1. Field of Invention
The invention relates to medical devices and methods for performing ablation procedures. More particularly, the invention relates to methods and apparatus for extending and/or retracting ablation electrode surfaces in vivo.
2. Discussion of Related Art
The human heart is a very complex organ, which relies on both muscle contraction and electrical impulses to function properly. The electrical impulses travel through the heart walls, first through the atria and then the ventricles, causing the corresponding muscle tissue in the atria and ventricles to contract. Thus, the atria contract first, followed by the ventricles. This order is essential for proper functioning of the heart.
Over time, the electrical impulses traveling through the heart can begin to travel in improper directions, thereby causing the heart chambers to contract at improper times. Such a condition is generally termed a cardiac arrhythmia, and can take many different forms. When the chambers contract at improper times, the amount of blood pumped by the heart decreases, which can result in premature death of the person.
Techniques have been developed which are used to locate cardiac regions responsible for the cardiac arrhythmia, and also to disable the short-circuit function of these areas. According to these techniques, electrical energy is applied to a portion of the heart tissue to ablate that tissue and produce scars which interrupt the reentrant conduction pathways or terminate the focal initiation. The regions to be ablated are usually first determined by endocardial mapping techniques. Mapping typically involves percutaneously introducing a catheter having one or more electrodes into the patient, passing the catheter through a blood vessel (e.g. the femoral vein or artery) and into an endocardial site (e.g., the atrium or ventricle of the heart), and deliberately inducing an arrhythmia so that a continuous, simultaneous recording can be made with a multichannel recorder at each of several different endocardial positions. When an arrythormogenic focus or inappropriate circuit is located, as indicated in the electrocardiogram recording, it is marked by various imaging or localization means so that cardiac arrhythmias emanating from that region can be blocked by ablating tissue. An ablation catheter with one or more electrodes can then transmit electrical energy to the tissue adjacent the electrode to create a lesion in the tissue. One or more suitably positioned lesions will typically create a region of necrotic tissue which serves to disable the propagation of the errant impulse caused by the arrythromogenic focus. Ablation is carried out by applying energy to the catheter electrodes. The ablation energy can be, for example, RF, DC, ultrasound, microwave, or laser radiation.
Atrial fibrillation together with atrial flutter are the most common sustained arrhythmias found in clinical practice.
Another source of arrhythmias may be from reentrant circuits in the myocardium itself. Such circuits may not necessarily be associated with vessel ostia, but may be interrupted by means of ablating tissue either within the circuit or circumscribing the region of the circuit. It should be noted that a complete ‘fence’ around a circuit or tissue region is not always required in order to block the propagation of the arrhythmia; in many cases simply increasing the propagation path length for a signal may be sufficient. Conventional means for establishing such lesion ‘fences’ include a multiplicity of point-by-point lesions, dragging a single electrode across tissue while delivering energy, or creating an enormous lesion intended to inactivate a substantive volume of myocardial tissue.
The size of a lesion is dependent on many factors, including energy emission and electrode size. Generally, higher applications of electrical power and larger electrodes lead to larger lesion sizes. However, overly high energy delivery can lead to undesirable effects such as tissue desiccation or charring, and in some circumstances, blood coagulation. Increased electrode dimensions present problems with insertion into a patient and introduction into the heart because the larger dimensions can make it difficult to maneuver a catheter through arteries and veins.
Embodiments of the present invention encompass apparatus and method for creating lesions in heart tissue (ablating) to create a region of necrotic tissue which serves to disable the propagation of errant electrical impulses caused by an arrhythmia. Embodiments of the present invention also encompass apparatus and methods for adjusting the dimensions of ablation electrodes that are positioned in a patient.
In one embodiment, a catheter comprises a longitudinal catheter shaft for positioning an ablation electrode within a patient's body. An ablation electrode is disposed on the shaft and has an outer surface. The electrode is convertible from a first configuration in which the electrode outer surface has a first axial size and a first radial size to a second configuration in which the electrode outer surface has a second axial size and maintains the first radial size.
According to another embodiment, a catheter comprises a longitudinal catheter shaft for positioning an ablation electrode within a patient's body. An ablation electrode is disposed on the shaft and has an outer surface. The electrode is convertible from a first configuration in which the electrode outer surface has a first axial size and a first radial size to a second configuration in which the electrode outer surface has a second radial size and maintains the first axial size.
