US20080234564A1 - Electrophysiology therapy catheter - Google Patents

Abstract

A mapping catheter is positioned in a heart chamber, and active electrode sites are activated to impose an electric field within the chamber. The blood volume and wall motion modulates the electric field, which is detected by passive electrode sites on the preferred catheter. Electrophysiology measurements, as well as geometry measurements, are taken from the passive electrodes and used to display a map of intrinsic heart activity.

Description

CROSS REFERENCED TO RELATED CASES
• This is a Divisional Application of U.S. Ser. No. 09/005,105, filed Jan. 9, 1998, entitled “Electrophysiology Mapping System;” which was a Continuation-In-Part of U.S. Ser. No. 08/387,832, officially filed May 26, 1995 and entitled “Endocardial Mapping System and Catheter Probe”; which is a national stage application based upon international application PCT/US93/09015, filed Sep. 23, 1993; which in turn is a Continuation-In-Part of both U.S. Ser. No. 07/950,448, filed Sep. 23, 1992 (now U.S. Pat. No. 5,291,549) and U.S. Ser. No. 07/949,690, also filed Sep. 23, 1992 (now U.S. Pat. No. 5,311,866). The parent application, Ser. No. 08/387,832, is incorporated by reference herein.
FIELD OF THE INVENTION
• The parent invention relates to electrophysiology apparatus which is used to measure and to visualize electrical activity occurring in a patient's heart. The system can display both a visual map of the underlying electrical activity originating in a chamber of a patient's heart and the location of a therapy catheter located within a heart chamber. The electrophysiology apparatus includes several subsystems including: a therapy catheter system, a measurement catheter system and a computer based signal acquisition, control and display system.
BACKGROUND OF THE INVENTION
• Many cardiac tachyarrhythmias are caused by conduction defects which interfere with the normal propagation of electrical signals in a patient's heart. These arrhythmias may be treated electrically, pharmacologically or surgically. The optimal therapeutic approach to treat a particular tachyarrhythmia depends upon the nature and location of the underlying conduction defect. For this reason electrophysiologic mapping is used to explore the electrical activity of the heart during a tachyarrhythmic episode. The typical electrophysiologic mapping procedure involves positioning an electrode system within the heart. Electrical measurements are made which reveal the electrical propagation of activity in the heart. If ablation is the indicated therapy then a therapy catheter is positioned at the desired location within the heart and energy is delivered to the therapy catheter to ablate the tissue.
• There are numerous problems associated with these electrophysiologic diagnostic and therapeutic procedures. First the testing goes on within a beating heart. The motion of the diagnostic catheter and treatment catheter can injure the heart and provoke bouts of arrhythmia which interfere with the collection of diagnostic information. During the delivery of ablation therapy it is common to use fluoroscopic equipment to visualize the location of the catheters. Many physicians are concerned about routine occupational exposure to X-rays. In addition, the traditional mapping techniques do not provide a high resolution view of the electrical activity of the heart which makes it difficult to precisely locate the source of the arrhythmia.
SUMMARY
• The electrophysiology apparatus of the invention is partitioned into several interconnected subsystems. The measurement catheter system introduces a modulated electric field into the heart chamber. The blood volume and the moving heart wall surface modify the applied electric field. Electrode sites within the heart chamber passively monitor the modifications to the field and a dynamic representation of the location of the interior wall of the heart is developed for display to the physician. Electrophysiologic signals generated by the heart itself are also measured at electrode sites within the heart and these signals are low pass filtered and displayed along with the dynamic wall representation. This composite dynamic electrophysiologic map may be displayed and used to diagnose the underlying arrhythmia.
• A therapy catheter system can also be introduced into the heart chamber. A modulated electrical field delivered to an electrode on this therapy catheter can be used to show the location of the therapy catheter within the heart. The therapy catheter location can be displayed on the dynamic electrophysiologic map in real time along with the other diagnostic information. Thus the therapy catheter location can be displayed along with the intrinsic or provoked electrical activity of the heart to show the relative position of the therapy catheter tip to the electrical activity originating within the heart itself. Consequently the dynamic electrophysiology map can be used by the physician to guide the therapy catheter to any desired location within the heart.
• The dynamic electrophysiologic map is produced in a step-wise process. First,the interior shape of the heart is determined. This information is derived from a sequence of geometric measurements related to the modulation of the applied electric field. Knowledge of the dynamic shape of the heart is used to generate a representation of the interior surface of the heart.
• Next, the intrinsic electrical activity of the heart is measured. The signals of physiologic origin are passively detected and processed such that the magnitude of the potentials on the wall surface may be displayed on the wall surface representation. The measured electrical activity may be displayed on the wall surface representation in any of a variety of formats. Finally, a location current may be delivered to a therapy catheter within the same chamber. The potential sensed from this current may be processed to determine the relative or absolute location of the therapy catheter within the chamber.
• These various processes can occur sequentially or simultaneously several hundred times a second to give a continuous image of heart activity and the location of the therapy device.
BRIEF DESCRIPTION OF THE DRAWINGS
• An exemplary and illustrative form of the invention is shown in the drawings and identical reference numerals refer to equivalent structure throughout.
• FIG. 1 is a schematic block diagram of the electrophysiology apparatus;
• FIG. 2 is a block diagram representing the partitioning of the electrophysiology apparatus;
• FIG. 3 is a diagram of an illustrative balloon electrode set implementation of the measurement catheter and a therapy catheter;
• FIG. 4 is a schematic diagram of an illustrative basket electrode set implementation of the measurement catheter;
• FIG. 5 is a flow chart showing the wall surface generation process;
• FIG. 6 is a schematic diagram of a row of electrodes of the balloon catheter and their use in measuring distance to the heart chamber wall;
