Fluid component analysis system and method for glucose monitoring and control

• US 8,417,311 B2
• Filed: 09/14/2009
• Issued: 04/09/2013
• Est. Priority Date: 09/12/2008
• Status: Active Grant

• Current Assignee: Insulet Corporation, OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US12/559,328
• Publication Number:
  US 20100121170A1
• Time in Patent Office: 1,303 Days
• Field of Search: 600345-347, 600/365, 435/4, 435/14, 422/50, 20440301-40315, 702/23
• US Class Current: 600/345
• 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 configured to frequently measure and control the concentration of an analyte in a body fluid of a patient whose insulin sensitivity may be rapidly changing due to trauma or injury, the system comprising:

a body fluid analyzer;

a fluid network coupled to the body fluid analyzer and configured to;

automatically and periodically draw samples of body fluid through a catheter connected to a patient; and

transport at least a portion of the samples of body fluid to the body fluid analyzer;

the body fluid analyzer configured to;

automatically and periodically measure a concentration of an analyte in the samples of body fluid; and

access an analyte history and store measured concentrations of the analyte in the analyte history; and

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

a source of a treatment substance;

a treatment dosing algorithm stored in a computer memory; and

a dose delivery device configured to automatically and periodically deliver doses to the patient from the source of a treatment substance through the fluid network in response to the treatment dosing algorithm;

the treatment dosing system configured to;

use the treatment dosing algorithm to calculate an updated estimated insulin sensitivity for the patient more frequently than once per hour, the calculation achieved by accessing the analyte history and a dosage history and comparing portions of the analyte history to portions of the dosage history;

use the treatment dosing algorithm to calculate a recommended treatment dosage for the patient more frequently than once per hour, the calculation based at least in part on the updated estimated treatment sensitivity;

administer, through the dose delivery device, a dose of the treatment substance to the patient to modify the concentration of the analyte in the body fluid of the patient based at least in part on the updated estimated treatment sensitivity; and

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

2. The patient treatment and analysis system of claim 1, wherein the treatment substance is IV insulin.

3. The patient treatment and analysis system of claim 1, wherein the fluid network is further configured to deliver the treatment dose to the patient using the same catheter used to draw the samples of body fluid.

4. 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 substance administered to the patient is determined at least in part by the input received from the user via the user interface.

5. The patient treatment and analysis system of claim 1, further comprising a user interface configured to display at least a portion of a history of measured concentrations of the analyte to a user, wherein the user interface is configured to receive input from the user, and wherein the dose of the treatment substance administered to the patient is determined at least in part by the input received from the user via the user interface.

6. A patient monitoring and dosing system, comprising:

a body fluid analyzer configured to measure a concentration of an analyte in a sample of body 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 updated estimated insulin sensitivity for the patient more frequently than once per hour, the calculation based at least in part on the measured concentration of the analyte; and

automatically calculate a recommended treatment dosage for the patient more frequently than once per hour, wherein the automatic calculation of the recommended treatment dosage is based at least in part on the updated estimated insulin sensitivity.

7. The patient monitoring and dosing system of claim 6, 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.

8. The patient monitoring and dosing system of claim 7, wherein the body fluid analyzer is configured to periodically measure samples of body 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 a next sample of body fluid is drawn.

9. The patient monitoring and dosing system of claim 7, wherein the body fluid analyzer is configured to periodically measure samples of body fluid, and the treatment dosing system is configured to deliver the recommended treatment dosage to the patient at least in part as a pulsatile infusion of a series of discrete doses administered between measurements, the treatment dosing system being configured to adjust the pulsatile infusion to deliver the recommended treatment dosage to the patient.

10. The patient monitoring and dosing system of claim 9, wherein the pulsatile infusion is halted at least five minutes before a next sample of body fluid is drawn.

11. The patient monitoring and dosing system of claim 6, 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 updated estimated insulin sensitivity based at least in part on the history of measured concentrations of the analyte.

12. The patient monitoring and dosing system of claim 11, 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 updated estimated insulin sensitivity based at least in part on the history of treatment doses.

13. The patient monitoring and dosing system of claim 12, 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 updated estimated insulin sensitivity based at least in part on the amount remaining for each of the plurality of active dose amounts.

14. The patient monitoring and dosing system of claim 12, wherein the treatment dosing algorithm is configured to calculate the updated estimated insulin 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.

15. The patient monitoring and dosing system of claim 6, wherein the treatment dosing algorithm is configured to calculate a predicted accuracy of the updated estimated insulin 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 updated estimated insulin sensitivity.

