Wound infection chromogenic membrane and analytical method / system based on electro-enhanced indicator materials

Abstract

The present application belongs to the field of biosensors, and particularly relates to a wound infection chromogenic membrane based on an electrically enhanced indicator material, and an analysis method and system. The wound infection chromogenic membrane comprises a base layer, a sensitive layer, a pad layer, an electrification layer, a colorimetric layer, and a sealing layer. The base layer is a medical bandage with adhesive on the bottom surface, and a through hole is provided in the middle. The sensitive layer is a modified PVA nanofiber membrane containing lead acetate, and is located on the adhesive side of the base layer and covers the through hole. The pad layer is annular and surrounds the outer periphery of the sensitive layer so that the sensitive layer remains suspended in use. The electrification layer is located on the non-adhesive side of the base layer above the through hole, and is made of a flexible transparent material that carries a negative charge when in contact with the sensitive layer. The colorimetric layer is black. The sealing layer covers the area corresponding to the pad layer below. The analysis method of the present application uses color comparison to quantify the test results. The present application solves the problems of difficulty in detecting wound infection, low efficiency, and poor patient experience.

Description

Technical Field

[0001] This invention belongs to the field of biosensors, specifically relating to a wound infection chromogenic membrane based on an electrically enhanced indicator material, a method for analyzing the degree of wound infection based on the wound infection chromogenic membrane, and an online analysis system. Background Technology

[0002] Skin wounds (such as surgical wounds, abrasions, and burns) are susceptible to pathogen invasion, and if not treated promptly and effectively, can lead to bacterial infection and delayed wound healing. Ineffective treatment of chronic wounds increases the risk of wound deterioration, leading to various complications such as organ failure, sepsis, and tetanus. Patients with diabetes and obesity have a relatively higher risk of developing chronic wounds. The underlying cause of chronic wound formation is bacterial infection, making timely detection of wound infections a crucial clinical issue. Clinically, wound assessment relies on observation (wound bed color and pus) and laboratory techniques (swabs and cultures). The former depends on the experience of healthcare professionals, while the latter is cumbersome, time-consuming, and requires trained personnel; both approaches carry the risk of misdiagnosis and unnecessary treatment due to subjective judgment. Furthermore, these methods lack universality for detecting various bacterial infections in wounds, are prone to causing pain to patients at the wound site, and have relatively low calibration efficiency.

[0003] In recent years, with the continuous development of biotechnology and information technology, an increasing number of wearable sensors are being launched and applied, and these sensors can be used to detect wounds and infections. This new detection tool collects information such as changes in the wound bed (temperature and size) and various biomarkers of bacterial metabolism (e.g., pH, uric acid, enzymes). Based on changes in the detection signals, it enables the monitoring and early warning of early bacterial infection in the wound.

[0004] Unlike traditional detection methods, these advanced wearable sensors do not require swabs or biopsies. Instead, they monitor and alert to wound infections by simply touching the unique markers and microenvironment of infecting bacteria. Therefore, these sensors can provide patients with real-time status information, opening up possibilities for continuous remote monitoring of bacterial infections in non-clinical settings. However, many obstacles remain to be overcome before these wearable sensors can be applied clinically. For example, most of these sensors require close proximity to the wound, which can lead to dye leaching, potentially causing sensor material to migrate to the wound surface and exacerbate infection. Furthermore, existing medical wearable sensors rely on the random adsorption of markers for signal transmission and detection. If the detection factor cannot stably adsorb at its adsorption site, causing molecular escape (adsorption energy Eads below 0.5 Ev), the sensor's performance will be degraded.

[0005] Therefore, how to develop a wound infection detection solution that causes less damage to the human body, is more comfortable, and has higher sensitivity has become a technical problem that urgently needs to be solved by those in the field. Summary of the Invention

[0006] To address the problems of high difficulty, low efficiency, poor patient experience, and reliance on medical staff experience in existing wound infection detection methods, this invention provides a wound infection chromogenic membrane based on an electrically enhanced indicator material, a method for analyzing the degree of wound infection based on the wound infection chromogenic membrane, and an online analysis system.

[0007] This invention is achieved using the following technical solution:

[0008] A wound infection chromogenic membrane based on an electrically enhanced indicator material is disclosed, which is used to capture characteristic gases produced by microorganisms during wound infection and to indicate the degree of infection based on the concentration of the characteristic gases. The wound infection chromogenic membrane comprises: a base layer, a sensitive layer, a padding layer, an electrifying layer, a colorimetric layer, and a sealing layer.

[0009] The base layer consists of a medical bandage with adhesive on the bottom and a through-hole in the center. The sensitive layer is a modified PVA nanofiber membrane containing lead acetate, which is adhered to the adhesive side of the base layer and completely covers the through-hole. The padding layer is adhered to the adhesive side of the base layer; the padding layer is annular and surrounds the sensitive layer to keep it suspended during use.

[0010] The charging layer is located on the non-adhesive side above the substrate, covering the through-hole. It is made of a flexible, transparent material that carries a negative charge when in contact with and separating from the sensitive layer. The colorimetric layer is located above the charging layer, near the center of the through-hole, and is black. The sealing layer is a transparent film adhered to the upper surface of the charging layer, completely covering the area of ​​the corresponding padding layer below.

[0011] In the solution provided by this invention, the method for preparing the material of the sensitive layer is as follows:

[0012] The powder was dissolved in water at a concentration of 12 wt%. The solution and DMF were mixed at a volume ratio of 1:9 and magnetically stirred at 65°C for 8 hours until the solution became clear and transparent. Next, 1 wt% lead acetate powder was added to the solution, and stirring continued for 2 hours to obtain a polymer solution suitable for spinning. Then, the PVA mixture was loaded into a syringe, and electrospinning was performed under the following conditions: electrospinning voltage of 20 kV, syringe pump speed of 0.5 mL / h, collection tank rotation speed of 200 r / min, and collection distance of 16 cm. The prepared nanofiber membrane was placed in a sealed container for crosslinking, and 25 wt% glutaraldehyde was added to the container, with hydrochloric acid used as a catalytic catalyst. Finally, the obtained material was dried in an oven at 80°C to obtain the desired sensitive layer film.

[0013] As a further improvement of the present invention, the padding layer is made of any one of the following soft materials: silicone, PVC, rubber, PDMS, and polyurethane. The charging layer is made of any one of the following materials: FEP, PVDF, PTFE, and polylactic acid. The sealing layer is made of any one of the following materials: polyethylene, polyvinyl chloride, polyvinylidene chloride, and polymethylpentene.

[0014] As a further improvement of the present invention, a release film is provided below the pad layer; the release film is used to seal the space in the pad layer to prevent the sensitive layer inside from failing during storage.

[0015] and / or

[0016] The infected wound membrane was sealed and stored.

[0017] The method of using the wound infection chromogenic membrane provided by this invention is as follows:

[0018] Select the appropriate size of wound infection chromogenic membrane according to the shape and size of the wound, so that the inner ring of the pad can completely cover the wound; attach the wound interference sensing membrane to the wound, keeping the sensitive layer facing the wound area; tap the charging layer several times to separate the charging layer from the sensitive layer, and wait for the sensitive layer to change color; observe that the greater the color difference of the sensitive layer before and after use, or the closer the sensitive layer is to the colorimetric layer after changing color, the more severe the infection is, and vice versa.

