Wearable multi-drug sustained release device

Abstract

The invention relates to the technical field of drug sustained release, and discloses a wearable multi-drug sustained release device which comprises a flexible base material, a sustained release drug delivery structure comprises a microneedle array cluster distributed on the inner side of the flexible base material, a modular drug box is arranged on one side of the microneedle array cluster, and a controlled release module is arranged on the inner side of the flexible base material; a snap fastener is fixed on the surface of the friction belt, and a rope binding belt is sewn on the flexible base material. According to the wearable multi-drug sustained release device, when the flexible base material and the flexible cavity tube deform, stress is mainly absorbed and extended by the flexible cavity tube, the rigid convex block bearing the microneedle cluster tube is kept stable, the angle is automatically adjusted to keep vertical puncture force on the skin surface, and the stability of the microneedle puncture state is ensured; different medicine storage boxes have different RFID identifications, and the effect of administration of different medicines at the same affected part can be achieved; for different sizes of binding parts, the binding stability can be improved by adopting snap fasteners or rope binding belts.

Description

Technical Field

[0001] This invention relates to the field of drug sustained-release technology, specifically to a wearable multi-drug sustained-release device. Background Technology

[0002] Sustained-release drug delivery, also known as controlled-release drug delivery, uses advanced technology to deliver the active ingredient of a drug into the body at a specific rate within a predetermined time and maintain it within the desired therapeutic concentration range. Its main purpose is to overcome the shortcomings of traditional drug delivery methods, and its core value lies in maintaining stable blood drug concentrations, reducing the frequency of administration, and targeted release.

[0003] A search revealed a device for relieving depression and insomnia in adolescents by applying traditional Chinese medicine acupoint patches, disclosed in Chinese patent publication number CN120324767A. This invention patent describes a flexible patch application module that is intelligently controlled to apply to specific acupoints on the human body. It can automatically control the application time and dosage. Combined with a microneedle array, it improves the transdermal efficiency of traditional Chinese medicine ingredients through physical penetration enhancement technology. At the same time, it adopts a medical-grade silicone low-allergenic adhesive structure to avoid damaging the sensitive skin of adolescents. Through an intelligent control system and wearable monitoring system, it can monitor the body's status in real time and control the flexible patch module to intelligently adjust the application of medicine.

[0004] However, this traditional Chinese medicine acupoint patch also uses microneedle array technology. It uses a silicone patch to adhere to the human skin, and after the microneedles pierce the dermis, the microfluidic chip is used to physically promote drug delivery. Because the joints of the human body are uneven, after the silicone patch adheres to the skin, the microneedles are directly fixed to the silicone substrate. When the silicone substrate adapts to the deformation of the human body, shearing forces are generated, which leads to problems such as microneedle misalignment, inconsistent puncture depth, and even breakage. This affects normal drug delivery and results in low drug delivery efficiency. At the same time, because the size of this acupoint patch is fixed, it cannot adapt to the stability of the wrapping when used on different parts of the human body. Therefore, further improvements are needed in terms of the stability of the microneedle structure and size adaptation. Hence, a wearable multi-drug sustained-release device is proposed. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] To address the shortcomings of existing technologies, this invention provides a wearable multi-drug sustained-release device that has the advantages of adapting to different parts of the human body and maintaining the stability of the microneedle structure. This solves the problems in the background art where existing traditional Chinese medicine acupoint patch devices for relieving adolescent depression and insomnia are inconvenient to use on different parts of the human body and require improved stability of microneedles in contact with the skin.

[0007] (II) Technical Solution

[0008] To achieve the above-mentioned purpose of adapting to different positions on the human body and maintaining the stability of the microneedle structure, the present invention provides the following technical solution: a wearable multi-drug sustained-release device, including a flexible substrate that adheres to human skin, a sustained-release drug delivery structure provided on the inner side of the flexible substrate, and an adjustment wearable component provided on the outer side of the flexible substrate.

