equipment, and realizes real-time monitoring of stress of different parts of a graft. The application solves the problem that local stress of a graft cannot be monitored in situ in a joint cavity after joint graft reconstruction, and solves the problem of poor graft-bone integration caused by local stress concentration.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of local pressure monitoring, and in particular to a local pressure monitoring system and method based on a double helix sensing suture. BACKGROUND

[0002] In the clinical field of orthopedics, the postoperative healing effect of intra-articular implants (taking anterior cruciate ligament reconstruction as an example) is closely related to the precise regulation of the biomechanical microenvironment. A large number of experimental studies have clearly confirmed that moderate mechanical stimulation can guide the ordered arrangement of collagen fibers according to the stress direction, providing a structural basis for the integration of the implant and the bone tissue, thereby accelerating the healing process; but this process has strict requirements for the "degree" of mechanical stimulation - the stress safety window is extremely narrow, and once the patient performs excessive load exercise beyond the tolerance range during the rehabilitation period, not only can it directly cause the secondary rupture of the implant, but also can cause poor integration due to the stress imbalance at the implant and bone interface, ultimately leading to implant loosening and surgical failure.

[0003] However, the current clinical rehabilitation training methods and equipment (including traditional manual therapy, elastic band training, isokinetic muscle strength instrument assisted training, etc.) all have a key technical shortcoming: they cannot achieve in-situ stress monitoring of intra-articular implants. The specific performance is as follows: during the treatment process, medical personnel mainly rely on clinical experience and hand feeling to control the force, which is highly subjective and lacks precision; and the monitoring indicators of existing rehabilitation equipment are limited to surface parameters such as joint movement angle and externally applied load, which have significant deviations from the real stress borne by the implant, and these parameters cannot be used as a basis for precise regulation. More importantly, key parameters such as stress peak (the maximum value of a single stress), loading rate (the speed of stress change), and fatigue accumulation (the superposition of damage caused by long-term repeated stress) are crucial for evaluating the safety of the implant, but there is a lack of real-time collection and feedback mechanism. This "blind" training directly leads to a significant reduction in rehabilitation effectiveness, making it difficult to ensure the healing quality of the implant and bone tissue, and the incidence of postoperative complications such as implant loosening and re-rupture is high.

[0004] Therefore, how to break through the technical bottleneck and achieve dynamic monitoring of the stress intensity of intra-articular implants in-situ has become a core problem for realizing controllable mechanical stimulation and promoting the scientific development of rehabilitation training.

[0005] The existing technologies and products for implant stress monitoring have exposed many defects in actual application, as follows:

[0006] A: Spatial resolution is missing (unable to locate local stress): The monitoring range of the currently published research papers and commercial products can only cover the whole ligament, and the output is the total strain value of the whole ligament, which cannot distinguish the stress difference of different parts of the graft. For example, it is difficult to accurately detect the stress change of the graft at the femoral stop point (the end point of the graft connected with the femur) and the tibial stop point (the end point of the graft connected with the tibia), which makes it difficult for the clinic to lock the specific position of stress concentration and cannot provide accurate basis for targeted intervention.

[0007] B: Insufficient biocompatibility (long-term implant failure): In existing animal experiments and clinical trials, there is a common problem of short-term failure of sensors - within 3 months after surgery, about 50% of the sensors will lose monitoring function. In-depth analysis of the reasons, mainly from two aspects: one is that the titanium coil used as a foreign body implanted in the body can easily cause rejection reaction, and the high local metal ion concentration can cause cytotoxicity, damaging the integration environment of the graft and the bone tissue; two is that the packaging material of the sensor (such as silicone) will swell in the body fluid environment, causing the structure stability of the coil to decrease, directly causing the sensitivity and accuracy of signal transmission to decrease significantly.

[0008] C: Poor mechanical adaptability (interference with graft healing): The anterior cruciate ligament is a key load-bearing structure for joint activity, and its graft needs to be adapted to the movement characteristics of the joint, such as flexion, rotation, etc., and has certain stretchability and elasticity. However, in the currently reported monitoring technology and products, the suture used is mostly rigid material that cannot be stretched, which is contrary to the mechanical deformation requirements of the graft during joint activity. This mismatch in mechanical properties can increase the stress burden on the graft and interfere with the normal healing process, ultimately leading to poor integration of the graft and the bone tissue.