• FIG. 7 is a screen display representing the motion of the cardiac wall surface;
• FIG. 8 is a schematic block diagram of the portion of the electrophysiology apparatus which implements the body orientation generation process;
• FIG. 9 is a flow charting showing the body orientation generation process;
• FIG. 10 is a flow chart showing the wall electrogram generation process;
• FIG. 11 is a representative screen display showing wall electrogram information;
• FIG. 12 is a representative screen display showing wall electrogram information;
• FIG. 13 is a representative screen display showing wall electrogram information;
• FIG. 14 is a flow chart showing the site electrogram generation process; and
• FIG. 15 is a flow chart showing the movable electrode location process.
• FIG. 16 is a schematic block diagram of the therapy catheter system;
• FIG. 17 is a schematic diagram of the laser delivery embodiment of the therapy catheter;
• FIG. 18 is a schematic diagram of a microwave delivery embodiment of the therapy catheter;
• FIG. 19 is a schematic diagram of a chemical delivery embodiment of the therapy catheter; and
• FIG. 20 is a schematic diagram of the angioplasty catheter embodiment of the therapy catheter.
DETAILED DESCRIPTION
• FIG. 1 shows theelectrophysiologic apparatus10 connected to apatient12. In a typical procedure amonitoring catheter system14 is placed in theheart16 to generate a display of the electrical activity of theheart16. After diagnosis atherapy catheter18 may be inserted into the heart to perform ablation or other corrective treatment.
• The monitoringcatheter14 has aproximal end20 which may be manipulated by the attending physician, and adistal end22 which carries a monitoring catheter electrode set44. In general thedistal end22 of themonitoring catheter14 will be relatively small and will float freely in the heart chamber. Thetherapy catheter18 has adistal end24 which carries a therapy catheter electrode set46. The therapy catheter also hasproximal end26 which can be manipulated by the attending physician.
• The electrode sets located on the catheters are coupled to aninterface system28, through appropriate cables. Thecable30 connects the monitoring catheter electrode set44 to theinterface system28 whilecable32 connects the therapy catheter electrode set46 to theinterface system28. Theinterface system28 contains a number of subsystems which are controlled by acomputer34. The data collected by theinterface system28 is manipulated by thecomputer34 and displayed on adisplay device36. Surface electrodes represented byelectrode40 may also be coupled to theelectrophysiology apparatus10 for several purposes via anappropriate cable42. Atherapy generator38 is connected to thetherapy catheter electrode60 and to thetherapy surface ground70, through theinterface system28. The skinsurface electrode cable42 couples theECG surface electrodes74 to theECG system39, which may be a subsystem ofinterface system28.
• FIG. 2 is a schematic diagram showing an illustrative segmentation of the electrode sets and their electrical connections to subsystems in theelectrophysiology apparatus10. For example the monitoring electrode set44 contains a subset ofpassive electrodes48 which are connected to asignal conditioner50. The monitoring electrode set44 also contains a subset ofactive electrodes52 which are connected to asignal generator54 through aswitch59. Thesignal generator54 is controlled by thecomputer34. In operation, thesignal generator54 generates a burst of (4800 Hz for example) signals which are supplied to the active electrode set52. This energy sets up an electric field within theheart16 chamber. The electrical potentials present on the passive electrode set48 represent the summation of the underlying electrophysiological signals generated by the heart and the field induced by the burst. Thesignal conditioner50 separates these two components. The preferred technique is to separate the signals based upon their frequency.
• Thehigh pass section56 of the signal conditioner extracts the induced field signals as modulated by the blood volume and the changing position of thechamber walls125. First, the signals are amplified with a gain of approximately 500 frompassive electrodes48 withamplifier151. Next, the signals are high pass filtered at roughly 1200 Hz byfilter153. Then the 4800 Hz signal is extracted bydemodulator155. Finally, the individual signals are converted to digital format by the analog todigital converter157 before being sent to thecomputer34.
• Thelow pass section58 of thesignal conditioner50 extracts physiologic signals. First, signal drift is reduced with a 0.01 Hzhigh pass filter143. Next, aprogrammable gain amplifier145 amplifies the signals. Then a low pass filter147 removes extraneous high frequency noise and the signal from the induced field. Finally, the physiologic signals are converted to digital format by the analog to digital converter149 before being sent to thecomputer34.
• The therapy catheter electrode set46 includes at least onetherapy delivery electrode60, and preferably one ormore monitoring electrodes62, and one ormore locator electrodes68. Thetherapy delivery electrode60 cooperates with theground electrode70, which is generally a skin patch electrode, to deliver ablation energy to the heart. These electrodes are coupled to theablation energy generator38 which is shown as an RF current source. Alocator electrode68 is provided which is preferably proximate thedelivery electrode60, but can be a separate electrode site located near thedistal end24 of thetherapy catheter18. This electrode site is coupled with anactive electrode52 through aswitch59 to thesignal generator54. In use, the electric field coupled to thetherapy catheter18 permits the physician to track and visualize the location of thelocator electrode68 on thedisplay device36. The therapy catheter electrode set46 can also be used to monitor the physiologic signals generated at thechamber wall125 by a lowpass signal conditioner141 which is similar to thelow pass section58 of thesignal conditioner50. These digitized signals are then sent to thecomputer34.
• At least oneelectrode pair119 ofsurface electrodes40 are also coupled to thesignal generator54 throughswitch59. Eachelectrode89 and115 are placed opposite each other on the body surface with theheart16 in-between them. The induced field is sensed bypassive electrodes48 and conditioned by thehigh pass section56 of thesignal conditioner50. This field helps thecomputer34 align or orient thepassive electrodes48 to the body for better visualization of the heart on themonitor36.
• TheECG subsystem39 accepts signals from standardECG skin electrodes74. It also contains a low pass section similar to thelow pass section58 ofsignal conditioner50. In general, the passive electrode set48 and active electrode set52 will reside on a single catheter, however it should be recognized that other locations and geometries are suitable as well. Both basket and balloon devices are particularly well suited to this application.
