Ultrasonic conductance therapeutic instrument

Abstract

The invention, which relates to the technical field of ultrasonic treatment, discloses an ultrasonic conductance therapeutic apparatus comprising a therapeutic apparatus host and a therapeutic head. The treatment head comprises a protective shell connected with the wire, and an ultrasonic transducer, a piezoelectric film layer and a microneedle patch layer which are sequentially arranged from inside to outside, and a sensor module is further arranged in the treatment head; the ultrasonic transducer consists of a plurality of groups of piezoelectric wafers; the piezoelectric film layer comprises a piezoelectric ceramic composite layer, a flexible substrate layer and a middle layer; the micro-needle patch layer comprises a micro-needle substrate layer, a main pore channel arranged on the micro-needle substrate layer and hollow micro-needles connected with the main pore channel, and the multiple groups of hollow micro-needles are distributed in a gradient height manner; the sensor module comprises a temperature sensor, a pressure sensor and an impedance biosensor, and the ultrasonic transducer switches the working frequency according to the tissue state fed back by the sensor module; according to the invention, the condition of insufficient or excessive medicine permeation caused by non-uniform energy field of the traditional ultrasonic transducer is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field related to ultrasonic therapy, and in particular to an ultrasonic conductance therapy device. Background Art

[0002] Ultrasonic conductivity therapy device is a therapeutic device that uses ultrasound as its main power to achieve needle-free injection of drugs into target sites. It uses the focused radiation pressure of ultrasound to generate impact force, which converts mechanical energy into strong kinetic energy, and launches drugs through the skin into the body to achieve the effect of needle-free injection. This treatment method replaces traditional chemotherapy and physical therapy, and is effective in treating chronic diseases such as rheumatism, especially in terms of treatment depth and intensity, which can be adjusted at will.

[0003] The existing therapeutic apparatus has the following problems when in use:

[0004] 1. The energy field distribution of traditional ultrasonic transducers is not uniform, which is affected by differences in tissue density or uneven application of coupling agent, resulting in local overload or ineffective coverage in the drug penetration area;

[0005] 2. Continuous ultrasonic output can easily accumulate heat in local tissues, causing epidermal burns or deep tissue damage, which is not conducive to use. Summary of the Invention

[0006] In order to solve the defects of the prior art, the present invention provides an ultrasonic conductivity therapeutic device.

[0007] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0008] The present invention provides an ultrasonic conductivity therapeutic device, comprising:

[0009] The therapeutic device host and the therapeutic head, one end of the therapeutic head is connected to the probe interface of the therapeutic device host through a wire, and the other end rests on the therapeutic bracket;

[0010] The treatment head includes a protective shell connected to the wire and an ultrasonic transducer, a piezoelectric film layer and a microneedle patch layer arranged in sequence from the inside to the outside. A sensor module is also arranged inside the treatment head;

[0011] The ultrasonic transducer comprises an annular inner layer and an outer layer, and the annular inner layer and the outer layer are both composed of a plurality of groups of piezoelectric wafers;

[0012] The piezoelectric film layer includes a piezoelectric ceramic composite layer bonded to the ultrasonic transducer, a flexible base layer disposed on the outermost side, and an intermediate layer disposed between the flexible base layer and the piezoelectric ceramic composite layer;

[0013] The microneedle patch layer includes a microneedle base layer, a main channel provided on the microneedle base layer, and a plurality of groups of hollow microneedles connected to the main channel, wherein the plurality of groups of hollow microneedles are distributed in a gradient height;

[0014] The sensor module includes a temperature sensor, a pressure sensor and an impedance biosensor, and the ultrasonic transducer switches the operating frequency according to the tissue state fed back by the sensor module.

[0015] As a preferred technical solution of the present invention, the intermediate layer is an etched aluminum electrode grid.

[0016] As a preferred technical solution of the present invention, the ultrasonic transducer and the piezoelectric film layer are electrically connected via a flexible electrode;

[0017] The microneedle base layer is bonded to the flexible base layer via an adhesive layer.

[0018] As a preferred technical solution of the present invention, the needle tip of the hollow microneedle is provided with a plurality of groups of barbs;

[0019] The hollow microneedle includes an outer ring portion, a middle portion, and an inner ring portion, and the length of the hollow microneedle is 50 to 1000 μm.

[0020] As a preferred technical solution of the present invention, the length of the outer ring portion is greater than that of the middle portion, and the length of the middle portion is greater than that of the inner ring portion.