[0009] The sustained-release drug delivery structure includes a cluster of microneedles distributed on the inner side of a flexible substrate, a modular drug cartridge is provided on one side of the microneedle array cluster, and a controlled-release module is provided on the inner side of the flexible substrate.

[0010] The adjustable wearable assembly includes a friction band sewn onto a flexible substrate, the surface of which is fixed with a snap fastener, and a drawstring sewn onto the flexible substrate, the inner side of which is filled with an airbag layer.

[0011] Preferably, the flexible substrate has a groove adapted to the skin curve on the side that fits the human skin, and the microneedle array cluster includes a flexible cavity tube encapsulated inside the groove. The flexible cavity tube is distributed in a wave-shaped structure, and silicone oil is injected inside the flexible cavity tube. Rigid protrusions are movably connected to the outside of the flexible cavity tube.

[0012] Preferably, the rigid protrusion has a hemispherical interface fixed on the side connected to the flexible cavity tube.

[0013] The rigid bump has a microneedle cluster formed on the side facing away from the flexible cavity tube, and a spiral microchannel tube is connected to the side of the hemispherical interface.

[0014] Preferably, the flexible substrate has several base grooves on the side facing away from human skin. Each base groove is fixedly installed with a micro peristaltic pump. A hollow probe is fixedly connected to the inner bottom wall of the base groove. One side of the micro peristaltic pump is connected to the hollow probe. The modular medicine box includes a medicine storage box adapted to the base groove. The medicine storage box has a cylindrical structure and is equipped with an RFID tag.

[0015] Preferably, an RFID tag detector is provided on the inner side of the base groove, and magnetic rings with magnetic adsorption are fixed on both the outer side of the drug storage box and the inner side of the base groove. A sealing layer is encapsulated on the side of the drug storage box that is connected to the hollow probe. The controlled release module includes a physical state sensor integrated inside the base groove. The physical state sensor is used to monitor the drug administration pressure and drug administration flow rate of the drug storage box.

[0016] Preferably, the controlled release module includes a flexible biosensor embedded on the outside of the groove, the flexible biosensor being used to monitor the temperature of the local skin, the pH value of the tissue fluid, and inflammatory factors, and also includes a microcontroller and a power module disposed on the top of the flexible substrate, the microcontroller including a signal receiving module, an analysis and processing module, and a communication management module, and the power module being used to achieve low power supply.

[0017] The signal receiving module receives data from multiple sensors, RFID tag information, and other sources.

[0018] The analysis and processing module is equipped with a PID controller and a drug delivery strategy algorithm model.

[0019] The communication management module connects to the mobile device APP via Bluetooth.

[0020] Preferably, there are two friction strips, which are sewn to the left and right sides of the flexible substrate respectively. A silicone micro-protrusion matrix layer is provided on the side of the friction strip that is in contact with human skin. The fastener includes a female fastener piece fixed on one of the friction strips and a female fastener piece corresponding to the female fastener piece fixed on the other friction strip. The female fastener pieces are distributed in an equidistant array.

[0021] Preferably, there are two drawstrings, both of which are made of elastic fabric and are sewn to the left and right sides of the flexible substrate respectively. One of the drawstrings has a burr-like surface sewn on its surface, and the other drawstring has a hook-like surface sewn on its surface. The inner layer of both drawstrings has a bladder cavity, and the air bladder layer is located inside the two bladder cavities. An inflation port is provided on the air bladder layer, and the inflation port is fixed to the surface of the drawstring.

[0022] (3) Beneficial effects

[0023] Compared with the prior art, the present invention provides a wearable multi-drug sustained-release device, which has the following beneficial effects:

[0024] 1. This wearable multi-drug sustained-release device forms a rigid island structure by fabricating several clustered microneedles on a small rigid protrusion. The rigid protrusion is connected to the flexible lumen via a hemispherical interface with slight movement. When the flexible substrate and the flexible lumen deform, the stress is mainly absorbed and extended by the flexible lumen, while the rigid protrusion supporting the microneedle cluster remains stable and automatically adjusts its angle to maintain the vertical puncture force on the skin surface, ensuring the stability of the microneedle puncture state and maintaining the effect of drug delivery.

