FLUID HANDLING CASSETTE

• US 20110190606A1
• Filed: 03/11/2011
• Published: 08/04/2011
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Zheng, Peng, Li, Kenneth I., Wechsler, Mark, Keenan, Richard
• Granted Patent: US 8,491,501 B2
• Time in Patent Office: Days
• US Class Current: 600/310
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• 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 5/150862 : intermediate range, e.g. within room or building
• 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: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/14212 : Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/38 : using hydrophilic or hydrophobic filters
• CPC Class Codes: G01N 2021/3595 : using FTIR
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/3577 : for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 2201/02 : Mechanical
• CPC Class Codes: G01N 2201/061 : Sources
• CPC Class Codes: Y10T 137/4478 : Line condition change responsive
• CPC Class Codes: Y10T 137/7722 : Line condition change responsive valves
• CPC Class Codes: Y10T 137/86485 : Line condition change responsive release of valve
• CPC Class Codes: Y10T 436/111666 : Utilizing a centrifuge or compartmented rotor
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

A fluid handling module that is removably engageable with a bodily fluid analyzer is provided. The module may comprise a fluid handling element, and a fluid component separator that is accessible via the fluid handling element and configured to separate at least one component of a bodily fluid transported to the fluid component separator. The fluid handling element may have at least one control element interface.

Claims

1. A cassette with a rotatable rotor and sample element for use with a fluid analysis system, the cassette comprising:

(i) a housing;

(ii) a fluid handling network comprising;

a patient end configured to be placed in fluid communication with a bodily fluid of a patient; and

one or more fluid passageways configured to transport the bodily fluid from the patient end through the fluid analysis system;

(iii) a fluid interface comprising;

a first fluid probe movable between an extended position and a retracted position, wherein the first fluid probe is configured for injection and/or removal of fluid;

a second fluid probe movable between an extended position and a retracted position, wherein the second fluid probe is configured for injection and/or removal of fluid;

a first fluid connector providing fluid communication between the first fluid probe and the one or more fluid passageways; and

a second fluid connector providing fluid communication between the second fluid probe and the one or more fluid passageways; and

(iv) a rotor configured to rotate with respect to the housing, wherein the rotation of the rotor is about an axis, the rotor comprising;

an interface configured to engage a drive system of the fluid analysis system and rotate the rotor at least between a sample loading position and a bypass position;

a first port configured to receive the first fluid probe when the rotor is in the sample loading position and when the first fluid probe is in the extended position;

a second port configured to receive the second fluid probe when the rotor is in the sample loading position and when the second fluid probe is in the extended position;

a sample element configured to rotate with the rotor and configured to hold a sample portion of the bodily fluid, wherein the sample element is configured to receive a sample portion of the bodily fluid from the fluid handling network through the first port and/or the second port;

a third port configured to receive the first fluid probe when the rotor is in the bypass position and when the first fluid probe is in the extended position;

a fourth port configured to receive the second fluid probe when the rotor is in the bypass position and when the second fluid probe is in the extended position; and

a bypass forming a fluid connection between the third port and the fourth port such that fluid can pass between the first fluid probe and the second fluid probe without passing through the sample element.

2. The cassette of claim 1, wherein the first fluid probe and the second fluid probe do not contact the rotor when in the retracted position such that the rotor is free to rotate about the axis.

3. The cassette of claim 1, wherein the rotor is a centrifuge rotor configured to rotate fast enough to separate components of the sample portion of the bodily fluid in the sample element.

4. The cassette of claim 1, wherein the cassette is a disposable unit.

5. The cassette of claim 1, wherein the first fluid probe and the second fluid probe are coupled together such that the first fluid probe and the second fluid probe move together between the extended position and the retracted position.

6. The cassette of claim 1, wherein the housing is configured to engage a housing of the fluid analysis system to secure the cassette to the fluid analysis system.

7. The cassette of claim 1, further comprising the fluid analysis system.

8. The cassette of claim 7, wherein the fluid analysis system comprises a fluid analyzing sensor, and wherein the sample element aligns with the fluid analyzing sensor when the rotor is in the bypass position.

9. The cassette of claim 8, wherein the fluid analyzing sensor is configured to analyze the sample portion of the bodily fluid using electrochemical methods.

10. The cassette of claim 8, wherein the fluid analyzing sensor is an optical sensor configured to analyze the sample portion of the bodily fluid using colorimetric methods.

