Source: https://patents.google.com/patent/US20040015194
Timestamp: 2018-04-26 17:39:55
Document Index: 117908681

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'art.\n13', 'art.\n18', 'art.\n22', 'art.\n23']

US20040015194A1 - Multi-electrode panel system for sensing electrical activity of the heart - Google Patents
US20040015194A1
US20040015194A1 US10364291 US36429103A US2004015194A1 US 20040015194 A1 US20040015194 A1 US 20040015194A1 US 10364291 US10364291 US 10364291 US 36429103 A US36429103 A US 36429103A US 2004015194 A1 US2004015194 A1 US 2004015194A1
US10364291
This is a divisional patent application which claims priority from U.S. patent application Ser. No. 09/611,179 filed Jul. 6, 2000, which claims the benefit of priority from U.S. Provisional Patent Application No. 60/189,611 filed Mar. 15, 2000, and U.S. Provisional Patent Application No. 60/200,965 filed May 1, 2000, the full disclosures of which are incorporated herein by reference.
In light of the above, it would be desirable to provide improved devices, systems, and methods for sensing heart cycle signals for localization of arrhythmias. It would be particularly beneficial if these improvements enhanced the efficiency of mounting an array upon a patient's torso, as well as increasing the adaptability of the arrays to a variety of patient external anatomies. It would further be beneficial if these improved arrays and body surface mapping methods provided improved safety, reliability, and sensing/ localization accuracy, despite the normal variations in physician experience and skill, and without excessive degradation in overall system performance when used in a high electromagnetic noise environment such as an electrophysiology lab. It would further be beneficial to maximize overall system performance without excessive expenditure on individual sensing system components and/or sterilization/reuse procedures. Some or all of these goals are provided by the invention described hereinbelow.
U.S. Pat. No. 5,483,968 describes a Method and Apparatus for Analyzing the Electrical Activity of the Heart, and Electrical Clamping Connection Device is described in U.S. Pat. No. 5,733,151. A similar electrode connector is described in PCT Publication No. WO 97/49143. U.S. Pat No. 6,047,206 which describes Generation of Localized Cardiac Measures, Related Systems, and/or Methods. Similar topics may also be discussed in one or more of U.S. Pat. Nos. 4,751,928; 4,974,598; 5,054,496; 5,634,469; 5,311,873; and 5,724,984.
Arne SippensGroenewegen, et al. described “Body Surface Mapping During Pacing at Multiple sites in the Human Atrium: P Wave Morphology of Ectopic Right Atrial Activation, ” in Circulation, 98:369-380 (1998). Heidi A. P. Peeters, et al. described related work in an article entitled, “Clinical Application of an Integrated 3-Phase Mapping Technique for Localization of the Site of Origin of Idiopathic Ventricular Tachycardia, ” in Circulation, 99:1300-1311 (1999). Arne SippensGroenewegen, et al. described “Value of Body Surface Mapping in Localizing the Site of Origin of Ventricular Tachycardia in Patients with Previous Myocardial Infarction, ” in J. Am. Coll. Cardiol. 24:1708-1724 (1994). “Continuous Localization of Cardiac Activation Sites Using a Database of Multichannel ECG Recordings, ” was described by Mark Potse, et al. in IEEE Trans. Biomed. Eng., 47:682-689 (2000).
