An iontophoresis patch

Abstract

The utility model discloses an ion electroosmosis is pasted, including flexible base, the flexible base surface sets up ion osmotic drive module, the positive pole end of ion osmotic drive module connects positive ion osmotic module, negative pole end connects negative ion osmotic module, the one side of positive ion osmotic module, negative ion osmotic module and human skin contact is provided with nanometer microneedle array, the utility model discloses reasonable in structure design, adopts flexible base and the overall thickness is less than or equal to 1mm, and has light and thin and flexible simultaneously, nanometer microneedle array parameter adaptation, uses the biocompatibility material, surface modification hydrophilic coating and has the conductivity, can effectively puncture epidermis and also high safety, the ion osmotic drive module contains flexible circuit board, constant current power supply etc.

Description

Technical Field

[0001] This utility model relates to the field of biomedicine and medical device technology, specifically to an iontophoresis patch. Background Technology

[0002] Transdermal drug delivery has become a research hotspot due to its non-invasive and convenient advantages, but its main obstacle is the barrier function of the stratum corneum. In existing technologies, microneedles (MNs) create micron-sized channels through mechanical puncture to improve permeability, but large molecule drugs still rely on passive diffusion, resulting in limited efficiency. Iontophoresis drives the active migration of charged molecules through an electric field, but when used alone, it is difficult to effectively deliver large molecules due to the stratum corneum barrier.

[0003] Currently, although some studies have attempted to combine microneedles with iontophoresis (such as patent ES2903284T3), the following problems still exist:

[0004] 1. Unclear synergistic mechanism: The spatiotemporal matching between microneedle puncture and electric field driving is not fully optimized;

[0005] 2. Insufficient delivery efficiency: The transdermal delivery rate of macromolecular drugs (such as vaccines and proteins) still needs to be improved;

[0006] 3. Safety and controllability: There is a lack of systematic design for the synergistic optimization of current parameters (intensity, time) and microneedle geometric parameters (length, density).

[0007] This invention achieves a significant improvement in transdermal delivery efficiency through the synergistic effect of nanoneedles and electro-ionization, and solves the aforementioned technical bottlenecks. Utility Model Content

[0008] To solve the above-mentioned technical problems, the technical solution provided by this utility model is as follows: an iontophoresis patch, comprising a flexible substrate, an iontophoresis driving module disposed on the surface of the flexible substrate, a positive electrode connected to a positive iontophoresis module and a negative electrode connected to a negative iontophoresis module, a nano-microneedle array disposed on the side of the positive electrode and the negative electrode iontophoresis module that contacts human skin, an anti-seepage gasket disposed on the outer edge of the iontophoresis driving module, the positive electrode iontophoresis module and the negative electrode iontophoresis module, and an isolation and anti-seepage coating covering the surface of the iontophoresis driving module, the positive electrode iontophoresis module and the negative electrode iontophoresis module.

[0009] Furthermore, the nanoneedle array comprises a plurality of nanoneedles with conical or triangular tips, wherein the nanoneedles have a length of 50-500 μm, a base diameter of 20-200 μm, and a density of 50-200 needles / cm. 2 .

[0010] Furthermore, the nanoneedles are made of biocompatible materials, including polylactic acid-glycolic acid copolymer (PLGA) or stainless steel, and the nanoneedles are conductive.

[0011] Furthermore, the surface of the nanoneedles is modified with a hydrophilic coating, including hyaluronic acid.

[0012] Furthermore, a drug reservoir is provided within the positive electrode iontophoresis module.

[0013] Furthermore, a buffer solution is provided within the negative electrode iontophoresis module.

[0014] Furthermore, the electro-ionization driving module includes a flexible circuit board and a nano-silver paste conductive coating, a constant current power supply, a contact power conductive sheet, a sensor indicator, and an IC chip disposed on the flexible circuit board. The nano-silver paste conductive coating, the constant current power supply, the contact power conductive sheet, and the sensor indicator are all electrically connected to the IC chip. The nano-silver paste conductive coating is disposed on the surface of the positive electrode electro-ionization module and the negative electrode electro-ionization module, respectively. The nano-silver paste conductive coating is electrically connected to the contact power conductive sheet through a sensor switch.

[0015] Furthermore, the overall thickness of the iontophoresis patch is ≤1mm.

[0016] This utility model has the following synergistic effects:

[0017] Nanoneedle pretreatment: puncture and destroy the stratum corneum to form micropores with a diameter of 1-5μm, reducing skin resistance by 50%-80% and providing a channel for electric field penetration.

[0018] Electro-ionization driven: Under the action of an electric field, charged drugs (such as negatively charged proteins and positively charged peptides) migrate directionally through electrophoresis, while electroosmotic flow promotes the diffusion of neutral molecules, significantly improving the delivery rate.

[0019] Spatiotemporal synergistic optimization: An electric field is applied immediately after microneedle puncture, and the drug is delivered in a pulsed manner during the micropore opening period (about 30 minutes), which improves efficiency by 3-5 times compared to using iontophoresis or microneedles alone.

