Patch device and method for promoting diabetic wound recovery and manufacturing method of patch device

Abstract

The embodiment of the invention provides a patch device and method for promoting diabetic wound recovery and a manufacturing method of the patch device, and belongs to the technical field of medical instruments. The patch device comprises a composite patch structure, a chip structure connected with the front end of the composite patch structure and two sterile elastic bands connected to the left end and the right end of the composite patch structure and the left end and the right end of the chip structure, and the composite patch structure comprises an external protective shell and multiple layers of internal composite patches. The chip structure comprises a shell, an ultrasonic transmitting circuit which is fixed in the shell and is used for controlling the multilayer composite patch to release medicines, an electromagnetic excitation microcircuit which is used for controlling the multilayer composite patch to generate a low-frequency pulse electromagnetic field, and a battery and a control unit which are electrically connected with the ultrasonic transmitting circuit and the electromagnetic excitation microcircuit. Through the synergistic effect of the low-frequency pulse electromagnetic field and the low-frequency ultrasound, the problems that in the prior art, medicine permeability is poor, the patient feels poor, and the wound healing speed is low are effectively solved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a patch device, a method and a manufacturing method thereof for promoting the recovery of diabetic wounds. Background Art

[0002] In today's society, diabetes has become a common chronic disease, which has a great impact on the quality of life of patients. Diabetic patients often face many complications, and among them, the poor wound healing ability is a prominent problem. Especially chronic wounds, such as diabetic foot ulcers, not only are accompanied by discomfort such as pain, but are also prone to bacterial infection, and the healing process is extremely slow.

[0003] Traditional wound care methods, such as dressing coverage and drug application, although can play a certain role in nursing to a certain extent, have many drawbacks. First of all, the drug permeability is poor, it is difficult to effectively penetrate deep into the wound, and the therapeutic effect of the drug cannot be fully exerted. Secondly, the wound is exposed to the external environment, increasing the risk of bacterial infection and making the wound healing more difficult. Moreover, due to the poor blood circulation and cell regeneration ability of diabetic patients themselves, the healing cycle is longer under traditional nursing methods. Finally, traditional dressings or drugs need to be changed frequently, which not only increases the pain of patients, but also raises the nursing cost. Summary of the Invention

[0004] The purpose of the embodiments of the present invention is to provide a patch device for promoting the recovery of diabetic wounds. The patch device for promoting the recovery of diabetic wounds can solve the problems of poor drug permeability, poor patient experience, slow wound healing speed, etc. in the prior art through a multi-functional integrated design.

[0005] To achieve the above purpose, the embodiments of the present invention provide a patch device for promoting the recovery of diabetic wounds. The patch device includes a composite patch structure, a chip structure connected to the front end of the composite patch structure, and sterile elastic bands connected to the left and right ends of the composite patch structure and the chip structure. Among them, the composite patch structure includes an external protective shell and a multi-layer composite patch inside. The chip structure includes a shell, an ultrasonic emission circuit fixed inside the shell for controlling the release of drugs by the multi-layer composite patch, and an electromagnetic excitation microcircuit for controlling the multi-layer composite patch to generate a low-frequency pulsed electromagnetic field, the ultrasonic emission circuit and the electromagnetic excitation microcircuit, and a battery and a control unit electrically connected to the ultrasonic emission circuit and the electromagnetic excitation microcircuit.

[0006] Optionally, the multi-layer composite patch sequentially includes, from top to bottom: an electromagnetic release layer, a patch flexible substrate layer, a flexible electrode layer, a piezoelectric layer, a drug sustained-release layer, and an antibacterial coating. Among them, the electromagnetic release layer covers the upper surface of the patch flexible substrate layer, the drug sustained-release layer is embedded at the bottom of the patch flexible substrate layer, the antibacterial coating covers the lower surface of the patch flexible substrate layer, the flexible electrode layer covers the surface of the piezoelectric layer, the piezoelectric layer covers the surface of the drug sustained-release layer, the ultrasonic emission circuit is used to emit an electrical signal to the piezoelectric layer, and the electromagnetic excitation microcircuit is used to emit a pulse signal to the electromagnetic release layer.

[0007] Optionally, the electromagnetic release layer adopts a coil bending arrangement structure for releasing a low-frequency pulsed electromagnetic field, and an insulating flexible protective layer covers the surface of the electromagnetic release layer.

