Methods for detecting failure states in a medicine delivery device

• US 8,547,239 B2
• Filed: 08/18/2009
• Issued: 10/01/2013
• Est. Priority Date: 08/18/2009
• Status: Active Grant

• Current Assignee: CeQur SA
• Original Assignee: CeQur SA
• Inventors: Peatfield, Greg, Gravesen, Peter
• Primary Examiner(s): La, Anh V
• Application Number:
  US12/542,954
• Publication Number:
  US 20110043357A1
• Time in Patent Office: 1,505 Days
• Field of Search: 340/522, 340/573.1, 340/603, 340/606, 340/611, 604/890.1, 604/65, 604/714, 604/174
• US Class Current: 340/603
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3358 Measuring barometric pressure, e.g. for compensation
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/16886 : for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile

Abstract

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.

Claims

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.