US20060241366A1 - Electrophysiology loop catheter - Google Patents

Abstract

An electrophysiology catheter including control, localization, and/or fluid delivery features, and methods of using the same. One embodiment of the invention is directed to an electrophysiology catheter including a superelastic wire and a cable, and a method of controlling the catheter using the cable. Another embodiment is directed to an electrophysiology catheter including an adhesive to bias the orientation of the catheter. A further embodiment is directed to an electrophysiology catheter including adhesive and one or more cables, and a method of controlling the catheter using the one or more cables. Another embodiment is directed to a method including acts of injecting a fluid into the heart of a patient and adjusting the diameter of an arcuate curve of the catheter. Further embodiments are directed to a catheter having multiple position sensors on an arcuate curve of the catheter, or a position sensor associated with a movable electrode of the catheter.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to electrophysiology catheters, and more particularly to electrophysiology catheters for performing endocardial mapping and/or ablation procedures.
• 2. Discussion of the 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.
• In some individuals, the electrical impulses of the heart develop an irregular propagation, disrupting the heart's normal pumping action. The abnormal heartbeat rhythm is termed a “cardiac arrhythmia.” Arrhythmias may occur when a site other than the sinoatrial node of the heart is initiating rhythms (i.e., a focal arrhythmia), or when electrical signals of the heart circulate repetitively in a closed circuit (i.e., a reentrant arrhythmia).
• 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 and into an endocardial site, 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.
• Current understanding is that atrial fibrillation is frequently initiated by a focal trigger from the orifice of or within one of the pulmonary veins. Though mapping and ablation of these triggers appears to be curative in patients with paroxysmal atrial fibrillation, there are a number of limitations to ablating focal triggers via mapping and ablating the earliest site of activation with a “point” radiofrequency lesion. One way to circumvent these limitations is to determine precisely the point of earliest activation. Once the point of earliest activation is identified, a lesion can be generated to electrically isolate the trigger with a lesion; firing from within those veins would then be eliminated or unable to reach the body of the atrium, and thus could not trigger atrial fibrillation.
• Another method to treat focal arrhythmias is to create a continuous, annular lesion around the ostia (i.e., the openings) of either the veins or the arteries leading to or from the atria thus “corralling” the signals emanating from any points distal to the annular lesion. Conventional techniques include applying multiple point sources around the ostia in an effort to create such a continuous lesion. Such a technique is relatively involved, and requires significant skill and attention from the clinician performing the procedures.
• 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.
SUMMARY OF THE INVENTION
• One embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft, and the tip assembly including a wire formed of a superelastic material and shaped to bias the tip assembly in a first orientation, and a cable, attached to the actuator and the tip assembly, that extends through the shaft, the cable being adapted to change an orientation of the tip assembly from the first orientation in response to movement of the actuator.
• Another embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, and a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the tip assembly including an adhesive cured in a configuration to bias the tip assembly in a first orientation.
• A further embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the tip assembly including an adhesive cured in a configuration to support the tip assembly in a first orientation including an arcuately curved shape at the distal end of the tip assembly having a first radius of curvature, a first cable, attached to the actuator and the tip assembly, that extends through the shaft, the first cable being adapted to change an orientation of the tip assembly from the first orientation to a second orientation including an arcuately curved shape at the distal end of the tip assembly having a second radius of curvature larger than the first radius of curvature in response to movement of the actuator, and a second cable, attached to the actuator and the tip assembly, that extends through the shaft, the second cable being adapted to change the orientation of the tip assembly from the second orientation to the first orientation in response to movement of the actuator.
• Another embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the tip assembly including an adhesive cured in a configuration to support the tip assembly in a first orientation including a bend at the proximal end of the tip assembly having a first angle of approximately ninety degrees relative to the longitudinal axis of the shaft, a first cable, attached to the actuator and the tip assembly, that extends through the shaft, the first cable being adapted to change an orientation of the tip assembly from the first orientation to a second orientation including a bend at the proximal end of the tip assembly having a second angle relative to the longitudinal axis that is smaller than the first angle in response to movement of the actuator, and a second cable, attached to the actuator and the tip assembly, that extends through the shaft, the second cable being adapted to change the orientation of the tip assembly from the second orientation to the first orientation in response to movement of the actuator.
• A further embodiment of the invention is directed to a method of shaping a tip assembly of a catheter. The method comprises acts of injecting an adhesive into a lumen of the catheter that extends along the tip assembly of the catheter, and curing the adhesive by maintaining a portion of the tip assembly of the catheter in a fixed position for a time sufficient to allow the adhesive to bias the tip assembly in a particular orientation.
