Safety limits for closed-loop infusion pump control
First Claim
1. A communication device for communicating with a computing element, the computing element executing a closed-loop algorithm for controlling a delivery rate of an infusion formulation by an infusion pump in response to a sensed biological state, the communication device comprising:
- an outer housing;
a power source;
a plurality of user-selectable operators attached to the housing, at least one of the plurality of user-selectable operators representing at least one exersise event of a user that affects the sensed biological state and the at least one user-selectable operator being selectable for initiating communication of signals to the computing element, the signals representing at least one exercise event; and
a transmission device for transmitting the signals to the computing element;
wherein the closed-loop algorithm processes the signals received by the computing element and adjusts the delivery rate of an infusion formulation in accordance with pre-programmed information relating to the at least one exercise event represented by the signals.
1 Assignment
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Accused Products
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.
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Citations
40 Claims
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1. A communication device for communicating with a computing element, the computing element executing a closed-loop algorithm for controlling a delivery rate of an infusion formulation by an infusion pump in response to a sensed biological state, the communication device comprising:
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an outer housing;
a power source;
a plurality of user-selectable operators attached to the housing, at least one of the plurality of user-selectable operators representing at least one exersise event of a user that affects the sensed biological state and the at least one user-selectable operator being selectable for initiating communication of signals to the computing element, the signals representing at least one exercise event; and
a transmission device for transmitting the signals to the computing element;
wherein the closed-loop algorithm processes the signals received by the computing element and adjusts the delivery rate of an infusion formulation in accordance with pre-programmed information relating to the at least one exercise event represented by the signals. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
a display for displaying events and event rankings affecting the sensed biological state.
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10. The communication device recited in claim 9, wherein the infusion formulation comprises an insulin formulation.
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11. The communication device recited in claim 9, wherein the sensed biological state comprises a sensed glucose level.
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12. The communication device recited in claim 9, wherein the event rankings comprise at least one of a set of rankings comprising relative values of:
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light,”
“
moderate,” and
“
heavy,”
or comprising relative values of “
short,” and
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long,”
or comprising relative values of “
low,” and
“
high.”
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13. A device as recited in claim 1, wherein the closed loop algorithm:
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detects a change in the sensed biological state;
determines an amount of infusion media for responding to the detected change;
determines whether the determined amount of infusion media is within a predefined limit;
determine whether the user-initiated signal is present; and
adjust the delivery rate in accordance with user-initiated signal if the determined amount of infusion media is not within the predefined limit and if the user-initiated signal is present.
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14. A device as recited in claim 1, wherein the closed loop algorithm:
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determines if an amount of infusion media for responding to a change in the sensed biological state is within a predefined limit; and
adjusts the delivery rate in accordance with user-initiated signal if the determined amount of infusion media is not within the predefined limit.
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15. A device as recited in claim 1, wherein the at least one user-selectable operator comprises an operator for entering an event ranking comprising at least one of a degree, quantity or measure associated with an exercise event of the user.
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16. A device as recited in claim 1, wherein the at least one user-selectable operator comprises an operator for entering an exercise event ranking from a selection of rankings comprising light, moderate and heavy relative amounts of exercise.
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17. A communication device for communicating with a computing element, the computing element executing a closed-loop algorithm for controlling a delivery of a medical treatment to a user in response to a sensed biological state of the user, the communication device comprising:
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a plurality of user-selectable operators, at least one of the user-selectable operators for representing at least one sleep event, medication event or stress event of the user that affects the sensed biological state and each of the plurality of user-selectable operators being selectable for initiating communication of signals to the computing element, the signals representing events affecting the at least one sleep, medication or stress event; and
a transmission device for transmitting the signals to the computing element;
wherein the closed-loop algorithm processes the signals received by the computing element and adjusts the delivery of the medical treatment in accordance with pre-programmed information relating to the at least one sleep, medication or stress event represented by the signals. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
detects a change in the sensed biological state;
determines an amount of a medical treatment for responding to the detected change;
determines whether the determined amount of medical treatment is within at least one predefined limit;
determine whether user-initiated signal is present if the determined amount of medical treatment is not within the at least one predefined limit; and
adjust the amount of medical treatment in accordance with user-initiated signal if the determined amount of medical treatment is not within the predefined limit and if the user-initiated signal is present.
