Bandage for monitoring a wound and releasing a medicament using acoustic waves and method of manufacture

Abstract

The application provides a bandage for monitoring a wound and releasing drugs by using acoustic waves and a manufacturing method, and belongs to the technical field of treatment, and comprises: a piezoelectric layer; a hydrogel film arranged on the top of the piezoelectric layer, and a drug is placed in the hydrogel film; a first interdigital electrode for generating Rayleigh wave to stimulate the release of drug molecules in the hydrogel; a functionalized two-dimensional film arranged on the bottom of the hydrogel film, and an aptamer factor for capturing inflammatory factors of a wound is arranged on the functionalized two-dimensional film; a second interdigital electrode arranged on the bottom of the piezoelectric layer; one end of the second interdigital electrode generates a high-frequency acoustic wave signal to detect the concentration of the inflammatory factors of the wound captured by the aptamer factor in the functionalized two-dimensional film, and the other end receives the high-frequency acoustic wave signal, converts the high-frequency acoustic wave signal into an electric signal, and then outputs the electric signal; and a bandage arranged on the bottom of the second interdigital electrode and used for winding around a patient's affected part. The device can collect the wound information of the patient by using a sensor, and can control the release of the drug by the hydrogel film to treat the wound in a timely manner according to the collected information.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of treatment, and particularly relates to a bandage for monitoring a wound and releasing drugs by using sound waves and a manufacturing method. BACKGROUND

[0002] Chronic wounds directly affect the daily life of 1-2% of the world's population, and more than 8 million patients in the United States are affected by chronic wounds, with an annual economic loss of more than 30 billion US dollars. The high cost of diagnosis and care places a long-term burden on patients, and higher requirements are placed on the ordinary care bandage, which is currently passive, non-customized and prone to secondary injury. With the development of micro-nano technology, intelligent bandages for monitoring the healing of wound surfaces and assisting treatment have been developed. Through the identification of wound biomarkers, the recovery of the wound is monitored online, and the drug release is carried out through active stimulation of the hydrogel according to the recovery of the wound.

[0003] At present, the care method for wounds mostly protects the wound surface to avoid deep infection and bacterial colonization, but the recovery of the wound cannot be understood in time, and the wound cannot be treated in time when it worsens. However, frequent visits, opening of the bandage or dressing process inevitably causes secondary injury, so that the patient's wound exists for a long time and recovers slowly. At present, the use of wound dressings is gradually increasing, but the auxiliary drug treatment is still passive, and it is difficult to judge the individualized wound condition in time and release the drug according to the wound condition. SUMMARY

[0004] In order to overcome the deficiencies of the prior art, the present application provides a bandage for monitoring a wound and releasing drugs by using sound waves.

[0005] In order to achieve the above purpose, the present application provides the following technical scheme:

[0006] A bandage for monitoring a wound and releasing drugs by using sound waves comprises:

[0007] A bandage body for winding around a patient's affected area;

[0008] A piezoelectric layer arranged on the top of the bandage body;

[0009] A hydrogel film arranged on the top of the piezoelectric layer, and the hydrogel film is used for placing drugs;

[0010] A first interdigital electrode arranged on the side of the hydrogel film, and used for generating Rayleigh wave to stimulate the release of drug molecules in the hydrogel;

[0011] A functionalized two-dimensional film arranged on the bottom of the hydrogel film, and the functionalized two-dimensional film is provided with an aptamer factor for capturing inflammatory factors of the wound.

[0012] a second interdigital electrode, arranged at the bottom of the piezoelectric layer, one end of which generates a high-frequency acoustic wave signal to detect the concentration of inflammatory factors in the wound captured by the aptamer factor in the functionalized two-dimensional film, and the other end receives the high-frequency acoustic wave signal and converts it into an electrical signal and outputs it;

[0013] a main control module, configured to determine the concentration of inflammatory factors in the wound according to the electrical signal output by the second interdigital electrode, and control the first interdigital electrode to generate a SAW to stimulate the release of drug molecules in the hydrogel when the concentration of inflammatory factors is higher than a threshold value.

