# US 11,027,064 B2 · Methods for providing sensor site rotation feedback and related infusion devices and systems

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- Number: US 11,027,064 B2
- Document ID: US11027064B2
- Status: Granted
- Kind: B2
- Application number: 16/224,697
- Filed: 2018-12-18
- Published: 2019-05-02
- Granted: 2021-06-08
- Earliest claimed: 2015-08-21
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic Minimed, Inc.
- Inventors: Neha J. Parikh; Rebecca K. Gottlieb; Benyamin Grosman; Anirban Roy; Di Wu
- Web page: https://patentgrep.com/patent/US11027064B2

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4839: {combined with drug delivery}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/16877: {Passive flow controllers; Devices for setting a flow rate (clamp-type valves A61M39/28)}
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/17: delivered via infusion or injection
- G16H 40/63: for local operation
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/684: {Indicating the position of the sensor on the body}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B 5/748: {Selection of a region of interest, e.g. using a graphics tablet}
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of providing site rotation feedback pertaining to a sensing arrangement providing sensed measurements of a physiological condition in a body of a user involves obtaining one or more reference measurements of the physiological condition in the body of the user, determining a lag associated with the sensing arrangement based on a relationship between the one or more reference measurements and one or more of the sensed measurements, identifying a current site location on the body of the user associated with the sensing arrangement from among a plurality of site locations based on the lag, determining one or more performance metrics associated with the current site location, and providing sensor site feedback in a manner that is influenced by the one or more performance metrics.

## Claims

### Claim 1

A method of providing site rotation feedback pertaining to a sensing arrangement providing sensed measurements of a physiological condition in a body of a user, the method comprising:
obtaining one or more reference measurements of the physiological condition in the body of the user;
determining a lag associated with the sensing arrangement providing the sensed measurements of the physiological condition in the body of the user based on a relationship between the one or more reference measurements and one or more of the sensed measurements;
identifying a current site location on the body of the user associated with the sensing arrangement from among a plurality of site locations based on the lag;
determining one or more performance metrics associated with the current site location; and
providing sensor site feedback in a manner that is influenced by the one or more performance metrics.

### Claim 2 (depends on 1)

The method of claim 1, the current site location comprising one of the plurality of site locations, the method further comprising:
maintaining an association between the lag and the one of the plurality of site locations; and
thereafter:
obtaining one or more subsequent reference measurements of the physiological condition in the body of the user;
determining a second lag associated with a second sensing arrangement providing subsequent sensed measurements of the physiological condition in the body of the user based on a relationship between the one or more subsequent reference measurements and the subsequent sensed measurements; and
identifying a site location associated with the second sensing arrangement as the one of the plurality of site locations based on the second lag, the lag, and the association between the lag and the one of the plurality of site locations.

### Claim 3 (depends on 1)

The method of claim 1, wherein determining the lag comprises:
generating a plurality of time shifted representations of the one or more of the sensed measurements having different amounts of time shifting;
determining a correlation metric for each of the plurality of time shifted representations based on the one or more reference measurements; and
identifying the lag as an amount of time shifting associated with a respective one of the plurality of time shifted representations having a highest value for the correlation metric.

### Claim 4 (depends on 1)

The method of claim 1, further comprising autonomously operating an infusion device to regulate the physiological condition based on the sensed measurements and a target value for the physiological condition in the body of the user, wherein the one or more performance metrics are determined based on the sensed measurements during the autonomous operation.

### Claim 5 (depends on 1)

The method of claim 1, wherein providing the sensor site feedback comprises generating a graphical representation of one or more recommended site locations different from the current site location.

### Claim 6 (depends on 5)

The method of claim 5, further comprising determining the one or more recommended site locations based on historical data associated with each of the plurality of site locations.

### Claim 7 (depends on 6)

The method of claim 6, further comprising determining the one or more recommended site locations based on site recommendation criteria associated with the user.

### Claim 8 (depends on 1)

The method of claim 1, further comprising:
determining a calibration factor associated with the sensed measurements based on the one or more reference measurements in a manner that is influenced by the lag; and
autonomously operating an infusion device to regulate the physiological condition based on the sensed measurements, the calibration factor, and a target value for the physiological condition in the body of the user.

### Claim 9 (depends on 1)

The method of claim 1, further comprising:
adjusting one or more control parameters in a manner that is influenced by the lag; and
autonomously operating an infusion device to regulate the physiological condition based on the sensed measurements, the one or more control parameters, and a target value for the physiological condition in the body of the user.

