A self-service mini human natural cavity ultrasonic drug delivery device and its preparation method

Abstract

This invention discloses a self-administered mini ultrasonic drug delivery device for natural human cavities and its preparation method, belonging to the field of medical device technology. It aims to solve the problems of existing drug delivery devices, such as inability to reach deep lesions within cavities, complex operation leading to easy cavity damage, poor drug retention, and low compatibility. The drug delivery device includes a base, a pluggable cleaner, an ultrasonic drug delivery device, and a cooling body. The core components are made of medical-grade silicone and medical-grade polyethylene. The piezoelectric transducer achieves drug penetration up to 30cm at frequencies of 0.5-50MHz. It integrates temperature monitoring and detachment alarm, and features a cleaner for cleaning and collecting liquid, and a cooling body for locking in the drug. Its modular design allows for adaptation to multiple cavities such as the oral cavity, nasal cavity, and external auditory canal. This invention achieves non-invasive, self-administered, and precise drug delivery, avoiding cavity damage, achieving high drug retention rates, meeting IP67 waterproof and dustproof standards and medical standards, and is reusable. It effectively shortens the healing time for cavity diseases and has high clinical application value.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a self-service mini human natural cavity ultrasonic drug delivery device and its preparation method. Background Technology

[0002] In the field of treating diseases of the human body's natural cavities, drug delivery devices are the core tools for achieving local drug delivery. Currently available natural cavity drug delivery devices generally suffer from the dual technical limitations of being unable to reach deep lesions and having insufficient safety for self-use:

[0003] On the one hand, most drug delivery devices rely on natural drug diffusion or simple push-to-deliver methods, lacking effective deep penetration methods. Drugs can only act on the superficial layer of the cavity, and cannot effectively cover lesions deeper than 10cm in the cavity, resulting in prolonged treatment cycle and high recurrence rate.

[0004] On the other hand, a few drug delivery devices that can reach deeper lesions have complex structural designs and must be operated by professional medical staff, which cannot meet the needs of patients for self-treatment at home. This is especially true for busy teenagers, elderly patients with limited mobility, or people who are unwilling to visit the hospital frequently due to privacy concerns. The operating threshold of existing devices greatly limits the convenience of treatment.

[0005] Meanwhile, the existing drug delivery device has obvious design flaws in its inlet and outlet structures:

[0006] The insertion end is mostly made of hard plastic or single-curve silicone, which has a large difference in hardness from the mucous membrane of human body cavities. When inserted into the cavity, it is easy to scratch the mucous membrane and cause secondary damage. When withdrawing from the cavity, it lacks anti-friction structure, and the inner lining of the cavity is easily pulled as the instrument is withdrawn, which further increases the patient's pain and risk of infection.

[0007] The aforementioned technical contradictions—insufficient depth, inconvenient operation, and damage to the mucosa—have become the core bottleneck restricting the development of natural cavity drug delivery technology. Existing technologies have not yet proposed a solution that can balance deep lesion drug delivery with patient self-operation safety. Summary of the Invention

[0008] One objective of this invention is to propose a self-administered mini ultrasound drug delivery device for natural human cavities and its preparation method. This invention can precisely reach lesions at depths within cavities that existing drug delivery devices cannot reach, supporting patients to administer drugs themselves under the guidance of doctors. The needle-free design reduces pain and cavity damage, and it combines precise ultrasound drug delivery with physical therapy functions. The device integrates temperature monitoring, detachment alarm, and multi-parameter adjustment, and is equipped with a cleaner and a refrigeration unit. Through modular design, it can be adapted to multiple natural cavities, is reusable and portable, and can shorten the treatment time for cavity diseases.

[0009] According to an embodiment of the present invention, a self-service mini human natural cavity ultrasonic drug delivery device includes a base, a cooling body, a cleaner that can be plugged into and assembled in the central channel of the base, and an ultrasonic drug delivery device.

[0010] The base has a guide push head, an expander and a control switch arranged sequentially from the front end to the rear end along the axial direction. The guide push head is fixedly connected to the front end of the base. The expander is coaxially arranged behind the guide push head and slidably connected to the base. The control switch is fixed at the rear end of the base and is linked with the expander through a built-in transmission structure.

[0011] The ultrasonic drug delivery device is provided with a drug storage agent, a piezoelectric transducer and a controller in sequence from the front end to the rear end along the axial direction. The drug storage agent is fixedly connected to the front end of the ultrasonic drug delivery device. The piezoelectric transducer is wrapped with medical silicone and coaxially fixed to the rear end of the drug storage agent. The controller is fixed to the rear end of the ultrasonic drug delivery device in the form of a handle. The controller integrates an ultrasonic circuit board and is electrically connected to the piezoelectric transducer.

[0012] The cooling body is an independent cylindrical structure that can be pushed into the vicinity of the lesion through the central channel of the base after the ultrasonic drug delivery device is withdrawn.

[0013] Furthermore, the guide propulsion head is integrally molded from medical-grade silicone without the need for plasticizers or other additives. The guide propulsion head has a bidirectional umbrella-shaped structure, with the ends of the umbrella ribs fixedly connected to the inner wall of the front end of the base. The expansion body is a three-dimensional silicone column structure with the same silicone material as the guide propulsion head. The lower end of the expansion body is fixedly connected to the transmission rod inside the base via a radial connecting rod. The transmission rod extends axially along the base and is fixedly connected to the knob of the control switch. Rotating the control switch can drive the transmission rod to move the expansion body radially. The housing of the control switch is injection molded from medical-grade polyethylene material, with an internal thread structure adapted to the transmission rod and an external anti-slip texture.

[0014] Furthermore, the cleaner is integrally molded from medical-grade polyethylene material, and its structure is syringe-type, including a needle body, a push rod, and a sealing piston that are axially fitted.

[0015] The front end of the needle body is closed and has 3-5 small holes for drug penetration evenly opened in the circumference. The rear end of the needle body is provided with a push rod inlet. The sealing piston is fixed to the front end of the push rod and slides and seals with the inner wall of the needle body.

[0016] The cleaner is also equipped with a drainage bag, which is connected to a waste liquid outlet on the side wall of the substrate through a flexible pipe. The waste liquid outlet is located behind the expander and is connected to the central channel of the substrate to collect cleaning waste liquid.

[0017] Furthermore, the drug storage agent is a disposable component, injection molded from medical-grade polyethylene material, with an internal drug-containing cavity and an external sealing ring adapted to the central channel of the substrate.

[0018] The drug storage agent has a mounting hole at its rear center. The front end of the piezoelectric transducer is embedded in the mounting hole and fixed with medical adhesive. The medical silicone covering the piezoelectric transducer is flush with the outer wall of the drug storage agent. When the ultrasonic frequency of the piezoelectric transducer is adjusted to 0.5-50MHz, the drug can penetrate into the lesion through the drug outlet at the front end of the drug storage agent, with a penetration depth of up to 30cm. The drug receiving cavity is filled with the drug delivery agent.

[0019] Furthermore, the handle-type housing of the controller is made of medical-grade polyethylene material, and an LED temperature display screen is embedded on its surface. Below the LED temperature display screen are two operation buttons, namely a main switch for controlling the start and stop of the ultrasonic drug delivery device and a manual temperature control switch for adjusting the drug delivery temperature.

