WO1996000041A1

WO1996000041A1 - Cardiac tissue ablation device

Info

Publication number: WO1996000041A1
Application number: PCT/US1995/007997
Authority: WO
Inventors: Stuart D. Edwards; Hugh R. Sharkey
Original assignee: Edwards Stuart D; Sharkey Hugh R
Priority date: 1994-06-24
Filing date: 1995-06-23
Publication date: 1996-01-04
Also published as: AU2871795A; US5681308A; US5769846A

Abstract

A device is provided for ablating tissue within a cavity of the heart using RF energy. The device may also be used to treat a variety of other tissue cavities. The ablation device includes an intracavity member such as an inflatable balloon (herein after balloon), a cavity filling member such as a foam rubber (herein after foam rubber) surrounding the intracavity member, and an electrode. The balloon assists in the placement of the foam rubber in contact with the tissue within the cavity being treated. The balloon is preferably shaped to enable the foam rubber to conform to the contours of the tissue cavity being treated. The foam rubber surrounds the balloon and is designed to receive a medium which inflates the foam rubber about the balloon such that the foam rubber closely conform to the cavity being treated. The foam rubber may be used to deliver therapeutic and diagnostic agents. These agents may be delivered throughout the foam rubber. Alternatively, the therapeutic and/or diagnostic agents may be selectively delivered to specific portions of the foam rubber and hence to specific sections of tissue surrounding the foam rubber. The electrode serves to deliver RF energy to the interior tissue layers of the cavity being treated. The electrode may be positioned on the exterior surface of the foam rubber such that it contacts the tissue. Alternatively, the electrode may be positioned within the wall of the foam rubber or on the interior surface of the foam rubber. Preferably however, the electrode is positioned within the foam rubber, for example, on the surface of the balloon, such that RF energy is conducted to the tissue through the electrolytic solution positioned between the balloon and the foam rubber.

Description

CARDIAC TISSUE ABLATION DEVICE

BACKGROUND OF THE INVENTION Relationship to Copendinα Application

This application is a continuation-in-part of U.S. Patent Application Serial No. 08/426,614, entitled "ABLATION APPARATUS FOR CARDIAC CHAMBERS" by Edwards, et al., filed April 21 , 1995, which is a continuation-in-part of U.S. Patent application Serial No. 08/345,142 entitled "Ablation Apparatus For Cardiac Chambers" by Edwards filed November 28, 1994, which is a continuation-in-part of U.S. Patent Application Serial No. 08/319,373 entitled "Thin Layer Ablation Apparatus" by Baker et al, filed October 6, 1994, which is a continuation-in-part of U.S. Patent Application Serial No. 08/286,862 entitled "Thin Layer Ablation

Apparatus" by Edwards et al, filed August 4, 1994, which is a continuation- in-part of U.S. Patent Application Serial No. 08/286,862 entitled 'Thin Layer Ablation Apparatus" by Edwards et al, filed August 4, 1994, which is a continuation-in-part of U.S. Patent Application Serial No. 08/272,162 entitled "Thin Layer Ablation Apparatus" by Edwards, et al, filed July 7,

1994, which is a continuation-in-part of U.S. Patent Application Serial No. 08/265,459 entitled 'Thin Layer Ablation Apparatus" by Edwards, filed June 24, 1994, each of which are incorporated herein by reference.

Field of the Invention

This invention relates generally to devices for mapping and ablating tissue lining the interior of a tissue cavity. More specifically, this invention relates to devices for ablating and mapping the tissue lining the interior of tissue cavities of the heart. Description of Related Art

There are a number of organs and lumens in the body which form cavities. Examples of such organs include, but are not limited to the heart, bladder, colon, stomach, intestines, nasal passages, and lungs. On occasion, tissue in these cavities develop abnormal conditions requiring treatment. Traditional methods for treating these abnormal conditions have included drug therapy, surgical removal of the body organ or lumen to treat the abnormal condition, the use of lasers, and the application of a thermal source. In the case of heart tissue abnormalities, traditional drug therapy is not always sufficient to correct the abnormality. Due to the critical function of the heart, surgical removal and replacement of the heart is impractical except for the few morbid patients with no alternative.

Ventricular arrhythmias represent a particularly common heart tissue abnormality for which an improved method of treatment is needed. In general, ventricular arrhythmias are caused by irregularities in the generation and conduction of electrical impulses used to control the contraction of heart muscles.

The Sino Atrial ("SA") node provides impulses which control the normal rhythmic contractions of the heart atria and the ventricles. This involves the transmission of the normal cardiac conduction pathways in the atria and the ventricles, which cause the heart to contract and relax in an orderly sequence at a rate set by the SA node.

A depolarization impulse begins with the SA node and spreads as an electrical wave in the SA node in the right atrium to the left atrium and down toward the lower chambers of the heart. At the junction of the atria and the ventricles there is another node known as the atrioventricular (AV) node. The impulse is conducted through the AV node in a slower fashion so as to coordinate the mechanical function of the atria and ventricles. The impulse continues to a common pathway, known as the Bundle of HIS between the right and left ventricles, and then into the Purkinje system and into multiple paths, the right and left bundle branches, each bundle branch supplying one ventricle. Each bundle branch divides into an extensive network of finer paths of conducting tissue, which spread from the inner to the outer surfaces of the heart and are referred to as the Purkinje fibers.

These fibers conduct the depolarization impulse into all portions of the ventricular myocardium.

As long as this depolarization impulse system is intact, impulses are transmitted normally and the normal sinus rhythm is maintained. Sometimes there are variations from the normal rhythm of the heart beat which are manifested as abnormal spontaneous contractions or as rapid sequences of impulses that dangerously speed the heart rhythm (tachycardia), or the heart rate may slow below normal (bradycardia) which can also compromise the individual. These abnormalities are clinically referred to as arrhythmias and can cause numerous unwanted and potentially dangerous complications for patients.

An arrhythmogenic focus that may initiate a tachyrhythmia is most often located in the endocardium or the interior surface of the heart. Since heart muscle contractions result from the progression of an excitation wave of electrical impulses. The location of an arrhythmogenic focus is accomplished by identifying the point from where the abnormal excitation wave originates by the use of intra-cardiac mapping.

Ventricular tachycardia (VT) and other ventricular arrhythmias, have been treated with a number of drugs such as lidocaine, quinidine, amiodarone and procainamide. Beta blocking drugs have also been used.

Certain surgical procedures have been used to ablate the foci of arrhythmias in either the atria or the ventricles, when drug therapy has been ineffective in preventing tachyrhythmias.

One surgical approach involves a thoracotomy with an incision through the pericardium and heart muscle. The arrhythmogenic focus is located, frozen and surgically removed. The surgical procedure utilizes either a hand held electrical mapping probe or a computerized array of electrodes that are placed on the endocardium (inner wall) or the epicardium (outside wall) of the heart, which acquire electrical activation data to identify the site of origin of the arrhythmia. Less traumatic solutions have also been developed.

Various types of intervention catheters have been developed and used for diagnosis and treatment of a number of cardiac abnormalities to avoid the trauma of open heart surgery, which requires a prolonged period of hospitalization and recuperation. In percutaneous catheter procedures, a catheter with recording electrodes is positioned in the heart under fluoroscopic guidance. Following acquisition of the electrical activation data, ablation energy is then delivered via the catheters either in a radiology suite or in the cardiac catheterization lab. Catheters have been proposed to map arrhythmogenic foci, as disclosed in U.S. Patents: 5,156,151; 5,255,697; 5,228,442; 5,263,493 and 5,279,299. However, these catheters fail to provide for the identification, isolation and quick instruction to treat an arrhythmogenic focus. The successful use of radio frequency (RF) energy to eliminate VT requires an accurate "pace map" of the earliest local activation from a catheter in contact with the endocardium.

For patients with coronary artery disease, failure to eliminate VT using RF energy delivered through a catheter has been hypothesized to be due to the small size and shallow depth of the lesion created by RF energy, preventing it from reaching subendocardial (or deeper) regions of the heart.

