Method and system for implantable glucose monitoring and control of a glycemic state of a subject

• US 8,348,842 B1
• Filed: 07/01/2011
• Issued: 01/08/2013
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Frei, Mark G.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US13/135,375
• Time in Patent Office: 557 Days
• Field of Search: 600/345, 600/347, 600/365, 604/48, 604/65, 604/500, 604502-504, 604/890.1, 604/891.1
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A method and system for monitoring and/or controlling a glycemic state of a subject, comprising a housing device having one or more chambers, extendable and retractable sensors, extendable and retractable catheters, insulin reservoir, neuroprotective agent reservoir, release mechanism for releasing insulin and neuroprotective agent into the subject, and a control mechanism with a processor for receiving and analyzing outputs from the sensors and for controlling the release mechanism, a clock mechanism for providing logging and/or circadian information to the processor.

Claims

1. A system for monitoring and/or controlling a glycemic state of a subject, the system comprising:

(a) at least one housing device adapted to be fully embedded internally within a subject wherein the at least one housing device includes;

(1) a self-sealing membrane,

(2) one or more sensors configured and adapted to produce a sensor output relating to a glycemic state wherein each of the one or more sensors is extendable through the self-sealing membrane into, and retractable back through the self-sealing membrane from being in, direct contact with a target of a subject,

(3) a reservoir containing insulin and having an output port,

(4) an injection mechanism configured to controllably inject the insulin through the output port,

(5) a control mechanism configured to;

(A) receive at least one sensor output from the one or more sensors,

(B) obtain at least one measurement of cognitive performance of the subject,

(C) analyze the at least one sensor output to detect an impending or occurring hypoglycemia and/or hyperglycemia condition and correlate the at least one sensor output with the at least one measure of cognitive performance to determine the presence of an impending or occurring neuroglycopenia, and

(D) responsively control the quantity of insulin injected through the output port by the injection mechanism; and

(6) an insertion mechanism controlled by the control mechanism, the insertion mechanism being configured and adapted to selectively extend at least one of the one or more sensors through the self-sealing membrane to be, and to selectively retract at least one of the one or more sensors back through the self-sealing membrane from being, in direct contact with a target of the subject; and

(b) a response mechanism that is activated when the control mechanism detects an impending or occurring neuroglycopenia, hypoglycemia and/or hyperglycemia condition as determined by the control mechanism from the sensor outputs as determined by the control mechanism from the sensor output(s) and measure(s) of cognitive performance; and

(c) wherein the control mechanism is further configured and adapted to automatically cause the sensor extensions and retractions by the insertion mechanism after a predetermined period of time.

2. The system as described in claim 1, wherein the neuroglycopenia is determined using cognitive, EEG, evoked potential, or autonomic function tests;

and hyperglycemia or hypoglycemia are determined by measuring the concentrations of glucose in the plasma, blood or tissue of a subject.

3. The system as described in claim 1 wherein, in the presence of neuroglycopenia or hypoglycemia, the response mechanism performs at least one of shutting down insulin delivery, or issuing a warning;

or releasing a carbohydrate, a compound that promotes glycogenolysis or gluconeogenesis, an energy equivalent substrate, or a neuroprotective agent.

4. A system for monitoring and/or controlling a glycemic state of a subject, the system comprising:

(a) at least one housing device adapted to be fully embedded internally within a subject wherein the at least one housing device includes;

(1) a self-sealing membrane,

(2) a sensor cleaning chamber,

(3) one or more sensors configured and adapted to produce a sensor output relating to a glycemic state wherein each of the one or more sensors is extendable through the self-sealing membrane into, and retractable back through the self-sealing membrane from being in, direct contact with a target of a subject,

(4) a reservoir containing insulin and having an output port,

(5) an injection mechanism configured to controllably inject the insulin through the output port,

(6) a control mechanism configured to;

(A) receive at least one sensor output from the one or more sensors,

(B) obtain at least one measurement of cognitive performance of the subject,

(C) analyze the at least one sensor output to detect an impending or occurring hypoglycemia and/or hyperglycemia condition and correlate the at least one sensor output with the at least one measure of cognitive performance to determine the presence of an impending or occurring neuroglycopenia, and

(D) to responsively control the quantity of insulin injected through the output port by the injection mechanism; and

(7) an insertion mechanism controlled by the control mechanism, the insertion mechanism being configured and adapted to selectively extend at least one of the one or more sensors through the self-sealing membrane to be, and to selectively retract at least one of the one or more sensors back through the self-sealing membrane from being, in direct contact with a target of the subject; and

(b) a response mechanism that is activated when the control mechanism detects an impending or occurring neuroglycopenia, hypoglycemia and/or hyperglycemia condition as determined by the control mechanism from the sensor outputs as determined by the control mechanism from the sensor output(s) and measure(s) of cognitive performance; and

(c) wherein the control mechanism is further configured and adapted to cause the insertion mechanism to automatically;

(1) extend another at least one sensor through the self-sealing membrane and into direct contact with a target of the subject, and

(2) retract an at least one sensor from a position wherein the at least one sensor is extending through the self-sealing membrane, back through the self-sealing membrane and into the sensor cleaning chamber with the retracted sensor being retained fully embedded within the subject.