In a further embodiment, a catheter comprises a longitudinal catheter shaft for positioning an ablation electrode within a patient's body. An ablation electrode is disposed on the shaft, and the electrode has a continuous outer ablating surface area that is adjustable. The electrode is substantially comprised of metal.
According to another embodiment, a catheter shaft comprises an outer shaft portion having a longitudinal passage extending through an outer surface, an inner shaft portion, and an electrode surface with a first end and a second end. The first end is coupled to the inner shaft portion, and the second end is coupled to the outer shaft portion. The electrode surface passes through the longitudinal passage. One of the outer shaft portion and the inner shaft portion is rotatable relative to the other of the outer shaft portion and the inner shaft portion, and relative rotation of the inner shaft portion and the outer shaft portion extends the electrode surface in a radial direction away from the outer shaft portion.
According to another embodiment, a catheter shaft comprises an outer shaft portion having a passage extending through an outer surface, an inner shaft portion, an ablation electrode member configured to pass through the passage, and a biasing element that biases the electrode member.
The accompanying drawings are not intended to be drawn to scale. In the drawings, like components that are illustrated in various figures are represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:
This invention is not limited in its application to the details of construction and the arrangement of components and acts set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having,” “containing”, “involving”, and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
In ablation procedures, lesion size may be improved by increasing the surface extension of an ablation electrode. By extending the surface geometry of the electrode radially, the reach of the electrical potential field created by the ablation electrode extends further into the ablation domain. It is desirable, however, to limit the cross-sectional size of catheters being inserted into patients. As a catheter is maneuvered through the vasculature, small sizes and flexibility are preferred.
Longer electrode sizes can also improve the uniformity of lesions by reducing the number of electrodes used. With a single, long electrode, overlapping electric fields and gaps in tissue ablation may be reduced. Longer electrodes, however, can reduce the flexibility of catheters, which may be undesirable when maneuvering a catheter within a patient.
Embodiments of the invention include expandable electrodes that may provide large surface areas for ablation procedures, but may maintain reduced cross-sectional profiles when being maneuvered through a patient's veins or arteries.
System Overview
Reference is now made to
In this description, various aspects and features of embodiments of the present invention will be described. The various features of the embodiments of the invention are discussed separately for clarity. One skilled in the art will appreciate that the features may be selectively combined in a device depending upon the particular application. Furthermore, any of the various features may be incorporated in a catheter and associated methods of use for ablation procedures.
Catheter Overview
Still referring to
Electrodes with Adjustable Dimensions
In producing long lesions, it may be desirable to use a continuous electrode that extends longitudinally along a catheter shaft. A series of ring electrodes that are spaced axially from one another may not reach all targeted tissue with adequate electrical potential. The potential fields of the series of electrodes do not necessarily sufficiently reach one another and certain volumes of tissue may not receive transmitted energy. Attempts to ablate those tissue volumes by increasing the power applied to the ring electrodes might result in overlapping potential fields that could lead to tissue overheating.
A single, long electrode may help to create a continuous lesion with a more uniform temperature and/or power distribution. Because electrodes are typically made with stiff materials such as metals, long electrodes can reduce the maneuverability of the catheter through arteries and veins. It would be desirable to have a maneuverable catheter that positions ablation electrodes able to produce continuous lesions.
Referring now to
In the retracted configuration, as illustrated, an outer electrode portion 104 encompasses inner electrode portions 106 and 108. Two additional electrode portions 110 and 112 are not visible in this configuration, but are illustrated in
In some embodiments, one electrode portion, such as the innermost electrode portion 108, is connected to an electrical lead 120 that delivers energy to electrode 102. The other electrode portions may remain electrically connected to ablation energy supply 4 by staying in electrical contact with an adjacent electrode portion regardless of whether electrode assembly 100 is in the retracted or extended configuration. In other embodiments, each electrode portion may be separately connected to electrical lead 120.
Electrode 102 is shown in an axially extended configuration in
Instead of passing pull wires 116, 118 through slot 114, pull wires 116, 118 may be attached to slidable magnets on an inner surface of shaft 12. Magnetically coupling these magnets to magnets attached to the electrode portions allows the pull wires 116, 118 to move the electrode portions without the use of a slot or other passage. In other embodiments, a series of electromagnets mounted internally or externally on shaft 12 may be consecutively energized to move electrode portions along shaft 12.