Additional contributing factors may also include inaccurate mapping in scarred ventricles or a location of the arrhythmogenic focus at sites below the surface of the endocardium. Direct current and RF energy have been utilized in these attempts. There has been successful elimination of idiopathic VT that originates in the right ventricle. This type of VT is usually found in patients without structural heart disease and is generally eliminated by direct current countershocks. However, complications such as barotrauma and risk of ventricular perforation associated with direct current countershocks make this technique less desirable unless very low energies are used.

Most of the work to date relating to the treatment of heart tissue abnormalities has focused on treating ventricular tissue abnormalities. However, a need also exists for devices and methods for treating atrial heart tissue abnormalities.

In order to treat heart tissue abnormalities, a device is needed which can be inserted into a heart chamber where it expands from a folded configuration to conform to the contours of the particular heart chamber. A need also exists for a device which can identify the heart tissue abnormality, such as an arrhythmogenic foci, and deliver energy to the abnormal tissue site for treatment.

With regard to treating arrhythmogenic foci, there is a need for a device which can be placed in intimate contact with the surface of the endocardium so that the arrhythmogenic focus may be treated transmurally. A need also exists for a device which provides ablation depths suitable to effectively treat arrhythmogenic foci, including an ability to reach the subendocardial or deeper region of the heart.

It would be desirable to provide an ablation device which is inserted into a heart chamber, such as an atrium which expands from a folded configuration, identifies and localizes the arrhythmogenic focus and then quickly instructs an energy delivery source to treat the arrhythmogenic focus. There is a need to treat arrhythmogenic foci deep in the endocardium with a system that can be in intimate contact with the irregular surface of the endocardium. It would be desirable to provide a cardiac ablation device which provides ablation depths suitable to effectively treat arrhythmogenic foci (transmurally across the muscular wall of the heart), including the ability to reach the subendocardial and deeper regions of the heart.

Accordingly, an object of the present invention is to provide a cardiac ablation device which provides a plurality of RF electrode segments for the controlled ablation of the endocardium and transmural regions of the heart muscle.

Another object of the present invention is to provide a cardiac ablation device which provides an expandable member that can simultaneously address the entire surface of a chamber while enabling blood or another bodily fluids which normally flow through the chamber to continue to traverse the chamber.

A further object of the present invention is to provide a cardiac ablation device which positions one or more RF electrodes in a spaced apart relationship to the tissue so that the tissue is ablated without intimate contact between the electrodes and the tissue being treated.

Yet another object of the present invention is to provide a cardiac ablation device which employs an electrolytic solution delivered to the endocardium that acts as a part of the RF circuit. Another object of the invention is to provide a cardiac ablation device which includes a cavity filling member, intracavity member and electrodes positioned on an outside surface of the intracavity member.

Still another object of the invention is to provide a cardiac ablation device which includes a cavity filling member, an intracavity member, RF electrodes positioned on at outside surface of the intracavity member, and a plurality of recording electrodes positioned on an exterior surface of the cavity filling member.

A further object of the invention is to provide a cardiac ablation device which provides a flexible circuit of RF electrodes with segments that can be multiplexed to provide tailored areas of ablation. Yet another object of the present invention is to provide a cardiac ablation and mapping device that includes a cavity filling member in direct contact with the endocardium, and resources to map the heart in order to determine the origin of the arrhythmia by identifying the location of endocardial activation and then to ablate an arrhythmogenic focus using an electrolytic solution to convey the RF energy.

SUMMARY OF THE INVENTION The present invention relates to a device for ablating tissue within a cavity of the heart using RF energy. The device of the present invention may also be used to treat a variety of other tissue cavities. The ablation device of the present invention generally includes an intracavity member, a cavity filling member surrounding the intracavity member, and an electrode. The intracavity member assists in the placement of the cavity filling member in contact with tissue interior to the cavity being treated. The intracavity member is preferably shaped to enable the cavity filling member to conform to the contours of the tissue cavity being treated.

The intracavity member may have a fixed shape, for example corresponding to the cavity to be treated. Preferably, however, the intracavity member is expandable and contractable in order to facilitate the delivery and removal of the device from the tissue cavity being treated. The intracavity member may be elastic or inelastic. For applications such as the treatment of heart tissue where there is a need to maintain the fluid flow through the tissue cavity, the intracavity member preferably includes an inner lumenal member. The inner lumenal member has a lumen which permits fluid, such as blood, to flow uninterrupted through the tissue cavity when the device is positioned in the cavity being treated.

A cavity filling member surrounds the intracavity member and is designed to be inflated about intracavity member such that the cavity filling member closely conforms to the cavity being treated. The cavity filing member may be permeable or impermeable and may be elastic or inelastic. In a preferred embodiment, the cavity filling member is formed of a microporous membrane which is inflated about the intracavity member using a fluid introduced between the intracavity member and the cavity filling member. The cavity filling member may be used to deliver therapeutic and diagnostic agents. These agents may be delivered throughout the cavity filling member. Alternatively, the therapeutic and/or diagnostic agents may be selectively delivered to specific portions of the cavity filling member and hence to specific sections of tissue surrounding the cavity filling member.

An electrode serves to deliver RF energy to the interior tissue layers of the cavity being treated. The electrode may be positioned on the exterior surface of the cavity filling member such that it contacts the tissue. Alternatively, the electrode may be positioned within the wall of the cavity filling member or on the interior surface of the cavity filling member. Preferably however, the electrode is positioned within the cavity filling member, for example, on the surface of the intracavity member, such that RF energy is conducted to the tissue through the an electrolytic solution positioned between the intracavity member and the cavity filling member which is used to inflate the cavity filling member.

The electrode may be configured to provide a variety of ablation patterns. The ablation pattern formed by the electrode may be patterned, segmented, full dimension and/or combinations thereof. A patterned ablation pattern refers to ablation patterns where a series of smaller areas of tissue are ablated. A segmented ablation pattern is intended to refer to a continuous area of ablated tissue. A full dimension ablation pattern is intended to refer to the ablation of the substantially the entire tissue cavity.

The ablation device may include electrical resources for acquiring electrical or thermal data from the tissue being treated. A variety of visualization markers may also be incorporated into the intracavity member and/or cavity filling member which enable one to detect the position of the ablation device in the tissue cavity being treated.

With regard to the deployment and removal of the ablation device from the tissue cavity being treated, it is generally preferred that the intracavity member be expandable and collapsible, particularly when the device is delivered percutaneously.

DESCRIPTION OF THE DRAWINGS Figures 1A-D illustrate mechanisms for expanding the intracavity member.

Figure 1 A illustrates control wires attached to the intracavity member to expand and collapse the member.

Figure 1B illustrates an expansion member positioned within the intracavity member having a plurality of radially extendable arms.

Figure 1C illustrates a mechanism for expanding the intracavity member in which the cavity filing member and the intracavity member are attached at one or more points.

Figure 1 D illustrates a device including the expansion mechanism illustrated in Figure 1C.

Figures 2A-D illustrate a variety of approaches for enabling the intracavity member and cavity filling member to be collapsed.

Figure 2A illustrates a the intracavity member as including a tether enabling the intracavity member to be retracted into a catheter. Figure 2A also illustrates the cavity filling member as including a scored break point such that retraction of the cavity filling member into the lumen of a catheter causes the cavity filling member to be ruptured, thereby causing fluid held within the cavity filling member to be released. Figure 2B illustrates a pointed implement for piercing the cavity filling member such that retraction of the cavity filling member into a catheter causes fluid in the cavity filling member to be expelled.

Figure 2C illustrates the ablation device as including a suction source for withdrawing fluid held between the cavity filling member and the intracavity member.

Figure 2D illustrates the lumen of a catheter including a spiral groove such that retraction of the intracavity member and cavity filling member into the catheter lumen causes the cavity filling member to be twisted as it is retracted along the spiral groove.

Figure 3 is a perspective view of the cardiac ablation and mapping device of the invention illustrating the creation of ablation zones suitable for the "MAZE" procedure. An ablation MAZE is illustrated.

Figure 4 is a cross-sectional view of the ablation and mapping device of Figure 3.

