Nursing membrane device and system for hepatobiliary operation wound healing

Abstract

The invention provides a nursing film device and system for hepatobiliary operation wound healing, and the nursing film device and system comprises a film-shaped carrier which is composed of a substrate layer and an adhesion layer, the substrate layer is adhered to the skin wound of a patient, and a plurality of hole grooves are formed in the substrate layer in a hollowed-out manner; the adhesion layer is adhered to the upper part of the substrate layer; the sensor assembly is composed of an infection indication sensor, an oxygenation sensor, a humidity indication sensor, a blood flow sensor and a wound healing progress sensor; monitoring the wound infection degree, oxygenation degree, humidity, blood flow degree and wound healing progress; the plurality of balloons are attached in the adhesive layer, and growth factors, analgesic and antibiotics are respectively wrapped in the balloons; wherein an electrode layer is arranged above the adhesion layer; the electrode layer is connected with a control assembly, and after the control assembly receives sensing information of the sensor assembly, the control assembly controls all the balloons to be released, and wound repairing is achieved.

Description

Technical Field

[0001] The present invention belongs to the field of hepatobiliary surgery nursing, and in particular relates to a nursing membrane device and system for wound healing in hepatobiliary surgery. Background Art

[0002] The treatment of hepatobiliary surgical wounds has always been an important and complex issue in the medical field. Especially after hepatobiliary surgery, patients often face various problems such as wound infection, delayed healing, pain and discomfort. Although existing treatments, such as drug therapy and physical therapy, have improved the healing of patients to a certain extent, these methods usually have limitations and are difficult to meet the personalized treatment needs of patients. Therefore, the development of an intelligent system that can monitor the wound healing status in real time and automatically adjust the drug release according to the physiological condition of the wound has become an important direction of current hepatobiliary surgery nursing research.

[0003] Problems with existing technology (1) Wound monitoring is incomplete and inaccurate. Currently, the commonly used wound monitoring methods mainly rely on manual observation, imaging examinations or certain basic sensor equipment. These methods have obvious shortcomings. First, traditional manual observation methods are easily affected by subjective factors and may ignore some early wound infections or healing problems, resulting in delayed treatment. Second, existing wound monitoring equipment is usually limited to monitoring a certain physiological parameter (such as temperature or humidity), and cannot comprehensively evaluate the wound's healing progress, infection level, oxygenation status and other multi-dimensional physiological parameters, making it difficult to achieve refined wound management.

[0004] (2) The hysteresis and non-personalization of drug release control. The current drug release control methods in most hepatobiliary surgery wound care systems often rely on preset fixed schemes, which are difficult to adjust according to the patient's actual wound condition. For example, the drug release dose and frequency are usually fixed, and cannot be personalized according to the healing progress, infection status or oxygenation level of different wounds. In addition, most of the existing drug release systems have a single release mode and cannot simultaneously consider multiple needs of the wound (such as anti-infection, promoting blood circulation, relieving pain, etc.), resulting in limited treatment effects.

[0005] (3) Lag in wound healing assessment. Traditional wound healing assessment methods often rely on regular clinical examinations or patients’ complaints. These methods are not only time-consuming, but may not reflect the actual condition of the wound in real time. In some special hepatobiliary surgeries, wound healing is slow and there may be problems such as subtle early infection. Without timely and accurate assessment, the best time for treatment may be missed, and even serious complications may occur.

[0006] (4) Insufficient comprehensive evaluation of multiple factors. In the treatment of hepatobiliary surgical wounds, wound healing is a complex physiological process involving multiple factors such as infection, oxygenation, humidity, and blood flow. Currently, most devices only focus on the changes in a single factor, such as monitoring the wound status only through temperature or humidity sensors, and cannot comprehensively evaluate the multiple factors that affect wound healing. Since these devices do not perform multi-dimensional data fusion analysis, it is difficult to provide scientific and reasonable treatment recommendations in some complex cases.

[0007] (5) Lack of intelligent treatment solutions. Current hepatobiliary surgical wound treatment still lacks intelligent and automated treatment systems. Although some studies have attempted to control drug release through intelligent systems, most systems are still in the experimental stage and have not yet been able to achieve real-time monitoring of wound status and precise control of dynamic drug release. This means that current hepatobiliary surgical wound treatment still lacks a comprehensive, intelligent solution, and it is difficult to make timely and accurate treatment adjustments based on the physiological changes and healing progress of the wound.

[0008] Main challenges of existing technologies (1) Difficulty in technology integration and data fusion. In multi-parameter wound monitoring, how to integrate and process various sensor data in real time to achieve accurate wound assessment and treatment adjustment is the main difficulty in current technology development. Existing technologies often rely on a single sensor or sensor array, and lack effective fusion and analysis tools after data collection, resulting in the inability to fully tap the potential value of the data.

[0009] (2) Limitation of sensor performance. Although there are a number of sensors on the market that can monitor certain specific parameters of wounds, such as humidity, temperature, and oxygenation status, the accuracy and sensitivity of these sensors often cannot meet the complex needs of hepatobiliary surgical wounds. For example, existing infection indicator sensors often only work when the infection is severe and cannot monitor subtle changes in the early stages of infection in a timely manner.

[0010] (3) Biocompatibility and comfort. In the treatment of hepatobiliary surgical wounds, wound dressings must not only have good therapeutic effects, but also ensure high biocompatibility and comfort with the patient's skin. Existing sensor membranes and drug release devices are often limited by material properties and may cause local skin discomfort or allergic reactions. In addition, long-term wearing may affect the patient's activities or cause discomfort, thereby affecting wound healing.

[0011] (4) Difficulties in intelligent control and personalized treatment. Although the application of intelligent control systems has been successful in some medical fields, the application of intelligent control in the treatment of hepatobiliary surgical wounds, especially in the precise control of drug release, still faces challenges. How to accurately judge the healing state of the wound through sensor data and dynamically adjust the drug release plan according to this state is still a technical problem that needs to be solved urgently.

