Methods for detecting failure states in a medicine delivery device

• US 10,226,588 B2
• Filed: 06/28/2017
• Issued: 03/12/2019
• 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:
  US15/635,248
• Publication Number:
  US 20170290997A1
• Time in Patent Office: 622 Days
• Field of Search: 340603, 340522, 3405731, 340606, 604 65, 604 67, 604506, 6048901
• 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 comprising a pressure sensor chamber disposed along a basal flow path, wherein the pressure sensor chamber comprises a sensor membrane; and

an indicator unit configured to be detachably coupled to the patient attachment unit, wherein the indicator unit comprises a pressure sensor in communication with the pressure sensor chamber, wherein the indicator unit comprises a well in which the pressure sensor is disposed, and wherein the well is filled with a gel to form a meniscus.

2. The system of claim 1, wherein the well comprises a raised lip.

3. The system of claim 2, wherein the raised lip is configured to abut a mounting platform of the patient attachment unit.

4. The system of claim 1, wherein the meniscus and the sensor membrane abut each other.

5. The system of claim 4, wherein deflections in the sensor membrane are configured to apply pressure to the meniscus of the gel, which transmits the pressure to the pressure sensor.

6. The system of claim 1, further comprising an ambient air channel formed between the patient attachment unit and the indicator unit.

7. The system of claim 6, further comprising a flexible pressure equalizing membrane disposed in the patient attachment unit, wherein the flexible pressure equalizing membrane is in communication with the ambient air channel.

8. The system of claim 6, further comprising a second pressure sensor disposed within the indicator unit.

9. The system of claim 8, wherein the indicator unit further comprises a second well in which the second pressure sensor is disposed.

10. The system of claim 9, wherein the second well is filled with a gel to form a meniscus, which is in communication with the ambient air channel.

11. A system for monitoring a fluid medicament delivery device, the system comprising:

a patient attachment unit comprising a mounting platform and a pressure sensor chamber disposed along a basal flow path, wherein the pressure sensor chamber comprises a sensor membrane; and

an indicator unit configured to be detachably coupled to the patient attachment unit, wherein the indicator unit comprises a pressure sensor disposed in a well having a raised lip, wherein the well is filled with a gel to form a meniscus, and wherein the pressure sensor is in communication with the pressure sensor chamber,

wherein the raised lip is configured to abut the mounting platform to form an ambient air channel between the patient attachment unit and the indicator unit.

12. The system of claim 11, wherein the meniscus and the sensor membrane abut each other.

13. The system of claim 12, wherein deflections in the sensor membrane are configured to apply pressure to the meniscus of the gel, which transmits the pressure to the pressure sensor.

14. The system of claim 11, further comprising a flexible pressure equalizing membrane disposed in the patient attachment unit, wherein the flexible pressure equalizing membrane is in communication with the ambient air channel.

15. The system of claim 11, further comprising a second pressure sensor disposed within the indicator unit.

16. The system of claim 15, wherein the indicator unit further comprises a second well in which the second pressure sensor is disposed, wherein the second well is filled with a gel to form a meniscus that is in communication with the ambient air channel.

17. A method for monitoring a fluid medicament delivery device, the method comprising:

providing a patient attachment unit comprising a pressure sensor chamber disposed along a basal flow path;

providing an indicator unit configured to be detachably coupled to the patient attachment unit, wherein the indicator unit comprises a pressure sensor in communication with the pressure sensor chamber, wherein the indicator unit comprises a well in which the pressure sensor is disposed, and wherein the well is filled with a gel to form a meniscus; and

determining a pressure condition in the basal flow path.

18. A system for monitoring a fluid medicament delivery device, the system comprising:

a patient attachment unit comprising a pressure sensor chamber disposed along a basal flow path, wherein the pressure sensor chamber comprises a sensor membrane; and

an indicator unit configured to be detachably coupled to the patient attachment unit, wherein the indicator unit comprises a pressure sensor in communication with the pressure sensor chamber;

an ambient air channel formed between the patient attachment unit and the indicator unit;

a second pressure sensor disposed within the indicator unit, wherein the indicator unit comprises a second well in which the second pressure sensor is disposed.