# US 12,000,725 B2 · Dose measurement system and method

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- Number: US 12,000,725 B2
- Document ID: US12000725B2
- Status: Granted
- Kind: B2
- Application number: 18/160,097
- Filed: 2023-01-26
- Published: 2023-08-03
- Granted: 2024-06-04
- Earliest claimed: 2012-05-21
- Assignees: Bigfoot Biomedical, Inc.
- Applicants: Bigfoot Biomedical, Inc.
- Inventors: Richard Whalley; James White
- Web page: https://patentgrep.com/patent/US12000725B2

## CPC

- G01F 22/00: Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
- A61M 5/16804: {Active flow controllers}
- A61M 5/16886: {for measuring fluid flow rate, i.e. flowmeters}
- A61M 5/1689: {Drip counters}
- G01F 11/021: {of the piston type (G01F11/04 takes precedence)}
- G01F 13/00: Apparatus for measuring by volume and delivering fluids or fluent solid materials, not provided for in the preceding groups
- G01F 17/00: Methods or apparatus for determining the capacity of containers or cavities, or the volume of solid bodies (measuring linear dimensions to determine volume G01B)
- G01F 23/284: Electromagnetic waves
- A61M 2005/3126: {related to dosing}
- A61M 2205/3306: Optical measuring means
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/70: with testing or calibration facilities
- G01N 21/1702: {with opto-acoustic detection, e.g. for gases or analysing solids}
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
- 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)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Embodiments described herein generally relate to devices, systems and methods for measuring the dose remaining in a drug delivery device that is used for delivering a dose to a patient. In some embodiments, a dose measurement system for measuring the liquid volume in a container includes a plurality of light sources which are disposed and configured to emit electromagnetic radiation toward the container. A plurality of sensors are located in the apparatus that are optically coupleable to the plurality of light sources and are disposed and configured to detect the electromagnetic radiation emitted by at least a portion of the light sources. The apparatus also includes a processing unit configured to receive data representing the portion of the detected electromagnetic radiation from each of the plurality of sensors. The processing unit is further operable to convert the received data into a signature representative of the electromagnetic radiation detected by the plurality of sensors.

## Claims

### Claim 1

An apparatus for measuring liquid volume in a drug container, the apparatus comprising:
a plurality of light sources disposed and configured to emit electromagnetic radiation toward the container;
a plurality of sensors optically coupleable to the plurality of light sources, each sensor of the plurality of sensors disposed and configured to detect the electromagnetic radiation emitted by at least a portion of the plurality of light sources; and
a processing unit configured to receive data representative of the portion of the detected electromagnetic radiation from each of the plurality of sensors, the processing unit operable to convert the received data into a signature representative of the electromagnetic radiation detected by the plurality of sensors,
wherein the processing unit is configured to turn off each of the plurality of light sources, wherein the plurality of sensors is configured to detect a background signature while each of the plurality of light sources are turned off,
wherein the processing unit is configured to associate the signature with the background signature to obtain a corrected signature that is corrected for background noise, and
wherein the processing unit is configured to compare the corrected signature to a plurality of reference signatures to determine the volume of liquid in the drug container.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the processing unit is further configured to associate the corrected signature with a reference signature, the reference signature being representative of a liquid volume in the container.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the plurality of light sources, the plurality of sensors and the processing unit are disposed in a housing, the housing configured to be removably coupleable to a drug delivery device.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the processing unit includes a memory configured to temporarily store at least one of the data representative of the portion of the detected electromagnetic radiation from each of the plurality of sensors and the signature representative of the electromagnetic radiation detected by the plurality of sensors.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the processing unit includes a memory configured to store a plurality of reference signatures, each of the plurality of reference signatures being representative of a liquid volume in the container.

### Claim 6 (depends on 1)

The apparatus of claim 1, further comprising:
a display configured to communicate information associated with a status of the apparatus to a user.

### Claim 7 (depends on 6)

The apparatus of claim 6, wherein the status includes at least one of a dose remaining, a history of use, remaining battery life, wireless connectivity status, and user reminders.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the plurality of light sources are disposed on a first side of the container and the plurality of sensors are disposed on a second side of the container, the second side substantially opposite the first side.

### Claim 9 (depends on 1)

The apparatus of claim 1, wherein the plurality of light sources are disposed at a first radial position with respect to the container and the plurality of sensors are disposed at a second radial position, the second radial location different than the first radial position.

