Drug delivery device dose setting mechanism

• US 9,205,197 B2
• Filed: 01/22/2009
• Issued: 12/08/2015
• Est. Priority Date: 09/14/2006
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Dette, Christoph, Jansen, Paul, Pommereau, Christian, Veasey, Robert Frederick, Perkins, Robert, Plumptre, David Aubrey
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US12/357,899
• Publication Number:
  US 20090264828A1
• Time in Patent Office: 2,511 Days
• Field of Search: 604/189, 604207-211, 604/224, 604/246
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• 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 5/31533 Dosing mechanisms, i.e. setting a dose administrating mechanisms A61M5/31565
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31565 Administration mechanisms, i.e. constructional features, modes of administering a dose dosing mechanisms for setting a dose A61M5/31533
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• 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

Abstract

A method and system for proving a drug delivery device. The device comprises a drug delivery device housing and a medicament contained in the drug delivery device housing. A dose dial sleeve is positioned in the housing and is rotatable to set a non-inverted dose of the medicament contained in the medical delivery device. The non-inverted dose may be increased by turning the dose dial sleeve in a direction towards a user of the drug delivery device. The dose medicament may be decreased by rotating the dose dial sleeve in a direction away from the user.

Claims

1. A drug delivery device, said device comprising:

a drug delivery device housing;

a medicament contained in said drug delivery device housing;

a dose dial sleeve comprising a scale arrangement that is provided for setting a dose, said dose dial sleeve positioned radially inward of said drug delivery device housing and in threaded engagement with said drug delivery device housing;

a piston rod comprising a first end and a second end, a first helical groove extending from the first end allowing a helical movement of the piston rod with respect to the housing, and a second helical groove extending from the second end and having a same lead as a threaded engagement of the dose dial sleeve with the housing; and

a drive sleeve comprising a helical groove engaging the second helical groove of the piston rod, the drive sleeve being prevented from rotating with respect to the housing during drug delivery;

a dose dial sleeve comprising a scale arrangement that is provided for setting a dose, said dose dial sleeve positioned radially inward of said drug delivery device housing and in threaded engagement with said drug delivery device housing,

the dose dial sleeve and the drive sleeve being releasably rotationally locked to one another for dialing a dose;

said dose dial sleeve rotatable out of said drug delivery device housing so that said scale arrangement is rotated to set a dose of said medicament contained in said drug delivery device;

wherein said dose may be increased by turning said dose dial sleeve in a direction clockwise in relation to a longitudinal axis of the drug delivery device when viewed from a position looking from a proximal end of the drug delivery device to a distal end of the drug delivery device along the longitudinal axis;

wherein said scale arrangement comprises a plurality of numerical values representative of said dose, the plurality of numerical values being helically arranged,

wherein said plurality of numerical values increase from a minimum value near a proximal end of said dose dial sleeve to a maximum value near a distal end of said dose dial sleeve,

wherein, when a user reads said plurality of numerical values from left to right along a surface of said dose dial sleeve from said proximal end of said dose dial sleeve to said distal end of said dose dial sleeve, said plurality of numerical values increase, are in a normal vertically readable orientation and are not inverted,

wherein said plurality of numerical values increase when said dose dial sleeve is turned in the clockwise direction;

wherein said dose dial sleeve translates out of said drug delivery device housing during a dose setting operation; and

wherein said dose dial sleeve translates back into said drug delivery device housing during dose administration.

2. The invention of claim 1 wherein said dose of said medicament may be decreased by rotating said dose dial sleeve in a direction counter-clockwise in relation to a longitudinal axis of the drug delivery device when viewed from a position looking from a proximal end of the drug delivery device to a distal end of the drug delivery device along the longitudinal axis.

3. The invention of claim 1 wherein said drug delivery device housing further comprises a label, said label representative of said medicament contained in said drug delivery device, said label comprising non-inverted text and readable by said user as said user sets said dose of medicament, wherein the non-inverted text is in a normal vertically readable orientation when a user reads said non-inverted text from left to right along the drug delivery device housing from a proximal end of said drug delivery device housing to a distal end of said drug delivery device housing.

4. The invention of claim 1 wherein said drug delivery device housing further includes a viewing window such that during said dose setting operation, said scale arrangement representative of said dose is viewable through said viewing window.

5. The invention of claim 1 wherein said drug delivery device is a disposable drug delivery device.

6. The invention of claim 1 wherein said drug delivery device is a reusable drug delivery device.

7. The invention of claim 1 wherein when said user injects said dose, said dose dial sleeve rotates back into said drug delivery device housing and in a direction counter-clockwise in relation to a longitudinal axis of the drug delivery device when viewed from a position looking from a proximal end of the drug delivery device to a distal end of the drug delivery device along the longitudinal axis.

8. The invention of claim 1 wherein said medicament contained in said drug delivery device is insulin.

9. The invention of claim 8 wherein said insulin comprises a long acting insulin.

10. The invention of claim 1 wherein said medicament contained in said drug delivery device is contained in a cartridge.

11. The invention of claim 10 wherein said cartridge is a removable cartridge.

12. The invention of claim 1 further comprising a colored portion, said colored portion indicating that said user sets said dose of medicament of said drug delivery device by rotating said dose dial sleeve in the direction clockwise in relation to the longitudinal axis.