• Another embodiment of the invention is directed to a method of using a catheter having a handle, a flexible shaft having a longitudinal axis, and a tip assembly, the shaft being connected between the handle and the tip assembly, a distal end of the tip assembly including an arcuate curve having a diameter. The method comprises acts of placing the tip assembly inside a heart of a patient, injecting a fluid from the tip assembly into the heart of the patient, and remotely, from outside the patient, adjusting the diameter of the arcuate curve.
• A further embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the distal end of the tip assembly being biased in an arcuately curved shape having a radius of curvature, a cable, attached to the actuator and the distal end of the tip assembly, that extends through the shaft, the cable being adapted to change the radius of curvature of the distal end of the tip assembly in response to movement of the actuator, and means for conducting a fluid along a length of the shaft and releasing the fluid from the tip assembly.
• Another embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the distal end of the tip assembly being biased in an arcuately curved shape having a radius of curvature, a cable, attached to the actuator and the distal end of the tip assembly, that extends through the shaft, the cable being adapted to change the radius of curvature of the distal end of the tip assembly in response to movement of the actuator, at least one lumen coupled to the shaft to conduct a fluid along a length of the shaft, and at least one opening in the lumen to release the fluid, the opening being disposed at a portion of the lumen coupled to the shaft at the tip assembly.
• A further embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the distal end of the tip assembly being biased in an arcuately curved shape having a radius of curvature, and a cable, attached to the actuator and the distal end of the tip assembly, that extends through the shaft, the cable being adapted to change the radius of curvature of the distal end of the tip assembly in response to movement of the actuator, wherein the distal end of the tip assembly includes a plurality of position sensors disposed in the distal end of the tip assembly.
• Another embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft, the proximal end of the tip assembly including a fixed bend of approximately ninety degrees relative to the longitudinal axis of the shaft, and the distal end of the tip assembly including an arcuate curve having a diameter, the arcuate curve being oriented in a plane that is approximately perpendicular to the longitudinal axis of the shaft, and a cable, attached to the actuator and the distal end of the tip assembly, that extends through the shaft, the cable being adapted to change the diameter of the arcuate curve in response to movement of the actuator, wherein the distal end of the tip assembly includes a plurality of position sensors disposed in the distal end of the tip assembly.
• A further embodiment of the invention is directed to a method of using a catheter having a handle, a flexible shaft having a longitudinal axis, and a tip assembly, the shaft being connected between the handle and the tip assembly, a distal end of the tip assembly including an arcuate curve having a diameter. The method comprises acts of placing the tip assembly inside a heart of a patient, sensing the location of at least one two points on the tip assembly, and remotely, from outside the patient, adjusting the diameter of the arcuate curve. Another embodiment of the invention is directed to a method of using a catheter having a handle, a flexible shaft having a longitudinal axis, and a tip assembly, the shaft being connected between the handle and the tip assembly, a distal end of the tip assembly including an arcuate curve having a diameter. The method comprises acts of placing the tip assembly inside a heart of a patient, sensing the location of a movable electrode disposed on the tip assembly, and remotely, from outside the patient, adjusting the diameter of the arcuate curve.
• A further embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including a first actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the distal end of the tip assembly being biased in an arcuately curved shape having a radius of curvature, wherein the distal end of the tip assembly includes a movable electrode assembly comprising an electrode, a position sensor, and means for moving the electrode and position sensor longitudinally along a portion of the length of the shaft, and a first cable, attached to the first actuator and the distal end of the tip assembly, that extends through the shaft, the cable being adapted to change the radius of curvature of the distal end of the tip assembly in response to movement of the actuator in a first direction.
• Another embodiment of the invention is directed to a flexible shaft of a catheter device. The shaft comprises a catheter body having a proximal end and a distal end and a longitudinal axis that extends along a length of the catheter body, and a channel formed of a superelastic material and shaped to bias a portion of the catheter body in a first orientation.
• A further embodiment of the invention is directed to an electrophysiology catheter comprising a handle having a distal end and a proximal end, the handle including an actuator, a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle, a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft, and the tip assembly including a channel formed of a superelastic material and shaped to bias the tip assembly in a first orientation, and a cable, attached to the actuator and the tip assembly and extending through the channel, the cable being adapted to change an orientation of the tip assembly from the first orientation in response to movement of the actuator.
