Multi-region transdermal drug delivery wearable device based on press-type microneedle

Abstract

This invention provides a wearable device for multi-region transdermal drug delivery based on press-type microneedles, relating to the field of microneedle drug delivery. The device includes a press-type microneedle structure, an elastic ring, an electrode sheet, and an anti-permeability ring structure stacked sequentially. The press-type microneedle structure is mounted on one side of the electrode sheet, and the anti-permeability ring structure is mounted on the other side. Multiple microneedles are provided on the side of the press-type microneedle structure, and multiple through holes are correspondingly provided on the electrode sheet, with the through holes and microneedles fitting together. The elastic ring is installed between the press-type microneedle structure and the electrode sheet. The anti-permeability ring structure includes an outer edge and a separator strip. The separator strip is fixedly connected to the inner side of the outer edge, and multiple receiving areas are formed inside the outer edge. Each receiving area has a detachable conductive hydrogel containing a drug component. During press-type drug delivery, the elastic ring is compressed, allowing the microneedles to penetrate the conductive hydrogel and puncture the affected skin. The conductive hydrogel makes conductive contact with the electrode sheet to transmit a stimulating current to the affected skin.

Description

Technical Field

[0001] This invention relates to the field of microneedle drug delivery technology, and in particular to a wearable device for multi-region transdermal drug delivery based on press-type microneedles. Background Technology

[0002] Rheumatoid arthritis is a common chronic autoimmune disease, with symptoms including joint pain, stiffness, and swelling. Currently, treatment options for rheumatoid arthritis include physical therapy, medication, and surgery.

[0003] I. Physical therapy methods include physiotherapy, heat therapy, and acupuncture. These require patients to visit a hospital and be performed by professionals, making the treatment inconvenient and with limited effectiveness. II. Drug therapy typically uses anti-inflammatory drugs and immunosuppressants. These drugs have certain side effects and require long-term use, potentially causing liver damage, gastrointestinal bleeding, and infections. Furthermore, these drugs may suppress the immune system, increasing the patient's risk of infection. Whether oral medications, topical ointments, or injections, uneven drug absorption and unstable treatment effects are common problems. III. Surgical treatments include joint replacement and joint switching. These methods involve high surgical risks and costs, and the recovery period is excessively long.

[0004] With the continuous development of microneedle technology, transdermal drug delivery has become a new treatment method. However, the soluble microneedles commonly used in the market often result in drug inactivation and insufficient delivery dose. Furthermore, the passive diffusion drug delivery method hinders the deep delivery of drugs to inflamed tissues, resulting in low drug absorption efficiency and poor delivery accuracy. Summary of the Invention

[0005] To address the aforementioned problems, the present invention aims to provide a wearable device for multi-region transdermal drug delivery based on press-type microneedles, thereby solving the common problems of drug inactivation and insufficient delivery dose in soluble microneedles, as well as the passive diffusion drug delivery method hindering the deep delivery of drugs to inflamed tissues, resulting in low drug absorption efficiency and poor delivery accuracy.

[0006] The technical solution of the wearable device for multi-region transdermal drug delivery based on press-type microneedles of the present invention is as follows:

[0007] The wearable device for multi-region transdermal drug delivery based on press-type microneedles includes a press-type microneedle structure, an elastic ring, an electrode sheet, and an anti-permeability ring structure arranged in sequence. The press-type microneedle structure is installed on one side of the electrode sheet, and the anti-permeability ring structure is installed on the other side of the electrode sheet.

[0008] The pressing microneedle structure has multiple microneedles on the side facing the electrode sheet, and the electrode sheet has multiple through holes corresponding to them. The through holes are clearance-fitted with the microneedles, and the elastic ring is installed between the pressing microneedle structure and the electrode sheet.

[0009] The seepage-proof ring structure includes an outer ring edge and a partition strip. The partition strip is fixedly connected to the inner side of the outer ring edge. Multiple accommodating areas are formed inside the outer ring edge. Each accommodating area is detachably fitted with conductive hydrogel, and the conductive hydrogel stores drug components.

