Disease management system

Patent metadata

Field	Value
Publication number	US-2024268721-A1
Application number	US-202418626074-A
Country	US
Kind code	A1
Filing date	Apr 3, 2024
Priority date	Aug 29, 2018
Publication date	Aug 15, 2024
Grant date	—

Abstract

Techniques are disclosed for measuring an analyte in a biological system. A system may include a medical device with an electrochemical sensor configured to sense the concentration of a plurality of analytes present in a biological system. Processing circuitry of the system may retrieve, identify, and process a respective signal from a respective work electrode to determine the concentration of a respective analyte. The system may further include an implantable medical device configured to sense a cardiac electrogram (EGM). In some examples, the system may be configured to determine one or more patient-specific relationships between the respective signals of the electrochemical sensor and the cardiac EGM during a first period of time. Based on the patient-specific relationships, the system may estimate concentrations of the one or more analytes corresponding to the respective signals based on the cardiac EGM of the patient collected over a second period of time.

First claim

What is claimed is:

1 . A system comprising:
an electrochemical sensor comprising one or more work electrodes configured to produce one or more signals indicative of a concentration of one or more analytes in a patient; an implantable medical device (IMD) configured to sense a cardiac electrogram (EGM) of the patient; and processing circuitry in communication with the electrochemical sensor and the IMD, wherein the processing circuitry is configured to:
determine one or more patient-specific relationships between the one or more signals indicative of the concentration of the one or more analytes over a first period of time and the cardiac EGM for the patient collected over the first period of time; and
based on the patient-specific relationships, determine an estimated concentration of the one or more analytes based on the EGM for the patient collected over a second period of time.

2 . The system of claim 1 , further comprising a biocompatible medical device comprising the electrochemical sensor and configured for insertion through skin and into interstitial fluid of the patient.

3 . The system of claim 1 ,
wherein the electrochemical sensor comprises:
a common counter electrode;
a common reference electrode; and
a work electrode platform comprising the one or more work electrodes, wherein the one or more work electrodes comprise:
a first work electrode comprising a first reagent substrate configured to react with potassium to produce a signal indicative of a concentration of potassium; and
a second work electrode comprising a second reagent substrate configured to react with glucose to produce a signal indicative of a concentration of glucose,

wherein the first work electrode and the second work electrode are electrically coupled to the common counter electrode and common reference electrode, and wherein the processing circuitry is further configured to:
receive from the electrochemical sensor a signal from each of the first work electrode and the second work electrode;
identify one or more of a signal corresponding to the first work electrode and a signal corresponding to the second work electrode; and
determine, based on the identified signal, one or more of the concentration of potassium and the concentration of glucose associated with the first work electrode or the second work electrode, respectively.

4 . The system of claim 1 , wherein the electrochemical sensor comprises a replaceable sensor portion comprising one or more work electrodes, and wherein the processing circuitry is further configured to:
determine the replaceable sensor portion has been replaced with a new sensor portion; determine, based on the one or more signals indicative of the concentration of the one or more analytes over the second period of time, a concentration of the one or more analytes over the second period of time; determine, based on the patient-specific relationships, that the concentration does not satisfy a threshold similarity with the estimated concentration of the one or more analytes; and calibrate the new sensor portion based on the EGM for the patient collected over the second period of time.

5 . The system of claim 1 , wherein the cardiac EGM comprises an electrocardiogram (ECG), and wherein the processing circuitry is configured to determine the one or more patient-specific relationships between the one or more signals and characteristics of the ECG.

6 . The system of claim 5 , wherein the characteristics comprise one or more of: an RT interval, a QT interval, T-wave amplitude, T-wave inversion, U-wave visibility, ST segment depression, R-wave amplitude, or QRS width.

7 . The system of claim 1 , wherein to determine the one or more patient-specific relationships between the one or more signals and the cardiac EGM, the processing circuitry is configured to:
train a machine learning model to determine the estimated concentration of the one or more analytes as output based on an input cardiac EGM segment using a set of training data that includes the one or more signals indicative of the concentration of the one or more analytes and the cardiac EGM, wherein each segment of the one or more signals includes a label indicating a corresponding segment of the cardiac EGM.

8 . The system of claim 1 , wherein each work electrode of the one or more work electrodes comprises a respective membrane disposed on a respective reagent substrate, and wherein the respective membrane is selectively permeable to the respective analyte.

9 . The system of claim 1 , wherein the first period of time comprises a week.

10 . The system of claim 1 , wherein the processing circuitry is further configured to determine, based on the patient-specific relationships and the one or more signals produced over a third period of time, an estimated heart rate variability for the patient.

11 . A method comprising:
producing, by an electrochemical sensor comprising one or more work electrodes, one or more signals indicative of a concentration of one or more analytes in a patient; sensing, by an implantable medical device (IMD), a cardiac electrogram (EGM) of the patient; determining, by the processing circuitry, one or more patient-specific relationships between the one or more signals indicative of the concentration of the one or more analytes over a first period of time and the cardiac EGM for the patient collected over the first period of time; and based on the patient-specific relationships, determining, by the processing circuitry, an estimated concentration of the one or more analytes based on the EGM for the patient collected over a second period of time.

12 . The method of claim 11 , wherein a biocompatible medical device comprises the electrochemical sensor and is configured for insertion through skin and into interstitial fluid of the patient.

13 . The method of claim 11 , further comprising:
from the electrochemical sensor, receiving, by the processing circuitry, a signal from each of a first work electrode comprising a first reagent substrate configured to react with potassium to produce a signal indicative of a concentration of potassium and a second work electrode comprising a second reagent substrate configured to react with glucose to produce a signal indicative of a concentration of glucose, wherein the first work electrode and the second work electrode are electrically coupled to a common counter electrode and a common reference electrode; identifying, by the processing circuitry, one or more of a signal corresponding to the first work electrode and a signal corresponding to the second work electrode; and based on the identified signal, determining, by the processing circuitry, one or more of a concentration of potassium and a concentration of glucose associated with the first work electrode or the second work electrode, respectively.

14 . The method of claim 11 , further comprising:
determining, by the processing circuitry, that a replaceable portion of the electrochemical sensor comprising one or more work electrodes has been replaced with a new sensor portion; based on the one or more signals indicative of the concentration of the one or more analytes over the second period of time, determining, by the processing circuitry, a concentration of the one or more analytes over the second period of time; based on the patient-specific relationships, determining, by the processing circuitry, that the concentration does not satisfy a threshold similarity with the estimated concentration of the one or more analytes; and calibrating, by the processing circuitry, the new sensor portion based on the EGM for

Assignees

• Medtronic Inc

Inventors

• Hahn Daniel
• Srinivasan Akhil
• Kinzie Patrick W
• Schulhauser Randal C
• Marckmann Jennifer L
• Askarinya Mohsen
• Carney James K
• Probst David L
• Vaddiraju Santhisagar
• Chavez Gaxiola Alejo
• O'Brien Richard J
• Tycon Anna M
• Mahdavi Omid
• Kelley Shawn C
• Anderson David A

Classifications

• A61B5/053

  Measuring electrical impedance or conductance of a portion of the body · CPC title

• A61B5/14532

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

• A61B5/1486

  using enzyme electrodes, e.g. with immobilised oxidase · CPC title

• A61B5/1468 Primary

  using chemical or electrochemical methods, e.g. by polarographic means · CPC title

• A61B5/14546

  for measuring analytes not otherwise provided for, e.g. ions, cytochromes · CPC title