Split type ultrasonic leading-in device, method and related system

Abstract

The invention provides a split type ultrasonic leading-in device, a split type ultrasonic leading-in method and a related system.The split type ultrasonic leading-in device comprises an ultrasonic driving module which comprises a first shell and a piezoelectric ceramic transducer arranged in a groove part of the first shell, the first shell comprises a groove part, a limiting part which extends outwards along the edge of the groove part, and an attaching part which extends outwards along the edge of the limiting part; the patch module comprises a plastic substrate and an anti-seepage component which is arranged on a first end face of the plastic substrate and provided with a middle milling sinking groove, the first end face is integrally provided with a first adhesive layer cover, and the first end face of the plastic substrate is provided with the middle milling sinking groove of the anti-seepage component and used for containing a functional carrier. The first end face with the first adhesive layer cover removed is used for being attached to a target area, the limiting part is used for being matched with the anti-seepage component to form a first matched state, and the attaching part is used for being attached to the patch module to form a second matched state. Therefore, in use, the ultrasonic driving module does not need to be discarded once, and the cost is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of transdermal patches, and in particular to a split type ultrasonic introduction device, method and related system. BACKGROUND

[0002] There are various technologies in the market that enhance the transdermal absorption of drugs by physical means. These technologies have problems such as low drug penetration efficiency, high use cost, and insufficient portability in transdermal drug absorption. The existing technologies for enhancing the transdermal absorption of drugs mainly include two types: integrated ultrasonic drug patch technology and continuous acoustic physiotherapy technology. The principle of the integrated ultrasonic drug patch technology is an integrated system that integrates drugs and ultrasonic transducer devices together. The continuous acoustic physiotherapy technology requires continuous wearing of ultrasonic treatment equipment. Since the integrated drug patch technology integrates complex piezoelectric transducers and microcircuits in a disposable patch, the process is complex and the cost of a single chip is high. The continuous acoustic physiotherapy technology mainly produces mild mechanical vibration by using high-frequency and low-intensity ultrasound, and cannot produce strong "cavitation effect", which cannot well deliver drugs to the specified site. In addition, the continuous acoustic physiotherapy needs to be worn for a long time, and has insufficient portability in use.

[0003] Therefore, how to reduce the use cost and improve the portability when using transdermal drug absorption therapy needs to be solved. SUMMARY

[0004] The embodiments of the present application provide a split type ultrasonic introduction device, method and related system, which realizes the reduction of use cost and the improvement of portability when using transdermal drug absorption therapy.

[0005] In a first aspect, the embodiments of the present application provide a split type ultrasonic introduction device, which comprises: An ultrasonic driving module comprising a first shell of a predetermined shape and a piezoelectric ceramic transducer arranged in a groove portion of the first shell, the first shell comprising the groove portion, a limiting portion extending outward along the edge of the groove portion, and a fitting portion extending outward along the edge of the limiting portion. A functional carrier; the functional carrier comprises a functional substance and a gel matrix.

[0006] Further, the split type ultrasonic introduction device further comprises a patch module, and the patch module comprises: a patch module comprising a plastic substrate, a first end face of the plastic substrate, a middle milling sink groove of the plastic substrate, a permeation prevention component arranged in the first end face of the plastic substrate, the first end face of the plastic substrate is provided with a first glue layer envelope, and the second end face of the plastic substrate opposite to the first end face is provided with a second glue layer envelope except the end face area of the middle milling sink groove. The first end surface of the plastic substrate is provided with the middle milling sink of the anti-permeation component for placing the functional carrier, the first end surface of the plastic substrate without the first adhesive layer cover is used for adhering to the target area, the limiting part is used for cooperating with the anti-permeation component to form a first cooperation state, and the adhering part is used for adhering to the second end surface of the patch module without the second adhesive layer cover to form a second cooperation state.

[0007] Further, the first adhesive layer cover and the second adhesive layer cover are both provided with medical-grade pressure-sensitive adhesive; the second adhesive layer cover is used for adsorbing the adhering part of the first shell, so that the relative position between the ultrasonic driving module and the patch module does not dislocate.

[0008] Further, the materials of the first adhesive layer cover and the second adhesive layer cover are PU film; the material of the anti-permeation component is PE material; the anti-permeation component is used for preventing horizontal exosmosis of the functional carrier, and in the first cooperation state, the ultrasonic driving module is assembled with the anti-permeation part; the material of the plastic substrate is the PU film or non-woven fabric, and the plastic substrate is used for carrying the functional carrier and maintaining the adhering state with the target area.

[0009] Further, the ultrasonic driving module further includes a power module and a driving module; the driving module is connected with the piezoelectric ceramic transducer through an electrode lead of a preset length, or the driving module is integrated on the piezoelectric ceramic transducer; the power module is connected with the driving module through an electric lead; The piezoelectric ceramic transducer is used for generating a first frequency ultrasonic wave. The driving module is used for receiving the electric energy transmitted by the power module and driving the piezoelectric ceramic transducer to generate an ultrasonic wave according to a preset frequency. The power module is used for providing the electric energy of the driving module.

[0010] Further, the ultrasonic driving module and the patch module are in a split structure; the ultrasonic driving module is used for acting on the middle milling sink of the patch module through the ultrasonic wave generated by the piezoelectric ceramic transducer, so that the functional carrier in the patch module forms a cavitation effect under the action of the ultrasonic wave, and / or forms a lead-in channel structure in the target area.

[0011] Further, the functional substance is loaded in a gel matrix, and the gel matrix is used for providing a carrier for the functional substance and providing ultrasonic coupling effect.

[0012] Further, a microneedle array is further arranged on the first end surface, which is used for forming an enhanced molecular transmission channel in the target area to improve the permeability of the functional carrier.

[0013] Further, the first shell is made of silica gel material, and is used to fix the piezoelectric ceramic transducer and position the target area through the bonding part.

[0014] Further, when the ultrasonic driving module is started, the driving module receives a start instruction; the driving module generates an alternating current signal of a preset frequency in response to the start instruction, and transmits the alternating current signal to the piezoelectric ceramic transducer through the electrode lead; the frequency and voltage of the alternating current are determined according to the alternating current signal; the piezoelectric ceramic transducer generates ultrasonic waves in response to the frequency and voltage, and the functional substance is acted on by the ultrasonic waves to generate a cavitation effect.

[0015] In a second aspect, an embodiment of the present application provides a split type ultrasonic introduction method, applied to a split type ultrasonic introduction device, the split type ultrasonic introduction device including a reusable ultrasonic driving module and a disposable patch module, and the method includes: The ultrasonic driving module is used to perform first ultrasonic waves on the target area for a preset first time period to obtain an introduction channel; the introduction channel is a channel formed by the target area after the target area is acted on by the ultrasonic waves; The ultrasonic driving module is used to apply the first ultrasonic waves to the patch module to activate the functional substance in the patch module to obtain activated substance molecules; The ultrasonic driving module is used to penetrate the activated substance molecules to the target area; When the first time period is less than a preset time threshold, the ultrasonic driving module is used to continue to apply the first ultrasonic waves to the patch module; when the first time period is greater than or equal to the time threshold, after the ultrasonic driving module is removed, the activated substance molecules in the patch module continue to penetrate to the target area through the introduction channel to assist the introduction of the functional substance in the patch module to the target area.

[0016] In a third aspect, an embodiment of the present application provides a split type ultrasonic introduction system, wherein the split type ultrasonic introduction system includes the device described in the first aspect of the present application.

[0017] In a fourth aspect, an embodiment of the present application provides a split type ultrasonic introduction device, including a processor, a memory, a communication interface, and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the processor, and the programs include instructions for executing the steps in the method of the second aspect of the present application.

[0018] In a fifth aspect, an embodiment of the present application provides a computer program product. The computer program product includes a non-transitory computer readable storage medium storing a computer program. The computer program is operable to cause a computer to perform some or all of the steps described in the method of the second aspect of the embodiments of the present application. The computer program product can be a software installation package.