[0010] When pressure is applied to administer the drug, the elastic coil is compressed to allow the microneedle to penetrate the conductive hydrogel and puncture the affected skin; when the pressure is removed, the elastic coil rebounds to reset the microneedle; the electrode is also electrically connected to a circuit board, and the conductive hydrogel makes conductive contact with the electrode to transmit a stimulating current to the affected skin.

[0011] As a further preferred embodiment, the outline of the seepage barrier structure is circular, and the plurality of accommodating areas are circumferentially spaced about the center of the seepage barrier structure.

[0012] As a further preferred embodiment, the seepage-proof ring structure also includes a central ring, which is arranged concentrically with the outer ring edge, and the interior of the central ring forms a central accommodating area;

[0013] An annular region is formed between the central ring and the outer ring edge. Multiple dividing strips are evenly arranged within the annular region, and a circumferential accommodating area is formed between two adjacent dividing strips.

[0014] As a further preferred embodiment, four separators are provided, which are distributed at 90° central angles. Rounded corners are provided between the separators and the central ring, and between the separators and the outer ring edge. The outline shape of the four circumferential accommodating areas is an arc-shaped waist hole.

[0015] As a further preferred embodiment, the electrode sheet is provided with a positive conductive part and a negative conductive part on the side corresponding to the anti-seepage ring structure. The positive conductive part is in contact with the conductive hydrogel of the corresponding accommodating area, and the negative conductive part is in contact with the conductive hydrogel of the corresponding accommodating area.

[0016] The conductive hydrogel contains positively charged nanoparticles that adsorb negatively charged drug molecules through electrostatic attraction to store the drug. Under the influence of the negative electrode, the drug molecules are expelled due to charge repulsion, thereby improving drug delivery efficiency.

[0017] As a further preferred embodiment, the pressing microneedle structure also includes a pressing plate, which is arranged parallel to and spaced apart from the electrode sheet. A plurality of microneedles are spaced apart and distributed in the middle of the side surface of the pressing plate, and the elastic ring is arranged around the side edge of the pressing plate.

[0018] As a further preferred embodiment, the circuit board is disposed on the outside of the electrode sheet, and the circuit board integrates a Bluetooth module for communication connection with a mobile phone.

[0019] As a further preferred option, all of the microneedles are 3D printed.

[0020] As a further preferred embodiment, the seepage-proof ring structure is made of insulating material.

[0021] As a further preferred embodiment, the drug components in the conductive hydrogel include methotrexate and / or ibuprofen, both of which are negatively charged drug molecules. Methotrexate is used for anti-inflammatory treatment of rheumatoid arthritis, and ibuprofen is used for pain relief.

[0022] Beneficial Effects: This wearable device for multi-region transdermal drug delivery based on press-type microneedles employs a design consisting of a press-type microneedle structure, an elastic ring, an electrode sheet, an impermeable ring structure, and a conductive hydrogel. These components are stacked sequentially. The press-type microneedle structure is located on one side of the electrode sheet, the impermeable ring structure on the other side, and the elastic ring is installed between the press-type microneedle structure and the electrode sheet. Multiple microneedles of the press-type microneedle structure can penetrate to the other side through through-holes in the electrode sheet. Applying pressure to the press-type microneedle structure causes the microneedles to puncture, or removing the pressure causes the microneedles to automatically retract.

[0023] Furthermore, conductive hydrogel can be detachably installed in multiple accommodating areas of the leak-proof ring structure. After the patient wears and secures the device, pressing the microneedle structure upwards with the conductive hydrogel adhering to the patient's skin compresses the thickness of the elastic ring by applying pressure to the microneedle structure, causing the microneedle to penetrate the conductive hydrogel and puncture the affected skin. Because the diameter of the microneedle is on the micrometer scale, it can form a microchannel on the skin surface, making the puncture process minimally invasive and painless. Subsequently, the microneedle automatically resets under the action of the elastic ring.