[0019] This invention also includes a method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. This method uses the aforementioned wound infection chromogenic membrane as a detection tool and performs quantitative analysis of the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of infection in this type of wound includes the following steps:

[0020] S1: The initial brightness L0, initial red-green value a0, and initial yellow-blue value b0 of the wound infection developing membrane in the corresponding sensitive layer area before use were detected by a colorimeter.

[0021] S2: The brightness L, red-green value a, and yellow-blue value b of the corresponding sensitive layer area of ​​the wound infection developing membrane are detected by a colorimeter after use.

[0022] S3: Calculate the first color difference value △E1 of the sensitive layer area of ​​the wound infection chromogenic membrane before and after use. The calculation formula is as follows:

[0023]

[0024] S4: Acquire a large number of sample data of the first color difference value ΔE1 detected from biological samples with different infection levels, and construct a characterization function to represent the relationship between the first color difference value ΔE1 and IL at each infection level.i A data lookup table or fitting function for mapping relationships between them.

[0025] S5: Detect the wound of any test object using a wound infection chromogenic membrane, obtain the first color difference value ΔE1, and query the data lookup table or fitting function to obtain the wound infection level IL of the current test object. i .

[0026] The present invention also includes a second method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. This method uses the aforementioned wound infection chromogenic membrane as a detection tool and performs quantitative analysis of the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of wound infection includes the following steps:

[0027] S01: Detecting the baseline brightness L of the colorimetric layer area of ​​the wound infection developing membrane using a colorimeter after use. * 0. Baseline red-green value a * 0 and the baseline yellow-blue value b * 0; and the detected brightness L, detected red-green value a, and detected yellow-blue value b of the sensitive layer area after use.

[0028] S02: Calculate the second color difference value ΔE2 between the sensitive layer and the colorimetric layer after using the chromogenic membrane for wound infection. The calculation formula is as follows:

[0029]

[0030] S03: Acquire a large amount of sample data of the second color difference value ΔE2 detected from biological samples with different infection levels, and construct a characterization method to represent the relationship between the second color difference value ΔE2 and IL at each infection level. i A data lookup table or fitting function for mapping relationships between them.

[0031] S04: Detect the wound of any test subject using a wound infection chromogenic membrane to obtain the second color difference value ΔE2. Based on this, consult the data comparison table or fitting function from the previous step to obtain the wound infection level IL of the current test subject. i .

[0032] This invention also provides a third method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. This method also uses the aforementioned wound infection chromogenic membrane as a detection tool and performs quantitative analysis on the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of wound infection includes the following steps:

[0033] S001: Biological samples with different degrees of infection are detected by using multiple wound infection chromogenic membranes.

[0034] S002: Acquire a sample image of the chromogenic membrane for wound infection after detection, and crop out a local image of the corresponding sensitive layer area.

[0035] S003: Obtain the RGB values ​​at specified sampling points in the local image, use these as sample data, and add corresponding infection level labels to each sample data according to the source of the sample image to form a training set and a test set.

[0036] S004: Train and test an SVM model using the training and test sets to obtain a network model that can be used to classify the infection level of samples; the input of the network model is one or more sets of R, G, B values, and the output is the corresponding infection level.

[0037] S005: Detect wounds on any target object using a wound infection chromogenic membrane, capture an image of the detected wound infection chromogenic membrane, extract the RGB values ​​of specified sampling sites in the sensitive layer, and input them into the network model trained in the previous step. The network model then outputs the classified infection level.

[0038] This invention also provides a fourth method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. This method uses the aforementioned wound infection chromogenic membrane as a detection tool and performs quantitative analysis of the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of wound infection includes the following steps:

[0039] S0001: Biological samples with different degrees of infection are detected by using multiple wound infection chromogenic membranes.

[0040] S0002: Obtain a sample image of the chromogenic membrane for wound infection detection, and crop out a local image of the corresponding sensitive layer area; the black area in the center of the local image is the colorimetric layer.

[0041] S0003: Convert the local image to a grayscale image and calculate the grayscale deviation ΔH between the sensitive layer region and the colorimetric layer region.

[0042] S0004: Acquire a large amount of sample data of grayscale deviation ΔH detected from biological samples with different infection levels, and construct a characterization method to represent the relationship between grayscale deviation ΔH and IL at each infection level. i A data lookup table or fitting function for mapping relationships between them.

[0043] S0005: Acquire an image of the wound infection chromogenic membrane used on any test object and convert it into a grayscale image. Calculate the grayscale deviation ΔH between the sensitive layer region and the colorimetric layer region in the grayscale image. Then, based on this, consult the data comparison table or fitting function to obtain the identified infection level.

[0044] This invention also provides an online analysis system for wound infection severity, which enables online analysis of a user's wound infection status. The online analysis system includes a mobile terminal and a server. The user takes an image of the wound infection development membrane using the mobile terminal and uploads it to the server. The server uses the aforementioned wound infection severity analysis method based on the wound infection development membrane to process the uploaded image, generate the corresponding infection level, and then feeds it back to the client.

[0045] The technical solution provided by this invention has the following beneficial effects:

[0046] This invention addresses the microbial response of human skin wounds under bacterial infection conditions. It designs a sensitive material that can indicate microbial metabolites, thereby enabling visualization of the degree of wound infection. The resulting chromogenic membrane for wound infection possesses advantages such as high detection efficiency, portability, ease of use, low cost, non-contact with the human body, safety, and no leaching, thus improving user experience. It has a very broad prospect for widespread application.

[0047] Building upon the visual inspection scheme, this invention further utilizes sensitive materials and corresponding electrostatic materials to construct a triboelectric enhanced interface that generates ample positive charges in the sensitive layer through triboelectric power generation. This triboelectric enhanced interface controllably enhances the "capture" efficiency of the sensitive layer for characteristic gases of wound infection, thereby improving the sensitivity of the wound infection chromogenic membrane to low concentrations of infection and reducing the response time of the sensitive layer. This enables early monitoring and rapid detection of wound infection.

[0048] This invention addresses the discoloration process of sensitive layer materials and designs a complete set of quantitative analysis methods for wound infection burden based on color changes. This method can quantitatively analyze the color changes of the sensitive layer through different strategies, thereby achieving accurate classification of the infection level of the wound and providing a basis for subsequent medical treatment of the wound. Attached Figure Description

[0049] Figure 1 This is a schematic diagram of the structure of a wound infection colorimetric membrane based on an electrically enhanced indicator material provided in Embodiment 1 of the present invention.

[0050] Figure 2 A schematic diagram of the chemical reaction principle of a modification scheme for sensitive materials in a wound infection display membrane.

[0051] Figure 3 The images show SEM images of conventional PVA nanofibers and the modified C-PVA nanofibers from this embodiment used in the performance testing experiment.