Arne SippensGroenewegen, et al. described “A Radiotransparent Carbon Electrode Array for Body Surface Mapping During Cardiac Catheterization ”, in the Proceedings of the 9th Annual Conference of IEEE Engineering in Medicine & Biology Society, New York: IEEE Publishing Services, pp. 178-181 (1987). Alexander C. Metting van Rijn, et al. “Patient Isolation in Multichannel Bioelectric Recordings by Digital Transmission Through a Single Optical Fiber, ” IEEE Trans. Biomed. Eng., 40:302-308 (1993); Alexander C. Metting van Rijn, et al. in “Amplifiers for Bioelectric Events: A Design with a Minimal Number of Parts, ” Med. & Biol. Eng. & Comput. 32:305-310 (1994); Alexander C. Metting van Rijn, et al. “High-Quality Recording of Bioelectric Events: Part II, Low-Noise, Low-Power Multichannel Amplifier Design, ” Med. & Biol. Eng. & Comput. 29:433-440 (1991); and Andre Linnenbank, et al. “Choosing the Resolution in AD Conversion of Biomedical Signals, ” Building Bridges in Electrocardiology: Proceedings of the CXXIInd Int'l. Congress on Electrocardiology, eds. A. van Oosterom, T. F. Oostendorp, G. J. H. Uijen, Nijmegen, The Netherlands: University Press Nijmegen, pp. 198-199 (1995), may also be relevant.
[0028]FIG. 1 illustrates a cardiac arrhythmia localization system and method for its use.
[0029]FIG. 1A schematically illustrates a sensor system having an array of sensing locations distributed across a patient's torso.
[0030]FIG. 1B graphically illustrates the method for calculating an integral value across a selected time portion of a heart signal cycle from a single sensor location.
[0031]FIG. 1C illustrates a plot of a data matrix generated by mapping the integral values with positions corresponding to the locations of the sensors across the patient's torso.
[0032]FIG. 2 schematically illustrates a method and computer program for localizing an ectopic or exit site, either absolutely (using a pre-established database) and/or relatively (based at least in part on measurements previously taken from the patient).
[0033]FIG. 3 graphically illustrates a database of known atrial paced heart cycles as 17 mean P wave integral maps.
[0034]FIG. 4 and 5 illustrate 17 known right atrial ectopic origins associated with the 17 mean P wave integral maps of FIG. 3.
[0036]FIG. 7 illustrates a database of QRS integral maps and associated ectopic origins within the right ventricle.
[0037]FIG. 8 illustrates a database of QRS integral maps and associated ectopic origins within the left ventricle.
[0039]FIG. 10A is a top view of an electrode of the array.
[0040]FIG. 10B is a cross-section showing an electrode of one of the four flexible panels.
[0042]FIGS. 12 and 13 schematically illustrate methods for locating a position and/or orientation of a chamber of a heart in space, and also schematically illustrate relative localization using information obtained from a particular patient.
[0043]FIGS. 14A and 14B schematically illustrate biplane three-dimensional guided positioning of a catheter for diagnosis and/or treatment of an arrhythmia.
[0044]FIG. 15 schematically shows biplane three-dimensional imaging of a patient's heart through imaging windows of a four-panel array system.
[0045]FIG. 16 schematically illustrates a system and/or kit for sensing arrhythmias.
[0046]FIG. 17 shows an exemplary substrate with electrodes and lead deposited thereon for use in an anterior left panel of a passive vest structure adapted for use in a low-noise environment.
When panels 4 are used to gather heart signal information in a low-noise environment, data transmitter 3 may alternatively comprise a recording system including a power supply (which may be alternating current and/or direct current such as a battery or the like), a buffer box (to augment signal strength), and a memory (which may comprise a non-volatile or other digital or analog signal memory, a magnetic and/or optical recording media with associated drive, or the like). Such low-noise systems are particularly useful when gathering data from patients over a long term, typically over two hours or more, and often over one day or even two days or more while the patient remains ambulatory.
[0070]Methods For Assembling A Right Atrial Database are described in detail in the J. Electrocardiol., 31 (Supp.):85-91 (1998), incorporated herein by reference. The mean P wave integral maps of atrial database 70 feature extreme positions and zero line contours without positive and negative integral contour lines. Alternative plot formats, such as three-dimensional or chest anatomy-based formats, map displays using various color schemes, and the like, may also be used. A similar left atrial database may be prepared using a trans-septal or retrograde aortic approach, with each database again benefiting from accurate information regarding the positioning of the pacing catheter, as described above and as described in more detail in a provisional application filed on Apr. 11, 2000 and entitled “Database of Body Surface ECG P Wave Integral Maps for Localization of Leftsided Atrial Arrhythmias,” the full disclosure of which is incorporated herein by reference.