[0009] D: Dynamic monitoring blind area (no real-time warning): The existing technology has obvious limitations in signal analysis, and most of them need to rely on large external equipment for manual operation, and through complex program analysis of frequency shift signals, it is impossible to achieve real-time stress warning during surgery or in the patient's daily movement state. The lack of small, convenient real-time signal analysis modules or devices makes it difficult for medical staff to obtain dangerous signals in time, and it is difficult to avoid graft damage caused by instantaneous overload or cumulative damage. SUMMARY

[0010] In view of the above problems, the purpose of the present application is to provide a local pressure monitoring system and method based on double helix sensing suture, aiming to solve the problem that the local stress of the joint implant (such as the anterior cruciate ligament) cannot be monitored in situ after reconstruction, and the poor graft-bone integration caused by local stress concentration, and to provide a wireless double helix sensing suture system that can realize: full-length axial / circumferential double-dimensional pressure distribution monitoring (resolution ≤2mm) of the graft; wireless and passive design (in vivo working period ≥180 days); and surgical suture integrated implant (reducing additional trauma), in order to better monitor the stress conditions of different parts of the graft, guide rehabilitation training and monitor the graft-bone integration.

[0011] The above application purpose of the present application is realized by the following technical scheme:

[0012] A local pressure monitoring system based on double helix sensing suture, comprising:

[0013] A suture base material optimization module selects polycaprolactone (PCL) fiber as the suture base material, which is used to provide a basic carrier for the local pressure detection system of the entire orthopedic joint implant;

[0014] A double helix sensing array module adopts PEDOT:PSS solution to process the suture base material to obtain functional conductive silk threads, and weaves the functional conductive silk threads into a cross-weaving array with a double bolt structure, and then encapsulates and protects the cross-weaving array after weaving by using medical silica gel;

[0015] A wireless power supply and transmission module is used to integrate a suture inductance coil on a degradable Mg-Zn alloy interface screw, and through the LC resonance circuit formed by the combination of the suture inductance coil and the Mg-Zn alloy interface screw, the wireless power supply of the double helix sensing array module and the data communication function with external equipment are realized;

[0016] A handheld decoding monitoring module is used to communicate with the wireless power supply and transmission module, receive and analyze stress signals, and realize real-time monitoring of the stress of different parts of the orthopedic joint implant.

[0017] Further, in the double helix sensing array module, PEDOT:PSS solution is used to process the suture base material to obtain functional conductive silk threads, specifically:

[0018] The suture base material of polycaprolactone PCL fiber is immersed in a PEDOT:PSS solution containing an additive dimethyl sulfoxide DMSO, after ultrasonic vibration treatment, the infiltration effect of the solution on the surface of the suture base material is enhanced, which promotes the uniform attachment of PEDOT:PSS on the surface of the polycaprolactone PCL fiber, and then solidification is carried out under preset temperature conditions, and the process is repeated several times, so that a conductive layer is formed on the surface of the suture base material, and the functionalized conductive silk line of PEDOT:PSS is obtained, which provides a basis for subsequent stress signal transmission.

[0019] Further, in the double helix sensing array module, the functionalized conductive silk line after processing is woven into a cross-weaving array in a double bolt structure, specifically:

[0020] The functionalized conductive silk line after processing is woven at a preset cross angle to form the cross-weaving array of the double bolt structure. The cross-weaving array will naturally divide the surface of the implant into micro-grid areas of fixed size, and each micro-grid area constitutes a pressure-sensitive unit. Through the cross-distribution of the functionalized conductive silk line, the stress of different micro-grid areas can be independently sensed.

[0021] Further, in the double helix sensing array module, the cross-weaving array after processing is packaged and protected by medical silicone, specifically:

[0022] After weaving, the cross-weaving array is pre-stretched, and then Ecoflex 00-30 medical silicone is coated to package the PEDOT:PSS on the cross-weaving array, so as to fix the morphology of the double helix structure and ensure the stability of the grid pressure-sensitive unit. At the same time, the PEDOT:PSS conductive layer is protected from wear and swelling, and its conductivity and stress sensing accuracy are maintained.

[0023] Further, in the wireless energy supply and transmission module, the suture inductance coil is integrated on the degradable Mg-Zn alloy interface screw. The LC resonance circuit formed by the suture inductance coil and the Mg-Zn alloy interface screw realizes the wireless energy supply of the double helix sensing array module and the data communication function with external equipment, specifically:

[0024] The degradable Mg-Zn alloy interface screw forms the LC resonant circuit with the integrated suture inductive coil while fixing the graft, provides wireless energy supply for the double helix sensing array module, wirelessly transmits the stress signals collected by the double helix sensing array module to the handheld radio frequency reading instrument outside, and the Mg-Zn alloy interface screw can be naturally degraded to avoid secondary surgery.

