US20010025175A1 - Expandable-collapsible electrode structures made of electrically conductive material - Google Patents

Abstract

Electrode assemblies and associated systems employ a nonporous wall having an exterior for contacting tissue. The exterior peripherally surrounds an interior area. The wall is essentially free of electrically conductive material. The wall is adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter. The assemblies and systems include a lumen that conveys a medium containing ions into the interior area. An element free of physical contact with the wall couples the medium within the interior area to a source of electrical energy to enable ionic transport of electrical energy from the source through the medium to the wall for capacitive coupling to tissue contacting the exterior of the wall.

Description

RELATED APPLICATION
• This application is a continuation-in-part of pending U.S. application Ser. No. 08/099,994, filed Jul. 30, 1993 and entitled “Large Surface Cardiac Ablation Catheter that Assumes a Low Profile During Introduction into the Heart,” which is itself a continuation-in-part of pending U.S. application Ser. No. 07/951,728, filed Sep. 25, 1992, and entitled “Cardiac Mapping and Ablation Systems.”[0001]
FIELD OF THE INVENTION
• The invention generally relates to electrode structures deployed in interior regions of the body. In a more specific sense, the invention relates to electrode structures deployable into the heart for diagnosis and treatment of cardiac conditions.[0002]
BACKGROUND OF THE INVENTION
• The treatment of cardiac arrhythmias requires electrodes capable of creating tissue lesions having a diversity of different geometries and characteristics, depending upon the particular physiology of the arrhythmia sought to be treated.[0003]
• For example, a conventional 8 F diameter/4 mm long cardiac ablation electrode can transmit radio frequency energy to create lesions in myocardial tissue with a depth of about 0.5 cm and a width of about 10 mm, with a lesion volume of up to 0.2 cm[0004]³. These small and shallow lesions are desired in the sinus node for sinus node modifications, or along the AV groove for various accessory pathway ablations, or along the slow zone of the tricuspid isthmus for atrial flutter (AFL) or AV node slow or fast pathway ablations.
• However, the elimination of ventricular tachycardia (VT) substrates is thought to require significantly larger and deeper lesions, with a penetration depth greater than 1.5 cm, a width of more than 2.0 cm, and a lesion volume of at least 1 cm[0005]³.
• There also remains the need to create lesions having relatively large surface areas with shallow depths.[0006]
• One proposed solution to the creation of diverse lesion characteristics is to use different forms of ablation energy. However, technologies surrounding microwave, laser, ultrasound, and chemical ablation are largely unproven for this purpose.[0007]
• The use of active cooling in association with the transmission of DC or radio frequency ablation energy is known to force the tissue interface to lower temperature values. As a result, the hottest tissue temperature region is shifted deeper into the tissue, which, in turn, shifts the boundary of the tissue rendered nonviable by ablation deeper into the tissue. An electrode that is actively cooled can be used to transmit more ablation energy into the tissue, compared to the same electrode that is not actively cooled. However, control of active cooling is required to keep maximum tissue temperatures safely below about 100° C., at which tissue desiccation or tissue boiling is known to occur.[0008]
• Another proposed solution to the creation of larger lesions, either in surface area and/or depth, is the use of substantially larger electrodes than those commercially available. Yet, larger electrodes themselves pose problems of size and maneuverability, which weigh against a safe and easy introduction of large electrodes through a vein or artery into the heart.[0009]
• A need exists for multi-purpose cardiac ablation electrodes that can selectively create lesions of different geometries and characteristics. Multi-purpose electrodes would possess the flexibility and maneuverability permitting safe and easy introduction into the heart. Once deployed inside the heart, these electrodes would possess the capability to emit energy sufficient to create, in a controlled fashion, either large and deep lesions, or small and shallow lesions, or large and shallow lesions, depending upon the therapy required.[0010]
SUMMARY OF THE INVENTION
• The invention provides electrode assemblies and associated systems employing a nonporous wall having an exterior for contacting tissue. The exterior peripherally surrounds an interior area. The wall is essentially free of electrically conductive material. The wall is adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter. The assemblies and systems include a lumen that conveys a medium containing ions into the interior area. An element free of physical contact with the wall couples the medium within the interior area to a source of electrical energy to enable ionic transport of electrical energy from the source through the medium to the wall for capacitive coupling to tissue contacting the exterior of the wall.[0011]
• In a preferred embodiment, the capacitive coupling of the wall is expressed in the following relationship:[0012]
• {square root}{square root over (R_PATH²+X_C²)}<R_TISSUE
• where:[0013]$R_{\mathrm{PATH}}=\frac{K}{S_E}{\rho }_s$

  
• and[0014]
• K is a constant that depends upon geometry of the wall,[0015]
• S[0016]_Eis surface area of the element, and
• ρ[0017]_Sis resistivity of the medium containing ions, and
• where:[0018]$X_C=\frac{1}{2\pi \mathrm{fC}}$

  
• and[0019]
• f is frequency of the electrical energy, and[0020]$C=\varepsilon \frac{S_B}{t}$