[0019] The application provides a split type ultrasonic introduction device, method and related system. The split type ultrasonic introduction device comprises an ultrasonic driving module, a piezoelectric ceramic transducer arranged in a groove part of a first shell, the first shell comprising the groove part, a limiting part extending outward along the edge of the groove part, and a fitting part extending outward along the edge of the limiting part; and a patch module comprising a plastic substrate, a barrier part arranged in a middle milled groove of a first end face of the plastic substrate, the first end face of the plastic substrate being provided with a first glue layer envelope, and a second end face of the plastic substrate opposite to the first end face being provided with a second glue layer envelope except the end face area of the middle milled groove. The middle milled groove of the first end face of the plastic substrate provided with the barrier part is used for placing a functional carrier, and the first end face of the plastic substrate without the first glue layer envelope is used for being attached to a target area. The limiting part is used for cooperating with the barrier part to form a first cooperation state, and the fitting part is used for being attached to the second end face of the patch module without the second glue layer envelope to form a second cooperation state. In this way, on the one hand, the expensive electronic components (ultrasonic driving module) can be repeatedly used for a long time, and the cheap consumables (patch module) can be used once, so as to reduce the cost of the user in use. On the other hand, through the split type structure (ultrasonic driving module and patch module), the user only needs to attach the patch module to the target area in use, and does not need to wear the ultrasonic driving module with a certain hardness and thickness on the target area, so as to improve the portability of the user. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0021] Figure 1 FIG. 1 is a structural schematic diagram of a split type ultrasonic introduction device provided by an embodiment of the present application; Figure 2 FIG. 2 is a structural schematic diagram of a patch module provided by an embodiment of the present application; Figure 3 FIG. 3 is a structural schematic diagram of an ultrasonic driving module provided by an embodiment of the present application; Figure 4This is a schematic diagram illustrating the collaborative operation of an ultrasonic drive module and a patch module, as provided in an embodiment of this application. Figure 5 This is a schematic flowchart of a split-type ultrasound delivery method provided in an embodiment of this application; Figure 6 This is a schematic diagram of the structure of a split-type ultrasound delivery device provided in an embodiment of this application; Figure 7 This is a block diagram of the functional modules of an ultrasonic implantation device provided in an embodiment of this application. Detailed Implementation

[0022] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present application, and not all embodiments. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present application.

[0023] The terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or apparatuses.

[0024] It should be understood that the term "and / or" in this document is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, the character " / " in this document indicates that the preceding and following related objects are in an "or" relationship. In the embodiments of this application, "multiple" refers to two or more.

[0025] In the embodiments of this application, "at least one item" or its similar expression refers to any combination of these items, including any combination of a single item or a plurality of items. "One or more" means one or more, while "multiple" means two or more. For example, "at least one item" of a, b, or c can represent the following seven cases: a, b, c; a and b; a and c; b and c; a, b, and c. Each of a, b, and c can be an element or a set containing one or more elements.

[0026] In this application, the term "connection" refers to various connection methods, such as direct connection or indirect connection, to achieve communication between devices. This application does not impose any limitations on this.

[0027] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0028] The following is an explanation of the relevant terms used in this application: Milling grooves: refers to the processing technology of machining grooves of specific shapes on the surface of a workpiece to meet shape and size requirements.

[0029] Piezoelectric ceramic transducer: It is an electromechanical conversion device made of piezoelectric ceramic as the core material, which realizes the mutual conversion of electrical energy and sound energy through the piezoelectric effect and the inverse piezoelectric effect.

[0030] Existing technologies for enhancing transdermal drug absorption mainly fall into two categories: integrated ultrasonic medicated patch technology and continuous acoustic therapy technology. Integrated ultrasonic medicated patch technology operates on the principle of an integrated system, combining medication and an ultrasonic transducer. Continuous acoustic therapy technology requires continuous wear of the ultrasonic treatment device. Because integrated medicated patch technology integrates complex piezoelectric transducers and microcircuits into a disposable patch, its manufacturing process is complex, resulting in high costs per patch. Continuous acoustic therapy technology uses high-frequency, low-intensity ultrasound, primarily generating mild mechanical vibrations, which cannot produce a strong "cavitation effect" and therefore cannot effectively deliver medication to the designated area. Furthermore, continuous acoustic therapy suffers from inconvenience due to the need for prolonged wear.

[0031] To address the aforementioned issues, this application provides a split-type ultrasound delivery device, method, and related system. This is achieved by setting up a split-type ultrasound drive module and patch module. Existing technologies for enhancing transdermal drug absorption mainly fall into two categories: integrated ultrasound patch technology and continuous acoustic therapy technology. Integrated ultrasound patch technology operates on the principle of an integrated system, combining the drug and ultrasound transducer. Continuous acoustic therapy technology requires continuous wear of the ultrasound treatment device. Because integrated patch technology integrates complex piezoelectric transducers and microcircuits into a disposable patch, its manufacturing process is complex, and the cost per patch is high. Continuous acoustic therapy technology uses high-frequency, low-intensity ultrasound, primarily generating mild mechanical vibrations, which cannot produce a strong "cavitation effect," thus failing to effectively deliver drugs to the designated area. Furthermore, continuous acoustic therapy suffers from insufficient portability due to the need for prolonged wear.

[0032] Therefore, how to reduce the cost and improve the portability of transdermal drug delivery therapy is an urgent issue to be addressed.

[0033] The following is combined Figure 1 The structure of a split-type ultrasound delivery device according to an embodiment of this application will be described. Figure 1 This is a schematic diagram of a split-type ultrasonic induction device provided in an embodiment of this application. The split-type ultrasonic induction device 100 includes: an ultrasonic driving module, including a first housing 113 of a preset shape and a piezoelectric ceramic transducer 111 disposed in a groove portion 114 of the first housing 113. The first housing includes the groove portion 114, a limiting portion extending outward along the edge of the groove portion 114, and a fitting portion 112 extending outward along the edge of the limiting portion; a functional carrier; the functional carrier includes a functional substance and a gel matrix.

[0034] In one possible embodiment, the split-type ultrasonic induction device further includes a patch module, the patch module comprising: a plastic substrate, and an anti-seepage component 115 with a central milled groove disposed on a first end face of the plastic substrate 117. The first end face of the plastic substrate is entirely provided with a first adhesive layer, and the second end face of the plastic substrate relative to the first end face, excluding the central milled groove, is provided with a second adhesive layer. The central milled groove of the anti-seepage component on the first end face of the plastic substrate is used to place a functional carrier 116. The first end face of the plastic substrate with the first adhesive layer removed is used to adhere to a target area. The limiting portion is used to cooperate with the anti-seepage component to form a first mating state, and the adhering portion is used to adhere to the second end face of the patch module with the second adhesive layer removed to form a second mating state.

[0035] The split-type ultrasound delivery device 100 comprises an ultrasound driving module and a patch module. This split design physically separates the energy driving and drug storage functions, thereby improving the reusability and operational safety of the device while maintaining low-cost consumables. The functional substance ultrasound driving module includes a first housing 113 of a pre-defined shape and a piezoelectric ceramic transducer 111 disposed within a groove 114 of the first housing 113. The first housing 113 has a groove 114, a limiting portion extending outward along the edge of the groove 114, and a fitting portion 112 further extending outward along the edge of the limiting portion. The groove 114 accommodates the piezoelectric ceramic transducer, forming a concentrated ultrasound energy emission area. The limiting portion achieves mechanical alignment between the driving module and the patch module. The fitting portion provides a sealed support interface when mating with the target area of ​​the user's skin, ensuring stable acoustic energy transmission. This layered housing design effectively prevents the transducer from shifting under high-frequency vibration and reduces the risk of structural stress concentration, thereby extending the transducer's service life. In another possible embodiment, the patch module may not have a plastic substrate; instead, the main structure can be formed entirely by a gel matrix. In this case, the gel matrix is ​​preferably a semi-solid hydrogel material, which simultaneously functions as a drug carrier and structural support. This hydrogel maintains flexibility while possessing a certain degree of deformation recovery, enabling close adhesion to the skin during application and providing excellent acoustic coupling performance under ultrasound. Since no additional substrate layer is required, this structure can further reduce material costs and biointerface impedance, improve drug penetration efficiency, and enhance user comfort. Furthermore, the first housing can have a frustum shape, a regular tetrahedron shape, or an irregular polyhedron shape; no limitation is made here, as long as it conforms to ergonomics and facilitates user operation. Preferably, the first housing is as follows: Figure 1 The shape shown in the image.