[0008] Optionally, the patch flexible substrate layer is made of a biocompatible material within a preset thickness range.

[0009] Optionally, the piezoelectric layer adopts a PVDF piezoelectric film.

[0010] Optionally, the antibacterial coating adopts a chitosan or silver nanoparticle coating within a preset thickness range.

[0011] Optionally, the ultrasonic emission circuit emits an electrical signal to the piezoelectric layer, causing the piezoelectric layer to generate a low-frequency and low-voltage pulsed ultrasonic wave, enabling the drug sustained-release layer to continuously release drugs. The electromagnetic excitation microcircuit emits a pulse signal to the electromagnetic release layer, causing the coil of the electromagnetic release layer to generate a low-frequency pulsed electromagnetic field.

[0012] An embodiment of the present invention further provides a manufacturing method of a patch device, including manufacturing a multi-layer composite patch and installing it inside a protective shell; manufacturing a chip structure, installing an ultrasonic emission circuit, an electromagnetic excitation microcircuit, a battery, and a control unit inside a housing, and electrically connecting the ultrasonic emission circuit and the electromagnetic excitation microcircuit to the battery; combining and installing the housing with the protective shell, and respectively fixing two sterile elastic bands at the left and right ends of the housing and the protective shell.

[0013] Optionally, manufacturing the multi-layer composite patch includes: manufacturing a drug sustained-release layer and a piezoelectric layer, covering the piezoelectric layer on the upper surface of the drug sustained-release layer; manufacturing a flexible electrode layer and covering it on the surface of the piezoelectric layer; manufacturing a patch flexible substrate layer and embedding the drug sustained-release layer in its lower part; manufacturing an antibacterial coating and attaching it to the bottom surface of the patch flexible substrate layer; manufacturing an electromagnetic release layer, covering it on the upper surface of the patch flexible substrate layer, and covering the patch flexible substrate layer on the surface of the flexible electrode layer.

[0014] An embodiment of the present invention also provides a method for promoting the recovery of diabetic wounds. The method is applied to the control unit of the above patch device, and the method includes: when fixing the composite patch structure on the surface of the diabetic wound site through a sterile elastic band, starting the ultrasonic emission circuit and the electromagnetic excitation microcircuit, and adjusting the corresponding pulse signal and electrical signal; using the coil in the electromagnetic release layer to receive the pulse signal and release a low-frequency pulsed electromagnetic field to promote wound repair; using the piezoelectric layer to receive the electrical signal and release a low-frequency low-pulse ultrasonic wave to cause the drug slow-release layer to release the drug and treat the wound site.

[0015] Through the above technical solution, an embodiment of the present invention provides a patch device for promoting the recovery of diabetic wounds. The patch device includes a composite patch structure, a chip structure connected to the front end of the composite patch structure, and a sterile elastic band connected to the left and right ends of the composite patch structure and the chip structure. Among them, the composite patch includes an external protective shell and a multi-layer composite patch inside. The chip structure includes a shell, an ultrasonic emission circuit and an electromagnetic excitation microcircuit fixed inside the shell, and a battery and a control unit electrically connected to the ultrasonic emission circuit and the electromagnetic excitation microcircuit. The patch device for promoting the recovery of diabetic wounds provided by the embodiment of the present invention promotes wound healing and nerve regeneration through an adjustable low-frequency pulsed electromagnetic field, promotes the continuous release of drugs by the drug slow-release layer through low-frequency ultrasound, and increases the drug absorption rate and absorption depth, and reduces the infection risk through an antibacterial coating. The present invention has the advantages of non-invasive, convenient to use, reusable, and significant healing promotion effect, and is suitable for the treatment of chronic wounds of diabetic patients.

[0016] Other features and advantages of the embodiments of the present invention will be described in detail in the subsequent specific implementation part. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The drawings are used to provide a further understanding of the embodiments of the present invention, and constitute a part of the specification. They are used to explain the embodiments of the present invention together with the following specific implementation manners, but do not constitute a limitation to the embodiments of the present invention. In the drawings: Figure 1 is a plan view of the patch device for promoting the recovery of diabetic wounds provided by the embodiment of the present invention; Figure 2 is an exploded schematic view of the structure of the composite patch structure provided by the embodiment of the present invention; Figure 3 is a schematic diagram of the internal coil arrangement of the electromagnetic release layer provided by the embodiment of the present invention; Figure 4 is a schematic diagram of the piezoelectric material arrangement of the piezoelectric layer provided by the embodiment of the present invention; Figure 5 is a flowchart of the manufacturing method provided by the embodiment of the present invention; Figure 6 It is a flowchart of a method for promoting the recovery of diabetic wounds provided by an embodiment of the present invention.