[0052] Figure 4These are SEM images of the sensitive layer C-PVA Pb(Ac)2 material before and after its reaction with the characteristic gas H2S during performance testing experiments.

[0053] Figure 5 The results are EDS analysis of the sensitive layer material after H2S gas exposure test in the performance testing experiment.

[0054] Figure 6 XRF analysis results of C, O, Pb, and S elements in four different samples (PVA, C-linked PVA, C-linked PVAPb(Ac)2, and C-linked PVAPb(Ac)2@H2S) before and after H2S gas exposure test in the performance test experiment.

[0055] Figure 7 An electrical model of the triboelectrically enhanced interface constructed in the wound infection chromogenic membrane designed for this invention.

[0056] Figure 8 In response to Figure 7 A simplified discharge model designed from the electrical model can be used for actual measurements.

[0057] Figure 9 This is a schematic diagram illustrating the electrostatic potential and charge transfer process of each material in the triboelectrically enhanced interface constructed in this invention.

[0058] Figure 10 The figures (a), (b), (c), and (d) curves of output voltage and power density as a function of external load resistance are obtained from the experimentally measured open-circuit voltage curve (a), short-circuit current curve (b), transferred charge curve (c), and output voltage and power density curves as a function of external load resistance (d) at different operating frequencies using a simplified discharge model in the performance test experiment.

[0059] Figure 11 This is a force analysis image of H2S gas at the positively charged sensitive layer in this invention.

[0060] Figure 12 The graph shows the DFT calculation of the adsorption energy diagram of H2S adsorbed on the surface of PVA molecules with different charges in the performance test experiment, as well as the relationship between the color value changes of the fiber membrane reacting with H2S with different charges.

[0061] Figure 13 This is a colorimetric diagram of the experimental group containing Staphylococcus aureus under different bacterial density conditions during performance testing.

[0062] Figure 14 This is a graph showing the change in colorimetric values ​​as a function of bacterial density in the experimental group containing Staphylococcus aureus, as statistically analyzed in the performance testing experiment.

[0063] Figure 15The graph shows the correlation between membrane color values ​​and bacterial concentration (lg CFU, Staphylococcus aureus). The lower left corner shows the scattering density matrix, and the upper right corner shows the correlation matrix.

[0064] Figure 16 This is a flowchart of the steps of the wound infection degree analysis method based on the wound infection chromogenic membrane provided in Scheme 1 of Example 2.

[0065] Figure 17 This is a flowchart of the steps of the wound infection degree analysis method based on the wound infection chromogenic membrane provided in Scheme 2 of Example 2.

[0066] Figure 18 This is a flowchart of the steps of the wound infection degree analysis method based on the wound infection chromogenic membrane provided in Scheme 3 of Example 2.

[0067] Figure 19 This is a flowchart of the steps of the wound infection degree analysis method based on the wound infection chromogenic membrane provided in Scheme 4 of Example 2.

[0068] Figure 20 This is a schematic diagram of the online wound infection degree analysis system provided in Embodiment 3 of the present invention. Detailed Implementation

[0069] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0070] Example 1

[0071] This embodiment provides a wound infection colorimetric membrane based on an electrically enhanced indicator material, which is used to capture characteristic gases produced by microorganisms during wound infection and indicate the degree of infection based on the concentration of these characteristic gases. The wound infection colorimetric membrane includes: a base layer, a sensitive layer, a padding layer, a charging layer, a colorimetric layer, and a sealing layer. The base layer is made of a skin-friendly adhesive material similar to medical bandages. The sensitive layer is made of a modified PVA nanofiber membrane (C-PVA Pb(Ac)2) containing lead acetate. The padding layer is made of a flexible material with waterproof and insulating properties, such as silicone, PVC, rubber, PDMS, or polyurethane. The charging layer is made of a material that can generate a negative charge after triboelectric charging with the sensitive layer; for example, FEP is used in this embodiment, but PVDF, PTFE, polylactic acid, etc., can also be used in other embodiments. The sealing layer is made of PVC or other similar transparent flexible films with waterproof properties.

[0072] like Figure 1As shown, the base layer is a medical bandage with adhesive on the bottom, and there is a through hole in the middle of the base layer. The sensitive layer is adhered to the adhesive side of the base layer and completely covers the through hole. The padding layer is adhered to the adhesive side of the base layer; the padding layer is ring-shaped and surrounds the periphery of the sensitive layer so that the sensitive layer remains suspended during use.

[0073] The charging layer is located on the non-adhesive side above the base layer, covering the through-hole. The colorimetric layer is located above the charging layer near the center of the through-hole, and is black. The sealing layer is adhered to the upper surface of the charging layer and completely covers the area of ​​the corresponding padding layer below.

[0074] The working principle of the wound infection chromogenic membrane based on electrically enhanced indicator materials provided in this embodiment is as follows:

[0075] Combination Figure 1 The resulting commercially available chromogenic wound infection membrane has a similar shape to a corn patch, but its dimensions can be customized to meet specific needs. Unlike conventional medical products like corn patches, the chromogenic wound infection membrane in this embodiment primarily involves wrapping a pad around the outer layer of the wound while keeping the sensitive layer inside the pad suspended on the wound surface. The pad and the sensitive layer together form a "reaction chamber." During use, when a patient's wound becomes infected, the life activities of bacteria and other microorganisms produce characteristic gases containing H2S. These gases enter the "reaction chamber," where some gas molecules are "captured" by the sensitive layer and react chemically with components within it. The resulting chemical products cause the sensitive layer to change color. In this embodiment, the sensitive layer is a special indicator of the characteristic gas concentration, while the upper electrostatic layer and sealing layer are transparent materials, allowing users to easily observe the color change of the internal sensitive layer from the surface of the chromogenic wound infection membrane.

[0076] In the chromogenic membrane for wound infection provided in this embodiment, the initial state of the sensitive layer is a light-colored state close to white. After capturing a sufficient concentration of characteristic gas, the sensitive layer gradually turns into a dark-colored state close to black. The degree of color change of the sensitive layer depends on the amount of characteristic gas captured, which is positively correlated with the concentration of characteristic gas produced on the wound surface. The concentration of characteristic gas produced on the wound surface is a typical indicator of the degree of wound infection. Therefore, the chromogenic membrane for wound infection in this embodiment can provide visual monitoring of the degree of infection of the wound.

[0077] Based on the explanation of the working principle of the wound infection chromogenic membrane above, it can be seen that, under the same detection conditions, the degree of color change of the sensitive layer material depends on two factors: the actual concentration of the characteristic gas generated in the "reaction chamber" and the "capture" efficiency of the characteristic gas by the sensitive layer. Specifically, the color difference in the response of the sensitive layer material to different concentrations of characteristic gas reflects the resolution of the wound infection chromogenic membrane as a biosensor; a wider response range to characteristic gas concentrations indicates higher resolution, i.e., a wider measurement range. Conversely, the "capture" efficiency of the sensitive layer material for the characteristic gas determines the sensitivity of the wound infection chromogenic membrane; a more pronounced response to low concentrations of characteristic gas indicates higher sensitivity.