[0012] In summary, the existing wound healing care technology for hepatobiliary surgery still has many shortcomings in terms of precise monitoring, drug release control, and formulation of intelligent treatment plans. Traditional treatment methods mostly rely on manual intervention, lack sufficient real-time and personalization, and are difficult to meet the diverse treatment needs of patients. Therefore, it is urgent to develop a new type of intelligent sensing membrane and drug release control device that can monitor the wound status in real time, comprehensively evaluate multiple physiological parameters, and accurately adjust the drug release plan according to the specific needs of the wound, thereby improving the efficiency of wound healing and the safety of treatment. Summary of the invention

[0013] The purpose of the present invention is to provide a care membrane device and system for wound healing in hepatobiliary surgery. The present invention can monitor the wound status in real time, comprehensively evaluate multiple physiological parameters, and accurately adjust the drug release scheme according to the specific needs of the wound, thereby improving the efficiency of wound healing and the safety of treatment.

[0014] To achieve the above object, the present invention provides the following technical solution: a care membrane device for wound healing in hepatobiliary surgery, comprising: The membrane carrier is composed of a base layer and an adhesive layer, wherein the base layer is adhered to the wound of the patient's skin and is hollowed out with a plurality of holes and grooves; the adhesive layer is adhered to the base layer; A sensor assembly, comprising an infection indicator sensor, an oxygenation sensor, a humidity indicator sensor, a blood flow sensor and a wound healing progress sensor; wherein the infection indicator sensor, the oxygenation sensor, the humidity indicator sensor, the blood flow sensor and the wound healing progress sensor are respectively installed in a plurality of holes and grooves of the base layer, and monitor the infection degree, oxygenation degree, humidity, blood flow degree and wound healing progress of the wound; A plurality of balloons are attached to the attachment layer, and growth factors, analgesics and antibiotics are respectively wrapped therein; an electrode layer is provided above the attachment layer; the electrode layer is connected to a control component, and after receiving the sensing information from the sensor component, the control component controls the release of the plurality of balloons to achieve wound repair.

[0015] Furthermore, the infection indicator sensor uses pH-sensitive materials combined with specific antibody sensors, which can respond to local pH changes and changes in bacterial metabolite concentrations. When the wound is infected, the local pH decreases and its color changes from green to yellow or red. The degree of infection is determined by irradiating its surface with a green LED and capturing the changes in reflected light with a photodiode (PD). The oxygenation sensor adopts a fluorescent detection material that is sensitive to oxygen concentration and uses a blue LD (laser diode) as an excitation light source; when the oxygenation state is poor, the fluorescence intensity decreases as the oxygen content decreases, and the emission light wavelength shifts, and the sensor appearance color may turn blue or red; when the oxygenation is good, the fluorescence signal is enhanced and turns green; by detecting the above fluorescence intensity and color changes through PD, the local oxygenation level of the wound can be evaluated; The humidity indicator sensor is made of super absorbent polymer or hydrogel. When the humidity of the wound increases, the material absorbs water and expands, and the color changes from yellow to blue. When the humidity is too low, it changes from blue to orange. The blue LED is used to illuminate and the PD is used to capture the change in the intensity of its reflected light. The blood flow sensor utilizes the absorption characteristics of hemoglobin to light of a specific wavelength (such as red light), and is combined with metal oxide semiconductor materials (such as titanium oxide or zinc oxide) and gold nanoparticles; when the blood flow increases, the sensor surface becomes dark red; when the blood flow decreases, the color changes to light pink or gray; a red LED is used as the excitation light source, and the intensity of the reflected light is captured by PD to reflect the blood flow situation; The wound healing progress sensor uses fluorescent dyes that are sensitive to biomarkers such as collagen and VEGF (vascular endothelial growth factor), and changes color from red → yellow → green as the concentration of the marker changes during the tissue repair process. The blue-violet light LD is used to excite the sensing material, and the PD is used to capture the fluorescence color change to evaluate the wound healing stage.

[0016] Furthermore, the sensor assembly also includes: The multi-channel optical receiving module includes at least one multi-channel detector for simultaneously or quickly capturing light signals of different wavelengths emitted by each sensor; a plurality of independent photodiode channels are arranged in the multi-channel detector, corresponding to the fluorescence or reflected light generated by LD excitation, and the reflected light generated by LED excitation; by separating and analyzing the electrical signals of each channel in real time, multi-dimensional detection of infection, oxygenation, humidity, blood flow and wound healing progress can be achieved.

[0017] Furthermore, the control component also includes: A signal processing module transmits the optical signal received from the multi-channel optical receiving module to the signal processing module signal, and the signal processing module is responsible for analyzing and decoding the color data and converting different color changes into quantitative physical parameters (such as pH value, oxygen concentration, humidity, etc.); The data fusion and synchronization module synchronously analyzes the physical parameters of the signal processing module to evaluate the infection, oxygenation, humidity, blood flow and healing progress; when the degree of infection increases, the system will combine the color change of the infection sensor and the data of other sensors (such as humidity and blood flow) to comprehensively judge the state of the wound.

[0018] Furthermore, the balloon adopts an electrodeformable polymer; the amount of electricity released by the electrode layer controls the physical change of the balloon opening, thereby controlling the timing, frequency and dosage of drug release.

[0019] Furthermore, the control component can also output current to the wound area through the electrode points on the electrode layer: wherein, the control component adjusts the intensity of the current according to the physiological needs of the wound; if the blood circulation in the wound area is poor, the control component may increase the current intensity to promote blood flow; the control component current also adjusts the frequency and waveform of the current according to different treatment goals; low-frequency current may be used for pain relief, while high-frequency current helps promote tissue healing.

[0020] A system for a care membrane device for wound healing in hepatobiliary surgery, comprising: Care film device; A data interaction module, connected to the control component of the care film device, for collecting and sending wound status data obtained by the sensor component; The remote monitoring terminal is communicatively connected to the data interaction module, and is used to receive the wound status data and display it visually; when wound abnormality is detected or a personalized treatment plan is required, the remote monitoring terminal sends a control instruction to the control component of the care film device to adjust the drug release and electrical stimulation parameters.

[0021] Furthermore, the data interaction module adopts wireless communication to perform two-way data transmission with the remote monitoring terminal, and the wireless communication method includes one or more of BLE, WiFi or cellular network; the remote monitoring terminal combines big data models or machine learning algorithms to perform comprehensive analysis on the collected historical monitoring data and current monitoring data to predict the risk of wound infection or healing trend, and send corresponding parameter optimization solutions to the care film device through communication instructions.

[0022] Furthermore, the remote monitoring terminal is equipped with a data visualization interface, which can display multi-dimensional parameters such as infection index, oxygenation level, humidity curve, blood flow changes and healing progress; when it is detected that the infection index continues to rise and the oxygenation level is lower than a predetermined threshold, the remote monitoring terminal automatically triggers the release of the antibiotic balloon and increases the intensity of electrical stimulation to inhibit infection and promote blood circulation.