• FIG. 3 shows an electrode configuration on aballoon catheter94 which has aninflatable balloon96 which underlies an array or set ofpassive electrodes48 typified bypassive electrode72. Thesepassive electrodes48 can be organized into rows, typified byrow123, and columns, typified bycolumn121. A pair ofactive excitation electrodes52 are typified byproximal electrode92 anddistal electrode98. Theballoon catheter94 configuration can be quite small in comparison with thebasket catheter80 configuration. This small size is desirable both for insertion into and for use in a beatingheart16.
• FIG. 3 also shows a movable, reference ortherapy catheter system18. This catheter is shown lying along theinterior surface125 of theheart16. A pair of electrodes shown asdelivery electrode60 andreference electrode62 are located a fixed distance apart on thecatheter body64. This auxiliary catheter may be used to supply ablation energy to the tissue during therapy. Thistherapy catheter18 may be used with either thebasket catheter80 configuration or theballoon catheter94 configuration.
• FIG. 4 shows an electrode configuration on abasket catheter80. The limbs of thebasket80, typified bylimb82 carry multiple passive electrode sites typified byelectrode84. A pair of active excitation electrodes are shown on thecentral shaft86 of thebasket80 as indicated byexcitation electrode88. Thebasket catheter80 electrodes lie gently against theinterior surface125 of theheart16 urged into position by the resilience of the limbs. Thebasket catheter80 permits unimpeded flow of blood through the heart during the mapping procedure which is very desirable. This form of catheter also places the electrodes into contact with theheart chamber wall125 for in-contact mapping of the physiologic potentials of theheart16.
• Returning toFIG. 1 andFIG. 2 these figures show one illustrative partitioning of system functions. In use, thesignal generator54 can generate a 4800 Hz sinusoidal signal burst on the active electrode set52 which creates an electric field in the heart. The changing position of thechamber walls125 and the amount of blood within the heart determines the signal strength present at thepassive electrode sites48. For purposes of this disclosure the chamber geometry is derived from the electric field as measured at thepassive electrode sites48 which may, or may not be in contact with thewalls125 of the heart. In the case of thebasket electrodes84 which lie on theheart surface125 the field strength is inversely proportional to the instantaneous physical wall location and the distance from theactive electrodes52 to these walls. In the case of the balloon catheter the potentials on the passive set ofelectrodes72 are related to the wall location, but a set of computationally intensive field equations must be solved to ascertain the position of the wall. In general, both the basket and balloon approach can be used to generate the dynamic representation of the wall surface.
• Thecomputer34 operates under the control of a stored program which implements several control functions and further displays data on adisplay device36. The principal software processes are the wall surface generation process (WSGP); the body orientation generation process (BOGP); the wall electrogram generation process (WEGP); the site electrogram generation process (SEGP); and the movable electrode location process (MELP).
Wall Surface Generation Process
• FIG. 5 is a flow chart describing the method used to generate the “wall surface” of the interior of theheart16. The step-wise processes are presented with certain physical parameters which are either known in advance by computation or are measured. This knowledge or information is shown inblock53, block55 andblock57. The WSGP process begins atblock41 with the insertion of themonitoring catheter14 in theheart16. Thiscatheter14 places an array ofelectrodes44 in aheart16 chamber. This array must have both passivemeasurement electrode sites48 and activeinterrogation electrode sites52 located in a known position. The process enters a measurement and display loop atblock43 where an interrogation pulse burst is generated by thesignal generator54 seen inFIG. 2. These pulses are generated first with the current source atsite92 and the current sink atsite98 and second with the current source atsite98 and the sink atsite92 as seen inFIG. 3. Atblock45 thesignal conditioner50 uses information on the frequency and timing of the interrogation current fromblock53 to demodulate the signals and analog to digital convert the signals received at thepassive measurement electrodes48. Atblock47 the information fromblock55 is used. This information includes both the current strength of the interrogation pulse and the location of the interrogation source and sink electrodes. Impedance is voltage divided by current. The voltage offset caused by the location of the current source can be reduced by the two measurements of opposite polarity. This information is used to determine the impedance which the chamber and the blood contained in that chamber imposes on the field generated by the interrogation current. The knowledge fromblock57 is used next.Block49 determines how the heart chamber tissue, which has roughly three times the impedance of blood, in combination with the type of electrode array affects the field generated by the interrogation electrodes.
• In a system as shown as the basket inFIG. 4 the blood effects the impedance directly as the field is propagated from the interrogation electrodes to the measurement electrodes. In general, if a point current course is used within a chamber the inverse of the measured voltage is proportional to the square root of the distance from the source. With the distance from eachelectrode84 to bothexcitation electrodes88 computed from the measured voltage and the known location of theelectrodes84 relative to each other, the locations of eachelectrode84 can be determined.
• In a system as shown inFIG. 3 the impedance of the field generated within the blood volume is modulated by the position of thewalls125, with their higher impedance, with respect to the location relative to the measurement electrodes. Using this knowledge and the measurements fromblock47 the distance from the interrogation electrodes to theheart chamber wall125 is determined at a point normal to the field generated by theactive interrogation electrodes52.
• Thepassive electrodes48 on theballoon catheter94 can be positioned inrows123 andcolumns121 with the columns in a line from the top of theballoon96 nearactive electrode92 to the bottom of theballoon96 nearactive electrode98. In a preferred embodiment three configurations are possible: 8 rows and 8 columns, 7 rows and 9 columns, and 6 rows and 10 columns. In each such embodiment the measurements from anyrow123 are treated independently. Using the 8 row, 8 column embodiment as an example, 8 measurements of distance are taken for any selected row of electrodes, giving a total of 64 measurements.
