Multi-electrode panel system for sensing electrical activity of the heart

• US 6,584,343 B1
• Filed: 07/06/2000
• Issued: 06/24/2003
• Est. Priority Date: 03/15/2000
• Status: Expired due to Fees

• Current Assignee: Resolution Medical, Inc.
• Original Assignee: Resolution Medical, Inc.
• Inventors: Ransbury, Terrance, Sippens Groenewegen, Arne
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/611,179
• Time in Patent Office: 1,083 Days
• Field of Search: 600/509, 600/510, 600/515-518, 600/521
• US Class Current: 600/509
• CPC Class Codes: A61B 2562/17 Comprising radiolucent components
• CPC Class Codes: A61B 5/0044 for the heart
• 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

Abstract

Improved systems, devices, and methods sense heart signals through a torso surface of a patient. These improved systems facilitate mounting of an array of sensors upon the patient'"'"'s torso by supporting the sensor arrays on one or more panels. Four separate panels can be adapted for engaging the torso surface, with the four panels supporting most and/or all of the sensors necessary for localizing an arrhythmia within a chamber of a heart of a patient. The panels may have integrated components for use with other electrophysiology lab equipment such as cardiac imagers, defibrillation power sources, therapeutic probes, standard 12-lead electrocardiogram (ECG) systems, and the like. An exemplary arrhythmia sensing system is adapted for use in the high-noise environment of an electrophysiology lab includes a series of powered circuits distributed among the electrodes of the array. A separate low-noise environment sensing system may initially record an abnormal irregular or regular heartbeat outside the electrophysiology lab.

Claims

1. An arrhythmia or ischemia localization method comprising:

independently affixing a plurality of panels against a torso of a patient body;

sensing heart cycle signals with an array of sensors supported by the panels, a plurality of the sensors of the array distributed along a superior-inferior length and distributed along a lateral width of each panel so as to define an at least two dimensional partial-array for each panel;

generating data in response to the sensed heart signals;

comparing the data with a database generated from abnormal heartbeats; and

localizing the arrhythmia or ischemia within a chamber of the heart using the comparison of the data generated from the sensed heart cycle signals with the database.

2. The method of claim 1, wherein the localizing step comprises localizing an arrhythmia within a chamber of the heart with the sensed heart signals.

3. The method of claim 2, further comprising processing the sensed heart cycle signals with a plurality of powered circuits supported by the panels and distributed among the sensors to inhibit signal noise transmission.

4. The method of claim 3, further comprising:

transmitting the sensed heart signals along leads extending between the sensors and the powered circuits; and

transmitting the processed heart cycle signals via electrical conductors along leads extending from the powered circuits to a coupler, wherein the sensor/powered circuit leads are shorter than the powered circuit/connector leads so as to inhibit signal noise.

5. The method of claim 3, further comprising imaging the heart through an imaging window of the panels while sensing the heart cycle signals.

6. The method of claim 5, wherein the imaging step comprises biplanor fluoroscopic imaging of the heart through 4 imaging windows of the panels.

7. The method of claim 5, wherein a plurality of sensors of the array are disposed outside the window, and wherein a sensor of the array is disposed within the window, the sensor within the window having greater transparency for imaging therethrough than the plurality of sensors outside the window.

8. The method of claim 5, further comprising pacing the heart while imaging the heart through the window and while sensing the heart cycle signals with the array.

9. The method of claim 2, further comprising stimulating the heart with an electrode of the panels through the patient'"'"'s torso.

10. The method of claim 2, further comprising inserting a probe into the patient, engaging a target tissue with the probe, and transmitting therapeutic electrical current from the probe to the target tissue engaged by the probe, and from the patient to a return electrode supported by the panels.

11. The method of claim 2, further comprising separating a cross-member of the panels to alter the panels from a first configuration to a second configuration, the first configuration suitable for an external anatomy different than that of the patient, the second configuration suitable for an external anatomy of the patient.

