Medical device for detecting ischemia and a method for such a device

• US 8,140,157 B2
• Filed: 02/28/2007
• Issued: 03/20/2012
• Est. Priority Date: 02/28/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Inventors: Holmström, Nils
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): WIELAND, ROBERT N
• Application Number:
  US12/528,467
• Publication Number:
  US 20100100147A1
• Time in Patent Office: 1,847 Days
• Field of Search: 424/464, 424/93.7, 600/407, 600/508, 600/547, 607/17
• US Class Current: 607/17
• CPC Class Codes: A61B 5/0044 for the heart
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

In a method and medical device for detecting an ischemic episode and to determine a location of ischemia in a heart of a patient, an impedance measuring circuit measures the impedances in the tissue between electrodes of at least one electrode configuration according to a predetermined measurement scheme and an ischemia detector evaluates the measured impedance values using at least one reference impedance image of the heart to detect changes in the measured impedances that are consistent with an ischemia and to determine a location of the ischemia to at least one region of the image.

Claims

1. An implantable medical device comprising:

a pulse generator that emits cardiac stimulation pulses;

at least one medical lead connected to said pulse generator that delivers said stimulating pulses in vivo to cardiac tissue of a heart of a patient;

an impedance measuring circuit that, during impedance measurement sessions, generates electrical signals applied between at least a first electrode and a second electrode, among electrodes carried by said at least one medical lead, in at least two electrode configurations according to a predetermined scheme, and that measures impedance in the tissue between said first electrode and said second electrode of each of said at least two electrode configurations; and

an ischemia detector that evaluates the measured impedances by comparing the measured impedances with at least one reference impedance image of the heart comprising a plurality of impedance regions, to detect changes in the measured impedances that are consistent with ischemia, and that determines a location of said ischemia with respect to at least one of said regions.

2. The medical device according to claim 1, wherein said ischemia detector is configured to create a present impedance image using said measured impedance values and to compare said present impedance image with said reference impedance images to detect changes in said measured impedances being consistent with an ischemia and to determine a location of said ischemia to at least one of said regions.

3. The medical device according to claim 1, wherein said impedance measuring circuit is configured to perform reference measurement sessions to obtain reference impedances for said electrode configurations in accordance with said predetermined scheme;

and wherein said medical device further comprises a storage unit that stores said measured reference impedances in an reference impedance matrix; and

wherein said ischemia detector is configured to create said reference impedance images of said heart using said reference impedance matrix and to store said impedance images.

4. The medical device according to claim 3, wherein said ischemia detector is configured to create said impedance images using a reconstruction algorithm.

5. The medical device according to claim 1, wherein said electrodes located in at least one position selected from the group consisting of a coronary vein on the left ventricle or left atrium, in the right atrium, in the right ventricle, in or at the epicardium, on a housing of said medical device.

6. The medical device according to claim 1, wherein said impedance measuring circuit is configured to generate electrical signals at least at a first frequency and at a second frequency and to measure the impedance in the tissue between said at least a first electrode and said at least a second electrode of said electrode configurations at said at least first frequency and said at least second frequency.

7. The medical device according to claim 1, wherein said ischemia detector is configured to:

evaluate said measured impedances including comparing said measured impedances at said first frequency with impedance images for said first frequency of said heart each including a number of impedance regions and comparing said measured impedances at said second frequency with impedance images for said second frequency of said heart each including a number of impedance regions, said regions of said impedance images at said second frequency substantially corresponding to said regions of said impedance images at said first frequency; and

detect changes in said measured impedances being consistent with an ischemia and to determine a location of said ischemia to at least one of said regions.

8. The medical device according to claim 7, wherein

said impedance measuring circuit configured to perform at least one reference measurement session to obtain reference impedances for said electrode configurations at said first frequency and at said second frequency;

and

wherein said medical device further comprises a storage unit that stores said measured reference impedances in a first reference impedance matrix containing impedances at said first frequency and in a second reference impedance matrix at said second frequency; and

wherein said ischemia detector is configured to create impedance images of said heart using said reference impedance matrices and to store said impedance images.

