Ankle joint intelligent plaster liner and pressure distribution analysis system

Abstract

This invention discloses an intelligent plaster cast pad for the ankle joint and a pressure distribution analysis system, belonging to the field of postoperative rehabilitation monitoring technology in foot and ankle surgery. The intelligent plaster cast pad includes a pad body, a flexible pressure sensor array, and a pressure transmission module. The flexible pressure sensor array is zoned in the medial malleolus, lateral malleolus, calcaneal, tibial, and metatarsal regions, and collects pressure using a matrix scanning method. The pressure transmission module has a built-in multi-channel selection switch that sequentially selects each region's flexible pressure sensor array and transmits the received pressure parameters to a mobile terminal. The pressure distribution analysis system consists of the intelligent plaster cast pad, the pressure distribution analysis module, and a hospital HIS system, completing pressure acquisition, wireless transmission, data analysis, over-limit alarm, and rehabilitation record archiving and evaluation. This invention is suitable for plaster cast immobilization scenarios, collects pressure parameters in zones, and enables quantitative monitoring of pressure in multiple regions after ankle joint surgery, providing objective data for clinical rehabilitation weight-bearing management.

Description

Technical Field

[0001] This invention belongs to the field of postoperative rehabilitation monitoring technology in foot and ankle surgery, specifically relating to an intelligent plaster liner for the ankle joint and a pressure distribution analysis system. Background Technology

[0002] Ankle fractures are one of the most common types of fractures in surgical clinics, accounting for about 10% of all fractures. Post-operative immobilization with plaster casts or braces is necessary, along with strict control of weight-bearing on the affected limb to ensure healing and prevent complications. The post-operative stress characteristics of different anatomical regions of the ankle joint vary significantly: the heel region is the main weight-bearing area during standing and walking, with concentrated force and high peak pressure; excessive weight-bearing can easily lead to loosening of internal fixation, redisplacement of the fracture, and collapse of the articular surface. The medial and lateral malleolar regions are the core areas of the fracture, being the most sensitive and vulnerable to stress; even slight over-stress can cause micromovement of the fracture ends, increased pain, delayed healing, and even failure of internal fixation. The tibia region is the main transmission site of axial force during ankle weight-bearing, corresponding to the distal tibial fracture fixation area; excessive weight-bearing here can easily lead to fracture displacement, failure of internal fixation, and skin damage caused by plaster cast pressure. The forefoot metatarsal head region is a compensatory weight-bearing area; patients often unconsciously use their forefoot to exert force, easily leading to excessive stress, which can cause ankle inversion or eversion, fracture misalignment, and deviation from the normal rehabilitation trajectory. Therefore, clinical practice and industry consensus clearly state that weight-bearing management after ankle fracture surgery is a core aspect of the rehabilitation process: premature or excessive weight-bearing can directly lead to serious adverse consequences such as internal fixation failure, redisplacement of fracture ends, and articular surface collapse, and may even require secondary surgical intervention; while excessively delayed weight-bearing can cause complications such as muscle atrophy of the affected limb, ankle stiffness, deep vein thrombosis, delayed fracture healing or nonunion, significantly reducing the quality of patient rehabilitation, prolonging the rehabilitation period, and increasing the physical and mental burden and medical costs of patients.

[0003] Currently, clinical weight-bearing management for patients after ankle fracture surgery mainly relies on verbal instructions from medical staff and the patient's own subjective feelings, lacking objective, continuous, quantitative, and zone-specific weight-bearing monitoring methods. After discharge, patients cannot accurately determine whether weight-bearing in each zone meets rehabilitation standards, easily leading to extreme situations such as "not daring to bear weight" or "over-bearing" in individual areas, posing a significant risk to rehabilitation outcomes.

[0004] While some intelligent devices for weight-bearing monitoring, such as smart insoles and wearable pressure sensors, exist in the current technology, they all have significant limitations and cannot meet the clinical needs of plaster cast immobilization after ankle fracture surgery. Medical plaster cast pads, as a crucial auxiliary tool between the plaster cast and the skin, primarily function to protect the skin, reduce friction, and absorb sweat, lacking any pressure monitoring capabilities and thus failing to meet the demands of precise postoperative rehabilitation. The core pain point of existing intelligent monitoring devices is that most products are placed directly inside the shoe, disconnected from the plaster cast immobilization scenario, and cannot reflect the actual stress on the fracture ends under the plaster cast. Furthermore, most devices can only collect single-point pressure values, ignoring the unique multi-regional pressure distribution characteristics of ankle fractures, and cannot analyze the dynamic pressure transfer patterns during weight-bearing. Consequently, they cannot provide comprehensive and accurate weight-bearing monitoring data for clinical use, making it difficult to assist medical staff in developing personalized rehabilitation plans.

