Dose measurement systems and methods

• US 10,183,120 B2
• Filed: 07/13/2017
• Issued: 01/22/2019
• Est. Priority Date: 07/15/2016
• Status: Active Grant

• Current Assignee: Bigfoot Biomedical, Inc.
• Original Assignee: Common Sensing, Inc.
• Inventors: Sihlanick, Kevin, Whalley, Richard, Legrand, Matthew, White, James, Carothers, Jeffrey
• Primary Examiner(s): Stafira, Michael P
• Application Number:
  US15/649,224
• Publication Number:
  US 20180064881A1
• Time in Patent Office: 558 Days
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/2006 Having specific accessories
• CPC Class Codes: A61M 2005/3254 Shielding of proximal needles, e.g. for pen needles
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/31 : Details
• CPC Class Codes: A61M 5/31535 : Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31541 : Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/31566 : Means improving security or handling thereof
• CPC Class Codes: A61M 5/31568 : Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: G01F 11/025 : with manually operated pistons G01F19/005 takes precedence
• CPC Class Codes: 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
• CPC Class Codes: G01F 23/2845 : for discrete levels G01F23/288, G01F23/292 take precedence
• CPC Class Codes: G01F 23/2927 : for several discrete levels, e.g. with more than one light-conducting sensing element
• CPC Class Codes: G01N 27/02 : by investigating impedance

Abstract

Embodiments described herein generally relate to devices, systems and methods for measuring a volume or number of doses 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 light guide disposed and configured to reflect electromagnetic radiation toward the container. The dose measurement system also includes a light guide disposed and configured to emit electromagnetic radiation into the light guide. A plurality of sensors are located in the apparatus that are optically coupleable to the light guide and are disposed and configured to detect the electromagnetic radiation emitted by at least a portion of the light guide. 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

1. An apparatus for measuring liquid volume in a container, the apparatus comprising:

a light source disposed and configured to emit electromagnetic radiation;

a light guide disposed and configured to receive at least a portion of the emitted electromagnetic radiation, the light guide including a plurality of openings to distribute at least a portion of the received electromagnetic radiation and to direct the distributed electromagnetic radiation toward the container;

a plurality of sensors optically coupleable to the plurality of openings, each sensor of the plurality of sensors disposed and configured to detect at least a portion of the distributed electromagnetic radiation; and

a processing unit configured to receive data representative of at least 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.

2. The apparatus of claim 1, further comprising:

an insulation structure for improving signal quality.

3. The apparatus of claim 2, wherein the insulation structure includes a metal lining configured to shield the electronic components of the apparatus from external electromagnetic noise.

4. The apparatus of claim 2, wherein the insulation structure is configured to prevent the emitted electromagnetic radiation from passing through the apparatus.

5. The apparatus of claim 1, wherein the light guide is 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.

6. The apparatus of claim 1, wherein the light guide is disposed on a light guide axis, the light guide axis being substantially parallel to a longitudinal axis defined by the apparatus.

7. The apparatus of claim 6, wherein the light source is disposed and configured to emit electromagnet radiation along the light guide axis.

8. The apparatus of claim 1, wherein the light guide is arranged such that the distribution of the electromagnetic radiation is along a substantially straight line.

9. The apparatus of claim 1, wherein the light source is the only light source disposed and configured to emit electromagnetic radiation into the light guide.

10. A method of estimating a volume of liquid in a drug container, the method comprising:

causing a light source to emit electromagnetic radiation into a light guide, the light guide including a plurality of openings to distribute at least a portion of the received electromagnetic radiation and to direct the distributed electromagnetic radiation toward the drug container;

detecting a signature of the electromagnetic radiation transmitted through the drug container with a plurality of sensors optically coupleable to the plurality of openings; and

comparing the signature to a plurality of reference signatures to determine the volume of liquid in the drug container.

11. The method of claim 10, further comprising:

correcting the signature for background light.

12. The method of claim 11, wherein the correction includes comparing the signature with a background signature representative of electromagnetic radiation detected by the plurality of sensors in a dark state of the light source.

13. The method of claim 10, further comprising:

associating the signature with one of the plurality of reference signatures using probabilistic matching, the probabilistic matching operable to determine the volume of liquid remaining in the drug container.

14. The method of claim 10, wherein the light source is the only light source caused to emit electromagnetic radiation into the light guide.

15. A method, comprising:

causing a light source to emit electromagnetic radiation into a light guide, the light guide including a plurality of openings to distribute at least a portion of the received electromagnetic radiation and to direct the distributed electromagnetic radiation toward the injection pen a first time;

detecting a first signature of the electromagnetic radiation transmitted through the injection pen with a plurality of sensors optically coupleable to the plurality of openings;

comparing the first signature to a plurality of reference signatures to determine a first volume of liquid in the injection pen;

causing the light source to emit electromagnetic radiation into the light guide such that the plurality of openings distribute at least a portion of the received electromagnetic radiation toward the injection pen a second time after the first time;

detecting a second signature of the electromagnetic radiation transmitted through the injection pen with the plurality of sensors;

comparing the second signature to the plurality of reference signatures to determine a second volume of liquid in the injection pen; and

estimating a dose delivered from the injection pen based on the first volume and the second volume.

16. The method of claim 15, wherein the light source, the light guide, and the plurality of sensors are disposed in an injection pen cap, the method further comprising:

detecting the first signature prior to the injection pen cap being removed from the injection pen; and

detecting the second signature after the injection pen cap has been replaced back on the injection pen.

17. The method of claim 16, further comprising:

switching the injection pen cap to a power save mode after a predetermined period of inactivity of the injection pen cap.

18. The method of claim 15, wherein the light source is the only light source caused to emit electromagnetic radiation into the light guide.