An integrated wireless pressure ulcer monitoring device and system

Abstract

The application discloses an integrated wireless pressure sore monitoring device and system, which divides a flexible printed circuit board into a sensor array area, a signal transmission area and a functional circuit area; wherein the sensor array area is provided with N flexible capacitive pressure sensors; the signal transmission area is provided with N transmission wires; and the functional circuit area is provided with a microprocessor, a wireless communication module, a voltage stabilizing module and N relaxation oscillation modules; since each flexible capacitive pressure sensor adopts an independent signal processing architecture, precise pressure collection can be realized; the microprocessor is used for realizing pressure value calculation of the flexible capacitive pressure sensor, and after all pressure value data are collected, the wireless communication module is used for wirelessly sending the pressure value data to an external data receiving terminal, so that pressure sore risk assessment can be facilitated; therefore, the application can realize dynamic and precise local pressure monitoring, and meet the needs of clinical precise prevention and early warning of pressure sores.

Description

Technical Field

[0001] This invention belongs to the field of medical pressure ulcer monitoring technology, and particularly relates to an integrated wireless pressure ulcer monitoring device and system. Background Technology

[0002] The normal structure and function of human skin and subcutaneous tissues depend on continuous blood perfusion and a suitable mechanical load environment. When local tissues are subjected to excessive mechanical load for a prolonged period, their blood perfusion is severely affected, leading to tissue damage and even necrosis, ultimately resulting in pressure ulcers. The occurrence of pressure ulcers is closely related to a patient's quality of life and recovery process, and is a crucial indicator of the quality of medical care. In the clinical field, early warning and real-time monitoring of pressure ulcers have become key aspects of nursing intervention and prognostic assessment for high-risk groups such as those who are bedridden or have limited mobility. It is widely used for pressure ulcer risk assessment in high-risk groups such as intensive care unit patients and patients with spinal cord injuries, as well as for evaluating the effectiveness of pressure ulcer prevention during postoperative rehabilitation. Numerous studies have confirmed the importance of pressure ulcer monitoring and emphasized its profound significance for the overall health maintenance and quality of life improvement of high-risk patients.

[0003] The core of pressure ulcer monitoring lies in accurately collecting continuous mechanical load on the skin and contact interface, and then achieving pressure ulcer risk classification and early warning by tracking two key indicators: pressure intensity and duration in real time. Currently, most digital monitoring solutions use large-size pressure ulcer monitoring mattresses. While these can achieve quantitative collection of pressure data, they have significant limitations in clinical application: they are bulky, have low spatial resolution, and struggle to accurately locate critical pressure peaks. Furthermore, pressure ulcer-prone areas change significantly with surgical sites and bedridden positions; large-size pressure ulcer monitoring mattresses have poor adaptability to the human body's curvature, making it impossible to achieve dynamic and accurate local pressure monitoring of high-risk areas such as bony prominences under different individuals and positions. This can lead to missed detections in critical areas and delayed warnings, failing to meet the clinical needs for precise prevention and early warning of pressure ulcers.

[0004] Therefore, it is necessary to design a pressure ulcer monitoring program that focuses on key areas of the patient and can achieve dynamic and accurate local pressure monitoring to meet the clinical needs for precise prevention and early warning of pressure ulcers. Summary of the Invention

[0005] The purpose of this invention is to provide an integrated wireless pressure ulcer monitoring device that can achieve dynamic and accurate local pressure monitoring, meeting the clinical needs for precise prevention and early warning of pressure ulcers.

[0006] To achieve the objectives of this invention, the following technical solution is adopted:

[0007] An integrated wireless pressure ulcer monitoring device includes:

[0008] Flexible printed circuit board, which has a sensor array area, a signal transmission area and a functional circuit area;

[0009] The sensor array area is provided with N flexible capacitive pressure sensors; the signal transmission area is provided with N transmission wires; the functional circuit area is provided with a microprocessor, a wireless communication module, a voltage regulator module, and N relaxation oscillation modules; where N is an integer.

