FLUID COMPONENT ANALYSIS SYSTEMS AND METHODS FOR GLUCOSE MONITORING AND CONTROL
First Claim
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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;
at least one pump system coupled to the fluid transport network, the pump system having a sampling mode in which the pump system is operable to withdraw a sample of bodily fluid from the patient end and transport said sample of bodily fluid toward the body fluid analyzer, and an infusion mode in which the pump system is operable to transport an infusion fluid to the patient;
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; and
a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol stored in a computer memory and configured to automatically determine a recommended dose of an infusion substance configured to provide glycemic control, wherein the body fluid analyzer determines the recommended dose based at least in part on the measured concentration of the analyte and the stored treatment dosing protocol,the treatment dosing system comprising a treatment pump having a variable pump rate to deliver the recommended dose of the infusion substance to the patient.
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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.
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Citations
59 Claims
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1. An analyte detection and treatment dosing system comprising:
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a fluid transport network configured to provide fluid communication with a body fluid in a patient through a patient end; at least one pump system coupled to the fluid transport network, the pump system having a sampling mode in which the pump system is operable to withdraw a sample of bodily fluid from the patient end and transport said sample of bodily fluid toward the body fluid analyzer, and an infusion mode in which the pump system is operable to transport an infusion fluid to the patient; 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; and a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol stored in a computer memory and configured to automatically determine a recommended dose of an infusion substance configured to provide glycemic control, wherein the body fluid analyzer determines the recommended dose based at least in part on the measured concentration of the analyte and the stored treatment dosing protocol, the treatment dosing system comprising a treatment pump having a variable pump rate to deliver the recommended dose of the infusion substance to the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An analyte detection and treatment dosing system comprising:
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a fluid transport network configured to provide fluid communication with a body fluid in a patient through a patient end; at least one pump system coupled to the fluid transport network, the pump system having a sampling mode in which the pump system is operable to withdraw a sample of bodily fluid from the patient end and transport said sample of bodily fluid towards the body fluid analyzer, and an infusion mode in which the pump system is operable to transport an infusion fluid to the patient; 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; and a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol stored in a computer memory and configured to automatically determine a recommended dose of an infusion substance 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, the treatment dosing system comprising a basal delivery system and a bolus injection system, both systems configured to deliver infusion substances to the patient through said patient end and through the same intravenous access line. - View Dependent Claims (19, 20, 21, 22)
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23. An analyte detection and control system to determine and regulate the concentration of one or more analytes in a sample of bodily fluid, the system comprising:
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a control system; an analyte detector configured to measure a characteristic of at least one analyte in the sample of bodily fluid and determine a concentration of the analyte in the sample based on the measured characteristic; a fluid handling system operatively coupled to the analyte detector, said fluid handling system comprising a fluid passageway in communication with a patient through a patient end; a pump unit configured to engage the fluid handling system and draw a sample of bodily fluid from the patient periodically at draw intervals of less than 1 hour for analysis; a source of infusion fluid configured to adjust glycemic levels in the patient, said infusion fluid source in fluid communication with the fluid handling system; and 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 the infusion fluid, 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. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. A method of analyzing an analyte in the body fluid of a patient, the method comprising:
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placing a body fluid analyzer in fluid communication with the body fluid in the patient; transporting a sample of the body fluid toward the body fluid analyzer; with the body fluid analyzer, measuring a characteristic of an analyte in the bodily fluid and determining the concentration of the analyte in the body fluid, while the analyzer is in fluid communication with the body fluid in the patient; and with a treatment dosing system in communication with the body fluid analyzer, determining a recommended dose for an infusion fluid based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and a treatment dosing protocol. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41)
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42. A method of monitoring and regulating the concentration of one or more analytes in a sample of bodily fluid, said method comprising:
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providing a fluid connection to a patient; periodically withdrawing a certain volume of bodily fluid from the patient at draw intervals of less than 1 hour; sensing a property of the withdrawn fluid using one or more sensors; dividing the withdrawn volume of fluid into an analysis portion and a return portion; measuring a characteristic of said analysis portion to determine the concentration of an analyte in said analysis portion; determining a recommended dose for an infusion fluid for an infusion fluid based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and a treatment dosing protocol; and providing an instruction to an infusion fluid system to infuse the recommended dose of infusion fluid into the patient at a prescribed infusion fluid delivery rate. - View Dependent Claims (44, 45, 46)
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43. An analyte detection and treatment dosing system comprising:
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a fluid transport network configured to provide fluid communication with a body fluid in a patient; 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 the 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 is located on the same housing, and the graphic user interface is configured to display the determined analyte concentration and the recommended dose.
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47. An analyte monitoring system comprising:
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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; an analyte detection system configured to analyze the sample of bodily fluid or a component of the sample of bodily fluid; and a fluid infusion system; wherein the analyte detection system is configured to determine the 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 configured to access a measurement database and calculate an average concentration of the analyte based on the determined concentration and one or more previous values for the concentration of the analyte stored in the measurement database. - View Dependent Claims (48, 49, 50)
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51. An analyte monitoring system comprising:
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a fluidic system in fluid communication with a source of bodily fluid, said fluidic system being configured to obtain a first sample of bodily fluid from the source at a first time; an analyte detection system configured to analyze the first sample of bodily fluid or a component of the first sample of bodily fluid; and a fluid infusion system; wherein the analyte detection system is configured to determine the concentration of an analyte in said first sample of the bodily fluid or a component of the first sample of the bodily fluid and store the value of the determined concentration in a measurement database, wherein the fluidic system further obtains a second sample of the bodily fluid at a second time and presents said second sample to the analyte detection system for analysis, wherein the analyte detection system analyzes the second sample or a component of the second sample and determines the concentration of the analyte in the second sample or the component of the second sample, wherein the analyte detection system calculates a rate of change of the concentration of the analyte and determines a treatment dose based on the rate of change of the concentration of the analyte if the concentration of the analyte in the second sample is not within a prescribed range, and wherein the analyte detection system communicates with the fluid infusion system to deliver the determined treatment dose.
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52. An analyte monitoring system comprising:
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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 give 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 the 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 estimated 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.
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53. An analyte monitoring system comprising:
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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 give 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 the 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 estimated 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.
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54. A combined glucose monitoring and adjustment system comprising:
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a fluid control device with pumps, valves, and fluid passageways configured to draw fluid from a fluid source and deliver a portion of that fluid to an analyte monitoring system; an optical glucose meter configured to irradiate the fluid or a portion thereof and detect secondary radiation, either transmitted or reflected, and determine, based on that secondary radiation, a concentration of an analyte in the fluid; a glucose adjustment system comprising; a repository of a treatment substance selected from the group consisting of insulin and a sugar; a pump configured to adjust the level of glucose in the fluid source by infusing insulin and/or sugar; and a controller configured to control the pump. - View Dependent Claims (55, 56, 57, 58, 59)
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Specification