Continuous localization and guided treatment of cardiac arrhythmias

• US 6,658,285 B2
• Filed: 03/14/2001
• Issued: 12/02/2003
• Est. Priority Date: 03/15/2000
• Status: Expired due to Fees

• Current Assignee: Resolution Medical, Inc.
• Original Assignee: Resolution Medical, Inc.
• Inventors: Potse, Mark, Grimbergen, Cornelis, Linnenbank, Andre, Groenewegen, Arne Sippens
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/808,735
• Publication Number:
  US 20020038093A1
• Time in Patent Office: 993 Days
• Field of Search: 600/515, 600/518, 600/411, 600/424, 607/99, 607/101
• US Class Current: 600/515
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/322 Physical templates or devices for measuring ECG waveforms, e.g. electrocardiograph rulers or calipers by template matching A61B5/35
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/6841 by using templates
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

Systems, devices, and methods localize and/or treat arrhythmias of a heart of a patient using signals sensed at an accessible body surface. Based on a database of known heart signals and associated ectopic origin sites or exit sites for treatment guidance, continuous localization identifies candidate ectopic or exit sites throughout a continuous region of tissue. An integral from a selected time interval of a reference heart cycle can be compared statistically with known body surface maps. Statistical interpolation can identify a candidate ectopic or exit site which is different than the known ectopic or exit sites. Relative localization provides accurate site identification from one or more known pacing sites (and the associated heart signals) taken from the patient.

Claims

1. An arrhythmia localization method making use of a database, the database including known heart signals and associated discrete known ectopic or exit sites, the arrhythmia localization method comprising:

measuring heart signals during an arrhythmia; and

identifying a candidate ectopic or exit site which is different than the known sites by comparing the measured heart signals to a plurality of known heart signals.

2. The arrhythmia localization method of claim 1, further comprising sensing the heart signals with an array of sensors distributed across an accessible body surface.

3. The arrhythmia localization method of claim 2, wherein the array has at least 6 sensing locations distributed across a torso.

4. The arrhythmia localization method of claim 3, further comprising integrating a selected portion of the measured heart signals at each sensing location to determine an associated integral value and generating a data matrix by arranging the integral values according to the associated sensing locations, the comparing step comprising comparing the data matrix with data matrices of the database generated from the known heart signals.

5. The arrhythmia localization method of claim 4, further comprising interpolating between a plurality of the known sites associated with the plurality of known heart signals based on the comparison of the measured heart signals to a plurality of the known heart signals.

6. The arrhythmia localization method of claim 5, further comprising determining correlations between the known heart signals and known sites, and selecting the candidate site using a statistical comparison of the measured heart signals with the known heart signals.

7. The arrhythmia localization method of claim 1, further comprising normalizing the database by transforming the known sites into a uniform coordinate system.

8. The arrhythmia localization method of claim 7, wherein the uniform coordinate system comprises a member selected from the group consisting of polar coordinates and cylindrical coordinates having an axis extending from an apex to a mitral or tricuspid valve ring and normalized based on a distance therebetween.

9. The arrhythmia localization method of claim 1, further comprising measuring paced heart signals by generating an artificial arrhythmia at a pacing site, wherein the candidate site identification is based in part on the paced signals.

10. The arrhythmia localization method of claim 9, wherein the candidate site is determined by calculating an estimated ectopic or exit site with the measured heart signal and the known heart signals, by calculating an estimated pacing site from the paced heart signals and the known heart signals, and by modifying the estimated site to generate the candidate site based on a difference between estimated pacing site and the pacing site.

11. The arrhythmia localization method of claim 9, further comprising generating a plurality of arrhythmias at a plurality of pacing sites, wherein the candidate site identification is based in part on the plurality of pacing sites.

12. The arrhythmia localization method of claim 1, further comprising measuring paced heart signals by generating a plurality of artificial arrhythmias at a plurality of pacing sites of a patient to generate the database, and wherein the measured heart signal is measured from said patient.