[0005] Therefore, developing an intelligent system that can fit the inner layer of plaster, adapt to plaster fixation scenarios, and monitor and analyze the weight-bearing pressure distribution of different anatomical zones of the affected limb after ankle fracture surgery would fill the gap in existing technology, meet the needs of clinical rehabilitation monitoring, and have significant clinical application value and prospects for promotion. Summary of the Invention

[0006] To overcome at least one technical problem existing in the prior art, the present invention provides an intelligent plaster cast pad for the ankle joint, including a pad body, a flexible pressure sensor array, and a pressure transmission module; the flexible pressure sensor array is arranged in the pad body, and the pressure transmission module is connected to the flexible pressure sensor array; in use, the flexible pressure sensor array collects pressure distribution parameters in different areas of the ankle joint and feeds back the collected pressure information to the pressure transmission module, and the pressure transmission module transmits the pressure information to a mobile terminal.

[0007] More preferably, the pad body includes a skin-adhesive layer and a plaster adapter layer, and the flexible pressure sensor array is disposed between the skin-adhesive layer and the plaster adapter layer.

[0008] More preferably, the flexible pressure sensor array is respectively set in the medial malleolus region, lateral malleolus region, calcaneal region, tibia region, and metatarsal region to realize pressure zone detection.

[0009] More preferably, the flexible pressure sensing array is composed of a number of flexible pressure sensing units arranged in a regular pattern; the center-to-center distance between the flexible pressure sensing units in each zone is 10mm to 15mm, and the number of flexible pressure sensing units in each zone is 20 to 42.

[0010] More preferably, the range of the flexible pressure sensing units in the tibia, medial malleolus, and lateral malleolus areas is 0–100 kPa; and the range of the flexible pressure sensing units in the calcaneus and metatarsal areas is 0–200 kPa.

[0011] More preferably, the flexible pressure sensor array in each zone of the intelligent plaster pad outputs a matrix scan line, and the matrix scan line is connected to the pressure transmission module via a flexible conductive line.

[0012] More preferably, the pressure transmission module includes a multiplexer, a timing control unit, a signal processing unit, a power supply unit, and a wireless communication unit; each partition row and column signal line is connected to the multiple input channels of the multiplexer, and the timing control unit performs periodic selection control on the multiplexer according to a preset timing logic; the original pressure signal is processed and then transmitted to an external mobile terminal in real time through the built-in wireless communication unit.

[0013] This invention also provides an ankle joint pressure distribution analysis system, including the aforementioned intelligent plaster cast pad for the ankle joint, a pressure distribution analysis module, and a hospital HIS system; the intelligent plaster cast pad is used to collect raw pressure data of relevant areas of the ankle joint and output it wirelessly; the pressure distribution analysis module is a smartphone APP or doctor-side software, used to receive raw pressure data of each area, perform data preprocessing, parameter calculation, safety threshold judgment and alarm operation, and generate a rehabilitation report; the hospital HIS system is used to receive the analysis data, alarm information, abnormal event records and rehabilitation reports uploaded by the pressure distribution analysis module, and realize centralized data management, archiving and rehabilitation effect evaluation.

[0014] More preferably, the pressure distribution analysis module has an adjustable safety threshold model built in based on different fracture types, postoperative weeks and patient weight, and presets peak pressure thresholds for different ROIs. When the pressure of any ROI exceeds the corresponding threshold for ≥3 seconds, the system issues a vibration or sound alarm and records the abnormal event.

[0015] Compared with the prior art, the beneficial effects of the present invention using the above solution are as follows: 1. Zonal Matrix Detection: Based on ankle joint anatomy and weight-bearing characteristics, the sensor array is deployed in zonal areas. Matrix scanning improves detection accuracy and wiring rationality, comprehensively reflecting pressure distribution.

[0016] 2. Suitable for plaster cast scenarios: The integrated padding design does not change the fixed process, collects the actual stress under the plaster cast, and the data fits clinical needs.