[0021] As a preferred technical solution of the present invention, the length of the outer ring portion is greater than that of the inner ring portion, and the length of the inner ring portion is greater than that of the middle portion.

[0022] As a preferred technical solution of the present invention, the operating frequency is switched to a low frequency band or a high frequency band according to the current temperature T monitored by the temperature sensor;

[0023] When the operating frequency is in the low frequency band, the ultrasonic field emitted by the ultrasonic transducer is used to penetrate the fat layer;

[0024] When the operating frequency is in the high frequency band, the ultrasonic field emitted by the ultrasonic transducer is used to penetrate the muscle layer.

[0025] As a preferred technical solution of the present invention, the ultrasonic transducer adjusts the duty cycle according to the change of the current temperature T (cooperatively reducing heat accumulation), and the duty cycle adjustment formula is as follows:

[0026]

[0027] Among them, D adj (T) is the duty cycle after adjustment according to temperature, D0 is the initial duty cycle, α is the sensitivity of temperature to duty cycle adjustment, Tmax The maximum safe temperature threshold is set.

[0028] As a preferred technical solution of the present invention, the piezoelectric film layer generates acoustic flow when in operation and guides the drug to migrate along the hollow microneedles. The optimization formula of the acoustic flow is:

[0029]

[0030] Among them, η flow is the optimization coefficient of acoustic flow on drug migration; P low is the sound wave power in the low frequency band; P high is the sound wave power in the high frequency band;

[0031] The optimization formula for drug migration rate is:

[0032] R drug =R0·(1+γ·P)·e δ·Z ·η flow ;

[0033] Among them, R drug is the optimized drug release rate, R0 is the initial drug release rate, γ is the coefficient of the influence of pressure data on the drug release rate, P is the pressure data collected by the pressure sensor, δ is the coefficient of the influence of impedance data on the drug release rate, and Z is the impedance data collected by the impedance sensor.

[0034] As a preferred technical solution of the present invention, the front of the therapeutic instrument host is embedded with an LCD display and an operation button module. The LCD display is used to display the monitoring data of the temperature sensor, pressure sensor and impedance biosensor in real time, and supports the selection of ultrasonic frequency or medium and low frequency pulse current mode through touch control.

[0035] The beneficial effects of the present invention are:

[0036] 1. The therapeutic device of the present invention can dynamically adjust the operating frequency and sound field intensity of ultrasound by combining real-time feedback from temperature, pressure and impedance sensors, so that the ultrasonic energy can be more evenly distributed in different tissue layers (such as subcutaneous fat and muscle layers), avoiding the insufficient or excessive drug penetration caused by the uneven energy field of traditional ultrasonic transducers. In addition, the microneedle base layer and hollow microneedle design enable the drug to be guided to the treatment area by ultrasound, optimizing the efficiency and accuracy of drug release.

[0037] 2. The present invention combines temperature sensors, pressure sensors and impedance biosensors to monitor tissue status in real time and adjust the operating frequency of ultrasound based on feedback, thereby reducing the risk of heat accumulation. In particular, when the temperature is too high, the duty cycle can be effectively adjusted to reduce heat accumulation and avoid tissue damage caused by excessive heat. At the same time, the automatic adjustment of the ultrasound frequency enables ultrasound to efficiently penetrate and provide appropriate energy in different tissue layers (such as fat layers and muscle layers), effectively avoiding the risk of tissue overheating. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention and do not constitute a limitation of the present invention.

[0039] In the attached figure:

[0040] Figure 1 It is a schematic diagram of the overall structure of the present invention.

[0041] Figure 2 A schematic cross-sectional view of the treatment head.

[0042] Figure 3 Schematic diagram of the planar structure of the ultrasonic transducer.

[0043] Figure 4 Schematic cross-sectional view of the piezoelectric film layer and the microneedle patch layer.

[0044] Figure 5 for Figure 4 A local enlarged schematic diagram of point A in the middle.

[0045] Figure 6 for Figure 4 A partial enlarged schematic diagram of point B in the middle.

[0046] Figure 7 Schematic diagram of the arrangement of hollow microneedles.

