CN113577531A - Microneedle patch for drug delivery or biological fluid collection and preparation method thereof - Google Patents

Abstract

The invention discloses a microneedle patch for drug delivery or biological fluid collection, which comprises a patch substrate, wherein a plurality of liquid storage tanks are uniformly arranged on the patch substrate, microneedles are arranged on two sides of each liquid storage tank, one side of each microneedle, which is close to the liquid storage tanks, is provided with a flow guide channel, the flow guide channels are communicated with the liquid storage tanks, each microneedle comprises a base connected with the patch substrate, a main body arranged above the base and a tip arranged at the top of the main body, and a preparation method of the microneedle patch is also disclosed; secondly, a mode of opening channels on the side surfaces of the microneedles is adopted, so that the flow can be guided well, and the channel cannot be blocked due to the interception of skin tissues; in addition, the whole manufacturing process does not need to be carried out in a super clean environment, the whole processing cost is low, and the process is simple and convenient.

Description

Microneedle patch for drug delivery or biological fluid collection and preparation method thereof

Technical Field

The invention belongs to the technical field of transdermal drug delivery and transdermal biological sampling, and particularly relates to a microneedle patch for drug delivery or biological fluid collection and a preparation method thereof.

Background

Although hypodermic needles are commonly used for blood sampling and analysis, there are limitations to the application of this technique. Hypodermic needles are painful and feared for both adults and children, requiring skilled medical operators to take blood samples with significant delays between blood and test results. Furthermore, blood analysis requires access to the pathology infrastructure, which may not be available in remote areas or in emergency situations. Venous access difficulties are encountered in different patient cohorts, namely infants, children, elderly, obese persons with poor venous permeability, and in emergencies such as shock. Drugs that are not bioavailable by gastric absorption are administered by intravenous infusion, intramuscular injection, or subcutaneous injection. Although oral medications are readily self-administered, parenteral medications require a skilled operator and are administered periodically by admission to a hospital. Transdermal administration has several advantages over other routes of administering pharmaceutical formulations to patients. For example, oral administration of some drugs may be ineffective because the drug is destroyed in the gastrointestinal tract or cleared by the liver, both of which can be avoided by transdermal administration.

In transdermal drug delivery and transdermal biosampling using microneedle arrays, particularly in patch-type devices, it is particularly desirable that the microneedles remain in their precise location, penetrating the location of the stratum corneum, to maintain fluid communication between the drug or sample collection reservoir and the tissue beneath the stratum corneum for an extended period of time. Conventional microneedle patch devices have the following disadvantages: 1. cannot conform well to irregular skin, such as silicon-based microneedle arrays, because the substrate is rigid; 2. the overall processing cost is high, the process is complex, for example, hollow microneedles are more in overall processing procedures and need to be carried out in a super-clean environment; 3. the function is single, for example, the solid micro-needle can only realize drug delivery by coating the drug on the surface, but biological fluid collection is difficult; 4. the main problem of conventional hollow microneedles for collecting biological fluids is that they easily block the channels due to skin tissue being trapped.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a microneedle patch for drug delivery or biological fluid collection and a preparation method thereof.

In order to achieve the purpose, the invention adopts the following technical scheme:

the utility model provides a micropin paster for drug delivery or biological fluid are collected, includes the paster basement, a plurality of liquid reservoirs have evenly been seted up on the paster basement, the liquid reservoir both sides all are provided with the micropin, the micropin is close to the water conservancy diversion channel has been seted up to one side of liquid reservoir, the water conservancy diversion channel with the liquid reservoir is linked together, the micropin includes the base that links to each other with the paster basement, sets up in the main part of base top, sets up in the pointed end at main part top.

Preferably, the patch base is of a rectangular structure.

Preferably, the base adopts a circular truncated cone-shaped structure, the main body adopts a cylindrical structure, and the tip adopts a conical structure.

Preferably, one end of the flow guide channel is positioned at the tip of the tip, and the other end of the flow guide channel is communicated with the liquid storage tank.

A preparation method of a microneedle patch for drug delivery or biological fluid collection comprises the following steps:

manufacturing a template;

microneedle patches were made.

Preferably, the template manufacturing method comprises the following steps:

modeling a three-dimensional graph structure of the microneedle through drawing software;

guiding the designed graph structure into a laser direct writing system to carry out three-dimensional laser photoetching;

dripping photoresist on the substrate;

after exposure to the laser, the unexposed areas of the negative tone resist and the exposed areas of the positive tone resist are removed in a developer bath to yield a template for the microneedle patch.

Preferably, the microneedle patch is manufactured by the following steps:

injecting a first polymer material in a molten state into the template to form a microneedle area, wherein the first polymer material is a thermoplastic polymer;

before the micro-needle is solidified, a second high polymer material is injected to form a substrate part, wherein the second high polymer material is a thermoplastic high polymer.

