Subcutaneous tissue fluid administration device based on air osmotic pressure power

Abstract

The invention provides a subcutaneous tissue fluid administration device based on air osmotic pressure power, and relates to the technical field of subcutaneous administration equipment.The subcutaneous tissue fluid administration device comprises a base and a microneedle array, a cavity is formed in the inner side of the base, an inner container is installed in the cavity, the microneedle array is installed at the lower end of the inner container, and the lower end of the microneedle array penetrates through the base; a protection assembly is installed below the base, a shell is arranged above the base and connected with the base through a connecting assembly, a solvent cavity is formed in the inner side of the shell, an opening is formed in the lower end of the shell, a semi-permeable membrane is installed on the inner side of the opening, a medicine tablet is installed on the inner side of the inner container, and two sets of silica gel injection nozzles which are symmetrically arranged are installed on the shell. A micro electric valve is mounted on the group of silica gel injection nozzles; a vent hole is formed in the shell; the device is simple in overall structure and convenient to use, a medicine solution is driven to flow through air osmotic pressure difference, and it is ensured that medicine is evenly released subcutaneously.

Description

Technical Field

[0001] The present invention relates to the technical field of subcutaneous drug delivery equipment, and in particular to a subcutaneous tissue fluid drug delivery device based on air osmotic pressure power. Background Art

[0002] With the development of society and the improvement of medical standards, people's attention to health has increased unprecedentedly. Traditional methods such as intravenous, subcutaneous, and intramuscular administration, which require multiple long-term administration, can no longer meet patients' needs for improving drug efficacy, reducing side effects, precise targeting, and high-quality life. Although the existing technology already has a variety of drug administration methods, such as conventional injections, pre-flushed injections, needle-free injections, and automatic emergency injection needles, etc. These drug administration methods work well in specific situations, but they still cannot meet people's needs for accurate, efficient, low-frequency, and comfortable drug administration methods.

[0003] Traditional subcutaneous drug delivery is mainly based on needle injection, which has the following disadvantages:

[0004] (1) Poor patient experience: Needle injection can easily cause pain and local tissue damage.

[0005] (2) Difficulty in controlling dosage: Due to individual differences, traditional injection methods cannot ensure uniform distribution of drugs under the skin.

[0006] (3) Low drug absorption efficiency: Some drugs are difficult to diffuse in subcutaneous tissue, which affects the absorption effect.

[0007] With the development of medical technology, the demand for painless, precise and controllable drug delivery is increasing. For example, the prior art (Announcement No. CN219630430U) discloses a microneedle-based subcutaneous sustained-release drug delivery device, which can directly act on the dermis, has better transdermal drug delivery effect, and is painless and safe.

[0008] However, based on the prior art, although the microneedle device can reduce the pain of traditional injections, due to the structure of the device itself, some electric methods are used to promote the flow of the solution. The overall device is relatively complex and difficult to replace and maintain. At the same time, it may not be accurate enough in the drug release rate and is easily affected by environmental factors. Therefore, the present invention proposes a subcutaneous tissue fluid drug delivery device based on air osmotic pressure power to solve the problems existing in the prior art. Summary of the invention

[0009] In view of the above problems, the purpose of the present invention is to propose a subcutaneous tissue fluid drug delivery device based on air osmotic pressure power, which has the advantage of being easy to use and can solve the problems existing in the prior art.

[0010] To achieve the purpose of the present invention, the present invention is implemented through the following technical solutions: a subcutaneous tissue fluid drug delivery device based on air osmotic pressure power, comprising a base and a microneedle array, a concave cavity is provided on the inner side of the base, and an inner liner is installed in the concave cavity, a microneedle array is installed at the lower end of the inner liner, the lower end of the microneedle array passes through the base, a protective component is installed below the base, a shell is provided above the base, the shell is connected to the base through a connecting component, a solvent cavity is provided on the inner side of the shell, an opening is provided at the lower end of the shell, and a semipermeable membrane is installed on the inner side of the opening, the lower end surface of the semipermeable membrane is in contact with the inner cavity of the inner liner, a drug tablet is installed on the inner side of the inner liner, two groups of symmetrically arranged silicone injection nozzles are installed on the shell, and a micro electric valve is installed on one group of silicone injection nozzles, an air vent is provided on the shell, and fixing components are installed on both sides of the shell.

[0011] A further improvement is that the fixing assembly comprises an articulated frame, a connecting block is hinged on the articulated frame, a medical tape is mounted on the connecting block, and one end of the medical tape is adhered to the lower end surface of the connecting block.

