# US 12,109,400 B2 · Medicament administration device and data collection device

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- Number: US 12,109,400 B2
- Document ID: US12109400B2
- Status: Granted
- Kind: B2
- Application number: 16/757,151
- Filed: 2018-10-19
- Published: 2020-09-03
- Granted: 2024-10-08
- Earliest claimed: 2017-10-19
- Assignees: Sanofi
- Applicants: Sanofi
- Inventors: Michael Helmer; Christian Rehbein
- Web page: https://patentgrep.com/patent/US12109400B2

## 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 5/31568: {Means keeping track of the total dose administered, e.g. since the cartridge was inserted}
- A61M 2005/3126: {related to dosing}
- A61M 2205/3306: Optical measuring means
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- 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

The application relates to a data collection device for mounting on a rotatable dose setting dial of a medicament administration device. A system comprising the data collection device and the medicament administration device is also provided.

## Claims

### Claim 1

A data collection device comprising:
a distal end, the distal end being open to allow the data collection device to be mounted on a rotatable dose setting dial of a medicament administration device;
a proximal end, the proximal end being closed;
a light source configured to project light from the distal end of the data collection device; and
an optical sensor, wherein when the data collection device is mounted on the dose setting dial of the medicament administration device:
the distal end of the data collection device faces a surface of at least one outward radial protrusion extending beyond an external surface of an external housing of the medicament administration device and the light source is configured to illuminate a portion of the surface of the at least one outward radial protrusion, wherein the at least one outward radial protrusion is located distally with respect to the data collection device and is part of a dial sleeve of the medicament administration device located partially inside the external housing of the medicament administration device and configured to rotate when a dose is dialed; and the optical sensor faces the surface of the at least one outward radial protrusion of the dial sleeve and is configured to receive light reflected by at least relatively reflective regions disposed on the surface of the at least one outward radial protrusion of the dial sleeve.

### Claim 2 (depends on 1)

The data collection device of claim 1, wherein the data collection device comprises an electronics assembly comprising the light source and the optical sensor.

### Claim 3 (depends on 2)

The data collection device of claim 2, wherein the electronics assembly comprises a processor configured to receive signals from the optical sensor and to detect an occurrence of a medicament delivery from the medicament administration device.

### Claim 4 (depends on 3)

The data collection device of claim 3, wherein the processor is configured to receive signals from the optical sensor and to determine an amount of rotation of the dial sleeve of the medicament administration device.

### Claim 5 (depends on 4)

The data collection device of claim 4, wherein the data collection device is configured to determine a dialed dose.

### Claim 6 (depends on 1)

The data collection device of claim 1, wherein the light source is an infrared light source.

### Claim 7

A medicament administration device comprising:
a housing having a proximal end and a distal end;
a rotatable dial sleeve located partially inside the housing, the rotatable dial sleeve having a proximal end and a distal end; and
a dose setting dial coupled via a clutch to the proximal end of the dial sleeve, wherein the dial sleeve comprises at least one outward radial protrusion arranged between the proximal end of the housing and a distal end of the dose setting dial and a relatively reflective portion on a proximal surface of the at least one outward radial protrusion of the dial sleeve, wherein the medicament administration device is configured such that the rotatable dial sleeve and the at least one outward radial protrusion are rotationally coupled with the dose setting dial during dose setting and the rotatable dial sleeve and the at least one outward radial protrusion are rotationally decoupled from, and rotate relative to, the dose setting dial during dose delivery.

### Claim 8 (depends on 7)

The medicament administration device of claim 7, wherein the at least one outward radial protrusion of the dial sleeve extends beyond an external surface of the housing.

### Claim 9 (depends on 7)

The medicament administration device of claim 7, wherein the at least one outward radial protrusion of the dial sleeve comprises a plurality of teeth.

### Claim 10 (depends on 9)

The medicament administration device of claim 9, wherein the teeth comprise relatively reflective portions formed on a surface of the teeth.

### Claim 11 (depends on 7)

The medicament administration device of claim 7, wherein the at least one outward radial protrusion of the dial sleeve is an annular flange.

### Claim 12

A system comprising:
a medicament administration device comprising a housing having a proximal end and a distal end;
a rotatable dial sleeve located partially inside the housing, the rotatable dial sleeve having a proximal end and a distal end;
a dose setting dial coupled via a clutch to the proximal end of the dial sleeve, wherein the dial sleeve comprises at least one outward radial protrusion arranged between the proximal end of the housing and the dose setting dial and extending beyond an external surface of an external housing of the medicament administration device; and
a data collection device configured to be mounted on the dose setting dial of the medicament administration device, the data collection device comprising:
a light source; and
an optical sensor, wherein the light source is configured to illuminate a portion of a surface of the at least one outward radial protrusion of the dial sleeve, and wherein the optical sensor is configured to receive light reflected by at least relatively reflective regions disposed on the surface of the at least one outward radial protrusion of the dial sleeve and incident on the distal end of the data collection device.

### Claim 13 (depends on 12)

The system of claim 12, wherein the data collection device is mounted on the dose setting dial of the medicament administration device.

### Claim 14 (depends on 12)

The system of claim 12, wherein when the data collection device is mounted on the dose setting dial, a distal end of the data collection device faces the at least one outward radial protrusion of the dial sleeve of the medicament administration device.

### Claim 15 (depends on 12)

The system of claim 12, wherein:
the data collection device comprises an electronics assembly comprising the light source and the optical sensor,
the electronics assembly comprises a processor configured to receive signals from the optical sensor and to detect an occurrence of a medicament delivery from the medicament administration device, and
the processor is configured to receive signals from the optical sensor and to determine an amount of rotation of the dial sleeve of the medicament administration device, and the data collection device is configured to determine a dialed dose.

### Claim 16 (depends on 12)

The system of claim 12, wherein the light source is an infrared light source.