12. The method of claim 11, wherein the cross-member is disposed between a first sensor of an associated panel and a second sensor of the associated panel, and wherein leads coupled to the sensors of the panel do not traverse the cross-member so as to avoid signal loss when the cross-member is separated.

13. The method of claim 11, wherein the external anatomy different than the patient is a male anatomy, wherein the external anatomy of the patient is a male anatomy, and wherein separation of the cross-member changes the panel from a male configuration to a female configuration so as to maintain electrical coupling between the sensors of the array and the torso while accommodating breasts of the patient.

14. The method of claim 2, wherein the plurality of panels comprises four flexible inelastic panels, the four panels being independently attached to the torso by referring to indicia of alignment displayed upon the panels.

15. The method of claim 14, wherein the plurality of panels comprises no more than 4 panels.

16. The method of claim 15, wherein a sensor of the array is coupled to the patient at a location beyond perimeters of each of the four panels.

17. The method of claim 2, further comprising integrating a reference portion of sensed heart cycle signals at an array of sensing locations during an abnormal heartbeat, generating a first data matrix of the integrated signals, comparing the first data matrix with a database of matrices generated from abnormal heartbeats, pacing a candidate arrhythmia site, generating a paced data matrix of integrated reference portions of paced heart cycle signals, and comparing the paced data matrix with the first data matrix.

18. The method of claim 17, wherein the abnormal heartbeat and paced heart cycle signals are measured with the sensors of a low-noise environment array and the array, respectively, the array being adapted for use in a high electromagnetic noise environment.

19. The method of claim 17, wherein the abnormal heartbeat and paced heart cycle signals are measured with the sensors of the array.

20. The method of claim 2, wherein the localization step further comprises localizing an atrial fibrillation within an atrium of the heart.

21. The method of claim 1,

wherein each panel comprises a flexible substrate supporting the sensors of the partial array, conductive traces disposed on the substrate and coupled to the sensors, adhesive foam distributed along the substrate surrounding and separated from the sensors, and conductive gel adjacent each sensor of the partial array to the torso;

wherein the affixing step comprises independently affixing each panel to the torso by engaging the adhesive foam against the torso so that the conductive gel couples each sensor of the partial array to the adjacent torso; and

further comprising transmitting the sensed heart signals along the conductive traces.

22. The method of claim 1, wherein the database comprises a plurality of candidate sites within the chamber of the heart associated with known abnormal heartbeats, and

wherein the localizing step comprises selecting a site from the plurality of sites.

23. An arrhythmia localization method comprising:

independently affixing a plurality of panels against a torso of a patient body;

sensing heart cycle signals with an array of sensors supported by the panels, a plurality of the sensors of the array distributed along a superior-inferior length and distributed along a lateral width of each panel so as to define an at least two dimensional partial-array for each panel;

generating data in response to the sensed heart signals;

comparing the data with a database generated from abnormal heartbeats; and

localizing atrial fibrillation within an atrium of the heart using the comparison of the data generated from the sensed heart cycle signals with the database.

24. The method of claim 23, further comprising:

transmitting the sensed heart signals along leads extending between the sensors and the powered circuits; and

transmitting the processed heart cycle signals along electrical conductors extending from the powered circuits to a coupler, wherein the sensor/powered circuit leads are shorter than the powered circuit/connector conductors so as to inhibit signal noise.

25. The method of claim 24, further comprising pacing a candidate arrhythmia site while sensing the heart cycle signals.

26. An arrhythmia or ischemia localization method comprising:

adhesively affixing at least one panel against a torso of a patient body by engaging adhesive foam of the panel against the torso;

sensing heart cycle signals with an array of sensors supported by the at least one panel, the at least one panel comprising a flexible substrate supporting a plurality of the sensors of the array, the adhesive foam distributed along the substrate and separated from the sensors with conductive gel coupling the sensors to the torso adjacent the sensors;

transmitting the sensed heart signals along conductive traces disposed on the substrate and

localizing the arrhythmia or ischemia within a chamber of the heart using the sensed heart cycle signals.