Figure 5 is a perspective view of an exterior wall of the inner lumenal member of the invention with the electrodes positioned on the exterior wall.

Figure 6 is an illustration of an ablation device for direct ablation of the endocardium by an electrolytic solution which forms an impedance interface between the RF electrodes and the tissue being ablated.

Figure 7 is a diagram of the relative impedance of the circuit of the present invention.

Figure 8 is a cross-sectional view of the ablation and mapping device of the invention with the RF electrodes positioned within the cavity filling member.

Figure 9 is a perspective view of a circuit on the exterior of the inner lumenal member with RF electrode segments.

Figure 10 is an illustration of a plurality of RF electrodes suitable for use with the present invention. Figure 11 illustrates the introduction of the ablation device into the desired vein.

Figure 12 is a cross-sectional view of the ablation device being positioned in the right atrium before it is expanded. Figure 13 is a cross-sectional view of the ablation device being positioned in the right atrium, which illustrates the seating of the device in the atrium.

Figure 14 illustrates an expanded ablation device positioned in the right atrium. Figure 15 illustrates the output from the ablation device on a display screen.

Figure 16 illustrates placement of the ablation device in the left atrium.

Figure 17 is a schematic diagram of the cardiac ablation and mapping system of the invention.

Figure 18 is a block diagram of the cardiac ablation and mapping system of the invention.

Figure 19 is a circuit diagram of the cardiac ablation and mapping system of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to devices for ablating tissue interior to cavities of the heart through the delivery of RF energy. The devices of the present invention may also be used in the treatment of a variety of other tissue cavities including, for example, the stomach, colon, intestines, nasopharynx, auditory canal and lungs.

The ablation device of the present invention generally includes an intracavity member, a cavity filling member surrounding the intracavity member, and an electrode. The intracavity member assists in the placement of the cavity filling member in contact with tissue interior to the cavity being treated. The intracavity member is preferably shaped to enable the cavity filling member to conform to the contours of the tissue cavity being treated. For example, when the device is to be used to treat cardiac arrhythmias, the intracavity member preferably enables the cavity filling member to conform to the shape of the heart cavity being treated. The intracavity member may be either elastic or inelastic.

The intracavity member may be coated with a variety of therapeutic agents. For example, the intracavity member may heparinized to reduce blood clotting.

The intracavity member may have a fixed shape, for example corresponding to the cavity to be treated. Preferably, however, the intracavity member is expandable and contractable in order to facilitate the delivery and removal of the device from the tissue cavity being treated. As discussed herein, it is particularly preferred that the intracavity member be expandable and collapsible to facilitate delivery and removal of the device to and from the tissue treatment site, particularly when the device is delivered percutaneously. For applications such as the treatment of heart tissue where there is a need to maintain the fluid flow through the tissue cavity, the intracavity member preferably includes an inner lumenal member. The inter lumenal member includes a lumen which permits fluid, such as blood, to flow uninterrupted through the cavity when the device is positioned in the cavity being treated. The inner lumenal member should not, however, allow fluid to pass through the lumen and into the space between the intracavity member and the cavity filling member.

A cavity filling member surrounds the intracavity member and is designed to receive a medium, such as gas, fluid, or foam which inflates the cavity filling member about intracavity member such that the cavity filling member closely conform to the cavity being treated. It is generally preferred that the cavity filling member conforms tightly with the interior of the cavity being treated so that substantially all of the tissue forming the cavity is in contact with the exterior surface of cavity filling member. This ensures that the ablation device does not have to be moved around the cavity to completely ablate the tissue treatment site. In addition, conformity of the cavity filling member with the cavity serves to hold the cavity filling member in position within the cavity, thereby ensuring that energy is accurately delivered to the desired portions of the tissue cavity. In general, the cavity filling member preferably has a thickness in the range of about

0.01 to 2.0 cm.

The cavity filling member can be coated with an anti-coagulating material, such as heparin, to prevent blood from clotting on the cavity filling member. Ions can also be deposited in the cavity filling member to improve the cavity filling member's Rf conductivity as well as the impedance interface between the tissue being ablated and the electrode supplying the RF energy. The cavity filling member may also be coated with materials, such as glycerin or Teflon which enhance the lubricity of the member. The cavity filling member may also be used to deliver therapeutic and diagnostic agents. These agents may be delivered throughout the cavity filling member. Alternatively, the therapeutic and/or diagnostic agents may be selectively delivered to specific portions of the cavity filling member and hence through specific sections of tissue surrounding the cavity filling member. The delivery of agents to selective portions of the cavity filling member may be accomplished by subdividing the space between the cavity filling member and the inner cavity member by forming the cavity filing member of materials having different permeability to the agents by delivering the agents to different sections of the cavity filling member. Examples of therapeutic agents that may be delivered through the cavity filling member include antiarrhythmics and antithrombogenic agents.

Clearly, however, a wide variety of therapeutic agents not listed may also be delivered through the cavity filling member depending on the particular treatment being performed.

Examples of diagnostic agents that may be delivered through the cavity filling member include contrastagents such as radiopaque dyes and albumin microspheres. Clearly, however, a wide variety of diagnostic agents not listed may also be delivered through the cavity filling member depending on the particular treatment being performed.

The cavity filling member is sealed to the intracavity member such that gas or a solution may be introduced between the intracavity member and the cavity filling member to inflate the cavity filling member and cause the cavity filling member to expand against the tissue site being treated. The cavity filling member may be made of elastic or inelastic material

When a solution is used to expand the cavity filling member, the solution preferably includes additives such as heparin, which prevents blood clotting, antiarrhythmics and antithrombogenic agents.

The media used to inflate the cavity filling member is generally provided by a gas fluid or foam source which can include a pump/pressure flow control device which is well known to those skilled in the art. A temperature regulating device for heating and cooling the inflation media can be associated with the media source. Suitable heating and cooling devices include, but are not limited to coils, bipolar RF electrodes, catalysts, and other devices.

The media used to inflate the cavity filling member is preferably an electrolytic solution. As described herein, an electrode for delivering RF energy may be positioned within the area covered by the cavity filling member such that RF energy is transmitted through the electrolytic solution and through the cavity filling member to the tissue surrounding the cavity filling member. When the media used to inflate the cavity filling member is electrolytic, the media is preferably a normal saline solution (0.9%) or a hypernatrenic saline solution. In addition to sodium, other electrolytes including potassium, calcium and rings such as lactates may be used. It is preferred that the electrolytic solution be hypernatrenic in order to improve the conduction of electromagnetic energy through the electrolyte to decrease impedance between the electrode and the tissue being treated.

The media used to expand the cavity filling member may be heated to a pre-selected temperature which can be modified and adjusted as necessary. For example, the media can be heated and maintained at a temperature between about 40 to 50 °C. The media can be brought to a first temperature when it is introduced into cavity filling member. This initial temperature of the media is generally insufficient to cause tissue ablation. Then, when RF energy is delivered to selected RF electrodes, an impedance interface is formed between the RF electrodes and the tissue by the media. The impedance interface causes localized motion of molecules in tissue which, in turn, causes heating of the tissue that results in ablation. When the electrodes are not placed on the surface of the cavity filling member, the media may be an electrolytic solution such that sufficient RF energy is transferred from the electrodes to the tissue site being treated to cause ablation. Providing a pre-heated electrolytic solution to the cavity filling member serves to reduce the level of RF energy that must be delivered to the electrodes. Alternatively, the media can be cooled. For example, in order to control the rate of ablation or the sections of tissue that are ablated, it may be desirable to cool the media used to inflate the cavity filling member.

