Skin protection sensing patch for promoting wound healing and preventing and treating wound infection

Abstract

The invention discloses a skin protection sensing patch for promoting wound healing and preventing wound infection, and relates to the technical field of medical dressings, the patch is of a double-layer design and comprises a base layer and a functional layer, the base layer and the functional layer are bonded, the base layer is made of flexible conductive silicone rubber with a shape memory function, and the functional layer is made of flexible conductive silicone rubber with a shape memory function. The functional layer is prepared from lignin-bimetal ion composite hydrogel, and the flexible conductive silicone rubber is subjected to modification treatment; an integrated sensing system is embedded between the base layer and the functional layer. According to the skin protection sensing patch for promoting wound healing and preventing and treating wound infection, biocompatible materials such as lignin, polyacrylamide hydrogel and silicone rubber are adopted, antibiotics or highly irritant chemical substances are not contained, and the skin protection sensing patch is suitable for newborns and children with delicate skin; and the patch is adhered through hydrogen bonds and ionic bonds, so that pain and skin injury when a traditional dressing is torn off are avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical dressings, in particular to a sensor patch for promoting wound healing, preventing and treating wound infection and protecting the skin. Background Art

[0002] Traditional wound patches are composed of medical tape, absorbent cotton pads, and isolation tape. They have no therapeutic effect on wounds. The absorbent cotton pads absorb blood oozing from the wound, which may cause insufficient contact between the absorbent cotton pad and the wound in actual use, affecting the hemostatic effect. Alternatively, the absorbent cotton pads may be tightly connected to the wound, making it difficult to remove during dressing changes, causing severe pain. A Chinese patent with publication number CN203988645U discloses a silicone gel wound patch that is used to address the problem of existing wound patches that are prone to wound infection and obvious scarring due to poor air permeability. The patch comprises a PU film, a first silicone gel layer, an auxiliary treatment layer, and a second silicone gel layer arranged in order from the outside to the inside. The auxiliary treatment layer is a bamboo charcoal fiber gauze strip. The upper surface of the PU film is provided with a PU film protective layer, and the lower surface of the second silicone gel layer is provided with a silicone gel protective layer. The silicone gel wound patch proposed in this utility model has a good application effect. The silicone gel and aloe vera mucus work together to quickly heal wounds and leave less obvious scars. It also has good air permeability, is non-irritating to the skin, is comfortable to apply, and is gentle to peel off. It does not cause pain and will not harm new tissue.

[0003] However, due to the imperfect skin barrier function and immune development of newborns, especially premature infants, they are very prone to pressure injuries and wound infections. The above dressings still have the following defects during use: 1. It lacks real-time monitoring capabilities and cannot detect signs of infection in a timely manner; 2. It does not have antibacterial capabilities and is difficult to deal with drug-resistant bacterial infections; 3. It is easy to cause secondary damage during replacement; 4. It cannot regulate the local immune microenvironment. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the present invention provides a skin protection sensor patch for promoting wound healing and preventing and treating wound infection, which solves the problems mentioned in the above background technology.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions: a skin protection sensor patch for promoting wound healing and preventing wound infection, the patch having a double-layer design, comprising: A base layer and a functional layer, the base layer and the functional layer are bonded together, wherein the base layer is made of flexible conductive silicone rubber with shape memory function, and the functional layer is made of lignin-double metal ion composite hydrogel; The flexible conductive silicone rubber is modified; An integrated sensing system is embedded between the base layer and the functional layer, and the integrated sensing system includes: Resistive exudate sensor: Utilizes the conductivity of electrolytes in exudate to monitor the dynamic changes in exudate volume during wound healing; Temperature sensor: monitors the surface temperature of the wound and reflects the inflammation status of the wound through thermal signals; Pressure sensor: It senses the deformation caused by pressure through the base layer, thereby sensing the changes in local mechanical stress in the wound and monitoring the healing of the wound.

[0006] Preferably, the thickness of the base layer is 50-100 μm, and the base layer is pre-stretched to 50-300%.

[0007] Preferably, the lignin-double metal ion composite hydrogel specifically contains lignin, Fe 3+ and Zn 2+ polyacrylamide hydrogel.

[0008] Preferably, the lignin content is 0.1-1wt%, and the Fe 3+ The content is 0.05-0.2wt%, the Zn 2+ The content is 0.1-0.5wt%.

[0009] Preferably, the skin protection sensor patch for promoting wound healing and preventing wound infection has an adhesive strength of 0.5-2 N / cm and a size of 2 cm×2 cm to 5 cm×5 cm.

