Implantable cardiac stimulation device and method for detecting asymptomatic diabetes

• US 7,103,412 B1
• Filed: 05/02/2003
• Issued: 09/05/2006
• Est. Priority Date: 05/02/2003
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kroll, Mark W.
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): Gedeon, Brian T.
• Application Number:
  US10/429,133
• Time in Patent Office: 1,222 Days
• Field of Search: 607/1, 607/9, 607/17, 607/18, 607/25, 600/300, 600/509, 600/510, 600/513, 600516-517, 128/899
• US Class Current: 607/17
• 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 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37258 Alerting the patient

Abstract

An implantable cardiac stimulation device for determining whether a patient has asymptomatic diabetes. A pulse generator delivers pacing pulses to the heart. A sensing circuit senses internal cardiac signals. A processor is programmed to measure at least one characteristic of the cardiac signals, which are processed to determine whether the patient has asymptomatic diabetes. Relative changes in the measured characteristics over time are indicative of whether the patient has asymptomatic diabetes. The measured characteristics may include, alone or in combination, T-wave morphology, corrected QT internal, QT dispersion and signal averaged QRS width.

Claims

1. In an implantable cardiac stimulation device, a system for detecting asymptomatic diabetes in a patient, the system comprising:

a pulse generator that generates pacing pulses for delivery to a heart;

a sensing circuit that senses internal cardiac signals of the heart;

circuitry connected to the pulse generator and the sensing circuit that is operative to measure at least one characteristic of the internal cardiac signals to provide measured values, and wherein the circuitry is further operative to process the measured values to determine whether the patient has asymptomatic diabetes; and

a memory circuit connected to the circuitry and that is operative to store the measured values.

2. The system of claim 1, wherein the circuitry is further operative to construct a surrogate for an external electrogram based on the internal cardiac signals.

3. The system of claim 2, wherein the surrogate for the external electrogram is a surrogate for a 12 lead electrogram.

4. The system of claim 1, further comprising a calibration circuit operative to calibrate the system and to calculate reference values.

5. The system of claim 1, wherein the sensing circuit senses the internal cardiac signals by far-field electrocardiography.

6. The system of claim 1, wherein the cardiac stimulation device further comprises pacing and sensing leads oriented in parallel to approximate far-field electrocardiography.

7. The system of claim 1, wherein the at least one characteristic of the internal cardiac signals measured to determine whether the patient has asymptomatic diabetes is T-wave morphology.

8. The system of claim 7, wherein the circuitry is programmed to measure a T-wave morphology value, to calculate a delta T-wave morphology value by determining a difference between the measured T-wave morphology value and a reference T-wave morphology value, and to store the delta T-wave morphology values over time, wherein relative changes in the delta T-wave morphology values over time indicate that the patient has asymptomatic diabetes.

9. The system of claim 1, wherein the at least one characteristic of the internal cardiac signals measured to determine whether the patient has asymptomatic diabetes is corrected QT interval.

10. The system of claim 9, wherein the circuitry is programmed to measure a corrected QT interval value, to calculate a delta corrected QT interval value by determining a difference between the measured corrected QT interval value and a reference corrected QT interval value, and to store the delta corrected QT interval values over time, wherein relative changes in the delta corrected QT interval values over time indicate that the patient has asymptomatic diabetes.

11. The system of claim 1, wherein the at least one characteristic of the internal cardiac signals measured to determine whether the patient has asymptomatic diabetes is QT dispersion.

12. The system of claim 11, wherein the circuitry is programmed to measure a QT dispersion value, to calculate a delta QT dispersion value by determining a difference between the measured QT dispersion value and a reference QT dispersion value, and to store the delta QT dispersion values over time, wherein relative changes in the delta QT dispersion values over time indicate that the patient has asymptomatic diabetes.

13. The system of claim 1, wherein the at least one characteristic of the internal cardiac signals measured to determine whether the patient has asymptomatic diabetes is signal averaged QRS width.

14. The system of claim 1, wherein the circuitry is programmed to measure a signal averaged QRS width value, to calculate a delta signal averaged QRS width value by determining a difference between the measured signal averaged QRS width value and a reference signal averaged QRS width value, and store the delta signal averaged QRS width values over time, wherein relative changes in the delta signal averaged QRS width values over time indicate that the patient has asymptomatic diabetes.

15. The system of claim 1, wherein the at least one characteristic of the internal cardiac signals measured to determine whether the patient has asymptomatic diabetes comprises at least one of T-wave morphology and corrected QT interval.

