Drug delivery device including motion detection system

• US 10,765,808 B2
• Filed: 07/15/2019
• Issued: 09/08/2020
• Est. Priority Date: 12/01/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Day, Shane Alistair, De Sausmarez Lintell, Daniel Thomas, Wimpenny, Steven, Jones, Christopher, O'Hare, Aidan Michael, Yates, Barry, Veasey, Robert Frederick, Smith, Christopher James, Boyd, Malcolm, Leak, David Martin, Keating, Carmen Patricia, Sanders, David, Marshall, Elizabeth Anne
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US16/512,127
• Publication Number:
  US 20200023129A1
• Time in Patent Office: 421 Days
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2411 from the front
• CPC Class Codes: A61M 2005/2496 via pivot
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 : Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31511 : Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31525 : Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31546 : Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: A61M 5/31583 : based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
• CPC Class Codes: A61M 5/3202 : Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3294 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3295 : Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
• CPC Class Codes: A61M 5/347 : rotatable, e.g. bayonet or screw A61M5/344 takes precedence

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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

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

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

12. 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.

13. 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.

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

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

16. 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.

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

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.