Granted Patent B2

US 12,514,979 · App. 16/859,886 · Granted Jan 6, 2026

Inventor: Peter Rule (Los Altos Hills, CA)

Assignee: INSULET CORPORATION

A61M5/1723A61B5/1427A61B5/14532A61B5/14535A61B5/14546A61B5/14557A61B5/15003A61B5/150221A61B5/150229A61B5/150305A61B5/150755A61B5/155A61B5/157A61B5/412A61B5/4839A61B5/7275A61B5/7475A61M5/1415A61M5/142G16H20/10G16H20/17A61B5/150389A61B5/150503A61B5/150786A61B5/150862A61M2005/1404A61M2005/14208A61M5/16827A61M2005/1726A61M2205/12A61M2205/18A61M2205/3313A61M2205/3569A61M2205/502A61M2205/52A61M2230/005A61M2230/201G16H20/00

Abstract

Claims (49)

1 . A patient monitoring and dosing system, comprising:

a monitoring device comprising a controller, computer code,

and a memory, wherein the monitoring device is configured to measure a concentration of an analyte in a sample of bodily fluid from a patient;

a source of a treatment substance; and

a treatment dosing system in communication with the monitoring device, said treatment dosing system comprising a processor, a treatment dosing algorithm stored in a computer memory and executable by the processor, wherein the treatment dosing algorithm, when executed by the processor of the treatment dosing system, configures the processor to:

access a history of insulin dosages from a database;

calculate an estimated insulin sensitivity for the patient based at least in part on both the measured concentration of the analyte in the sample and the history of insulin dosages over a prior time period;

calculate an accuracy of the calculated estimated insulin sensitivity based at least in part on previously measured concentrations of the analyte of the patient; and

calculate a recommended treatment dosage of the treatment substance for the patient using a sliding scale protocol that increases a responsiveness of the treatment dosing algorithm to changes in the measured concentration of the analyte in calculating the recommended treatment dosage as the accuracy of the calculated estimated insulin sensitivity increases, wherein the calculation of the recommended treatment dosage is based at least in part on the calculated estimated insulin sensitivity and based at least in part on the accuracy of the estimated insulin sensitivity,

wherein the treatment dosing system is configured to automatically deliver the calculated recommended treatment dosage from the source of the treatment substance to the patient.

2 . The patient monitoring and dosing system of claim 1 , wherein:

the monitoring device is further configured to:

periodically measure samples of bodily fluid, and

the treatment dosing system is further configured to:

adjust a basal infusion rate to deliver the recommended treatment dosage to the patient; and

deliver the recommended treatment dosage to the patient at least in part as a basal infusion at the adjusted basal rate,

wherein the basal infusion is halted at least five minutes before a next measurement of a sample of bodily fluid is taken.

3 . The patient monitoring and dosing system of claim 1 , wherein the monitoring device is further configured to:

periodically measure samples of bodily fluid, and

the treatment dosing system is further configured to:

deliver the recommended treatment dosage to the patient at least in part as a bolus injection delivered at least five minutes before the next measurement is taken.

4 . The patient monitoring and dosing system of claim 1 , wherein the database is further configured to store a history of treatment doses delivered to the patient, and

wherein the processor, when executing the treatment dosing algorithm, is further configured to:

calculate the estimated insulin sensitivity based at least in part on the history of treatment doses.

5 . The patient monitoring and dosing system of claim 4 , wherein the history of treatment doses includes a plurality of active dose amounts delivered to the patient at different times, and

the processor, when executing the treatment dosing algorithm, is further configured to:

calculate an amount remaining for each of the plurality of active dose amounts based at least in part on a treatment fluid half-life, and

calculate the estimated insulin sensitivity based at least in part on the amount remaining for each of the plurality of active dose amounts.

6 . The patient monitoring and dosing system of claim 4 , wherein the processor, when executing the treatment dosing algorithm, is further configured to:

calculate the estimated insulin sensitivity based at least in part on a comparison of at least a portion of the history of measured concentrations of the analyte to at least a portion of the history of treatment doses.

7 . The patient monitoring and dosing system of claim 1 , wherein the processor, when executing the treatment dosing algorithm, is further configured to:

calculate an expected analyte concentration range based at least in part on the estimated insulin sensitivity, and

trigger an alert if the measured analyte concentration falls outside the expected analyte concentration range.

8 . The patient monitoring and dosing system of claim 1 , wherein the processor, when executing the treatment dosing algorithm, is further configured to:

calculate the estimated insulin sensitivity based at least in part on additional patient data, the additional patient data including patient feeding information, patient medication information, or patient exercise information.

9 . The patient monitoring and dosing system of claim 1 , wherein the monitoring device is configured to execute a glucose control solution calibration no more than once per day.

10 . The patient monitoring and dosing system of claim 1 , wherein the monitoring device is configured to execute a glucose control solution calibration no more than once each week.

11 . A patient monitoring and dosing system, comprising:

a monitoring device comprising a controller, computer code,

and a memory, wherein the monitoring device is configured to measure a concentration of an analyte in a sample of bodily fluid from a patient;

a source of a treatment substance; and

a treatment dosing system in communication with the monitoring device, said treatment dosing system comprising a processor, a treatment dosing algorithm stored in a computer memory and executable by the processor, wherein the treatment dosing algorithm, when executed by the processor of the treatment dosing system, configures the processor to:

access a history of insulin dosages from a database;

calculate an estimated insulin sensitivity for the patient based at least in part on both the measured concentration of the analyte in the sample and the history of insulin dosages over a prior time period;

calculate an accuracy of the calculated estimated insulin sensitivity based at least in part on previously measured concentrations of the analyte of the patient and an actual insulin sensitivity value of the patient; and

calculate a recommended treatment dosage of the treatment substance for the patient, wherein the calculation of the recommended treatment dosage is based at least in part on the calculated estimated insulin sensitivity and based at least in part on the accuracy of the estimated insulin sensitivity, wherein the processor, when executing the treatment dosing algorithm, is further configured, when calculating the recommended treatment dosage, to:

calculate the recommended treatment dosage according to a first dosing protocol if the accuracy is above a predetermined level, and

calculate the recommended treatment dosage according to a second dosing protocol if the accuracy is below the predetermined level, wherein the second dosing protocol less sensitive to changes in the measured concentration of the analyte than the first dosing protocol;

wherein the treatment dosing system is configured to automatically deliver the calculated recommended treatment dosage from the source of the treatment substance to the patient.

Assignments (4)

Continuity (8)

References Cited (400)