• FIG. 6 is a schematic drawing of the embodiment required to measure thedistance129 from thecentroid127 of theballoon96 through thepassive electrode131 to theheart chamber wall125. Thepassive electrode131 is one of eight electrodes on a row ofelectrodes123. Starting withelectrode131 and labeling it as electrode A, the other electrodes on therow123 are labeled B, C, D, E, F, G and H by proceeding around theballoon96 in a clockwise direction. The measurements of impedance “I” at these electrodes are thus labeled I_A, I_B, I_C, I_D, I_E, I_F, I_Gand I_H. To compute thedistance129 in the direction ofelectrode131 the following equation is computed:
• $\ln \left(D_A\right)=c0+c1*\ln \left(I_A\right)+c2*\ln \left(I_B\right)+c3*\ln \left(I_c\right)+c4*\ln \left(I_D\right)+c5*\ln \left(I_E\right)+c4*\ln \left(I_F\right)+c3*\ln \left(I_G\right)+c2*\ln \left(I_H\right)$
• where D_Ais the desireddistance129 and c0 through c5 are optimized parameters. A typical vector of these parameters is (c0, c1, c2, c3, c4, c5)=(3.26, −0.152, −0.124, −0.087, −0.078, −0.066).
• Once thedistance129 in the direction ofelectrode131 is determined then the computation can be redone by shifting this direction clockwise one electrode, relabeling electrodes A through H and solving the above equation again. Once the distances for this row ofelectrodes123 are determined then the next row distances are determined in the same way until the distances at all 64 electrodes are determined.
• Returning toFIG. 5, with multiple wall locations in space determined by this method, a model of thechamber wall125 shape can be created inblock51. Various techniques for creating a shape are possible, including cubic spline fits, and best fit of an ellipsoid. The positions of theactive electrodes52 and thepassive electrodes48 relative to theheart16 chamber walls are also determined at this point. The loop continues as the method moves back to block43. This loop continues at a rate fast enough to visualize the real-time wall motion of the heart chamber, at least at twenty times per second.
• There are numerous display formats or images which can be used to present the dynamic endocardial wall surface to the physician. It appears that one of the most useful is to unfold the endocardial surface and project it onto a plane. Wire grid shapes representing a perspective view of the interior of the heart chamber are useful as well. It appears that each individual physician will develop preferences with respect to preferred output image formats. In general, different views of the endocardial surface will be available or may be used for diagnosis of arrythmia and the delivery of therapy. One distinct advantage of the present invention is that the image of the heart wall is not static or artificial. In this system the image is a measured property of the heart wall, and is displayed in motion.
• FIG. 7 shows two separate frames of the dynamic representation of the heart wall.Wire frame71 shows the heart at systole whilewire frame73 shows the heart at diastole.Path arrow75 andpath arrow77 represent the dynamic cycling through several intermediate shapes between the systole and diastole representation. These views are useful as they indicate the mechanical pumping motion of the heart to the physician.
Body Orientation Generation Process
• FIG. 8 is a schematic drawing of the apparatus required to perform the body orientation generation process. It shows a patient12 with at least onepair119 ofskin electrodes40 attached to the body surface in a stationary position on the body and in a known configuration. These electrodes are typified byexample surface electrodes89 and115 each of which could be anECG electrode74, an RF generationcurrent sink electrode70, or another electrode specifically dedicated to the BOGP. Ideally,electrode89 and115 are opposite one another on the body with theheart16 directly in between them. This pair of electrodes is attached to thesignal generator54 through theswitch59 via anappropriate cable117. Thedistal end22 ofmonitoring catheter14 is situated in theheart16 where thepassive electrodes48 can measure the signals generated across theelectrode89 andelectrode115.
• FIG. 9 is a flow chart describing the method used to align the wall surface representation of the WSGP to the body orientation. The process begins atstep101 where themonitoring catheter14 with a set ofpassive electrodes48 is inserted intoheart16 chamber and a pair ofsurface electrodes119 are attached at a known position on thebody12. The process begins cycling atstep102 where thesignal generator54 generates a signal across theskin electrode89 andskin electrode115. Atstep103 the voltage created by thesignal generator54 is measured frompassive electrode48 by thehigh pass section56 of thesignal conditioner50 by using the information fromblock110 which includes the frequency and timing of the field generated by thesignal generator54. This voltage information is stored in an array “Y”.
• At step104 a regression analysis is performed which creates a vector which lines up with the field generated instep103. This regression method is the same whether a basket catheter as shown inFIG. 4 or a balloon catheter as shown inFIG. 3 is used. The location of each passive electrode48.is provided to the method byblock110. This information comes from different sources in each case however. In the case of abasket catheter80 these three dimensional electrode locations come from the WSGP. In the case of theballoon catheter94 these three dimensional electrode locations are known a priori. In each case they are saved in an array “X”. The regression to compute the orientation vector uses the standard regression equation for the computation of a slope:
• 
  b=Σxy/Σx²
• where “X” is the array of electrode locations, “Y” is the array of measured voltages and “b” is the orientation vector. If more than one pair of skin electrodes are used then an orthogonal set of orientation vectors can be created and any rotation of themonitoring catheter14 relative to thebody12 can be detected.
• Instep105 the information on the location of thechamber walls125 from theWSGP109 can be used to create a three dimensional model of theheart16 chamber as seen inFIG. 7. By combining this model with the computed orientation fromstep104 and the known location of theskin electrodes108 this representation can be shown in a known orientation relative to the body instep106. In step107 a specific orientation such as typical radiological orientations RAO (right anterior oblique), LAO (left anterior oblique), or AP (anterior/posterior) can be presented. By repeatedly showing this view a dynamic representation can be presented which matches the view shown on a standard fluoroscopic display. Thus such an image can be presented without the need for using ionizing radiation.
Wall Electrogram Generation Process
