Operating a portable medical device

• US 10,226,572 B2
• Filed: 10/02/2014
• Issued: 03/12/2019
• Est. Priority Date: 09/06/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C., Wenger, Mitchell
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US14/504,899
• Publication Number:
  US 20150038939A1
• Time in Patent Office: 1,622 Days
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/16804 Flow controllers
• 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 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Some embodiments of a portable medical device, such as an infusion pump, can receive an external reference signal (e.g., a radio, cellular and/or satellite signal) to provide an automatic time-setting and maintenance operation. In these circumstances, the medical device can maintain accurate time and date information even in the event of a power interruption, a time-zone change and/or an internal clock error, for example. In this manner, the portable medical device provides safe operation and added convenience to the user.

Claims

1. A method of operating an infusion pump system for treatment of diabetes, comprising:

removably attaching a portable controller device having at least one user input component to a pump device such that the controller device is mechanically mounted with the pump device, wherein the at least one user input component of the portable controller device can be manually manipulated by a user to provide input to the portable controller device,

wherein the pump device includes;

a drive system to dispense medicine from the pump device,

a pump housing to contain the drive system and to define a space to receive a medicine,

a first electrical connector that is externally accessible along the pump housing, and

wherein the portable controller device includes;

a controller housing to mechanically mate with the pump housing,

control circuitry housed within the controller housing,

computer-readable memory storing a dispensing rate schedule based on time of day,

a second electrical connector that is externally accessible along the controller housing and that is engageable with the first connector to provide electrical communication between the control circuitry of the controller device and the drive system of the pump device, and

a wireless communication antenna system housed in the controller housing and electrically connected to the control circuitry;

wherein power for the portable controller device is supplied by a battery and power may be removed from the portable controller device during a battery change or if the battery becomes depleted over time;

communicating, in response to a replacement of the battery causing re-powering of the portable controller device and from the portable controller device to a portable computing device, a request for an external reference signal indicative of a time of day;

after communicating the request for the external reference signal, wirelessly receiving at the wireless communication antenna system the external reference signal indicative of the time of day which is transmitted from the portable computing device configured to provide short range wireless communication with the portable controller device via a short range wireless communication connection;

automatically updating an internal time setting of the portable controller device in response to receiving the external reference signal from the portable computing device, wherein the internal time setting comprises a stored time of day; and

operating the portable controller device to activate the drive system of the pump device based on the updated time setting to deliver one or more dosages of insulin, wherein an amount of time between dosages or the size of the one or more dosages of insulin depends upon the updated time setting.

2. The method of claim 1, wherein the step of updating the internal time setting of the portable controller device includes sending a time-and-date update signal from external reference circuitry to the control circuitry of the portable controller device.

3. The method of claim 1, wherein the step of updating the internal time setting of the portable controller device occurs repeatedly at predetermined intervals of time.

4. The method of claim 1, further comprising:

storing data in a computer-readable memory of the portable controller device; and

time-stamping the data based on the updated time setting.

5. The method of claim 1, further comprising adjusting a medicine dispensing rate to be dispensed from the pump device based on the updated time setting.

6. The method of claim 1, wherein the portable controller device comprises a user interface display device, wherein the user interface display device of the portable controller device shows a time value indicative of the updated time setting.

7. The method of claim 6, wherein the user interface display device is electrically connected to the control circuitry.

8. The method of claim 1, wherein the portable computing device comprises a laptop computer.

9. The method of claim 1, wherein the portable computing device is connected to a computer network having a network time protocol.

10. The method of claim 1, wherein the portable controller device activates the drive system of the pump device according to a dispensing rate schedule based on the stored time of day.

11. The method of claim 10, further comprising identifying a time-zone change based on the external reference signal and shifting the dispensing rate schedule based on the time-zone change.

12. The method of claim 11, wherein the dispensing rate schedule is incrementally shifted to gradually correspond to the time-zone change.

13. The method of claim 11, wherein the dispensing rate schedule is step shifted to immediately correspond to the time-zone change.

14. The method of claim 11, further comprising querying a user via a user interface display device to confirm whether operation of the infusion pump system should be adjusted based on the time-zone change, and wherein the dispensing rate schedule shifting based on the time-zone change is only executed in response to input to a user interface of the user interface display device.

15. The method of claim 1, wherein the pump housing that defines the space is configured to define the space to slidably receive a medicine cartridge, wherein the pump device includes at least one retainer structure configured to hinder removal of the medicine cartridge after exhaustion of the medicine cartridge and thereby prevent reuse of the pump device with a new medicine cartridge.

16. The method of claim 1, wherein the pump housing that defines the space is configured to define the space to slidably receive a medicine cartridge inserted through an external opening of the pump housing, the space being an interior cavity space, wherein the pump device further comprises a separate cap device configured to mate with the pump housing and cover the external opening so as to seal the medicine cartridge in the interior cavity space.

17. The method of claim 16, wherein the cap device includes a penetration member to pierce a septum of the medicine cartridge when the cap device is mated with the pump housing.

18. The method of claim 1, wherein the external reference signal indicative of the time of day is provided from the portable computing device using a network time protocol (NTP) of a computer network that includes the portable computing device.