Dose measurement system and method

• US 9,250,111 B2
• Filed: 07/17/2014
• Issued: 02/02/2016
• Est. Priority Date: 05/21/2012
• Status: Active Grant

• Current Assignee: Bigfoot Biomedical, Inc. (Abbott Laboratories)
• Original Assignee: Common Sensing, Inc.
• Inventors: Whalley, Richard, White, James
• Primary Examiner(s): STAFIRA, MICHAEL PATRICK
• Application Number:
  US14/334,181
• Publication Number:
  US 20150085286A1
• Time in Patent Office: 565 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• 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 2205/3584 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 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/702 automatically during use
• 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 5/1689 Drip counters
• CPC Class Codes: A61M 5/24 : Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31 : Details
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31525 : Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/3202 : Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: F04C 2270/041 : Controlled or regulated
• CPC Class Codes: G01F 11/021 : of the piston type G01F11/04 takes precedence
• CPC Class Codes: G01F 13/00 : Apparatus for measuring by volume and delivering fluids or fluent solid materials, not provided for in the preceding groups
• 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 22/00 : Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
• CPC Class Codes: G01N 21/1702 : with opto-acoustic detection, e.g. for gases or analysing solids
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

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

1. An apparatus, comprising:

a plurality of light sources disposed and configured to emit electromagnetic radiation toward a 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 two of the plurality of light sources; and

at least one processor configured to receive data representative of the detected electromagnetic radiation from each of the plurality of sensors, and generate a signal signature representative of the electromagnetic radiation detected by the plurality of sensors,

wherein the plurality of light sources, the plurality of sensors, and the at least one processor are at least one of integrated with and coupled to a drug delivery device, and

wherein the at least one processor is further configured to dynamically adapt a drug delivery schedule based on at least the signal signature.

2. The apparatus of claim 1, further comprising a communications module configured to communicate data between the apparatus and at least one of a user and a remote device.

3. The apparatus of claim 2, the communicated data including at least one of the signal signature, a reference signature representative of a liquid volume in the container, an ON/OFF status of the apparatus, a level of power remaining for the apparatus, a level of connectivity, a current time, a current location of the apparatus, a date of expiration for any contents of the container, a number of any doses remaining in the container, a history of any use of the apparatus, a recommended dose, and a temperature of at least one of the apparatus, the container, and the any contents of the container.

4. An apparatus for estimating a dose delivered from an injection pen, the apparatus comprising:

a communication interface;

a memory to store processor-executable instructions; and

at least one processor communicatively coupled to the memory and the communication interface, wherein upon execution of the processor-executable instructions by the at least one processor, the at least one processor;

receives and combines first data representative of a portion of detected electromagnetic radiation from each of a plurality of sensors at a first time, the plurality of sensors optically coupleable to a plurality of light sources disposed and configured to emit electromagnetic radiation toward the injection pen, the plurality of sensors disposed and configured to detect the electromagnetic radiation emitted by at least a portion of the plurality of light sources, the at least one processor operable to convert the received first data to obtain a first signature representative of the electromagnetic radiation detected by the plurality of sensors at the first time;

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

receives and combines second data representative of a portion of the detected electromagnetic radiation from each of the plurality of sensors at a second time after the first time, the at least one processor operable to convert the received second data to obtain a second signature representative of the electromagnetic radiation detected by the plurality of sensors at the second time;

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

estimates a dose delivered from the injection pen based on the first volume and the second volume,

wherein the plurality of light sources, the plurality of sensors, and the at least one processor are at least one of integrated with and coupled to the injection pen, and

wherein the at least one processor at least one of compares the estimated dose delivered from the injection pen to a medication schedule to monitor compliance and dynamically adapts the medication schedule based on at least the estimated dose.

5. The apparatus of claim 4, wherein the at least one processor:

associates a signature with a reference signature using probabilistic matching, the probabilistic matching operable to determine a volume of liquid remaining in the injection pen.

6. The apparatus of claim 4, wherein the at least one communication interface is configured to allow two-way communication between the apparatus and at least one of a user and a remote device.

7. The apparatus of claim 6, the communicated data including at least one of the estimated dose delivered from the injection pen, an ON/OFF status of the apparatus, a level of power remaining for the apparatus, a level of connectivity, a current time, a current location of the apparatus, a date of expiration for any contents of the container, a number of any doses remaining in the container, a history of any use of the apparatus, a recommended dose, and a temperature of at least one of the apparatus, the container, and the any contents of the container.

8. A health management system, comprising:

a drug delivery device including a drug reservoir; and

a dose measurement subsystem 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 from at least two of the plurality of light sources, the quantity of electromagnetic radiation communicated through the drug reservoir being a signature representative of the volume of liquid remaining in the drug reservoir; and

a display configured to present information to a user.

