Methods for detecting failure states in a medicine delivery device

• US 9,694,147 B2
• Filed: 09/22/2015
• Issued: 07/04/2017
• Est. Priority Date: 08/18/2009
• Status: Active Grant

• Current Assignee: CeQur SA
• Original Assignee: CeQur SA
• Inventors: Peatfield, Gregory H., Gravesen, Peter
• Primary Examiner(s): La, Anh V
• Application Number:
  US14/860,951
• Publication Number:
  US 20160022926A1
• Time in Patent Office: 651 Days
• Field of Search: 34087028, 3403097, 34030916, 340603, 604 31, 604506, 604 65, 604111, 604500, 604151
• 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 delivering a fluid medicament contained therein to a patient; and

an indicator unit adapted to be coupled to the patient attachment unit, the indicator unit comprising;

a timer adapted to measure a usage time of the system;

a processor in electrical communication with the timer; and

a memory in electrical communication with the processor, the memory comprising instructions which program the processor to;

receive an input from the patient;

in response to the input;

compare the usage time of the system to a first threshold operating time that is based on an expected time of use of the system, the expected time of use being based, at least in part, on a fluid storage capacity of the system, and

determine if the first threshold operating time has elapsed; and

provide the patient with an appropriate response.

2. The system of claim 1, wherein, if the first threshold operating time has elapsed, the appropriate response comprises a warning signal relating to replacement of the patient attachment unit.

3. The system of claim 1, wherein, if the first threshold operating time has not elapsed, the appropriate response comprises at least one of:

(i) a normal-operation response, and (ii) no response.

4. The system of claim 1, wherein the instructions further program the processor to:

determine if a second threshold operating time has elapsed; and

if the second threshold operating time has elapsed, provide the patient with a patient attachment unit replace notification.

5. The system of claim 4, wherein the first threshold operating time is at least about two-thirds as long as the second threshold operating time.

6. The system of claim 4, wherein the instructions further program the processor to determine if the second threshold operating time has elapsed without input received from the patient.

7. The system of claim 4, wherein the replace notification comprises at least one of a greater magnitude, a greater frequency, and a different notification type than the warning signal.

8. The system of claim 4, wherein at least one of the warning signal and the replace notification comprise a notification type selected from the group consisting of a visual alert, an audible alert, and a tactile alert.

9. The system of claim 4, wherein the instructions further program the processor to:

determine that at least one subsequent time interval has elapsed since the second operating threshold operating time elapsed; and

after each subsequent time interval has elapsed, provide the patient with a subsequent patient attachment unit replace notification.

10. The system of claim 9, wherein the subsequent time interval comprises no greater than 30 minutes.

11. The system of claim 9, wherein each subsequent patient attachment unit replace notification comprises at least one of a greater magnitude, a greater frequency, and a different notification type than a previous patient attachment unit replace notification.

12. The system of claim 9, wherein the instructions further program the processing unit to:

determine if an acknowledgement input has been received from the patient; and

if the acknowledgement input has been received, stop providing the patient with the subsequent patient attachment unit replace notification.

13. The system of claim 4, wherein the instructions further program the processor to:

determine if a third threshold operating time has elapsed; and

if the third threshold operating time has elapsed, provide the patient with an empty notification.

14. The system of claim 13, wherein the empty notification comprises at least one of a greater magnitude, a greater frequency, and a different notification type than the replace notification.

15. The system of claim 13, further comprising:

a notification module adapted to provide the patient with at least one of the warning signal, the replace notification, and the empty notification.

16. The system of claim 1, further comprising:

an indicator button to receive the input by the patient.

17. A method of operating a fluid medicament delivery device, the method comprising the steps of:

measuring a usage time of a system by a non-transitory processor, the system comprising a patient attachment unit for delivering a fluid medicament contained therein to a patient and an indicator unit adapted to be coupled to the patient attachment unit;

receiving an input from the patient;

in response to the input;

comparing the usage time of the system to a first threshold operating time that is based on an expected time of use of the system, the expected time of use being based, at least in part, on a fluid storage capacity of the system, and

determining if a first threshold operating time has elapsed; and

providing the patient with an appropriate response.

18. The method of claim 17, wherein, if the first threshold operating time has elapsed, the providing step comprises providing the patient with a warning signal relating to replacement of the patient attachment unit.

19. The method of claim 17, wherein, if the first threshold operating time has not elapsed, the providing step comprises providing the patient with at least one of:

(i) a normal-operation response, and (ii) no response.

20. The method of claim 17, further comprising:

determining if a second threshold operating time has elapsed; and

if the second threshold operating time has elapsed, providing the patient with a patient attachment unit replace notification.

21. The method of claim 20, wherein the first operating threshold is at least about two-thirds as long as the second threshold operating time.

22. The method of claim 20, further comprising:

determining if the second threshold operating time has elapsed without receiving input from the patient.

23. The method of claim 20, wherein the patient attachment unit replace notification comprises at least one of a greater magnitude, a greater frequency, and a different notification type than the warning signal.

24. The method of claim 20, wherein at least one of the warning signal and the patient attachment unit replace notification comprise a notification type selected from the group consisting of a visual alert, an audible alert, and a tactile alert.

25. The method of claim 20, further comprising:

determining that at least one subsequent time interval has elapsed since the second operating threshold operating time elapsed; and

after each subsequent time interval has elapsed, providing the patient with a subsequent patient attachment unit replace notification.

26. The method of claim 25, wherein the subsequent time interval comprises no greater than 30 minutes.

27. The method of claim 25, wherein each subsequent patient attachment unit replace notification comprises at least one of a greater magnitude, a greater frequency, and a different notification type than a previous patient attachment unit replace notification.

28. The method of claim 25, further comprising:

determining if an acknowledgement input has been received from the patient; and

if the acknowledgement input has been received, stop providing the patient with the subsequent patient attachment unit replace notification.

29. The method of claim 20, further comprising:

determining if a third threshold operating time has elapsed; and

if the third threshold operating time has elapsed, providing the patient with an empty notification.

30. The method of claim 29, wherein the empty notification comprises at least one of a greater magnitude, a greater frequency, and a different notification type than the patient attachment unit replace notification.