FLUID ANALYSIS SYSTEM

• US 20170296112A1
• Filed: 01/27/2017
• Published: 10/19/2017
• Est. Priority Date: 07/20/2009
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Lim, Eugene, Tong, Roger, Rule, Peter, Braig, James R., Keenan, Richard, Callicoat, David N.
• Granted Patent: US 10,201,303 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/0228 using calibration standards
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• 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 5/150755 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 5/150992 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 5/412 : Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6866 : Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 2005/14208 : with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2039/1033 : Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 39/10 : Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/1011 : Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• 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: G01N 2021/0346 : Capillary cells; Microcells
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/07 : Centrifugal type cuvettes G01N21/09 takes precedence
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 33/491 : by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Systems and method are disclosed for determining a concentration of an analyte in a fluid (e.g., blood). The system can draw blood from a patient and deliver the blood to a sample cell. A particular component of the fluid (e.g., plasma) may be separated and/or positioned such that the concentration of the analyte is measured in the particular component of the fluid (e.g., plasma). The sample cell can include a sample container that has two window pieces. The system can have a fluid passage having a tip configured to mate with a multi-lumen catheter without leaking. The multi-lumen catheter can have proximal and distal ports. A fluid pressure system can be configured to periodically draw fluid from vasculature through a proximal intravascular opening and the proximal port while maintaining a low pressure and/or flow rate to thereby reduce risk of reversing the fluid flow in a vessel and drawing infusates upstream into another intravascular opening.

Claims

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21. A cuvette comprising:

a first window piece that is configured to be transparent to light emitted by an optical measurement system for measuring the concentration of an analyte in a sample of bodily fluid in the cuvette;

a second window piece that is configured to be transparent to the light emitted by the optical measurement system;

a spacer positioned between the first window piece and the second window piece to provide a gap between the first window piece and the second window piece, wherein the gap forms a sample chamber between the first window piece and the second window piece, and wherein the sample chamber is configured to receive the sample of bodily fluid from a fluid handling system;

a first clamping element; and

a second clamping element, wherein the first and second clamping elements are positioned on opposite outer sides of the first and second window pieces, wherein the first and second clamping elements are secured to each other to provide support to the first and second window pieces, wherein the first and second clamping elements are configured to permit the light emitted by the fluid measurement system to pass through the sample chamber of the cuvette.

22. A fluid analysis system comprising:

a fluid handling system that includes a patient end configured to provide access to a bodily fluid of a patient, wherein the fluid handling system is configured to draw a sample of bodily fluid from the patient through the patient end;

a sample preparation system comprising the cuvette of claim 21, wherein the sample preparation system is configured to receive the sample of bodily fluid from the fluid handling system and separate the sample of bodily fluid into a plurality of components; and

an optical measurement system configured to measure the concentration of an analyte in the sample of bodily fluid.

23. The fluid analysis system of claim 22, comprising:

a fluid passage having a tip configured to mate with a multi-lumen catheter without leaking, the multi-lumen catheter having;

a proximal port communicating with a proximal port lumen that provides a fluid path to a proximal intravascular opening that is configured to open into a vessel having a fluid flow; and

a distal port communicating with a distal port lumen that is independent from and not in fluid communication with the proximal port lumen and that provides a fluid path to a distal intravascular opening that is configured to open into the vessel distal of and downstream from the proximal intravascular opening to infuse infusates;

a fluid pressure system in fluid communication with the fluid passage, the fluid pressure system configured to periodically automatically draw fluid from the vessel through the proximal intravascular opening and the proximal port and through the tip back into the fluid passage while maintaining a low pressure and/or flow rate to thereby reduce risk of reversing the fluid flow in the vessel and drawing infusates back upstream into the proximal intravascular opening.

24. The fluid analysis system of claim 23, wherein the fluid pressure system comprises a controller and a pressure monitor that provides feedback to the controller.

25. The fluid analysis system of claim 24, wherein the controller is configured to maintain the withdrawal pressure below 99% of the pressure of blood in the vessel.

