Automated point-of-care fluid testing device and method of using the same

• US 8,523,797 B2
• Filed: 05/04/2009
• Issued: 09/03/2013
• Est. Priority Date: 05/08/2008
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Lowery, Michael G., Fathallah, Marwan A., Ziegler, John S., Brumund, Ryan R., Barclay, Brian, Walsworth, Frank J., Jacobson, James D., Moy, Yei Feng, Johnson, Thomas D.
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): Leedy, Megan
• Application Number:
  US12/435,074
• Publication Number:
  US 20090281460A1
• Time in Patent Office: 1,583 Days
• Field of Search: 600/573, 600575-579, 604/4.01, 604/5.01, 604/6.05, 604/6.07, 604/6.1, 604/6.11, 604/27, 604 65- 67
• US Class Current: 604/4.01
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member

Abstract

A point of care fluid testing system for determining properties of a fluid comprises a patient connection, a primary fluid routing portion, a pump, a secondary fluid routing portion, and a flushing fluid connection. The patient connection connects the system to a patient. The primary fluid routing portion has a pump region, a fluid transfer region, and an in-line testing region. The pump region pumps the fluid sample from the patient to the testing portion and back to the patient. The in-line testing region evaluates a first characteristic of the fluid sample. The fluid transfer region transmits a portion of the fluid sample out of the primary fluid routing portion. The secondary fluid routing portion includes an off-line testing portion that receives the portion of the fluid sample transmitted from the fluid transfer region. The off-line testing portion evaluates a second characteristic of the fluid sample.

Claims

1. A point of care fluid testing system for determining properties of a fluid comprising:

a patient connection adapted to connect the system to a patient to collect a fluid sample;

a primary fluid routing portion having a pump region, a fluid transfer region comprising a valve, and an in-line testing region, the fluid transfer region disposed between the pump region and the in-line testing region of the primary fluid routing portion, the pump region adapted to pump the fluid sample from the patient to the in-line testing portion, and to pump a portion of the fluid sample from the primary fluid routing portion back to the patient following testing, the in-line testing region comprising a first sensor adapted to evaluate at least a first characteristic, comprising a concentration of an analyte, of the fluid sample, and the fluid transfer region being adapted to allow a portion of the fluid sample to be transmitted out of the primary fluid routing portion;

a pump that interacts with the pump region of the primary fluid routing portion;

a secondary fluid routing portion including an off-line testing portion adapted to receive the portion of the fluid sample transmitted out of the primary fluid routing portion via the fluid transfer region when the valve is in an open position, and adapted to close-off the portion of the fluid sample received from the primary fluid routing portion in the off-line testing portion when the valve is in a closed position so that the portion of the fluid sample in the off-line testing portion is prevented from flowing back into the primary fluid routing portion, the off-line testing portion comprising a second sensor adapted to evaluate a second characteristic of the fluid sample;

a main body comprising a housing, the first sensor of the in-line testing region and the second sensor of the off-line testing portion both disposed within the housing; and

a flushing fluid connection adapted to connect the system to a flushing fluid to flush the system following the pumping of the fluid sample back to the patient.

2. The fluid testing system of claim 1 further comprising a communications device adapted to communicate information regarding the first characteristic and the second characteristic of the fluid sample to a receiving device.

3. The fluid testing system of claim 1, wherein the fluid comprises blood.

4. The fluid testing system of claim 1, wherein the first characteristic of the fluid sample comprises a glucose level of the fluid sample.

5. The fluid testing system of claim 1, wherein the second characteristic of the fluid sample comprises a coagulation rate of the fluid sample.

6. The fluid testing system of claim 2, wherein the communication device wirelessly communicates with the receiving device.

7. The fluid testing system of claim 2, wherein the receiving device comprises an infusion pump.

8. The fluid testing system of claim 1, wherein the second sensor comprises a sensor pack having a plurality of test sensors used sequentially over a number of tests.