FIGS. 9A-D illustrate panels 4A-D, respectively, which include powered components for use in a high noise environment (this panel system sometimes being called an active panel system). Describing the structure of panels 4 using the exemplary panel 4A illustrated in FIG. 9A, the panels generally comprise a thin, planar, and flexible (but often not elastic) polymer film substrate 60. Substrate 60 has an axially length L and a lateral width W suitable for supporting most and/or all of the sensors 12 to be mounted on a quadrant of the patient's torso for localization of an arrhythmia. Sensors 12 will generally define an at least two-dimensional panel array on each panel. More specifically, the sensors will typically define a two-dimensional array when a flexible panel is maintained in a planar configuration (prior to mounting on the torso), and will define a three-dimensional array once the panel is in a curved configuration such as when the panel is mounted on the torso for use. Preferably, at least seven sensors will be supported by each panel 4. Electrically conductive leads 62 extend from each sensor 12 to a connector 65 for coupling of panel 4A to analyzer 6. Leads 62 may be defined by selectively depositing a conductive material onto substrate 60, and/or by selectively removing portions of a conductive layer applied across substrate 60 using known circuit fabrication techniques.
To enhance image quality, sensors 12 b within window 70 maybe be adapted to have a greater transparency than at least some of the sensors disposed beyond the window. For example, some of the sensors disposed beyond window 70 may include a metallic electrode, such as a silver/silver chloride electrode, while sensors 12 b within window 70 may comprise a nonmetallic electrode such as a carbon electrode, or a metallically impregnated carbon electrode with a sufficiently low metal content so that the electrode is functionally transparent for imaging. Suitable carbon electrodes include those described by Arne SippensGroenewegen, et al. in “A Radiotransparent Carbon Electrode Array for Body Surface Mapping During Cardiac Catheterization ”, Proceedings of the 9th Annual Conference of IEEE Engineering in Medicine and Biology Society, New York: IEEE Publishing Services, pages 178-181 (1987), previously incorporated herein by reference. Similarly, leads 62 within window 70 may comprise a nonmetallic material such as carbon, while at least some of the electrical connection between sensors 12 and analyzer 6 beyond window 70 can optionally make use of metallic structures. Shielded leads may also be used to improve signal quality.
In some embodiments, one or more of the sensors 12 may have powered circuits 96 colocated with, and dedicated to, a particular sensor 12. Circuit components may be disposed within a protective structure 98 of hardened polymer deposited over and/or adjacent, electrode body 90, the protective structure sometimes referred as a “glop-top”. Protective structure 98 adds structural rigidity as well as voltage isolation. Such rigidity helps maintain electrical continuity between the electrical components and leads 62.
Once an ectopic origin or exit site has been sufficiently localized, ablation of the ectopic origin or exit site is effected, often using an ablation electrode of pacing catheter 110. A variety of alternative tissue treatment modalities might be applied to the ectopic origin, including RF ablation, cryogenic cooling, ultrasound, laser, microwave, bioactive agents, and the like. Similarly, a variety of intracardiac localization techniques might be used in place of intracardiac pace mapping under fluoroscopy. Suitable three-dimensional electro-anatomical point-by-point mapping systems may be commercially available for localization of an ectopic origin or exit site from BIOSENSE-WEBSTER, INC. under the trademark CARTO®, and a related Real-Time Position Management™ system may be available from CARDIAC PATHWAYS CORPORATION of California. An electrical localization system may be available from Medtronic under the trademark Localisa™. Alternative multi-electrode catheters may be commercially available from CARDIMA, INC., BIOSENSE-WEBSTER, INC., CARDIAC PATHWAYS, INC., BARD, INC. and/or EP TECHNOLOGIES, INC. A still further alternative for localizing of the ectopic origin or exit site maybe provided using a three-dimensional non-contact multi-electrode mapping system under development by ENDOCARDIAL SOLUTIONS, INC. Exemplary cryogenic systems may be available from CRYOCATH, INC. and from CRYOGEN, INC. A suitable cooled RF ablation catheter is sold commercially as the CHILLI®—Cooled Ablation System from CARDIAC PATHWAYS CORPORATION of California. Pulmonary vein isolation systems for use with the invention are now being developed by ATRIONIX (ultrasound), IRVINE BIOMEDICAL (ultrasound), and CARDIOFOCUS (laser ablation).