[0014] Further, the device further comprises:

[0015] a third interdigital electrode, arranged at the top of the piezoelectric layer, configured to detect the humidity of the wound by using a resonant SAW;

[0016] a temperature sensor electrode, arranged at the top of the piezoelectric layer, configured to detect the temperature of the wound;

[0017] The main control module determines the infection condition of the wound according to the humidity and temperature of the wound.

[0018] Further, the device further comprises:

[0019] a response layer, arranged at the bottom of the second interdigital electrode, and electrically connected with the main control module;

[0020] The response layer is a flexible NFC response circuit, configured to respond to the instructions generated by the external device and feed back the detection information.

[0021] Further, a shielding layer is arranged between the response layer and the second interdigital electrode.

[0022] Further, a charging layer is arranged between the response layer and the shielding layer.

[0023] Further, the shielding layer is an electromagnetic wave shielding metal sheet or a polymer film.

[0024] Further, the functionalized two-dimensional film comprises:

[0025] a single-layer graphene, arranged at the top of the piezoelectric layer;

[0026] a Nafion film, arranged at the top of the single-layer graphene, and the aptamer factor is arranged at the top of the Nafion film.

[0027] Further, the thickness of the piezoelectric layer is 4 um, and the material is ZnO or AlN.

[0028] Further, the threshold value of the concentration of inflammatory factors is 30 fmol / ml.

[0029] A method for manufacturing a bandage for monitoring a wound and releasing drugs by using acoustic waves, comprising:

[0030] A piezoelectric layer is deposited on a flexible polymer substrate by a magnetron sputtering process;

[0031] A first interdigital electrode and a second interdigital electrode are prepared on the piezoelectric layer by a photolithography process;

[0032] The first interdigital electrode and the second interdigital electrode are metallized by a magnetron sputtering or evaporation process;

[0033] Single-layer graphene is picked up to the interdigital center sensing area by a wet graphene transfer process; after a quantitative bridging film is dropped on the single-layer graphene, drying is performed, and aptamer modification is performed to obtain a functional two-dimensional film;

[0034] A hydrogel film is attached to the center area of the functional two-dimensional film, and the hydrogel film is adsorbed and shaped under vacuum.

[0035] The bandage for monitoring a wound and releasing drugs by using acoustic waves has the following beneficial effects:

[0036] The second interdigital electrode generates high-frequency acoustic waves to detect the concentration of inflammatory factors in the wound captured by the aptamer factor in the functional two-dimensional film; when the concentration of inflammatory factors is higher than a threshold value, the first interdigital electrode is controlled to generate a SAW to stimulate the release of drug molecules in the hydrogel; the structure that the second interdigital electrode is arranged on the back and the first interdigital electrode is arranged on the top of the piezoelectric layer realizes the detection of the middle wound area and the synergistic work of stimulating the hydrogel film; the back design of the second interdigital electrode utilizes the characteristic that the acoustic waves propagate in the entire layer during the propagation of the acoustic waves in the film, so that the detection function is realized, and the interdigital distortion problem caused by the acoustic wave interference of the first interdigital electrode and the large deformation of the upper surface is avoided.

[0037] The bandage can be continuously attached to the wound and release drugs according to the condition of the wound, and the gauze and drugs do not need to be replaced every time, which solves the problem that the patient's wound exists for a long time and recovers slowly due to the secondary injury caused by the process of frequent visits, opening of the bandage or dressing. BRIEF DESCRIPTION OF DRAWINGS

[0038] In order to more clearly illustrate the embodiments of the present application and the design scheme thereof, the following will briefly introduce the drawings required by the present embodiment. The drawings in the following description are only part of the embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor on the basis of these drawings.

[0039] Figure 1 It is a schematic diagram of the acoustic wave intelligent bandage for long-term monitoring and auxiliary treatment.

