Methods for detecting failure states in a medicine delivery device
A fluid medicament delivery device includes a patient attachment unit, containing the fluid medicament, and an indicator unit adapted to be detachably coupled to the patient attachment unit. A method for monitoring the fluid medicament includes independently setting a flow rate of a fluid medicament with the patient attachment unit. A pressure and/or a flow rate of the fluid medicament is sensed with a sensor located in a separate indicator unit in a sensing mode. A status of the fluid medicament delivery device is determined based at least in part on the pressure and/or the flow rate.
1. A system for monitoring a fluid medicament delivery device, the system comprising:
a patient attachment unit for independently setting a flow rate of a fluid medicament contained therein; and
an indicator unit, adapted to be detachably coupled to the patient attachment unit, for monitoring a parameter of interest of the fluid medicament, the indicator unit comprising:
a sensing module for receiving a signal from a sensor located in the patient attachment unit, the signal indicating at least one of a pressure and a flow rate of the fluid medicament;
a status determination module for determining a status of the fluid medicament delivery device based at least in part on the received signal; and
a notification module for notifying a patient of the status,
wherein the indicator unit is not adapted to change the flow rate of the patient attachment unit.
2. The system of claim 1 , wherein the patient attachment unit is adapted to be attached to a skin surface of the patient.
3. The system of claim 1 , wherein the sensing module comprises a MEMS sensor.
4. The system of claim 1 , further comprising an initialization module for performing a system initialization test.
5. The system of claim 4 , wherein the system initialization test comprises a battery status test.
6. The system of claim 5 , wherein the notification module notifies the patient based on a result of the battery status test.
7. The system of claim 5 , wherein a result of the battery status test is based at least in part on at least one of a volume of the fluid medicament and an amount of time.
8. The system of claim 1 , wherein the status comprises a fault condition based at least in part on a volume of the fluid medicament, a pressure of the fluid medicament, a flow rate of the fluid medicament, a hardware fault, and an amount of time.
9. The system of claim 8 , wherein the fault condition comprises at least one of an out-of-fluid condition and a time limit condition.
10. The system of claim 1 , wherein the status comprises a system-OK condition.
11. The system of claim 1 , wherein the status comprises at least one of an occlusion condition and a low-reservoir volume condition.
12. The system of claim 1 , wherein the patient attachment unit comprises a variable-volume chamber and a fluid is at least partially contained therein.
13. The system of claim 1 , wherein the variable-volume chamber unit comprises a flexible member and wherein a movement of the flexible member is sensed by the sensing module.
14. The system of claim 1 , wherein the notification module further comprises an alarm.
15. The system of claim 14 , wherein the alarm comprises at least one of an audible alarm, a visual alarm, and a tactile alarm.
16. A method for monitoring a fluid medicament delivery device comprising a patient attachment unit and an indicator unit adapted to be detachably coupled to the patient attachment unit, the method comprising:
independently setting a flow rate of a fluid medicament with a patient attachment unit comprising a reservoir for receiving the fluid medicament therein;
sensing, during a sensing mode, at least one of a pressure and a flow rate of the fluid medicament with a sensor located in a separate indicator unit lacking components for changing the flow rate;
determining a status of the fluid medicament delivery device based at least in part on a result of at least one of the pressure and the flow rate; and
notifying the patient of the status.
17. The method of claim 16 , wherein the patient attachment unit is adapted to be attached to a skin surface of the patient.
18. The method of claim 16 , further comprising initiating the sensing mode upon receipt of an interrupt request.
19. The method of claim 18 , wherein the interrupt request is triggered by an expiration of a sample timer.
20. The method of claim 18 , wherein the interrupt request is triggered by an actuation of a button.
21. The method of claim 16 , further comprising sensing an ambient air pressure.
22. The method of claim 21 , further comprising comparing the ambient air pressure to the fluid pressure.
23. The method of claim 16 , further comprising storing forensic data in a nonvolatile memory.
24. The method of claim 16 , further comprising conducting a system initialization test.
25. The method of claim 24 , wherein the system initialization test comprises a battery power test.
26. The method of claim 25 , further comprising notifying the patient in the event of low battery power.
27. The method of claim 24 , wherein conducting the system initialization test comprises detecting a hardware fault.
28. The method of claim 16 , wherein notifying the patient comprises sending a discreet notification followed by an overt notification.
29. The method of claim 28 , further comprising cancelling the overt notification based at least in part on a request from the patient.
30. The method of claim 16 , wherein notifying the patient comprises sending an audible notification comprising at least two tones.