[0010] Each of the flexible capacitive pressure sensors is electrically connected to a corresponding relaxation oscillation module via a corresponding transmission wire; the relaxation oscillation module is used to output an oscillation waveform of a corresponding frequency according to the capacitance value of its corresponding flexible capacitive pressure sensor.

[0011] The microprocessor is electrically connected to the wireless communication module and each of the relaxation oscillation modules, respectively, and is used to receive the oscillation waveform output by each of the relaxation oscillation modules, calculate the pressure value borne by the corresponding flexible capacitive pressure sensor according to the frequency of the oscillation waveform, and output the calculated pressure values ​​as pressure value data to the wireless communication module.

[0012] The wireless communication module is used to receive the pressure value data and wirelessly transmit the pressure value data to an external data receiving terminal.

[0013] The voltage regulator module is used to regulate the external power input to provide a stable operating voltage for the microprocessor, the wireless communication module, and the relaxation oscillation module.

[0014] According to a specific embodiment, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the relaxation oscillation module is configured to output an oscillation waveform as a square wave; the microprocessor is configured to calculate the square wave period based on the rising or falling edge of the oscillation waveform, then calculate the frequency of the oscillation waveform based on the square wave period, and calculate the capacitance value of the flexible capacitive pressure sensor based on the frequency of the oscillation waveform and the circuit parameters of the relaxation oscillation module, and then calculate the pressure value borne by the flexible capacitive pressure sensor based on the inherent capacitance-pressure characteristics of the flexible capacitive pressure sensor.

[0015] According to one specific embodiment, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the microprocessor is further configured to, after detecting a calibration trigger signal, use the currently calculated capacitance value as the zero point of pressure detection to eliminate the zero-point drift of the flexible capacitive pressure sensor; wherein, the calibration trigger signal is generated by a button circuit provided in the functional circuit area or received by the wireless communication module.

[0016] According to one specific embodiment, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the flexible capacitive pressure sensor includes:

[0017] Planar dielectric layer;

[0018] A microarray structure dielectric layer is bonded to the planar structure dielectric layer to form a complementary coupling dielectric structure;

[0019] A superhydrophobic modified layer is applied to the surface of the planar dielectric layer and / or the microarray dielectric layer.

[0020] And electrodes respectively attached to both sides of the complementary coupling dielectric structure.

[0021] According to a specific embodiment, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the dielectric layer of the microarray structure has an n×n solid hemispherical array structure, where n is an integer from 3 to 5; the diameter of each solid hemisphere is 2 to 5 mm.

[0022] According to a specific embodiment, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the sensor array area is provided with N electrode pads and at least one grounding pad, and each electrode pad is respectively welded to one side electrode of the flexible capacitive pressure sensor; a flexible grounding circuit board is also provided above the sensor array area, the flexible grounding circuit board is provided with N electrode pads and at least one grounding pad, and each pad is respectively welded to the other side electrode of the flexible capacitive pressure sensor; moreover, the electrode pads on the flexible grounding circuit board are electrically connected to the grounding pad provided thereon, and the grounding pad of the flexible grounding circuit board is electrically connected to the grounding pad of the sensor array area.

[0023] According to one specific embodiment, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the sensor array area and the flexible grounding circuit board are treated with a superhydrophobic process relative to the outer surface of the pad.

[0024] According to one specific embodiment, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the wireless communication module is a Bluetooth communication module.

[0025] Based on the same inventive concept, the present invention also provides a wireless pressure ulcer monitoring system, which includes:

[0026] A data receiving terminal; and the integrated wireless pressure ulcer monitoring device provided by the present invention;

[0027] The data receiving terminal is used to receive the pressure value data sent by the integrated wireless pressure ulcer monitoring device, and to perform a pressure ulcer risk assessment based on the pressure value data to determine whether to issue an early warning.

