System and method for determining a treatment dose for a patient

• US 8,251,907 B2
• Filed: 02/08/2010
• Issued: 08/28/2012
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Sterling, Bernhard B., Braig, James R., Rule, Peter, King, Richard A.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/702,196
• Publication Number:
  US 20100240964A1
• Time in Patent Office: 932 Days
• Field of Search: 600/309, 600345-366, 600/300, 435/283.1, 435/286.1, 435/286.4, 435/287.1, 435/287.3, 204/193, 204/400, 204/403.01
• US Class Current: 600/366
• 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 5/14557 specially adapted to extracorporeal circuits
• 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 5/150213 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 5/150389 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 5/150854 long distance, e.g. between patient's home and doctor's office
• 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 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 21/274 : Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 2201/1293 : resolving multicomponent spectra
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

In certain embodiments, a method of maintaining health of a patient uses an analyte detection system. The analyte detection system is coupled to the patient such that a bodily fluid of the patient is accessible to the analyte detection system. The method includes automatically initiating and conducting a measurement of an analyte in the bodily fluid using the analyte detection system. The method further includes determining a treatment dose for the patient based on the measurement using the analyte detection system.

Claims

1. A method of maintaining health of a patient using an analyte detection system coupled to said patient such that a bodily fluid of said patient is accessible to said analyte detection system, said method comprising:

providing a housing having a fluid handling system disposed therein, the fluid handling system comprising;

at least one fluid source passageway within the housing that is configured to be placed into fluid communication with a fluid source;

a patient connection passageway within the housing that is configured to be placed into fluid communication with a venous or arterial line;

a selective junction between the fluid source passageway and the patient connection passageway and within the housing, the selective junction configured to selectively connect the patient connection passageway to an analyzer that is also within the housing;

a valve in fluid communication with the selective junction to selectively allow fluid from the fluid source to pass into the patient connection passageway or to allow bodily fluid from the patient to pass into the analyzer; and

a pump in fluid communication with the selective junction;

drawing a sample of the bodily fluid into the fluid handling system;

automatically initiating and conducting a measurement of an analyte in said bodily fluid using said analyte detection system; and

determining a treatment dose for said patient based on said measurement using said analyte detection system;

wherein the fluid handling system is adapted to use a single lumen for each of the following;

to withdraw a sample of blood from the patient in a first mode of operation, to return some withdrawn blood to the patient in a second mode of operation, and to deliver the treatment dose to the patient in a third mode of operation.

2. The method of claim 1, wherein said analyte is glucose.

3. The method of claim 2, wherein said bodily fluid is blood.

4. The method of claim 2, wherein said bodily fluid is plasma.

5. The method of claim 1, further comprising drawing a portion of said bodily fluid from said patient through a conduit.

6. The method of claim 5, wherein said conduit provides fluid communication between said patient and said analyte detection system.

7. The method of claim 5, wherein conducting said measurement comprises analyzing said portion of said bodily fluid from said patient using said analyte detection system.

8. The method of claim 1, wherein said treatment dose comprises a dose of insulin.

9. The method of claim 1, wherein conducting said measurement comprises conducting an optical measurement.

10. The method of claim 9, wherein said optical measurement is a spectroscopic measurement.

11. The method of claim 1, wherein conducting said measurement comprises conducting an optical measurement and an electrochemical measurement.

12. The method of claim 1, wherein said treatment dose is determined based on said measurement and on additional information.

13. The method of claim 12, further comprising determining a rate of change of said analyte in said bodily fluid, wherein said additional information comprises said rate of change.

14. The method of claim 12, further comprising determining a response of said patient to one or more previously administered treatment doses, wherein said additional information comprises said response.

15. The method of claim 12, wherein said additional information comprises one or more measurements of one or more additional analytes.

16. The method of claim 15, wherein said one or more additional analytes comprises lactate, carbon dioxide, hematocrit, BUN, creatinine, PO2, PCO2, or a medicament.

17. The method of claim 12, further comprising conducting an additional measurement of an additional analyte using said analyte detection system, wherein said additional information comprises said additional measurement.

18. The method of claim 17, wherein said additional analyte is lactate, carbon dioxide, hematocrit, BUN, creatinine, PO2, PCO2, or a drug taken by or administered to said patient.

19. The method of claim 12, wherein said additional information comprises information obtained from a data network connected to said analyte detection system.

20. The method of claim 12, wherein said additional information comprises a treatment dosing protocol.

21. An analyte detection system for measuring an analyte in a bodily fluid of a patient, the system comprising:

a housing;

an analyzer positioned within the housing;

a disposable fluid handling cassette configured for positioning within the housing;

a fluid handling system within the disposable cassette, the fluid handling system comprising;

a fluid source passageway within the cassette that is configured to be placed into fluid communication with a fluid source;

a patient connection passageway within the cassette that is configured to be placed into fluid communication with a venous or arterial line;

a selective junction within the cassette between the fluid source passageway and the patient connection passageway, the selective junction configured to selectively connect the patient connection passageway to the analyzer; and

a valve in fluid communication with the selective junction to selectively allow fluid from the fluid source to pass into the patient connection passageway or to allow bodily fluid from the patient to proceed to the analyzer;

a sensor operatively connected to the analyzer and configured to provide information relating to the analyte in a sample of the bodily fluid;

a processor; and

stored program instructions executable by the processor such that the analyte detection system automatically draws a sample of the bodily fluid into the fluid handling system and conducts a measurement of the sample with the sensor;

wherein the fluid handling system is adapted to use a single lumen to withdraw the sample from the patient in a first mode of operation and to return some withdrawn sample to the patient in a second mode of operation.