Delivery of two or more medicaments through a single dose selection and dispense interface

• US 9,592,342 B2
• Filed: 06/01/2010
• Issued: 03/14/2017
• Est. Priority Date: 06/02/2009
• Status: Expired due to Fees

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: De Sausmarez Lintell, Daniel Thomas, Boyd, Malcolm Stanley, Leak, David Martin, Keating, Carmen Patricia, Sanders, David, Marshall, Elizabeth Anne, Graham, Jay, MacArthur, Ross Douglas Laurie, Heald, Michael James, Smith, Christopher James, Ortiz, Elliot Lucas
• Primary Examiner(s): Bouchelle, Laura
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US13/375,525
• Publication Number:
  US 20120136334A1
• Time in Patent Office: 2,478 Days
• Field of Search: 604/86, 604/87, 604/203, 604/88, 604/191, 604/59, 604/60
• US Class Current: 1/1
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 15/0035 Piercing means
• CPC Class Codes: A61M 2005/1787 Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2455 with sealing means to be broken or opened
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/3294 comprising means for injection of two or more media, e.g. by mixing

Abstract

An injection system for co-delivery of two medicaments (1, 2) having a drug delivery device (7) containing a primary reservoir (11) containing a first medicament (1) and having a secondary reservoir (5, 17, 30) containing a second medicament (2) where the drug delivery device (7) has only one dose setter (12) for the primary reservoir (11) and that automatically determines the dose of the second medicament (2). Both medicaments (1, 2) are delivered through a single dispense interface (3, 16, 21, 31).

Claims

1. A drug delivery system operable to deliver a first medicament and a second medicament through a single dispense interface, comprising:

a primary drug delivery device comprising;

a primary reservoir containing the first medicament, wherein the first medicament comprises at least one first drug agent, and wherein the primary reservoir comprises a pierceable seal, and

a dose button operably connected to the primary reservoir; and

a medicated module configured to be attached to a distal end of the primary drug delivery device, the medicated module comprising;

an engagement interface configured such that attachment of the medicated module to the distal end of the primary drug delivery device causes the engagement interface to pierce the pierceable seal of the primary reservoir,

a dispense interface configured for fluid communication with the primary reservoir via the engagement interface, and

a secondary reservoir containing the second medicament, wherein the second medicament comprises at least one second drug agent, and wherein the secondary reservoir is configured for fluid communication with the dispense interface,

wherein the medicated module is configured such that when the medicated module is attached to the distal end of the primary drug delivery device, a single activation of the dose button causes the first medicament from the primary reservoir and a non-user settable dose of the second medicament to be expelled through the dispense interface, and

where the single activation of the dose button causes the first medicament from the primary reservoir to be expelled through the dispense interface after a therapeutic dose of the non-user settable dose of second medicament has been expelled through the dispense interface.

2. The system of claim 1 comprising a housing containing a single dose setter operably connected to the primary reservoir of the first medicament.

3. The system of claim 1, where at least one of the secondary reservoir and the primary reservoir contains a single dose.

4. The system of claim 1 where at least one of the primary reservoir and the secondary reservoir contains a liquid medicament.

5. The system of claim 1 where at least one of the primary reservoir and the secondary reservoir contains multiple doses of medicament.

6. The system of claim 1 where the dispense interface is a hollow needle.

7. The system of claim 1 where the medicated module is disposable and replaceable with a replacement module containing a new secondary reservoir of medicament and a new dispense interface.

8. The system of claim 7 where the medicated module contains a safety shield.

9. The system of claim 1 where at least one of the primary reservoir and the secondary reservoir is replaceable.

10. The system of claim 1 where at least one of the primary reservoir and the secondary reservoir is in fluid communication with the dispense interface.

15. The system of claim 1, wherein the engagement interface comprises a needle.

11. A method of dispensing a first medicament and a second medicament from separate reservoirs, comprising, in combination, the steps of:

providing a primary drug delivery device comprising;

a primary reservoir containing the first medicament, wherein the first medicament comprises at least one first drug agent, and

a dose button operably connected to the primary reservoir;

providing a medicated module configured to be attached to a distal end of the primary drug delivery device, the medicated module comprising;

a dispense interface configured for fluid communication with the primary reservoir, and

a secondary reservoir containing the second medicament, wherein the second medicament comprises at least one second drug agent, and wherein the secondary reservoir is configured for fluid communication with the dispense interface;

attaching the medicated module to the distal end of the primary drug delivery device;

activating the dose button, wherein activation of the dose button causes the first medicament from the primary reservoir and a non-user settable dose of the second medicament from the secondary reservoir to be expelled through the dispense interface, and

where the activation of the dose button causes the first medicament from the primary reservoir to be expelled through the dispense interface after a therapeutic dose of the non-user settable dose of second medicament has been expelled through the dispense interface.

12. A method of dispensing a non-user settable dose of a second medicament and a dose of a first medicament from separate reservoirs, comprising, in combination, the steps of:

a) setting a dose of the first medicament contained in a primary reservoir using a single dose setter of a primary drug delivery device, the primary reservoir comprising a pierceable seal;

b) attaching a medicated module to a distal end of the primary drug delivery device,

wherein attachment causes a dispense interface to pierce the pierceable seal of the primary reservoir, and

wherein the medicated module comprises a secondary reservoir containing the second medicament;

c) moving the set dose of the first medicament from the primary reservoir causing it to flow in a distal direction; and

d) expelling the set dose of the first medicament through the dispense interface of the medicated module after expulsion of a therapeutic dose of a non-user settable dose of the second medicament through the dispense interface of the medicated module.

13. The method of claim 12, wherein expelling the set dose of the first medicament from the primary reservoir simultaneously forces the non-user settable dose of the second medicament through the dispense interface.

14. The method of claim 12, wherein at least 80% of the second medicament is expelled through the dispense interface.