[0078] Specifically, to improve the sensitivity of the wound infection chromogenic membrane, this embodiment features a triboelectric-enhanced interface comprising a base layer, a sensitive layer, and a charging layer. This interface induces triboelectric charging during use through contact separation cycles between the charging layer and the sensitive layer, accumulating a sufficient amount of positive charge in the sensitive layer. The positively charged sensitive layer significantly increases the "capture" efficiency of the characteristic gas, and the probability of the characteristic gas escaping from the membrane surface is significantly reduced. This allows the wound infection chromogenic membrane to respond rapidly to extremely low concentrations of the characteristic gas, thereby enabling early monitoring of wound infections in patients. The actual performance of this component will be verified through subsequent experiments.

[0079] In this embodiment, the sensitive layer material, C-PVA Pb(Ac)2, is a PVA fiber membrane with lead acetate (Pb(Ac)2) particles loaded on its surface. Pb(Ac)2 is the color-developing material in the sensitive layer; it reacts with H2S gas to generate black PbS. This is the intrinsic mechanism by which the sensitive layer in this embodiment responds to the characteristic gas and changes color. The PVA fiber membrane serves as the carrier of the color-developing material and is also one of the triboelectric electrodes used to construct the triboelectric enhancement interface in this case. However, because ordinary PVA fiber membranes are hydrophilic, they are prone to disintegration in humid environments, leading to unstable color of the sensitive layer and severely affecting triboelectric power generation performance. To address this problem, this embodiment uses a modified C-PVA Pb(Ac)2 membrane material. Specifically, the preparation method of the membrane material used in this embodiment is as follows:

[0080] The powder was dissolved in water at a concentration of 12 wt%. The solution and DMF were mixed at a volume ratio of 1:9 and magnetically stirred at 65°C for 8 hours until the solution became clear and transparent. Next, 1 wt% lead acetate powder was added to the solution, and stirring was continued for 2 hours to obtain a polymer solution suitable for spinning. Then, the PVA mixture was loaded into a syringe, and electrospinning was performed under the following conditions: electrospinning voltage of 20 kV, syringe pump speed of 0.5 mL / h, collection tank rotation speed of 200 r / min, and collection distance of 16 cm. The prepared nanofiber membrane was placed in a sealed container for crosslinking, and 25 wt% glutaraldehyde was added to the container, with hydrochloric acid used as a catalytic catalyst. Finally, the obtained material was dried in an oven at 80°C to obtain the desired sensitive layer film.

[0081] The modified C-PVA Pb(Ac)2 membrane material provided in this embodiment improves the hydrophobic properties of the membrane through chemical crosslinking. For example... Figure 2 As shown, the main mechanism of the modification process in this embodiment is the acetal reaction between glutaraldehyde and the PVA substrate under the catalysis of acid vapor, which consumes most of the hydrophilic hydroxyl groups (-OH) in the PVA substrate. Furthermore, the fibers in the modified membrane material exhibit stronger H2S resistance and can maintain a stable fiber morphology under long-term exposure conditions. Excellent adhesion is maintained to both the unreacted Pb(Ac)2 and the post-reaction PbS particles.

[0082] In the commercially available wound infection chromogenic membrane based on electrically enhanced indicator materials provided in this embodiment, a release film is typically provided beneath the padding layer; the release film seals the space within the padding layer. The release film prevents impurities from adhering to the sensitive layer when not in use, and also prevents the sensitive layer and other structures from absorbing moisture and failing, thus improving the product's shelf life. Specifically, the wound infection chromogenic membrane based on electrically enhanced indicator materials provided in this embodiment should be stored in a dry, sealed environment. Under preferred storage conditions, the wound infection chromogenic membrane can be sealed and stored within sealed packaging material.

[0083] The method of using the wound infection chromogenic membrane provided in this embodiment is as follows:

[0084] Select a wound infection chromogenic membrane of appropriate size according to the shape and size of the wound, ensuring that the inner ring of the pad completely covers the wound. Attach the wound interference sensing membrane to the wound, ensuring the sensitive layer is directly opposite the wound area. Gently tap the charged layer area several times to separate the charged layer from the sensitive layer, thus maintaining a sufficiently strong positive charge on the sensitive layer. Then wait for the sensitive layer to absorb the characteristic gas generated on the wound surface and emit a color change. Finally, observe the color change of the sensitive layer area in the wound infection chromogenic membrane. A greater color difference before and after use (the darker the color of the sensitive layer), indicates a more severe infection; conversely, a smaller color difference indicates a milder infection.

[0085] Furthermore, considering that the color change of the sensitive layer is a relatively slow process, rather than an instantaneous one, a colorimetric layer is also provided at the center of the sensitive layer in this embodiment to facilitate observation of the degree of color change. The colorimetric layer is a material whose color does not change during use. In this embodiment, the colorimetric layer is set to black. Therefore, users can also observe the color difference between the sensitive layer and the colorimetric layer in the later stages of detection to understand the infection status of the wound. The closer the sensitive layer changes color to the colorimetric layer, the more severe the wound infection; conversely, the closer it is to the colorimetric layer, the milder the wound infection.

[0086] To create a clear visual difference between the colors before and after the reaction with the sensitive layer, black pigment is used in the colorimetric layer in this embodiment. In other embodiments, the colorimetric layer may also be selected from other colors that are significantly different from the color of the sensitive layer. The color of the colorimetric layer is not limited in this embodiment.

[0087] Performance testing

[0088] To verify the performance of the wound infection chromogenic membrane provided in Embodiment 1 of the present invention, technicians also manufactured a small number of product samples and set up relevant test experiments to verify the detection performance of the product.

[0089] I. Performance Testing of Sensitive Layer Materials

[0090] 1.1 SEM Scanning Experiment of Materials

[0091] To investigate the impact and effect of the preparation process on the fiber membrane material in this embodiment, the surface morphology and structure of conventional PVA nanofibers and the C-PVA modified in this embodiment were observed using SEM. The results are shown below. Figure 3 As shown. Observation Figure 3 It can be seen that the modified C-PVA fiber membrane in this case, like the conventional PVA fiber membrane, exhibits smooth, uniform, and continuous nanofiber filaments.

[0092] Further testing was conducted to examine the changes in the microstructure, structure, and elemental content of the sensitive layer C-PVA Pb(Ac)2 material provided in this embodiment after its reaction with the characteristic gas H2S. Among these tests, Figure 4 Here are SEM images of the materials before and after the reaction, from... Figure 4As can be seen, after C-PVA Pb(Ac)2 responds to H2S, a large number of impurity particles grow on the surface of the fiber filaments. These particles can actually be attributed to the PbS precipitation produced by the reaction of lead acetate on the fiber surface with H2S. Meanwhile, after exposing the C-PVA Pb(Ac)2 fiber membrane to H2S gas (5 ppm) for 4 hours, it can be observed that the fibers in the sensitive layer still maintain an intact fiber morphology and no material disintegration occurs. This reflects the good tolerance of the modified C-PVA Pb(Ac)2 to the characteristic gas.

