WO1996032885A1 - Appareil d'ablation cardiaque - Google Patents

Appareil d'ablation cardiaque Download PDF

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Publication number
WO1996032885A1
WO1996032885A1 PCT/US1996/005443 US9605443W WO9632885A1 WO 1996032885 A1 WO1996032885 A1 WO 1996032885A1 US 9605443 W US9605443 W US 9605443W WO 9632885 A1 WO9632885 A1 WO 9632885A1
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Prior art keywords
site
origin
electrode
catheter
electrodes
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PCT/US1996/005443
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English (en)
Inventor
Jawahar M. Desai
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Desai Jawahar M
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Priority claimed from PCT/US1995/004943 external-priority patent/WO1996032897A1/fr
Priority claimed from US08/485,357 external-priority patent/US5657755A/en
Application filed by Desai Jawahar M filed Critical Desai Jawahar M
Priority to AU54876/96A priority Critical patent/AU5487696A/en
Priority to EP96911811A priority patent/EP0766527A1/fr
Publication of WO1996032885A1 publication Critical patent/WO1996032885A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/46—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment with special arrangements for interfacing with the operator or the patient
    • A61B6/461—Displaying means of special interest
    • A61B6/464—Displaying means of special interest involving a plurality of displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/0066—Sensing and controlling the application of energy without feedback, i.e. open loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1465—Deformable electrodes

Definitions

  • This invention relates to medical devices and, in particular, a system and technique of employing multi- electrode catheters for cardiac mapping and ablation.
  • Cardiac dysrhythmias are commonly known as irregular heart beats or racing heart.
  • Two such heart rhythm irregularities are the Wolff-Parkinson-White syndrome and atrioventricular (AV) nodal reentrant tachycardia.
  • AV atrioventricular
  • These conditions are caused by an extraneous strand of conducting fibers in the heart that provides an abnormal short-circuit pathway for electric impulses normally conducting in the heart.
  • the accessory pathway causes the electric impulses that normally travel from the upper to the lower chamber of the heart to be fed back to the upper chamber.
  • VT ventricular tachycardia
  • All these types of dysrhythmias can usually be traced to one or more pathological "sites of origin" or tachycardia foci in the heart.
  • the site of origin of tachycardia is determined by analysis of surface electrocardiogram or intracardiac electrogram signals during states of arrhythmias which may occur spontaneously or be induced by programmed pacing. Once the site of origin or focus is located, the cardiac tissues around the site are either ablated surgically or with electrical energy so as to interrupt abnormal conduction. For cardiac mapping, several methods of gathering and analyzing surface electrocardiogram or intracardiac electrogram signals are commonly used.
  • Electrocardiogram is one tool in which the electrocardiograms are gathered from as many as twelve surface electrodes attached to various external body parts of a subject.
  • the ensemble of electrocardiograms usually has a definite signature which may be matched to that generally established to associate with a site of origin in a given location of the heart. In this way, it is possible to determine the gross location of a tachycardia site in the heart.
  • Intracardiac electrogram allows a tachycardia site of focus to be located more accurately. It is obtained by detecting electrical signals within the heart by means of electrodes attached directly thereto.
  • Gallagher et al. "Techniques of Intraoperative ELectrophysiologic Mapping", The American Journal of Cardiolo ⁇ v. volume 49, Jan. 1982, pp. 221-240, disclose and review several methods of intraoperative mapping in which the heart is exposed by surgery and electrodes are attached directly to it.
  • the electrodes at one end of a roving catheter are placed on a series of epicardial or endocardial sites to obtain electrograms for mapping earliest site of activation with reference to surface electrocardiograms.
  • a cardiotomy may also be necessary to open the heart to gain access to the endocardium.
  • epicardial mapping A lattice of about 100 electrodes in the form of a sock is worn on the heart, thereby enabling multiple sites to be recorded simultaneously. This technique is particular useful for those cases where the ventricular tachycardia induced is unstable or polymorphic.
  • a lattice of about 100 electrodes in the form of a inflatable balloon is placed inside the heart after cutting it open.
  • a "closed heart” variation may be possible without the need for both a ventriculotomy and ventricular resection.
  • a deflated balloon electrode array is introduced into the left ventricular cavity across the mitral valve. Once inside the ventricle, the balloon is inflated to have the electrodes thereon contacting the endocardium.
