Method and system for verifying the integrity of normal sinus rhythm templates

• US 20060079796A1
• Filed: 11/28/2005
• Published: 04/13/2006
• Est. Priority Date: 03/12/1999
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Marcovecchio, Alan F., Hsu, William
• Granted Patent: US 7,653,430 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/35 by template matching

Abstract

A method and system for verifying the integrity of normal sinus rhythm (NSR) templates and updating the NSR template after selected time intervals. At selected time intervals after establishing a NSR template, cardiac complexes are sensed and values for one or more cardiac parameters are measured. The values of the cardiac parameters are compared to predetermined value ranges for NSR cardiac complexes. When the values of the cardiac parameters fall within the predetermined value ranges, values for the differences between the values of the cardiac parameters for the cardiac complexes and the values for the cardiac parameters of the NSR cardiac complexes are calculated. When the values of the differences are greater than one or more threshold values, the NSR template is updated as a function of the sensed cardiac complexes.

Claims

1. A medical device, comprising:

a morphology analyzer adapted to extract and measure sensed cardiac complex parameter values;

a template generating circuit connected to the morphology analyzer and adapted to receive the sensed cardiac complex parameter values and generate a normal sinus rhythm (NSR) template; and

a template comparison circuit connected to the template generating circuit and adapted to compare sensed cardiac complex parameter values to predetermined cardiac parameter values,

wherein the template comparison circuit and the template generating circuit cooperate to update the NSR template based on the compared sensed cardiac complex parameter values and the predetermined cardiac parameter values.

2. The medical device of claim 1, wherein the template comparison circuit and the template generating circuit are adapted to cooperate to update the NSR template when the sensed cardiac complex parameter values vary from a current NSR template by a calculated threshold value.

3. The medical device of claim 2, wherein the template comparison circuit is adapted to calculate the threshold value by multiplying parameter values for the current NSR template by a predetermined deviation percentage.

4. The medical device of claim 3, wherein the template comparison circuit is adapted to determine a number of attempts to evaluate the sensed cardiac complex parameter values.

5. The medical device of claim 4, further comprising input circuitry connected to the morphology analyzer and adapted to be connected to at least one electrode on at least one lead.

6. The medical device of claim 1, wherein the template comparison circuit is adapted to compare sensed cardiac complex parameter values to predetermined cardiac parameter values after a selected time interval has elapsed.

7. A device, comprising:

input circuitry adapted to be electrically connected to at least one electrode to sense cardiac complexes including normal sinus rhythm (NSR) cardiac complexes;

a morphology analyzer circuit connected to the input circuitry and adapted to measure sensed cardiac complex parameter values;

a template generating circuit connected to the morphology analyzer circuit and adapted to receive the sensed cardiac complex parameter values and generate a NSR template; and

a template comparison circuit connected to the template generating circuit and adapted to compare sensed cardiac complex parameter values to predetermined cardiac parameter values after a selected time interval has elapsed,

wherein the template comparison circuit and the template generating circuit cooperate to update the NSR template based on the compared sensed cardiac complex parameter values and the predetermined cardiac parameter values.

8. The device of claim 7, further comprising:

a microprocessor adapted to connect to the input circuitry, the morphology analyzer circuit, the template generating circuit, and the template comparison circuit.

9. The device of claim 8, wherein the microprocessor includes a timer for counting the selected time interval.

10. The device of claim 7, wherein the template comparison circuit and the template generating circuit are adapted to cooperate to update the NSR template when the sensed cardiac complex parameter values vary from a current NSR template by a calculated threshold value.

11. The device of claim 10, wherein the template comparison circuit is adapted to calculate the threshold value by multiplying parameter values for the current NSR template by a predetermined deviation percentage.

12. The device of claim 7, wherein the input circuitry is adapted to be electrically connected to at least one electrode via at least one implantable lead.

13. The device of claim 8, further comprising a display connected to the microprocessor.

14. The device of claim 7, wherein the selected time interval is programmable.

15. The device of claim 14, wherein the selected time interval is programmed to be progressively longer after the device has been implanted in a patient.

16. The device of claim 7, wherein the input circuitry includes at least one amplifier.

17. The device of claim 8, further comprising:

a detector circuit adapted to connect to the input circuitry and to convey information relating to cardiac rate to the microprocessor.

18. The device of claim 7, further comprising:

a battery adapted to connect to the input circuitry, the morphology analyzer circuit, the template generating circuit, and the template comparison circuit, and adapted to provide power to the device.

19. The device of claim 8, further comprising:

a memory circuit connected to the microprocessor and adapted to store the NSR template, the compared sensed cardiac complex parameter values, and the predetermined cardiac parameter values.

20. The device of claim 8, further comprising:

a transmitter/receiver adapted to communicate with the microprocessor through a programmer.

