System and method for mitigating risk in automated medicament dosing

• US 9,867,937 B2
• Filed: 09/08/2014
• Issued: 01/16/2018
• 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
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US14/479,994
• Publication Number:
  US 20150073337A1
• Time in Patent Office: 1,226 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 a delivery of a medicament to a user;

a memory adapted to store one or more parameters relating to the delivery of the medicament;

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

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 an additional amount of the medicament should automatically be delivered to the user;

review at least one parameter of the one or more parameters stored in the memory that relates to mitigating risk in automatically delivering the medicament based on the information received from the continuous glucose monitor;

determine whether the additional amount of the medicament can be delivered to the user in view of the at least one parameter that relates to mitigating risk; and

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

wherein the at least one parameter that relates to mitigating risk in automatically delivering the medicament includes an excess medicament amount limit defining a maximum amount by which the medicament delivered to the user can be increased, and determining whether the additional amount of the medicament can be delivered includes comparing the additional amount of the medicament to the excess medicament amount limit.

2. The portable infusion pump of claim 1, wherein it is determined that all of the additional amount of the medicament can be delivered to the user if the additional amount of the medicament is below the excess medicament amount limit.

3. The portable infusion pump of claim 1, wherein the processor is further configured, if it is determined that the additional amount of the medicament is greater than the excess medicament amount limit, to control the delivery mechanism to deliver a portion of the additional amount of the medicament equal to the excess medicament amount limit.

4. The portable infusion pump of claim 1, wherein the excess medicament amount limit is determined as a percentage of a current basal rate currently in use to deliver the medicament to the user.

5. The portable infusion pump of claim 4, wherein the percentage is user-selectable and between 0% and 500% of the current basal rate.

6. The portable infusion pump of claim 1, wherein the excess medicament amount limit is determined as a fixed amount of the medicament above a previously delivered bolus amount of the medicament or a percentage of the previously delivered bolus amount of the medicament.

7. The portable infusion pump of claim 6, wherein the excess medicament amount 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.

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

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

10. A portable infusion pump, comprising:

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

a memory adapted to store one or more parameters relating to the delivery of the medicament;

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

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 an additional amount of the medicament should automatically be delivered to the user;

review at least one parameter of the one or more parameters stored in the memory that relates to mitigating risk in automatically delivering the medicament based on the information received from the continuous glucose monitor;

determine whether the additional amount of the medicament can be delivered to the user in view of the at least one parameter that relates to mitigating risk; and

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

wherein the at least one parameter that relates to mitigating risk in automatically delivering the medicament includes a threshold relating to predicted accuracy of the continuous glucose monitor after which automatic adjustment of the delivery of the medicament based on the information from the continuous glucose monitor is not permitted.

11. The portable infusion pump of claim 10, wherein the threshold is set as an amount of time that has elapsed since a most recent calibration of the continuous glucose monitor.

12. The portable infusion pump of claim 10, wherein the threshold is set as a maximum predicted error of the continuous glucose monitor.

13. The portable infusion pump of claim 10, 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.

14. A portable infusion pump, comprising:

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

a memory adapted to store one or more parameters relating to the delivery of the medicament;

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

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 an additional amount of the medicament should automatically be delivered to the user;

review at least one parameter of the one or more parameters stored in the memory that relates to mitigating risk in automatically delivering the medicament based on the information received from the continuous glucose monitor;

determine whether the additional amount of the medicament can be delivered to the user in view of the at least one parameter that relates to mitigating risk; and

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

wherein the at least one parameter that relates to mitigating risk in automatically delivering the medicament includes a parameter utilizing an algorithm executed by the processor that determines whether or not the additional amount of the medicament can be delivered utilizing an estimated current maximum error of the continuous glucose monitor.