• FIG. 10 is a flow chart describing the wall electrogram generation process (WEGP). This process begins atblock61 when amonitoring catheter14 with an array ofpassive measurement electrodes48 is placed in aheart chamber16 and deployed. The process enters a loop atblock63. The frequency of the interrogation pulses generated by thesignal generator54 is provided byblock85. With this knowledge the lowpass filter section58 of thesignal conditioner50 measures the voltage at frequencies lower than the generated interrogation pulses. Typically the highest frequency of the biopotentials is 100 Hz but can be as high as 250 Hz.
• In the case of a basket system as seen inFIG. 4 the measurements are contact voltages from thechamber wall125 tissue contacting theelectrodes84.
• In the case of a balloon system as seen inFIG. 3 the measurements are measurements of the field generated throughout the blood volume by the tissue on thechamber wall125. Atstep65, a model of the array boundary and thechamber wall125 boundary is created from the information inblock87. This information includes the location of thepassive electrodes48 on the array and thechamber wall125 locations from the WSGP.
• In the case of a basket system as seen inFIG. 4, the array boundary and thechamber wall125 boundary are the same since they are in contact. The locations are determined in three-dimensional space of the sites on the chamber wall where potentials are measured.
• In the case of the balloon system as seen inFIG. 3, the array boundary and thechamber wall125 boundary are different. Duringstep65, locations are generated in three-dimensional space of the sites on the chamber wall where potentials are to be determined.
• Atstep66, the potentials are projected on to the sites on the chamber wall specified instep65. In the case of a basket system as seen inFIG. 4, the measured potentials are assigned to these sites.
• In case of a balloon system as seen inFIG. 3, a three dimensional technique such as those typically used in field theory is used to generate a representation of the three dimensional field gradients in the blood volume of the heart chamber. Two examples of appropriate techniques are a spherical harmonics solution to Laplace's equation, and boundary element analysis. A more detailed description of spherical harmonics is given in the parent disclosure which is incorporated by reference herein.
• For the boundary element method in the mapping system of the invention, the voltage is measured at thepassive electrodes48 on the probe orballoon catheter94. From the voltage at the electrodes on the probe and the knowledge that the probe is nonconducting, the voltage and normal current at a previously selected set of nodes on theendocardial surface125 are determined by the boundary element method in the following manner.
• It is known that the voltage in the blood pool between the probe and the endocardium satisfies Laplace's equation that states that the net current flow across any specific boundary is zero. To find the voltage and/or normal current on the endocardium, one must find the solution of Laplace's equation in the blood pool and calculate the values of this solution on the endocardium. Standard finite element and finite difference methods can be used to find the solution to Laplace's equation, but they have large computational overhead for generating and keeping track of a three-dimensional grid in the whole blood pool. In the mapping system of the invention, Laplace's equation is solved by the boundary element method, a specialized finite element method that permits one to restrict the calculations to the two-dimensional probe and endocardial surfaces (and not have to deal with calculations over the blood pool between these two surfaces). In order to create an accurate map of the endocardial voltage and/or normal current based on the voltage information from a limited number of electrodes on the probe, the system uses a higher-order version of the boundary element method. This system currently uses bicubic splines to represent the probe and endocardial surfaces and bilinear elements and bicubic splines to represent the voltage and the normal current on these surfaces.
• The boundary element method consists of creating and solving a set of linear equations for the voltage and the normal current on the endocardium based on the voltage measurements at the electrodes on the probe. Each of the elements in the matrices that are involved in this set consists of two-dimensional integrals, which are calculated by numerical and analytical integration.
• Using Laplace's equation with data given on the probe is a so-called “ill-posed” problem. For such problems, all solution procedures, including the boundary element method, are ill conditioned, that is, small errors in the measured voltage on the probe surface can result in large errors in the calculated voltage and/or normal current on the endocardium. To minimize the errors on the endocardium, options for regularization or constraints have been included in the software code. For example: the user can choose parameters that cause the code to add equations for known or expected values of the voltage and/or normal current on the endocardium. This capability is often but not exclusively used to add equations that take into account the voltage and/or normal current of the map of the previous instant(s) in time (the previous “frame(s)”). This process uses historical data from the previous frame to constrain the values subsequently computed.
• The solution of the set of the boundary element equations and regularizing equations (if any) is normally accomplished by singular value decomposition but there is an option to solve the linear system by decomposition (Gaussian elimination) or direct or inherent methods. When singular value decomposition is used, there is an option to turn off the influence of high-frequency errors (that is, do a type of regularization) by setting various small singular values to zero, the result of which can be an increase in the accuracy of the calculated voltage and normal current on the endocardium.
• Inblock67, a large number of points are calculated on the three-dimensional chamber surface125. In the case of a basket catheter as seen inFIG. 4, this is done through interpolation using bilinear or bicubic splines. In the case of a balloon catheter as seen inFIG. 3, this can be done either by using the model, such as the boundary element method or spherical harmonics to generate more points. Alternatively, bilinear or bicubic splines can be used to interpolate between a smaller number of points.