[0040] Figure 2 A cross-sectional view of a sound wave intelligent bandage for long-term monitoring and auxiliary treatment according to the present application;

[0041] Figure 3 A circuit design diagram in a sound wave intelligent bandage for long-term monitoring and auxiliary treatment according to the present application;

[0042] Figure 4 A flow chart of a preparation method of a functional layer in a sound wave intelligent bandage for long-term monitoring and auxiliary treatment according to the present application;

[0043] Figure 5 An implementation step flow chart of a use method of a sound wave intelligent bandage for long-term monitoring and auxiliary treatment according to the present application. DETAILED DESCRIPTION

[0044] In order to better understand the technical solutions of the present application and to enable one skilled in the art to carry them out, the present application will be described in detail below in conjunction with the accompanying drawings and specific embodiments. The following embodiments are only used to more clearly illustrate the technical solutions of the present application, and cannot be used to limit the protection scope of the present application.

[0045] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only used to facilitate the description of the technical solutions of the present application and simplify the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0046] Embodiment:

[0047] The present application provides a bandage for monitoring a wound and releasing a drug by using sound waves, specifically as follows Figures 1-2As shown, it comprises: a bandage body 100 for winding around the patient's affected area; a piezoelectric layer 501 arranged on the top of the bandage body 100; a hydrogel film 522 arranged on the top of the piezoelectric layer 501, and the hydrogel film is used for placing drugs; a first interdigital electrode 521 arranged on the side of the hydrogel film 522, which is used to generate Rayleigh wave to stimulate the release of drug molecules in the hydrogel; a functional two-dimensional film 512 arranged on the bottom of the hydrogel film 522, and the functional two-dimensional film 512 is provided with aptamer factors for capturing inflammatory factors of the wound; a second interdigital electrode 511 arranged on the bottom of the piezoelectric layer 501; one end of the second interdigital electrode 511 generates a high-frequency acoustic wave signal to detect the concentration of inflammatory factors of the wound captured by the aptamer factors in the functional two-dimensional film 512, and the other end receives the high-frequency acoustic wave signal and then converts the high-frequency acoustic wave signal into an electric signal and outputs; a master control module is used to judge the concentration of inflammatory factors of the wound according to the electric signal output by the second interdigital electrode 511, and when the concentration of inflammatory factors is higher than a threshold value, the first interdigital electrode 521 is controlled to generate Rayleigh wave to stimulate the release of drug molecules in the hydrogel.

[0048] The acoustic wave detection is to judge the wound recovery condition through a specific wound marker. At present, the inflammatory state of the wound is a good standard for evaluating the wound recovery, and the concentration of inflammatory factors can evaluate the inflammatory state and stage. Therefore, when the acoustic wave is transmitted between the interdigital electrodes, the concentration is judged by the interference of the transmission of the acoustic wave by the inflammatory factors captured in the modification layer. After the inflammatory factors on the surface are captured by the aptamer, the mass of the sensitive area is increased, and the wave speed, frequency and phase are reduced by the mass effect of the acoustic wave, so that the concentration of the captured inflammatory factors is judged.

[0049] The following is the detail of the application:

[0050] The intelligent bandage aims to realize long-term monitoring and auxiliary treatment of skin wounds by using acoustic method. The bandage for monitoring wounds and releasing drugs comprises a bandage layer 100, a response layer 200, a charging layer 300, a shielding layer 400 and a functional layer 500.

[0051] The layers are distributed from bottom to top.

[0052] The functional layer 500 comprises a piezoelectric layer 501, a second interdigital electrode 511, a functional two-dimensional film 512, a first interdigital electrode 521, a hydrogel film 522, a third interdigital electrode 530 and a temperature sensor electrode 540. Each group of interdigital electrodes has one side input electrode and corresponding output electrode, and the information transmission and resonance are realized by using piezoelectric effect and inverse piezoelectric effect.

[0053] The piezoelectric layer 501 is a flexible piezoelectric layer such as ZnO, AlN, piezoelectric ceramic polymer film and array PZT, which is used as a conversion layer of positive and negative piezoelectric effect, and bears different frequency resonance to realize the combination of driving and sensing.

[0054] The functional two-dimensional film 512 is modified with an inflammation-related recognition factor, and the non-contact biosensing is realized by combining the second interdigital electrode 511;

[0055] The hydrogel film 522 contains a wound medicine, which is used to realize long-term contact between the bandage and the wound, maintain the surface humidity and temperature of the wound, and assist in drug delivery treatment under direct contact with the wound;

[0056] The functional two-dimensional film 512 in the application bridges the nucleic acid aptamer factor on the perfluorosulfonic acid membrane, so that different aptamer factors can be designed to realize the function of various biomolecules, and the application takes TNF-alpha as an example for monitoring.