[0018] Explanation of reference numerals 10. Composite patch structure; 11. Protective shell; 12. Electromagnetic release layer; 13. Patch flexible base layer; 14. Flexible electrode layer; 15. Piezoelectric layer; 16. Drug sustained-release layer; 17. Antibacterial coating; 20. Chip structure; 21. Outer shell; 22. Ultrasonic emission circuit; 23. Electromagnetic excitation microcircuit; 24. Battery; 30. Sterile elastic band. Detailed implementation manners

[0019] The following will describe in detail the specific implementation manners of the embodiments of the present invention with reference to the accompanying drawings. It should be understood that the specific implementation manners described herein are only for explaining and illustrating the embodiments of the present invention, and are not used to limit the embodiments of the present invention.

[0020] It should be noted that the acquisition, transmission, storage, use, processing, etc. of data in the technical solution of this application all comply with the relevant regulations of national laws and regulations. In the embodiments of this application, some industry-existing solutions such as certain software, components, models, etc. may be mentioned. They should be regarded as exemplary. The purpose is only to illustrate the feasibility in the implementation of the technical solution of this application, but it does not mean that the applicant has already or necessarily used this solution.

[0021] In today's society, diabetes has become a common chronic disease, which has a great impact on the quality of life of patients. Diabetic patients often face many complications, among which the poor wound healing ability is a prominent problem. Especially chronic wounds, such as diabetic foot ulcers, not only cause discomfort such as pain, but are also prone to bacterial infection, and the healing process is extremely slow.

[0022] In view of this problem, the present invention provides a patch device, method and manufacturing method for promoting the recovery of diabetic wounds, which solves the problems of poor drug permeability, poor patient experience, slow wound healing speed, etc. in the prior art.

[0023] Figure 1It is a plan view of a patch device for promoting diabetic wound recovery provided by an embodiment of the present invention. The patch device includes a composite patch structure 10, a chip structure 20 connected to the front end of the composite patch structure 10, and two sterile elastic bands 30 connected to the left and right ends of the composite patch structure 10 and the chip structure 20. Among them, the composite patch structure includes an external protective shell 11 and a multi-layer composite patch inside. The chip structure 20 includes a shell 21, an ultrasonic emission circuit 22 fixed inside the shell 21 for controlling the release of drugs by the multi-layer composite patch, and an electromagnetic excitation microcircuit 23 for controlling the generation of a low-frequency pulsed electromagnetic field by the multi-layer composite patch. The ultrasonic emission circuit 22 is used to emit ultrasonic waves to the drug slow-release layer 16, and the electromagnetic excitation microcircuit 23 is used to excite the electromagnetic release layer 12, as well as a battery 24 and a control unit electrically connected to the ultrasonic emission circuit 22 and the electromagnetic excitation microcircuit 23.

[0024] The patch device provided by the embodiment of the present invention has a simple and easy-to-use patch design and belongs to non-invasive treatment. The patch can be used by simply contacting it and can be used repeatedly.

[0025] Please refer to Figure 2 Example. Preferably, the multi-layer composite patch includes, from top to bottom in sequence: an electromagnetic release layer 12, a patch flexible base layer 13, a flexible electrode layer 14, a piezoelectric layer 15, a drug slow-release layer 16, and an antibacterial coating 17. Among them, the electromagnetic release layer 12 covers the upper surface of the patch flexible base layer 13, the drug slow-release layer 16 is embedded at the bottom of the patch flexible base layer 13, the antibacterial coating 17 covers the lower surface of the patch flexible base layer 13, the flexible electrode layer 14 covers the surface of the piezoelectric layer 15, the piezoelectric layer 15 covers the surface of the drug slow-release layer 16, the ultrasonic emission circuit 22 is used to emit an electrical signal to the piezoelectric layer 15, and the electromagnetic excitation microcircuit 23 is used to emit a pulsed signal to the electromagnetic release layer 12.

[0026] Please refer to Figure 3 Example. Preferably, the electromagnetic release layer 12 adopts a coil bending arrangement structure to release a low-frequency pulsed electromagnetic field, and an insulating flexible protective layer covers the surface of the electromagnetic release layer 12.