[0028] According to a specific embodiment, in the wireless pressure ulcer monitoring system provided by the present invention, the data receiving terminal is configured to: calculate a pressure ulcer risk index based on a set pressure threshold and the pressure values ​​borne by each of the flexible capacitive pressure sensors indicated in the pressure value data; and calculate an early warning progress index by integrating and accumulating the pressure ulcer risk index and the recorded total pressure bearing time; if the early warning progress index reaches a set early warning level threshold, an early warning prompt corresponding to the early warning level is issued.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] 1. The integrated wireless pressure ulcer monitoring device provided by this invention divides the flexible printed circuit board into a sensor array area, a signal transmission area, and a functional circuit area. The sensor array area is attached to the pressure ulcer-prone parts of the human body and employs an independent signal processing architecture where each flexible capacitive pressure sensor corresponds to a relaxation oscillation module, enabling accurate pressure acquisition by each sensor. A microprocessor calculates the pressure values ​​borne by the flexible capacitive pressure sensors, and after summarizing all pressure data, it wirelessly transmits it to an external data receiving terminal via a wireless communication module, facilitating pressure ulcer risk assessment. Therefore, this invention enables dynamic and accurate local pressure monitoring, meeting the clinical needs for precise prevention and early warning of pressure ulcers.

[0031] 2. In the integrated wireless pressure ulcer monitoring device provided by this invention, the flexible capacitive pressure sensor includes a planar dielectric layer and a microarray dielectric layer. The microarray dielectric layer has a solid hemispherical array structure. When pressure is applied, the concentrated deformation at the point contact of the solid hemisphere amplifies the change in the thickness of the dielectric layer. This increased thickness directly enhances the capacitance change, making the sensor more sensitive to minute pressures. Regarding the expansion of the dynamic measurement range, the solid microspheres exhibit gradient deformation characteristics. Under low pressure, only the top of the hemisphere undergoes elastic deformation; under high pressure, the entire hemisphere gradually compresses. This staged deformation pattern can cover multiple pressure ranges from low to medium to high pressure, avoiding the problems of insufficient deformation under low pressure and premature saturation under high pressure inherent in planar dielectric layers. Therefore, this invention, through structural optimization of the flexible capacitive pressure sensor, can improve the sensitivity of pressure detection and the dynamic measurement range.

[0032] 3. In the wireless pressure ulcer monitoring system provided by this invention, the data receiving terminal calculates the pressure ulcer risk index based on the set pressure threshold and the pressure values ​​borne by each flexible capacitive pressure sensor indicated in the pressure value data. It then integrates and accumulates the pressure ulcer risk index and the recorded total pressure-bearing time to calculate the early warning progress index and performs graded early warnings based on the early warning progress index. Therefore, this invention, considering the impact of pressure-time accumulation on tissue tolerance, can achieve accurate prediction of early hidden injuries, providing a scientific basis for clinical nursing intervention. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of the integrated wireless pressure ulcer monitoring device of the present invention;

[0034] Figure 2 This is a circuit connection diagram of the tension-relaxation oscillation module in the integrated wireless pressure ulcer monitoring device of the present invention;

[0035] Figure 3 This is a circuit connection diagram of the voltage stabilizing module in the integrated wireless pressure ulcer monitoring device of the present invention;

[0036] Figure 4 This is a schematic diagram of the flexible capacitive pressure sensor in the integrated wireless pressure ulcer monitoring device of the present invention;

[0037] Figure 5 This is a schematic diagram of the test of the integrated wireless pressure ulcer monitoring device of the present invention;

[0038] Figure 6 This is a stepped signal response diagram of the flexible capacitive pressure sensor in the integrated wireless pressure ulcer monitoring device of the present invention under graded pressure.

[0039] Figure 7 This is a signal response diagram of the flexible capacitive pressure sensor in the integrated wireless pressure ulcer monitoring device of the present invention under instantaneous loading and unloading.

[0040] Figure 8 This is a schematic diagram of the wireless pressure ulcer monitoring system provided by the present invention. Detailed Implementation

[0041] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0042] like Figures 1-3 As shown, the integrated wireless pressure ulcer monitoring device provided by the present invention includes:

[0043] The flexible printed circuit board 10 has a sensor array area 11, a signal transmission area 12, and a functional circuit area 13.

