Device and method for delivery of two or more drug agents

• US 9,457,142 B2
• Filed: 11/29/2010
• Issued: 10/04/2016
• Est. Priority Date: 12/01/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Lintell, Daniel Thomas De Sausmarez, Day, Shane Alistair, 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:
  US13/509,603
• Publication Number:
  US 20120330228A1
• Time in Patent Office: 2,136 Days
• US Class Current: 1/1
• 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 device comprising:

an electro-mechanical drive system operative to expel;

a dose of primary medicament from a primary reservoir containing the primary medicament; and

,

a dose of fluid agent from a secondary reservoir containing the fluid agent, where the fluid agent is not the primary medicament;

a dispense assembly in fluid communication with both the primary and secondary reservoirs; and

a control unit operably coupled to the electro-mechanical drive system and configured to first receive information on a dose of the primary medicament,

wherein said control unit after receiving the information on the dose of primary medicament determines at least one value of the dose of a fluid agent based at least in part on said dose of said primary medicament and a therapeutic dose profile, where the therapeutic dose profile is predetermined and programmed within the device,

wherein the therapeutic dose profile is a non-linear profile of the primary medicament and the fluid agent;

wherein the control unit is configured to activate the electro-mechanical drive system to expel;

the at least one value of a dose of the fluid agent from the secondary reservoir; and

,

the said dose of primary medicament from the primary reservoir;

such that the at least one value of the dose of the fluid agent and the dose of primary medicament are both dispensed through the dispense assembly.

2. The device of claim 1, wherein the control unit comprises a microcontroller and a memory configured to store the therapeutic dose profile.

3. The device of claim 1, wherein the fluid agent is a secondary medicament.

4. The device of claim 1, further comprising an operator interface in communication with said control unit, wherein said information on the dose of the primary medicament is received by the control unit from said operator interface.

5. The device of claim 1, wherein the at least one value of the dose of the fluid agent is a range of values.

6. The device of claim 5, wherein the operator interface is configured to display the range of values of the dose of the fluid agent on a display, and

wherein the control unit is configured to receive a user selection of a dose value within the range of the dose of the fluid agent from the operator interface.

7. The device of claim 1, wherein said control unit is further configured to determine at least one value of a dose of another fluid agent based at least in part on said dose of said primary medicament and said therapeutic dose profile.

8. The device of claim 1, wherein said primary medicament comprises at least one of an insulin and an insulin analog.

9. The device of claim 1, wherein said fluid agent comprises at least one of a GLP-1 and a GLP-1 analog.

10. The device of claim 1, further comprising:

said electro-mechanical drive unit coupled to a primary reservoir containing and a secondary reservoir; and

.

11. The device of claim 10, wherein activation of an injection button causes said electro-mechanical drive unit to dispense said dose of said primary medicament and said dose of said fluid agent through said single dispense assembly.

12. The device of claim 10, wherein said single dispense assembly comprises a first inner body, said first inner body comprising a first piercing needle in fluid communication with said primary reservoir and a second piercing needle in fluid communication with said secondary reservoir, and wherein said single dispense assembly comprises a double ended needle assembly.

13. The device of claim 10, wherein said primary and said secondary reservoirs are contained in at last one multi-dose cartridge comprising a stopper and a pierceable septum.

14. The device of claim 1 further comprising a non-transitory computer readable medium having instructions stored thereon that, in response to execution by the control unit contained in a medical device causes the control unit to perform operations for initiating administration of the dose of primary medicament and the dose of fluid agent in accordance with a therapeutic dose profile, the instructions comprising:

instructions for receiving at the control unit information on a predetermined and preprogramed therapeutic dose profile;

instructions for first receiving at the control unit information on the dose of a primary medicament;

instructions for determining at the control unit after receiving the information on the dose of the primary medicament at least one value of the dose of a fluid agent based at least in part on said information on said dose of said primary medicament and the therapeutic dose profile; and

instructions for initiating administration of said dose of said primary medicament and said dose of said fluid agent in accordance with the therapeutic dose profile,

wherein the therapeutic dose profile is a non-linear profile of the primary medicament and the fluid agent.

15. The device as claimed in claim 1 wherein the electro-mechanical drive system is mechanically and operably coupled to:

a first piston rod associated with the primary reservoir; and

;

a second piston rod associated with the secondary reservoir;

wherein the control unit activates the electro-mechanical drive system to move both;

the first piston rod an axial distance within the primary reservoir to dispense the dose of primary medicament; and

,

the second piston rod an axial distance within the secondary reservoir to dispense the at least one value of a dose of the fluid agent.