• In block69 a representation of the electrical potentials on thesurface125 are used to display the patterns. These types of displays include color maps, maps of iso-potential lines, maps of potential gradient lines and others. The electro-physiologic information is reconstructed on thedynamic wall surface125. In general the measured electrical activity is positioned by the WSGP at the exact location which gives rise to the activity. The high resolution of the system creates an enormous amount of information to display. Several techniques may be used to display this information to the physician. For example the electrogram data can be shown in false color gray-scale on a two dimensional wall surface representation. In this instance areas of equal potential areas are shown in the same color. Also a vectorized display of data can be shown on a wire grid as shown inFIG. 11 where the distance between any two dots typified bydot pair91 and93 represent a fixed potential difference. The more active electrical areas show clusters of dots. In a dynamic display the dot movement highlights areas of greater electrical activity. InFIG. 12 gradient lines typified byline135 represent the change in potential over the chamber wall surface. Those areas with the largest change per unit area have the longest gradient lines oriented in the direction of steepest change. InFIG. 13 iso-potential lines typified byline95 represent equal electrical potential. In this representation the closeness of lines represents more active electrical areas.
Site Electrogram Generation Process
• FIG. 14 is a flow chart of the site electrogram generation process (SEGP). This process is used to extract and display a time series representation of the electrical activity at a physician selected site.FIG. 13 shows asite97 that has been selected and atime series electrogram99 is shown on thedisplay device36 along with the dynamic wall representation. Returning toFIG. 14 this process begins atblock76 when a catheter with an array with bothpassive measurement electrodes48 andactive electrodes52 is placed in a heart chamber and deployed. The process enters a loop at78. The inputs to the method include the wall locations fromblock37. Then thewall electrogram generator35 provides the electrical potentials on this surface at79. The user will use thedisplay36 to determine a location of interest inblock33 which will then be marked on thedisplay device36 atstep81. The voltage from this location will be collected atblock83. This voltage will be plotted in a wave-form representation99 inblock31. The loop continues at this point at a rate sufficient to display all of the frequencies of such atime series electrogram99, at least 300 points per second.
• The false color and vectorized display images may direct the physician to specific sites on the endocardial surface for further exploration. The system may allow the physician to “zoom” in on an area to show the electrical activity in greater detail. Also the physician may select a site on theendocardial wall125 and display a traditionaltime series electrogram99 originating at that site.
Movable Electrode Location Process
• FIG. 15 is a flow-chart of the movable electrode location process (MELP). It begins atblock11 when a catheter with an array ofpassive measurement electrodes48 andactive electrodes52 is placed in aheart16 chamber and deployed. At block13 asecond catheter18 with at least one electrode is introduced into the same chamber. The process enters a loop atblock15 where thesignal generator54 generates a carrier current between themovable location electrode68 and anactive electrode52. Atblock17 thehigh pass section56 ofsignal conditioner50, using the frequency and timing information of the location signal fromblock29, produces measured voltages from thepassive measurement electrodes48. Atblock19 the information fromblock27 is used to determine the location of theelectrode68 where the location current is generated. This information includes the strength of the generated location current, the impedances of blood and tissue, the location of theactive electrode52 in use and the location of all thepassive measurement electrodes48. One method for using this information would entail performing a three dimensional triangulation of the point source location signal using four orthogonalpassive electrode48 sites. The implementation ofstep19 is the same both for the case of a basket system as seen inFIG. 3 and for the case of a balloon system as seen inFIG. 4. In this preferred implementation, two data sets are acquired closely spaced in time such that they are effectively instantaneous relative to the speed of cardiac mechanical activity. Alternatively, the data sets could be acquired simultaneously, by driving signals at two different frequencies, and separating them electronically by well known filtering means.
• The first data set is acquired by driving the current carrier from thelocation electrode68 to a first sink or active electrode as typified byelectrode98. This electrode is at a known location on the body of themonitoring catheter14 relative to the array ofpassive electrodes48. The location of this first sink electrode is ideally displaced distally from thecentroid127 of the array of electrodes by at least 25 millimeters. A second data set is then acquired by driving the current from thelocation electrode68 to a secondactive electrode92, located ideally at least 25 millimeters proximally from thecentroid127 of the array of electrodes.
• The location algorithm is performed by minimizing the following equation:
• $\sum _{i=1}^n{\left(\frac{k}{{\left({\stackrel{->}{R}}_i-{\stackrel{->}{R}}_L\right)}^{0.5}}-v_{{\mathrm{pi}}_1}-b_1-\frac{k}{{\left({\stackrel{->}{R}}_i-{\stackrel{->}{R}}_{S_1}\right)}^{0.5}}\right)}^2+{\left(\frac{k}{{\left({\stackrel{->}{R}}_i-{\stackrel{->}{R}}_L\right)}^{0.5}}-v_{{\mathrm{pi}}_2}-b_2-\frac{k}{{\left({\stackrel{->}{R}}_i-{\stackrel{->}{R}}_{S_2}\right)}^{0.5}}\right)}^2$
• Where n is the number of array electrodes, where k, b₁and b₂are fitting parameters, V_piare the potentials measured from each i^thelectrode72, R_iis a vector from the origin (centroid of the array of electrodes96) to the i^thprobe electrode72, R_Lis the “location vector”, or three dimensional location to be solved for in the minimization, and R_s1, R_s2are the location vectors of the active sink electrodes (eg.92 and98) which are known at locations on the axis of the array ofpassive electrodes48.
• Additional data sets could be incorporated, following the same logic as above. Each additional squared parenthetical term requires the probe data set Vpi, another ‘b’ fitting term, and the particularactive sink electrode52 vector R_sused during the acquisition of that data set. If thesink electrode52 is far enough away, for example using a right leg patch electrode, the fourth term in the squared expression for that data set may be deleted as R_sbecomes very large.
• It is also noted that the method does not require two data sets. The first squared expression in the above expression (requiring only data set V_pi1) may be sufficiently accurate.
• The non-linear least squares minimization may be performed on the above summation by any of several well-known methods. The Levenberg-Marquardt method has been used in practice to accomplish this with efficient and robust results. Nominal values for k and b are 70 and 0 respectively, when normalizing the potential values obtained as if the current source were 1 ampere. The number of parameters in the minimization for the above expression are six: k, b₁, b₂, and the x, y, and z coordinates of vector R_L(assuming a Cartesian coordinate system with origin at the center of the array of electrodes96).
