# US 10,478,564 B2 · Injection device

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- Number: US 10,478,564 B2
- Document ID: US10478564B2
- Status: Granted
- Kind: B2
- Application number: 14/782,666
- Filed: 2014-04-08
- Published: 2016-03-10
- Granted: 2019-11-19
- Earliest claimed: 2013-04-10
- Assignees: Sanofi
- Applicants: Sanofi
- Inventors: Anthony Paul Morris
- Web page: https://patentgrep.com/patent/US10478564B2

## CPC

- A61M 5/3155: {by rotational movement of dose setting member, e.g. during setting or filling of a syringe}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/31553: {without axial movement of dose setting member}
- A61M 5/3157: {Means providing feedback signals when administration is completed (A61M5/20 takes precedence)}
- A61M 5/31583: {the piston rod being moved by the rotational movement of a component directly in contact with it}
- A61M 5/31591: {Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means}
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- 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 handheld injection device includes a housing containing a cartridge, a dose setting means being operable in a first direction to set a desired dose to be dispensed, a piston rod being adapted to cooperate with a piston so as to cause a set dose to be injected from the cartridge, and a first clicker component, which is largely rotationally constrained to the housing, and a second clicker component, which is rotatable relative to the housing during dose dispensing. The clicker components are adapted to contact each other only at the end of dispensing of a set dose to thereby provide an audible and/or tactile first feedback to a user. The first clicker component is displaceable relative to the housing between a proximal dose setting position and a distal dose dispensing position.

## Claims

### Claim 1

An injection device comprising
a housing containing a cartridge;
a dose setting mechanism being operable in a first direction to set a dose during dose setting;
a piston rod being adapted to cooperate with a piston to eject the dose from the cartridge during dose dispensing;
a first clicker component rotationally fixed to the housing, the first clicker component being displaceable relative to the housing between a dose setting position and a dose dispensing position, the dose setting position being proximal to the dose dispensing position, and the first clicker component being stationary in the dose dispensing position during the dose dispensing; and
a second clicker component rotatable relative to the housing during the dose dispensing,
wherein the first clicker component and the second clicker component are adapted to contact each other only near an end of the dose dispensing to provide an audible and/or tactile feedback to a user, the audible and/or tactile feedback being provided only if the injection device is in a dose dispensing mode in which the first clicker component is in the dose dispensing position, and
wherein the first clicker component and the second clicker component are configured not to engage one another when the injection device is in a dose setting mode to prevent the audible and/or tactile feedback from being generated.

### Claim 2 (depends on 1)

The injection device of claim 1, wherein the dose setting mechanism is further operable in a second direction opposite to the first direction to cancel the set dose during dose cancelling without the first and second clicker components contacting each other.

### Claim 3 (depends on 1)

The injection device of claim 1, wherein:
the audible and/or tactile feedback is a first audible and/or tactile feedback, and
the injection device further comprises a clicker configured to produce a second audible and/or tactile feedback during at least one of the dose setting or the dose dispensing, the second audible and/or tactile feedback being distinct from the first audible and/or tactile feedback.

### Claim 4 (depends on 1)

The injection device of claim 1, wherein the second clicker component comprises a number sleeve threadedly engaged with the housing and splined to the dose setting mechanism.

### Claim 5 (depends on 1)

The injection device of claim 1, wherein:
the piston rod defines a first longitudinal axis, and
the dose setting mechanism defines a second longitudinal axis parallel to and spaced apart from the first longitudinal axis.

### Claim 6 (depends on 5)

The injection device of claim 5, further comprising:
a driver coupled to the piston rod, and
a release clutch configured to inhibit rotation of the driver during the dose setting and to enable rotation of the driver during the dose dispensing.

### Claim 7 (depends on 6)

The injection device of claim 6, wherein the driver comprises:
a drive tube rotatable about the first longitudinal axis and directly coupled to the piston rod, and
a drive sleeve rotatable about the second longitudinal axis and coupled to a power reservoir.

