Closed-loop response type dressing based on semiconductor yarn logic gate circuit

Abstract

The invention discloses a closed-loop response type dressing based on a semiconductor yarn logic gate circuit, and belongs to the technical field of biomedical materials and flexible electronics. According to the dressing, an integrated solution is provided for solving the problems that an existing intelligent dressing is high in single biological parameter response false triggering rate, poor in multi-mode treatment synergy, insufficient in rigid electronic device biocompatibility and the like. The dressing comprises a biological sensing module which is integrated on the inner surface of the dressing and monitors key physiological indexes of a wound in real time through a plurality of sensitive yarns; the core of the logic control module is a logic gate circuit woven by semiconductor yarns, a treatment loop is triggered based on a multi-parameter collaborative judgment mechanism (only when all monitoring parameters exceed preset thresholds simultaneously), and the false triggering rate is remarkably reduced; the execution module is used for applying specific electric field pulses through the same voltage modulation electrode, synchronously driving the electric field responsive drug-loaded core-shell microspheres to accurately release drugs and applying directional electrical stimulation to wound tissues so as to realize treatment synergy; the wireless transmission module is used for realizing encrypted communication of monitoring data, early warning and event information; the self-powered system adopts a flexible yarn zinc air battery and realizes continuous energy supply based on oxygen reaction in air. The flexible yarn device and the three-dimensional weaving integration technology are combined, it is ensured that the dressing and the dynamic wound surface are attached in a self-adaptive conformal mode, and high biocompatibility, wearing comfort and energy self-sustaining performance are achieved; through a'perception-decision-execution-communication 'closed-loop architecture, the accuracy, the intelligent level and the intervention timeliness of chronic wound management are remarkably improved.

Description

Technical Field

[0001] The present invention relates to the field of biomedical materials and flexible electronic technology, and in particular to a closed-loop responsive dressing based on a semiconductor yarn logic gate circuit. Background Art

[0002] Chronic wounds, such as diabetic foot ulcers, pose huge challenges to clinical treatment due to their complex pathophysiological environment and healing barriers. Wound dressings are a basic means of managing wounds. Traditional dressings (such as gauze, sponges, hydrocolloid dressings, etc.) mainly provide passive functions such as covering, absorbing exudate and maintaining a moist environment. However, they lack the ability to monitor key physiological and biochemical indicators of wounds (such as pH, specific enzyme activity, inflammatory factors, temperature, humidity, etc.) in real time. Medical staff usually need to change dressings regularly and perform visual observation or sampling tests to assess the status of the wound, which may lead to delays in the judgment and intervention of problems such as infection, increased inflammation or stagnant healing.

[0003] In order to improve the intelligence level of dressings, researchers have developed a variety of "smart dressings". One type of smart dressing is based on environmentally responsive materials, such as thermosensitive or pH-sensitive hydrogels. This type of dressing can release drugs or manage exudates by changing the physical and chemical properties of the material itself (such as swelling / contraction, degradation) when detecting specific stimuli (such as temperature or pH changes). However, this type of system based on a single material response can usually only respond to changes in a single or a few biomarkers, making it difficult to make a comprehensive judgment on the wound status. For example, a single increase in pH may be a signal of infection or a manifestation of the inflammatory stage in the normal healing process, which can easily lead to nonspecific responses or false triggering.

[0004] Another type of smart dressing attempts to integrate electronic systems based on silicon-based semiconductor technology (such as microsensors, microprocessors, and actuators). This type of system has advantages in signal processing, logical judgment, and multi-parameter integration. However, traditional silicon-based electronic devices are generally rigid and brittle, and there is a significant mismatch with the mechanical properties (such as flexibility and stretchability) of human soft tissue (especially wounds in active areas). Long-term use may cause patient discomfort, stress damage to the skin, and even failure of the device itself. In addition, providing continuous power supply for such electronic systems is also a challenge. Relying on wires to connect to an external power source or using traditional batteries in rigid packages will limit the patient's freedom of movement and may pose safety risks (such as leakage, heat generation) or increase the size and hardness of the dressing.

[0005] Therefore, developing a closed-loop responsive smart dressing that can monitor wound status non-invasively, in real time, and with multiple parameters, has reliable logical judgment capabilities to distinguish different wound conditions, and can accurately trigger treatment (such as on-demand drug release and electrical stimulation), while maintaining excellent flexibility, biocompatibility, and wearing comfort, and solves the problem of long-term reliable energy supply, is of great significance for improving chronic wound management and enhancing patients' quality of life. Summary of the Invention

[0006] The purpose of the present invention is to address the problems of high false triggering rate, poor coordination of treatment modes, and biocompatibility and comfort caused by the mismatch between rigid electronic devices and the mechanical properties of soft tissues caused by the insufficient multi-parameter comprehensive judgment ability of existing intelligent wound dressings. The present invention provides a closed-loop responsive dressing based on semiconductor yarn logic gate circuits.

[0007] The technical solution adopted to achieve the purpose of the present invention is:

[0008] A closed-loop responsive dressing based on a semiconductor yarn logic gate circuit, comprising a dressing body, a biosensor module, a logic control module, an execution module, a wireless transmission module, a self-powered system, and a packaging structure;

[0009] The dressing body is made of a breathable and biocompatible material;

[0010] The biosensor module is integrated into the inner surface area of ​​the dressing body corresponding to the wound location and includes 3 to 6 physiological indicator monitoring yarns, which are used to monitor changes in key wound indicator data to fully reflect the physiological environment and metabolic state of the wound;

[0011] The logic control module is integrated into the dressing body and includes: a signal conditioning unit, an analog-to-digital conversion unit, a core logic processing unit based on a semiconductor yarn transistor woven structure, and a threshold judgment and comparison unit; the logic control module is configured to: receive signals from the biosensor module, and activate a warning signal if at least K (K is a preset value, 2≤K≤5) of the monitored physiological index parameters exceed their independent thresholds; and activate a treatment enable signal if all M (M is the total number of input parameters, 3≤M≤6) parameters exceed their respective thresholds;