[0093] 1.2 EDS Analysis of Materials

[0094] The testing process also included energy-dispersive X-ray spectroscopy (EDS) analysis of the sensitive layer material exposed to H2S. The analysis results are as follows: Figure 5 As shown, Figure 5 The results showed that Pb was finely distributed throughout the PVA polymer fibers, with a mass fraction of approximately m ≈ 0.9%, indicating that the chromogenic material Pb(Ac)₂ was very uniformly distributed in the fiber carrier, and that the fiber membrane carrier had a high loading capacity for the chromogenic material. Simultaneously, an additional signal from S was detected in the sensitive layer material, with m ≈ 0.66%, indicating that lead acetate and H₂S gas reacted uniformly to form PbS precipitate.

[0095] To more accurately investigate the changes in elemental content of different samples before and after H2S exposure testing, this experiment also performed XRF analysis on four groups of samples: PVA, C-linked PVA, C-linked PVA Pb(Ac)2, and C-linked PVA Pb(Ac)2@H2S. The changes in C, O, S, and Pb content of each sample are shown below. Figure 6 As shown. Analysis Figure 6 The data shows that all four sample groups exhibited peaks for carbon and oxygen. In the fiber membrane not exposed to H2S, a characteristic peak for Pb was observed. However, after exposure to hydrogen sulfide, the fiber membrane displayed characteristic peaks for both Pb and S. This indicates that the fiber membrane in the sensitive layer adsorbed H2S and produced PbS precipitate.

[0096] The above experiments confirm that the sensitive layer material C-PVA Pb(Ac)2 used in the wound infection colorimetric membrane based on electro-enhanced indicator material provided by this invention has strong chemical stability and exhibits sensitivity to H2S characteristic gas.

[0097] II. Relevant Tests of Triboelectric Reinforced Interfaces

[0098] 2.1 Verification of the charging effect

[0099] In this embodiment, a triboelectric enhancement interface is constructed using a charged layer (FEP), a sensitive layer (C-PVA Pb(Ac)2), and a base layer (perforated medical tape). The electrical model of this interface structure is as follows: Figure 7 As shown in the figure, the C-PVA Pb(Ac)2 fiber membrane uses a single-electrode model of a triboelectric nanogenerator for charge accumulation. Its working principle is based on contact electrification and electrostatic induction coupling. When the sensitive layer of the wound infection chromogenic membrane is subjected to external force, the sealing layer (PVC transparent film) and the electrifying layer deform and bend, causing the two triboelectric layers to contact and separate, generating a charge accumulation effect. Figure 7 The charge transfer mechanism.

[0100] To verify Figure 7 The charging effect of the charge transfer mechanism was tested by constructing an experimental setup as follows. Figure 8 A simplified discharge model was constructed, with one end consisting of a C-PVA Pb(Ac)2 fiber membrane and the other end using a commercially available FEP film as the contact material. When the FEP contacts the C-PVA Pb(Ac)2 membrane, electrostatics occur at the interface, inducing equal but opposite charges on both electrodes. As the two surfaces separate, the net charge of the C-PVA Pb(Ac)2 membrane induces electron movement in the 3M Electronics, generating a transient current. Subsequently, when the FEP moves sufficiently far, the two friction layers reach electrical equilibrium, and the circuit ceases to generate charge movement. Conversely, if the FEP approaches the C-PVA Pb(Ac)2, the accumulated negative charge in the 3M Electronics flows to the ground, generating an opposite electrical signal. This cycle continues until the device returns to its initial state, and then the alternating current generation continues. Test experiments were conducted using COMSOL to simulate the potential distribution under three different states, yielding the following results: Figure 12 The potential distribution diagram.

[0101] To investigate the potential distribution of the molecular chain, DFT calculations were performed on the elements of the PVA molecular chain in the test experiment. The electrostatic potential diagram of the structural elements is shown below. Figure 9 As shown, the blue and red regions represent the positive and negative potential regions, corresponding to the electron-depleted and electron-rich regions, respectively. Due to the strong electron-withdrawing ability of FEP, when it comes into contact with C-PVA Pb(Ac)2, electrons from the H groups in the positive potential region of PVA may transfer to the more electronegative F groups of FEP. To demonstrate this, DFT analysis was performed in the test experiment, considering that as the two materials at the PVA-FEP interface approach each other, the total energy of the system gradually decreases and reaches a minimum, at which point the distance between the two molecules is the equilibrium interfacial distance. The Hirshfeld atomic charge of the system at this equilibrium can be used for charge transfer from PVA. When approaching... At this point, the positive charge of H atoms in PVA at the interface decreases, while the charge of F atoms at the interface of FEP increases. This indicates that charge transfer occurs between the H atoms of PVA and the F atoms of FEP.

[0102] The output of SE-TENG is closely related to its operating frequency. Therefore, the test experiment also included installing the triboelectric reinforced interface on the linear motor for performance testing. The test data are as follows: Figure 10 As shown, when the operating frequency of the linear motor increases from 0.5Hz to 3Hz, the Voc, Isc, and Qsc of the triboelectric reinforced interface all increase. Next, the charging capability of the triboelectric reinforced interface was tested at an operating frequency of 2Hz. The results showed that with an external load resistance of 50MΩ, the maximum peak output power was 69.5mW / m². This indicates that the triboelectric reinforced interface designed in this embodiment can indeed efficiently convert human motion energy into electrical energy, allowing sufficient positive charge to accumulate in the sensitive layer material.

[0103] 2.2 Verification of the Enhanced Adsorption Performance of Characteristic Gases

[0104] Based on the principle of triboelectricity at the interface, the sensitive layer C-PVA / Pb(Ac)2 accumulates and stores electrons as the user's hand repeatedly touches the FEP layer, causing electrostatic adsorption. This accelerates and stabilizes the adsorption of the characteristic gas on the C-PVA / Pb(Ac)2 surface. This process can be explained by strong Coulomb forces, combined with... Figure 11 Assuming an ideal state where intermolecular attraction is negligible, the electric field will not change with the adhesion of gas. Since C-PVA / Pb(Ac)₂ generates an electric field (E) after becoming charged, under the influence of Coulomb force (qE), gas molecules accelerate towards the C-PVA / Pb(Ac)₂ film. As their velocity increases, they will experience air resistance (F). f When the gas reaches its terminal velocity Ff = qE, the motion of the gas molecules in the electric field can be calculated using the following formula:

[0105]

[0106] Where μ is the velocity of the gas, m is the mass of the gas molecule, and R... d It is the radius of a gas molecule. It is the air speed, η g It is the viscosity of air.

[0107] Due to the acceleration timescale Compared to flight time It's one to two orders of magnitude smaller.

[0108] Therefore, the velocity at which the characteristic gas reaches its terminal is given by the formula.

[0109]

[0110] As can be seen from the above formula, the electric field generated by the charge accumulated in the sensitive layer in this embodiment is indeed beneficial for capturing characteristic gas molecules.

