# US 11,998,711 B2 · Microneedle patch and production method therefor

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- Number: US 11,998,711 B2
- Document ID: US11998711B2
- Status: Granted
- Kind: B2
- Application number: 16/720,803
- Filed: 2019-12-19
- Published: 2020-04-23
- Granted: 2024-06-04
- Earliest claimed: 2014-06-02
- Assignees: Amolifescience Co., Ltd.
- Applicants: Amolifescience Co., Ltd.
- Inventors: Jae Yeong Lee
- Web page: https://patentgrep.com/patent/US11998711B2

## CPC

- A61M 37/0015: {by using microneedles}
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/003: {having a lumen}
- A61M 2037/0038: {having a channel at the side surface}
- A61M 2037/0053: {Methods for producing microneedles}
- A61M 2207/00: Methods of manufacture, assembly or production
- B01D 2323/26: Spraying processes
- B01D 2323/39: Electrospinning
- B05D 1/04: involving the use of an electrostatic field {(B05D1/025 and B05D1/14 take precedence)}
- B29C 45/0001: {characterised by the choice of material}
- B29C 2045/0094: {injection moulding of small-sized articles, e.g. microarticles, ultra thin articles}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- B05D: PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (conveying articles or workpieces through baths of liquid B65G, e.g. B65G49/02)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)

## Abstract

Provided are a micro-needle patch and a manufacturing method thereof. The micro-needle patch includes: a support on one surface of which grooves are formed; a gel membrane for delivery of a transmitter to be transferred in which the grooves are filled with a mixture of the transmitter with a biodradable resin, the mixture being in a gel phase; a plurality of micro-needles projected on the other surface of the support and for penetrating the skin; a first protective film that covers the gel membrane and is adhered on the support; and a second protective film that covers the plurality of micro-needles and is adhered on the other surface, wherein passages are formed by being penetrated from the support to each of the plurality of micro-needles or formed by penetrating the support between the plurality of micro-needles, so that the transmitter of the gel membrane is transferred to the skin.

## Claims

### Claim 1

A method of manufacturing a micro-needle patch, the method comprising:
forming a support inserted into a receiving portion in a tray, the support having a first surface and a second surface opposite the first surface, wherein the support includes: a plurality of supports each inserted into the receiving portion in the tray;
forming a plurality of micro-needles projecting from the first surface of the support;
forming a first passage from the support to each of the micro-needles or a second passage from the support between two neighboring micro-needles;
forming a groove in the second surface of the support,
electrospinning a spinning solution into the groove to form nanofibers, the spinning solution comprising a transmitter to be transferred, a biodegradable resin, and a solvent;
accumulating the nanofibers in the groove to form a gel membrane for delivery of the transmitter to be transferred,
adhering a first protective film on the gel membrane to protect the gel membrane; and
adhering a second protective film on the first surface of the support to cover the micro-needles.

### Claim 2 (depends on 1)

The method of claim 1, wherein the plurality of the supports differ from one another in size.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the first passage is formed at a center of the each of the micro-needles.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the support comprises polyetherimide.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the support comprises a material that is biodegradable or soluble by a human body fluid.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the material comprises polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol, cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, or hydroxypropylmethylcellulose.

### Claim 7 (depends on 1)

The method according to claim 1, wherein a width of an upper region of the micro-needles is narrower than a width of a lower region relative to the first surface of the support.

### Claim 8 (depends on 1)

The method according to claim 1, wherein a height of the micro-needles is less than 1000 μm.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the transmitter comprises at least one selected from the group consisting of anesthetics, narcotic vaccines, adjuvants, immunogens, immunomodulators, immune reagents, immune stimulants, analgesics, antibiotics, chitosans, collagens, gelatins, hyaluronic acids, polylactic acids, polyglycolic acids, and a mixture thereof.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the transmitter comprises a skin cosmetic treatment fluid.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the second passage is formed at a side wall of the each of the micro-needles.

### Claim 12

A method of manufacturing a micro-needle patch, the method comprising:
forming a support inserted into a receiving portion in a tray, the support having a first surface and a second surface opposite the first surface, wherein the support includes: a plurality of supports each inserted into the receiving portion in the tray;
forming a plurality of micro-needles projecting from the first surface of the support;
forming a first passage from the support to each of the plurality of micro-needles or a second passage from the support between two neighboring micro-needles;
forming a groove in the second surface of the support,
electrospraying a spraying solution into the groove to form droplets, the spraying solution comprising a transmitter to be transferred, a biodegradable resin, and a solvent;
accumulating the droplets in the groove to form a gel membrane for delivery of the transmitter to be transferred,
adhering a first protective film on the gel membrane to protect the gel membrane; and
adhering a second protective film on the first surface of the support to cover the micro-needles.

### Claim 13 (depends on 12)

The method of claim 12, wherein the plurality of the supports differ from one another in size.

### Claim 14 (depends on 12)

The method according to claim 12, wherein the support comprises a material that is biodegradable or soluble by a human body fluid.