9. The fluid testing system of claim 1, wherein the pump is a peristaltic pump.

10. The fluid testing system of claim 1, wherein the first characteristic and the second characteristic are the same.

11. The fluid testing system of claim 1, wherein the first characteristic and the second characteristic are different.

12. The fluid testing system of claim 1 wherein the first sensor comprises an optical sensor, the optical sensor positioned in optical communication with an optical sensing zone of the primary fluid routing portion, the optical sensor adapted to generate an output indicative of an intensity of light passing through the optical sensing zone of the primary fluid routing portion.

13. The fluid testing system of claim 1 wherein the primary fluid routing portion and the secondary fluid routing portion are both disposable.

14. The fluid testing system of claim 1 wherein the housing comprises a primary fluid routing portion access door for accessing the in-line testing region, and a secondary fluid routing portion access door for accessing and removing or replacing the second sensor of the off-line testing portion while the valve is in the closed position without disrupting the flow of the fluid sample in the primary fluid routing portion.

15. The fluid testing system of claim 1 further comprising a member for attaching the housing to a patient.

16. The fluid testing system of claim 1 wherein the fluid transfer region comprises a valve plug that is configured to be moved into a first position apart from a valve nozzle to place the valve in the open position and allow the fluid sample to flow from the fluid transfer region into the off-line testing portion, and which is configured to be moved into a second position against the valve nozzle to place the valve in the closed position to prevent the portion of the fluid sample in the off-line testing portion from flowing back into the primary fluid routing portion.

17. The fluid testing system of claim 16 further comprising a valve pin, and a camshaft, wherein the camshaft is configured to move the valve pin to controllably move the valve plug between the first and second positions.

18. The fluid testing system of claim 17 further comprising a diaphragm, and a diaphragm pin, wherein the camshaft is configured to move the diaphragm pin towards the diaphragm to prevent the fluid sample from flowing through a fluid channel in the fluid transfer region and to move the diaphragm pin in a direction away from the diaphragm to allow the fluid sample to flow through the fluid channel.

19. The fluid testing system of claim 1 wherein the secondary fluid routing portion further comprises a sensor indexer which rotates a carousel carrying the second sensor comprising a plurality of off-line test sensors.

20. The fluid testing system of claim 19 wherein the secondary fluid routing portion further comprises a heater for controllably heating the plurality of off-line test sensors.

21. The fluid testing system of claim 20 wherein the secondary fluid routing portion further comprises a thermistor for monitoring temperature of the plurality of off-line test sensors.

22. The fluid testing system of claim 15 wherein the member comprises a strap.

23. A method of evaluating at least two characteristics of a fluid sample of a patient comprising:

attaching a fluid connector to a patient;

providing a fluid testing system for determining properties of a fluid, the fluid testing system comprising;

a patient connection;

a primary fluid routing portion having a pump region, a fluid transfer region comprising a valve, and an in-line testing region comprising a first sensor, the fluid transfer region being disposed between the pump region and the in-line testing region of the primary fluid routing portion;

a secondary fluid routing portion including an off-line testing portion comprising a second sensor; and

a communications device;

connecting the fluid connector to the patient connection of the testing system;

installing the first sensor of the primary fluid routing portion and the second sensor of the secondary fluid routing portion within at least one opening of a main body comprising a housing;

collecting a fluid sample from the patient via the fluid connector and the patient connection using the pump region of the testing system to draw the fluid sample from the patient to the primary fluid routing portion of the testing device;

analyzing the fluid sample in the in-line testing region of the primary fluid routing portion to determine a first characteristic, comprising a concentration of an analyte, of the fluid sample;

transferring a portion of the fluid sample through the fluid transfer portion of the primary fluid routing portion to the off-line testing portion of the secondary fluid routing portion while the valve is in an open position, and then closing the valve to prevent the transferred portion of the fluid sample in the off-line testing portion from flowing back into the primary fluid routing portion;

determining a second characteristic of the fluid sample in the off-line testing portion while the valve is closed; and

returning the remaining portion of the fluid sample in the primary fluid routing portion to the patient while the valve is closed, following the act of transferring, via the fluid connector and the patient connection using the pump region of the testing system to pump the fluid sample back into the patient.

