Systems and methods for detecting leaks

• US 9,863,837 B2
• Filed: 12/17/2014
• Issued: 01/09/2018
• Est. Priority Date: 12/18/2013
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter, Causey, III, James D.
• Primary Examiner(s): Gibson, Randy
• Assistant Examiner(s): Kidanu, Gedeon M
• Application Number:
  US14/573,868
• Publication Number:
  US 20150198501A1
• Time in Patent Office: 1,119 Days
• Field of Search: 73 405 R
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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: G01M 3/2846 for tubes G01M3/30 takes precedence

Abstract

Various embodiments disclosed herein relate to detecting leaks in a patient monitoring system. The system can include a fluid handling network configured to receive a fluid sample drawn from a patient and to deliver at least a portion of the fluid sample to an analyte measurement system. The system can isolate at least a portion of the fluid handling network, can apply pressure to the at least a portion of the fluid handling network, can measure the pressure in the at least a portion of the fluid handling network, and can determine whether a leak is present in the at least a portion of the fluid handling network based at least in part on the measured pressure.

Claims

1. A bodily fluid sample analysis system comprising:

an analyte measurement system configured to determine concentration of an analyte in a bodily fluid;

a fluid handling network comprising a plurality of tubes and at least one junction between the plurality of tubes, wherein the fluid handling network comprises a patient end configured to receive bodily fluid drawn from a patient, wherein the fluid handling network is configured to provide at least a portion of the drawn bodily fluid to the analyte measurement system;

an arrival sensor configured to detect the arrival of the bodily fluid at a location in the fluid handling network;

one or more valves having a closed position and an open position;

one or more pumps configured to apply pressure to the fluid handling network;

at least one pressure sensor configured to measure pressure in the fluid handling network; and

a controller configured to;

actuate at least one of the one or more pumps to draw bodily fluid from a patient through the patient end into the fluid handling network and to transport the bodily fluid to the location in the fluid handling network associated with the arrival sensor;

receive data from the arrival sensor indicating the arrival of the bodily fluid at the location;

determine whether the fluid handling network is leaking based at least in part on the time that the bodily fluid arrived at the location associated with the arrival sensor;

close at least one of the one or more valves to block fluid flow through a tube between the patient end and the at least one junction;

apply pressure to the fluid handling network using the one or more pumps;

receive data from the at least one pressure sensor regarding a pressure in the fluid handling network;

confirm whether the fluid handling network is leaking based at least in part on the data received from the at least one pressure sensor;

actuate the one or more valves to isolate a first portion of the fluid handling network;

apply pressure to the isolated first portion of the fluid handling network using the one or more pumps;

receive data from the at least one pressure sensor to measure a pressure in the isolated first portion of the fluid handling network;

determine whether the isolated portion of the fluid handling network is leaking based at least in part on the data received from the at least one pressure sensor;

isolate a second portion of the fluid handling network;

apply pressure to the isolated second portion of the fluid handling network;

measure a pressure in the isolated second portion of the fluid handling network; and

determine a location of a leak based at least in part on the measured pressure of the first isolated portion of the fluid handling network and the measured pressure of the second isolated portion of the fluid handling network.

2. The system of claim 1, wherein the controller is configured to determine whether the fluid handling network is leaking by comparing the time that the bodily fluid arrived at the location with an acceptable time threshold.

3. The system of claim 1, wherein the controller is configured to determine whether the fluid handling network is leaking by comparing the time that the bodily fluid arrived at the location with one or more arrival times from one or more previous measurement cycles.

4. The system of claim 1, wherein the controller is configured to cause a sample of bodily fluid to be received into the fluid handling network after determining that the fluid handling network is not leaking.

5. The system of claim 1, wherein the controller is configured to post an alarm after determining that the fluid handling network is leaking.

6. The system of claim 1, wherein the system is configured to perform a plurality of measurement cycles, and wherein the system is configured to check the fluid handling network for leaks before receiving a fluid sample into the fluid handling network for each measurement cycle.

7. The system of claim 1, wherein the first portion of the fluid handling network overlaps at least part of the second portion of the fluid handling network.

8. The system of claim 1, wherein the first portion of the fluid handling network and the second portion of the fluid handling network do not overlap.

9. The system of claim 1, wherein the controller is configured to:

determine whether a leak is present in the first portion of the fluid handling network based at least in part on the measured pressure in the first portion of the fluid handling network; and

determine whether a leak is present in the second portion of the fluid handling network based at least in part on the measured pressure in the second portion of the fluid handling network.

10. The system of claim 1, wherein the controller is configured to output an indicator of the location of the leak.

11. The system of claim 1, wherein the controller is configured to apply more pressure to the fluid handling network when testing for leaks than when providing the at least a portion of the fluid sample to the analyte measurement system.

12. The system of claim 1, wherein the analyte comprises glucose.

13. The system of claim 1, wherein the fluid sample comprises whole blood.

14. The system of claim 1, wherein the controller is configured to determine whether the fluid handling network is leaking based at least in part on the time it takes for the bodily fluid to move from a starting point to the location associated with the arrival sensor.

15. The system of claim 14, further comprising a second arrival sensor configured to detect the arrival of the bodily fluid at the starting point, wherein the controller is configured to receive data from the second arrival sensor indicating the arrival of the bodily fluid at the starting point.

16. The system of claim 14, wherein the starting point is a junction in the fluid handling network and wherein a start time comprises the time that the bodily fluid is drawn through the junction.