9. The medical device according to claim 6, wherein said impedance measuring circuit is configured to generate electrical signals across a band of frequencies including said first and second frequencies.

10. The medical device according to claim 1, wherein

said impedance measuring circuit is configured to perform said impedance measurement sessions at predetermined intervals;

and

wherein said ischemia detector is adapted to evaluate said measured impedances at said predetermined intervals to determine a trend over time for said measured impedances for respective region of said impedance image.

11. The medical device according to claim 1, wherein said ischemia detector is configured to:

determine a trend of the real part of the measured impedance over time and/or a trend of the imaginary part of the measured impedance over time;

determine an increase in said real part of said impedance over time within a predetermined period of time above a first predetermined threshold and/or a decrease in said imaginary part within a predetermined interval of time below a second predetermined threshold as being consistent with an ischemia; and

determine a location of said ischemia to at least one region for which a time derivative of said real part is above said first predetermined threshold and/or a time derivative of said imaginary part of said impedance is below said second predetermined threshold.

12. The medical device according to claim 11, wherein said ischemia detector is configured to determine a location of said ischemia to a region for which a time derivative of said real part is the highest and/or a time derivative of said imaginary part of said impedance is the lowest.

13. The medical device according to claim 10, wherein said ischemia detector is configured to:

determine a trend of the real part of the measured impedance at said first frequency and said second frequency, respectively, over time and/or a trend of the imaginary part of the measured impedance at said first frequency and said second frequency, respectively, over time, said first frequency being lower than said second frequency;

compare said real part at said first frequency and said second frequency, respectively, at a predetermined point of time and/or compare said imaginary part at said first frequency and said second frequency, respectively, at said predetermined point of time;

determine an absolute value of a quote between said real part at said first frequency and said real part at said second frequency being above a first predetermined quote threshold and/or an absolute value of a quotient between said imaginary part at said first frequency and said imaginary part at said second frequency being above a second predetermined quotient threshold as being consistent with an ischemia; and

determine a location of said ischemia to at least one region for which said absolute value of said quotient between said real part at said first frequency and said real part at said second frequency is above a first predetermined quotient threshold and/or said absolute value of said quote between said imaginary part at said first frequency and said imaginary part at said second frequency is above a second predetermined quote threshold.

14. The medical device according to claim 10, wherein said ischemia detector is configured to determine a location of said ischemia to a region for which said absolute value of said quotient between said real part at said first frequency and said real part at said second frequency is the highest and/or said absolute value of said quotient between said imaginary part at said first frequency and said imaginary part at said second frequency is the highest.

15. The medical device according to claim 1, and wherein said ischemia detector is configured to:

wherein said ischemia detector is adapted to evaluate said measured impedances at said predetermined intervals to determine a trend over time for said measured impedances for respective region of said impedance image

determine a trend of the phase angle of the impedance at a predetermined frequency over time;

determine an increase of said phase angle within a predetermined interval of time above a predetermined threshold as being consistent with an ischemia; and

determine a location of said ischemia to at least one region for which a time derivative of said phase angle is above said predetermined threshold.

16. The medical device according to claim 15, wherein said ischemia detector is configured to determine a location of said ischemia to a region for which a time derivative of said phase angle is the highest.

17. The medical device according to claim 1, further comprising:

an activity sensor configured that measures an activity level of said patient; and

wherein said ischemia detector is configured to determine whether said measured activity level is below a predetermined activity level limit and to use this determination when evaluating said measured impedances.

18. The medical device according to claim 1 wherein said impedance measuring circuit comprises a timing circuit that synchronizes said impedance measurements with cardiac cycles of said patient such that said impedance measurements are performed at substantially the same point of time in said cardiac cycles.

19. The medical device according to claim 18, wherein said timing circuit causes the impedance measurements to be performed during end-diastole.

20. The medical device according to claim 1, wherein said impedance measuring circuit is configured to perform each impedance measurement session over a predetermined number of consecutive cardiac cycles and to calculate each impedance value as a mean value over said predetermined number of cardiac cycles.

