Multi-dimensional electronic control microneedle injection drug introduction system

Abstract

The invention provides a multi-dimensional electronic regulation and control microneedle injection medicine introduction system, and belongs to the technical field of medical instruments. The system comprises a shell, a user interaction module, a control and drive module, a drive execution module and a microneedle module integrated with an adjustment protection device. The user interaction module is used for realizing multi-parameter collaborative setting and real-time display of injection pressure, dose and speed through a display screen and a control key; the control and driving module generates a regulation and control instruction according to the set parameters; the driving execution module accurately controls liquid medicine conveying according to the instruction; an adjusting protection device of the microneedle module can control the penetration depth of the microneedle and provide protection when the microneedle module is not used. By means of electronic integrated control, multi-dimensional, quantifiable and self-adaptive precise regulation and control of the drug introduction process are achieved, the safety, effectiveness and operation convenience of injection are effectively improved, and the system is suitable for various drug administration scenes such as clinic and families.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a multi-dimensional electronically controlled microneedle injection drug delivery system. Background Technology

[0002] Transdermal drug delivery is an important method of drug delivery. Compared to oral or intravenous injection, it avoids the first-pass effect, increases local drug concentration, and reduces systemic side effects. However, the stratum corneum of human skin forms a strong physical and chemical barrier, severely limiting the transdermal absorption of most drug molecules, especially large molecules (such as proteins, peptides, and nucleic acids). While traditional subcutaneous injection can deliver a variety of drugs, it uses sharp needles, causing pain and fear for patients, and requires professional training, making it inconvenient for home use or long-term self-administration scenarios.

[0003] Microneedling, as an emerging transdermal drug delivery method, utilizes micron-scale needle-like structures to penetrate the outermost layer of the skin, the stratum corneum, creating micron-scale channels above the dermis. This significantly promotes drug penetration, and the small size of the needles (typically avoiding nerve endings deep in the dermis) allows for painless or minimally painful drug delivery. However, existing microneedling systems, especially those for active drug delivery, still have several limitations:

[0004] Injection parameter control is often simplistic and crude: Many active microneedle systems can only perform simple "inject / stop" functions or adjust only a single parameter (such as injection speed). They struggle to achieve multi-dimensional, precise, and coordinated control of key parameters like injection pressure, injection rate, and injection dosage based on the drug's physicochemical properties (such as viscosity), the tissue characteristics of the treatment site, and individual patient differences. This "one-size-fits-all" injection approach can lead to uneven drug distribution within tissues, excessively high local pressure causing tissue damage, or low injection efficiency.

[0005] Lack of intelligence and adaptability: Most existing systems are open-loop controlled, unable to dynamically adjust output based on real-time feedback during injection (such as tissue back pressure), resulting in poor adaptability. When dealing with soft tissues of varying skin thickness and density, fixed injection procedures may not guarantee precise drug delivery to the target depth and area.

[0006] Safety and ease of use need improvement: the microneedles of some systems are exposed, posing a risk of accidental punctures. Furthermore, the user interface is often complex, and parameter settings are not intuitive, limiting their widespread application in non-professional medical environments.

[0007] To address the aforementioned issues, the applicant proposes a multi-dimensional electronically controlled microneedle injection drug delivery system. Summary of the Invention

[0008] The purpose of this invention is to provide a multi-dimensional electronically controlled microneedle injection drug delivery system to solve the problems in the prior art.

[0009] To achieve the above objectives, the present invention provides the following technical solution: a multi-dimensional electronically controlled microneedle injection drug delivery system, comprising:

[0010] case;

[0011] The user interaction module is located on the housing and includes a display screen for displaying operation information and control buttons for inputting control commands.

[0012] A microneedle module, which at least partially protrudes from the housing, includes:

[0013] Microneedles;

[0014] An adjustable protection device is provided, wherein the microneedle is at least partially disposed within the adjustable protection device, and the adjustable protection device is configured to adjust the insertion depth of the microneedle and / or provide protection for the microneedle;

[0015] A control and drive module, housed within the housing, is electrically connected to the user interaction module and is used to generate drive signals based on parameters set via the control buttons. These parameters include at least injection pressure, injection dose, and injection speed.

[0016] The drive execution module is electrically connected to the control and drive module and the microneedle, and is used to receive the drive signal and control the microneedle to perform drug injection operation based on the drive signal.

[0017] Optionally, the adjustment protection device includes:

[0018] A protective sleeve is retractably disposed at the front end of the housing, and the microneedles are located inside the protective sleeve;

[0019] A drive mechanism, connected to the control and drive module, is used to drive the protective sleeve to extend and retract along its axial direction, so as to retract the microneedle into the sleeve before injection, expose the microneedle during injection, and control its insertion depth.

