Medicated Module for Administering Fixed Dose

• US 20130218089A1
• Filed: 10/31/2011
• Published: 08/22/2013
• Est. Priority Date: 11/03/2010
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Davies, James Alexander, Draper, Paul Richard, Wimpenny, Steven
• Granted Patent: US 9,180,253 B2
• Time in Patent Office: Days
• US Class Current: 604/191
• CPC Class Codes: A61M 2005/1787 Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 2005/31516 reducing dead-space in the syringe barrel after delivery
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/283 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3294 comprising means for injection of two or more media, e.g. by mixing

Abstract

A medicated module attachable to a drug delivery device. The medicated module comprises a housing configured for attachment to a drug delivery device. The drug delivery device comprises a first medicament. A collapsible reservoir is contained within the housing. A pre-determined volume of a second medicament is contained within the reservoir. A needle arrangement is configured within the housing and the needle arrangement is arranged in fluid communication with the collapsible reservoir. A needle shroud may be configured, such that, during an injection step, the shroud acts on the reservoir to inject the second medicament.

Claims

1. A medicated module for use with a drug delivery device, said medicated module comprising:

a housing configured for attachment to said drug delivery device, said drug delivery device comprising a first medicament;

a collapsible reservoir contained within said housing;

a pre-determined volume of a second medicament contained within said collapsible reservoir;

a needle arrangement configured within said housing, said needle arrangement arranged in fluid communication with said collapsible reservoir and said drug delivery device; and

a needle shroud configured partially within said housing;

wherein, said needle shroud is configured to compress said collapsible reservoir to dispense said second medicament through said needle arrangement.

2. The medicated module of claim 1, wherein, during dispense, said second medicament is dispensed before a first dose of said first medicament contained within said drug delivery device.

3. The medicated module of claim 2, wherein said first dose of said first medicament contained within said drug delivery device comprises a fixed dose.

4. The medicated module of claim 2, wherein said first dose of said first medicament comprises a variable dose.

5. The medicated module of claim 1, wherein said pre-determined volume of said second medicament contained within said collapsible reservoir comprises a fixed dose of said second medicament.

6. The medicated module of claim 1, wherein said housing is configured for permanent attachment to said drug delivery device.

7. The medicated module of claim 1, wherein said shroud is biased within said housing.

8. The medicated module of claim 7, wherein said shroud is biased within said housing by a spring.

9. The medicated module of claim 1, wherein a portion of said shroud comprises a tubular shape so that said tubular shape substantially conceals a portion of said needle arrangement.

10. The medicated module of claim 1, wherein said needle arrangement comprises

a first needle in fluid communication with said collapsible reservoir, and

a second needle in fluid communication with both said first medicament contained within said drug delivery device and said collapsible reservoir.

11. The medicated module of claim 1, wherein said needle arrangement comprises a single unitary needle configured to be in fluid communication with both the first and second medicaments;

wherein said single unitary needle comprises (i) a proximal piercing end configured for fluid communication with the drug delivery device;

(ii) a distal piercing end configured for injection;

(iii) and at least one side-cored hole located inside said collapsible reservoir;

wherein the at least one hole is arranged to facilitate the flow of medicament from the collapsible reservoir on retraction of the needle shroud.

12. The medicated module of claim 11 wherein, the at least one side-cored hole is located just below the top piercing member of the collapsible reservoir.

13. The medicated module of claim 11 wherein, on retraction of the shroud the sealed reservoir slides up along the needle and the medicament is expelled.

14. The medicated module of claim 1, wherein said second medicament comprises a GLP-1 or GLP-1 analog.

15. The medicated module of claim 1, wherein said drug delivery device comprises a pen injector.