Fluid component analysis systems and methods for glucose monitoring and control

• US 9,414,782 B2
• Filed: 09/14/2012
• Issued: 08/16/2016
• 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, Rivas, Gil, Seetharaman, Mahesh
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/619,825
• Publication Number:
  US 20130165900A1
• Time in Patent Office: 1,432 Days
• Field of Search: 417/477.2, 600431-435, 604 65- 67, 604118-121, 604131-147, 604151-155, 6048901-8921
• US Class Current: 1/1
• 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. An analyte detection and treatment dosing system comprising:

a fluid transport network configured to provide fluid communication with a body fluid in a patient through a patient end;

a body fluid analyzer accessible via the fluid transport network, the body fluid analyzer configured to measure a characteristic of at least one analyte in the body fluid and determine the concentration of the at least one analyte from the measured characteristic;

a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol and configured to determine a recommended dose for an infusion fluid configured to provide glycemic control, wherein the recommended dose is determined based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and the treatment dosing protocol;

a treatment pump coupled to the fluid transport network, the treatment pump operable to transport the infusion fluid to the patient through the patient end; and

a fluid system controller comprising a graphic user interface, said fluid system controller configured to actuate the treatment pump and control a pump rate of the pump;

wherein the fluid system controller and the body fluid analyzer are both included within a single housing, the graphic user interface being located on the same housing, and the graphic user interface being configured to display the determined analyte concentration and the recommended dose.

2. The system of claim 1, wherein the graphic user interface includes an input element configured to accept user input, the user interface further configured to adjust an actual dose of the infusion fluid based at least in part on the user input.

3. The system of claim 2, wherein the graphic user interface is configured to display both the recommended dose and the actual dose, where both the recommended dose and the actual dose are expressed as infusion rates.

4. The system of claim 1, wherein the graphic user interface includes an input element configured to accept user input, the user interface configured to actuate the pump unit based at least in part on the user input.

7. The system of claim 1, wherein the treatment pump is configured to deliver infusion substance continuously at a basal rate through the patient end.

8. The system of claim 1, wherein the treatment pump is configured to deliver the recommended dose of the infusion substance as a bolus injection through the patient end.

9. The system of claim 1, wherein the treatment pump is configured to deliver the infusion substance continuously at a basal rate combined with intermittent bolus injections of the recommended dose.

10. The system of claim 1, wherein the treatment dosing system is configured to provide signals to the fluid system controller to stop the delivery of the infusion fluid if the concentration of the at least one analyte is below a certain threshold.

5. An analyte monitoring system comprising:

a fluidic system in fluid communication with a source of bodily fluid, said fluidic system being configured to obtain a sample of bodily fluid from the source several times in a given time interval;

an analyte detection system configured to analyze the sample of bodily fluid or a component of the sample of bodily fluid and determine a concentration of an analyte in said sample of the bodily fluid or a component of the sample of the bodily fluid, wherein the analyte detection system is further configured to access a measurement history and store the concentration of the analyte in the measurement history;

a feedback system; and

a user interface configured to accept an input from a user;

wherein the feedback system calculates a predicted value for the concentration of the analyte at a future time based on the input from the user and one or more previous values for the concentration of the analyte stored in the measurement history, and

wherein the feedback system alerts the user if the predicted value for the concentration is not within an acceptable range.

11. The system of claim 5, wherein the fluidic system comprises a treatment pump, the treatment pump operable to deliver one or more infusion fluids from the fluid infusion system to the patient through the fluidic system.

12. The system of claim 11, wherein the feedback system is configured to provide signals to the treatment pump to control the rate of delivery of the one or more infusion fluids based on the predicted value for the concentration of the analyte.

13. The system of claim 12, wherein the feedback system is configured to provide signals to the treatment pump to automatically and completely stop delivery of the one or more infusion fluids based on the predicted value for the concentration of the analyte.

6. An analyte monitoring system comprising:

a fluidic system in fluid communication with a source of bodily fluid, said fluidic system being configured to obtain a sample of bodily fluid from the source several times in a given time interval;

an analyte detection system configured to analyze the sample of bodily fluid or a component of the sample of bodily fluid and determine a concentration of an analyte in said sample of the bodily fluid or a component of the sample of the bodily fluid, wherein the analyte detection system is further configured to access a measurement history and store the determined concentration of the analyte in the measurement history;

a fluid infusion system comprising a plurality of infusion fluid sources, each infusion fluid source configured to provide one or more drugs or chemicals;

a user feedback system;

a watch list comprising a catalog of spectra related to various known substances that may present medical hazards, alone or in combination, the watch list being electronically accessible to the user feedback system; and

a user interface configured to provide information to a user and accept input from the user;

wherein the feedback system is configured to obtain one or more spectroscopic measurements of the contents of the plurality of infusion fluid sources, compare the spectroscopic measurements with the watch list, and alert the user through the user interface if any substance in the watch list is detected in the plurality of infusion fluid sources.

14. The system of claim 6, wherein the fluid infusion system comprises a treatment pump, the treatment pump operable to deliver one or more infusion fluids from the fluid infusion system to the patient through the fluidic system.

15. The system of claim 14, wherein the feedback system is configured to provide signals to the treatment pump to control the rate of delivery of the one or more infusion fluids based on the determined concentration of the analyte.

16. The system of claim 15, wherein the feedback system is configured to provide signals to the treatment pump to automatically and completely stop delivery of the one or more infusion fluids based on the determined concentration of the analyte.