[0017] 3. Closed-loop system management: The system integrates data collection, transmission, analysis, alarm, and archiving, supporting remote monitoring and personalized rehabilitation guidance to improve rehabilitation safety and efficiency.

[0018] 4. Reasonable structure and range: The sensor unit specifications, matrix size, and range are matched to the stress in each area, ensuring accurate and reliable detection, and the flexible structure fits comfortably. Attached Figure Description

[0019] Figure 1 A schematic diagram of a smart plaster pad structure for the ankle joint; Figure 2 A schematic diagram of a partitioned intelligent plaster cast pad for the ankle joint; Explanation of reference numerals in the attached figures: 1. Skin adhesion layer; 2. Flexible pressure sensor array; 3. Plaster adapter layer; 4. Metatarsal region; 5. Calcaneal region; 6. Tibial region; 7. Lateral malleolus region; 8. Pressure transmission module. Detailed Implementation

[0020] To better understand the above-mentioned objectives, features, and advantages of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0021] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and therefore the scope of protection of the invention is not limited to the specific embodiments disclosed below.

[0022] Example 1: Intelligent plaster pad for ankle joint This invention discloses an intelligent plaster cast pad for the ankle joint, comprising a pad body, a flexible pressure sensor array, and a pressure transmission module; the flexible pressure sensor array is arranged in the pad body, and the pressure transmission module is connected to the flexible pressure sensor array; in use, the flexible pressure sensor array collects pressure distribution parameters in different areas of the ankle joint and feeds back the collected pressure information to the pressure transmission module, which then transmits the pressure information to a mobile terminal.

[0023] like Figure 1As shown in the preferred embodiment of the present invention, the intelligent plaster cast pad for the ankle joint provided by the present invention has a two-layer composite structure, including a skin-adhesive layer and a plaster fitting layer, with a flexible pressure sensor array partitioned between the two layers. The skin-adhesive layer is in direct contact with the patient's ankle skin and needs to have excellent skin-friendliness, breathability, and moisture absorption, while also possessing a certain degree of elasticity to closely conform to the physiological contour of the ankle joint. In this embodiment, a medical-grade pure cotton non-woven fabric and viscose cotton composite material is preferred. The plaster fitting layer is located on the outermost side of the pad and is in direct contact with the plaster, serving to support and shape it, protect the internal flexible pressure sensor array from damage caused by the curing and compression of the plaster, and improve the adhesion between the plaster and the plaster. Therefore, a medical-grade breathable non-woven polyester flexible composite material is preferentially selected for the plaster fitting layer.

[0024] like Figure 2 As shown, a flexible pressure sensor array is sandwiched between the skin adhesion layer and the plaster adapter layer. Based on the ankle joint anatomy, the key stress areas of the ankle joint are divided into the medial malleolus, lateral malleolus, calcaneal, tibial, and metatarsal regions, with an independent flexible pressure sensor array for each region. Each flexible pressure sensor array uses a row-column matrix scanning mode to acquire point pressure signals. Each group of flexible pressure sensor arrays, according to its own row and column arrangement, leads out corresponding row control lines and column signal lines. The row control lines and column signal lines led out from each zone's flexible pressure sensor array are bundled together through flexible conductive lines and plugged into the signal input interface of the pressure transmission module. In this embodiment, the flexible conductive lines are flexible printed circuits (FPCs); in another embodiment, the flexible conductive lines can also be flexible flat cabling (FFCs). The pressure transmission module integrates a multiplexer, a timing control unit, a signal processing unit, a power supply unit, and a wireless communication unit; the row and column signal lines of each zone, accessed via the FPC flexible printed circuit, are respectively connected to the multiple input channels of the multiplexer. The timing control unit periodically selects and controls the multiplexer switch according to preset timing logic, sequentially activating signal paths for different zones and rows / columns, and reading pressure acquisition signals from each flexible pressure sensor array point by point in a polling manner. After signal conditioning, filtering, amplification, and analog-to-digital conversion, the raw pressure signal is transmitted in real-time to an external mobile terminal via Bluetooth wireless transmission through the built-in wireless communication unit. The power supply unit can be powered by, but is not limited to, button batteries, rechargeable lithium batteries, flexible thin-film batteries, flexible supercapacitors, piezoelectric generators, or triboelectric nanometers; combinations of these power supply methods are also possible, such as a hybrid power supply method using button batteries or rechargeable lithium batteries as the primary power source and piezoelectric generators utilizing the electrical energy generated by deformation under load as an auxiliary power source. Rechargeable lithium batteries can also be used with wireless charging coils to achieve interface-less charging.