[0047] In the figure: 1. Therapeutic device main unit; 11. LCD display; 12. Operation button module; 2. Treatment head; 21. Protective shell; 3. Treatment bracket; 4. Ultrasonic transducer; 41. Annular inner layer; 42. Outer layer; 43. Piezoelectric chip; 5. Piezoelectric film layer; 51. Piezoelectric ceramic composite layer; 52. Flexible base layer; 53. Middle layer; 6. Microneedle patch layer; 61. Microneedle base layer; 62. Main channel; 63. Hollow microneedle; 631. Outer ring; 632. Middle part; 633. Inner ring; 64. Barb part; 7. Sensor module; 71. Temperature sensor; 72. Pressure sensor; 73. Impedance biosensor; 8. Adhesive layer. DETAILED DESCRIPTION

[0048] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0049] like Figure 1-Figure 4 As shown, an ultrasonic conductance therapy device includes a therapy device main unit 1 and a therapy head 2. One end of the therapy head 2 is connected to the probe interface of the therapy device main unit 1 via a wire, and the other end rests on a therapy support 3. The therapy head 2 includes a protective shell 21 connected to the wire, and an ultrasonic transducer 4, a piezoelectric film layer 5, and a microneedle patch layer 6 arranged from the inside to the outside. A sensor module 7 is also provided inside the therapy head 2. Optionally, the therapy head 2 and the protective shell 21 are detachably connected via a magnetic buckle.

[0050] The ultrasonic transducer 4 includes an annular inner layer 41 and an outer layer 42. Both the annular inner layer 41 and the outer layer 42 are composed of a plurality of groups of piezoelectric wafers 43. The spacing between each piezoelectric wafer 43 is not less than 0.5 mm. The multiple groups of piezoelectric wafers 43 in the annular inner layer 41 form an annular structure. This design can effectively improve the output and efficiency of ultrasonic energy, effectively enhance the output of energy, and make the distribution of sound waves in the treatment area more uniform, thereby improving the treatment effect. The multiple groups of piezoelectric wafers 43 in the outer layer 42 allow the transducer to cover a larger contact area, so that ultrasonic waves can be transmitted over a wider area, thereby improving the treatment effect.

[0051] The piezoelectric film layer 5 includes a piezoelectric ceramic composite layer 51 that is bonded to the ultrasonic transducer 4, a flexible base layer 52 that is arranged on the outermost side, and an intermediate layer 53 that is arranged between the flexible base layer 52 and the piezoelectric ceramic composite layer 51. The piezoelectric ceramic composite layer 51 is a PZT-5H and lead magnesium niobate staggered array structure. The piezoelectric ceramic composite layer 51 can effectively improve the conversion efficiency and output intensity of ultrasonic waves. Through the above design, the output stability and accuracy of ultrasonic waves are improved, and the treatment depth and intensity can be more accurately controlled. The flexible base layer 52 is made of PVDF material and can adapt to different skin surface shapes to ensure close contact with the ultrasonic treatment head 2. The intermediate layer 53 is an etched aluminum electrode grid to ensure uniform distribution of electrodes, avoid unstable or uneven energy output caused by uneven electrodes, and improve the working efficiency and stability of the transducer;

[0052] The microneedle patch layer 6 includes a microneedle base layer 61, a main channel 62 provided on the microneedle base layer 61, and a plurality of groups of hollow microneedles 63 connected to the main channel 62. The plurality of groups of hollow microneedles 63 are distributed in a gradient height. The main channel 62 on the microneedle base layer 61 and the hollow microneedles 63 connected thereto are designed to ensure that the drug can be guided to the treatment area through the microneedles, thereby optimizing the drug transmission channel. This not only improves the drug penetration efficiency, but also makes the drug release more uniform, avoiding uneven or excessive drug penetration.

[0053] The sensor module 7 includes a temperature sensor 71, a pressure sensor 72 and an impedance biosensor 73. The impedance biosensor 73 can help determine the depth of drug penetration and the state of the tissue by monitoring the tissue resistance, thereby optimizing the ultrasonic working parameters. The ultrasonic transducer 4 switches the working frequency according to the tissue state feedback from the sensor module 7. Optionally, the temperature sensor 71 is a thin film sensor attached between the flexible base layer 52 and the microneedle base layer 61, and the pressure sensor 72 is a MEMS piezoresistive sensor (range 0-20N / cm 2 ) can be deployed on the outside of the treatment head (on the supporting structure that contacts the patient's skin), the middle layer 53 serves as the electrode of the impedance biosensor 73, and the impedance change between the piezoelectric film layer and the skin is measured through the electrode grid. The data processing module and other structures in the impedance biosensor 73 can be set on the outside of the treatment head.