  
• where:[0021]
• ε is the dielectric constant of wall,[0022]
• S[0023]_Bis the area of the interior area, and
• t is thickness of the wall located between the medium containing ions and tissue, and[0024]
• where R[0025]_TISSUEis resistivity of tissue contacting the wall.
• The invention also provides systems and methods for heating or ablating body tissue. The systems and methods provide a catheter tube having a distal end that carries an electrode of the type described above. The systems and methods electrically couple a source of radio frequency energy to the electrically conductive element within the electrode body and to a return electrode in contact with body tissue.[0026]
• According to this aspect of the invention, the systems and methods guide the catheter tube into a body with the wall in the collapsed geometry and then cause the wall to assume the expanded geometry at least in part by conveying a medium containing ions into the interior area of the body. The systems and methods then ohmically heat or ablate body tissue by transmitting radio frequency energy to the electrically conductive element for ionic transport through the medium to the wall for capacitive coupling to tissue located between the return electrode and the electrode.[0027]
• Features and advantages of the inventions are set forth in the following Description and Drawings.[0028]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a plan view of a system for ablating heart tissue, which includes an expandable electrode structure that embodies the features of the invention;[0029]
• FIG. 2 is a side elevation view of an expandable electrode structure usable in association with the system shown in FIG. 1, in which an inflation medium is used to expand the structure;[0030]
• FIG. 3A is a side elevation view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, in which an inflation medium is used to expand separate multiple chambers within the structure;[0031]
• FIG. 3B is a side elevation view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, in which an inflation medium is used to expand integrally formed multiple chambers within the structure;[0032]
• FIG. 3C is a top section view of the electrode structure shown in FIG. 3B, taken generally along line[0033]3C-3C in FIG. 3B;
• FIG. 3D is a side elevation view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, in which an inflation medium is used to expand a single chamber within the structure;[0034]
• FIG. 3E is a top view of an alternative expandable-collapsible electrode structure with a body having interior coextruded webs that compartmentalize the body into multiple interior chambers;[0035]
• FIG. 4 is a side elevation view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, in which an open spline structure is used to expand the structure;[0036]
• FIG. 5 is the expandable electrode shown in FIG. 4, in which a slidable sheath is used to collapse the structure;[0037]
• FIG. 6 is a side elevation view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, in which an interwoven mesh structure is used to expand the structure;[0038]
• FIG. 7 is the expandable electrode shown in FIG. 6, in which a slidable sheath is used to collapse the structure;[0039]
• FIG. 8 is a side elevation view of an alternative expandable interwoven mesh electrode structure usable in association with the system shown in FIG. 1, in which an interior bladder is used to expand the structure;[0040]
• FIG. 9 is a side elevation view of an alternative expandable foam electrode structure usable in association with the system shown in FIG. 1;[0041]
• FIG. 10 is a side elevation view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, in which an electrically actuated spline structure is used to expand the structure;[0042]
• FIG. 11A is a side elevation view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, in which the electrode structure is pleated or creased to promote folding upon collapse;[0043]
• FIG. 11B is the electrode shown in FIG. 11A in the process of folding while collapsing;[0044]
• FIG. 11C is the electrode shown in FIG. 11A as folded upon collapse;[0045]
• FIG. 12 is a side elevation view of an expandable electrode structure usable in association with the system shown in FIG. 1, in which a steering mechanism proximal to the structure steers the structure at the end of a catheter tube;[0046]
• FIG. 13 is a side elevation view of an expandable electrode structure usable in association with the system shown in FIG. 1, in which a steering mechanism within the structure steers the structure at the end of a catheter tube;[0047]
• FIG. 14 is a side elevation view of an expandable electrode structure usable in association with the system shown in FIG. 1, in which an axially and radially movable stilette in the structure is used to alter the shape of the structure;[0048]
• FIGS. 15A to[0049]15E are plan views of an assembly process for manufacturing an expandable electrode structure using an inflation medium to expand the structure;
• FIGS. 16A to[0050]16D are plan views of an assembly process for manufacturing an expandable electrode structure using an interior spline structure to expand the structure;
• FIG. 17 is a side elevation view of an expandable electrode structure usable in association with the system shown in FIG. 1, in which an electrically conductive shell is deposited on the distal end of the structure;[0051]
• FIG. 18 is a side elevation view of an expandable electrode structure usable in association with the system shown in FIG. 1, in which an electrically conductive foil shell is positioned for attachment on the distal end of the structure;[0052]
• FIG. 19 is an enlarged section view of the wall of an expandable electrode structure usable in association with the system shown in FIG. 1, in which an electrically conductive material is coextruded within the wall;[0053]
• FIG. 20 is a top view of an expandable electrode structure having an exterior shell of electrically conductive material formed in a segmented bull's-eye pattern;[0054]
• FIGS. 21 and 22 are, respectively, side and top views of an expandable electrode structure having an exterior shell of electrically conductive material formed in a segmented pattern of energy transmission zones circumferentially spaced about a preformed, foldable body, and including multiple temperature sensing elements;[0055]
• FIGS. 23, 24A, and[0056]24B are enlarged side views showing the deposition of electrically conductive material to establish fold lines on the exterior of an expandable electrode structure;
• FIG. 25 is a top view of an expandable electrode structure showing the preferred regions for attaching signal wires to an electrically conductive shell deposited on the distal end of the structure;[0057]
• FIG. 26 is a side view of an expandable electrode structure showing the preferred regions for attaching signal wires to an electrically conductive shell deposited in a circumferentially segmented pattern on the structure;[0058]
• FIG. 27 is a top view of an expandable electrode structure showing the preferred regions for attaching signal wires to an electrically conductive shell deposited in a bull's-eye pattern on the structure;[0059]
• FIGS. 28A and 28B are, respectively side section and top views showing the attachment of signal walls to an electrically conductive shell deposited on the distal end of the structure, the signal wires being led through the distal end of the structure;[0060]
• FIG. 29A is an enlarged side view of the distal end of an expandable electrode structure usable in association with the system shown in FIG. 1, showing the attachment of an ablation energy signal wire to the electrically conductive shell using a mechanical fixture at the distal end of the structure;[0061]
• FIG. 29B is an enlarged exploded side view, portions of which are in section, of the mechanical fixture shown in FIG. 29A;[0062]
• FIGS. 30 and 31 are side section views showing the attachment of a signal wire to an electrically conductive shell, the signal wire being snaked through the wall of the structure either one (FIG. 30) or multiple times (FIG. 31);[0063]
• FIG. 32 is an enlarged section view of the wall of an expandable electrode structure usable in association with the system shown in FIG. 1, showing the laminated structure of the wall and the attachment of an ablation energy signal wire to the electrically conductive shell using laser windowing techniques;[0064]
• FIG. 33 is a side view, with portions broken away and in section, of an expandable electrode structure usable in association with the system shown in FIG. 1, showing the attachment of a temperature sensing element to a fixture at the distal end of the structure;[0065]
• FIG. 34 is an enlarged side section view of the wall of an expandable electrode structure usable in association with the system shown in FIG. 1, showing ways of attaching temperature sensing elements inside and outside the wall;[0066]
• FIG. 35 is an enlarged side section view of the wall of an expandable electrode structure usable in association with the system shown in FIG. 1, showing a laminated structure and the creation of temperature sensing thermocouples by laser windowing and deposition;[0067]
• FIG. 36 is a top view of an expandable electrode structure showing the preferred regions for attaching temperature sensing elements with respect to an electrically conductive shell deposited on the distal end of the structure;[0068]
• FIG. 37 is a side view of an expandable electrode structure showing the preferred regions for attaching temperature sensing elements with respect to an electrically conductive shell deposited in a circumferentially segmented pattern on the structure;[0069]
• FIG. 38 is a top view of an expandable electrode structure showing the preferred regions for attaching temperature sensing elements with respect to an electrically conductive shell deposited in a bull's-eye pattern on the structure;[0070]
• FIG. 39 is a side view of an expandable electrode structure showing a pattern of holes for cooling the edge regions of an electrically conductive shell deposited in a circumferentially segmented pattern on the structure, the pattern of holes also defining a fold line between the segments of the pattern;[0071]
• FIGS. 40A and 40B are enlarged views of a hole formed in the structure shown in FIG. 39, showing that the hole defines a fold line;[0072]
• FIG. 41A is a side sectional view of an expandable electrode structure usable in association with the system shown in FIG. 1, which is capacitively coupled to tissue;[0073]
• FIG. 41B is a diagrammatic view showing the electrical path that ablation energy follows when the electrode shown in FIG. 40A is capacitively coupled to tissue;[0074]
• FIG. 42A is an side sectional view of an alternative expandable electrode structure usable in association with the system shown in FIG. 1, which is capacitively coupled to tissue;[0075]
• FIG. 42B is a diagrammatic view showing the electrical path that ablation energy follows when the electrode shown in FIG. 41A is capacitively coupled to tissue;[0076]
• FIG. 43 is a diagrammatic view of neural network usable for predicting maximum temperature conditions when the expandable-collapsible electrode structure carries multiple ablation energy transmitting segments; and[0077]
• FIG. 44 is a side elevation view of an expandable electrode structure that embodies the features of the invention, used in association with pacing and sensing electrodes.[0078]
• The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.[0079]
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• I. Overview of a System With an Expandable-Collapsible Electrode Structure[0080]
• FIG. 1 shows a[0081]tissue ablation system10 that embodies the features of the invention.
• The[0082]system10 includes aflexible catheter tube12 with aproximal end14 and adistal end16. Theproximal end14 carries ahandle18. Thedistal end16 carries anelectrode structure20, which embodies features of the invention. The purpose of theelectrode structure20 is to transmit ablation energy.
• As the embodiments of FIGS. 2 through 11 show in greater detail, the[0083]electrode structure20 includes an expandable-collapsible wall forming abody22. The geometry of thebody22 can be altered between an enlarged, or expanded, geometry having a first maximum diameter (depicted in various forms, for example, in FIGS. 2, 3,4,6, and11A) and a collapsed geometry having a second maximum diameter less than the first maximum diameter (depicted in various forms, for example, in FIGS. 5, 7,11B/C).
• This characteristic allows the expandable-[0084]collapsible body22 to assume a collapsed, low profile (ideally, less than8 French diameter, i.e., less than about 0.267 cm) when introduced into the vasculature. Once located in the desired position, the expandable-collapsible body22 can be urged into a significantly expanded geometry of, for example, approximately 7 to 20 mm.
• The expanded geometry of the[0085]body22, coupled with its inherent flexibility, significantly enhance the lesion creation characteristics of the electrode structure. Further details of the body and the ways to alter its geometry will be provided later.
• All or a portion of the wall forming the[0086]body22 carries an electrically conductive material that forms an electrode surface. As the embodiments shown FIGS. 2 through 11 show in greater detail, the electrically conductive material comprises an electricallyconductive shell24 overlying all or a portion of the expandable-collapsible body22. Theshell24 serves as the transmitter of energy that ablates body tissue. While the type of ablation energy used can vary, in the illustrated and preferred embodiment, theshell24 serves to transmit radio frequency (RF) electromagnetic energy.
• The[0087]shell24 is flexible enough to adopt to the range of geometries, from collapsed to expanded, that the expandable-collapsible body22 assumes. Still, theshell24 preferably resists stretching within this range, to thereby minimize “thinning.” Thinning of theshell24 creates localized changes to theshell24, with attendant increases in resistance and “hot spots.” For this reason, the elasticity of the expandable-collapsible body22 andshell24 should be selected to fall within acceptable bounds so that the ability to fold is retained while preserving stability during inflation. Further details of theenergy transmitting shell24 will be provided later.
• As will be shown in greater detail later (see FIGS.[0088]25 to32), theshell24 is coupled to one ormore signal wires26. Thesignal wires26 extend from theshell24, through thecatheter tube12, to external connectors28 on the handle18 (see FIG. 1). The connectors28 electrically couple theshell24 to aradio frequency generator30.
• In the preferred and illustrated embodiment (see FIG. 1), a[0089]controller32 is associated with thegenerator30, either as an integrated unit or as a separate interface box. Thecontroller32 governs the delivery of radio frequency ablation energy to theshell24 according to preestablished criteria. Further details of this aspect of thesystem10 will be described later.
• The[0090]system10 as just described is suited for ablating myocardial tissue within the heart. In this environment, a physician moves thecatheter tube12 through a main vein or artery into a heart chamber, while the expandable-collapsible body22 of theelectrode structure20 is in its low profile geometry. Once inside the desired heart chamber, the expandable-collapsible body22 is enlarged into its expanded geometry, and theshell24 is placed into contact with the targeted region of endocardial tissue. Radio frequency energy is conveyed from thegenerator30 to theshell24, as governed by thecontroller32. Theshell24 transmits radio frequency energy into tissue to a return electrode, which is typically an external patch electrode (forming a unipolar arrangement). Alternatively, the transmitted energy can pass through tissue to an adjacent electrode in the heart chamber (forming a bipolar arrangement), or between segments in theshell24, as will be described later (also forming a bipolar arrangement). The radio frequency energy heats the tissue forming a lesion.
• The expanded geometry of the expandable-[0091]collapsible body22 enhances the energy transmission characteristics of thestructure20. Thestructure20, when expanded, is able to form tissue lesions that are significantly larger in terms of size and volume than the body's initial collapsed profile during introduction would otherwise provide.
• It should also be appreciated that the expandable-[0092]collapsible electrode structure20 as just described is also suited for mapping myocardial tissue within the heart. In this use, theshell24 senses electrical activity in the heart. The sensed electrical activity is conveyed to an external monitor, which processes the potentials for analysis by the physician. The use of an expandable-collapsible electrode structure for this purpose is generally disclosed in Edwards et al. U.S. Pat. No. 5,293,869.
• It should also be appreciated that the expandable-[0093]collapsible electrode structure20 can be used alternatively, or in combination with sensing electrical activities, to convey pacing signals. In this way, thestructure20 can carry out pace mapping or entrainment mapping. The expandedelectrode structure20 can also be used to convey pacing signals to confirming contact with tissue before ablating. The ability to carry out pacing to sense tissue contact is unexpected, given that the expandedstructure20 presents a surface area significantly greater than that presented by a conventional 4 mm/8 Felectrode.
• As FIG. 44 shows, the[0094]catheter tube20 can also carry one or moreconventional ring electrodes21 for bipolar sensing. A conventional pacing orunipolar sensing electrode23 may also be provided, appended at the distal end of thestructure20.
• II. The Expandable-Collapsible Body[0095]
• The expandable-[0096]collapsible body22 is made from a material selected to exhibit the following characteristics:
• (i) the material must be capable, in use, of transition between an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first diameter. In this respect, the material can be formed into an expandable-collapsible bladder or balloon body having an open interior. The body is flexible enough to assume the expanded geometry as a result of a normally open solid support structure within the interior, or the opening of a normally closed support structure within the interior, or the introduction of fluid pressure into the interior, or a combination of such interior forces. In this arrangement, the body is caused to assume the collapsed geometry by an exterior compression force against the normally open interior support structure, or the closing of the interior support structure, or the removal of the interior fluid pressure, or a combination of such offsetting forces. Alternatively, the material can be a preformed body with a memory urging it toward a normally expanded geometry. In this arrangement, the preformed body is caused to assume the collapsed geometry by the application of an external compression force. In this arrangement, the preformed body can have an open interior, or can comprise, for example, a collapsible composite foam structure.[0097]
• (ii) the material must be biocompatible and able to withstand high temperature conditions, which arise during manufacture and use.[0098]
• (iii) the material must possess sufficient strength to withstand, without rupture or tearing, external mechanical or fluid forces, which are applied to support and maintain its preformed geometry during use.[0099]
• (iv) the material must lend itself to attachment to the[0100]catheter tube12 through the use of straightforward and inexpensive adhesive, thermal, or mechanical attachment methods.
• (v) the material must be compatible with the electrically[0101]conductive shell24 to achieve secure adherence between the two.
• Thermoplastic or elastomeric materials that can be made to meet these criteria include polyimide. (kapton), polyester, silicone rubber, nylon, mylar, polyethelene, polyvinyl chloride, and composite structures using these and other materials.[0102]
• The incidence of tissue sticking to the exterior of the[0103]body22 during use can be mediated by the inclusion of low friction materials like PTFE. The propensity of the exterior of thebody22 to cause blood clotting and/or embolization can be reduced by incorporating non-thrombogenic material onto or into the exterior of thebody22.
• Polyimide is particularly preferred for the expandable-collapsible body. Polyimide is flexible, but it is not elastic. It can withstand very high temperatures without deformation. Because polyimide is not elastic, it does not impose stretching forces to the shell, which could lead to electrical conductivity decreases, as above described.[0104]
• The expandable-[0105]collapsible body22 can be formed about the exterior of a glass mold. In this arrangement, the external dimensions of the mold match the desired expanded internal geometry of the expandable-collapsible body22. The mold is dipped in a desired sequence into a solution of the body material until the desired wall thickness is achieved. The mold is then etched away, leaving the formed expandable-collapsible body22.
• Various specific geometries, of course, can be selected. The preferred geometry is essentially spherical and symmetric, with a distal spherical contour, as FIGS.[0106]2 to11 show in various forms. However, nonsymmetric geometries can be used. For example, the expandable-collapsible body22 may be formed with a flattened distal contour, which gradually curves or necks inwardly for attachment with thecatheter tube12.
• The expandable-[0107]collapsible body22 may also be blow molded from extruded tube. In this arrangement, thebody22 is sealed at one end using a mechanical clamp, adhesive, or thermal fusion. The opposite open end of thebody22 is left open. The sealed expandable-collapsible body22 is placed inside the mold. An inflation medium, such as high pressure gas or liquid, is introduced through the open tube end. The mold is exposed to heat as thetube body22 is inflated to assume the mold geometry. The formed expandable-collapsible body22 is then pulled from the mold.
• A. Expansion Using Interior Fluid Pressure[0108]
• In the embodiments shown in FIGS. 2 and 3A/B/C, fluid pressure is used to inflate and maintain the expandable-[0109]collapsible body22 in the expanded geometry.
• In this arrangement, the[0110]catheter tube12 carries aninterior lumen34 along its length. The distal end of thelumen34 opens into the hollow interior of the expandable-collapsible body22, which has been formed in the manner just described. The proximal end of thelumen34 communicates with a port36 (see FIG. 1) on thehandle18.
• An inflation fluid medium ([0111]arrows38 in FIG. 2) is conveyed under positive pressure through theport36 and into thelumen34. Thefluid medium38 fills the interior of the expandable-collapsible body22. Thefluid medium38 exerts interior pressure to urge the expandable-collapsible body22 from its collapsed geometry to the enlarged geometry desired for ablation.
• The inflating fluid medium[0112]38 can vary. Preferably, it comprises a liquid such as water, saline solution, or other biocompatible fluid. Alternatively, the inflating fluid medium38 can comprise a gaseous medium such as carbon dioxide or air.