[0027] In the embodiment of the present invention, the bent coils can make the magnetic field more evenly distributed in a certain area and can better interact with the surrounding magnetic field, improving the electromagnetic coupling efficiency. The electromagnetic release layer 12 can release a low-frequency pulsed electromagnetic field to promote wound healing.

[0028] Preferably, the patch flexible base layer 13 adopts a biocompatible material within a preset thickness range.

[0029] For example, the patch flexible substrate layer 13 can be made of biocompatible materials such as medical silicone or PDMS with a thickness of 0.5-1.0 mm. Such biocompatible materials can avoid triggering immune responses in the human body, such as allergies and rejections. These materials can form a good affinity relationship with biological tissues, promote cell adhesion, proliferation and differentiation, and contribute to tissue repair and regeneration.

[0030] Please refer to Figure 4 the example Figure 4 FIG. is a schematic diagram of the arrangement of piezoelectric materials in the piezoelectric layer 15.

[0031] Preferably, the piezoelectric layer 15 is made of PVDF piezoelectric film.

[0032] Among them, the PVDF piezoelectric film has a high piezoelectric coefficient and can effectively perform energy conversion. The frequency response range of the PVDF piezoelectric film is very wide, and it can maintain good piezoelectric performance from low frequency to high frequency. This enables it to have excellent performance in detecting vibration or pressure signals of different frequencies and can be used to receive and transmit ultrasonic signals of different frequencies.

[0033] Preferably, the antibacterial coating 17 is made of chitosan or silver nanoparticle coating within a preset thickness range.

[0034] For example, the antibacterial coating 17 can be made of chitosan or silver nanoparticle coating with a thickness of 10-50 microns. Silver nanoparticles have strong antibacterial ability and can interact with the cell membrane, proteins and DNA of bacteria, interfere with the metabolic process of bacteria, and destroy the cell structure, thus effectively killing a variety of bacteria, including common pathogenic bacteria such as Staphylococcus aureus and Escherichia coli. Chitosan also has certain antibacterial activity. It can change the permeability of the cell membrane by interacting with anions on the surface of bacteria and inhibit the growth and reproduction of bacteria.

[0035] Preferably, the flexible electrode layer 14 is made of copper-silver electrodes. When the copper-silver electrodes are in contact with other conductive materials, they can form a good electrical connection with low contact resistance, which helps the current flow to the piezoelectric layer 15. At the same time, the copper-silver electrodes can quickly and effectively dissipate the generated heat during operation, avoid performance degradation or damage of the electrodes due to overheating, and extend the service life of the patch device.

[0036] Preferably, the drug sustained-release layer 16 contains drugs that promote wound healing. The drugs can be selected from growth factors (such as EGF), antibacterial agents (such as silver ions) and anti-inflammatory agents (such as hydrocortisone), and the sustained release is achieved through nanoparticle or microcapsule technology.

[0037] In the embodiments of the present invention, nanoparticles or microcapsules can encapsulate sensitive active substances inside, isolating them from the external environment, reducing the influence of factors such as light, oxygen, and moisture on the active substances, improving their stability, and extending the shelf life. And by adjusting parameters such as the particle size, wall thickness, and material composition of the nanoparticles or microcapsules, the release rate of the active substances can be precisely controlled to achieve long-acting sustained release or on-demand release.

[0038] Preferably, the ultrasonic emission circuit 22 emits an electrical signal to the piezoelectric layer 15, causing the piezoelectric layer 15 to generate low-frequency and low-voltage pulsed ultrasonic waves, enabling the drug sustained-release layer 16 to continuously release drugs. The electromagnetic excitation microcircuit 23 emits a pulsed signal to the electromagnetic release layer 12, causing the coil of the electromagnetic release layer 12 to generate a low-frequency pulsed electromagnetic field.

[0039] Illustrated by an example, when the piezoelectric layer 15 emits low-frequency and low-pulse ultrasonic waves, cavitation occurs when the ultrasonic waves propagate in the liquid medium, that is, the tiny bubbles in the liquid undergo a rapid expansion and compression process under the action of the ultrasonic waves. When the bubbles are compressed to a certain extent, they will burst, generating local high temperature, high pressure, and strong shock waves. The shock waves can destroy the structure of the nanoparticles or the wall material of the microcapsules, releasing the substances loaded inside and promoting wound healing. And by adjusting parameters such as the power, frequency, and action time of the ultrasonic waves, the intensity of the cavitation effect can be controlled, thereby adjusting the drug release rate of the drug sustained-release layer 16. For example, at lower power and frequency, the cavitation effect is relatively weak, and only some microcapsule wall materials may show tiny cracks, resulting in slow drug release; while at higher power and frequency, the cavitation effect is enhanced, causing more microcapsules to rupture and the release rate to increase, which is suitable for patients with different recovery needs.

