FLUID COMPONENT ANALYSIS SYSTEMS AND METHODS FOR GLUCOSE MONITORING AND CONTROL

• US 20110264071A1
• Filed: 06/30/2011
• Published: 10/27/2011
• Est. Priority Date: 10/10/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Keenan, Richard, Rule, Peter, Seetharaman, Mahesh, Rivas, Gil
• Granted Patent: US 8,449,524 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• 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 5/14535 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 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• 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 5/150267 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 5/150862 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 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 2005/1404 : Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: A61M 2005/14208 : with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• 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: G16H 20/17 : delivered via infusion or injection

Abstract

Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g., insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

Claims

1. A method of analyzing an analyte in the body fluid of a patient, the method comprising:

placing a body fluid analyzer in fluid communication with the body fluid in the patient;

transporting a sample of the body fluid toward the body fluid analyzer;

with the body fluid analyzer, measuring at lease one characteristic of at least one analyte in the body fluid and determining the concentration of the at least one analyte in the body fluid from the at least one measured characteristic;

with a treatment dosing system in communication with the body fluid analyzer, Automatically determining a recommended dose for an infusion fluid based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and on a treatment dosing protocol stored in a computer memory;

infusing a dose of the infusion fluid toward the patient, wherein the dose of the infusion fluid is based at least in part on the recommended dose determined by the treatment dosing system; and

with the treatment dosing system, automatically stopping the flow of the infusion fluid to the patient if one or more of the following conditions are met;

the concentration of the at least one analyte is below a threshold level; and

a trend in the concentration of the at least one analyte indicates that the concentration will soon fall below the threshold level.

2. The method of claim 1, wherein the body fluid analyzer comprises a spectroscopic analyzer.

3. The method of claim 1, wherein the at least one analyte comprises glucose or dextrose and the infusion fluid comprises insulin.

4. The method of claim 3, wherein the treatment dosing system comprises a tight glycemic control protocol.

5. The method of claim 1, further comprising providing a user interface indicating information related to the recommended dose, an actual dose of the infusion fluid, or both.

6. The method of claim 5, further comprising adjusting the actual dose of the infusion fluid in response to user input received via the user interface.

7. The method of claim 1, wherein placing a body fluid analyzer in fluid communication with the body fluid in the patient further comprises:

providing a fluid transport network having a patient end; and

with the fluid transport network, establishing fluid communication with the body fluid in the patient through the patient end, the body fluid analyzer accessible via the fluid transport network; and

wherein transporting a sample of the body fluid toward the body fluid analyzer comprises drawing a sample of the body fluid from the patient end and toward the body fluid analyzer.

8. The method of claim 1, further comprising varying a pump rate of at least one pump system to infuse the dose of infusion fluid toward the patient.

9. The method of claim 1, further comprising infusing a portion of the infusion fluid toward the patient via a basal delivery system at a basal rate, and infusing a portion of the infusion fluid toward the patient via a bolus injection system as a bolus injection.

10. The method of claim 9, wherein the basal delivery system and the bolus injection system both infuse the infusion fluid through the same intravenous access line.

11. The method of claim 9, wherein the basal delivery system and the bolus injection system both infuse the infusion fluid through a patient end, and wherein transporting a sample of the body fluid toward the body fluid analyzer comprises drawing a sample of the body fluid through the patient end.

12. The method of claim 9, wherein the basal delivery system and the bolus injection system are controlled by a single treatment pump having a variable pump rate.

13. The method of claim 1, wherein the body fluid analyzer comprise an electro-chemical analyzer.

14. The method of claim 1, further comprising:

accessing a measurement database;

calculating an average concentration of the at least one analyte based on one or more determinations made by the body fluid analyzer of the concentration of the at least one analyte; and

determining the recommended dose for the infusion fluid based on the average concentration of the at least one analyte.

15. The method of claim 1, further comprising:

accessing a measurement database;

calculating a rate of change in the concentration of the at least one analyte based on one or more determinations made by the body fluid analyzer of the concentration of the at least one analyte; and

determining the recommended dose for the infusion fluid based on the rate of change of the concentration of the at least one analyte.

16. The method of claim 1, wherein at least one pump system has a sampling mode in which the at least one pump system is operable to transport the sample of the body fluid toward the body fluid analyzer and an infusion mode in which the at least one pump system is operable to infuse the infusion fluid toward the patient.

17. The method of claim 1, further comprising transporting a sample of the body fluid toward the body fluid analyzer at draw intervals of 30 minutes or less.

18. The method of claim 1, further comprising transporting a sample of the body fluid toward the body fluid analyzer at draw intervals of 15 minutes or less.

19. The method of claim 1, wherein the infusion source is located within a short distance of the patient to allow infusion of the dose of the infusion fluid before a next sample is drawn.

20. The method of claim 1, further comprising:

with the body fluid analyzer, determining the concentration of the at least one analyte in a second sample of body fluid;

calculating a rate of change of the concentration of the at lest one analyte, and

automatically stopping the flow of the infusion fluid to the patient if the rate of change of the concentration of the analyte is below a certain prescribed value and the concentration of the at least one analyte in the first or second sample is close to the threshold level.