# US 9,039,664 B2 · Elastic seal member for prefilled syringe

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- Number: US 9,039,664 B2
- Document ID: US9039664B2
- Status: Granted
- Kind: B2
- Application number: 14/112,092
- Filed: 2012-04-16
- Published: 2014-03-06
- Granted: 2015-05-26
- Earliest claimed: 2011-04-26
- Assignees: Taisei Kako Co., Ltd.
- Applicants: Yukihiro Ogawa; Yasuyuki Shiraishi; Taiji Horita; Ichiro Suzuki
- Inventors: Yukihiro Ogawa; Yasuyuki Shiraishi; Taiji Horita; Ichiro Suzuki
- Web page: https://patentgrep.com/patent/US9039664B2

## CPC

- A61M 5/2466: {by piercing without internal pressure increase (A61M5/2429 takes precedence)}
- A61M 5/315: Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod {or piston}; Appliances on the rod for facilitating dosing {; Dosing mechanisms}
- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/2429: {by telescoping of ampoules or carpules with the syringe body}
- A61M 5/31513: {Piston constructions to improve sealing or sliding}
- A61M 2207/00: Methods of manufacture, assembly or production
- B01L 3/50825: {Closing or opening means, corks, bungs}
- 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)}
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

In a prefilled syringe including an elastic seal member to be pierced with a needle for use to eject a protein pharmaceutical preparation therefrom, the elastic seal member ensures smooth and reliable piercing thereof with the needle while reliably preventing an active substance of the protein pharmaceutical preparation from being adsorbed thereon. When a protective film (3) is laminated to a top surface of a seal body (2) of an elastic material, the protective film (3) is stretched to a greater extent by a recess (4) provided in the top surface. Further, the piercing portion to be pierced with the needle is provided in a bottom of the recess (4). Thus, the protective film (3) is formed as locally having a smaller thickness in the piercing portion.

## Claims

### Claim 1

An elastic seal member for a prefilled syringe including a drug containing portion filled with a content liquid, the elastic seal member being adapted to seal the drug containing portion and having a piercing portion to be pierced with a needle for use, the elastic seal member comprising:
a seal body of an elastic material; and
a protective film laminated to at least a surface portion of the seal body opposed to the drug containing portion,
wherein the protective film has a relaxed state wherein the protective film has a first thickness,
wherein the protective film has an applied state with the protective film laminated to the surface portion of the seal body,
wherein in the applied state, the protective film is changed from the relaxed state by being locally stretched more in the piercing portion than around the piercing portion as a result of which the laminated protective film is locally changed from the first thickness and has a locally smaller thickness in the piercing portion than around the piercing portion.

### Claim 2 (depends on 1)

The prefilled-syringe elastic seal member according to claim 1,
wherein the seal body has a recess provided in the surface portion thereof,
wherein the piercing portion is provided in a bottom of the recess,
wherein the protective film is in intimate contact with a part of the surface portion present in the recess.

### Claim 3 (depends on 2)

The prefilled-syringe elastic seal member according to claim 2,
wherein the surface portion of the seal body opposed to the drug containing portion is substantially conformal to a bottom surface of the syringe,
wherein the recess is provided at a center of the surface portion so that a tip of the needle penetrating through the piercing portion is accommodated in the recess.

### Claim 4 (depends on 1)

The prefilled-syringe elastic seal member according to claim 1,
wherein the content liquid is a protein pharmaceutical preparation,
wherein the protective film is a film of a fluorine-containing resin or an ultra-high molecular weight polyethylene predisposed to prevent a protein from adsorbing onto the film.

### Claim 5 (depends on 1)

The prefilled-syringe elastic seal member according to claim 1, wherein a surface adhesion force between the protective film and the seal member in the piercing portion is greater than an external force which acts on the protective film to separate the protective film from the seal body when the piercing portion is pierced with the needle.