Device and method for delivery of two or more drug agents

• US 10,350,355 B2
• Filed: 08/24/2016
• Issued: 07/16/2019
• 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, Smith, Christopher James, Boyd, Malcolm, Leak, David Martin, Keating, Carmen Patricia, Sanders, David, Marshall, Elizabeth Anne
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US15/245,821
• Publication Number:
  US 20160361495A1
• Time in Patent Office: 1,056 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. An injection device comprising:

a primary reservoir containing multiple doses of a primary medicament;

a secondary reservoir containing multiple doses of a fluid agent that is different than the primary medicament;

an electro-mechanical drive system operatively engaged with both the primary reservoir and the secondary reservoir;

a single dispense assembly in fluid communication with the primary reservoir and the secondary reservoir simultaneously;

a predetermined therapeutic dose profile stored in memory of the injection device that correlates doses of the primary medicament with doses of the fluid agent; and

a control unit operably coupled to the electro-mechanical drive system and a human interface,

where the control unit is configured to;

receive a value for or a selection of a value for a set dose of the primary medicament entered through the human interface,

determine a single dose of the fluid agent based on a comparison of the value for the set dose of the primary medicament with the predetermined therapeutic dose profile, and

activate the electro-mechanical drive system to expel the set dose of the primary medicament and the single dose of the fluid agent through the single dispense assembly.

2. The injection device of claim 1 wherein the human interface comprises a digital display.

3. The injection device of claim 1 further comprising:

a main body; and

a removable end cap configured to cover the single dispense assembly and configured to have a frictional fit with the main body of the injection device.

4. The injection device of claim 3 further comprising a cartridge holder configured to be removably attached to the main body and configured to hold two cartridges.

5. The injection device of claim 4 wherein the cartridge holder comprises two cartridge retainers, at least one of the two cartridge retainers including a cartridge detecting system.

6. The injection device of claim 3 further comprising two cartridge retainers hingedly attached to the main body, each configured to hold a cartridge of medicament.

7. The injection device of claim 6 wherein at least one of the two cartridge retainers includes a cartridge detecting system.

8. The injection device of claim 1 wherein the single dispense assembly includes a first inner body comprising:

a first piercing needle in fluid communication with the primary reservoir; and

a second piercing needle in fluid communication with the secondary reservoir.

9. The injection device of claim 8 wherein the single dispense assembly comprises a double ended needle assembly including the first piercing needle and the second piercing needle.

10. The injection device of claim 1 wherein the electro-mechanical drive system is coupled to the primary reservoir by way of a first drive train and to the secondary reservoir by way of a second drive train.

11. The injection device of claim 1 wherein the primary medicament comprises an insulin or an insulin analog and the fluid agent comprises a GLP-1 or a GLP-1 analog.