An acoustic-electric coupling treatment patch

Abstract

The application relates to an acoustic-electric coupling treatment patch, which comprises a main machine, the main machine comprising a flexible circuit protection shell and a flexible circuit board integrated with a battery and a high-frequency pulse voltage generating circuit in the flexible circuit protection shell; an ultrasonic array electrically connected with the high-frequency pulse voltage generating circuit through a first flexible flat cable to generate ultrasonic signals; a transduction array and an electric stimulation coil connected through a second flexible flat cable and arranged on two sides of the ultrasonic array respectively; the transduction array is used for collecting the ultrasonic signals generated on one side of the ultrasonic array and converting the ultrasonic signals into pulse voltage to be conducted to the electric stimulation coil, so that the electric stimulation coil on one side of the treatment patch realizes combined stimulation of ultrasonic waves and pulse voltage.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an acoustic-electric coupling therapy patch. Background Technology

[0002] As the largest organ in the human body, the skin plays a vital role in resisting pathogens, sensing changes in the external environment, and regulating body temperature. Various harmful stimuli can damage the skin's structure and integrity, leading to wounds. Wound formation signifies the loss of the body's most important natural barrier, which can result in infection, inflammation, and functional disorders of blood vessels and nerves.

[0003] Skin wound healing is basically divided into three stages: the inflammatory phase, the proliferative phase, and the tissue remodeling phase. Although human skin has a spontaneous repair function, necessary wound care is of great importance for preventing infection, preventing dryness, reducing pain, protecting open areas, accelerating healing, and avoiding scarring, especially for acute wounds such as falls and burns caused by strong external stimuli, as well as chronic wounds such as diabetic ulcers, vascular ulcers, and pressure sores caused by complications.

[0004] Therefore, a new approach is urgently needed to help skin wounds heal. Summary of the Invention

[0005] To overcome the problems existing in related technologies, embodiments of the present invention provide an acoustic-electric coupling therapy patch. The technical solution is as follows:

[0006] According to a first aspect of an embodiment of the present invention, an acoustic-electric coupling therapeutic patch is provided, comprising:

[0007] The host includes a flexible circuit protective shell and a flexible circuit board encapsulated within the flexible circuit protective shell, which integrates a battery and a high-frequency pulse voltage generating circuit.

[0008] An ultrasonic array is electrically connected to the high-frequency pulse voltage generating circuit via a first flexible cable to generate ultrasonic signals.

[0009] The transducer array and the electrical stimulation coil are connected by a second flexible cable and are respectively disposed on both sides of the ultrasound array. The transducer array is used to collect the ultrasound signal generated on one side of the ultrasound array and convert it into a pulse voltage, which is then conducted to the electrical stimulation coil, so that the side of the treatment patch where the electrical stimulation coil is located can simultaneously achieve combined stimulation by ultrasound and pulse voltage.

[0010] In one embodiment of this application, the host further includes:

[0011] An impedance measurement module is used to measure the impedance of wound and non-wound areas by using the electrical stimulation coil as a probe to obtain impedance values.

[0012] The processor is used to determine the current wound recovery period based on the impedance value measured by the impedance measurement module and the preset correspondence between the impedance value and the wound recovery period, and to control the operating parameters of the high-frequency pulse voltage generation circuit corresponding to the current wound recovery period based on the preset correspondence between the wound recovery period and the operating parameters of the high-frequency pulse voltage generation circuit.

[0013] In one embodiment of this application, the ultrasonic array includes:

[0014] The first adhesive conductive cloth includes a parallel positive electrode and a parallel negative electrode with a preset shape. The parallel positive electrode and the parallel negative electrode are connected to one end of the first flexible flat cable, and the other end of the first flexible flat cable is connected to the high-frequency pulse voltage generating circuit.

[0015] Multiple first transducer elements are connected in parallel, with a positive electrode and a negative electrode attached to the first side of the first adhesive conductive cloth based on the preset shape.

[0016] The ultrasonic array is encapsulated in a flexible material.

[0017] In one embodiment of this application, the transducer array includes:

[0018] The second adhesive conductive cloth includes series electrodes with a preset shape, and the two poles of the series electrodes are connected to one end of the second flexible ribbon cable.

