초록 ▼

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

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.

대표청구항 ▼

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

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; anda 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. 2. The infusion pump system of claim 1, wherein the pre-programmed nominal basal rate of delivery changes over a period of time. 3. The infusion pump system of claim 1, wherein delivery of the infusion formulation is further limited to a maximum of a percentage lower than a pre-programmed nominal basal rate of delivery. 4. The infusion pump system of claim 1, wherein a delivery rate of the infusion formulation is further limited from dropping below a minimum allowable rate. 5. The infusion pump system of claim 1, wherein the pre-programmed nominal basal rate comprises a profile of plural different nominal basal rates over a predefined period of time. 6. The infusion pump system of claim 1, wherein the infusion formulation is insulin. 7. The infusion pump system of claim 1, wherein if the adjusted delivery of the infusion formulation is not within the maximum and minimum values and there is no user-initiated signal present, the computing element queries the user. 8. The infusion pump system of claim 1, wherein the computing element is configured to determine the maximum value. 9. The infusion pump system of claim 1, wherein the pre-programmed nominal basal rate is predetermined for the user, and wherein the computing element is configured to determine the maximum value for the user as a percentage higher than the predetermined nominal basal rate that has been predetermined for that user. 10. A method of delivering an infusion formulation to a user, comprising: 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; anddelivering 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. 11. The method of claim 10, wherein the pre-programmed nominal basal rate of delivery changes over a period of time. 12. The method of claim 10, wherein delivery of the infusion formulation is limited to a maximum of a percentage lower than a pre-programmed nominal basal rate of delivery. 13. The method of claim 10, wherein a delivery rate of the infusion formulation is limited from dropping below a minimum allowable rate. 14. The method of claim 10, wherein the pre-programmed nominal basal rate comprises a profile of plural different nominal basal rates over a predefined period of time. 15. The method of claim 10, wherein the infusion formulation is insulin. 16. The method of claim 10, further including: querying the user if the adjusted delivery of the infusion formulation is not within the maximum and minimum values and there is no user-initiated signal present. 17. The method of claim 10, further comprising determining with a computing element, the maximum value as a value that is a pre-defined percentage higher than the pre-programmed nominal basal rate of delivery. 18. The method of claim 10, further comprising obtaining a basal rate that has been determined for the user, storing the basal rate determined for the user as the pre-programmed nominal basal rate, and configuring an electronic computing element to determine the maximum value for the user as a percentage higher than the predetermined nominal basal rate that has been determined for that user. 19. An infusion pump system to deliver an infusion formulation to a user, comprising: 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; anda pump in communication with the computing element to deliver the infusion formulation to the user. 20. The infusion pump system of claim 19, wherein the computing element includes a programmable portion in which a basal profile of plural basal rates over a period of time for the user is programmed. 21. The infusion pump system of claim 19, wherein the basal profile includes a basal rate for night time that is different than a basal rate for another time. 22. The infusion pump system of claim 19, wherein the predefined percentage value is fifty percent (50%). 23. The infusion pump system of claim 19, wherein the infusion formulation delivered to the user is limited to a predefined minimum value. 24. The infusion pump system of claim 19, wherein the maximum value to which delivery of infusion formulation is limited is a maximum infusion rate. 25. The infusion pump system of claim 19, wherein the computing element is configured to determine the maximum value.