The disclosure relates to cardiac mapping, and, more particularly to a catheter with multiple splines each having multiple electrodes which are freely positionable to allow for more accurate mapping.
Cardiac catheter ablation is a minimally-invasive procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, atrial tachycardia, and ventricular tachycardia. If not controlled, arrhythmias may increase the risk of major adverse events including death. The catheter ablation procedure can be classified by energy source: including radiofrequency ablation and cryoablation. Cardiac catheter ablation involves advancing several flexible catheters in through the patient's blood vessels towards the heart. Electrical impulses are then used to induce the arrhythmia and local heating or freezing is used to ablate (destroy) the abnormal tissue that is causing the arrhythmia.
Atrial fibrillation mapping and ablation have undergone significant advances since the advent of pulmonary vein isolation in 1999. The main emphasis of atrial fibrillation ablation is now on detection of non-pulmonary vein atrial triggers and drivers, e.g. rotors, of atrial fibrillation particularly in patients with persistent atrial fibrillation. Recent advances in mapping and ablation techniques of atrial fibrillation and of ventricular tachycardias require detailed mapping of endocardial and/or epicardial potentials. The endocardial surface is not spherical, but is 3-dimensionally complex and has ridges and recesses. As a result, the endocardial surface is not adequately mapped by conventional basket/arrays devices such as those disclosed in any of U.S. Pat. Nos. 4,699,147, 5,846,196, 5,848,972, 8,224,416, and 8,346,339 due to less than optimal contact achieved and inadequate density and distribution of multielectrode splines and electrodes.
The limitations of current cardiac mapping baskets and arrays devices, include, but are not limited to, inadequate number/density of splines, inadequate number/density of electrodes on each spline, and inadequate or non-uniformly distributed contact with the complex atrial endocardial contours, e.g. bunching up of some splines and excessive separation of other splines which are not equidistant once deployed. The expansion of current basket design devices typically results in simultaneous equal expansion of all splines including those which already have achieved contact with partial expansion, thereby resulting in a spheroidal symmetric basket in the non-spheroidal non-symmetric cardiac chamber.
Accordingly, need exists for an apparatus and technique which can provide more uniform density of contact for global mapping of a heart chamber as well as the option for higher density mapping in regions of interest by achieving a mapping catheter configuration within the targeted heart chamber that can be customized to the patient's individual anatomy and dimensions.
Disclosed is a cardiac mapping catheter which enables three-dimensional (3D) real-time mapping of electrograms and simultaneous mapping of the entire cardiac chamber. The catheter comprises a plurality of free-standing, independently expandable, high density splines containing electrodes and and/or 3D positioning sensors/emitters. The disclosed cardiac mapping catheter provides the ability to advance each spline individually until optimal contact is achieved without effecting deployment and contact already achieved in the other splines. Once the entire cardiac chamber has been mapped, the splines can then be freely adjusted to increase the density of splines and electrodes on one area, e.g. multiple splines can be simultaneously placed on any wall or region of interest. In one embodiment, the mapping catheter may comprise a distal tip configuration which enables one or more of the splines to be free and unconnected to the other splines. In another embodiment, the distal ends of plural splines are coupled to a distal connector tip while still enabling each spline to be advanced individually and expanded to different degrees independently. In another embodiment, the distal ends of plural splines are coupled to a distal expansile ring for epicardial application.
Disclosed is a mapping catheter comprising a common valved introducer, a common lumen, a common distal end port; and a plurality of pre-shaped multi-electrode splines introducible individually or in groups through a standard transseptal sheath.
According to one aspect of the disclosure, a catheter comprises a multiplicity of low-profile (small French size) multielectrode splines, with each spline having a low profile enabling a higher number of electrodes on each spline and each spline being separately and independently advancable or retractable from the other splines.
According to another aspect of the disclosure, a catheter comprises a multiplicity of low-profile (small French size) multielectrode splines being separately and independently advancable or retractable from the other splines and whose distal ends are freely positionable within the cardiac chamber.
According to still another aspect of the disclosure, a catheter comprises a multiplicity of low-profile (small French size) multielectrode splines being separately and independently advancable or retractable from the other splines and whose distal ends are attached to a common distal cap.
According to yet another aspect of the disclosure, the inclusion of 3-D positioning sensor/emitter on splines enables 3-dimensional electro-anatomical reconstruction of all maps and provides the option of incorporating such reconstruction into commercially available systems, such as Mediguide, and Navex and others.
According to another aspect of the disclosure, one or more of the splines may be implemented with a guidewire comprising an elongate tubular body having a core wire extending therethrough to a tip at a distal end thereof. The distal end of the guidewire further comprises multiple pairs of small surface area, closely spaced electrodes electrically couplable to a current source at the proximal end of the guidewire. The electrodes can sense electrical signals from the myocardium immediately adjacent to the electrodes, can pace the heart and can also perform pace-entrainment mapping in addition to activation mapping.
