Local pressure monitoring system and method based on double-helix sensing suture line

Abstract

The invention relates to the technical field of local pressure monitoring, and provides a local pressure monitoring system based on a double-helix sensing suture line, and the system comprises a suture line base material optimization module which selects a polycaprolactone (PCL) fiber as a suture line base material; the double-helix sensing array module adopts a PEDOT: PSS (poly (3, 4-ethylenedioxythiophene): poly (styrenesulfonate)) solution to process a suture line base material so as to obtain a functionalized conductive silk thread, and the functionalized conductive silk thread is woven into a cross-woven array with a double-bolt structure and is packaged and protected by medical silica gel; according to the wireless energy supply and transmission module, a suture line inductance coil is integrated on a degradable Mg-Zn alloy interface screw, and a formed LC resonance circuit is combined, so that wireless energy supply of the double-helix sensing array module and a data communication function with external equipment are realized; and the handheld decoding monitoring module is used for receiving and analyzing the stress signal and realizing real-time monitoring on the stress of different parts of the graft. The problems that local stress in an articular cavity cannot be monitored in situ after reconstruction of an intra-articular graft, and graft-osseointegration is poor due to local stress concentration are solved.

Description

Technical Field

[0001] This invention 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 Technology

[0002] In the field of orthopedic clinical practice, the postoperative healing effect of intra-articular grafts (taking anterior cruciate ligament reconstruction as an example) is closely related to the precise regulation of the biomechanical microenvironment. Numerous experimental studies have clearly demonstrated that appropriate mechanical stimulation can guide collagen fibers to align in an orderly manner according to the direction of force, providing a structural basis for the integration of the graft and bone tissue, thereby accelerating the healing process. However, this process has stringent requirements on the "degree" of mechanical stimulation—the stress safety window is extremely narrow. Once patients engage in excessive exercise beyond their tolerance during the rehabilitation phase, it may not only directly cause secondary fracture of the graft, but also lead to poor integration due to the imbalance of force at the graft-bone interface, ultimately resulting in graft loosening and surgical failure.

[0003] However, current clinical rehabilitation training methods and equipment (including traditional manual therapy, elastic band training, and isokinetic muscle strength testing) all suffer from a key technical shortcoming: the inability to monitor in-situ stress of grafts within the joint cavity. Specifically, during treatment, medical staff rely primarily on clinical experience and tactile sensation to control the applied force, resulting in high subjectivity and insufficient precision. Furthermore, existing rehabilitation equipment's monitoring indicators are limited to surface parameters such as joint range of motion and externally applied loads. These parameters significantly deviate from the actual stress experienced by the graft, making them unsuitable for precise control. More importantly, crucial parameters for assessing graft safety—such as peak stress (the maximum value of a single stress application), loading rate (the rate of stress change), and fatigue accumulation (the cumulative damage from repeated long-term stress)—lack real-time acquisition and feedback mechanisms. This "blind" training directly leads to significantly reduced rehabilitation outcomes, difficulty in guaranteeing the quality of graft-bone healing, and a persistently high incidence of postoperative complications (such as graft loosening and re-fracture).

[0004] Therefore, how to overcome technical bottlenecks and achieve dynamic monitoring of the force intensity of intra-articular grafts in situ has become a core challenge in realizing controllable mechanical stimulation and promoting the scientific development of rehabilitation training.

[0005] Existing technologies and products for monitoring graft stress have revealed numerous shortcomings in practical applications, as follows: A: Lack of spatial resolution (inability to locate local stress): Currently published research papers and commercial products can only monitor the entire ligament, outputting the overall total strain value, and cannot distinguish the stress differences in different parts of the graft. For example, it cannot accurately detect stress changes at the femoral insertion point (the end point where the graft connects to the femur) and the tibial insertion point (the end point where the graft connects to the tibia), making it difficult for clinicians to pinpoint the specific location of abnormal stress concentration and failing to provide precise evidence for targeted intervention.

[0006] B: Insufficient biocompatibility (long-term implantation failure): In existing animal experiments and clinical trials, short-term sensor failure is a common problem—approximately 50% of sensors lose their monitoring function within 3 months post-surgery. In-depth analysis reveals two main causes: First, the titanium coil, as a foreign object implanted in the body, easily triggers a rejection reaction, and excessively high local metal ion concentrations can cause cytotoxicity, disrupting the integration environment between the graft and bone tissue. Second, the sensor's encapsulation material (such as silicone) swells in bodily fluids, leading to decreased coil structural stability and a significant reduction in signal transmission sensitivity and accuracy.

