# US 9,038,675 B2 · Cylinder-piston unit suitable for storing injection solutions for a needle-free injector and method for the bubble-free automatic or manual filling of the cylinder-piston unit, also under atmospheric pressure

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- Number: US 9,038,675 B2
- Document ID: US9038675B2
- Status: Granted
- Kind: B2
- Application number: 14/063,037
- Filed: 2013-10-25
- Published: 2014-04-10
- Granted: 2015-05-26
- Earliest claimed: 2009-05-29
- Assignees: LTS Lohmann Therapie-Systeme AG
- Applicants: Rudolf Matusch
- Inventors: Rudolf Matusch
- Web page: https://patentgrep.com/patent/US9038675B2

## CPC

- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61M 5/1782: {Devices aiding filling of syringes in situ (combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003)}
- A61M 5/30: Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
- A61M 5/286: {upon internal pressure increase, e.g. pierced or burst (A61M5/283 takes precedence)}
- A61M 2005/3128: {Incorporating one-way valves, e.g. pressure-relief or non-return valves}
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- 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)}
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)

## Abstract

A pressure-stable cylinder/piston unit which blocks water vapor and oxygen and is designed for a needle-free injector, with a chamber arranged in a cylinder, which blocks water vapor and oxygen, and designed for long-term and sterile storage of an injection solution, an end wall with at least one nozzle bore or one outlet element, a pressure-stable outer cylinder, and a pressure-stable piston arranged movably in the chamber and blocking water vapor and oxygen. Methods for bubble-free, automatic or manual filling of the cylinder/piston unit, also at atmospheric pressure are also disclosed.

## Claims

### Claim 1

A method for filling a cylinder/piston unit (1) for a needle-free injector, the cylinder/piston unit (1) comprising a chamber (3) arranged in a cylinder (2), the chamber (3) for long-term and sterile storage of an injection solution (4), an end wall (5) with at least one nozzle bore or one outlet element (6), a pressure-stable outer cylinder (13), and a pressure-stable piston (7) arranged movably in the chamber (3) and blocking water vapor and oxygen, the chamber (3) formed with a first chamber (8) and a second, concentric chamber (9), wherein the cross section of the first chamber (8) is greater than the cross section of the second chamber (9), and each nozzle bore or each outlet element (6) is closed in a sterile manner by a membrane (26) supported by a closure cap (10) for blocking water vapor and oxygen and the membrane (26) opens at an overpressure and the piston (7) comprising a piston rod (21) and an inner piston body (18) and a flange (22), the piston (7) is surrounded by an outer compressible piston ring (17) for blocking water vapors and oxygen in a pressure stable and sterile closing manner, a transition area between the first chamber (8) and the second chamber (9) is formed as an interior annular surface (16) of cylinder (2), the cylinder (2) including annular pressure contours (B) and (C) and the outer cylinder (13) including annular pressure contour (A), said method comprising at least the following steps:
filling the second chamber (9) with an injection solution (4), wherein the volume of the injection solution (4) is smaller than the volume of the second chamber (9);
inserting the piston (7) with the outer compressible piston ring (17), so that the air flow passes by, into the first chamber (8) until the outer compressible piston ring (17) bears on the annular surface (16) in order to close the second chamber (9), wherein a gas cushion remains in the second chamber (9);
rotating the piston/cylinder unit through about 180 degrees about the horizontal axis and waiting until the gas cushion in the second chamber (9) has risen fully upward to the at least the one nozzle bore or one outlet element (6);
moving the inner piston body (18) with the flange (22) by means of the piston rod (21) out of the outer piston ring (17) into the second chamber (9), wherein the gas cushion is forced through the nozzle bore(s) or outlet element(s) (6) from the second chamber (9), and, the membrane (26) of the closure cap (10) lifts off from the nozzle bore(s) or outlet element(s) (6) and annular pressure contours A, B and C, and, after the emergence of the gas cushion, again closes the nozzle bore(s) or outlet element(s) (6) at the annular pressure contours A, B and C in a sterile manner.

### Claim 2 (depends on 1)

The method as claimed in claim 1, further comprising the of step of the complete emergence of the gas cushion is detected by the surveillance of the nozzle bore(s) or respectively the outlet element(s) (6) by a light barrier with respect to the release of the injection solution.

### Claim 3 (depends on 1)

The method as claimed in claim 1, said method further comprising the step of a manual filling of a cylinder-piston unit (1) wherein the piston (7) being positioned about 2-3 millimeters in front of the annular surface (16);
and, with the nozzle (6) pointing upward, the injection solution (4) is injected through the outer piston ring (17) into the chamber (3); and,
by advancing the piston (7) up to the annular surface (16), and further advancing the inner piston body (18), the air is forced through the overpressure valve formed by the membrane (26).