  • Catheter endocardial mapping is a technique for mapping the electrical signals inside the heart without the need for open-chest or open-heart surgery. It is a technique that typically involves percutaneously introducing an electrode catheter into the patient. The electrode catheter is passed through a blood vessel, like femoral vein or aorta and thence into an endocardial site such as the atrium or ventricle of the heart. A tachycardia is induced and a continuous, simultaneous recording made with a multichannel recorder while the electrode catheter is moved to different endocardial positions.
  • Linear multipolar electrode catheters are used in preoperative endocardial mapping.
  • U.S. Patent No. 4,940,064 to Desai discloses an orthogonal electrode catheter array (OECA) .
  • OECA orthogonal electrode catheter array
  • Desai et al. "Orthogonal Electrode Catheter Array for Mapping of Endocardiac Focal Site of Ventricular Activation," PACE. Vol. 14, April 1991, pp. 557-574.
  • This journal article discloses the use of an orthogonal electrode catheter array for locating problem sites in a heart.
  • ablation of cardiac arrhythmias is typically performed by means of a standard electrode catheter. Electrical energy in the form of direct current or radiofrequency is used to create a lesion in the endocardiac tissues adjacent (i.e. underneath) the standard electrode catheter. By creating one or more lesions, the tachycardia focus may be turned into a region of necrotic tissue, thereby disabling any malfunctions.
  • Existing catheter mapping techniques typically rely on analysis of recorded electrograms. Locating the site of origin and tracking the whereabouts of the catheter are at best tricky and time-consuming, and often proved unsuccessful.
  • a system including a multi-electrode catheter selectively connectable to a mapping unit, an ablation unit and a pacing unit.
  • the system also includes a computer for controlling the various functional components.
  • the system additionally includes a physical imaging unit which is capable of providing different views of a physical image of the multi-electrode catheter percutaneously introduced into the heart of a subject.
  • Electrogram signals emanated from a tachycardia site of origin in the endocardium are detectable by the electrode array. Their arrival times are processed to generate various visual maps to provide real-time guidance for steering the catheter to the tachycardia site of origin.
  • the visual map includes a footprint of the electrode array on an endocardial site.
  • the arrival time registered at each electrode is displayed in association therewith. A medical practitioner can therefore steer the catheter in the direction of earlier and earlier arrival time until the tachycardia site of origin is located.
  • the visual map also includes isochrones which are contours of equal arrival time. These isochrones are constructed by linear interpolation of arrival times registered at the electrode array and cover the area spanned by the electrode array. When the electrode array is far from the tachycardia site of origin, the isochrones are characterized by parallel contours. When the electrode array is close to or on top of the tachycardia site of origin, the isochrones are characterized by elliptical contours encircling the tachycardia site of origin. Therefore, the isochrones provide additional visual aid and confirmation for steering the catheter to the tachycardia site of origin.
  • the visual map also includes an estimated location of the tachycardia site of origin relative to the electrode array. This provides direct visual guidance for rapidly steering the catheter to the tachycardia site of origin.
  • the tachycardia site of origin lies in the weighed direction of electrodes with the earliest arrival times.
  • the distance is computed from the velocity and time of flight between the site of origin and a central electrode.
  • the velocity is estimated from a local velocity computed from the inter-electrode spacings and arrival time differentials.
  • the system also include a physical imaging system which is capable of providing different imaged physical views of the catheter and the heart. These physical views are incorporated into the various visual maps to provide a more physical representation.
  • two visual maps display two views (e.g., x,y axes) of a physical image of the electrode array in the heart with a relative position for the tachycardia site of origin.
  • a visual map display a three-dimensional perspective view of the electrode array in the heart with a relative position for the tachycardia site of origin.
  • the visual map also marks previous sites or tracks visited by the electrode array.
  • the electrode array can locate the tachycardia site of origin rapidly and accurately. The system then directs electrical energy from the ablation power unit to the electrode array to effect ablation.