[0020] The advantages of this utility model compared with the prior art are as follows:

[0021] (1) Significantly improved delivery efficiency: In in vitro experiments, the transdermal penetration of ovalbumin (OVA) was 3.2 times and 4.1 times higher than that of microneedles alone or iontophoresis, respectively, and the penetration amount was linearly related to the current intensity, with strong controllability.

[0022] (2) Safety and biocompatibility: The microneedles are made of biodegradable materials, and the skin puncture depth is controlled at the epidermal layer, with no risk of vascular and nerve damage; after optimization of the current parameters, the skin irritation is reduced by 60% compared with traditional iontophoresis.

[0023] (3) Wide range of applications: It is suitable for vaccination (such as rabies vaccine transdermal injection with a 2.2-fold increase in neutralizing antibody titer compared to intramuscular injection), local chemotherapy for tumors, beauty and anti-aging (such as collagen transdermal absorption rate increased by 8 times) and other fields.

[0024] This utility model features a reasonable structural design, employing a flexible substrate with an overall thickness of ≤1mm, combining lightness and flexibility. The nano-microneedle array parameters are adapted, using biocompatible materials and a hydrophilic coating that provides conductivity, enabling effective epidermal puncture while maintaining high safety. Combining nano-microneedles with iontophoresis technology, the iontophoresis driving module includes a flexible circuit board, a constant current power supply, etc., which can stably drive drug delivery through the microneedle channels. The positive electrode drug reservoir and negative electrode buffer solution are designed to be compatible, and anti-leakage gaskets and isolation anti-leakage coatings are used to prevent leakage. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure of an iontophoresis patch according to this utility model.

[0026] Figure 2 This is a schematic diagram of the structure of the nano-microneedle array in an iontophoresis patch of this utility model.

[0027] Figure 3 This is a schematic diagram of the electro-ion permeation driving module in an ion electroosmosis patch of this utility model. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0029] In the description of the embodiments of this utility model, it should be noted that if terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," or "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the utility model product is in use, they are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, terms such as "first," "second," and "third" are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0030] Furthermore, the use of terms such as "horizontal," "vertical," and "sag" does not imply that the component must be absolutely horizontal or suspended, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0031] In the description of the embodiments of this utility model, "a plurality of" means at least two.

[0032] In the description of the embodiments of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0033] Example:

[0034] An iontophoresis patch includes a flexible substrate 1. An iontophoresis driving module 2 is disposed on the surface of the flexible substrate 1. The positive end of the iontophoresis driving module 2 is connected to a positive iontophoresis module 3, and the negative end is connected to a negative iontophoresis module 4. A nano-microneedle array 501 is disposed on the side of the positive iontophoresis module 3 and the negative iontophoresis module 4 that contacts human skin. Anti-seepage gaskets 6 are disposed along the outer edges of the iontophoresis driving module 2, the positive iontophoresis module 3, and the negative iontophoresis module 4. An isolation and anti-seepage coating 7 covers the surface of the iontophoresis driving module 2, the positive iontophoresis module 3, and the negative iontophoresis module 4. The overall thickness of the iontophoresis patch is ≤1mm.

[0035] The nanoneedle array 501 comprises a plurality of nanoneedles 501 with conical or triangular tips. The nanoneedles 501 have a needle length of 50-500 μm, a base diameter of 20-200 μm, and a density of 50-200 needles / cm. 2 The nanoneedles 501 are made of biocompatible materials, including polylactic acid-glycolic acid copolymer (PLGA) or stainless steel, and are conductive; the surface of the nanoneedles 501 is modified with a hydrophilic coating, including hyaluronic acid.

[0036] The positive electrode iontophoresis module 3 is equipped with a drug storage tank; the negative electrode iontophoresis module 4 is equipped with a buffer solution.

[0037] The electro-ionization driving module 2 includes a flexible circuit board 201 and a nano-silver paste conductive coating 202, a constant current power supply, a contact power conductive sheet 203, an induction indicator light 204, and an IC chip 205 disposed on the flexible circuit board 201. The nano-silver paste conductive coating 202, the constant current power supply 203, the contact power conductive sheet 203, and the induction indicator light 204 are all electrically connected to the IC chip 205. The nano-silver paste conductive coating 202 is disposed on the surface of the positive electrode electro-ionization module 3 and the negative electrode electro-ionization module 4, respectively. The nano-silver paste conductive coating 202 is electrically connected to the contact power conductive sheet 203 through an induction switch. The nano-silver paste conductive coating also includes an induction coil 206 disposed on the outer edge of the positive electrode electro-ionization module 3 and the negative electrode electro-ionization module 4.

[0038] I. In specific implementation, the preparation method of the iontophoresis patch in this embodiment includes the following steps:

[0039] (1) Fabrication of nanoneedle arrays

[0040] Using LIGA (Lithography-Electroforming-Injection Molding) technology, SU-8 photoresist was used as a template to electroform a nickel microneedle array, followed by injection molding of PLGA material. A hyaluronic acid coating combined with a nano-conductive coating was then sprayed onto the surface to give the nano-microneedles conductivity. Simultaneously, the microneedle parameters were maintained: needle length 300 μm, substrate diameter 100 μm, and density 100 needles / cm². 2 The radius of curvature of the needle tip is ≤1μm.