[0007] C: Poor biomechanical compatibility (interference with graft healing): As a key load-bearing structure for joint movement, the anterior cruciate ligament (ACL) graft needs to be compatible with the joint's flexion, extension, and rotation characteristics, possessing a certain degree of tensile strength and elasticity. However, current monitoring technologies and products mostly use non-stretchable rigid sutures, which contradicts the biomechanical deformation requirements of the graft during joint movement. This mismatch in biomechanical properties increases the stress on the graft, interferes with the normal healing process, and ultimately leads to poor integration of the graft with the bone tissue.

[0008] D: Dynamic Monitoring Blind Spot (No Real-Time Early Warning): Existing technologies have significant limitations in signal analysis. Most rely on large external equipment for manual operation, using complex procedures to analyze frequency shift signals. This makes it impossible to provide immediate stress warnings during surgery or during the patient's daily activities. The lack of miniaturized, convenient real-time signal analysis modules or devices prevents medical staff from timely obtaining danger signals, making it difficult to avoid graft injuries caused by instantaneous overload or cumulative damage. Summary of the Invention

[0009] To address the aforementioned problems, the present invention aims to provide a local pressure monitoring system and method based on a double-helix sensing suture. This system addresses the inability to monitor local stress in situ within the joint cavity after intra-articular graft (such as anterior cruciate ligament) reconstruction, leading to graft-osseous incompatibility due to stress concentration. The invention provides a wireless double-helix sensing suture system capable of: full-length axial / circumferential dual-dimensional pressure distribution monitoring of the graft (resolution ≤2mm); wireless and passive design (in vivo working cycle ≥180 days); and integrated surgical suture implantation (reducing additional trauma). This system better monitors stress at different graft sites, guides rehabilitation training, and monitors graft-osseous integration.

[0010] The above-mentioned objective of this invention is achieved through the following technical solutions: A local pressure monitoring system based on a double-helix sensing suture includes: 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 dual-helix sensor 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 cross-braided array with a double-bolt structure. 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.

[0011] Furthermore, 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.

[0012] Furthermore, in the double-helix sensing array module, the processed functionalized conductive wires are braided into a cross-braided array with a double-bolt structure, specifically as follows: 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.

[0013] Furthermore, in the double-helix sensing array module, the cross-woven array, after being encapsulated and protected with medical-grade silicone after its fabrication is completed, 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.

[0014] Furthermore, 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 the 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.

[0015] Furthermore, the handheld decoding and monitoring module is communicatively connected to the wireless power supply and transmission module to receive and analyze stress signals, thereby enabling real-time monitoring of stress in different parts of the graft. 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.

[0016] Furthermore, 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.

[0017] A method for monitoring local pressure using a dual-helix sensing suture based on a local pressure monitoring system as described above, comprising: S1: Construct a suture substrate optimization module, selecting polycaprolactone (PCL) fiber as the suture substrate, which provides a basic carrier for the local pressure detection system of the entire orthopedic intra-articular graft; 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. 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. 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.

[0018] A computer device includes 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 the method described above.

[0019] A computer-readable storage medium storing computer code that, when executed, performs the method described above.

[0020] Compared with the prior art, the present invention has at least one of the following beneficial effects: (1) High spatial resolution and accuracy stress monitoring around intra-articular grafts: By utilizing the capacitance shift caused by changes in helical spacing due to pressure variations, stress monitoring at different locations of the intra-articular graft is achieved. The stress monitoring accuracy can reach ±0.5N, and the spatial resolution accuracy is controlled within ±1mm. Compared with traditional manual training, this invention can monitor the stress concentration points of the patient's graft, providing patients with more scientific and accurate rehabilitation training, promoting graft-bone integration and joint function recovery.

[0021] (2) Wireless power supply and communication: The biodegradable Mg-Zn alloy interface screw can fix the graft on the one hand, and realize wireless power supply and communication through the LC resonant circuit formed by the inductor coil integrated into the biodegradable Mg-Zn alloy anchor on the other hand.

[0022] (3) Long service life and fatigue life: The working cycle of the Mg-Zn alloy interface in the body is ≥180 days, and the suture can achieve a service life of >300,000 cycles, realizing full-cycle monitoring of implants (such as anterior cruciate ligament).