[0025] Further, in the handheld decoding monitoring module, the wireless energy supply and transmission module is in communication connection, receives and analyzes the stress signals, and realizes real-time monitoring of the stress of different parts of the graft, specifically:

[0026] The handheld decoding monitoring module includes a handheld radio frequency reading instrument equipped with a Bluetooth transmission system and a data decoding monitoring system to realize real-time monitoring and collection of the stress of different parts of the graft;

[0027] The handheld radio frequency reading instrument is used to directly collect the signals generated by the cross-woven array transmitted by the wireless energy supply and transmission module, without relying on complex programs and instruments, and the collected signals are transmitted to the data decoding monitoring system through the Bluetooth transmission system. The data decoding monitoring system analyzes the signals, thereby conveniently realizing real-time monitoring of the stress of different parts of the graft in different motion states, and feeding back the monitoring results to the user or medical professionals in real time.

[0028] Further, it also includes a deployment and signal interpretation module for deploying the cross-woven array and interpreting the signals read by the handheld decoding monitoring module, specifically:

[0029] During deployment, the cross-woven array and the graft are inserted into the pre-set loading tunnel of the graft together, and after the anchor is fixed, the zero-point pressure under different angles is calibrated;

[0030] During signal interpretation, the radio frequency reading instrument and the data decoding monitoring system monitor the stress on the graft of the postoperative patient, and when any one pressure-sensitive unit continuously detects pressure greater than a preset value, the data decoding and monitoring system triggers an audible and visual alarm.

[0031] A double helix sensing suture-based local pressure monitoring method using the double helix sensing suture-based local pressure monitoring system as described above, comprising:

[0032] S1: Construct a suture base material optimization module, select polylactide PCL fiber as the suture base material, and the suture base material provides a basic carrier for the entire orthopedic intra-articular graft local pressure detection system;

[0033] S2: Constructing a double helix sensing array module, using PEDOT:PSS solution to process the suture substrate to obtain a functional conductive silk thread, and using the processed functional conductive silk thread to weave into a cross-weaving array with a double bolt structure, and then encapsulating and protecting the cross-weaving array after weaving is completed by using medical silica gel;

[0034] S3: Constructing a wireless power supply and transmission module, integrating a suture inductor coil on a degradable Mg-Zn alloy interface screw, and forming an LC resonance circuit through the suture inductor coil and the Mg-Zn alloy interface screw, so as to realize the functions of wireless power supply and data communication with external devices for the double helix sensing array module;

[0035] S4: Constructing a handheld decoding monitoring module, which is in communication connection with the wireless power supply and transmission module, and is used for receiving and analyzing stress signals to realize real-time monitoring of stress at different positions of an orthopedic intra-articular implant.

[0036] A computer device includes a memory and one or more processors, the memory has computer code stored therein, and the computer code is executed by the one or more processors to cause the one or more processors to perform the method as described above.

[0037] A computer readable storage medium stores computer code, and when the computer code is executed, the method as described above is performed.

[0038] Compared with the prior art, the present application has at least one of the following beneficial effects:

[0039] (1) High spatial resolution and accurate stress monitoring around the intra-articular implant: The monitoring of stress at different positions of the intra-articular implant is realized through the capacitance value offset caused by the change of the helical pitch caused by the change of pressure, and the stress monitoring accuracy can reach ±0.5N, and the spatial resolution accuracy is controlled within ±1mm. Compared with traditional manual training, the stress concentration position of the patient's implant can be monitored through the present application, so that more scientific and accurate rehabilitation training is provided for the patient, and the implant-bone integration and joint function recovery are promoted.

[0040] (2) Wireless power supply and communication: The degradable Mg-Zn alloy interface screw can fix the implant, and the LC resonance circuit formed by the inductor coil integrated in the degradable Mg-Zn alloy anchor screw realizes wireless power supply and communication.

[0041] (3) Longer service time and fatigue life: The in-vivo working cycle of the Mg-Zn alloy interface is ≥180 days, and the suture can realize a cycle service life of >300,000 times, realizing the full-cycle monitoring of the implant (such as the anterior cruciate ligament).

[0042] (4) In vitro rapid decoding and monitoring: through the development of a handheld radio frequency reading instrument, the signal generated by the sensing suture can be further decoded without complex programs and instruments, realizing the rapid decoding and monitoring of the stress distribution of different parts of the anterior cruciate ligament graft under different motion states. It can provide further guidance for patient rehabilitation training. BRIEF DESCRIPTION OF DRAWINGS

[0043] Figure 1 It is the overall structure diagram of the local pressure monitoring system based on the double helix sensing suture of the application;

[0044] Figure 2 It is the working schematic diagram of the local pressure monitoring system based on the double helix sensing suture of the application;

[0045] Figure 3 It is the overall flow chart of the local pressure monitoring method based on the double helix sensing suture of the application. DETAILED DESCRIPTION

[0046] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0047] Those skilled in the art can understand that, unless specifically stated, the singular forms "a", "an" and "said" used herein also include the plural forms. It should be further understood that the phrase "comprising" used in the specification of the present application means that the features, integers, steps, operations, elements and / or components exist, but does not exclude the existence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof.