[0044] The sensor array area 11 is provided with N flexible capacitive pressure sensors; the signal transmission area 12 is provided with N transmission lines; the functional circuit area 13 is provided with a microprocessor, a wireless communication module, a voltage regulator module, and N relaxation oscillation modules; where N is an integer.

[0045] Each of the flexible capacitive pressure sensors is electrically connected to a corresponding relaxation oscillation module via a corresponding transmission wire; the relaxation oscillation module is used to output an oscillation waveform of a corresponding frequency according to the capacitance value of its corresponding flexible capacitive pressure sensor.

[0046] The microprocessor is electrically connected to the wireless communication module and each of the relaxation oscillation modules, respectively, and is used to receive the oscillation waveform output by each of the relaxation oscillation modules, calculate the pressure value borne by the corresponding flexible capacitive pressure sensor according to the frequency of the oscillation waveform, and output the calculated pressure values ​​as pressure value data to the wireless communication module.

[0047] The wireless communication module is used to receive the pressure value data and wirelessly transmit the pressure value data to an external data receiving terminal.

[0048] The voltage regulator module is used to regulate the external power input to provide a stable operating voltage for the microprocessor, the wireless communication module, and the relaxation oscillation module.

[0049] Specifically, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the relaxation oscillation module is configured to output an oscillation waveform as a square wave; the microprocessor is configured to calculate the square wave period based on the rising or falling edge of the oscillation waveform, then calculate the frequency of the oscillation waveform based on the square wave period, and calculate the capacitance value of the flexible capacitive pressure sensor based on the frequency of the oscillation waveform and the circuit parameters of the relaxation oscillation module, and then calculate the pressure value borne by the flexible capacitive pressure sensor based on the inherent capacitance-pressure characteristics of the flexible capacitive pressure sensor.

[0050] In implementation, such as Figure 2As shown, the relaxation oscillation module is a relaxation oscillation circuit based on a TLV3501 chip, with an output oscillation waveform of a square wave. The flexible capacitive pressure sensor can be considered a variable capacitor. Since the frequency of the output square wave in the relaxation oscillation circuit is related to the parameters of the capacitors and resistors in the circuit, the output frequency of the square wave will change according to the capacitance value of the flexible capacitive pressure sensor. Thus, the capacitance value of the flexible capacitive pressure sensor can be measured by measuring the frequency of the square wave output by the relaxation oscillation module. Meanwhile, the other fixed capacitors and resistors in this relaxation oscillation circuit are of high precision type.

[0051] Furthermore, the microprocessor uses the STM32F407 series chip. The square wave output of the TLV3501 chip in the relaxation oscillation module is sent to the microprocessor. The microprocessor triggers an interrupt on the rising or falling edge. The microprocessor's timer records the internal clock count value of the two interrupts, thus obtaining the square wave period and calculating the square wave frequency.

[0052] In implementation, such as Figure 3 As shown, the voltage regulator module uses the ME6211C33R5G chip, which can regulate the external power input voltage in the range of 3.3–5V to a stable 3.3V output, thereby providing a stable operating voltage for the microprocessor, relaxation oscillation module and wireless communication module.

[0053] In implementation, the wireless communication module adopts a low-power BLE5.2 Bluetooth module with a communication distance of 10-100m; the microprocessor summarizes all the calculated pressure values ​​into pressure value data and outputs it to the Bluetooth module; after receiving the pressure value data, the Bluetooth module converts the pressure value data into wireless Bluetooth transmission data according to the Bluetooth transmission protocol and transmits it wirelessly to the data receiving terminal via Bluetooth. Similarly, the data receiving terminal receives the wireless Bluetooth transmission data through the Bluetooth module.

[0054] In implementation, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the microprocessor is further configured to, after detecting a calibration trigger signal, use the currently calculated capacitance value as the zero point of pressure detection to eliminate the zero-point drift of the flexible capacitive pressure sensor; wherein, the calibration trigger signal is generated by a button circuit provided in the functional circuit area or received by the wireless communication module.