[0054] Among them, by combining real-time feedback from temperature, pressure, and impedance sensors, the operating frequency and sound field intensity of the ultrasound can be dynamically adjusted, so that the ultrasound energy can be more evenly distributed in different tissue layers (such as subcutaneous fat and muscle layers), avoiding the situation of insufficient or excessive drug penetration caused by the uneven energy field of the traditional ultrasonic transducer 4. In addition, the design of the microneedle base layer 61 and the hollow microneedles 63 enables the drug to be guided to the treatment area by ultrasound, optimizing the efficiency and accuracy of drug release;

[0055] By combining the temperature sensor 71, the pressure sensor 72 and the impedance biosensor 73, the tissue status can be monitored in real time and the operating frequency of the ultrasound can be adjusted according to the feedback, thereby reducing the risk of heat accumulation. Especially when the temperature is too high, the duty cycle can be effectively adjusted to reduce heat accumulation and avoid tissue damage caused by excessive heat. At the same time, the automatic adjustment of the ultrasound frequency enables the ultrasound to efficiently penetrate and provide appropriate energy in different tissue layers (such as fat layers and muscle layers), effectively avoiding the risk of tissue overheating.

[0056] It should be noted that the ultrasonic transducer 4 and the piezoelectric film layer 5 are encapsulated together inside the protective shell 21;

[0057] The therapeutic device host 1 is provided with a control module, the ultrasonic transducer 4 is electrically connected to the control module, and the control module is also electrically connected to the sensor module 7. The control module is not shown in the figure;

[0058] The microneedle patch layer 6 is made of medical-grade polylactic acid (PLA) or silicone material, and is detachably connected to the flexible base layer 52 through a snap-fit structure, supporting high-temperature and high-pressure sterilization and repeated use.

[0059] The probe interface of the therapeutic device host 1 adopts a multi-channel multiplexing design, supporting the simultaneous connection of at least two sets of treatment heads 2. Each set of treatment heads 2 can independently configure the ultrasonic frequency and drug loading scheme of the microneedle patch layer 6. The control module presets three clinical treatment schemes: wound repair, analgesia and anti-inflammatory, and skin regeneration. The optimal parameter combination is matched based on the skin electrical characteristics feedback from the impedance biosensor 73.

[0060] Further, if Figure 4-Figure 5 As shown, the ultrasonic transducer 4 and the piezoelectric film layer 5 are electrically connected via flexible electrodes. The core purpose of this design is to ensure that the ultrasonic transducer 4 can efficiently transmit electrical energy to the piezoelectric film layer 5, thereby exciting the piezoelectric ceramic composite material in the piezoelectric film layer 5 to generate the necessary ultrasonic energy;

[0061] The microneedle base layer 61 is bonded to the flexible base layer 52 through an adhesive layer 8 (preferably a polydopamine coating). The microneedle base layer 61 and the flexible base layer 52 need to ensure seamless bonding. The application of the polydopamine coating can not only ensure firm bonding between the microneedle base layer 61 and the flexible base layer 52, but also avoid displacement or instability of the microneedles, ensuring precise operation during the treatment process. The microneedle patch layer 6 can accurately deliver therapeutic drugs to the required area and synergize with ultrasonic treatment to ensure the depth of treatment and the uniformity of drug release.

[0062] Further, if Figure 4-Figure 6 As shown, the needle tip of the hollow microneedle 63 is provided with a plurality of groups of barbs 64. The design of these barbs 64 can effectively enhance the stability and anchoring ability of the microneedle during the puncture process. The barbs 64 can be made of biodegradable materials, which enables the microneedle to gradually degrade after the treatment is completed and will not have long-term effects on the human body. Preferably, the barbs 64 include polylactic acid, polycaprolactone, etc., which have good biocompatibility and biodegradability, ensuring the safety of the hollow microneedle 63 after use and its adaptability to human tissue;

[0063] The barb 64 at the needle tip can not only effectively puncture the skin layer, but also form an anchoring effect after puncture, reducing the impact of the microneedle on the drug delivery effect due to movement during the treatment process. During use, the piezoelectric film enhances the puncture effect of the barb 64 by vibrating. When the piezoelectric film generates ultrasonic waves or other forms of vibration, the barb 64 can help the microneedle to remain stably in the puncture position, preventing the microneedle from shifting due to external factors (such as skin movement or device vibration);

[0064] The barbs 64 are anchored to the subcutaneous tissue after penetrating the skin. The angle of the barbs 64 is usually designed to be relatively small (e.g., 15°-30°). The anchoring force ensures that the barbs do not cause excessive cutting force, but rather "separate" the stratum corneum to cause cracking or breaking, thereby reducing cutting damage to the epidermis.

