# US 9,517,311 B2 · Drive mechanism for a drug delivery device

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- Number: US 9,517,311 B2
- Document ID: US9517311B2
- Status: Granted
- Kind: B2
- Application number: 14/858,103
- Filed: 2015-09-18
- Published: 2016-01-07
- Granted: 2016-12-13
- Earliest claimed: 2004-10-04
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Terumo Corporation; Sanofi-Aventis Deutschland GmbH
- Inventors: Masaru Saiki
- Web page: https://patentgrep.com/patent/US9517311B2

## CPC

- A61M 5/31551: {including axial movement of dose setting member}
- A61M 5/31501: {Means for blocking or restricting the movement of the rod or piston (A61M5/5013 takes precedence)}
- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/31528: {by means of rotational movements, e.g. screw-thread mechanisms}
- A61M 5/3158: {the component being manually operated or triggered by an axially moving actuator operated by user, e.g. an axially movable injection button}
- A61M 5/31585: {the component being manually operated or triggered by an axially moving actuator operated by user, e.g. an axially movable injection button}
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 5/31558: {using scaling up or down transmissions, e.g. gearbox}
- A61M 5/31575: {using scaling up or down transmissions, e.g. gearbox}
- A61M 5/31586: {the component being manually operated or triggered by a rotating or pivoting actuator operated by user, e.g. an injection lever or handle}
- A61M 2202/0478: Heparin
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A drive mechanism for a drug delivery device having a rotationally fixed plunger rod driven by a lead screw. The lead screw engages a free lock which is coupled to a release knob. A dose setting dial cooperates with an inner cylinder using a clutch to establish the axial movement of the plunger rod during dose setting and dispensing.

## Claims

### Claim 1

A drive mechanism for use in a drug delivery device comprising:
a housing having a proximal end, a distal end and an internal thread;
a dose setting dial threadedly engaged with the internal thread and configured to simultaneously rotate and traverse axially towards the proximal end during dose setting and to simultaneously rotate and traverse axially towards the distal end during dose dispensing;
a plunger rod rotatably fixed relative to the housing during both dose setting and dose dispensing, the plunger rod having a hollow portion and a distal end configured to abut and move a cartridge piston during dose dispensing;
a lead screw threadedly engaged with the threaded hollow portion such that the lead screw can rotate relative to the plunger rod;
an inner cylinder engaged with and positioned within the dose setting dial such that axial movement of the dose setting dial causes simultaneous axial movement of the inner cylinder, where the inner cylinder is rotatably fixed relative the lead screw; and
a plunger rod holder rotatably fixed relative to the housing and keyed to the plunger rod to prevent the plunger rod from rotating during dose setting, where during dose dispensing the plunger rod holder allows the plunger rod to move axially towards the distal end.

### Claim 2 (depends on 1)

The drive mechanism according to claim 1 further comprising a cylindrical rotating knob rotatably fixed relative to the dose setting dial.

### Claim 3 (depends on 2)

A drug delivery device comprising the drive mechanism according to claim 2.

### Claim 4 (depends on 1)

The drive mechanism according to claim 1 further comprising a release knob configured to move axially and distally during dose dispensing to cause the dose setting dial and inner cylinder to simultaneously move distally.

### Claim 5 (depends on 4)

A drug delivery device comprising the drive mechanism according to claim 4.

### Claim 6 (depends on 1)

A drug delivery device comprising the drive mechanism according to claim 1.

### Claim 7 (depends on 6)

A drug delivery device according to claim 6 containing insulin, heparin, or a derivative or analogue thereof.

### Claim 8 (depends on 6)

A method of delivering a pharmaceutical formulation to a human or animal body comprising administering the pharmaceutical formulation from a drug delivery device according to claim 6.

### Claim 9 (depends on 8)

A method according to claim 8 wherein the pharmaceutical formulation contains insulin, heparin, a derivative thereof or an analogue thereof.

### Claim 10 (depends on 1)

A method of delivering a pharmaceutical formulation to a human or animal body comprising administering the pharmaceutical formulation from a drug delivery device comprising the drive mechanism according to claim 1.

### Claim 11 (depends on 10)

A method according to claim 10 wherein the pharmaceutical formulation contains insulin, heparin, a derivative thereof or an analogue thereof.

### Claim 12 (depends on 1)

A method of assembling a drug delivery device comprising a drive mechanism according to claim 1, comprising mounting the drive mechanism to any other components of the drug delivery device.

### Claim 13 (depends on 1)

The drive mechanism of claim 1 where the plunger rod does not move axially during dose setting.
