Ultrasonic conductive therapeutic apparatus

Abstract

The application discloses an ultrasonic conductive therapeutic instrument, and relates to the technical field of ultrasonic treatment, which comprises a therapeutic instrument host and a treatment head; the treatment head comprises a protective shell connected with a lead wire and an ultrasonic transducer, a piezoelectric film layer and a microneedle patch layer arranged in sequence from inside to outside; the inside of the treatment head is further provided with a sensor module; the ultrasonic transducer is composed of a plurality of groups of piezoelectric chips; the piezoelectric film layer comprises a piezoelectric ceramic composite layer, a flexible substrate layer and an intermediate layer; the microneedle patch layer comprises a microneedle substrate layer, a main stem channel arranged on the microneedle substrate layer and hollow microneedles connected with the main stem channel; a plurality of groups of hollow microneedles are distributed in a gradient height; the sensor module comprises a temperature sensor, a pressure sensor and an impedance biosensor; the ultrasonic transducer switches the working frequency according to the tissue state fed back by the sensor module; and the application avoids the insufficient or excessive drug penetration caused by the uneven energy field of the traditional ultrasonic transducer.

Description

Technical Field

[0001] This invention relates to the field of ultrasound therapy, specifically to an ultrasound electrotherapy device. Background Technology

[0002] Ultrasonic electroconduction therapy is a therapeutic device that uses ultrasound as the main power source to achieve needle-free drug delivery to the target site. It utilizes the focused radiation pressure of ultrasound to generate impact force, which converts mechanical energy into powerful kinetic energy, and emits drugs through the skin to enter the body, achieving the effect of needle-free injection. This treatment method replaces traditional chemotherapy and physical therapy, and is significantly effective in treating chronic diseases such as rheumatism. In particular, the treatment depth and intensity can be adjusted at will.

[0003] The existing therapeutic devices have the following problems when in use:

[0004] 1. The energy field distribution of traditional ultrasonic transducers is not uniform enough. Due to differences in tissue density or uneven application of coupling agent, local overload or ineffective coverage of the drug penetration area may occur.

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

[0006] To address the shortcomings of existing technologies, this invention provides an ultrasonic electrotherapy device.

[0007] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0008] This invention provides an ultrasonic electrotherapy device, comprising:

[0009] The treatment device includes a main unit and a treatment head, with one end of the treatment head connected to the probe interface of the main unit via a wire, and the other end resting on the treatment support.

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

[0011] The ultrasonic transducer includes an inner annular layer and an outer annular layer, both of which are composed of several sets of piezoelectric crystals.

[0012] The piezoelectric thin film layer includes a piezoelectric ceramic composite layer that is bonded to the ultrasonic transducer, a flexible substrate layer disposed on the outermost side, and an intermediate layer disposed between the flexible substrate layer and the piezoelectric ceramic composite layer.

[0013] The microneedle patch layer includes a microneedle base layer, a main channel disposed on the microneedle base layer, and several sets of hollow microneedles connected to the main channel, wherein the multiple sets of hollow microneedles are distributed in a gradient height.

[0014] The sensor module includes a temperature sensor, a pressure sensor, and an impedance biosensor. The ultrasonic transducer switches its operating frequency based on the tissue state feedback from the sensor module.

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

[0016] In a preferred embodiment of the present invention, the ultrasonic transducer and the piezoelectric thin film layer are electrically connected via flexible electrodes;

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

[0018] As a preferred embodiment of the present invention, the tip of the hollow microneedle is provided with several sets of barbs;

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

[0020] In a preferred embodiment 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] In a preferred embodiment 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 embodiment 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 range, 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 range, the ultrasonic field emitted by the ultrasonic transducer is used to penetrate the muscle layer.

[0025] As a preferred embodiment of the present invention, the ultrasonic transducer adjusts its duty cycle according to the change in the current temperature T (to synergistically reduce heat accumulation), and the adjustment formula for the duty cycle is as follows:

[0026]

[0027] Among them, D adj (T) represents the duty cycle adjusted according to temperature, D0 represents the initially set duty cycle, and α represents the sensitivity of temperature to duty cycle adjustment.max This is the maximum safe temperature threshold that is set.