[0010] Preferably, the detection sensitivity of the resistive exudate sensor is 50 μL, and the monitoring accuracy of the temperature sensor is ±0.2°C; The detection range of the resistive exudate sensor is less than 500 mL / 24 h; the detection range of the temperature sensor is 36.0-37.5 ° C; the detection range of the pressure sensor is 0-10 kPa; The resistive exudate sensor, temperature sensor and pressure sensor are all electrically connected to the terminal device, and the terminal device is provided with a warning light electrically connected to each sensor respectively. When the detection data is within the detection range of each sensor, the warning light is green, and when the detection data is not within the detection range of each sensor, the warning light is red.

[0011] Preferably, the modification method of the flexible conductive silicone rubber is: S1. After plasma treatment of the silicone rubber surface, ultrasonic cleaning was performed with deionized water and anhydrous ethanol for 5 minutes; S2. Soak in dopamine hydrochloride again at room temperature for 24 hours, then rinse with anhydrous ethanol.

[0012] Preferably, the concentration of dopamine hydrochloride is 4 mg / mL and the pH value is 8.5.

[0013] Preferably, the preparation method of the lignin-double metal ion composite hydrogel is as follows: dissolving acrylamide in deionized water, adding sodium ligninate, ferric chloride and zinc chloride, stirring until clear and transparent, adding initiator and cross-linking agent, and continuing rapid stirring for 10-15 minutes.

[0014] Preferably, the initiator is ammonium persulfate and the cross-linking agent is N,N'-methylenebisacrylamide; The addition amount of each raw material is as follows: 4 parts by weight of acrylamide, 6 parts by weight of deionized water, 0.0045 parts by weight of sodium lignin, 0.0075 parts by weight of ferric chloride, 0.01 parts by weight of zinc chloride, 0.04 parts by weight of ammonium persulfate, and 0.01 parts by weight of a cross-linking agent. Beneficial effects

[0015] The present invention provides a skin protection sensor patch for promoting wound healing and preventing wound infection. Compared with the existing technology, it has the following advantages: (1) High safety and good biocompatibility: By using biocompatible materials such as lignin, polyacrylamide hydrogel and silicone rubber, it does not contain antibiotics or strong irritating chemicals and is suitable for newborns and children with delicate skin. The patch adheres through hydrogen bonds and ionic bonds, avoiding the pain and skin damage caused by traditional dressings when they are removed, such as epidermal shedding caused by adhesive tape, and is especially suitable for the fragile skin of premature infants.

[0016] (2) Reduce frequent replacement and reduce medical operation risks: Zn 2+ Sustained release provides 24-hour antibacterial protection, reducing the risk of secondary infection caused by frequent dressing changes; by monitoring exudate, temperature and pressure through changes in resistance, medical staff can monitor wounds without having to frequently remove the dressing for inspection, reducing interference with the wound and discomfort to the child.

[0017] (3) Adapting to the special physiological needs of children: The silicone rubber layer has a high elastic modulus, fits well to the active parts of children (such as joints and abdomen), and is not easy to fall off; for drug-resistant bacterial infections, only 30 minutes of short-term exposure is needed to kill the bacteria, avoiding the damage to the intestinal flora of children caused by systemic antibiotic use.

[0018] (4) Promote healing and reduce scar formation: simulate natural wound contraction behavior, accelerate epithelialization, and reduce the risk of scarring; inhibit pro-inflammatory factors such as TNF-α, promote the polarization of anti-inflammatory macrophages, and create a low-inflammatory microenvironment, which is suitable for the characteristics of children's immature immune system development.

[0019] (5) Easy operation for parents and medical staff: Infection or abnormality is indicated by changes in color or resistance, making it convenient for parents to provide home care; the patch is ready to use and the light antibacterial operation is simple.

[0020] In summary, the patch of the present invention adopts a double-layer design, integrating shape memory, real-time monitoring, photothermal antibacterial and immunomodulatory functions, and is particularly suitable for the care needs of the fragile skin of newborns; the patch thickness is <200μm, has mild adhesive properties, and can be painlessly removed; through the synergistic effect of lignin and bimetallic ions, it can not only quickly kill drug-resistant bacteria, but also regulate the local immune microenvironment; the integrated sensing system can monitor the wound status in real time, providing an objective basis for clinical care; animal experiments have shown that the patch can make the wound healing rate reach more than 95% within 7 days, and there are no adverse reactions. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A schematic diagram of the patch structure provided by the present invention; Figure 2 The present invention provides a monitoring diagram of seepage, temperature and pressure changes; Figure 3 A comparison chart of the short-term antibacterial rate test with and without light provided by the present invention; Figure 4 A comparison chart of the long-term light-free antibacterial test provided by the present invention; Figure 5 A comparative diagram of anti-inflammatory and angiogenesis-promoting effects provided by the present invention; Figure 6 A comparison chart of wound healing in mice provided by the present invention; Figure 7 This is a volume shrinkage diagram of the SR@AM Gel hydrogel provided by the present invention at 37°C. DETAILED DESCRIPTION