[0019] Multiple second transducers are attached to the series electrode on the first side of the second adhesive conductive cloth based on the preset shape, thereby realizing the series connection of multiple second transducers;

[0020] The transducer array is encapsulated in a flexible material;

[0021] The first side of the transducer array covers the second side of the ultrasound array; the position of the second transducer element corresponds one-to-one with that of the first transducer element.

[0022] The transducer element includes PZT-4 with the same resonant frequency.

[0023] In one embodiment of this application, the electrical stimulation coil includes an outer coil electrode and a rod-shaped ground electrode. The outer coil electrode is electrically connected to the two poles at the other end of the second flexible cable, and the rod-shaped ground electrode is electrically connected to the middle contact of the second flexible cable.

[0024] In one embodiment of this application, the electrical stimulation coil is patterned using laser direct writing, employs a flexible substrate, and is formed by pure gold plasma evaporation.

[0025] In one embodiment of this application, the preset shape is a ring.

[0026] In one embodiment of this application, the transducer array and the electrical stimulation coil are bonded to the ultrasound array by hydrogel.

[0027] The acoustic-electric coupling therapy patch provided in the embodiments of the present invention adopts an integrated acoustic-electric coupling therapy mode. Ultrasound is responsible for deep treatment, and electric field is responsible for superficial repair. The two work together and complement each other. The integrated device is free from the constraints of traditional power cords, so that treatment can be performed without affecting daily activities. The fully flexible design has a good fit to various injured parts of the human body. The acoustic-electric coupling therapy patch can promote the reconstruction of wound skin tissue and has a significant therapeutic effect. It is of great significance for the later repair and care of wounds.

[0028] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit the invention. Attached Figure Description

[0029] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0030] Figure 1 This is a schematic diagram of an acoustic-electric coupling therapy patch according to an exemplary embodiment;

[0031] Figure 2 This is a schematic diagram of the main unit of an acoustic-electric coupling therapy patch according to an exemplary embodiment;

[0032] Figure 3 This is a schematic diagram of a high-frequency pulse voltage generating circuit for an acoustic-electric coupling therapeutic patch according to an exemplary embodiment;

[0033] Figure 4 This is a schematic diagram of an ultrasonic array for an acoustic-electric coupling therapy patch according to an exemplary embodiment;

[0034] Figure 5 This is a schematic diagram of the transducer array and electrical stimulation coil of an acoustic-electric coupling therapy patch according to an exemplary embodiment;

[0035] Figure 6 This is a schematic diagram of an acoustic-electric coupling therapy patch according to an exemplary embodiment;

[0036] Figure 7 This is a test diagram of the electrical properties of a ceramic wafer according to an exemplary embodiment;

[0037] Figure 8 This is a test diagram of the transducer array's transducer capability according to an exemplary embodiment;

[0038] Figure 9 This is a statistical graph illustrating cell scratch and proliferation experiments under different stimuli according to an exemplary embodiment;

[0039] Figure 10 This is a statistical graph illustrating cortical thickness testing under different stimuli according to an exemplary embodiment;

[0040] Figure 11 This is a summary of impedance measurement and patterns of wound-skin using an electrical stimulation coil, as illustrated in an exemplary embodiment. Detailed Implementation

[0041] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of apparatuses and methods consistent with some aspects of the invention as detailed in the appended claims.

[0042] This application provides an acoustic-electric coupling therapeutic patch. For example, such as... Figure 1 As shown, the acoustic-electric coupling therapy patch includes:

[0043] The host 10 includes a flexible circuit protective shell 101 and a flexible circuit board 103 encapsulated in the flexible circuit protective shell 101, which integrates a battery 102 and a high-frequency pulse voltage generating circuit.

[0044] The ultrasonic array 20 is electrically connected to a high-frequency pulse voltage generating circuit via a first flexible cable 50 to generate ultrasonic signals.

[0045] The transducer array 30 and the electrical stimulation coil 40 are connected by a second flexible cable 60 and are respectively disposed on both sides of the ultrasound array 20.