• At step21 a model of theheart16 chamber wall is generated from the information provided from theWSGP25. Such a model can be represented on adisplay36 in a manner typified inFIG. 6. Once this surface is rendered, within this surface a second figure representing the distal end of themonitoring catheter14 can be presented. In this way, the full three dimensional geometry of the chamber and the array catheter can be presented.
• Instep23 this geometry is updated repeatedly to provide a dynamic view of the chamber, the monitoringcatheter18, along with a representation of thedistal end24 of thetherapy catheter18. If this is then combined with the electrical potentials generated by the WEGP, the therapy catheter can be moved to an electrical site of interest represented by a point in three dimensional space.
Calibration Process
• Calibration of the system to insure that physical dimensions are accurately scaled is not a necessity for use of the system in a diagnostic or therapeutic setting. However, the availability of heart geometry in real time can permit various hemodynamic measurements to be made and displayed to the physician as well. These measurements include systolic time intervals, stroke volume and cardiac output. Calibration, where desired, requires at least twoelectrodes60 and62 a known distance apart placed along the inner-surface of theheart chamber16, as shown inFIG. 3. In general the two electrode sites will each be coupled to thelocation signal generator54. The MELP ofFIG. 15 can be calibrated by scaling thecalculations50 the distance between computed locations match the known distance apart of the twoelectrodes60 and62. Since theelectrodes60 and62 are positioned on thechamber wall125, the WSGP ofFIG. 5 can be calibrated by scaling the distance measured by the WSGP in the direction ofelectrodes60 and62 to the calibrated distances measured by MELP. Finally, since the electrodes are contacting the chamber wall and providing electrograms, the WEGP ofFIG. 10 and SEGP ofFIG. 14 can be calibrated to those measurements by computing the voltages at the same locations on thechamber wall125 whereelectrodes60 and62 are located. These computed voltages can then be scaled to match the physically measured voltages fromelectrodes60 and62.
Therapy Catheter
• FIG. 16 is a schematic diagram of the therapy catheter system. Thetherapy catheter18 has both adistal end24 and aproximal end26. Ahandle163 is on theproximal end26 which allows the user to manipulate thedistal end24 and position it in theheart16. Referring toFIG. 1, this handle also permits thetherapy catheter18 to connect to theinterface system28 of theelectrophysiologic apparatus10 through thecable32. The location current is generated by thesignal generator54 through theswitch59 and subsequently through thewire177 ofcable32 which is connected directly to thelocator electrode68. The therapy catheter system also includes atherapy generator38 which is connected to the therapy catheter handle163 viatherapy supply line161. Thetherapy supply line161 extends through thehandle163, through thecatheter body64, to thetherapy deployment apparatus60 at thedistal end24 of the catheter. Thelocator electrode68 is in close proximity to thetherapy deployment apparatus60 in order to determine its location within theheart16.
• FIG. 17 shows an embodiment of thetherapy catheter18 using laser energy to supply the therapy. Thislaser catheter165 includes thelocation wire177 which connects theinterface system28 to thelocator electrode68 at the catheter'sdistal end24. In this instance thetherapy supply line161 is afiber optic cable167 and thetherapy deployment apparatus60 is afiber optic terminator169 which directs the laser energy to the site of therapy delivery.
• FIG. 18 shows an embodiment of thetherapy catheter18 using microwave energy to supply the therapy. Thismicrowave catheter171 includes thelocation wire177 which connects theinterface system28 to thelocator electrode68 at the catheter'sdistal end24. In this instance thetherapy supply line161 is amicrowave wave guide173 and thetherapy deployment apparatus60 is amicrowave emitter175 which directs the microwave energy to the site of therapy delivery.
• FIG. 19 shows an embodiment of thetherapy catheter18 using a chemical to supply the therapy. This chemical delivercatheter181 includes thelocation wire177 which connects theinterface system28 to thelocator electrode68 at the catheter'sdistal end24. In this instance thetherapy supply line161 is a chemical filledlumen183. This lumen extends to thedistal end24 of thechemical delivery catheter181 where aneedle185 is used to infuse the chemical into theheart chamber wall125. During introduction of thechemical delivery catheter181 into the heart chamber theneedle185 is withdrawn into the catheter body throughwithdrawal action187. Once the location of thedistal end24 is determined to be at the site of interest thechemical delivery needle185 can be deployed through the reverse ofwithdrawal action187. Potential chemicals to be used in the therapeutic delivery process include formaldehyde and alcohol.
• Each of thetherapy catheters18 shown inFIG. 17 throughFIG. 19 as well as the radio frequency catheter shown inFIG. 2 can be miniaturized and inserted into the coronary arterial tree. The location signal generated atlocator electrode68 can still be sensed by thepassive electrodes48 even though the signal is coming from the epicardium of theheart16 rather than from within the heart chamber. Thus the movable electrode location process ofFIG. 15 can be used in this instance to help determine the location of thedistal end24 of thetherapy catheter18 in the coronary arterial tree and whether it is close to a site of abnormal electrical activity. Assuming that a site of ischemia will commonly be a site of abnormal electrical activity, the MELP will also enable more rapid location of potential sites for angioplasty.
• FIG. 20 shows an embodiment of thetherapy catheter18 using balloon inflation to supply the therapy. Thisangioplasty catheter191 includes thelocation wire177 which connects theinterface system28 to thelocator electrode68 at the catheter'sdistal end24. In this instance thetherapy supply line161 is an inflationmedia supply lumen193 and thetherapy deployment apparatus60 is anangioplasty balloon195. In use, a site of interest would be determined after viewing the wall electrogram generated by the WEGP ofFIG. 10. Next theangioplasty therapy catheter191 would be positioned in the coronary arterial tree and its position determined relative to the site of interest. Next, when thedistal end24 of theangioplasty catheter191 was at the proper location theballoon195 would be deployed to open the artery. Finally, the electrical activity of the site would be reviewed to determine whether theunderlying tissue125 was now receiving a proper blood supply and thus was no longer electrically abnormal.