[0020] Optionally, the user interaction module further includes:

[0021] The parameter selection unit is used to provide a parameter selection interface on the display screen to set or switch the type of parameter to be adjusted.

[0022] The parameter adjustment unit, associated with the control buttons, is used to continuously or incrementally adjust the value of the selected parameter by operating the control buttons after selecting the parameter type.

[0023] Optionally, the drive execution module includes:

[0024] A micropump is connected to the fluid channel of the microneedle;

[0025] A pressure sensor is used to monitor the injection pressure at the tip of the microneedle in real time;

[0026] The control and drive module is configured to receive feedback signals from the pressure sensor and dynamically adjust the output of the micro pump through closed-loop control to make the actual injection pressure consistent with the set injection pressure.

[0027] Optionally, the system further includes:

[0028] A drug storage unit, detachably connected to the housing, is used to hold the drug to be injected;

[0029] A connecting catheter is used to connect the drug storage unit to the fluid channel of the microneedle.

[0030] Optionally, the control and drive module further includes:

[0031] The injection mode selection unit is configured to provide a variety of preset injection modes, each associated with a set of preset pressure, dose and speed parameters.

[0032] The user interaction module is configured to allow users to select the injection mode via the control buttons.

[0033] Optionally, the microneedles are microneedle arrays containing multiple microneedle tips.

[0034] Optionally, the control and drive module further includes a storage unit for recording and storing parameter settings, execution time, and user identification information for each injection operation.

[0035] Beneficial Effects: Achieving precise multi-parameter synergistic control and enhancing drug delivery: This invention, through an integrated electronic control module, allows users or operators to independently or collaboratively set and adjust key parameters such as injection pressure, dosage, and speed. This multi-dimensional precision control completely avoids individual operator differences, ensuring a precise, controllable, and homogeneous injection process. Pressure control extends its application from ordinary intradermal injections to injections into hard, tough scars. Speed ​​control allows for instantaneous delivery of local drugs, and the combination of microneedle injection heads for simultaneous injection at multiple sites significantly reduces pain and treatment time. The microneedle matrix arrangement ensures uniform injection point distribution, avoiding the unevenness of traditional methods. Precise depth adjustment perfectly suits various ages and skin / tissue thicknesses, ensuring consistent depth. Multiple microneedle (design) modules with various arrangements can be selected for injection areas of different shapes and sizes. Multi-dimensional control allows the system to optimize the injection procedure based on the rheological properties of different types of drugs, the physiological characteristics of the target tissue, and specific treatment needs. For example, for high-viscosity drugs, the pressure can be appropriately increased, and for fragile tissues, the speed can be reduced, thereby ensuring that the drug is distributed more evenly and controllably in the soft tissue, improving the effectiveness and consistency of treatment, and reducing tissue damage or drug waste caused by improper injection parameters.

[0036] Enhancing the system's intelligent adaptability and safety: By setting closed-loop or open-loop control logic between the drive execution module and the control module, the system can accurately execute preset injection parameters. Integrating feedback components such as pressure sensors further enables adaptive injection based on real-time tissue back pressure, preventing excessive local pressure. Furthermore, the microneedle's adjustment and protection device not only effectively protects the microneedle from contamination and accidental punctures when not in use, but also assists in adjusting the insertion depth during injection, further improving operational safety and precision.

[0037] Improving User Experience and Ease of Use: By incorporating an intuitive screen and buttons into the user interaction module, the system simplifies the complex process of setting injection parameters into clear, visual operations. Users can directly view and adjust various parameters, and the user interface is user-friendly. This design lowers the professional skill requirements for operators, making the system more suitable for home self-administration, community healthcare, and clinical scenarios requiring frequent adjustments to injection strategies, greatly enhancing usability and scalability.

[0038] Integrated Functions and Diverse Modes: This system integrates parameter control, microneedle actuation and protection, and drug storage into a compact structure. By pre-setting multiple injection modes (such as continuous infusion and pulsed injection), it can quickly adapt to different clinical or research needs, improving the system's functional flexibility and application scope. Simultaneously, the data recording function provides a basis for treatment process traceability and personalized treatment plan optimization. Attached Figure Description

[0039] Figure 1 This is a schematic diagram of the process of an embodiment of the present invention; Detailed Implementation

[0040] The preferred embodiments of the present invention are described below with reference to the accompanying drawings to make the technical content clearer and easier to understand. The present invention can be embodied in many different forms, and the scope of protection of the present invention is not limited to the embodiments mentioned herein.