[0048] First embodiment

[0049] As shown in Figure 1 and 2 , the present embodiment provides a local pressure monitoring system based on double helix sensing suture, which comprises:

[0050] The suture base material optimization module selects polycaprolactone PCL fiber as the suture base material, which is used to provide a basic carrier for the local pressure detection system of the entire orthopedic intra-articular graft.

[0051] In this embodiment, the substrate is first optimized: polycaprolactone PCL fiber can achieve better biocompatibility and mechanical strength adaptation. PCL is an FDA-approved biodegradable biomaterial with excellent biocompatibility, as well as good mechanical strength, which can withstand the huge pressure between the graft and the bone.

[0052] The selection of polycaprolactone (PCL) fiber as the suture substrate is based on its double advantages in biocompatibility and mechanical properties. As an FDA-approved biodegradable biomaterial, PCL fiber can be well compatible with human tissues, reducing the risk of rejection and cytotoxicity after implantation, providing biological safety guarantee for the long-term stable work of the system in vivo. At the same time, its good mechanical strength can effectively withstand the huge pressure generated between the graft and the bone during joint movement, adapt to the stress requirements of the anterior cruciate ligament graft, and avoid affecting the normal healing of the graft or causing interference with the monitoring function of the system due to insufficient substrate strength. This substrate selection not only provides a stable physical carrier for the entire local pressure detection system, but also lays a foundation for the reliability of the system through the characteristics of the material itself in terms of biocompatibility and mechanical adaptation.

[0053] The double helix sensing array module uses PEDOT:PSS solution to treat the suture substrate to obtain functional conductive silk threads, and uses the treated functional conductive silk threads to weave into a cross-weaving array with a double bolt structure, and then encapsulates and protects the treated cross-weaving array with medical silicone after weaving is completed.

[0054] In this embodiment, the double helix sensing array module includes the following technical processes:

[0055] (1) The suture substrate is treated with PEDOT:PSS solution to obtain functional conductive silk threads, specifically:

[0056] The suture substrate of polycaprolactone PCL fiber is immersed in a PEDOT:PSS solution containing an additive dimethyl sulfoxide (DMSO), and after ultrasonic vibration treatment, the infiltration effect of the solution on the surface of the suture substrate is enhanced to promote the uniform adhesion of PEDOT:PSS on the surface of the polycaprolactone PCL fiber. Then, solidification is carried out under a predetermined temperature condition, and this process is repeated several times to form a conductive layer on the surface of the suture substrate, obtaining the functional conductive silk threads of PEDOT:PSS, which provides a basis for subsequent stress signal conduction.

[0057] The process of converting ordinary PCL suture into conductive silk thread by combining chemical and physical treatment. The core logic is to use the conductive properties of PEDOT:PSS (poly(3,4-ethylenedioxythiophene)-poly(styrene sulfonate)) to improve its adhesion effect on the surface of PCL fiber with the assistance of dimethyl sulfoxide (DMSO). Specifically, DMSO as an additive can improve the wettability of PEDOT:PSS solution to PCL substrate, and ultrasonic vibration treatment can further promote the full contact of solution and fiber surface through physical action, ensuring uniform coverage of PEDOT:PSS. The curing step at a preset temperature can stabilize the attached conductive material and form a uniform and reliable conductive layer on the surface of PCL fiber. Through repeated processes, the functional conductive silk thread not only retains the biocompatibility and mechanical properties of PCL substrate, but also has stress signal transmission capability, laying the foundation for subsequent construction of double helix sensing array and precise perception of stress on the graft.

[0058] (2) Use the treated functional conductive silk thread to weave into a cross-weaving array with a double bolt structure, specifically:

[0059] Use several treated functional conductive silk threads to weave at a preset cross angle to form the cross-weaving array with the double bolt structure. The cross-weaving array will naturally divide the graft surface into fixed-size micro-grid areas (such as 5x5mm). Each micro-grid area constitutes a pressure-sensitive unit, and the cross-distribution of the functional conductive silk thread realizes independent sensing of stress in different micro-grid areas. Numerous pressure-sensitive units can ensure that the sensing suture system has higher spatial resolution and more accurate stress collection.

