Safety processor for a drug delivery device

• US 10,213,547 B2
• Filed: 10/28/2016
• Issued: 02/26/2019
• Est. Priority Date: 12/26/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Rosinko, Michael
• Primary Examiner(s): Negron, Daniell L
• Application Number:
  US15/336,930
• Publication Number:
  US 20170043085A1
• Time in Patent Office: 851 Days
• Field of Search: None
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 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: G08C 17/02 using a radio link
• CPC Class Codes: G08C 2201/93 Remote control using other portable devices, e.g. mobile phone, PDA, laptop
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method provide for enhanced reliability and safety of programming and/or operating a medical device, such as an infusion pump. A safety processor can check whether an operating command is within acceptable parameters.

Claims

1. An apparatus for reviewing medicament delivery commands for a system providing closed loop therapy to a patient with an ambulatory infusion pump, comprising:

a memory adapted to store at least one acceptable operation parameter for closed loop delivery of medicament with an ambulatory infusion pump;

a processor communicatively coupled with the memory, the processor configured to;

communicate with a device that calculates at least one medicament delivery parameter for delivery of medicament to a patient in a closed loop system based at least in part on data relating to glucose levels of the patient;

review one or more medicament delivery parameters calculated for delivery of medicament in the closed loop system;

determine whether it is permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters based on the at least one acceptable operation parameter for closed loop delivery of medicament with the ambulatory infusion pump stored in the memory; and

enable the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters if it is determined that it is permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters.

2. The device of claim 1, wherein the device that calculates the at least one medicament delivery parameter is a remote control device of the closed loop therapy system.

3. The device of claim 1, wherein the device that calculates the at least one medicament delivery parameter is the ambulatory infusion pump.

4. The device of claim 1, wherein the at least one medicament delivery parameter is a modification to an ongoing medicament delivery to the user.

5. The device of claim 4, wherein the ongoing medicament delivery is delivery of a basal rate.

6. The device of claim 1, wherein the processor is configured to prohibit the ambulatory infusion pump from delivering the medicament according to the one or more medicament delivery parameters if the processor determines that it is not permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters.

7. The device of claim 6, wherein the processor is configured to determine that it is not permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters if an amount of one or more of the medicament delivery parameters is not below a maximum permissible value.

8. The device of claim 6, wherein the processor is configured to determine that it is not permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters if an amount of one or more of the medicament delivery parameters is not within an acceptable range.

9. The device of claim 6, wherein the processor is configured to determine that it is not permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters if a timing of delivery of one or more medicament delivery parameters is not acceptable.

10. The device of claim 6, wherein the processor is further configured to provide a notification to the patient if the processor determines that it is not permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters.

11. A system for providing closed loop therapy to a patient with an ambulatory infusion pump, comprising:

an ambulatory infusion pump;

a device configured to receive data relating to glucose levels of the patient and calculate at least one medicament delivery parameter for delivery of medicament to the patient based on the data relating to glucose levels; and

a safety processor configured to communicate with the device to receive and review one or more medicament delivery parameters calculated by the device, determine whether it is permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters based on at least one acceptable operation parameter for closed loop delivery of medicament with the ambulatory infusion pump, and enable the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters if it is determined that it is permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters.

12. The system of claim 11, wherein the device configured to receive data relating to glucose levels of the patient and calculate at least one medicament delivery parameter for delivery of medicament to the patient based on the data relating to glucose levels is incorporated into the ambulatory infusion pump.

13. The system of claim 11, wherein the device configured to receive data relating to glucose levels of the patient and calculate at least one medicament delivery parameter for delivery of medicament to the patient based on the data relating to glucose levels is a separate device from the ambulatory infusion pump.

14. The system of claim 13, wherein the device is a remote control device for the ambulatory infusion pump.

15. The system of claim 11, wherein the at least one medicament delivery parameters is a modification to an ongoing medicament delivery to the user.

16. The system of claim 15, wherein the ongoing medicament delivery is delivery of a basal rate.

17. The system of claim 11, wherein the safety processor is configured to prohibit the ambulatory infusion pump from delivering the medicament according to the one or more medicament delivery parameters if the safety processor determines that an amount of one or more of the medicament parameters is not permissible.

18. The system of claim 17, wherein the safety processor is configured to determine that the amount of one or more of the medicament parameters is not permissible if the amount is not below a maximum permissible value or is not within an acceptable range.

19. The system of claim 11, wherein the safety processor is configured to prohibit the ambulatory infusion pump from delivering the medicament according to the one or more medicament delivery parameters if the safety processor determines that a timing of delivery of one or more medicament parameters is not acceptable.

20. The system of claim 11, wherein the safety processor is further configured to provide a notification to the patient if it is determined that it is not permissible for the ambulatory infusion pump to deliver the medicament according to the one or more medicament delivery parameters.