[0111] Since the main matrix of the C-PVA / Pb(Ac)2 film is PVA, a segment of the PVA molecular chain was selected as the adsorption model in the test experiment to study the adsorption behavior on the C-PVA / Pb(Ac)2 film under different charge states. Density functional theory (DFT) was used to simulate and calculate the adsorption energy of hydrogen sulfide gas on the C-PVA / Pb(Ac)2 film. The results show that as the positive charge increases from 0e to 3e, the adsorption energy of the gas on the C-PVA / Pb(Ac)2 film increases from -0.35eV to -0.82eV, indicating that the injected charge increases the interaction between the gas and the surface. Furthermore, the study also showed that when the adsorption energy is greater than -0.50 eV, the solid surface can more effectively capture gas molecules. Therefore, due to the larger adsorption energy of the charged surface (-0.82 eV > -0.50 eV > -0.35 eV), the possibility of hydrogen sulfide gas escaping from the C-PVA / Pb(Ac)2 film surface is smaller. This will also be more beneficial for the sensitive layer in this embodiment to capture the characteristic gas and respond with a color change.

[0112] In particular, to more intuitively demonstrate this process, the test experiment also involved injecting charges into the C-PVA / Pb(Ac)2 membrane to study its response to the monitored characteristic gas H2S under different charge states. The test results are as follows: Figure 12 As shown, with the increase of charge, the color difference ΔE before and after detection of the sensitive layer increased from 22.5 to 36 (ΔH = 0.9°), and the visual color change capability improved by 60%. Compared with the response time to reach the same color value, the response time of the charged sensitive layer decreased by 37.5%. This change is mainly attributed to the L* (white-to-black) and b* (yellow-to-blue) chromaticity attributes. Exposing the PVA / Pb(Ac)2 film to hydrogen sulfide liquid (0-3 ppm) at 37°C (application temperature) resulted in a color value change in the PVA / Pb(Ac)2 film, indicating a visual detection level below 0.5 ppm (ΔE > 3.5). The color change is primarily due to the reaction of hydrogen sulfide with lead acetate to form lead sulfide.

[0113] Based on the above experimental results, it can be confirmed that the triboelectric enhanced interface constructed in this embodiment has a significant enhancing effect on improving the sensitivity of the sensitive layer. By enabling the sensitive layer material to carry a positive charge through triboelectric generation, its color development effect on low-concentration characteristic gases can be effectively improved, and the response time can be shortened.

[0114] III. Characteristic Metabolic Monitoring of Bacterial Infections

[0115] Bacteria are the main cause of wound infection. In order to verify the actual detection effect of the wound infection chromogenic membrane provided in this embodiment, Staphylococcus aureus (Gram-positive bacteria) was also selected as a model bacteria to conduct a sensitivity test on the wound infection chromogenic membrane.

[0116] In the experiment, the chromogenic membrane for wound infection was placed on top of a petri dish containing bacteria. A blank group (no bacteria, no culture medium) and a control group (no bacteria, with culture medium) were set up to eliminate the influence of the culture environment and culture on the membrane. After 18 hours of incubation, the color changes of the chromogenic membrane for wound infection in the bacterial-bearing experimental group were as follows: Figure 13 As shown in the figure. The changes in color values ​​displayed by the wound infection chromogenic membrane for each group as a function of bacterial density were statistically analyzed, resulting in the following: Figure 14 The statistical chart. Combined with Figure 13 It is evident that as bacterial concentration increases, the chromogenic membranes of infected wounds gradually change from a visible white to black, while the color of bacteria-free samples shows no significant change. Furthermore, from... Figure 14 It can also be found that the color difference ΔE of the Staphylococcus aureus group showed a significant trend of first increasing (0-55) and then slightly decreasing (55-48) with the increase of bacteria. This is mainly due to the decrease in the brightness L of the film in the later stage as the color deepens.

[0117] Based on the condition that ΔE > 3.3 indicates visually identifiable information, the detection limit for this membrane against Staphylococcus aureus can be determined to be 6 × 10⁻⁶. 1 CFU / mL. To facilitate experimental consistency and comparison, bacterial concentrations were converted to logCFU / mL, and membrane color values ​​L, a, b were converted to R, G, B values. After conversion, correlation analysis revealed a clear mapping relationship between color values ​​and bacterial concentration values, as shown in the correlation matrix. Figure 15 As shown, Figure 15 The data show that the color value of the membrane is negatively correlated with the bacterial concentration, and the hierarchical classification is clear.

[0118] The experimental data above confirms that the wound infection chromogenic membrane provided in this embodiment indicates the quantity of characteristic bacterial communities in wound infections, thus providing a good visualization effect on the degree of wound infection. Furthermore, there is a significant correlation between the color of the wound infection chromogenic membrane and the degree of infection, laying a material foundation for continuous monitoring or quantitative analysis of wound infection status.

[0119] Example 2

[0120] The wound infection chromogenic membrane based on an electrically enhanced indicator material provided in Example 1 is a detection tool for detecting wound infection. The sensitive layer region of the membrane acts as a "window" for visualizing the degree of wound infection. This monitoring tool is well-suited for qualitative measurement of wound infection severity; however, quantitative analysis of infection severity is typically impossible relying solely on visual observation. Therefore, this embodiment, based on the scheme of Example 1, further provides four schemes for quantitative analysis of the detection results from the wound infection chromogenic membrane.

[0121] Option 1:

[0122] This embodiment provides a method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. It uses the wound infection chromogenic membrane as described in Example 1 as the detection tool and performs quantitative analysis of the detection results to obtain the wound infection grade (IL) of the tested object. i .like Figure 16 As shown, the method for analyzing the degree of infection in this type of wound includes the following steps:

[0123] S1: The initial brightness L0, initial red-green value a0, and initial yellow-blue value b0 of the wound infection developing membrane in the corresponding sensitive layer area before use were detected by a colorimeter.

[0124] S2: The brightness L, red-green value a, and yellow-blue value b of the corresponding sensitive layer area of ​​the wound infection developing membrane are detected by a colorimeter after use.

[0125] S3: Calculate the first color difference value △E1 of the sensitive layer area of ​​the wound infection chromogenic membrane before and after use. The calculation formula is as follows:

[0126]

[0127] S4: Acquire a large number of sample data of the first color difference value ΔE1 detected from biological samples with different infection levels, and construct a characterization function to represent the relationship between the first color difference value ΔE1 and IL at each infection level. i A data lookup table or fitting function for mapping relationships between them.

[0128] S5: Detect the wound of any test object using a wound infection chromogenic membrane, obtain the first color difference value ΔE1, and query the data lookup table or fitting function to obtain the wound infection level IL of the current test object. i .

[0129] Option 2:

[0130] This embodiment provides a method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. It uses the wound infection chromogenic membrane as described in Example 1 as the detection tool and performs quantitative analysis of the detection results to obtain the wound infection grade (IL) of the tested object. i .like Figure 17 As shown, the method for analyzing the degree of wound infection includes the following steps:

[0131] S01: Detecting the baseline brightness L of the colorimetric layer area of ​​the wound infection developing membrane using a colorimeter after use. * 0. Baseline red-green value a * 0 and the baseline yellow-blue value b * 0; and the detected brightness L, detected red-green value a, and detected yellow-blue value b of the sensitive layer area after use.