[0023] The present invention relates to a nursing membrane device and system for wound healing in hepatobiliary surgery. The design combines sensing technology with drug release technology, in order to improve the effect of wound healing in hepatobiliary surgery by real-time monitoring of the wound healing process and precise control of drug release. By using a variety of sensors and intelligent drug release control technology, the system of the present invention has the following significant beneficial effects: 1. Real-time monitoring of wound status and providing accurate diagnosis basis The present invention integrates an infection indicator sensor, an oxygenation sensor, a humidity indicator sensor, a blood flow sensor, and a wound healing progress sensor into the same sensing membrane, thereby realizing multi-dimensional real-time monitoring of wounds. The sensor can monitor the degree of infection, oxygenation status, humidity changes, blood flow, and healing progress of the wound area. Changes in these physiological parameters provide accurate wound healing information for clinicians. Traditional wound healing monitoring usually relies on manual observation or intermittent medical examinations, which not only increases the workload of nursing, but also makes it difficult to reflect the immediate changes of the wound in real time. The present invention can provide timely feedback to medical staff through continuous monitoring of the sensing membrane, helping doctors make faster and more accurate treatment decisions.

[0024] 2. Optimize treatment plans and personalize them The drug release system of the present invention combines an intelligent electrode layer with a control component, and can automatically adjust the timing, frequency and dosage of drug release according to the wound status data (such as infection degree, oxygenation status, etc.) fed back by the sensor in real time. For example, when the sensor detects that the wound is seriously infected, the system will automatically release antibiotics to quickly treat the wound; when the oxygenation status is detected to be poor, the system will adjust the drug release method to help restore the oxygenation level of the wound. In this way, drug release can be personalized according to the specific needs of the wound, which not only avoids excessive medication, but also ensures that the drug is accurately delivered, thereby improving the treatment effect.

[0025] 3. Electrical stimulation promotes wound healing The balloon drug release system of the present invention is also designed with an electrical stimulation function. Each balloon is provided with an electrical stimulation point at the top. When the electrode layer outputs current, the electrical stimulation point will generate current to promote blood flow and local tissue repair. Low-frequency current helps relieve pain and reduce wound discomfort, while high-frequency current can promote tissue regeneration and accelerate the wound healing process. Through this electrical stimulation method, not only can wound healing be further accelerated, but blood circulation can also be improved and the ability of tissue repair can be enhanced.

[0026] 4. Improve patient comfort and compliance The sensor membrane and drug release system of the present invention are designed with flexible membrane materials, which can fit the wound area tightly and reduce irritation and discomfort to the patient. The base layer of the membrane carrier adheres to the patient's skin wound, and the attachment layer adheres thereto. The overall structure ensures the stability of the sensor and the drug release device, which are not easy to fall off or shift. In addition, due to the automation of drug release and wound monitoring, patients do not need to go to the hospital frequently for examinations, and can more conveniently perform wound care and treatment. This convenience not only improves the patient's comfort, but also enhances the patient's treatment compliance, thereby helping to improve the healing effect.

[0027] 5. Reduce medical costs and care burden Traditional wound care usually requires a lot of manual participation, especially for complex wounds in hepatobiliary surgery. Doctors and nurses need to frequently check wounds, adjust drug treatment plans, evaluate treatment effects, etc., which not only increases medical costs, but also increases the workload of nursing staff. The sensor membrane and drug release system of the present invention can monitor the wound status in real time and automatically adjust the drug release plan, greatly reducing the workload of nursing staff. By reducing human resource investment, medical costs can be reduced, and treatment delays or poor results caused by nursing omissions can be effectively avoided.

[0028] 6. Highly integrated multi-sensor technology The sensing membrane of the present invention adopts multi-sensor integration technology, which can simultaneously monitor multiple physiological parameters related to wound healing, such as pH value, oxygenation level, humidity, blood flow and wound healing progress. Each sensor is based on different principles, such as pH sensitive materials, fluorescence detection technology, optical absorption characteristics, etc., to comprehensively analyze the wound from different dimensions. These sensors can transmit data in real time through the optical receiving module, and analyze and process it through the signal processing module, and finally provide accurate wound healing status. This multi-sensor integration method can monitor wound changes more comprehensively and accurately, ensuring that every link in the treatment process is intervened and adjusted in time.

[0029] 7. Improve the accuracy and safety of wound treatment By combining real-time data analysis with an intelligent control system, the present invention can monitor in real time possible complications during wound healing, such as infection, poor oxygenation, etc., thereby improving the accuracy of treatment. In particular, in terms of infection detection, the infection indicator sensor can respond to the occurrence of infection through pH changes and promptly alert medical staff to prevent the wound infection from worsening, reducing the risk of failure to promptly treat the infection. In addition, the automatic adjustment function of the entire system avoids insufficient human intervention or excessive treatment, thereby improving the safety of treatment.

[0030] 8. Multi-channel data fusion to optimize treatment effects The system of the present invention uses a data fusion and synchronization module to comprehensively analyze the signals of each sensor and evaluate the overall state of the wound in real time. When the sensor detects that a physiological parameter is abnormal, the system will make a judgment based on the results of other sensors to ensure the optimization of the treatment plan. For example, when the degree of infection worsens, the system not only releases antibiotics based on the data of the infection sensor, but also combines the sensor data such as humidity and blood flow to comprehensively analyze the condition of the wound, thereby optimizing the release time and dosage of the drug and improving the treatment effect.

[0031] In summary, the sensor membrane and drug release control device and system for wound healing in hepatobiliary surgery provided by the present invention have many beneficial effects such as real-time monitoring, intelligent control, precise drug release, accelerated healing by electrical stimulation, and improved patient comfort. Its innovative multi-sensor integration technology and intelligent control mechanism can not only significantly improve the healing effect of hepatobiliary surgery wounds, but also reduce the workload of medical staff, reduce medical costs and improve patient compliance, and has important application prospects and broad clinical value. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is a schematic diagram of the overall structure of the present invention; Figure 2 It is a schematic diagram of the side view structure of the present invention; Figure 3 It is a bottom view structural schematic diagram of the present invention.