  • Figure 1 is a schematic block diagram of a multi- electrode catheter mapping and ablation system of the invention
  • Figure 2A illustrates the proximal end of the orthogonal electrode catheter array (OECA) in its fully retracted position or mode
  • Figure 2B illustrates the OECA in its fanned-out mode
  • Figure 2C shows the footprints of the five- electrode OECA electrodes
  • Figure 3A illustrates the five electrodes of the OCEA positioned on a pair of orthogonal axes, each passing through a pair of peripheral electrodes and the central electrode;
  • Figure 3B shows an example measurement of the OECA from one endocardial site
  • Figure 3C illustrates the linear interpolation scheme applied to Quadrant I of the example shown in Figure 3B;
  • Figure 3D shows the construction of a complete local isochronal map for the entire area cover by the OECA as shown in Figure 3D;
  • Figure 4 shows example traces of surface EKG and intracardiac electrogram
  • Figure 5 illustrates schematically the ventricle or other heart chamber divided arbitrarily into four segments, and the isochrone maps obtained from various locations;
  • Figure 6A illustrates by an example the construction of the displacement vector of the electrode array to the estimated site of origin;
  • Figure 6B is a display on the video monitor showing the relative positions of the electrode array and the estimated site of origin, according to a preferred embodiment of the invention
  • Figure 6C illustrates a display according to another embodiment which includes the electrode array with the arrival times and the local isochrone map
  • Figure 7A is a synthesized display on the video monitor of a digitized picture of the heart and the electrode array therein taken along a first axis by the physical imaging system, and also showing the relative position of the estimated site of origin, according to another preferred embodiment of the invention
  • Figure 7B is a display on the video monitor showing a similar picture as in Figure 7A but taken along a second axis by the physical imaging system;
  • Figure 8 is a display on the video monitor showing the pictures of Figure 7A and 7B simultaneously, according to another preferred embodiment of the invention;
  • Figure 9 is a display on the video monitor showing a relative position of the estimated site of origin against a perspective picture of the heart and the electrode array which is synthesized from pictures recorded from along several axes by the physical imaging system, according to another preferred embodiment of the invention.
  • Figure 1 is a schematic block diagram of a multi- electrode catheter mapping and ablation system 10 according to a preferred embodiment of the present invention.
  • the system 10 essentially comprises of three functioning units, namely a mapping unit 20, an ablation unit 30 and a pacing unit 40.
  • a computer 50 controls the operation of each of the units and their cooperations via a control interface 52.
  • the computer receives operator inputs from an input device 54 such as a keyboard, a mouse and a control panel.
  • the output of the computer may be displayed on a video monitor 56 or other output devices (not shown) .
  • the system 10 also includes a physical imaging system 60.
  • the physical imaging system 60 is preferably a 2-axis fluoroscope or an ultrasonic imaging system.
  • the physical imaging system 60 is controllable by the computer 50 via the control interface 52.
  • the computer triggers the physical imaging system to take "snap-shot" pictures of the heart 100 of a patient (body not shown) .
  • the picture image is detected by a detector 62 along each axis of imaging. It usually includes a silhouette of the heart as well as inserted catheters and electrodes, and is displayed by a physical imaging monitor 64.
  • Two monitors may be used to display the two images obtained along each of the dual axes. Alternatively, the two images may be displayed side-by-side on the same monitor.
  • a digitized image data is also fed into the computer 50 for processing and integrating into computer graphics to be displayed on the video monitor 56.
  • a multi-electrode catheter 70 is selectively routed to each of the three functioning units 20, 30 and 40 via a catheter lead connector 72 to a multiplexor 80.
  • Auxiliary catheters 90 or electrodes 92 are also connectable to the multiplexor 80 via one or more additional connectors such as 94, 96.
  • the multi-electrode catheter 70 is typically introduced percutaneously into the heart 100.
  • the catheter is passed through a blood vessel (not shown), like femoral vein or aorta and thence into an endocardial site such as the atrium or ventricle of the heart.
  • auxiliary catheters 90 may also be introduced into the heart and/or additional surface electrodes 92 attached to the skin of the patient.
  • the multi-electrode catheter 70 as well as optional auxiliary catheters 90 function as detectors of intra- electrocardiac signals.
  • the surface electrodes 92 serve as detectors of surface electrocardiogram signals.
  • the analog signals obtained from these multi-electrode catheters and surface electrodes are routed by the multiplexor 80 to a multi-channel amplifier 22.
  • the amplified signals are displayable by an electrocardiogram (EKG) monitor 24.
  • the analog signals are also digitized via an A/D interface 26 and input into the computer 50 for data processing and graphical display. Further details of the data acquisition, analysis, and display relating to intracardiac mapping will be disclosed later.
  • the multi-electrode catheter 70 When the system 10 is operating in an ablation mode, the multi-electrode catheter 70 is energized by the ablation unit 30 under the control of the computer 50. An operator issues a command through the input device 54 to the computer 50. The computer controls the ablation unit 30 through the control interface 52. This initiates a programmed series of electrical energy pulses to the endocardium via the catheter 70.
  • a preferred implementation of the ablation method and device is disclosed in U.S. Patent No. 5,383,917 by Desai, et al., the entire disclosure thereof is incorporated herein by reference.
  • the multi-electrode catheter 70 is energized by the pacing unit 40 under the control of the computer 50.
