SYSTEM AND METHOD FOR PROVIDING CLOSED LOOP INFUSION FORMULATION DELIVERY

• US 20150018757A1
• Filed: 06/24/2014
• Published: 01/15/2015
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Starkweather, Timothy J., Lebel, Ronald J., Shah, Rajiv, Miller, Michael E.
• Granted Patent: US 9,480,796 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm'"'"'s programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Claims

1-51. -51. (canceled)

52. An insulin formulation delivery system, comprising:

an infusion device that delivers an amount of insulin formulation in accordance with a basal rate component; and

a controller that receives a sensor signal representative of a sensed blood glucose level from a sensor at predefined timed intervals, compares the sensed blood glucose level in the sensor signal to a predefined blood glucose level threshold, and generates commands that are communicated to the infusion device including a command to disable delivery of the basal rate component if the sensed blood glucose level crosses the predefined blood glucose level threshold.

53. The system of claim 52, wherein the controller disables insulin formulation delivery if the sensed blood glucose level is less than the predefined blood glucose level threshold.

54. The system of claim 52, wherein the controller causes an insulin formulation to be delivered if the sensed blood glucose level is greater than the predefined blood glucose level threshold.

55. The system of claim 52, wherein the controller calculates an amount by which the sensed blood glucose level exceeds the predefined blood glucose level threshold, determines a rate at which the sensed blood glucose level is changing, and delivers an amount of insulin formulation based on the amount which the sensed blood glucose level exceeds the predefined blood glucose level threshold and the rate at which the sensed blood glucose level is changing.

56. The system of claim 55, wherein the controller causes an adjustment to be introduced into the amount of insulin formulation delivered not related to the amount which the sensed blood glucose level exceeds the predefined blood glucose level threshold or the rate at which the sensed blood glucose level is changing.

57. The system of claim 56, wherein the controller is configured with programmable control parameters for introduction of the adjustment.

58. The system of claim 55, wherein the controller determines at predetermined intervals the rate at which the sensed blood glucose level is changing.

59. The system of claim 58, wherein the predetermined intervals are programmable.

60. The system of claim 55, wherein the controller calculates an amount by which the sensed blood glucose level is offset over time from the predefined blood glucose level threshold.

61. The system of claim 52, further comprising a filter to filter out high frequency components of the sensed blood glucose level.

62. An insulin formulation delivery system, comprising:

an infusion device that delivers an amount of insulin formulation in accordance with a basal rate component;

a sensor that generates a sensor signal representative of a sensed blood glucose level at predefined timed intervals; and

a controller that receives the sensor signal from the sensor, compares the sensed blood glucose level in the sensor signal to a predefined blood glucose level threshold, and generates commands that are communicated to the infusion device including a command to disable delivery of the basal rate component if the sensed blood glucose level crosses the predefined blood glucose level threshold.

63. The system of claim 62, wherein the controller disables insulin formulation delivery if the sensed blood glucose level is less than the predefined blood glucose level threshold.

64. The system of claim 62, wherein the controller causes an insulin formulation to be delivered if the sensed blood glucose level is greater than the predefined blood glucose level threshold.

65. The system of claim 62, wherein the controller calculates an amount by which the sensed blood glucose level exceeds the predefined blood glucose level threshold, determines a rate at which the sensed blood glucose level is changing, and delivers an amount of insulin formulation based on the amount which the sensed blood glucose level exceeds the predefined blood glucose level threshold and the rate at which the sensed blood glucose level is changing.

66. The system of claim 65, wherein the controller causes an adjustment to be introduced into the amount of insulin formulation delivered not related to the amount which the sensed blood glucose level exceeds the predefined blood glucose level threshold or the rate at which the sensed blood glucose level is changing.

67. The system of claim 66, wherein the controller is configured with programmable control parameters for introduction of the adjustment.

68. The system of claim 65, wherein the controller determines at predetermined intervals the rate at which the sensed blood glucose level is changing.

69. The system of claim 68, wherein the predetermined intervals are programmable.

70. The system of claim 65, wherein the controller calculates an amount by which the sensed blood glucose level is offset over time from the predefined blood glucose level threshold.

71. The system of claim 62, further comprising a filter to filter out high frequency components of the sensed blood glucose level.