[0024] After pressure is applied for puncture, the circuit board generates current according to a control signal. The electrode pads transmit this current to the conductive hydrogel, stimulating it to release the drug components. These components then rapidly and efficiently penetrate the inflamed tissue through the skin's microchannels. The circuit board can also output square wave signals, using low-frequency electrical stimulation for physical analgesia, simulating physiotherapy and providing anti-inflammatory and analgesic effects. Compared to common soluble microneedles, the drug can directly penetrate after the microchannels are formed, avoiding the risk of drug inactivation and insufficient dosage that can occur when the drug adheres to the microneedle. Furthermore, the active diffusion drug delivery method accelerates the delivery of the drug to deeper layers of inflamed tissue, improving absorption efficiency and delivery accuracy. Attached Figure Description

[0025] Figure 1 This is an exploded perspective view of the multi-region transdermal drug delivery wearable device based on a press-type microneedle according to a specific embodiment of the present invention.

[0026] Figure 2 This is a three-dimensional schematic diagram of the press-type microneedle structure in a specific embodiment of the multi-region transdermal drug delivery wearable device based on press-type microneedles of the present invention.

[0027] Figure 3 This is an in vitro test diagram of electrically controlled drug release in a specific embodiment of the wearable device for multi-region transdermal drug delivery based on press-type microneedles of the present invention.

[0028] Figure 4 This is a three-dimensional schematic diagram of the circuit board in a specific embodiment of the wearable device for multi-region transdermal drug delivery based on press-type microneedles of the present invention.

[0029] Figure 5 This is a top view of the circuit board in a specific embodiment of the wearable device for multi-region transdermal drug delivery based on press-type microneedles of the present invention;

[0030] Figure 6 This is a bottom view of the circuit board in a specific embodiment of the multi-region transdermal drug delivery wearable device based on press-type microneedles of the present invention.

[0031] Figure 7 This is a control flowchart of the multi-region transdermal drug delivery wearable device based on a press-type microneedle, as described in a specific embodiment of the present invention.

[0032] In the figure: 1-pressing microneedle structure, 10-pressing plate, 11-microneedle, 2-elastic ring, 3-electrode sheet, 30-through hole, 4-proof ring structure, 40-outer ring edge, 41-separator strip, 42-central ring, 43-central accommodating area, 44-circumferential accommodating area, 5-conductive hydrogel;

[0033] 6-Circuit board, 60-Bluetooth broadcast and signal receiving module, 61-Step-down module, 62-Charging module, 63-Boost module, 64-Constant current source module, 65-DC signal magnitude control module, 66-Square wave signal module, 67-Output mode control module, 68-I / O control module, 69-Bluetooth module. Detailed Implementation

[0034] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0035] Specific embodiment 1 of the wearable device for multi-region transdermal drug delivery based on press-type microneedles of the present invention, such as Figures 1 to 7 As shown, the wearable device for multi-region transdermal drug delivery based on press-type microneedles includes a press-type microneedle structure 1, an elastic ring 2, an electrode sheet 3, and an anti-permeability ring structure 4 arranged in sequence. The press-type microneedle structure 1 is installed on one side of the electrode sheet 3, and the anti-permeability ring structure 4 is installed on the other side of the electrode sheet 3. Multiple microneedles 11 are arranged on the side of the press-type microneedle structure 1 facing the electrode sheet 3, and multiple through holes 30 are correspondingly opened on the electrode sheet 3. The through holes 30 are clearance-fitted with the microneedles 11, and the elastic ring 2 is installed between the press-type microneedle structure 1 and the electrode sheet 3.