[0012] A further improvement is that the protection component includes a protection shell, the upper end of the protection shell is connected to the base by a plug-in installation method, and protective silicone is installed on the inner side of the protection shell, and the number and position of the protective silicone correspond to the number and position of the microneedles in the microneedle array.

[0013] A further improvement is that a silicone gasket is installed on the inner side of the air vent, a breathable membrane and a dustproof net are installed on the inner side of the silicone gasket, and the dustproof net is located above the breathable membrane.

[0014] A further improvement is that the connecting assembly includes an extension portion, the extension portion is designed as an integral unit with the housing, an annular groove is provided on the base, the extension portion is located in the annular groove and is connected to the base via a thread.

[0015] A further improvement is that a contact rubber ring is installed on the inner side of the annular groove, the contact rubber ring is connected to the base through a spring, and the spring is evenly arranged in several groups.

[0016] A further improvement is that a silicone spacer ring is installed at the lower end of the base.

[0017] A further improvement is that: blocks are installed on both sides of the inner container, and the blocks are in contact with the medicine tablets.

[0018] A further improvement is that the number of microneedles in the microneedle array is 3 to 9.

[0019] The beneficial effects of the present invention are:

[0020] (1) The present invention drives the flow of drug solution through air osmotic pressure difference, and does not rely on a complex electric drive system. The regulation of air osmotic pressure can accurately control the flow rate of solvent and drug, which ensures the uniform release of drug under the skin. During use, the air osmotic pressure difference can stably control the release rate of the drug, so that the drug is delivered to the target area at the best time and at an appropriate speed, thereby improving the accuracy and consistency of drug delivery.

[0021] (2) The driving method of drug administration of the present invention is simpler, avoiding the use of an electric drive system, making the entire device more compact and lightweight, reducing the possibility of failure, reducing the difficulty of maintenance, and further reducing the pressure and discomfort on the skin. At the same time, the drug is dissolved by injection solvent and enters the subcutaneous tissue in a gentler manner, avoiding the pain or discomfort caused by traditional injection methods, and further improving the comfort of patients.

[0022] (3) The overall structure of the present invention is relatively simple, and a detachable and replaceable design is mostly adopted, so that users and caregivers can easily clean, maintain and replace it, avoiding complicated maintenance operations, thereby facilitating the use of the device in a long-term environment. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a front view structural schematic diagram of the present invention.

[0024] Figure 2 It is a front view schematic diagram of the right side medical tape of the present invention after being unfolded.

[0025] Figure 3 It is a front view structural schematic diagram of the present invention after the protective shell is removed.

[0026] Figure 4 It is a front view schematic diagram of the connection between the inner container and the microneedle array of the present invention.

[0027] Among them: 1. base; 2. microneedle array; 3. liner; 4. outer shell; 5. solvent chamber; 6. semipermeable membrane; 7. drug tableting; 8. silicone injection nozzle; 9. micro electric valve; 10. connecting block; 11. medical tape; 14. protective shell; 15. protective silicone; 16. silicone gasket; 17. breathable membrane; 18. dustproof net; 19. extension; 20. annular groove; 21. contact rubber ring; 22. silicone spacer ring; 24. stopper. DETAILED DESCRIPTION

[0028] In order to deepen the understanding of the present invention, the present invention will be further described in detail below in conjunction with examples. The examples are only used to explain the present invention and do not constitute a limitation on the protection scope of the present invention.

[0029] The wall of a blood vessel has three layers: the intima composed of endothelial cells, the middle membrane composed of smooth muscle cells, and the adventitia composed of extracellular matrix and fascia. The space inside the blood vessel cavity is where blood flows, and recent studies have shown that there is also space for tissue fluid to flow in the adventitia of the blood vessel. Unlike the single liquid flow space in the "pipe-like" structure, there are at least three types of liquid flow spaces in the adventitia tissue: 1. The gap between the adventitia matrix and the fascia; 2. The "interface area" on the surface of the fiber filaments inside the adventitia matrix; 3. The gap between the adventitia matrix and the middle membrane. When tissue fluid enters these three spaces, under the continuous action of external forces, the tissue fluid can flow along the adventitia of the vascular tree, forming a vascular adventitia tissue fluid circulation network around the arteries and veins of the systemic circulation and pulmonary circulation.