Preferably, the laser direct writing system can recognize three-dimensional images and perform three-dimensional laser lithography, and the principle is that ultraviolet laser scans the surface of a photosensitive material, a two-dimensional pattern of a polymeric material is generated through single photon absorption, and a three-dimensional microstructure is manufactured through a layer-by-layer method.

In summary, due to the adoption of the technical scheme, the invention has the beneficial effects that:

according to the invention, the microneedle is made of a high-hardness polymer material and is provided with a conical tip, so that the microneedle can be ensured to well penetrate into the skin, the side surface of the microneedle is provided with a flow guide channel which is communicated with the liquid storage tank of the substrate, so that the microneedle can well guide flow, cannot block a channel due to interception of skin tissues, and can be applied to drug delivery or extraction of biological body fluid;

in the invention, the substrate of the patch is made of high polymer material with higher flexibility, so that the patch can be better attached to the skin, and the fluid communication time between the drug or sample collection reservoir and the tissue under the stratum corneum is prolonged;

in the invention, the whole manufacturing process does not need to be carried out in a super clean environment, the whole processing cost is low, and the process is simple and convenient.

Drawings

Fig. 1 is a schematic view of the overall structure of a microneedle patch for drug delivery or biological fluid collection according to the present invention;

fig. 2 is a top view of a microneedle patch of the present invention for drug delivery or biological fluid collection;

fig. 3 is a bottom view of a microneedle patch for drug delivery or biological fluid collection in accordance with the present invention.

Reference numerals: 1. a patch substrate; 2. a liquid storage tank; 3. microneedles; 4. a base; 5. a main body; 6. a tip; 7. a flow guide channel.

Detailed Description

The following will further illustrate a specific embodiment of a microneedle patch for drug delivery or biological fluid collection and a method for manufacturing the same according to the present invention with reference to fig. 1 to 3. The microneedle patch for drug delivery or biological fluid collection and the method for manufacturing the same according to the present invention are not limited to the description of the following examples.

Example 1:

the embodiment provides a specific implementation mode of a micropin paster for drug delivery or biological fluid collection, as shown in fig. 1-3, includingpaster basement 1, evenly seted up a plurality ofliquid storage tanks 2 on thepaster basement 1, the liquid storage tank both sides all are provided withmicropin 3, and waterconservancy diversion channel 7 has been seted up to one side thatmicropin 3 is close toliquid storage tank 2, and waterconservancy diversion channel 7 is linked together withliquid storage tank 2, andmicropin 3 includesbase 4 that links to each other withpaster basement 1, sets up in the main part 5 ofbase 4 top, sets up in the most advanced 6 at main part 5 top.

Further, thepatch substrate 1 has a rectangular structure.

Further, thebase 4 adopts a circular truncated cone-shaped structure, the main body 5 adopts a cylindrical structure, and thetip 6 adopts a conical structure.

Furthermore, one end of theflow guide channel 7 is positioned at the top of thetip 6, and the other end is communicated with theliquid storage tank 2.

By adopting the technical scheme:

thepatch substrate 1 is made of flexible polymer materials, is soft in property and can be well attached to the skin, and meanwhile, aliquid storage tank 2 is arranged on the substrate and connected with aflow guide channel 7 on themicroneedle 3 and used for storing medicines or collecting biological body fluid;

theflexible substrate 1 is provided with amicroneedle 3, themicroneedle 3 mainly comprises a cylindrical main body 5, a super-sharptip 6 for penetrating tissues, abase 4 connected with a liquid storage tank on the flexible substrate, and an open channel, namely aflow guide channel 7, extending from the tip to themicroneedle base 4 along one side of the main body; the mode of opening the channel on the side surface of the microneedle is adopted, so that the flow guide is good, and the channel blockage caused by the interception of skin tissues can be avoided.

Example 2:

this example presents a specific implementation of a method for preparing a microneedle patch for drug delivery or biological fluid collection, including the following steps:

manufacturing a template;

microneedle patches were made.

Further, the template manufacturing method comprises the following steps:

modeling a three-dimensional graph structure of the microneedle through drawing software;

guiding the designed graph structure into a laser direct writing system to carry out three-dimensional laser photoetching;

dripping photoresist on the substrate;

after exposure to the laser, the unexposed areas of the negative tone resist and the exposed areas of the positive tone resist are removed in a developer bath to yield a template for the microneedle patch.

Further, the microneedle patch is manufactured, and the method comprises the following steps:

injecting a molten state of a first high polymer material into the template to form a microneedle area, wherein the first high polymer material is a thermoplastic high polymer;

before the micro-needle is solidified, a second high polymer material is injected to form a substrate part, wherein the second high polymer material is a thermoplastic high polymer.

