Drive mechanisms suitable for use in drug delivery devices

Patent metadata

Field	Value
Publication number	US-10653841-B2
Application number	US-201916528080-A
Country	US
Kind code	B2
Filing date	Jul 31, 2019
Priority date	Mar 3, 2003
Publication date	May 19, 2020
Grant date	May 19, 2020

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.

First claim

The invention claimed is:

1. A drug delivery device comprising:
an elongate outer housing comprising a dose dispensing end and a first thread;
a dose indicator comprising an elongate tubular body with a second thread configured to engage the first thread;
a sleeve that is (i) disposed radially inward of the dose indicator and (ii) configured to be engaged with the dose indicator;
a first clicker feature comprising a flexible arm and a tooth; and
a second clicker feature spaced axially apart from the first clicker feature and comprising teeth;

wherein:
the dose indicator is disposed between the housing and the sleeve and is configured to (i) rotate and traverse axially away from the dose dispensing end during dialing up of a dose of medicament and (ii) rotate and traverse axially towards the dose dispensing end during dialing down of a dose of medicament and during dose dispensing;
the first clicker feature is configured to traverse axially as a dose of medicament is dialed up, dialed down, and dispensed, and the first clicker feature is configured to provide audible clicks by dragging the tooth over splines of the drug delivery device;
the second clicker feature is configured to traverse axially as a dose of medicament is dialed up, dialed down, and dispensed, and the second clicker feature is configured to (i) produce audible clicks by contacting the sleeve and (ii) to produce audible clicks as a dose of medicament is dialed down and not produce audible clicks as a dose of medicament is dialed up; and
the sleeve is configured to traverse axially with the dose indicator.

2. The drug delivery device of claim 1 , comprising an elongate piston member comprising a third thread.

3. The drug delivery device of claim 2 , comprising a piston member holder that is fixed relative to the housing and configured to (i) prevent the piston member from rotating during dialing up and dialing down of a dose of medicament and (ii) permit the piston member to traverse axially towards the dose dispensing end during dose dispensing.

4. The drug delivery device of claim 2 , wherein the piston member is a lead screw.

5. The drug delivery device of claim 2 , wherein the third thread is an external thread.

6. The drug delivery device of claim 1 , wherein the sleeve is a clutch.

7. The drug delivery device of claim 1 , comprising an arc-shaped stop element comprising inner and outer curved surfaces, the stop element being configured to traverse axially relative to the housing, tracking each set dose of medicament,
wherein the stop element is configured to abut a stop when a final dose position is reached, preventing the dose indicator from further rotating to dial up a dose of medicament, the final dose position is reached as a final dose is dialed up and before the final dose is dispensed.

8. The drug delivery device of claim 7 , wherein the stop element comprises threads that cause the stop element to traverse axially relative to the housing when a dose of medicament is dialed up and dialed down.

9. The drug delivery device of claim 8 , wherein the threads of the stop element are configured to engage with corresponding threads to cause the stop element to traverse axially and the stop is separate from the corresponding threads.

10. The drug delivery device of claim 1 , where the teeth of the second clicker feature produce clicks by riding over teeth of the sleeve.

11. The drug delivery device of claim 1 , wherein the flexible arm extends circumferentially from a fixed end to a free end and the tooth resides at the free end of the flexible arm.

12. The drug delivery device of claim 1 , wherein the housing comprises an inwardly protruding zero dose stop.

13. The drug delivery device of claim 1 , wherein the dose indicator is configured to traverse axially between a zero dose position and a limit of travel away from the dose dispensing end and wherein the dose indicator can rotate and traverse axially towards the dose dispensing end from any axial position between the zero dose position and the limit of travel to dial down a dose of medicament.

14. A drug delivery device comprising:
an elongate outer housing comprising a dose dispensing end and a first thread;
a dose indicator comprising an elongate tubular body with a second thread configured to engage the first thread;
a sleeve that is (i) disposed radially inward of the dose indicator and (ii) configured to be engaged with the dose indicator; and
a clicker comprising (i) a plurality of one-way teeth and (ii) a flexible arm with a tooth on a free end of the flexible arm;

wherein:
the dose indicator is disposed between the housing and the sleeve and is configured to (i) rotate and traverse axially away from the dose dispensing end during dialing up of a dose of medicament and (ii) rotate and traverse axially towards the dose dispensing end during dialing down of a dose of medicament and during dose dispensing;
the flexible arm is configured to (i) produce audible clicks while the clicker is traversing axially relative to the housing in a first direction during dialing up of a dose of medicament, and (ii) not produce audible clicks while the clicker is traversing axially relative to the housing in a second, opposite direction during dialing down of a dose of medicament without dispensing medicament;
the one-way teeth are configured to (i) produce audible clicks while the clicker is traversing axially relative to the housing in the second direction during dialing down of a dose of medicament without dispensing the medicament, and (ii) not produce audible clicks while the clicker is traversing axially relative to the housing in the first direction during dialing up of a dose of medicament; and
the sleeve is configured to traverse axially with the dose indicator.

15. The drug delivery device of claim 14 , comprising an elongate piston member comprising a third thread.

16. The drug delivery device of claim 15 , comprising a piston member holder that is fixed relative to the housing and configured to (i) prevent the piston member from rotating during dialing up and dialing down of a dose of medicament and (ii) permit the piston member to traverse axially towards the dose dispensing end during dose dispensing.

17. The drug delivery device of claim 15 , wherein the piston member is a lead screw.

18. The drug delivery device of claim 15 , wherein the third thread is an external thread.

19. The drug delivery device of claim 14 , wherein the sleeve is a clutch.

20. The drug delivery device of claim 14 , comprising an arc-shaped stop element comprising inner and outer curved surfaces, the stop element being configured to traverse axially relative to the housing, tracking each set dose of medicament,
wherein the stop element is configured to abut a stop when a final dose position is reached, preventing the dose indicator from further rotating to dial up a dose of medicament, the final dose position is reached as a final dose is dialed up and before the final dose is dispensed.

21. The drug delivery device of claim 20 , wherein the stop element comprises threads that cause the stop element to traverse axially relative to the housing when a dose of medicament is dialed up and dialed down.

22. The drug delivery device of claim 21 , wherein the threads of the stop element are configured to engage with corresponding threads to cause the stop element to traverse axially and the stop is separate from the corresponding threads.

Assignees

• Sanofi Aventis Deutschland

Inventors

• Veasey Robert Frederick
• Perkins Robert
• Plumptre David Aubrey

Classifications

• A61M5/31575

  using scaling up or down transmissions, e.g. gearbox · CPC title

• A61M5/31593

  Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir · CPC title

• A61M5/31585

  performed by axially moving actuator, e.g. an injection button · CPC title

• A61M5/31541

  Means preventing setting of a dose beyond the amount remaining in the cartridge · CPC title

• A61M5/31533

  Dosing mechanisms, i.e. setting a dose (administrating mechanisms A61M5/31565) · CPC title