# US 10,245,384 B2 · Sensor for use with a drug delivery device

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- Number: US 10,245,384 B2
- Document ID: US10245384B2
- Status: Granted
- Kind: B2
- Application number: 15/543,507
- Filed: 2016-01-14
- Published: 2017-12-28
- Granted: 2019-04-02
- Earliest claimed: 2015-01-16
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Sanofi-Aventis Deutschland GmbH
- Inventors: Markus Ploch
- Web page: https://patentgrep.com/patent/US10245384B2

## CPC

- A61M 5/31533: {Dosing mechanisms, i.e. setting a dose (administrating mechanisms A61M5/31565)}
- A61M 5/009: {Electronic or electro-mechanical add-on modules}
- A61M 5/3155: {by rotational movement of dose setting member, e.g. during setting or filling of a syringe}
- A61M 5/31551: {including axial movement of dose setting member}
- A61M 5/31553: {without axial movement of dose setting member}
- 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}
- G16H 20/13: delivered from dispensers
- G16H 20/17: delivered via infusion or injection
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 5/31583: {the piston rod being moved by the rotational movement of a component directly in contact with it}
- A61M 2005/3126: {related to dosing}
- A61M 2205/3306: Optical measuring means
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/583: by visual feedback
- A61M 2205/6063: Optical identification systems
- A61M 2205/6081: Colour codes
- H04N 23/00: Cameras or camera modules comprising electronic image sensors; Control thereof
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H04N: PICTORIAL COMMUNICATION, e.g. TELEVISION

## Abstract

An optical decoding system including an optical sensor integral with or attachable to a housing of a drug delivery device and configured to be directed at first and second rotatable components of a dose setting and dispensing mechanism of the drug delivery device and a processor configured to: (i) cause the optical sensor to capture images of the first and second rotatable components at least at the beginning and end of a medicament dose dispensing process; (ii) determine a rotational position of both the first and second rotatable components in each of the captured images; and (iii) determine from the rotational positions of the first and second rotatable components an amount of medicament delivered by the dose setting and dispensing mechanism of the drug delivery device.

## Claims

### Claim 1

An optical decoding system comprising:
a single optical sensor integral with or attachable to a housing of a drug delivery device and configured to be directed at first and second rotatable components of a dose setting and dispensing mechanism of the drug delivery device; and
a processor configured to:
cause the single optical sensor to capture one or more images of the first and second rotatable components at least at a beginning and an end of a medicament dose dispensing process;
determine a rotational position of both the first and second rotatable components in each of the captured images; and
determine from the rotational positions of the first and second rotatable components an amount of medicament delivered by a dose setting and a dispensing mechanism of the drug delivery device.

### Claim 2 (depends on 1)

The optical decoding system according to claim 1, wherein the processor is configured to cause the single optical sensor to capture the one or more images of the first and second rotatable components during a medicament dose setting process.

### Claim 3 (depends on 2)

The optical decoding system according to claim 2, wherein the processor is configured to determine based on the one or more captured images whether the drug delivery device is in a medicament dose dialing mode or a medicament dose dispensing mode.

### Claim 4 (depends on 3)

The optical decoding system according to claim 3, wherein in the medicament dose dialing mode, the first rotatable component is configured to rotate in a first direction and the second rotatable component remains stationary and in the medicament dose dispensing mode the first rotatable component is configured to rotate in a second direction opposite to the first direction and the second rotatable component is configured to rotate in the first direction.

### Claim 5 (depends on 1)

The optical decoding system according to claim 1, wherein the processor is configured to identify encoded images associated with each of the first and second rotatable components, each encoded image encoding a different rotational orientation of the respective rotatable component.

### Claim 6 (depends on 5)

The optical decoding system according to claim 5, wherein the lowest common multiple of the number of unique rotational orientations of the first and second rotatable components is higher than a maximum dose which can be dialed into the drug delivery device.

### Claim 7 (depends on 6)

The optical decoding system according to claim 6, wherein the maximum dose which can be dialed into the drug delivery device is 120 units.

### Claim 8 (depends on 5)

The optical decoding system according to claim 5, wherein the processor is configured to determine a rotational orientation of both the first and second rotatable components at the beginning and end of the medicament dose dispensing process and to determine an amount of medicament dispensed based on the determined orientations.

### Claim 9 (depends on 1)

The optical decoding system according to claim 1, wherein the first rotatable component comprises a hollow cylindrical number sleeve having numbers marked on a first portion of an outer surface and wherein the encoded images are provided on a second portion of the outer surface.

### Claim 10 (depends on 1)

The optical decoding system according to claim 1, wherein the second rotatable component comprises a gear wheel having a plurality of teeth.

### Claim 11 (depends on 10)

The optical decoding system according to claim 10, wherein the encoded images on the gear wheel are marked on a crest of each of the plurality of teeth.

### Claim 12 (depends on 1)

The optical decoding system according to claim 1 wherein the single optical sensor is configured to be activated by movement of the first rotatable component.

### Claim 13 (depends on 12)

The optical decoding system according to claim 12, wherein the optical decoding system comprises a switch and wherein a change in the state of the switch is configured to cause the single optical sensor to be activated.

### Claim 14 (depends on 13)

The optical decoding system according to claim 13, wherein the drug delivery device and the switch are configured to be arranged such that the state of the switch changes when the drug delivery device moves from a zero unit drug dose arrangement to a single unit drug dose arrangement.

### Claim 15 (depends on 1)

The optical decoding system according to claim 1, comprising a display device and wherein the processor is configured to cause the display device to display an indication of an amount of medicament that has been delivered.

### Claim 16 (depends on 1)

The optical decoding system according to claim 1, wherein the optical decoding system is part of a supplementary device configured to be attached to the drug delivery device.

### Claim 17

A medicament delivery system comprising:
a drug delivery device comprising first and second rotatable components each having a plurality of encoded images disposed around an outer surface thereof, wherein each of the encoded images corresponds to a discreet rotational orientation of respective first and second components; and
an optical decoding system retained in a housing of the drug delivery device, the optical decoding system comprising:
a single optical sensor configured to be directed at the first and second rotatable components; and
a processor configured to:
cause the single optical sensor to capture one or more images of the first and second rotatable components at least at a beginning and an end of a medicament dose dispensing process of the drug delivery device,
determine a rotational position of both the first and second rotatable components in each of the captured images, and
determine from the rotational positions of the first and second rotatable components an amount of medicament delivered by a dose setting and a dispensing mechanism of the drug delivery device.

### Claim 18 (depends on 17)

The medicament delivery system according to claim 17, wherein:
the first rotatable component comprises a hollow cylindrical number sleeve having numbers marked on a first portion of an outer surface;
the encoded images on the number sleeve are provided on a second potion of the outer surface;
the second rotatable component comprises a gear wheel having a plurality of teeth; and
the gear wheel is configured to be engaged with a drive sleeve of the drug delivery device during the medicament dose dispensing process.

### Claim 19 (depends on 18)

The medicament delivery system according to claim 18, wherein the number of encoded images on the number sleeve is 24 and the number of encoded images on the gear wheel is 7.

### Claim 20 (depends on 1)

An optical decoding system according to claim 1, wherein the processor comprises software configured to isolate the one or more images of the first and second rotatable components.
