Safety limits for closed-loop infusion pump control

• US 7,569,030 B2
• Filed: 11/03/2004
• Issued: 08/04/2009
• Est. Priority Date: 09/07/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Starkweather, Timothy, Lebel, Ronald J.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US10/979,980
• Publication Number:
  US 20050065465A1
• Time in Patent Office: 1,735 Days
• Field of Search: 604 65- 67, 604/31, 604/48, 604500-504, 604/131, 128/DIG.12, 128/DIG.13
• US Class Current: 604/65
• 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 use in delivery of an infusion formulation, the system comprising:

a pump for delivering measured doses of an infusion formulation;

a sensing device for sensing a biological state;

a computing element communicating with the sensing device, the computing element being programmed to receive information about the sensed biological state from the sensing device and to regulate the delivery of the infusion formulation in accordance with the received information; and

a communication device communicating with the computing element, the communication device for communicating a user-initiated event signal to the computing element, the user-initiated event signal being representative of an event affecting the sensed biological state;

wherein the computing element is further programmed to determine whether an amount of the delivery of the infusion formulation is outside of a user basal range and, upon determining that the amount is outside of the user basal range, to receive the user-initiated event signal and initiate a variation in the delivery of the infusion formulation in accordance with the received user-initiated signal.

2. The infusion pump system recited in claim 1, wherein the variation in the delivery of the infusion formulation is substantially contemporaneous with the receipt of the user-initiated signal.

3. The infusion pump system recited in claim 1, wherein the sensing device for sensing the biological state comprises a sensing device for sensing a glucose level.

4. The infusion pump system recited in claim 1, wherein the computing element is programmed to regulate the delivery of an insulin formulation.

5. The infusion pump system recited in claim 4, wherein the computing element is programmed to initiate an event-based variation in the delivery of the insulin formulation which comprises at least one of an increase in an amount of the delivered insulin formulation and a decrease in an amount of the delivered insulin formulation.

6. The infusion pump system recited in claim 4, wherein the computing element is further programmed to initiate an event-based variation in the delivery of the insulin formulation which comprises a bolus delivery of the insulin formulation.

7. The infusion pump system recited in claim 1, wherein the user-initiated event signal is representative of at least one of a meal event, an exercise event, a stress event, a sleep event, and a medication event.

8. The infusion pump system recited in claim 7, wherein the communication device further communicates a user-initiated event ranking signal representative of an event ranking.

9. The infusion pump system recited in claim 8, wherein the computing element is further programmed to dynamically adjust the amount of infusion formulation delivered based on a first user-initiated event ranking signal when a second user-initiated event ranking signal is received by the computing element.

10. The infusion pump system recited in claim 1, wherein the communication device comprises a plurality of user-selectable operators corresponding to respective ones of a plurality of events, the user-selectable operators being selectable for communicating to the computing element the user-initiated signal.

11. The infusion pump system recited in claim 1, wherein the communication device comprises a plurality of user-selectable operators corresponding to respective ones of a plurality of event rankings.

12. The infusion pump system recited in claim 1, wherein the communication device comprises a display for displaying events and event rankings affecting the sensed biological state.

13. The infusion pump system recited in claim 12, wherein the communication device further comprises a plurality of user-selectable operators for selecting particular events and event rankings on the display and for initiating communication of the signals to the computing element, the signals representing the events and the event rankings.

14. The infusion pump system recited in claim 1, wherein the computing element is further programmed to maintain a history of user-initiated event signals.

15. The infusion pump system recited in claim 14, wherein the history is accessible to at least one of the user and the user'"'"'s physician.

16. The infusion pump system recited in claim 1, wherein the pump is an implantable pump.

17. The infusion pump system recited in claim 1, wherein the computing element is programmed to compare the amount to at least one of a pre-programmed minimum value and a pre-programmed maximum value to determine whether the amount is outside of the user basal range.

18. An infusion pump system for use in delivery of an infusion formulation, the system comprising:

a pump for delivering measured doses of an infusion formulation;

a sensing device for sensing a biological state;

a computing element communicating with the sensing device, the computing element being programmed to receive information about the sensed biological state from the sensing device and to regulate the delivery of the infusion formulation in accordance with the received information; and

a communication device communicating with the computing element, the communication device for communicating a user-initiated event signal to the computing element, the user-initiated event signal being representative of an event affecting the sensed biological state;

wherein the computing element is further programmed to receive the user-initiated event signal and initiate a variation in the delivery of the infusion formulation in accordance with the received user-initiated signal, and

wherein the computing element is further programmed to perform diagnostics in order to verify that the user initiated event signal is consistent with a detected change in the sensed biological state.

19. The infusion pump system recited in claim 18, wherein the user is alerted when the user initiated event signal is not consistent with the detected change in the sensed biological state.

20. The infusion pump system recited in claim 18, wherein the closed-loop algorithm ceases an automatic control of the infusion pump and returns to a manual operation of the infusion pump when the user initiated event signal is not consistent with the detected change in the sensed biological state.