[0065] The multiple groups of hollow microneedles 63 are distributed in a gradient height. Specifically, the hollow microneedles 63 include an outer ring portion 631, a middle portion 632 and an inner ring portion 633. The length of the hollow microneedles 63 is 50 to 1000 μm. The shorter microneedle length is suitable for the treatment of the skin surface and shallow tissue, while the longer microneedle length can penetrate into the middle layer or deeper tissue of the skin, which is suitable for occasions requiring deeper drug delivery.

[0066] It should be noted that the interior of each hollow microneedle 63 is filled with a pH-responsive hydrogel (such as polyacrylic acid-co-chitosan). The hydrogel dissolves upon contact with the skin to form a micro drug channel, thereby reducing the epidermal barrier resistance.

[0067] Further, if Figure 7 As shown, generally speaking, the length of the outer ring portion 631 is greater than that of the middle portion 632 , and the length of the middle portion 632 is greater than that of the inner ring portion 633 .

[0068] For example, the length of the outer ring portion 631 is 800 μm, the length of the middle portion 632 is 400 μm, and the length of the inner ring portion 633 is 100 μm. The microneedles in the outer ring portion 631 are longer and can cover a larger skin area, thereby being able to quickly and evenly deliver drugs to a larger area. Through the longer outer ring microneedles, the drugs can reach the skin surface more quickly and begin to take effect immediately, and have a good fixing effect on the microneedle patch layer 6. As the microneedles in the outer ring portion 631 continue to penetrate deeper, the microneedles in the middle portion 632 will penetrate deeper into the middle layer of the skin and can penetrate the boundary between the epidermis and dermis of the skin, which is suitable for some treatments that require deeper drug delivery. Finally, the inner ring portion 633 can penetrate deeper into the epidermis of the skin to treat skin surface lesions.

[0069] In addition, since the microneedles in the outer ring portion 631 have played a certain guiding role, the microneedles in the middle portion 632 and the inner ring portion 633 can penetrate more smoothly, which can reduce damage during penetration.

[0070] As another optional embodiment, the length of the outer ring portion 631 is greater than that of the inner ring portion 633 , and the length of the inner ring portion 633 is greater than that of the middle portion 632 .

[0071] For example, the length of the outer ring 631 is 800 μm, the length of the middle part 632 is 100 μm, and the length of the inner ring 633 is 400 μm. Unlike the traditional design, in this design, the microneedles of the inner ring 633 are longer than the middle part 632. The inner ring 633 provides drug delivery between the epidermis and dermis of the skin. Since the microneedles in the middle part 632 are shorter, they mainly play the role of transition for skin puncture, helping the microneedles of the outer ring 631 and the inner ring 633 to transition smoothly, avoiding the discomfort caused by the sudden change of microneedles of different lengths during the puncture process. Although the short microneedles in the middle part 632 have a shallow penetration depth, they can help the drug be more evenly distributed between the skin layers. Through proper transition, the penetration of the drug can avoid concentrated release, thereby ensuring the stability of the therapeutic effect.

[0072] Through the gradient design of the microneedle lengths of the outer ring part 631, the middle part 632 and the inner ring part 633, the hollow microneedle 63 can achieve drug delivery at different depths while avoiding excessive concentration of drugs in a certain layer, ensuring uniform distribution of drugs in all layers of the skin.

[0073] Furthermore, the operating frequency is switched to a low frequency band or a high frequency band according to the current temperature T monitored by the temperature sensor 71. Preferably, the low frequency band is 1 MHz and the high frequency band is 3 MHz.

[0074] When the operating frequency is in the low frequency band, the ultrasonic field emitted by the ultrasonic transducer 4 is used to penetrate the fat layer. The low-frequency ultrasonic wave has a longer wavelength and a lower vibration frequency, which enables it to effectively penetrate the thicker layers of the skin, especially the fat layer.

[0075] When operating in the low-frequency band, the outer layer 42 and the annular inner layer 41 of the ultrasonic transducer 4 work simultaneously. This design can simultaneously exert two different levels of ultrasonic effects. The outer layer 42 is responsible for a wide range of energy distribution, while the annular inner layer 41 enhances penetration through more concentrated ultrasonic effects and ensures that energy penetrates evenly into the deep fat layer. The effect of the annular inner layer 41 can help more accurately control the treatment area, avoid excessive energy concentration, and ensure uniform treatment.

[0076] When the operating frequency is in the high frequency band, the ultrasonic field emitted by the ultrasonic transducer 4 is used to penetrate the muscle layer. Ultrasonic waves in the high frequency band have a shorter wavelength and a higher vibration frequency, which makes it more suitable for shallow layer treatment, especially the muscle layer.