[0030] The flow of tissue fluid in this adventitia network is very different from the rapid flow of blood in blood vessels. It flows along the vascular tree while passing through the fascia layer that wraps the blood vessels and enters the perivascular tissue along the way. This flow and diffusion flow is more like an "irrigation system."

[0031] The systemic circulation network of tissue fluid is not only distributed along the adventitia of the vascular tree, but also widely distributed in the connective tissues of the dermis and subcutaneous tissue of the skin, the epineurium, the perineurium and the endometrium, the fascia, etc. The periodic coordinated movement of the heart and lungs not only drives the systemic flow of tissue fluid along the vascular tree, but is also likely to be the "power source" of the tissue fluid flow network distributed in other parts such as the skin, nerves, and fascia.

[0032] The principle of traditional subcutaneous drug delivery is the free diffusion of drugs in subcutaneous tissue. Therefore, this device can cooperate with the systemic circulation network of tissue fluid to more accurately deliver drugs to the area in need of treatment, avoid the distribution of drugs in non-target tissues, and reduce the dosage of drugs.

[0033] Therefore, according to Figure 1-Figure 4As shown, this embodiment proposes a subcutaneous tissue fluid drug delivery device based on air osmotic pressure power, including a base 1 and a microneedle array 2, a concave cavity is provided on the inner side of the base 1, and an inner liner 3 is installed in the concave cavity, and a microneedle array 2 is installed at the lower end of the inner liner 3, and the microneedle array 2 and the inner liner 3 are both made of stainless steel. Correspondingly, the microneedle array 2 is composed of several groups of distributed microneedles, and the inner cavity of the microneedle is connected to the inner cavity of the inner liner 3. There are also several groups of drug delivery holes on the microneedle. The structure and arrangement of these microneedles are to ensure that the drug can be delivered evenly and effectively. The number of microneedles in the microneedle array is 3 to 9. In this embodiment, the number of microneedles is set to 6, which adopts a polymer material with good biocompatibility (such as polylactic acid-glycolic acid copolymer, PLGA). For the microneedle, its length is 300 to 500 microns, the diameter is 34G, about 0.18 mm (or 180 microns), and the needle spacing is 100 to 200 microns. In this embodiment, four groups of drug delivery holes are evenly distributed in a ring shape on the side of each group of microneedles.

[0034] Accordingly, the position and shape of the liner 3 are precisely designed to ensure that the microneedle array 2 can be stably installed and effectively contact the skin. The lower end of the corresponding microneedle array 2 passes through the base 1. A protective component is installed below the base 1. The protective component includes a protective shell 14. The upper end of the protective shell 14 is connected to the base 1 by a plug-in installation method. A protective silica gel 15 is installed on the inner side of the protective shell 14. The number and position of the protective silica gel 15 correspond to the number and position of the microneedles in the microneedle array 2. When not in use, the protective component can ensure that the microneedle array is fully protected when not in use to prevent it from contacting with external objects and causing damage or contamination. Accordingly, the plug-in installation method is adopted to make the protective shell 14 easy to install and remove, so as to facilitate use.

[0035] A shell 4 is provided above the base 1, and the shell 4 is connected to the base 1 through a connecting assembly. The connecting assembly includes an extension 19, and the extension 19 is designed as an integral part with the shell 4, which improves the connection stability between the extension 19 and the shell 4. An annular groove 20 is provided on the base 1, and the extension 19 is located in the annular groove 20 and is connected to the base 1 through a thread. The threaded connection is a common and reliable mechanical connection method, which can ensure the tight connection between the shell 4 and the base 1, and avoid the device from loosening due to vibration or external force during use. A contact rubber ring 21 is installed on the inner side of the annular groove 20, and the contact rubber ring 21 is connected to the base 1 through a spring, and the spring is evenly provided in several groups. Accordingly, the use of the contact rubber ring 21 can form a seal between the shell 4 and the base 1, prevent air, moisture or dust from entering the interior of the device, thereby protecting the internal medicine. Further, through the uniform elasticity of the spring, it can be ensured that the connection between the shell 4 and the base 1 always maintains an appropriate pressure during use, avoiding the problem of looseness or poor contact, thereby improving the sealing performance and connection stability of the device in long-term use.

[0036] A solvent chamber 5 is provided inside the housing 4, an opening is provided at the lower end of the housing 4, and a semipermeable membrane 6 is installed inside the opening. The function of the semipermeable membrane 6 is to prevent gas from entering, while the solvent can pass through, and then the semipermeable membrane 6 helps to maintain the pressure balance inside the device. For the semipermeable membrane, in this embodiment, a natural polymer membrane is used, such as cellulose acetate and cellulose acetate-sodium chloride composite membrane, which has good biocompatibility and biodegradability and is suitable for drug delivery systems.