[0046] The transducer array 30 is used to collect the ultrasonic signals generated on one side of the ultrasonic array 20 and convert them into pulse voltages that are conducted to the electrical stimulation coil 40, so that the side of the treatment patch where the electrical stimulation coil 40 is located can simultaneously achieve combined stimulation by ultrasonic waves and pulse voltages.

[0047] This embodiment adopts an integrated acoustic-electric coupling treatment mode, with ultrasound responsible for deep treatment and electric field responsible for superficial repair, the two working together and complementing each other; the integrated device is free from the constraints of traditional power cords, allowing treatment to be performed without affecting daily activities; the fully flexible design provides good fit to various injured parts of the human body; the acoustic-electric coupling treatment patch can promote the reconstruction of the wound skin tissue, with significant therapeutic effects, and is of great significance for the later repair and care of wounds.

[0048] In one embodiment of this application, as Figure 2 The diagram shown is an exemplary host 10. Figure 2 As shown, the flexible circuit board 103 integrates a battery 102 and a high-frequency pulse voltage generating circuit. The battery 102 can be a commercially available 5V rechargeable lithium battery and can be attached to the flexible circuit board 103 with adhesive. Figure 2 The diagram schematically illustrates the main components of a high-frequency pulse voltage generating circuit: chip 104, resistors and capacitors 105, inductor 106, and board-to-board connector 107. A 430kHz pulse voltage can be generated through the chip and related resistors and capacitors, and then boosted to 10V or 20V through the inductor. The BTB board (i.e., board-to-board connector 107) outputs the high-frequency pulse voltage. Figure 3 The diagram shown is a specific circuit diagram of an exemplary high-frequency pulse voltage generator circuit, in which the pulse output terminal can be connected to a BTB board to realize the output of a high-frequency pulse signal.

[0049] The flexible circuit protection shell 101 may include a 3D-printed TPU (thermoplastic polyurethane) upper shell 1011 and a lower shell 1012 for encapsulating the above components. The upper and lower shells can have any shape, as long as they can accommodate the circuit board and form a closed shell. Figure 2 As shown, the upper and lower shells can form a square shell. The upper and lower shells can have corresponding joining structures, which facilitates closing and opening. In one embodiment, the four corners of the upper shell 1011 have tenon structures, which correspond one-to-one with the four corner mortise structures of the lower shell 1012, forming perfect protection.

[0050] In one embodiment of this application, as Figure 4 As shown, an exemplary structure of the ultrasound array 20 is illustrated. Figure 4 As shown, the ultrasound array 20 includes:

[0051] The first adhesive conductive cloth includes a parallel positive electrode 2011 and a parallel negative electrode 2012 with a preset shape. The parallel positive electrode 2011 and the parallel negative electrode 2012 are electrically connected to one end of the first flexible flat cable 50, and the other end of the first flexible flat cable 50 is electrically connected to a high-frequency pulse voltage generating circuit.

[0052] Multiple first transducer elements 202 are connected in parallel with a positive electrode and a negative electrode, which are adhered to the first side of the first adhesive conductive cloth based on the preset shape, thereby realizing the parallel connection of multiple first transducer elements;

[0053] The ultrasonic array is encapsulated in a flexible material.

[0054] One end of the first flexible flat cable 50 is electrically connected to the first parallel positive electrode 2011 and the first parallel negative electrode 2022 of the first adhesive conductive cloth. The other end of the first flexible flat cable 50 is electrically connected to the BTB board in the high-frequency pulse voltage generating circuit to obtain driving energy. In one embodiment, the parallel positive electrode 2011 and the parallel negative electrode 2012 of the first adhesive conductive cloth can be directly formed in one step using a patterned laser. Both are double-sided adhesive, and the back side (i.e., the second side of the ultrasonic array) can also be covered with a PET (Polyethylene terephthalate) backing layer to improve Young's modulus. This backing layer is then attached to a spin-coated and cured first lower PDMS (polydimethylsiloxane) encapsulation layer 203 substrate. The front side (i.e., the first side of the ultrasonic array) is electrically connected to six first PZT-4 (a type of piezoelectric ceramic wafer) 202. The specifications of the PZT-4 are, for example, a diameter of 5 mm, a thickness of 1 mm, and a resonant frequency of 430 kHz. Finally, a first upper PDMS encapsulation layer 204 is spin-coated on top. PDMS is an elastomer with excellent thermal stability, biocompatibility, corrosion resistance, flexibility, low cost, ease of use, chemical inertness, proliferative properties, and breathability. The encapsulation material can be transparent.