[0040] The patch device provided by the embodiments of the present invention for promoting the recovery of diabetic wounds promotes wound healing and nerve regeneration through adjustable low-frequency pulsed electromagnetic fields, promotes the continuous release of drugs by the drug sustained-release layer 16 through low-frequency ultrasound, increases the drug absorption rate and absorption depth, and reduces the infection risk through the antibacterial coating 17. The present invention has the advantages of non-invasive, convenient to use, reusable, and significant healing promotion effect, and is suitable for the treatment of chronic wounds of diabetic patients.

[0041] Figure 5 It is a schematic flow chart of the manufacturing method of the patch device provided by the embodiments of the present invention. Please refer to Figure 2 and Figure 5 , and the manufacturing method may include the following steps: Step S101: Fabricate a multi-layer composite patch and install it inside the protective shell 11; Step S102: Fabricate the chip structure 20, install the ultrasonic emission circuit 22, the electromagnetic excitation microcircuit 23, the battery 24, and the control unit inside the housing 21, and electrically connect the ultrasonic emission circuit 22 and the electromagnetic excitation microcircuit 23 to the battery 24; Step S103: Assemble and install the housing 21 with the protective shell 11, and fix two sterile elastic bands 30 to the left and right ends of the housing 21 and the protective shell 11 respectively.

[0042] Preferably, step S101 may include: fabricating the drug release layer 16 and the piezoelectric layer 15, covering the piezoelectric layer 15 on the upper surface of the drug release layer 16; fabricating the flexible electrode layer 14 and covering it on the upper surface of the piezoelectric layer 15; fabricating the patch flexible substrate layer 13 and embedding the drug release layer 16 in its lower part; fabricating the antibacterial coating 17 and attaching it to the bottom surface of the patch flexible substrate layer 13; fabricating the electromagnetic release layer 12, covering it on the upper surface of the patch flexible substrate layer 13, and covering the patch flexible substrate layer 13 on the surface of the flexible electrode layer 14.

[0043] Illustrated by way of example, when manufacturing a patch device for promoting the recovery of diabetic wounds, first fabricate the drug release layer 16 and the piezoelectric layer 15, and cover the piezoelectric layer 15 on the upper surface of the drug release layer 16. Subsequently, fabricate the flexible electrode layer 14 and cover it on the upper surface of the piezoelectric layer 15. Then, fabricate the patch flexible substrate layer 13 and embed the drug release layer 16 in its lower part. Subsequently, fabricate the antibacterial coating 17 and attach it to the bottom surface of the patch flexible substrate layer 13. Fabricate the electromagnetic release layer 12, cover it on the upper surface of the upper flexible substrate layer, and cover the upper flexible substrate layer on the surface of the flexible electrode layer 14. Then, fix the entire fabricated multi-layer composite patch inside the protective shell 11, with the antibacterial coating 17 at the bottom. Subsequently, fabricate the chip structure 20, install the ultrasonic emission circuit 22, the electromagnetic excitation microcircuit 23, the battery 24, and the control unit inside the housing 21, and electrically connect the ultrasonic emission circuit 22 and the electromagnetic excitation microcircuit 23 to the battery 24. Finally, fix the housing 21 to the rear end of the protective shell 11, and fix two sterile elastic bands 30 to the left and right ends of the housing 21 and the protective shell 11 respectively to complete the fabrication.

[0044] In addition, an embodiment of the present invention further provides a method for promoting the recovery of diabetic wounds, which is applied to the control unit of the above patch device.

[0045] Please refer to Figure 6Example. The power supply module shown in the figure includes an ultrasonic emission circuit 22, an electromagnetic excitation microcircuit 23, and a battery 24. The method for promoting the recovery of diabetic wounds includes: when the composite patch structure 10 is fixed on the surface of the diabetic wound site through a sterile elastic band 30, starting the ultrasonic emission circuit 22 and the electromagnetic excitation microcircuit 23, and adjusting the corresponding pulse signals and electrical signals; using the coil in the electromagnetic release layer 12 to receive the pulse signals and release low-frequency pulsed electromagnetic fields to promote wound repair; using the piezoelectric layer 15 to receive the electrical signals and release low-frequency low-pulse ultrasonic waves to cause the drug slow-release layer 16 to release drugs for treating the wound site.