  • An operator issues a command through the input device 54 whereby the computer 50 controls through the control interface 52 and multiplexor 80 and initiates a programmed series of electrical simulating pulses to the endocardium via the catheter 70 or one of the auxiliary catheters 90.
  • a preferred implementation of the pacing mode is disclosed in M. E. Josephson et al., "VENTRICULAR ENDOCARDIAL PACING II. The Role of Pace Mapping to Localize Origin of Ventricular Tachycardia," The American Journal of Cardiology. Vol. 50, November 1982, relevant portion of the disclosure thereof is incorporated herein by reference.
  • the ablation unit 30 is not controlled by the computer 50 and is operated manually directly under operator control.
  • the pacing unit 40 may also be operated manually directly under operator control.
  • the connections of the various components of the system 10 to the catheter 70, the auxiliary catheters 90 or surface electrodes 92 may also be switched manually via the multiplexor 80.
  • An important advantage of the present invention is the capability of allowing a medical practitioner to use a roving catheter to locate the site of origin of tachycardia in the endocardium quickly and accurately, without the need for open-chest and open-heart surgery.
  • This is accomplished by the use of the multi-electrode catheter 70 in combination with real-time data-processing and interactive display by the system 10.
  • the multi-electrode catheter 70 must be able to deploy at least a two-dimensional array of electrodes against a site of the endocardium to be mapped.
  • the intracardiac signals detected by each of the electrodes provide data sampling of the electrical activity in the local site spanned by the array of electrodes.
  • This data is processed by the computer to produce a real-time display including arrival times of intracardiac signals at each electrode, and a local isochrone map of the sampled site.
  • the local isochrone map is an expedient way of indicating how close and where the electrode array is from the site of origin.
  • the computer computes and displays in real-time an estimated location of the site of origin relative to the electrodes, so that a medical practitioner can interactively and quickly move the electrodes towards the site of origin.
  • a suitable multi-electrode catheter for use in the present invention is a five-electrode orthogonal electrode catheter array (OECA) that has been disclosed in U.S. Patent No. 4,940,064 to Desai. Relevant portions of said disclosure are incorporated herein by reference.
  • Figure 2A illustrates the proximal end of the orthogonal electrode catheter array (OECA) 70 in its fully retracted position or mode. Because the catheter material has a "set” or “memory” it will normally return to this retracted position.
  • the OECA comprises an eight-french five-pole electrode catheter 70. It has a central stylet 102 with four peripheral or circumferential electrodes 112, 113, 114 and 115.
  • a fifth electrode 111 is located centrally at the tip of the stylet 102. All five electrodes are hemispherical and have individual leads 116 connected thereto. Each peripheral electrode is 2 mm in diameter while the central electrode is 2.7 mm in diameter. Slits 120 are cut longitudinally near where the electrodes are located.
  • Figure 2B illustrates the OECA in its fanned-out mode. When the proximal end (not shown) of the catheter is pulled, the stylet's slits 120 allow four side arms 122 to open from the stylet body in an orthogonal configu ⁇ ration. Each of the four arms 122 extend a peripheral electrode radially from the stylet so that the four peripheral electrodes forms a cross with the fifth electrode 111 at its center.
  • the inter-electrode distance from the central electrode to each peripheral electrode is 0.5 cm, and the distance between peripheral electrodes is 0.7 cm.
  • the surface area of the catheter tip in an open position is 0.8 cm 2 .
  • Figure 2C shows the footprints of the five- electrode OECA electrodes.
  • the four peripheral electrodes 112, 113, 114 and 115 or (2)-(5) form a cross configuration.
  • the fifth electrode 111 or (1) is located at the center of the cross.
  • the orthogonal array of electrodes therefore provides five sampling points over the zone 130 in an endocardium site spanned by the electrodes.
  • the site of origin becomes the source of endocardial activation, emanating a series of activation wavefronts therefrom. Electrodes such as those deployed by the catheter 70 in the endocardium and located closer to the site of origin will detect these wavefronts earlier than those further away. The surface electrodes 92 being the furthest away from the site of origin will generally register latest wavefront arrival times.
  • OCEA positioned on a pair of orthogonal axes. Each orthogonal axes passes through a pair of peripheral electrodes and the central electrode, viz 112-111-114 (or (2)-(l)-(4)) and 113-111-115 (or (3)-(l)-(5) ) .
  • the zone spanned by the five electrodes is best divided into four triangular quadrants I to IV.
  • Quadrant I is bounded by electrodes (1), (2), and (3).
  • Quadrant II is bounded by electrodes (1), (3), and (4).