[0036] The anti-seepage ring structure 4 includes an outer ring edge 40 and a separator strip 41. The separator strip 41 is fixedly connected to the inner side of the outer ring edge 40. Multiple receiving areas are formed inside the outer ring edge 40. Conductive hydrogel 5 is detachably installed in each receiving area. The conductive hydrogel 5 stores drug components. When the drug is administered by pressing, the elastic ring 2 is compressed so that the microneedle 11 can penetrate the conductive hydrogel 5 and puncture the skin at the affected area. When the pressure is removed, the elastic ring 2 rebounds to reset the microneedle 11. The electrode sheet 3 is also electrically connected to a circuit board (not shown in the figure). The conductive hydrogel 5 is in conductive contact with the electrode sheet 3 to transmit a stimulating current to the skin at the affected area.

[0037] This wearable device for multi-region transdermal drug delivery based on press-type microneedles adopts a design consisting of a press-type microneedle structure 1, an elastic ring 2, an electrode sheet 3, an impermeable ring structure 4, and a conductive hydrogel 5. The press-type microneedle structure 1, elastic ring 2, electrode sheet 3, and impermeable ring structure 4 are stacked sequentially. The press-type microneedle structure 1 is located on one side of the electrode sheet 3, the impermeable ring structure 4 is located on the other side of the electrode sheet 3, and the elastic ring 2 is installed between the press-type microneedle structure 1 and the electrode sheet 3. Multiple microneedles 11 of the press-type microneedle structure 1 can penetrate to the other side through the through holes 30 of the electrode sheet 3. By applying pressure to the press-type microneedle structure 1, the microneedles 11 can puncture, or the microneedles 11 can automatically retract after the pressure is removed.

[0038] Furthermore, conductive hydrogels 5 are detachably installed in multiple accommodating areas of the leak-proof ring structure 4. After the patient wears and secures the device, pressing the microneedle structure 11 upwards and ensuring the conductive hydrogel 5 adheres to the patient's skin compresses the thickness of the elastic ring 2 by applying pressure to the microneedle structure 11, thereby driving the microneedle 11 through the conductive hydrogel 5 and puncturing the affected skin. Since the diameter of the microneedle 11 is in the micrometer range, it can form a microchannel on the skin surface, making the puncture process minimally invasive and painless. Subsequently, the microneedle 11 automatically resets under the action of the elastic ring 2.

[0039] After pressure is applied for puncture, the circuit board generates current according to the control signal. The electrode 3 transmits the current to the conductive hydrogel 5, stimulating the hydrogel 5 to release the drug components. The drug components penetrate rapidly and efficiently to the inflamed tissue through the skin microchannels. The circuit board can output square wave signals, and low-frequency electrical stimulation provides physical analgesia, simulating physiotherapy and achieving anti-inflammatory and analgesic effects. Compared with common soluble microneedles, the drug can directly penetrate after the microchannels are formed, avoiding the problems of drug inactivation and insufficient delivery when attached to the microneedle. Moreover, the active diffusion drug transport method accelerates the delivery of the drug to the deeper layers of inflamed tissue, improving the absorption efficiency and delivery accuracy of the drug.

[0040] In this embodiment, the anti-seepage ring structure 4 has a circular outline, and multiple accommodating areas are circumferentially spaced about the center of the anti-seepage ring structure 4. Specifically, the anti-seepage ring structure 4 also includes a central ring 42, which is concentrically arranged with the outer ring edge 40. The interior of the central ring 42 forms a central accommodating area 43. An annular region is formed between the central ring 42 and the outer ring edge 40, and multiple partition strips 41 are evenly arranged within the annular region. The space between two adjacent partition strips forms a circumferential accommodating area 44. By dividing the anti-seepage ring structure 4 into the central accommodating area 43 and multiple circumferential accommodating areas 44, each accommodating area can be fitted with conductive hydrogel 5 containing different drug components, which can deliver more types of drug components and ensure the therapeutic effect on rheumatoid arthritis.