• Regardless of the type of fluid medium[0113]38, the inflation preferably occurs under relatively low pressures of up to 30 psi. The pressure used depends upon the desired amount of inflation, the strength and material used for thebody22, and the degree of flexibility required, i.e., high pressure leads to a harder, lessflexible body22.
• More than one[0114]fluid conveying lumen34 may be used. Themultiple lumens34 can, for example, speed up the introduction or removal of the inflatingmedium38 from thebody22. Multiple lumens can also serve to continuously or intermittently recycle the inflatingmedium38 within thebody22 for controlling the temperature of the body, as will be described in greater detail later. Multiple lumens can also be used, with at least one of the lumens dedicated to venting air from thestructure20.
• In an alternative embodiment shown in FIG. 3A, a group of sealed bladders compartmentalize the interior of the formed body into[0115]chambers40. One or more lumens42 passing through thecatheter tube12 convey the inflating gas or liquid medium38 into eachchamber40, as described above. Theinflated chambers40 collectively hold the expandable-collapsible body22 in its expanded condition. Removal of theinflation medium38 deflates thechambers40, collapsing the expandable-collapsible body22.
• The bladders defining the[0116]chambers40 may be separately formed by molding in generally the same fashion as the main expandable-collapsible body22. The bladder material need not have the same resistance to high temperature deformation as the expandable-collapsible body22. If desired, the bladders may also be deposition coated with a thermal insulating material to thermally insulate them from the main expandable-collapsible body22.
• Alternatively, as FIGS. 3B and 3C show, the[0117]interior chambers40 can take the form of tubular, circumferentially spacedribs41 attached to the interior of thebody22. In this arrangement, theribs41 preferable constitute integrally molded parts of thebody22.
• As explained in connection with the FIG. 3A embodiment, a single lumen may service all[0118]chambers ribs41. However, multiple lumens individually communicating with eachrib41 provide the ability to more particularly control the geometry of the expandedbody22, by selectively inflating some but not all theribs41 orchambers40.
• As FIG. 3E shows, the[0119]body22 may be extruded withinterior webs43. When the body is in its expanded geometry, theinterior webs43 compartmentalize thebody22 into theinterior chambers40, as already described. As before described, multiple lumens preferably individually communicate with each formedchamber40 for conveying inflation medium and for venting air.
• As FIG. 3D shows, a separate, single[0120]interior chamber124 can be used instead of thecompartmentalized chambers40 orribs41 shown in FIGS. 3A, 3B, and3C to receive the inflation medium for theexterior body22. As will be described in greater detail later, this arrangement creates anintermediate region126 between the interior of thebody22 and the exterior of thechamber124, through whichsignal wires26 can be passed for coupling to theshell24.
• B. Interior Support Structures[0121]
• In the embodiments shown in FIGS.[0122]4 to7, collapsible,interior structures44 sustain the expandable-collapsible body22 in the expanded geometry. The presence of theinterior support structure44 eliminates the need to introduce air or liquid as aninflation medium38. Possible difficulties of fluid handling and leakage are thereby avoided.
• In the embodiment shown in FIGS. 4 and 5, the expandable-[0123]collapsible body22 is held in its expanded geometry by an openinterior structure44 formed by an assemblage offlexible spline elements46. Thespline elements46 are made from a resilient, inert wire, like nickel titanium (commercially available as Nitinol material), or from a resilient injection molded inert plastic or stainless steel. Thespline elements46 are preformed in a desired contour and assembled to form a three dimensional support skeleton, which fills the interior space of the expandable-collapsible body22.
• In this arrangement, the supported expandable-[0124]collapsible body22 is brought to a collapsed geometry by outside compression applied by an outer sheath48 (see FIG. 5), which slides along thecatheter tube12. As FIG. 5 shows, forward movement of thesheath48 advances it over the expanded expandable-collapsible body22. The slidingsheath48 encompasses the expandable-collapsible body22, compressing theinterior spline elements46 together. The expandable-collapsible body22 collapses into its low profile geometry within thesheath48.
• Rearward movement of the sheath[0125]48 (see FIG. 4) retracts it away from the expandable-collapsible body22. Free from the confines of thesheath48, theinterior support structure44 ofspline elements46 springs open into the three dimensional shape. The expandable-collapsible body22 returns to its expanded geometry upon thespline elements46.
• In an alternative embodiment, as FIGS. 6 and 7 show, the expandable-[0126]collapsible body22 is supported upon a closed, threedimensional structure44 formed by a resilient mesh50. The mesh structure50 is made from interwoven resilient, inert wire or plastic filaments preformed to the desired expanded geometry. The mesh structure50 provides interior support to hold the expandable-collapsible body22 in its expanded geometry, in the same way as the open structure ofspline elements46 shown in FIG. 4.
• As FIG. 7 further shows, a sliding sheath[0127]48 (as previously described) can also be advanced along thecatheter tube12 to compress the mesh structure50 to collapse mesh structure50 and, with it, the expandable-collapsible body22. Likewise, retraction of thesheath48 removes the compression force (as FIG. 6 shows), and the freed mesh structure50 springs open to return the expandable-collapsible body22 back to its expanded geometry.
• By interweaving the mesh filaments close enough together, the mesh structure[0128]50 itself could serve as the support for the electricallyconductive shell24, without need for the intermediate expandable-collapsible body22. Indeed, all or a portion of the mesh filaments could be made electrically conductive to themselves serve as transmitters of ablation energy. This arrangement of interwoven, electrically conductive filaments could supplement or take the place of the electricallyconductive shell24.
• Alternatively, as FIG. 8 shows, the mesh structure[0129]50 can be made to normally assume the collapsed geometry. In this arrangement, one or moreinterior bladders126 can accommodate the introduction of an inflation medium to cause the mesh structure50 to assume the expanded geometry.
• If the mesh structure[0130]50 is tightly woven enough to be essentially liquid impermeable , theinterior bladder126 could be eliminated. In this arrangement, the introduction of a biocompatible liquid, such as sterile saline, directly into the interior of the structure50 would cause the structure to assume the expanded geometry.
• FIG. 9 shows yet another alternative expandable-collapsible structure. In this embodiment, a[0131]foam body128 molded to normally assume the shape of the expanded geometry forms the interior support structure for thebody22. As with theinterior structures44, the presence of thefoam body128 eliminates the need to introduce air or liquid as an inflation medium. Also like theinterior structures44, a sliding sheath (not shown but as previously described) can be advanced along thecatheter tube12 to compress thefoam body128 andoverlying body22 into the collapsed geometry. Likewise, retraction of the sheath removes the compression force. Thefoam body128, free of the sheath, springs open to return the expandable-collapsible body22 back to the expanded geometry. It should be appreciated that thefoam body128 can provide interior, normally expanded support to the mesh structure50 in the same way.
• As FIG. 10 shows, the geometry of the expandable-[0132]collapsible body22 can be controlled electrically. This arrangement includes an assemblage ofspline elements132 within thebody22. Thespline elements132 are made of a material that undergoes shape or phase change in response to heating. Nickel titanium wire is a material having this characteristic. Alternatively, thespline elements132 could comprise an assembly of two metals having different coefficients of expansion.
• The[0133]body22 overlies thespline elements132. Thespline elements132 are coupled to an electricalcurrent source134. Current flow from thesource134 through thespline elements132 resistively heats theelements132. As a result, thespline elements132 change shape.
• As FIG. 10 shows, the[0134]spline elements132 normally present the collapsed geometry. Current flow through thespline elements132 causes expansion of theelements132, thereby creating the expanded geometry (as shown by arrows and phantom lines in FIG. 10). It should be appreciated that thespline elements132 could alternatively normally present the expanded geometry and be made to contract, thereby assuming the collapsed geometry, in response to current flow.
• C. Folding[0135]
• In all the representative embodiments, the expandable-[0136]collapsible body22 can be molded with preformed regions52 (see FIGS.11A/B/C) of reduced thickness, forming creases. To create thesecrease regions52, the mold has a preformed surface geometry such that the expandable-collapsible material would be formed slightly thinner, indented, or ribbed along the desiredregions52. Alternatively, the use ofinterior coextruded webs43, as FIG. 3E shows, also serves to form thecrease regions52 along the area where thewebs43 contact the interior wall of thebody22.
• As FIGS.[0137]11B/C show, the expandable-collapsible body22 collapses about theseregions52, causing thebody22 to circumferentially fold upon itself in a consistent, uniform fashion. The resulting collapsed geometry can thus be made more uniform and compact.
• In the embodiments where an[0138]inflation medium38 applies positive pressure to expand the expandable-collapsible body22, a negative fluid pressure can be applied inside the expandable-collapsible body22 to draw thefold regions52 further inward. In the embodiment where theinterior structure44 ofopen spline elements46 supports the expandable-collapsible body22, thefold regions52 are preferably aligned in the spaces between thespline elements46 to take best advantage of the prearranged folding action.
• Alternative ways of creating[0139]fold regions52 in thebody22 will be described in greater detail later.
• D. Steering[0140]
• In the illustrated and preferred embodiment, a distal steering mechanism[0141]54 (see FIG. 1) enhances the manipulation of theelectrode structure20, both during and after deployment.
• The[0142]steering mechanism54 can vary. In the illustrated embodiment (see FIG. 1), thesteering mechanism54 includes a rotating cam wheel56 coupled to anexternal steering lever58 carried by thehandle18. The cam wheel56 holds the proximal ends of right and leftsteering wires60. Thewires60 pass with the ablationenergy signal wires26 through thecatheter tube12 and connect to the left and right sides of a resilient bendable wire orleaf spring62 adjacent the distal tube end16 (see FIG. 12). Further details of this and other types of steering mechanisms are shown in Lundquist and Thompson U.S. Pat. No. 5,254,088, which is incorporated into this Specification by reference.
• In FIG. 12, the[0143]leaf spring62 is carried within in thedistal end16 of thecatheter tube12, to which theelectrode structure20 is attached. As FIGS. 1 and 12 show, forward movement of the steeringlever58 pulls on onesteering wire60 to flex or curve theleaf spring62, and, with it, thedistal catheter end16 and theelectrode structure20, in one direction. Rearward movement of the steeringlever58 pulls on theother steering wire60 to flex or curve theleaf spring62, and, with it, thedistal catheter end16 and theelectrode structure20, in the opposite direction.
• In FIG. 13, the[0144]leaf spring62 is part of adistal fixture66 carried within theelectrode structure20 itself. In this arrangement, theleaf spring62 extends beyond thedistal catheter end16 within atube64 inside the expandable-collapsible body22. The distal end of theleaf spring62 is secured to adistal fixture66. Thedistal fixture66 is itself attached to the distal end of thebody22. Further details of attaching thefixture66 to the distal end of thebody22 will be described in greater detail later.
• As FIG. 13 shows, forward movement of the steering[0145]lever58 bends theleaf spring62 in one direction within the expandable-collapsible body22, deflecting thedistal fixture66 with it. This deforms the expandable-collapsible body22 in the direction that theleaf spring62 bends. Rearward movement of the steeringlever58 bends theleaf spring62 in the opposite direction, having the opposite deformation effect upon the expandable-collapsible body22.
• In either arrangement, the[0146]steering mechanism54 is usable whether the expandable-collapsible body is in its collapsed geometry or in its expanded geometry.
• E. Push-Pull Stiletto[0147]
• In FIG. 14, a[0148]stilette76 is attached to thedistal fixture66. The stilette extends inside thebody22, through thecatheter tube12, to a suitable push-pull controller70 on the handle18 (see FIG. 1). Thestilette76 is movable along the axis of thecatheter tube12. Moving thestilette76 forward pushes axially upon thedistal fixture66. Moving thestilette76 rearward pulls axially upon thedistal fixture66. The geometry of thebody22 elongates or expands accordingly.
• The[0149]stilette76 can be used in association with an expandable-collapsible body22 that is expanded by aninflation medium38. In this arrangement, when the expandable-collapsible body22 is collapsed, forward movement of thestilette76, extends thedistal fixture66 to further urge the expandable-collapsible body22 into a smaller diameter profile for introduction.
• When used in association with an expandable-[0150]collapsible body22 that is internally supported by thespline structure46 or the mesh structure50, thestilette76 can be used instead of the slidableouter sheath48 to expand and collapse the expandable-collapsible body22. Pushing forward upon thestilette76 extends thespline structure46 or mesh structure50 to collapse the expandable-collapsible body22. Pulling rearward upon thestilette76, or merely releasing the pushing force, has the opposite effect, allowing thespline structure46 or mesh structure50 to assume its expanded geometry.
• When used with either inflated or mechanically expanded expandable-[0151]collapsible bodies22, pulling rearward upon thestilette76 also has the effect of altering the expanded geometry by flattening the distal region of the expandable-collapsible body22.
• While the[0152]stilette76 can be used by itself, in the illustrated embodiment (see FIG. 14), the distal end of thestilette76 near thefixture66 comprises thebendable leaf spring62, thereby providing a radial steering function in tandem with the axial push-pull action of thestilette76.
• There are various ways to combine the[0153]steering mechanism54 with thestilette76. In the illustrated embodiment, acollar136 is retained by a heat-shrink fit withintubing64. Thecollar136 has acentral aperture138 through which aleaf spring62 at the end of the stilette76 passes for movement along the axis of thecatheter tube12.Steering wires60 are attached to thecollar136. Pulling on thesteering wires60 radially deflects thecollar136, thereby bending theleaf spring62 at the end of thestilette76 in the direction of the pulledsteering wire60.
• F. Attachment to Catheter Tube[0154]
• A sleeve[0155]78 (see, e.g., FIG. 2) couples the near end of the expandable-collapsible body22 to thedistal end16 of the catheter tube. Thesleeve78 withstands the forces exerted to expand the expandable-collapsible body22, resisting separation of thebody22 from thecatheter tube12. In FIG. 2, where aninflation medium38 is used, thesleeve78 also forms a fluid seal that resists leakage of the medium at inflation pressures.
• The[0156]sleeve78 can be secured about the catheter tube in various ways, including adhesive bonding, thermal bonding, mechanical bonding, screws, winding, or a combination of any of these.
• FIGS. 15A to[0157]15E show the details of a preferred assembly process for an expandable-collapsible body22 whose geometry is altered by use of fluid pressure, such as previously shown in FIGS. 2 and 3. Thebody22 is extruded as atube140 having an extruded interior diameter, designated ID₁(see FIG. 15A) . The extruded interior diameter ID₁is selected to be less than the exterior diameter of thedistal stem142 of thecatheter tube12 to which thebody22 will ultimately be attached.
• As FIG. 15D shows, the[0158]stem142 comprises an elongated, stepped-down tubular appendage, which extends beyond thedistal end16 of thecatheter tube12. The distal end of thestem142 is sealed. The exterior diameter of thestem142 is designated in FIG. 15D as ED_S. Thestem142 includes acentral lumen152 for carrying inflation medium. Spaced apart holes154 on thestem142 communicate with the lumen to convey the inflation medium into thebody22, when attached to thestem142.
• As FIG. 15A shows, the material of the extruded[0159]tube140 is preferably cross linked by exposure togamma radiation168 or an equivalent conventional treatment. The cross linking enhances the capability of the material of thetube140 to recover its shape after mechanical deformation.
• After cross linking, the extruded[0160]tube140 is mechanically deformed by heat molding into thebody22 having the desired collapsed geometry, in a manner previously described. The body geometry (see FIG. 15B) includes proximal anddistal neck regions144 and146 and an intermediatemain body region148. Theneck regions144 and146 have an enlarged interior diameter (designated ID₂in FIG. 15B) that is slightly greater than catheter stem diameter ED_S, to permit a slip fit of thebody22 over thestem142. The intermediatemain body region148 has an enlarged exterior diameter selected for the collapsed geometry of thebody22. To preserve the desired wall thickness, the enlarged exterior diameter of thetube140 should be about twice the original extruded outer diameter of thetube140.
• As FIG. 15C shows, the tubing ends[0161]150 extending beyond theneck regions144 and146 are cut away. As FIG. 15D shows, thebody22 is slip fitted over thestem142. Heat is applied to shrink fit theneck regions144 and146 about the stem142 (see FIG. 15E). Due to molding, the memory of theseregions144 and146, when heated, seek the original interior diameter ID₁of thetubing140, thereby proving a secure interference fit about thestem142.
• Preferably, after forming the interference fit between the[0162]neck regions144 and146 and thestem142, additional heat is provided to thermally fuse theregions144 and146 to thestem142. Last, thesleeve78 is heat-shrunk in place about the proximal neck region144 (see FIG. 15E). Thesleeve78 can comprise a heat-shrink plastic material or phase changeable metal material, like nickel titanium. Alternatively, thesleeve78 can be heat-shrunk into place without an intermediate thermal fusing step.
• FIGS. 16A to[0163]16D show the details of a preferred assembly process for an expandable-collapsible body22 whose geometry is altered by use of aninterior support structure44 ofspline elements46, such as previously shown in FIGS. 4 and 5. After heat molding thebody22 in the manner shown in FIGS. 15A to15C, thedistal neck region146 is secured by heat shrinking about the distal fixture66 (see FIG. 16A). As FIG. 16A shows, thedistal fixture66 has, preattached to it, the distal end of thespline element structure44, as well as any desiredsteering mechanism54,stilette76, or combination thereof (not shown in FIGS. 16A to16D). When initially secured to thefixture66, themain region148 of thebody22 is oriented in a direction opposite to thespline element structure44.
• After securing the[0164]distal neck region146 to thefixture66, as just described, thebody22 is everted about thedistal fixture66 over the spline element structure44 (see FIG. 16B). The proximal end of thespline element structure44 is secured to ananchor156 carried by the distal catheter end16 (see FIG. 16C), and the evertedproximal neck region144 is then slip fitted over thecatheter stem158. As FIG. 16C shows, thecatheter stem158 in this arrangement does not extend beyond theneck region144 of thebody22.
• Heat is then applied to shrink fit the[0165]neck region144 about the stem158 (see FIG. 16D). Preferably, after forming this interference fit between theneck region144 and thestem158, additional heat is provided to thermally fuse theregion144 to thestem158. Last, thesleeve78 is heat-shrunk in place about theproximal neck region144. Alternatively, thesleeve78 can be heat-shrunk into place without an intermediate thermal fusing step.
• III. The Electrically conducting Shell[0166]
• The purpose of the electrically conducting[0167]shell24 is to transmit ablation energy, which in the illustrated and preferred embodiment comprises electromagnetic radio frequency energy with a frequency below about 1.0 GHz. This type of ablating energy heats tissue, mostly ohmically, to form lesions without electrically stimulating it. In this arrangement, theshell24 should possess the characteristics of both high electrical conductivity and high thermal conductivity. It should also be appreciated that theshell24 could form an antenna for the transmission of higher frequency microwave energy.
• By altering the size, location, and pattern of the[0168]shell24, along with adjusting the power level and time that the radio frequency ablation energy is transmitted, theelectrode structure20 is able to create lesions of different size and geometries.
• A. Shell Geometry (Thermal Convective Cooling)[0169]
• In one application, the shell creates lesion patterns greater than about 1.5 cm deep and/or about 2.0 cm wide. These lesion patterns are significantly deeper and wider than those created by conventional 8 F diameter/4 mm long electrodes, which are approximately 0.5 cm deep and 10 mm wide. The deeper and wider lesion patterns that the[0170]shell24 can provide are able to destroy epicardial and intramural ventricular tachycardia (VT) substrates.
• As the following Example shows, the size and location of the[0171]shell24 on the expandable-collapsible body22, when expanded, significantly affects the size and geometry of the lesions formed by transmitting radio frequency ablation energy.
EXAMPLE 1
• Finite element analysis was performed for a flexible, expanded[0172]electrode structure20 having a 1.4 cm diameter and a wall thickness of approximately 200 μm. The model assumed a 100 μm thick coating of gold over the distal hemisphere of thestructure20, forming the electricallyconductive shell24. The constraint for the model was a lower limit on thickness and therefore the thermal conductivity of theshell24.
• For the model, the percent of electrically[0173]conductive shell24 in contact with myocardial tissue, with the balance exposed to blood, was changed from 5%, 20%, 41%, and 100% tissue contact. Time and power of energy transmission were also varied. Power was changed to keep the maximum temperature of tissue under theshell24 at 90° C. Maximum lesion depth, width, and volume were measured.
• The following Table 1 presents the results:[0174]