[0022] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0023] In this application, the integrated sensing system includes a resistive exudate sensor, a temperature sensor and a pressure sensor, and the detection sensitivity of the resistive exudate sensor is 50μL, the monitoring accuracy of the temperature sensor is ±0.2℃, the detection range of the pressure sensor is 0-10kPa, and the data monitored by the sensor is received through the terminal.

[0024] The data monitored by the resistive exudate sensor, temperature sensor and pressure sensor are converted into electrical signals and transmitted to the background terminal device. The detection range of the resistive exudate sensor is less than 500mL / 24h; the detection range of the temperature sensor is 36.0-37.5℃, and the detection range of the pressure sensor is 0-10kPa; the resistive exudate sensor, temperature sensor and pressure sensor are all electrically connected to the terminal device, and the terminal device is provided with a prompt light electrically connected to each sensor respectively. When the detection data is within the detection range of each sensor, the prompt light is green, and when the detection data is not within the detection range of each sensor, the prompt light is red. Example 1

[0025] (1) After the surface of the silicone rubber was plasma treated, it was ultrasonically cleaned with deionized water and anhydrous ethanol for 5 minutes; then it was immersed in 4 mg / mL dopamine hydrochloride (pH = 8.5) at room temperature for 24 hours, and then washed with anhydrous ethanol to obtain modified silicone rubber; (2) Dissolve 4 g of acrylamide in 6 g of deionized water, add 0.0045 g of sodium ligninate, 0.0075 g of ferric chloride, and 0.01 g of zinc chloride, and stir until clear and transparent. Add 0.04 g of ammonium persulfate and 0.01 g of N, N'-methylenebisacrylamide, and continue to stir rapidly for 10 min to obtain a lignin-double metal ion composite hydrogel; (3) The composite hydrogel was quickly and evenly spread onto a modified silicone rubber with a thickness of 50 μm and pre-stretched to 50%, and cured at room temperature. The integrated sensing system was embedded between the composite hydrogel and the modified silicone rubber. (4) The cured patch can be made into a size of 2cm×2cm. Example 2

[0026] (1) After the surface of the silicone rubber was plasma treated, it was ultrasonically cleaned with deionized water and anhydrous ethanol for 5 minutes; then it was immersed in 4 mg / mL dopamine hydrochloride (pH = 8.5) at room temperature for 24 hours, and then washed with anhydrous ethanol to obtain modified silicone rubber; (2) Dissolve 4 g of acrylamide in 6 g of deionized water, add 0.0045 g of sodium ligninate, 0.0075 g of ferric chloride, and 0.01 g of zinc chloride, and stir until clear and transparent. Add 0.04 g of ammonium persulfate and 0.01 g of N, N'-methylenebisacrylamide, and continue to stir rapidly for 15 min to obtain a lignin-double metal ion composite hydrogel; (3) The composite hydrogel was quickly and evenly spread onto a modified silicone rubber with a thickness of 80 μm and pre-stretched to 180%, and cured at room temperature. The integrated sensing system was embedded between the composite hydrogel and the modified silicone rubber. (4) The cured patch can be made into a size of 3cm×3cm. Example 3

[0027] (1) After the surface of the silicone rubber was plasma treated, it was ultrasonically cleaned with deionized water and anhydrous ethanol for 5 minutes; then it was immersed in 4 mg / mL dopamine hydrochloride (pH = 8.5) at room temperature for 24 hours, and then washed with anhydrous ethanol to obtain modified silicone rubber; (2) Dissolve 4 g of acrylamide in 6 g of deionized water, add 0.0045 g of sodium ligninate, 0.0075 g of ferric chloride, and 0.01 g of zinc chloride, and stir until clear and transparent. Add 0.04 g of ammonium persulfate and 0.01 g of N, N'-methylenebisacrylamide, and continue to stir rapidly for 15 min to obtain a lignin-double metal ion composite hydrogel; (3) The composite hydrogel was quickly and evenly spread onto a modified silicone rubber with a thickness of 100 μm and pre-stretched to 300%, and cured at room temperature. The integrated sensing system was embedded between the composite hydrogel and the modified silicone rubber. (4) The cured patch can be made into a size of 5cm×5cm.