Furthermore, the laser direct writing system can identify three-dimensional images and carry out three-dimensional laser photoetching, and the principle is that ultraviolet laser scans the surface of a photosensitive material, two-dimensional patterns of a polymerization material are generated through single photon absorption, and a three-dimensional microstructure is manufactured through a layer-by-layer method.

By adopting the technical scheme:

making of shuttering

Step one, modeling a three-dimensional microneedle structure in drawing software such as CAD (computer-aided design);

step two, guiding the designed graphic structure into a laser direct writing system, wherein the system can identify a three-dimensional image and realize three-dimensional laser photoetching, and the principle is that the surface of a photosensitive material is scanned by ultraviolet laser, a two-dimensional pattern of a polymerization material is generated by single photon absorption, and a three-dimensional microstructure is manufactured by a layer-by-layer method; photosensitive materials have a high absorptivity in the ultraviolet range and are generally transparent in the Infrared (IR) range. Therefore, when the simultaneous energy of two or more photons exceeds the absorption energy threshold of the photosensitive material, any three-dimensional microstructure can be prepared by using the high-intensity ultrashort femtosecond near-infrared laser pulse.

And step three, dripping photoresist on a proper substrate, and removing the unexposed areas of the negative tone resist and the exposed areas of the positive tone resist in a proper developer bath after exposure to laser, thereby obtaining the template of the microneedle patch.

The preparation of the micro-needle patch,

injecting a molten polymer material into the template to form a microneedle area, wherein the material is a thermoplastic polymer and has high hardness after being solidified, and is used for penetrating into skin;

and fifthly, before the micro-needle is cured, injecting another high polymer material to form thepatch substrate 1, wherein the material is a thermoplastic high polymer, has good flexibility after being cured, is used for storing medicines or biological body fluid, and can be better attached to the skin.

The working principle is as follows:

firstly, the base of the patch is made of flexible material, so that the patch can be well attached to the skin; secondly, a mode of opening channels on the side surfaces of the microneedles is adopted, so that the flow can be guided well, and the channel cannot be blocked due to the interception of skin tissues; in addition, the whole manufacturing process does not need to be carried out in a super clean environment, the whole processing cost is low, and the process is simple and convenient.

The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.

Claims (8)

1. A microneedle patch for drug delivery or biological fluid collection, characterized in that: including paster basement (1), a plurality of liquid storage tanks (2) have evenly been seted up on paster basement (1), the liquid storage tank both sides all are provided with micropin (3), micropin (3) are close to water conservancy diversion channel (7) have been seted up to one side of liquid storage tank (2), water conservancy diversion channel (7) with liquid storage tank (2) are linked together, micropin (3) include base (4) that link to each other with paster basement (1), set up in main part (5) of base (4) top, set up in most advanced (6) at main part (5) top.

2. A microneedle patch for drug delivery or biological fluid collection according to claim 1, wherein: the patch substrate (1) is of a rectangular structure.

3. A microneedle patch for drug delivery or biological fluid collection according to claim 1, wherein: the base (4) adopts a round platform-shaped structure, the main body (5) adopts a cylindrical structure, and the tip (6) adopts a conical structure.

4. A microneedle patch for drug delivery or biological fluid collection according to claim 1, wherein: one end of the flow guide channel (7) is positioned at the top of the tip (6), and the other end of the flow guide channel is communicated with the liquid storage tank (2).

5. A preparation method of a microneedle patch for drug delivery or biological fluid collection is characterized by comprising the following steps:

manufacturing a template;

microneedle patches were made.

6. A method of fabricating a microneedle patch for drug delivery or collection of biological fluids according to claim 1, wherein said fabricating a template comprises the steps of:

modeling a three-dimensional graph structure of the microneedle through drawing software;

guiding the designed graph structure into a laser direct writing system to carry out three-dimensional laser photoetching;

dripping photoresist on the substrate;

after exposure to the laser, the unexposed areas of the negative tone resist and the exposed areas of the positive tone resist are removed in a developer bath to yield a template for the microneedle patch.

7. A method of manufacturing a microneedle patch for drug delivery or collection of biological fluids according to claim 6, wherein said manufacturing of microneedle patch comprises the steps of:

injecting a first polymer material in a molten state into the template to form a microneedle area, wherein the first polymer material is a thermoplastic polymer;

before the micro-needle is solidified, a second high polymer material is injected to form a substrate part, wherein the second high polymer material is a thermoplastic high polymer.

8. A method of preparing a microneedle patch for drug delivery or collection of biological fluids according to claim 7, wherein: the laser direct writing system can identify three-dimensional images and carry out three-dimensional laser photoetching, and the principle is that ultraviolet laser scans the surface of a photosensitive material, two-dimensional patterns of a polymerization material are generated through single photon absorption, and a three-dimensional microstructure is manufactured through a layer-by-layer method.

Images