### Claim 10 (depends on 1)

The method of claim 1, further comprising:
receiving, by a server coupled to a network, the sensed measurements from the sensing arrangement via the network; and
determining, by the server, one or more recommended site locations based on historical data associated with the user stored in a database, wherein:
identifying the current site location comprises the server identifying the current site location based on the sensed measurements and the historical data associated with the user stored in the database; and
providing the sensor site feedback comprises the server generating, on a client device coupled to the server via the network, a graphical indication of the one or more recommended site locations in response to the one or more performance metrics failing to satisfy a threshold.

### Claim 11 (depends on 1)

The method of claim 1, further comprising receiving, by a server coupled to a network, the sensed measurements from the sensing arrangement via the network, wherein:
identifying the current site location comprises the server identifying the current site location based on the sensed measurements and historical data associated with the user stored in a database; and
providing the sensor site feedback comprises the server generating, on a client device coupled to the server via the network, a graphical representation of the one or more performance metrics associated with the current site location.

### Claim 12 (depends on 1)

The method of claim 1, wherein:
determining the one or more performance metrics comprises calculating a performance metric comprising one of a percentage of time the sensed measurements are below a hypoglycemic threshold value, a percentage of time the sensed measurements are above a hyperglycemic threshold value, a percentage of time the sensed measurements are in a euglycemic range, a number or frequency of glycemic excursions, and a glycemic variability metric; and
providing the sensor site feedback comprises indicating a recommended site location when the performance metric fails to satisfy a rotation threshold.

### Claim 13 (depends on 1)

The method of claim 1, wherein the sensing arrangement comprises a continuous glucose monitoring (CGM) sensor.

### Claim 14

A system comprising:
a sensing arrangement to obtain sensed measurement values for a physiological condition from a body of a user;
a user interface; and
a control system coupled to the user interface and the sensing arrangement to:
obtain one or more reference measurements of the physiological condition in the body of the user;
determine a lag associated with the sensing arrangement based on a relationship between the one or more reference measurements and one or more of the sensed measurement values;
identify a current site location on the body of the user associated with the sensing arrangement from among a plurality of site locations based on the lag;
determine one or more performance metrics associated with the current site location based on the sensed measurement values; and
provide sensor site feedback via the user interface in a manner that is influenced by the one or more performance metrics.

### Claim 15 (depends on 14)

The system of claim 14, wherein the control system updates a calibration factor associated with the sensed measurement values in a manner that is influenced by the lag.

### Claim 16 (depends on 14)

The system of claim 14, wherein the sensor site feedback comprises a graphical representation of one or more recommended site locations different from the current site location.

### Claim 17 (depends on 14)

The system of claim 14, wherein:
the one or more performance metrics comprise a performance metric selected from a group consisting of a percentage of time the sensed measurement values are below a hypoglycemic threshold value, a percentage of time the sensed measurement values are above a hyperglycemic threshold value, a percentage of time the sensed measurement values are in a euglycemic range, a number or frequency of glycemic excursions, and a glycemic variability metric; and
the sensor site feedback comprises a recommended site location indicated when the performance metric fails to satisfy a rotation threshold.

### Claim 18

A system comprising:
a sensing arrangement to obtain sensed measurement values for a physiological condition from a body of a user;
a database to maintain historical data associated with the user; and
a server coupled to the database and a network to:
obtain one or more reference measurements of the physiological condition in the body of the user;
determine a lag associated with the sensing arrangement based on a relationship between the one or more reference measurements and one or more of the sensed measurement values;
identify a current site location on the body of the user associated with the sensing arrangement from among a plurality of site locations based on the lag and one or more of the sensed measurement values and the historical data;
determine one or more performance metrics associated with the current site location based on the sensed measurement values; and
provide site rotation feedback in a manner that is influenced by the one or more performance metrics and the historical data.

### Claim 19 (depends on 18)

The system of claim 18, wherein the site rotation feedback comprises a graphical representation of one or more recommended site locations different from the current site location presented on a client device coupled to the server via the network in response to the one or more performance metrics failing to satisfy a threshold, wherein the server determines the one or more recommended site locations based on the historical data.

### Claim 20 (depends on 18)

The system of claim 18, the historical data including sensor lags associated with respective ones of the plurality of site locations, wherein the server identifies the current site location as one of the plurality of site locations based on a relationship between the lag and the sensor lags.