SAFETY PROCESSOR FOR WIRELESS CONTROL OF A DRUG DELIVERY DEVICE

• US 20170043085A1
• Filed: 10/28/2016
• Published: 02/16/2017
• Est. Priority Date: 12/26/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Rosinko, Michael
• Granted Patent: US 10,213,547 B2
• Time in Patent Office: Days
• 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, with a remote control device, such as a mobile phone (e.g., a smartphone). A safety processor acts as an intermediary device between the smartphone and medical device to review transmissions from the smartphone prior to the transmissions being delivered to the medical device. The safety processor can determine whether the smartphone is compatible with the medical device by checking the type and version of the smartphone as well as the versions of the operating software and/or firmware resident on the phone. The safety processor can also check whether the operating command entered into the smartphone is within acceptable parameters.

Claims

1. A device for facilitating communications between a medical device and a remote electronic device, comprising:

a communications device adapted to send communications to and receive communications from a medical device and a remote electronic device;

a memory adapted to store parameters related to operation of the medical device; and

a processor communicatively coupled with the communications device and memory, the processor configured to;

receive from the remote electronic device a communication configured as an operating command for operation of the medical device;

determine whether it is permissible to execute the operating command on the medical device based on the parameters related to operation of the medical device stored in the memory; and

if it is determined that it is permissible to execute the operating command on the medical device, transmit the operating command to the medical device for execution on the medical device.

2. The device of claim 1, wherein the processor is configured to determine whether it is permissible to execute the operating command on the medical device by determining whether the remote electronic device is compatible with the medical device for providing operating commands to the medical device.

3. The device of claim 2, wherein determining whether the remote electronic device is compatible with the medical device includes:

determining whether the remote electronic device is an approved device for transmitting operating commands to the medical device;

determining whether software operating on the remote electronic device is approved for transmitting operating commands to the medical device.

4. The device of claim 1, wherein the processor is configured to determine whether it is permissible to execute the operating command on the medical device by determining whether the operating command is compatible with therapy parameter guidelines for the medical device stored in the memory.

5. The device of claim 4, wherein the therapy parameter guidelines include parameters for a specific patient being treated with the medical device.

6. The device of claim 1, wherein the processor is further configured to receive information from a continuous glucose monitor through the communications device, and wherein the processor is configured to determine whether it is permissible to execute the operating command on the medical device by utilizing at least in part the information from the continuous glucose monitor.

7. The device of claim 1, wherein the medical device is a portable infusion pump.

8. The device of claim 7, wherein the portable infusion pump is configured to deliver insulin to the patient.

9. A system for facilitating communications between a medical device and a remote electronic device, comprising:

a programmable medical device configured to carry out operating commands for treatment of a patient; and

a safety processor including a communications device, a memory configured to store parameters relating to operation of the medical device and a processor, the processor configured to;

receive through the communications device a communication from a remote electronic device configured as an operating command for operation of the medical device;

determine whether it is permissible to execute the operating command on the medical device based on the parameters relating to operation of the medical device stored in the memory; and

if it is determined that it is permissible to execute the operating command on the medical device, transmit the operating command to the medical device for execution on the medical device.

10. The system of claim 9, wherein the processor of the safety processor is configured to determine whether it is permissible to execute the operating command on the medical device by determining whether the remote electronic device is compatible with the medical device for providing operating commands to the medical device.

11. The system of claim 10, wherein determining whether the remote electronic device is compatible with the medical device includes:

determining whether the remote electronic device is an approved device for transmitting operating commands to the medical device;

determining whether software operating on the remote electronic device is approved for transmitting operating commands to the medical device.

12. The system of claim 9, wherein the processor of the safety processor is configured to determine whether it is permissible to execute the operating command on the medical device by determining whether the operating command is compatible with therapy parameter guidelines for the medical device stored in the memory.

13. The system of claim 12, wherein the therapy parameter guidelines include parameters for a specific patient being treated with the medical device.

14. The system of claim 9, wherein the processor of the safety processor is further configured to receive information from a continuous glucose monitor through the communications device, and wherein the processor is configured to determine whether it is permissible to execute the operating command on the medical device by utilizing at least in part the information from the continuous glucose monitor.

15. The system of claim 9, wherein the medical device is a portable infusion pump.

16. The system of claim 15, wherein the portable infusion pump is configured to deliver insulin to the patient.

17. A safety processor configured to facilitate communications between a medical device and a remote electronic device, comprising:

a transmitter/receiver, a memory and a processor communicatively coupled with the transmitter/receiver and memory, the processor configured to;

receive through the transmitter/receiver a communication from a remote electronic device sent as an operating command for execution by a programmable medical device;

determine based on information stored in the memory whether the remote electronic device is approved for providing operating commands to the programmable medical device;

determine based on information stored in the memory whether the operating command is within guidelines for use of the medical device; and

transmit the operating command to the medical device for execution on the medical device if it is determined that the remote electronic device is approved for providing operating commands to the programmable medical device and that the operating command is within guidelines for use of the medical device.

18. The safety processor of claim 17, wherein the processor is configured to determine whether the remote electronic device is approved for providing operating commands to the medical device by determining whether the remote electronic device is approved hardware and whether the software operating on the remote electronic device is approved software.

19. The safety processor of claim 17, wherein the guidelines for use of the medical device include parameters for a specific patient being treated with the medical device.

20. The safety processor of claim 17, wherein the medical device is a portable infusion pump.