[0077] In the high frequency band, the ultrasonic transducer 4 of the annular inner layer 41 continues to work and is mainly responsible for the treatment within the muscle layer. The annular inner layer 41 usually ensures that the energy can penetrate deeply into the target area through precise energy concentration while avoiding unnecessary damage. Through this design, the ultrasonic wave can be concentrated on the depth of the muscle layer during the treatment process to ensure the maximum effect.

[0078] It should be noted that the therapeutic device supports synchronous or alternating output of medium- and low-frequency pulse current (frequency 1-100Hz, intensity 5-30mA) and ultrasound, with an alternating cycle of 5-10 seconds to alleviate tissue adaptability;

[0079] The therapeutic device is suitable for the targeted treatment of acute and chronic pain (such as cervical spondylosis, lumbar disc herniation, and frozen shoulder), and is equipped with a contraindication screening function to detect skin integrity through an impedance sensor.

[0080] Furthermore, the ultrasonic transducer 4 adjusts the duty cycle according to the change of the current temperature T (cooperatively reducing heat accumulation), and the duty cycle adjustment formula is as follows:

[0081]

[0082] Among them, D adj (T) is the duty cycle adjusted according to temperature. This value will be adjusted in real time as the temperature changes. D0 is the initial duty cycle setting. α is the sensitivity of temperature to duty cycle adjustment, which indicates the degree of influence of temperature change on duty cycle adjustment. The larger the value of α, the greater the influence of temperature change on duty cycle adjustment. T max The maximum safe temperature threshold is set. Exceeding this temperature may cause thermal damage to the tissue. Therefore, when the temperature approaches or exceeds this threshold, the system will reduce the output energy of the ultrasound by adjusting the duty cycle to avoid overheating. Optionally, T max Set to 42°C.

[0083] During operation, it adopts a design that adjusts the duty cycle based on temperature changes. The duty cycle adjustment aims to reduce heat accumulation synergistically, so that the energy output of ultrasound can always remain within a safe range, avoid damage to tissues caused by overheating, and improve the safety and effectiveness of treatment.

[0084] The current temperature T is close to or exceeds the set maximum safety temperature threshold (T max ), the duty cycle will be automatically adjusted to a lower value to reduce the ultrasonic output time to avoid overheating.

[0085] For example, when T is close to T max When D adj (T) will tend to zero, indicating that the energy output of the ultrasound is reduced. When the current temperature (T) is low, the duty cycle remains close to the initially set value D0 and will not be significantly adjusted. At this time, the output energy of the ultrasound is maintained at a relatively stable level, and the treatment effect will not be affected by excessive reduction in output energy.

[0086] It should be noted that when the temperature sensor 71 monitors the value T≥T max When the device fails to output, it will automatically interrupt the output and trigger an alarm, while recording the fault code to the host storage module.

[0087] Furthermore, the piezoelectric film layer 5 generates acoustic streaming when in operation and guides the migration of drugs along the hollow microneedles 63. Specifically, the piezoelectric film excites multimodal standing waves under a 40kHz alternating electric field, and controls the distribution of acoustic pressure nodes through electrode coding to generate parallel acoustic streaming along the microneedle channel. The acoustic streaming effect and ultrasonic cavitation work synergistically to form a concentration gradient diffusion of drug molecules along the microneedle-acoustic streaming path, thereby achieving directional drug delivery. The optimization formula for the acoustic streaming is:

[0088]

[0089] Among them, η flow is the optimization coefficient of acoustic flow on drug migration; P low is the sound wave power in the low frequency band; P high is the sound wave power in the high frequency band;

[0090] Ultrasonic therapy devices optimize the migration of drugs through the microneedle channel by adjusting the power ratio of these two frequency bands. Low-frequency sound waves are usually used to drive the drug to migrate outward along the channel, while high-frequency sound waves help to enhance this migration effect.

[0091] This coefficient reflects the relative contribution of low-frequency and high-frequency sound waves to drug migration. By adjusting the power of the two frequency bands, the therapeutic device can effectively regulate the migration rate of the drug.

[0092] The optimization formula for drug migration rate is:

[0093] R drug =R0·(1+γ·P)·e δ·Z ·η flow ;

[0094] Among them, R drugis the optimized drug release rate, R0 is the initial drug release rate, γ is the coefficient of the influence of pressure data on the drug release rate, P is the pressure data collected by the pressure sensor, δ is the coefficient of the influence of impedance data on the drug release rate, and Z is the impedance data collected by the impedance sensor.