[0033] In the accompanying drawings, 100, electrode layer; 200, balloon; 300, sensor component; 310, pH sensitive material; 320, fluorescent detection material sensitive to oxygen concentration; 330, hydrogel; 340, metal oxide semiconductor material and gold nanoparticle polymer; 350, fluorescent dye sensitive to biomarkers such as collagen and VEGF (vascular endothelial growth factor); 360, light source; 370, multi-channel detector; 400, electrical stimulation point; 500, basal layer. DETAILED DESCRIPTION

[0034] The care film device provided by the present invention is mainly composed of a membrane carrier, a sensor component 300, a balloon 200 drug release system, an electrode layer 100 and a control component, and is used to monitor the postoperative wound status of patients undergoing hepatobiliary surgery in real time and accurately regulate drug release and electrical stimulation according to the monitoring results, thereby accelerating wound healing and reducing the risk of infection.

[0035] In an embodiment, Figure 1 , Figure 2 and Figure 3 As shown, the membrane carrier is mainly composed of a base layer 500 and an attachment layer; the base layer 500 is a flexible film material with good biocompatibility. Its lower surface can be adhered to the patient's skin wound to ensure that the sensor assembly 300 is in close contact with the wound area; at the same time, a number of holes and grooves are pre-opened on the base layer 500 to accommodate different types of sensors. The attachment layer is arranged above the base layer 500 to support the sensor assembly 300 and the drug release balloon 200. After the attachment layer and the base layer 500 are attached, an integral membrane structure is formed, which is not easy to shift or fall off, thereby improving the stability of the device during use.

[0036] The present invention integrates the following five types of sensors in the multiple holes and grooves provided in the base layer 500 to achieve multi-dimensional monitoring of the wound: Infection indicator sensor: pH sensitive material 310 is used in combination with specific antibody sensor, which can respond to local pH changes and changes in bacterial metabolite concentration. When the wound is infected, the local pH decreases and the sensor color changes from green to yellow or red. The LED light source 360 ​​(green LED) is used to illuminate the sensor surface and the photodiode PD captures the change of reflected light to determine the degree of infection.

[0037] Oxygenation sensor: uses fluorescent detection material 320 that is sensitive to oxygen concentration, and uses blue LD (laser diode) as an excitation light source 360; when the oxygenation state is poor, the fluorescence intensity decreases as the oxygen content decreases, and the wavelength of the emitted light shifts, and the appearance color of the sensor may turn blue or red; when the oxygenation is good, the fluorescence signal is enhanced and turns green; by detecting the above fluorescence intensity and color changes through PD, the local oxygenation level of the wound can be evaluated; Humidity indicator sensor: Made of super absorbent polymer or hydrogel 330, when the humidity of the wound increases, the material absorbs water and swells, and the color changes from yellow to blue; when the humidity is too low, it changes from blue to orange. Blue LED can be used to illuminate and PD can be used to capture the change in the intensity of its reflected light.

[0038] Blood flow sensor: Utilizes the absorption characteristics of hemoglobin to light of a specific wavelength (such as red light), combined with metal oxide semiconductor materials (such as titanium oxide or zinc oxide) and polymers of gold nanoparticles 340. When blood flow increases, the sensor surface turns dark red; when blood flow decreases, the color changes to light pink or gray. Red LED is used as the excitation light source 360, and the intensity of reflected light is captured by PD to reflect the blood flow situation.

[0039] Wound healing progress sensor: It uses fluorescent dye 350 that is sensitive to biomarkers such as collagen and VEGF (vascular endothelial growth factor). The color changes from red to yellow to green as the concentration of the marker changes during tissue repair. The blue-violet laser diode (LD) is used to excite the sensing material, and the PD is used to capture the fluorescence color change to evaluate the wound healing stage.

[0040] Here, for further accurate explanation, the above LD / LED selection is given; 1. Infection indicator sensor (green LED excitation) Light source wavelength: Green LEDs are usually in the 520–530 nm band, such as the common 525 nm green LED.

[0041] Reason: When the pH-sensitive material binds to the specific antibody and the color changes from green to yellow or red, there will be a significant change in reflected light under 520-530nm green light, which is convenient for the photodiode (PD) to accurately capture.

[0042] PD side design: A photodiode with good sensitivity in the range of 500–580 nm can be selected, and a bandpass filter can also be used to reduce ambient light interference.

[0043] 2. Oxygenation sensor (blue LD excitation) Light source wavelength: The common wavelength of blue laser diode (LD) is 450 nm or 460 nm. If the absorption peak of the oxygenation probe is at 445–465 nm, 450 nm LD can be preferred to obtain better excitation efficiency.

[0044] Reason: This type of oxygen-sensitive fluorescent material usually has high absorption in the blue light or blue-violet light range. If the oxygen content is insufficient after excitation, the fluorescence intensity will weaken and the wavelength will shift; if the oxygen content is sufficient, the fluorescence intensity will increase and appear green.

[0045] PD side design: It is advisable to select a photodiode with good responsivity in the 450–600 nm region, and add a short-pass or band-pass filter when necessary to remove stray light.

[0046] 3. Humidity indicator sensor (blue LED excitation) Light source wavelength: Blue LEDs commonly use 460–470 nm; commercial high-power blue LEDs around 450 nm can also be used.

[0047] Reason: The super absorbent polymer or hydrogel 330 has a significant change in reflected light intensity when irradiated with blue light of 460–470 nm in the color conversion range of yellow-blue-orange, which makes it easy to detect the change through PD.

[0048] PD side design: You can choose a photodiode with higher sensitivity to the 450-500 nm blue light region; if you need to eliminate interference from other visible light in the environment, you can use the corresponding filter.

[0049] 4. Blood flow sensor (red LED excitation) Light source wavelength: Red LEDs usually use 620–640 nm; for example, 630 nm and 635 nm are both common wavelength choices.

[0050] Reason: Hemoglobin absorbs red light strongly; when blood flow increases, more red light is absorbed and the sensor surface appears dark red; when blood flow decreases, the reflected light increases and the color becomes lighter.

[0051] PD-side design: It should have a good response in the 600–700 nm range and should be combined with an appropriate bandpass filter (such as a central wavelength of 630 nm) to exclude interference from other bands.

[0052] 5. Wound healing progress sensor (blue-violet light LD excitation) Light source wavelength: Common blue-violet laser diode wavelengths include 405 nm, 410 nm, or 430–450 nm. If the fluorescent dye has a significant absorption peak around 405 nm, a 405 nm LD can be selected.