9. The system of claim 8, wherein the dose measurement subsystem is configured to communicate data representative of the volume of liquid remaining in the drug reservoir to a remote device for estimating a dose delivered to the patient.

10. The system of claim 9, wherein the dose management subsystem is configured to receive user health data from the remote device, the user health data including at least one of a user blood glucose level, user diet, user exercise, and user home health monitored data.

11. The system of claim 9, wherein the presented information includes at least one of the estimated dose, an ON/OFF status of at least one of the drug delivery device and the dose measurement subsystem, a level of power remaining for the at least one of the drug delivery device and the dose measurement subsystem, a level of connectivity, a current time, a current location of the at least one of the drug delivery device and the dose measurement subsystem, a date of expiration for any contents of the drug reservoir, a number of any doses remaining in the drug reservoir, a history of any use of the at least one of the drug delivery device and the dose measurement subsystem, a recommended dose, and a temperature of the system, the drug reservoir, and the any contents of the drug reservoir.

12. The system of claim 8, further configured for monitoring a medication status of a patient so as to facilitate a determination by at least one of a monitor and an authorized drug dispenser of 1) a need for more medication, 2) an effect of prior medication, and/or 3) the patient'"'"'s compliance with a medication schedule, the system further comprising:

at least one communication interface;

at least one memory to store processor-executable instructions; and

at least one processor communicatively coupled to the at least one memory and the at least one communication interface, wherein upon execution of the processor-executable instructions by the at least one processor, the at least one processor;

receives and combines first data representative of a portion of the detected electromagnetic radiation from each of the plurality of sensors at a first time, the at least one processor operable to convert the received first data to obtain a first signature representative of the electromagnetic radiation detected by the plurality of sensors at the first time;

compares the first signature to a plurality of reference signatures to determine a first volume of liquid in the drug reservoir;

receives and combines second data representative of a portion of the detected electromagnetic radiation from each of the plurality of sensors at a second time after the first time, the at least one processor operable to convert the received second data to obtain a second signature representative of the electromagnetic radiation detected by the plurality of sensors at the second time;

compares the second signature to the plurality of reference signatures to determine a second volume of liquid in the drug reservoir; and

controls the at least one communication interface to transmit to a remote device associated with the at least one of the monitor and the authorized drug dispenser, information associated with the medication status of the patient based at least in part on the first volume and the second volume of liquid in the drug reservoir, and thereby facilitating the determination by the at least one of the monitor and the authorized drug dispenser of the need for more medication, the effect of prior medication, and/or the patient'"'"'s compliance with the medication schedule.

13. The system of claim 12, wherein the medication status of the patient includes at least one of the estimated dose delivered from the medication container, timestamps indicating the first time and the second time, a number of doses remaining in the medication container, a history of use, and an alert that liquid volume in the medication container is critically low.

14. The system of claim 12, wherein the at least one processor is configured to receive, via the at least one communication interface, from the remote device at least one of a medication schedule, the estimated dose delivered from the medication container, a number of doses remaining in the medication container, a reminder, and an alert that liquid volume in the medication container is critically low.

15. The system of claim 12, further comprising at least one of a blood glucose sensor and a home health monitor.

16. The system of claim 15, wherein the at least one processor obtains patient health data including at least one of a blood glucose level, a weight, a blood pressure level, an EKG recording, an oxygen saturation level, an actigraphy recording, a pulmonary function test result, a water retention level, a body temperature, an exercise log, and a diet log.

17. The apparatus of claim 8, wherein the dose measurement subsystem includes a communications module configured to communicate data between the dose measurement subsystem and at least one of a user and a remote device.

18. The system of claim 17, wherein the dose measurement subsystem is configured to communicate, via the communications module, data representative of the volume of liquid remaining in the drug reservoir to a remote device for estimating a dose delivered to the patient.

19. An apparatus, comprising:

a plurality of light sources disposed and configured to emit electromagnetic radiation toward a 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 two of the plurality of light sources;

at least one processor configured to receive data representative of the detected electromagnetic radiation from each of the plurality of sensors, and generate a signal signature representative of the electromagnetic radiation detected by the plurality of sensors; and

a communications module configured to communicate data between the apparatus and at least one of a user and a remote device.

20. The apparatus of claim 19, wherein the plurality of light sources, the plurality of sensors, and the at least one processor are at least one of integrated with and coupled to a drug delivery device.

21. The apparatus of claim 20, wherein the at least one processor is further configured to dynamically adapt a drug delivery schedule based on at least the signal signature.

22. The apparatus of claim 19, the communicated data including at least one of the signal signature, a reference signature representative of a liquid volume in the container, an ON/OFF status of the apparatus, a level of power remaining for the apparatus, a level of connectivity, a current time, a current location of the apparatus, a date of expiration for any contents of the container, a number of any doses remaining in the container, a history of any use of the apparatus, a recommended dose, and a temperature of at least one of the apparatus, the container, and the any contents of the container.