17. A patient monitoring system comprising:

an analyte measurement system configured to determine concentration of an analyte in a bodily fluid;

a fluid handling network comprising a plurality of tubes and at least one junction between the plurality of tubes, wherein the fluid handling network comprises a patient end configured to receive bodily fluid drawn from a patient, and wherein the fluid handling network is configured to provide at least a portion of the drawn bodily fluid to the analyte measurement system;

a valve having a closed position and an open position, wherein the closed position blocks fluid flow through a tube between the patient end and the at least one junction, and wherein the open position permits fluid flow through the tube between the patient end and the at least one junction;

at least one pump configured to apply pressure to the fluid handling network;

at least one pressure sensor configured to measure pressure in the fluid handling network; and

a controller configured to;

close the valve to block fluid flow through a tube between the patient end and the at least one junction;

apply pressure to fluid handling network using the at least one pump;

receive data from the at least one pressure sensor regarding a pressure in the fluid handling network;

determine whether the fluid handling network is leaking based at least in part on the data received from the at least one pressure sensor;

actuate one or more valves to isolate a first portion of the fluid handling network;

apply pressure to the first portion of the fluid handling network using the at least one pump;

measure a pressure in the first portion of the fluid handling network using the at least one pressure sensor;

actuate the one or more valves to isolate a second portion of the fluid handling network;

apply pressure to the second portion of the fluid handling network using the at least one pump;

measure a pressure in the second portion of the fluid handling network using the at least one pressure sensor; and

determine a location of a leak based at least in part on the measured pressure of the first portion of the fluid handling network and the measured pressure of the second portion of the fluid handling network.

18. The patient monitoring system of claim 17, wherein the controller is configured to cause a sample of bodily fluid to be drawn into the fluid handling network after determining that the fluid handling network is not leaking.

19. The patient monitoring system of claim 17, wherein the controller is configured to post an alarm after determining that the fluid handling network is leaking.

20. The patient monitoring system of claim 17, wherein the system is configured to perform a plurality of measurement cycles, and wherein the system is configured to check the fluid handling network for leaks before drawing bodily fluid into the fluid handling network for each measurement cycle.

21. The patient monitoring system of claim 17, wherein the first portion of the fluid handling network overlaps at least part of the second portion of the fluid handling network.

22. The patient monitoring system of claim 17, wherein the first portion of the fluid handling network and the second portion of the fluid handling network do not overlap.

23. The patient monitoring system of claim 17, wherein the controller is configured to:

determine whether a leak is present in the first portion of the fluid handling network based at least in part on the measured pressure in the first portion of the fluid handling network; and

determine whether a leak is present in the second portion of the fluid handling network based at least in part on the measured pressure in the second portion of the fluid handling network.

24. The patient monitoring system of claim 17, wherein the controller is configured to output an indicator of the location of the leak.

25. The patient monitoring system of claim 17, wherein the controller is configured to apply more pressure to the fluid handling network when testing for leaks than when drawing bodily fluid or when providing the at least a portion of the drawn bodily fluid to the analyte measurement system.

26. The patient monitoring system of claim 17, wherein the analyte comprises glucose.

27. The patient monitoring system of claim 17, wherein the bodily fluid comprises whole blood.

28. A fluid sample analysis system comprising:

an analyte measurement system configured to determine concentration of an analyte in a fluid sample;

a fluid handling network configured to receive a fluid sample and to provide at least a portion of the fluid sample to the analyte measurement system;

one or more valves having a closed position and an open position;

at least one pump configured to apply pressure to the fluid handling network;

at least one pressure sensor configured to measure pressure in the fluid handling network; and

a controller configured to;

actuate the one or more valves to isolate a first portion of the fluid handling network;

apply pressure to the isolated first portion of the fluid handling network using the at least one pump;

receive data from the at least one pressure sensor to measure a pressure in the isolated first portion of the fluid handling network;

determine whether the isolated first portion of the fluid handling network is leaking based at least in part on the data received from the at least one pressure sensor;

isolate a second portion of the fluid handling network;

apply pressure to the second isolated portion of the fluid handling network;

measure a pressure in the second isolated portion of the fluid handling network; and

determine a location of a leak based at least in part on the measured pressure of the first isolated portion of the fluid handling network and the measured pressure of the second isolated portion of the fluid handling network.

29. The system of claim 28, wherein the controller is configured to cause a fluid sample to be received into the fluid handling network after determining that the fluid handling network is not leaking.

30. The system of claim 28, wherein the controller is configured to post an alarm after determining that the fluid handling network is leaking.

31. The system of claim 28, wherein the system is configured to perform a plurality of measurement cycles, and wherein the system is configured to check the fluid handling network for leaks before receiving a fluid sample into the fluid handling network for each measurement cycle.

32. The system of claim 28, wherein the first portion of the fluid handling network overlaps at least part of the second portion of the fluid handling network.

33. The system of claim 28, wherein the first portion of the fluid handling network and the second portion of the fluid handling network do not overlap.

34. The system of claim 28, wherein the controller is configured to:

determine whether a leak is present in the first portion of the fluid handling network based at least in part on the measured pressure in the first portion of the fluid handling network; and

determine whether a leak is present in the second portion of the fluid handling network based at least in part on the measured pressure in the second portion of the fluid handling network.

35. The system of claim 28, wherein the controller is configured to output an indicator of the location of the leak.

36. The system of claim 28, wherein the controller is configured to apply more pressure to the fluid handling network when testing for leaks than when providing the at least a portion of the fluid sample to the analyte measurement system.

37. The system of claim 28, wherein the analyte comprises glucose.

38. The system of claim 28, wherein the fluid sample comprises whole blood.