Analyte monitoring systems and methods

• US 9,289,169 B2
• Filed: 11/22/2013
• Issued: 03/22/2016
• Est. Priority Date: 05/18/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter, Rivas, Gil
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/088,076
• Publication Number:
  US 20140275868A1
• Time in Patent Office: 851 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/029 adapted for auto-initiation
• CPC Class Codes: A61B 2560/0437 Trolley or cart-type apparatus
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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 5/14557 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 5/1495 Calibrating or testing of in-vivo probes
• 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 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150992 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 5/155 : 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 5/7435 : Displaying user selection data, e.g. icons in a graphical user interface
• 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 2205/6072 : Bar codes
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• 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 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 21/3577 : for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 21/359 : using near infrared light
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

Some embodiments provide a system for synchronizing and configuring monitoring devices. In some embodiments, a patient monitoring device settings module is configured to automatically provide configuration settings to a plurality of patient monitoring devices. A monitoring device data module is configured to receive measurement data from at least one of the patient monitoring devices. An electronic medical records system interface is configured to provide patient data at least partially derived from the received measurement data to an electronic medical records system. A patient records interface is configured to provide patient data to at least one of the patient monitoring devices.

Claims

1. A fluid sampling and analysis system that determines the concentration of an analyte in undiluted bodily fluid, the system comprising:

a fluid handling network that maintains fluid communication with a bodily fluid of a patient and draws bodily fluid at intervals into the fluid handling network when the fluid sampling and analysis system is in operation, the fluid handling network comprising;

a first fluid passageway connectable to a source of bodily fluid;

a fluid junction fluidically connected to the first fluid passageway;

a second fluid passageway comprising a loop of tubing fluidically connected to the fluid junction;

a bodily fluid sensor connected to the second fluid passageway, wherein the bodily fluid sensor detects the presence of bodily fluid at a sensor position within the second fluid passageway, wherein the loop of tubing is sized to permit undiluted bodily fluid to be present at the fluid junction when the bodily fluid sensor detects fluid comprising at least some bodily fluid at the sensor position; and

a third fluid passageway fluidically connected to the fluid junction;

a processor in communication with or incorporated into the fluid sampling and analysis system;

stored program instructions stored in a memory device and executable by the processor to;

determine that undiluted bodily fluid is present at the fluid junction when the bodily fluid sensor detects fluid comprising at least some bodily fluid at the sensor position; and

subsequently, direct undiluted bodily fluid through the third fluid passageway towards a sample cell;

and

a bodily fluid analyzer that determines the concentration of an analyte in a sample of bodily fluid after at least a portion of the sample arrives at the sample cell.

2. The system of claim 1, wherein the system determines that undiluted bodily fluid is present at the fluid junction when the bodily fluid sensor senses a pre-set value in the mixture of saline and bodily fluid present at the sensor position.

3. The system of claim 2, wherein the pre-set value is reached after approximately 2 mL of fluid has been drawn from the source of bodily fluid.

4. The system of claim 2, wherein the pre-set value is a level of hemoglobin in the mixture of saline and bodily fluid at the sensor position.

5. The system of claim 2, wherein the bodily fluid sensor comprises a color sensor, and wherein the bodily fluid sensor senses the pre-set value by detecting a color of the mixture of saline and bodily fluid at the sensor position.

6. The system of claim 1, wherein the bodily fluid analyzer comprises a spectroscopic analyzer.

7. The system of claim 1, wherein the analyte comprises glucose.

8. The system of claim 1, wherein the system returns unused bodily fluid to the patient after undiluted bodily fluid is directed through the third fluid passageway towards the sample cell.

9. The system of claim 1, wherein the undiluted bodily fluid is mixed with an anticoagulant and subsequently analyzed by the bodily fluid analyzer.

10. The system of claim 1, wherein the loop of tubing is capable of containing at least approximately 1 mL of fluid.

11. The system of claim 1, wherein the loop of tubing is disposed between the fluid junction and the bodily fluid sensor.

12. The system of claim 1, wherein the first fluid passageway is sized to contain a first volume of fluid, and wherein the loop of tubing is sized to contain a second volume of fluid greater than the first volume of fluid.

13. A method of determining a concentration of an analyte in undiluted bodily fluid, the method comprising:

drawing a sample of bodily fluid from a fluid source into a fluid handling network, wherein the fluid handling system comprises fluid passageways and a bodily fluid sensor that senses a property of the bodily fluid;

directing the sample of bodily fluid past a fluid junction through a first fluid passageway comprising a sensor position of the bodily fluid sensor and a loop of tubing located in the first fluid passageway between the sensor position and the fluid junction, wherein the loop of tubing is sized to permit undiluted bodily fluid to be present at the fluid junction when the bodily fluid sensor detects a mixture of saline and bodily fluid at the sensor position;

determining that undiluted bodily fluid is present at the fluid junction when the bodily fluid sensor detects a mixture of saline and bodily fluid at the sensor position;

after determining that undiluted bodily fluid is present at the fluid junction, directing undiluted bodily fluid through a second fluid passageway towards a sample cell of a bodily fluid analyzer; and

determining a concentration of an analyte in a sample of bodily fluid after at least a portion of the sample arrives at the sample cell.

14. The method of claim 13, further comprising priming at least the first fluid passageway with saline before drawing the sample of bodily fluid into the fluid handling network.

15. The method of claim 13, wherein the bodily fluid sensor senses a property at the sensor position that indicates whether undiluted bodily fluid is present at the fluid junction.

16. The method of claim 15 wherein the bodily fluid sensor detects a level of hemoglobin in fluid at the sensor position.

17. The method of claim 15, wherein the bodily fluid sensor detects the color of fluid at the sensor position.

18. The method of claim 13, wherein the bodily fluid analyzer comprises a spectroscopic analyzer.

19. The method of claim 13, wherein the analyte comprises glucose.

20. The method of claim 13, further comprising returning unused bodily fluid to the fluid source after drawing the sample of bodily fluid from the fluid source.

21. The method of claim 13, further comprising mixing the undiluted bodily fluid with an anticoagulant before analysis by the bodily fluid analyzer.