[0095] When pressure increases during treatment, the drug migration rate typically increases. This is because pressure helps propel the drug outward through the microneedle channel. Therefore, the γ coefficient determines the extent to which pressure affects the drug migration rate. Increased electrical impedance typically affects the tissue's ability to transmit sound waves, which in turn affects the drug release rate. Impedance data is collected in real time by an impedance sensor, and the δ coefficient determines the strength of the impedance's impact on the drug migration rate.

[0096] By optimizing the design of acoustic flow and drug migration rate, the drug release efficiency is improved, and precise control is achieved through multiple physical quantities (such as acoustic wave power, pressure and impedance) to ensure the effectiveness and accuracy of the drug during treatment.

[0097] Specifically, by combining the effects of pressure, impedance, and acoustic flow, the ultrasonic conductivity therapy device can precisely regulate the migration rate of drugs. This optimization mechanism ensures that the drug is released at the optimal rate during treatment, thereby improving treatment efficiency and reducing side effects.

[0098] In addition, by adjusting the power ratio of low-frequency and high-frequency sound waves in real time, the therapeutic device can flexibly optimize the drug release path according to actual treatment needs. This optimization mechanism can be adaptively adjusted according to specific circumstances (such as tissue characteristics, treatment needs, etc.), thereby maximizing the treatment effect.

[0099] By combining the combined effects of pressure, impedance and acoustic flow, the therapeutic device realizes a multi-factor coordinated control mechanism. This design not only improves the efficiency of drug release, but also can dynamically adjust the drug release rate during the treatment process to ensure that the drug can accurately reach the target treatment area.

[0100] Further, if Figure 1 As shown, the front of the therapeutic instrument host 1 is embedded with a liquid crystal display 11 and an operation button module 12. The liquid crystal display 11 is used to display the monitoring data of the temperature sensor 71, the pressure sensor 72 and the impedance biosensor 73 in real time, and supports the selection of ultrasonic frequency or medium and low frequency pulse current mode through touch control, providing users with real-time monitoring data, treatment mode selection and precise control functions, making the treatment process more convenient, intuitive and flexible. At the same time, the alarm and prompt functions of the equipment can ensure the safety of the treatment, improve the intelligence level of the equipment and user experience.

[0101] It should be noted that the therapeutic device host 1 has a built-in wireless communication module (Wi-Fi / Bluetooth), which supports exporting treatment data as PDF reports or uploading them to a medical management platform.

[0102] Working process:

[0103] In the pretreatment stage, after the microneedle patch layer 6 contacts the skin, the pH-responsive hydrogel quickly dissolves, and the hollow microneedles 63 with barbed structures penetrate the epidermis, forming a low-resistance drug channel;

[0104] In the low-frequency penetration stage, all the piezoelectric chips 43 in the outer layer 42 and the annular inner layer 41 work at a low frequency of 1 MHz simultaneously, generating wide-field ultrasonic waves (wavelength of about 1.5 mm). The ultrasonic field is coupled to the flexible base layer 52 through the piezoelectric film layer 5, and the acoustic flow intensity is calculated as η. flow Regulate and promote the migration of drugs along the microneedle channel;

[0105] During the high-frequency focusing stage, the transducer switches to a high frequency of 3 MHz, and only the piezoelectric chip 43 of the annular inner layer 41 is activated, generating a focused acoustic spot and promoting the penetration of drug molecules into the muscle layer through the outer ring portion 631 of the microneedle (the longest microneedle channel);

[0106] Dynamic closed-loop adjustment stage, for example, when the temperature T is greater than 40°C, the pulse intermittent mode is started, and the duty cycle is reduced by 20%. When the temperature T is greater than 42°C, the therapeutic device host 1 automatically interrupts the output and triggers an alarm prompt;

[0107] Safely exit the mechanism by turning off the therapeutic device host 1 and removing the therapeutic head 2 from the patient's skin.