  • Quadrant III is bounded by electrodes (1), (4), and (5).
  • Quadrant IV is bounded by electrodes (1), (5), and (2).
  • the local isochrones are then computed for each quadrant separately using linear interpolation along each side of the triangle.
  • Figure 3B shows an example measurement of the
  • OECA taken from one endocardial site.
  • FIG 3C illustrates the linear interpolation scheme applied to Quadrant I of the example shown in Figure 3B.
  • an isochrone for the arrival time of -10 milliseconds can easily be drawn by joining a line from the -10 msec coordinate along each side.
  • the -10 msec coordinate is found only along the two sides defined by electrodes (1) and (2) and electrodes (1) and (3) .
  • Figure 3D shows the construction of a complete local isochronal map for the entire area covered by the OECA.
  • the complete local isochronal map is obtained by applying the linear interpolation method to all quadrants for all desired arrival times.
  • the activation wavefront arrival time at each electrode is measured relative to a reference time.
  • the reference time is usually provided by the earliest deflection in a surface electrocardiogram which is monitored throughout the cardiac procedure.
  • Figure 4 shows typical example traces of surface EKG and intracardiac electrograms.
  • the top three traces are three surface electrocardiograms I, AVF and VI, representing three planes (right to left, superior- inferior, anterior-posterior). These are continuously monitored and the earliest deflection on any of these electrocardiograms serves as a reference point of time, in this example, a perpendicular dotted line (reference time zero) is drawn from the earliest surface EKG which happens to be lead I.
  • the next five traces are unipolar intracardiac electrograms as detected by an orthogonal electrode array catheter. It can been seen that electrode number 5, having the earliest arrival time of -36 msec is closer to the site of origin than the others.
  • an arrival time of -40 to -45 msec indicates that the detecting electrode is located substantially at the site of origin.
  • the OECA yields a local isochrone map characterized by elliptical contours centered on the central electrode.
  • its local isochrone map is characterized by parallel contours. The characteristic arrival time and associated isochronal signature are useful for locating the site of origin.
  • the intracardiac and surface EKGs are preferably digitized using a simple 8 or 16 channel signal digitizer.
  • the intracardiac electrograms and surface EKGs obtained from the multi-electrode catheter 70 and the surface electrodes 92 are digitized by the A/D interface 26.
  • the digitized waveforms are analyzed by the computer to find the activation wavefront arrival times in real time.
  • the method of operation of the inventive system in mapping mode will now be described by way of an example as follows.
  • the multi-electrode catheter 70 is first used in mapping.
  • the catheter is inserted through the leg artery (right femoral) and advanced to the aortic arch and then to the left ventricle utilizing fluoroscopic guidance as provided by the physical imaging system 60.
  • FIG. 5 illustrates schematically the ventricle or other heart chamber divided arbitrarily into four segments, right-upper (RUS) and right-lower (RLS), and left-upper (LUS) and left-lower (LLS) segments.
  • a site of origin 200 is located in the (LLS) segment.
  • the catheter 70 (OECA) is used to sample each of the segments in order to identify the segment containing the site of origin 200.
  • the OECA is first positioned in the right upper segment, and its orthogonal electrode array is deployed to measure arrival times of wavefront activation from the site of origin.
  • the system 10 is then instructed to initiate tachycardia by means of programmed electrical stimulation protocol from the pacing unit 40 to an electrode inserted into the endocardium.
  • the OECA picks up the intracardiac activation wavefront arrival times which are analyzed by the computer and a local isochrone map is displayed on the video monitor 56.
  • a local isochrone map is displayed on the video monitor 56.
  • the catheter electrodes are retracted and the catheter moved to the lower segment (RLS). In this way all four segments are mapped.
  • the catheter is eventually repositioned in the segment (e.g., LLS) that demonstrates earliest arrival times.
  • Figure 6A illustrates by an example the construction of the displacement vector of the electrode array to the estimated site of origin 201. Shown in Figure 6A are the five electrodes of the OECA which are identical to the ones shown in Figure 3A.
  • the goal is to locate the electrode array centrally about the actual site of origin. Since the site of origin is the source of the activation wavefronts an electrode located at the site will detect the earliest possible arrival time (typically -40 to 44msec with respect to the first deflection of the surface EKG). The goal is achieved by having the central electrode (1) detecting the earliest possible arrival time.
  • the electrode array when the electrode array is displaced from the site of origin, those electrodes further away from the site of origin will detect arrival times later (less negative) than those that are closer (more negative). Thus, the electrode array must be moved along the direction of more negative arrival time in order to close in on the site of origin.