[0012] The execution module is integrated into the dressing body and includes an electrically controlled drug release unit composed of drug-loaded core-shell microspheres and a voltage modulation electrode; the shell of the core-shell microspheres is an electric field responsive material, and the electrically controlled drug release unit is distributed in a sheet-like manner on the voltage modulation electrode; the execution module is configured to: after receiving the treatment enable signal, apply electric field stimulation through the voltage modulation electrode to trigger the core-shell microspheres to release the drug and perform electrical stimulation treatment on the wound;

[0013] The wireless transmission module is integrated into the dressing body and is used for data communication;

[0014] The self-powered system is integrated on the outer surface of the dressing body and includes a flexible yarn zinc-air battery and a battery management system; the battery management system includes a voltage monitoring circuit for triggering a low-battery warning when the battery voltage falls below a critical value;

[0015] The packaging structure covers the dressing body and each module.

[0016] In the above technical solution, the physiological indicator monitoring yarn of the biosensor module adopts a serpentine arrangement structure to improve tensile strain tolerance.

[0017] In the above technical solution, the electrical stimulation therapy outputs symmetrical or asymmetrical biphasic pulses.

[0018] In the above technical solution, the pulses output by the voltage modulation electrode include: a first type of pulse with a frequency range of 50 Hz to 200 Hz and a pulse width range of 50 μs to 200 μs, which is mainly used to enhance tissue permeability; and a second type of pulse with a frequency range of 0.1 Hz to 5 Hz and a pulse width range of 5 ms to 100 ms, which is mainly used to drive the core-shell microspheres to release drugs; wherein the electric field response threshold of the core-shell microsphere shell material matches the amplitude and duration of the second type of pulse.

[0019] In the above technical solution, the semiconductor yarn transistor adopts a cross-woven structure of P-type and N-type yarns to form a complementary logic circuit.

[0020] In the above technical solution, the wireless transmission module adopts low-power Bluetooth or proprietary ISM band protocol, supports encryption frame structure and dynamic key update mechanism; and adopts event-driven wake-up mechanism and duty cycle polling mechanism with less than 1% to work.

[0021] In the above technical solution, the dressing body is formed by multi-layer fabric integrated weaving technology, wherein: the inner contact layer is composed of antibacterial fabric; the middle functional layer includes the vertical interconnection structure of the biosensor module, logic control module and execution module; and the outer packaging layer is a waterproof and breathable layer.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] 1. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit of the present invention significantly reduces the false trigger rate caused by fluctuations in a single parameter and improves the accuracy and reliability of the judgment of wound status (such as infection) through a multi-parameter (3-6) biosensor network combined with configurable threshold logic judgment (at least K over-threshold warnings and all M over-threshold trigger treatments).

[0024] 2. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit of the present invention adopts all-yarn-based devices (sensing yarn, semiconductor yarn transistor, battery yarn) and three-dimensional weaving integration technology, so that the entire dressing system has extremely low bending stiffness and excellent stretchability, and can conform to the dynamic wound surface, greatly improving the compatibility of the bioelectronic interface and reducing stress damage and discomfort caused by long-term use.

[0025] 3. The closed-loop responsive dressing based on semiconductor yarn logic gate circuits utilizes a single pair of electrodes to achieve spatiotemporal coordination of electrically controlled drug release and electrical stimulation therapy. Electric field pulses with specific parameters not only trigger on-demand drug release but also act directly on wound tissue, promoting cell proliferation, angiogenesis, collagen synthesis, enhancing local blood circulation, and inhibiting bacterial biofilm formation, thereby accelerating wound healing.

[0026] 4. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit of the present invention adopts flexible yarn zinc-air battery as energy source, which has high energy density. Its unique chemical properties enable it to have a certain capacity recovery potential after shallow discharge. Combined with the low power warning of the battery management system, it supports the long-term continuous or intermittent working requirements of the dressing.

[0027] 5. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit of the present invention constructs a complete "perception (biosensing) - decision-making (logic control) - execution (drug release / electrical stimulation)" closed-loop response architecture. Based on real-time multi-parameter wound information, it makes autonomous and dynamic decisions and triggers precise treatment through semiconductor yarn logic circuits, realizing intelligent and personalized treatment intervention.

[0028] 6. The closed-loop responsive dressing based on semiconductor yarn logic gate circuits of the present invention integrates a low-power wireless transmission module and supports encrypted data communication, which facilitates medical staff to remotely monitor wound status and treatment history, protects patient privacy and system security, and avoids the trouble of frequent dressing changes for testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 Shown is a schematic diagram of the planar layout of the closed-loop responsive dressing based on semiconductor yarn logic gate circuits of the present invention.

[0030] Figure 2 Shown is a schematic diagram of the semiconductor yarn logic gate circuit structure of the closed-loop responsive dressing based on the semiconductor yarn logic gate circuit of the present invention.

[0031] Figure 3 Shown is a schematic diagram of the connection between the yarn comparator unit and the signal processing circuit of the closed-loop responsive dressing based on the semiconductor yarn logic gate circuit of the present invention.

[0032] Figure 4 Shown is a working logic block diagram of the closed-loop responsive dressing based on semiconductor yarn logic gate circuit of the present invention.

[0033] Figure 5 Shown is a schematic diagram of the three-dimensional layered structure of the closed-loop responsive dressing based on semiconductor yarn logic gate circuits of the present invention.

[0034] Figure 6 Shown is a control logic flow chart of the closed-loop responsive dressing based on semiconductor yarn logic gate circuits of the present invention.