The cavity filling member may be made of a permeable or an inpermeable material. In a preferred embodiment, the cavity filling member is formed of a microporous membrane which allows fluid and certain agents to traverse the membrane. This is particularly preferred when a solution is used to inflate the cavity filling member. When the cavity filling member is a microporous membrane, the size and density of the pores of the membrane may be selected, in combination with the pressure by the media used to inflate the cavity filling member, to provide the desired amount of media flow across the membrane. The size and density of the pores of the membrane may also be used to control the rate at which various agents, such as therapeutic and contrast agents, traverse the membrane. The electrode serves to deliver RF energy to the interior tissue layers of the cavity being treated. The electrode may be positioned on an exterior surface of the cavity filling member in contact with the tissue being treated. For example, the electrode may be a conductive surface of the cavity filling member, e.g., the surface located adjacent to the tissue being treated, can be coated with an anti-coagulating material. Ions can also be deposited into the cavity filling member to improve RF energy conductivity.

The electrode can also be positioned on the interior of the cavity filling member, embedded in the walls of the cavity filling member or within the cavity filling member, for example on the surface of the intracavity member. In these embodiments, the electrodes and tissue are in a spaced apart relationship so that there is no direct contact between the electrodes and the tissue being treated. When the electrode is not positioned on the surface of the cavity filling member in contact with the tissue being treated, an electrolytic solution is preferably employed to inflate the cavity filling member and to conduct electricity between the electrode and the tissue being treated.

Alternatively, at least some of the plurality of treatment electrodes may include an insulator formed on a surface of the treatment electrode adjacent to the cavity filling member. The insulator is partially deposited on the treatment electrodes so that a back side of the cavity filling member is insulated from the direct delivery of RF energy from that treatment electrode. The insulator prevents RF energy from passing directly through the cavity filling member. Instead, RF energy is applied indirectly to the tissue being treated by causing a thermal effect on the tissue. RF energy from the treatment electrodes arcs out through the cavity filling member.

The cavity filling member support can serve as an additional insulator.

In addition to the placement of the electrode, the electrode may be configured to provide a variety of ablation patterns. For example, the electrode may comprise a series of electrode segments that can be multiplexed to provide tailored areas of ablation. The circuit forming the electrode can be flexible and made of individual circuit segments, such as a printed circuit that is deposited, etched or painted with a conductive ink on intracavity member, or on a separate support member.

The ablation pattern formed by the electrode, whether the electrode is multiplexed or not, may be patterned, segmented, full dimension and/or combinations thereof. A patterned ablation pattern refers to ablation patterns where a series of smaller areas of tissue are ablated. For example, in the treatment of cardiac arrhythmias, a series of linear ablations are made into the walls of the atrium. A segmented ablation pattern is intended to refer to a continuous area of ablated tissue. A full dimension ablation pattern is intended to refer to the ablation of the substantially the entire tissue cavity.

According to these embodiments a ground pad can be attached to an exterior surface of a patient for monopolar use or the device can be operated in a bipolar mode.

A variety of energy regimens may be used in conjunction with the ablation devices of the present invention.

For example, ablation may be controlled by controlling the ablation time. Ablation may also be controlled by the amount of current provided. When a solution is used to inflate the cavity filling member, the temperature of the solution used to inflate the cavity filling member may also be used to control ablation. When an electrolytic solution is used, ablation can be controlled by controlling the flow rate of the electrolyte through the cavity filling member, which is controlled by the pore size and density of the cavity filling member as well as the pressure exerted upon the cavity filling member when a solution is used to inflate the cavity filling member.

RF energy may be provided by the electrode as either a continuous current or in the form of a pulsed energy delivery. The frequency as well as the configuration of the waveform of the RF energy may also be controlled.

The ablation device may further include electrical resources for acquiring electrical or thermal data from the tissue being treated. For example, the RF energy source can incorporate a controller as well as both temperature and impedance monitoring devices. The temperature and impedance monitoring devices provide feedback to the RF generator to monitor and control the therapeutic output of RF energy to the plurality of RF electrodes.

The data acquiring electrical resources may also include a plurality of recording electrodes and electrical resources positioned on an exterior surface of cavity filling member to map the heart to acquire electrical activation data which may be used, for example, to seek the origin of an arrhythmia, provide early local endocardial activation, electrical function feedback to an RF generator, and then provide a therapeutic output via the RF electrodes and surrounding electrolytic solution to ablate an arrhythmogenic focus.

The recording electrodes may be monophasic action potential ("MAP") electrodes, comprised of a silver, silver chloride matrix which can be either deposited on the surface of cavity filling member, or more conventional intracardial electrode compositions. Alternatively, the recording electrodes may be independent electrodes that are placed on the outside surface of cavity filling member.

With regard to the deployment and removal of the ablation device from the tissue cavity and body being treated, it is generally preferred that the intracavity member be expandable and collapsible, particularly when the device is delivered percutaneously.

Expansion of the intracavity member may be accomplished by air or hydraulic deployment (e.g., inflating the intracavity member with either air or a fluid such as water). Expansion of the intracavity member may also be accomplished by using a foam-like substance. In the case of either air or hydraulic deployment, the air or fluid may be continuously passed through the intracavity member in order to, for example, control the temperature of the device and surrounding tissue. Alternatively, the intracavity member may be inflated with a volume of air or fluid which does not continuously flow through the intracavity member.

Expansion of the intracavity member may also be accomplished using a physical structure positioned within the interior of the intracavity member which pushes the walls of the intracavity member outwardly against the tissue cavity to be treated. For example, as illustrated in Figure 1A, control wires 11 may be attached to the intracavity member 16 to expand and collapse the member. Alternatively, the control wires may be attached to the cavity filling member 14 (not shown) to expand and collapse the cavity filing member 14. The cavity filling member 14 may be attached to the intracavity member 16 at one or more points such that expansion of the cavity filling member 14 causes expansion of the intracavity member 16. As illustrated in Figure 1B, an expansion member 19 may be positioned within the intracavity member 16 which has a plurality of radially extendable arms 21 that can be used to expand the intracavity member 16. Expansion of the intracavity member may also be accomplished by the cavity filling member surrounding the intracavity member. As described above, the intracavity member is surrounded by a cavity filling member which is sealed so as to enable the cavity filling member to receive a media and become inflated, thereby causing the cavity filling member to substantially conform to the heart cavity to be treated. According to this embodiment, previously described in U.S. Patent Application Serial No. 08/426,614, entitled "ABLATION APPARATUS FOR CARDIAC CHAMBERS" by Edwards, et al., filed April 21, 1995 which is incorporated herein by reference, the cavity filling member is designed in combination with the intracavity member such that the intracavity member is expanded when the cavity filling member is inflated. For example, Figure 1C illustrates an embodiment of the expansion mechanism in which the cavity filling member 14 and the intracavity member 16 are attached at one or more points 140. As illustrated in Figure 1C, fluid 154 may be introduced into the space 142 between the cavity filling member 14 and the intracavity member 16 to inflate the cavity filling member. The attachment points 140 between the cavity filling member 14 and the intracavity member 16 cause the intracavity member 16 to become inflated when the cavity filling member 14 is inflated. As illustrated in Figure 1C, the attachment points

140 between the intracavity member 16 and the cavity filling member 14 may form one or more expandable segments 144 where the expandable segments are analogous to an inflatable raft having multiple interconnected inflatable segments. A variety of visualization markers may be incorporated into the intracavity member and/or cavity filling member which enable one to detect the position of the ablation device in the tissue cavity being treated. Visualization markers that may be used include radiopaque markers and contrast agents. Figure 1 D illustrates an embodiment of the device where the segmented expansion mechanism illustrated in Figures 1C is employed. These same visualization markers may also be used to monitor the ablation pattern. For example, when a multi-segmented electrode is employed, staggered radiopaque markers can be utilized to ascertain which electrode segments are located closest to the desired tissue area to be ablated. By observing the staggered relationship of the markers, the physician can select the signals coming from a specific electrode segment to analyze the ablation pattern using a computer. The electrodes of the ablation device of the present invention may be delivered to the tissue cavity site to be treated by a variety of methods. For example, the electrodes may be delivered percutaneously, transthoracically, interoperatively (e.g., through an incision) or through an external orifice of the body, (e.g. mouth, nose, rectal). Some tissue treatment sites impose severe size constraints on the delivery of the ablation device. For example, when delivering the ablation device to the atrium or ventricle, the ablation device must generally have a diameter of less than 10 French. In order to accommodate the size constraints imposed on the device, it is desirable for the intracavity member and cavity filling member to be collapsible into a small volume, such as the lumen of catheter used to introduce the ablation device into the tissue treatment site.

