Safety limits for closed-loop infusion pump control

• US 9,782,540 B2
• Filed: 07/07/2014
• Issued: 10/10/2017
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Lebel, Ronald J., Starkweather, Timothy
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/325,201
• Publication Number:
  US 20140323959A1
• Time in Patent Office: 1,191 Days
• Field of Search: 604 65- 67, 604131, 604151, 128DIG 12, 128DIG 13, 600300-301, 600309, 600361-365, 600345
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• 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 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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 40/67 for remote operation
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A system and process for providing safety limits on the delivery of an infusion formulation by an infusion pump system in response to a sensed biological state. The safety limits may comprise user-initiated event signals corresponding to events that may significantly affect the biological state. The safety limits may further comprise user-initiated event ranking signals for respective events which specify a degree, quantity, or measure for the respective event. The user-initiated event and event ranking signals may be communicated to a computing element associated with the infusion pump by an associated communication device having a user interface which comprises a plurality of user-selectable operators for entering information about the events and event rankings.

Claims

1. An infusion pump system for delivering an infusion media to a user, the infusion pump system comprising:

a sensing device to monitor glucose levels in the user;

a user interface for receiving user input relating to a food ingestation event;

a pump for delivering an infusion media to a user;

a computing element operatively connected to the pump and configured to adjust delivery of the infusion media dependent at least in part on glucose levels monitored by the sensing device and at least in part on user input received through the user interface;

the computing element configured to adjust delivery of the infusion media by the pump, based at least in part on an initial user input received by the user interface, relating to the food ingestation event,

the computing element configured to further adjust delivery of the infusion media by the pump, based at least in part on an updated user input received by the user interface, relating to the food ingestation event.

2. An infusion pump system as recited in claim 1, wherein the computing element is configured to further adjust delivery of the infusion media by the pump, based at least in part on both the initial input relating to the at least one food ingestation event and the updated input relating to the at least one food ingestation event.

3. An infusion pump system as recited in claim 1, wherein the computing element is configured to dynamically adjust delivery of the infusion media by the pump based at least in part on the updated input at a time when the pump is already delivering the infusion media based at least in part on the initial input.

4. An infusion pump system as recited in claim 1, wherein the initial input relating to the at least one food ingestation event comprises an initial event ranking and wherein the updated input relating to the at least one food ingestation event comprises an updated event ranking that is different from the initial event ranking.

5. An infusion pump system as recited in claim 1, wherein:

the initial event ranking comprises a ranking selected from a plurality of rankings that include first, second and third rankings, where the first ranking is lighter than the second ranking, and wherein the second ranking is lighter than the third ranking; and

the updated event ranking comprises a different ranking selected from the plurality of rankings that include first, second and third rankings.

6. An infusion pump system as recited in claim 1, wherein:

the initial event ranking comprises a ranking selected from a plurality of rankings comprising a light ranking, a moderate ranking and a heavy ranking; and

the updated event ranking comprises a different one of the plurality of rankings.

7. An infusion pump system as recited in claim 1, further comprising electronic memory for storing data corresponding to a history of user input relating to one or more food ingestation events.

8. An infusion pump system as recited in claim 1, further comprising electronic memory for storing data corresponding to a history of user input corresponding to one or more rankings of one or more food ingestation events.

9. An infusion pump system as recited in claim 1, further comprising a display device associated with the user interface, the display device coupled to the computing element and configured, with the computing element, to display a plurality of user selectable data relating to a food ingestation event.

10. An infusion pump system as recited in claim 1, wherein the initial input relating to the food ingestation event comprises input corresponding to an amount of carbohydrates, and wherein the updated input relating to the food ingestation event comprises input corresponding to a different amount of carbohydrates relative to the initial input.

11. An infusion pump system as recited in claim 1, wherein the initial input relating to the food ingestation event comprises input corresponding to an amount of at least one of fat and protein, and wherein the updated input relating to the food ingestation event comprises input corresponding to a different amount of at least one of fat and protein relative to the initial input.

12. An infusion pump system as recited in claim 1, wherein the food ingestation event comprises a single meal.

13. A method of making an infusion pump system for delivering an infusion media to a user, the method comprising:

providing a sensing device to monitor glucose levels in the user;

providing a user interface for receiving user input relating a food ingestation event;

providing a pump for delivering an infusion media to a user;

coupling a computing element to the pump; and

configuring the computing element to adjust delivery of the infusion media dependent at least in part on glucose levels monitored by the sensing device and at least in part on user input received through the user interface;

further configuring the computing element to adjust delivery of the infusion media by the pump, based at least in part on an initial user input received by the user interface, relating to the food ingestation event; and

further configuring the computing element to further adjust delivery of the infusion media by the pump, based at least in part on an updated user input received by the user interface, relating to the food ingestation event.

14. A method as recited in claim 13, further comprising configuring the computing element to further adjust delivery of the infusion media by the pump, based at least in part on both the initial input relating to the at least one food ingestation event and the updated input relating to the at least one food ingestation event.

15. A method as recited in claim 13, further comprising configuring the computing element to dynamically adjust delivery of the infusion media by the pump based at least in part on the updated input at a time when the pump is already delivering the infusion media based at least in part on the initial input.

16. A method as recited in claim 13, wherein the initial input relating to the at least one food ingestation event comprises an initial event ranking and wherein the updated input relating to the at least one food ingestation event comprises an updated event ranking that is different from the initial event ranking.

17. A method as recited in claim 13, wherein:

the initial event ranking comprises a ranking selected from a plurality of rankings that include first, second and third rankings, where the first ranking is lighter than the second ranking, and wherein the second ranking is lighter than the third ranking; and

the updated event ranking comprises a different ranking selected from the plurality of rankings that include first, second and third rankings.

18. A method as recited in claim 13, wherein:

the initial event ranking comprises a ranking selected from a plurality of rankings comprising a light ranking, a moderate ranking and a heavy ranking; and

the updated event ranking comprises a different one of the plurality of rankings.

19. A method as recited in claim 13, further comprising providing an electronic memory for storing data corresponding to a history of user input relating to one or more food ingestation events.

20. A method as recited in claim 13, wherein the initial input relating to the food ingestation event comprises input corresponding to an amount of carbohydrates, and wherein the updated input relating to the food ingestation event comprises input corresponding to a different amount of carbohydrates relative to the initial input.

21. A method as recited in claim 13, wherein the initial input relating to the food ingestation event comprises input corresponding to an amount of at least one of fat and protein, and wherein the updated input relating to the food ingestation event comprises input corresponding to a different amount of at least one of fat and protein relative to the initial input.

22. A method as recited in claim 13, wherein the food ingestation event comprises a single meal.