[0055] Furthermore, using the reference condition of all flexible capacitive pressure sensors being in an unloaded, zero-pressure state as the calibration reference condition, the microprocessor is electrically connected to the calibration button circuit. When a calibration trigger signal is detected, the microprocessor automatically calibrates the currently calculated capacitance value as the zero point of pressure detection. Of course, the calibration trigger signal sent by the data receiving terminal can be received through a wireless communication module, which not only simplifies the circuit but also facilitates user operation.

[0056] In practice, the number of flexible capacitive pressure sensors in the sensor array area of ​​the integrated wireless pressure ulcer monitoring device provided by this invention can be adaptively adjusted according to the required area and spatial resolution of the pressure ulcer monitoring zone. The length of the transmission wire in the signal transmission area can also be adjusted according to actual needs.

[0057] Because the integrated wireless pressure ulcer monitoring device provided by this invention uses the above-mentioned technical means to divide the flexible printed circuit board into a sensor array area, a signal transmission area, and a functional circuit area; wherein, the sensor array area is attached to the parts of the human body prone to pressure ulcers, and adopts an independent signal processing architecture with each flexible capacitive pressure sensor corresponding to a relaxation oscillation module, so as to achieve accurate pressure acquisition of each flexible capacitive pressure sensor; the microprocessor calculates the pressure value borne by the flexible capacitive pressure sensor, and after summarizing all pressure value data, it is wirelessly transmitted to an external data receiving terminal through a wireless communication module, which facilitates pressure ulcer risk assessment; therefore, this invention can achieve dynamic and accurate local pressure monitoring, and can meet the clinical needs for precise prevention and early warning of pressure ulcers.

[0058] like Figure 4 As shown, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the flexible capacitive pressure sensor includes:

[0059] Planar dielectric layer 101;

[0060] The microarray structure dielectric layer 102 is bonded to the planar structure dielectric layer 101 to form a complementary coupling dielectric structure.

[0061] A superhydrophobic modified layer is applied to the surface of the planar dielectric layer and / or the microarray dielectric layer.

[0062] And electrodes respectively attached to both sides of the complementary coupling dielectric structure.

[0063] Specifically, the dielectric layer of the microarray structure has an n×n solid hemispherical array structure, where n is an integer from 3 to 5; the diameter of each solid hemisphere 103 is 2 to 5 mm.

[0064] In implementation, the planar dielectric layer 101 and the microarray dielectric layer 102 are made of an elastic composite material doped with multi-walled carbon nanotubes; the mass percentage of multi-walled carbon nanotubes in the elastic composite material is 3% to 6%. The superhydrophobic modified layer is formed by spraying and curing a solution composed of hydrophobic silica nanoparticles, cyclohexane, PDMS prepolymer, and a curing agent. The solid hemispherical array structure on the microarray dielectric layer can be fabricated by designing a corresponding mold.

[0065] like Figure 5As shown, the integrated wireless pressure ulcer monitoring device provided by this invention was tested using an oscilloscope; specific test data are as follows. Figure 6 and Figure 7 As shown. In Figure 6 The flexible capacitive pressure sensor exhibits a stepped, stable response characteristic under different pressure gradients. This characteristic stems from the gradient deformation properties of the solid hemispherical array of the dielectric layer in the microarray structure. Under low pressure, only the top of the solid hemisphere undergoes elastic deformation, resulting in a slight change in the dielectric layer thickness, and the sensor output signal shows a slow, stable upward trend. As the pressure gradually increases, the solid hemisphere begins to compress, and the change in dielectric layer thickness increases accordingly, with the sensor signal also showing a stepped increase. This fundamentally solves the technical problems of traditional planar dielectric layer sensors, such as insufficient deformation under low pressure leading to weak signals and premature saturation under high pressure limiting the detection range. It achieves continuous and accurate detection across the entire pressure range from low to high, allowing the sensor to maintain stable detection performance at different pressure levels. Figure 7 The signal response of the flexible capacitive pressure sensor under instantaneous loading and unloading shows that when pressure is applied and removed instantaneously, the sensor signal can quickly follow the pressure change and recover. This is because the solid hemispherical point contact structure concentrates the force at the hemispherical contact point when pressure is applied, greatly amplifying the change in dielectric layer thickness and directly increasing the amplitude of capacitance change. This makes the sensor extremely sensitive to minute pressures. At the same time, the dielectric layer material of the elastic composite material has good elastic recovery, allowing the dielectric layer to quickly return to its initial state after the pressure is removed, and the sensor signal also quickly returns to zero. This ensures accurate capture of instantaneous pressure changes and effectively guarantees the real-time and accuracy of dynamic pressure monitoring, meeting the monitoring needs of subtle changes in local pressure in the human body during clinical practice.