[0060] The embodiment focuses on converting functional conductive wires into a cross-woven array with high-resolution stress sensing capability through a specific weaving method. The core of the design is to utilize the electrical conductivity of the functional conductive wires and the spatial distribution characteristics of the woven structure to achieve fine monitoring of the stress on the surface of the graft. Specifically, the cross-angle preset weaving method is not randomly selected, but is designed to naturally form a small grid area (such as 5x5mm) on the surface of the graft. Each grid area serves as an independent pressure-sensitive unit that can produce a unique electrical signal response to stress changes. Since the contact state of the functional conductive wires at the intersection changes with stress, this structural design allows each unit to independently sense the stress in the area, thereby accurately capturing the stress differences in different parts of the graft (such as the femoral and tibial stop points). The synergistic effect of numerous pressure-sensitive units greatly improves the spatial resolution of the system, avoiding the limitations of traditional techniques that can only obtain the total strain value of the entire ligament, providing a key structural foundation for subsequent accurate analysis of stress concentration sites and guidance for rehabilitation training.

[0061] (3) After the preparation is completed, the cross-woven array is packaged and protected by medical silicone, specifically:

[0062] After weaving is completed, the cross-woven array is pre-stretched, and then Ecoflex 00-30 medical silicone is coated to encapsulate the PEDOT:PSS on the cross-woven array, to fix the morphology of the double helix structure, ensure the stability of the grid pressure-sensitive unit, and protect the PEDOT:PSS conductive layer from wear and swelling, maintaining its electrical conductivity and stress sensing accuracy.

[0063] The embodiment details the specific method of packaging and protecting the cross-woven array, with the core purpose being to ensure the stability and performance reliability of the sensing structure through a combination of physical processing and material encapsulation. Pre-stretching is performed on the cross-woven array after weaving is completed, which allows the double helix structure to better adapt to the mechanical changes caused by joint activity during subsequent use, reducing structural deformation caused by repeated stretching and laying the foundation for the stable distribution of the grid pressure-sensitive unit. The choice of Ecoflex 00-30 medical silicone for coating and encapsulation takes advantage of its good biocompatibility, avoiding irritation to the body's tissues, and forms a protective layer that effectively isolates the external environment from the PEDOT:PSS conductive layer - preventing wear of the conductive layer due to friction during joint activity, while blocking the swelling problem caused by body fluid erosion, thereby maintaining the stability of the electrical conductivity and the accuracy of the stress sensing, ensuring the long-term effective working state of the entire sensing system in the body.

[0064] The wireless power supply and transmission module is used for integrating a suture inductance coil on a degradable Mg-Zn alloy interface screw, and an LC resonance circuit formed by the suture inductance coil and the Mg-Zn alloy interface screw realizes wireless power supply of the double helix sensing array module and data communication function with external equipment.

[0065] In the embodiment, the wireless power supply and transmission module specifically is:

[0066] The degradable Mg-Zn alloy interface screw provides wireless energy supply for the double helix sensing array module while fixing the implant by the LC resonance circuit formed by the suture inductance coil integrated thereon, and wirelessly transmits the stress signals collected by the double helix sensing array module to a handheld radio frequency reading instrument, and the Mg-Zn alloy interface screw can be naturally degraded to avoid secondary surgery.

[0067] The embodiment focuses on the design of the wireless power supply and transmission module, and the core is to realize functional integration and wireless operation by combining the degradable Mg-Zn alloy interface screw and the suture inductance coil. The Mg-Zn alloy interface screw itself bears the clinical function of fixing the implant, and after the suture inductance coil is integrated thereon, the LC resonance circuit formed by the two becomes a key functional carrier: on the one hand, the circuit can receive external energy and convert it into the required power of the system to provide wireless power supply for the double helix sensing array module, which gets rid of the restriction of wired power supply on joint movement; on the other hand, it can wirelessly transmit the stress signals collected by the sensing array to the handheld radio frequency reading instrument to realize contactless data transmission. At the same time, the degradable property of the Mg-Zn alloy ensures that the screw is naturally degraded after completing the fixing and power supply communication mission, avoiding the disadvantages of traditional non-degradable screws that need secondary surgery for removal, which not only simplifies the treatment process, but also reduces the trauma and risk of patients, so that the whole system meets the clinical needs while having safety and convenience.

[0068] The handheld decoding monitoring module is used for being in communication connection with the wireless power supply and transmission module, receiving and analyzing the stress signals, and realizing real-time monitoring of stress of different parts of the orthopedic intra-articular implant.

[0069] In the embodiment, the handheld decoding monitoring module specifically is:

[0070] The handheld decoding monitoring module includes a handheld radio frequency reading instrument equipped with a Bluetooth transmission system and a data decoding monitoring system to realize real-time monitoring and collection of stress of different parts of the implant.

