Field update of an ambulatory infusion pump system

Patent metadata

Field	Value
Publication number	US-2016129185-A1
Application number	US-201614995958-A
Country	US
Kind code	A1
Filing date	Jan 14, 2016
Priority date	Mar 15, 2013
Publication date	May 12, 2016
Grant date	—

Abstract

Portable or ambulatory infusion devices and systems capable of remotely updating an ambulatory fluid delivery device include safety protocols that verify the status of the ambulatory fluid delivery device before and after a field update of software. Methods of accomplishing the same field update of software are also described.

First claim

1 . An ambulatory fluid delivery device, comprising:
a user interface that a user operates to input directions and data that determine the dosing of a medicament to a patient; a liquid drug repository that contains the medicament; a pump fluidly connected to the liquid drug repository; an electrical controller configured to direct the pump to release the medicament; and a digital storage component, operably connected to the electrical controller, configured to store
data regarding administered doses of the medicament;
one or more device history logs of the fluid delivery device;
an operating system of fluid delivery device;
user profile information;
identifying information regarding the fluid delivery device; and
safety protocols for the fluid delivery device; and
a signal processing component that sends and receives electrical data to and from the controller, wherein the fluid delivery device is configured to
receive software updates sent from a qualified source;
verify the appropriateness of the software updates for the fluid delivery device based upon the identifying information and device history logs;
automatically install the software updates;
update the device history logs; and
perform tests conforming to the safety protocols after installation of the software.

2 . The ambulatory fluid delivery device of claim 1 , wherein software updates are received after the user requests the software update.

3 . The ambulatory fluid delivery device of claim 1 , wherein the software updates are automatically received by the ambulatory fluid delivery device.

4 . The ambulatory fluid delivery device of claim 1 , wherein the software updates are only installed after verifying that the ambulatory fluid delivery device is in a safe condition for update.

5 . The ambulatory fluid delivery device of claim 4 , wherein the safe condition for update comprises: not currently administering the medicament, not being attached to the patient, the liquid drug repository not being in fluid communication with the patient, not containing any medicament, any combination thereof.

6 . The ambulatory fluid delivery device of claim 1 , further comprising an alarm system that indicates at least one of a start and a finish of the software update installation.

7 . The ambulatory fluid delivery device of claim 1 , wherein the signal processing component comprises:
a wireless connection means for sending and receiving digital signals; a physical port for connecting cables to a computer or other device; or both a wireless connection means and a physical port.

8 . The ambulatory fluid delivery device of claim 1 , wherein the device is configured to display interactive verification tests on the user interface prior to installing the software updates.

9 . The ambulatory fluid delivery device of claim 8 , wherein the verification tests comprise tests to verify proximity to a source of the software updates, the willingness of the user to initiate the software updates, or both.

10 . A system for safely administering a medication to a patient comprising:
the ambulatory fluid delivery device of claim 1 ; and a central computing system that exchanges data, instructions, or both data and instructions with the ambulatory fluid delivery device.

11 . The system of claim 10 , wherein the central computing system exchanges data comprising the device history logs of the ambulatory fluid delivery device, a patient basal medication dosage profile, patient information, or any combination thereof.

12 . The system of claim 10 , wherein the central computing system verifies the condition of the ambulatory fluid delivery device prior to sending software updates.

13 . The system of claim 12 , wherein verifying the condition of the ambulatory fluid delivery device comprises:
examining the device history logs for irregular device performance; retrieving a current status of the ambulatory fluid delivery device to ensure that it is in a safe configuration for update; verifying an amount of digital memory and other computing hardware parameters are suitable for the software updates; confirming that software updates and existing software currently operating on the ambulatory fluid delivery device are compatible; or any combination thereof.

14 . The system of claim 10 , further comprising:
a remote controller that communicates between the ambulatory fluid delivery device and the central computing system; a sensor system that communicates with the ambulatory fluid delivery device, the central computing system, or both the ambulatory fluid delivery device and the central computing system; an intermediate computing device that communicates between the ambulatory fluid delivery device and the central computing system; or any combination thereof.

15 . The system of claim 14 , wherein the remote controller comprises:
a dedicated hand-held remote controlling device; a second ambulatory fluid delivery device; a portable computing device that is configured to communicate wirelessly with the ambulatory fluid delivery device; or any combination thereof.

16 . The system of claim 14 , wherein the sensor system comprises:
a continuous glucose monitoring system; a patient temperature monitoring system; a blood oxygen saturation monitoring system; a heart rate monitoring system; a blood pressure monitoring system; a patient activity monitoring system; or any combination thereof.

17 . The system of claim 14 , wherein the intermediate computing device comprises:
a hand-held computing device, comprising: a tablet, a personal digital assistant, a mobile phone, or any combination thereof; a desktop computer; a laptop computer; a computing device configured to exchange data with the ambulatory fluid delivery device through a wireless connection and with the central computing system through the internet via a wired connection; a computing device configured to exchange data with the ambulatory fluid delivery device through a wireless connection and with the central computing system through a wireless connection comprising Wi-Fi, a cellular phone signal, or both; a computing device configured to exchange data with the ambulatory fluid delivery device and with the central computing system both through via a wired connection; a computing device configured to exchange data with the ambulatory fluid delivery device through a wired connection and with the central computing system through the internet via a wireless connection comprising Wi-Fi, a mobile phone signal, or both; or any combination thereof.

18 . A method for remotely updating software on an ambulatory fluid delivery device comprising:
from a central computing system, interrogating the ambulatory fluid delivery device and obtaining data comprising a device history log; by the central computing system, verifying that the ambulatory fluid delivery device has not exhibited unusual performance within a certain time period, verifying that the ambulatory fluid delivery device is compatible with a software update and verifying that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device; sending the software update from the central computing system to the ambulatory fluid delivery device; on the central computing system, confirming that existing data on the ambulatory fluid delivery device is duplicated; performing the software update on the ambulatory fluid delivery device; and verifying that the ambulatory fluid delivery device in i

Assignees

• Tandem Diabetes Care Inc

Inventors

• Ludolph Don

Classifications

• A61M2230/20

  Blood composition characteristics · CPC title

• A61M2205/18

  with alarm · CPC title

• A61M5/1723

  using feedback of body parameters, e.g. blood-sugar, pressure (measurement of body parameters A61B5/00) · CPC title

• A61M2230/63

  Motion, e.g. physical activity · CPC title

• A61M2230/50

  Temperature · CPC title