[0035] In the figure: 1-dressing body; 1-1-dressing first bonding area; 1-2-dressing second bonding area; 2-biosensor module; 2-1-pH sensitive yarn; 2-2-glucose sensitive yarn; 2-3-uric acid sensitive yarn; 2-4-reference electrode; 2-5-counter electrode; 3-electrically controlled drug release unit; 4-voltage modulation electrode; 5-logic control module; 6-execution module; 7-self-powered system; 8-semiconductor yarn transistor; 9-biosensing and response treatment layer; 10-transmission layer; 11-execution layer; 12-wireless transmission module. DETAILED DESCRIPTION

[0036] The present invention will be further described in detail below with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0037] Example 1

[0038] See also Figure 1-4 This embodiment provides a closed-loop responsive dressing based on a semiconductor yarn logic gate circuit. The dressing comprises a multi-layered functional structure: a dressing body 1 (with a first adhesive region 1-1 and a second adhesive region 1-2 at both ends, such as a hook-and-loop fastener structure for adjusting the tightness of the dressing). A biosensor module 2, a logic control module 5, and an execution module 6 are integrated onto the dressing body surface. The biosensor module 2, the logic control module 5, and the execution module 6 are integrated into the dressing body through a packaging structure.

[0039] The biosensor module 2 includes a pH-sensitive yarn 2-1, a glucose-sensitive yarn 2-2, a uric acid-sensitive yarn 2-3, a reference electrode 2-4 and a counter electrode 2-5 for providing a stable potential reference, which together constitute a multi-parameter synchronous detection network.

[0040] The logic control module 5 is integrated into the dressing body and includes: (1) a signal conditioning unit: connected to the output end of the biosensor module 2, including a low-noise preamplifier (gain range 20-100 dB) and an anti-aliasing filter (the cut-off frequency is set according to the physiological signal characteristics, for example, it is set to 0.1 Hz for slowly changing pH values), which is used to pre-process the original analog sensor signal; (2) an analog-to-digital conversion unit: using a successive approximation (SAR) analog-to-digital converter (ADC) with a design resolution of ≥12 bits (the sampling rate is programmable from 1 to 100 SPS, and 1 to 10 SPS is used in typical monitoring mode). The reference voltage source of the ADC has low temperature drift (typical value <50ppm / ℃) and high stability; (3) Core logic processing unit: A complementary (CMOS-like) multi-input AND gate circuit (a 3-input AND gate is used as an example in this embodiment) is formed by cross-weaving multiple P-type and N-type organic semiconductor yarn transistors (typical channel length 20-100μm, channel width 50-200μm, switching time <100μs). This circuit receives the logic level signal output from the threshold judgment and comparison unit (logic level: 0V / logic "0", 1.2-1.5V / logic "1", determined by the power supply voltage VDD); (4) Threshold judgment and comparison unit: Contains multiple window comparator circuits based on organic semiconductor differential amplifiers (one for each key parameter). The comparator sets a precise trigger threshold voltage (Vth, the programmable range corresponds to 10%-90% of the sensing range) and hysteresis voltage (Vhys, the typical value is set in the range of 20-40mV). The comparator response time is <500μs, and its output is a logic level signal (exceeding the limit = "1", not exceeding the limit = "0") and is sent to the core logic processing unit (AND gate) and the early warning logic unit respectively; (5) Early warning logic unit: composed of a counter or logic gate circuit, receiving the logic signals output by all comparators.

[0041] The operating logic of logic control module 5 is as follows: when the warning logic unit detects that the comparator outputs corresponding to at least K parameters (K is a preset value, K=2 in this embodiment) are logical "1" (i.e., exceeding their independent thresholds), it activates a warning signal. Only when the comparator outputs corresponding to all M parameters (M is the total number of input parameters, M=3 in this embodiment) are simultaneously logical "1" does the core logic processing unit (AND gate) output a valid (logical "1"), enabling the treatment circuit (i.e., turning on the control signal of execution module 6). This circuit design has a noise tolerance (typical value >100mV) and a power supply voltage rejection ratio (PSRR>40dB) to ensure reliability under flexible battery power fluctuations.

[0042] The execution module 6 is integrated into the dressing body and includes an electrically controlled drug release unit 3 and a voltage modulation electrode 4. The electrically controlled drug release unit 3 is composed of core-shell microspheres loaded with therapeutic drugs (such as antibiotics, growth factors, etc.), and its shell is an electric field responsive material (such as a polyelectrolyte complex). The entire electrically controlled drug release unit 3 is in the form of a sheet and evenly distributed on the voltage modulation electrode 4. The pulse voltage output by the voltage modulation electrode 4 is used to trigger the core-shell microspheres to release drugs after receiving the treatment enable signal, and can also simultaneously apply electrical stimulation therapy to the wound tissue, thereby accelerating wound healing.

[0043] The self-powered system 7 is located on the outer surface of the dressing body and uses a flexible yarn zinc-air battery. The key parameters of the battery system include: nominal output voltage 1.2V-1.5V, areal energy density ≥5mWh / cm 2 (To meet the requirement of the dressing working continuously for ≥7 days), the maximum continuous discharge current is ≥1mA (to meet the peak power consumption requirements of logic circuits, sensors and actuators). At a certain depth of discharge (DoD, for example <30%), the battery can recover part of its capacity (recovery rate >50%) during non-working periods (such as when changing the outer dressing) by reacting with ambient oxygen, supporting long-term use (weeks to months). The battery management system includes a voltage monitoring circuit (monitoring accuracy ±50mV), which triggers a low-battery warning signal when the battery voltage falls below a critical value (such as 0.9V).

[0044] This embodiment significantly reduces the false trigger rate caused by fluctuations in a single parameter through configurable multi-parameter threshold comparison and strict AND logic (all parameters must simultaneously exceed the threshold for treatment to occur). Furthermore, the all-yarn-based devices (sensing yarn, semiconductor yarn transistor, battery yarn) and 3D braided integration technology give the dressing excellent flexibility and stretchability, achieving conformal fit with dynamic wound surfaces, improving patient comfort and long-term biocompatibility.