[0066] In the integrated wireless pressure ulcer monitoring device provided by this invention, the flexible capacitive pressure sensor includes a planar dielectric layer and a microarray dielectric layer. The microarray dielectric layer has a solid hemispherical array structure. When pressure is applied, the point contact of the solid hemisphere with concentrated deformation amplifies the change in the thickness of the dielectric layer. The increased change in the thickness of the dielectric layer directly improves the capacitance change, making the sensor more sensitive to small pressures. In terms of expanding the dynamic measurement range, because the solid microsphere has gradient deformation characteristics, only the top of the hemisphere undergoes elastic deformation under low pressure, while the entire hemisphere gradually compresses under high pressure. This staged deformation mode can cover multiple ranges from low pressure to medium pressure to high pressure, thus avoiding the problems of insufficient deformation of the planar dielectric layer under low pressure and premature saturation under high pressure.

[0067] Combined Figure 1As shown, in the integrated wireless pressure ulcer monitoring device provided by the present invention, the sensor array area is provided with N electrode pads and at least one grounding pad, and each electrode pad is respectively soldered to one side electrode of the flexible capacitive pressure sensor; a flexible grounding circuit board is also provided above the sensor array area, and the flexible grounding circuit board ( Figure 1 (Not shown in the image) The flexible grounding circuit board has N electrode pads and at least one grounding pad. Each pad is used to weld the other electrode of the flexible capacitive pressure sensor. Furthermore, the electrode pads on the flexible grounding circuit board are electrically connected to the grounding pads thereon, and the grounding pads of the flexible grounding circuit board are electrically connected to the grounding pads of the sensor array area.

[0068] In implementation, the sensor array region and the outer surface of the flexible grounding circuit board relative to the pads are treated with a superhydrophobic process. This superhydrophobic process involves spraying hydrophobic silica nanoparticles onto the outer surface of the sensor array region and the flexible grounding circuit board relative to the pads. Simultaneously, to improve the durability of the sensor array region, a reinforcing material is used to increase its strength; the preferred reinforcing material is polyimide.

[0069] In implementation, both the flexible printed circuit board and the flexible grounding circuit board are FPCBs, and all components on the flexible printed circuit board are preferably surface-mount packages to avoid poor contact of the vias and contact pins of through-hole components when the flexible board is bent. At the same time, rigid pins will generate continuous wear and compressive stress on the opening area, causing irreversible damage such as substrate cracking and metallized hole failure, which significantly reduces the mechanical reliability and long-term working stability of the system.

[0070] In addition, for the convenience of clinical or home use, the external power input of the integrated wireless pressure ulcer monitoring device provided by the present invention is preferably a lithium battery with a capacity of more than 1000mAh to drive the wireless pressure ulcer monitoring device to work for a long time.

[0071] like Figure 8 As shown, the present invention also provides a wireless pressure ulcer monitoring system, which includes:

[0072] A data receiving terminal; and the integrated wireless pressure ulcer monitoring device provided by the present invention;

[0073] The data receiving terminal is used to receive the pressure value data sent by the integrated wireless pressure ulcer monitoring device, and to perform a pressure ulcer risk assessment based on the pressure value data to determine whether to issue an early warning.