[0071] The handheld radio frequency reading instrument is used for directly collecting the signal generated by the cross-woven array transmitted by the wireless power supply and transmission module, without relying on complex programs and instruments, and the collected signal is transmitted to the data decoding monitoring system through the Bluetooth transmission system, and the signal is analyzed by the data decoding monitoring system, so that real-time monitoring of stress of different parts of the implant in different motion states is conveniently realized, and the monitoring result is fed back to the user or medical professional in real time.

[0072] The embodiment focuses on the design and function implementation of the handheld decoding monitoring module, aiming to convert the stress information captured by the in-vivo sensing array into monitoring data that can be directly used for clinical guidance through a convenient and efficient signal receiving and analyzing mechanism. The handheld radio frequency reading instrument as a front-end acquisition device is free from the dependence on complex programs and auxiliary instruments, and can directly receive the signal transmitted by the wireless power supply and transmission module. Its portability makes it suitable for various scenes such as intraoperative and patient daily motion. The integration of the Bluetooth transmission system realizes wireless transmission of the signal, and the collected original signal is quickly sent to the data decoding monitoring system. The data decoding monitoring system as a core analysis unit can accurately present the stress distribution of each part of the implant in different motion states after processing the signal, and feed back to the user or medical professional in real time, providing immediate basis for adjusting the rehabilitation training plan, effectively solving the problem of dynamic monitoring blind area in traditional technology, and improving the timeliness and practicality of monitoring.

[0073] The embodiment also includes a deployment and signal interpretation module for deploying the cross-woven array and interpreting the signal read by the handheld decoding monitoring module, specifically:

[0074] During deployment, the cross-woven array and the implant are inserted into the pre-set loading tunnel of the implant together, and after the anchor is fixed, the zero-point pressure under different angles is calibrated. During signal interpretation, the radio frequency reading instrument and the data decoding monitoring system monitor the stress on the postoperative patient implant. When any one pressure sensitive unit continuously detects pressure greater than a preset value, the data decoding and monitoring system triggers an audible and visual alarm.

[0075] Second embodiment

[0076] As shown in Figure 3 The embodiment provides a double-helix sensing suture-based local pressure monitoring method executed by a double-helix sensing suture-based local pressure monitoring system as in the first embodiment, comprising:

[0077] S1: Construct a suture base material optimization module, select polycaprolactone PCL fiber as the suture base material, and the suture base material provides a basic carrier for the entire orthopedic intra-articular implant local pressure detection system;

[0078] S2: Construct a double-helix sensing array module. Use PEDOT:PSS solution to treat the suture substrate to obtain functionalized conductive threads. Use the treated functionalized conductive threads to weave a double-bolt structure cross-braided array. After weaving, encapsulate and protect the treated cross-braided array with medical silicone.

[0079] S3: Construct a wireless power supply and transmission module, integrate the suture inductor coil onto the biodegradable Mg-Zn alloy interface screw, and realize the wireless power supply and data communication functions of the double helix sensor array module with external devices through the LC resonant circuit formed by the combination of the suture inductor coil and the Mg-Zn alloy interface screw.

[0080] S4: Construct a handheld decoding and monitoring module, which is connected to the wireless power supply and transmission module to receive and analyze stress signals, thereby enabling real-time monitoring of stress at different locations of orthopedic intra-articular grafts.

[0081] Third Embodiment

[0082] This embodiment provides a specific implementation method, and the specific process is as follows:

[0083] (1) Implant preparation process:

[0084] (11) Functionalization of sutures:

[0085] Polycaprolactone (PCL) sutures with a diameter of 0.5 mm were selected and immersed in a PEDOT:PSS solution (solid content 1.8 wt%) containing 5% dimethyl sulfoxide (DMSO). The solution was then subjected to ultrasonic vibration at 300 W for 30 minutes to enhance the wettability of the PCL fiber surface through ultrasonic cavitation, promoting uniform adhesion of PEDOT:PSS. Subsequently, the solution was cured in an 80℃ forced-air oven for 60 minutes. This process of dipping-ultrasonication-curing was repeated four times to ultimately form a conductive layer with a sheet resistance ≤10 Ω / cm, ensuring the stability of stress signal transmission.

[0086] (12) Double helix array weaving:

[0087] Four functionalized conductive sutures were used to form a double helix structure at a 75° cross angle using precision weaving equipment. This angle design naturally divides the graft surface into a 5×5mm grid area, balancing spatial resolution and structural stability. After weaving, a 5% pre-tension stress was applied to the entire array (lasting 10 minutes) to simulate the in vivo mechanical environment. Subsequently, a 0.1mm thick layer of Ecoflex 00-30 medical-grade silicone was uniformly coated and cured at room temperature for 24 hours to achieve a sealing protection for the conductive layer, preventing swelling or wear caused by bodily fluid erosion.