[0053] Reason: Fluorescent dyes that are sensitive to markers such as collagen and VEGF often have ideal absorption in the blue-violet region of 400–450 nm; after excitation, the color can gradually transition from red to yellow and green, representing different stages of healing.

[0054] PD side design: A photodiode array with good response to the 400–550 nm band can be selected, and when necessary, a filter or spectrometer can be used to distinguish different fluorescence conversion stages.

[0055] 6. Comprehensive design considerations Wavelength matching: Each sensor material (pH sensitive agent, fluorescent probe, nanoparticles, etc.) has a specific absorption peak; choosing the LED / LD with the corresponding wavelength can obtain the best sensitivity and signal-to-noise ratio.

[0056] Filtering and data separation: if the excitation light of multiple sensors has potential overlap (such as 450 nm blue light LED and 460 nm blue light LD), band separation can be performed through time-division excitation or multi-channel optical receivers; if necessary, filters or beam splitters can be added to suppress cross-interference.

[0057] Irradiation intensity and safety: For LD (laser diode), attention should be paid to the output light power and skin surface safety; for patch-type devices, heat dissipation and biosafety assessments should be carried out to avoid additional effects of high-energy light on tissues.

[0058] PD response and reading accuracy. The photodiode corresponding to each sensor can be single or multi-channel to ensure high responsiveness to the specified band range. The data fusion module needs to consider factors such as ambient light, noise, and calibration curve to ensure measurement accuracy.

[0059] The overall system is synchronized. If different wavelength light sources 360 work simultaneously, a multi-channel detector 370 and a filter combination should be used. If the power consumption or hardware limitation is high, each light source 360 ​​can also be controlled in time to reduce interference and aliasing to the PD.

[0060] Through the above example selection and precautions for each band, it is possible to ensure that infection indication, oxygenation monitoring, humidity detection, blood flow measurement, and healing progress assessment are carried out efficiently and accurately in the same care film device, thereby providing reliable real-time data support for personalized regulation of wound repair (drug release, electrical stimulation schemes, etc.).

[0061] At the same time, please note that Figure 3 As shown, by presetting a reasonable spatial arrangement and spacing for each sensing material on the base layer, each sensor can acquire the corresponding physiological signal independently and without interfering with each other, thereby meeting the needs of multi-dimensional monitoring of the wound.

[0062] In order to perform parallel or rapid time-sharing detection of optical signals of multiple sensors (infection indicator sensor, oxygenation sensor, humidity indicator sensor, blood flow sensor and wound healing progress sensor) in a single measurement process, a multi-channel optical receiving module is provided in the sensor assembly 300. This module is used in conjunction with the excitation light source 360 ​​(LD / LED) to achieve the distinction and real-time analysis of optical signals of different wavelengths through the following structure and working principle: The light input area is used to guide the fluorescence signals reflected or emitted by each sensor surface into different detection channels. This area can be integrated with microlens arrays, optical coupling components or fiber bundles to improve the efficiency of light signal collection and reduce environmental interference. If the wavelength distribution required for detection is wide, collimation elements can be further designed to enable each channel to have better optical path stability.

[0063] A multi-channel detector 370 (photodiode array), which is composed of several independent photodiode (PD) channels, is used to convert the reflection or fluorescence signals excited by different excitation light sources 360 (LD / LED) into corresponding electrical signals. Each PD channel can respond to a certain range of wavelengths, and can also be combined with micro filters or spectroscopic elements for more precise wavelength differentiation as needed.

[0064] When the embodiment does not require a filter, the signal can be distinguished by time-division excitation (lighting up the LD or LED for each sensor at different times) or by using the obvious wavelength difference of different sensor principles. The electrical signal of each PD channel is collected in real time in an independent amplification and processing circuit to achieve synchronous or rapid polling detection of multiple physiological parameters.

[0065] Channel isolation and spectrum management: Physical isolation structures or different field of view angles are usually used between PD channels to prevent light from a certain sensor from entering other channels. If high-precision spectral separation is required, a micro filter or a beam splitter prism can be configured at the front end of the channel so that each channel only receives the target wavelength, thereby improving the ability to resolve subtle differences in color or fluorescence.

[0066] For scenes that do not require precise spectral division, timing control (lighting up an excitation light source of a certain wavelength 360 degrees in sequence) can also be used to record the signals of each time period at the detection end to achieve the purpose of distinguishing the outputs of different sensors.

[0067] Signal output and synchronous analysis, the multi-channel detector 370 can output multiple electrical signals in parallel within a measurement or a data acquisition cycle. These signals correspond to the real-time monitoring results of the above five types of sensors on the degree of wound infection, oxygenation status, humidity level, blood flow and healing progress.

[0068] The signal processing module performs A / D conversion, denoising and quantification on the photoelectric conversion data of each channel, and then sends it to the data fusion and synchronization module for comprehensive evaluation; thereby accurately identifying, recording and analyzing the optical changes reflected or emitted by each sensor, providing precise and real-time physiological basis for subsequent drug release and electrical stimulation regulation.

[0069] By combining the above-mentioned multi-channel optical receiving module with the multi-channel detector 370, the care film device of the present invention can distinguish and measure multiple wavelength signals in a single detection process, and no longer relies on a mechanical filter wheel or multiple repeated acquisitions. This not only improves the data acquisition efficiency, but also greatly reduces the errors that may be caused by multiple switching, and provides timely and accurate monitoring support for subsequent intelligent treatment plans (such as balloon 200 release, growth factor injection, electrical stimulation intensity adjustment, etc.).

[0070] Several balloons 200 are evenly distributed inside the attachment layer, and different types of drugs, such as growth factors, analgesics, antibiotics, etc., can be encapsulated inside each balloon 200. In order to better control the release of drugs, the present invention has made improvements in the following aspects: Balloon 200 material: The balloon 200 is made of an electrodeformable polymer, which is sensitive to electrical signals and can be deformed under the action of an external voltage, thereby controlling the opening or closing of the balloon 200.