21. The medical device according to claim 1, further comprising:

a posture detecting circuit connected to said impedance measuring circuit and being configured to detect at least a predetermined posture of said patient; and

wherein said impedance measuring circuit is configured to initiate said impedance measuring sessions when said patient is in said at least one predetermined posture.

24. The method according to claim 21 further comprising the steps of:

performing a reference measurement session to obtain reference impedances for said electrode configurations in accordance with said predetermined scheme;

storing said measured reference impedances in an reference impedance matrix; and

wherein said step of creating said reference impedance images of said heart using said reference impedance matrix and to store said impedance images.

25. The method according to claim 1, comprising of creating said impedance images using a reconstruction algorithm.

26. The method according to any one of preceding claim 21, placing said electrodes on said at least one medical lead at a position selected from the group consisting of a coronary vein on the left ventricle or left atrium, in the right atrium, in the right ventricle, in or on the epicardium, and on the can of said medical device.

27. The method according to claim 21, wherein the step of generating comprises generating electrical signals at least at a first frequency and at a second frequency and wherein said step of measuring comprises measuring the impedance in the tissue between said at least a first electrode and said at least a second electrode of said electrode configurations at said at least first frequency and said at least second frequency.

28. The method according to claim 26, wherein the step of evaluating further comprises:

evaluating said measured impedances including comparing said measured impedances at said first frequency with impedance images for said first frequency of said heart each including a number of impedance regions; and

comparing said measured impedances at said second frequency with impedance images for said second frequency of said heart each including a number of impedance regions, said regions of said impedance images at said second frequency substantially corresponding to said regions of said impedance images at said first frequency, to detect changes in said measured impedances being consistent with an ischemia and to determine a location of said ischemia to at least one of said regions.

29. The method according to claim 27, further comprising:

performing at least one reference measurement session to obtain reference impedances for said electrode configurations at said first frequency and at said second frequency;

storing said measured reference impedances in a first reference impedance matrix containing impedances at said first frequency and in a second reference impedance matrix at said second frequency; and

wherein said step of creating comprises creating reference impedance images of said heart using said reference impedance matrices and to store said impedance images.

30. The method according to claim 26, wherein the step of generating comprises generating electrical signals across a band of frequencies including said first and second frequencies.

31. The method according to claim 21, further comprising:

performing said impedance measurement sessions at predetermined intervals; and

wherein the step of evaluating comprises evaluating said measured impedances at said predetermined intervals to determine a trend over time for said measured impedances for respective region of said impedance image.

32. The method according to claim 30, wherein said step of evaluating further comprises the steps of:

determining a trend of the real part of the measured impedance over time and/or a trend of the imaginary part of the measured impedance over time;

determining an increase in said real part of said impedance over time within a predetermined period of time above a first predetermined threshold and/or a decrease in said imaginary part within a predetermined interval of time below a second predetermined threshold as being consistent with an ischemia; and

determining a location of said ischemia to at least one region for which a time derivative of said real part is above said first predetermined threshold and/or a time derivative of said imaginary part of said impedance is below said second predetermined threshold.

33. The method according to claim 32, wherein the step of determining a location comprises determining a location of said ischemia to a region for which a time derivative of said real part is the highest and/or a time derivative of said imaginary part of said impedance is the lowest.

34. The method according to claim 30, wherein the step of evaluating further comprises the steps of:

determining a trend of the real part of the measured impedance at said first frequency and said second frequency, respectively, over time and/or a trend of the imaginary part of the measured impedance at said first frequency and said second frequency, respectively, over time, said first frequency being lower than said second frequency;

comparing said real part at said first frequency and said second frequency, respectively, at a predetermined point of time and/or compare said imaginary part at said first frequency and said second frequency, respectively, at said predetermined point of time;

determining an absolute value of a quotient between said real part at said first frequency and said real part at said second frequency being above a first predetermined quotient threshold and/or an absolute value of a quotient between said imaginary part at said first frequency and said imaginary part at said second frequency being above a second predetermined quotient threshold as being consistent with an ischemia; and

determining a location of said ischemia to at least one region for which said absolute value of said quotient between said real part at said first frequency and said real part at said second frequency is above a first predetermined quotient threshold and/or said absolute value of said quotient between said imaginary part at said first frequency and said imaginary part at said second frequency is above a second predetermined quotient threshold.