### Claim 8 (depends on 6)

The injection device of claim 6, further comprising a component movable along the second longitudinal axis between a dose setting position, in which the dose setting mechanism is rotatable relative to the housing and relative to the driver, and a dose dispensing position, in which the driver is rotatable relative to the housing, the component forming a portion of at least one of the dose setting mechanism or the driver.

### Claim 9 (depends on 6)

The injection device of claim 6, wherein the dose setting mechanism comprises a dial assembly and a dial sleeve, the dial assembly and the dial sleeve being rotatable about the second longitudinal axis, and the dial sleeve being configured to be decoupled from the driver during the dose setting and to be coupled to the driver during the dose dispensing.

### Claim 10 (depends on 6)

The injection device of claim 6, further comprising a reverse wound flat spiral spring having a first end and a second end, the first end being attached to a first spool located on the first longitudinal axis, the second end being attached to a second spool located on the second longitudinal axis, and at least one of the first end or the second end being coupled to the driver.

### Claim 11 (depends on 6)

The injection device of claim 6, wherein the dose setting mechanism comprises a release button axially displaceable along the second longitudinal axis, and the injection device further comprises a friction mechanism configure to engage with the driver to decelerate the driver based on a position of the release button along the second longitudinal axis.

### Claim 12 (depends on 5)

The injection device of claim 5, wherein:
the piston rod comprises a threaded lead screw, and
the housing has a threaded portion cooperating with a threaded outer surface of the piston rod so that rotation of the piston rod axially displaces the piston rod along the first longitudinal axis.

### Claim 13 (depends on 1)

The injection device of claim 1, comprising a limiter mechanism defining a maximum settable dose and a minimum settable dose.

### Claim 14 (depends on 1)

The injection device of claim 1, comprising a last dose protection mechanism to inhibit setting of an excess dose exceeding an amount of liquid remaining in a cartridge loaded in the housing.

### Claim 15 (depends on 1)

The injection device of claim 1, wherein a length of the device before the dose setting and a length of the device after dose setting is the same.

### Claim 16 (depends on 1)

The injection device of claim 1, further comprising the cartridge and the piston, the cartridge containing a medicament, and the piston configured to displace the medicament.

### Claim 17 (depends on 16)

The injection device of claim 16, wherein the piston rod comprises a bearing at its end facing the piston, the bearing being configured to abut the piston in an unused delivery state of the device.

### Claim 18

A feedback mechanism for an injection device, the feedback mechanism comprising:
a first clicker component configured to be rotationally fixed to a housing of the injection device, the first clicker component being displaceable relative to the housing between a dose setting position and a dose dispensing position, the dose setting position being proximal to the dose dispensing position, and the first clicker component being stationary in the dose dispensing position during dose dispensing; and
a second clicker component configured to be rotatable relative to the housing of the injection device during the dose dispensing,
wherein the first clicker component and the second clicker component are adapted to contact each other only near an end of the dose dispensing to provide an audible and/or tactile feedback to a user, the audible and/or tactile feedback being provided only if the injection device is in a dose dispensing mode in which the first clicker component is in the dose dispensing position, and
wherein the first clicker component and the second clicker component are configured not to engage one another when the injection device is in a dose setting mode to prevent the audible and/or tactile feedback from being generated.

### Claim 19 (depends on 18)

The feedback mechanism of claim 18, wherein the first clicker component and the second clicker component are configured such that the first clicker component does not contact the second clicker component during dose cancelling.

### Claim 20 (depends on 18)

The feedback mechanism of claim 18, wherein the audible and/or tactile feedback is a first audible and/or tactile feedback, and the feedback mechanism further comprises a clicker producing a second audible and/or tactile feedback during at least one of the dose setting or the dose dispensing, the second audible and/or tactile feedback being distinct from the first audible and/or tactile feedback.