  TABLE 1
  LESION GEOMETRY AS A FUNCTION OF
  TISSUE vs. BLOOD CONTACT WITH THE
  ELECTRICALLY CONDUCTIVE SHELL

  %
  Tis-
  sue					Lesion	Lesion	Lesion
  Con-	Temp.	Voltage	Current	Power	Depth	Width	Volume
  tact	(° C.)	(Volts)	(Amps)	(Watts)	(cm)	(cm)	(cm2)

  <5%	92.1	84	1.67	140	2.1	5.4	36
  20%	89.7	81	1.55	125	2.5	4.9	41
  41%	89.6	77	1.4	107	2.3	3.5	17
  100%	92.3	61	0.92	56	1.4	2.6	7

• The lesions created in the above Table 1 are capable of making transmural lesions in the left ventricle and can therefore ablate epicardial VT substrates. The Table 1 shows that lesion size increases with an electrically[0175]conductive shell24 presenting less percentage contact with tissue than blood. The shell presenting 100% contact with tissue (and none with blood), compared to theshell24 presenting up to 41% percent of its surface to tissue had lower lesion depths.
• With less relative contact with tissue than blood, the[0176]shell24 is more exposed to the blood pool and its convective cooling effect. The blood cools theshell24 it contacts. Heat is lost from tissue under theshell24 into the blood pool. This emulation of active cooling of theshell24 causes more power to be transmitted to the tissue before maximum tissue temperatures are achieved, thereby creating larger lesions.
• Table 1 highlights the importance of relatively high thermal conductivity for the[0177]shell24, which can be achieved by material selection and controlling thickness. Given the same percentage contact with tissue versus blood, a higher thermal conductivity results in a higher cooling effect and a corresponding increase in lesion size.
• The above Table 1 demonstrates the ability of the[0178]structure20 carrying theshell24 to transmit the proper amount of radio frequency energy to create large and deep lesions.
• Additional tests were performed using[0179]shells24 with a desirable lower percentage contact with tissue relative to blood (less than 50%). These tests varied the time of ablation energy transmission to gauge the effect upon lesion size.
• The following Table 2 presents the results:[0180]

  TABLE 2
  LESION GEOMETRY AS A FUNCTION OF TIME OF
  ABLATION ENERGY TRANSMISSION, GIVEN THE
  SAME TISSUE vs. BLOOD CONTACT WITH THE
  ELECTRICALLY CONDUCTIVE SHELL

  % Tissue	Power	Time	Lesion	Lesion
  Contact	(Watts)	(Sec.)	Depth (cm)	Width (cm)

  5%	110	25	0.5	1.6
  5%	110	60	1.2	2.4
  41%	67	25	0.35	1.4
  41%	67	60	0.9	2.0

• The above Table 2 demonstrates the ability of the structure carrying the[0181]shell24 to transmit the proper amount of radio frequency energy to create wide and shallow lesions. The effect is achieved by controlling both the delivered radio frequency power and the time of radio frequency energy application. Wide and shallow lesion patterns are effective in the treatment of some endocardially located substrates and atrial fibrillation substrates.
• Tables 1 and 2 demonstrate the capability of the same expandable-[0182]collapsible electrode structure20 with the desirable lower percentage contact with tissue relative to blood (less than 50%) to ablate epicardial, intramural, or endocardial substrates with a range of lesion patterns from wide and shallow to large and deep.
• B. Surface Deposition of Shell[0183]
• The electrically[0184]conductive shell24 may be deposited upon the exterior of the formed expandable-collapsible body22.
• In this embodiment, a mask is placed upon the surface of the expandable-[0185]collapsible body22 that is to be free of theshell24. Preferably, as generally shown in FIG. 17, theshell24 is not deposited on at least the proximal ⅓rd surface of the expandable-collapsible body22. This requires that at least the proximal ⅓rd surface of the expandable-collapsible body22 be masked, so that no electrically conductive material is deposited there.
• The masking of the at least proximal ⅓rd surface of the expandable-[0186]collapsible body22 is desirable for several reasons. This region is not normally in contact with tissue, so the presence of electrically conductive material serves no purpose. Furthermore, this region also presents the smallest diameter. If electrically conductive, this region would possess the greatest current density, which is not desirable. Masking the proximal region of smallest diameter, which is usually free of tissue contact, assures that the maximum current density will be distributed at or near the distal region of the expandable-collapsible body22, which will be in tissue contact. The presence of thesteering mechanism54, already described, also aids in placing the shell-carrying distal tip in tissue contact.
• The[0187]shell24 comprises a material having a relatively high electrical conductivity, as well as a relative high thermal conductivity. Materials possessing these characteristics include gold, platinum, platinum/iridium, among others. These materials are preferably deposited upon the unmasked, distal region of the expandable-collapsible body22. Usable deposition processes include sputtering, vapor deposition, ion beam deposition, electroplating over a deposited seed layer, or a combination of these processes.
• Preferably (see FIG. 17), to enhance adherence between the expandable-[0188]collapsible body22 and theshell24, anundercoating80 is first deposited on the unmasked distal region before depositing theshell24. Materials well suited for theundercoating80 include titanium, iridium, and nickel, or combinations or alloys thereof.
• The total thickness of the[0189]shell24 deposition, including theundercoating80, can vary. Increasing the thickness increases the current-carrying and thermal conductive capacity of theshell24. However, increasing the thickness also increases the potential of shell cracking or peeling during enlargement or collapse of the underlying expandable-collapsible body22.
• In a preferred embodiment, the deposition of the electrically conductive shell material should normally have a thickness of between about 5 μm and about 50 μm. The deposition of the[0190]adherence undercoating80 should normally have a thickness of about 1 μm to about 5 μm.
• C. Foil Shell Surface[0191]
• In an alternative embodiment (see FIG. 18), the[0192]shell24 comprises a thin sheet or foil82 of electrically conductive metal affixed to the wall of the expandable-collapsible body22. Materials suitable for the foil include platinum, platinum/iridium, stainless steel, gold, or combinations or alloys of these materials. Thefoil82 is shaped into a predetermined geometry matching the geometry of the expandable-collapsible body22, when expanded, where thefoil82 is to be affixed. The geometry of themetal foil82 can be accomplished using cold forming or deep drawing techniques. Thefoil82 preferably has a thickness of less than about 0.005 cm (50 μm). Thefoil82 is affixed to the expandable-collapsible body22 using an electrically insulating epoxy, adhesive, or the like.
• The[0193]shell24 offoil82 offers advantages over the depositedshell24. For example, adherence of theshell foil82 upon the expandable-collapsible body22 can be achieved without using the depositedundercoating80. Theshell foil82 also aids in the direct connection ofablation energy wires26, without the use of additional connection pads and the like, as will be described in greater detail later. Theshell foil82 also offers greater resistance to stretching and cracking in response to expansion and collapse of the underlying expandable-collapsible body22. This offers greater control over resistance levels along the ablation energy transmitting surface.
• D. Co-Extruded Electrically Conductive Shell[0194]
• In an alternative embodiment (see FIG. 19), all or a portion of the expandable-collapsible wall forming the[0195]body22 is extruded with an electricallyconductive material84.Materials84 suitable for coextrusion with the expandable-collapsible body22 include carbon black and chopped carbon fiber. In this arrangement, the coextruded expandable-collapsible body22 is itself electrically conductive. Anadditional shell24 of electrically conductive material can be electrically coupled to thecoextruded body22, to obtain the desired electrical and thermal conductive characteristics. The extraexternal shell24 can be eliminated, if thecoextruded body22 itself possesses the desired electrical and thermal conductive characteristics.
• The integral electrically conducting[0196]material84 coextruded into thebody22 offers certain advantages over the external deposited shell24 (FIG. 17) or shell foil82 (FIG. 18). Coextrusion avoids the necessity of adherence between theshell24 and the expandable-collapsible body22. Abody22 coextruded with electrically conductingmaterial84 also permits more direct connection ofablation energy wires34, without the use of additional connection pads and the like. The integrated nature of thecoextruded material84 in thebody22 protects against cracking of the ablation energy transmitting surface during expansion and collapse of the expandable-collapsible body22.
• The integral electrically conducting[0197]material84 coextruded into thebody22 also permits the creation of a family ofelectrode structures20, with thestructures20 differing in the amount ofconductive material84 coextruded into the wall of therespective body22. The amount of electrically conductive material coextruded into a givenbody22 affects the electrical conductivity, and thus the electrical resistivity of thebody22, which varies inversely with conductivity. Addition of more electrically conductive material increases electrical conductivity of thebody22, thereby reducing electrical resistivity of thebody22, and vice versa. It is thereby possible to specify among the family ofstructures20 having electricallyconductive bodies22, the use of a givenstructure20 according to a function that correlates desired lesion characteristics with the electrical resistivity values of the associatedbody22.
EXAMPLE 2
• A three-dimensional finite element model was created for an electrode structure having a body with an elongated shape, with a total length of 28.4 mm, a diameter of 6.4 mm, and a body wall thickness of 0.1 mm. The body of the structure was modeled as an electric conductor. Firm contact with cardiac tissue was assumed along the entire length of the electrode body lying in a plane beneath the electrode. Contact with blood was assumed along the entire length of the electrode body lying in a plane above the electrode. The blood and tissue regions had resistivities of 150 and 500 ohm.cm, respectively.[0198]
• Analyses were made based upon resistivities of 1.2 k-ohm.cm and 12 k-ohm.cm for the electrode body.[0199]
• Table 3 shows the depth of the maximum tissue temperature when RF ablation power is applied to the electrode at various power levels and at various levels of resistivity for the body of the electrode.[0200]

  TABLE 3
  				Depth of
  			Maximum	Maximum
  Resistivity of			Tissue	Tissue
  the Body	Power	Time	Temperature	Temperature
  (k-ohm·cm)	(Watts)	(Sec)	(° C.)	(cm)

  1.2	58	120	96.9	1.1
  1.2	58	240	97.9	1.4
  12	40	120	94.4	0.8
  12	40	240	95.0	1.0

• The electrode body with higher resistivity body was observed to generate more uniform temperature profiles, compared to a electrode body having the lower resistivity value. Due to additional heating generated at the tissue-electrode body interface with increased electrode body resistivity, less power was required to reach same maximal temperature. The consequence was that the lesion depth decreased.[0201]
• Therefore, by specifying resistivity of the[0202]body22, the physician can significantly influence lesion geometry. The use of a low-resistivity body22 results in deeper lesions, and vice versa. The following Table 4, based upon empirical data, demonstrates the relationship between body resistivity and lesion depths.

  TABLE 4
  Resistivity	Power	Temperature	Lesion Depth
  (ohm·cm)	(Watts)	(° C.)	(cm)	Time (sec)

  850	94	97	1.2	120
  1200	58	97	1.1	120
  12,000	40	95	0.8	120

• E. shell Patterns[0203]
• When it is expected that ablation will occur with the distal region of[0204]body22 oriented in end-on contact with tissue, theshell24 should, of course, be oriented about the distal tip of the expandable-collapsible body22. For this end-on orientation, theshell24 may comprise a continuous cap deposited upon the distal ⅓rd to ½ of thebody22, as FIG. 17 shows. However, when distal contact with tissue is contemplated, the preferred embodiment (see FIG. 20) segments the electricallyconductive shell24 into separateenergy transmission zones122 arranged in a concentric “bull's-eye” pattern about the distal tip of thebody22.
• The concentric bull's-[0205]eye zones122 are formed by masking axially spaced bands on the distal region of thebody22, to thereby segment the deposit of the electricallyconductive shell24 into theconcentric zones122. Alternatively, preformedfoil shells82 can be applied in axially spaced bands on the distal region to form the segmentedenergy transmitting zones122.
• When it is expected that ablation will occur with the side region of the[0206]body22 oriented in contact with tissue, theshell24 is preferably segmented into axially elongatedenergy transmission zones122, which are circumferentially spaced about the distal ⅓rd to ½ of the body22 (see FIGS. 21 and 22).
• The circumferentially spaced[0207]zones122 are formed by masking circumferentially spaced areas of the distal region of thebody22, to thereby segment the deposit of the electricallyconductive shell24 into thezones122. Alternatively, preformedfoil shells82 can be applied in circumferentially spaced-apart relationship on the distal region to form the segmentedenergy transmitting zones122. Still alternatively, the circumferentially segmentedenergy transmission zones122 may take the form of semi-rigid pads carried by the expandable-collapsible body22. Adjacent pads overlap each other when thebody22 is in its collapsed geometry. As thebody22 assumes its expanded geometry, the pads spread apart in a circumferential pattern on thebody22.
• Preferably, regardless of the orientation of the zones[0208]122 (bull's-eye or circumferential), eachenergy transmission zone122 is coupled to adedicated signal wire26 or a dedicated set ofsignal wires26. This will be described later in greater detail. In this arrangement, thecontroller32 can direct ablation energy differently to eachzone122 according to prescribed criteria, as will also be described in greater detail later.
• The above describes the placement of a[0209]shell24 on the exterior of thebody22. It should be appreciated that electrically conductive material can be deposited or otherwise affixed to the interior of thebody22. For example (as FIG. 44 shows), the interior surface of thebody22 can carry electrodes402 suitable for unipolar or bipolar sensing or pacing. Different electrode placements can be used for unipolar or bipolar sensing or pacing. For example, pairs of 2-mm length and 1-mm width electrodes402 can be deposited on the interior surface of thebody22.Connection wires404 can be attached to theseelectrodes100. Preferably the interelectrode distance is about 1 mm to insure good quality bipolar electrograms. Preferred placements of these interior electrodes are at the distal tip and center of thebody22. Also, when multiple zones are used, it is desired to have the electrodes402 placed in between the ablation regions.
• It is also preferred to deposit[0210]opaque markers406 on the interior surface of thebody22 so that the physician can guide the device under fluoroscopy to the targeted site. Any high-atomic weight material is suitable for this purpose. For example, platinum, platinum-iridium. can be used to build themarkers406. Preferred placements of thesemarkers106 are at the distal tip and center of thestructure22.
• P. Folding Segmented Shells[0211]
• As FIGS. 21 and 22 show, segmented[0212]energy transmitting zones122 are well suited for use in association with folding expandable-collapsible bodies22, as previously described in connection with FIGS.11A/B/C. In this arrangement, the regions that are masked before deposition of the electrical conductive shell comprise thefolding regions52. In this way, theregions52 of the expandable-collapsible body22 that are subject to folding and collapse are those that do not carry an electricallyconductive shell24. The electricallyconductive shell24 is thereby protected against folding and stretching forces, which would cause creasing and current interruptions, or increases in resistance, thereby affecting local current densities and temperature conditions.
• The selective deposition of the[0213]shell24 in segmented patterns can itself establishpredefined fold lines52 on thebody22, without special molding of preformed regions of the body22 (as FIGS.11A/B/C contemplate). As FIGS. 23, 24A and24B show, by controlling the parameters by which theshell segments122 are deposited,predefined fold lines52 can be created at the boarders between theshell segments122. These fold lines52 are created due to the difference in thickness between adjacent regions which are coated with theshell24 and those which are not.
• More particularly, as FIGS. 23, 24A and[0214]24B show, the region between segmented shell coatings will establish afold line52, when the distance between the coatings (designated x in FIGS. 24A and B) is greater than or equal to twice the thickness of the adjacent shell coatings122 (designated t in FIGS. 24A and B) divided by the tangent of one half the minimum selected fold angle (designated α_MINin FIG. 24A). This fold line relationship is mathematically expressed as follows:$x\succcurlyeq \frac{2t}{\mathrm{Tan}{\alpha }_{\mathrm{MIN}}}$

