# US 10,864,360 B2 · Microneedle unit

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- Number: US 10,864,360 B2
- Document ID: US10864360B2
- Status: Granted
- Kind: B2
- Application number: 14/992,560
- Filed: 2016-01-11
- Published: 2016-05-05
- Granted: 2020-12-15
- Earliest claimed: 2013-07-11
- Assignees: Toppan Printing Co., Ltd.
- Applicants: Toppan Printing Co., Ltd.
- Inventors: Hiroyuki Kato
- Web page: https://patentgrep.com/patent/US10864360B2

## CPC

- A61M 37/0015: {by using microneedles}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/0046: {Solid microneedles}
- A61M 2037/0053: {Methods for producing microneedles}
- 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)}

## Abstract

A microneedle unit includes a liquid holder, a microneedle, and a support member. The liquid holder has an enclosure that holds liquid including a substance to be administered. The microneedle has a base body and protrusions extending from the surface of the base body. The protrusions are of a hardness sufficient to pierce the liquid holder. The support member supports the base body in a state such that the microneedle is arranged at a position in which the tips of the protrusions and the enclosure holding the liquid are opposed to each other with a gap provided therebetween. The tips of the protrusions can be displaced to a position where the tips of the protrusions penetrate through the liquid holder in response to an external force applied to the base body.

## Claims

### Claim 1

A microneedle unit, comprising:
a liquid holder comprising a base material and having an enclosure portion surrounded by the base material such that the enclosure portion holds and seals a liquid in the base material;
a microneedle having a base body and a protrusion extending from a surface of the base body such that the protrusion has a hardness that allows the protrusion to penetrate through the enclosure portion of the liquid holder; and
a container having a concaved shape and supporting the microneedle inside the container such that the microneedle is positioned at a bottom of the container and that a tip portion of the protrusion and the enclosure portion holding the liquid are opposed to each other with a gap therebetween,
wherein the liquid includes a substance to be administered, and the liquid holder is adhered to the container to close an opening of the container at an end of the container on an opposite side with respect to the bottom of the container such that the microneedle is accommodated inside the container, that the tip portion of the protrusion of the microneedle faces the enclosure portion of the liquid holder and that the container moves the tip portion of the protrusion of the microneedle toward the enclosure portion of the liquid holder and the tip portion penetrates through the enclosure portion of the liquid holder when an external force is applied to the bottom of the container.

### Claim 2 (depends on 1)

The microneedle unit according to claim 1, wherein the base material of the liquid holder comprise polyethylene terephthalate.

### Claim 3 (depends on 2)

The microneedle unit according to claim 2, wherein the liquid holder is adhered to the container to close the opening of the container at the end of the container on the opposite side with respect to the bottom of the container such that the enclosure portion of the liquid holder has an area in a size of 1.1 times greater than or equal to a size of an area in which the protrusion is formed.

### Claim 4 (depends on 3)

The microneedle unit according to claim 3, wherein the base body has a plate shape having a rear surface fixed to the bottom of the container, and the container is flexible such that when the bottom receives a pressing force directed towards the opening of the container, the container bends towards the opening.

### Claim 5 (depends on 2)

The microneedle according to claim 2, wherein the protrusion is made of a material soluble in the liquid held in the liquid holder.

### Claim 6 (depends on 2)

The microneedle according to claim 2, wherein the protrusion is formed in a plurality on the surface of the base body, the plurality of protrusions are positioned such that the plurality of protrusions faces the enclosure portion of the liquid holder, and the enclosure portion has an area larger than an area on the surface of the base body where the protrusions are formed.

### Claim 7 (depends on 1)

The microneedle unit according to claim 1, wherein the liquid holder is adhered to the container to close the opening of the container at the end of the container on the opposite side with respect to the bottom of the container such that the enclosure portion of the liquid holder has an area in a size of 1.1 times greater than or equal to a size of an area in which the protrusion is formed.

### Claim 8 (depends on 7)

The microneedle unit according to claim 7, wherein the base body has a plate shape having a rear surface fixed to the bottom of the container, and the container is flexible such that when the bottom receives a pressing force directed towards the opening of the container, the container bends towards the opening.

### Claim 9 (depends on 8)

The microneedle according to claim 8, wherein the protrusion is made of a material soluble in the liquid held in the liquid holder.

### Claim 10 (depends on 8)

The microneedle according to claim 8, wherein the protrusion is formed in a plurality on the surface of the base body, the plurality of protrusions are positioned such that the plurality of protrusions faces the enclosure portion of the liquid holder, and the area of the enclosure portion is larger than an area on the surface of the base body where the protrusions are formed.

### Claim 11 (depends on 7)

The microneedle according to claim 7, wherein the protrusion is made of a material soluble in the liquid held in the liquid holder.

### Claim 12 (depends on 7)

The microneedle according to claim 7, wherein the protrusion is formed in a plurality on the surface of the base body, the plurality of protrusions are positioned such that the plurality of protrusions faces the enclosure portion of the liquid holder, and the area of the enclosure portion is larger than an area on the surface of the base body where the protrusions are formed.

### Claim 13 (depends on 7)

The microneedle according to claim 7, wherein the liquid holder is a film having the liquid sealed in the enclosure portion of the film.

### Claim 14 (depends on 1)

The microneedle according to claim 1, wherein the protrusion is made of a material soluble in the liquid held in the liquid holder.

### Claim 15 (depends on 1)

The microneedle according to claim 1, wherein the protrusion is formed in a plurality on the surface of the base body, the plurality of protrusions are positioned such that the plurality of protrusions faces the enclosure portion of the liquid holder, and the enclosure portion has an area larger than an area on the surface of the base body where the protrusions are formed.

### Claim 16 (depends on 1)

The microneedle according to claim 1, wherein the liquid holder is adhered to the container to close the opening of the container at the end of the container on the opposite side with respect to the bottom of the container such that the enclosure portion of the liquid holder has an area in a size of 1.5 times greater than or equal to a size of an area in which the protrusion is formed and less than or equal to 4.0 times the size of the area in which the protrusion is formed.

### Claim 17 (depends on 16)

The microneedle unit according to claim 16, wherein the base body has a plate shape having a rear surface fixed to the bottom of the container, and the container is flexible such that when the bottom receives a pressing force directed towards the opening of the container, the container bends towards the opening.

### Claim 18 (depends on 16)

The microneedle according to claim 16, wherein the protrusion is made of a material soluble in the liquid held in the liquid holder.

### Claim 19 (depends on 16)

The microneedle according to claim 16, wherein the protrusion is formed in a plurality on the surface of the base body, the plurality of protrusions are positioned such that the plurality of protrusions faces the enclosure portion of the liquid holder, and the area of the enclosure portion is larger than an area on the surface of the base body where the protrusions are formed.

### Claim 20 (depends on 1)

The microneedle according to claim 1, wherein the liquid holder is a film having the liquid sealed in the enclosure portion of the film.