As illustrated in Figures 2A-D, a variety of approaches may be used to enable the intracavity member 16 and cavity filling member 14 to be collapsed.

For example, Figure 2A illustrates a tethered retractor system. As illustrated in Figure 2A, the device may include a tether 151 attached near the distal end of the intracavity member 16 such that retraction of the tether into the lumen 152 of the catheter 153 causes the retraction of the intracavity member into the catheter lumen 152. As also illustrated in Figure 2A, the cavity filling member 14 may include a scored break point 150 or some other point of structural weakness engineered into the cavity filling member 14 such that retraction of the cavity filling member into the lumen 152 of a catheter 153 causes the cavity filling member 14 to be ruptured at the break point 150, thereby causing fluid 154 held within the cavity filling member 14 to be released.

As illustrated in Figure 2B, a pointed implement 155 may be used to pierce the cavity filling member 14 such that retraction of the cavity filling member 14 into a catheter 153 causes fluid 154 in the cavity filling member 14 to be expelled.

As illustrated in Figure 2C, the ablation device may include a suction source 156 for withdrawing fluid 154 held within the cavity filling member 14, thereby enabling the cavity filling member 14 to be retracted.

As illustrated in Figure 2D, the lumen 152 of a catheter 153 may include a spiral groove 158 running longitudinally along the length of the catheter 153 such that retraction of the intracavity member and cavity filling member into the catheter lumen 154 causes the cavity filling member to be twisted as it is retracted along the spiral groove 158.

When designing the ablation device of the present invention for use in the atrium or ventricle of the heart, the cavity filling member is preferably designed such that it closely conforms to the shape of the atrium or ventricle. The cavity filling member is also preferably coated with an anti- coagulating material, such as heparin, as well as an tiarrhythmia drugs. The intracavity member is preferably expandable and collapsible to facilitate the delivery and removal of the ablation device from the atrium or ventricle.

When mapping and ablating tissue within the atrium and ventricle, it is important to maintain blood flow through the heart. Accordingly, the intracavity member preferably includes an inner lumenal member which permits blood to flow through the atrium or ventricle. The inner lumenal member should be designed to prevent blood from flowing from the inner lumenal member of the intracavity member into the space between the intracavity member and the cavity filling member.

With regard to ablation patterns, it is preferred that devices for ablating the atrium form linear ablation patterns while devices for ablating the ventricle preferably form linear or segmented ablation patterns.

When an electrolytic solution is employed in devices for treating tissue within the atrium or ventricle, it is preferred that the electrolytic solution be hypernatrenic and include heparin. The device also preferably includes an inner lumena-i member having a lumen through which blood may pass as the heart chamber is treated.

Delivery of the ablation device of the present invention to the atrium or ventricle may be done through the femoral, internal jugular and subclavian arteries. Delivery may also be performed interoperatively. With regard to the electrode used in ablation devices for treating an atrium or ventricle, the electrode may be further designed to record intracardiac electrograms, assess intracardiac conduction times record monophasic action potentials. The electrode may also be configured to pace the heart , for example, in overdrive to terminate a tachycardia arrhythmia, to induce an arrhythmia or to support pacing of the heart in response to a bradycardia arrhythmia.

Ablation devices of the present invention and their use in mapping and ablating cardiac tissue are illustrated by the following detailed example of an atrial ablation device. Further objectives and advantages other than those set forth above will become apparent from the detailed example and accompanying drawings.

An atrial ablation device of the present invention is illustrated with regard to Figures 3-19. Figures 3 and 4 illustrate a cardiac ablation and mapping system 10 particularly suitable for the right atrium which includes a cardiac ablation and mapping device 12. The ablation device 12 includes a cavity filling member 14 which surrounds an intracavity member 16. The cavity filling member 14 is separated from and inflated about the cavity filling member 14 by an electrolytic solution 154 introduced between the intracavity member 16 and the cavity filling member 14. The electrolytic solution 154 serves both to conduct RF energy to the tissue to be treated, as discussed herein, and to cause the cavity filling member 14 to expand to substantially fill the atrium.

The intracavity member 16 includes an inner lumenal member 17 formed by the intracavity member 16. The inner lumenal member 17 includes a lumen 19 through which blood may flow through the heart chamber in which the device 12 has been placed. The inner lumenal member 17 also provides a separation between the electrolytic solution flowing between the cavity filling member 14 and the intracavity member 16 and the blood flowing through the lumen 19 in the inner lumenal member 17.

Cavity filling member 14 can be of the microporous type and be made of Mylar, expanded PFT such as Gortex available from Gore Company and the like. Cavity filling member 14 is relatively strong and sufficiently heat resistant for the amount of thermal energy formed at the endocardium. The flow rate of electrolytic solution through cavity filling member 14 is determined by, (i) the porosity of cavity filling member 14 and (ii) the introduction rate of the electrolytic solution to cavity filling member 14. A plurality of recording electrodes 15 are positioned on an exterior surface of cavity filling member 14. Recording electrodes 15 can be MAP monophasic action potential electrodes, comprised of a silver or a silver chloride matrix which can be either deposited on the surface of cavity filling member 14 or more conventional intracardial electrode compositions. Alternatively, recording electrodes 15 can be independent electrodes that are placed on the outside surface of cavity filling member 14. Cavity filling member 14 substantially surrounds inner lumenal member 16. Inner lumenal member 16 includes a sealed proximal end 18 and a sealed distal end 20. It will be appreciated that ends 18 and 20 can be configured to be positioned next to the associated venous inlet or valve, to more readily orient ablation device 12 and position it properly in the left or right atrium. Ends 18 and 20 are sealed but include an aperture 22 and 24 respectively, formed therein, defining a central lumen 26 which extends in a general longitudinal direction through intracavity member 16 permitting blood to flow through inner lumenal member 17 and the heart chamber. Intracavity member 16 is attached to cavity filling member 14 and is expanded to a non-distensible state when cavity filling member 14 is inflated with solution.

A catheter 28, with a distal end 30, may be attached to cavity filling member 14 or intracavity member 16 with attachment devices including, but not limited to hooks, loops and the like. Catheter 28 may be a combination of a latex/silicon rubber composite that has a non-pliable, non- flexible, inner sleeve or glove. Catheter 28 can also serve as a "spine" for ablation device 12. Prior to deployment, cavity filling member 14 and intracavity member 16 are in a folded or rolled type of basket, non- expanded configuration, and wound around catheter distal end 30.

Catheter distal end 30 can be introduced into the right atrium through, (i) the subclavian vein, requiring a catheter 28 length of about 30 to 40 cm, (ii) the internal jugular, requiring a catheter 28 length of about 30 to 40 cm or (iii) the femoral artery, requiring a catheter 28 length of about 110 cm.

Generally, cardiac ablation and mapping device 12 can be a monopolar or bipolar RF electrode system that is capable of expanding so that cavity filling member 14 becomes expanded within the heart chamber, and RF energy is delivered by electrolytic solution to the wall of the heart through cavity filling member 14. RF energy is passed by the electrolytic solution through the endocardium and subendocardium or deeper, for a time period sufficient to achieve a desired level of ablation at an arrhythmogenic focus. It can be used in the "MAZE" procedure which does not address a particular focus but creates a condition where reentry is inhibited.

In a monopolar mode, an RF current flows through body tissue from a return electrode in the form of a conductive pad applied to the patient's outer skin. Maximum heating occurs where the current density is the greatest. The electric current flowing through the endocardium causes heating due to the resistance of the tissue. Intravascular or cardial ablation can be accomplished as a relatively simple medical procedure.

Cavity filling member 14 conforms tightly with the interior of the heart so that substantially all of the heart wall is in contact with the exterior surface of cavity filling member 14. Cavity filling member 14 fits substantially into the entire heart chamber and does not have to be moved about the heart to complete the treatment. Cavity filling member 14 is made of a material that suitably conforms to a surface to be ablated and can have a thickness in the range of about 0.01 to 2.0 cm. Fluid flow can be continuous or non-continuous. The electrolytic solution delivered to cavity filling member 14 can be heated or cooled.

