Fluid component analysis system and method for glucose monitoring and control

• US 9,302,045 B2
• Filed: 04/05/2013
• Issued: 04/05/2016
• Est. Priority Date: 09/12/2008
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): Weston, Tiffany
• Application Number:
  US13/857,949
• Publication Number:
  US 20140066844A1
• Time in Patent Office: 1,096 Days
• 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 5/14557 specially adapted to extracorporeal circuits
• 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 5/150786 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 5/155 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 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• 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 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• 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 5/142 : Pressure infusion, e.g. using pumps
• 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 20/00 : ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Disclosed are methods and apparatuses 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 dose (e.g. insulin, dextrose, etc.) and provide glycemic control. The dose of the treatment drug may be based on the patient'"'"'s calculated sensitivity to treatment dosing, for example. 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. Delivery of the treatment drug can be cut off if the determined analyte concentration indicates that continued delivery would be harmful to the patient.

Claims

1. A patient treatment and analysis system, comprising:

a body fluid analyzer configured to;

measure a concentration of an analyte in a bodily fluid; and

access an analyte history database and store the measured concentration of the analyte in the analyte history database; and

a treatment dosing system in communication with the body fluid analyzer, the treatment dosing system comprising;

a source of a treatment substance; and

a treatment dosing algorithm stored in a computer memory;

wherein the treatment dosing system is configured to;

use the treatment dosing algorithm to calculate an estimated treatment sensitivity for the patient by accessing the analyte history database and a dosage history database and comparing portions of the analyte history database to portions of the dosage history database;

use the treatment dosing algorithm to calculate a recommended treatment dosage for the patient based at least in part on the estimated treatment sensitivity;

administer a dose of the treatment substance to the patient; and

access a dosage history database and store a record of the administered dose therein;

wherein the treatment dosing algorithm is configured to calculate a predicted accuracy of the estimated treatment sensitivity, and wherein the treatment dosing algorithm is configured to calculate the recommended treatment dosage based at least in part on the predicted accuracy of the estimated treatment sensitivity.

2. The patient treatment and analysis system of claim 1, further comprising a communication interface configured to communicate with an external infusion pump, wherein the communication interface is configured to receive infusion information from the external infusion pump and the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on the infusion information received from the external infusion pump.

3. The patient treatment and analysis system of claim 1, wherein the analyte is glucose and the treatment substance is insulin.

4. The patient treatment and analysis system of claim 3, wherein the treatment substance is IV insulin.

5. The patient treatment and analysis system of claim 1, wherein the system is configured to perform a measurement cycle more frequency than once per hour.

6. The patient treatment and analysis system of claim 5, wherein the patient treatment and analysis system is configured to perform the measurement cycle at least once every thirty minutes.

7. The patient treatment and analysis system of claim 6, wherein the patient treatment and analysis system is configured to perform the measurement cycle at least once every fifteen minutes.

8. The patient treatment and analysis system of claim 1, further comprising a fluid network that is configured to draw a sample of bodily fluid through a catheter connected to the patient and transport at least a portion of the sample of bodily fluid to the body fluid analyzer, wherein the fluid network is further configured to deliver the treatment dose to the patient using the same catheter used to draw samples of bodily fluid.

9. The patient treatment and analysis system of claim 1, wherein the dose of the treatment fluid administered to the patient is the recommended treatment dosage calculated by the treatment dosing system.

10. The patient treatment and analysis system of claim 1, further comprising a user interface configured to display the recommended treatment dosage to a user and to receive input from the user, and wherein the dose of the treatment fluid administered to the patient is determined at least in part by the input received from the user via the user interface.

11. The patient treatment and analysis system of claim 1, wherein the source of the treatment substance is a non-dedicated reservoir.

12. The patient treatment and analysis system of claim 1, wherein the treatment dosing algorithm is configured to apply a first dosing protocol if the predicted accuracy is above a predetermined level and apply a second dosing protocol if the predicted accuracy is below the predetermined level, wherein the second dosing protocol is more conservative than the first dosing protocol.

13. The patient treatment and analysis system of claim 1, wherein the treatment dosing algorithm comprises a sliding scale dosing protocol having a varying level of aggressiveness that is based at least in part on the predicted accuracy, such that the aggressiveness of the sliding scale dosing protocol increases as the predicted accuracy increases.

14. A patient monitoring and dosing system, comprising:

a body fluid analyzer configured to measure a concentration of an analyte in a sample of bodily fluid from a patient; and

a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system comprising a treatment dosing algorithm stored in a computer memory, the treatment dosing algorithm being configured to automatically calculate;

an estimated treatment sensitivity for the patient based at least in part on the measured concentration of the analyte; and

a recommended treatment dosage for the patient, wherein the automatic calculation of the recommended treatment dosage is based at least in part on the estimated treatment sensitivity;

wherein the treatment dosing algorithm is configured to calculate a predicted accuracy of the estimated treatment sensitivity, and wherein the treatment dosing algorithm is configured to calculate the recommended treatment dosage based at least in part on the predicted accuracy of the estimated treatment sensitivity.

15. The patient monitoring and dosing system of claim 14, wherein the treatment dosing system further comprises a source of treatment fluid, the treatment dosing system being configured to automatically deliver the recommended treatment dosage to the patient.