13. The arrhythmia localization method of claim 1, further comprising imaging a heart tissue and graphically indicating the candidate site on an image of the heart tissue.

14. The arrhythmia localization method of claim 13, wherein the image of the heart tissue comprises a three-dimensional image, and wherein the candidate site is indicated as a three-dimensional position.

15. The arrhythmia localization method of claim 14, further comprising positioning a catheter at the candidate site by reference to the graphical indication.

16. An arrhythmia localization system comprising:

a database having known heart signals and associated discrete known ectopic or exit sites;

a heart signal sensor array for measuring heart signals during an arrhythmia; and

a processor coupled to the database and the sensor array, the processor calculating a candidate ectopic or exit site, which is different than the known sites, in response to the measured heart signals and the known heart signals.

17. The arrhythmia localization system of claim 16, wherein the sensor is adapted for engaging a torso to define at least 6 sensing locations distributed across at least two dimensions of the torso.

18. The arrhythmia localization system of claim 17, wherein the processor integrates a selected portion of the measured heart signals at each sensing location to determine an associated integral value and generates a data matrix of the integral values according to the associated sensing locations, the processor comparing the data matrix with data matrices of the database generated from the known heart signals.

19. The arrhythmia localization system of claim 18, wherein the processor interpolates between a plurality of the known sites associated with the plurality of known heart signals based on the comparison of the measured heart signals to a plurality of the known heart signals.

20. The arrhythmia localization system of claim 19, the processor determining correlations between the known heart signals and known sites, and selecting the candidate site using a statistical comparison of the measured signals with the known signals.

21. The arrhythmia localization system of claim 16, wherein the processor normalizes the database by transforming the known ectopic or exit sites into a uniform coordinate system.

22. The arrhythmia localization system of claim 21, wherein the uniform coordinate system comprises a member selected from the group consisting of polar coordinates and cylindrical coordinates having an axis extending from an apex to a mitral or tricuspid valve ring and normalized based on a distance therebetween.

23. The arrhythmia localization system of claim 16, wherein the sensor array transmits paced heart signals to the processor, the paced heart signals resulting from an artificial arrhythmia generated at a pacing site, wherein the candidate site identification is calculated with the paced signals.

24. The arrhythmia localization system of claim 23, wherein the candidate site is determined by calculating an estimated ectopic or exit site with the measured heart signal and the known heart signals, by calculating an estimated pacing site from the paced heart signals and the known heart signals, and by modifying the estimated site based on a difference between the estimated pacing site and the pacing site.

25. The arrhythmia localization system of claim 23, wherein the candidate site is calculated in response to a plurality of pacing sites.

26. The arrhythmia localization system of claim 16, the database comprising a plurality of heart signals induced by pacing at a plurality of pacing sites of a patient, and wherein the candidate site identifies a location of a heart tissue of said patient.

27. The arrhythmia localization system of claim 16, further comprising an imaging system coupled to the processor, the imaging system graphically indicating the candidate site on an image of the heart tissue.

28. The arrhythmia localization system of claim 27, wherein the image of the heart tissue comprises a three-dimensional image, and wherein the candidate site is indicated as a three-dimensional position.

29. The arrhythmia localization system of claim 27, further comprising a catheter having a distal portion with an image visible with the imaging system, the catheter having at least one of an arrhythmia treatment element and a pacing element.

30. The arrhythmia localization system of claim 29, further comprising a catheter localization system coupled to the processor for transmitting catheter element location signals.

31. The arrhythmia localization system of claim 16, further comprising a display coupled to the processor, the display showing navigation information for positioning of a probe in alignment with the candidate site for treatment of the arrhythmia.

32. The arrhythmia localization system of claim 31, wherein the navigation information comprises a candidate site marker or a vector indicating a desired probe movement from an actual position to the candidate site.

33. The arrhythmia localization system of claim 16, wherein the processor generates a potential map indicating potential distribution across the array at a sensing time.