BRIEF DESCRIPTION OF THE DRAWINGS
• Illustrative, non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, in which:
• FIG. 1 illustrates a schematic view of a mapping and/or ablation catheter system in accordance with the present invention;
• FIG. 2 is an end elevational view of a distal end tip assembly, taken along line2-2 inFIG. 1, that may be used with the catheter system ofFIG. 1 according to one embodiment of the present invention;
• FIG. 3 is a perspective view of the distal end tip assembly ofFIG. 2;
• FIG. 4 is an alternative perspective view of the distal end tip assembly ofFIG. 2 illustrating the manner in which the radius of curvature of the distal end may be changed;
• FIG. 5 illustrates a first jig that may be used to impart a fixed shape to the distal end tip assembly according to one embodiment of the present invention;
• FIG. 6 illustrates a side elevational view of the jig ofFIG. 5;
• FIG. 7 is a cross sectional side view of a second jig that may be used to impart a fixed shape to the distal end tip assembly according to another embodiment of the present invention;
• FIG. 8 is an exploded perspective view of the jig ofFIG. 7;
• FIG. 9 is a cross sectional side view of a third jig that may be used to impart a fixed shape to the distal end of the tip assembly according to another embodiment of the present invention;
• FIG. 10 is an exploded perspective view of the jig ofFIG. 9;
• FIG. 11 is an enlarged end elevational view of the distal end tip assembly ofFIG. 2;
• FIG. 12 is a schematic view of the distal end tip assembly ofFIG. 11 in a tightly coiled position;
• FIG. 13 is a schematic view of the distal end tip assembly ofFIG. 11 in a loosely coiled position;
• FIG. 14 is a side elevational view of the distal end of a finished catheter prior to shaping with any one of the jigs ofFIGS. 5-10;
• FIG. 15 is a cross sectional view of the distal end of the catheter ofFIG. 14 taken along line15-15 inFIG. 14;
• FIG. 15A is a fragmentary cross sectional view of the distal end of the catheter ofFIG. 15 showing an alternative raised profile electrode;
• FIG. 16 is a cross sectional view of the distal end of the catheter ofFIG. 15 taken along line16-16 inFIG. 15;
• FIG. 17 is a cross sectional view of the distal end of the catheter ofFIG. 15 taken along line17-17 inFIG. 15;
• FIG. 18 is a perspective view of a distal end tip assembly according to another embodiment of the present invention that may be used with the catheter system ofFIG. 1, and which includes a sliding electrode;
• FIG. 19 is a cross sectional side view of the distal end tip assembly ofFIG. 18 taken along line19-19 inFIG. 18;
• FIG. 20 is a cross sectional end view of the distal end of tip assembly ofFIG. 19 taken along line20-20 inFIG. 19;
• FIG. 21 is a perspective view of a distal end tip assembly according to another embodiment of the present invention that may be used with the catheter system ofFIG. 1;
• FIG. 21A is a cross sectional view of the distal end tip assembly ofFIG. 21 taken alongline21A-21A inFIG. 21;
• FIG. 22 is an exploded view of a handle, taken along line22-22 inFIG. 1, that may be used with the catheter system ofFIG. 1 according to another embodiment of the present invention;
• FIG. 23 is a schematic cross sectional view of a slide actuator for the handle ofFIG. 22 in a neutral or unloaded state;
• FIG. 24 is a schematic cross sectional view of a slide actuator for the handle ofFIG. 22 in a deployed or loaded state;
• FIG. 25 is a cross sectional end view of the slide actuator ofFIG. 23 taken along line25-25 inFIG. 23;
• FIG. 26 is an exploded perspective view of the left section of the handle ofFIG. 22;
• FIG. 27 is a schematic cross sectional view of a thumbwheel actuator for the handle ofFIG. 22 in a neutral or unloaded state;
• FIG. 28 is a schematic cross sectional view of the thumbwheel actuator for the handle ofFIG. 22 in a deployed or loaded state;
• FIG. 29A is an elevational view of another handle that may be used with the catheter system ofFIG. 1 according to another embodiment of the invention that includes a third actuator;
• FIG. 29B is a schematic view of another handle according to another embodiment of the invention that includes a plunger-type third actuator;
• FIG. 30 is a side elevational view of a handle that may be used with the catheter system ofFIG. 1 and which includes features that provide tactile feedback to a user when using one of the actuators;
• FIG. 31 is a schematic cross sectional view of one implementation for providing tactile feedback to a user that is adapted for use with the slide actuator ofFIG. 30;
• FIG. 32 is a schematic cross sectional view of another implementation for providing tactile feedback to a user that is also adapted for use with the slide actuator ofFIG. 30;
• FIG. 33 is a side elevational view of an handle that includes graphical indicia indicative of a radius of curvature of the distal end tip assembly according to another embodiment of the present invention;
• FIG. 34 is a side elevational view of a distal end tip assembly according to another embodiment of the present invention that includes a localization sensor and a temperature sensor;
• FIG. 35 illustrates the insertion of a catheter of the present invention into a body of a patient;
• FIG. 36 illustrates the insertion of the catheter of the present invention into a heart; and
• FIG. 37 illustrates the insertion of the distal end of the catheter into the ostium of a pulmonary vein in the heart.