According to another aspect of the disclosure, a mapping catheter comprises: an elongate tubular body extending between proximal and distal ends thereof; and a plurality of intravascular devices simultaneously disposable within the elongate tubular body, each of the plurality of intravascular devices having a plurality of electrodes carried on an exterior portion thereof; wherein each of the plurality of intravascular devices is advancable and retractable relative to the distal end of the tubular body independent of others of the plurality of vascular devices. In one embodiment, each of the plurality of intravascular devices has a distal tip which is coupled to a common distal cap which is positionable beyond the distal end of the elongate tubular body.
According to yet another aspect of the disclosure, a mapping catheter comprises: an elongate tubular body extending between proximal and distal ends thereof; and a plurality of intravascular devices simultaneously disposable within the elongate tubular body, each of the plurality of intravascular devices having a distal region with a preshaped with a curve; wherein each of the plurality of intravascular devices is advancable and retractable relative to the distal end of the tubular body independent of others of the plurality of vascular devices. In one embodiment, less than all of the plurality of intravascular devices have a same predefined curvature.
According to another aspect of the disclosure, a method for mapping comprises: A) introducing into a space a plurality of intravascular devices through a common tubular body, each of the plurality of intravascular devices having a plurality of electrodes carried on an exterior portion thereof; and B) advancing one of the plurality of intravascular devices relative to a distal end of the tubular body independent of others of the plurality of vascular devices so that one of the plurality of electrodes is proximate a greatest extent of the space.
The various features and advantages of the present invention may be more readily understood with reference to the following detailed description taken in conjunction with the accompanying drawings, wherein like reference numerals designate like structural elements, and in which:
The present disclosure will be more completely understood through the following description, which should be read in conjunction with the drawings. In this description, like numbers refer to similar elements within various embodiments of the present disclosure. The skilled artisan will readily appreciate that the methods, apparatus and systems described herein are merely exemplary and that variations can be made without departing from the spirit and scope of the disclosure.
In embodiments, the wire implementation multielectrode spines 31 may have a lubricious hydrophyllic coating. The inner walls of lumens 42 may also have a lubricious hydrophyllic coating.
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In the embodiments, the axial position, and, therefore, the extent of each spline 31 protruding distantly from distal end port 43, may be implemented with an actuating mechanism coupled to the proximal handle 45, such actuating mechanism including a rotary control or thumb wheel mechanism mechanically coupled to one or more of splines 31 to allow advancement or retraction of the line relative to the distal end of catheter 30. Such an actuating mechanism is disclosed in US Patent Application Publication US201 seen in my ritual in FIG. 1 a no 7/0165064, such mechanism being able to advance and retract any of the splines 31 relative to the distal end of the tubular body independent of the other splines 31 or stylus 53.
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In embodiments, an optional gauge disposed at the proximal end 47 of catheter 30 can quantify length of a spline 31 advanced beyond the distal tip of tubular body 40 and may also quantify the amount of mechanical resistance, e.g. contact force, to further advancement of spline 31.
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In embodiments, multielectrode spines 31 and mapping catheter 40 may be coated with covalently-bonded-heparin as an anticoagulant. The mapping catheter 40 may have a proximal side arm, comprising a transparent material for bubble detection, for continuous flushing of heparinized saline fluid.
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In embodiments, the mapping catheter 30 may be manufactured as an assembly with splines 31 preloaded therein. A method for utilizing embodiments of mapping catheter 30 described herein is as follows. Catheter 30 may be introduced to the target heart chamber, e.g. into the left atrium, by transseptal access either through an outer deflectable or non-deflectable transseptal sheath or directly without an outer sheath achieved by an over-the-wire exchange from an initial transseptal sheath. With the over-the-wire exchange option, central lumen 42 of catheter 30, accommodates a delivery, e.g. transseptal, guidewire. In embodiments, mapping catheter 30 may be non-deflectable or deflectable by use of deflection wires embedded in the outer wall or inner core of the tubular body 40, in a manner understood in the art, to assist with proper placement.
Once in position, the multielectrode splines 31 with the greatest curvature are advanced distantly using the proximal control mechanisms described herein to exit through individual channels 42 in the outer peripheral ring of the distal end port 41 of catheter 30 so as to allow contact with and recordings made along the interatrial septum of the left atrium as well as the right side of the left atrium and the right pulmonary veins and antra. The multielectrode splines 31 with less curvature are advanced distantly using the proximal mechanisms described herein to exit through individual channels 42 in the inner peripheral ring of the distal end port 41 of catheter 40 so as to allow contact with and recordings made along the main body of the left atrium and left lateral aspect of the left atrium and the left pulmonary veins and antra and the left atrial appendage.
In embodiments, as part of the disclosed technique, an additional electrode may be added on the elongate tubular body 40, positionable in the inferior vena cava, to provide a reference for unipolar electrograms from the intracardiac spline electrodes 31.