16. The patient monitoring and dosing system of claim 15, wherein the body fluid analyzer is configured to periodically measure samples of bodily fluid, and the treatment dosing system is configured to deliver the recommended treatment dosage to the patient at least in part as a basal infusion, the treatment dosing system being configured to adjust a basal infusion rate to deliver the recommended treatment dosage to the patient, and wherein the basal infusion is halted at least five minutes before the next measurement is taken.

17. The patient monitoring and dosing system of claim 15, wherein the body fluid analyzer is configured to periodically measure samples of bodily fluid, and the treatment dosing system is configured to deliver the recommended treatment dosage to the patient at least in part as a bolus injection delivered at least five minutes before the next measurement is taken.

18. The patient monitoring and dosing system of claim 15, wherein the body fluid analyzer is configured to periodically measure samples of bodily fluid, and the treatment dosing system is configured to deliver the recommended treatment dosage to the patient at least in part as a bolus injection delivered about midway between sample measurements.

19. The patient monitoring and dosing system of claim 14, further comprising a database in communication with the body fluid analyzer, the database being configured to store a history of measured concentrations of the analyte, wherein the treatment dosing algorithm is configured to access the database and calculate the estimated treatment sensitivity based at least in part on the history of measured concentrations of the analyte.

20. The patient monitoring and dosing system of claim 19, wherein the database is configured to store a history of treatment doses delivered to the patient, and wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on the history of treatment doses.

21. The patient monitoring and dosing system of claim 20, wherein the history of treatment doses comprises a plurality of active dose amounts delivered to the patient at different times, and the treatment dosing algorithm is configured to calculate an amount remaining for each of the plurality of active dose amounts based at least in part on a treatment fluid half-life, and the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on the amount remaining for each of the plurality of active dose amounts.

22. The patient monitoring and dosing system of claim 20, wherein the treatment dosing system further comprises a source of treatment fluid, the treatment dosing system being configured to automatically deliver the recommended treatment dosage to the patient, the treatment dosing system being configured to access the database and update the history of treatment doses.

23. The patient monitoring and dosing system of claim 20, wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on a comparison of at least a portion of the history of measured concentrations of the analyte to at least a portion of the history of treatment doses.

24. The patient monitoring and dosing system of claim 23, wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity using a weighted average, the weighted average giving greater weight to more recent entries in the history of measured concentrations of the analyte and the history of treatment doses.

25. The patient monitoring and dosing system of claim 19, wherein the body fluid analyzer is configured to measure a new concentration of the analyte and update the history of measured concentrations of the analyte at least once every hour, and the treatment dosing algorithm is configured to calculate a new estimated treatment sensitivity and a new recommended treatment dosage at least once every hour.

26. The patient monitoring and dosing system of claim 19, wherein the body fluid analyzer is configured to measure a new concentration of the analyte and update the history of measured concentrations of the analyte at least once every thirty minutes, and the treatment dosing algorithm is configured to calculate a new estimated treatment sensitivity and a new recommended treatment dosage at least once every thirty minutes.

27. The patient monitoring and dosing system of claim 19, wherein the body fluid analyzer is configured to measure a new concentration of the analyte and update the history of measured concentrations of the analyte at least once every fifteen minutes, and the treatment dosing algorithm is configured to calculate a new estimated treatment sensitivity and a new recommended treatment dosage at least once every fifteen minutes.

28. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm is configured to apply a first dosing protocol if the predicted accuracy is above a predetermined level and apply a second dosing protocol if the predicted accuracy is below the predetermined level, wherein the second dosing protocol is more conservative than the first dosing protocol.

29. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm comprises a sliding scale dosing protocol having a varying level of aggressiveness that is based at least in part on the predicted accuracy, such that the aggressiveness of the sliding scale dosing protocol increases as the predicted accuracy increases.

30. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm is configured to calculate an expected analyte concentration range based at least in part on the estimated treatment sensitivity, and the treatment dosing algorithm is configured to trigger an alert if the measured analyte concentration falls outside the expected analyte concentration range.

31. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on additional patient data, the additional patient data including patient feeding information, patient medication information, or patient exercise information.

32. The patient monitoring and dosing system of claim 14, wherein the body fluid analyzer is configured for glucose control solution calibration no more than once per day.

33. The patient monitoring and dosing system of claim 14, wherein the body fluid analyzer is configured for glucose control solution calibration no more than once each week.

34. The patient monitoring and dosing system of claim 14, further comprising a fluid network connected to the patient and the body fluid analyzer, the fluid network configured to draw a sample of bodily fluid through a catheter connected to the patient and transport at least a portion of the sample of bodily fluid to the body fluid analyzer for measurement.

35. The patient monitoring and dosing system of claim 34, further comprising a source of treatment fluid, and wherein the treatment and dosing system is configured to automatically deliver the recommended treatment dosage to the patient through the same catheter used to draw the sample of bodily fluid.

36. The patient monitoring and dosing system of claim 14, wherein the analyte is glucose and the estimated treatment sensitivity is estimated insulin sensitivity and the recommended treatment dosage is a recommended dose of insulin.

37. The patient monitoring and dosing system of claim 14, wherein the treatment dosing system further comprises a display configured to display the recommended treatment dosage to a user.