[0028] Instructions for use: Clean the wound and apply; receive sensor data through the terminal; and receive light treatment for 15-45 minutes daily.

[0029] Figure 2-7 In the figure, Control is an untreated silicone rubber patch; AM Gel is a lignin-double metal ion composite hydrogel patch; SR@AM Gel is a modified silicone rubber-lignin-double metal ion composite hydrogel patch.

[0030] like Figure 7 As shown in the figure, the volume shrinkage characteristics of SR@AM Gel hydrogel at 37°C: after contact with simulated body fluids, the pre-stretched flexible silicone rubber@AM hydrogel patch exhibited a significant shrinkage rate of 112.7%, which was in sharp contrast to the 9.3% swelling rate of AM hydrogel alone under the same conditions. This difference indicates that the flexible silicone rubber effectively offsets the swelling tendency of the hydrogel through anisotropic elasticity, thereby ensuring the generation of contraction force, which is conducive to promoting wound contraction.

[0031] Meanwhile, the contents not described in detail in this specification belong to the prior art known to those skilled in the art.

[0032] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0033] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A skin protection sensor patch for promoting wound healing and preventing wound infection, characterized in that: The patch is a double-layer design, including: A base layer and a functional layer, the base layer and the functional layer are bonded together, wherein the base layer is made of flexible conductive silicone rubber with shape memory function, and the functional layer is made of lignin-double metal ion composite hydrogel; The flexible conductive silicone rubber is modified; An integrated sensing system is embedded between the base layer and the functional layer, and the integrated sensing system includes: Resistive exudate sensor: Utilizes the conductivity of electrolytes in exudate to monitor the dynamic changes in exudate volume during wound healing; Temperature sensor: monitors the surface temperature of the wound and reflects the inflammation status of the wound through thermal signals; Pressure sensor: It senses the deformation caused by pressure through the base layer, thereby sensing the changes in local mechanical stress in the wound and monitoring the healing of the wound.

2. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 1, characterized in that: The thickness of the base layer is 50-100 μm, and the base layer is pre-stretched to 50-300%.

3. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 1, characterized in that: The lignin-double metal ion composite hydrogel specifically contains lignin, Fe 3+ and Zn 2+ polyacrylamide hydrogel.

4. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 3, characterized in that: The lignin content is 0.1-1wt%, the Fe 3+ The content is 0.05-0.2wt%, the Zn 2+ The content is 0.1-0.5wt%.

5. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 1, characterized in that: The skin protection sensor patch for promoting wound healing and preventing wound infection has an adhesive strength of 0.5-2N / cm and a size of 2cm×2cm to 5cm×5cm.

6. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 1, characterized in that: The detection sensitivity of the resistive exudate sensor is 50 μL, and the monitoring accuracy of the temperature sensor is ±0.2°C; The detection range of the resistive exudate sensor is less than 500 mL / 24 h; the detection range of the temperature sensor is 36.0-37.5 ° C; the detection range of the pressure sensor is 0-10 kPa; The resistive exudate sensor, temperature sensor and pressure sensor are all electrically connected to the terminal device, and the terminal device is provided with a warning light electrically connected to each sensor respectively. When the detection data is within the detection range of each sensor, the warning light is green, and when the detection data is not within the detection range of each sensor, the warning light is red.

7. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 1, characterized in that: The modification treatment method of the flexible conductive silicone rubber is: S1. After plasma treatment of the silicone rubber surface, ultrasonic cleaning was performed with deionized water and anhydrous ethanol for 5 minutes; S2. Soak in dopamine hydrochloride again at room temperature for 24 hours, then rinse with anhydrous ethanol.

8. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 7, characterized in that: The concentration of the dopamine hydrochloride is 4 mg / mL, and the pH value is 8.

5.

9. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 1, characterized in that: The preparation method of the lignin-double metal ion composite hydrogel is as follows: dissolving acrylamide in deionized water, adding sodium ligninate, ferric chloride and zinc chloride, stirring until clear and transparent, adding an initiator and a cross-linking agent, and continuing to stir rapidly for 10-15 minutes.

10. The skin protection sensor patch for promoting wound healing and preventing wound infection according to claim 9, characterized in that: The initiator is ammonium persulfate and the cross-linking agent is N,N'-methylenebisacrylamide; The addition amount of each raw material is as follows: 4 parts by weight of acrylamide, 6 parts by weight of deionized water, 0.0045 parts by weight of sodium lignin, 0.0075 parts by weight of ferric chloride, 0.01 parts by weight of zinc chloride, 0.04 parts by weight of ammonium persulfate, and 0.01 parts by weight of a cross-linking agent.

Images