[0036] The piezoelectric ceramic transducer 111 serves as the energy source for the ultrasound, generating a low-frequency, high-energy sound field through electrical drive. Its vibration direction aligns with the axis of the housing, allowing the acoustic energy to act vertically on the central region of the lower patch module. Through the design of the groove 114, the ultrasonic energy can form a concentrated sound pressure zone in the center of the patch module, improving the energy coupling efficiency of the drug reservoir layer and achieving a more significant permeation and activation effect. Furthermore, the inner wall of the groove can be coated with a damping coating or use a polymer buffer pad to absorb edge-reflected sound waves and avoid interference that could cause uneven energy distribution.

[0037] The patch module includes a plastic substrate 117, an anti-seepage component 115 disposed in a milled groove in the middle of the first end face of the plastic substrate 117, and a functional carrier 116 placed in the central area of ​​the anti-seepage component. The plastic substrate 117 can be made of medical-grade polyurethane or polypropylene, which has excellent flexibility and breathability, and can achieve close adhesion to the skin surface. The anti-seepage component 115 is made of a material with low permeability, used to block the lateral diffusion of drugs and limit the drug reservoir area, thereby concentrating the drug distribution in the central axis area to improve the utilization rate of ultrasound energy and the uniformity of delivery. The first end face of the plastic substrate 117 is entirely covered with a first adhesive layer for protection and to keep the adhesive surface clean. During use, the user removes the first adhesive layer to expose the end face and allow it to adhere to the target skin area. The second end face of the plastic substrate, excluding the central milled groove, is covered with a second adhesive layer for sealing connection with the ultrasonic drive module's bonding portion. By removing the second adhesive layer, a uniform contact interface is formed between the ultrasonic drive module's bonding portion 112 and the outer edge of the plastic substrate, ensuring effective cooperation between the ultrasonic drive module and the patch module, while also enabling effective transmission of ultrasonic waves without air gap reflection. The limiting portion cooperates with the outer edge of the anti-leakage component 115 to form a first mating state, ensuring alignment of the two modules during assembly and preventing ultrasonic energy from deviating from the center of the drug reservoir. The second mating state is the state formed when the patch module is adhered to the target area after the ultrasonic drive device is removed.

[0038] For easier understanding, please refer to Figure 2 , Figure 2This is a schematic diagram of a patch module provided in an embodiment of this application. As can be seen, the patch module 200 mainly includes a substrate 201, a waterproofing element 202, and a functional medium layer 203. The substrate 201 serves as the carrier of the patch module 200, its main function being to provide the overall structural dimensions and to fix the patch module to a designated area of ​​the user's skin. The plastic substrate can be made of flexible PU (polyurethane) or medical-grade PET (polyethylene terephthalate), possessing excellent biocompatibility and temperature resistance. It can adhere to the skin surface and maintain good flexibility during application, avoiding localized warping or peeling caused by the rigidity of the substrate. An anti-permeability element 202 is disposed in the middle milled groove of the substrate 201 to define the distribution area of ​​the functional medium layer 203 and prevent the horizontal diffusion of drugs or active ingredients under ultrasonic action. This anti-permeability element 202 is preferably made of polyethylene (PE) or fluoropolymer material, possessing good chemical inertness and low hygroscopicity. Its closed-loop structure forms a stable boundary interface, allowing the functional medium to permeate only in the vertical direction (i.e., the normal direction of the patch), ensuring concentrated drug energy delivery to the target skin area. The functional medium layer 203 is located in the central area defined by the anti-permeability element 202, and its interior can be filled with a functional carrier with therapeutic, repairing, or activating effects. The functional substances in the functional carrier can be, for example, small molecule transdermal drugs, peptide active factors, vitamin solutions, or microcapsule-type drug-loaded gels. The functional medium layer 203 can be in the form of a gel, liquid, or film structure, with viscosity and flowability set according to different application requirements. Under the action of ultrasound, drug molecules in the medium layer are excited by cavitation and acoustic flow and introduced into the microchannels formed in the skin, achieving efficient transdermal absorption. Furthermore, to further ensure the stability of the patch module 200 in practical applications, the substrate 201 and the anti-leakage component 202 are sealed together using a hot-pressing or medical-grade pressure-sensitive adhesive process to form an integrated sealed structure. A release membrane can be provided on the back of the patch module to maintain drug activity and prevent contamination before use; during use, the release membrane can be removed to attach the patch module to the target skin area, achieving precise alignment with the ultrasound-driven module.

[0039] It should be noted that the split-type ultrasound delivery device 100's separate structural design allows for the separation of the ultrasound drive module's lifespan and hygiene requirements from those of the patch module. The ultrasound drive module is reusable, does not directly contact medication or skin, and avoids cross-contamination, while the patch module is a disposable consumable; it is simple in structure, low in cost, and can be customized with different medication formulations for different treatment scenarios. This structure not only improves user convenience and safety but also significantly reduces the overall system cost. Furthermore, through... Figure 1The spatial arrangement shown can be a ring design, a square arrangement, an elliptical design, or other irregular shapes; no limitation is made here, but it is necessary to ensure that the limiting part and the anti-leakage component cooperate. Preferably, a ring design is adopted, with the geometric center of the piezoelectric ceramic transducer 111 coinciding with that of the functional carrier 116, which can form an axisymmetric acoustic field distribution in the drug reservoir layer. This structure can generate a stable radial acoustic flow and cavitation microjets during driving, thereby accelerating the directional migration of drug molecules and the formation of skin channels. After testing, the energy transmission efficiency of this structure is improved by about 30% compared with the traditional planar bonding type, and the drug penetration flux is increased by about 2 times, significantly enhancing the penetration-promoting effect and energy utilization rate.

[0040] In one possible embodiment, both the first adhesive layer and the second adhesive layer are provided with medical-grade pressure-sensitive adhesive; the second adhesive layer is used to adsorb the bonding portion of the first housing so that the relative positions between the ultrasonic drive module and the patch module do not become misaligned.

[0041] The medical-grade pressure-sensitive adhesive uses acrylate or silicone-based colloid materials with high biocompatibility and low allergy rates. These colloids exhibit excellent adhesive stability, remaining soft and resistant to detachment in skin contact environments for extended periods, without causing skin surface damage upon removal. The first adhesive layer is primarily used to ensure stable adhesion between the patch module and the user's skin. The second adhesive layer, located on the back of the patch module, forms a reliable bond with the ultrasonic drive module, maintaining a constant relative position during ultrasonic vibration and preventing energy transfer path deviation due to vibration, sweat, or skin surface deformation. Furthermore, the medical-grade pressure-sensitive adhesive also reduces acoustic matching characteristics; its adhesive layer thickness is typically controlled between 50μm and 150μm to ensure acoustic impedance closely approximates the acoustic characteristics of soft tissue, thereby reducing ultrasonic energy reflection and attenuation at the interface.

[0042] Specifically, during operation, the operator removes the first adhesive layer before use, applying the first end face to the target skin area. Then, the second adhesive layer is removed, and the bonding portion of the ultrasonic drive module is aligned with the center of the patch module, gently pressed to ensure a firm bond. At this point, the pressure-sensitive adhesive layer of the second adhesive layer forms a uniform adhesion interface with the bonding portion of the first shell. This not only ensures assembly alignment accuracy but also acts as an acoustic buffer, absorbing edge stress generated by ultrasonic vibration and preventing the interface from cracking or detaching due to high-frequency vibration. During operation, the elasticity of the pressure-sensitive adhesive layer can finely adjust the contact interface according to the periodic deformation of the ultrasonic waves, resulting in a more uniform sound energy distribution and reducing the risk of heat accumulation caused by excessively high local sound intensity.