[0041] As a further preferred embodiment, four separator strips 41 are provided, distributed at 90° central angles. Rounded corners are provided between the separator strips 41 and the central ring 42, and between the separator strips 41 and the outer ring edge 40. The outline shape of the four circumferential receiving areas 44 is an arc-shaped waist-like opening. The arc-shaped waist-like circumferential receiving areas 44 have a high degree of matching with the shape of the conductive hydrogel 5, facilitating accurate installation of the conductive hydrogel 5 and ensuring full contact between the conductive hydrogel 5 and the skin surface.

[0042] Furthermore, the electrode sheet 3 is provided with a positive conductive part and a negative conductive part on the side corresponding to the anti-seepage ring structure 4. The positive conductive part is in contact with the conductive hydrogel 5 of the corresponding accommodating area, and the negative conductive part is in contact with the conductive hydrogel 5 of the corresponding accommodating area. The conductive hydrogel contains positively charged nanoparticles to adsorb negatively charged drug molecules through electrostatic interaction for drug storage. Under the action of the negative electrode, the drug molecules are expelled due to charge repulsion, thereby improving drug delivery efficiency.

[0043] One of the accommodating areas is selected as the positive electrode area, and the other accommodating area is selected as the negative electrode area. The conductive hydrogel 5 in the positive electrode area corresponds to the positive conductive part of the electrode plate 3, and the conductive hydrogel 5 in the negative electrode area corresponds to the negative conductive part of the electrode plate 3. The other three areas are selected as drug delivery areas. The drug components in the conductive hydrogel of the drug delivery area include methotrexate and / or ibuprofen. Both methotrexate and ibuprofen are negatively charged drug molecules. Methotrexate is used for anti-inflammatory treatment of rheumatoid arthritis, and ibuprofen is used for pain relief. It can be used to treat inflammation of the affected area.

[0044] The type of current output from the circuit board can be adjusted. For example, low-frequency electrical stimulation can be applied to the affected area through the conductive hydrogel 5 in both the positive and negative electrode regions to relieve pain. This combination of physical therapy and drug therapy can provide a combined therapeutic effect for rheumatoid arthritis.

[0045] The circuit board 6 includes a substrate, and mounted on the substrate are a Bluetooth broadcast and signal receiving module 60, a buck module 61, a charging module 62, a boost module 63, a constant current source module 64, a DC signal magnitude control module 65, a square wave signal module 66, an output mode control module 67, an I / O control module 68, and a Bluetooth module 69. Figures 4 to 7 As shown, its control process is that the power module supplies power to each module, and the output mode control module 67 controls each module to work, so as to realize the purpose of Bluetooth signal communication transmission and electrical stimulation therapy.

[0046] In addition, the microneedle structure also includes a pressing plate 10, which is arranged parallel to and spaced apart from the electrode sheet 3. Multiple microneedles 11 are spaced apart on the center of the side of the pressing plate 10, and an elastic ring 2 surrounds the side edge of the pressing plate 10. A circuit board is located on the outside of the electrode sheet 3, and the circuit board integrates a Bluetooth module for communication with a mobile phone. Furthermore, all microneedles 11 are 3D printed. The anti-seepage ring structure 4 is made of insulating material.

[0047] To verify the practical effectiveness of this scheme, the following in vitro experiments were conducted:

[0048] Calcein was loaded into a hydrophilic gel to simulate negatively charged small drug molecules. In in vitro diffusion cell experiments, as shown... Figure 3 As shown, the release rate of small drug molecules changes under stimulation by different current magnitudes. Furthermore, the diffusion rate after applying current is significantly higher than that of the natural diffusion group without current, thus demonstrating the feasibility of electrically controlled drug release.

[0049] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and substitutions can be made without departing from the technical principles of the present invention, and these improvements and substitutions should also be considered within the scope of protection of the present invention.

