Monitoring the operating health of a force sensor in a fluid infusion device

• US 10,478,554 B2
• Filed: 08/21/2017
• Issued: 11/19/2019
• Est. Priority Date: 12/22/2010
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Bazargan, Afshin, Vazquez, Pablo, Kow, Hsiao-Yu S., Monirabbasi, Salman, Hanson, Ian B.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US15/682,394
• Publication Number:
  US 20170340819A1
• Time in Patent Office: 820 Days
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, a force sensor, and an electronics module. The drive motor assembly regulates delivery of fluid by actuating a piston of a fluid reservoir, and the force sensor generates output levels in response to force imparted thereto during, for example, fluid delivery operations. The electronics module processes the output levels of the force sensor to assess the operating health of the force sensor, to check for occlusions in the fluid delivery path, and to monitor the seating status of the fluid reservoir.

Claims

1. A device for delivering fluid to a user, the device comprising:

a housing;

a drive motor assembly in the housing to regulate delivery of fluid by actuating a piston of a fluid reservoir;

a force sensor associated with the drive motor assembly to generate output levels in response to force imparted thereto; and

an electronics module coupled to the force sensor to process the output levels to determine if the fluid reservoir is seated within the housing and the electronics module;

determines a baseline actuation force imparted to the force sensor during a priming operation;

determines a measured actuation force imparted to the force sensor during a fluid delivery operation;

compares the measured actuation force to a force threshold and the baseline actuation force; and

initiates corrective action if the measured actuation force is less than a difference between the baseline actuation force and the force threshold.

2. The device of claim 1, wherein the electronics module:

compares the measured actuation force to the force threshold; and

initiates corrective action if the measured actuation force is less than the force threshold.

3. The device of claim 1, wherein the electronics module:

determines a plurality of measured actuation forces imparted to the force sensor for consecutive fluid delivery operations;

calculates a difference between a first one of the plurality of measured actuation forces and a second one of the plurality of measured actuation forces; and

initiates corrective action if the difference between the first one of the plurality of measured actuation forces and the second one of the plurality of measured actuation forces is greater than a threshold force value.

4. The device of claim 3, wherein initiating corrective action includes generating a seating status alert at the device.

5. A device for delivering fluid to a user, the device comprising:

a housing;

a drive motor assembly in the housing to regulate delivery of fluid by actuating a piston of a fluid reservoir;

a force sensor associated with the drive motor assembly to generate output levels in response to force imparted thereto, the force sensor disposed in the housing proximal to the drive motor assembly and between a proximal end of the drive motor assembly and a proximal end of the housing; and

an electronics module coupled to the force sensor to process the output levels to determine a rewind force imparted to the force sensor during a rewind operation,

wherein the electronics module initiates corrective action when the rewind force is not within a specified range.

6. The device of claim 5, further comprising a memory element to store the specified range.

7. The device of claim 5, wherein the electronics module further processes the output levels of the force sensor to determine if the fluid reservoir is seated in the housing.

8. The device of claim 5, wherein the electronics module determines an operating health of the force sensor based on the rewind force.

9. The device of claim 5, wherein the electronics module further processes the output levels of the force sensor to determine if an occlusion is present in a fluid flow path associated with the fluid reservoir.

10. The device of claim 5, wherein the electronics module initiates generation of a user alert at the device when the rewind force is not within the specified range.

11. A device for delivering fluid to a user, the device comprising:

a housing;

a drive motor assembly in the housing to regulate delivery of fluid by actuating a piston of a fluid reservoir;

a force sensor associated with the drive motor assembly to generate output levels in response to force imparted thereto, the force sensor disposed in the housing proximal to the drive motor assembly and between a proximal end of the drive motor assembly and a proximal end of the housing; and

an electronics module coupled to the force sensor to process the output levels to determine a rewind force imparted to the force sensor during a rewind operation and to determine if the fluid reservoir is seated in the housing,

wherein the electronics module initiates corrective action when the rewind force is not within a specified range.

12. The device of claim 11, wherein the electronics module determines an operating health of the force sensor based on the rewind force.

13. The device of claim 11, wherein the electronics module further processes the output levels of the force sensor to determine if an occlusion is present in a fluid flow path associated with the fluid reservoir.

14. The device of claim 11, wherein the electronics module:

determines a measured actuation force imparted to the force sensor during a fluid delivery operation;

compares the measured actuation force to a force threshold; and

initiates corrective action if the measured actuation force is less than the force threshold.

15. The device of claim 11, wherein the electronics module:

determines a baseline actuation force imparted to the force sensor during a priming operation;

determines a measured actuation force imparted to the force sensor during a fluid delivery operation;

compares the measured actuation force to a force threshold and the baseline actuation force; and

initiates corrective action if the measured actuation force is less than a difference between the baseline actuation force and the force threshold.

16. The device of claim 11, wherein the electronics module:

determines a plurality of measured actuation forces imparted to the force sensor for consecutive fluid delivery operations;

calculates a difference between a first one of the plurality of measured actuation forces and a second one of the plurality of measured actuation forces; and

initiates corrective action if the difference between the first one of the plurality of measured actuation forces and the second one of the plurality of measured actuation forces is greater than a threshold force value.

17. The device of claim 16, wherein initiating corrective action includes generating a seating status alert at the device.

18. The device of claim 11, wherein the electronics module initiates generation of a user alert at the device when the rewind force is not within the specified range.