# US 12,109,395 B2 · Device and mixing and/or reconstitution method

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- Number: US 12,109,395 B2
- Document ID: US12109395B2
- Status: Granted
- Kind: B2
- Application number: 16/764,041
- Filed: 2018-11-15
- Published: 2020-09-03
- Granted: 2024-10-08
- Earliest claimed: 2017-11-17
- Assignees: Sanofi; Sagentia Limited
- Applicants: Sanofi
- Inventors: Michael Schabbach; Claus Geiger; Andrea Heiberger; Dieter Kadereit; Charlotte Emma Harvey; Congyi Huang; Timothy Charles Frearson; Alexander David Norman
- Web page: https://patentgrep.com/patent/US12109395B2

## CPC

- A61M 5/19: having more than one chamber
- A61J 1/1406: {Septums, pierceable membranes}
- A61J 1/16: Holders for containers
- A61J 1/201: {having one piercing end}
- A61J 1/2093: {Containers having several compartments for products to be mixed}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61M 5/2066: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/31596: {comprising means for injection of two or more media, e.g. by mixing}
- A61J 2205/60: using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
- 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 5/2053: {Media being expelled from injector by pressurised fluid or vacuum (for infusion A61M5/145, A61M5/155)}
- A61M 5/2448: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/31598: {having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed}
- A61M 5/445: {the media being heated in the reservoir, e.g. warming bloodbags}
- A61M 2005/2013: {triggering of discharging means by contact of injector with patient body}
- A61M 2005/2474: {with movable piercing means, e.g. ampoule remains fixed or steady}
- A61M 2005/3128: {Incorporating one-way valves, e.g. pressure-relief or non-return valves}
- A61M 2005/3267: {Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body}
- A61M 2205/0272: Electro-active or magneto-active materials
- A61M 2209/045: for filling, e.g. for filling reservoirs
- 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)}
- 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

## Abstract

The disclosure refers to a device, for example a cartridge, a syringe or an autoinjector, which reduces the possibility of user error and provides an easy and automatic operation during mixing and/or reconstitution. The device is adapted such that activation of the device causes movement one of a first piston and a second piston in second chamber in an axial direction of the device, thereby moving the other one of the first piston and the second piston into the same axial direction of the device, opening a fluid communication path between the second chamber and a first chamber of the device, and expelling a second material from the second chamber into the first chamber via the fluid communication path. The disclosure is further directed to a respective mixing and/or reconstitution method.

## Claims

### Claim 1

A device comprising:
a housing;
a first chamber within the housing, wherein the first chamber contains a first material;
a second chamber containing a first piston and a second piston, wherein the first piston and the second piston are axially moveable within the second chamber; and
a second material initially contained within the second chamber between the first piston and the second piston,
wherein the device is adapted such that activation of the device causes movement of one of the first piston or the second piston in an axial direction of the device thereby
moving the other of the first piston and the second piston in the axial direction of the device,
opening a fluid communication path between the second chamber and the first chamber, and
expelling the second material from the second chamber into the first chamber via the fluid communication path, and
wherein the device further comprises a plunger which closes a proximal end of the first chamber within the housing, wherein the plunger contains the second chamber, wherein the plunger is axially moveable within the housing of the device, and wherein axial movement of the plunger within the housing activates the device and causes a pressure drop in the first chamber;
and wherein the plunger comprises a through-hole at its distal end closed by a plug, which is connected with the second piston.

### Claim 2 (depends on 1)

The device of claim 1, wherein at least one of an inner surface of the plunger or an outer surface of the plug comprises web-like elements dimensioned such that after activation of the device by pulling the plunger, the pressure drop in the first chamber causes the second piston to move in a distal direction relative to the plunger.

### Claim 3 (depends on 2)

The device of claim 2, wherein the web-like elements are configured to, in response to the second piston moving in the distal direction relative to the plunger, counteract with the plug and/or the inner surface of the plunger thereby creating the fluid communication path between the second chamber and the first chamber and expelling the second material into the first chamber.

### Claim 4 (depends on 3)

The device of claim 3, wherein the inner surface of the plunger comprises an inner surface of the through-hole of the plunger.

### Claim 5 (depends on 3)

The device of claim 3, wherein the plunger comprises a handle at its proximal end.

### Claim 6 (depends on 3)

The device of claim 3, wherein the plug comprises a set of longitudinal ribs at its outer surface.

### Claim 7 (depends on 1)

The device of claim 1, wherein the second material is driven into the first chamber by a high speed jet.

### Claim 8 (depends on 1)

The device of claim 1, wherein the first material is a fluid or a solid material, and the second material is a diluent.

### Claim 9 (depends on 1)

The device of claim 1, wherein the first piston and the second piston close a proximal end and a distal end of the second chamber, respectively.

### Claim 10 (depends on 9)

The device of claim 9, wherein the first piston and the second piston are configured such that movement of one of the first piston or the second piston drives movement of the other of the first piston or the second piston via pressure transfer through the second material.

### Claim 11 (depends on 1)

The device of claim 1, wherein opening the fluid communication path between the second chamber and the first chamber causes the pressure drop in the first chamber to cause a pressure drop in the second chamber.