FLOW CONTROL VALVES FOR LEAKAGE DETECTION, FREE-FLOW PREVENTION AND OCCLUSION DETECTION

• US 20120059313A1
• Filed: 02/25/2011
• Published: 03/08/2012
• Est. Priority Date: 08/27/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International Ltd.
• Inventors: Shergold, Oliver
• Granted Patent: US 8,568,349 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

An injection device for injecting a fluid into an organism, in particular a human or animal body, which can comprise a fluid providing section including a container for storing the fluid and a supply means for supplying the fluid. The fluid injecting section for injecting the fluid provided by the fluid providing section into the organism includes a catheter means and is characterized by the fluid injecting section being provided with a pressure recognition arrangement which can be located close to and/or in the catheter means for detecting a pressure increase and/or a pressure loss.

Claims

1. An injection device for injecting a fluid into an organism the injection device comprising:

a fluid providing section including a container for storing the fluid and a supply means for supplying the fluid; and

a fluid injecting section for injecting the fluid provided by the fluid providing section into the organism and includes a catheter means, wherein

the fluid injecting section is provided with a pressure recognition arrangement located at least close to the catheter means for detecting at least one of a pressure increase and a pressure loss.

2. The injection device according to claim 1, wherein the fluid injecting section further comprises at least one control valve for maintaining a pressure in the fluid injecting section.

3. The injection device according to claim 1, further comprises a controller configured to operate the pressure recognition arrangement.

4. The injection device according to claim 2, wherein at least two of the control valves have pressures at which flow through the control valves is enabled which are different from one another.

5. The injection device according to claim 4, wherein the control valves are arranged such that the pressures of the control valves, at which flow through the control valves is enabled, increase downstream along the fluid injecting section downstream from the supply means.

6. The injection device according to claim 1, further comprises a permanent memory configured to store at least one reference value for the pressure of the fluid.

7. The injection device according to claim 1, wherein the supply means comprises a pump unit.

8. The injection device according to claim 1, wherein the supply means comprises both a driven member and a displacement member.

9. The injection device according to claim 1, further comprises a controller configured to extrapolate a time series of measured pressure values in the fluid injecting section and to send a signal to an alarm device if the extrapolated values attain a certain relation to at least one given reference pressure value.

10. The injection device according to claim 1, further comprises a fluid pressure sensor for sensing at least one of pressure, occlusion and leakage in the fluid injecting section for sending a measured value to a controller, the controller comparing the measured value to at least one reference value and outputting a result of this comparison based on the result an information signal is supplied.

11. The injection device according to claim 10, wherein the information signal is sent to an alarm device, which information signal can give rise to a corresponding information emitted by the alarm device.

12. The injection device according to claim 2, wherein the control valve is located in an infusion set in a part of the fluid injecting section stretching from a connection of a part of the infusion set lying immediately downstream of the connection between a constituent of the fluid injecting section located upstream of the upstream end of the infusion set to a part of the infusion set which lies immediately upstream of a connection between a constituent of the fluid injecting section located downstream of the downstream end of the infusion set.

13. The injection device according to claim 1, further comprising a multitude of control valves with different pressures at which flow through the control valves is enabled, wherein the control valve with the highest pressure at which flow through the control valves is enabled is located in an infusion set in a part of the fluid injecting section stretching from a connection of a part of the infusion set which lies immediately downstream of the connection between the constituent of the flow path located upstream of the upstream end of the infusion set to a part of the infusion set which lies immediately upstream of a connection between a constituent of the fluid injecting section located downstream of the downstream end of the infusion set.

14. A method of controlling an injection device according to claim 1 comprising:

providing a control unit to operate the pressure recognition arrangement of the injection device, said control device measures the pressure in the fluid injecting section and compares the measured pressure value to at least one reference pressure value and a predetermined interval around the reference pressure value, and if the measured pressure value is not equal to the at least one reference pressure value or does not lie within a predetermined interval around the reference pressure value, the control unit stops a driving unit which is operably connected to the fluid providing section of the injection device.

15. The method of claim 14, further comprising issuing an alarm.

16. The method of claim 14, further comprising:

checking whether the pressure recognition arrangement is in a state to detect a pressure increase or a pressure loss; and

if the pressure recognition arrangement is not in a state to detect a pressure increase or a pressure loss, enable the pressure recognition arrangement to detect a pressure increase or a pressure loss.

17. The method of claim 14, further comprising at least one of the following steps:

if the position of a driven member of the injection device is not in accordance with a predetermined position of the driven member relative to the measured pressure value, stopping the driving unit;

driving the driven member such that the pressure in the fluid injecting section is reduced; and

emitting a signal based on the comparison of the measured pressure value to at least one of the reference pressure value and a predetermined interval around the reference pressure value.