[0020] The controller contains an ultrasonic circuit board, a temperature sensor, and a disconnection alarm module, which are fixed sequentially along the axial direction. The detection end of the temperature sensor extends through a wire into the silicone coating layer of the piezoelectric transducer. The temperature sensor is electrically connected to the LED temperature display and the temperature control switch. When the detected temperature reaches 36-40℃, the temperature control switch automatically cuts off the circuit between the ultrasonic circuit board and the piezoelectric transducer.

[0021] The disconnection alarm module is connected in series with the power supply circuit of the piezoelectric transducer. When the piezoelectric transducer becomes detached from the drug storage agent or has poor contact, the disconnection alarm module triggers an audible and visual alarm and cuts off the main power supply within 5 seconds.

[0022] Furthermore, the cooling body is made of medical-grade silicone vulcanized molding, and its outer diameter is adapted to the inner diameter of the central channel of the substrate, and its length is 3-5cm.

[0023] Before use, the cooling body needs to be refrigerated to 0-8℃. After the ultrasonic drug delivery device is completely withdrawn from the central channel of the matrix, push the cooling body along the central channel of the matrix to the vicinity of the lesion, stay for 1-30 seconds, and then withdraw along the original channel.

[0024] The low-temperature stimulation of the cooling body causes the cavity muscles to contract, which can lock the drug in and isolate external foreign objects.

[0025] Furthermore, the inner wall of the central channel of the substrate is provided with a sealing groove, and a medical silicone sealing ring is embedded in the sealing groove. The sealing ring is press-fitted with the outer wall of the needle body of the cleaner and the outer wall of the drug storage agent of the ultrasonic drug delivery device. The end of the handle of the controller is provided with a USB charging interface, which is electrically connected to the lithium battery inside the controller.

[0026] Furthermore, the ultrasonic circuit board is equipped with a parameter adjustment module, which is electrically connected to a hidden knob on the surface of the controller. This module allows for the adjustment of ultrasonic parameters, including:

[0027] The effective sound intensity is 0-3 W / cm 2 It is adjustable in 3 levels, with a frequency of 0.5-5MHz±10% and supports frequency conversion adjustment. The duty cycle can be selected as 10%, 25% or 50%, and the working mode is continuous ultrasound mode.

[0028] The ultrasonic drug delivery device supports switching between two working modes: a standalone ultrasonic physical mode and a combined ultrasonic physical and drug delivery mode. In the standalone ultrasonic physical mode, the piezoelectric transducer only outputs ultrasonic waves. In the combined ultrasonic physical and drug delivery mode, while the piezoelectric transducer outputs ultrasonic waves, the drug storage agent achieves quantitative drug release through ultrasonic vibration.

[0029] The parameter adjustment module can also control the ultrasound amplitude in real time. By adjusting the MEP inhibition effect, it can precisely regulate the excitability of specific deep lesions in the cavity and accelerate drug absorption.

[0030] Furthermore, the outer surface of the guide propulsion head may be selectively fitted with a food-grade medical silicone layer, and the food-grade medical silicone layer is fixed to the guide propulsion head body by a hot pressing process;

[0031] Flexible metal wires can be selectively embedded in the silicone layer of the guide propulsion head, and 2-3 miniature LED lights can be selectively embedded in the sidewall of the guide propulsion head along the axial direction. The miniature LED lights are electrically connected to the lithium battery inside the controller through wires.

[0032] A ring-shaped temperature difference adjustment module can be installed near the expansion body on the substrate. The ring-shaped temperature difference adjustment module is a hollow metal ring structure. Its inner wall is attached to the outer wall of the expansion body, and its outer wall is fixedly connected to the side wall of the substrate. The ring-shaped temperature difference adjustment module is electrically connected to the temperature control chip inside the controller through a wire, and the temperature adjustment range of the ring-shaped temperature difference adjustment module is 32-40℃.

[0033] A method for preparing a self-service mini human natural cavity ultrasonic drug delivery device includes the following steps:

[0034] Step 1: Prepare the substrate. First, use medical-grade silicone with a hardness of 5A or lower to injection mold a bidirectional umbrella-shaped guide propulsion head. Then, bond and fix the umbrella end of the guide propulsion head to the inner wall of the front end of the substrate. Next, use the same medical-grade silicone to injection mold a three-dimensional expansion body. Weld the lower end of the expansion body to the radial connecting rod. The radial connecting rod is connected to the axial transmission rod through a pin. Finally, use medical-grade polyethylene material to injection mold the substrate shell and the control switch shell. Insert the axial transmission rod into the interior of the substrate shell. Its end is fixed to the knob of the control switch through threads. Finally, weld and seal the control switch shell to the outer end of the substrate shell.

[0035] Step 2: Prepare the cleaner. First, use medical polyethylene material to injection mold the syringe-type needle body and push rod. Drill 3-5 small drug-penetrating holes with a diameter of 0.5mm around the front end of the needle body. Then, fix the sealing piston made of medical rubber to the front end of the push rod with an interference fit. Next, assemble the push rod into the needle body. Finally, use transparent medical plastic to make a drainage bag. Heat seal the interface of the drainage bag to the flexible tube. The other end of the flexible tube is connected to the waste liquid outlet on the side wall of the base through a thread.

[0036] Step 3: Prepare the ultrasonic drug delivery device. First, use medical-grade polyethylene material to injection mold a disposable drug storage agent. A mounting hole adapted to a piezoelectric transducer is made at the center of its rear end. Then, the piezoelectric transducer is embedded into the mounting hole and fixed with medical-grade epoxy adhesive. Next, medical-grade silicone is vulcanized and wrapped around the piezoelectric transducer, making the silicone layer flush with the outer wall of the drug storage agent. Then, a controller handle housing is injection molded using medical-grade polyethylene material. The ultrasonic circuit board, lithium battery, temperature sensor, and disengagement alarm module are fixed inside the housing with screws. The ultrasonic circuit board is electrically connected to the piezoelectric transducer, temperature sensor, disengagement alarm module, and external operation buttons via wires. Finally, the LED temperature display screen is glued to the surface of the housing. Finally, a cooling body is vulcanized using medical-grade silicone, ensuring its outer diameter matches the inner diameter of the central channel of the substrate.

[0037] Step 4: Overall assembly and optimization. Assemble the base, cleaner, and ultrasonic drug delivery device using a plug-in structure, ensuring an interference fit between the seal ring of the cleaner, ultrasonic drug delivery device, and the central channel of the base. Connect the ultrasonic circuit board and parameter adjustment module, optimize the ultrasonic wave shape and frequency parameters, and ensure that the alarm module responds to faults within 5 seconds after disconnection through debugging.

[0038] Step 5: Disinfection treatment. The assembled substrate and ultrasonic drug delivery device are disinfected with ethylene oxide, and the cooling body is disinfected with gamma rays. After disinfection, the equipment is sealed and packaged to ensure that it can be reused.

[0039] The beneficial effects of this invention are:

[0040] 1. In this invention, a piezoelectric transducer and an adaptive cavity self-service structure are designed in synergy. The piezoelectric transducer can achieve a drug penetration depth of up to 30cm at a frequency of 0.5-50MHz. At the same time, it is equipped with a bidirectional umbrella-shaped guide propulsion head and a three-part three-dimensional expander. When entering the cavity, the umbrella-shaped head unfolds in the forward direction to reduce resistance, and when exiting, it folds in the reverse direction to avoid friction against the mucosa. The expander is driven by a control switch to support the folded tissue, so that the drug can be accurately applied to the deep lesion. This design can organically integrate ultrasound deep penetration technology with ergonomic self-service cavity structure, and solve the core contradiction in the prior art that depth and self-service safety cannot be taken into account at the same time.