[0043] In one possible embodiment, the first adhesive layer and the second adhesive layer are made of PU film; the anti-seepage component is made of PE material; the anti-seepage component is used to prevent the functional medium from horizontally seeping out, and in the first mating state, the ultrasonic drive module is assembled with the anti-seepage component; the plastic substrate is made of the PU film or non-woven fabric, and the plastic substrate is used to support the functional carrier and maintain a close fit with the target area.

[0044] The PU (polyurethane) film possesses excellent flexibility and breathability, allowing it to stretch freely along the skin's curves without wrinkling, thus ensuring a stable fit between the patch module and the skin. The high moisture permeability of the PU film effectively reduces stuffiness and skin discomfort caused by prolonged application. Simultaneously, its smooth surface and good acoustic permeability, with an acoustic impedance close to that of human tissue, facilitate energy coupling and uniform sound field distribution during ultrasound transmission. The non-woven fabric, composed of randomly interwoven fibers, exhibits excellent flexibility and plasticity, providing good support while maintaining a thin structure. Its microporous surface structure offers high breathability and moisture regulation, contributing to comfort during prolonged skin contact. Furthermore, its porous fiber structure forms stable acoustic transmission channels under the influence of sound waves, ensuring effective transmission of ultrasound energy to the functional material layer. Preferably, the plastic substrate material can be a PU film, non-woven fabric, or any material possessing flexibility, biocompatibility, and acoustic permeability; no limitation is imposed here. The anti-seepage component is made of PE (polyethylene) material. PE material has high chemical inertness and low surface energy, which can effectively prevent the water or oil components in the drug carrier from penetrating and diffusing in the horizontal direction. It has good anti-seepage and moisture-proof performance and can form an isolation barrier between the drug storage layer and the plastic substrate, thereby preventing the active ingredients of the drug from diffusing outside the annular area or being absorbed by the skin edge, ensuring that the drug action area is concentrated and the energy conduction is stable.

[0045] Specifically, during implementation, the waterproofing component is embedded in the middle of the plastic substrate through hot pressing. Its thickness is typically set to 2-6 mm to provide sufficient waterproofing strength while maintaining the flexibility of the overall structure. When the ultrasonic drive module is installed on the patch module, its limiting part forms a first mating state with the outer edge of the waterproofing component. This structure not only enables automatic positioning between modules but also allows the ultrasonic energy emitted by the piezoelectric ceramic transducer to accurately act on the functional medium layer below the central region of the waterproofing component. In addition, since the acoustic permeability of the PE waterproofing component is lower than that of the drug medium, its boundary can act as a sound field focusing agent, limiting the diffusion of sound waves in the radial direction, thereby improving the energy transmission efficiency in the vertical direction.

[0046] In one possible embodiment, the ultrasonic driving module further includes a power supply module and a driving module; the driving module is connected to the piezoelectric ceramic transducer via an electrode wire of a preset length, or the driving module is integrated onto the piezoelectric ceramic transducer; the power supply module is connected to the driving module via an electrical wire; the piezoelectric ceramic transducer is used to generate ultrasonic waves of a first frequency; the driving module is used to receive electrical energy transmitted by the power supply module and drive the piezoelectric ceramic transducer to generate ultrasonic waves at a preset frequency; the power supply module is used to provide electrical energy to the driving module.

[0047] The power module can be a rechargeable lithium battery unit or an external power adapter module, which is not limited here. Its output voltage range is preferably 3.7V to 12V to adapt to piezoelectric transducers of different sizes and impedance characteristics. The power module may be equipped with a voltage regulator and overcurrent protection circuit to prevent abnormal transducer power caused by transient current fluctuations during the driving phase. The drive module is the core of ultrasonic energy control and may include a signal modulation unit, a power amplification unit, and a frequency feedback unit. The signal modulation unit generates a square wave or pulse signal matching the target frequency according to the control program; the power amplification unit amplifies the signal voltage to a level range capable of driving the piezoelectric ceramic transducer; the frequency feedback unit adjusts the output frequency in real time by detecting impedance changes or echo signals of the transducer to keep it in a resonant state, thereby improving energy utilization and acoustic field stability. Furthermore, the drive module can be independently mounted outside the housing or integrated and directly packaged on the back of the transducer, thereby reducing signal loss and improving system compactness.

[0048] Specifically, when the user starts the device, the power module outputs stable electrical energy to the drive module. The drive module generates a drive signal according to the set parameters, which is transmitted to the piezoelectric ceramic transducer through the electrode wires. Under the action of an alternating electric field, the piezoelectric ceramic transducer undergoes periodic mechanical deformation, generating ultrasonic waves of a specific frequency. These ultrasonic waves are focused by the groove and limiting part and act on the central region of the drug reservoir in the patch module, achieving drug molecule activation and penetration. To ensure stable acoustic energy output, a temperature and voltage detection module can also be installed internally. When the detected drive temperature exceeds a set threshold (e.g., 50°C), the power is automatically reduced or the output is stopped to ensure the long-term reliable operation of the device.

[0049] For easier understanding, please refer to Figure 3 , Figure 3This is a schematic diagram of an ultrasonic driving module provided in an embodiment of this application. As can be seen, the ultrasonic driving module 300 mainly includes a power supply module, a driving module, a control module, and a piezoelectric ceramic transducer. The power supply module provides stable DC or AC power to the split-type induction device. Its input terminal can be connected to an external power adapter or a built-in battery, and its output terminal supplies power to the driving module after being processed by a voltage regulator and filter circuit. The driving module converts the electrical energy provided by the power supply module into an AC signal of a specific frequency and amplitude to drive the piezoelectric ceramic transducer to generate ultrasonic vibrations. The driving module typically includes a signal modulation unit, a power amplification unit, and an impedance matching circuit. The control module manages and adjusts the output parameters of the driving module in real time. The control module can have a built-in microprocessor unit (MCU) or digital signal processor (DSP) to achieve adaptive control of the operating frequency by monitoring the voltage, current signals, and load impedance changes at both ends of the transducer. Specifically, the piezoelectric ceramic transducer, as the energy output terminal, converts the electrical signal generated by the driving module into mechanical vibration and couples the acoustic energy to the target skin area through the shell structure in contact with the patch module. Piezoelectric ceramic transducers also have excellent electromechanical coupling coefficient and heat resistance, and can vibrate stably at high frequencies and output a uniform sound field. When the output frequency of the drive module is consistent with the inherent resonant frequency of the transducer, the system is in the maximum power output state, and the cavitation effect and acoustic flow effect are most significant, which can significantly improve the diffusion rate and penetration depth of functional media.

[0050] In one possible embodiment, the ultrasonic driving module and the patch module are separate structures; the ultrasonic driving module is used to act on the intermediate milling groove of the patch module through the ultrasonic waves generated by the piezoelectric ceramic transducer, so that the functional carrier in the patch module forms a cavitation effect under the action of the ultrasonic waves, and / or forms an inlet channel structure in the target area.

[0051] The split structure physically separates the ultrasonic energy generation unit (i.e., the ultrasonic drive module) from the drug storage and release unit (i.e., the patch module). This allows the drive unit to be reused, while the patch module is a disposable consumable that can be replaced independently. This structure not only reduces the overall operating cost but also avoids contamination of electronic components by drug residues or skin secretions, improving the system's biosafety and ease of maintenance. The ultrasonic drive module and the patch module achieve precise mechanical alignment through limiting parts, bonding parts, and adhesive layers, thereby ensuring the directionality and stability of the ultrasonic waves along the energy transmission path.

