# US 10,869,966 B2 · Syringe systems, piston seal systems, stopper systems, and methods of use and assembly

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- Number: US 10,869,966 B2
- Document ID: US10869966B2
- Status: Granted
- Kind: B2
- Application number: 15/048,366
- Filed: 2016-02-19
- Published: 2016-08-25
- Granted: 2020-12-22
- Earliest claimed: 2015-02-20
- Assignees: Regeneron Pharmaceuticals, Inc.
- Applicants: Regeneron Pharmaceuticals, Inc.
- Inventors: Michael Cupicha; Alexei Goraltchouk; Ian Hart; Mike Stelmah
- Web page: https://patentgrep.com/patent/US10869966B2

## CPC

- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/2053: {Media being expelled from injector by pressurised fluid or vacuum (for infusion A61M5/145, A61M5/155)}
- A61M 5/3129: {Syringe barrels (A61M5/3205, A61M5/50 take precedence)}
- A61M 5/31513: {Piston constructions to improve sealing or sliding}
- A61M 5/31515: {Connection of piston with piston rod}
- F16J 1/005: {obtained by assembling several pieces}
- F16J 9/20: Rings with special cross-section (L-section rings F16J9/02); Oil-scraping rings {(F16J9/06 takes precedence)}
- A61M 5/14526: {the piston being actuated by fluid pressure}
- A61M 2005/3131: {specially adapted for improving sealing or sliding}
- A61M 2005/31523: {for reducing reflux}
- A61M 2207/00: Methods of manufacture, assembly or production
- 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)}
- F16J: PISTONS {(specially adapted for dampers F16F9/32)}; CYLINDERS; SEALINGS

## Abstract

A syringe system, piston seal systems, stopper systems, and methods for assembling and using the syringe systems. The piston seal system including a piston seal member and a piston head member. The injection system including a container, a piston seal system positioned within the container, and a stopper system coupled to an end of the container. The method of assembling an injection system, the method includes obtaining a container, a piston seal system, and a stopper system. The method also includes inserting the piston seal system into a cavity within the container. The method further includes securing the stopper system at an end of the container in an opening of the cavity. Methods of using the syringe system, piston seal systems, and stopper systems are also disclosed.

## Claims

### Claim 1

An injection device, comprising:
a container having a first end and a second end;
a piston configured to move toward the second end of the container;
a seal disposed between the first end of the container and the piston, the seal being spaced apart from and coupled to the piston such that movement of the seal and the piston occur simultaneously, wherein an outer surface of the piston and an outer surface of the seal are configured to engage an interior surface of the container; and
a pressure delivery device configured to convey a first fluid, from exterior of the container, into the container and into contact with the seal to urge initial movement of the seal and the piston from a resting position toward the second end of the container;
wherein a second fluid is configured to be disposed in the container and in direct contact with the piston, wherein movement of the seal and the piston toward the second end of the container urges the second fluid out of the container, and further including a stopper configured to seal the first end of the container.

### Claim 2 (depends on 1)

The injection device of claim 1, further including a needle coupled to the second end of the container.

### Claim 3 (depends on 1)

The injection device of claim 1, further including a stopper configured to seal the first end of the container, wherein the piston is configured to move relative to the stopper.

### Claim 4 (depends on 3)

The injection device of claim 3, wherein the pressure delivery device is configured to convey the first fluid through the stopper into the container.

### Claim 5 (depends on 1)

The injection device of claim 1, wherein the first fluid is pressurized before delivery into the container.

### Claim 6 (depends on 1)

The injection device of claim 1, wherein the piston includes a circumferential ring configured to seal against an inner surface of the container.

### Claim 7 (depends on 1)

The injection device of claim 1, wherein the seal is coupled to the piston by a shaft.

### Claim 8 (depends on 7)

The injection device of claim 7, wherein a diameter of the shaft is less than the outer diameter of the piston, and also is less than the outer diameter of the seal.

### Claim 9 (depends on 8)

The injection device of claim 8, wherein a space between the seal and the piston is configured to contain any first fluid that leaks distally of the seal.

### Claim 10 (depends on 7)

The injection device of claim 7, wherein the shaft is configured to prevent angular shift or tilting of the seal when the pressure delivery device conveys the first fluid into the container.

### Claim 11 (depends on 1)

The injection device of claim 1, wherein the seal includes a circumferential ring configured to seal against an inner surface of the container.

### Claim 12 (depends on 1)

The injection device of claim 1, wherein at least a portion of the stopper is disposed exterior of the container.

### Claim 13 (depends on 1)

The injection device of claim 1, wherein at least a portion of the stopper is disposed within the container.

### Claim 14 (depends on 1)

The injection device of claim 1, wherein the stopper is secured to the first end of the container.

### Claim 15

An injection device, comprising:
a container having a first end and a second end;
a piston configured to move toward the second end of the container;
a seal disposed between the first end of the container and the piston, the seal being longitudinally spaced apart from the piston, wherein an outer surface of the piston and an outer surface of the seal are configured to engage an interior surface of the container;
a second fluid disposed between the piston and the second end of the container, wherein the piston directly contacts the second fluid; and
a pressure delivery device configured to convey a pressurized first fluid from exterior of the container, into the container and into contact with the seal to urge the seal and the piston toward the second end of the container to advance the second fluid out of the second end of the container, wherein a space between the piston and the seal is configured to trap any second fluid that leaks proximally past the piston, and trap any pressurized first fluid that leaks distally past the seal, wherein the first fluid is a gas that drives initial movement of the seal.

### Claim 16 (depends on 15)

The injection device of claim 15, wherein the seal and the piston each includes a plurality of longitudinally spaced apart circumferential rings that are configured to seal against an inner surface of the container.

### Claim 17

An injection device, comprising:
a container having a first end and a second end;
a piston configured to move toward the second end of the container;
a seal disposed between the first end of the container and the piston, the seal being spaced apart from and coupled to the piston such that movement of the seal and the piston occur simultaneously, wherein an outer surface of the piston and an outer surface of the seal are configured to engage an interior surface of the container;
a pressure delivery device configured to convey a first fluid, from exterior of the container, into the container and into contact with the seal to urge initial movement of the seal and the piston from a resting position toward the second end of the container; and
a stopper configured to seal the first end of the container, wherein the piston is configured to move relative to the stopper;
wherein a second fluid is configured to be disposed in the container between the piston and the second end of the container such that:
the piston is configured to directly contact the second fluid; and
movement of the seal and the piston toward the second end of the container is configured to urge the second fluid out of a distalmost portion of the container.

### Claim 18 (depends on 17)

The injection device of claim 17, further including a needle coupled to the second end of the container.

### Claim 19 (depends on 17)

The injection device of claim 17, wherein the pressure delivery device is configured to convey the first fluid through the stopper into the container.

### Claim 20 (depends on 17)

The injection device of claim 17, wherein the first fluid is pressurized before delivery into the container.

### Claim 21 (depends on 17)

The injection device of claim 17, wherein the first fluid is a gas.
