Drive mechanisms suitable for use in drug delivery devices

• US 9,827,379 B2
• Filed: 06/30/2014
• Issued: 11/28/2017
• Est. Priority Date: 03/03/2003
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Veasey, Robert Frederick, Perkins, Robert, Plumptre, David Aubrey
• Primary Examiner(s): Gilbert, Andrew
• Application Number:
  US14/319,377
• Publication Number:
  US 20140316374A1
• Time in Patent Office: 1,247 Days
• CPC Class Codes: A61M 2005/2407 from the rear
• 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 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 5/31528 by means of rotational movements, e.g. screw-thread mechanisms
• 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 5/31536 Blocking means to immobilize a selected dose, e.g. to administer equal doses
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: A61M 5/31551 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 5/31563 interacting with a displaceable stop member
• 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 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31578 based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: A61M 5/31593 : Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/32 : Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

Abstract

A drive mechanism suitable for use in drug delivery devices is disclosed. The drive mechanism may be used with injector-type drug delivery devices, such as those permitting a user to set the delivery dose. The drive mechanism may include a housing, a dose dial sleeve, and a drive sleeve. A clutch is configured to permit rotation of the drive sleeve and the dose dial sleeve with respect to the housing when the dose dial sleeve and drive sleeve are coupled through the clutch. Conversely, when the dose dial sleeve and drive sleeve are in a de-coupled state, rotation of the dose dial sleeve with respect to the housing is permitted and rotation of the drive sleeve with respect to the housing is prevented. In the de-coupled state, axial movement of the drive sleeve transfers force in a longitudinal direction for actuation of a drug delivery device.

Claims

1. A drive mechanism for use in a drug delivery device comprising:

a housing;

a dose dial sleeve;

a drive sleeve releasably connected to the dose dial sleeve;

a piston rod engaged with the drive sleeve;

a clutch located between the dose dial sleeve and the drive sleeve, where the clutch is rotationally fixed and axially slidable relative to the drive sleeve, and wherein the clutch comprises a plurality of teeth; and

a dose button,

wherein the dose dial sleeve is configured to rotate relative to the dose button and the drive sleeve during dose delivery.

2. The drive mechanism of claim 1 further characterized in that the dose button is “

T”

shaped and comprises a stem, a head, and a skirt.

3. The drive mechanism of claim 2 where the piston rod has a receiving access at a distal end configured to accept the stem of the dose button.

4. The drive mechanism of claim 2 where the stem extends through an inner diameter of the drive sleeve and is retained for limited axial movement within the drive sleeve.

5. The drive mechanism of claim 2 where the stem is retained against rotation with respect to the drive sleeve.

6. The drive mechanism of claim 2 further comprising a dose dial grip rotationally fixed relative to the dose dial sleeve and configured to accept the skirt when the dose button is in the dose delivery position.

7. The drive mechanism of claim 1 where the dose button engages the clutch to move the clutch proximally in an axial direction when the dose button moves from the dose setting position to the dose delivery position.

8. The drive mechanism of claim 6 where the stem extends through an opening in the dose dial grip and through an extension in the drive sleeve and into a receiving recess of the piston rod when the dose button is in the dose setting position.

9. The drive mechanism of claim 1, wherein the piston rod is threadedly engaged with the drive sleeve.

10. The drive mechanism of claim 1, wherein the dose dial sleeve is threadedly engaged with the housing.

11. The drive mechanism of claim 1, wherein the clutch comprises a plurality of one-way ratchet teeth.

12. A drive mechanism for use in a drug delivery device

comprising:

a housing;

a dose dial sleeve;

a drive sleeve releasably connected to the dose dial sleeve;

a piston rod engaged with the drive sleeve;

a clutch located between the dose dial sleeve and the drive sleeve, where the clutch is rotationally fixed and axially slidable relative to the drive sleeve; and

a dose button configured to engage the drive sleeve in a dose setting position and in a dose delivery position, where the dose button is biased distally in the dose setting position by a spring.

13. A method of setting and delivering a dose of medicament comprising:

providing a drug delivery device having a drive mechanism comprising

a housing,

a dose dial sleeve,

a drive sleeve releasably connected to the dose dial sleeve,

a piston rod engaged with the drive sleeve,

a clutch located between the dose dial sleeve and the drive sleeve, where the clutch is rotationally fixed and axially slidable relative to the drive sleeve, and wherein the clutch comprises a plurality of teeth,

a “

T”

shaped dose button comprising a stem, a head, and a skirt, and

a dose dial grip rotationally fixed relative to the dose dial sleeve and configured to accept the skirt when the dose button is in the dose delivery position;

rotating the dose dial grip to cause the dose dial sleeve to rotate and translate axially away from the housing in a distal direction while simultaneously rotating the clutch and the drive sleeve relative to the housing causing the stem of the dose button to disengage from a receiving recess in the piston rod that remains axially and rotationally fixed relative to the housing;

continuing rotating the dose dial grip until a desired dose of medicament is set;

exerting an axial force on the dose button in a proximal direction to overcome a distal biasing force exerted by a spring on the dose button moving the dose button from the dose setting position to the dose delivery position and causing disengagement of the clutch from the dose dial sleeve to allow the dose dial sleeve and dose dial grip to rotate and translate proximally relative to the clutch and drive sleeve; and

continuing exerting the axial force on the dose button causing the clutch and drive sleeve to move axially in the proximal direction without rotation and causing the piston rod to rotate and translate proximally relative to the housing to deliver the set dose while returning the dose button to the dose setting position.