SYSTEM AND METHOD FOR MITIGATING RISK IN AUTOMATED MEDICAMENT DOSING

• US 20180110921A1
• Filed: 12/20/2017
• Published: 04/26/2018
• Est. Priority Date: 09/06/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Saint, Sean, Rosinko, Michael
• Granted Patent: US 10,864,322 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

A portable infusion pump can communicate with glucose monitor, such as a continuous glucose monitor (CGM), to receive continuous feedback relating to a user'"'"'s blood glucose level during insulin or other medicament therapy and can automatically deliver insulin to a user when the CGM data indicates a need for additional insulin. Due to potential unreliability in the correlation of the CGM data to the user'"'"'s actual blood glucose level, risk mitigation can be employed to limit the amount of extra insulin that can be delivered by the pump in response to the CGM data.

Claims

1. A portable infusion pump, comprising:

a delivery mechanism adapted to facilitate delivery of medicament to a user;

memory adapted to store parameters relating to the delivery of medicament;

a communications device adapted to receive information from a continuous glucose monitor;

a processor functionally linked to the delivery mechanism and the memory and to the communications device to obtain the information from the continuous glucose monitor, the processor configured to;

monitor the information received from the continuous glucose monitor;

determine from the information received from the continuous glucose monitor that additional medicament should automatically be delivered to the user;

review one or more parameters stored in the memory relating to mitigating risk in automatically delivering medicament based on the information received from the continuous glucose monitor;

determine an amount of the additional medicament that can be delivered to the user in view of the parameters relating to mitigating risk; and

cause the delivery mechanism to deliver the amount of the additional medicament if it is determined that an amount of the additional medicament can be delivered to the user.

2. The portable infusion pump of claim 1, wherein one of the parameters relating to mitigating risk in automatically delivering medicament includes an excess medicament limit, and determining whether the additional medicament can be delivered includes comparing the additional medicament to the excess medicament limit.

3. The portable infusion pump of claim 2, wherein it is determined that all of the additional medicament can be delivered to the user if the additional medicament is below the excess medicament limit.

4. The portable infusion pump of claim 2, wherein the processor is further configured, if it is determined that the additional medicament is greater than the excess medicament limit, to control the delivery mechanism to deliver a portion of the additional medicament equal to the excess medicament limit.

5. The portable infusion pump of claim 2, wherein the excess medicament limit is determined as a percentage of a basal rate currently in use to deliver medicament to the user.

6. The portable infusion pump of claim 5, wherein the percentage is user-selectable and between 0% and 500% of the current basal rate.

7. The portable infusion pump of claim 2, wherein the excess medicament limit is determined as a fixed amount of medicament above a previously delivered bolus amount of medicament or a percentage of the previously delivered bolus amount of medicament.

8. The portable infusion pump of claim 7, wherein the excess medicament limit is utilized for a predefined time period after delivery of the previous bolus amount, and one or more of the fixed amount, percentage and predefined time period are user-selectable.

9. The portable infusion pump of claim 1, wherein the additional medicament is determined as an amount of medicament necessary to lower the user'"'"'s blood glucose level to a target blood glucose level or below a high blood glucose threshold.

10. The portable infusion pump of claim 1, further comprising presenting a recommendation to the user on a user interface to calibrate the continuous glucose monitor if it is determined that any portion of the additional medicament cannot be delivered to the user.

11. The portable infusion pump of claim 1, wherein one of the parameters relating to mitigating risk in automatically delivering medicament includes a threshold relating to predicted accuracy of the continuous glucose monitor after which automatic adjustment of the delivery of medicament based on the information from the continuous glucose monitor is not permitted.

12. The portable infusion pump of claim 11, wherein the threshold is set as an amount of time that has elapsed since a most recent calibration of the continuous glucose monitor.

13. The portable infusion pump of claim 11, wherein the threshold is set as a maximum predicted error of the continuous glucose monitor.

14. The portable infusion pump of claim 11, wherein the threshold is set as a maximum difference between a blood glucose level at a most recent calibration of the continuous glucose monitor and a current estimated blood glucose level of the continuous glucose monitor.

15. The portable infusion pump of claim 1, wherein one of the parameters relating to mitigating risk in automatically delivering medicament includes a parameter utilizing an algorithm executed by the processor that determines whether or not the additional medicament can be delivered utilizing an estimated current maximum error of the continuous glucose monitor.

16. A portable infusion pump, comprising:

a delivery mechanism adapted to facilitate delivery of medicament to a user;

memory adapted to store parameters relating to the delivery of medicament;

a communications device adapted to receive information from a continuous glucose monitor;

a processor functionally linked to the delivery mechanism and the memory and to the communications device to obtain the information from the continuous glucose monitor, the processor configured to;

store in memory an excess medicament limit defined as a maximum amount of excess medicament that can be delivered based on the information from the continuous glucose monitor;

monitor the information received from the continuous glucose monitor;

determine from the information received from the continuous glucose monitor that an amount of additional medicament should be automatically delivered to the user;

compare the amount of additional medicament to the excess medicament limit; and

cause the delivery mechanism to;

deliver all of the amount of additional medicament if the amount of additional medicament is less than or equal to the excess medicament limit;

or

deliver a portion of the amount of additional medicament equal to the excess medicament limit if the amount of additional medicament is greater than the excess medicament limit.

17. The portable infusion pump of claim 16, wherein the excess medicament limit is determined as a percentage of a basal rate currently in use to deliver medicament to the user.

18. The portable infusion pump of claim 17, wherein the percentage is user-selectable and between 0% and 500% of the current basal rate.

19. The portable infusion pump of claim 16, wherein the excess medicament limit is determined as a fixed amount of medicament above a previously delivered bolus amount of medicament or a percentage of the previously delivered bolus amount of medicament.

20. The portable infusion pump of claim 19, wherein the excess medicament limit is utilized for a predefined time period after delivery of the previous bolus amount, and one or more of the fixed amount, percentage and predefined time period are user-selectable.