[0025] 2. This wearable multi-drug sustained-release device uses multiple modular drug cartridges to adapt to different flexible lumens. The drug cartridges are connected to a micro-peristaltic pump through a hollow probe. The micro-peristaltic pump delivers the drug into the microfluidic tube, which then guides the drug into the microneedle cluster tube for administration. Different drug cartridges have different RFID tags, enabling different drugs to be administered to the same affected area.

[0026] 3. For the wrist and forearm, where the binding area is relatively small, this wearable multi-drug sustained-release device can be fixed by using a female and female buckle connection, and the silicone micro-protrusion matrix layer can be used to improve the friction fixation effect. For the upper arm and thigh, where the binding area is relatively large, elastic fabric straps can be used to fix the device by bonding the burr and hook surfaces, while the air bladder layer is inflated to increase the pressure on the affected area, thereby improving the binding stability. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the bottom structure of the flexible substrate of the present invention;

[0028] Figure 2 This is a schematic diagram of the top structure of the flexible substrate of the present invention;

[0029] Figure 3 for Figure 1 Schematic diagram of the middle section;

[0030] Figure 4 This is a schematic diagram of the microneedle array cluster structure of the present invention;

[0031] Figure 5 for Figure 2 Schematic diagram of the middle section;

[0032] Figure 6 This is a schematic diagram of the modular medicine box structure of the present invention.

[0033] In the figure: 1. Flexible substrate; 2. Sustained-release drug delivery structure; 201. Microneedle array cluster; 2011. Flexible lumen; 2012. Rigid bump; 2013. Microneedle cluster tube; 2014. Microfluidic tube; 202. Modular drug cartridge; 2021. Drug storage box; 2022. Magnetic ring; 203. Controlled release module; 2031. Physical state sensor; 2032. Flexible biosensor; 2033. Microcontroller; 2034. Power module; 3. Adjustable wearable component; 301. Friction band; 302. Snap fastener; 3021. Female snap fastener; 3022. Female snap fastener; 303. Cable tie; 304. Airbag layer; 4. Groove; 5. Base groove; 6. Micro-peristaltic pump; 7. Hollow probe; 8. Silicone micro-bump lattice layer; 9. Burred surface; 10. Hooked surface. Detailed Implementation

[0034] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] Example 1

[0036] In this embodiment, the flexible substrate 1 can be made of materials such as medical silicone, memory foam and medical low protein latex to ensure high flexibility and adaptability to the curves of human skin. At the same time, it is covered with a wear-resistant, moisture-resistant and antibacterial fabric layer to improve the effect of friction resistance, sweat resistance and inhibition of bacterial growth on human skin when worn.

[0037] When the flexible substrate 1 adapts to the deformation of human skin, the working process of its microneedle array cluster 201 includes:

[0038] 1) The microneedle cluster tube 2013 adopts a biomimetic castle-shaped and serrated needle tip structure design with a length of 500-800μm, ensuring that it penetrates the stratum corneum but does not touch the subcutaneous nerves, increasing wearing comfort and avoiding stinging sensation;

[0039] 2) Each microneedle is equipped with an independent drug delivery channel, which is connected to a drug storage unit to deliver the drug. Biodegradable polymer materials are used to improve comfort and safety on human skin.

[0040] 3) The small cluster of microneedles is fabricated on the rigid bump 2012. A highly stretchable, wave-shaped flexible cavity tube 2011 with built-in flexible flow channel is used to connect multiple rigid bumps 2012 and encapsulate them in the flexible substrate 1. The rigid bumps 2012 are connected to the flexible cavity tube 2011 through a hemispherical interface with slight movement.