[0055] In one embodiment of this application, as Figure 5 As shown, an exemplary structure of the transducer array 30 is illustrated. Figure 5 As shown, the transducer array 30 includes:

[0056] The second adhesive conductive cloth 301 includes series electrodes with a preset shape, and the two poles of the series electrodes are electrically connected to one end of the second flexible ribbon cable 60.

[0057] The second transducer 302 may include, for example, multiple identical transducers, which are adhered to the series electrodes on the first side of the second adhesive conductive cloth 301 based on a preset shape, thereby realizing the series connection of multiple second transducers.

[0058] The transducer array 30 is encapsulated in a flexible material;

[0059] When the transducer array 30 is set in the ultrasonic array 20, the first side of the transducer array 30 is usually covered by the second side of the ultrasonic array 20, and the position of the second transducer element 302 corresponds one-to-one with the first transducer element in the ultrasonic array.

[0060] As shown above, the transducer array 30 is similar in process and structure to the ultrasonic array 20. The transducer array 30 is encapsulated with a flexible material. A second series electrode 301 with adhesive conductive cloth is adhered to a spin-coated and cured second lower PDMS encapsulation layer 303. Six second PZT-4 302 electrodes (5mm in diameter, 1mm thick, resonant frequency 430kHz) are adhered to the second series electrode with adhesive conductive cloth. The topmost layer is a spin-coated and cured second upper PDMS encapsulation 304, and the encapsulation material can be transparent. The positions of the six first PZT-4 202 electrodes and the six second PZT-4 302 electrodes correspond one-to-one.

[0061] like Figure 5 As shown, the electrical stimulation coil 40 includes an outer ring electrode 401 and a rod-shaped ground electrode 402. The outer ring electrode 401 is electrically connected to the two poles at the other end of the second flexible cable 60, and the rod-shaped ground electrode 402 is electrically connected to the middle contact of the second flexible cable 60.

[0062] In one embodiment, the electrical stimulation coil 40 can be patterned using laser direct writing, employing a flexible substrate, and formed by pure gold plasma evaporation.

[0063] In the above embodiments, the first adhesive conductive cloth of the ultrasonic array 20 is patterned in a circular serpentine shape using laser direct writing. Specifically, the parallel positive electrode 2011 on the outer ring and the parallel negative electrode 2012 on the inner ring form a serpentine circle, resulting in an overall annular shape, increasing flexibility and stretchability. Multiple first PZT-4 annular rings are arranged at equal intervals on the first side of the first adhesive conductive cloth. Ultrasonic waves released from one side of the ultrasonic array act on the wound, while those released from the other side are absorbed by the transducer array. The second adhesive conductive cloth of the transducer array 30 is also patterned using laser direct writing, including a series of electrodes that are generally annular. The outer electrode of the electrical stimulation coil 40 is also generally annular. In one embodiment, the outer diameter of the ring is 30 mm, the inner diameter is 10 mm, and the thickness is 1.5 mm. The hollow ring is used for wound drug delivery and ventilation. The transducer array collects the ultrasonic waves generated by the ultrasonic array, generates pulse voltage through the positive piezoelectric effect, and conducts it to the electrical stimulation coil to act on the wound.

[0064] like Figure 6 As shown, the transducer array 30, the electrical stimulation coil 40, and the ultrasound array 20 can be bonded together using hydrogel. In one embodiment of this application, the transducer array 30 and the electrical stimulation coil 40 can also be removed from the ultrasound array, allowing the treatment patch to perform a single ultrasound function.