  
• The minimum selected fold angle 2α[0215]_MINcan vary according to the profile of thebody22 desired when in the collapsed geometry. Preferably, the minimum fold angle 2α_MINis in the range of 1° to 5°.
• In this arrangement (see FIG. 23), the fold lines[0216]52 created by controlled deposition of shell segments lie uniformly along (i.e., parallel to) the long axis of the body22 (designated170 in FIG. 23).
• The uncoated fold lines[0217]52 created at the boarders between the thickercoated shell segments122 can also be characterized in terms of relative electrical resistivity values. Thecoated segments122 of electrically conductive material possess higher electrical conductivity than the uncoated fold lines52. The resistivity of the fold lines52, which varies inversely with conductivity, is thereby higher than the resistivity of thesegments122. To achieve the desired folding effect due to differential coating, the region in which folding occurs should have a resistivity that is greater than about ten times the resistivity of thesegments122 carrying electrically conductive material.
• IV. Electrical Connection to Shell[0218]
• It is necessary to electrically connect the shell[0219]24 (or other ablation energy transmitting material84) to the radiofrequency energy generator30 using the one ormore signal wires26. As before described, thesesignal wires26, electrically connected to theshell24, extend between thebody22 and the external connectors28 through thecatheter tube12.
• The connection between the[0220]signal wires26 and theshell24, whether deposited, foil layered, or coextruded, must remain intact and free of open circuits as the expandable-collapsible body22 andshell24 change geometries.
• The electrical connection is preferably oriented proximate to the geometric center of the pattern that the associated[0221]ablation zone122 defines. As FIGS.25 to27 show, the geometric center (designated GC) varies depending upon whether thezone122 comprises a cap pattern (as FIG. 25 shows), or a circumferential segment pattern (as FIG. 26 shows), or a circumferential band or bull's-eye pattern (as FIG. 27 shows). At least one electrical connection should be present proximate to the respective geometric center of the pattern. This ensures that maximum current density is distributed about the geometric center of the zone and that similar current densities are distributed at the edges of the pattern.
• Regardless of the shape of the pattern, additional electrical connections are preferably made in each ablation zone. In the case of a cap pattern or a segment pattern, the additional electrical connections (designated AC in, respectively, FIGS. 25 and 26) are distributed uniformly about the geometric center. In the case of a circumferential band of a bull's-eye pattern, the additional electrical connections (designated ACG in FIG. 27) are distributed uniformly along the arc along which the geometric center of the band lies.[0222]
• Multiple electrical connections, at least one of which occurs proximate to the geometric center, provide more uniform current density distribution in the zone. These multiple connections are especially needed when the resistivity of the[0223]shell24 or of the corresponding patterns is high. These connections prevent inefficient RF energy delivery due to RF voltage drops along parts of theshell24 or the corresponding patterns.
• In a preferred embodiment of the cap or bull's-eye pattern (see FIGS. 28A and 28B),[0224]multiple signal wires26 are lead through the interior of thebody22 and out through acenter aperture74 in thedistal fixture66.Multiple signal wires26 are preferred, as multiple electrical connections provide a more uniform current density distribution on theshell24 than a single connection.
• The[0225]signal wires26 are enclosed within electrical insulation160 (see FIG. 28B) except for their distal ends. There, theelectrical insulation160 is removed to exposed theelectrical conductor162. The exposedelectrical conductor162 is also preferably flattened by mechanical means to provide an increased surface area. The flattenedconductors162 are affixed by an electrically conductive adhesive proximate to the geometric center and elsewhere at additional uniformly spaced intervals about it on the cap pattern, as well as along the geometric center of the concentric bands of the bull's-eye pattern, which theshell24, when deposited, will create.
• It is preferred that the adhesive connections of the[0226]conductors162 to thebody22 be positioned, when possible, relatively close to an established support area onbody22, such as provided by thedistal fixture66. The support that thefixture66 provides a more secure attachment area for the electrical connections.
• After the electrical connections are made, the[0227]shell24 is deposited in the desired pattern on thebody22, over the adhesively attachedconductors162, in a manner previously described. Thecenter aperture74 in thedistal fixture66 is sealed closed by adhesive or equivalent material.
• In an alternative embodiment (as FIGS.[0228]29A/B show), thedistal fixture66 can also be used to create a mechanical connection to electrically couple asingle signal wire26 to the geometric center of the cap of the bull's-eye pattern. In the arrangement, thefixture66 is made from an electrically conductive material. As FIGS.29A/B show, thesignal wire26 is connected by spot welding, soldering, or electrically conductive adhesive to thefixture66 within the expandable-collapsible body22. Anut74 engaging a threadedfixture end164 sandwiches the distal tip of thebody22 between it and the collar68 (see FIG. 29B). Epoxy, which could be electrically conductive, could be used to further strengthen the mechanical connection between thenut74 and thebody22 sandwiched beneath it. Theshell24 is next deposited on thebody22 andnut74 in a manner previously described.
• Alternatively, the[0229]shell24 can be deposited on thebody22 before attachment of thenut74. In this arrangement, thenut74 sandwiches theshell24 between it and thecollar68, mechanically establishing the desired electrical connection between thesignal wire26 and theshell24.
• Alternatively, instead of a threaded nut connection, a heat shrunk slip ring of nickel titanium material can be used.. Essentially, any riveting, swagging, electrically conductive plating, or bonding technique can be used to hold the[0230]shell24 in contact against thecollar68.
• It should be appreciated that additional[0231]solid fixtures66 and associated electrical connection techniques can be used in other regions of theshell22 distant from the distal tip of thebody22 to establish electrical contact in the circumferential bands of the bull's-eye pattern or proximate the geometric center and elsewhere on the circumferential segments. However, electrical connections can be made in these regions without usingfixtures66 or equivalent structural elements.
• For example, as FIG. 30 shows,[0232]insulated signal wires26 passed into the interior of the body can be snaked through thebody22 at the desired point of electrical connection. As before described, theelectrical insulation160 of the distal end of the snaked-throughwire26 is removed to exposed theelectrical conductor162, which is also preferably flattened. As also before described, the flattenedconductors162 are affixed by an electrically conductive adhesive172 tobody22, over which theshell24 is deposited.Adhesive172 is also preferable applied in the region of thebody22 where thewire26 passes to seal it. As FIG. 31 shows, thesame signal wire26 can be snaked through thebody22 multiple times to establish multiple electrical connections within the same ablation zone.
• In conjunction with any ablation zone pattern (see FIG. 32), the expandable-[0233]collapsible body22 can be formed as alaminate structure90. Thelaminate structure90 comprises abase layer92, formed from an electrically insulating material which peripherally surrounds the interior of the body-22. Thelaminate structure90 further includes one or moreintermediate layers94 formed on thebase layer92. Anablation energy wire26 passes through eachintermediate layer94. Eachintermediate layer94 is itself bounded by alayer96 of electrically insulating material, so that thewires26 are electrically insulated from each other. Thelaminate structure90 also includes anouter layer98 which is likewise formed from an electrically insulating material.
• The[0234]laminate structure90 can be formed by successively dipping a mold having the desired geometry in a substrate solution of electrically insulating material. Theablation energy wires26 are placed on substrate layers between successive dippings, held in place by electrically conductive adhesive or the like.
• After molding the[0235]laminated structure90 into the desired geometry, one ormore windows100 are opened through theouter insulation layer98 in the region which the electricallyconductive shell24 will occupy. Eachwindow100 exposes an ablationenergy signal wire26 in a chosen layer.
• Various windowing techniques can be employed for this purpose. For example, CO[0236]₂laser, Eximer laser, YAG laser, high power YAG laser, or other heating techniques can be used to remove insulation to the desired layer and thereby expose the desiredsignal wire26.
• After windowing, the formed expandable-[0237]collapsible body22 is masked, as before described. Theshell24 of electrically conductive material is deposited over the unmasked area, including thewindows100, which have been previously opened.
• As FIG. 32 shows, the deposited[0238]shell24 enters thewindows100, making electrically conductive contact with the exposedwires26. A plating or other deposition process may be used in thewindow100, before depositing the electricallyconductive shell24. The plating f ills in thewindow100 to assure good electrical contact with the over-deposit ofshell24.
• FIG. 3D shows an alternative equivalent laminated structure, in which the[0239]chamber124 occupies the interior of thebody22. This creates a multiple layer structure equivalent to the laminated structure just described. An openintermediate layer126 exists between the interior of thebody22 and the exterior of thechamber124, through whichsignal wires26 can be passed for electrical connection to theshell24. The electrical connection can be made using either adistal fixture66 or by snaking the wires through the exterior body22 (as FIG. 3D shows), both of which have already been described.
• V. Temperature sensing[0240]
• A. Connection of Temperature Sensors[0241]
• As before described (see FIG. 1), a[0242]controller32 preferably governs the conveyance of radio frequency ablation energy from thegenerator30 to theshell24. In the preferred embodiment, thecollapsible electrode structure20 carries one or moretemperature sensing elements104, which are coupled to thecontroller32. Temperatures sensed by thetemperature sensing elements104 are processed by thecontroller32. Based upon temperature input, the controller adjusts the time and power level of radio frequency energy transmissions by theshell24, to achieve the desired lesion patterns and other ablation objectives.
• The[0243]temperature sensing elements104 can take the form of thermistors, thermocouples, or the equivalent. Atemperature sensing element104 may be located within thedistal fixture66 to sense temperature at the distal tip, as FIG. 33 shows. Alternatively, multiple temperature sensing elements may be scattered at spaced apart locations on theshell24 or expandable-collapsible body22, as FIG.34 shows.
• The connection of[0244]temperature sensing elements104 to theshell24 or expandable-collapsible body22 can be achieved in various ways.
• As shown in FIG. 34, when the expandable-[0245]collapsible body22 comprises a thermal conductive material, the temperature sensing element (designated104A in FIG. 34) can be attached to the interior surface of thebody22 in the region where measurement of exterior surface temperature is desired. A thermally conductive, but electrically insulating adhesive106 can be used to secure thetemperature sensing element104A to the inside of thebody22. The temperaturesensing element wires110 extend through thecatheter tube12 for coupling (using a suitable connector28, shown in FIG. 1)to thecontroller32.
• Alternatively, the temperature sensing element (designated[0246]104B and104C in FIG. 34) can be attached to the exterior surface of thebody22 in the region where measurement of temperatures is desired. As just described, a thermally conductive, but electrically insulating adhesive106 can be used to secure the temperature sensing element to the outside of thebody22.
• As shown with[0247]element104B, the electricallyconductive shell24 can be deposited over thetemperature sensing element104B, in the manner previously described. In this way, thetemperature sensing element104B resides under the electricallyconductive shell24, and no discontinuities in theshell24 are present.
• Alternatively, as shown with element[0248]104C, the element104C can be masked at the time the electricallyconductive shell24 is deposited. In this arrangement, there is no electrically conductive material over the temperature sensing element104C.
• The[0249]signal wires110 attached to the temperature sensing element104C can be attached by electrically insulating adhesive to the outside of the expandable-collapsible body22. Alternatively, as shown byelement104B, thesignal wires110 can be brought from the interior of the expandable-collapsible body22 through the expandable-collapsible body22 for attachment by a thermally conductive, but electrically insulating adhesive106 to the outside of thebody22. The same type ofadhesive106 can also be used to anchor insignal wires110 to the inside of the expandable-collapsible body22.
• As shown in FIG. 35,[0250]temperature sensing thermocouples112 may also be integrally formed by deposition on the expandable-collapsible body. In this embodiment, thebody22 comprises alaminated structure114, like that previously shown in FIG. 31, comprising abase layer92, anouter layer98, and one or moreintermediate layers94. In thelaminate structure114, theintermediate layers94 formed in this structure thermocouple wires116 (t-type or other combinations). Before depositing the electricallyconductive shell24, windowing of the laminated expandable-collapsible body116 in the manner previously described exposes the thermocouple wires. A conductingmaterial118, which, for a t-type thermocouple is copper or constantan, is deposited over the exposed thermocouple wires, forming thethermocouple112. An electrically insulatingmaterial120, like aluminum oxide or silicon dioxide, is then applied over thethermocouple112.
• The[0251]electrically conducting shell24 can be deposited over the formedthermocouple112. In this way, the thermocouples reside under the electricallyconductive shell24, and no discontinuities in theshell24 are present. Alternatively, asthermocouple112A shows in FIG. 35, thethermocouple112A can be masked at the time the electricallyconductive shell24 is deposited. In this arrangement, there is no electrically conductive material over thethermocouple112A.
• B. Location of Temperature Sensing Elements[0252]
• Preferably, as FIGS. 20 and 21A/B show, multiple[0253]temperature sensing elements104 are located on and about theshell24 to ascertain temperature conditions during radio frequency energy ablation. Thecontroller32 uses temperature information from temperature sensing elements to control the transmission of ablation energy by theshell24.
• Generally speaking, at least one[0254]temperature sensing element104 is preferably placed proximal to the geometric center of theenergy transmitting shell24. When theshell24 is segmented (as FIGS. 20 and 21A/B show), at least onetemperature sensing element104 should be proximal to the geometric center of eachenergy transmitting segment122.
• Preferably, as FIGS. 20 and 21A/B further show,[0255]temperature sensing elements104 are also placed along the edges of theshell24, where it adjoins a masked, electrically non-conductive region of thebody22. When theshell24 is segmented,temperature sensing elements104 should be placed along the edge of eachenergy transmitting segment122. High current densities occur along these regions where energy transmitting material adjoins non-energy transmitting material. These edge effects lead to higher temperatures at the edges than elsewhere on theshell24. Placingtemperature sensing elements104 along the edges assures that the hottest temperature conditions are sensed.
• In the case of a[0256]shell24 segmented into adjacentenergy transmitting zones122, it is also desirable to place at least onetemperature sensing element104 between adjacent energy transmitting zones, as FIGS. 20 and 21A/B show. Placing multipletemperature sensing elements104 in thesegments122, between thesegments122, and along the edges of thesegments122 allows thecontroller32 to best govern power distribution to themultiple segments122 based upon predictions of hottest temperature conditions. Further details of the use of multiple temperature sensing elements, including edge temperature sensing elements, and the use of temperature prediction methodologies, are found in copending U.S. patent application Ser. No. 08/439,824, filed May 12, 1995, and entitled “Systems and Methods for Controlling Tissue Ablation Using Multiple Temperature Sensing Elements.”
• The presence of segmented[0257]energy transmission zones122, each with its own prescribed placement oftemperature sensing elements104, allows thecontroller32 to govern the delivery of power to eachzone122 separately. Thecontroller32 is thereby able to take into account and react to differences in convective cooling effects in eachzone122 due to blood flow, differences in contact pressure and surface area between eachzone122 and the tissue its contacts, and other nonlinear factors affecting the power required to heat tissue adjacent eachzone122 to a predetermined temperature to achieve the desired lesion geometry and pattern.
• Thus, whereas for any given transmission zone (like the continuous,[0258]non-segmented shell24 shown in FIG. 25 or eachsegmented zone122 shown in FIGS. 26 and 27), it is desirable to allow some contact with the blood pool to allow beneficial convective cooling effects, it is not desirable that any given zone contact only or substantially only the blood pool. Loss of power into the blood pool with no tissue ablation effects occurs. Withsegmented zones122, it is possible to sense, using thetemperature sensing elements104, where insubstantial tissue contact exists. It is thereby possible to sense and to channel available power only to thosezones122 where substantial tissue contact exists. Further details of tissue ablation using segmented electrode structures are disclosed in copending U.S. patent application Ser. No. 08/139,304, filed Oct. 19, 1993 and entitled “Systems and Methods for Creating Lesions in Body Tissue Using Segmented Electrode Assemblies.”
• Further details of the use of multiple ablation energy transmitters controlled using multiple temperature sensing elements are disclosed in copending U.S. patent application Ser. No. 08/286,930, filed Aug. 8, 1994, and entitled “Systems and Methods for Controlling Tissue Ablation Using Multiple Temperature Sensing Elements”.[0259]
• FIG. 36 shows a preferred representative embodiment when the[0260]shell24 comprises a continuous cap pattern. In this arrangement, thestructure20 carries fivetemperature sensing elements104 spaced apart on theshell24. Thetemperature sensing elements104 are connected in a selected one or more of the manners previously described.
• Preferably, sensing elements Tn[0261]₁and Tn₂are placed at diametrically opposite regions at the most proximal edge of theshell24. Sensing elements Tm₁and Tm₂are placed at diametrical sides of the middle region of theshell24, for example, at about 50% of the radius of the structure. The sensor Tc is placed proximal the geometric center of theshell24. All temperature sensors are coupled to a temperature controller, which processes information from the sensors.
• In this arrangement, the[0262]temperature controller32 infers the percentage of tissue contact with theshell24 contact based upon where significant increases in temperature conditions from an established baseline level (for example, 37° C.) are sensed on theshell24. These increased temperature conditions indicate the absence of convective cooling effects, as would occur with contact with the blood pool, thereby suggesting tissue contact. As the preceding Tables 1 and 2 show, percentage of contact between theshell24 and tissue dictate effective power levels to achieve the type of lesion desired.
• The relationship between percentage shell-tissue contact and power desired for a given lesion characteristic can be based upon empirical or theoretical data in the manner set forth in the preceding Example. These relationships can be set forth in look up table format or incorporated in equivalent decision matrices, which the[0263]controller32 retains in memory.
• For example, if large deep lesions are desired, significant increase in temperature above the baseline at Tc, but not elsewhere, indicates a 20% tissue contact condition, and a first power level is commanded for the[0264]generator30 based upon the selected power criteria. Significant increase in temperature above the baseline also at Tm₁and Tm₂indicates a 50% tissue contact condition, and second power level less than the first is commanded for thegenerator30 based upon the selected power criteria. Significant increase in temperature above the baseline also at Tn₁and Tn₂indicates a 100% tissue contact condition, and third power level less than the second is commanded based upon the selected power criteria.
• FIG. 37 shows a preferred representative embodiment when the[0265]shell24 comprises a circumferentially spaced, segmented pattern. In this arrangement, thestructure20 carries at least four temperature sensing elements on each shell segment.
• The sensor Tc is common to all segments and is located at the distal end of the pattern. The sensor T[0266]_GCis located at the geometric center of each segment, while the sensors T_E1and T_E2are located along opposite edges of each segment, where theshell24 adjoins the non-electrically conductive regions separating the segments. An additional sensor T_Mis preferably also located generally between the segments for the reasons discussed before.
• FIG. 38 shows a preferred representative embodiment when the[0267]shell24 comprises a bull's-eye pattern. Sensors T_GCare located at the geometric center of each segment of the pattern, while the sensors T_E1and T_E2are located along opposite edges of each segment, where theshell24 adjoins the non-electrically conductive regions separating the segments. An additional sensor T_Mis preferably also located generally between the segments for the reasons discussed before.
• VI. Active Cooling[0268]
• The capability of the[0269]shell24 to form large lesions can be enhanced by actively cooling theshell24 while transmitting ablation energy.
• Active cooling can be accomplished by the use of multiple lumens to cycle a cooled fluid through the expandable-[0270]collapsible body22 while transmitting ablation energy. Alternatively, a high pressure gas can be transported by the lumens for expansion within the expandable-collapsible body to achieve a comparable active cooling effect. In yet another alternative arrangement, the cooled medium can be conveyed outside the expandable-collapsible body22 to achieve an active cooling effect.
• With active cooling, more power can be applied, while maintaining the same maximum tissue temperature conditions, thereby creating larger and deeper lesions. With active cooling, the percentage contact of the[0271]shell24 with tissue relative to blood can be increased above 50%, and may be as much as 100%.
• Further details concerning the use of active cooling to enhance lesion formation are found in copending U.S. patent application Ser. No. 08/431,790, filed May 1, 1995, and entitled “Systems and Methods for obtaining Desired Lesion Characteristics While Ablating Body Tissue”.[0272]
• It should be appreciated that the entire surface of the[0273]shell24 need not be cooled to achieve at least some of the benefits of active cooling. For example, only selected regions of theshell24 which are prone to localized edge heating effects, as previously described, can be subjected to active cooling. The edge effects on current densities occur at the boundary between theshell24 and expandable-collapsible body22 that is free of theshell24 create higher temperatures. Localized cooling of these edge regions can help minimize the effects of hot spots on lesion formation.
• In this arrangement, as FIG. 39 shows, a pattern of[0274]small holes174 is created in the region betweensegmented shell patterns122. Liquid cooling medium is perfused from inside thebody22 through theholes174 to provide localized cooling adjacent the edges of theshell segments122. It should be appreciated thathole patterns174 could be used elsewhere on thebody22 to provide active cooling effects.
• As FIGS. 39, 40A and[0275]40B show, the selective establishment ofhole patterns174 on thebody22 can also itself establishpredefined fold lines52, eliminating the need to specially mold preformed folding regions thebody22. The pattern ofsmall holes174 createfold lines52 by the removal of material, thereby increasing the flexibility of thebody22 along theholes174 betweenadjacent regions122. In this arrangement (see FIG. 39), the fold lines52 created byhole patterns174 lie uniformly along (i.e., parallel to) the long axis of thebody22.
• VII. Obtaining Desired Lesion Characteristics[0276]
• As Tables 1 and 2 in the foregoing Example demonstrate, the same expandable-[0277]collapsible electrode structure20 is able to selectively form lesions that are either wide and shallow or large and deep. Various methodologies can be used to control the application of radio frequency energy to theshell24 of thebody20 to achieve this result.
• A. D[0278]_50CFunction
• In one representative embodiment, the[0279]controller32 includes an input300 for receiving from the physician a desired therapeutic result in terms of (i) the extent to which the desired lesion should extend beneath the tissue-electrode interface to a boundary depth between viable and nonviable tissue and/or (ii) a maximum tissue temperature developed within the lesion between the tissue-electrode interface and the boundary depth.
• The[0280]controller32 also includes a processing element302, which retains a function that correlates an observed relationship among lesion boundary depth, ablation power level, ablation time, actual or predicted sub-surface tissue temperature, and electrode temperature. The processing element302 compares the desired therapeutic result to the function and selects an operating condition based upon the comparison to achieve the desired therapeutic result without exceeding a prescribed actual or predicted sub-surface tissue temperature.
• The operating condition selected by the processing element[0281]302 can control various aspects of the ablation procedure, such as controlling the ablation power level, the rate at which thestructure20 is actively cooled, limiting the ablation time to a selected targeted ablation time, limiting the ablation power level subject to a prescribed maximum ablation power level, and/or the orientation of theshell24, including prescribing a desired percentage contact between theshell24 and tissue. The processing element302 can rely upon temperature sensors carried by or otherwise associated with the expandable-collapsible structure20 that penetrate the tissue to sense actual maximum tissue temperature. Alternatively, the processing element302 can predict maximum tissue temperature based upon operating conditions.
• In the preferred embodiment, the[0282]electrode structure20 carries at least onetemperature sensing element104 to sense instantaneous localized temperatures (T1) of the thermal mass of theshell24. The temperature T1 at any given time is a function of the power supplied to theshell24 by thegenerator30 and the rate at which theshell24 is cooled, either by convective cooling by the blood pool, or active cooling by another cooling medium brought into contact with theshell24, or both.
• The characteristic of a lesion can be expressed in terms of the depth below the tissue surface of the 50° C. isothermal region, which will be called D[0283]_50C. The depth D_50Cis a function of the physical characteristics of the shell24 (that is, its electrical and thermal conductivities and size); the percentage of contact between the tissue and theshell24; the localized temperature T1 of the thermal mass of theshell24; the magnitude of RF power (P) transmitted by theshell24 into the tissue, and the time (t) the tissue is exposed to the RF power.
• For a desired lesion depth D[0284]50C, additional considerations of safety constrain the selection of an optimal operating condition among the operating conditions listed in the matrix. The principal safety constraints are the maximum tissue temperature TMAX and maximum power level PMAX.
• The maximum temperature condition TMAX lies within a range of temperatures which are high enough to provide deep and wide lesions (typically between about 85° C. and 95° C.), but which are safely below about 100° C., at which tissue desiccation or tissue micro-explosions are known to occur. It is recognized that TMAX will occur a distance below the electrode-tissue interface between the interface and D[0285]_50C.
• The maximum power level PMAX takes into account the physical characteristics of the electrode and the power generation capacity of the[0286]RF generator30.
• These relationships can be observed empirically and/or by computer modeling under controlled real and simulated conditions, as the foregoing examples illustrate. The D[0287]50C function for a givenshell24 can be expressed in terms of a matrix listing all or some of the foregoing values and their relationship derived from empirical data and/or computer modeling.
• The processing element[0288]302 includes in memory this matrix of operating conditions defining the D50C temperature boundary function, as described above for t=120 seconds and TMAX=95° C. and for an array of other operating conditions.
• The physician also uses the input[0289]300 to identify the characteristics of thestructure20, using a prescribed identification code; set a desired maximum RF power level PMAX; a desired time t; and a desired maximum tissue temperature TMAX.
• Based upon these inputs, the processing element[0290]302 compares the desired therapeutic result to the function defined in the matrix (as exemplified by the above Tables 1 and 2). Themaster controller58 selects an operating condition to achieve the desired therapeutic result without exceeding the prescribed TMAX by controlling the function variables.
• This arrangement thereby permits the physician, in effect, to “dial-a-lesion” by specifying a desired D[0291]_50C. By taking into account the effects of convective cooling based upon percentage of shell contact with tissue and by using active cooling in association with time and power control, the processing element can achieves the desired D_50Cwithout the need to sense actual tissue temperature conditions.
• Further details of deriving the D[0292]_50Cfunction and its use in obtaining a desired lesion pattern are found in copending U.S. application Ser. No. 08/431,790, filed May 1, 1995, entitled “Systems and Methods for Obtaining Desired Lesion Characteristics While Ablating Body Tissue,” which is incorporated herein by reference.
• B. Predicting Maximum Tissue Temperature[0293]
• The[0294]structure20 is cooled either by convective blood flow (depending upon percentage contact between theshell24 and tissue), or by actively using another cooling medium, or both. The level of RF power delivered to the cooledstructure20 and/or the cooling rate can be adjusted based upon a prediction of instantaneous maximum tissue temperature, which is designated Ψ_MAX(t).
• In a preferred implementation, the prediction of Ψ[0295]_MAXis derived by a neural network, which has as inputs a prescribed number of previous power levels, previous rates at which heat has been removed to cool thestructure20, and previous shell temperature.
• The heat removal rate is identified by the expression Å, where[0296]
• Å=c×ΔT×RATE
• where:[0297]
• c is the heat capacity of the cooling medium used (in Joules (J) per kilogram (kg) Kelvin (K), or J/kg K)[0298]
• ΔT is the temperature drop in the cooling medium during passing through the structure[0299]20 (K), and
• RATE is the mass flow rate of the cooling medium through the structure (kg/sec).[0300]
• The heat generated by the[0301]structure20 into the tissue is the difference between the heat generated by Joule effect and the heat removed by cooling. At a given localized shell temperature T1 and flow rate of cooling medium, the magnitude of Å increases as RF power delivered to theshell24 increases. Together, T1 and Å represent an indirect measurement of how rapidly the sub-surface tissue temperature is changing. Together, T1 and Å are therefore predictive of the depth and magnitude of the hottest sub-surface tissue temperature Ψ_MAX, and thus indirectly predictive of the lesion boundary depth D_50C. Large deep lesions are predicted when T1 is maintained at a low relative temperature (by controlling cooling rate) and the maximal predicted tissue temperature, TMAX, is maintained at approximately 85° C. to 95° C. by controlling RF power. Likewise, more shallow lesions are predicted when T1 is maintained at a high relative temperature and TMAX is maintained at lower values.
• Further details of deriving the this prediction function and its use in obtaining a desired lesion pattern are found in copending U.S. application Ser. No. 08/431,790, filed May 1, 1995, entitled “Systems and Methods for Obtaining Desired Lesion Characteristics While Ablating Body Tissue,” which is incorporated herein by reference.[0302]
• C. Segmented Shells: Duty Cycle Control[0303]
• Various RF energy control schemes can also be used in conjunction with segmented shell patterns shown in FIG. 20 (the axially spaced, bull's-eye pattern of zones) and FIGS. 21 and 22 (the circumferentially spaced zones). For the purpose of discussion, the zones (which will also be called electrode regions)[0304]122 will be symbolically designated E(J), where J represents a given zone122 (J=1 to N).
• As before described, each electrode region E(J) has at least one[0305]temperature sensing element104, which will be designated S(J,K), where J represents the zone and K represents the number of temperature sensing elements on each zone (K=1 to M).
• In this mode, the[0306]generator30 is conditioned through an appropriated power switch interface to deliver RF power in multiple pulses ofduty cycle 1/N.
• With pulsed power delivery, the amount of power (P[0307]_E(J)) conveyed to each individual electrode region E(J) is expressed as follows:
• P_E(J)αAMP_E(J)²×DUTYCYCLE_E(J)
• where:[0308]
• AMP[0309]_E(J)is the amplitude of the RF voltage conveyed to the electrode region E(J), and
• DUTYCYCLE[0310]_E(J)is the duty cycle of the pulse, expressed as follows:${\mathrm{DUTYCYCLE}}_{E\left(J\right)}=\frac{{\mathrm{TON}}_{E\left(J\right)}}{{\mathrm{TON}}_{E\left(J\right)}+{\mathrm{TOFF}}_{E\left(J\right)}}$

