Method and implantable system for blood-glucose concentration monitoring using parallel methodologies

• US 9,282,895 B2
• Filed: 12/10/2013
• Issued: 03/15/2016
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Farazi, Taraneh Ghaffari, Park, Euljoon, Falkenberg, Eric, Benser, Michael E., Wenzel, Brian Jeffrey
• Primary Examiner(s): CANELLA, KAREN A
• Application Number:
  US14/101,942
• Publication Number:
  US 20140221771A1
• Time in Patent Office: 826 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

In an implantable medical device for monitoring glucose concentration in the blood, a blood-glucose concentration analysis is performed using correlations of blood-glucose concentration with measures of metabolic oxygen consumption including oxymetric, and/or temperature. Analysis of electrocardiographic data is used in a parallel method to detect and/or confirm the onset and/or existence and/or extent of hypoglycemia and/or hyperglycemia. Blood-glucose concentration calculation is enhanced by using the combination of the oxygen metabolism analysis and electrocardiographic analysis.

Claims

1. An implantable system for monitoring blood-glucose concentration in a patient, comprising:

an EGM sensing circuit configured to sense one or more cardiac electrical signal and generate EGM data indicative of the one or more cardiac electrical signal;

an EGM analysis unit that is configured to receive the EGM data from the EGM sensing circuit and generate a first metric of blood-glucose concentration using the EGM data;

an oxygen metabolism sensor configured to monitor one or more property of oxygen metabolism and, to generate oxygen metabolism data indicative of the one or more property of oxygen metabolism;

an oxygen metabolism analysis unit configured to receive the oxygen metabolism data from the oxygen metabolism sensor and, to generate a second metric of blood-glucose concentration using the oxygen metabolism data; and

a blood-glucose concentration analysis unit configured to receive the first metric of blood-glucose concentration and the second metric of blood-glucose concentration and, to generate an enhanced metric of blood-glucose concentration.

2. The implantable system of claim 1, wherein the EGM analysis unit is further configured to generate the first metric of blood-glucose concentration using a function of at least one of:

a T-wave amplitude in the EGM data;

a Q-T interval in the EGM data; and

an S-T deviation in the EGM data.

3. The implantable system of claim 1, wherein the oxygen metabolism unit is further configured to generate the second metric of blood-glucose concentration using the metabolic oxygen conformation method.

4. The implantable system of claim 1, wherein the oxygen metabolism sensor is further configured to monitor one or more of:

a property of venous oxygen saturation;

a property of hematocrit; and

a property of arterial oxygen saturation.

5. The implantable system of claim 1, wherein the blood-glucose concentration analysis unit is further configured to use the first metric of blood-glucose concentration to confirm the second metric of blood-glucose concentration and, to determine the enhanced metric of blood-glucose concentration.

6. The implantable system of claim 1, wherein the blood-glucose concentration analysis unit is further configured to use the second metric of blood-glucose concentration to confirm the first metric of blood-glucose concentration and, to determine the enhanced metric of blood-glucose concentration.

7. The implantable system of claim 1, further comprising an effector for delivering a therapy in response to the enhanced metric of blood-glucose concentration.

8. The implantable system of claim 1, further comprising a warning control circuit that is configured to activate a warning device if the enhanced metric of blood-glucose concentration is indicative of hypoglycemia or hyperglycemia.

9. The implantable system of claim 1, further comprising:

a memory configured to store the enhanced blood-glucose concentration generated at a plurality of times; and

a communication circuit adapted to transmit the enhanced blood-glucose concentration generated at a plurality of times from the memory to a device external to the patient.

10. An implantable cardiac stimulation device comprising:

an EGM sensing circuit configured to sense one or more cardiac electrical signal and, to generate EGM data indicative of the one or more cardiac electrical signal;

an EGM analysis unit configured to receive the EGM data from the EGM sensing circuit and, to generate a first metric of blood-glucose concentration using the EGM data;

an oxygen metabolism input circuit configured to receive oxygen metabolism signals indicative of one or more property of oxygen metabolism and, to generate oxygen metabolism data using the oxygen metabolism signals;

an oxygen metabolism analysis unit configured to receive the oxygen metabolism data from the oxygen metabolism input circuit, and to generate a second metric of blood-glucose concentration using the oxygen metabolism data;

a blood-glucose concentration analysis unit configured to receive the first metric of blood-glucose concentration and the second metric of blood-glucose concentration, and to generate an enhanced metric of blood-glucose concentration; and

an effector that is configured to deliver at least one of a therapy, a diagnosis and a warning in response to the enhanced metric of blood-glucose concentration.