### Claim 10

A method of estimating a volume of liquid in a drug container, the method comprising:
causing a plurality of light sources to emit electromagnetic radiation toward the drug container;
detecting a signature of the emitted electromagnetic radiation through the drug container with a plurality of sensors;
turning off each of the plurality of light sources;
detecting, with the plurality of sensors, a background signature while each of the plurality of light sources being turned off;
associating the signature with the background signature to obtain a corrected signature that is corrected for background noise; and
comparing the corrected signature to a plurality of reference signatures to determine the volume of liquid in the drug container.

### Claim 11 (depends on 10)

The method of claim 10, wherein detecting the signature of the emitted electromagnetic radiation through the drug container includes detecting at least a portion of the electromagnetic radiation emitted from at least a portion of the plurality of light sources with each of the plurality of sensor devices.

### Claim 12 (depends on 11)

The method of claim 11, wherein the portion of the electromagnetic radiation detected by each of the plurality of sensors is compiled into the signature.

### Claim 13 (depends on 10)

The method of claim 10, further comprising:
associating the signal signature with the reference signature using probabilistic matching, the probabilistic matching operable to determine the volume of liquid remaining in the drug container.

### Claim 14

A health management system, comprising:
a drug delivery device including a drug reservoir; and
a dose measurement system configured to be removably coupleable to the drug delivery device, the dose measurement system including
a plurality of light sources disposed and configured to emit electromagnetic radiation toward the drug reservoir;
a plurality of sensors optically coupleable to the plurality of light sources, each sensor of the plurality of sensors disposed and configured to detect a quantity of electromagnetic radiation communicated through the drug reservoir, and
a processing unit configured to receive data representative of the portion of the detected electromagnetic radiation from each of the plurality of sensors, the processing unit operable to convert the received data into a signature representative of the electromagnetic radiation detected by the plurality of sensors,
wherein the processing unit is configured to turn off each of the plurality of light sources,
wherein the plurality of sensors is configured to detect a background signature while each of the plurality of light sources are turned off,
wherein the processing unit is configured to associate the signature with the background signature to obtain a corrected signature that is corrected for background noise, and
wherein the processing unit is configured to compare the corrected signature to a plurality of reference signatures to determine the volume of liquid in the drug container;
and
a display configured to present information to a user indicative of the volume of liquid remaining in the drug reservoir.

### Claim 15 (depends on 14)

The health management system of claim 14, wherein the dose management system is configured to communicate data representative of the volume of liquid remaining in the drug reservoir to a remote device.

### Claim 16 (depends on 15)

The health management system of claim 15, wherein communication of the data representative of the volume of liquid remaining in the drug reservoir to a remote device allows the remote device to calculate a dose delivered to the patient.

### Claim 17 (depends on 1)

The apparatus of claim 1, further comprising a detection mechanism configured to check for a drug delivery device,
wherein, upon the detection mechanism detecting that the drug delivery device is attached to the apparatus, the apparatus is configured to cause the plurality of light sources to emit the electromagnetic radiation toward the drug container,
wherein, upon detecting that the drug delivery device is not attached to the apparatus, the apparatus is configured to automatically check for outstanding data in a memory to be logged to an external device, and
wherein, upon determining that the apparatus does not have onboard data to be logged to the external device, the apparatus is configured to enter a power save mode for a predefined time, the power save mode including the processing unit being configured to turn off electronics controlling at least one of the plurality of light sources and the plurality of sensors.

### Claim 18 (depends on 10)

The method of claim 10, further comprising:
a detection mechanism checking for a drug delivery device;
upon detecting that the drug delivery device being attached to a dose measurement system, the method causing the plurality of light sources to emit the electromagnetic radiation toward the drug container;
upon detecting that the drug delivery device is not attached to the dose measurement system, the dose measurement system automatically checking for outstanding data in a memory to be logged to an external device; and
upon determining that the dose measurement system does not have onboard data to be logged to the external device, the dose measurement system entering a power save mode for a predefined time, the power save mode including turning off electronics controlling at least one of the plurality of light sources and the plurality of sensors.

### Claim 19 (depends on 14)

The health management system of claim 14, wherein the dose measurement system further includes a detection mechanism configured to check for a drug delivery device,
wherein, upon the detection mechanism detecting that the drug delivery device is attached to the dose measurement system, the dose measurement system is configured to cause the plurality of light sources to emit the electromagnetic radiation toward the drug container,
wherein, upon detecting that the drug delivery device is not attached to the dose measurement system, the dose measurement system is configured to automatically check for outstanding data in a memory to be logged to an external device, and
wherein, upon determining that the dose measurement system does not have onboard data to be logged to the external device, the dose measurement system is configured to enter a power save mode for a predefined time, the power save mode including the processing unit being configured to turn off electronics controlling at least one of the plurality of light sources and the plurality of sensors.