[0025] Flexible pressure sensor arrays can be flexible, thin, and meet the requirements of overall soft and conformal padding, including but not limited to MXene nanocomposite flexible thin film pressure sensor arrays, flexible piezoresistive sensor arrays, flexible capacitive sensor arrays, and flexible piezoelectric sensor arrays.

[0026] The skin-adhesive layer, flexible pressure sensor array, and plaster adapter layer are seamlessly bonded together using medical-grade environmentally friendly adhesive. Combined with ultrasonic edge sealing technology, a flat and non-protruding overall structure is formed. The flexible pressure sensor array and internal wiring are embedded between the inner and outer layers. After the padding wraps the ankle joint area, it can be wrapped with an ultra-thin medical elastic bandage (avoiding the pressure detection area) and fixed with medical low-sensitivity pressure-sensitive adhesive.

[0027] The flexible pressure sensor array consists of several flexible pressure sensor units arranged in a regular pattern. To ensure that the local pressure characteristics of the key stress areas of the ankle joint can be accurately reproduced on the generated pressure cloud map, and to avoid pressure gradient distortion or "oversmoothing" due to insufficient spatial sampling, the design prerequisites must be based on the comprehensive requirements of pressure cloud map imaging accuracy, local feature identification, and pressure gradient restoration. The center spacing of the flexible pressure sensor units is then determined through theoretical calculations. After the center spacing is determined, the number of flexible pressure sensor units required for each pressure acquisition area can be calculated based on the actual coverage area of ​​each area. The process for determining the center spacing of the flexible pressure sensor units is as follows: Post-ankle fracture rehabilitation (such as bimalleolar fractures and Pilon fractures) focuses on weight-bearing management and pressure ulcer prevention. In clinical diagnosis, doctors do not focus on the total pressure value, but rather on the spatial distribution characteristics of the pressure. Specific requirements include: 1. Identify abnormal stress "hotspots": Postoperative patients often experience stress shifts due to pain or plaster cast immobilization (such as over-reliance on the heel or one side of the ankle). These abnormally high-pressure areas (hotspots) typically manifest as localized pressure peaks. Clinical studies have shown that the pressure distribution in the foot and ankle is significantly non-uniform, and key pathological features (such as early pressure sores or stress concentration points) are often concentrated within an anatomical scale of approximately 30 mm (such as the medial and lateral malleolar prominences, and the calcaneal tuberosity).

[0028] 2. Monitor changes in pressure gradient: Rehabilitation is a dynamic process, and doctors need to observe the movement trajectory of the center of pressure (COP) and the gradient change of pressure from "point concentration" to "area uniformity".

[0029] Based on the above reasons, to meet the clinical diagnostic needs for local tissue protection and biomechanical assessment after ankle fracture surgery, the monitoring method and pressure cloud map involved in this embodiment must be able to distinguish local pressure plaques at the 30mm scale. This indicator ensures that clinicians can accurately identify abnormal high-pressure "hot spots" (such as stress points on bony prominences) at this scale through the cloud map and effectively identify subtle changes in the pressure gradient, thereby providing a reliable visual basis for postoperative stress pattern assessment and pressure ulcer risk warning.

[0030] Characteristic scale definition: Defines the minimum effective pressure characteristic width that needs to be monitored clinically ( W feature The diameter is 30mm.

[0031] According to the Nyquist-Shannon sampling theorem, in order to reconstruct a signal without distortion, the sampling frequency must be greater than twice the highest frequency of the signal. In the spatial domain, this means the sampling interval ( d The width must be less than or equal to half of the feature width.

[0032]

[0033] Calculation of center distance of flexible pressure sensing unit:

[0034] According to the Nyquist-Shannon spatial sampling criterion, a center-to-center spacing of no more than 15mm is sufficient to achieve distortion-free reconstruction of local pressure features at the 30mm scale. If the center-to-center spacing is greater than 15mm, there will be problems of insufficient spatial sampling and overlapping of pressure hotspots and pressure gradient distortions, which cannot meet the requirements for clinical identification. If the center-to-center spacing is less than 10mm, it will result in oversampling, which will not provide additional clinical gain for the identification of pressure features at the foot and ankle anatomical scale. It will also lead to an excessive number of sensor units, a significant increase in hardware acquisition channels and costs, and excessive wiring density will easily cause signal crosstalk. The fit and wearing comfort of the flexible pad will also be significantly reduced.