[0074] Specifically, in the wireless pressure ulcer monitoring system provided by the present invention, the data receiving terminal is configured to: calculate a pressure ulcer risk index based on a set pressure threshold and the pressure values ​​borne by each of the flexible capacitive pressure sensors indicated in the pressure value data; and calculate an early warning progress index by integrating and accumulating the pressure ulcer risk index and the recorded total pressure bearing time; if the early warning progress index reaches a set early warning level threshold, an early warning prompt corresponding to the early warning level is issued.

[0075] In implementation, the data receiving terminal is a mobile terminal. A smartphone application is developed, featuring a Bluetooth connection interface, a patient information and basic measurement parameter input interface, an n×n colorimetric pressure cloud map display interface, an early warning progress interface, and an alarm prompt interface. The colorimetric pressure cloud map display interface of the smartphone application uses a dynamic gradient color scale from 0 to 1000 kPa. Patient parameter configuration functions include monitoring site selection, pressure threshold setting (range 20-500 kPa), and alarm delay setting (range 10 min-5 h). Simultaneously, the smartphone application incorporates a dual-index pressure-time integral risk assessment algorithm, which integrates and accumulates the pressure ulcer risk index and the recorded total pressure bearing time to calculate the early warning progress index. The earliest non-zero pressure value data received after monitoring is initiated is used as the starting time for recording the total pressure bearing time.

[0076] The wireless pressure ulcer monitoring system provided by this invention first places the sensor array area on the area to be monitored. Then, patient information and basic measurement parameters are entered on the mobile terminal. After monitoring is started, the pressure sensed by the sensor array area in real time is converted into a real-time capacitance value. The relaxation oscillator module in the functional circuit area outputs an oscillation waveform of the corresponding frequency based on the capacitance value of the corresponding flexible capacitive pressure sensor. The microprocessor then performs frequency measurement and calculates the capacitance value and pressure value of the flexible capacitive pressure sensor. All calculated pressure values ​​are then summarized into pressure value data and output to the Bluetooth module. The pressure value data is then transmitted to the mobile terminal via Bluetooth. Based on the received pressure value data, the mobile terminal displays the pressure distribution of each flexible capacitive pressure sensor in the sensor array area in real time through a colorimetric pressure cloud map display interface. It also calculates the warning progress index using a dual-index pressure-time integral risk assessment algorithm. Simultaneously, thresholds corresponding to each warning level are set with reference to clinically set tissue tolerance thresholds. If the warning progress index reaches the set warning level threshold, a warning prompt for the corresponding warning level is issued. For example, when the warning progress index reaches 60%, 80%, and 100%, a graded alarm will be triggered on the mobile phone.

[0077] The pressure ulcer risk index is calculated based on the proximity of the actual pressure on the affected area to a set pressure threshold. The specific calculation method is as follows:

[0078] .

[0079] Therefore, the wireless pressure ulcer monitoring system provided by this invention, through the above-mentioned technical means, takes into account the impact of pressure-time accumulation on tissue tolerance, and sets up a dual-index pressure-time integral risk assessment algorithm, which can achieve accurate prediction of early hidden damage and provide a scientific basis for clinical nursing intervention.

[0080] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An integrated wireless pressure ulcer monitoring device, characterized in that, include: Flexible printed circuit board, which has a sensor array area, a signal transmission area and a functional circuit area; The sensor array area is provided with N flexible capacitive pressure sensors; the signal transmission area is provided with N transmission wires; the functional circuit area is provided with a microprocessor, a wireless communication module, a voltage regulator module, and N relaxation oscillation modules; where N is an integer. Each of the flexible capacitive pressure sensors is electrically connected to a corresponding relaxation oscillation module via a corresponding transmission wire; the relaxation oscillation module is used to output an oscillation waveform of a corresponding frequency according to the capacitance value of its corresponding flexible capacitive pressure sensor. The microprocessor is electrically connected to the wireless communication module and each of the relaxation oscillation modules, respectively, and is used to receive the oscillation waveform output by each of the relaxation oscillation modules, calculate the pressure value borne by the corresponding flexible capacitive pressure sensor according to the frequency of the oscillation waveform, and output the calculated pressure values ​​as pressure value data to the wireless communication module. The wireless communication module is used to receive the pressure value data and wirelessly transmit the pressure value data to an external data receiving terminal. The voltage regulator module is used to regulate the external power input to provide a stable operating voltage for the microprocessor, the wireless communication module, and the relaxation oscillation module.

