Methods and systems for calculating analyte levels

Patent metadata

Field	Value
Publication number	US-12303265-B2
Application number	US-202217818171-A
Country	US
Kind code	B2
Filing date	Aug 8, 2022
Priority date	Aug 14, 2017
Publication date	May 20, 2025
Grant date	May 20, 2025

Abstract

Disclosed are systems and methods for detecting analyte levels. These systems and methods may include a sensor configured for at least partial placement in an analyte-containing medium. The sensor may include one or more transducers and one or more diffusion barriers. The diffusion barriers may be arranged to delay diffusion of analyte to one transducer relative to another transducer. This delay may be used for purposes such as calculating and/or compensating for lag between a measured analyte level and a physiological analyte level of interest.

First claim

The invention claimed is:

1. An analyte monitoring system, the system comprising:
a sensor configured for at least partial placement in an interstitial fluid, the sensor comprising:
a first transducer that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the first transducer, wherein the first transducer includes first indicator molecules;
a first diffusion barrier arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the first diffusion barrier before reaching the first transducer, wherein the first diffusion barrier is configured such that the analyte contained in the interstitial fluid diffuses through the first diffusion barrier at a first diffusion rate r 1 ;
a second transducer that exhibits one or more detectable properties based on the amount or concentration of the analyte in proximity to the second transducer,

wherein the second transducer includes second indicator molecules;
one or more light sources configured to emit excitation light;
one or more first photodetectors configured to receive first emission light emitted by the first indicator molecules in response to the excitation light and output a first signal indicative of an amount of the received first emission light; and
one or more second photodetectors configured to receive second emission light emitted by the second indicator molecules in response to the excitation light and output a second signal indicative of an amount of the received second emission light; and

a transceiver configured to:
receive first sensor data collected from the first transducer, wherein the first sensor data corresponds to the first signal;
receive second sensor data collected from the second transducer, wherein the second sensor data corresponds to the second signal;
calculate an interstitial fluid analyte level rate of change based on at least the first sensor data, the second sensor data, and the first diffusion rate r 1 .

2. The system of claim 1 , further comprising a second diffusion barrier arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the second diffusion barrier before reaching the second transducer, wherein the second diffusion barrier is further configured such that the analyte contained in the interstitial fluid diffuses through the second diffusion barrier at a second diffusion rate r 2 , the second diffusion rate r 2 being greater than the first diffusion rate r 1 ;
wherein calculating the interstitial fluid analyte level rate of change is further based on the second diffusion rate r 2 .

3. The system of claim 2 , wherein the second diffusion rate r 2 is determined or measured before the interstitial fluid analyte level rate of change is calculated.

4. The analyte monitoring system of claim 1 , wherein the first transducer comprises a first polymer graft and the first indicator molecules, and the second transducer comprises a second polymer graft and the second indicator molecules.

5. The system of claim 1 , wherein the transceiver is configured to calculate the interstitial fluid analyte level rate of change using the following formula:
R ISF ˜ (C G1 (t)−C G0 (t))/(τ 1 −τ 0 ), wherein:
R ISF is the interstitial fluid analyte level rate of change;
C G1 (t) is the first sensor data collected from the first transducer at a time t;
C G0 (t) is the second sensor data collected from the second transducer at the time t;
τ 1 is a delay associated with the first diffusion barrier and is inversely related to the first diffusion rate r 1 ; and
τ 0 is (a) zero if no diffusion barrier is disposed over the second transducer such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid need not diffuse through a diffusion barrier before reaching the second transducer or (b) if a second diffusion barrier is arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the second diffusion barrier before reaching the first transducer, a delay associated with the second diffusion barrier.

6. The system of claim 5 , wherein τ 1 is equal to 1/r 1 .

7. The system of claim 1 , wherein the transceiver is further configured to calculate an interstitial fluid analyte level based on at least (a) the first sensor data, (b) the second sensor data, or (c) the first sensor data and the second sensor data.

8. The system of claim 7 , wherein the transceiver is further configured to calculate a blood analyte level based on the interstitial fluid analyte level and the interstitial fluid analyte level rate of change.

9. The system of claim 1 , wherein the first diffusion rate r 1 is determined or measured before the interstitial fluid analyte level rate of change is calculated.

10. A method comprising:
using a first transducer of a sensor to exhibit one or more detectable properties based on an amount or concentration of an analyte in proximity to the first transducer, wherein the sensor is placed at least partially in an interstitial fluid, a first diffusion barrier of the sensor is arranged such that the analyte contained in the interstitial fluid diffuses through the first diffusion barrier before reaching the first transducer, the first diffusion barrier is configured such that the analyte contained in the interstitial fluid diffuses through the first diffusion barrier at a first diffusion rate r 1 , and using the first transducer to exhibit the one or more detectable properties based on the amount or concentration of the analyte in proximity to the first transducer comprises:
using one or more light sources to emit excitation light; and
using one or more first photodetectors to receive first emission light emitted by first indicator molecules of the first transducer in response to the excitation light and output a first signal indicative of an amount of the received first emission light;

using a second transducer of the sensor to exhibit one or more detectable properties based on the amount or concentration of the analyte in proximity to the second transducer, wherein using the second transducer to exhibit the one or more detectable properties based on the amount or concentration of the analyte in proximity to the second transducer comprises:
using the one or more light sources to emit the excitation light; and
using one or more second photodetectors to receive second emission light emitted by second indicator molecules of the second transducer in response to the excitation light and output a second signal indicative of an amount of the received second emission light;

using a transceiver to receive first sensor data collected from the first transducer, wherein the first sensor data corresponds to the first signal;
using the transceiver to receive second sensor data collected from the second transducer, wherein the second sensor data corresponds to the second signal; and
using the transceiver to calculate an interstitial fluid analyte level rate of change based on at least the first sensor data, the second sensor data, and the first diffusion rate r 1 .

11. The method of claim 10 , wherein the transceiver calculates the interstitial fluid analyte level rate of change using the following formula:
R ISF ˜ (C G1 (t)−C G0 (t))/(τ 1 −τ 0 ), wherein:
R ISF is the interstitial fluid analyte level rate of change;
C G1 (t) is the first sensor data collected from the first transducer at a time t;
C G0 (t) is the second sensor data collected from the second transducer at the tim

Assignees

• Senseonics Inc

Inventors

• Masciotti James
• Chavan Abhi
• Dehennis Andrew

Classifications

• A61B5/742

  using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339) · CPC title

• A61B5/1451

  for interstitial fluid · CPC title

• A61B5/0071

  by measuring fluorescence emission · CPC title

• A61B5/07

  Endoradiosondes · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title