[0071] Electrical stimulation point 400: An electrical stimulation point 400 is set on the top of the balloon 200, and the electrical stimulation point 400 is only used to adjust the opening of the balloon 200 to achieve precise control of drug release. To this end, an electrode layer 100 is arranged above the attachment layer, and the electrode layer 100 is electrically connected to the control component through a reasonable routing design. When the control component decides to release the drug in a certain balloon 200 according to sensor feedback or a preset scheme, it will apply an appropriate electrical signal to the electrical stimulation point 400 corresponding to the balloon 200, causing the electrodeformable polymer to deform, thereby opening or closing the opening of the balloon 200. By adjusting the intensity and frequency of the current, the control component can selectively adjust the release time, frequency and dosage of each balloon 200; thus, different drugs (such as growth factors, analgesics or antibiotics) can be injected into the wound area at the right time to meet personalized treatment needs.

[0072] The control component includes the following functional modules: Signal processing module: used to receive and process light signals, fluorescence signals, etc. from multi-channel optical receivers and various sensors. By analyzing the color change and intensity change, the pH value, oxygen concentration, humidity, blood flow and healing progress of the wound can be quantitatively obtained.

[0073] Data fusion and synchronization module: The above multi-dimensional physiological parameters are integrated and analyzed to comprehensively evaluate the wound healing status. Once abnormal conditions such as severe infection or poor oxygenation are found, the control component can call the corresponding response strategy in real time.

[0074] Drug release control module: by sending a control signal to the electrode layer 100, the opening deformation of the balloon 200 is controlled to adjust the timing, frequency and dosage of drug release.

[0075] Current output module: outputs the required current (including intensity, frequency and waveform) through the electrode layer 100 to meet different treatment goals, such as low-frequency current for pain relief and high-frequency current for promoting tissue repair and blood flow.

[0076] At the same time, it should be noted here that although both the drug release control module and the current output module need to output electrical signals through the electrode layer 100, the control targets and signal forms are different; The drug release control module needs to trigger or adjust the deformation of the balloon 200 with an electrical signal, so as to control the timing, frequency and dosage of drug release; it mainly targets the material of the balloon 200 (usually an electrodeformable polymer), and achieves precise adjustment of drug output by changing the opening or closing state of the balloon 200; its signal is usually used to drive the deformation of the balloon 200 (which may be a pulse or a certain voltage / current regulation), and does not necessarily need to enter the human body to produce a biological stimulation effect, and focuses on mechanical control (opening and closing deformation).

[0077] The current output module outputs current to the wound or surrounding tissue to produce medical stimulation; it acts directly on the patient's skin / tissue, such as for analgesia, promoting blood circulation, accelerating tissue repair, etc.; the signal generally needs to adjust the current (including intensity, frequency, waveform) according to the specific treatment goal to achieve low-frequency analgesia, high-frequency promotion of regeneration and other biological effects, with an emphasis on physiological / therapeutic stimulation.

[0078] Therefore, a single electrode layer 100, multi-channel partitions or independent two-layer electrode layers 100 can be provided here; Among them, the implementation method of the single electrode layer 100 and the multi-channel partitioning is as follows: Different wiring and partitions can be arranged on the same electrode layer 100 to output the driving signal required for drug release and the current required for therapeutic electrical stimulation respectively. In terms of circuit design, the channel used to drive the electrodeformable polymer balloon 200 can be physically isolated or signal isolated from the channel for tissue electrical stimulation, and no interference can be achieved through multi-channel control.

[0079] Its overall structure is simpler, with limited increase in thickness, reducing material and process costs, but it requires sufficient isolation and anti-interference in electrical wiring and control algorithms to ensure that the two signals are stable and non-coupled.

[0080] The implementation method of independent two-layer electrodes is as follows: The electrode layer 100 for controlling drug release and the electrode layer 100 for tissue electrical stimulation are arranged separately and physically independent of each other. The two layers of electrodes can be implemented at different positions or different levels of the membrane structure, such as being arranged in layers between the base layer 500 or the attachment layer.

[0081] Its hardware and signal paths are easier to distinguish and do not interfere with each other, and can be more accurately optimized for different functions. However, an extra layer of electrode means a more complicated process, increased thickness, and a corresponding increase in cost.

[0082] In a specific application, whether a single electrode layer 100 or a multi-layer electrode is needed mainly depends on: the overall thickness and flexibility requirements of the device; interference control and safety considerations; whether there are large differences in signal strength and frequency bandwidth for drug release and electrical stimulation; and production process and cost factors.

[0083] Therefore, if the two signals can be ensured not to interfere with each other through reasonable circuit design and layout (such as multi-channel, multi-layer routing, good shielding and isolation), then using only one electrode layer 100 can also meet the dual needs of drug release and electrical stimulation; but in certain harsh environments or high-precision demand scenarios, in order to further reduce signal coupling and improve reliability, two layers of electrodes are also a feasible and more reliable design solution.

[0084] In one embodiment, when the nursing film of the present invention is attached to the wound area of ​​the patient's hepatobiliary surgery, the various sensors on the base layer 500 are in close contact with the skin wound. The sensor assembly 300 obtains the following through optical detection (LED or LD excitation → reflection or fluorescence signal → PD capture): infection indication (pH and bacterial metabolites, etc.), oxygenation level and humidity changes, blood flow, and wound healing progress (collagen deposition, cell proliferation, etc.).

[0085] This information is then transmitted in real time to the signal processing module of the control component for analysis; the signal processing module will perform preliminary decoding on the optical signals output by the above sensors, and the data fusion and synchronization module will further integrate the various parameters: if the degree of infection is found to be increasing, and parameters such as humidity and blood flow also undergo abnormal changes, it can be inferred that the wound has a potential risk of infection; if oxygenation is severely insufficient, it may be necessary to increase local oxygen supply or promote blood circulation; if the healing progress sensor shows that healing is slow, it may be necessary to release more growth factors or combine electrical stimulation to accelerate repair.

[0086] After data fusion, the drug release control module will accurately control the release of antibiotics, analgesics, growth factors, etc. in the balloon 200 according to the current wound status: when the infection indicator sensor signal indicates that the local pH has dropped significantly or the color has changed from green to red, the system will give priority to releasing the contents of the antibiotic balloon 200 to inhibit infection. When the oxygenation sensor shows insufficient oxygenation or the blood flow sensor shows a decrease in blood flow, the system will adjust the release of growth factors and assist with necessary electrical stimulation to enhance local blood circulation and accelerate tissue repair. When the wound healing progress sensor detects that the healing is in the critical stage of collagen deposition or tissue hyperplasia, the system can release more growth factors in a targeted manner to promote tissue regeneration. If the sensor detects that the patient has obvious pain (which can be combined with the patient's self-report or a special neural electrical stimulation sensor module), a certain dose of analgesics can be released to relieve discomfort.