[0065] like Figure 7 , 8 As shown, the acoustic performance of the ultrasonic array 20 and the electrical performance of the transducer array 30 were characterized. Figure 7The left figure shows the basic characterization of the ceramic wafer. The resonant frequency of the ceramic wafer was found through impedance spectrum and phase angle tests. The right figure shows the impedance changes under tension and bending, demonstrating that the acoustic output is relatively stable in the original, tensile, and bent states. The transduction capability of the transducer array 30 is determined by the voltage input to the ultrasonic array 20. The transducer output is attenuated by about 20% compared to the input voltage. That is, if the high-frequency pulse voltage generating circuit inputs a 20V voltage to the ultrasonic array 20, the transducer array 30 can generate a voltage of about 16V. Figure 8 As shown, when the input voltage of the ultrasonic array is 23, 19, 15, 11, 7, and 3V, the output voltage of the transducer array is 20, 15, 10, 5, and 2V.

[0066] Figure 9 , 10 The effectiveness of the acoustic-electric coupling therapy patch was verified. Figure 9 As shown in the statistical significance reports of the cell scratch assay and cell proliferation assay, after 48 hours, the proportion of cell migration area in the acoustic-electric coupling stimulation group was generally 25% higher than that in the control group, with statistically significant differences (P values ​​< 0.01). In the cell proliferation assay, after 48 hours, the cell viability in the acoustic-electric coupling stimulation group increased to over 125%, with P values ​​< 0.0001. This demonstrates the significant effect of acoustic-electric coupling stimulation on cell migration and proliferation. Figure 10 As shown, by applying an acoustic-electric coupling patch to mice with wounds of 0.8 cm in diameter, and after the wounds had fully healed, a staining experiment on the dermal tissue showed that the mice that had received acoustic-electric stimulation had smoother epidermal skin and thicker dermal tissue (P < 0.0001).

[0067] In one embodiment of this application, the host may further include:

[0068] An impedance measurement module is used to measure the impedance of wound and non-wound areas by using the electrical stimulation coil as a probe to obtain impedance values.

[0069] The processor is used to determine the current wound recovery period based on the impedance value measured by the impedance measurement module and the preset correspondence between the impedance value and the wound recovery period, and to control the operating parameters of the high-frequency pulse voltage generation circuit corresponding to the current wound recovery period based on the preset correspondence between the wound recovery period and the operating parameters of the high-frequency pulse voltage generation circuit.

[0070] Figure 11Wound-skin impedance was measured and summarized, and the different stages of wound healing were divided into five distinct periods based on impedance values ​​and changes in impedance, making the wound healing status visible. These five periods correspond to the inflammation phase, cell proliferation phase, scar formation phase, epidermal and other tissue regeneration phase, and maturation phase. The correspondence between impedance values ​​and wound healing periods can be preset, as can the correspondence between wound healing periods and the operating parameters of the high-frequency pulse voltage generator circuit. In actual use, an electrical stimulation coil is used as a probe to measure impedance values ​​in both wound and non-wound areas to determine the current wound healing period. Based on the preset correspondence between the wound healing period and the operating parameters of the high-frequency pulse voltage generator circuit, the operating parameters of the circuit corresponding to the current wound healing period are controlled, thereby dynamically adjusting the stimulation time and intensity to achieve personalized treatment for different individuals and different wound types.

[0071] When using the aforementioned acoustic-electric coupling therapy patch, which can promote the remodeling of the wound's dermal tissue, for wound care, the patch can be directly applied to the affected area (with the side of the electrical stimulation coil in contact with the skin). Wound care should be performed twice daily for 10 minutes each time, and the application should be dynamically adjusted according to the healing progress.

[0072] The acoustic-electric coupling therapy patch proposed in this invention, which promotes the remodeling of dermal tissue in wounds, has the following beneficial effects: It is a fully integrated device, freeing it from the constraints of traditional power cords, allowing treatment without affecting daily activities; the integrated acoustic-electric coupling therapy mode utilizes ultrasound for deep treatment and an electric field for superficial repair, with both working synergistically and complementarily; its fully flexible design provides good fit to various injured areas of the body; the patch employs a modular design, allowing for individual ultrasound stimulation or combined acoustic-electric stimulation; the ultrasound array generates heat close to body temperature while producing ultrasound, which has a positive effect on the care of the injured area; in addition to providing pulsed electrical stimulation, the electrical stimulation coil can also measure the impedance of the wound and surrounding tissues, judging the wound healing process by changes in impedance at the wound site and dynamically adjusting the stimulation intensity and duration; the patch has significant therapeutic effects and is of great importance for the later repair and care of wounds.