  
• where:[0311]
• TON[0312]_E(J)is the time that the electrode region E(J) emits energy during each pulse period,
• TOFF[0313]_E(J)is the time that the electrode region E(J) does not emit energy during each pulse period.
• The expression TON[0314]_E(J)+TOFF_E(J)represents the period of the pulse for each electrode region E(J).
• In this mode, the[0315]generator30 can collectively establish duty cycle (DUTYCYCLE_E(J)) of 1/N for each electrode region (N being equal to the number of electrode regions).
• The[0316]generator30 may sequence successive power pulses to adjacent electrode regions so that the end of the duty cycle for the preceding pulse overlaps slightly with the beginning of the duty cycle for the next pulse. This overlap in pulse duty cycles assures that thegenerator30 applies power continuously, with no periods of interruption caused by open circuits during pulse switching between successive electrode regions.
• In this mode, the[0317]temperature controller32 makes individual adjustments to the amplitude of the RF voltage for each electrode region (AMP_E(J)), thereby individually changing the power P_E(J)of ablating energy conveyed during the duty cycle to each electrode region, as controlled by thegenerator30.
• In this mode, the[0318]generator30 cycles in successive data acquisition sample periods. During each sample period, thegenerator30 selects individual sensors S(J,K), and temperature codes TEMP(J) (highest of S(J,K)) sensed by thesensing elements104, as outputted by thecontroller32.
• When there is more than one sensing element associated with a given electrode region (for example, when edge-located sensing elements are used, the[0319]controller32 registers all sensed temperatures for the given electrode region and selects among these the highest sensed temperature, which constitutes TEMP(J).
• In this mode, the[0320]generator30 compares the temperature TEMP(J) locally sensed at each electrode E(J) during each data acquisition period to a set point temperature TEMP_SETestablished by the physician. Based upon this comparison, thegenerator30 varies the amplitude AMP_E(J)of the RF voltage delivered to the electrode region E(J), while maintaining the DUTYCYCLE_E(J)for that electrode region and all other electrode regions, to establish and maintain TEMP(J) at the set point temperature TEMP_SET.
• The set point temperature TEMP[0321]_SETcan vary according to the judgment of the physician and empirical data. A representative set point temperature for cardiac ablation is believed to lie in the range of 40° C. to 95° C., with 70° C. being a representative preferred value.
• The manner in which the[0322]generator30 governs AMP_E(J)can incorporate proportional control methods, proportional integral derivative (PID) control methods, or fuzzy logic control methods.
• For example, using proportional control methods, if the temperature sensed by the first sensing element TEMP([0323]1)>TEMP_SET, the control signal generated by thegenerator30 individually reduces the amplitude AMP_E(1)of the RF voltage applied to the first electrode region E(1), while keeping the duty cycle DUTYCYCLE_E(1)for the first electrode region E(1) the same. If the temperature sensed by the second sensing element TEMP(2)<TEMP_SET, the control signal of thegenerator30 increases the amplitude AMP_E(2)of the pulse applied to the second electrode region E(2), while keeping the duty cycle DUTYCYCLE_E(2)for the second electrode region E(2) the same as DUTYCYCLE_E(1), and so on. If the temperature sensed by a given sensing element is at the set point temperature TEMP_SET, no change in RF voltage amplitude is made for the associated electrode region.
• The generator continuously processes voltage difference inputs during successive data acquisition periods to individually adjust AMP[0324]_E(J)at each electrode region E(J), while keeping the collective duty cycle the same for all electrode regions E(J). In this way, the mode maintains a desired uniformity of temperature along the length of the ablating element.
• Using a proportional integral differential (PID) control technique, the generator takes into account not only instantaneous changes that occur in a given sample period, but also changes that have occurred in previous sample periods and the rate at which these changes are varying over time. Thus, using a PID control technique, the generator will respond differently to a given proportionally large instantaneous difference between TEMP (J) and TEMP[0325]_SET, depending upon whether the difference is getting larger or smaller, compared to previous instantaneous differences, and whether the rate at which the difference is changing since previous sample periods is increasing or decreasing.
• Further details of individual amplitude/collective duty cycle control for segmented electrode regions based upon temperature sensing are found in copending U.S. application Ser. No. 08/439,824, filed May 12, 1995 and entitled “Systems and Methods for Controlling Tissue Ablation Using Multiple Temperature Sensing Elements,” which is incorporated herein by reference.[0326]
• D. Segmented Shells: Differential Temperature Disabling[0327]
• In this control mode, the[0328]controller32 selects at the end of each data acquisition phase the sensed temperature that is the greatest for that phase (TEMP_SMAX). Thecontroller32 also selects for that phase the sensed temperature that is the lowest (TEMP_SMIN).
• The generator compares the selected hottest sensed temperature TEMP[0329]_SMAXto a selected high set point temperature TEMP_HISET. The comparison generates a control signal that collectively adjusts the amplitude of the RF voltage for all electrodes using proportional, PID, or fuzzy logic control techniques.
• In a proportion control implementation scheme:[0330]
• (i) If TEMP[0331]_SMAX>TEMP_HISET, the control signal collectively decreases the amplitude of the RF voltage delivered to all segments;
• (ii) If TEMP[0332]_SMAX<TEMP_HISET, the control signal collectively increases the amplitude of the RF voltage delivered to all segments:
• (iii) If TEMP[0333]_SMAXTEMP_HISET, no change in the amplitude of the RF voltage delivered to all segments.
• It should be appreciated that the generator can select for amplitude control purposes any one of the sensed temperatures TEMP[0334]_SMAX, TEMP_SMIN, or temperatures in between, and compare this temperature condition to a preselected temperature condition.
• The generator governs the delivery of power to the segments based upon difference between a given local temperature TEMP (J) and TEMP[0335]_SMIN. This implementation computes the difference between local sensed temperature TEMP(J) and TEMP_SMINand compares this difference to a selected set point temperature difference ΔTEMP_SET. The comparison generates a control signal that governs the delivery of power to the electrode regions.
• If the local sensed temperature TEMP(J) for a given electrode region E(J) exceeds the lowest sensed temperature TEMP[0336]_SMINby as much as or more than ΔTEMP_SET(that is, if TEMP(J)−TEMP_SMIN≧ΔTEMP_SET), the generator turns the given segment E(J) off. The generator turns the given segment E(J) back on when TEMP(J)−TEMP_SMIN<ΔTEMP_SET.
• Alternatively, instead of comparing TEMP(J) and TEMP[0337]_SMIN, the generator can compare TEMP_SMAXand TEMP_SMIN. When the difference between TEMP_SMAXand TEMP_SMINequals or exceeds a predetermined amount ΔTEMP_SET, the generator turns all segments off, except the segment where TEMP_SMINexists. The controller231 turns these segments back on when the temperature difference between TEMP_SMAXand TEMP_SMINis less than ΔTEMP_SET.
• Further details of the use of differential temperature disabling are found in copending U.S. patent application Ser. No. 08/286,930, filed Aug. 8, 1994, and entitled “Systems and Methods for Controlling Tissue Ablation Using Multiple Temperature sensing Elements,” which is incorporated herein by reference.[0338]
• E. Segmented Shells (Predicted Hottest Temperature)[0339]
• Because of the heat exchange between the tissue and the[0340]electrode region122, thetemperature sensing elements104 may not measure exactly the maximum temperature at theregion122. This is because the region of hottest temperature occurs beneath the surface of the tissue at a depth of about 0.5 to 2.0 mm from where the energy emitting electrode region122 (and the associated sensing element104) contacts the tissue. If the power is applied to heat the tissue too quickly, the actual maximum tissue temperature in this subsurface region may exceed 100° C. and lead to tissue desiccation and/or micro-explosions.
• FIG. 43 shows an implementation of a[0341]neural network predictor400, which receives as input the temperatures sensed by multiple sensing elements S(J,K) at each electrode region, where J represents a given electrode region (J=1 to N) and K represents the number of temperature sensing elements on each electrode region (K=1 to M). Thepredictor400 outputs a predicted temperature of the hottest tissue region T_MAXPRED(t). Thegenerator30 derives the amplitude and duty cycle control signals based upon T_MAXPRED(t), in the same manner already described using TEMP(J).
• The[0342]predictor400 uses a two-layer neural network, although more hidden layers could be used. As shown in FIG. 43, the predictor300 includes a first and second hidden layers and four neurons, designated N_(L,X), where L identifies thelayer1 or2 and X identifies a neuron on that layer. The first layer (L=1) has three neurons (X=1 to 3), as follows N_(1,1); N_(1,2); and N_(1,3). The second layer (L=2) comprising one output neuron (X=1), designated N_(2,1).
• Temperature readings from the multiple sensing elements, only two of which—TS[0343]1(n) and TS2(n)—are shown for purposes of illustration, are weighed and inputted to each neuron N_(1,1); N_(1,2); and N_(1,3)of the first layer. FIG. 43 represents the weights as W_(k,N)^L, where L=1; k is the input sensor order; and N is theinput neuron number1,2, or3 of the first layer.
• The output neuron N[0344]_(2,1)of the second layer receives as inputs the weighted outputs of the neurons N_(1,1)); N_(1,2); and N_(1,3). FIG. 43 represents the output weights as W_(O,X)^L, where L=2O is theoutput neuron1,2, or3 of the first layer; and X is the input neuron number of the second layer. Based upon these weighted inputs, the output neuron N_(2,1)predicts T_MAXPRED(t).
• Alternatively, a sequence of past reading samples from each sensor could be used as input. By doing this, a history term would contribute to the prediction of the hottest tissue temperature.[0345]
• The[0346]predictor400 must be trained on a known set of data containing the temperature of the sensing elements TS1 and TS2 and the temperature of the hottest region, which have been previously acquired experimentally. For example, using a back-propagation model, thepredictor400 can be trained to predict the known hottest temperature of the data set with the least mean square error. Once the training phase is completed, the predictor300 can be used to predict T_MAXPRED(t).
• Other types of data processing techniques can be used to derive T[0347]_MAXPRED(t). See, e.g., copending patent application Ser. No. 08/266,934, filed Jun. 27, 1994, and entitled “Tissue Heating and Ablation Systems and Methods Using Predicted Temperature for Monitoring and Control.”
• The illustrated and preferred embodiments use digital processing controlled by a computer to analyze information and generate feedback signals. It should be appreciated that other logic control circuits using micro-switches, AND/OR gates, invertors, analog circuits, and the like are equivalent to the micro-processor controlled techniques shown in the preferred embodiments.[0348]
• VIII. Capacitive Coupling[0349]
• In the preceding embodiments, the[0350]electrode structure20 transmits ablation energy to tissue by exposing tissue to an electricallyconductive surface24 carried about the exterior of the expandable-collapsible body22. The alternative embodiments shown in FIGS. 41A and 42A include anelectrode structure176 comprising an expandable-collapsible body178 having an exterior free of an electrically conductive surface. In these embodiments, thebody178 is capacitively coupled to tissue for the purpose of transmitting ablation energy.
• In the embodiment shown in FIG. 41A, the expandable-[0351]collapsible body178 is molded in same fashion as thebody22 previously described. Thebody178 includes an electricallyconductive structure180 in contact with at least a portion of theinterior surface182 of thebody178.
• The interior[0352]conductive structure180 can be assembled in various ways. In the embodiment shown in FIG. 41A, thestructure180 comprises aninterior shell184 of electrically conductive material deposited on at least a portion of theinterior surface182 of thebody178. Like theexterior shell24 previously described, theinterior shell184 comprises a material having a relatively high electrical conductivity, as well as a relative high thermal conductivity, such as gold, platinum, platinum/iridium, among others. Theshell184 is preferably deposited upon the exterior of thebody178 after molding using deposition process like sputtering, vapor deposition, ion beam deposition, electroplating over a deposited seed layer, or a combination of these processes. Thebody178 is then everted in the manner previously described (as FIG. 16B shows) to place the depositedshell184 inside the evertedbody178. One ormore signal wires186 are coupled to theinterior shell184 using electrically conductive adhesive, soldering, or equivalent connection techniques.
• The[0353]body178 can be caused to assume expanded and collapsed geometries by the introduction of an air or liquid inflation medium, as previously described. Alternatively, thebody178 can employ any previously describedinterior support structure44 to affect expansion and collapse. Thesupport structures44 could also by electrically conductive to affect capacitive coupling, with or without the presence of the depositedshell184. For example, an electrically conductive interior resilient mesh structure (like that shown in FIG. 6), or a skeleton of flexible, electrically conductive spline elements (like that shown in FIG. 4), or an open cell foam structure coated with an electrically conductive material (like that shown in FIG. 9), can be used both to provide interior support and to provide capacitive coupling betweensignal wires186 and tissue, with or without the presence of the depositedinterior shell184. In these alternative arrangements, one ormore signal wires184 are coupled to the electrically conductive support structures.
• FIG. 41B shows the electrical[0354]equivalent circuit188 of the capacitive coupling effect that thestructure176 in FIG. 41A provides. In the electrical path190 that theablation energy192 follows, theinterface194 formed among the expandable-collapsible body178, theconductive structure180 contacting the inside thebody178, and thetissue196 contacting the outside of thebody178 functions as a capacitor (designated C), whose impedance X_Cis expressed as:$X_C=\frac{1}{2\pi \mathrm{fC}}$