Referring now to FIGS. 17, 18, 19 and 20, an alternative panel system comprising four panels 160A, 160B, 160C, and 160D (collectively panels 160) include substrates 60 on which sensors 12 are coupled to connector 65 via leads 62, as described above regarding panels 4. However, in these embodiments leads 62 generally directly couple the electrodes of sensors 12 to connector 65 without preprocessing of the signal. Such “passive” panel structures are particularly well suited for a low-noise environment, and/or for ambulatory or long-term tests. These long-term and/or ambulatory data sensing (and as described above, optionally recording) sessions are particularly useful for screening and measurement of arrhythmias and other diseases of the heart before an invasive diagnosis and/or treatment. For example, as described in copending provisional patent application serial No. 60/189,611, as filed on Mar. 15, 2000 (the full disclosure of which was previously incorporated by reference), measurements of a heartbeat at or near the initiation of a naturally occurring AFib episode can be particularly beneficial for localization and/or treatment.
1. An sensing system for use diagnosing and/or treating a heart of a patient, the patient having a torso surface, the sensing system comprising:
an array of sensors for sensing heart cycle signals;
four sensor support panels having inner panel surfaces adapted for engaging the torso surface, the four panels supporting a majority of the sensors of the array in operative association with the torso surface when the panels engage the torso surface.
2. The sensing system of claim 1, wherein the array defines at least 40 sensing locations, and wherein each panel supports at least 7 sensors.
3. The sensing system of claim 2, wherein each panel is adapted for alignment with the torso surface so as to define a superior-inferior length and a lateral width, the sensors of each panel being distributed in an at least two-dimensional array across the length and width of the panel.
4. The sensing system of claim 1, wherein the panels have leads extending from the sensors for transmitting sensor signals to the analyzer, the leads extending from the panels toward a first side of the patient to enhance access to the patient via a second side of the patient.
5. The sensing system of claim 4, wherein each panel comprises a flexible panel substrate, the leads being defined by selectively depositing or etching a lead material along the substrate.
6. The sensing system of claim 6, wherein openings through the substrate define at least one separable panel cross-member, the panel having a first configuration adapted to accommodate a first external anatomy before separation of the cross-member, the panel having a second configuration adapted to accommodate a second external anatomy after the cross-member is separated, the leads being routed around the cross-member so as to remain contiguous if the cross-member is separated.
7. The sensing system of claim 1, the torso having four quadrants including a right front quadrant, a left front quadrant, a right rear quadrant, and a left rear quadrant, wherein each panel is adapted for sensing the heart cycle signals at a majority of the sensing locations uses by the analyzer for an associated quadrant of the torso.
8. The sensing system of claim 1, further comprising means for accessing standard heart cycle signals at 12 standard sensing locations.
9. The sensing system of claim 1, further comprising means for independently supporting each panel against the torso surface.
10. The sensing system of claim 9, further comprising indicia of panel positioning visible on the panels.
11. The sensing system of claim 1, further comprising a cardiac stimulation or defibrillation electrode mounted to at least one of the panels.
12. The sensing system of claim 1, further comprising at least one imaging window extending through at least one of the panels for imaging the heart.
13. The sensing system of claim 1, further comprising sensor signal transmission circuitry, the transmission circuitry comprising a plurality of powered circuits distributed among the sensors of the array.