[0035] Considering clinical identification needs, spatial sampling constraints, hardware manufacturing costs, and human wearing comfort, this invention limits the spacing of the flexible pressure sensing unit centers to 10mm to 15mm; in this embodiment, the critical maximum spacing is preferably 15mm, which is the optimal balance point for balancing accuracy, cost, and wearing experience.

[0036] Based on the established 15mm center-to-center spacing of the flexible pressure sensing units, this embodiment directly employs square sensing units, a standard configuration commonly used in foot and ankle pressure sensing array applications in this field. The size selection of a single sensing unit must simultaneously satisfy the following requirements: no structural interference between adjacent units, reasonable isolation gaps to avoid signal crosstalk, guaranteed effective pressure sensing area at a single point, adaptability to flexible bending and fitting of the foot and ankle surface, and compliance with industry-standard mass production specifications. Based on these principles, and combined with the 15mm fixed center-to-center spacing, the effective sensitive area side length of the flexible pressure sensing unit is limited to a range of 8mm to 12mm. Within this range, this embodiment preferably uses a 10mm effective sensitive area side length, ensuring reasonable parameter matching and meeting the requirements for foot and ankle pressure acquisition, array deployment, and actual wear use.

[0037] Based on the determination of the size parameters and center spacing of the flexible pressure sensing unit, the foot and ankle anatomical monitoring area is further divided, the effective acquisition area range of each area is defined, and then the range of the number of flexible pressure sensing units to be deployed is calculated by combining the established center spacing and area range, and finally the matching design of the flexible pressure sensing array is completed.

[0038] like Figure 2 As shown, based on the physiological and anatomical structure of the human foot and ankle, five independent anatomical monitoring areas are defined: the medial malleolus area, the lateral malleolus area (lateral stress zone of the ankle), the calcaneal area (posterior malleolus / calcaneal fracture risk zone), the tibial area (anterior region of the distal tibia), and the metatarsal area (forefoot compensatory weight-bearing zone). Each area is separated by the natural physiological contour of the human body, and they are independent of each other, with pressure acquisition ranges that do not overlap or interfere with each other. The above five anatomical monitoring areas constitute different regions of interest (ROIs). These ROIs are based on the anatomical structure of the ankle joint and fracture risk areas, and each ROI corresponds to different fracture risks and weight-bearing monitoring needs. Considering the individual differences in foot and ankle body shape among adults and the inherent dimensional characteristics of each anatomical region, while ensuring the integrity and functional independence of pressure acquisition in each region, the effective pressure acquisition area range of each anatomical monitoring area is uniformly defined as 45cm² to 70cm². This area range is compatible with individual differences in the thickness and size of the foot and ankle among different adult populations, providing a unified design benchmark for the subsequent standardized array arrangement of flexible pressure sensing units.

[0039] In this embodiment, the preferred spacing between the centers of the flexible pressure sensing units is 1.5cm. Each flexible pressure sensing unit occupies a reference grid area of ​​1.5cm × 1.5cm = 2.25cm² in the array arrangement. Therefore, the number of flexible pressure sensing units suitable for a single anatomical monitoring area can be calculated to be between 20 and 31. Based on this range and considering a certain margin, this embodiment limits the overall matrix arrangement of the flexible pressure sensing array to the range of 4×5 to 6×7. The arrangement can be rectangular or square. This range matches the number of flexible pressure sensing units required in a single area and the effective acquisition area requirement of 45cm² to 70cm². Simultaneously, engineering design margins are reserved to ensure that the array arrangement does not exceed the boundaries of the anatomical area and does not overlap or interfere with adjacent monitoring areas.

[0040] The medial malleolus, lateral malleolus, and calcaneal regions have regular, nearly square outlines. In this embodiment, a 5×5 square matrix is ​​preferably used for the flexible pressure sensing unit arrangement. The metatarsal region and the lower tibial region have a narrow and elongated surface feature. In this embodiment, a 5×6 rectangular matrix is ​​preferably used for the flexible pressure sensing unit arrangement.