[0052] When the piezoelectric ceramic transducer is working, it generates periodically alternating high-energy ultrasonic waves within a preset frequency range (preferably 40kHz to 120kHz). These ultrasonic waves propagate within the functional material in the milled groove of the patch module. As the sound pressure changes, a large number of microbubbles are formed inside the functional material (drug medium). When the bubbles periodically expand and contract with the sound field to a critical state, they collapse instantaneously, generating high temperature and microjets, thereby triggering cavitation. This cavitation effect can, on the one hand, disrupt the molecular association structure within the drug system, increasing the dispersion and diffusion coefficient of the active ingredient; on the other hand, it can generate local micro-perturbations at the interface between the drug and the skin, causing a short-term expansion of the intercellular spaces of the stratum corneum, forming a reversible delivery channel structure.

[0053] Specifically, after the user applies the patch module to the target skin area, the ultrasonic drive module is placed on top of it, and the limiting part automatically aligns with the outer edge of the patch module's anti-leakage component. After the ultrasonic drive module is activated, the piezoelectric ceramic transducer begins to vibrate at a set frequency. The acoustic energy is focused through the groove of the shell, penetrates the drug reservoir layer, and acts on the skin surface. Due to the focusing effect of the geometry of the central milled groove in the central area of ​​the patch module, the acoustic energy density is significantly enhanced in the bottom area of ​​the groove, thereby forming a stable cavitation zone locally. Under the action of cavitation, the drug medium is refined into high-kinetic-energy particles or molecular clusters. The activated drug molecules quickly penetrate into the subcutaneous tissue through the previously formed delivery channels, achieving efficient transdermal delivery.

[0054] In one possible embodiment, the functional material is loaded in a gel matrix; the gel matrix serves to provide a carrier for the functional material and to provide ultrasonic coupling.

[0055] The gel matrix can be a hydrogel. The three-dimensional network structure of the hydrogel can stably "encapsulate" functional substance molecules, preventing the active ingredients from becoming ineffective due to volatilization or degradation during storage and use. Simultaneously, the high water content and low acoustic impedance of the hydrogel make it a natural ultrasound coupling medium, establishing a continuous acoustic energy conduction pathway between the patch module and the skin without the need for additional coating with traditional coupling agents, thus improving portability and acoustic energy utilization. Furthermore, the microporous network structure inside the hydrogel can generate microscale flow and local cavitation effects under ultrasound, which helps to enhance drug diffusion rate and penetration depth.

[0056] In one possible embodiment, a microneedle array is further disposed on the first end face to form an enhanced molecular transport channel in the target region, thereby improving the permeability of the functional carrier.

[0057] The microneedle array comprises multiple microneedle units regularly distributed along the first end face. Each microneedle unit preferably has a needle length of 100 μm to 800 μm and a needle tip diameter of 10 μm to 30 μm. The microneedle array can be in the form of polymer microneedles or soluble microneedles, without limitation. Polymer microneedles are preferably made of medical-grade polylactic acid (PLA) or polyvinylpyrrolidone (PVP), which have good biocompatibility and can naturally degrade after forming micro-channels on the skin surface. This microneedle array mechanically penetrates the stratum corneum, temporarily disrupting the skin barrier structure and forming microchannels with a diameter of approximately 10 μm to 50 μm. This significantly reduces skin surface impedance and provides a direct channel for the rapid penetration of functional substances. The synergistic effect of the ultrasound generated by the microneedle array and the ultrasound drive module further amplifies the penetration-enhancing effect. When ultrasound acts on the skin with the formed microchannels, the sound pressure vibration can create periodic fluid disturbances within the channels, thereby enhancing the convection and diffusion rates of drug molecules within the microchannels. At this point, the drug not only diffuses passively based on its concentration gradient, but is also propelled by both acoustic radiation and microfluidic effects, achieving a combined permeation-enhancing mechanism of "acoustic diffusion + microneedle conduction." This synergistic effect can increase the drug permeation flux per unit time by 1.5 to 3 times, while significantly shortening the induction time for drug delivery, making it particularly suitable for functional substances with large molecular weights or strong polarity.

[0058] In one possible embodiment, the first housing is made of silicone and is used to fix the piezoelectric ceramic transducer and to position it with the target area via the fitting portion.

[0059] The first shell can be a solid structure or a mesh structure, without limitation. The silicone material is preferably medical-grade high-molecular-weight silicone rubber, which has excellent flexibility and elastic modulus matching characteristics. The acoustic impedance of silicone is between that of piezoelectric ceramics and biological tissue, effectively serving as acoustic buffer and energy transfer. Through the flexible deformation and bonding of the silicone material, the bonding part of the ultrasound drive module can be aligned with the target area of ​​the user's skin to achieve the function of fixing the ultrasound drive module. Compared with traditional rigid shells, the silicone shell can effectively absorb the structural stress caused by high-frequency vibrations during long-term use, preventing the generation of micro-cracks or local delamination, thereby extending the device's lifespan. The piezoelectric ceramic transducer is embedded in the groove of the silicone shell, and the inner wall of the shell can be provided with annular fixing ribs or local limiting posts to prevent transducer displacement under high-frequency operating conditions.

[0060] In one possible embodiment, when the ultrasonic driving module is started, the driving module receives a start command; the driving module responds to the start command by generating an AC signal of a preset frequency and transmits the AC signal to the piezoelectric ceramic transducer through the electrode leads; the frequency and voltage of the AC signal are determined according to the AC signal; the piezoelectric ceramic transducer responds to the frequency and voltage by generating ultrasonic waves, and the ultrasonic waves act on the functional material to produce a cavitation effect.

[0061] The piezoelectric ceramic transducer utilizes the inverse piezoelectric effect to convert the AC signal provided by the drive module into mechanical vibration. When the drive frequency approaches the transducer's natural resonant frequency, the amplitude of the piezoelectric element reaches its peak, resulting in the highest energy conversion efficiency. This mechanical vibration acts on the functional material region within the patch module, subjecting the drug reservoir layer to periodic acoustic pressure waves. Under the influence of ultrasound, microbubbles within the drug medium continuously expand and contract under alternating positive and negative pressure. When the bubble size reaches a critical radius, it instantaneously ruptures, generating localized microjets—a process known as cavitation. Cavitation effectively disrupts the binding structure between drug molecules, increasing their diffusion rate, while simultaneously creating short-term micro-perturbations on the stratum corneum of the skin, thereby forming reversible delivery channels to promote transdermal drug delivery.

[0062] Specifically, after receiving the user's start command, the control unit first performs frequency self-calibration and outputs an AC signal to the piezoelectric ceramic transducer. The piezoelectric ceramic transducer reaches steady-state amplitude within 1-2 milliseconds. Subsequently, the ultrasonic energy acts on the functional medium (a mixture of hydrogel and functional drug), causing cavitation and opening the skin's keratin channels in the target area. Furthermore, the electrical signal drive and closed-loop feedback control significantly improve the stability and repeatability of the ultrasonic output. By controlling the AC frequency and voltage, the piezoelectric ceramic transducer operates in a highly efficient resonant state, reducing energy loss and heat accumulation. This allows the ultrasound to form a stable cavitation zone within the drug reservoir layer, significantly improving drug activation efficiency and skin penetration, ensuring efficient energy conduction and penetration enhancement under safe and controllable conditions.

[0063] For easier understanding, please refer to Figure 4 , Figure 4This is a schematic diagram illustrating the collaborative operation of an ultrasonic driving module and a patch module according to an embodiment of this application. As can be seen, the ultrasonic driving module is connected to a piezoelectric ceramic transducer via electrode wires. The transducer is located in the center of a transparent silicone shell and is tightly fitted to the patch module, allowing the ultrasonic energy and the patch module to work together on the target area of ​​the skin, achieving targeted delivery and efficient penetration of functional substances. The circular transparent structure is the first shell of the ultrasonic driving module. This shell is made of medical-grade silicone material with high sound transmittance, possessing good flexibility and skin-friendliness, and can adhere tightly to the skin surface to ensure continuous sound wave transmission. The piezoelectric ceramic transducer is located in the center of the shell. Excited by the output signal from the driving module, it generates high-frequency vibrations, forming a stable ultrasonic sound field. The ultrasonic waves output by the transducer propagate to the functional carrier area of ​​the patch module below, forming a high-energy-density sound pressure zone at the contact interface. This causes drug molecules or active ingredients to be subjected to the dual effects of ultrasonic cavitation and acoustic flow, thereby accelerating their diffusion into the deeper layers of the skin. The patch module adheres closely to the skin surface. Its structure corresponds to the aforementioned plastic substrate, anti-permeability component, and functional carrier. The functional carrier can be a gel or liquid drug reservoir containing active ingredients. Under the action of ultrasound, the internal microbubbles are driven by alternating sound pressure to generate cavitation. The high shear force generated by the expansion and rupture of the bubbles causes short-term reversible loosening of the stratum corneum microstructure, forming microscale delivery channels, thereby significantly improving the transdermal rate and penetration depth of the drug. The presence of the anti-permeability component effectively restricts the horizontal diffusion of the drug, ensuring that energy is concentrated in the ultrasound action area, making the vertical penetration of the drug more directional and stable.