[0023] (4) Rapid in vitro decoding and monitoring: Using the developed handheld radio frequency reader, the signals generated by the sensing sutures can be rapidly decoded and monitored under different movement states without the need for complex procedures and instruments. This can provide further guidance for patients' rehabilitation training. Attached Figure Description

[0024] Figure 1 This is an overall structural diagram of the local pressure monitoring system based on double-helix sensing suture of the present invention; Figure 2 This is a schematic diagram of the local pressure monitoring system based on double-helix sensing suture of the present invention. Figure 3 This is an overall flowchart of the local pressure monitoring method based on double-helix sensing sutures of the present invention. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0026] Those skilled in the art will understand that, unless specifically stated otherwise, the singular forms “a,” “an,” “the,” and “the” used herein may also include the plural forms. It should be further understood that the term “comprising” as used in this specification means the presence of the stated features, integers, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0027] First Embodiment like Figure 1 and 2 As shown, this embodiment provides a local pressure monitoring system based on a double-helix sensing suture, including: 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.

[0028] In this embodiment, the substrate is first optimized: polycaprolactone (PCL) fibers achieve a better balance between biocompatibility and mechanical strength. PCL is an FDA-approved biodegradable biomaterial with excellent biocompatibility and good mechanical strength, capable of withstanding the enormous pressure between the graft and bone.

[0029] The selection of polycaprolactone (PCL) fiber as the suture substrate is based on its optimized design, leveraging its dual advantages in biocompatibility and mechanical properties. As an FDA-approved biodegradable biomaterial, PCL fiber exhibits excellent biocompatibility with human tissue, reducing the risk of rejection and cytotoxicity after implantation, thus ensuring biosafety for the long-term stable operation of the system in vivo. Simultaneously, its excellent mechanical strength effectively withstands the significant pressure generated between the graft and bone during joint movement, adapting to the stress requirements of anterior cruciate ligament grafts and preventing insufficient substrate strength from affecting normal graft healing or interfering with system monitoring functions. This substrate selection not only provides a stable physical carrier for the entire local pressure monitoring system but also, through the inherent properties of the material, lays the foundation for the system's reliability in terms of both biocompatibility and mechanical compatibility.

[0030] The dual-helix sensor 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 cross-braided array with a double-bolt structure. After the weaving is completed, the cross-braided array is encapsulated and protected with medical silicone.

[0031] In this embodiment, the double-helix sensor array module includes the following technical processes: (1) Functionalized conductive filaments are obtained by treating the suture substrate with PEDOT:PSS solution, specifically: 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.

[0032] This embodiment transforms ordinary PCL sutures into conductive threads through a combination of chemical and physical treatments. The core logic lies in utilizing the conductive properties of PEDOT:PSS (poly(3,4-ethylenedioxythiophene)-poly(styrene sulfonate)) and enhancing its adhesion to the PCL fiber surface with the assistance of dimethyl sulfoxide (DMSO). Specifically, DMSO, as an additive, improves the wettability of the PEDOT:PSS solution to the PCL substrate, while ultrasonic vibration further promotes sufficient contact between the solution and the fiber surface through physical action, ensuring uniform coverage of PEDOT:PSS. A curing step at a preset temperature allows the attached conductive material to stabilize and solidify. By repeating this process multiple times, a uniformly thick and reliably conductive layer is formed on the PCL fiber surface. The resulting functionalized conductive thread not only retains the biocompatibility and mechanical properties of the PCL substrate but also possesses stress signal transmission capabilities, laying a crucial foundation for the subsequent construction of a double-helix sensor array and the accurate sensing of graft stress.

[0033] (2) The treated functionalized conductive wires are braided into a cross-braided array with a double-bolt structure, specifically: Using several processed functional conductive threads, the threads are braided at a preset crossing angle to form the cross-braided array of the double-bolt structure. This cross-braided array naturally divides the graft surface into micro-grid areas of fixed size (e.g., 5×5mm). Each micro-grid area constitutes a pressure-sensitive unit. The cross-distribution of the functional conductive threads enables independent sensing of stress in different micro-grid areas. Numerous pressure-sensitive units ensure that the sensing suture system has higher spatial resolution and more accurate stress acquisition.