[0028] In a preferred embodiment of the present invention, the piezoelectric thin film layer generates acoustic flow during operation and guides the drug to migrate along the hollow microneedles. The optimized formula for the acoustic flow is as follows:

[0029]

[0030] Where, η flow P represents the optimization coefficient for acoustic flow on drug migration. low P represents the power of sound waves in the low-frequency range. high This refers to the power of sound waves in the high-frequency band.

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

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

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

[0034] As a preferred embodiment of the present invention, the front of the main unit of the therapeutic device is embedded with an LCD screen and an operation button module. The LCD screen 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 this invention are:

[0036] 1. The therapeutic device of the present invention, by combining temperature, pressure and impedance sensors for real-time feedback, can dynamically adjust the working frequency and sound field intensity of ultrasound, so that ultrasound 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 uneven energy field in traditional ultrasound transducers. Furthermore, the microneedle base layer and hollow microneedle design allow the drug to be guided to the treatment area by ultrasound, optimizing the efficiency and precision of drug release.

[0037] 2. By combining a temperature sensor, a pressure sensor, and an impedance biosensor, this invention can monitor tissue status in real time and adjust the working frequency of ultrasound based on feedback, thereby reducing the risk of heat accumulation. Especially when the temperature is too high, it can effectively adjust the duty cycle to reduce heat accumulation and avoid tissue damage caused by excessive heat. At the same time, the automatic adjustment of the ultrasound frequency allows ultrasound to penetrate efficiently and provide appropriate energy in different tissue layers (such as fat and muscle layers), effectively avoiding the risk of tissue overheating. Attached Figure Description

[0038] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof.

[0039] In the attached diagram:

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

[0041] Figure 2 This is a cross-sectional view of the treatment head.

[0042] Figure 3 This is a schematic diagram of the planar structure of an ultrasonic transducer.

[0043] Figure 4 This is a cross-sectional schematic diagram of the piezoelectric thin film layer and the microneedle patch layer.

[0044] Figure 5 for Figure 4 A magnified view of a portion of point A in the middle.

[0045] Figure 6 for Figure 4 A magnified view of a portion of point B in the middle.

[0046] Figure 7 This is a schematic diagram of the arrangement of hollow microneedles.

[0047] In the diagram: 1. Main unit of the treatment device; 11. LCD screen; 12. Operation button module; 2. Treatment head; 21. Protective shell; 3. Treatment support; 4. Ultrasonic transducer; 41. Inner ring layer; 42. Outer layer; 43. Piezoelectric crystal; 5. Piezoelectric thin film layer; 51. Piezoelectric ceramic composite layer; 52. Flexible base layer; 53. Intermediate layer; 6. Microneedle patch layer; 61. Microneedle base layer; 62. Main channel; 63. Hollow microneedle; 631. Outer ring; 632. Intermediate part; 633. Inner ring; 64. Barbed part; 7. Sensor module; 71. Temperature sensor; 72. Pressure sensor; 73. Impedance biosensor; 8. Adhesive layer. Detailed Implementation

[0048] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0049] like Figures 1-4 As shown, an ultrasonic electrotherapy device includes a main unit 1 and a treatment head 2. One end of the treatment head 2 is connected to the probe interface of the main unit 1 via a wire, and the other end rests on a treatment support 3. The treatment 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 sequentially from the inside to the outside. A sensor module 7 is also provided inside the treatment head 2. Optionally, the treatment head 2 and the protective shell 21 are detachably connected by a magnetic snap-fit.

[0050] The ultrasonic transducer 4 includes an inner ring layer 41 and an outer ring layer 42. Both the inner ring layer 41 and the outer ring layer 42 are composed of several sets of piezoelectric crystals 43. The spacing between each piezoelectric crystal 43 is not less than 0.5 mm. The multiple sets of piezoelectric crystals 43 in the inner ring layer 41 form a ring structure. This design can effectively improve the output and efficiency of ultrasonic energy, effectively enhance the energy output, and make the sound waves more evenly distributed in the treatment area, thereby improving the treatment effect. The multiple sets of piezoelectric crystals 43 in the outer ring layer 42 allow the transducer to cover a larger contact area, enabling ultrasonic waves to be transmitted in a wider area, thereby improving the treatment effect.