One outer electrode portion 104 and four inner electrode portions 106, 108, 110, 112 are provided in the embodiment illustrated in
Typically, the further an ablation electrode extends radially from an catheter shaft, the larger the volume of tissue that can be ablated because a larger electrode can extend the potential field further into the domain than a smaller electrode. The diameter of an ablation electrode is limited, however, because the catheter and electrodes move through a patient's arteries and/or veins. An electrode with a large diameter also may be difficult to initially introduce into a patient.
One embodiment of an electrode assembly 200 that extends an ablation electrode surface radially is illustrated in
Of course in some embodiments, even in an expanded configuration, electrode assembly 200 may be smaller than non-expandable electrodes which are sized to be maneuverable within a patient. Control of the size of electrode surface 202 may be one objective for the use of an electrode assembly such as electrode assembly 200, rather than increasing electrode size beyond a typically maneuverable size. By using a metal plate, metal sheet, or other stiff materials in constructing an electrode assembly, the dimensions and/or placement of an electrode surface may be known or measured to a greater accuracy than electrode surfaces associated with balloon inflation or flexible surfaces.
In the embodiment illustrated in
Rotation of outer shaft portion 204 relative to inner shaft portion 206 adjusts electrode surface 202 between the retracted configuration and the expanded configuration. In the embodiment illustrated in
Electrode surface 202 includes an electrically-conductive material such as platinum, silver, gold, chromium, aluminum, tungsten, or any other suitable electrically-conductive material. In some embodiments, electrode surface 202 is substantially comprised of an electrically-conductive material such as metal, that is, electrode surface 202 is not made up of a non-conductive material that is coated with a conductive material.
In another embodiment, illustrated in
Electrode surface 202 is attached to outer shaft portion 204 by passing first end 208 of electrode surface through a slot 212 in outer shaft 204 and fixing first end 208 to an inside surface 214 of outer shaft portion 204. Similarly, second end 209 may be attached to inner shaft portion 206 by passing second end 209 through a slot 216 in inner shaft portion 206. As should be evident to one of skill in the art, other suitable methods of attaching first end 208 and second end 209 to their respective shaft portions may be employed.
In some embodiments, electrode assemblies may be provided that allow adjustment of electrode dimensions in both the radial direction and the axial direction. Such embodiments may include combinations of structures disclosed herein or equivalents.
An electrode surface that extends from shaft 12 along certain radii may allow for deeper embedding of an electrode surface into tissue. Additionally, electric fields may be more directed than with cylindrical electrodes.
One embodiment of an electrode assembly 300 that allows for the extension and retraction of an electrode surface along certain radii is illustrated in
In the illustrated embodiment of
Fins 302 may be constructed with an electrically-conductive material that is flexible enough to be extended and retracted through slots 310. In further embodiments, fins 302 may be constructed of a non-electrically conducting material, such as a plastic or a rubber, that is coated with an electrically-conductive coating.
As shown in
Referring now to
Having thus described several aspects of at least one embodiment of this invention, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure, and are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description and drawings are by way of example only.
This application claims priority under 35 U.S.C. § 19(e) to U.S. Provisional Application Ser. No. 60/458,489, entitled “Electrode for Electrophysiology Catheter Having an Eccentric Surface”, filed on Mar. 28, 2003, U.S. Provisional Application Ser. No. 60/458,490, entitled “Electrophysiology Catheter Allowing Adjustment Between Electrode and Tissue Gap”, filed on Mar. 28, 2003, U.S. Provisional Application Ser. No. 60/458,491, entitled “Shape Shifting Electrode Geometry for Electrophysiology Catheters”, filed on Mar. 28, 2003, U.S. Provisional Application Ser. No. 60/458,643, entitled “Method and Apparatus for Selecting Temperature/Power Set Points in Electrophysiology Procedures”, filed on Mar. 28, 2003, and U.S. Provisional Application Ser. No. 60/458,856, entitled “Catheter Tip/Electrode Junction Design for Electrophysiology Catheters” filed on Mar. 28, 2003, all five of which are each incorporated herein by reference in their entireties.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US04/09618 | 3/29/2004 | WO | 8/14/2006 |
Number | Date | Country | |
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60458489 | Mar 2003 | US | |
60458490 | Mar 2003 | US | |
60458491 | Mar 2003 | US | |
60458643 | Mar 2003 | US | |
60458856 | Mar 2003 | US |