Claims (19)

1-3. (canceled)

4. A catheter assembly for mapping the electrical activity of a heart chamber, comprising:

a lead body having a proximal end and a distal end for insertion into the heart chamber; and

a deployable array of electrodes located at the distal end of the lead body, wherein the deployable array includes a plurality of limbs, each limb carrying one or more electrodes adapted to measure voltage on a surface of the heart chamber.

5. The catheter assembly ofclaim 4, wherein the deployable array further includes at least one active electrode.

6. The catheter assembly ofclaim 4, wherein each limb carries two electrodes.

7. The catheter assembly ofclaim 6, wherein at least one electrode on each limb is a ring electrode.

8. The catheter assembly ofclaim 4, further comprising:

a handle coupled to the proximal end of the lead body, wherein the handle is configured to manipulate the position of the deployable array of electrodes.

9. The catheter assembly ofclaim 4 wherein at least one electrode is a passive electrode.

10. The catheter assembly ofclaim 9, wherein each passive electrode is configured to sense electrophysiological data.

11. The catheter assembly ofclaim 10, wherein each passive electrode is configured to sense an impedance.

12. The catheter assembly ofclaim 4, wherein the each of the plurality of limbs is connected to the distal end of the lead body at a proximal end of the limb.

13. The catheter assembly ofclaim 12, wherein the limbs in the plurality of limbs are connected at a distal end of the plurality of limbs.

14. A method for mapping electrical activity in a heart chamber, comprising:

inserting a catheter having a plurality of limbs into the heart chamber;

deploying the limbs of the catheter to place a plurality of passive electrodes onto a surface of the heart chamber;

determining the position of the plurality of electrodes;

measuring electrical activity on the surface of the heart chamber using the plurality of electrodes; and

creating a electrophysiologic map of the measured electrical activity.

15. The method ofclaim 14, wherein the deploying step further comprises deploying an active electrode into the heart chamber.

16. The method ofclaim 14, wherein the deploying step further comprises deploying the limbs of the catheter to place a plurality of passive electrodes at precisely spaced intervals onto the surface of the heart chamber.

17. The method ofclaim 14, wherein the measuring step further comprises receiving electrophysiological data from the surface of the heart chamber.

18. The method ofclaim 17, wherein the measuring step further comprises measuring an impedance at the surface of the heart chamber.

19. The method ofclaim 14, wherein the deploying step further comprises deploying the limbs of the catheter such that the limbs are connected at a proximal end of the plurality of limbs.

20. The method ofclaim 19, wherein the deploying step further comprises deploying the limbs of the catheter such that the limbs are connected at a distal end of the plurality of limbs.

21. The method ofclaim 14, wherein the creating step further comprises creating a three-dimensional dynamic electrophysiologic map of the measured electrical activity.

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