[0041] Using the normal adult weight of 70kg as the design benchmark, the body weight is evenly distributed on both lower limbs when the human body is standing naturally, and each foot bears about half of the vertical load of the total body weight. During the rehabilitation stage after ankle fracture surgery, partial weight-bearing conditions are adopted. Extreme impact and full load are not allowed. Only static standing, small-amplitude posture activities and gentle gait are maintained. This is the design premise for the pressure values ​​of each zone. Based on the physiological structure of the foot and ankle and the characteristics of postoperative stress, the pressure-bearing attributes are classified as follows: The tibial region, medial malleolus region, and lateral malleolus region are not vertical main weight-bearing areas and do not share the static pressure load of the body weight. They only generate weak pressure under the action of limb flexion and extension, skin traction, and compression from clothing fit. The maximum allowable pressure limit under postoperative conditions is 20 kPa. The metatarsal region and calcaneal region are the core main weight-bearing areas of the unilateral foot, directly sharing the body weight load of the unilateral body. They are the main pressure-bearing areas under postoperative partial weight-bearing conditions. The normal maximum pressure range of the metatarsal region after surgery is 50 kPa to 100 kPa, while the calcaneal region has more concentrated stress and a higher load-bearing ratio. The normal maximum pressure range of the calcaneal region after surgery is 80 kPa to 150 kPa.

[0042] If flexible pressure sensor arrays for the tibia, medial malleolus, and lateral malleolus are matched with flexible pressure sensor units with a range of 0–20 kPa, they will just fit the upper limit of pressure bearing without any design margin. This can easily lead to pressure signal saturation and distortion due to localized minor stress concentrations, gaps in the fit, and slight posture movements, which is not conducive to long-term stable monitoring. This embodiment, based on the principles of device standardization, redundancy in operating conditions, and consideration of detection accuracy, uniformly selects flexible pressure sensor units with a standard range of 0–100 kPa for the flexible pressure sensor arrays of the tibia, medial malleolus, and lateral malleolus. For the calcaneus and metatarsal regions, considering postoperative concentrated stress and instantaneous pressure fluctuations, flexible pressure sensor units with a range of 0–200 kPa are selected after reserving redundancy.

[0043] Example 2 Ankle Joint Pressure Distribution Analysis System This embodiment provides an ankle joint pressure distribution analysis system, which includes the ankle joint intelligent plaster cast pad, pressure distribution analysis module, and hospital HIS system described in Embodiment 1. The three work together to form a complete closed-loop management system from pressure acquisition, wireless transmission, data analysis to safety alarm, rehabilitation assessment and data archiving. It is suitable for weight-bearing monitoring and rehabilitation guidance throughout the plaster fixation process after ankle fracture surgery.

[0044] The ankle joint intelligent plaster pad serves as the system's front-end data acquisition terminal, collecting raw pressure data in real time from the medial malleolus, lateral malleolus, calcaneal region, tibia, and metatarsal region. This data is then transmitted wirelessly via a Bluetooth communication unit built into the pressure transmission module, ensuring stable transmission of the normalized raw pressure data.

[0045] The pressure distribution analysis module is implemented using a smartphone app or dedicated software program for doctors. It can receive raw pressure data from each zone in real time from the pressure transmission module and perform preprocessing operations such as noise reduction, filtering, and zero-point calibration on the raw data. Based on this, key characteristic parameters such as peak pressure, average pressure, and pressure change rate of each zone are calculated. At the same time, it uses a built-in safety threshold model to determine the pressure safety status. This safety threshold model has adjustable parameters and can set appropriate peak pressure safety thresholds for different monitoring zones based on individual information such as the patient's fracture type, postoperative rehabilitation period, and body weight. When the pressure value in any zone exceeds the corresponding set threshold for 3 seconds or more, the system immediately issues a warning signal through vibration or voice prompts, and automatically records event information such as the time of the abnormality, the location of the abnormal area, and the real-time pressure value, realizing immediate early warning and intervention for dangerous conditions such as excessive weight-bearing on the affected limb and excessive local pressure. Based on real-time monitoring and over-limit warning, the pressure distribution analysis module can automatically generate phased rehabilitation reports based on the massive amount of continuously collected pressure data, intuitively presenting the patient's weight-bearing habits, pressure distribution patterns, and frequency and distribution characteristics of abnormal events during the rehabilitation cycle.