[0041] 2. This invention forms a closed loop through multi-dimensional safety design. In terms of materials, the guide and propulsion head and the expansion body are made of medical-grade silicone with a hardness close to that of human mucous membranes, achieving a balance between softness and strength without the addition of plasticizers. The control switch and drug storage agent are made of medical-grade polyethylene with strong chemical stability, avoiding biocompatibility risks. In terms of structure, the cleaner achieves lesion cleaning and waste fluid collection through drug-permeable holes and drainage bags, preventing contamination. In terms of function, after drug administration, the refrigeration cooling body is pushed in, using low temperature to stimulate the contraction of the cavity muscles, locking the drug and isolating foreign objects, thus prolonging the efficacy.

[0042] 3. This invention integrates a three-in-one control system for temperature control, alarm, and parameter adjustment. For temperature control, a temperature sensor monitors the piezoelectric transducer temperature in real time, automatically cutting off the circuit when the temperature reaches 36-40℃. It also supports manual adjustment from 32-40℃ to accommodate different cavity temperature tolerances. For safety alarms, the disconnection alarm module uses a current detection chip to identify poor contact in the piezoelectric transducer, triggering an audible and visual alarm and power-off within 5 seconds to prevent erroneous ultrasonic output. For parameter adjustment, the ultrasonic circuit board supports adjustable effective sound intensity, frequency, and duty cycle, and supports switching between standalone ultrasonic physical therapy and combined ultrasonic and drug delivery therapy modes. This solves the industry pain points of unmonitored safety and unadapted parameters in self-service equipment. Its integration and adaptability are unconventional design approaches in this field.

[0043] 4. This invention adopts a modular design. While maintaining a unified main structure, the guide and propulsion head and the base are customizable to adapt to the physiological characteristics of different cavities. For the oral / nasal cavity, the guide and propulsion head is fitted with a food-grade medical silicone layer to meet ingestion safety requirements. For the external auditory canal, the guide and propulsion head is embedded with a flexible metal wire and a miniature LED light to solve the operational problems of poor field of vision and cavity curvature. For the anus / vagina, the base is equipped with a ring-shaped hot and cold temperature difference adjustment module to adapt to temperature-sensitive cavities. This design is not simply a change of component size, but a customized innovation based on the physiological safety requirements of different cavities, operating environment requirements, and treatment parameter requirements. While ensuring specificity, the main structure is universal, significantly reducing R&D costs and the barrier to patient use. Attached Figure Description

[0044] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used in conjunction with embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings:

[0045] Figure 1 This is a flowchart illustrating the steps of a self-service mini human natural cavity ultrasonic drug delivery device proposed in this invention.

[0046] Figure 2 This is a schematic diagram of the substrate structure of a self-service mini human natural cavity ultrasonic drug delivery device proposed in this invention;

[0047] Figure 3 This is a schematic diagram of the cleaning device structure of a self-service mini human natural cavity ultrasonic drug delivery device proposed in this invention;

[0048] Figure 4 This is a schematic diagram of the ultrasonic drug delivery device structure of a self-service mini human natural cavity ultrasonic drug delivery device proposed in this invention. Detailed Implementation

[0049] To make the technical means and objectives and effects of the present invention easier to understand, the embodiments of the present invention will be described in detail below with reference to specific illustrations.

[0050] This invention discloses a self-service mini human natural cavity ultrasonic drug delivery device and its preparation method, aiming to solve the problems of existing natural cavity drug delivery devices being unable to reach deep lesions, complex operation, and easy damage to the cavity lining. Through optimized structural design combined with ultrasound technology, it achieves non-invasive, precise, and self-service drug delivery. The following detailed description, in conjunction with specific technical solutions, provides a detailed explanation of the structural composition, connection relationships of various components, material parameters, usage process, and embodiments of this invention, ensuring that each technical feature is fully disclosed and completely corresponds to the claims.

[0051] The self-service mini human natural cavity ultrasonic drug delivery device of the present invention includes a base, a cooling body, and a cleaner and an ultrasonic drug delivery device that can be plugged into and assembled in the central channel of the base.

[0052] The substrate is axially arranged from the front end near the inside of the human cavity to the end end outside the body, consisting of a guide propulsion head, an expander, and a control switch. The guide propulsion head is fixedly connected to the front end of the substrate by adhesive bonding to ensure stability during insertion into the cavity. The expander is coaxially sleeved behind the guide propulsion head and slidably connected to the inner wall of the substrate, allowing it to extend and retract radially. The control switch is fixed to the far end of the substrate by screws and has an internal transmission structure consisting of gears and screws. One end of this transmission structure is fixed to the knob of the control switch, and the other end is connected to the lower end of the expander. Rotating the control switch drives the expander to extend and retract radially, thus supporting the folded tissues of the cavity.

[0053] The ultrasonic drug delivery device also consists of a drug reservoir, a piezoelectric transducer, and a controller arranged axially from front to back. The drug reservoir is fixedly connected to the front end of the ultrasonic drug delivery device via a snap-fit ​​structure, directly facing the lesion area. The piezoelectric transducer is covered with a 0.5-1mm thick medical-grade silicone coating and is fixed to the rear end of the drug reservoir via a coaxial nesting method. The silicone coating is flush with the outer wall of the drug reservoir to avoid friction during insertion. The controller has an arc-shaped handle structure and is fixed to the end of the ultrasonic drug delivery device via a threaded connection for easy hand operation. The controller integrates an ultrasonic circuit board inside via a bracket. This ultrasonic circuit board is electrically connected to the piezoelectric transducer via wires, providing ultrasonic drive signals to the piezoelectric transducer.

[0054] The cooling body is an independent cylindrical structure with a clearance fit between its outer diameter and the inner diameter of the central channel of the base. After the ultrasonic drug delivery device is completely withdrawn from the central channel of the base, it can be pushed into the vicinity of the lesion by the push rod, thereby achieving drug locking after administration.

[0055] The guide propulsion head is made of medical-grade silicone in one piece. No plasticizers or other chemical additives are added during the molding process to ensure biocompatibility. The silicone hardness is controlled at 5A or below, which is close to the hardness of the mucous membrane of the human body's natural cavities, avoiding damage to the inner lining. The guide propulsion head has a bidirectional umbrella-shaped structure with 3-4 sets of umbrella ribs. The end of each set of umbrella ribs is fixedly connected to the inner wall of the front end of the base with medical adhesive. When entering the cavity, the umbrella ribs are in a forward-opening state to reduce the resistance to entry. When exiting, the umbrella ribs are folded in the reverse state under the reaction force of the inner wall of the cavity to avoid friction with the inner lining of the cavity and reduce the risk of sensitization.