[0034] This embodiment focuses on transforming functionalized conductive threads into a cross-woven array with high-resolution stress sensing capabilities through a specific weaving method. The core design leverages the conductivity of the functionalized conductive threads and the spatial distribution characteristics of the weaving structure to achieve precise monitoring of stress on the graft surface. Specifically, the weaving method with preset cross angles is not randomly selected, but rather designed to naturally form uniformly sized micro-grid areas (e.g., 5×5mm) on the graft surface. Each grid area acts as an independent pressure-sensitive unit, generating a unique electrical signal response to stress changes. Since the contact state of the functionalized conductive threads at the cross points changes with stress, this structural design allows each unit to independently sense the stress in its area, thereby achieving precise capture of stress differences at different graft locations (e.g., femoral and tibial insertions). The synergistic effect of numerous pressure-sensitive units significantly improves the system's spatial resolution, avoiding the limitations of traditional techniques that can only acquire the total strain value of the entire ligament segment. This provides a crucial structural foundation for subsequent accurate analysis of stress concentration areas and guidance of rehabilitation training.

[0035] (3) The cross-braided array, after being encapsulated and protected with medical silicone after completion, is specifically as follows: 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.

[0036] This embodiment details the specific method of encapsulating and protecting the cross-braided array. Its core purpose is to ensure the stability and reliability of the sensing structure through a combination of physical processing and material encapsulation. Pre-stretching is performed on the completed cross-braided array. This step allows the double-helix structure to better adapt to the mechanical changes caused by joint movement during subsequent use, reducing structural deformation caused by repeated stretching and laying the foundation for the stable distribution of the gridded pressure-sensitive units. The selection of Ecoflex 00-30 medical-grade silicone for coating and encapsulation utilizes its excellent biocompatibility, avoiding irritation to internal tissues, and forms a protective layer that effectively isolates the PEDOT:PSS conductive layer from external environmental influences—preventing wear due to friction during joint movement and blocking swelling caused by body fluid erosion. This maintains the stability of conductivity and the accuracy of stress sensing, ensuring the long-term effective operation of the entire sensing system within the body.

[0037] The wireless power supply and transmission module integrates a suture inductor coil onto a biodegradable Mg-Zn alloy interface screw. Through the LC resonant circuit formed by the suture inductor coil and the Mg-Zn alloy interface screw, the module achieves wireless power supply and data communication with external devices.

[0038] In this embodiment, the wireless power supply and transmission module specifically comprises: 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.

[0039] This embodiment focuses on the design of a wireless power supply and transmission module. The core of this design lies in the integration of a biodegradable Mg-Zn alloy interface screw and a suture inductor coil to achieve functional integration and wireless operation. The Mg-Zn alloy interface screw itself performs the clinical function of fixing the graft. Integrating the suture inductor coil onto it creates an LC resonant circuit that becomes the key functional carrier. On one hand, this circuit can receive external energy and convert it into the electrical energy required by the system, providing wireless power to the dual-helix sensor array module, eliminating the limitations of wired power supply on joint movement. On the other hand, it can wirelessly transmit the stress signals collected by the sensor array to a handheld RF reader, achieving contactless data transfer. Simultaneously, the biodegradable nature of the Mg-Zn alloy ensures that the screw naturally degrades after fulfilling its fixation and power communication functions, avoiding the drawbacks of traditional non-degradable screws requiring secondary surgery for removal. This simplifies the treatment process, reduces patient trauma and risk, and makes the entire system both safe and convenient while meeting clinical needs.

[0040] 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.

[0041] In this embodiment, the handheld decoding monitoring module specifically comprises: 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.

[0042] This embodiment focuses on the design and functionality of a handheld decoding monitoring module. It aims to transform stress information captured by an in vivo sensor array into monitoring data directly applicable to clinical guidance through a convenient and efficient signal reception and analysis mechanism. The handheld radio frequency reader, as the front-end acquisition device, eliminates the reliance on complex procedures and auxiliary instruments, directly receiving signals from the wireless power supply and transmission module. Its portability makes it suitable for various scenarios, including intraoperative procedures and patients' daily activities. The integrated Bluetooth transmission system enables wireless signal transmission, rapidly sending the acquired raw signals to the data decoding monitoring system. The data decoding monitoring system, as the core analysis unit, processes the signals and accurately presents the stress distribution of different parts of the graft under various movement states, providing real-time feedback to users or medical professionals. This provides immediate evidence for adjusting rehabilitation training programs, effectively solving the problem of blind spots in dynamic monitoring in traditional technologies and improving the timeliness and practicality of monitoring.