[0046] Taking an example to illustrate, when the patch device is in use, first, the composite patch structure 10 is fixed on the surface of the diabetic wound site through the sterile elastic band 30. Subsequently, the user starts the ultrasonic emission circuit 22 and the electromagnetic excitation microcircuit 23 through the control unit to make them emit pulse signals and electrical signals, and adjusts the magnitudes of the pulse signals and electrical signals according to the condition of the wound. At this time, the coil in the electromagnetic release layer 12 receives the pulse signals and releases low-frequency pulsed electromagnetic fields to promote wound repair. At the same time, the piezoelectric layer 15 receives the electrical signals and releases low-frequency low-pulse ultrasonic waves to cause the drug slow-release layer 16 to release drugs for treating the wound site.

[0047] The patch device, method, and its manufacturing method for promoting the recovery of diabetic wounds provided by the embodiments of the present invention achieve significant advantages in many aspects through innovative multifunctional integrated design. The synergistic effect of low-frequency pulsed electromagnetic fields and low-frequency ultrasound effectively accelerates cell regeneration and nerve function recovery, significantly shortening the healing cycle of diabetic patients' wounds. The unique drug slow-release layer 16 combined with the ultrasonic effect breaks through the limitation of poor drug permeability in the traditional way, realizing efficient drug penetration and continuous release to ensure that the drugs fully exert their efficacy. The antibacterial coating 17 and the design of reducing the number of dressing changes effectively reduce the infection risk from both inside and outside, creating a suitable environment for wound healing. The non-invasive patch design is simple and convenient to operate, greatly improving the treatment experience of patients. In addition, the patch can be reused, reducing the high costs brought by traditional frequent dressing changes, alleviating the economic burden of patients and the nursing cost, and having great application value in the field of diabetic wound recovery.

[0048] It should be understood that in various embodiments of the present invention, the magnitudes of the serial numbers of the above processes do not mean the order of execution. The order of execution of each process should be determined by its function and internal logic, and should not constitute any limitation to the implementation process of the embodiments of the present invention.

[0049] In addition, the terms "system" and "network" in this document are often used interchangeably herein. The term "and / or" in this document is merely a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone. In addition, the character " / " in this document generally represents an "or" relationship between the associated objects before and after.

[0050] It should be understood that in the embodiments of the present invention, "B corresponding to A" means that B is associated with A, and B can be determined according to A. However, it should also be understood that determining B according to A does not mean determining B only according to A, and B can also be determined according to A and / or other information.

[0051] Those of ordinary skill in the art can realize that the units and algorithm steps of each example described in combination with the embodiments disclosed in this document can be implemented by electronic hardware, computer software, or a combination of the two. To clearly illustrate the interchangeability of hardware and software, the composition and steps of each example have been generally described according to functions in the above description. Whether these functions are executed in a hardware or software manner depends on the specific application and design constraints of the technical solution. Professional technicians can use different methods to implement the described functions for each specific application, but such implementation should not be considered to exceed the scope of the present invention.

[0052] Those skilled in the art can clearly understand that for the convenience and conciseness of description, the specific working processes of the systems, devices, and units described above can refer to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0053] In several embodiments provided in this application, it should be understood that the disclosed systems, devices, and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For example, the division of the units is only a logical function division, and there can be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. In addition, the displayed or discussed couplings or direct couplings or communication connections to each other can be indirect couplings or communication connections through some interfaces, devices, or units, and can also be electrical, mechanical, or other forms of connection.

[0054] The units described as separate components may or may not be physically separated, and the components displayed as units may or may not be physical units, that is, they can be located in one place, or can be distributed to multiple network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the solution of the embodiments of the present invention.

[0055] In addition, in each embodiment of the present invention, each functional unit may be integrated into one processing unit, may exist separately as individual physical units, or two or more units may be integrated into one unit. The above-mentioned integrated units may be implemented in the form of hardware or in the form of software functional units.