13. The invention of claim 12 wherein said colored portion is provided on a label.

14. The invention of claim 12 wherein said colored portion is provided on said drug delivery device housing.

15. A pen type drug delivery device comprising:

a drug delivery device housing, said drug delivery device housing having a distal end for mounting a needle assembly and a proximal end;

a dose dial grip;

a cartridge contained in said drug delivery device housing, said cartridge containing a medication;

a dose dial sleeve comprising a scale and situated radially inward of said drug delivery device housing;

a piston rod comprising a first end and a second end,

a first helical groove extending from the first end allowing a helical movement of the piston rod with respect to the housing, and

a second helical groove extending from the second end and having a same lead as a threaded engagement of the dose dial sleeve with the housing;

a drive sleeve comprising a helical groove engaging the second helical groove of the piston rod, the drive sleeve being prevented from rotating with respect to the housing during drug delivery;

a dose dial sleeve comprising a scale and situated radially inward of said drug delivery device housing,

the dose dial sleeve and the drive sleeve being releasably rotationally locked to one another for dialing a dose;

said dose dial sleeve threaded and rotatably mounted in said drug delivery device housing and operatively coupled to said dose dial grip,

such that said dose dial grip may be rotated in a direction towards a user and clockwise in relation to a longitudinal axis of said pen type drug delivery device when viewed from a proximal end of the drug delivery device housing along a longitudinal axis to a distal end of the drug delivery device housing, a user of said pen type drug delivery device can set a dose of said medication such that,

wherein as said dose dial grip is rotated, both said dose dial grip and said dose dial sleeve translate away from said proximal end of said drug delivery device housing, and

the scale viewable in a window of said drug delivery device housing in a non-inverted orientation, said scale representative of said dose set by said user,

wherein said dose dial sleeve rotates back into said drug delivery device housing during dose injection, and

wherein said scale comprises a plurality of numerical values representative of said dose set by said user, the plurality of numerical values being helically arranged, wherein the scale is provided for setting a dose, wherein said plurality of numerical values increase from a minimum value near a proximal end of said dose dial sleeve to a maximum value near a distal end of said dose dial sleeve, wherein, when a user reads said plurality of numerical values from left to right along a surface of said dose dial sleeve from said proximal end of said dose dial sleeve to said distal end of said dose dial sleeve, said plurality of numerical values increase, are in a normal vertically readable orientation and are not inverted, wherein said plurality of numerical values increase when said dose dial grip is turned in the clockwise direction.

16. The invention of claim 15 wherein said dose may be decreased by turning said dose dial grip in a counter-clockwise direction.

17. The invention of claim 15 wherein during an injection of said set dose, said dose dial sleeve rotates back into said proximal end of said drug delivery device housing and rotates in a counter-clockwise direction.

18. The invention of claim 17 wherein during said injection of said set dose, said scale is viewable in the window of said drug delivery device housing.

19. The invention of claim 15 wherein said drug delivery device housing further comprises a label, said label comprising text that is viewable by said user in a normal vertically readable and non-inverted orientation as said user sets said dose of medication and when a user reads said text from left to right along the drug delivery device housing from the proximal end of said drug delivery device housing to the distal end of said drug delivery device housing.

20. A drug delivery device, comprising:

a housing having a distal end provided for mounting a needle assembly and a proximal end;

a dose setting mechanism arranged in the housing;

a dose dial sleeve of the dose setting mechanism, the dose dial sleeve being in threaded engagement with the housing and comprising a scale arrangement;

a piston rod comprising a first end and a second end,

a first helical groove extending from the first end allowing a helical movement of the piston rod with respect to the housing, and

a second helical groove extending from the second end and having a same lead as a threaded engagement of the dose dial sleeve with the housing;

a drive sleeve comprising a helical groove engaging the second helical groove of the piston rod, the drive sleeve being prevented from rotating with respect to the housing during drug delivery;

a dose dial sleeve of the dose setting mechanism, the dose dial sleeve being in threaded engagement with the housing and comprising a scale arrangement,

the dose dial sleeve and the drive sleeve being releasably rotationally locked to one another for dialing a dose;

wherein said scale arrangement comprises a plurality of numerical values representative of a dose, the plurality of numerical values being helically arranged, wherein the scale arrangement is provided for setting a dose,

wherein said plurality of numerical values progress from a first value near a proximal end of said dose dial sleeve to a second value near a distal end of said dose dial sleeve, wherein, when a user reads said plurality of numerical values from left to right along a surface of said dose dial sleeve from said proximal end of said dose dial sleeve to said distal end of said dose dial sleeve, said plurality of numerical values progress, are in a normal vertically readable orientation and are not inverted, wherein said plurality of numerical values progress when said dose dial sleeve is turned in the clockwise direction;

a dose dial grip coupled to the dose dial sleeve, the dose dial grip projecting from the proximal end; and

a window in the housing showing part of the scale arrangement.

21. The drug delivery device according to claim 20, wherein

the scale arrangement comprises a helical column of numerals arranged in a sequence progressing from left to right when a user reads said plurality of numerical values from left to right along a surface of said dose dial sleeve from said proximal end of said dose dial sleeve to said distal end of said dose dial sleeve.