[0045] Example 2

[0046] This embodiment further explains the electric field controlled drug release and synergistic therapeutic mechanism. The electrically controlled drug release unit 3 is composed of core-shell microspheres loaded with therapeutic drugs (such as antibiotics, growth factors, etc.), and its shell is an electric field responsive material (such as a polyelectrolyte complex or a conductive polymer). The entire electrically controlled drug release unit 3 is evenly distributed on the voltage modulation electrode 4 in a sheet shape. When a pulsed electric field with specific parameters is applied, the electric field triggers drug release through one or more of the following mechanisms: (1) Structural response: The electric field causes the charge redistribution of the shell of the core-shell microsphere, resulting in shell expansion, conformational change or increased porosity, thereby accelerating drug diffusion; (2) Electroosmotic drive: The electric field gradient induces electroosmotic flow on the surface of the microsphere or the surrounding tissue fluid, promoting the directional migration of drug molecules to the wound tissue; (3) Electrochemical regulation: By adjusting the pulse voltage and frequency, the redox reaction of the microsphere shell material is controlled, and its permeability or swelling behavior is dynamically adjusted, thereby regulating the drug release rate.

[0047] The execution module 6 realizes the coordinated operation of electrical stimulation and electrically controlled drug release by time-sharing multiplexing the same pair of voltage modulation electrodes 4: (1) Electrical stimulation mode: output symmetrical or asymmetrical biphasic pulses. The key parameters with dynamically adjustable range include: pulse amplitude (current density) 0.01 mA / cm 2 Up to 0.5mA / cm 2 ; Single-phase pulse width: 50μs to 10ms; pulse frequency 0.5Hz to 100Hz; duty cycle 1% to 50%. These parameters can be adaptively matched to the optimal electrophysiological parameters according to the different stages of tissue repair (such as inflammation, proliferation, and remodeling) through preset algorithms or remote instructions to effectively promote angiogenesis, keratinocyte migration, and inhibit bacterial biofilm formation. (2) Drug release synergistic mode: This mode uses a pulse sequence with specific parameters to drive drug release and enhance its effect: Increase tissue permeability pulse: Apply a high-frequency short-pulse width pulse sequence (frequency range 50-200Hz, single pulse width range 50-200μs). The total duration of this sequence is usually 1-5 minutes. The main function of this stage is to electrically stimulate the enhancement of tissue gap permeability, creating favorable conditions for subsequent drug penetration. Drive drug release pulse: Apply a low-frequency long-pulse width pulse sequence (frequency range 0.1-5Hz, single pulse width range 5-100ms). The total duration of this sequence is set according to the required drug release amount. The pulse amplitude and pulse width together determine the degree of shell deformation and drug diffusion rate of the core-shell microspheres, enabling dynamic regulation of drug release rate. The electric field response threshold of the selected microsphere shell material is matched to the amplitude of the driving pulse (typically 0.5-3V RMS) and pulse width to ensure effective triggering of drug release.

[0048] In one cycle of triggered treatment, a sequence of "pulses to increase tissue permeability" can be applied first (e.g., lasting 2 minutes), followed by or alternating application of a sequence of "pulses to drive drug release" (e.g., lasting 10 minutes). During this process, adapted "electrical stimulation mode" pulses can be interspersed or continuously applied to maintain the therapeutic effect. The electric field output by the voltage-modulated electrode 4, while driving the microspheres to release drugs, its spatial distribution (for example, when the electrode is designed as a specific pattern such as a ring array, a gradient electric field can be formed in the wound area) helps to guide the charged drug molecules to the target area (such as the wound center or the high-inflammation area) for directional migration and enrichment through the electrophoretic effect, and promotes drug penetration into deep tissues through the field intensity gradient.

[0049] Example 3

[0050] This embodiment, based on Examples 1 and 2, optimizes the structure of the dressing substrate and key modules to further enhance mechanical reliability and deformation adaptability. The dressing body 1 utilizes a flexible substrate made of a biocompatible polymer material (such as medical-grade silicone or polyurethane). The signal transmission lines of the biosensor module 2 utilize a serpentine arrangement. This design significantly improves the electrical connection reliability and ductility of the sensor network under tensile strain, preventing wire breakage or a sharp increase in resistance.

[0051] The core logic processing units (e.g., AND gate circuits) of the logic control module 5 are improved and optimized using a complementary (CMOS-like) semiconductor yarn weaving architecture. Specifically, P-type organic semiconductor yarns are cross-woven and interconnected with N-type organic semiconductor yarns to form the required logic gate transistor network (e.g., P-type yarns primarily form the pull-up network, while N-type yarns primarily form the pull-down network). This complementary weaving structure optimizes the switching characteristics and stability of the circuit in a bent state, while reducing power consumption.

[0052] The wireless transmission module 12 uses Bluetooth Low Energy (BLE) or a proprietary ISM band communication protocol (such as a custom protocol based on IEEE802.15.4), supporting encrypted frame structures (such as AES-128 encryption) and dynamic key update mechanisms to protect patient privacy and communication security. The module operates using an event-driven wake-up mechanism (activated only when data needs to be transmitted or an external command is received) and a polling mechanism with a duty cycle of less than 1% (which briefly turns on the receiver at an extremely low frequency while in the listening state). Its sleep state current is less than 1μA, significantly reducing the system's average power consumption and extending battery life.

[0053] The above-mentioned optimization of the sensor interconnect structure and logic circuit structure, combined with the low-power wireless communication strategy, significantly enhances the deformation adaptability and long-term working reliability of the dressing when attached to dynamic and active parts.