[0132] S02: Calculate the second color difference value ΔE2 between the sensitive layer and the colorimetric layer after using the chromogenic membrane for wound infection. The calculation formula is as follows:

[0133]

[0134] S03: Acquire a large amount of sample data of the second color difference value ΔE2 detected from biological samples with different infection levels, and construct a characterization method to represent the relationship between the second color difference value ΔE2 and IL at each infection level. i A data lookup table or fitting function for mapping relationships between them.

[0135] S04: Detect the wound of any test subject using a wound infection chromogenic membrane to obtain the second color difference value ΔE2. Based on this, consult the data comparison table or fitting function from the previous step to obtain the wound infection level IL of the current test subject. i .

[0136] Option 3:

[0137] This embodiment also provides a method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. This method also uses the wound infection chromogenic membrane as described in Example 1 as the detection tool, and performs quantitative analysis of the detection results to obtain the wound infection grade (IL) of the tested object. i .like Figure 18 As shown, the method for analyzing the degree of wound infection includes the following steps:

[0138] S001: Biological samples with different degrees of infection are detected by using multiple wound infection chromogenic membranes.

[0139] S002: Acquire a sample image of the chromogenic membrane for wound infection after detection, and crop out a local image of the corresponding sensitive layer area.

[0140] S003: Obtain the RGB values ​​at several specified sampling points in the local image, use them as sample data, and add corresponding infection level labels to each sample data according to the source of the sample image to form a training set and a test set.

[0141] S004: Train and test an SVM model using the training and test sets to obtain a network model that can be used to classify the infection level of samples; the input of the network model is one or more sets of R, G, B values, and the output is the corresponding infection level.

[0142] S005: Detect wounds on any target object using a wound infection chromogenic membrane, capture an image of the detected wound infection chromogenic membrane, extract the RGB values ​​of specified sampling sites in the sensitive layer, and input them into the network model trained in the previous step. The network model then outputs the classified infection level.

[0143] Option 4:

[0144] This embodiment provides a method for analyzing the degree of wound infection based on a wound infection chromogenic membrane. It uses the wound infection chromogenic membrane as described in Example 1 as the detection tool and performs quantitative analysis of the detection results to obtain the wound infection grade (IL) of the tested object. i .like Figure 19 As shown, the method for analyzing the degree of wound infection includes the following steps:

[0145] S0001: Biological samples with different degrees of infection are detected by using multiple wound infection chromogenic membranes.

[0146] S0002: Obtain a sample image of the chromogenic membrane for wound infection detection, and crop out a local image of the corresponding sensitive layer area; the black area in the center of the local image is the colorimetric layer.

[0147] S0003: Convert the local image to a grayscale image and calculate the grayscale deviation ΔH between the sensitive layer region and the colorimetric layer region.

[0148] S0004: Acquire a large amount of sample data of grayscale deviation ΔH detected from biological samples with different infection levels, and construct a characterization method to represent the relationship between grayscale deviation ΔH and IL at each infection level. i A data lookup table or fitting function for mapping relationships between them.

[0149] S0005: Acquire an image of the wound infection chromogenic membrane used on any test object and convert it into a grayscale image. Calculate the grayscale deviation ΔH between the sensitive layer region and the colorimetric layer region in the grayscale image. Then, based on this, consult the data comparison table or fitting function to obtain the identified infection level.

[0150] Example 3

[0151] This invention also provides an online analysis system for the degree of wound infection, which is used to perform online analysis of a user's wound infection status. For example... Figure 20 As shown, the online analysis system includes a mobile terminal and a server terminal. Users take images of the wound infection chromogenic membranes using their mobile terminals and upload them to the server terminal. The server terminal processes the uploaded images using methods such as Scheme 3 or Scheme 4 in Example 2, and then generates the corresponding infection level and sends it back to the client terminal.

[0152] In this online wound infection severity analysis system, both the mobile terminal and the server terminal are computer devices. The mobile terminal can be a smartphone, tablet, laptop, smartwatch, or other wearable device capable of executing programs. The server terminal can be a desktop computer, rack server, blade server, tower server, or cabinet server (including standalone servers or server clusters composed of multiple servers). The computer devices in this embodiment include, but are not limited to, memory and processors that can communicate with each other via a system bus.

[0153] In this embodiment, the memory (i.e., the readable storage medium) includes flash memory, hard disk, multimedia card, card-type memory (e.g., SD or DX memory), random access memory (RAM), static random access memory (SRAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), programmable read-only memory (PROM), magnetic memory, disk, optical disk, etc. In some embodiments, the memory can be an internal storage unit of a computer device, such as the hard disk or RAM of the computer device. In other embodiments, the memory can also be an external storage device of the computer device, such as a plug-in hard disk, smart media card (SMC), secure digital card (SD), flash card, etc., equipped on the computer device. Of course, the memory can also include both internal storage units and external storage devices of the computer device. In this embodiment, the memory is typically used to store the operating system and various application software installed on the computer device. In addition, the memory can also be used to temporarily store various types of data that have been output or will be output.

[0154] In some embodiments, the processor may be a central processing unit (CPU), a controller, a microcontroller, a microprocessor, or other data processing chip. The processor is typically used to control the overall operation of a computer device.

[0155] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An electro-enhanced indicator material-based wound infection chromogenic membrane for capturing a characteristic gas produced by microorganisms at the time of wound infection and indicating the degree of infection of the wound according to the concentration of the characteristic gas, characterized by, The wound infection color developing film comprises: a base layer made of a medical bandage with adhesive on the bottom surface, wherein a through hole is arranged in the middle of the base layer; a sensitive layer made of a modified PVA nanofiber film containing lead acetate, which is pasted on the side with adhesive below the base layer and completely covers the through hole; the sensitive layer is used to capture and react with the characteristic gas containing H2S generated when the wound is infected, and the degree of color change after the reaction indicates the concentration of the characteristic gas related to the degree of infection; a pad layer pasted on the side with adhesive of the base layer; the pad layer is annular and surrounds the outer periphery of the sensitive layer, so that the sensitive layer remains suspended in use; an electrification layer located on the side without adhesive above the base layer and slightly smaller than the through hole, which is made of a transparent material that carries a negative charge when in contact with the sensitive layer; a colorimetric layer located above the electrification layer near the center of the through hole, which is black; and a sealing layer made of a transparent film and pasted on the upper surface of the electrification layer, which completely covers the area below corresponding to the pad layer; When the pad layer contacts the wound edge, the sensitive layer is suspended on the upper surface of the wound, and the pad layer and the sensitive layer around them form a reaction chamber; the base layer, the sensitive layer and the electrification layer form a triboelectric enhancement interface; the triboelectric enhancement interface is used to induce triboelectricity by the contact-separation cycle between the electrification layer and the sensitive layer, and accumulate a sufficient amount of positive charge in the sensitive layer, thereby enhancing the "capture" efficiency of the sensitive layer for the characteristic gas in the reaction chamber.