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

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

[0053] Sensor module 7 includes a temperature sensor 71, a pressure sensor 72, and an impedance biosensor 73. The impedance biosensor 73 monitors tissue resistance to help determine the depth of drug penetration and the state of the tissue, thereby optimizing the ultrasonic operating parameters. The ultrasonic transducer 4 switches its operating frequency based on the tissue state feedback from sensor module 7. Optionally, temperature sensor 71 is a thin-film sensor attached between flexible substrate layer 52 and microneedle substrate layer 61, and pressure sensor 72 is a MEMS piezoresistive sensor (range 0-20 N / cm). 2 The middle layer 53 can be deployed on the outside of the treatment head (on the support structure that contacts the patient's skin). The middle layer 53 serves as the electrode of the impedance biosensor 73. The impedance change between the piezoelectric thin 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] By combining real-time feedback from temperature, pressure, and impedance sensors, the working frequency and sound field intensity of ultrasound can be dynamically adjusted, allowing ultrasound energy to be distributed more evenly in different tissue layers (such as subcutaneous fat and muscle layers). This avoids the situation of insufficient or excessive drug penetration caused by uneven energy field in traditional ultrasound transducers 4. Furthermore, the design of the microneedle base layer 61 and hollow microneedles 63 allows the drug to be guided to the treatment area by ultrasound, optimizing the efficiency and precision of drug release.

[0055] By combining temperature sensor 71, pressure sensor 72, and impedance biosensor 73, the tissue state can be monitored in real time and the working frequency of ultrasound can be adjusted according to 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 allows ultrasound to penetrate efficiently and provide appropriate energy in different tissue layers (such as fat layer and muscle layer), effectively avoiding the risk of tissue overheating.

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

[0057] The main unit 1 of the therapeutic instrument is equipped with a control module. The ultrasonic transducer 4 is electrically connected to the control module. 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 main unit 1 of the treatment device adopts a multi-channel multiplexing design, which supports the simultaneous connection of at least two treatment heads 2, and each treatment head 2 can be independently configured with ultrasonic frequency and drug loading scheme of microneedle patch layer 6; the control module is preset with three clinical treatment schemes: wound repair, analgesia and anti-inflammation and skin regeneration, and the optimal parameter combination is matched by the skin electrical characteristics fed back by impedance biosensor 73.

[0060] Furthermore, such as Figures 4-5 As shown, the ultrasonic transducer 4 and the piezoelectric thin film layer 5 are electrically connected by flexible electrodes. The core purpose of this design is to ensure that the ultrasonic transducer 4 can efficiently transmit electrical energy to the piezoelectric thin film layer 5, thereby exciting the piezoelectric ceramic composite material in the piezoelectric thin film layer 5 and generating the necessary ultrasonic energy.

[0061] The microneedle base layer 61 is bonded to the flexible base layer 52 via an adhesive layer 8 (preferably a polydopamine coating). A seamless fit between the microneedle base layer 61 and the flexible base layer 52 is required. The application of the polydopamine coating not only ensures a strong bond between the microneedle base layer 61 and the flexible base layer 52, but also prevents microneedle displacement or instability, ensuring precise operation during treatment. The microneedle patch layer 6 can accurately deliver therapeutic drugs to the desired area and works synergistically with ultrasound therapy to ensure the depth of treatment and the uniformity of drug release.

[0062] Furthermore, such as Figures 4-6 As shown, the tip of the hollow microneedle 63 is provided with several sets 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 allows the microneedle to gradually degrade after treatment without causing 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 tissues.

[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 microneedle movement on drug delivery during treatment. During use, the piezoelectric film enhances the puncture effect of the barb 64 through vibration. When the piezoelectric film generates ultrasound or other forms of vibration, the barb 64 can help the microneedle stay stably in the puncture position, preventing the microneedle from shifting due to external factors (such as skin movement or equipment vibration).

[0064] After penetrating the skin, the barb 64 anchors to the subcutaneous tissue. Its angle is usually designed to be a small angle (such as 15°-30°), and the anchoring force ensures that it does not cause too much cutting force. Instead, it causes the stratum corneum to crack or break through in a "separation" manner, which can reduce cutting damage to the epidermis.