Referring now to Figure 5, a plurality of RF electrodes 34 are positioned on an exterior surface of inner lumenal member 16. There is no direct contact or RF electrodes 34 to the endocardium.

An electrolytic solution, including but not limited to saline, flows through cavity filling member 14 and comes in contact with RF electrodes

34. RF energy is then delivered, via the electrolytic solution, to the endocardium. Thus, the actual electrode for treatment purposes is not RF electrodes 34 but is the electrolytic solution which forms an impedance interface between the RF electrodes 34 and the tissue, as illustrated in Figure 6. The impedance of the circuit of the present invention is illustrated in Figure 7. There is a constant impedance from the RF energy source to RF electrodes 34. When electrolytic solution is placed in intimate contact with RF electrodes 34 there is a decrease in impedance. At the tissue interface the impedance increases because there is higher resistance. Through the rest of the body, and to ground, the impedance is then constant.

RF electrodes 34 can also be positioned in cavity filling member 14, as shown in Figure 7. Again, energy transfer occurs through the electrolytic solution which is in contact with RF electrodes 34. The electrolytic solution serves to form an impedance interface and there is no direct contact of RF electrodes 34 to the endocardium.

Referring now to Figure 9, a circuit 38 which can be flexible and made of individual circuit segments 40, can be a printed circuit that is deposited, etched or painted with a conductive ink on inner lumenal member 16, or on a separate support member. Each circuit segment 40 or RF electrode 34 connects to a separate feedwire 42, with all of the wires going to a ribbon connector 44. Feedwires 42 are insulated. Each RF electrode 34 or circuit segment 40, is wired with a constantan wire in order to receive RF energy from an RF energy source. A copper wire is connected to each constantan wire. This results in the formation of a T type thermocouple "TC".

RF power is applied to the desired RF electrode 34 delivering RF energy only to the electrolytic solution in proximity with the desired RF electrode, which then transfers the RF energy to a selected site of the endocardium. The use of different RF electrodes 34 permits circuit 38 to be multiplexed. The size of individual RF electrodes 34 and circuit segments 40 is designed to provide the correct current density. RF power can be sequentially supplied to each RF electrode 34 and feedwire 42 in ribbon connector 44, or it can be applied to only certain selected feedwires 42. This enables only selected RF electrodes 34 to deliver RF energy individually to the electrolytic solution and then to the endocardium.

One or more impedance monitors 46 can be used to confirm, before an ablation event, so that good coupling of energy is achieved. Also, included is one or more thermal sensors 48. Thermal sensors 48 are conventional thermoresistors or thermocouples and can be positioned on

RF electrodes 34 or segments 40.

With reference now to Figure 10, individual RF electrodes 34 can be used and multiplexed in either mono-polar or bi-polar configurations. Circuit segments 40 and -RF electrodes 34 are capable of multiplexing so that only one delivers RF energy to surrounding electrolytic solution at a particular time period. RF energy is selectively delivered so that the amount of energy delivered by each circuit segment 40 or RF electrode 34 can vary depending on the detected characteristics of endocardium at a particular area.

In Figure 11 , ablation device 12 is shown as being introduced through the jugular or subclavian veins. In Figure 12, ablation recording electrodes 15 are shown as being positioned on an exterior surface of cavity filling member 14 in a folded or rolled configuration as ablation device 12 is introduced into the right atrium. Ablation device 12 begins to unfold in Figure 13, with end 20 seeking its position in the tricuspid annulus. In Figure 14, ablation device 12 has become expanded so that cavity filling member 14, and recording electrodes 15, are in a contacting relationship with the wall of the right atrium. Blood flow is not impeded and flows through lumen 26 of inner lumenal member 17 through apertures 22 and 24 respectively. With ablation device 12 in its expanded state and positioned in an atrium there is constrained contraction of the atrium. Mapping and analysis of the heart chamber activation, with the use of recording electrodes 15, occurs substantially at once and can occur within less than ten heart beats or sufficiently long enough to obtain the required intracavitary map.

Figure 15, shows, uninterrupted blood flow through the superior vena cava, inferior vena cava and the tricuspid value. The electrical data output and intracavitary map can be presented on a viewing screen.

In Figure 16, ablation device 12 is introduced into the left atrium. There are four pulmonary veins. Ablation device 12 covers only two of the pulmonary veins at one time and the mitral valve. Therefore, ablation device 12 is flipped over in the right atrium to cover the other two pulmonary veins and mitral valve. Ablation device 12 is introduced into the left atrium either with a puncture type of structure across the septal wall or through a patent ductus.

Referring now to Figure 17, endocardial ablation and mapping system 10 is illustrated. A high voltage connector 50 and a signal connector are connected to the electrodes (not shown) and form part of catheter 28. A cable 29 is connected to an interface module 54 which supplies and receives signals to and from the electrodes and from a computer 58 that is provided with a disc drive 60 and a monitor 62. Computer 58 is also provided with a keyboard (not shown) for use in controlling the operation of computer 58.

As shown in Figure 18, ablation system 10 can include an RF energy source 66 and an electrolytic solution source 68, all coupled to ablation device 12. RF energy source 66 can incorporate a controller as well as both temperature and impedance monitoring devices. An output is associated with RF energy source 66.

Electrolytic solution source 68 can include a pump/pressure flow control device 70, well known to those skilled in the art. A heating device for heating the electrolytic solution can be associated with electrolytic solution source 68. Suitable heating devices include, but are not limited to coils, bipolar RF electrodes, catalysts, and other devices. Referring to Figures 17-19, as soon as distal end 30 of catheter 28 is positioned within the desired chamber, energy conduction connector 50 and signal connector 52 are interconnected with mating connectors 74 and 76, so that the plurality of electrodes are connected to interface module 54 and computer 58. Cavity filling member 14 is then expanded by electrolytic solution causing cavity filling member 14 to become distended and be self- retained in the heart.

Electrolytic solution in cavity filling member 14 can be heated to a pre-selected temperature which can be modified and adjusted as necessary. For example, electrolytic solution can be heated and maintained at a temperature between about 40 to 50 °C. The electrolytic solution can be brought to a first temperature when it is introduced into cavity filling member 14. The initial temperature of the electrolytic solution is insufficient to create tissue ablation. RF energy is delivered to selected RF electrodes 34 which transfer the RF energy to the surrounding electrolytic solution, which then contacts endocardial tissue causing a desired ablation effect. The amount of energy transferred from RF electrodes 34 to the surrounding electrolytic solution is sufficient to cause the surrounding electrolytic solution to become an electrode that transfers RF energy to endocardial tissue and result in ablation. Providing pre¬ heated electrolytic solution to cavity filling member 14 merely reduces the level of necessary RF energy delivered to RF electrodes.

Once this is accomplished, cavity filling member 14 is in a contacting and conforming relationship to the wall of the chamber of the heart. RF energy is conducted through cavity filling member 14 and to a selected tissue site of the heart chamber to cause ablation. When cavity filling member 14 becomes expanded its exterior surface and recording electrodes 15 are in a contacting relationship with the wall of the chamber. Cavity filling member 14 moves with the chamber with its constrained contraction and expansion. Lumen 26 in inner lumenal member 17 permits blood to flow in and out of the heart chamber.

Electrical resources acquire electrical data from the heart and provide electrical function feedback to RF generator 66. RF generator 66 then supplies a therapeutic output to RF electrodes 34. These electrical resources map the heart with recording electrodes 15 to acquire activation data, seek the origin of the arrhythmia, provide early local endocardium activation, provide ablation, further mapping, and further ablation if required. Operation and use of cardiac ablation and mapping device 12 in connection with interrace module 56 and computer 58 is now described.

