# US 10,765,808 B2 · Drug delivery device including motion detection system

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- Number: US 10,765,808 B2
- Document ID: US10765808B2
- Status: Granted
- Kind: B2
- Application number: 16/512,127
- Filed: 2019-07-15
- Published: 2020-01-23
- Granted: 2020-09-08
- Earliest claimed: 2009-12-01
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Sanofi-Aventis Deutschland GmbH
- Inventors: Shane Alistair Day; Daniel Thomas De Sausmarez Lintell; Steven Wimpenny; Christopher Jones; Aidan Michael O'Hare; Barry Yates; Robert Frederick Veasey; Christopher James Smith; Malcolm Boyd; David Martin Leak; Carmen Patricia Keating; David Sanders; Elizabeth Anne Marshall
- Web page: https://patentgrep.com/patent/US10765808B2

## CPC

- A61M 5/19: having more than one chamber
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/14248: {of the skin patch type}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/31525: {Dosing (burettes, pipettes B01L3/02)}
- A61M 5/31546: {Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 5/3294: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/3295: {Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel}
- A61M 5/347: {rotatable, e.g. bayonet or screw (A61M5/344 takes precedence)}
- A61M 5/31583: {the piston rod being moved by the rotational movement of a component directly in contact with it}
- A61M 2005/2407: {from the rear}
- A61M 2005/2411: {from the front}
- A61M 2005/2496: {via pivot}
- A61M 2005/3126: {related to dosing}
- A61M 2005/31518: {designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members}
- A61M 2005/31588: {electrically driven}
- A61M 2205/14: Detection of the presence or absence of a tube, a connector or a container in an apparatus
- A61M 2205/3306: Optical measuring means
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/6063: Optical identification systems
- A61M 2205/6072: Bar codes
- A61M 2205/8206: battery-operated
- 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 computerized electro-mechanical drug delivery device configured to deliver at least one dose of two or more medicaments. The device comprises a control unit. An electro-mechanical drive unit is operably coupled to the control unit and a primary reservoir for a first medicament and a secondary reservoir for a fluid agent, e.g. a second medicament. An operator interface is in communication with the control unit. A single dispense assembly is configured for fluid communication with the primary and the secondary reservoir. Activation of the operator panel sets a first dose from the primary reservoir and based on the first dose and a therapeutic dose profile, the control unit is configured to determine a dose or range of the fluid agent. Alternatively, the control unit determines or calculates a dose or range of a third medicament. Further, a dispense interface for use with a drug delivery device is disclosed.

## Claims

### Claim 1

A drug delivery device comprising:
a motor configured to advance a stopper in a cartridge of medicament, the motor comprising a rotatable output shaft and a pinion attached to the output shaft;
a cartridge retainer configured to receive the cartridge of medicament, the cartridge retainer moveable between an open position and a closed position;
a controller;
a motion detection system configured to provide positional feedback to the controller, wherein the motion detection system comprises an optical encoder and at least one element operatively coupled to the pinion of the motor and configured to rotate with the pinion such that the at least one element passes through the optical encoder; and
one or more switches configured to detect or confirm whether the cartridge retainer has been properly closed.

### Claim 2 (depends on 1)

A drug delivery device according to claim 1, wherein the optical encoder is configured to send electrical pulses to the controller as the at least one element passes through the optical encoder.

### Claim 3 (depends on 1)

A drug delivery device according to claim 1, wherein the at least one element is a plurality of elements symmetrically spaced around a cylindrical axis of the pinion.

### Claim 4 (depends on 1)

A drug delivery device according to claim 1, wherein the controller is configured to monitor rotation of the output shaft and to detect a position error of the motor.

### Claim 5 (depends on 1)

A drug delivery device according to claim 1, wherein the controller is configured to monitor rotation of the output shaft and to detect a jamming of a drive train of the drug delivery device.

### Claim 6 (depends on 1)

A drug delivery device according to claim 1, wherein the controller is configured to monitor rotation of the output shaft and to detect a blocked needle event.

### Claim 7 (depends on 1)

A drug delivery device according to claim 1, wherein the at least one element comprises a plurality of flags protruding radially from the pinion of the motor.

### Claim 8 (depends on 7)

A drug delivery device according to claim 7, wherein the optical encoder comprises an emitter and a detector, and wherein each of the plurality of flags is configured to interrupt a signal between the emitter and detector as it passes through the optical encoder.

### Claim 9 (depends on 7)

A drug delivery device according to claim 7, wherein the plurality of flags comprises at least a first flag and a second flag.

### Claim 10 (depends on 1)

A drug delivery device according to claim 1, wherein the motor is a stepper motor.

### Claim 11 (depends on 1)

A drug delivery device according to claim 1, wherein the motor is a brushless DC motor.

### Claim 12 (depends on 1)

A drug delivery device according to claim 1, wherein the drug delivery device further comprises at least one switch configured to determine a position of the stopper in the cartridge of medicament.

### Claim 13 (depends on 1)

A drug delivery device according to claim 1, wherein the motor is configured to advance the stopper in the cartridge of medicament via a piston rod that is mechanically linked to the motor, the piston rod being moveable between a first fully withdrawn position and a second fully extended position.

### Claim 14 (depends on 13)

A drug delivery device according to claim 13, wherein a rotational movement of the motor causes a distal movement of the piston rod.

### Claim 15 (depends on 13)

A drug delivery device according to claim 13, wherein the piston rod exerts a force on the stopper in the cartridge of medicament.

### Claim 16 (depends on 13)

A drug delivery device according to claim 13, wherein the drug delivery device further comprises an end stop switch configured to detect when the piston rod is in the first fully withdrawn position.

### Claim 17 (depends on 1)

A drug delivery device according to claim 1, wherein the drug delivery device is a portable, ambulatory device.

### Claim 18

A method of operating a drug delivery device comprising: a motor including a rotatable output shaft and a pinion attached to the output shaft; a cartridge retainer configured to receive the cartridge of medicament, the cartridge retainer moveable between an open position and a closed position; a controller; and a motion detection system including an optical encoder and at least one element operatively coupled to the pinion of the motor and configured to rotate with the pinion such that the at least one element passes through the optical encoder; and one or more switches configured to detect or confirm whether the cartridge retainer has been properly closed, the method comprising:
the one or more switches detecting or confirming that the cartridge retainer has been properly closed;
the optical encoder sending electrical pulses to the controller as the at least one element passes through the optical encoder; and
the controller monitoring rotation of the output shaft via the electrical pulses and detecting a position error of the motor or a jamming of a drive train of the drug delivery device.