35. The method according to claim 34, wherein said step of determining a location comprises determining a location of said ischemia as a region for which said absolute value of said quotient between said real part at said first frequency and said real part at said second frequency is the highest and/or said absolute value of said quotient between said imaginary part at said first frequency and said imaginary part at said second frequency is the highest.

36. The method according to claim 30, wherein the step of evaluating further comprises the steps of:

determining a trend of the phase angle of the impedance at a predetermined frequency over time;

determining an increase of said phase angle within a predetermined interval of time above a predetermined threshold as being consistent with an ischemia; and

determining a location of said ischemia to at least one region for which a time derivative of said phase angle is above said predetermined threshold.

37. The method according to claim 35, wherein the step of determining a location comprises determining a location of said ischemia as a region for which a time derivative of said phase angle is the highest.

38. The method according to claim 21, further comprising the steps of:

measuring an activity level of said patient;

determining whether said measured activity level is below a predetermined activity level limit; and

using this determination when evaluating said measured impedances.

39. The method according to claim 21, further comprising:

synchronizing said impedance measurements with cardiac cycles of said patient such that said impedance measurements are performed at substantially the same point of time in said cardiac cycles.

40. The method according to claim 39, comprising performing the impedance measurements are performed during end-diastole.

41. The method according to claim 21, further comprising the steps of:

performing each impedance measurement session over a predetermined number of consecutive cardiac cycles; and

calculating each impedance value as a mean value over said predetermined number of cardiac cycles.

42. The medical device according to claim 21, further comprising the steps of:

detecting at least a predetermined posture of said patient; and

initiating said impedance measuring sessions when said patient is in said at least one predetermined posture.

22. A method for operating an implantable medical device including a pulse generator that emits cardiac stimulating pulses and is connected to at least one medical lead for delivering said pulses in vivo to cardiac tissue of a heart of a patient, comprising the steps of:

generating, during impedance measurement sessions, electrical signals to be applied between at least a first electrode and at least a second electrode among electrodes carried by said at least one medical lead in at least two electrode configurations according to a predetermined scheme;

measuring the impedances in the tissue between said at least first electrode and said at least second electrode of said at least two electrode configurations to the applied electrical signals; and

evaluating said measured impedance values including comparing said measured impedances with at least one reference impedance image of said heart comprising a number of impedance regions to detect changes in said measured impedances being consistent with an ischemia and to determine a location of said ischemia to at least one of said regions.

23. The method according to claim 22, further comprising the step of creating (S504) a present impedance image using said measured impedance values and wherein the step of evaluating comprises comparing said present impedance image with said reference impedance images to detect changes in said measured impedances being consistent with an ischemia and to determine a location of said ischemia to at least one of said regions.

43. A computer-readable medium encoded with programming instructions, said medium being loadable into a control unit of a medical device comprising a pulse generator that emits cardiac stimulating pulses and that is connected to at least one medical lead for delivering said pulses in vivo to cardiac tissue of a heart of a patient, and an impedance measuring circuit and a processor, said programming instructions causing said control unit to:

operate said impedance circuit, during impedance measurement sessions, to apply electrical signals between at least a first electrode and at least a second electrode among electrodes carried by said at least one medical lead in at least two electrode configurations according to a predetermined scheme;

operate said impedance circuit to measure impedances in tissue between said first electrode and said second electrode in each of said at least two electrode configurations; and

operate said processor to evaluate the measured impedances by comparing the measured impedances with at least one reference impedance image of the heart comprising a plurality of impedance regions, to detect changes in the measured impedances that are consistent with ischemia, and to determine a location of said ischemia relative to at least one of said regions.