[0041] 4) When the flexible substrate 1 and the flexible cavity tube 2011 deform, the stress is mainly absorbed and extended by the flexible cavity tube 2011, while the rigid protrusion 2012 supporting the microneedle cluster tube 2013 remains stable and automatically adjusts the angle to maintain the vertical puncture force on the skin surface.

[0042] 5) The spiral microchannel layout can adapt to deformation by unwinding during stretching, instead of breaking directly. At the connection between the rigid protrusion 2012 and the flexible cavity tube 2011, annular reinforcing ribs or hemispherical interfaces are designed to prevent the interface from cracking or leaking after repeated deformation.

[0043] Example 2

[0044] In this embodiment, the drug storage box 2021 is used to store drug preparations. It has good biocompatibility, low air and water permeability to prevent drug degradation or solvent evaporation, and compatibility with drugs without adsorption or reaction. Different drug storage boxes 2021 can be used to hold different drug components. Each drug storage box 2021 is independently equipped with an RFID tag. The code is quickly identified by the reader to distinguish different drug storage boxes 2021. At this time, the drug storage box 2021 is connected to the base groove 5 by the magnetic ring 2022.

[0045] The hollow probe 7 pierces the sealing layer and delivers the drug to the micro-peristaltic pump 6. The micro-peristaltic pump 6 then introduces the drug into the microneedle cluster tube 2013 through the microfluidic tube 2014 for drug delivery. The physical state sensor 2031 is used to monitor the drug delivery pressure and flow rate of the drug storage box 2021. The flexible biosensor 2032 is used to monitor the local skin temperature, tissue fluid pH value, and inflammatory factors, and then feeds back the data to the microcontroller 2033 to control the delivery flow rate of the micro-peristaltic pump 6.

[0046] In summary, this wearable multi-drug sustained-release device forms a rigid island structure by fabricating several clustered microneedle tubes 2013 on a small rigid protrusion 2012. At the same time, the rigid protrusion 2012 is connected to the flexible cavity tube 2011 through a hemispherical interface with slight movement. When the flexible substrate 1 and the flexible cavity tube 2011 deform, the stress is mainly absorbed and extended by the flexible cavity tube 2011, while the rigid protrusion 2012 supporting the microneedle tubes 2013 remains stable and automatically adjusts its angle to maintain the vertical puncture force on the skin surface, ensuring the stability of the microneedle puncture state and maintaining the effect of drug delivery.

[0047] By setting up multiple modular drug cartridges 202 to adapt to different flexible tubes 2011, the drug storage cartridge 2021 is connected to the micro peristaltic pump 6 through the hollow probe 7. The micro peristaltic pump 6 delivers the drug into the microfluidic tube 2014, and the microfluidic tube 2014 introduces the drug into the microneedle cluster tube 2013 for drug administration. Different drug storage cartridges 2021 have different RFID tags, which can achieve the effect of drug administration to the same affected area.

[0048] For smaller areas like the wrist and forearm, the female buckle 3021 and the female buckle 3022 can be fastened together for fixation, and the silicone micro-protrusion dot matrix layer 8 can be used to improve the friction fixation effect. For larger areas like the upper arm and thigh, the elastic fabric drawstring 303 can be used to fix the area by bonding the burr surface 9 and the hook surface 10. At the same time, the air bladder layer 304 can be inflated to increase the pressure on the affected area, thereby improving the stability of the binding.

[0049] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0050] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A wearable multi-drug sustained-release device, comprising a flexible substrate (1) that adheres to human skin, characterized in that: The flexible substrate (1) has a sustained-release drug delivery structure (2) on its inner side and an adjustable wearable component (3) on its outer side. The sustained-release drug delivery structure (2) includes a microneedle array cluster (201) distributed on the inner side of the flexible substrate (1), a modular drug cartridge (202) is provided on one side of the microneedle array cluster (201), and a controlled-release module (203) is provided on the inner side of the flexible substrate (1). The adjustable wearable component (3) includes a friction band (301) sewn onto a flexible substrate (1), the surface of which is fixed with a snap fastener (302), and a drawstring (303) sewn onto the flexible substrate (1), the inner side of which is filled with an airbag layer (304).