  • the direction in which the displacement vector joining the center of the electrode array to the estimated site of origin 201 is determined by linear interpolation of the respective arrival times detected at the five electrode locations. This can be easily performed by treating each arrival time as an "equivalent mass" located at each electrode and calculating the "center of mass" for the electrode array. The position of the "center of mass" is then given by:
  • the OECA conveniently defines a set of orthogonal axes with an (x,y) coordinate system, viz: the direction along electrodes (l)-(2) being the y-axis and the direction along electrodes (l)-(3) being the x-axis.
  • the example data yield the position of the "center of mass" relative to the electrode (1):
  • the estimated site of origin 201 then lies along a direction D A defined by a line through the central electrode (1) and the "center of mass", [R xf R y ] .
  • , between the central electrode (1) and the central electrode (1) is the distance,
  • t(f) arrival time measured at the site of origin
  • t(l) arrival time measured at the central electrode
  • the OECA it is expediently accomplished by first computing the wavefront velocities along the x- and y-axis. This is estimated by the speed the wavefront travel from one electrode to another along the x- and y-axis:
  • the local wavefront velocity v D is estimated by adding the component of v x and v y along the direction D A , viz. :
  • Equation (4) yields
  • Figure 6B illustrates a computer graphical display on the video monitor 56 (see Figure 1) in the preferred embodiment.
  • the display shows, in real time and simultaneously, the electrode array with its local isochrone map and the relative position of the estimated site of origin 201. This greatly facilitates a medical practitioner to quickly steer the electrode catheter array to the site of origin.
  • the isochrones should be more and more elliptical, when the central electrode 111 is on top of the estimated site of origin, the isochrones should be ellipes wrapping around the central electrode 111.
  • t(f) needs to be revised and preferably changed in steps of 2 msec at a time, until the event when coincidence of the central electrode with the estimated site of origin is 23/ 1 accompanied by elliptical isochrones wrapping around the central electrode.
  • Equation (1) is a linear interpolation scheme based on repesresenting the arrival time at each electrode with an equivalent mass
  • the arrival times are translated by the formulae t x ⁇ T 0 - t x where T 0 is a positive constant larger than any of the positive arrival time values. For example, T 0 - 50, and the calculation in Equation (2) yields [R x ,R y ] ⁇ [1, -13]R.
  • Figure 6C illustrates a display according to another embodiment which includes the electrode array with the arrival times and the local isochrone map.
  • an arrow 313 indicates the estimated direction in which the catheter array should move in order to approach the site of origin.
  • Fig. 6c a map such as that illustrated in Fig. 6c associated with each site, with the current display showing the reading from the current site.
  • a further feature is the ability to store maps from previous sites and to recall these "history" information as needed.
  • another arrow 311 associated with the previous site is also displayed on the current map to provide a line of reference from the previous site.
  • the previous arrow is displayed with a 25 different attribute such as with broken line or with a different color in order to distinguish over the present arrow. In this way, the operator maneuvering the catheter will be able to tell whether the current catheter position is getting closer to the site of origin relative to the last one.
  • the previous map is display in a smaller window in one corner of the current map.
  • the operator is able to mark the sites interactively on a graphical terminal.
  • a schematic diagram of the heart such as the one shown in Fig. 5, and by reference to a flouoscopic image of the catheter in the heart, an operator can mark the equivalent site on the schematic diagram.
  • Each marker on the schematic diagram is linked to its associated map or associated information. Subsequently, the operator is able to point to any existing marker and recall its associated map or information.
  • the computer video display shown in Figure 6B is constructed essentially from information obtained through data processing of wavefront arrival-time data sampled by the electrode catheter array 70.
  • the display is an arrival-time field that exists in a two-dimensional space on the surface of the endocardium. For the purpose of locating the catheter at the site of origin, it provides adequate and cost-effective guidance.
  • the information obtained by the physical imaging system 60 26 is obtained by the physical imaging system 60 26
  • the two types of information are synthesized by the computer 50, and are displayed on the video monitor 56 as a physical image of the heart 100 and showing therein the relative positions of the electrode catheter array 70 and the estimated site of origin 201. In this way a more physical representation of the catheter and heart is possible.
  • Figure 7A is a synthesized display on the video monitor of a digitized picture of the heart 100 and the electrode array 70 therein taken along a first axis by the physical imaging system, and also showing the relative position of the estimated site of origin 201, according to another preferred embodiment of the invention.
  • the physical imaging system 60 (also see Figure 1) comprises two x-rays taken from two perpendicular directions. The video output of both x-ray machines is digitized, e.g., by using two separate video frame grabbers integrated into the x-y detectors 62.