2. The electro-enhanced indicator material-based wound infection chromogenic membrane according to claim 1, wherein: The preparation method of the material of the sensitive layer is as follows: Dissolve the powder in water at a concentration of 12wt%, mix the solution and DMF at a volume ratio of 1:9, and magnetically stir at 65℃ for 8 hours until the solution becomes clear and transparent; then, add 1wt% of lead acetate powder to the solution, continue to stir for 2 hours to obtain a polymer solution suitable for spinning; then, load the PVA mixed solution into a syringe, and perform electrospinning under the following process conditions: electrospinning voltage of 20kV, syringe pump speed of 0.5mL / h, collection barrel rotation speed of 200r / min, and collection distance of 16cm; place the prepared nanofiber film in a sealed container for crosslinking, add 25wt% of glutaraldehyde in the container, and catalyze the reaction with hydrochloric acid; finally, dry the obtained material in an oven at 80℃; obtain the required sensitive layer film.

3. The electro-enhanced indicator material-based wound infection chromogenic membrane according to claim 2, wherein: The pad layer is made of any one of silicone, PVC, rubber, PDMS, and polyurethane soft materials; the electrification layer is made of any one of FEP, PVDF, PTFE, and polylactic acid materials; and the sealing layer is made of any one of polyethylene, polyvinyl chloride, polyvinylidene chloride, and polymethylpentene materials.

4. The electro-enhanced indicator material-based wound infection chromogenic membrane according to claim 1, wherein: The bottom of the pad layer is also provided with a release film; And / or The wound infection color developing film is sealed and stored.

5. The electro-enhanced indicator material-based wound infection chromogenic membrane as claimed in claim 1, wherein, The use method of the wound infection color developing film is as follows: According to the shape and size of the wound, a wound infection color developing film of a proper specification is selected so that the inner ring of the pad layer can completely cover the wound; the wound interference sensing film is pasted at the wound, and the sensitive layer is kept opposite to the wound area; the electrifying layer is lightly tapped several times so that the electrifying layer and the sensitive layer are in contact and separation, and the sensitive layer is waited to change color; the greater the color difference of the sensitive layer before and after use or the closer the sensitive layer is to the colorimetric layer after changing color, the more serious the infection degree is, and vice versa.

6. A method of analysis of the degree of wound infection based on a wound infection chromogenic membrane, characterized in that, It uses the wound infection chromogenic membrane as described in any one of claims 1-5 as the detection tool, and performs quantitative analysis on the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of wound infection includes the following steps: S1: detecting the initial brightness L0, the initial red-green value a0 and the initial yellow-blue value b0 of the sensitive layer area of the wound infection color developing film before use according to any one of claims 1-5 by a colorimeter; S2: detecting the detection brightness L, the detection red-green value a and the detection yellow-blue value b of the sensitive layer area of the wound infection color developing film after use by a colorimeter; S3: calculating the first color difference value ΔE1 of the sensitive layer area of the wound infection color developing film before and after use, and the calculation formula is as follows: S4: obtaining a large number of first color difference values △E1 detected from different infection levels of biological samples as sample data respectively, and constructing a data comparison table or fitting function for representing the mapping relationship between the first color difference values △E1 and the respective infection levels IL i ; S5: detecting the wound of any detection object by the wound infection color developing film to obtain a first color difference value ΔE1, and querying the data reference table or the fitting function to obtain the wound infection level IL of the current detection object i .

7. A method of analysis of the degree of wound infection based on a wound infection chromogenic membrane, characterized in that, It uses the wound infection chromogenic membrane as described in any one of claims 1-5 as the detection tool, and performs quantitative analysis on the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of wound infection includes the following steps: S01: detecting the reference brightness L of the colorimetric layer area of the wound infection color developing film after use by a colorimeter * 0, reference red-green value a * 0, and reference yellow-blue value b * 0; and the detected brightness L, the detected red-green value a, and the detected yellow-blue value b of the sensitive layer area after use S02: calculating the second color difference value ΔE2 between the sensitive layer and the colorimetric layer area of the wound infection color developing film after use, and the calculation formula is as follows: S03: obtaining a large number of second color difference values DE2 detected from different infection levels of biological samples as sample data respectively, and constructing a data comparison table or fitting function for representing the mapping relationship between the second color difference values DE2 and the respective infection levels IL i ; S04: detecting the wound of any detection object by the wound infection color developing film to obtain a second color difference value ΔE2, and inquiring the data reference table or the fitting function to obtain the wound infection level IL of the current detection object i .

8. A method of analysis of the degree of wound infection based on a wound infection chromogenic membrane, characterized in that, It uses the wound infection chromogenic membrane as described in any one of claims 1-5 as the detection tool, and performs quantitative analysis on the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of wound infection includes the following steps: S001: detecting different infection degrees of biological samples by a plurality of wound infection color developing films; S002: obtaining the sample image of the wound infection color developing film after detection, and cutting out the local image of the corresponding sensitive layer area; S003: obtaining the RGB value of a plurality of sampling sites specified in the local image as sample data, adding a corresponding infection level label to each sample data according to the source of the sample image, and constituting a training set and a test set; S004: training and testing an SVM model by using the training set and the test set, obtaining a network model that can be used to classify the infection level of the sample; the input of the network model is a single group or multiple groups of R, G and B values, and the output is the corresponding infection level; S005: detecting the wound of any detection object by the wound infection color developing film, shooting the image of the wound infection color developing film after detection, extracting the RGB value of the specified sampling site in the sensitive layer, and inputting the network model trained in the previous step to output the classified infection level.

9. A method of analysis of the degree of wound infection based on a wound infection chromogenic membrane, characterized in that, It uses the wound infection chromogenic membrane as described in any one of claims 1-5 as the detection tool, and performs quantitative analysis on the detection results to obtain the wound infection grade (IL) of the tested object. i The method for analyzing the degree of wound infection includes the following steps: S0001: detecting different infection degrees of biological samples by a plurality of wound infection color developing films; S0002: obtaining the sample image of the wound infection color developing film after detection, and cutting out the local image of the corresponding sensitive layer area; The black area in the center of the local image is the colorimetric layer; S0003: converting the local image into a gray-scale image, and calculating the gray-scale deviation ΔH of the sensitive layer area and the colorimetric layer area; S0004: Obtain a large number of grayscale deviations ΔH detected from biological samples with different infection levels as sample data, and construct a characterization method to represent the relationship between grayscale deviations ΔH and IL at each infection level. i A data lookup table or fitting function for the mapping relationship between them; S0005: collecting the image of the wound infection color developing film used by any detection object and converting it into a gray-scale image, calculating the gray-scale deviation ΔH of the sensitive layer area and the colorimetric layer area in the gray-scale image, and then querying the data reference table or the fitting function to obtain the identified infection level.

10. An online system for analysis of the extent of wound infection, characterized in that, It is used for realizing online analysis of wound infection of a user, the online analysis system comprises a mobile terminal and a server terminal, the user shoots an image of a wound infection color developing film used by the mobile terminal and uploads to the server terminal; the server terminal adopts the analysis method of wound infection degree based on the wound infection color developing film as claimed in claim 8 or 9, carries out data processing on the uploaded image, then generates a corresponding infection grade and feeds back to the client terminal.

Images