2. The integrated wireless pressure ulcer monitoring device as described in claim 1, characterized in that, The relaxation oscillation module is configured to output a square wave oscillation waveform; the microprocessor is configured to calculate the square wave period based on the rising or falling edge of the oscillation waveform, then calculate the frequency of the oscillation waveform based on the square wave period, and calculate the capacitance value of the flexible capacitive pressure sensor based on the frequency of the oscillation waveform and the circuit parameters of the relaxation oscillation module, and then calculate the pressure value borne by the flexible capacitive pressure sensor based on the inherent capacitance-pressure characteristics of the flexible capacitive pressure sensor.

3. The integrated wireless pressure ulcer monitoring device as described in claim 2, characterized in that, The microprocessor is also configured to, upon detecting a calibration trigger signal, use the currently calculated capacitance value as the zero point of pressure detection to eliminate zero-point drift of the flexible capacitive pressure sensor; wherein the calibration trigger signal is generated by a button circuit in the functional circuit area or received by the wireless communication module.

4. The integrated wireless pressure ulcer monitoring device as described in claim 1, characterized in that, The flexible capacitive pressure sensor includes: Planar dielectric layer; A microarray structure dielectric layer is bonded to the planar structure dielectric layer to form a complementary coupling dielectric structure; A superhydrophobic modified layer is applied to the surface of the planar dielectric layer and / or the microarray dielectric layer. And electrodes respectively attached to both sides of the complementary coupling dielectric structure.

5. The integrated wireless pressure ulcer monitoring device as described in claim 4, characterized in that, The dielectric layer of the microarray structure has an n×n solid hemispherical array structure, where n is an integer from 3 to 5; the diameter of each solid hemisphere is 2 to 5 mm.

6. The integrated wireless pressure ulcer monitoring device as described in claim 4, characterized in that, The sensor array area is provided with N electrode pads and at least one ground pad, and each electrode pad is respectively welded to one side electrode of the flexible capacitive pressure sensor; a flexible grounding circuit board is also provided above the sensor array area, and the flexible grounding circuit board is provided with N electrode pads and at least one ground pad, and each pad is respectively welded to the other side electrode of the flexible capacitive pressure sensor; moreover, the electrode pads on the flexible grounding circuit board are electrically connected to the ground pad provided thereon, and the ground pad of the flexible grounding circuit board is electrically connected to the ground pad of the sensor array area.

7. The integrated wireless pressure ulcer monitoring device as described in claim 6, characterized in that, The sensor array area and the flexible grounding circuit board are treated with a superhydrophobic process on the outer surface of the surface where the pads are located.

8. The integrated wireless pressure ulcer monitoring device as described in claim 1, characterized in that, The wireless communication module is a Bluetooth communication module.

9. A wireless pressure ulcer monitoring system, characterized in that, include: Data receiving terminal; And, the integrated wireless pressure ulcer monitoring device as described in any one of claims 1 to 8; The data receiving terminal is used to receive the pressure value data sent by the integrated wireless pressure ulcer monitoring device, and to perform a pressure ulcer risk assessment based on the pressure value data to determine whether to issue an early warning.

10. The wireless pressure ulcer monitoring system as described in claim 9, characterized in that, The data receiving terminal is configured to: calculate a pressure ulcer risk index based on a set pressure threshold and the pressure values ​​borne by each of the flexible capacitive pressure sensors indicated in the pressure value data; and calculate an early warning progress index by integrating and accumulating the pressure ulcer risk index and the recorded total pressure bearing time. If the early warning progress index reaches the set early warning level threshold, an early warning prompt corresponding to the early warning level will be issued.

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