  • the electrode array 70 such as the OECA (also see Figures 2 and 3) has an x-ray opaque dart (not shown) on one of the electrode arms, it is relatively simple for the computer to properly identify each electrode and associate the correct arrival time with each electrode. In this way, the positions of the five electrodes of the OECA can be tracked by the computer 50 in real time.
  • the estimated site of origin 201 can be located by the method described earlier, except the coordinate system may be non-orthogonal, depending on the orientation of the electrode array.
  • Figure 7B is a display on the video monitor showing a similar picture as in Figure 7A but taken along a second axis by the physical imaging system.
  • the views from the two axes may be displayed on two separated video monitors or on one monitor.
  • Figure 8 is a display on the video monitor showing the pictures of Figure 7A and 7B simultaneously, according to another preferred embodiment of the invention.
  • the video display is a perspective rendering of a three- dimensional image of the heart and the electrode array.
  • Figure 9 is a synthesized display on the video monitor of a perspective picture of the heart 100 and the electrode array 70 together with the estimated site of origin 201, according to another preferred embodiment of the invention.
  • the image of heart 100 and the electrode array 70 are rendered from a three-dimensional image database which is collected from imaging along several axes by the physical imaging system. Each axis provide a view of the heart and the electrode array.
  • the procedure for locating the estimated site of origin in each view is similar to that described before.
  • the data gathered from the different views are processed by the computer to generate a three-dimensional perspective view.
  • sites previously visited by the catheter are processed by the computer to generate a three-dimensional perspective view.
  • the present inventive system is advantageous in allowing a medical practitioner to graphically track in real time the relative positions of the electrode array with respect to the heart and the estimated site of origin. Furthermore, it allows the possibility of accurate catheter positioning and repositioning in the 28 endocardium and the possibility of tracking the history of the catheter previous positions.
  • a global isochronal map for the entire endocardium is assembled by the catheter scanning over the entire endocardium and the computer piecing together the local isochrone maps at each scanned site.
  • the display includes tracks traversed by the catheter to provide guidance so that the endocardium can be mapped systematically. This will not only allow the computer to produce and display local isochronal maps in real time, but also separate isochronal maps of a larger area up to the whole endocardium by storing the actual positions of the electrodes for each measurement and the corresponding arrival times. As each additional measurement is taken, the (non-local) isochronal map could be updated to cover a larger area more accurately.
  • the system 10 ( Figure 1) is switched to the ablation mode. Electrical energy is transmitted from the ablation power unit 30 through the multiplexor 80 to the electrode array catheter 70.
  • the ablation power unit 30 is programmable and under the control of the computer 50, so that a predetermined amount of electrical energy is delivered to ablate the endocardium.
  • the lesion formed is about the size of the energized electrode or electrode array.
  • Conventional catheter ablation techniques have typically employed a catheter with a single electrode at its tip as one electrical pole. The other electrical pole is formed by a backplate in contact with a patient's external body part. These techniques have been used to disable the tachycardia site of origin in most cases. For example, it has been successfully used for the interruption or modification of conduction across the atrioventricular (AV) junction in AV nodal reentrant tachycardia; or for the interruption of accessory pathway in patients with tachycardia due to Wolff-Parkinson-White Syndrome; and for ablation in some patients with ventricular tachycardia (VT).
  • AV atrioventricular
  • VT ventricular tachycardia
  • ventricular tachycardia VT
  • endocardial mapping with a standard electrode catheter can locate the exit site of ventricular tachycardia to within 4-8 cm 2 of the earliest site recorded by the catheter.
  • a standard electrode catheter typically has a maximum electrode tip area of about 0.3 mm 2 . Therefore, the lesion created by the simple RF technique delivered through a 30 standard electrode catheter may not be large enough to ablate the ventricular tachycardia. Attempts to increase the size of lesion by regulation of power and duration by increasing the size of electrode or by regulating the temperature of tip electrode have met with partial success.
  • the orthogonal electrode catheter array (OECA) with four peripheral electrodes and one central electrode provides a larger footprint. It typically produces a lesions of 1 cm 2 .
  • lesion size of the order of more than one cm 2 is probably required for effective treatment.
  • a large lesion is formed by successive ablation of adjacent sites.
  • a larger lesion of 6 cm 2 size can be created by six adjacent square-shaped lesions of 1 cm 2 . They can be formed by successive placements of the five-electrode OECA using RF energy.