  
• where:[0355]
• f is the frequency of the radio[0356]frequency ablation energy192, and$C=\varepsilon \frac{s}{t}$

  
• where[0357]
• ε is the dielectric constant of the material of the expandable-[0358]collapsible body178, which ranges from about 1.2 to about 10.0 (multiplied by 8.85×10⁻¹²Farads per meter) for most plastic materials,
• s is the surface area of the electrically[0359]conductive structure184, and
• t is the thickness of the[0360]body178 located between the electricallyconductive structure180 and the contactedtissue196.
• In the electrical path[0361]190 that theablation energy192 follows, thetissue196 functions as a resistor (designated R_TISSUE) series coupled to C. Typically, R_TISSUEis about 100 ohms.
• To have efficient capacitive coupling to the tissue, X[0362]_Cof thestructure180 must be less than R_TISSUE. This relationship assures that the desired ohmic heating effect is concentrated in tissue.
• To maximize the capacitive coupling effect, it is thereby important to use ablation energy at higher frequencies (for example, between 10 and 20 Mhz). It is also important to aim to maximize C as much as possible, by controlling thickness of the[0363]body178 as well as by maximizing as much as possible the surface area of contact with the electricallyconductive structure180 inside thebody178. For this reason, a continuous electricallyconductive shell182 or equivalent mesh structure are preferred, compared to a more open spline element structure. However, a more dense, conductive spline element structure having many spline elements and/or large surface area splines could be used to maximize C, if desired.
• FIG. 42A shows an alternative embodiment of an expandable-[0364]collapsible electrode structure198 that provides capacitive coupling to tissue. Thestructure198 comprises aninterior electrode200 of electrically conductive material located within interior of thebody178. Theinterior electrode200 comprises a material having a relatively high electrical conductivity, as well as a relative high thermal conductivity, such as gold, platinum, platinum/iridium, among others. Asignal wire202 is coupled to the electrode to conduct ablation energy to it.
• In this embodiment, a hypertonic (i.e., 9%)[0365]saline solution204 fills the interior of thebody178. Thesaline solution204 serves as an electrically conductive path to convey radio frequency energy from theelectrode200 to thebody178. Thesaline solution204 also serves as the inflation medium, to cause thebody178 to assume the expanded geometry. Removal of thesaline solution204 causes thebody178 to assume the collapsed geometry.
• FIG. 42B shows the electrical[0366]equivalent circuit206 of the capacitive coupling effect that thestructure198 shown in FIG. 42A provides. In theelectrical path208 that theablation energy210 follows, theinterface212 formed among the expandable-collapsible body178, thehypertonic saline solution204 contacting the inside thebody178, and thetissue196 contacting the outside of thebody178 functions as a capacitor (designated C), whose impedance X_Cis expressed as:$X_C=\frac{1}{2\pi \mathrm{fC}}$

