FLUID COMPONENT ANALYSIS SYSTEMS AND METHODS FOR GLUCOSE MONITORING AND CONTROL

• US 20170188943A1
• Filed: 08/15/2016
• Published: 07/06/2017
• Est. Priority Date: 10/10/2007
• Status: Abandoned Application

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter, Rivas, Gil, Keenan, Richard, Braig, James R., Seetharaman, Mahesh
• Application Number:
  US15/236,831
• Publication Number:
  US 20170188943A1
• Time in Patent Office: Days
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• 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 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• 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 5/150992 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 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• 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 5/7475 : 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 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• 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
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

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.

Claims

1-53. -53. (canceled)

54. A combined glucose monitoring and adjustment system comprising:

a fluid control device with pumps, valves, and fluid passageways configured to automatically draw fluid from a patient multiple times per hour and deliver a portion of that fluid to an analyte monitoring system each time;

the analyte monitoring system comprising 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 glucose in the fluid; and

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 patient by infusing insulin and/or sugar; and

a controller configured to control the pump and provide signals to the pump multiple times per hour, including signals to automatically stop infusion of insulin if determination of concentration of glucose is below a first threshold.

55. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than twice per day.

56. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once per day.

57. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once every 36 hours.

58. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once every two days.

59. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once every three days.

60. The analyte detection system of claim 54, further comprising a treatment dosing system configured to determine a dose of insulin and/or sugar to be infused based on one or more determinations of concentration of glucose.

61. The analyte detection system of claim 60, wherein the treatment dosing system is configured to compare a determination of concentration of glucose with a target glucose concentration to determine a dose of insulin and/or sugar to be infused.

62. The analyte detection system of claim 60, wherein the treatment dosing system is configured to determine a dose of insulin and/or sugar to be infused based on at least one of:

the patient'"'"'s medical conditions and medical history, an effectiveness of the dose, presence or absence of other analytes in the fluid or other medications being administered.

63. The analyte detection system of claim 54, wherein the controller is further configured to provide signals to the pump or a second pump to infuse an increased amount of sugar if determination of concentration of glucose is below the first threshold.

64. A method of glucose monitoring and adjusting a level of glucose comprising:

automatically withdrawing fluid from a patient multiple times per hour and delivering a portion of the withdrawn fluid each time to an analyte monitoring system via a fluid control device with pumps, valves, and fluid passageways;

determining a concentration of glucose in the fluid using a glucose meter

adjusting an amount of glucose in the fluid using 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 patient by infusing insulin and/or sugar; and

a controller configured to control the pump; and

providing signals to the pump multiple times per hour, including signals to automatically stop infusion of insulin if determination of concentration of glucose is below a first threshold.

65. The method of claim 64, further comprising determining a dose of insulin and/or sugar to be infused based on one or more determinations of concentration of glucose.

66. The method of claim 65, wherein the dose of insulin and/or sugar to be infused is determined by comparing a determination of concentration of glucose with a target glucose concentration to determine.

67. The method of claim 65, wherein the dose of insulin and/or sugar to be infused is determined based on at least one of:

the patient'"'"'s medical conditions and medical history, an effectiveness of the dose, presence or absence of other analytes in the fluid or other medications being administered.

68. The method of claim 64, further comprising providing signals to the pump or a second pump to infuse an increased amount of sugar if determination of concentration of glucose is below the first threshold.

69. The method of claim 64, wherein determining concentration of glucose in the fluid comprises directing an optical radiation towards the fluid or a portion thereof and detecting secondary radiation, either transmitted or reflected.