21. A device, comprising:

means for comparing one or more sensed cardiac complex parameter values to one or more predetermined cardiac complex parameter values;

means for determining whether the one or more sensed cardiac complex parameter values and the one or more predetermined cardiac complex parameter values have differences greater than a threshold; and

means for updating a normal sinus rhythm (NSR) template upon determining that the one or more sensed cardiac complex parameter values and the one or more predetermined cardiac complex parameter values have differences that are greater than the threshold.

22. The device of claim 21, further comprising means for retaining the NSR template upon determining that the one or more sensed cardiac complex parameter values and the one or more predetermined cardiac complex parameter values do not have differences that are greater than the threshold.

23. The device of claim 21, further comprising means for determining whether the one or more sensed cardiac complex parameter values are within one or more ranges of normal values prior to comparing the one or more sensed cardiac complex parameter values to the one or more predetermined cardiac complex parameter values, wherein the one or more sensed cardiac complex parameter values are compared upon determining that the one or more sensed cardiac complex parameter values are within the one or more ranges of normal values.

24. The device of claim 23, further comprising:

means for determining whether a maximum number of attempts has been made to evaluate the one or more sensed cardiac complex parameter values, upon determining that the one or more sensed cardiac complex parameter values are not within the one or more ranges of normal values; and

means for retaining the NSR template, upon determining that the maximum number of attempts has been made.

25. The device of claim 21, further comprising means for waiting a selected time period before comparing the one or more sensed cardiac complex parameter values to one or more predetermined cardiac complex parameter values and determining whether the one or more sensed cardiac complex parameter values and the one or more predetermined cardiac complex parameter values have differences greater than a threshold.

26. The device of claim 21, further comprising means for creating an initial NSR template which is updated when the sensed cardiac complex parameter values and the predetermined cardiac complex parameter values have differences that are greater than the threshold.

27. The method of claim 26, wherein the means for creating an initial NSR template includes:

means for determining whether one or more sensed cardiac complex parameter values are within one or more ranges of normal parameter values; and

means for setting the initial NSR template based on the one or more sensed cardiac complex parameter values.

28. The method of claim 27, further comprising means for displaying a proposed NSR template, and determining whether the proposed NSR template is approved prior to setting the initial NSR template.

29. The device of claim 27, further comprising:

means for determining whether a maximum number of attempts has been made to evaluate the one or more sensed cardiac complex parameter values, upon determining that the one or more sensed cardiac complex parameter values are not within one or more ranges of normal parameter values; and

means for redefining one or more ranges of acceptable parameter values, upon determining that a maximum number of attempts has been made.

30. The device of claim 29, further comprising means for displaying a proposed NSR template, and determining whether the proposed NSR template is approved prior to setting the updated NSR template.

31. A device, comprising:

means for creating a normal sinus rhythm (NSR) template;

means for determining whether sensed cardiac complex parameter values are within a range of normal values;

means for comparing the sensed cardiac complex parameter values to predetermined cardiac complex parameter values, upon determining that the sensed cardiac complex parameter values are within a range of normal values;

means for determining whether the sensed cardiac complex parameter values and the predetermined cardiac complex parameter values have differences greater than a threshold; and

means for updating the NSR template upon determining that the sensed cardiac complex parameter values and the predetermined cardiac complex parameter values have differences that are greater than the threshold.

32. The device of claim 31, further comprising:

means for determining whether a maximum number of attempts has been made to evaluate the sensed cardiac complex parameter values, upon determining that the sensed cardiac complex parameter values are not within a range of normal values; and

means for retaining the NSR template, upon determining that the maximum number of attempts has been made.

33. The device of claim 31, further comprising means for waiting a selected time period before comparing sensed cardiac complex parameter values to predetermined cardiac complex parameter values and determining whether the sensed cardiac complex parameter values and the predetermined cardiac complex parameter values have differences greater than a threshold.

34. The device of claim 31, wherein the means for creating a NSR template includes:

means for determining whether sensed cardiac complex parameter values are within a range of normal parameter values;

means for displaying a proposed NSR template based on the sensed cardiac complex parameter values;

means for determining whether the proposed NSR template is approved; and

means for setting the proposed NSR template as the NSR template.

35. The device of claim 31, wherein the means for updating the NSR template upon determining that the sensed cardiac complex parameter values and the predetermined cardiac complex parameter values have differences that are greater than the threshold includes:

means for displaying a proposed updated NSR template;

means for determining whether the proposed updated NSR template is approved; and

means for setting the proposed updated NSR template an updated NSR template, upon determining that the proposed updated NSR template is approved.

36. The device of claim 31, wherein the means for comparing the sensed cardiac complex parameter values to predetermined cardiac complex parameter values includes means for comparing sensed cardiac complex parameter values to physician-programmed values.

37. The device of claim 31, wherein the means for comparing the sensed cardiac complex parameter values to predetermined cardiac complex parameter values includes means for comparing sensed cardiac complex parameter values to values derived from the NSR template.