[0056] For cavities like the oral cavity and nasal cavity, which come into direct contact with the mucous membrane and may be entry points, the outer surface of the guide and propulsion head can be selectively fitted with a 0.5mm thick food-grade medical silicone layer. This silicone layer is fixed by a hot-pressing process at a temperature of 120℃, a pressure of 0.5MPa, and a pressing time of 10 minutes, further enhancing safety. For cavities like the external auditory canal, which have poor visibility and curved structures, a 0.3mm diameter flexible metal wire can be selectively embedded within the silicone layer of the guide and propulsion head, allowing for unconventional bending adjustments from 0-90°. Additionally, 2-3 miniature LED lights with a power of 0.1W and a color temperature of 6500K can be selectively embedded along the axial direction on the side wall of the guide and propulsion head. These lights are electrically connected to a lithium battery inside the controller via wires and can be turned on by pressing a hidden button on the side of the control switch, facilitating observation of the lesion location.

[0057] The expander is a three-dimensional silicone column structure with a silicone material that is completely consistent with the guide and propulsion head, ensuring overall biocompatibility. The lower end of the expander is fixedly connected to the axial transmission rod inside the base body through three radial connecting rods. The radial connecting rods and the transmission rod are hinged by pins, which can achieve angle adjustment. The transmission rod extends along the axial direction of the base body and has an external thread at its end, which is adapted to the internal thread inside the control switch knob. When the control switch knob is rotated, the transmission rod moves axially, which in turn drives the radial connecting rod to push the expander to expand or contract radially. After expansion, it can support the folded tissue in the cavity flat, ensuring that subsequent drug delivery is accurately applied to the lesion.

[0058] For temperature-sensitive cavities such as the anus, urethra, and vagina, a ring-shaped temperature difference adjustment module can be selectively installed near the expander on the substrate. This module is a hollow metal ring structure made of medical-grade titanium alloy, with its inner diameter matching the outer diameter of the expander. The outer diameter is fixed to the sidewall of the substrate by laser welding. The adjustment module is electrically connected to the temperature control chip inside the controller via wires. The temperature adjustment range is 32-40℃, with an adjustment step of 0.5℃. Temperature stimulation improves the comfort of drug administration and promotes local blood circulation, enhancing drug absorption.

[0059] The housing of the control switch is injection molded from medical-grade polyethylene material, which has strong chemical stability and can withstand multiple sterilizations. The internal thread structure of the housing has a precision of M3-M5 to ensure smooth transmission, and the exterior is equipped with diamond-shaped anti-slip texture to increase hand friction and prevent slippage during operation.

[0060] The cleaner is made of medical-grade polyethylene material and is integrally molded. The overall structure is like a syringe, including a needle body that fits along the axis, a push rod and a sealing piston.

[0061] The syringe body is 5-8cm long, closed at the front end, and has 3-5 0.5mm diameter drug-penetrating holes evenly distributed around its circumference. The holes are set at a 45° angle to ensure that the saline solution can be sprayed evenly onto the lesion surface. The rear end of the syringe body has a circular push rod inlet with a dust cover. The sealing piston is made of medical rubber and is fixed to the front end of the push rod by interference fit, forming a sliding seal with the inner wall of the syringe body. When the push rod is pushed, the saline solution can be forced out from the drug-penetrating holes, and leakage is prevented.

[0062] The cleaner is also equipped with a transparent drainage bag made of medical-grade PVC material with a capacity of 50-100mL. Its top is connected to the waste liquid outlet on the side wall of the substrate through a flexible silicone tube. The waste liquid outlet is located behind the expander and is connected to the central channel of the substrate. Waste liquid generated during the cleaning process can flow into the waste liquid outlet through the central channel and then be collected into the drainage bag through the flexible tube, thus avoiding waste liquid contamination of the cavity or the external environment.

[0063] The drug storage agent is a single-use component, injection molded from medical-grade polyethylene material. It has a drug-containing cavity with a capacity of 1-5mL inside, and the inner wall of the cavity is polished to avoid drug residue.

[0064] The drug-containing cavity is filled with a drug delivery agent, which has a nano-liquid crystal structure with a particle size of <200nm and contains one of the following formulations by weight:

[0065] Formula 1: 48 parts trioleic acid glyceride, 3 parts lecithin, 2 parts poloxamer, 20 parts povidone-iodine, 2 parts Tween 20, 0.5 parts tea tree oil, 14.5 parts purified water, 4.9 parts NaCl, 5 parts propylene glycol, and 0.1 parts citric acid;

[0066] Formula 2: 60 parts of dilinoleic acid oleic acid glyceride, 3.0 parts of phosphamide ester, 20 parts of dodecyl dimethyl benzyl ammonium chloride, 2 parts of polyglycerol ester, 0.5 parts of wintergreen oil, 13.95 parts of purified water, 0.45 parts of NaCl, and 0.1 parts of lactic acid;

[0067] Formula 3: 40 parts palmitate dioleoyl ester, 3.0 parts polyglycerol polyricinoleate, 20 parts benzalkonium chloride, 2 parts pea protein, 0.5 parts ginger oil, 34.95 parts purified water, 0.45 parts NaCl, and 0.1 parts malic acid;

[0068] Formula 4: 50 parts linoleic acid dioleoyl glyceride, 3.0 parts lecithin, 20 parts hydrogen peroxide, 2 parts arabinoxylan, 0.5 parts chamomile oil, 20 parts purified water, 4.4 parts NaCl, and 0.1 parts gluconolactone;

[0069] Formula 5: 30 parts dioleoyl glyceride stearate, 3.0 parts PGPR, 20 parts sodium hypochlorite, 2 parts cyclodextrin, 0.5 parts peppermint oil, 40.5 parts purified water, 3.9 parts NaCl, and 0.1 parts citric acid;

[0070] It is worth mentioning that when the temperature of the drug drops to 34.8℃, the mucosal adhesion is increased by ≥40% compared to 25℃, and it does not contain harmful polyphenolic components. It achieves mucosal protection and virus prevention functions through a specific acid buffer system.

[0071] Secondly, the liquid medication in the delivery device is applied to the lesion through ultrasonic vibration. After the medication comes into contact with the mucous membrane in the body's natural cavities, it forms a dense protective film. The active ingredients contained therein can effectively prevent the invasion of viruses such as HPV, HIV, and syphilis. For damaged mucous membranes, it can promote mucosal repair, while isolating bacteria and reducing the spread of pathogens caused by friction from the device.

[0072] Cavity compatibility optimization: The drug delivery system is a nano-liquid crystal structure, prepared by high-pressure homogenization process, which improves the absorption efficiency by 3-5 times compared with traditional micron-level liquid crystal products; and at 34.8℃, the mucosal adhesion is increased by 42%-45% compared with room temperature, solving the problem of traditional drugs being easily lost with cavity secretions.

[0073] Ingredient safety: The drug delivery system breaks through the limitations of single phospholipid components, adopting a compound system of trioleic acid glyceride / dilinoleic acid glyceride and lecithin / phosphatidylcholine, which does not contain harmful polyphenolic components; the buffer system is constructed with citric acid, lactic acid and other substances, and the pH value is stable at 4.0-4.5, with no risk of mucosal irritation.

[0074] Specifically, taking the vaginal canal-compatible drug delivery system of Formula 2 as an example, the drug delivery process will be explained in detail:

[0075] Oil phase preparation: Weigh 60g of dilinoleic acid glyceryl ester, 3.0g of phosphamide ester, and 2g of polyglycerol ester, add 5g of propylene glycol, place in a 38℃ water bath, and stir with an electric stirrer for 15 minutes until completely clear and free of visible particles.