[0056] In summary, the above are only the preferred embodiments of the technical solution of the present invention, and are not intended to limit the protection scope of the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A patch device for promoting recovery of diabetic wounds, characterized in that: The patch device comprises a composite patch structure, a chip structure connected to the composite patch structure, and a sterile elastic band connected to the left and right ends of the composite patch structure and the chip structure. The composite patch structure includes an outer protective shell and an inner multi-layer composite patch. The chip structure includes a shell, an ultrasonic transmitting circuit fixed inside the shell for controlling the multi-layer composite patch to release drugs, an electromagnetic excitation microcircuit for controlling the multi-layer composite patch to generate a low-frequency pulsed electromagnetic field, and a battery and a control unit electrically connecting the ultrasonic transmitting circuit and the electromagnetic excitation microcircuit.

2. The patch device according to claim 1, characterized in that: The multi-layer composite patch includes, from top to bottom, an electromagnetic release layer, a patch flexible substrate layer, a flexible electrode layer, a piezoelectric layer, a drug sustained-release layer and an antibacterial coating. The electromagnetic release layer covers the upper surface of the flexible base layer of the patch, the drug sustained-release layer is embedded in the bottom of the flexible base layer of the patch, the antibacterial coating covers the lower surface of the flexible base layer of the patch, the flexible electrode layer covers the surface of the piezoelectric layer, and the piezoelectric layer covers the surface of the drug sustained-release layer. The ultrasonic transmitting circuit is used for transmitting an electrical signal to the piezoelectric layer, and the electromagnetic excitation microcircuit is used for transmitting a pulse signal to the electromagnetic release layer.

3. The patch device according to claim 2, characterized in that: The electromagnetic release layer adopts a coil bending arrangement structure for releasing a low-frequency pulse electromagnetic field, and the surface of the electromagnetic release layer is covered with an insulating flexible protective layer.

4. The patch device according to claim 2, characterized in that: The flexible base layer of the patch is made of a biocompatible material within a preset thickness range.

5. The patch device according to claim 2, characterized in that: The piezoelectric layer adopts PVDF piezoelectric film.

6. The patch device according to claim 2, characterized in that: The antibacterial coating is a chitosan or silver nanoparticle coating within a preset thickness range.

7. The patch device according to claim 2, characterized in that: The ultrasonic transmitting circuit transmits an electrical signal to the piezoelectric layer, so that the piezoelectric layer generates a low-frequency and low-pressure pulse ultrasonic wave, so that the drug sustained-release layer continuously releases the drug. The electromagnetic excitation microcircuit transmits a pulse signal to the electromagnetic release layer, so that the coil of the electromagnetic release layer generates a low-frequency pulse electromagnetic field.

8. A method for manufacturing a patch device, characterized in that: The manufacturing method comprises: Make a multi-layer composite patch and install it inside the protective case; Making a chip structure, installing an ultrasonic transmitting circuit, an electromagnetic excitation microcircuit, a battery and a control unit in a housing, and electrically connecting the ultrasonic transmitting circuit and the electromagnetic excitation microcircuit to the battery; The outer shell and the protective shell are assembled and installed, and two sterile elastic bands are fixed to the left and right ends of the outer shell and the protective shell respectively.

9. The manufacturing method according to claim 8, characterized in that: The manufacturing of the multi-layer composite patch comprises: Making a drug sustained-release layer and a piezoelectric layer, and covering the upper surface of the drug sustained-release layer with the piezoelectric layer; Making a flexible electrode layer and covering it on the surface of the piezoelectric layer; A flexible base layer of the patch is prepared, and the drug sustained-release layer is embedded in the lower part thereof; Making an antibacterial coating and attaching it to the bottom surface of the flexible base layer of the patch; An electromagnetic release layer is manufactured and covered on the upper surface of the patch flexible base layer, and the patch flexible base layer is covered on the surface of the flexible electrode layer.

10. A method for promoting recovery of diabetic trauma, characterized in that: The method is applied to the control unit of the patch device according to claims 1 to 8, and the method comprises: When the composite patch structure is fixed to the surface of the diabetic wound site by a sterile elastic band, Start the ultrasonic transmitting circuit and the electromagnetic excitation microcircuit, and adjust the pulse signal and the electrical signal accordingly; The coil in the electromagnetic release layer receives pulse signals and releases low-frequency pulse electromagnetic fields to promote wound repair. The piezoelectric layer receives electrical signals and releases low-frequency, low-pulse ultrasound, causing the drug sustained-release layer to release drugs to treat the injured area.

Images