[0054] Example 4

[0055] See also Figure 5 This embodiment demonstrates a closed-loop responsive dressing implementation scheme based on a three-dimensional braided architecture, aiming to improve integration and structural stability. The architecture mainly includes three functional structures: (1) Antibacterial contact layer: as the innermost layer of the dressing, it directly contacts the wound surface and uses a protein-modified composite fabric with antibacterial function (for example, a blend of chitosan-coated fibers and silver-loaded fibers) to provide basic antibacterial protection for the wound. (2) Vertical interconnection functional layer: located above the antibacterial contact layer. This layer uses three-dimensional wiring technology (for example, using vertical conductive yarn braiding interconnection or a preset conductive through-hole structure) to achieve efficient electrical connection and physical integration of key functional units such as the monitoring yarn of the biosensor module 2, the signal conditioning and analog-to-digital conversion unit of the logic control module 5, and the voltage modulation electrode 4 of the execution module 6 in three-dimensional space. The monitoring yarn of the biosensor module 2 can be arranged in a circular symmetrical manner to enhance the uniformity of coverage of the wound area monitoring. (3) Control and communication layer: This layer is integrated above the functional layer or in a specific area and contains the core logic processing unit of the logic control module 5 (i.e., a multi-input AND gate circuit whose wiring is optimized in three dimensions to reduce delay and interference) and the wireless transmission module 12. The flexible yarn zinc-air battery of the energy supply system 7 can be placed in this layer or on the outer surface and efficiently transmits electrical energy to each functional module through an optimized embedded conductive network (e.g., a low-resistivity, short-path woven power bus) to stabilize the operating voltage and improve the overall reliability of the system.

[0056] The three-dimensional architecture of this embodiment optimizes the signal transmission path and power supply network through compact spatial layout and reliable vertical interconnection, which helps to improve the mechanical stability and electrical performance stability of the dressing in dynamic environments.

[0057] Example 5

[0058] This embodiment builds upon the closed-loop responsive dressing described in Examples 1-3 to create an intelligent system that supports remote monitoring and management. This system is implemented through the collaborative work of the dressing terminal system and the cloud / medical management platform.

[0059] Dressing terminal system enhancement: (1) Extended function of wireless transmission module 12: Based on the low-power wireless communication of embodiment 3, the module firmware integrates a security protocol stack (such as a secure transport layer based on TLS1.2 or higher, combined with AES-128 encryption and dynamic key update of embodiment 3) to ensure the confidentiality and integrity of communication with the cloud management platform. (2) The logic control module 5 integrates a threshold management unit: This unit is responsible for performing local dynamic threshold adjustment. Specifically implemented as follows: The microcontroller (or programmable logic) reads and analyzes the recently stored sensor historical data (such as the mean and standard deviation of pH value and glucose level in the past 24 hours) periodically (for example, daily) or when a specific event (such as changing the dressing or receiving an instruction) occurs. According to a preset algorithm (for example, new threshold = baseline threshold + K* recent standard deviation, where K is an adjustable coefficient; or based on a local simple linear model to predict the trend), the trigger threshold (Vth) corresponding to the parameter is automatically fine-tuned to adapt to individual differences in patients or physiological changes in the wound healing stage. The adjusted threshold is stored in a non-volatile memory. The unit supports receiving threshold update instructions from the cloud and overwriting local settings. (3) Data caching and event reporting: The logic control module 5 adds a data cache area to store key events (such as warning triggering, treatment execution, threshold adjustment) and associated sensor snapshot data. The wireless transmission module 12 packages and encrypts the cached data and uploads it when an event is detected or at a preset period (such as every 4 hours).

[0060] Cloud / medical management platform: (1) Secure access and data storage: Provide a secure Web API interface (such as HTTPS+OAuth 2.0 authentication) for dressings to connect. The received encrypted data is decrypted and stored in a secure database. (2) Real-time monitoring and warning dashboard: Provide a graphical interface to display the status of connected dressings, sensor data streams, and event logs (warnings, treatments, low battery) in real time (or near real time). When a warning event reported by the dressing is received or a high-level warning is issued by the cloud analysis module, the platform triggers a multi-channel alarm (such as SMS, email, in-app push) to notify medical staff. (3) (Optional) Cloud prediction model service: Train a wound status prediction model based on a historical database (such as using logistic regression or lightweight neural network). Model inputs may include: historical trends of multi-parameter sensors, basic patient information, and treatment records. The output is the infection risk level or the probability of the healing stage. The prediction results can be: displayed on the medical dashboard to assist in decision-making; automatically generate threshold adjustment suggestions or treatment plan optimization suggestions, and sent to the dressing end after review and confirmation by medical staff. (4) Remote configuration interface: allows medical staff to remotely view current dressing parameters (such as threshold settings, battery status) through the platform interface and securely issue modification instructions (such as manually adjusting specific thresholds, updating treatment mode parameters).

[0061] Interaction and collaboration: (1) The local threshold management unit at the dressing end is the first responder for threshold adjustment, ensuring basic adaptability when there is no network connection. (2) The cloud platform provides more powerful analysis and global views. The generated recommended instructions are sent to the dressing through a secure link to update local settings or trigger specific operations. (3) The event-driven mechanism and optimized wireless transmission ensure low-power operation of remote management functions. Dynamic voltage scaling (DVS), such as the microcontroller at the dressing end supports this feature, can dynamically adjust the core voltage / frequency when it processes different load tasks such as communication and logical operations, further reducing the energy consumption of the computing unit.

[0062] This embodiment combines the local adaptive capabilities of the dressing end with the powerful analysis and remote intervention capabilities of the cloud platform to build a complete intelligent closed-loop management system, significantly improving the level of refinement of chronic wound management, the timeliness of intervention, and the reliability of long-term monitoring.

[0063] Example 6

[0064] To verify the key performance indicators of the logic control module and the overall system of the present invention, the following laboratory tests were conducted (unless otherwise specified, all tests were conducted at room temperature of 25°C and system power supply voltage VDD = 1.5V):

[0065] (1) Logic gate function and speed test: Test object: Build a complementary semiconductor yarn AND gate test circuit with 4 inputs (such as the core logic processing unit described in Example 1). Test method: Apply a synchronized standard square wave signal (amplitude: 0V / 1.5V, frequency: 1kHz) to the 4 inputs. Use a digital oscilloscope to simultaneously monitor the input and output signal waveforms. Test results: Logic function: When and only when all 4 inputs are high level (1.5V), the output is high level (measured range: 1.42V-1.48V, meeting the requirement of >0.9*VDD=1.35V); when any input is low level (0V), the output is low level (measured range: 0.02V-0.08V, meeting the requirement of <0.1*VDD=0.15V). The function is as expected. Propagation Delay: This measures the time from when the input signal transitions to when the output signal reaches 50% VDD. The average value is 85μs (range: 70μs-100μs), below the design target of <100μs. Static Power Consumption: In a stable logic state, the circuit's quiescent current is measured and calculated to be <10μW.

