Joint-diagnostic spectroscopic and biosensor meter

• US 8,206,650 B2
• Filed: 05/02/2006
• Issued: 06/26/2012
• Est. Priority Date: 04/12/2005
• Status: Active Grant

• Current Assignee: ChroMedX Ltd. (Relay Medical Corp.)
• Original Assignee: ChroMedX Inc.
• Inventors: Samsoondar, James
• Primary Examiner(s): Bullock, In Suk
• Assistant Examiner(s): Kingan, Timothy G
• Application Number:
  US11/415,284
• Publication Number:
  US 20060228259A1
• Time in Patent Office: 2,247 Days
• Field of Search: None
• US Class Current: 422/82.05
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/085 Protection against injuring the user
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 : fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0688 : surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502753 : characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: G01N 2021/0346 : Capillary cells; Microcells
• CPC Class Codes: G01N 21/03 : Cuvette constructions

Abstract

Some embodiments of the invention provide a system comprising a meter and a disposable cartridge for analyzing a fluid sample typically blood that is drawn into the cartridge by capillary action, negative pressure, positive pressure, or a combination thereof. The cartridge has at least one flow path, and includes at least one optical chamber for spectroscopic measurement, and at least one biosensor for biosensor measurement. The meter has a sample slot for receiving the disposable cartridge. The cartridges have electrical output contacts, and the meter slot has electrical input contacts. When the output contacts mate with the input contacts, the optical chamber becomes positioned for spectroscopic measurement. The present invention can provide joint-diagnostic spectroscopic and biosensor measurements.

Claims

1. A spectroscopic and biosensor system for analyzing a blood sample taken from a patient, the system comprising:

a disposable cartridge, the disposable cartridge comprising;

a cartridge housing;

an inlet opening in the cartridge housing for receiving the blood sample;

one or more than one flow path to receive the blood sample from the inlet opening;

an optical chamber in the one or more than one flow path, the optical chamber having at least one optical window to facilitate detection of an electromagnetic radiation-based signal derived from the blood;

a biosensor chamber in the one or more than one flow path, the biosensor chamber comprising a pH biosensor, the cartridge housing further comprising an electrical output contact in electrical communication with the pH biosensor for receiving sample biosensor data from the pH biosensor after the blood sample makes contact with the pH biosensor

at least one of an outlet vent and a compression suction chamber for facilitating flow of the blood sample inside the one or more than one flow path; and

a meter absent one or more blood fluid connection with the disposable cartridge, the meter further comprising;

a meter housing;

a meter source of electromagnetic radiation;

a slot in the meter housing for receiving the cartridge, the slot having an electrical input contact for mating with the output contact of the cartridge when the cartridge is inserted into the slot; and

one or more than one photodetector for measuring electromagnetic radiation transmitted through or reflected from the blood sample within the optical chamber and for providing an electromagnetic radiation-based signal derived from the electromagnetic radiation transmitted through or reflected from the blood sample; and

a processor, the processor comprising;

a blood hemoglobin oxygen saturation calibration algorithm for transforming the electromagnetic radiation-based signal into a blood hemoglobin oxygen saturation result; and

a pH calibration algorithm for transforming the sample biosensor data into a pH result,

the processor being in communication with i) the one or more than one photodetector to receive the electromagnetic radiation-based signal, and ii) the electrical input contact to receive the sample biosensor data;

whereby the blood hemoglobin oxygen saturation result and the blood pH result will provide an assessment of the patient'"'"'s oxygenation and acid-base status.

2. The system according to claim 1, wherein

the disposable cartridge further comprises:

a cavity within the cartridge housing having a sealed calibration pouch containing a calibration fluid for calibrating the pH biosensor;

a puncture element for puncturing the sealed calibration pouch and for releasing the calibration fluid from the sealed calibration pouch;

a conduit for transporting the calibration fluid from the cavity to the biosensor chamber, the conduit being in fluid communication with the cavity and the biosensor chamber;

a compressible air chamber within the cartridge housing, the compressible air chamber being fluidly connected to the biosensor chamber at a point in the one or more than one flow path located between the inlet opening and the biosensor chamber, the compressible air chamber being operable to displace the calibration fluid; and

the system further comprises;

means for facilitating operation of the compressible air chamber when the one or more than one flow path comprises a plurality of openings.

