# US 10,478,554 B2 · Monitoring the operating health of a force sensor in a fluid infusion device

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- Number: US 10,478,554 B2
- Document ID: US10478554B2
- Status: Granted
- Kind: B2
- Application number: 15/682,394
- Filed: 2017-08-21
- Published: 2017-11-30
- Granted: 2019-11-19
- Earliest claimed: 2010-12-22
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic Minimed, Inc.
- Inventors: Afshin Bazargan; Pablo Vazquez; Hsiao-Yu S. Kow; Salman Monirabbasi; Ian B. Hanson
- Web page: https://patentgrep.com/patent/US10478554B2

## CPC

- A61M 5/16854: {by monitoring line pressure}
- 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 (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)
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/16863: {Occlusion detection}
- A61M 2205/332: Force measuring means
- 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)}

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 3)

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

### Claim 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.

### Claim 6 (depends on 5)

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

### Claim 7 (depends on 5)

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.

### Claim 8 (depends on 5)

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

### Claim 9 (depends on 5)

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.

### Claim 10 (depends on 5)

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.

### Claim 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.

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 11)

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.

### Claim 14 (depends on 11)

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.

### Claim 15 (depends on 11)

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.

### Claim 16 (depends on 11)

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.

### Claim 17 (depends on 16)

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

### Claim 18 (depends on 11)

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.