2. The wearable multi-drug sustained-release device according to claim 1, characterized in that: The flexible substrate (1) has a groove (4) on one side that conforms to the skin curve. The microneedle array cluster (201) includes a flexible cavity tube (2011) encapsulated inside the groove (4). The flexible cavity tube (2011) is distributed in a wave-shaped structure. Silicone oil is injected inside the flexible cavity tube (2011). Rigid protrusions (2012) are movably connected to the outside of the flexible cavity tube (2011).

3. The wearable multi-drug sustained-release device according to claim 2, characterized in that: The rigid protrusion (2012) has a hemispherical interface fixed on the side connected to the flexible cavity tube (2011), and a microneedle cluster tube (2013) is formed on the side of the rigid protrusion (2012) facing away from the flexible cavity tube (2011). A spiral microchannel tube (2014) is connected to the side of the hemispherical interface.

4. The wearable multi-drug sustained-release device according to claim 1, characterized in that: The flexible substrate (1) has several base grooves (5) on the side facing away from human skin. A micro peristaltic pump (6) is fixedly installed inside each base groove (5). A hollow probe (7) is fixedly connected to the inner bottom wall of the base groove (5). One side of the micro peristaltic pump (6) is connected to the hollow probe (7). The modular medicine box (202) includes a medicine storage box (2021) adapted to the base groove (5). The medicine storage box (2021) is a cylindrical structure and is equipped with an RFID tag.

5. A wearable multi-drug sustained-release device according to claim 4, characterized in that: The inner side of the base groove (5) is equipped with an RFID tag detector. The outer side of the drug storage box (2021) and the inner side of the base groove (5) are both fixed with magnetically compatible magnetic rings (2022). A sealing layer is encapsulated on the side of the drug storage box (2021) that is connected to the hollow probe (7). The controlled release module (203) includes a physical state sensor (2031) integrated inside the base groove (5). The physical state sensor (2031) is used to monitor the drug administration pressure and drug administration flow rate of the drug storage box (2021).

6. A wearable multi-drug sustained-release device according to claim 2, characterized in that: The controlled release module (203) includes a flexible biosensor (2032) embedded in the outside of the groove (4). The flexible biosensor (2032) is used to monitor the temperature of the local skin, the pH value of the tissue fluid, and inflammatory factors. It also includes a microcontroller (2033) and a power module (2034) disposed on the top of the flexible substrate (1). The microcontroller (2033) includes a signal receiving module, an analysis and processing module, and a communication management module. The power module (2034) is used to achieve low power supply. The signal receiving module receives data from multiple sensors, RFID tag information, and other sources. The analysis and processing module is equipped with a PID controller and a drug delivery strategy algorithm model. The communication management module connects to the mobile device APP via Bluetooth.

7. A wearable multi-drug sustained-release device according to claim 1, characterized in that: There are two friction strips (301), which are sewn to the left and right sides of the flexible substrate (1) respectively. A silicone micro-protrusion matrix layer (8) is provided on the side of the friction strip (301) that is in contact with human skin. The male and female buckles (302) include a female buckle piece (3021) fixed on one of the friction strips (301) and a female buckle piece (3022) corresponding to the female buckle piece (3021) fixed on the other friction strip (301). The female buckle pieces (3022) are distributed in an equidistant array.

8. A wearable multi-drug sustained-release device according to claim 1, characterized in that: There are two cord straps (303), both of which are made of elastic fabric and are sewn to the left and right sides of the flexible substrate (1). One cord strap (303) has a burr surface (9) sewn on its surface, and the other cord strap (303) has a hook-and-prick surface (10) sewn on its surface. The inner layer of both cord straps (303) has a bladder cavity. The air bladder layer (304) is located inside the two bladder cavities. An inflation port is provided on the air bladder layer (304) and the inflation port is fixed to the surface of the cord strap (303).

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