[0037] The entry of gas may interfere with the stability of osmotic pressure, thereby affecting the release rate of the drug. By preventing gas from entering, the semipermeable membrane ensures that the osmotic pressure difference between the medicine cavity and the water cavity can be maintained at a constant state. The lower end surface of the semipermeable membrane 6 contacts the inner cavity of the liner 3, and the solvent cavity 5 is located above the semipermeable membrane 6. The inner side of the liner 3 is equipped with a drug tablet 7, and both sides of the liner 3 are equipped with a stopper 24, which contacts the drug tablet 7. In this embodiment, the drug tablet 7 is composed of the drug itself and a permeating agent. The permeating agent is a substance that can enhance drug absorption or dissolution by changing the osmotic pressure of the solution. Common permeating agents include some small molecule chemicals, such as salts (such as sodium chloride, potassium chloride) or sugars (such as glucose). By combining the drug with the permeating agent to form a tablet, the characteristics of the permeating agent can be used to promote the dissolution of the drug or penetration into the skin. The permeating agent helps the drug to dissolve or diffuse faster and more evenly in the body, thereby improving bioavailability or release rate. In this device, the drug administration is controlled based on the osmotic pressure difference. When in use, the user injects the corresponding solvent into the solvent chamber 5 through an external injection device. Before the injection, there is air in the solvent chamber 5, which acts as a gas pressure source, thereby providing an initial pressure. After the solvent is injected, the air is gradually discharged, and the remaining liquid and the solution formed during the drug dissolution process will rely on this osmotic pressure difference to push the drug to diffuse from the drug chamber to the microneedle array, and then enter the body through the skin. In this process, the discharge of air helps the pressure inside the system to reach a balance, and then a drug solution is formed after the drug tablet 7 is dissolved. When an osmotic pressure difference is formed between the solvent and the drug solution, the drug will enter the skin through the microneedle array 2 under the action of the membrane.

[0038] Two groups of symmetrically arranged silicone injection nozzles 8 are installed on the housing 4. The silicone injection nozzle 8 is an elastic and soft component that can remain closed when not in use to prevent external contamination or drug spillage. The use of silicone material makes the injection nozzle have good sealing and softness, and can adapt well to the connection of the external injection device when inserted. A group of silicone injection nozzles 8 is installed with a micro electric valve 9. The silicone injection nozzle 8 is in a closed state when not in use. When in use, the injection nozzle of the external injection device needs to be inserted into the silicone injection nozzle 8. Accordingly, in this device, two groups of silicone injection nozzles 8 are provided, and one group is installed with a micro electric valve 9. The micro electric valve 9 can adjust the speed of solvent injection to ensure that the release of the drug solution has precise flow control, thereby ensuring the stability and uniformity of the drug during the administration process. Patients can adjust the release rate of the drug according to different treatment needs, while the other group is used for the standard injection process, that is, it is suitable for scenes where rapid injection flow rate control is not required, so that the device has flexibility in different usage scenarios.

[0039] The housing 4 is provided with a vent, which allows air to circulate, ensuring the gas exchange requirements inside the device, ensuring that the device can maintain an appropriate pressure balance, and allowing air to circulate. A silicone gasket 16 is installed on the inner side of the vent. The silicone gasket 16 has soft and elastic properties and can effectively seal with other components. A breathable membrane 17 and a dustproof net 18 are installed on the inner side of the silicone gasket 16. The dustproof net 18 is located above the breathable membrane 17. The breathable membrane 17 allows gas to pass through, but prevents liquid or larger particles from entering the device. The dustproof net 18 can effectively prevent dust, pollen or other large particles from entering the device, reducing the impact of external pollution sources on drug delivery. Accordingly, the vent, silicone gasket 16, breathable membrane 17 and dustproof net 18 form a multiple protection system. This design can ensure that the device is ventilated while preventing pollutants from entering the interior, ensuring the safety, cleanliness and stability of drug delivery.