[0066] (2) Threshold comparator accuracy test: Test object: Window comparator circuit based on organic semiconductor differential amplifier (such as the threshold judgment and comparison unit described in Example 1). Test method: Use a high-precision programmable DC voltage source (accuracy ±1mV) to apply a slowly changing DC voltage to the comparator input. Monitor the comparator output flip point and measure the actual flip threshold voltage (Vth+, Vth-) and hysteresis voltage (Vhys=Vth+-Vth-). Apply an input step signal (amplitude exceeds the threshold) to measure the response time. Test results: Threshold setting accuracy: Within the threshold setting range of 0.5V to 1.0V, the deviation between the measured threshold voltage and the set value is within ±15mV. Hysteresis voltage: The comparator supports programmable hysteresis voltage within the range of 20mV to 40mV. The test results show that within this range, the actual implementation accuracy of the set value is ±5mV. Response time: When the input step signal exceeds the threshold, the output response time is <400μs.

[0067] (3) ADC performance test: Test object: successive approximation analog-to-digital converter (ADC) (analog-to-digital conversion unit as described in Example 1, with a design resolution ≥ 12 bits). Test method: Apply a standard sine wave signal to the ADC input (frequency: 1Hz, amplitude: 0-1V, covering the main input range of the ADC). At a sampling rate of 10SPS, a sufficient number of output codes are collected, and FFT analysis is performed to calculate the signal-to-noise ratio (SNR) and effective number of bits (ENOB). Test results: At a sampling rate of 10SPS, the measured SNR>65dB, and ENOB>10.5 bits. This effective accuracy meets the system's requirements for digital acquisition of physiological and biochemical signals (such as pH and glucose, which usually have lower frequencies and dynamic ranges).

[0068] (4) System power consumption test: Test object: Complete dressing system prototype (including the main modules described in Examples 1-3). Test method: Typical working mode: Configure 3 sensors to work continuously (simulated monitoring), the logic control module is running, and the wireless transmission module sends a simulated data packet (including typical status information) every 5 minutes, without treatment triggering. Use a high-precision ammeter in series in the power supply circuit to measure and record the average working current I for a long time (>1 hour). avg Treatment trigger mode: trigger the execution module to work (simulate electrical stimulation and drug release process), measure the peak current I peak and its duration t peak Test results: Under typical working mode, the system average working current I avg The peak current I peak ≤500μA, duration t peak <1 minute. Endurance analysis: The typical operating voltage of the system is about 1.4V, and the average power consumption is Pavg ≈1.4V*20μA=28μW. Combined with the surface energy density of the self-powered system 7 in Example 1, ≥5mWh / cm 2 , assuming the effective battery power supply area is Acm 2 , then the total available energy E batt ≥5000*AμWh. Theoretical endurance time (considering only static power consumption) T=E batt / P avg ≥(5000*A) / 28≈178.57*A hours. The effective area of ​​the battery in this dressing is A=1.2cm 2 , we calculated that T≥214.3 hours≈8.93 days, which meets the design goal of supporting >7 days of continuous monitoring. (Note: Peak power consumption accounts for a very small proportion and its impact can be ignored)

[0069] (5) False trigger rate test: Test object: Complete closed-loop control system (sensing, logic, execution). Test environment and method: Wound environment was simulated in a culture dish containing pH 7.4 phosphate buffer solution (PBS) at a constant temperature of 37°C. Background noise (bandwidth 0.1-100Hz, peak-to-peak value Vpp=50mV white noise) was injected into the sensor signal path. Periodically (e.g., once per hour), a controllable single parameter fluctuation was introduced (e.g., the pH sensitive yarn signal simulated a brief increase in pH from 7.4 to 7.8 for 5 minutes). The logic trigger condition was set: M=3 parameters must exceed the threshold at the same time (K=2 warning in this test), and the hysteresis voltage Vhys=30mV. The continuous monitoring system was run for >48 hours, and all treatment triggering events and the parameter status at the time of triggering were recorded. Test results: During the total test time of >48 hours (including 48 simulated single parameter fluctuation events), the system falsely triggered treatment only 0 times when all three parameters did not exceed the standard at the same time. Calculated based on simulated fluctuation events, the false trigger rate is <1 / 48*100%≈2.08%; calculated based on the total monitoring time, the false trigger rate is <<0.1% (or 0 false triggers). Test results show that under the specified interference conditions, the multi-parameter AND logic combined with the threshold hysteresis design effectively suppresses false triggers caused by single parameter fluctuations or background noise.

[0070] Example 7

[0071] This embodiment describes in detail the working process of a closed-loop responsive dressing based on a semiconductor yarn logic gate circuit:

[0072] Step 1: Dressing application and system activation

[0073] The dressing body 1 is applied to the wound surface. The dressing body 1's three-dimensional woven structure and flexible material properties enable it to adaptively maintain good conformal contact with the dynamic wound surface. A flexible yarn zinc-air battery (self-powered system 7) powers the system, initiating the initialization self-test procedures of the logic control module 5 and the biosensor module 2.

[0074] Step 2: Wound microenvironment monitoring and signal processing

[0075] Three to six physiological indicator monitoring yarns (e.g., pH, glucose, and uric acid-sensitive yarns) on the inner surface of the biosensor module 2 begin collecting real-time wound microenvironment data. The raw sensor signals are transmitted to the logic control module 5 via a highly ductile, serpentine routing layout. The signals first pass through a signal conditioning unit (amplification and filtering) and then are digitized with high precision by a successive approximation analog-to-digital converter (ADC). The digital signals for each parameter are then fed into a threshold determination and comparison unit.

