Medicine delivery device having detachable pressure sensing unit

• US 8,672,873 B2
• Filed: 08/18/2009
• Issued: 03/18/2014
• Est. Priority Date: 08/18/2009
• Status: Active Grant

• Current Assignee: CeQur SA
• Original Assignee: CeQur SA
• Inventors: Gravesen, Peter, Arndt, Heiko, Chiriaev, Serguei
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US12/542,808
• Publication Number:
  US 20110046558A1
• Time in Patent Office: 1,673 Days
• Field of Search: 604/67, 604/141, 604/180, 604/65, 604/890.1, 737/14, 340/522, 340/573.1, 340/603, 340/606, 340/611
• US Class Current: 604/65
• 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 2205/3331 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 2205/581 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 2205/70 with testing or calibration facilities
• 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 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• 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 and a separate indicator unit. The patient attachment unit includes a housing and a fluid channel located therein, wherein at least a portion of the fluid channel includes a flexible member substantially coterminous with the housing. The separate indicator unit is adapted to be detachably coupled to the housing of the patient attachment unit and includes a first sensing element for contacting the flexible member when the indicator unit is coupled to the housing to sense a flexure of the flexible member.

Claims

1. A fluid medicament delivery device comprising:

a patient attachment unit comprising a housing and a fluid channel located therein, wherein at least a portion of the fluid channel comprises a flexible member substantially coterminous with the housing;

a separate indicator unit adapted to be detachably coupled to the housing of the patient attachment unit, the indicator unit comprising a first sensing element for contacting the flexible member when the indicator unit is coupled to the housing, wherein the first sensing element senses a flexure of the flexible member; and

a equalizing membrane exposed to an ambient pressure external to the housing, wherein the equalizing membrane is adapted for enabling analysis of various pressure conditions during operation at different ambient pressures.

2. The fluid medicament delivery device of claim 1, wherein the indicator unit further comprises a second sensing element for sensing the ambient pressure.

3. The fluid medicament delivery device of claim 2, wherein the second sensing element comprises a pressure sensor adapted to sense the ambient pressure, and at least one of a fluid and a gel adapted to transmit the ambient pressure to the pressure sensor.

4. The fluid medicament delivery device of claim 1, wherein the first sensing element comprises a pressure sensor.

5. The fluid medicament delivery device of claim 4, wherein the first sensing element further comprises at least one of a fluid and a gel adapted to contact the flexible member, wherein the flexure of the flexible member is transmitted by the at least one of the fluid and the gel to the pressure sensor.

6. The fluid medicament delivery device of claim 5, wherein the separate indicator unit defines a well for containing at least one of the liquid and the gel.

7. The fluid medicament delivery device of claim 6, wherein the separate indicator unit comprises a raised lip surrounding the well, wherein the raised lip is disposed above a proximate portion of the separate indicator unit.

8. The fluid medicament delivery device of claim 7, wherein the raised lip is adapted to contact the housing of the patient attachment unit.

9. The fluid medicament delivery device of claim 1, wherein the housing comprises a hermetically-sealed housing defining an interior space and comprising the equalizing membrane, the equalizing membrane adapted for transmitting the ambient pressure to the interior space.

10. The fluid medicament delivery device of claim 9, wherein the equalizing membrane is located on a portion of the patient attachment unit facing the separate indicator unit and wherein the second sensing element is located on a portion of the separate indicator unit facing the patient attachment unit, when the patient attachment unit is coupled to the separate indicator unit.

11. The fluid medicament delivery device of claim 1, wherein the patient attachment unit is adapted for adhesion to a skin surface of a patient.

12. The fluid medicament delivery device of claim 1, further comprising a processor adapted for interpreting a signal from a pressure sensor, wherein the signal is sent to the processor based at least in part on the flexure of the flexible member.

13. A method of monitoring pressure within a fluid channel of a fluid medicament delivery device, the method comprising:

measuring an actual pressure of a fluid within the fluid channel across a flexible member;

equalizing an ambient pressure external to the device and an internal pressure across a equalizing membrane;

measuring the ambient pressure external to the device;

calculating a pressure differential based on the actual pressure and the ambient pressure;

comparing the pressure differential to a pressure range comprising a maximum pressure differential and a minimum pressure differential; and

sending a notification when the pressure differential is outside of the pressure range.

14. The method of claim 13, further comprising:

modifying the pressure differential based on the ambient pressure to obtain a corrected pressure differential; and

comparing the corrected pressure differential to the pressure range.

15. The method of claim 13, further comprising:

modifying the maximum pressure differential and a minimum pressure differential of the pressure range based on the ambient pressure to obtain a corrected pressure range; and

comparing the corrected pressure range to the pressure differential.

16. The method of claim 13, wherein when the pressure differential exceeds the maximum pressure differential, the notification comprises at least one of a downstream occlusion notification and a near-empty reservoir notification.

17. The method of claim 13, wherein when the pressure differential is less than the minimum pressure differential, the notification comprises at least one of an upstream occlusion notification and an empty reservoir notification.