  
• where:[0367]
• f is the frequency of the radio[0368]frequency ablation energy210, and$C=\varepsilon \frac{S_B}{t}$

  
• where[0369]
• ε is the dielectric constant of the material of the[0370]body178,
• S[0371]_Bis the area of thebody178 contacting thehypertonic saline solution204, and
• t is the thickness of the[0372]body178 located between the electricallyconductive saline solution204 and thetissue196.
• In the electrical path that the ablation energy follows, the[0373]tissue196 functions as a resistor (designated R_TISSUE) series coupled to C, which value is about 100 ohms. Thepath216 through thehypertonic saline204 between theinterior electrode200 and theinterior surface214 of thebody178 also functions as a resistor (designated R_PATH) series coupled to C. The value of R_PATHis expressed:$R_{\mathrm{PATH}}=\frac{K}{S_E}\rho$

  
• where:[0374]
• K is a constant that depends upon the geometry of the[0375]structure198,
• S[0376]_Eis the surface area of theinterior electrode200, and
• ρ is the resistivity of the[0377]hypertonic saline204.
• The following relationship establishes efficient capacitive coupling between the[0378]structure198 andtissue196 to achieve the desired ohmic tissue heating effect:
• {square root}{square root over (R_PATH²+X_C²)}<R_TISSUE
• The use of capacitive coupling provides structural benefits. It isolates possible shell adherence problems to inside the[0379]body178 of thestructure176, where flaking and chipping of theshell184 can be retained out of the blood pool. Capacitive coupling also avoids potential problems that tissue sticking to exterior conductive materials could create.
• In addition to these structural benefits, the temperature control of the ablation process (as described above in conjunction with the structure[0380]20) is improved using capacitive coupling. When using a metal surface to ablate tissue, the tissue-electrode interface is convectively cooled by surrounding blood flow. Due to these convective cooling effects, the region of maximum tissue temperature is located deeper in the tissue. As a result, the temperature conditions sensed by sensing elements associated with metal electrode elements do not directly reflect actual maximum tissue temperature. In this situation, maximum tissue temperature conditions must be inferred or predicted from actual sensed temperatures, as set forth above. Using capacitive coupling instructures176 or198, convective cooling of the tissue-electrode interface by the surrounding blood flow is minimized. As a result, the region of maximum temperature is located at the interface between tissue and the porous electrode. As a result, the temperature conditions sensed by sensing elements associated with the capacitively coupledstructures176 or198 will more closely reflect actual maximum tissue.
• IX. Conductive Polymer Surfaces[0381]
• As previously mentioned in conjunction with FIG. 19, all or a portion of the[0382]body22 can comprise an electrically conductive polymer. The conductivity of the polymer used preferably has a resistivity close to the resistivity of tissue (i.e., about 500 ohm.cm). In use, the electricallyconductive body22 can be used in association with aninterior electrode200, like that shown in FIG. 42A. In such an arrangement, ahypertonic saline solution204 also fills the interior of the electrically conductive body22 (as also shown in FIG. 42A), to serve as an electrically conductive path to convey radio frequency energy from theelectrode200 to thebody22. In effect, in this arrangement, the electricallyconductive body22 functions as a “leaky” capacitor in transmitting radio frequency energy from theinterior electrode200 to tissue.
• Various methodologies can be used to control the application of radio frequency energy to capacitively coupled electrode structures and to electrode structures having electrically conductive bodies. The previously described D[0383]_50CFunction can be used, as can the previously described Duty Cycle and Temperature Disabling techniques. With capacitively coupled electrode structures and electrode structures having electrically conductive bodies, the minimal effects of convective cooling by the blood pool enables the use of actual sensed temperature conditions as maximum tissue temperature TMAX, instead of predicted temperatures. Because of this, such structures also lend themselves to the use of a proportional integral differential (PID) control technique. An illustrative PID control techniques usable in association with these electrode structures are disclosed in copending U.S. patent application Ser. No. 08/266,023, filed Jun. 27, 1994, entitled “Tissue Heating and Ablation Systems and Methods Using Time-Variable Set Point Temperature Curves for Monitoring and Control.”
• Various features of the invention are set forth in the following claims.[0384]

Claims (42)

We claim:

1. An electrode assembly comprising

a nonporous wall having an exterior for contacting tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter,

a lumen to convey a medium containing ions into the interior area, and

an element free of physical contact with the wall that couples the medium within the interior area to a source of electrical energy to enable ionic transport of electrical energy from the source through the medium to the wall for capacitive coupling to tissue contacting the exterior of the wall.

2. An electrode assembly comprising

a nonporous wall having an exterior for contacting tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter,

a medium containing ions filling the interior area, and

an element free of physical contact with the wall coupling the medium to a source of electrical energy to enable ionic transport of electrical energy from the source through the medium to the wall for capacitive coupling to tissue contacting the exterior of the wall.

3. An electrode assembly comprising

a nonporous wall having an exterior for contacting tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter,

a generator of radio frequency energy,

a fluid source holding a medium containing ions,

a lumen communicating with the interior area and the fluid source to convey into the interior area the medium containing ions,

an element free of physical contact with the wall coupled to the generator to establish electrical contact between the medium within the interior area and the generator to enable ionic transport of radio frequency energy from the generator through the medium to the wall for capacitive coupling to tissue contacting the exterior of the wall.

4. An assembly according to

claim 1

or

2

or3

wherein the element comprises an electrically conductive electrode in the interior area.

5. An assembly according to

claim 4

wherein the electrically conductive electrode comprises a nobel metal.

6. An assembly according to

claim 4

wherein the electrically conductive electrode includes a material selected from the group consisting essentially of gold, platinum, platinum/iridium, or combinations thereof.

7. An assembly according to

claim 1

or

2

or3

wherein the medium comprises a hypertonic solution.

8. An assembly according to

claim 7

wherein the hypertonic solution includes sodium chloride.

9. An assembly according to

claim 8

wherein the sodium chloride is present in a concentration at or near saturation.

10. An assembly according to

claim 8

wherein the sodium chloride is present in a concentration of up to about 9% weight by volume.

11. An assembly according to

claim 1

or

2

or3

wherein the capacitive coupling of the wall is expressed in the following relationship:

{square root}{square root over (R_PATH²+X_C²)}<R_TISSUE

where:$R_{\mathrm{PATH}}=\frac{K}{S_E}{\rho }_s$

and

K is a constant that depends upon geometry of the wall,

S_Eis surface area of the element, and

ρ_Sis resistivity of the medium containing ions, and

where:$X_C=\frac{1}{2\pi \mathrm{fC}}$

and

f is frequency of the electrical energy, and$C=\varepsilon \frac{S_B}{t}$

where:

ε is the dielectric constant of wall,

S_Bis the area of the interior area, and

t is thickness of the wall located between the medium containing ions and tissue, and

where R_TISSUEis resistivity of tissue contacting the wall.

12. An assembly according to

claim 11

wherein R_TISSUEis about 100 ohms.

13. An assembly according to

claim 1

or

2

or3

and further including members assembled within the interior area to form a support structure underlying the wall.

14. An assembly according to

claim 13

wherein the solid support members are made from metal material.

15. An assembly according to

claim 14

wherein the metal material includes nickel titanium.

16. An assembly according to

claim 14

wherein the metal material includes stainless steel.

17. An assembly according to

claim 13

wherein the solid support members are made from plastic material.

18. An assembly according to

claim 13

wherein the solid support members comprise elongated spline elements assembled in a circumferentially spaced relationship.

19. An assembly according to

claim 1

or

2

or3

and further including at least one temperature sensing element carried by the wall.

20. A system for heating body tissue comprising

a catheter tube having a distal end,

a return electrode,

a fluid source of a medium containing ions,

an electrode on the distal end of the catheter tube comprising a nonporous wall having an exterior for contacting tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter, a lumen to convey the medium containing ions into the interior area, and an electrically conductive element within the interior area free of physical contact with the wall, and

means for coupling the return electrode and the electrically conductive element to the source of energy to enable ionic transport of electrical energy from the source through. the medium to the wall for capacitive coupling to tissue to heat tissue located between the return electrode and the electrode.

21. A system for ablating body tissue comprising

a catheter tube having a distal end,

a return electrode,

a fluid source of a medium containing ions,

an electrode on the distal end of the catheter tube comprising a nonporous wall having an exterior for contacting tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter, a lumen to convey the medium containing ions into the interior area, and an electrically conductive element within the interior area free of physical contact with the wall, and

means for coupling the return electrode and the electrically conductive element to the source of energy to enable ionic transport of electrical energy from the source through the medium to the wall for capacitive coupling to tissue to ablate tissue located between the return electrode and the electrode.

22. A system for ablating heart tissue comprising

a catheter tube having a distal end for deployment in a heart chamber,

a return electrode,

a fluid source of a medium containing ions,

an electrode on the distal end of the catheter tube comprising a nonporous wall having an exterior for contacting heart tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter, a lumen to convey the medium containing ions into the interior area, and an electrically conductive element within the interior area free of physical contact with the wall, and

means for coupling the return electrode and the electrically conductive element to the source of energy to enable ionic transport of electrical energy from the source through the medium to the wall for capacitive coupling to tissue to ablate heart tissue located between the return electrode and the electrode.

23. A system according to

claim 20

or

21

or22

wherein the electrically conductive element comprises an electrically conductive electrode in the interior area.

24. A system according to

claim 23

wherein the electrically conductive electrode comprises a nobel metal.

25. A system according to

claim 23

wherein the electrically conductive electrode includes a material selected from the group consisting essentially of gold, platinum, platinum/iridium, or combinations thereof.

26. A system according to

claim 20

or

21

or22

wherein the medium comprises a hypertonic solution.

27. A system according to

claim 26

wherein the hypertonic solution includes sodium chloride.

28. A system according to

claim 27

wherein the sodium chloride is present in a concentration at or near saturation.

29. A system according to

claim 27

wherein the sodium chloride is present in a concentration of up to about 9% weight by volume.

30. A system according to

claim 20

or

21

or22

wherein the capacitive coupling of the wall is expressed in the following relationship:

{square root}{square root over (R_PATH²+X_C²)}<R_TISSUE

where:$R_{\mathrm{PATH}}=\frac{K}{S_E}{\rho }_s$

and

K is a constant that depends upon geometry of the wall,

S_Eis surface area of the element, and

ρ_Sis resistivity of the medium containing ions, and

where:$X_C=\frac{1}{2\pi \mathrm{fC}}$

and

f is frequency of the electrical energy, and$C=\varepsilon \frac{S_B}{t}$

where:

ε is the dielectric constant of wall,

S_Bis the area of the interior area, and

t is thickness of the wall located between the medium containing ions and tissue, and

where R_TISSUEis resistivity of tissue contacting the wall.

31. A system according to

claim 30

wherein R_TISSUEis about 100 ohms.

32. A system according to

claim 20

or

21

or22

and further including members assembled within the interior area to form a support structure underlying the wall.

33. A system according to

claim 32

wherein the solid support members are made from metal material.

34. A system according to

claim 33

wherein the metal material includes nickel titanium.

35. A system according to

claim 33

wherein the metal material includes stainless steel.

36. A system according to

claim 32

wherein the solid support members are made from plastic material.

37. A system according to

claim 32

wherein the solid support members comprise elongated spline elements assembled in a circumferentially spaced relationship.

38. A system according to

claim 20

or

21

or22

and further including at least one temperature sensing element carried by the wall.

39. A method for heating body tissue comprising the steps of

providing a catheter tube having a distal end that carries an electrode comprising a nonporous wall having an exterior for contacting heart tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter, a lumen to convey the medium containing ions into the interior area, and an electrically conductive element within the interior area free of physical contact with the wall,

electrically coupling a source of radio frequency energy to the electrically conductive element and to a return electrode in contact with body tissue,

guiding the catheter tube into a body with the wall in the collapsed geometry,

causing the wall to assume the expanded geometry at least in part by conveying a medium containing ions into the interior area, and

ohmically heating body tissue by transmitting radio frequency energy to the electrically conductive element for ionic transport through the medium to the wall for capacitive coupling to tissue located between the return electrode and the electrode.

40. A method for ablating tissue comprising the steps of

providing a catheter tube having a distal end that carries an electrode comprising a nonporous wall having an exterior for contacting heart tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter, a lumen to convey the medium containing ions into the interior area, and an electrically conductive element within the interior area free of physical contact with the wall,

electrically coupling a source of radio frequency energy to the electrically conductive element and to a return electrode in contact with body tissue,

guiding the catheter tube into a body with the wall in the collapsed geometry,

causing the wall to assume the expanded geometry at least in part by conveying a medium containing ions into the interior area, and

ohmically ablating body tissue by transmitting radio frequency energy to the electrically conductive element for ionic transport through the medium to the wall for capacitive coupling to tissue located between the return electrode and the electrode.

41. A method for ablating heart tissue comprising the steps of

providing a catheter tube having a distal end that carries an electrode comprising a nonporous wall having an exterior for contacting heart tissue, the exterior peripherally surrounding an interior area, the wall being essentially free of electrically conductive material, the wall being adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter, a lumen to convey the medium containing ions into the interior area, and an electrically conductive element within the interior area free of physical contact with the wall,

electrically coupling a source of radio frequency energy to the electrically conductive element and to a return electrode in contact with body tissue,

guiding the catheter tube into a heart chamber with the wall in the collapsed geometry,

causing the wall to assume the expanded geometry at least in part by conveying a medium containing ions into the interior area, and

ohmically ablating heart tissue by transmitting radio frequency energy to the electrically conductive element for ionic transport through the medium to the wall for capacitive coupling to tissue located between the return electrode and the electrode.

42. A method according to

claim 39

or

40

or41

and further including the step of controlling the transmission of radio frequency energy, at least in part, by sensing temperature proximate to the wall.

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