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

• US 7,727,147 B1
• Filed: 05/13/2005
• Issued: 06/01/2010
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Frei, Mark G., Osorio, Ivan
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US11/128,600
• Time in Patent Office: 1,845 Days
• Field of Search: 600/365, 600/345, 600/347, 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, an internal analysis chamber, a byproduct storage chamber, a sampling mechanism, a transfer mechanism, a self-sealing membrane, a calibration chamber, a replacement sensor chamber, a prevention mechanism to prevent deposition of unwanted substances on a sensor or catheter, a removal mechanism to remove unwanted substances from a sensor or catheter, a warning mechanism, a real-time clock and non-volatile memory to store and log information processed by the processor, a failure detection mechanism, and wired and/or wireless communication linkages both internally and externally.

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 receive and analyze at least one sensor output from the one or more sensors and to 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 the 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) wherein the control mechanism is further configured and adapted to determine whether the performance of the at least one sensor extending through the self-sealing membrane has deteriorated below a predetermined level whereupon the control mechanism causes the insertion mechanism to automatically;

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

(2) retract the deteriorated sensor back through the self-sealing membrane with the deteriorated sensor being retained fully embedded within the subject.

2. 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 receive and analyze at least one sensor output from the one or more sensors and to 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) wherein the control mechanism is further configured and adapted to automatically cause the sensor extractions and retractions by the insertion mechanism after a predetermined period of time.

3. 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 receive and analyze at least one sensor output from the one or more sensors and 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) 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 which 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.