14. An apparatus for use with a cardiac stimulation power source and an arrhythmia analyzer for localizing an arrhythmia within a chamber of a heart of a patient, the patient having a torso surface, the apparatus comprising:
at least one panel adapted for engaging the torso surface;
a cardiac stimulation electrode mounted to the at least one panel for transmitting energy from the stimulation power source to stimulate the heart; and
an array of sensors mounted to the at least one panel, the sensor array transmitting sensor signals to the analyzer for localizing the arrhythmia.
15. The apparatus of claim 14, wherein the stimulation electrode comprises a defibrillation electrode, and wherein at least one of the sensors is disposed within a perimeter of the stimulation electrode and is electrically isolated from the stimulation electrode.
16. The apparatus of claim 14, further comprising a pair of stimulation electrodes mounted to the at least one panel for positioning the heart of the patient therebetween.
17. The apparatus of claim 14, further comprising at least one imaging window extending through the at least one panel for imaging the heart.
18. The apparatus of claim 17, wherein at least a portion of the stimulation electrode is disposed within the imaging window, the at least a portion of the electrode adapted to allow imaging therethrough.
19. The apparatus of claim 14, wherein a plurality of powered circuits are distributed among the sensors of the array, and wherein at least one of the circuits is disposed on an electrode.
20. The apparatus of claim 14, further comprising a plurality of panels, the panels independently mountable on the torso surface.
21. An apparatus for use with an heart signal analyzer and one or more remote imagers when diagnosing or treating a patient, the patient having a heart within a torso surface, the apparatus comprising:
at least one panel having an inner panel surface suitable for engaging at least a portion of the torso surface;
an array of cardiac signal sensors mounted to the at least one panel, the sensor array generating signals in response to heart cycle signals for transmission to the analyzer; and
an imaging window through the at least one panel for imaging the heart.
22. The apparatus of claim 21, further comprising a plurality of imaging windows through the at least one panel for three-dimensional imaging of the heart.
23. The apparatus of claim 21, wherein at least one sensor of the array is disposed within the imaging window, the at least one sensor being more transparent to the imager than at least some of the sensors disposed beyond the imaging window, and wherein at least one lead portion is disposed within the imaging window, the at least one lead portion being more transparent than at least some of the lead portions disposed beyond the imaging window.
24. The apparatus of claim 21, wherein a plurality of amplifier circuits are distributed among the sensors of the array outside the imaging window.
25. The apparatus of claim 21, further comprising a cardiac stimulation electrode mounted to at least one of the panels.
26. An arrhythmia localization system for diagnosing a heart within a torso surface of a patient, the arrhythmia localization system comprising:
a noisy-environment sensor system including a substrate for mounting upon the torso surface, an array of sensors mounted to the substrate, and a plurality of powered circuits distributed among the sensors for transmitting sensor signals; and
an arrhythmia analyzer coupleable to the powered circuits for identifying a candidate arrhythmia site within a chamber of the heart of the patient.
27. The arrhythmia localization system of claim 26, further comprising a low-noise environment sensor system including a substrate for mounting upon the torso surface with an array of sensors mounted to the substrate for recording an abnormal heartbeat, wherein the arrhythmia analyzer identifies the candidate arrhythmia site in response to heart cycle signals sensed by the noisy-environment sensor system, and in response to the recorded abnormal heartbeat.
28. The arrhythmia localization system of claim 26, further comprising at least one element selected from a group consisting of a cardiac imaging window, a cardiac stimulation electrode, and means for accessing 12 standard ECG signals.
US10364291 2000-03-15 2003-02-10 Multi-electrode panel system for sensing electrical activity of the heart Abandoned US20040015194A1 (en)
US09611179 Division US6584343B1 (en) 2000-03-15 2000-07-06 Multi-electrode panel system for sensing electrical activity of the heart
US20040015194A1 true true US20040015194A1 (en) 2004-01-22
US6584343B1 (en) 2003-06-24 grant
Wang et al. 2011 Noninvasive electroanatomic mapping of human ventricular arrhythmias with electrocardiographic imaging