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19. A device as recited in claim 18, wherein the at least one predefined limit comprises a maximum amount of medical treatment.
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20. A device as recited in claim 18, wherein the at least one predefined limit comprises a minimium amount of medical treatment.
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21. A device as recited in claim 18, wherein the at least one predefined limit comprises a minimium amount of medical treatement and a maximum amount of medical treatment.
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22. A device as recited in claim 17, wherein the delivery of a medical treatment comprises delivering an insuline formulation to the user at a rate determined by the closed-loop algorithm.
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23. A device as recited in claim 17, wherein the delivery of a medical treatment comprises delivering an infusion medium to the user.
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24. A device as recited in claim 23, wherein the closed loop algorithm:
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detects a change in the sensed biological state;
determines a delivery rate of infusion media for responding to the detected change;
determines whether the determined rate of infusion media is within at least one predefined limit;
determine whether user-initiated signal is present if the determined amount of infusion media is not within the at least one predefined limit; and
adjust the delivery rate in accordance with user-initiated signal if the determined amount of infusion media is not within the predefined limit and if the user-initiated signal is present.
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25. A device as recited in claim 24, wherein the at least one predefined limit comprises a maximum delivery rate.
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26. A device as recited in claim 24, wherein the at least one predefined limit comprises a minimium delivery rate.
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27. A device as recited in claim 24, wherein the at least one predefined limit comprises a minimium delivery rate and a maximum delivery rate.
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28. A device as recited in claim 24, wherein the closed loop algorithm:
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determines if an amount of infusion media for responding to a change in the sensed biological state is within at least one predefined limit; and
adjusts the delivery rate in accordance with user-initiated signal if the determined amount of infusion media is not within the predefined limit.
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29. A device as recited in claim 28, wherein the at least one predefined limit comprises a maximum delivery rate.
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30. A device as recited in claim 28, wherein the at least one predefined limit comprises a minimium delivery rate.
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31. A device as recited in claim 28, wherein the at least one predefined limit comprises a minimium delivery rate and a maximum delivery rate.
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32. A device as recited in claim 17, wherein the at least one user-selectable operator comprises an operator for entering an event ranking comprising at least one of a degree, quantity or measure associated with a sleep event of the user.
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33. A device as recited in claim 17, wherein the at least one user-selectable operator comprises an operator for entering a sleep event ranking from a selection of rankings comprising light, moderate and heavy relative amounts of sleep.
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34. A device as recited in claim 17, wherein the at least one user-selectable operator comprises an operator for entering a sleep event ranking comprising at least one of a degree, quantity or measure associated with a stress event of the user.
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35. A device as recited in claim 17, wherein the at least one user-selectable operator comprises an operator for entering a stress event ranking from a selection of rankings comprising light, moderate and heavy relative amounts of stress.
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36. A device as recited in claim 17, wherein the at least one user-selectable operator comprises an operator for entering an event ranking comprising at least one of a degree, quantity br measure associated with a medication event of the user.
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37. A device as recited in claim 17, wherein the at least one user-selectable operator comprises an operator entering a medication event ranking from a selection of rankings comprising light, moderate and heavy relative amounts of medication.
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38. A device as recited in claim 17, wherein the at least one sleep event, medication event or stress event of the user comprises at least one sleep event.
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39. A device as recited in claim 17, wherein the at least one sleep event, medication event or stress event of the user comprises at least one medication event.
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40. A device as recited in claim 17, wherein the at least one sleep event, medication event or stress event of the user comprises at least one stress event.
Specification