System and method for detecting hypoglycemia based on a paced depolarization integral using an implantable medical device

• US 7,590,443 B2
• Filed: 04/27/2005
• Issued: 09/15/2009
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bharmi, Rupinder
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Bertram; Eric D
• Application Number:
  US11/117,624
• Publication Number:
  US 20060247685A1
• Time in Patent Office: 1,602 Days
• Field of Search: 600/365, 600/509
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

Techniques are provided for use with an implantable medical device such as a pacemaker or implantable cardioverter/defibrillator (ICD) for predicting and detecting hypoglycemia. In one example, the device tracks changes in a paced depolarization integral (PDI). A significant increase in PDI over a relatively short period of time indicates the onset of hypoglycemia (this can also be confirmed with QT changes). Upon detection of hypoglycemia, appropriate warning signals are generated to alert the patient. Certain therapies automatically provided by the implantable device may also be controlled in response to hypoglycemia. For example, if the patient is an insulin-dependent diabetic and the implantable device is equipped with an insulin pump capable of delivering insulin directly into the bloodstream, insulin delivery is automatically suspended until blood glucose levels return to acceptable levels. If the device is an ICD, it may be controlled to begin charging defibrillation capacitors upon detection of hypoglycemia so as to permit prompt delivery of a defibrillation shock, which may be needed if hypoglycemia triggers ventricular fibrillation. The detection techniques may be used in conjunction with other hypoglycemia detection techniques to improve detection specificity.

Claims

1. A method for use with an implantable medical device for detecting hypoglycemia in a patient in which the device is implanted, the method comprising:

detecting electrical cardiac signals corresponding to ventricular evoked responses; and

detecting an episode of hypoglycemia based on changes in a parameter representative of the energy associated with the electrical cardiac signals corresponding to ventricular evoked responses;

wherein the parameter incorporates an integral of portions of the electrical cardiac signals corresponding to ventricular evoked responses.

2. The method of claim 1 wherein the parameter is a paced depolarization integral (PDI).

3. The method of claim 1 wherein detecting an episode of hypoglycemia based on the parameter comprises detecting one or more of a significant increase in the parameter and a significant rate of change of a mean of the parameter.

4. The method of claim 3 wherein detecting a significant increase in the parameter is performed to detect an increase above a hypoglycemia detection threshold.

5. The method of claim 1 further comprising controlling therapy in response to the detection of an episode of hypoglycemia.

6. The method of claim 5 wherein an implantable drug pump is provided for delivering insulin and wherein controlling therapy in response to the detection of an episode of hypoglycemia comprises reducing insulin delivery to the patient using the insulin pump.

7. The method of claim 5 wherein an implantable drug pump is provided for delivering selected medications in response to hyperinsulinism and wherein controlling therapy in response to the detection of an episode of hypoglycemia comprises delivering the selected medications.

8. The method of claim 1 further comprising generating a warning signal in response to detection of an episode of hypoglycemia.

9. The method of claim 8 wherein an implantable warning device is provided and wherein generating a warning signal comprises delivering a perceptible warning signal to the patient via the implantable warning device.

10. The method of claim 8 wherein an external warning device is provided and wherein generating a warning signal comprises transmitting control signals to the external warning device for controlling the external device to generate warning signals.

11. The method of claim 1 wherein the implantable device includes a defibrillator with defibrillation shock capacitors and wherein the method further comprises charging the capacitors in response to detection of an episode of hypoglycemia.

12. The method of claim 1 further comprising recording diagnostic information representative of the parameter representative of the energy associated with electrical cardiac signals corresponding to ventricular evoked responses.

13. The method of claim 12 further comprising examining the recording diagnostic information to predict episodes of hypoglycemia.

14. The method of claim 13 wherein examining the recording diagnostic information to predict episodes of hypoglycemia is performed by identifying a trend in increasing PDI.

15. The method of claim 1 wherein detecting a parameter comprises tracking changes in the parameter over time.

16. A system for use with an implantable medical device for detecting hypoglycemia in a patient in which the device is implanted comprising:

means for detecting electrical cardiac signals corresponding to ventricular evoked responses; and

means for detecting an episode of hypoglycemia based on changes in a parameter representative of the energy associated with the electrical cardiac signals corresponding to ventricular evoked responses;

wherein the parameter incorporates an integral of portions of the electrical cardiac signals corresponding to ventricular evoked responses.