3. A spectroscopic and biosensor system for analyzing a blood sample taken from a patient, the system comprising:

a disposable cartridge;

spectroscopic means for measuring a blood hemoglobin oxygen saturation value; and

biosensor means for measuring a blood pH value;

wherein the disposable cartridge comprises;

a cartridge housing;

an inlet opening in the cartridge housing for receiving the blood sample;

one or more than one flow path in the cartridge housing for receiving the blood sample from the inlet opening;

an optical chamber in the one or more than one flow path, the optical chamber having at least one optical window to facilitate the spectroscopic means for measuring a blood hemoglobin oxygen saturation value;

a biosensor chamber in the one or more than one flow path, the biosensor chamber comprising a pH biosensor to facilitate the biosensor means for measuring a blood pH value; and

one of an outlet vent and a compression suction chamber for promoting flow of the blood sample inside the flow path;

whereby the blood hemoglobin oxygen saturation value and the blood pH value will provide an assessment the patient'"'"'s oxygenation and acid-base status.

4. The system according to claim 3, wherein

the biosensor means further comprises;

a cavity within the cartridge housing having a sealed calibration pouch containing a calibration fluid for calibrating the pH biosensor;

a capillary break disposed between the optical chamber and the biosensor chamber, the capillary break being operable to retain at least one of the fluid sample and a calibration fluid away from the biosensor chamber and the optical chamber, respectively.

5. The system according to claim 3, wherein the spectroscopic means further includes

means for reducing average attenuation of electromagnetic radiation due to scattering of electromagnetic radiation by red blood cells in the blood in order to measure the blood hemoglobin oxygen saturation value in the blood absent induced hemolysis.

6. A spectroscopic and biosensor method for analyzing a blood sample taken from a patient, the method comprising:

obtaining a blood sample from the patient;

providing a disposable cartridge comprising;

a cartridge housing;

an inlet opening in the cartridge housing for receiving the blood;

one or more than one flow path to receive the blood from the inlet opening;

an optical chamber in the one or more than one flow path, the optical chamber comprising at least one optical window to facilitate detection of an electromagnetic radiation-based signal derived from the blood;

a biosensor chamber in the one or more than one flow path, the biosensor chamber comprising a pH biosensor;

an electrical output contact in communication with the pH biosensor; and

at least one of an outlet vent and a compression suction chamber to facilitate blood flow inside the one or more than one flow path;

providing a meter comprising;

a meter housing;

a meter source of electromagnetic radiation;

a slot in the meter housing for receiving the disposable cartridge, the slot comprising an electrical input contact; and

one or more than one photodetector;

urging the blood into the one or more than one flow path in order to fill at least the optical chamber;

positioning the optical chamber to receive the meter source of electromagnetic radiation by mating the electrical output contact with the electrical input contact and, at one of

a period prior to urging the blood into the one or more than one flow path and

a period after urging the blood into the one or more than one flow path;

irradiating the blood in the optical chamber with the meter source of electromagnetic radiation and measuring electromagnetic radiation transmitted through or reflected from the blood with the one or more than one photodetector, thereby generating the electromagnetic radiation-based signal;

urging the blood into the biosensor chamber for the blood to make contact with the pH biosensor, if the blood is not yet urged into the biosensor chamber, for generating blood biosensor data; and

processing the electromagnetic radiation-based signal and the blood biosensor data to produce a blood hemoglobin oxygen saturation value and a blood pH value respectively,

whereby the blood hemoglobin oxygen saturation value and the blood pH value will provide an assessment of the patient'"'"'s oxygenation and acid-base status.

7. The method according to claim 6, wherein the cartridge comprises one flow path, wherein the optical chamber is fluidly connected to the inlet opening, and the biosensor chamber is fluidly connected to the inlet opening via the optical chamber.

8. The method according to claim 6, wherein the cartridge further comprises a manifold for splitting the blood into a first flow path comprising an optical chamber and a second flow path comprising a biosensor chamber.

9. The method according to claim 6, further comprising calibrating the pH biosensor prior to urging the blood to fill the optical chamber.

10. The method according to claim 6, further comprising calibrating the pH biosensor prior to urging the blood into the biosensor chamber.

11. The method according to claim 6, further comprising maintaining red blood cells in the blood substantially intact during irradiating the blood absent induced hemolysis.

12. The method according to claim 6, further comprising maintaining the one or more than one flow path restricted to the cartridge housing absent one or more blood fluid connection between the cartridge and the meter.

13. The method according to claim 9, wherein the cartridge further comprises a compressible air chamber fluidly connected to the biosensor chamber, and the method further comprises:

closing at least one opening in the one or more than one flow path;

compressing the compressible air chamber; and

displacing the calibration fluid from the calibration chamber with the blood, using air from the air chamber.

14. The method according to claim 10, wherein the cartridge further comprises a compressible air chamber fluidly connected to the biosensor chamber, and the method further comprises:

closing at least one opening in the one or more than one flow path;

compressing the compressible air chamber; and

displacing the calibration fluid from the calibration chamber with the blood, using air from the air chamber.