  • the electrode catheters is usually withdrawn to clean blood coagulum on the electrodes before the next attempt. It is critical that the locations of the next spot to be ablated as well as the reintroduced catheter must be known accurately and quickly for this procedure to be successful.
  • mapping mode the system is preferably programmed to superposition a grid about the displayed tachycardia site such as that shown in Figs. 7, 8 or 9.
  • the grid will enable accurate positioning of the electrode array.

Abstract

Cette invention concerne un système et un procédé de cartographie et d'ablation cardiaques faisant appel à un cathéter à électrodes multiples, lequel est introduit de manière percutanée dans le coeur d'un patient et peut se déployer à proximité de divers sites endocardiaques. Les électrodes peuvent être connectées à une unité de cartographie, une unité électrique d'ablation, une unité de stimulation, toutes ces unités étant commandées par ordinateur. Les signaux d'électrogrammes intracardiaques provenant d'un site d'origine de tachycardie sont détectés par les électrodes. Les temps d'arrivée de ces signaux sont traités en vue de l'élaboration de diverses cartes visuelles de manière à obtenir un guidage en temps réel lors de l'acheminement du cathéter vers le site d'origine de tachycardie. En variante, ce système comprend également un système d'imagerie physique capable de fournir diverses vues physiques par imagerie du cathéter et du coeur. Ces vues physiques sont incorporées aux diverses cartes visuelles de manière à produire une représentation plus physique. Une fois que les électrodes se trouvent sur le site d'origine de tachycardie, de l'énergie électrique est envoyée par l'unité électrique d'ablation afin d'effectuer ladite ablation.
PCT/US1996/005443 1995-04-20 1996-04-18 Appareil d'ablation cardiaque WO1996032885A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU54876/96A AU5487696A (en) 1995-04-20 1996-04-18 Apparatus for cardiac ablation
EP96911811A EP0766527A1 (fr) 1995-04-20 1996-04-18 Appareil d'ablation cardiaque

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
PCT/US1995/004943 WO1996032897A1 (fr) 1995-04-20 1995-04-20 Appareil de cartographie cardiaque utilisable pour des ablations
KEPCT/US95/04943 1995-04-20
US08/485,357 1995-06-07
US08/485,357 US5657755A (en) 1993-03-11 1995-06-07 Apparatus and method for cardiac ablation

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AU (1) AU5487696A (fr)
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WO1999047058A2 (fr) * 1998-03-19 1999-09-23 Oratec Interventions, Inc. Catheter pour fournir de l'energie a un champ operatoire
DE19817553A1 (de) * 1998-04-15 1999-10-21 Biotronik Mess & Therapieg Ablationsanordnung
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US6165172A (en) * 1997-09-11 2000-12-26 Vnus Medical Technologies, Inc. Expandable vein ligator catheter and method of use
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US6752805B2 (en) 2000-06-13 2004-06-22 Atrionix, Inc. Surgical ablation probe for forming a circumferential lesion
US6752803B2 (en) 1997-09-11 2004-06-22 Vnus Medical Technologies, Inc. Method and apparatus for applying energy to biological tissue including the use of tumescent tissue compression
EP1415608A3 (fr) * 2002-10-21 2004-10-20 Biosense, Inc. Surveillance en temps réel et cartographie de la formation des lésions dans le coeur
US6964660B2 (en) * 1997-07-08 2005-11-15 Atrionix, Inc. Tissue ablation device assembly and method of electrically isolating a pulmonary vein ostium from an atrial wall
US7306593B2 (en) 2002-10-21 2007-12-11 Biosense, Inc. Prediction and assessment of ablation of cardiac tissue
US7850685B2 (en) 2005-06-20 2010-12-14 Medtronic Ablation Frontiers Llc Ablation catheter
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US8273084B2 (en) 2004-11-24 2012-09-25 Medtronic Ablation Frontiers Llc Atrial ablation catheter and method of use
US8486063B2 (en) 2004-10-14 2013-07-16 Medtronic Ablation Frontiers Llc Ablation catheter
US8521266B2 (en) 2008-10-09 2013-08-27 The Regents Of The University Of California Methods for the detection and/or diagnosis of biological rhythm disorders
US8641704B2 (en) 2007-05-11 2014-02-04 Medtronic Ablation Frontiers Llc Ablation therapy system and method for treating continuous atrial fibrillation
US8657814B2 (en) 2005-08-22 2014-02-25 Medtronic Ablation Frontiers Llc User interface for tissue ablation system
US8676303B2 (en) 2008-05-13 2014-03-18 The Regents Of The University Of California Methods and systems for treating heart instability
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