# US 10,870,223 B2 · Method of manufacturing needle-like array sheet

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- Number: US 10,870,223 B2
- Document ID: US10870223B2
- Status: Granted
- Kind: B2
- Application number: 15/695,014
- Filed: 2017-09-05
- Published: 2018-03-08
- Granted: 2020-12-22
- Earliest claimed: 2016-09-06
- Assignees: FUJIFILM Corporation
- Applicants: FUJIFILM Corporation
- Inventors: Shotaro Ogawa; Keio Okano
- Web page: https://patentgrep.com/patent/US10870223B2

## CPC

- B29C 39/025: {for making multilayered articles}
- A61M 37/0015: {by using microneedles}
- B29C 37/0053: {Moulding articles characterised by the shape of the surface, e.g. ribs, high polish (mould construction therefor B29C33/42; surface shaping of articles B29C59/00; by incorporating filler in or near the surface B29C70/64)}
- B29C 41/22: Making multilayered or multicoloured articles
- A61M 2037/0053: {Methods for producing microneedles}
- A61M 2037/0061: {Methods for using microneedles}
- B29C 35/02: Heating or curing, e.g. crosslinking or vulcanizing {during moulding, e.g. in a mould}(cold vulcanisation B29C35/18 {; vulcanising tyres, presses therefor B29D30/0601})
- B29K 2105/0073: {Solution}
- B29K 2995/006: Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
- B29L 2031/7544: {Injection needles, syringes}
- B29L 2031/756: {Microarticles, nanoarticles}
- 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)
- 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)}
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

A method of manufacturing a needle-like array sheet includes supplying a first needle-like array-forming solution consisting of an aqueous solution on a first mold having a first recess; interrupting drying in a wet state and forming a needle-like distal end part; supplying a second needle-like array-forming solution consisting of an aqueous solution on a second mold having a second recess; peeling a sheet part molding product, which is dried and solidified and has a protrusion corresponding to the second recess, after the sheet part molding product is formed; inserting the protrusion of the sheet part molding product into the first recess of the first mold; drying and solidifying the needle-like distal end part and the sheet part molding product after inserting the protrusion, bonding the needle-like distal end part and the protrusion of the sheet part molding product together, and forming a needle-like array sheet having the needle-like array.

## Claims

### Claim 1

A method of manufacturing a needle-like array sheet, comprising:
a first liquid supply step of supplying a first needle-like array-forming solution consisting of an aqueous solution on a first mold having a first recess with a shape corresponding to a needle-like array;
a first liquid drying step of partially drying the first needle-like array-forming solution and forming a needle-like distal end part;
a second liquid supply step of supplying a second needle-like array-forming solution consisting of an aqueous solution of a water-soluble material on a second mold having a second recess corresponding to a shape from which a portion of the shape corresponding to the needle-like array is removed;
a sheet part molding product forming step of peeling a sheet part molding product from the second mold after the second needle-like array-forming solution is dried and solidified and the sheet part molding product having a protrusion corresponding to the second recess is formed;
an insertion step of inserting the protrusion of the sheet part molding product into the first recess of the first mold after the first liquid drying step, wherein the needle-like distal end part is in a wet state and in contact with the protrusion of the sheet part molding product;
an entire drying step of drying and solidifying the needle-like distal end part and the sheet part molding product after the insertion step, bonding the needle-like distal end part and the protrusion of the sheet part molding product together, and forming a needle-like array sheet having the needle-like array; and
a peeling step of peeling the needle-like array sheet from the first mold.

### Claim 2 (depends on 1)

The method of manufacturing a needle-like array sheet according to claim 1,
wherein the second recess of the second mold has a shape in which a distal end of the first recess of the first mold is filled.

### Claim 3 (depends on 1)

The method of manufacturing a needle-like array sheet according to claim 1,
wherein a thickness of the second recess of the second mold is greater than a thickness of the first recess of the first mold.

### Claim 4 (depends on 1)

The method of manufacturing a needle-like array sheet according to claim 1,
wherein the first liquid supply step, the first liquid drying step, the insertion step, the entire drying step, and the peeling step are performed under sterile conditions.

### Claim 5 (depends on 1)

The method of manufacturing a needle-like array sheet according to claim 1, further comprising
a sterilization step of sterilizing the sheet part molding product after the sheet part molding product forming step.

### Claim 6 (depends on 1)

The method of manufacturing a needle-like array sheet according to claim 1,
wherein the second recess of the second mold has a through-hole.

### Claim 7 (depends on 1)

The method of manufacturing a needle-like array sheet according to claim 1,
wherein the sheet part molding product comprises saccharides or proteins.