16. The system of claim 15, wherein the circuitry is programmed to measure a T-wave morphology value, to measure a corrected QT interval value, to calculate a delta T-wave morphology value by determining a difference between the measured T-wave morphology value and a reference T-wave morphology value, to calculate a delta corrected QT interval value by determining a difference between the measured corrected QT interval and a reference corrected QT interval value, to store the delta T-wave morphology values over time, and to store the delta corrected QT interval values over time, wherein relative changes in the delta T-wave morphology values and delta corrected QT interval values over time indicate that the patient has asymptomatic diabetes.

17. The system of claim 1, wherein the at least one characteristic of the internal cardiac signals measured to determine whether the patient has asymptomatic diabetes comprises at least one of corrected QT interval and QT dispersion.

18. The system of claim 17, wherein the circuitry is programmed to measure a corrected QT interval value, to measure a QT dispersion value, to calculate a delta corrected QT interval value by determining a difference between the measured corrected QT interval value and a reference corrected QT interval value, to calculate a delta QT dispersion value by determining a difference between the measured QT dispersion value and a reference QT dispersion value, to store the delta corrected QT interval values over time, and to store the delta QT dispersion values over time, wherein relative changes in the delta corrected QT interval values and delta QT dispersion values over time indicate that the patient has asymptomatic diabetes.

19. The system of claim 1, wherein the at least one characteristic of the internal cardiac signals measured to determine whether the patient has asymptomatic diabetes comprises at least one of T-wave morphology, corrected QT interval and QT dispersion.

20. The system of claim 19, wherein the circuitry is programmed to measure a T-wave morphology value, to measure a corrected QT interval value, to measure a QT dispersion value, to calculate a delta T-wave morphology value by determining a difference between the measured T-wave morphology value and a reference T-wave morphology value, to calculate a delta corrected QT interval value by determining a difference between the measured corrected QT interval value and a reference corrected QT interval value, to calculate a delta QT dispersion value by determining a difference between the measured QT dispersion value and a reference QT dispersion value, to store the delta T-wave morphology value over time, to store the delta corrected QT interval value over time, and store the delta QT dispersion value over time, wherein relative changes in the delta T-wave morphology values, delta corrected QT interval and delta QT dispersion over time indicate that the patient has asymptomatic diabetes.

21. The system of claim 1, wherein the circuitry is further operative to calculate a diabetes mellitus indicator score.

22. The system of claim 21, wherein the diabetes mellitus indicator score is stored in a memory over time.

23. The system of claim 22, wherein the circuitry is further operative to compare the diabetes mellitus indicator score to a threshold value stored in the memory, and wherein the system is further operative to alert the patient if the diabetes mellitus indicator score is greater than or equal to the threshold value for a pre-determined period of time.

24. In an implantable cardiac stimulation device, a method for detecting asymptomatic diabetes in a patient, the method comprising:

sensing cardiac signals of the patient'"'"'s heart using the implantable cardiac stimulation device;

measuring at least one characteristic of the cardiac signals to provide measured values; and

analyzing the measured values to determine whether the patient has asymptomatic diabetes.

25. The method of claim 24, wherein sensing cardiac signals comprises sensing the cardiac signals by far-field electrocardiography.

26. The method of claim 24, wherein analyzing the measured values comprises:

(a) measuring a T-wave morphology value;

(b) calculating a delta T-wave morphology value by determining a difference between the measured T-wave morphology value and a reference T-wave morphology value, the reference T-wave morphology value determined as a result of a calibration step; and

(c) storing the delta T-wave morphology value in a memory,

wherein relative changes in the delta T-wave morphology value over time indicate that the patient has asymptomatic diabetes.

27. The method of claim 24, wherein analyzing the measured values comprises:

(a) measuring a corrected QT interval value;

(b) calculating a delta corrected QT interval value by determining a difference between the measured corrected QT interval value and a reference corrected QT interval value, the reference corrected QT interval value determined as a result of a calibration step; and

(c) storing the delta corrected QT interval value in a memory,

wherein relative changes in the delta corrected QT interval value over time indicate that the patient has asymptomatic diabetes.

28. The method of claim 24, further comprising calibrating the implantable device prior to detecting asymptomatic diabetes in the patient.

29. In an implantable cardiac stimulation device, a system for detecting asymptomatic diabetes in a patient, the system comprising:

means for sensing cardiac signals of the heart;

means for measuring at least one characteristic of the cardiac signals to provide measured values; and

means for processing the measured values to determine whether the patient has asymptomatic diabetes.

30. The system of claim 29 wherein the means for measuring comprises means for measuring T-wave morphology.

31. The system of claim 29 wherein the means for measuring comprises means for measuring a corrected QT interval.

32. The system of claim 29 wherein the means for measuring comprises means for measuring a signal averaged QRS width.

33. The system of claim 29 wherein the means for measuring comprises means for measuring QT dispersion.