[0046] The hospital's HIS system, serving as a backend data management and professional assessment terminal, receives all data uploaded by the pressure distribution analysis module, including pressure analysis parameters, over-limit alarm information, abnormal event records, and phased rehabilitation reports. It centrally stores, uniformly manages access permissions, and maintains long-term electronic archiving of all types of monitoring information. Medical staff can access patients' historical monitoring curves, alarm records, and rehabilitation assessment reports at any time through the hospital's HIS system. Based on the trends in pressure data changes, they can objectively assess the rehabilitation progress, adjust rehabilitation training programs and weight-bearing limits accordingly, and achieve remote rehabilitation guidance and individualized medical management. This transforms post-ankle surgery rehabilitation from a traditional experience-based model relying on patients' subjective feelings into a quantifiable, traceable, and real-time intervention-enabled precision rehabilitation management model.

[0047] Those skilled in the art will understand that the parameters mentioned in the above embodiments are merely exemplary selections and are not intended to limit the present invention. Without departing from the core concept of the present invention, those skilled in the art have reason to reasonably adjust and extend the above parameters according to the specific needs of actual application scenarios, system resource limitations, or clinical usage requirements, and such parameter adjustments should all fall within the protection scope of the present invention.

Claims

1. A smart plaster cast pad for the ankle joint, characterized in that, It includes a pad body, a flexible pressure sensor array, and a pressure transmission module; the flexible pressure sensor array is arranged in the pad body, and the pressure transmission module is connected to the flexible pressure sensor array; in use, the flexible pressure sensor array collects pressure distribution parameters in different areas of the ankle joint and feeds back the collected pressure information to the pressure transmission module, and the pressure transmission module transmits the pressure information to a mobile terminal.

2. The intelligent plaster cast pad for the ankle joint according to claim 1, characterized in that, The pad body includes a skin-adhesive layer and a plaster adapter layer, and the flexible pressure sensor array is disposed between the skin-adhesive layer and the plaster adapter layer.

3. The intelligent plaster cast pad for the ankle joint according to claim 2, characterized in that, The flexible pressure sensor array is respectively set in the medial malleolus, lateral malleolus, calcaneus, tibia, and metatarsal regions to realize pressure zone detection.

4. The intelligent plaster cast pad for the ankle joint according to claim 3, characterized in that, The flexible pressure sensing array is composed of several flexible pressure sensing units arranged in a regular pattern; the center-to-center spacing of the flexible pressure sensing units in each zone is 10mm to 15mm, and the number of flexible pressure sensing units in each zone is 20 to 42.

5. The intelligent plaster cast pad for the ankle joint according to claim 4, characterized in that, The range of the flexible pressure sensing units in the tibia, medial malleolus, and lateral malleolus regions is 0–100 kPa; the range of the flexible pressure sensing units in the calcaneus and metatarsal regions is 0–200 kPa.

6. The intelligent plaster cast pad for the ankle joint according to claim 5, characterized in that, The flexible pressure sensor array in each zone of the intelligent gypsum liner outputs a matrix scan line, which is connected to the pressure transmission module via a flexible conductive line.

7. The intelligent plaster cast pad for the ankle joint according to claim 6, characterized in that, The pressure transmission module includes a multiplexer, a timing control unit, a signal processing unit, a power supply unit, and a wireless communication unit. Each partition row and column signal line is connected to the multiple input channel of the multiplexer switch. The timing control unit performs periodic selection control on the multiplexer switch according to the preset timing logic. After signal processing, the original pressure signal is sent to an external mobile terminal in real time through the built-in wireless communication unit.

8. An ankle joint pressure distribution analysis system, characterized in that, The invention includes the ankle joint intelligent plaster cast pad, pressure distribution analysis module, and hospital HIS system as described in any one of claims 1-7; the intelligent plaster cast pad is used to collect raw pressure data of the ankle joint related areas and output it wirelessly; the pressure distribution analysis module is a smartphone APP or doctor-side software, used to receive raw pressure data of each area, perform data preprocessing, parameter calculation, safety threshold judgment and alarm operation, and generate a rehabilitation report; the hospital HIS system is used to receive the analyzed data, alarm information, abnormal event records and rehabilitation reports uploaded by the pressure distribution analysis module, and realize centralized data management, archiving and rehabilitation effect evaluation.

9. The ankle joint pressure distribution analysis system according to claim 8, characterized in that, The pressure distribution analysis module has a built-in adjustable safety threshold model based on different fracture types, postoperative weeks and patient weight. It presets peak pressure thresholds for different ROIs. When the pressure of any ROI exceeds the corresponding threshold for ≥3 seconds, the system will issue a vibration or sound alarm and record the abnormal event.

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