# US 12,008,916 B2 · Devices and methods for drug administration and mixing, and training of proper techniques therefor

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- Number: US 12,008,916 B2
- Document ID: US12008916B2
- Status: Granted
- Kind: B2
- Application number: 17/240,192
- Filed: 2021-04-26
- Published: 2021-08-12
- Granted: 2024-06-11
- Earliest claimed: 2015-06-19
- Applicants: Janssen Pharmaceutica NV
- Inventors: Peter Krulevitch; Ian Scrimgeour; Scott Martin; James McLusky; James Glencross; Blair Hutton; Nick Foley; Jose Antonio Buron Vidal
- Web page: https://patentgrep.com/patent/US12008916B2

## CPC

- G09B 23/28: for medicine
- A61J 1/16: Holders for containers
- A61J 1/2055: {having gripping means}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61J 7/0053: {Syringes, pipettes or oral dispensers}
- 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)}
- G09B 5/02: with visual presentation of the material to be studied, e.g. using film strip
- G09B 23/285: {for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas}
- A61J 2200/70: Device provided with specific sensor or indicating means
- A61M 2205/50: with microprocessors or computers
- A61M 2205/581: by audible feedback
- G09B: EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS (devices for psychotechnics or for testing reaction times A61B5/16; games, sports, amusements A63; projectors, projector screens G03B)
- 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)}

## Abstract

A device for training users in a proper mixing of pharmaceutical components, or for aiding in the mixing, or for performing the mixing, and administration of pharmaceutical components is disclosed. The device comprises a housing for receiving a pharmaceutical delivery device containing the pharmaceutical components. There is also a microcontroller disposed in the housing and a motion/orientation detection device disposed within or on the housing and in communication with the microcontroller. A method for use of the device is also disclosed, along with a substance for use as one of the pharmaceutical components.

## Claims

### Claim 1

A device attachable to a syringe for training users in a proper mixing of pharmaceutical components, the device comprising:
a housing that extends along a longitudinal axis, the housing comprising a syringe accepting slot configured to receive a plunger rod of a syringe and to attach the housing to a finger flange of the syringe;
a power source disposed in the housing;
a microcontroller disposed in the housing and electrically powered by the power source; a user notification device; and
an accelerometer disposed in the housing and electrically connected to the microcontroller so that the microcontroller is configured to detect a motion and orientation of the housing and indicate via the user notification device as to whether the motion or orientation of the housing being shaken during one of a drug administration or a training event is sufficient with respect to predetermined thresholds including magnitude of the force applied during the shaking, the orientation of the housing and duration of such shaking.

### Claim 2 (depends on 1)

The device of claim 1, wherein the user notification device comprises one or more of: a display, a tactile feedback unit, a light emitting device, and/or a vibratory alert unit.

### Claim 3 (depends on 1)

The device of claim 1, wherein the user notification device is mounted on an external surface of the housing for notifying a user as to its status.

### Claim 4 (depends on 3)

The device of claim 3, wherein the user notification device is a display and the microcontroller is configured to indicate via the display the state of mixing of the pharmaceutical components in a real-time manner.

### Claim 5 (depends on 4)

The device of claim 4, wherein the microcontroller is configured to change progressively the color and/or pattern of one or more display elements on the display as shaking takes place until sufficient shaking has taken place for satisfactory mixing of the pharmaceutical components for delivery.

### Claim 6 (depends on 1)

The device of claim 1, wherein the accelerometer comprises a 3-axis accelerometer.

### Claim 7 (depends on 1)

The device of claim 1, further comprising a start switch electrically connected to the microcontroller.

### Claim 8 (depends on 7)

The device of claim 7, wherein the start switch is configured to activate the microcontroller from a power conservation mode into an active mode upon detection of movement of the housing during one of a drug mixing and administration event, or a training event.

### Claim 9 (depends on 8)

The device of claim 8, wherein the microcontroller is configured, during the power conservation mode, to draw reduced power with respect to the active mode, or no power at all, from the power source.

### Claim 10 (depends on 7)

The device of claim 7, wherein the start switch is the accelerometer.

### Claim 11 (depends on 7)

The device of claim 7, wherein the start switch is separate to the accelerometer.
