SYSTEMS AND METHODS FOR VERIFICATION OF SAMPLE INTEGRITY

• US 20100145175A1
• Filed: 08/24/2009
• Published: 06/10/2010
• Est. Priority Date: 08/22/2008
• Status: Abandoned Application

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Soldo, Monnett H., Rule, Peter
• Application Number:
  US12/546,568
• Publication Number:
  US 20100145175A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/0437 Trolley or cart-type apparatus
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• 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 5/15003 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 5/150305 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 5/150862 intermediate range, e.g. within room or building
• 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: 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 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

Abstract

Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can include an additive system for adding an additive to a sample to reduce the adverse affects of bubbles and microbubbles in the sample. Some systems and methods disclosed herein include performing an auxiliary measurement cycle in the event of a failure of a scheduled measurement cycle. Some systems and methods disclosed herein include a measurement system configured for use with multiple patients.

Claims

1. A patient monitoring system comprising:

a fluid transport system configured to automatically draw a fluid sample from a patient at scheduled measurement times according to a sample draw schedule;

a fluid analyzer operatively connected to the fluid transport system and configured to determine a scheduled measurement of the concentration of an analyte in the fluid sample; and

a controller comprising a processor and a computer-readable medium encoded with instructions executable by the processor, the controller operatively connected within the patient monitoring system and configured to;

determine whether the scheduled measurement has failed;

cause the fluid transport system to draw an auxiliary fluid sample from the patient before the next scheduled measurement time when it is determined that the scheduled measurement has failed; and

determine an auxiliary measurement of the concentration of the analyte in the auxiliary fluid sample using the fluid analyzer.

2. The patient monitoring system of claim 1, wherein the controller is configured to recognize when a scheduled measurement has failed due to contaminants contained in the fluid sample.

3. The patient monitoring system of claim 1, wherein the controller is configured to recognize when a scheduled measurement has failed due to the presence of microbubbles in the fluid sample.

4. The patient monitoring system of claim 1, wherein the controller is configured to recognize when a scheduled measurement has failed due to an obstruction in the fluid transport system.

5. The patient monitoring system of claim 1, further comprising one or more sensors configured to detect a collect data and deliver the data to the controller, the controller configured to recognize when a scheduled measurement has failed based at least in part on the data.

6. The patient monitoring system of claim 1, wherein the scheduled measurement times are no more than one hour apart.

7. The patient monitoring system of claim 6, wherein the scheduled measurement times are no more than thirty minutes apart.

8. The patient monitoring system of claim 7, wherein the scheduled measurement times are no more than fifteen minutes apart.

9. The patient monitoring system of claim 1, wherein the controller is configured to determine a cause of a measurement failure and perform an automatic corrective action before or during the auxiliary measurement, wherein the corrective action is based at least in part on the cause of the measurement failure.

10. The patient monitoring system of claim 9, wherein the corrective action comprises reducing a flow rate at which the auxiliary fluid sample travels through the fluid transport system.

11. The patient monitoring system of claim 9, wherein the corrective action comprises increasing an amount of flush fluid used to flush the fluid transport system between measurements.

12. The patient monitoring system of claim 1, wherein the controller is configured to determine a cause of a measurement failure, instruct the user via a user interface to perform a corrective action based at least in part on the cause of the measurement failure, and cause the fluid transport system to obtain the auxiliary fluid sample after completion of the corrective action.

13. The patient monitoring system of claim 12, wherein the corrective action is checking or changing a line in the fluid transport system, changing a fluid that has run out, or changing a waste container that has been filled.

14. The patient monitoring system of claim 1, wherein the controller is configured to cause the fluid transport system to obtain the auxiliary fluid sample within five minutes of recognizing that a scheduled measurement has failed.

15. The patient monitoring system of claim 1, wherein the controller is configured to cause the fluid transport system to obtain the auxiliary fluid sample within one minute of recognizing that a scheduled measurement has failed.

16. The patient monitoring system of claim 1, wherein the controller is configured to cause the fluid transport system to obtain the auxiliary fluid sample as soon as it is able after recognizing that a scheduled measurement has failed.

17. The patient monitoring system of claim 1, wherein the fluid sample is obtained from a sample of a patient'"'"'s blood.

18. The patient monitoring system of claim 1, wherein the analyte is glucose.

19. The patient monitoring system of claim 1, wherein the fluid transport system comprises a patient end configured to connect to a patient to draw bodily fluid from the patient into the fluid transport system through the patient end.

20. A method for monitoring a concentration of an analyte in a bodily fluid of a patient, the method comprising:

performing a scheduled measurement cycle intermittently at scheduled measurement times, the scheduled measurement cycle comprising;

drawing a scheduled sample of bodily fluid from a patient into a fluid transport system;

delivering at least a portion of the scheduled sample of bodily fluid to a fluid analyzer;

measuring at least one characteristic of the at least a portion of the scheduled sample of bodily fluid; and

determining a concentration of an analyte based at least in part on the at least one measured characteristic;

determining whether the scheduled measurement cycle has failed; and

performing an auxiliary measurement cycle before a next scheduled measurement cycle when it is determined that the scheduled measurement cycle has failed.

21. The method of claim 20, wherein the auxiliary measurement cycle comprises:

drawing an auxiliary sample of bodily fluid from the patient into the fluid transport system;

delivering at least a portion of the auxiliary sample of bodily fluid to the fluid analyzer;

measuring at least one characteristic of the at least a portion of the auxiliary sample of bodily fluid; and

determining a concentration of the analyte based at least in part on the at least one measured characteristic.

22. The method of claim 20, further comprising:

determining a cause of a measurement failure; and

performing automatic corrective action before or during the auxiliary measurement cycle, wherein the automatic corrective action is based at least in part on the cause of the measurement failure.

23. The method of claim 20, further comprising:

determining a cause of a measurement failure;

providing instructions for performing corrective action to the user, wherein the corrective action is based at least in part on the cause of the measurement failure; and

initiating the auxiliary measurement cycle after completion of the corrective action.