[0065] The hollow microneedles 63 are distributed in a gradient height. Specifically, the hollow microneedles 63 include an outer ring 631, a middle ring 632, and an inner ring 633. The length of the hollow microneedles 63 is 50 to 1000 μm. Shorter microneedles are suitable for the treatment of the skin surface and superficial tissues, while longer microneedles can penetrate into the middle or deeper layers of the skin, which is suitable for occasions that require deeper drug delivery.

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

[0067] Furthermore, such as 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 outer ring 631 has a length of 800 μm, the middle ring 632 has a length of 400 μm, and the inner ring 633 has a length of 100 μm. The outer ring 631 microneedles are longer, which can cover a larger skin area, thus enabling rapid and uniform delivery of 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 also provide good fixation for the microneedle patch layer 6. As the outer ring 631 microneedles continue to penetrate deeper, the middle ring 632 microneedles will penetrate into the middle layer of the skin, and can penetrate the boundary between the epidermis and dermis, which is suitable for some treatments that require deeper drug delivery. Finally, the inner ring 633 can penetrate into the epidermis to treat lesions on the skin surface.

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

[0070] Alternatively, the outer ring portion 631 is longer than the inner ring portion 633, and the inner ring portion 633 is longer than the middle portion 632.

[0071] For example, the outer ring 631 has a length of 800 μm, the middle ring 632 has a length of 100 μm, and the inner ring 633 has a length of 400 μm. Unlike traditional designs, in this design, the microneedles of the inner ring 633 are longer than those of the middle ring 632. The inner ring 633 provides drug delivery between the epidermis and dermis. Since the microneedles of the middle ring 632 are shorter, they mainly serve as a transition for skin puncture, helping the microneedles of the outer ring 631 and inner ring 633 to transition smoothly and avoid discomfort caused by sudden changes in the length of the microneedles during puncture. Although the short microneedles of the middle ring 632 penetrate to a shallower depth, they can help the drug be distributed more evenly between the skin layers. Through proper transition, drug penetration can avoid concentrated release, thereby ensuring the stability of the treatment effect.

[0072] Through the gradient design of the microneedle lengths of the outer ring 631, the middle ring 632, and the inner ring 633, the hollow microneedle 63 can achieve drug delivery at different depths, while avoiding excessive concentration of drugs in a certain layer and 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 1MHz and the high-frequency band is 3MHz.

[0074] When the operating frequency is in the low-frequency range, the ultrasonic field emitted by the ultrasonic transducer 4 is used to penetrate the fat layer. The low-frequency ultrasonic waves have a longer wavelength and a lower vibration frequency, which makes them able to effectively penetrate thicker layers of the skin, especially the fat layer.

[0075] When operating at low frequencies, the outer layer 42 and the inner ring layer 41 of the ultrasound transducer 4 work simultaneously. This design can simultaneously exert the effects of two different levels of ultrasound. The outer layer 42 is responsible for the large-scale energy distribution, while the inner ring layer 41 enhances the penetration power through more concentrated ultrasound waves and ensures that the energy penetrates evenly into the deep fat layer. The function of the inner ring layer 41 can help to more accurately control the treatment area, avoid excessive energy concentration, and ensure the uniformity of treatment.

[0076] When the operating frequency is in the high-frequency range, the ultrasonic field emitted by the ultrasonic transducer 4 is used to penetrate the muscle layer. The high-frequency ultrasonic waves have shorter wavelengths and higher vibration frequencies, which makes them more suitable for treatment at shallower levels, especially the muscle layer.

[0077] At high frequencies, the annular inner layer 41 ultrasound transducer 4 continues to operate and is primarily responsible for treatment within the muscle layer. The annular inner layer 41 typically ensures that energy can penetrate deeply into the target area through precise energy concentration, while avoiding unnecessary damage. Through this design, ultrasound waves can be concentrated to the depth of the muscle layer during treatment, ensuring maximum effectiveness.

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

[0079] The treatment device is suitable for 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, which detects skin integrity through an impedance sensor.