[0040] Both sides of the housing 4 are provided with fixing components, the fixing components including a hinge frame, a connecting block 10 is hingedly connected to the hinge frame, a medical tape 11 is installed on the connecting block 10, one end of the medical tape 11 is adhered to the lower end surface of the connecting block 10, in the present device, the upper end of the medical tape 11 is fixed to the connecting block 10, and the lower end thereof can be torn off, so that Figure 2As shown, the medical tape 11 is in an unfolded state, and then cooperates with the hinged connecting block 10, which can better fit the user's body and adapt to body parts of different shapes and curves, thereby improving the comfort and stability when worn, and then the device can be fixed on the user's body. Then the combination of the medical tape 11 and the hinged frame ensures that the device can be firmly fixed during use, preventing the device from loosening due to movement, friction or external force, thereby ensuring the stability of drug delivery, and allowing patients to easily fix and remove the device, reducing the complexity in use.

[0041] A silicone spacer ring 22 is installed at the lower end of the base 1. When the device is fixed on the user's body, the silicone spacer ring 22 can provide a soft contact effect, avoiding direct contact with hard materials or other unsuitable materials, ensuring the comfort of the wearing area. Accordingly, through the elasticity of silicone, the spacer ring can adapt to skin surfaces of different shapes and sizes, making the device more stable when worn.

[0042] The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited by the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the framework and scope of application of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A subcutaneous tissue fluid drug delivery device based on air osmotic pressure power, comprising a base (1) and a microneedle array (2), characterized in that: The base (1) is provided with a concave cavity on the inner side, and an inner liner (3) is installed in the concave cavity. A microneedle array (2) is installed at the lower end of the inner liner (3), and the lower end of the microneedle array (2) passes through the base (1). A protective component is installed below the base (1). A shell (4) is provided above the base (1). The shell (4) is connected to the base (1) through a connecting component, and a solvent cavity (5) is provided on the inner side of the shell (4). An opening is provided at the lower end of the shell (4), and a semipermeable membrane (6) is installed on the inner side of the opening. The lower end surface of the semipermeable membrane (6) is in contact with the inner cavity of the inner liner (3). A drug tablet (7) is installed on the inner side of the inner liner (3). Two groups of symmetrically arranged silicone injection nozzles (8) are installed on the shell (4), and a micro electric valve (9) is installed on one group of silicone injection nozzles (8). A vent is provided on the shell (4), and fixing components are installed on both sides of the shell (4).

2. A subcutaneous tissue fluid drug delivery device based on air osmotic pressure according to claim 1, characterized in that: The fixing assembly comprises an articulated frame, a connecting block (10) is hinged on the articulated frame, a medical tape (11) is installed on the connecting block (10), and one end of the medical tape (11) is adhered to the lower end surface of the connecting block (10).

3. The subcutaneous tissue fluid administration device based on air osmotic pressure power according to claim 1, characterized in that: The protective component comprises a protective shell (14), the upper end of the protective shell (14) is connected to the base (1) in a plug-in installation manner, and a protective silica gel (15) is installed on the inner side of the protective shell (14), and the number and position of the protective silica gel (15) correspond to the number and position of the microneedles in the microneedle array (2).

4. The subcutaneous tissue fluid administration device based on air osmotic pressure power according to claim 1, characterized in that: A silicone gasket (16) is installed on the inner side of the air vent, and a breathable membrane (17) and a dustproof net (18) are installed on the inner side of the silicone gasket (16), and the dustproof net (18) is located above the breathable membrane (17).

5. The subcutaneous tissue fluid administration device based on air osmotic pressure power according to claim 1, characterized in that: The connecting assembly comprises an extension portion (19), the extension portion (19) and the housing (4) are designed as an integral unit, an annular groove (20) is provided on the base (1), the extension portion (19) is located in the annular groove (20), and is connected to the base (1) via a thread.

6. The subcutaneous tissue fluid administration device based on air osmotic pressure power according to claim 5, characterized in that: A contact rubber ring (21) is installed inside the annular groove (20). The contact rubber ring (21) is connected to the base (1) via a spring, and the spring is evenly arranged in a plurality of groups.

7. The subcutaneous tissue fluid drug delivery device based on air osmotic pressure according to claim 1, characterized in that: A silicone spacer ring (22) is installed at the lower end of the base (1).

8. The subcutaneous tissue fluid administration device based on air osmotic pressure power according to claim 1, characterized in that: Stoppers (24) are installed on both sides of the inner container (3), and the stoppers (24) are in contact with the medicine tablet (7).

9. The subcutaneous tissue fluid drug delivery device based on air osmotic pressure according to claim 1, characterized in that: The number of microneedles in the microneedle array (2) is 3 to 9.

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