[0087] In one embodiment, the membrane device of the present invention is gently attached to the wound site after hepatobiliary surgery, so that the base layer 500 is closely attached to the wound surface, ensuring that each sensor can accurately obtain physiological parameters at the wound. After the system is powered on, the sensor component 300, the control component and the balloon 200 drug release system enter the standby state and perform initialization self-test (such as light source 360 ​​intensity calibration, sensor baseline calibration, etc.).

[0088] During the entire healing cycle, the sensor assembly 300 continuously monitors the wound status in a multi-channel, continuous or periodic manner. The obtained optical or electrical signals are processed by the multi-channel optical receiver and the signal processing module, converted into quantitative physical parameters (pH, oxygenation concentration, humidity, blood flow, healing progress value, etc.), and stored in the storage module of the control assembly, so that medical staff can view or conduct subsequent analysis at any time.

[0089] In one embodiment, the system determines based on preset thresholds or algorithms. For example, when the infection parameters exceed the set thresholds, it will automatically trigger the release of antibiotics; when the healing progress is at a critical stage, it will automatically release growth factors and start electrical stimulation.

[0090] At the same time, medical staff can also remotely or manually adjust the intensity of electrical stimulation, drug release time or dosage on site based on monitoring data and patient feedback. This mode is suitable for early debugging or when special cases require more flexible treatment plans.

[0091] After detecting a change in wound status, the control component will instantly update the treatment plan, such as: When humidity is detected to be too high, the release of the aqueous gel 330 drug is reduced or suspended, and the frequency of dressing changes may be increased.

[0092] As blood flow improves, the frequency of electrical stimulation is reduced to avoid overstimulation.

[0093] If the infection sensor shows that the infection has subsided, the antibiotic release is reduced or stopped to prevent the abuse of antibiotics.

[0094] When the wound healing sensor shows that the healing degree has reached the set standard and there is no obvious infection or insufficient oxygenation, the membrane device can be removed according to the patient's wound condition. Subsequently, simpler dressings can be used for general care as needed, or the device can continue to be used for low-frequency monitoring to prevent infection or poor healing after surgery.

[0095] In one embodiment, based on the existing nursing film device, a data interaction module and a remote monitoring terminal are further introduced to construct a complete nursing system that can perform remote monitoring and automatic control. The nursing film device is applied to the wound area of ​​the patient after hepatobiliary surgery, and local physiological data is acquired in real time through integrated multiple sensors (infection indicator sensor, oxygenation sensor, humidity indicator sensor, blood flow sensor, and wound healing progress sensor). After the control component completes preliminary signal processing and data fusion, the monitoring results are sent to the remote monitoring terminal with the help of the data interaction module to achieve remote observation and dynamic intervention.

[0096] The data interaction module is a communication bridge between the care film device and the remote monitoring terminal, and performs two-way data transmission via wired or wireless means. The wireless communication method described in claim 9 can use BLE, WiFi or cellular network to achieve more flexible patient activities and remote medical deployment. When the care film device obtains new monitoring data, the data interaction module will send it to the remote monitoring terminal to facilitate medical staff to view the real-time status of the wound; conversely, the remote monitoring terminal can also issue instructions to the care film device to adjust the drug release or electrical stimulation parameters of the balloon 200.

[0097] The remote monitoring terminal can be a central monitoring system or cloud server platform configured by the hospital, or a mobile terminal (such as a tablet computer, smart phone, etc.) used by patients or medical staff. The terminal has a visual interface that can display the values ​​and trend graphs of various sensor data, such as infection index, oxygenation level, humidity curve, blood flow changes, wound healing progress, etc., to help doctors or caregivers quickly evaluate wound recovery. For scenarios with large amounts of data, it can also be combined with big data models or machine learning algorithms to conduct a comprehensive analysis of historical and current monitoring data, thereby predicting infection risks or healing speeds, and providing targeted intervention recommendations.

[0098] In this system, once an abnormal condition is detected (such as a significant increase in the infection index, insufficient oxygenation, poor blood flow, etc.), the remote monitoring terminal can automatically or manually send control instructions to the care film device by medical staff to trigger the release of the drug in the corresponding balloon 200 and adjust the intensity and frequency of electrical stimulation. If the wound is too wet or dry, the working mode of the care film device can also be switched remotely to speed up the discharge of liquid or maintain moderate humidity. This closed-loop control mechanism enables the system to identify problems at an early stage and intervene in real time, greatly reducing the incidence of serious complications.

[0099] The system has obvious advantages in practical applications. Since the care film device itself can obtain key physiological indicators of the wound in real time, both doctors and patients can keep abreast of the detailed changes in postoperative recovery. With the help of remote monitoring terminals, even if the patient is recuperating at home, the data can be sent to the hospital or community medical center through a wireless network; medical staff do not need to frequently visit the patient for inspection, and can conduct remote assessments and decisions. In case of emergency, the system will automatically alarm and start the corresponding drug release and electrical stimulation program to ensure that the infection is contained or blood circulation is promoted in the first place.

[0100] In summary, this embodiment adds a data interaction module and a remote monitoring terminal to the original nursing film device, forming a nursing system that combines visualization, remote control and automatic regulation. This "device + system" structure can not only meet the needs of personalized treatment, but also effectively reduce the hospitalization period and the workload of medical staff, improve patient comfort and compliance, and has broad clinical application prospects and commercial value.

[0101] In summary, the nursing membrane device and system for wound healing in hepatobiliary surgery provided by the present invention uses a membrane carrier as a carrier, integrates various types of sensors in the pores, and monitors the wound in real time through multi-channel optical detection and data fusion; combined with the electrodeformable polymer balloon 200, precise control of drug release is achieved, and the electrode layer 100 is used to output electrical stimulation to promote tissue repair. The present invention can not only significantly improve the healing efficiency and safety of hepatobiliary surgical wounds, but also effectively reduce the intensity of care and medical costs, and has a wide range of clinical application value. The above-mentioned embodiments are only used to illustrate the technical ideas of the present invention. All modifications, equivalent substitutions, etc. made within the scope of the claims of the present invention should be included in the scope of protection of the present invention.

