Safety limits for closed-loop infusion pump control
First Claim
1. An infusion pump system to deliver an infusion formulation to a user, comprising:
- a sensing device to monitor glucose levels in the user;
a computing element to receive sensing device input and to adjust delivery of the infusion formulation as a function of the rate of change of the glucose levels in the user over time, wherein the infusion formulation delivered to the user is limited to maximum and minimum values; and
a pump in communication with the computing element to deliver the infusion formulation to the user;
wherein delivery of the infusion formulation is limited to a maximum value determined as a percentage higher than a pre-programmed nominal basal rate of delivery.
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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.
247 Citations
25 Claims
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1. An infusion pump system to deliver an infusion formulation to a user, comprising:
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a sensing device to monitor glucose levels in the user; a computing element to receive sensing device input and to adjust delivery of the infusion formulation as a function of the rate of change of the glucose levels in the user over time, wherein the infusion formulation delivered to the user is limited to maximum and minimum values; and a pump in communication with the computing element to deliver the infusion formulation to the user; wherein delivery of the infusion formulation is limited to a maximum value determined as a percentage higher than a pre-programmed nominal basal rate of delivery. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of delivering an infusion formulation to a user, comprising:
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monitoring glucose levels in the user; receiving input of the glucose levels monitored and adjusting delivery of the infusion formulation as a function of the rate of change of the glucose levels in the user over time, wherein the infusion formulation delivered to the user is limited to maximum and minimum values; and delivering the infusion formulation to the user; wherein delivery of the infusion formulation is limited to a maximum value determined as a percentage higher than a pre-programmed nominal basal rate of delivery. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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19. An infusion pump system to deliver an infusion formulation to a user, comprising:
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a sensing device to monitor levels of a predefined parameter in the user; a computing element to receive sensing device input and to adjust delivery of the infusion formulation as a function of a basal rate of the user and the levels of the predefined parameter in the user, wherein the basal rate of the user changes over a time period, and wherein the infusion formulation delivered to the user at any given time within the time period is limited to a maximum value that is determined based on a predefined percentage value above the basal rate of the user at the given time; and a pump in communication with the computing element to deliver the infusion formulation to the user. - View Dependent Claims (20, 21, 22, 23, 24, 25)
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Specification