Drive mechanisms suitable for use in drug delivery devices

• US 9,604,008 B2
• Filed: 06/30/2014
• Issued: 03/28/2017
• Est. Priority Date: 03/03/2003
• Status: Expired due to Term

• 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:
  US14/319,388
• Publication Number:
  US 20140316348A1
• Time in Patent Office: 1,002 Days
• US Class Current: 1/1
• 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 comprising a helical thread;

a dose dial sleeve having a threaded surface that is engaged with the helical thread of the housing,

an insert provided in the housing, where the insert has a threaded circular opening;

a drive sleeve releasably connected to the dose dial sleeve and having an internal helical thread;

a piston rod having a first thread and a second thread, wherein the first thread is engaged with the threaded circular opening of the insert and the second thread is engaged with the internal helical thread of the drive sleeve; and

a clutch located between the dose dial sleeve and the drive sleeve, wherein the clutch is located (i) radially outward of the drive sleeve and (ii) radially inward of the dose dial sleeve.

2. The drive mechanism of claim 1, wherein the drive sleeve comprises a threaded outer surface, the drive mechanism further comprising a limiting nut being threadedly engaged with the threaded outer surface of drive sleeve, where the limiting nut is rotationally fixed and slidable relative to the housing.

3. The drive mechanism of claim 1, wherein the insert is secured in the housing against rotational and longitudinal motion.

4. The drive mechanism of claim 2, wherein the limiting nut translates distally along the threaded outer surface relative to two radially extending flanges as the drive sleeve is rotated during dose setting.

5. The drive mechanism of claim 2, wherein the threaded outer surface of the drive sleeve is located between two radially extending flanges.

6. The drive mechanism of claim 1, wherein the housing comprises a window insert at a distal end of the housing, where the distal end of the housing has the helical thread, where the window insert is rotationally fixed relative to the housing.

7. The drive mechanism of claim 1, wherein the threaded surface of the dose dial sleeve has a first lead.

8. The drive mechanism of claim 7, wherein the first thread of the piston rod has a second lead.

9. The drive mechanism of claim 8, wherein the internal drive sleeve thread has a lead equal to the first lead.

10. The drive mechanism of claim 1, where the clutch is rotationally fixed to the drive sleeve and dose dial sleeve during dose setting.

11. The drive mechanism of claim 1, wherein the helical thread of the housing is an internal helical thread and the dose dial sleeve has a threaded outer surface that is engaged with the internal helical thread of the housing.

12. The drive mechanism of claim 1 where the piston rod rotates and translates axially in a proximal direction relative to and through the threaded circular opening during dose delivery.

13. The drive mechanism of claim 6 where the window insert comprises a frame having a stop that is configured to engage a stop on the dose dial sleeve when a predetermined maximum dose is set by rotation of the dose dial sleeve.

14. The drive mechanism of claim 9 where the ratio of leads of the first thread of the piston rod to the second thread of the piston rod is in the range from about 1:

1.01 to 1;

20.

15. The drive mechanism of claim 9 where the ratio of leads of the first thread of the piston rod to the second thread of the piston rod is in the range from about 1:

1.1 to 1;

10.

16. The drive mechanism of claim 1 where the second thread of the piston rod is a part thread.

17. The drive mechanism of claim 1 where the first and second threads of the piston rod are oppositely disposed.

18. The drive mechanism of claim 1 where the first thread and the second thread of the piston rod are configured such that the piston rod is prevented from rotating during dose setting.

19. The drive mechanism of claim 1 where the drive sleeve is configured to rotate and climb the piston rod at a rate equal to a rate of rotation of the dose dial sleeve when the dose dial sleeve is rotated to set a dose.