[0076] Matrix preparation: Take a 100mL beaker, add 13.95g of purified water, 20g of dodecyl dimethyl benzyl ammonium chloride and 0.45g of NaCl, stir at 42℃ until completely dissolved, and cool to 35℃ for later use.

[0077] Emulsification / dispersion: Turn on the magnetic stirrer and drop the oil phase into the matrix at a rate of 1.5 mL / min. After the drop is complete, continue stirring for 18 minutes to form a milky white homogeneous emulsion.

[0078] Homogenization / Degassing: The emulsion is fed into a high-pressure homogenizer, the pressure is set to 40MPa, and it is circulated 4 times. The particle size is sampled and tested. Then, it is treated with a vacuum degasser for 5 minutes to remove internal air bubbles.

[0079] Adjustments before dispensing: Add 0.5g of wintergreen oil and 0.1g of lactic acid, stir for 8 minutes, filter through a 0.22μm sterile filter membrane to obtain the finished drug product for later use.

[0080] In practical use, taking "patients with vaginal inflammation and HPV exposure risk" as an example, the usage process is explained as follows:

[0081] Equipment preparation: Select a substrate suitable for the vaginal cavity, a drug storage agent for filling the medication in Formula 2, and a cooling body; wipe the outside of the substrate with 75% alcohol, turn on the controller power, and set the temperature of the annular hot and cold temperature difference adjustment module to 34.8℃.

[0082] Cavity cleaning: Insert the cleaning device into the central channel of the body and push it into the vagina to a depth of 8-10cm. Push the plunger to inject 10mL of physiological saline. After 3 minutes, remove the cleaning device and collect the waste fluid through the drainage bag.

[0083] Ultrasonic drug delivery: Insert the ultrasonic drug delivery device with the drug already prepared, press and hold the main switch for 3 seconds to switch to "Ultrasonic + Drug Delivery Combined Mode"; observe the temperature through the LED display, and adjust the ultrasonic parameters: frequency 2MHz, sound intensity 1.5W / cm². 2 The duty cycle is 50%; the administration time is 30 minutes, during which the drug is slowly released under ultrasonic vibration, forming a protective film and penetrating into the submucosal lesion.

[0084] Drug locking and termination: After drug administration, remove the ultrasonic drug delivery device, push it into the refrigerated cooling body, and hold for 10 seconds; rotate the control switch to contract the expander and slowly withdraw it from the substrate.

[0085] Efficacy verification: After use, the residual rate of the drug in the vaginal mucosa reached 85%, the inflammatory symptoms were relieved after 3 days, and the HPV prevention efficacy rate was verified to be 92% through in vitro experiments, which meets the national infectious disease prevention and control requirements.

[0086] In addition, other drug formulations can be selected based on strength; specific selections can be found in Table 1.

[0087] Table 1: Drug Formulation Selection Table for Other Cavities

[0088]

[0089]

[0090]

[0091]

[0092] The drug storage agent has two annular medical silicone sealing rings on the outside. The outer diameter of the sealing rings is interference-fitted with the inner diameter of the central channel of the substrate to ensure that the drug will not leak from the gap when it is administered.

[0093] The rear center of the drug storage agent has a circular mounting hole, the diameter of which matches the outer diameter of the piezoelectric transducer. The front end of the piezoelectric transducer is embedded in the mounting hole and fixed with medical epoxy adhesive. The adhesive cures for 24 hours to ensure a firm connection. The medical silicone covering the piezoelectric transducer is flush with the outer wall of the drug storage agent. The silicone is made by vulcanization process and has a Shore hardness of 10A-20A, combining flexibility and sealing properties.

[0094] When the ultrasonic frequency of the piezoelectric transducer is adjusted to 0.5-50MHz, the ultrasound can cause the drug in the drug storage agent to vibrate and diffuse. The drug penetrates to the lesion through the drug outlet at the front end of the drug storage agent. The penetration depth can be adjusted according to different frequencies, up to 30cm, to meet the drug delivery needs of deep lesions. For example, for deep oral ulcer lesions, a 2mL drug storage agent can be used, filled with Kangfuxin solution, and the ultrasonic frequency can be set to 3MHz to achieve deep coverage of the lesion. For external auditory canal inflammation lesions, a 1mL volume can be used, filled with antibiotic ear drops, and the frequency can be set to 4MHz to match the depth of the ear canal. For vaginal inflammation lesions, a 5mL volume can be used, filled with metronidazole gel, and the frequency can be set to 2MHz to ensure uniform penetration of the drug in the cavity.

[0095] The controller's handle-style housing is injection molded from medical-grade polyethylene material, with a housing thickness of 2-3mm and a weight of 50-80g, making it easy to hold.

[0096] The housing surface is embedded with a 1.5-inch LED temperature display screen with a resolution of 128×64, which can display the working temperature of the piezoelectric transducer in real time. Below the display screen are two circular operation buttons with a diameter of 8mm. These are the main switch for controlling the start and stop of the ultrasonic drug delivery device and the manual temperature control switch for adjusting the drug delivery temperature. The button travel is 0.5mm and the feedback is clear.

[0097] The controller contains an ultrasonic circuit board, a temperature sensor, and a disconnection alarm module, all mounted axially with screws. These three components are connected in series via wires. The temperature sensor's detection end extends through a high-temperature resistant wire into the silicone coating of the piezoelectric transducer, achieving a detection accuracy of ±0.5℃. This temperature sensor is electrically connected to both an LED temperature display and a temperature control switch. When the detected temperature reaches 36-40℃, the temperature control switch automatically cuts off the circuit between the ultrasonic circuit board and the piezoelectric transducer, stopping the ultrasonic output. If the temperature does not reach the threshold, the user can manually adjust the temperature using the temperature control switch, with an adjustment range of 32-40℃. For example, in vaginal drug delivery scenarios, the temperature can be adjusted to 37℃, which is close to human body temperature, improving comfort.

[0098] The disconnection alarm module is connected in series with the power supply circuit of the piezoelectric transducer and has an internal current detection chip. When the piezoelectric transducer becomes disconnected from the drug storage agent or has poor contact, the circuit current will change suddenly. The disconnection alarm module will trigger an audible and visual alarm within 0.5 seconds after detecting the sudden change and cut off the main power supply within 5 seconds to ensure the safety of various cavities during use.

[0099] The cooling body is made of medical-grade silicone through vulcanization. Its length is 3-5cm, and its outer diameter is matched with the inner diameter of the central channel of the base, with an error controlled within ±0.1mm. Before use, the cooling body needs to be refrigerated in a refrigerator at 0-8℃ for 2-4 hours to ensure the low-temperature effect. After the ultrasonic drug delivery device is completely withdrawn from the central channel of the base, the cooling body is pushed into the central channel of the base to the vicinity of the lesion using a special push rod. The dwell time is adjusted according to the type of cavity, for example, 5 seconds for oral administration, 3 seconds for external auditory canal administration, and 10 seconds for vaginal administration, and then withdrawn along the original channel. The low temperature of the cooling body can stimulate the muscle contraction of the cavity, locking the drug in the lesion area, while preventing the entry of external foreign objects and prolonging the drug's action time.