[0041] This invention provides a multi-dimensional electronically controlled microneedle injection drug delivery system. Its core lies in the use of an electronic and integrated control module to achieve coordinated and precise control of key parameters such as injection pressure, dosage, and speed, thereby improving the safety and convenience of operation. The following will describe in detail the system's specific structure, workflow, optional extended functions, and application scenarios.

[0042] First, the overall structure of this system is described. The main body of the system is an integrated handheld device, typically containing an ergonomically designed housing. The main electronic and mechanical components are housed inside the housing, while the user interface is integrated externally. The user interface module is the window through which the operator directly interacts with the system; it includes at least a display screen and several control buttons. The display screen is preferably a liquid crystal display (LCD) or an organic light-emitting diode (OLED) display screen, used to clearly and intuitively display the current system status, set injection parameters (such as target pressure value, preset dose, injection speed level), real-time monitoring data (such as injected volume, current pressure), battery level, and operation menus. The control buttons can be physical buttons, capacitive touch buttons, or virtual buttons integrated into the touchscreen display. Their functions include at least a power switch, parameter selection keys (for switching between parameters such as pressure, dose, and speed), parameter adjustment keys (usually increase and decrease keys, used for continuous or step-by-step adjustment of selected parameters), and a start / stop injection control key. A more optimized design could include a multi-functional knob that allows for parameter selection and coarse adjustment by rotation, and confirmation or fine adjustment by pressing, thereby further improving operational efficiency.

[0043] The core drive component of the system is located inside the housing. The control and drive module can be considered the brain of the system, typically built upon a microcontroller unit (MCU) or microprocessor (MPU). This module processes input commands from the user interaction module, runs control algorithms, and generates corresponding drive signals. Its internal firmware or software logic defines all system functions, such as responding to button operations, updating screen displays, executing parameter setting logic, and managing the injection process (including self-testing, driving injection, safety monitoring, and termination procedures). The drive execution module is the system's "hands" and "muscles," receiving commands from the control and drive module and translating them into actual mechanical or fluid control actions. For active injection systems, the core of the drive execution module is a precision fluid drive mechanism. This is typically a plunger or screw pump driven by a micro-motor (such as a stepper motor or brushless DC motor). The motor is connected to an injection piston via a reduction gear, and the piston moves within a drug reservoir or syringe barrel, precisely pushing the drug solution. The motor's speed and torque directly determine the injection speed and output pressure. Another approach is to use piezoelectric ceramic drives or shape memory alloy drives, which allow for finer displacement control. To achieve precise pressure control, a pressure sensing and feedback unit must be integrated into the system. This typically involves placing a miniature, high-precision pressure sensor at the base of the microneedle or the end of the fluid channel to monitor the interstitial fluid pressure (i.e., back pressure) at the injection point in real time. This pressure signal is fed back to the control and drive module, where the control algorithm (such as a PID control algorithm) compares the real-time pressure value with the user-set target pressure value and dynamically adjusts the output of the drive motor (e.g., adjusting the motor current or speed), forming a closed-loop control system that ensures the actual injection pressure remains stable near the set value, regardless of changes in tissue characteristics. Dosage control is achieved by precisely measuring the piston's displacement stroke or the number of motor rotations. The control module can calculate the required total number of motor steps or running time based on the set total injection dose and speed.

[0044] The microneedle module represents the forefront of the entire system's interaction with biological tissues. While microneedles can be single-needle structures, arrays of dozens to hundreds of micrometer-sized needle tips are more common and effective, expanding drug delivery area and efficiency. Microneedles can be made of medical-grade stainless steel, silicon, polymers (such as polylactic acid and polyglycolic acid), or soluble materials (such as hyaluronic acid and sugars). Microfluidic channels are provided inside or on the surface of the microneedles to guide the drug delivery from the drive module to the needle tip. One key feature of this invention is the integration of an "adjustment and protection device" into the microneedle module. This device has at least two functions: first, physical protection, completely covering or storing the microneedles when not in use or during transport and storage to prevent needle tip contamination, damage, or accidental punctures; second, depth adjustment, controlling the exposed length of the microneedle array during injection preparation to adapt to different skin thicknesses (such as infants, adult abdomens, arms, thighs, and hypertrophic keloid scars), achieving controllable insertion depth. One specific implementation involves using a retractable protective sleeve. By default, a sleeve (potentially made of medical-grade plastic) extending from the front of the housing completely covers the microneedle array. When ready to inject, a "ready" command is triggered via the user interface. The control and drive module then activates a dedicated micro-motor or electromagnetic actuator for the sleeve, causing it to retract inwards, gradually exposing the microneedles. The final position of the retracted sleeve (i.e., the length of the exposed microneedles) can be preset by the user (e.g., by selecting "shallow," "standard," or "deep" modes via the interface) or set in conjunction with injection parameters. After injection, the sleeve automatically resets, re-covering the microneedles. This significantly improves operational safety and standardization.

