# US 10,117,969 B2 · Agent for regenerating tympanic membrane or external auditory canal

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- Number: US 10,117,969 B2
- Document ID: US10117969B2
- Status: Granted
- Kind: B2
- Application number: 14/849,001
- Filed: 2015-09-09
- Published: 2016-03-10
- Granted: 2018-11-06
- Earliest claimed: 2008-06-26
- Assignees: Nobelpharma AB
- Applicants: Nobelpharma Co., Ltd.
- Inventors: Shin-ichi Kanemaru
- Web page: https://patentgrep.com/patent/US10117969B2

## CPC

- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61K 9/0046: {Ear}
- A61K 38/1825: {Fibroblast growth factor [FGF]}
- A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61L 27/20: Polysaccharides
- A61L 27/222: {Gelatin}
- A61L 27/225: {Fibrin; Fibrinogen}
- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 27/34: Macromolecular materials
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 27/16: Otologicals
- A61F 11/20: Ear surgery
- A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L 2300/414: Growth factors
- A61L 2430/14: for ear reconstruction or ear implants, e.g. implantable hearing aids
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Provided is a tympanic membrane or ear canal regeneration agent comprising a combination of a gelatin sponge that carries basic fibroblast growth factor (bFGF) and a covering material. The covering material is used not only to fix the gelatin sponge to the affected portion, but also for the purpose of preventing drying and infections to provide a culturing environment that is favorable for regenerating tissue isolated from the outside. To promote tissue regeneration, the margin of the tympanic membrane or ear canal defect is preferably freshened in advance.

## Claims

### Claim 1

A tympanic membrane or ear canal regeneration agent comprising: (1) a gelatin sponge that carries a therapeutically effective amount of basic fibroblast growth factor to regenerate a tympanic membrane perforation or ear canal soft tissue defect in a subject having a tympanic membrane perforation or ear canal soft tissue defect and (2) fibrin glue as a covering material, and (3) a material insulating the regenerating portion from the outside.

### Claim 2 (depends on 1)

The tympanic membrane or ear canal regeneration agent of claim 1, wherein the gelatin sponge carries about 0.1 to about 1000 μg of basic fibroblast growth factor.

### Claim 3 (depends on 1)

The tympanic membrane or ear canal regeneration agent of claim 1, wherein the gelatin sponge comprises fine pores.

### Claim 4 (depends on 3)

The tympanic membrane or ear canal regeneration agent of claim 3, wherein the fine pores are of about 100 to about 400 μm diameter.

### Claim 5 (depends on 1)

A kit comprising the tympanic membrane or ear canal regeneration agent of claim 1, and instructions for its use.