24. The method of claim 23 further comprising:

transmitting data indicative of the first characteristic and the second characteristic of the fluid sample wirelessly to a receiving device.

25. The method of claim 24 further comprising:

recording the results of the first characteristic and the second characteristic of the fluid sample electronically into the patient'"'"'s electronic medical record.

26. The method of claim 23 further comprising:

flushing the fluid testing system with a flushing fluid to remove the fluid sample, including flushing the fluid transfer region of the primary fluid routing portion and the fluid connector connected to the patient.

27. The method of claim 23, wherein the fluid connector is attached to an artery or vein of the patient.

28. The method of claim 23 further comprising:

modifying at least one medication dosage provided to the patient based on the determined first characteristic of the fluid sample or the second characteristic of the fluid sample.

29. The method of claim 23 further comprising:

flushing the fluid testing system with a flushing fluid to calibrate the in-line testing region of the primary fluid routing portion.

30. The method of claim 23, wherein the analyzing the fluid sample in the in-line testing region and the transferring a portion of the fluid sample through the fluid transfer portion of the primary fluid routing portion to the off-line testing portion occur nearly simultaneously.

31. The method of claim 23, wherein the fluid flow is stopped while the fluid sample in the in-line testing region is analyzed.

32. The method of claim 23 further comprising:

ascertaining an identity of the fluid sample within the in-line testing region using the first sensor comprising an optical sensor.

33. The method of claim 23 further comprising attaching the housing to the patient.

34. The method of claim 23 further comprising attaching the housing to the patient with a strap.

35. The method of claim 23 further comprising accessing the in-line testing region by opening a primary fluid routing portion access door of the housing.

36. The method of claim 23 further comprising accessing the off-line testing portion by opening a secondary fluid routing portion access door of the housing, while the valve is closed, and removing or replacing the second sensor of the off-line testing portion without disrupting the flow of the fluid sample in the primary fluid routing portion.

37. The method of claim 23 further comprising disposing of at least one of the primary fluid routing portion, the pump region, the fluid transfer region, the in-line testing region, or the secondary fluid routing portion.

38. A method of evaluating at least two characteristics of a fluid sample of a patient comprising:

attaching a fluid connector to a patient;

providing a fluid testing system for determining properties of a fluid, the fluid testing system comprising;

a patient connection;

a primary fluid routing portion having a pump region, a fluid transfer region comprising a valve, and an in-line testing region comprising a first sensor;

a secondary fluid routing portion including an off-line testing portion comprising a second sensor; and

a communications device;

connecting the fluid connector to the patient connection of the testing system;

installing the first sensor of the primary fluid routing portion and the second sensor of the secondary fluid routing portion within at least one opening of a main body comprising a housing;

collecting a fluid sample from the patient via the fluid connector and the patient connection using the pump region of the testing system to draw the fluid sample from the patient to the primary fluid routing portion of the testing device;

analyzing the fluid sample in the in-line testing region of the primary fluid routing portion to determine a first characteristic, comprising a concentration of an analyte, of the fluid sample;

transferring a portion of the fluid sample through the fluid transfer portion of the primary fluid routing portion to the off-line testing portion of the secondary fluid routing portion while the valve is in an open position, and then closing the valve to prevent the transferred portion of the fluid sample in the off-line testing portion from flowing back into the primary fluid routing portion;

determining a second characteristic of the fluid sample in the off-line testing portion while the valve is closed;

returning the remaining portion of the fluid sample in the primary fluid routing portion to the patient while the valve is closed, following the act of transferring, via the fluid connector and the patient connection using the pump region of the testing system to pump the fluid sample back into the patient; and

accessing the off-line testing portion by opening a secondary fluid routing portion access door of the housing, while the valve is closed, and removing or replacing the second sensor of the off-line testing portion without disrupting the flow of the fluid sample in the primary fluid routing portion.