MEDICINE DELIVERY DEVICE HAVING DETACHABLE PRESSURE SENSING UNIT

• US 20110046558A1
• Filed: 08/18/2009
• Published: 02/24/2011
• Est. Priority Date: 08/18/2009
• Status: Active Grant

• Current Assignee: CeQur SA
• Original Assignee: CeQur SA
• Inventors: Arndt, Heiko, Chiriaev, Serguei, Gravesen, Peter
• Granted Patent: US 8,672,873 B2
• Time in Patent Office: Days
• US Class Current: 604/180
• 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; and

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.

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

3. The fluid medicament delivery device of claim 2, wherein the pressure external to the housing comprises an ambient pressure.

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 2, wherein the second sensing element comprises a pressure sensor adapted to sense the pressure external to the housing, and at least one of a fluid and a gel adapted to transmit the pressure external to the housing to the pressure sensor.

10. The fluid medicament delivery device of claim 2, wherein the housing comprises a hermetically-sealed housing defining an interior space and comprising at least one substantially flexible housing portion, the substantially flexible housing portion adapted for transmitting the pressure external to the housing to the interior space.

11. The fluid medicament delivery device of claim 10, wherein the substantially flexible housing portion 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.

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

13. 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.

14. 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;

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

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

15. The method of claim 14, further comprising measuring a pressure external to the fluid medicament delivery device.

16. The method of claim 15, further comprising:

modifying the actual pressure based on the external pressure to obtain a corrected pressure; and

comparing the corrected pressure to the pressure range.

17. The method of claim 15, further comprising:

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

comparing the corrected pressure range to the actual pressure.

18. The method of claim 14, wherein when the actual pressure exceeds the maximum pressure, the notification comprises at least one of a downstream occlusion notification and a near-empty reservoir notification.

19. The method of claim 14, wherein when the actual pressure is less than the minimum pressure, the notification comprises at least one of an upstream occlusion notification and an empty reservoir notification.

20. A method of manufacturing a pressure sensing element, the method comprising:

securing a pressure sensor to a base;

securing a template defining a well therein to the base, such that the pressure sensor is located in a bottom portion of the well;

filling at least partially the well with a gel comprising a substantially liquid state, wherein the well comprises a filled portion and an unfilled portion, wherein the filled portion and the unfilled portion are characterized by a presence or an absence of gel;

solidifying the gel in the filled portion to a substantially gelled state; and

filling the unfilled portion with a gel comprising a substantially liquid state.