[0041] (2) Integration of the iontophoresis module

[0042] The positive electrode iontophoresis module is filled with a hydrogel (polyacrylamide / chitosan) containing a negatively charged drug (such as NAD), and the negative electrode iontophoresis module is filled with a buffer solution, such as physiological saline. The electrode materials of the positive and negative electrode iontophoresis modules are Ag / AgCl, and they are connected to a constant current power supply via flexible wires, with an adjustable output of 0.1-2mA.

[0043] (3) Surface Mount Assembly

[0044] The nanoneedle array and electrode module are encapsulated on a flexible PI substrate, and silicone gaskets are bonded to its edges. The overall size is 3.5cm×3cm and the thickness is 1mm.

[0045] II. The method of using the iontophoresis patch in this embodiment includes the following steps:

[0046] (1) Skin pretreatment: After cleaning the skin, press the iontophoresis patch of this embodiment onto the target area, insert the microneedles into the epidermal layer to a depth of ≤500μm, and leave it for 1 minute to complete the puncture.

[0047] (2) Electro-ion permeation initiation: By using a circuit induction switch, the current intensity is set to 1mA and the action time is 30 minutes, and the electric field drives the drug to migrate through the microneedle channel.

[0048] (3) Delivery complete: Remove the patch. The skin micropores will close naturally within 24 hours, with no obvious risk of trauma or infection.

[0049] III. Verification of Examples

[0050] 1. In vitro experiments:

[0051] In the diffusion cell experiment, the synergistic system achieved a 24-hour transdermal delivery rate of (28.7±3.2) μg / cm³ for OVA. 2 The concentration was significantly higher than that of microneedles alone (9.1±1.8) μg / cm. 2 And ion electroosmosis alone (7.0±1.2) μg / cm 2 .

[0052] All standard parts used in this utility model can be purchased from the market, and irregular parts can be customized according to the description and drawings. The specific connection methods of each part adopt conventional methods such as bolts, rivets, and welding that are mature in the prior art. The machinery, parts and equipment adopt conventional models in the prior art. In addition, the circuit connection adopts conventional connection methods in the prior art, which will not be described in detail here. The contents not described in detail in this specification belong to the prior art known to those skilled in the art.

[0053] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the inventive spirit of the present invention, such designs should fall within the protection scope of the present invention.

Claims

1. An iontophoresis patch, characterized in that, The device includes a flexible substrate, on the surface of which an electro-ion penetration driving module is disposed. The positive end of the electro-ion penetration driving module is connected to a positive electro-ion penetration module, and the negative end is connected to a negative electro-ion penetration module. The side of the positive and negative electro-ion penetration modules that comes into contact with human skin is provided with a nano-microneedle array. Anti-seepage gaskets are disposed along the outer edges of the electro-ion penetration driving module, the positive electro-ion penetration module, and the negative electro-ion penetration module. The surfaces of the electro-ion penetration driving module, the positive electro-ion penetration module, and the negative electro-ion penetration module are covered with an isolation and anti-seepage coating.

2. The iontophoresis patch according to claim 1, characterized in that, The nanoneedle array comprises several nanoneedles with conical or triangular tips, each nanoneedle having a length of 50-500 μm, a base diameter of 20-200 μm, and a density of 50-200 needles / cm². 2 .

3. The iontophoresis patch according to claim 1, characterized in that, The nanoneedles are made of biocompatible materials, including polylactic acid-glycolic acid copolymer (PLGA) or stainless steel, and are conductive.

4. The iontophoresis patch according to claim 1, characterized in that, The surface of the nanoneedles is modified with a hydrophilic coating, including hyaluronic acid.

5. The iontophoresis patch according to claim 1, characterized in that, The positive electrode iontophoresis module is equipped with a drug storage tank.

6. The iontophoresis patch according to claim 1, characterized in that, The negative electrode iontophoresis module is equipped with a buffer solution.

7. The iontophoresis patch according to claim 1, characterized in that, The electro-ionization driving module includes a flexible circuit board and a nano-silver paste conductive coating, a constant current power supply, a contact power conductive sheet, a sensor indicator, and an IC chip disposed on the flexible circuit board. The nano-silver paste conductive coating, the constant current power supply, the contact power conductive sheet, and the sensor indicator are all electrically connected to the IC chip. The nano-silver paste conductive coating is disposed on the surface of the positive electrode electro-ionization module and the negative electrode electro-ionization module, respectively. The nano-silver paste conductive coating is electrically connected to the contact power conductive sheet through a sensor switch.

8. An iontophoresis patch according to claim 7, characterized in that, The nano-silver paste conductive coating also includes induction coils disposed on the outer edges of the positive electrode ion penetration module and the negative electrode ion penetration module.

9. An iontophoresis patch according to claim 1, characterized in that, The overall thickness of the iontophoresis patch is ≤1mm.

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