[0045] The drug delivery system is typically designed to be detachable and replaceable to accommodate the needs of different patients and medications. A drug reservoir interface is located on the system housing for connecting a pre-filled syringe or a dedicated drug reservoir. The reservoir is connected to the fluid inlet of the microneedle module base via a flexible, sterile connecting catheter. This modular design facilitates drug loading, replacement, and system cleaning and maintenance.

[0046] Next, a typical usage process will be described in detail. The first step is system preparation and self-test. The operator presses and holds the power button to start the device. The system MCU powers on and performs a hardware self-test (checking the motor, sensors, screen, battery status, etc.). After the self-test passes, the main interface is displayed on the screen. The second step is drug installation. The operator installs the sterile syringe or reservoir containing the drug to be injected into the designated slot in the housing and pushes the connecting catheter and microneedle module interface to lock it in place. The system may automatically identify the specifications of the drug container (e.g., through RFID tags or mechanical codes) and display the drug information on the screen. The third step is parameter setting. The operator enters the parameter setting interface via buttons or knobs. First, it may be necessary to select a preset "injection mode," such as "standard subcutaneous injection," "superficial intradermal injection," "large-volume infusion," or "high-viscosity drug mode." After selecting a mode, the system will automatically load a set of default parameters optimized for that mode (such as baseline values ​​for pressure, rate, and dosage). Subsequently, the operator can fine-tune the parameters according to the patient's specific condition or personal experience. For example, under the "Pressure" adjustment submenu, use the increase / decrease keys to set the target pressure to a certain value (e.g., 15 kPa); under the "Dosage" submenu, set the total injection volume to 0.5 mL; under the "Speed" submenu, select the "Medium Speed" setting or directly set the flow rate to 10 μL / s. All parameter settings are displayed on the screen in real time for operator confirmation. The fourth step is injection preparation and positioning. The operator holds the device, vertically aligning the end integrating the microneedles and protective sleeve with the sterilized skin target point and gently pressing it. Click the "Prepare" button on the screen. At this time, the adjustment and protection device is activated, the sleeve slowly retracts, the microneedle array gradually emerges, and finally pierces the skin to the preset depth. This process is usually smooth, painless, or virtually painless. The screen may display "Ready" or "Pierced" status. The fifth step is to execute the injection. The operator presses the "Start" button. The control and drive module commands the execution module to start working according to the set parameters and algorithms. The micro motor starts rotating, pushing the drug solution into the microneedle channel. The pressure sensor monitors and feeds back data in real time, allowing the control system to dynamically adjust. The screen simultaneously displays the injection progress bar, injected dose, real-time pressure, and remaining time. The entire process is smooth and controllable. The sixth step is termination and exit. When the injected dose reaches the set value, the system automatically stops driving and may briefly maintain a small negative pressure to prevent backflow of the medication. The system then prompts "Injection Complete." The operator presses the "Exit" button, and the adjustment device extends the sleeve, safely withdrawing the microneedle from the skin and re-covering it. Finally, the operator removes the empty medication container, turns off the device power, and completes a single treatment.

[0047] To further enhance the system's intelligence and application value, the following extended functions can be introduced. First, a Bluetooth or Wi-Fi wireless communication module. This enables the system to connect to smartphones, tablets, or hospital information systems. Through a dedicated application (APP), doctors can remotely set complex injection protocols (such as multi-stage variable-speed, variable-pressure injection procedures) on their mobile devices and issue them to the device for execution. After injection, the device can encrypt and upload a complete operation log (including time, all parameters, actual execution curve, patient ID, etc.) to the cloud or electronic medical record system for treatment traceability, efficacy analysis, and research data collection. Second, biometric identification or security lock functions. For example, integrating fingerprint recognition or password verification into the device or APP ensures that only authorized personnel can use it, preventing misoperation or abuse, which is particularly important for potent medications used at home (such as biologics). Third, dedicated modes for specific application scenarios. For example, for intradermal vaccine injection, an "intradermal mode" can be developed. In this mode, the system automatically uses an extremely low injection speed, a small dose (e.g., 0.1 mL), and a high pressure setting, combined with a specially designed short needle array, to optimize the vaccine's immune response. For local anesthesia, an "infiltration injection mode" can be developed. This mode may employ a multi-point, low-dose, stepwise injection strategy, automatically controlled by the system. Fourthly, there is the integration of advanced diagnostic or monitoring functions. In the future, microelectrodes can be integrated into microneedle arrays for non-invasive monitoring of skin impedance, interstitial fluid glucose levels (for diabetic patients), or other biomarkers before or during injection, achieving "integrated diagnosis and treatment." The control module can automatically calculate and adjust the injection dose based on the monitored physiological parameters, achieving truly personalized closed-loop treatment.