[0088] (13) Wireless module integration:

[0089] Degradable magnesium alloy wires with a purity of 99.9% were selected to wind inductance coils with a diameter of 2 mm and 12 turns, with a coil spacing of 0.1 mm to optimize the resonance efficiency. The coils were fixed on the surface groove of the Mg-Zn alloy interface screw (diameter 4 mm, length 15 mm) by 1064 nm wavelength laser welding (power 5 W, welding time 20 ms). The coil leads were connected to the pressure-sensitive unit of the double helix array through PEDOT:PSS conductive wires with a diameter of 0.1 mm. Biocompatible insulating glue was used to seal the connection to prevent signal interference.

[0090] (2) Intraoperative deployment specification:

[0091] According to the size of the patient's anterior cruciate ligament, a femoral / tibial tunnel with a diameter of 4.5 mm was prepared, and the sensing suture was inserted into the tunnel together with the graft (such as the hamstring tendon) to ensure that the double helix array completely adhered to the surface of the graft.

[0092] Biodegradable screws (diameter 4.5 mm) were used to fix the two ends of the graft, and the tightening torque was controlled at 3.5 N・m to avoid excessive compression. After fixation, a handheld radio frequency reading instrument was used to calibrate the zero pressure at 0°, 30°, 60°, and 90° joint angles to eliminate mechanical errors.

[0093] (3) Signal interpretation and early warning mechanism:

[0094] Real-time monitoring: The handheld radio frequency reading instrument (working frequency 13.56 MHz) receives the stress signals transmitted by the LC resonance circuit, and sends them to the data decoding system through the Bluetooth module (transmission rate 2 Mbps). The system's built-in algorithm can analyze the stress values of each 5×5mm grid unit within 100ms, with a spatial resolution of ±1mm and a stress detection accuracy of ±0.5N.

[0095] Early warning threshold: When any grid unit detects a pressure >18MPa (based on the yield limit of the ligament 16.3MPa, with a 10% increase) for 3 seconds, the system automatically triggers an 85dB audible and visual alarm, prompting the patient to terminate the current action.

[0096] Clinical data example: The gait cycle monitoring of 10 patients 8 weeks after surgery showed that the peak pressure at the femoral insertion point was 19.3±2.1MPa (mean±standard deviation), and the peak pressure at the tibial insertion point was 14.7±1.8MPa, with a significant difference (P<0.05), which accurately reflected the difference in stress distribution of the graft.

[0097] A computer readable storage medium stores computer code which, when executed, performs the method described above. It is understood by those skilled in the art that all or part of the steps in the above-described embodiments of the various methods can be instructed by a program to relevant hardware, and the program can be stored in a computer readable storage medium, which can include a read-only memory (ROM), a random access memory (RAM), a magnetic disk or an optical disk, etc.

[0098] The above description is only preferred embodiments of the present application, and the protection scope of the present application is not limited to the above-described embodiments. Any technical solution falling within the concept of the present application shall fall within the protection scope of the present application. It should be noted that, for ordinary skilled in the art, some improvements and refinements can be made without departing from the principles of the present application, and these improvements and refinements shall be considered as falling within the protection scope of the present application.

[0099] The technical features of the above-described embodiments can be combined arbitrarily. In order to make the description concise, all possible combinations of the technical features in the above-described embodiments are not described, however, as long as the combinations of the technical features do not contradict each other, they shall be considered as falling within the scope of the present application.

[0100] It should be noted that the above-described embodiments can be freely combined as needed. The above description is only preferred embodiments of the present application, and it should be noted that, for ordinary skilled in the art, some improvements and refinements can be made without departing from the principles of the present application, and these improvements and refinements shall be considered as falling within the protection scope of the present application.

Claims

1. A local pressure monitoring system based on a double-helix sensing suture, characterized in that, include: The suture substrate optimization module selects polycaprolactone (PCL) fiber as the suture substrate to provide a basic carrier for the local pressure detection system of the entire orthopedic intra-articular graft. The double-helix sensing array module uses PEDOT:PSS solution to treat the suture substrate to obtain functionalized conductive threads, and then uses the treated functionalized conductive threads to weave a double-helix cross-braided array. After the weaving is completed, the cross-braided array is encapsulated and protected with medical silicone. A wireless power supply and transmission module is used to integrate a suture inductor coil onto a biodegradable Mg-Zn alloy interface screw. Through the LC resonant circuit formed by the combination of the suture inductor coil and the Mg-Zn alloy interface screw, the wireless power supply and data communication functions of the double helix sensor array module with external devices are realized. The handheld decoding and monitoring module is used to communicate with the wireless power supply and transmission module, receive and analyze stress signals, and realize real-time monitoring of stress at different parts of orthopedic intra-articular grafts.