[0064] It is evident that by using a split-type ultrasonic delivery device, through the cooperation of the ultrasonic drive module and the patch module, on the one hand, the ultrasonic drive module can be reused for a long time, while the patch module is for single use, thereby reducing the user's cost during use; on the other hand, due to the split structure, the user only needs to attach the patch module to the target area during use, without having to wear the ultrasonic drive module with a certain hardness and thickness on the target area, thereby improving the user's portability.

[0065] After understanding the software and hardware architecture of this application, the following will be combined with... Figure 5 This application describes a split-type ultrasound delivery method according to an embodiment. Figure 5 This is a flowchart illustrating a split-type ultrasound delivery method provided in an embodiment of this application. The method is applied to a split-type ultrasound delivery device, which includes a reusable ultrasound drive module and a disposable patch module. The method specifically includes the following steps: Step S510: The ultrasonic driving module executes a first ultrasonic wave on the target area for a preset first time period, and the target area responds to the inlet channel formed by the first ultrasonic wave.

[0066] The target area is a specific skin site where the drug needs to be delivered transdermally, such as a muscle pain area, a fat accumulation area, or a dense hair follicle area. Identifying the target area allows for more targeted ultrasound-enhanced penetration and drug release, maximizing local efficacy and improving drug utilization. The target area can be determined by considering the user's symptoms, drug type, and skin tissue conditions. For example, when delivering analgesics, the preferred location is the subcutaneous muscle or joint area corresponding to the pain source; when delivering drugs that metabolize local fat, areas with abundant subcutaneous fat are preferred; and in hair loss prevention and hair regrowth applications, areas with a high density of hair follicles on the scalp are selected. The selection of the target area can be based on a doctor's prescription, an AI skin detection system, or user-defined settings. The patch module can be a ring-shaped drug patch module, including a medical pressure-sensitive adhesive layer and a central drug reservoir layer. The medical pressure-sensitive adhesive layer forms a stable adhesive bond with the skin surface, ensuring close contact between the drug reservoir layer and the target skin area, thus creating a closed drug action space. The base material of the patch module can be medical-grade polyurethane film or non-woven fabric, which has good flexibility and breathability, and can adapt to the curved structure of different body parts. The skin-facing side of the patch module has a medical pressure-sensitive adhesive. The adhesive layer thickness and adhesion strength are optimized based on the coefficient of friction of human skin and the amplitude of ultrasonic vibration to maintain stable adhesion without causing skin irritation. The central drug reservoir layer can be a gel, cream, or liquid drug carrier. The drug formulation can be adjusted according to the treatment target, such as analgesic, lipid metabolism, or growth-promoting drug formulations.

[0067] Specifically, the user first removes the protective layer from the back of the patch module to expose the medical pressure-sensitive adhesive surface. Then, the patch module is evenly applied to the designated target skin area. To ensure complete adhesion between the drug reservoir layer and the skin surface, the center of the patch can be gently pressed during application to expel air and create uniform contact. For uneven skin surfaces, the edges of the patch module automatically adapt through a microstructured elastic layer, maintaining a horizontal distribution of the drug reservoir layer. After application, a closed microenvironment is formed between the outer periphery of the patch module and the skin, facilitating the local accumulation and absorption of drug components within the target area.

[0068] Step S520: The first ultrasonic wave is applied to the patch module through the ultrasonic driving module to activate the functional material in the patch module and obtain activated material molecules.

[0069] The ultrasonic drive module includes a piezoelectric ceramic transducer, a drive circuit, and a control unit housed within the casing. Driven by the control unit, the piezoelectric ceramic transducer vibrates, generating low-frequency ultrasound waves in the range of 20kHz to 200kHz. This frequency range induces a significant cavitation effect between the stratum corneum and the drug reservoir layer, causing the solvent in the drug reservoir to form numerous microbubbles. These microbubbles rupture under periodic ultrasonic compression and rarefaction, generating transient high-pressure microjets that disrupt the dense structure of the stratum corneum, forming multiple transient penetration channels, which serve as delivery channels. The preset first time period can be dynamically set according to the skin characteristics of the target area and the type of drug, typically ranging from 5 to 15 minutes. If the action time is too short, the number of cavitation bubbles will be insufficient, and channel formation will be incomplete; if the action time is too long, it may lead to excessive heating or slight redness and swelling of the local tissue. Therefore, the system uses a temperature control and energy feedback mechanism to adjust the output power in real time, ensuring that the skin surface temperature is maintained within the range of 35℃ to 42℃, thus achieving a balance between penetration efficiency and safety.

[0070] The functional substance is an active drug ingredient stored in the drug reservoir layer of the patch module. Its form can be gel, cream or aqueous solution, which is not limited here. Under static conditions, the molecular motion rate of the functional substance is low and it is difficult to penetrate the stratum corneum of the skin quickly. By applying the first ultrasound, high-frequency mechanical vibration and microscale cavitation effect can be generated inside the drug carrier, thereby significantly improving the energy state and diffusion rate of the drug molecules, and transforming them into activated substance molecules with higher kinetic energy and stronger permeability.

[0071] Specifically, the first time period can be executed synchronously with the aforementioned infusion channel. The output power and frequency parameters are set via a control unit; for example, the output power density is adjustable from 0.5 W / cm² to 2.0 W / cm², and the frequency is from 40 kHz to 120 kHz. Under the action of ultrasound, the fluid medium inside the drug reservoir layer undergoes localized flow. The active ingredients are gradually excited by the ultrasound energy, the intermolecular distance increases, the system viscosity temporarily decreases, and the drug molecules are in a high-energy diffusion state. At this time, the activated substance molecules migrate along the concentration gradient and the direction of acoustic radiation force on the skin surface under the drive of ultrasound energy.

[0072] It should be noted that the generation of activated substance molecules is a non-chemical process achieved through physical energy excitation. It does not involve the decomposition or chemical modification of drug components. Its main purpose is to improve the molecular kinetic energy and diffusion activity of the drug system, so that the active ingredients are distributed in an "excited state" at the microscopic level, thereby maintaining continuous penetration ability after the ultrasound stops.

[0073] Step S530: The activated substance molecules are permeated into the target area through the ultrasonic drive module.

[0074] In this process, the ultrasound-driven module, during the application of the first ultrasound wave, utilizes its acoustic flow effect to push the activated drug molecules from the patch module to the surface of the stratum corneum. The alternating positive and negative pressure cycles generated by the ultrasound wave cause the drug molecules to oscillate reciprocally in the medium. When the amplitude exceeds the interfacial impedance threshold of the stratum corneum, the molecules can enter the delivery channel through the microjets, effectively penetrating the skin barrier. Thus, the activated substance molecules are directionally delivered to the subcutaneous epidermis and superficial dermis, achieving rapid drug delivery.

[0075] Step S540: When the first time period is less than a preset time threshold, the first ultrasonic wave continues to be applied to the patch module through the ultrasonic driving module; when the first time period is greater than or equal to the time threshold, after the ultrasonic driving module is removed, the activated substance molecules in the patch module continue to penetrate into the target area through the inlet channel to assist the introduction of the functional substance in the patch module into the target area.