[0048] In summary, this invention combines advanced electronic control technology, precise microfluidic actuation technology, and safe microneedle transdermal technology to create a highly controllable, safe, convenient, and feature-rich drug delivery platform. It is not only suitable for replacing routine subcutaneous injections in hospital outpatient clinics and wards, but can also be extended to a wide range of fields, including home self-administration (such as insulin, growth hormone, and anticoagulants), medical aesthetics (such as hyaluronic acid fillers), mass vaccination, local treatment of skin diseases, and the delivery of cutting-edge gene and cell therapy drugs. Its core advantage of multi-dimensional parameter regulation enables physicians and researchers to explore and optimize dosing regimens with unprecedented precision, potentially driving the development of personalized precision medicine.

[0049] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the scope of the invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0050] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A multi-dimensional electronically controlled microneedle injection drug delivery system, characterized in that, include: case; The user interaction module is located on the housing and includes a display screen for displaying operation information and control buttons for inputting control commands. A microneedle module, which at least partially protrudes from the housing, includes: Microneedles; An adjustable protection device is provided, wherein the microneedle is at least partially disposed within the adjustable protection device, and the adjustable protection device is configured to adjust the insertion depth of the microneedle and / or provide protection for the microneedle; A control and drive module, housed within the housing, is electrically connected to the user interaction module and is used to generate drive signals based on parameters set via the control buttons. These parameters include at least injection pressure, injection dose, and injection speed. The drive execution module is electrically connected to the control and drive module and the microneedle, and is used to receive the drive signal and control the microneedle to perform drug injection operation based on the drive signal.

2. The multi-dimensional electronically controlled microneedle injection drug delivery system according to claim 1, characterized in that, The adjustment and protection device includes: A protective sleeve is retractably disposed at the front end of the housing, and the microneedles are located inside the protective sleeve; A drive mechanism, connected to the control and drive module, is used to drive the protective sleeve to extend and retract along its axial direction, so as to retract the microneedle into the sleeve before injection, expose the microneedle during injection, and control its insertion depth.

3. The multi-dimensional electronically controlled microneedle injection drug delivery system according to claim 1, characterized in that, The user interaction module also includes: The parameter selection unit is used to provide a parameter selection interface on the display screen to set or switch the type of parameter to be adjusted. The parameter adjustment unit, associated with the control buttons, is used to continuously or incrementally adjust the value of the selected parameter by operating the control buttons after selecting the parameter type.

4. The multi-dimensional electronically controlled microneedle injection drug delivery system according to claim 1, characterized in that, The drive execution module includes: A micropump is connected to the fluid channel of the microneedle; A pressure sensor is used to monitor the injection pressure at the tip of the microneedle in real time; The control and drive module is configured to receive feedback signals from the pressure sensor and dynamically adjust the output of the micro pump through closed-loop control to make the actual injection pressure consistent with the set injection pressure.

5. The multi-dimensional electronically controlled microneedle injection drug delivery system according to claim 1, characterized in that, The system also includes: A drug storage unit, detachably connected to the housing, is used to hold the drug to be injected; A connecting catheter is used to connect the drug storage unit to the fluid channel of the microneedle.

6. The multi-dimensional electronically controlled microneedle injection drug delivery system according to claim 1, characterized in that, The control and drive module also includes: The injection mode selection unit is configured to provide a variety of preset injection modes, each associated with a set of preset pressure, dose and speed parameters. The user interaction module is configured to allow users to select the injection mode via the control buttons.

7. The multi-dimensional electronically controlled microneedle injection drug delivery system according to claim 1, characterized in that, The microneedles are microneedle arrays, containing multiple microneedle tips.

8. The multi-dimensional electronically controlled microneedle injection drug delivery system according to claim 1, characterized in that, The control and drive module also includes a storage unit for recording and storing parameter settings, execution time, and user identification information for each injection operation.

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