[0057] As shown in Figure 1 , Figure 1 The core working layer of the acoustic wave intelligent bandage for long-term monitoring and auxiliary treatment provided in the embodiment of the application is the functional layer 500, which includes the piezoelectric layer 501, the second interdigital electrode 511, the functional two-dimensional film 512, the first interdigital electrode 521, the hydrogel film 522, the third interdigital electrode 530, and the temperature sensor electrode 540.

[0058] The second interdigital electrode 511 and the first interdigital electrode 521 are both used as positive and negative piezoelectric response excitation and reception of acoustic waves, the piezoelectric layer has a thickness of 4 um and is composed of ZnO or AlN; the width of the second interdigital electrode is 5 um, the width of the first interdigital electrode is 75 um, and the composition is chromium 20 nm and gold 60 nm.

[0059] The functional two-dimensional film 512 has a total thickness of about 50 nm, is composed of single-layer graphene, Nafion film and aptamer modification, the single-layer graphene is used as a fixing layer to effectively bind to the surface of the functional layer and is also a binding substrate of the Nafion film, and the Nafion film can be dissolved in ethanol and can be repeatedly constructed.

[0060] The sensitive factor can be specifically:

[0061] 5`-NH2-TGG TGG ATG GCG CAG TCG GCG ACAA-3`.

[0062] The first interdigital electrode 521 has a long resonance period and can excite a large-amplitude fluctuation to make the acoustic radiation force directly enter the hydrogel film 522, and the vibration process of the hydrogel film 522 can enhance the drug release capacity and perform active auxiliary treatment of the drug contained in the hydrogel layer.

[0063] The following is a preparation method of the application, including the following steps:

[0064] Step 1: depositing the designed piezoelectric film on the flexible polymer substrate by a magnetron sputtering process;

[0065] Step 2, using a photolithography process to prepare a pattern shape of interdigital on the piezoelectric film;

[0066] Step 3, interdigital metalization by magnetron sputtering or evaporation process;

[0067] Step 4, by wet graphene transfer process to single-layer graphene to the interdigital center sensing area;

[0068] Step 5, drop a quantitative bridging film on the graphene and then dry, and then perform aptamer modification;

[0069] Step 6, the drug-containing hydrogel is attached to the center area, and the shape is adsorbed under vacuum.

[0070] The application uses steps:

[0071] After the acoustic wave intelligent bandage system is successfully installed on the user, the following workflow is used:

[0072] Step 1, according to the external device to issue an instruction signal as a work instruction, using near field communication protocol to communicate with the NFC circuit inside the bandage;

[0073] Step 2, the inside of the bandage changes from standby state to working state, the sensitive electrode starts to work, and the resonant frequency variation parameter of the excited acoustic wave transmission area is returned to the internal circuit, and the temperature and humidity return the parameter to the memory;

[0074] Step 3, the CPU inside the bandage analyzes the inflammation state, temperature, and humidity of the wound for the collected data, analyzes whether active intervention treatment is needed, and transmits the data to the external device;

[0075] Step 4, in the case of active intervention treatment, the first interdigital electrode starts to work, generates a large amplitude vibration to stimulate the release of drug molecules in the hydrogel, and works intermittently for 5 cycles, and then the wound parameter monitoring and data uploading are performed again;

[0076] Step 5, after active treatment intervention, the device confirms the remaining power of the intelligent bandage, reminds the external device to charge when the power is lower than 30%, and stops the auxiliary treatment function.

[0077] The above-described embodiments are only the preferred specific embodiments of the present application, and the protection scope of the present application is not limited thereto, and any simple changes or equivalent replacements of the technical solutions within the technical range disclosed by the present application can be obtained by those skilled in the art, and all belong to the protection scope of the present application.