Claims

1. A nursing membrane device for wound healing in hepatobiliary surgery, characterized in that: include: The membrane carrier is composed of a base layer and an adhesive layer, wherein the base layer is adhered to the wound of the patient's skin and is hollowed out with a plurality of holes and grooves; the adhesive layer is adhered to the base layer; A sensor assembly, comprising an infection indicator sensor, an oxygenation sensor, a humidity indicator sensor, a blood flow sensor and a wound healing progress sensor; wherein the infection indicator sensor, the oxygenation sensor, the humidity indicator sensor, the blood flow sensor and the wound healing progress sensor are respectively installed in a plurality of holes and grooves of the base layer, and monitor the infection degree, oxygenation degree, humidity, blood flow degree and wound healing progress of the wound; A plurality of balloons are attached to the attachment layer, and growth factors, analgesics and antibiotics are respectively wrapped therein; an electrode layer is provided above the attachment layer; the electrode layer is connected to a control component, and after receiving the sensing information from the sensor component, the control component controls the release of the plurality of balloons to achieve wound repair.

2. A nursing membrane device for wound healing in hepatobiliary surgery according to claim 1, characterized in that: The infection indicator sensor uses pH-sensitive materials combined with specific antibody sensors to respond to local pH changes and changes in bacterial metabolite concentrations. When a wound is infected, the local pH decreases and its color changes from green to yellow or red. The degree of infection is determined by irradiating its surface with a green LED and capturing the changes in reflected light with a photodiode (PD). The oxygenation sensor adopts a fluorescent detection material that is sensitive to oxygen concentration and uses a blue LD (laser diode) as an excitation light source; when the oxygenation state is poor, the fluorescence intensity decreases as the oxygen content decreases, and the emission light wavelength shifts, and the sensor appearance color may turn blue or red; when the oxygenation is good, the fluorescence signal is enhanced and turns green; by detecting the above fluorescence intensity and color changes through PD, the local oxygenation level of the wound can be evaluated; The humidity indicator sensor is made of super absorbent polymer or hydrogel. When the humidity of the wound increases, the material absorbs water and expands, and the color changes from yellow to blue. When the humidity is too low, it changes from blue to orange. The blue LED is used to illuminate and the PD is used to capture the change in the intensity of its reflected light. The blood flow sensor utilizes the absorption characteristics of hemoglobin to light of a specific wavelength (such as red light), and is combined with metal oxide semiconductor materials (such as titanium oxide or zinc oxide) and gold nanoparticles; when the blood flow increases, the sensor surface becomes dark red; when the blood flow decreases, the color changes to light pink or gray; a red LED is used as the excitation light source, and the intensity of the reflected light is captured by PD to reflect the blood flow situation; The wound healing progress sensor uses fluorescent dyes that are sensitive to biomarkers such as collagen and VEGF (vascular endothelial growth factor), and changes color from red → yellow → green as the concentration of the marker changes during the tissue repair process. The blue-violet light LD is used to excite the sensing material, and the PD is used to capture the fluorescence color change to evaluate the wound healing stage.

3. The nursing membrane device for wound healing in hepatobiliary surgery according to claim 1, characterized in that: The sensor assembly also includes: The multi-channel optical receiving module includes at least one multi-channel detector for simultaneously or quickly capturing light signals of different wavelengths emitted by each sensor; a plurality of independent photodiode channels are arranged in the multi-channel detector, corresponding to the fluorescence or reflected light generated by LD excitation, and the reflected light generated by LED excitation; by separating and analyzing the electrical signals of each channel in real time, multi-dimensional detection of infection, oxygenation, humidity, blood flow and wound healing progress can be achieved.

4. The nursing membrane device for wound healing in hepatobiliary surgery according to claim 3, characterized in that: The control component also includes: A signal processing module transmits the optical signal received from the multi-channel optical receiving module to the signal processing module signal, and the signal processing module is responsible for analyzing and decoding the color data and converting different color changes into quantitative physical parameters (such as pH value, oxygen concentration, humidity, etc.); The data fusion and synchronization module synchronously analyzes the physical parameters of the signal processing module to evaluate the infection, oxygenation, humidity, blood flow and healing progress; when the degree of infection increases, the system will combine the color change of the infection sensor and the data of other sensors (such as humidity and blood flow) to comprehensively judge the state of the wound.

5. The nursing membrane device for wound healing in hepatobiliary surgery according to claim 1, characterized in that: The balloon is made of an electrodeformable polymer; the amount of electricity released by the electrode layer controls the physical changes of the balloon opening, thereby controlling the timing, frequency and dosage of drug release.

6. The nursing membrane device for wound healing in hepatobiliary surgery according to claim 1, characterized in that: The control component can also output current to the wound area through the electrode points on the electrode layer: wherein, the control component adjusts the intensity of the current according to the physiological needs of the wound; if the blood circulation in the wound area is poor, the control component may increase the current intensity to promote blood flow; the control component current also adjusts the frequency and waveform of the current according to different treatment goals; low-frequency current may be used for pain relief, while high-frequency current helps promote tissue healing.

7. A system of a care membrane device for wound healing in hepatobiliary surgery according to claims 1-6, characterized in that: include: Care film device; A data interaction module, connected to the control component of the care film device, for collecting and sending wound status data obtained by the sensor component; The remote monitoring terminal is communicatively connected to the data interaction module, and is used to receive the wound status data and display it visually; when wound abnormality is detected or a personalized treatment plan is required, the remote monitoring terminal sends a control instruction to the control component of the care film device to adjust the drug release and electrical stimulation parameters.

8. A system for wound healing in hepatobiliary surgery according to claim 7, characterized in that: The data interaction module uses wireless communication to perform two-way data transmission with the remote monitoring terminal, and the wireless communication method includes one or more of BLE, WiFi or cellular network; the remote monitoring terminal combines big data models or machine learning algorithms to perform comprehensive analysis on the collected historical monitoring data and current monitoring data to predict the risk of wound infection or healing trend, and sends the corresponding parameter optimization plan to the care film device through communication instructions.

9. A system for wound healing in hepatobiliary surgery according to claim 8, characterized in that: The remote monitoring terminal is equipped with a data visualization interface, which can display multi-dimensional parameters such as infection index, oxygenation level, humidity curve, blood flow changes and healing progress; when it is detected that the infection index continues to rise and the oxygenation level is lower than a predetermined threshold, the remote monitoring terminal automatically triggers the release of the antibiotic balloon and increases the intensity of electrical stimulation to inhibit infection and promote blood circulation.

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