[0100] The inner wall of the central channel of the substrate has two sealing grooves along the axial direction. The grooves are 1mm deep and 2mm wide. Each sealing groove is embedded with a medical silicone sealing ring with a circular cross-section. The diameter of the sealing ring is 2.5mm and the Shore hardness is 30A. The sealing ring is interference-fitted with the outer wall of the syringe body of the cleaner and the outer wall of the drug storage agent of the ultrasonic drug delivery device. The interference is 0.2mm, ensuring that the whole meets the IP67 waterproof and dustproof requirements, can be used in humid environments, and is easy to clean and disinfect.

[0101] The controller handle has a Type-C USB charging port at the end with a waterproof plug. The charging port is connected to the internal lithium battery via a wire. The lithium battery has a capacity of 1000mAh and supports household 220V voltage charging via a charger. The charging time is 2-3 hours. After a full charge, it can work continuously for 2-4 hours, meeting the needs of multiple drug administrations. Whether it is daily oral administration or periodic vaginal administration, there is no need for frequent charging.

[0102] A parameter adjustment module is soldered onto the ultrasonic circuit board. This module is an independent PCB board and is electrically connected to a hidden knob on the surface of the controller. The knob is located on the side of the handle and can rotate 360° to adjust the ultrasonic parameters.

[0103] Specific adjustable parameters include: effective sound intensity of 0-3 W / cm². 2 Low (0-1W / cm) 2 ), medium (1-2W / cm) 2 ), high (2-3W / cm) 2 The dosage is adjustable to 3 levels; for example, 0.8 W / cm can be selected when administering medication through the external auditory canal. 2 To avoid irritating the ear canal, use a low sound intensity; when administering vaginally, choose 1.5 W / cm². 2The ultrasonic drug delivery device features enhanced drug penetration with medium-intensity sound. The frequency ranges from 0.5-5MHz ± 10%, supporting frequency conversion adjustment in 0.1MHz steps. The duty cycle is selectable at 10%, 25%, or 50%, switchable via a knob. For example, a 25% duty cycle can be used for oral administration, a 10% duty cycle for external auditory canal administration, and a 50% duty cycle for vaginal administration, adapting to the different cavities' tolerance to ultrasonic energy. The operating mode is fixed as continuous ultrasound mode, ensuring sustained drug penetration. The device supports two operating modes, triggered by pressing and holding the main switch for 3 seconds: In the standalone ultrasound physical mode, the piezoelectric transducer only outputs ultrasound waves without drug release, suitable for simple physical therapy; in the combined ultrasound physical and drug delivery mode, while the piezoelectric transducer outputs ultrasound waves, the drug storage medium is quantitatively released under ultrasonic vibration at a rate of 0.1-0.5 mL / min, adjustable via ultrasound intensity.

[0104] In addition, the parameter adjustment module can also adjust the ultrasound amplitude in real time, with an amplitude adjustment range of 5-20μm. By changing the amplitude adjustment MEP inhibition effect, it can precisely adjust the excitability of specific deep lesions in the cavity, accelerate the drug absorption efficiency, and is especially suitable for cavity lesions with high sensitivity.

[0105] The preparation method of the present invention specifically includes the following steps:

[0106] Step 1: Substrate Preparation: First, using medical-grade silicone with a hardness of 5A or lower, a bidirectional umbrella-shaped guide propulsion head is injection molded at a temperature of 180-200℃ and a pressure of 50MPa in an injection molding machine. The injection holding time is 20-30 seconds. After cooling to room temperature, the umbrella-shaped end of the guide propulsion head is bonded and fixed to the inner wall of the front end of the substrate using medical adhesive. The adhesive thickness is 0.1-0.2mm. If it needs to fit the oral cavity or nasal cavity, a food-grade medical silicone layer is hot-pressed onto the outer surface of the guide propulsion head. If it needs to fit the external auditory canal, a flexible metal wire is embedded in the silicone layer and a miniature LED light is installed. Subsequently, using the same specification of medical-grade silicone, a three-part three-dimensional expansion body is formed with the same injection molding parameters. After cooling, the lower end of the expansion body is welded and fixed to three radial connecting rods made of stainless steel. The rod has a diameter of 1mm and a length of 5mm. The radial connecting rod and the axial transmission rod are then hinged together by a pin. The transmission rod is a 2mm diameter stainless steel rod with an M3 external thread on its surface. If it is to be adapted to the anus, urethra, or vagina, a ring-shaped hot and cold temperature difference adjustment module is laser-welded to the base near the dilator. Finally, medical-grade polyethylene material is used to injection mold the base shell and control switch shell at a temperature of 190-210℃ and a pressure of 40MPa. The length of the base shell is adjusted according to the adapted cavity, and the inner diameter is 5-8mm. After cooling, the axial transmission rod is inserted into the base shell, and its end is fixed to the control switch knob by a thread. The knob has an M3 internal thread. Finally, the control switch shell and the outer end of the base shell are sealed by ultrasonic welding with a welding power of 1500W and a welding time of 5 seconds.

[0107] Step 2, Preparation of the Cleaner: First, using medical-grade polyethylene material, injection mold the syringe-type needle body and push rod at a temperature of 180-200℃ and a pressure of 35MPa. The inner diameter of the needle body is adjusted according to the matching cavity, and the length is 8-12cm. The diameter of the push rod is 0.1mm smaller than the inner diameter of the needle body. Drill 3-5 small drug-permeable holes with a diameter of 0.5mm around the front end of the needle body using a drilling machine, with uniform spacing between the holes. Then, fix the sealing piston made of medical rubber to the front end of the push rod with an interference fit of 0.1mm to ensure sliding seal. Finally, use transparent medical PVC material to heat-seal a drainage bag with a capacity of 50-100mL. Connect the interface of the drainage bag to a flexible silicone tube with a length of 15-20cm by heat sealing at a temperature of 160℃ for 3 seconds. The other end of the flexible tube is processed with external threads and connected to the waste liquid outlet on the side wall of the substrate by thread. The tightening torque is 2N·m.

[0108] Step 3: Preparation of the ultrasonic drug delivery device: First, medical-grade polyethylene material is used to injection mold a disposable drug storage agent at a temperature of 180-200℃ and a pressure of 30MPa. The drug-containing cavity capacity of the drug storage agent is adjusted according to the matching cavity. A mounting hole for the piezoelectric transducer is drilled at the center of the rear end using a drilling machine, with a hole diameter error of ±0.05mm. Then, the piezoelectric transducer is embedded in the mounting hole and fixed with medical epoxy adhesive, with an adhesive thickness of 0.1mm, and cured for 24 hours. Next, medical-grade silicone is vulcanized around the piezoelectric transducer using a vulcanizing machine at a temperature of 150℃, a pressure of 10MPa, and a time of 15 minutes, ensuring that the silicone layer is flush with the outer wall of the drug storage agent. Then, medical... The controller handle housing is injection molded from polyethylene material at a temperature of 190-210℃ and a pressure of 40MPa. After cooling, the ultrasonic circuit board, 1000mAh lithium battery, temperature sensor, and detachment alarm module are fixed inside the housing with M2 screws, with a screw tightening torque of 0.5N·m. The ultrasonic circuit board is electrically connected to the piezoelectric transducer, temperature sensor, detachment alarm module, and external operation buttons via wires. The wires are made of medical-grade silicone with a diameter of 0.3mm. Finally, the LED temperature display is glued to the surface of the housing with double-sided adhesive, ensuring that the display is flush with the housing. At the same time, a cooling body is molded from medical-grade silicone with the same vulcanization parameters, so that its outer diameter matches the inner diameter of the central channel of the substrate.

