AUTOMATED POINT-OF-CARE FLUID TESTING DEVICE AND METHOD OF USING THE SAME

• US 20090281460A1
• Filed: 05/04/2009
• Published: 11/12/2009
• Est. Priority Date: 05/08/2008
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Brumund, Ryan R., Walsworth, Frank J., Ziegler, John S., Fathallah, Marwan A., Jacobson, James D., Barclay, Brian, Johnson, Thomas D., Lowery, Michael G., Moy, Yei Feng
• Granted Patent: US 8,523,797 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• 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, and an in-line testing region, the pump region adapted to pump the fluid sample from the patient to the testing portion, and to pump a substantial portion of the fluid sample from the primary fluid routing portion back to the patient following testing, the in-line testing region being adapted to evaluate at least a first characteristic 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, the off-line testing portion being further adapted to evaluate a second characteristic of the fluid sample; 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 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 the 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 off-line testing portion 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 fluid transfer region is disposed between the pump region and the in-line testing region of the primary fluid routing portion.

13. The fluid testing system of claim 12, wherein the in-line testing region is located at a distal end of the primary fluid routing portion and the pump region is located at a proximal end of the primary fluid routing portion.

14. The fluid testing system of claim 1 further comprising an optical sensor, the optical sensor being positioned in optical communication with an optical sensing zone of the primary fluid routing portion proximal of the in-line testing region, the optical sensor being adapted to generate an output indicative of an intensity of light passing through the optical sensing zone of the primary fluid routing portion.

15. 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 having a patient connection;

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

the testing system further having an secondary fluid routing portion including an off-line testing portion; and

a communications device;

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

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 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;

determining a second characteristic of the fluid sample in the off-line testing portion;

returning the remaining portion of the fluid sample to the patient, 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.

16. The method of claim 15 further comprising:

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

17. The method of claim 16 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.

18. The method of claim 15 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.

19. The method of claim 15, wherein the fluid connector attaches to an artery of the patient.

20. The method of claim 15 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.

21. The method of claim 15, wherein the fluid connector attaches to a vein of the patient.

22. The method of claim 15 further comprising:

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

23. The method of claim 15, 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.

24. The method of claim 15, wherein the fluid flow is stopped while the fluid sample in the in-line testing region is analyzed.

25. The method of claim 15 further comprising:

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

26. A disposable primary fluid routing portion comprising:

a pump region adapted to interact with a reversible pump to draw a fluid sample into a disposable testing portion for testing and to pump most of the fluid sample out of the disposable testing portion back in the direction from which the fluid sample entered the pump region;

a fluid transfer region adapted to allow a portion of the fluid sample to be transmitted through the fluid transfer region and out of the primary fluid routing portion; and

an in-line testing region, the in-line testing region having an analyzer adapted to analyze the fluid sample to determine a first characteristic of the fluid sample.

27. The disposable primary fluid routing portion of claim 26, wherein the analyzer is a reagent adapted to interact with the fluid sample.

28. The disposable primary fluid routing portion of claim 26, wherein the analyzer is for use with a chemical analysis.

29. The disposable primary fluid routing portion of claim 26, wherein the analyzer is for use with an electrochemical analysis.

30. The disposable primary fluid routing portion of claim 26, wherein the analyzer is for use with an optical analysis.

31. The disposable primary fluid routing portion of claim 26, wherein the in-line testing region is positioned upstream of the fluid transfer region relative to the direction of fluid flow during the fluid draw.

32. The disposable primary fluid routing portion of claim 31, wherein the fluid transfer region is disposed in a fluid passage between the pump region and the in-line testing region.

33. The disposable primary fluid routing portion of claim 32, wherein the in-line testing region is located at a distal end of the primary fluid routing portion and the pump region is located at a proximal end of the primary fluid routing portion.

34. The disposable primary fluid routing portion of claim 26 further comprising a fluid sensing zone having a generally optically transparent region that allows light to pass through the fluid sensing zone, the fluid sensing zone being positioned proximally of the in-line testing region.

35. The disposable primary fluid routing portion of claim 26, wherein the fluid sensing zone has a raised fluid channel adapted to extend above a remainder of a fluid channel within the primary fluid routing portion.