[0076] Step 3: Multi-parameter logical judgment and decision-making

[0077] The threshold judgment and comparison unit compares the digitized signal of each parameter with the preset independent threshold and outputs a logic level signal (exceeding the standard = "1", not exceeding the standard = "0"). Early warning decision: When the early warning logic unit detects that the comparator output corresponding to at least K (K is the preset value, 2≤K≤5) parameters is logic "1" (i.e., exceeding the threshold), the early warning signal is activated. Treatment decision: The core logic processing unit (multi-input AND gate circuit) receives the logic outputs of all comparators. Only when the comparator outputs corresponding to all M (M is the total number of input parameters, 3≤M≤6) parameters are logic "1" at the same time, the AND gate output is valid (logic "1"). If the early warning condition is met, an encrypted real-time alarm signal is sent to medical staff through the wireless transmission module 12. If the treatment condition is met (AND gate outputs "1"), the treatment circuit is enabled and the execution module 6 is triggered.

[0078] Step 4: Closed-loop treatment implementation

[0079] After receiving the treatment enable signal, the execution module 6 works according to the preset timing: (1) Electrical stimulation stage (optional or coordinated with drug release): the voltage modulation electrode 4 applies a biphasic pulsed electric field with specific parameters (as described in Example 2). Its main purpose is to: directionally enhance the permeability of tissue gaps, promote cell migration and angiogenesis, and possibly inhibit bacterial biofilms. (2) Drug sustained release stage: the voltage modulation electrode 4 applies an electric field pulse specifically used to trigger drug release (such as the low-frequency long-pulse width pulse described in Example 2). The therapeutic drug loaded in the core-shell microspheres (electrically controlled drug release unit 3) initiates responsive release under the stimulation of the electric field, and delivers the drug to the wound site.

[0080] Step 5: Continuous monitoring and data reporting

[0081] During treatment and throughout the entire use period, the biosensor module 2 continuously monitors wound parameters. The logic control module 5 records key events (e.g., warning triggering, treatment execution, parameter data snapshots). The wireless transmission module 12 uploads encrypted monitoring data, event logs, and system status information to a remote cloud server (as described in Example 5) at a preset interval (e.g., every hour) or upon detection of a significant event.

[0082] Step 6: Long-term support

[0083] The flexible yarn zinc-air battery (self-powered system 7) has the potential to recover some of its discharged capacity during periods of inactivity or low-load rest (such as when the patient is sleeping or when changing an outer dressing) by reacting with ambient oxygen. This allows the dressing to operate continuously or intermittently for long periods (weeks to months). The battery management system continuously monitors the voltage and issues an early warning if the charge is too low.

[0084] Remote monitoring and management: Medical staff can view the wound data, event logs, and system status uploaded by the dressing in real time (or near real time) through the remote management platform described in Example 5. Based on professional judgment, they can safely issue instructions to remotely adjust parameters (such as K / M thresholds, electrical stimulation parameters) or intervene in treatment plans when necessary.

[0085] Example 8

[0086] See also Figure 6 This embodiment describes in detail the control logic flow of the closed-loop responsive dressing based on the semiconductor yarn logic gate circuit:

[0087] 1. System Startup and Initialization (Start): The dressing is applied to the wound surface and activated. The flexible yarn zinc-air battery (self-powered system 7) provides power, and the logic control module 5 and biosensor module 2 perform initialization and self-test procedures.

[0088] 2. Continuous monitoring of the wound microenvironment: The physiological indicator monitoring yarns (such as pH, glucose, uric acid sensitive yarns, etc.) integrated in the biosensor module 2 continuously collect key physiological parameter data of the wound in real time.

[0089] 3. Independent judgment of parameter thresholds (Threshold Checks-A, B, C...):

[0090] The threshold judgment and comparison unit of the logic control module 5 independently judges the digitized signal of each key parameter.

[0091] The judgment is based on whether the parameter value exceeds its preset independent threshold (i.e., reaches the "exceeding standard" state). The figure uses three parameter judgments (A, B, C) as an example. The actual number of parameters M (3≤M≤6) and their types are determined by the dressing design.

[0092] The judgment result of each parameter is output as a binary logic signal: exceeding the limit = logic "1"; not exceeding the limit = logic "0". The judgment process takes into account the threshold hysteresis (Vhys) to enhance noise immunity.

[0093] 4. Warning Logic-K out of M:

[0094] The early warning logic unit receives the logic signals output by all parameter judgment nodes.

[0095] If it is detected that the output corresponding to at least K (K is a preset value, 2≤K≤5) parameters is logical "1" (i.e. exceeds the threshold), the early warning signal is activated.

[0096] After the early warning signal is activated, the encrypted early warning information and associated parameter snapshot data are reported to the remote management platform (as described in Example 5) through the wireless transmission module 12 to notify medical staff.

[0097] 5. Therapeutic Enable Logic-AND Gate:

[0098] The core logic processing unit (a multi-input AND gate circuit composed of woven semiconductor yarns) receives the logic signals output by all parameter judgment nodes.

[0099] The AND gate circuit outputs a treatment enable signal (logic "1") only when the outputs corresponding to all M parameters are simultaneously logical "1" (i.e., all parameters exceed their respective thresholds). This "simultaneous" condition, determined based on the system sampling clock or a predefined judgment time window, is a key mechanism for reducing false triggering caused by fluctuations in a single parameter. If any parameter remains within its threshold (outputting logic "0"), a disabling signal (logic "0") is output.

[0100] 6. No Therapeutic Action: If the treatment enable logic judgment result is not enabled (logic "0"), the system does not activate execution module 6 and directly returns to step 2 for continuous monitoring.

[0101] 7. Execution module activation and treatment execution (Therapeutic Action): If the treatment enable logic judgment result is enabled (logic "1"):

[0102] The execution module 6 is activated.

[0103] Collaborative treatment execution: The voltage modulation electrode 4 outputs a pulsed electric field with specific parameters according to a preset or programmable timing:

[0104] (Optional) Tissue permeability enhancement stage: Apply high-frequency short-width pulses (frequency range 50-200 Hz, pulse width range 50-200 μs) to enhance the permeability of wound tissue gaps, create conditions for drug penetration, and possibly provide electrical stimulation to promote cell migration, etc.