16. The patient monitoring and dosing system of claim 15, 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.

17. The patient monitoring and dosing system of claim 15, 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.

18. The patient monitoring and dosing system of claim 6, wherein the treatment dosing algorithm is configured to calculate an expected analyte concentration range based at least in part on the updated estimated insulin sensitivity, and the treatment dosing algorithm is configured to trigger an alert if the measured analyte concentration falls outside the expected analyte concentration range.

19. The patient monitoring and dosing system of claim 6, wherein the treatment dosing algorithm is configured to calculate the updated estimated insulin 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.

20. A method for controlling the concentration of an analyte in a body fluid of a patient whose treatment sensitivity may be rapidly changing due to trauma or injury, the method comprising:

automatically drawing samples of body fluid from a patient using a fluid network more frequently than once per hour;

automatically transporting at least a portion of the samples of body fluid to a body fluid analyzer using the fluid network;

automatically measuring a concentration of an analyte in the samples of body fluid using the body fluid analyzer;

storing measured concentrations of the analyte in an analyte history stored in computer-readable memory;

calculating, using one or more computer processors, an updated estimated insulin sensitivity for the patient more frequently than once per hour, wherein the calculation is achieved by accessing the analyte history and a dosage history and comparing portions of the analyte history to portions of the dosage history;

calculating, using the one or more computer processors, a recommended treatment dosage for a patient more frequently than once per hour, based at least in part on the updated estimated treatment sensitivity;

administering a dose of a treatment substance to the patient to modify the concentration of the analyte in the body fluid based at least in part on the updated estimated treatment sensitivity; and

storing a record of the administered dose in the dosage history stored in a computer-readable memory.

21. The method of claim 20, wherein the treatment substance is IV insulin.

22. The method of claim 20, wherein the treatment dose is administered to the patient using a catheter, wherein the same catheter is used to draw the samples of body fluid.

23. The method of claim 20, further comprising:

displaying the recommended treatment dosage; and

receiving input via a user interface, wherein the dose of the treatment substance administered to the patient is determined at least in part by the input received via the user interface.

24. The method of claim 20, further comprising:

displaying at least a portion of a history of measured concentrations of the analyte; and

receiving input via a user interface, wherein the dose of the treatment substance administered to the patient is determined at least in part by the input received via the user interface.

25. The method of claim 20, wherein the dose of the treatment substance is administered to the patient at least in part as a basal infusion, and wherein the basal infusion is halted at least five minutes before the next sample of body fluid is drawn.

26. The method of claim 20, wherein the dose of the treatment substance is administered to the patient at least in part as a pulsatile infusion of a series of discrete doses administered between measurements.

27. The method of claim 26, wherein the pulsatile infusion is halted at least five minutes before the sample of body fluid is drawn.

28. A method for recommending dosage of a treatment substance for controlling the concentration of an analyte in a body fluid of a patient whose treatment sensitivity may be rapidly changing due to trauma or injury, the method comprising:

automatically measuring a concentration of an analyte in samples of a body fluid using a body fluid analyzer;

storing measured concentrations of the analyte in an analyte history stored in computer-readable memory;

calculating, using one or more computer processors, an updated estimated insulin sensitivity for the patient more frequently than once per hour, wherein the calculation is achieved by accessing the analyte history and a dosage history and comparing portions of the analyte history to portions of the dosage history; and

calculating, using the one or more computer processors, a recommended treatment dosage for a patient more frequently than once per hour, based at least in part on the updated estimated treatment sensitivity.

29. The method of claim 28, wherein the dosage history comprises a plurality of active dose amounts delivered to the patient at different times, and wherein calculating an updated estimated insulin sensitivity comprises calculating, using the one or more computer processors, an amount remaining for each of the plurality of active dose amounts based at least in part on a treatment substance half-life.

30. The method of claim 28, further comprising calculating, using the one or more computer processors, a predicted accuracy of the updated estimated insulin sensitivity, and wherein calculating the recommended treatment dosage is based at least in part on the predicted accuracy of the updated estimated treatment sensitivity.

31. The method of claim 30, wherein calculating the recommended treatment dosage comprises applying a first dosing protocol if the predicted accuracy is above a predetermined level and applying 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.

32. The method of claim 30, wherein calculating the recommended treatment dosage comprises applying 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.

33. The method of claim 28, further comprising:

calculating, using the one or more computer processors, an expected analyte concentration range based at least in part on the updated estimated treatment sensitivity; and

triggering an alert if the measured concentration of the analyte falls outside the expected analyte concentration range.

34. The method of claim 28, calculating the updated estimated insulin sensitivity is based at least in part on additional patient data, the additional patient data including at least one of patient feeding information, patient medication information, and patient exercise information.