[0043] This embodiment also includes a deployment and signal interpretation module, used to deploy the cross-braided array and interpret 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 preset loading tunnel. After the anchor is fixed, the zero-point pressure at different angles is calibrated. During signal interpretation, the stress on the graft of the postoperative patient is monitored by an RF reader and a data decoding monitoring system. When any pressure-sensitive unit continuously detects pressure greater than the preset value, the data decoding and monitoring system triggers an audible and visual alarm.

[0044] Second Embodiment like Figure 3 As shown, this embodiment provides a local pressure monitoring method based on a double-helix sensing suture, executed using the local pressure monitoring system based on a double-helix sensing suture as described in the first embodiment, comprising: S1: Construct a suture substrate optimization module, selecting polycaprolactone (PCL) fiber as the suture substrate, which provides a basic carrier for the local pressure detection system of the entire orthopedic intra-articular graft; 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. 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. 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.

[0045] Third Embodiment This embodiment provides a specific implementation method, and the specific process is as follows: (1) Implant preparation process: (11) Functionalization of sutures: 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.

[0046] (12) Double helix array weaving: 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.

[0047] (13) Wireless module integration: A biodegradable magnesium alloy wire with a purity of 99.9% was used to wind an inductor coil with a diameter of 2mm and 12 turns, with a coil spacing of 0.1mm to optimize resonance efficiency. The coil was fixed in the groove of a Mg-Zn alloy interface screw (4mm diameter, 15mm length) by 1064nm wavelength laser welding (5W power, welding time 20ms). The coil lead was connected to the pressure-sensitive unit of the double helix array through a 0.1mm diameter PEDOT:PSS conductive wire, and the connection was sealed with biocompatible insulating adhesive to prevent signal interference.

[0048] (2) Intraoperative deployment guidelines: Preoperatively, based on the patient's anterior cruciate ligament size, a femoral / tibial tunnel with a diameter of 4.5 mm is prepared. The sensing suture and the graft (such as the hamstring tendon) are inserted into the tunnel together to ensure that the double helix array completely fits the graft surface.

[0049] Bioabsorbable screws (4.5mm in diameter) were used to secure both ends of the graft, with the tightening torque controlled at 3.5 N·m to avoid excessive pressure. After fixation, a handheld radio frequency reader was used to calibrate the zero-point pressure at joint angles of 0°, 30°, 60°, and 90° to eliminate mechanical errors.

[0050] (3) Signal interpretation and early warning mechanism: Real-time monitoring: The stress signal transmitted by the LC resonant circuit is received by a handheld RF reader (operating frequency 13.56MHz) and sent to the data decoding system via Bluetooth module (transmission rate 2Mbps). The built-in algorithm of the system can resolve the stress value of each 5×5mm grid unit within 100ms, with a spatial resolution of ±1mm and a stress detection accuracy of ±0.5N.

[0051] Warning threshold: When any grid cell detects pressure >18MPa for 3 consecutive seconds (determined by 10% above the ligament yield limit of 16.3MPa), the system automatically triggers an 85dB audible and visual alarm to prompt the patient to terminate the current action.

[0052] Clinical data example: 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. The difference between the two was significant (P<0.05), which can accurately reflect the difference in force distribution of the graft.

[0053] A computer-readable storage medium stores computer code that, when executed, performs the methods described above. Those skilled in the art will understand that all or part of the steps in the various methods of the above embodiments can be implemented by a program instructing related hardware. This program can be stored in a computer-readable storage medium, which may include: read-only memory (ROM), random access memory (RAM), a magnetic disk, or an optical disk, etc.

[0054] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions falling within the scope of the present invention's concept are within the scope of protection of the present invention. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of the present invention should also be considered within the scope of protection of the present invention.

[0055] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0056] It should be noted that the above embodiments can be freely combined as needed. The above description is only a preferred embodiment of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

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 dual-helix sensor 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 cross-braided array with a double-bolt structure. 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 method for monitoring local pressure using a double-helix sensing suture, executed by the local pressure monitoring system based on a double-helix sensing suture as described in any one of claims 1-7, characterized in that, include: S1: Construct a suture substrate optimization module, selecting polycaprolactone (PCL) fiber as the suture substrate, which provides a basic carrier for the local pressure detection system of the entire orthopedic intra-articular graft; 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. 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. 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.

9. 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 the method of claim 8.

10. A computer-readable storage medium storing computer code that, when executed, performs the method of claim 8.

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