[0073] Compared with existing technologies, the above-mentioned acoustic-electric coupling therapy patch has the characteristics of being fully integrated, multimodal, low power consumption, wearable, having good biocompatibility, and having a significant effect on wound dermal tissue reconstruction.

[0074] Other embodiments of the invention will readily occur to those skilled in the art upon consideration of the specification and practice of the invention described herein. This application is intended to cover any variations, uses, or adaptations of the invention that follow the general principles of the invention and include common knowledge or customary techniques in the art not invented herein. The specification and examples are to be considered exemplary only, and the true scope and spirit of the invention are indicated by the following claims.

[0075] It should be understood that the present invention is not limited to the precise structure described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of the invention is limited only by the appended claims.

Claims

1. A acoustic-electric coupling therapeutic patch, characterized in that, include: The host includes a flexible circuit protective shell and a flexible circuit board encapsulated within the flexible circuit protective shell, which integrates a battery and a high-frequency pulse voltage generating circuit. An ultrasonic array is electrically connected to the high-frequency pulse voltage generating circuit via a first flexible cable to generate ultrasonic signals. The transducer array and the electrical stimulation coil are connected by a second flexible cable and are respectively disposed on both sides of the ultrasound array. The transducer array is used to collect the ultrasound signal generated on one side of the ultrasound array and convert it into a pulse voltage, which is then conducted to the electrical stimulation coil, so that the side of the treatment patch where the electrical stimulation coil is located can simultaneously achieve combined stimulation by ultrasound and pulse voltage.

2. The therapeutic patch according to claim 1, characterized in that, The host also includes: An impedance measurement module is used to measure the impedance of wound and non-wound areas by using the electrical stimulation coil as a probe to obtain impedance values. The processor is used to determine the current wound recovery period based on the impedance value measured by the impedance measurement module and the preset correspondence between the impedance value and the wound recovery period, and to control the operating parameters of the high-frequency pulse voltage generation circuit corresponding to the current wound recovery period based on the preset correspondence between the wound recovery period and the operating parameters of the high-frequency pulse voltage generation circuit.

3. The therapeutic patch according to claim 1, characterized in that, The ultrasonic array includes: The first adhesive conductive cloth includes a parallel positive electrode and a parallel negative electrode with a preset shape. The parallel positive electrode and the parallel negative electrode are connected to one end of the first flexible flat cable, and the other end of the first flexible flat cable is connected to the high-frequency pulse voltage generating circuit. Multiple first transducer elements are connected in parallel, with a positive electrode and a negative electrode attached to the first side of the first adhesive conductive cloth based on the preset shape. The ultrasonic array is encapsulated in a flexible material.

4. The therapeutic patch according to claim 3, characterized in that, The transducer array includes: The second adhesive conductive cloth includes series electrodes with a preset shape, and the two poles of the series electrodes are connected to one end of the second flexible ribbon cable. Multiple second transducers are attached to the series electrode on the first side of the second adhesive conductive cloth based on the preset shape, thereby realizing the series connection of multiple second transducers; The transducer array is encapsulated in a flexible material; The first side of the transducer array covers the second side of the ultrasound array; the position of the second transducer element corresponds one-to-one with that of the first transducer element.

5. The therapeutic patch according to claim 3 or 4, characterized in that, The transducer element includes PZT-4 with the same resonant frequency.

6. The therapeutic patch according to claim 3 or 4, characterized in that, The electrical stimulation coil includes an outer coil electrode and a rod-shaped ground electrode. The outer coil electrode is electrically connected to the two poles at the other end of the second flexible cable, and the rod-shaped ground electrode is electrically connected to the middle contact of the second flexible cable.

7. The therapeutic patch according to claim 6, characterized in that, The electrical stimulation coil is patterned using laser direct writing, employs a flexible substrate, and is formed by pure gold plasma evaporation.

8. The therapeutic patch according to claim 3 or 4, characterized in that, The preset shape is a circular ring.

9. The therapeutic patch according to claim 1, characterized in that, The transducer array and the electrical stimulation coil are bonded to the ultrasound array by hydrogel.

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