[0080] Furthermore, the ultrasonic transducer 4 adjusts its duty cycle according to the change in the current temperature T (to synergistically reduce heat accumulation), and the adjustment formula for the duty cycle is as follows:

[0081]

[0082] Among them, D adj (T) represents the duty cycle adjusted according to temperature. This value is adjusted in real time as the temperature changes. D0 is the initially set duty cycle. α is the sensitivity of the duty cycle to temperature adjustment, indicating the degree of influence of temperature changes on the duty cycle adjustment. The larger the value of α, the greater the influence of temperature changes on the duty cycle adjustment. max The system has a set maximum safe temperature threshold. Exceeding this temperature may cause thermal damage to tissue. Therefore, when the temperature approaches or exceeds this threshold, the system will adjust the duty cycle to reduce the output energy of the ultrasound waves, thereby avoiding overheating. Optionally, T... max Set to 42℃.

[0083] During operation, it adopts a design that adjusts the duty cycle based on temperature changes. The adjustment of the duty cycle aims to reduce heat accumulation in a coordinated manner, so that the energy output of ultrasound can always be kept within a safe range, avoiding overheating and causing damage to tissues, thereby improving the safety and effectiveness of treatment.

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

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

[0086] It should be noted that when the temperature sensor 71 monitors a value T ≥ T max When this occurs, the therapeutic device automatically interrupts its output and triggers an alarm, while simultaneously recording the fault code to the host storage module.

[0087] Furthermore, the piezoelectric thin film layer 5 generates acoustic flow during operation and guides the drug migration along the hollow microneedles 63. Specifically, the piezoelectric thin film excites multimodal standing waves under a 40kHz alternating electric field. The distribution of acoustic pressure nodes is controlled by electrode encoding, generating a parallel acoustic flow along the microneedle channel. The acoustic flow effect, combined with ultrasonic cavitation, causes drug molecules to diffuse along the microneedle-acoustic flow path, forming a concentration gradient, thereby achieving targeted drug delivery. The optimized formula for the acoustic flow is:

[0088]

[0089] Where, η flow P represents the optimization coefficient for acoustic flow on drug migration. low P represents the power of sound waves in the low-frequency range. high This refers to the power of sound waves in the high-frequency band.

[0090] Ultrasonic therapy devices optimize drug migration through microneedle channels 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 contributions 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 drug migration rate.

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

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

[0094] Among them, R drugFor the optimized drug release rate, R0 is the initial drug release rate, γ is the coefficient of influence of pressure data on drug release rate, P is the pressure data collected by the pressure sensor, δ is the coefficient of influence of impedance data on 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 channels; therefore, the γ coefficient determines the extent to which pressure affects the drug migration rate. Increased electrical impedance typically affects the tissue's conduction of sound waves, thus affecting the drug release rate. Impedance data is acquired in real time by an impedance sensor, and the δ coefficient determines the strength of the impedance's influence 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 various physical quantities (such as acoustic power, pressure, and impedance) to ensure the effectiveness and accuracy of the drug during treatment.

[0097] In detail, by combining the effects of pressure, impedance, and acoustic flow, the ultrasonic electroconduction therapy device can precisely control the migration rate of drugs. This optimization mechanism ensures that drugs are 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 adaptively adjust according to specific circumstances (such as tissue characteristics, treatment needs, etc.) to maximize the therapeutic effect.

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

[0100] Furthermore, such as Figure 1 As shown, the front of the main unit 1 of the therapeutic device is embedded with an LCD screen 11 and an operation button module 12. The LCD screen 11 is used to display the monitoring data of the temperature sensor 71, pressure sensor 72 and impedance biosensor 73 in real time, and supports the selection of ultrasonic frequency or low-frequency pulse current mode through touch control. It provides users with the functions of real-time monitoring data, treatment mode selection and precise control, making the treatment process more convenient, intuitive and flexible. At the same time, the alarm and prompt functions of the device can ensure the safety of treatment and improve the intelligence level of the device and the user experience.

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

[0102] Work process:

[0103] During the pretreatment stage, after the microneedle patch layer 6 comes into contact with the skin, the pH-responsive hydrogel dissolves rapidly, and the hollow microneedles 63 with barbed structures penetrate the epidermal layer, forming a low-resistance drug channel.