26. The fluid analysis system of claim 24, further comprising a patient blood pressure monitor that provides feedback to the controller to allow a baseline for comparison to the withdrawal pressure.

27. The fluid analysis system of claim 24, wherein the pressure monitor is configured to monitor the pressure at or near the proximal port.

28. The fluid analysis system of claim 23, wherein the fluid pressure system is configured to maintain a constant rate for the majority of the time blood is being withdrawn through the proximal port.

29. The fluid analysis system of claim 23, wherein the fluid pressure system is configured to adjust the withdrawal rate to be lower when infusates are being infused through the distal port.

30. The cuvette of claim 21, wherein the first and second window pieces have a plurality of corners and wherein each of the plurality of corners are covered by at least one of the first clamping element and the second clamping element.

31. The cuvette of claim 21, wherein the entire periphery of the first and second window pieces except for an inlet and an outlet are covered by at least one of the first clamping element and the second clamping element.

32. The cuvette of claim 21, wherein the first and second clamping elements are secured to apply a force to press the first window piece and the second window piece towards each other.

33. The cuvette of claim 21, wherein the sample chamber comprises a lubricant configured to facilitate removal of the sample of bodily fluid from the sample chamber.

34. The cuvette of claim 21, wherein the first and second window pieces are transparent to mid-infrared light.

35. A cuvette comprising:

a first transparent window piece;

a second transparent window piece;

a spacer positioned between the first window piece and the second window piece to provide a gap between the first window piece and the second window piece, wherein the gap forms a sample chamber between the first window piece and the second window piece, and wherein the sample chamber is configured to hold a fluid sample;

a first clamping element; and

a second clamping element, wherein the first and second clamping elements are positioned on opposite sides of the first and second window pieces, wherein the first and second clamping elements are secured to each other to provide support to the first and second window pieces;

wherein the cuvette is configured to provide an optical pathway that extends through the first window piece, through the sample chamber, and through the second window piece.

36. A fluid analysis system comprising:

the cuvette of claim 35; and

an optical measurement system configured to direct light along the optical pathway through the cuvette to measure the concentration of an analyte in the fluid sample in the sample chamber.

37. The cuvette of claim 35, wherein the first and second window pieces have a plurality of corners and wherein each of the plurality of corners are covered by at least one of the first clamping element and the second clamping element.

38. The cuvette of claim 35, wherein the entire periphery of the first and second window pieces except for an inlet and an outlet are covered by at least one of the first clamping element and the second clamping element.

39. The cuvette of claim 35, wherein the first and second clamping elements are secured to apply a force to press the first window piece and the second window piece towards each other.

40. The cuvette of claim 35, wherein the first and second window pieces are transparent to mid-infrared light.

41. A fluid analysis system comprising:

a fluid handling system that includes a patient end configured to provide access to a bodily fluid of a patient, wherein the fluid handling system is configured to draw a sample of bodily fluid from the patient through the patient end;

a sample preparation system in fluid communication with the fluid handling system, wherein the sample preparation system is configured to receive the sample of bodily fluid from the fluid handling system, and wherein the sample preparation system is configured to lyse cells in the sample of bodily fluid; and

a fluid measurement system configured to measure the concentration of an analyte in the sample of bodily fluid after the cells have been lysed.

42. The system of claim 41, wherein the sample preparation system is configured to separate the sample of bodily fluid into a plurality of components before the measurement system measures the concentration of the analyte.

43. The system of claim 41, wherein the sample preparation system comprises a cuvette, the cuvette comprising:

a first transparent window piece;

a second transparent window piece;

a spacer positioned between the first window piece and the second window piece to provide a gap between the first window piece and the second window piece; and

a first clamping element and a second clamping element positioned on opposite outer sides of the first and second window pieces, wherein the first and second clamping elements are secured to each other to provide support to the first and second window pieces.

44. The system of claim 41, wherein the sample preparation system is configured to receive a second sample of bodily fluid, and wherein the fluid measurement system is configured to measure the concentration of an analyte in the second sample of bodily fluid without lysing cells in the second sample of bodily fluid.