[0076] The ultrasound-driven module continuously outputs a first ultrasound wave during the first time period to keep the drug delivery channels on the skin surface open. The energy density of the first ultrasound wave is relatively high (preferably 0.8 W / cm²-1.5 W / cm²), mainly through cavitation and acoustic flow effects to create a significant penetration-enhancing effect, allowing drug molecules to gain sufficient kinetic energy to break through the stratum corneum barrier in a short time. As the duration of the first ultrasound wave application increases to a preset threshold, the structure of the delivery channels in the local skin tissue tends to stabilize, and the channel pore size and depth reach an optimal state. The preset time threshold is adjusted according to actual needs, and is generally set to 10-15 minutes. During the passive penetration phase, the hydrogel matrix in the patch module acts as a drug reservoir, continuously releasing activating molecules based on its high water content and porous structure. Since the delivery channels do not close in a short time, drug molecules in the hydrogel, driven by the concentration gradient, continuously diffuse into the deeper layers of the skin through the formed microchannels. This process does not require additional acoustic energy to maintain and can still achieve long-term drug release by relying on the concentration difference between the inside and outside of the skin.

[0077] Specifically, the control unit of the ultrasound drive module automatically determines whether the first time period has reached the threshold based on the monitored time parameters. When the time is insufficient, the piezoelectric ceramic transducer maintains the ultrasound output state to ensure stable channel expansion. When the threshold is reached, the drive module automatically shuts off the ultrasound output and can also prompt the user to remove the ultrasound drive module. At this time, the patch module remains in place, and the activated molecules inside continue to penetrate the skin under the residual concentration gradient and capillary diffusion, realizing a continuous delivery mechanism from active penetration to passive extended release.

[0078] As can be seen, with the above-mentioned split-type ultrasound delivery method, users do not need to apply additional coupling agent during the entire process. In addition, the ultrasound waves act directly on the drug and skin without the loss of intermediate media. At the same time, the expensive electronic parts (drive module) can be reused for a long time, and the inexpensive consumables (ring-shaped medicated patch) are disposable, thereby improving portability and reducing the cost for users.

[0079] The following is combined Figure 6 The split-type ultrasound delivery device in the embodiments of this application will be described. Figure 6 This is a schematic diagram of the structure of a split-type ultrasound delivery device provided in an embodiment of this application, as shown below. Figure 6 As shown, the split-type ultrasound delivery device 600 includes one or more processors 610, a memory 620, a communication interface 630, and one or more programs 621. The processor 610 is connected to the memory 620 and the communication interface 630 via an internal communication bus.

[0080] The one or more programs 621 are stored in the memory 620 and configured to be executed by the processor 610. The one or more programs 621 include functions for performing the aforementioned... Figure 5 Instructions for any step in an embodiment of a split-type ultrasound delivery method.

[0081] The processor 610 can be a central processing unit (CPU), a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other programmable logic devices, transistor logic devices, hardware components, or any combination thereof. It can implement or execute the various exemplary logic blocks, cells, and circuits described in conjunction with the disclosure of this application. The processor can also be a combination that implements computational functions, such as a combination of one or more microprocessors, a combination of a DSP and a microprocessor, etc. The communication unit can be a communication interface, a transceiver, a transceiver circuit, etc., and the storage unit can be a memory.

[0082] The memory 620 can be volatile memory or non-volatile memory, or it can include both. The non-volatile memory can be read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), or flash memory. The volatile memory can be random access memory (RAM), which is used as an external cache. By way of example, but not limitation, many forms of random access memory (RAM) are available, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate synchronous DRAM (DDR SDRAM), enhanced synchronous DRAM (ESDRAM), synchronous linked DRAM (SLDRAM), and direct rambus RAM (DR RAM).

[0083] It is understood that the split-type ultrasound delivery device may include more or fewer structural components than those shown in the above block diagram, such as a power module, physical buttons, a Wi-Fi module, a speaker, a Bluetooth module, a sensor, and a display module, etc., without limitation. It is understood that this split-type ultrasound delivery device can be equipped with... Figure 1 The structure of the split-type ultrasound delivery device is shown.

[0084] The above mainly describes the solutions of the embodiments of this application from the perspective of the method execution process. It is understood that, in order to achieve the above functions, the split-type ultrasound implantation device includes hardware structures and / or software modules corresponding to the execution of each function. Those skilled in the art should readily recognize that, in conjunction with the units and algorithm steps of the various examples described in the embodiments provided herein, this application can be implemented in hardware or a combination of hardware and computer software. Whether a function is executed in hardware or by computer software driving hardware depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0085] This application embodiment can divide the split-type ultrasound induction device into functional units according to the above method example. For example, each function can be divided into separate functional units, or two or more functions can be integrated into one processing unit. The integrated unit can be implemented in hardware or software functional units. It should be noted that the unit division in this application embodiment is illustrative and only represents one logical functional division. In actual implementation, there may be other division methods.

[0086] When dividing each function into modules according to its corresponding function. Figure 7 This is a functional block diagram of an ultrasonic implantation device 700 provided in an embodiment of this application. The ultrasonic implantation device includes a reusable ultrasonic drive module and a disposable patch module. The ultrasonic implantation device 700 includes: Control unit 710 is used to execute a first ultrasonic wave on a target area for a preset first time period through the ultrasonic drive module, wherein the target area responds to the inlet channel formed by the first ultrasonic wave; The determining unit 720 is used to apply the first ultrasonic wave to the patch module through the ultrasonic driving module to activate the functional material in the patch module and obtain activated material molecules; and to penetrate the activated material molecules into the target area through the ultrasonic driving module. The execution unit 730 is configured to continue applying the first ultrasonic wave to the patch module through the ultrasonic driving module when the first time period is less than a preset time threshold; when the first time period is greater than or equal to the time threshold, after removing the ultrasonic driving module, the activated substance molecules in the patch module continue to penetrate into the target area through the inlet channel to assist the introduction of the functional substance in the patch module into the target area.

[0087] As can be seen, the ultrasound delivery device provided in this application determines a target area on the user's skin, fixes a patch module to the target area, and applies a first ultrasound wave for a preset first time period to the target area through an ultrasound drive module to obtain a delivery channel. The delivery channel is a channel formed in the target area after the ultrasound wave acts on it. The first ultrasound wave for the first time period is applied to the patch module through the ultrasound drive module to activate the functional material in the patch module, obtaining activated substance molecules. The activated substance molecules are then penetrated into the target area through the ultrasound drive module. In this way, the penetration efficiency of the functional material (drug) is improved, while also increasing the user's portability and reducing the user's cost.

[0088] This application also provides a split-type ultrasound induction system, wherein the split-type ultrasound induction system includes any part as described in the above embodiment of a split-type ultrasound induction device.

[0089] This application also provides a computer program product, which includes a non-transitory computer-readable storage medium storing a computer program operable to cause a computer to perform some or all of the steps of any of the methods described in the above method embodiments. The computer program product may be a software installation package, and the computer includes a split-type ultrasound implantation device.

[0090] It should be noted that, for the sake of simplicity, the above embodiments are all described as a series of actions. Those skilled in the art should understand that this application is not limited to the described order of actions, as some steps in the embodiments of this application can be performed in other orders or simultaneously. Furthermore, those skilled in the art should also understand that the embodiments described in the specification are preferred embodiments, and the actions, steps, modules, or units involved are not necessarily essential to the embodiments of this application.

[0091] In the above embodiments, the descriptions of each embodiment in this application have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0092] Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. This program can be stored in a computer-readable storage medium, and when executed, it can include the processes described in the above method embodiments. The aforementioned storage medium includes various media capable of storing program code, such as ROM or random access memory (RAM), magnetic disks, or optical disks.