In one specific embodiment, the plurality of RF electrodes 34 can be operated in the bipolar mode. Bipolar RF electrode pairs are connected to a differential amplifier 78. Each of the differential amplifiers 78 are provided with input circuitry 80, which consists of current limiting resistors

R1 and R2 connected to diodes D1 and D2 on opposite sides of the input line, with the diode D2 being connected to ground and diode D1 being connected to a positive voltage. Diodes D4 and D6 are connected to the other input line with diode D4 being connected to ground and diode D6 being connected to the positive voltage. These serially connected diodes serve to protect the inputs to differential amplifiers 78 during the time that ablation voltages are being applied.

The iriput circuitry has the capability of limiting the voltage rise at the inputs of differential amplifiers 78 to approximately 1/2 volt. Differential amplifiers 78 have a suitable gain which is typically between 100 and 500.

Outputs of differential amplifiers 78 are connected by a number of lines depending of the number of RF electrodes and pairs to an analog multiplexer 82. Multiplexer 82 can have a number of inputs, as for example, 64. Inputs are connected to circuit 38 at connector 44. Certain inputs can be grounded. While other inputs can be connected to a positive voltage supply. One or two of the inputs can be utilized for providing a synchronization signal for demultiplexing, as hereinafter described.

Multiplexer 82 is driven by a 6 bit binary counter 84, which is supplied with a clock frequency from an oscillator 86 that is controlled by crystal 88 of a suitable frequency as for example, 200 KHz. The 200 KHz oscillator frequency can provide a five microsecond cycle length per channel. Counter 84 supplies an output 90 on six lines 92 to multiplexer 82. Multiplexer 82 is provided with an output line 94 which is controlled by binary counter 84, so that the output from each of the amplifiers 78 appear on output line 94 for the five microsecond pulse length provided by oscillator 86.

Information can be received on as many as 56 channels with each channel having a 5 microsecond duration, followed by a synchronizing pulse that is 20 microseconds wide to complete one cycle of multiplexer 82 of 320 microseconds, followed by the next 320 microsecond cycle. This provides an effective sampling rate of about 3000 samples per second.

Output 94 is connected to a buffer amplifier 100 which provides its output 102 on pin 3 of connector 52. The other pins 1 and 2 in connector 52 are connected to ground and a plus voltage, respectively, in interface module 54.

A multiplexer chip 104 is connected to leads 106 which in turn are connected to selected RF electrodes 34 (Figure 17). The power of multiplexer chip 104, associated with cardiac ablation and mapping device 12, is supplied from interface module 54 through pins 1 and 2 of connector 76, as shown in Figure 19. Pin 3 of connector 76 receives the output signal from pin 3 of connector 52 and supplies it through a line 108 to a demultiplexer 110. Demultiplexer 110 is supplied with a plurality of output channels 112. Assuming there are 64 input channels in multiplexer 82, there will be a corresponding number of output channels 112 in demultiplexer 110. The information on line 108, containing the synchronizing signal, is also supplied through a capacitor C1 to a phase locked loop 114, and is connected to an RF filter network 116 consisting of a resistor R5 and a capacitor C2 connected to ground. Phase locked loop 114 is provided with an output line 118 and has provided thereon a reconstructed 200 KHz voltage controlled oscillator output which is supplied to a counter 120. Counter 120 is provided with a plurality of output lines 122 which are connected to demultiplexer 110. Lines 122 are provided with frequencies ranging from 100 KHz to 3,125 KHz, with the 3,125 being connected to phase locked loop 114 by a line 124 which serves to couple the VCO output to phase locked loop 114. The use of the phase locked loop 114 allows the reconstruction of the 200 KHz clock, which is synchronized to the 200 KHz in multiplexer chip 104.

Demultiplexer 110 serves to demultiplex the information supplied from multiplexer 82 and supplies it on the 56 channels 112 to circuitry 126; which includes sample and hold circuitry, filter circuitry and A/D converters, to provide an output on lines 128 in the form of a signal that is supplied to computer 58 and display monitor 62. Computer 58 is provided with software that has the capability of analyzing information being supplied to it by utilizing sampling techniques well known to those in the art. Computer

58 performs an analysis of the information including but not limited to mapping of the heart to acquire electrical activation data and early endocardial activation. With the use of propagation and delay time analysis computer 58 identifies and isolates the area within a heart chamber which may contain an arrhythmogenic focus to be ablated. This information is displayed on the screen of monitor 62 so that it can be reviewed by the physician who then decides whether or not ablation is desirable.

After the mapping has been accomplished by use of cardiac ablation and mapping device 12 (recording electrodes 15), and an arrhythmogenic focus has been located, the same cardiac ablation and mapping device 12, while still in place in the heart chamber, is used for accomplishing the ablation with electrolytic solution receiving RF energy from RF electrodes 34. The attending physician inputs the desired commands to the keyboard connected to computer 58 to give the command to proceed with an ablation. As soon as such a command is received by computer 58, it sends a channel number serially to pin 3 of connector 74; which is connected to the corresponding pin 3 of connector 50 in a serial to parallel shift register 130 that is disposed in electrode grid ablation device 12. Shift register 130 supplies the channel number to demultiplexer 110 on the six lines 132 to a high voltage demultiplexer 134. Shift register 130 is provided with a clocking signal on pin 4 of connector 50 that is supplied with a clock signal on the corresponding pin 4 of connector 74 from computer 58.

The output of computer 58 is also connected to a high voltage ablation power supply 136. High voltage ablation power supply 136 is programmable as to channel number and the amount of energy to be supplied on the channel. High voltage ablation power supply 136 supplies its output to pins 1 and 2 of connector 74, connected to corresponding pins

1 and 2 of connector 50, which are connected to demultiplexer 134. Demultiplexer 134 is provided with high voltage transistors which can tolerate the ablation voltages supplied by ablation power supply 136. Ablation power supply 136 can supply a high voltage, high frequency (typically 50-100 volts at 750 KHz to 1 MHz) pulse across the pins 1 and

2 of connector 74. This high voltage pulse appears on the corresponding the pins 1 and 2 of connector 50, and is supplied by demultiplexer 134 to the appropriate channel and appropriate RF electrode 34 or RF electrode pair through lines 138 connected to leads 106. This pulse is transmitted across a RF electrode 34 or RF electrode pair, and causes an ablation, of suitable depth, to occur in the endocardium of the right atrium. Alternatively, ablation can be accomplished between one or more RF electrodes 34 and an external ground RF electrode placed on the chest of the patient. In this manner, it can be seen that a highly controlled ablation is provided which is precisely positioned with respect to the selected RF electrodes 34 which can be multiplexed, and a maze type of ablation can be produced.

Several milliseconds after the ablation pulse has been supplied to the appropriate RF electrode or electrode pair, mapping can again be resumed to ascertain whether or not arrhythmogenic foci are still present. If the mapping indicates that atrial fibrillation is inducible additional pulses can be programmed by computer 58 and supplied to other appropriate RF electrodes 34 until the arrhythmias can no longer be initiated.

Programmed stimulation can be performed by using a selectable number of recording electrodes 15. In this mode of operation, interface 54 provides a programmable level of low voltage pulses (5-10 volts) via the high voltage connector 58 to stimulate the heart with synchronized pulses in order to induce or convert an arrhythmia.

Staggered radiopaque markers can be utilized to ascertain which segments 40 are located closest to the anatomical point of interest in the heart cavity, as for example, the right atrium. By observing this staggered relationship of the markers, the physician can select the signals coming from a specific segment 40 to analyze the same in computer 58.

Cardiac ablation and mapping device 12 can be provided with an increased number or decreased number of RF electrodes 34 if desired. Any number of channels can be readily provided in multiplexer 82 and demultiplexer 110. The shape of circuit segments 40 can be made so that they conform to the wall of the heart, through cavity filling member 14, as it expands and contracts through the entire cardiac cycle. Segments 40 do not directly touch the wall of the heart chamber. Instead, they are preferably formed on the exterior of inner lumenal member 16. Cavity filling member 14 maintains intimate contact with the wall of the heart chamber, minimizing the amount of energy which is dissipated into the blood pool within the cavity of the heart during ablation.

Once the desired procedures are completed, cardiac ablation and mapping device 12 is removed from the heart chamber, for example by one of the removal methods described above.