11. The cassette of claim 1, wherein sample element comprises a window configured to allow light of an optical fluid analyzing sensor of the fluid analysis system to pass through the sample portion of the bodily fluid contained in the sample element.

12. The cassette of claim 1, wherein the first fluid probe and the second fluid probe are biased toward the retracted position and are configured to be moved to the extended position by an actuator.

13. A disposable cassette with an integrated rotor and rotatable sample element for use with a fluid analysis system, the cassette comprising:

(i) a housing;

(ii) a fluid handling network comprising;

a patient end configured to be placed in fluid communication with a bodily fluid of a patient; and

one or more fluid passageways configured to transport some of the bodily fluid from the patient end through the fluid analysis system;

(iii) a rotor configured to rotate with respect to the housing, the rotation of the rotor being about an axis;

(iv) a sample element configured to rotate with the rotor and hold a sample portion of the bodily fluid; and

(v) a fluid interface configured for fluid communication between the fluid handling network and the sample element, thereby allowing the sample element to receive a sample portion of the bodily fluid from the fluid handling network through the fluid interface, when;

the rotor is in a sample loading position with respect to the fluid interface; and

the fluid interface is in a filling position with respect to the sample element; and

(vi) a mechanical interface configured to engage a drive system of the fluid analysis system for rotating the rotor, wherein the rotor is configured for rotation when the fluid interface is in a non-filling position with respect to the sample element, which avoids contact with the rotor and allows the rotor to freely rotate about the axis.

14. The cassette of claim 13, wherein the fluid interface comprises a first fluid probe in fluid communication with a first portion of the fluid handling network and a second fluid probe in fluid communication with a second portion of the fluid handling network.

15. The cassette of claim 14, wherein the rotor comprises:

a first port configured to receive the first injection probe when the rotor is in the sample loading position and when the fluid interface is in the filling position; and

a second port configured to receive the second fluid probe when the rotor is in the sample loading position and when the fluid interface is in the filling position.

16. The cassette of claim 13, wherein the rotor is a centrifuge rotor configured to rotate fast enough to separate components of the sample portion of the bodily fluid in the sample element.

17. The cassette of claim 13, wherein the cassette is a disposable unit.

18. The cassette of claim 13, wherein the housing is configured to engage a housing of the fluid analysis system to secure the cassette to the fluid analysis system.

19. The cassette of claim 13, further comprising the fluid analysis system.

20. The cassette of claim 19, wherein the fluid analysis system comprises a fluid analyzing sensor, and wherein the sample element aligns with the fluid analyzing sensor when the rotor is in an analysis position.

21. The cassette of claim 20, wherein the fluid analyzing sensor is configured to analyze the sample portion of the bodily fluid using electrochemical methods.

22. The cassette of claim 20, wherein the fluid analyzing sensor is an optical sensor configured to analyze the sample portion of the bodily fluid using colorimetric methods.

23. The cassette of claim 13, wherein sample element comprises a window configured to allow light of an optical fluid analyzing sensor of the fluid analysis system to pass through the sample portion of the bodily fluid contained in the sample element.

24. The cassette of claim 13, wherein the fluid interface is biased toward the non-filling position and is configured to be moved to the filling position by an actuator of the fluid analysis system.

25. A cassette for use with a fluid analysis system, the cassette comprising:

(i) a housing;

(ii) a fluid handling network comprising;

a patient end configured to be placed in fluid communication with a bodily fluid of a patient; and

one or more fluid passageways configured to transport the bodily fluid from the patient end through the fluid analysis system;

(iii) a fluid interface comprising;

a first fluid probe movable between an abutting position and a separated position, wherein the first fluid probe is in fluid communication with the one or more fluid passageways and is configured for injection and/or removal of fluid; and

a second fluid probe movable between an abutting position and a separated position, wherein the second fluid probe is in fluid communication with the one or more fluid passageways and is configured for injection and/or removal of fluid; and

(iv) a first port configured to receive the first fluid probe when the first fluid probe is in the abutting position;

(v) a second port configured to receive the second fluid probe when the second fluid probe is in the abutting position; and

(vi) a sample element configured to hold a sample portion of the bodily fluid, wherein the sample element is in fluid communication with the first port and with the second port so as to receive the sample portion of the bodily fluid from the fluid handling network.