2. The local pressure monitoring system based on double-helix sensing sutures according to claim 1, characterized in that, In the double-helix sensor array module, the suture substrate is treated with a PEDOT:PSS solution to obtain functionalized conductive filaments, specifically as follows: The suture substrate made of polycaprolactone (PCL) fiber is immersed in a PEDOT:PSS solution containing dimethyl sulfoxide (DMSO) as an additive. After ultrasonic vibration treatment, the wetting effect of the solution on the surface of the suture substrate is enhanced, which promotes the uniform adhesion of PEDOT:PSS to the surface of the PCL fiber. Then, it is cured under a preset temperature condition. This process is repeated several times to form a conductive layer on the surface of the suture substrate, thereby obtaining the functionalized conductive filament of PEDOT:PSS, which provides a basis for subsequent stress signal transmission.

3. The local pressure monitoring system based on double-helix sensing sutures according to claim 1, characterized in that, In the double-helix sensor array module, the processed functionalized conductive wires are braided into a cross-braided array with a double-bolt structure, specifically: Using several of the processed functional conductive wires, the cross-braided array of the double-bolt structure is woven at a preset cross angle. The cross-braided array will naturally divide the surface of the graft into micro-grid areas of a fixed size. Each micro-grid area constitutes a pressure-sensitive unit. The stress of different micro-grid areas can be independently sensed through the cross distribution of the functional conductive wires.

4. The local pressure monitoring system based on double-helix sensing sutures according to claim 1, characterized in that, In the aforementioned double-helix sensor array module, the cross-woven array, after being encapsulated and protected with medical-grade silicone after fabrication, specifically comprises: After weaving is completed, the cross-woven array is pre-stretched, and then Ecoflex 00-30 medical silicone is applied to encapsulate PEDOT:PSS on the cross-woven array to fix the shape of the double helix structure, ensure the stability of the gridded pressure-sensitive unit, and protect the PEDOT:PSS conductive layer from wear and swelling, maintaining its conductivity and the accuracy of stress sensing.

5. The local pressure monitoring system based on double-helix sensing sutures according to claim 1, characterized in that, In the wireless power supply and transmission module, a suture inductor coil is integrated onto a biodegradable Mg-Zn alloy interface screw. The LC resonant circuit formed by the suture inductor coil and the Mg-Zn alloy interface screw enables wireless power supply and data communication with external devices for the double-helix sensor array module. Specifically: The biodegradable Mg-Zn alloy interface screw, while fixing the graft, provides wireless power to the double-helix sensor array module through the LC resonant circuit formed by the screw and the integrated suture inductor coil. At the same time, it wirelessly transmits the stress signal collected by the double-helix sensor array module to a handheld radio frequency reader. The Mg-Zn alloy interface screw can degrade naturally to avoid secondary surgery.

6. The local pressure monitoring system based on double-helix sensing sutures according to claim 1, characterized in that, The handheld decoding and monitoring module is communicatively connected to the wireless power supply and transmission module, receiving and parsing stress signals to achieve real-time monitoring of stress at different locations of orthopedic intra-articular grafts. Specifically: The handheld decoding monitoring module includes a handheld radio frequency reader equipped with a Bluetooth transmission system and a data decoding monitoring system to realize real-time monitoring and collection of stress at different parts of the graft; The handheld radio frequency reader is used to directly collect the signals generated by the cross-braided array transmitted by the wireless power supply and transmission module. It does not rely on complicated programs and instruments. The collected signals are transmitted to the data decoding and monitoring system through the Bluetooth transmission system. The data decoding and monitoring system analyzes the signals, thereby conveniently realizing real-time monitoring of stress in different parts of the graft under different motion states, and feeding back the monitoring results to the user or medical professionals in real time.

7. The local pressure monitoring system based on double-helix sensing sutures according to claim 1, characterized in that, It also includes a deployment and signal interpretation module for deploying the cross-braided array and interpreting the signals read by the handheld decoding and monitoring module, specifically: During deployment, the cross-braided array and the graft are inserted together into the graft's pre-loaded tunnel. After the anchor is fixed, the zero-point pressure at different angles is calibrated. During signal interpretation, the stress on the postoperative patient's graft is monitored by an RF reader and a data decoding monitoring system. When any pressure-sensitive unit continuously detects pressure greater than a preset value, the data decoding and monitoring system triggers an audible and visual alarm.

8. A computer device comprising a memory and one or more processors, the memory storing computer code that, when executed by the one or more processors, causes the one or more processors to perform a local pressure monitoring process in the system as described in any one of claims 1-7.

9. A computer-readable storage medium storing computer code that, when executed, executes a local pressure monitoring process in the system as described in any one of claims 1-7.

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