Claims

1. A wearable device for multi-region transdermal drug delivery based on press-type microneedles, characterized in that, It includes a pressable microneedle structure, an elastic ring, an electrode sheet, and a seepage-proof ring structure arranged in sequence. The pressable microneedle structure is installed on one side of the electrode sheet, and the seepage-proof ring structure is installed on the other side of the electrode sheet. The pressing microneedle structure has multiple microneedles on the side facing the electrode sheet, and the electrode sheet has multiple through holes corresponding to them. The through holes are clearance-fitted with the microneedles, and the elastic ring is installed between the pressing microneedle structure and the electrode sheet. The seepage-proof ring structure includes an outer ring edge and a partition strip. The partition strip is fixedly connected to the inner side of the outer ring edge. Multiple accommodating areas are formed inside the outer ring edge. Each accommodating area is detachably fitted with conductive hydrogel, and the conductive hydrogel stores drug components. When the pressure is applied to administer the drug, the elastic coil is compressed to allow the microneedle to penetrate the conductive hydrogel and puncture the skin at the affected site; when the pressure is removed, the elastic coil rebounds to reset the microneedle; the electrode is also electrically connected to a circuit board, and the conductive hydrogel makes conductive contact with the electrode to transmit a stimulating current to the skin at the affected site. The outline of the seepage barrier structure is circular, and the plurality of the accommodating areas are circumferentially spaced about the center of the seepage barrier structure. The electrode sheet is provided with a positive conductive part and a negative conductive part on the side corresponding to the anti-seepage ring structure. The positive conductive part is in contact with the conductive hydrogel of the corresponding accommodating area, and the negative conductive part is in contact with the conductive hydrogel of the corresponding accommodating area. The conductive hydrogel contains positively charged nanoparticles to adsorb negatively charged drug molecules through electrostatic interaction for drug storage, and under the action of the negative electrode, the drug molecules are expelled due to mutual repulsion of charges, thereby improving drug delivery efficiency. One of the accommodating regions is selected as the positive electrode region, and another accommodating region is selected as the negative electrode region. The conductive hydrogel in the positive electrode region corresponds to the positive electrode conductive part, and the conductive hydrogel in the negative electrode region corresponds to the negative electrode conductive part. The other three regions are used as drug delivery regions.

2. The wearable device for multi-region transdermal drug delivery based on press-type microneedles according to claim 1, characterized in that, The seepage-proof ring structure also includes a central ring, which is arranged concentrically with the outer ring edge, and the interior of the central ring forms a central accommodating area; An annular region is formed between the central ring and the outer ring edge. Multiple dividing strips are evenly arranged within the annular region, and a circumferential accommodating area is formed between two adjacent dividing strips.

3. The wearable device for multi-region transdermal drug delivery based on press-type microneedles according to claim 2, characterized in that, The four dividing strips are arranged at 90° central angle intervals. The dividing strips are provided with rounded corners between the dividing strips and the central ring, and between the dividing strips and the outer ring edge. The outline shape of the four circumferential accommodating areas is an arc-shaped waist hole.

4. The wearable device for multi-region transdermal drug delivery based on press-type microneedles according to claim 1, characterized in that, The pressing microneedle structure also includes a pressing plate, which is arranged parallel to and spaced apart from the electrode sheet. A plurality of microneedles are spaced apart in the middle of the side of the pressing plate, and the elastic ring is arranged around the side edge of the pressing plate.

5. The wearable device for multi-region transdermal drug delivery based on press-type microneedles according to claim 1, characterized in that, The circuit board is located on the outside of the electrode sheet, and the circuit board integrates a Bluetooth module for communication with a mobile phone.

6. The wearable device for multi-region transdermal drug delivery based on press-type microneedles according to claim 1, characterized in that, All of the microneedles were 3D printed.

7. The wearable device for multi-region transdermal drug delivery based on press-type microneedles according to claim 1, characterized in that, The seepage-proof ring structure is made of insulating material.

8. The wearable device for multi-region transdermal drug delivery based on press-type microneedles according to claim 1, characterized in that, The conductive hydrogel contains methotrexate and / or ibuprofen, both of which are negatively charged drug molecules. Methotrexate is used for anti-inflammatory treatment of rheumatoid arthritis, and ibuprofen is used for pain relief.

Images