[0109] Step 4, Overall Assembly and Optimization: Assemble the substrate, cleaner, and ultrasonic drug delivery device using a plug-in structure. Insert the cleaner and ultrasonic drug delivery device into the central channel of the substrate, ensuring an interference fit between the outer wall of the syringe body of the cleaner, the outer wall of the drug storage agent of the ultrasonic drug delivery device, and the sealing ring of the central channel of the substrate. After assembly, perform a pull test; the resistance should be uniform and without jamming. Connect the ultrasonic circuit board and parameter adjustment module by soldering wires. Optimize the ultrasonic waveform and frequency parameters using a signal generator, adjusting the waveform to a sine wave, ensuring the frequency error is within ±10%. Simulate the scenario of the piezoelectric transducer detaching from the drug storage agent, and debug the detachment alarm module to ensure accurate alarm triggering and power cut-off within 5 seconds. If the substrate has a temperature difference adjustment module, the temperature control chip needs to be debugged simultaneously to ensure precise temperature control within the range of 32-40℃.

[0110] Step 5, Disinfection: The assembled substrate and ultrasonic drug delivery device are disinfected with ethylene oxide at a temperature of 30-50℃, a humidity of 40-60%, an ethylene oxide concentration of 600 mg / L, and a disinfection time of 2-4 hours. After disinfection, the device is ventilated and desorbed for 12 hours to remove residues. The cooling body is disinfected with gamma rays at a dose of 25-30 kGy to ensure sterility. The disinfected substrate, ultrasonic drug delivery device, and cooling body are then sealed in sterile aluminum foil bags. The disposable drug storage agent is packaged separately in sterile plastic bags to ensure sterility during transportation and storage.

[0111] In practical use, the operating procedures for different cavities can be adapted and adjusted according to the above structure and parameters. For example, when using it for deep oral ulcer lesions, first select a substrate with a food-grade medical silicone layer and a length of 8cm. Disinfect the substrate, cleaner, and outer surface of the ultrasonic drug delivery device by wiping with 75% alcohol. Slowly push the guide head of the substrate into the oral cavity to the vicinity of the ulcer lesion. Rotate the control switch to unfold the expander to support the folded tissue of the oral cavity wall. Inject physiological saline into the cleaner. Push the push rod to clean the lesion surface through the drug delivery hole. Collect the waste liquid through the drainage bag. After removing the cleaner, insert the ultrasonic drug delivery device containing 2mL of Kangfuxin solution. Press and hold the main switch for 3 seconds to switch to the combined mode. Set the ultrasonic frequency to 3MHz and the effective sound intensity to 1W / cm through the parameter adjustment module. 2 The duty cycle is set to 25%, and the drug delivery time is 20 minutes. After drug delivery, remove the ultrasonic drug delivery device, push the refrigerated cooling body near the lesion and hold it for 5 seconds, remove the cooling body and rotate the control switch to contract the expander, and slowly withdraw the base to complete the drug delivery. After use, the patient's ulcer is evenly covered with drug, and the pain can be significantly relieved. The ulcer usually heals after 3 days. When used for external auditory canal inflammation, select a base with a flexible metal wire and a miniature LED light, 10cm in length. Turn on the LED light to observe the location of the lesion. Adjust the flexible metal wire according to the curvature of the ear canal to align the guide head with the lesion. Rotate the control switch to expand the expander. After cleaning with a cleaner, insert the ultrasonic drug delivery device containing 1mL of antibiotic ear drops. In the combined mode, set the frequency to 4MHz and the sound intensity to 0.8W / cm. 2 With a duty cycle of 10%, drug administration takes 15 minutes. After administration, insert the cooling device, hold for 3 seconds, and then withdraw it from the substrate. Inflammation can subside within one week without ear canal damage. When used for vaginal lesions, select a 15cm long substrate with a temperature difference adjustment module. Set the adjustment module temperature to 37℃, disinfect, and insert it into the vagina to the lesion. After cleaning the expander, insert the ultrasonic drug delivery device containing 5mL metronidazole gel. In combined mode, set the frequency to 2MHz and the sound intensity to 1.5W / cm. 2 With a duty cycle of 50%, administration was performed 30 minutes later. After administration, the cooling device was inserted, held for 10 seconds, and then withdrawn. After two weeks, inflammatory markers returned to normal without mucosal irritation. The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A self-service mini human natural cavity ultrasonic drug delivery device, characterized in that, Includes a substrate, a coolant, a cleaner that can be plugged into the central channel of the substrate, and an ultrasonic drug delivery device; The base has a guide push head, an expander and a control switch arranged sequentially from the front end to the rear end along the axial direction. The guide push head is fixedly connected to the front end of the base. The expander is coaxially arranged behind the guide push head and slidably connected to the base. The control switch is fixed at the rear end of the base and is linked with the expander through a built-in transmission structure. The ultrasonic drug delivery device is provided with a drug storage agent, a piezoelectric transducer and a controller in sequence from the front end to the rear end along the axial direction. The drug storage agent is fixedly connected to the front end of the ultrasonic drug delivery device. The piezoelectric transducer is wrapped with medical silicone and coaxially fixed to the rear end of the drug storage agent. The controller is fixed to the rear end of the ultrasonic drug delivery device in the form of a handle. The controller integrates an ultrasonic circuit board and is electrically connected to the piezoelectric transducer. The cleaner is integrally molded from medical-grade polyethylene material and has a syringe-like structure, including an axially fitted needle body, a push rod, and a sealing piston. The front end of the needle body is closed and has 3-5 drug-permeable holes evenly distributed around its circumference. The rear end of the needle body has a push rod inlet. The sealing piston is fixed to the front end of the push rod and slides and seals with the inner wall of the needle body. The cleaner is also equipped with a drainage bag, which is connected to a waste liquid outlet on the side wall of the base through a flexible tube. The waste liquid outlet is located behind the expander and is connected to the central channel of the base. The cooling body is an independent cylindrical structure, made of medical-grade silicone vulcanized. Its outer diameter is matched with the inner diameter of the central channel of the base. Its length is 3-5cm. It needs to be refrigerated to 0-8℃ before use. After the ultrasonic drug delivery device is withdrawn, it can be pushed into the vicinity of the lesion through the central channel of the base. After staying for 1-30 seconds, it is withdrawn along the original channel. The low temperature stimulation causes the cavity muscles to contract, thereby locking the drug and isolating external foreign objects.

2. The self-service mini human natural cavity ultrasonic drug delivery device according to claim 1, characterized in that, The guide propulsion head is integrally molded from medical-grade silicone without the need for plasticizers or other additives. The guide propulsion head has a bidirectional umbrella-shaped structure, with the ends of the umbrella ribs fixedly connected to the inner wall of the front end of the base. The expander is a three-dimensional silicone column structure with the same silicone material as the guide propulsion head. The lower end of the expander is fixedly connected to the transmission rod inside the base via a radial connecting rod. The transmission rod extends axially along the base and is fixedly connected to the knob of the control switch. Rotating the control switch can drive the transmission rod to move the expander radially. The housing of the control switch is injection molded from medical-grade polyethylene material, with an internal thread structure adapted to the transmission rod and an external anti-slip texture.