In embodiments, as part of the disclosed technique, the degree of contact of each electrode (electrode pair) may be based on radiographic appearance, electrogram amplitude, electrogram high frequency components (which can be achieved by Fast Fourier Transform analysis and spectral analysis), electrogram fractionation, pacing threshold, impedance (myocardium has a higher impedance than blood) between each electrode and between neighboring electrode pairs, and by electrolocation whereby a charge applied between neighboring electrode pairs, e.g. the two electrodes of each pair being common, generates an electric field and changes in this field brought about by proximity to myocardium as opposed to the uniform conducting medium of blood is detected
The electrode pairs may be formed of any biocompatible electrically conductive material as can the electrical leads extending proximally along the axial length of the guidewire and connectable to a signal source and measurement circuit module 16. In one embodiment, the electrode pairs and their respective leads may be designed for MRI compatability, e.g. gold electrodes and copper wire leads or carbon and/or plastics conductive materials. In embodiments, the electrode leads may be embedded in the wall of elongate cylindrical tube 20 for mechanical and electrical isolation.
Guidewire 10 includes an elongate cylindrical tube 20 of semi-rigid material, such as a natural or synthetic resin, having enough columnar strength to allow it to be advanced through tortuous vasculature but flexible enough to negotiate curves within the vasculature. The guidewire exterior, particularly the distal end region 21 may have a polymer covered distal tip 22. The distal end of the guidewire 10 may be implemented with a helical platinum coil 24 coupled to a hemispherical bead tip 25, as illustrated in
Proximal electrode pair 11,12 and distal electrode pair 13,14 may be carried on the exterior surface of cylindrical tube 20, either on the exterior diameter thereof or seated in indentations in the surface of tube 20, and are electrically coupled to leads which extend proximally through guidewire 10 for electrical coupling with the interface of measurement circuit module 16. Such electrical leads will be typically insulated and may extend through the hollow interior of 20 or may be embedded in the wall thereof. The source of a current signal may also be included within measurement circuit module 16. Note, in embodiments, the individual electrodes 11,12,13,14 may be coupled to a signal generator as well as measurement circuit module 16 in any configuration become as appropriate or in selectable configurations, e.g. electrode pairs electrically coupled in series with a signal generator or measurement circuit module 16, all electrodes in parallel with a signal generator or measurement circuit module 16, electrode pairs in parallel with a signal generator or measurement circuit module 16, or other configurations.
In practice, the guidewire 10 is connected to a signal source and measurement circuit module 16 and is inserted through a dedicated lumen or a common goal of catheter 30 and positioned within a cardiac chamber or other cavity inside the body.
In embodiments, one or more of the multi-electrode splines 31 can have an incorporated 3-D positioning sensor/emitter 52 located at the distal tip thereof to enable real-time electroanatomical mapping of the atrial chambers. In other embodiments two or three 3-D positioning sensor/emitter 52 may be located at reference sites along each spline 31 so that the precise location of the electrodes is known.
In embodiments, one or more of the multi-electrode splines 31 can have a soft distal end which is implemented with either a straight or J shaped coil. Such coil may be made or partially from a radiopaque material. Alternatively, a radio-opaque marker may be disposed at the distal end thereof. In other embodiments, the distal coil may be made of a shape memory material which assumes a predetermined shape once position in situ within the body.
The multielectrode splines 31 may be round, as illustrated in
As indicated elsewhere herein although
Connections within or proximal (external) to the handle 45 the catheter 30 may be hardwired or may be via wireless communication, e.g. blue tooth/WiFi/medical band RF, non-contact communication to a recording-signal and processing-display system 15, 16. In embodiments, the handle 45 may also be implemented with a battery to allow pacing without a hard-wired external source. In embodiments, an external connection option comprises an optical fiber connection with simultaneous parallel multiple, e.g. 64, fibers or wires, or, alternatively comprises an optical fiber connection with pulsed sequential sampling from each of 64 electrodes.
The disclosed multi-electrode guidewire 10 may be combined with multiple similar guide wires into the catheter 30 to perform epicardial mapping as well as to deliver ablative radiofrequency or electric energy to cause deliberate ablation/cauterization of myocardium (sub-epicardium) directly or to cause deliberate occlusion of a coronary artery or coronary vein. Such epicardial application may be applied to the atrium or to the ventricle. Similarly our endocardial mapping catheter can be applied to the atrium or the ventricle.
It will be appreciated that any of the described aspects, features and options described in view of the disclosed methods apply equally to the system, measurement circuit module and guidewire device. It will be understood that any one or more of the described aspects, features and options as described herein can be combined. For purposes of clarity and a concise description, features are described herein as part of the same or separate embodiments, however, it will be appreciated that scope of the concepts may include embodiments having combinations of all or some of the features described herein.
It will be obvious to those reasonably skilled in the art that modifications to the apparatus and process disclosed here in may occur, including substitution of various components or values, without parting from the true spirit and scope of the disclosure.
Number | Date | Country | |
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62362634 | Jul 2016 | US |