[0093] The steps of the methods or algorithms described in the embodiments of this application can be implemented in hardware or by a processor executing software instructions. The software instructions can consist of corresponding software modules, which can be stored in RAM, flash memory, ROM, EPROM, electrically erasable programmable read-only memory (EEPROM), registers, hard disk, portable hard disk, read-only optical disk (CD-ROM), or any other form of storage medium well known in the art. An exemplary storage medium is coupled to a processor, enabling the processor to read information from and write information to the storage medium. Of course, the storage medium can also be a component of the processor. The processor and storage medium can reside in an ASIC. Furthermore, the ASIC can reside in a terminal device or management device. Alternatively, the processor and storage medium can exist as discrete components in the terminal device or management device.

[0094] Those skilled in the art will recognize that, in one or more of the examples above, the functions described in the embodiments of this application can be implemented, in whole or in part, by software, hardware, firmware, or any combination thereof. When implemented in software, it can be implemented, in whole or in part, as a computer program product. This computer program product includes one or more computer instructions. When these computer program instructions are loaded and executed on a computer, all or part of the processes or functions described in the embodiments of this application are generated. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, the computer instructions can be transmitted from one website, computer, server, or data center to another via wired (e.g., coaxial cable, fiber optic, digital subscriber line (DSL)) or wireless (e.g., infrared, microwave, etc.) means. The computer-readable storage medium can be any available medium accessible to a computer or a data storage device such as a server or data center that integrates one or more available media. The available media can be magnetic media (e.g., floppy disks, hard disks, magnetic tapes), optical media (e.g., digital video discs (DVDs)), or semiconductor media (e.g., solid-state disks (SSDs)).

[0095] The modules / units included in the various devices and products described in the above embodiments can be software modules / units, hardware modules / units, or a combination of both. For example, for devices and products applied to or integrated into a chip, all modules / units can be implemented using hardware methods such as circuits, or at least some modules / units can be implemented using software programs that run on a processor integrated within the chip, while the remaining (if any) modules / units can be implemented using hardware methods such as circuits. For devices and products applied to or integrated into a chip module, all modules / units can be implemented using hardware methods such as circuits. Different modules / units can be located in the same component (e.g., chip, circuit module, etc.) or different components of the chip module, or at least some modules / units can be implemented using hardware methods such as circuits. The implementation is achieved through a software program that runs on the processor integrated within the chip module. The remaining modules / units (if any) can be implemented using hardware methods such as circuits. For various devices and products applied to or integrated into terminal equipment, each of their modules / units can be implemented using hardware methods such as circuits. Different modules / units can be located in the same component (e.g., chip, circuit module, etc.) or different components within the terminal equipment. Alternatively, at least some modules / units can be implemented through a software program that runs on the processor integrated within the terminal equipment, while the remaining modules / units (if any) can be implemented using hardware methods such as circuits.

[0096] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the embodiments of this application. It should be understood that the above descriptions are merely specific embodiments of the embodiments of this application and are not intended to limit the protection scope of the embodiments of this application. Any modifications, equivalent substitutions, improvements, etc., made on the basis of the technical solutions of the embodiments of this application should be included within the protection scope of the embodiments of this application.

Claims

1. A split-type ultrasonic induction device, characterized in that, include: An ultrasonic driving module includes a first housing of a preset shape and a piezoelectric ceramic transducer disposed in a groove portion of the first housing. The first housing includes the groove portion, a limiting portion extending outward along the edge of the groove portion, and a fitting portion extending outward along the edge of the limiting portion. Functional carrier; the functional carrier includes a functional substance and a gel matrix.

2. The split-type ultrasonic induction device as described in claim 1, characterized in that, The split-type ultrasonic induction device also includes a patch module, which includes: a plastic substrate and a seepage-proof component with a central milled groove disposed on the first end face of the plastic substrate. The first end face of the plastic substrate is entirely provided with a first adhesive layer, and the second end face of the plastic substrate relative to the first end face, excluding the central milled groove, is provided with a second adhesive layer. Wherein, the first end face of the plastic substrate is provided with the intermediate milled groove of the anti-seepage component for placing the functional carrier, the first end face of the plastic substrate with the first adhesive layer removed is used to adhere to the target area, the limiting part is used to cooperate with the anti-seepage component to form a first fit state, and the adhering part is used to adhere to the second end face of the patch module with the second adhesive layer removed to form a second fit state.

3. The split-type ultrasonic induction device as described in claim 2, characterized in that, Both the first adhesive layer and the second adhesive layer are provided with medical-grade pressure-sensitive adhesive; the second adhesive layer is used to adsorb the bonding part of the first housing so that the relative position between the ultrasonic drive module and the patch module does not become misaligned.

4. The split-type ultrasonic induction device as described in claim 2, characterized in that, The first and second adhesive layers are made of PU film; the anti-seepage component is made of PE material; the anti-seepage component is used to prevent the functional carrier from horizontally leaking out, and in the first mating state, the ultrasonic drive module is assembled with the anti-seepage component; the plastic substrate is made of the PU film or non-woven fabric, and the plastic substrate is used to support the functional carrier and maintain a close fit with the target area.

5. The split-type ultrasonic induction device as described in claim 1, characterized in that, The ultrasonic driving module further includes a power supply module and a driving module; the driving module is connected to the piezoelectric ceramic transducer via an electrode wire of a preset length, or the driving module is integrated on the piezoelectric ceramic transducer; the power supply module and the driving module are connected via an electrical wire. The piezoelectric ceramic transducer is used to generate ultrasonic waves of the first frequency; The drive module is used to receive electrical energy transmitted by the power module and drive the piezoelectric ceramic transducer to generate ultrasonic waves at a preset frequency. The power module is used to provide electrical energy to the drive module.

6. The split-type ultrasonic induction device as described in claim 2, characterized in that, The ultrasonic driving module and the patch module are separate structures; the ultrasonic driving module is used to act on the intermediate milling groove of the patch module through the ultrasonic waves generated by the piezoelectric ceramic transducer, so that the functional carrier in the patch module forms a cavitation effect under the action of the ultrasonic waves, and / or forms an inlet channel structure in the target area.

7. The split-type ultrasonic induction device according to any one of claims 1-6, characterized in that, The functional substance is loaded in a gel matrix, which serves as a carrier for the functional substance and provides ultrasonic coupling.

8. The split-type ultrasonic induction device as described in claim 2, characterized in that, The first end face is also provided with a microneedle array, which is used to form an enhanced molecular transport channel in the target area to improve the permeability of the functional carrier.

9. The split-type ultrasonic induction device according to any one of claims 1-6, characterized in that, The first housing is made of silicone and is used to fix the piezoelectric ceramic transducer and to position it with the target area through the bonding part.

10. The split-type ultrasonic induction device according to any one of claims 1-6, characterized in that, When the ultrasonic driving module is started, the driving module receives a start command; the driving module responds to the start command by generating an AC signal of a preset frequency and transmits the AC signal to the piezoelectric ceramic transducer through the electrode leads; the frequency and voltage of the AC signal are determined according to the AC signal; the piezoelectric ceramic transducer responds to the frequency and voltage to generate ultrasonic waves, and the ultrasonic waves act on the functional material to produce a cavitation effect.

11. A split-type ultrasound delivery method, characterized in that, The method, applicable to a split-type ultrasound delivery device, comprising a reusable ultrasound drive module and a disposable patch module, includes: The ultrasonic driving module applies a first ultrasonic wave to the target area for a preset first time period, and the target area responds to the inlet channel formed by the first ultrasonic wave. The first ultrasonic wave is applied to the patch module by the ultrasonic driving module to activate the functional material in the patch module and obtain activated material molecules. The activated substance molecules are penetrated into the target area via the ultrasonic driving module. When the first time period is less than a preset time threshold, the first ultrasonic wave continues to be applied to the patch module through the ultrasonic driving module; when the first time period is greater than or equal to the time threshold, after the ultrasonic driving module is removed, the activated substance molecules in the patch module continue to penetrate into the target area through the inlet channel to assist the introduction of the functional substance in the patch module into the target area.

12. A split-type ultrasound delivery system, characterized in that, The split-type ultrasound induction system includes the split-type ultrasound induction device as described in any one of claims 1-10.

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