Claims

1. A bandage that uses sound waves to monitor wounds and release medication, characterized in that, include: The main body of the bandage (100) is used to wrap around the patient's affected area; A piezoelectric layer (501) is disposed on the top surface of the bandage body (100); the piezoelectric layer is a flexible piezoelectric layer; the thickness of the piezoelectric layer is 4 μm, and the material is ZnO or AlN; A hydrogel membrane (522) is disposed on top of the piezoelectric layer (501), and the hydrogel membrane is used to place drugs. The first interdigital electrode (521) is disposed on the side of the hydrogel membrane (522) and is used to generate Rayleigh waves to stimulate the release of drug molecules in the hydrogel. A functionalized two-dimensional film (512) is disposed at the bottom of the hydrogel film (522), and an aptamer factor for capturing inflammatory factors of wounds is provided on the functionalized two-dimensional film (512); the functionalized two-dimensional film (512) constructs the aptamer factor by bridging the perfluorosulfonic acid film on the two-dimensional film; The functionalized two-dimensional thin film (512) includes: a monolayer graphene disposed on top of the piezoelectric layer (501); a Nafion film disposed on top of the monolayer graphene; and an aptamer factor disposed on top of the Nafion film. The second interdigital electrode (511) is located at the bottom of the piezoelectric layer (501); one end of it generates a high-frequency acoustic wave signal to detect the concentration of inflammatory factors in the wound captured by the aptamer factor in the functionalized two-dimensional thin film (512), and the other end receives the high-frequency acoustic wave signal and converts the high-frequency acoustic wave signal into an electrical signal for output. The main control module is used to determine the concentration of inflammatory factors in the wound based on the electrical signal output by the second interdigital electrode (511). When the concentration of inflammatory factors is higher than the threshold, the first interdigital electrode (521) is controlled to generate Rayleigh waves to stimulate the release of drug molecules in the hydrogel.

2. A bandage for monitoring wounds and releasing medication using sound waves according to claim 1, characterized in that, Also includes: The third interdigital electrode (530) is disposed on the top of the piezoelectric layer (501) and is used to detect the humidity of the wound using resonant surface acoustic waves; A temperature sensor electrode (540) is disposed on top of the piezoelectric layer (501) for detecting the temperature of the wound; The main control module determines the infection status of the wound based on the wound's humidity and temperature.

3. A bandage for monitoring wounds and releasing medication using sound waves according to claim 1, characterized in that, Also includes: A response layer (200) is disposed at the bottom of the second interdigitated electrode (511); Electrically connected to the main control module; The response layer (200) is a flexible NFC response circuit used to respond to commands issued by peripheral devices and to provide feedback on various detection information.

4. A bandage for monitoring wounds and releasing medication using sound waves according to claim 3, characterized in that, A shielding layer (400) is provided between the response layer (200) and the second interdigital electrode (511).

5. A bandage for monitoring wounds and releasing medication using sound waves according to claim 4, characterized in that, A charging layer (300) is provided between the response layer (200) and the shielding layer (400).

6. A bandage for monitoring wounds and releasing medication using sound waves according to claim 5, characterized in that, The shielding layer (400) is an electromagnetic wave shielding metal sheet or a polymer film.

7. A bandage for monitoring wounds and releasing medication using sound waves according to claim 1, characterized in that, The threshold for inflammatory factor concentration is 30 fmol / ml.

8. A method for manufacturing a bandage that utilizes sound waves to monitor wounds and release medication, based on any one of claims 1 to 7, comprising: A piezoelectric layer (501) was deposited on a flexible polymer substrate by magnetron sputtering. The pattern shapes of the first interdigital electrode (521) and the second interdigital electrode (511) are fabricated on the piezoelectric layer (501) using photolithography. The first interdigital electrode (521) and the second interdigital electrode (511) are metallized by magnetron sputtering or vapor deposition. A single-layer graphene was retrieved to the interdigitated center sensing region using a wet graphene transfer process; a quantitative bridging film was dropped onto the single-layer graphene and dried, followed by aptamer modification to obtain a functionalized two-dimensional thin film (512). The hydrogel membrane (522) is attached to the central region of the functionalized two-dimensional film (512), and the hydrogel membrane (522) is adsorbed and shaped under vacuum.

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