[0108] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art will be able to modify the technical solutions described in the aforementioned embodiments or substitute equivalents for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. An ultrasonic conductivity therapeutic device, characterized in that: include: A therapeutic apparatus main unit (1) and a therapeutic head (2), wherein one end of the therapeutic head (2) is connected to a probe interface of the therapeutic apparatus main unit (1) via a wire, and the other end rests on a therapeutic support (3); The treatment head (2) comprises a protective shell (21) connected to a wire, and an ultrasonic transducer (4), a piezoelectric film layer (5), and a microneedle patch layer (6) arranged in sequence from the inside to the outside. A sensor module (7) is also provided inside the treatment head (2); The ultrasonic transducer (4) comprises an annular inner layer (41) and an outer layer (42), wherein the annular inner layer (41) and the outer layer (42) are both composed of a plurality of groups of piezoelectric wafers (43); The piezoelectric film layer (5) comprises a piezoelectric ceramic composite layer (51) bonded to the ultrasonic transducer (4), a flexible base layer (52) disposed on the outermost side, and an intermediate layer (53) disposed between the flexible base layer (52) and the piezoelectric ceramic composite layer (51); The microneedle patch layer (6) comprises a microneedle base layer (61), a main pore channel (62) arranged on the microneedle base layer (61), and a plurality of groups of hollow microneedles (63) connected to the main pore channel (62), wherein the plurality of groups of hollow microneedles (63) are distributed in a gradient height. The sensor module (7) includes a temperature sensor (71), a pressure sensor (72), and an impedance biosensor (73); the ultrasonic transducer (4) switches the operating frequency according to the tissue state fed back by the sensor module (7).

2. The ultrasonic conductance therapy device according to claim 1, characterized in that: The intermediate layer (53) is an etched aluminum electrode grid.

3. The ultrasonic conductance therapy device according to claim 1, characterized in that: The ultrasonic transducer (4) and the piezoelectric film layer (5) are electrically connected via a flexible electrode; The microneedle base layer (61) is bonded to the flexible base layer (52) via an adhesive layer (8).

4. The ultrasonic conductivity therapeutic device according to claim 1, characterized in that: The needle tip of the hollow microneedle (63) is provided with a plurality of groups of barbs (64); The hollow microneedle (63) includes an outer ring portion (631), a middle portion (632) and an inner ring portion (633), and the length of the hollow microneedle (63) is 50 to 1000 μm.

5. The ultrasonic conductivity therapeutic device according to claim 4, characterized in that: The length of the outer ring portion (631) is greater than that of the middle portion (632), and the length of the middle portion (632) is greater than that of the inner ring portion (633).

6. The ultrasonic conductivity therapeutic device according to claim 4, characterized in that: The length of the outer ring portion (631) is greater than that of the inner ring portion (633), and the length of the inner ring portion (633) is greater than that of the middle portion (632).

7. The ultrasonic conductance therapy device according to claim 1, characterized in that: The operating frequency is switched to a low frequency band or a high frequency band according to the current temperature T monitored by the temperature sensor (71); When the operating frequency is in the low frequency band, the ultrasonic field emitted by the ultrasonic transducer (4) is used to penetrate the fat layer; When the operating frequency is in the high frequency band, the ultrasonic field emitted by the ultrasonic transducer (4) is used to penetrate the muscle layer.

8. The ultrasonic conductance therapy device according to claim 7, characterized in that: The ultrasonic transducer (4) adjusts the duty cycle according to the change of the current temperature T (cooperating to reduce heat accumulation), and the duty cycle adjustment formula is as follows: Among them, D adj (T) is the duty cycle after adjustment according to temperature, D0 is the initial duty cycle, α is the sensitivity of temperature to duty cycle adjustment, T max The maximum safe temperature threshold is set.

9. The ultrasonic conductance therapy device according to claim 7, characterized in that: The piezoelectric film layer (5) generates acoustic flow when in operation and guides the drug to migrate along the hollow microneedle (63). The optimization formula of the acoustic flow is: Among them, η flow is the optimization coefficient of acoustic flow on drug migration; P low is the sound wave power in the low frequency band; P high is the sound wave power in the high frequency band; The optimization formula for drug migration rate is: R drug =R0·(1+γ·P)·e δ·Z ·or flow ; Among them, R drug is the optimized drug release rate, R0 is the initial drug release rate, γ is the coefficient of the influence of pressure data on the drug release rate, P is the pressure data collected by the pressure sensor, δ is the coefficient of the influence of impedance data on the drug release rate, and Z is the impedance data collected by the impedance sensor.

10. The ultrasonic conductance therapy device according to claim 1, characterized in that: The front of the therapeutic device host (1) is embedded with a liquid crystal display (11) and an operation button module (12). The liquid crystal display (11) is used to display the monitoring data of the temperature sensor (71), the pressure sensor (72) and the impedance biosensor (73) in real time, and supports the selection of ultrasonic frequency or medium and low frequency pulse current mode through touch control.

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