[0105] During the drug release phase, a low-frequency, long-width pulse (frequency range 0.1-5 Hz, pulse width range 5-100 ms) is applied. This electric field acts on the core-shell microsphere shell (e.g., a polyelectrolyte complex) of the electrically controlled drug release unit 3, triggering the precise release of the loaded therapeutic drug (e.g., antibiotics, growth factors) into the wound area through an electric field response mechanism (e.g., structural change, electroosmosis, electrochemical regulation). The pulse parameters are matched to the electric field response threshold of the microsphere shell material.

[0106] While driving drug release, the electric field also directly applies targeted electrical stimulation to wound tissue, promoting angiogenesis, cell proliferation, collagen synthesis, and inhibiting bacterial biofilms. The electrical stimulation parameters (amplitude, frequency, pulse width, and duty cycle) can be adapted to the stage of tissue repair.

[0107] 8. Data Logging & Reporting: During monitoring, alerting, and treatment execution, the logic control module 5 records key events (parameter excursions, alert triggering, treatment enabling, treatment execution) and associated sensor data snapshots. The wireless transmission module 12 uploads encrypted monitoring data, event logs, and system status information to a remote cloud server based on a preset period (e.g., hourly) or event-driven (e.g., alert triggering, treatment execution).

[0108] 9. Return to continuous monitoring (Feedback Loop): After the treatment procedure is completed, the system immediately returns to step 2 and continues to monitor the wound microenvironment. This forms a complete closed-loop control process: monitoring (2) → parameter judgment (3) → early warning judgment (4) → treatment enable judgment (5) → treatment execution (7) or no action (6) → data reporting (8) → return to monitoring (2). This loop runs continuously, dynamically deciding and implementing intervention measures based on the real-time changes in the wound status until the wound heals.

[0109] For ease of explanation, spatial relative terms such as "upper", "lower", "inside", and "outside" are used in the embodiments to illustrate the relationship of one element or feature shown in the figures relative to another element or feature. It should be understood that, in addition to the orientation shown in the figures, spatial terms are intended to include different orientations of the device in use or operation. For example, if the device in the figure is inverted, the element described as being "under" other elements or features will be positioned "above" other elements or features. Therefore, the exemplary term "under" can include both upper and lower orientations. The device can be positioned in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used here can be interpreted accordingly.

[0110] Moreover, relational terms such as “first” and “second” are merely used to distinguish one component from another having the same name, but do not necessarily require or imply any actual relationship or order between these components.

[0111] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A closed-loop responsive dressing based on semiconductor yarn logic gate circuit, characterized in that: It includes a dressing body, a biosensor module, a logic control module, an execution module, a wireless transmission module, a self-powered system and a packaging structure; The dressing body is made of a breathable and biocompatible material; The biosensor module is integrated into the inner surface area of ​​the dressing body corresponding to the wound location and includes 3 to 6 physiological indicator monitoring yarns, which are used to monitor changes in key wound indicator data to fully reflect the physiological environment and metabolic state of the wound; The logic control module is integrated into the dressing body and includes: a signal conditioning unit, an analog-to-digital conversion unit, a core logic processing unit based on a semiconductor yarn transistor woven structure, and a threshold judgment and comparison unit; the logic control module is configured to: receive signals from the biosensor module, and activate a warning signal if at least K (K is a preset value, 2≤K≤5) of the monitored physiological index parameters exceed their independent thresholds; and activate a treatment enable signal if all M (M is the total number of input parameters, 3≤M≤6) parameters exceed their respective thresholds; The execution module is integrated into the dressing body and includes an electrically controlled drug release unit composed of drug-loaded core-shell microspheres and a voltage modulation electrode; the shell of the core-shell microspheres is an electric field responsive material, and the electrically controlled drug release unit is distributed in a sheet-like manner on the voltage modulation electrode; the execution module is configured to: after receiving the treatment enable signal, apply electric field stimulation through the voltage modulation electrode to trigger the core-shell microspheres to release the drug and perform electrical stimulation treatment on the wound; The wireless transmission module is integrated into the dressing body and is used for data communication; The self-powered system is integrated on the outer surface of the dressing body and includes a flexible yarn zinc-air battery and a battery management system; the battery management system includes a voltage monitoring circuit for triggering a low-battery warning when the battery voltage falls below a critical value; The packaging structure covers the dressing body and each module.

2. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit according to claim 1, characterized in that: The physiological indicator monitoring yarn of the biosensor module adopts a serpentine arrangement structure to improve tensile strain tolerance.

3. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit according to claim 1, characterized in that: The electrical stimulation therapy outputs symmetrical or asymmetrical biphasic pulses.

4. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit according to claim 1, characterized in that: The pulses output by the voltage modulation electrode include: a first type of pulse with a frequency range of 50 Hz to 200 Hz and a pulse width range of 50 μs to 200 μs, which is mainly used to enhance tissue permeability; and a second type of pulse with a frequency range of 0.1 Hz to 5 Hz and a pulse width range of 5 ms to 100 ms, which is mainly used to drive the core-shell microspheres to release drugs; wherein the electric field response threshold of the shell material of the core-shell microspheres matches the amplitude and duration of the second type of pulse.

5. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit according to claim 1, characterized in that: The semiconductor yarn transistor adopts a cross-woven structure of P-type and N-type yarns to form a complementary logic circuit.

6. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit according to claim 1, characterized in that: The wireless transmission module adopts low-power Bluetooth or proprietary ISM band protocol, supports encryption frame structure and dynamic key update mechanism; and adopts event-driven wake-up mechanism and polling mechanism with a duty cycle of less than 1% to work.

7. The closed-loop responsive dressing based on semiconductor yarn logic gate circuit according to claim 1, characterized in that: The dressing body is formed by multi-layer fabric integrated weaving technology, wherein: the inner contact layer is composed of antibacterial fabric; the middle functional layer contains the vertical interconnection structure of the biosensor module, logic control module and execution module; and the outer packaging layer is a waterproof and breathable layer.

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