26. The cassette of claim 25, further comprising a fluid component separator configured to separate the sample portion of the bodily fluid into two or more components.

27. The cassette of claim 26, wherein the fluid component separator comprises a filter membrane.

28. The cassette of claim 26, wherein the fluid component separator comprises a centrifuge rotatable with respect to the housing, the rotation being about an axis.

29. The cassette of claim 28, wherein the first fluid probe and the second fluid probe do not contact the centrifuge when in the separated position such that the centrifuge is free to rotate.

30. The cassette of claim 25, wherein the cassette is a disposable unit.

31. The cassette of claim 25, wherein the first fluid probe and the second fluid probe together form a flow path that allows fluid to flow from the first fluid probe into the sample element when the first fluid probe is in the abutting position and also allows fluid to flow from the sample element into the second fluid probe when the second fluid probe is in the abutting position.

32. The cassette of claim 25, wherein the housing is configured to engage a housing of the fluid analysis system to secure the cassette to the fluid analysis system.

33. The cassette of claim 25, further comprising the fluid analysis system.

34. The cassette of claim 25, wherein sample element comprises a window configured to allow light of an optical fluid analyzing sensor of the fluid analysis system to pass through the sample portion of the bodily fluid contained in the sample element.

35. The cassette of claim 25, wherein the first fluid probe and the second fluid probe are biased toward the separated position and are configured to be moved to the abutting position by an actuator of the fluid analysis system.

36. A rotor for use with a fluid analysis system, the rotor comprising:

an interface configured to engage a drive system of the fluid analysis system for rotating the rotor at least between a sample loading position and a bypass position;

a first port configured to receive a first fluid probe when the rotor is in the sample loading position;

a second port configured to receive a second fluid probe when the rotor is in the sample loading position;

a sample element interface configured to engage a sample element for holding a sample portion of a fluid such that the sample element can rotate with the rotor, wherein the sample element interface is configured for fluid communication with the first port and with the second port so that the sample portion of the fluid can be received and removed from the sample element using the first and second fluid probes;

a third port configured to receive the first fluid probe when the rotor is in the bypass position;

a fourth port configured to receive the second fluid probe when the rotor is in the bypass position; and

a bypass forming a fluid connection between the third port and the fourth port such that fluid can pass between the first fluid probe and the second fluid probe without passing through the sample element.

37. The rotor of claim 36, further comprising a sample element engaged by the sample element interface.

38. The rotor of claim 37, wherein sample element comprises a window configured to allow light of an optical fluid analyzing sensor to pass through the sample portion of the fluid contained in the sample element.

39. The rotor of claim 36, wherein the rotor is a centrifuge rotor configured to rotate fast enough to separate components of the sample portion of the fluid in the sample element.

40. The rotor of claim 36, wherein the rotor is disposable.

41. A disposable cassette with an integrated sample conditioning and analysis element for use with a non-disposable analyzer, the cassette comprising:

a fluid handling network having an analysis fluid input;

a housing configured to contain the fluid handling network, prevent fluid from undesired contact with the non-disposable analyzer, and allow hygienic disposal of a fluid-contacting object comprising the disposable cassette; and

a sample conditioning and analysis element configured to;

receive a sample portion of the analysis fluid from the fluid handling network, wherein the fluid handling network is configured to avoid contamination of the analysis fluid while delivering the analysis fluid to the sample conditioning and analysis element;

de-couple from the housing for sample conditioning; and

allow the non-disposable analyzer access to the sample portion of the analysis fluid for analysis thereof.

42. The disposable cassette of claim 41, further comprising a fluid interface movable between a filling position for filling the sample conditioning and analysis element and a retracted position for de-coupling the sample conditioning and analysis element from the housing.

43. The disposable cassette of claim 41, further comprising a fluid separator configured to provide the sample conditioning by separating the sample portion of the analysis fluid into multiple components.

44. The disposable cassette of claim 43, wherein the fluid separator comprises a rotor with a mechanical interface configured to engage a drive system of the non-disposable analyzer for rotating the rotor.

45. The disposable cassette of claim 44, further comprising a fluid interface movable between a filling position for filling the sample conditioning and analysis element and a retracted position for de-coupling the sample conditioning and analysis element and allowing the rotor to rotate with the drive system without interference from other portions of the cassette.