[0104] During the low-frequency penetration phase, all piezoelectric wafers 43 of the outer layer 42 and the annular inner layer 41 operate simultaneously at a low frequency of 1MHz, generating wide-field ultrasonic waves (wavelength approximately 1.5mm). The ultrasonic field couples to the flexible substrate layer 52 through the piezoelectric thin film layer 5, and the acoustic flux intensity is proportional to η. flow Regulation and promotion of drug migration along microneedle channels;

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

[0106] During the dynamic closed-loop adjustment phase, for example, when the temperature T is greater than 40℃, the pulse intermittent mode is activated and the duty cycle is reduced by 20%. When the temperature T is greater than 42℃, the main unit 1 of the therapeutic instrument automatically interrupts the output and triggers an alarm.

[0107] To safely exit the treatment, simply turn off the main unit 1 and remove the treatment 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 foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An ultrasonic electrotherapy device, characterized in that, include: The treatment device host (1) and the treatment head (2) are provided. One end of the treatment head (2) is connected to the probe interface of the treatment device host (1) through a wire, and the other end rests on the treatment support (3). The treatment 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 sequentially from the inside to the outside. The treatment head (2) also has a sensor module (7) inside. The ultrasonic transducer (4) includes an annular inner layer (41) and an outer layer (42), both of which are composed of several sets of piezoelectric crystals (43). The piezoelectric thin film layer (5) includes a piezoelectric ceramic composite layer (51) that is bonded to the ultrasonic transducer (4), a flexible substrate layer (52) disposed on the outermost side, and an intermediate layer (53) disposed between the flexible substrate layer (52) and the piezoelectric ceramic composite layer (51). The microneedle patch layer (6) includes a microneedle base layer (61), a main channel (62) disposed on the microneedle base layer (61), and a number of hollow microneedles (63) connected to the main channel (62), wherein the multiple 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 its operating frequency according to the tissue state feedback from the sensor module (7). When the piezoelectric thin film layer (5) is in operation, it generates acoustic flow and guides the drug to migrate along the hollow microneedle (63). The optimized formula for the acoustic flow is: ； Where, η flow P represents the optimization coefficient for acoustic flow on drug migration. low P represents the power of sound waves in the low-frequency range. high This refers to the power of sound waves in the high-frequency band. The optimized formula for drug migration rate is: ； Among them, R drug For the optimized drug release rate, R0 is the initial drug release rate, γ is the coefficient of influence of pressure data on drug release rate, P is the pressure data collected by the pressure sensor, δ is the coefficient of influence of impedance data on drug release rate, and Z is the impedance data collected by the impedance sensor.

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

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

4. The ultrasonic electrotherapy device according to claim 1, characterized in that, The hollow microneedle (63) has several sets of barbs (64) at its tip. The hollow microneedle (63) includes an outer ring (631), a middle ring (632) and an inner ring (633), and the length of the hollow microneedle (63) is 50 to 1000 μm.

5. The ultrasonic electrotherapy device according to claim 4, characterized in that, The outer ring (631) is longer than the middle ring (632), and the middle ring (632) is longer than the inner ring (633).

6. The ultrasonic electrotherapy device according to claim 4, characterized in that, The outer ring (631) is longer than the inner ring (633), and the inner ring (633) is longer than the middle ring (632).

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

8. The ultrasonic electrotherapy device according to claim 7, characterized in that, The ultrasonic transducer (4) adjusts its duty cycle according to the change in the current temperature T. The adjustment of the duty cycle aims to reduce heat accumulation through synergy, so that the energy output of the ultrasonic waves is always kept within a safe range. The formula for adjusting the duty cycle is as follows: ； Among them, D adj (T) represents the duty cycle adjusted according to temperature, D0 represents the initially set duty cycle, and α represents the sensitivity of temperature to duty cycle adjustment. max This is the maximum safe temperature threshold that is set.

9. The ultrasonic electrotherapy device according to claim 1, characterized in that, The front of the main unit (1) of the therapeutic device is embedded with an LCD screen (11) and an operation button module (12). The LCD screen (11) is used to display the monitoring data of the temperature sensor (71), pressure sensor (72) and 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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