Drug delivery device with indicator

• US 10,561,797 B2
• Filed: 08/14/2017
• Issued: 02/18/2020
• Est. Priority Date: 08/14/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Nazzaro, David, McLaughlin, Ian, Allis, Daniel, Kozin, Simon, McCaffrey, Maureen
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US15/676,604
• Publication Number:
  US 20180043105A1
• Time in Patent Office: 918 Days
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14533 cam actuated
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2202/0468 non-physiological
• 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 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• 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 2205/584 having a color code
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/1685 by detection of position of a floating member
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3155 : by rotational movement of dose setting member, e.g. during setting or filling of a syringe
• 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 11/029 : provided with electric controlling means G01F11/022 and G01F11/024 take 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

Abstract

Systems and methods for monitoring an operational state and/or a fill status of a drug container of a drug delivery device are provided. The drug container can hold a liquid drug. A plunger can be positioned within the drug container. A drive system can advance the plunger to expel the liquid drug from the container. A monitoring system can detect a movement and/or a position of the plunger and/or any component coupled to the plunger. The detection can enable determination of an amount of liquid drug that has been expelled and/or an amount of liquid drug remaining in the drug container. Dosing rates, flow rates, and dosage completion can also be determined.

Claims

1. An apparatus, comprising:

a drug container configured to hold a liquid drug;

a plunger positioned in the drug container;

a drive system coupled to the plunger, the drive system configured to advance the plunger to expel a portion of the liquid drug from the drug container for delivery to a patient, the drive system comprising one or more spherical elements and a drive spring;

a Hall effect sensor positioned adjacent to the drug container; and

a controller coupled to the Hall effect sensor,

wherein the Hall effect sensor is configured to measure a varying magnetic field caused by the one or more spherical elements passing the Hall effect sensor,

wherein the Hall effect sensor is configured to generate a signal indicative of the measured varying magnetic field,

wherein the controller receives the signal generated by the Hall effect sensor and determines a count of a number of the one or more spherical elements that pass the Hall effect sensor.

2. The apparatus of claim 1, wherein the controller is configured to determine an amount of the liquid drug remaining in the drug container based on the number of the one or more spherical elements that pass the Hall effect sensor.

3. The apparatus of claim 1, wherein the controller is configured to determine the portion of the liquid drug expelled from the drug container based on the number of the one or more spherical elements that pass the Hall effect sensor.

4. The apparatus of claim 1, wherein the controller is configured to determine when a desired dose of the liquid drug has been provided to the patient based on the number of the one or more spherical elements that pass the Hall effect sensor.

5. The apparatus of claim 1, wherein the controller is configured to provide a notification to the patient indicating a fill status of the drug container based on the number of the one or more spherical elements that pass the Hall effect sensor.

6. The apparatus of claim 5, wherein the notification indicates a desired dose of the liquid drug has been provided to the patient.

7. The apparatus of claim 6, wherein the notification comprises at least one of an audible notification, a visual notification, and a vibrational notification.

8. The apparatus of claim 1, wherein the Hall effect sensor detects an end of a stroke of the plunger.

9. The apparatus of claim 8, wherein the Hall effect sensor is a first Hall effect sensor positioned adjacent to a first end of the drug container, the apparatus further comprising a second Hall effect sensor positioned adjacent to a second, opposite end of the drug container.