3. The self-service mini human natural cavity ultrasonic drug delivery device according to claim 1, characterized in that, The drug storage agent is a disposable component, injection molded from medical polyethylene material. It has a drug-containing cavity inside and a sealing ring on the outside that is adapted to the central channel of the substrate. The drug storage agent has a mounting hole at its rear center. The front end of the piezoelectric transducer is embedded in the mounting hole and fixed with medical adhesive. The medical silicone covering the piezoelectric transducer is flush with the outer wall of the drug storage agent. When the ultrasonic frequency of the piezoelectric transducer is adjusted to 0.5-50MHz, the drug can penetrate into the lesion through the drug outlet at the front end of the drug storage agent, with a penetration depth of up to 30cm. The drug receiving cavity is filled with the drug delivery agent.

4. A self-service mini human natural cavity ultrasonic drug delivery device according to claim 1, characterized in that, The controller's handle-type housing is made of medical-grade polyethylene material, with an LED temperature display screen embedded on its surface. Below the LED temperature display screen are two operation buttons: a main switch to control the start and stop of the ultrasonic drug delivery device, and a manual temperature control switch to adjust the drug delivery temperature. The controller contains an ultrasonic circuit board, a temperature sensor, and a disconnection alarm module, which are fixed sequentially along the axial direction. The detection end of the temperature sensor extends through a wire into the silicone coating layer of the piezoelectric transducer. The temperature sensor is electrically connected to the LED temperature display and the temperature control switch. When the detected temperature reaches 36-40℃, the temperature control switch automatically cuts off the circuit between the ultrasonic circuit board and the piezoelectric transducer. The disconnection alarm module is connected in series with the power supply circuit of the piezoelectric transducer. When the piezoelectric transducer becomes detached from the drug storage agent or has poor contact, the disconnection alarm module triggers an audible and visual alarm and cuts off the main power supply within 5 seconds.

5. A self-service mini human natural cavity ultrasonic drug delivery device according to claim 1, characterized in that, The inner wall of the central channel of the substrate is provided with a sealing groove, and a medical silicone sealing ring is embedded in the sealing groove. The sealing ring is press-fitted with the outer wall of the needle body of the cleaner and the outer wall of the drug storage agent of the ultrasonic drug delivery device. The handle of the controller is provided with a USB charging interface, which is electrically connected to the lithium battery inside the controller.

6. A self-service mini human natural cavity ultrasonic drug delivery device according to claim 1, characterized in that, The ultrasonic circuit board is equipped with a parameter adjustment module, which is electrically connected to a hidden knob on the surface of the controller. This module allows for the adjustment of ultrasonic parameters, including: The effective sound intensity is 0-3W / cm² and is adjustable in 3 levels. The frequency is 0.5-5MHz±10% and supports frequency conversion adjustment. The duty cycle can be selected as 10%, 25% or 50%. The working mode is continuous ultrasound mode. The ultrasonic drug delivery device supports switching between two working modes: a standalone ultrasonic physical mode and a combined ultrasonic physical and drug delivery mode. In the standalone ultrasonic physical mode, the piezoelectric transducer only outputs ultrasonic waves. In the combined ultrasonic physical and drug delivery mode, while the piezoelectric transducer outputs ultrasonic waves, the drug storage agent achieves quantitative drug release through ultrasonic vibration. The parameter adjustment module can also control the ultrasound amplitude in real time. By adjusting the MEP inhibition effect, it can precisely regulate the excitability of specific deep lesions in the cavity and accelerate drug absorption.

7. A self-service mini human natural cavity ultrasonic drug delivery device according to claim 1, characterized in that, The outer surface of the guide propulsion head may be selectively fitted with a food-grade medical silicone layer, and the food-grade medical silicone layer is fixed to the guide propulsion head body by a hot pressing process; Flexible metal wires can be selectively embedded in the silicone layer of the guide propulsion head, and 2-3 miniature LED lights can be selectively embedded in the side wall of the guide propulsion head along the axial direction. The miniature LED lights are electrically connected to the lithium battery inside the controller through wires. A ring-shaped temperature difference adjustment module can be installed near the expansion body on the substrate. The ring-shaped temperature difference adjustment module is a hollow metal ring structure. Its inner wall is attached to the outer wall of the expansion body, and its outer wall is fixedly connected to the side wall of the substrate. The ring-shaped temperature difference adjustment module is electrically connected to the temperature control chip inside the controller through a wire, and the temperature adjustment range of the ring-shaped temperature difference adjustment module is 32-40℃.

8. A method for preparing a self-service mini human natural cavity ultrasonic drug delivery device, characterized in that, Includes the following steps: Step 1: Prepare the substrate. First, use medical-grade silicone with a hardness of 5A or lower to injection mold a bidirectional umbrella-shaped guide propulsion head. Then, bond and fix the umbrella end of the guide propulsion head to the inner wall of the front end of the substrate. Next, use the same medical-grade silicone to injection mold a three-dimensional expansion body. Weld the lower end of the expansion body to the radial connecting rod. The radial connecting rod is connected to the axial transmission rod through a pin. Finally, use medical-grade polyethylene material to injection mold the substrate shell and the control switch shell. Insert the axial transmission rod into the interior of the substrate shell. Its end is fixed to the knob of the control switch through threads. Finally, weld and seal the control switch shell to the outer end of the substrate shell. Step 2: Prepare the cleaner. First, use medical polyethylene material to injection mold the syringe-type needle body and push rod. Drill 3-5 small drug-penetrating holes with a diameter of 0.5mm around the front end of the needle body. Then, fix the sealing piston made of medical rubber to the front end of the push rod with an interference fit. Next, assemble the push rod into the needle body. Finally, use transparent medical plastic to make a drainage bag. Heat seal the interface of the drainage bag to the flexible tube. The other end of the flexible tube is connected to the waste liquid outlet on the side wall of the base through a thread. Step 3: Prepare the ultrasonic drug delivery device. First, use medical-grade polyethylene material to injection mold a disposable drug storage agent. Make a mounting hole at the center of its rear end to fit the piezoelectric transducer. Then, insert the piezoelectric transducer into the mounting hole and fix it with medical-grade epoxy adhesive. Next, vulcanize and wrap the piezoelectric transducer with medical-grade silicone, making the silicone layer flush with the outer wall of the drug storage agent. Then, use medical-grade polyethylene material to injection mold the controller handle housing. Fix the ultrasonic circuit board, lithium battery, temperature sensor, and disengagement alarm module inside the housing with screws. Connect the ultrasonic circuit board to the piezoelectric transducer, temperature sensor, disengagement alarm module, and external operation buttons via wires. Finally, attach the LED temperature display to the surface of the housing. Finally, use medical-grade silicone to vulcanize and mold a cooling body, making its outer diameter consistent with the inner diameter of the central channel of the substrate. Step 4: Overall assembly and optimization. Assemble the base, cleaner, and ultrasonic drug delivery device using a plug-in structure, ensuring an interference fit between the seal ring of the cleaner, ultrasonic drug delivery device, and the central channel of the base. Connect the ultrasonic circuit board and parameter adjustment module, optimize the ultrasonic wave shape and frequency parameters, and ensure that the alarm module responds to faults within 5 seconds after disconnection through debugging. Step 5: Disinfection treatment. The assembled substrate and ultrasonic drug delivery device are disinfected with ethylene oxide, and the cooling body is disinfected with gamma rays. After disinfection, the equipment is sealed and packaged to ensure that it can be reused.

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