The foregoing description of preferred embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.

Claims

What is claimed is:

1. A cardiac ablation device for ablating tissue within a chamber of the heart comprising: an intracavity member including an inner lumenal member for allowing blood to flow through the heart chamber when the intracavity member is inserted into the heart chamber; a cavity filling member surrounding the intracavity member; an inflation source adapted to provide an electrolytic fluid or foam to the cavity filling member in a manner to expand the cavity filling member to conform to at least a portion of the heart chamber; one or more RF electrodes positioned in the device to deliver RF energy through the electrolytic solution to the tissue; and an electrical connector device connecting the electrode to an RF energy source.

2. The cardiac ablation device according to claim 1 , wherein the cavity filling member has an interior surface facing the intracavity member and an exterior surface facing the heart chamber to be treated and wherein the position of the one or more electrodes in the device is selected from the group consisting of on the interior surface of the cavity filling member, embedded in the cavity filling member, in an area between the cavity filling member and the intracavity member, and on the intracavity member.

3. The cardiac ablation device according to claim 1 wherein the heart chamber is a ventricle.

4. The cardiac ablation device according to claim 1 wherein the heart chamber is an atrium.

5. The cardiac ablation device according to claim 4 wherein the inner lumenal member lumen includes at least three lumen openings allowing blood to flow between the superior vena cava, the inferior vena cava and the tricuspid valve of the heart.

6. The cardiac ablation device according to claim 1 wherein the intracavity member is elastic.

7. The cardiac ablation device according to claim 1 wherein the intracavity member is inelastic.

8. The cardiac ablation device according to claim 1 wherein the intracavity member is heparinized.

9. The cardiac ablation device according to claim 1 wherein the intracavity member is expandable and collapsible.

10. The cardiac ablation device according to claim 1 wherein the cavity filling member is elastic.

11. The cardiac ablation device according to claim 1 wherein the cavity filling member is inelastic.

12. The cardiac ablation device according to claim 1 wherein the cavity filling member is a impermeable.

13. The cardiac ablation device according to claim 12 wherein the cavity filling member is a permeable membrane.

14. The cardiac ablation device according to claim 13 wherein the membrane is a microporous membrane.

15. The cardiac ablation device according to claim 1 , wherein the cavity filling member conforms to the shape of the heart chamber being treated.

16. The cardiac ablation device according to claim 1 , wherein the cavity filling member is permeable to a therapeutic or a diagnostic agent.

17. The cardiac ablation device according to claim 1, further including a temperature regulating source for heating or cooling fluid from the fluid delivery source.

18. The cardiac ablation device according to claim 1 wherein the one or more electrodes include a series of electrode segments that can be multiplexed.

19. The cardiac ablation device according to claim 1 , further including a temperature monitoring device for monitoring the therapeutic output of RF energy.

20. The cardiac ablation device according to claim 1, further including an impedance monitoring device for monitoring the therapeutic output of RF energy.

21. The cardiac ablation device according to claim 20, wherein the impedance monitoring device includes a plurality of recording electrodes and electrical resources positioned on the cavity filling member.

22. The cardiac ablation device according to claim 21 , wherein the recording electrodes are monophasic action potential electrodes.

23. The cardiac ablation device according to claim 1 , further including visualization markers for detecting the position of the device in the tissue cavity.

24. The cardiac ablation device according to claim 1, further including an expanding mechanism for expanding the intracavity member.

25. The cardiac ablation device according to claim 24, wherein the expanding mechanism includes a series of control wires attached to the intracavity member to expand and collapse the member.

26. The cardiac ablation device according to claim 24, wherein the expanding mechanism includes a plurality of radially extendable arms.

27. A cardiac ablation device for ablating tissue within a chamber of the heart comprising: an intracavity member including an inner lumenal member having a lumen for allowing blood to flow through the heart chamber when the intracavity member is inserted into the heart chamber; a cavity filling member surrounding the intracavity member; an inflation source adapted to provide an electrolytic fluid or foam to the cavity filling member in a manner to expand the cavity filling member to conform to at least a portion of the heart chamber; one or more RF electrodes positioned in the device to deliver RF energy through the electrolytic solution to the tissue; an electrical connector device connecting the electrode to an RF energy source; and a catheter having a lumen, the cavity filling member and intracavity member being extendable from and retractable into the catheter.

28. The cardiac ablation device according to claim 27, further including a tether attached to the intracavity member for drawing the intracavity member into the catheter lumen.

29. The cardiac ablation device according to claim 27, wherein the cavity filling member includes a scored break point which breaks during retraction of cavity filling member into the catheter lumen to facilitate deflation of the cavity filling member.

30. The cardiac ablation device according to claim 27, further including a pointed implement which punctures the cavity filling member to facilitate deflation of the cavity filling member.

31. The cardiac ablation device according to claim 27, further including a suction source attached to the cavity filling member for deflating the cavity filling member.

32. The cardiac ablation device according to claim 27 wherein the lumen of the catheter includes a spiral groove running longitudinally along the length of the catheter such that retraction of the cavity filling member into the catheter lumen causes the cavity filling member to be twisted as the cavity filling member is retracted into the catheter lumen.

33. An endocardial ablation apparatus for introduction into a heart chamber formed by a wall, comprising: a cavity filling member formed of a flexible porous membrane adapted to receive an electrolytic solution and become inflated to substantially conform an exterior surface of the cavity filling member to the wall of the heart chamber; an intracavity member surrounded by and attached to the cavity filling member, the intracavity member including an inner lumenal member having a lumen that permits blood flow through the inner lumenal member and heart chamber; an introducer catheter that introduces the cavity filling member and intracavity member into a selected heart chamber; a plurality of RF electrodes defining a circuit positioned in the cavity filling member or on an exterior surface of the intracavity member, the RF electrodes transferring RF energy to the electrolytic solution providing an ablation of a selected site of the heart chamber; an RF power source coupled to the RF electrodes; and a source of electrolytic solution coupled to the cavity filling member.

34. An endocardial ablation apparatus for introduction into a heart chamber formed by a wall, comprising: a cavity filling member formed of a flexible porous membrane adapted to receive an electrolytic solution and become inflated to substantially conform a conductive surface of the cavity filling member to the wall of the heart chamber; an intracavity member surrounded by the cavity filling member including a sealed proximal end and a sealed distal end, each end having an aperture formed therein defining an inner lumenal member that permits blood flow through the intracavity member and heart chamber, the intracavity member being attached to the cavity filling member and expanded to a non-distensible state when the cavity filling member is inflated; a catheter with a distal end attached to the cavity filling member or the intracavity member, wherein the cavity filling member and the intracavity member are introduced into the heart chamber by the catheter in a non-expanded state, and become expanded to an expanded state by inflating the cavity filling member with the electrolytic solution; a plurality of treatment electrodes defining a circuit formed on an exterior surface of the intracavity member; an RF power source coupled to the treatment electrodes; and a source of electrolytic solution coupled to the cavity filling member.

35. An endocardial ablation apparatus for introduction into a heart chamber formed by a wall, comprising: a cavity filling member formed of a flexible porous membrane adapted to receive an electrolytic solution and become inflated to substantially conform a conductive surface of the cavity filling member to the wall of the heart chamber; a intracavity member surrounded by the cavity filling member including a sealed proximal end and a sealed distal end defining an inner lumenal member in the intracavity member that permits blood flow through the intracavity member and the heart chamber, the intracavity member being attached to the cavity filling member and expanded to a non- distensible state when the cavity filling member is inflated; a catheter with a distal end attached to the cavity filling member or the intracavity member, wherein the cavity filling member and intracavity member are introduced into the heart chamber by the catheter in a non- expanded state, and become expanded to an expanded state by inflating the cavity filling member with the electrolytic solution; a plurality of treatment electrodes positioned between the intracavity member and the surrounding cavity filling member, at least a portion of the plurality of treatment electrodes including an insulator formed on a surface of the electrode adjacent to the cavity filling member; an RF power source coupled to the treatment electrodes; and a source of electrolytic solution coupled to the cavity filling member.