• FIG. 38 is an enlarged end elevational view of the distal end tip assembly according to another embodiment of the invention in which a superelastic wire is used to bias the orientation of the tip assembly;
• FIGS. 39A and 39B are schematic views illustrating a first configuration for controlling the distal end of the tip assembly with a superelastic wire and a pull wire;
• FIGS. 40A and 40B are schematic views illustrating a first configuration for controlling the proximal end of the tip assembly with a superelastic wire and a pull wire;
• FIGS. 41A and 41B are schematic views illustrating a second configuration for controlling the distal end of the tip assembly with a superelastic wire and a pull wire;
• FIGS. 42A and 42B are schematic views illustrating a second configuration for controlling the proximal end of the tip assembly with a superelastic wire and a pull wire;
• FIGS. 43A and 43B are schematic views illustrating a third configuration for controlling the distal end of the tip assembly with a superelastic wire and a pull wire;
• FIGS. 44A and 44B are schematic views illustrating a third configuration for controlling the proximal end of the tip assembly with a superelastic wire and a pull wire;
• FIG. 45 is an enlarged end elevational view of the distal end tip assembly according to another embodiment of the invention in which an adhesive is used to bias the orientation of the tip assembly;
• FIGS. 46A and 46B are schematic views illustrating a first configuration for controlling the distal end of the tip assembly with a cured adhesive and a pull wire;
• FIGS. 47A and 47B are schematic views illustrating a first configuration for controlling the proximal end of the tip assembly with a cured adhesive and a pull wire;
• FIGS. 48A and 48B are schematic views illustrating a second configuration for controlling the distal end of the tip assembly with a cured adhesive and a pull wire;
• FIGS. 49A and 49B are schematic views illustrating a second configuration for controlling the proximal end of the tip assembly with a cured adhesive and a pull wire;
• FIGS. 50A and 50B are schematic views illustrating a third configuration for controlling the distal end of the tip assembly with a cured adhesive and a pull wire;
• FIGS. 51A and 51B are schematic views illustrating a third configuration for controlling the proximal end of the tip assembly with a cured adhesive and a pull wire;
• FIG. 52 is a schematic view illustrating the distal end of the tip assembly according to another embodiment of the invention in which an adhesive is used to impart a fixed bias to the orientation of the tip assembly;
• FIG. 53 is a schematic view illustrating the proximal end of the tip assembly according to the embodiment ofFIG. 52;
• FIG. 54 is a perspective view of a tip assembly including multiple localization sensors in accordance with another embodiment of the present invention;
• FIG. 55 is a perspective view of a tip assembly including a movable electrode assembly with a localization sensor in accordance with another embodiment of the present invention;
• FIG. 56 is a side view of a tip assembly including a fluid delivery structure in accordance with another embodiment of the present invention;
• FIG. 57 is a side view of a tip assembly including a fluid delivery structure in accordance with further embodiment of the present invention;
• FIG. 58 is a cross sectional view of the tip assembly ofFIG. 56 taken along line58-58 inFIG. 56;
• FIG. 59 is a cross sectional view of the tip assembly ofFIG. 57 taken along line59-59 inFIG. 57;
• FIG. 60 illustrates the delivery of fluid into the heart via the distal tip of the catheter in accordance with an embodiment of the invention;
• FIG. 61 illustrates the delivery of fluid into the heart via the proximal end of the tip assembly of the catheter in accordance with another embodiment of the invention.
• FIGS. 62A and 62B illustrate a catheter including a fluid delivery structure in accordance with another embodiment of the present invention;
• FIG. 63 illustrates a sheath including a fluid delivery structure in accordance with an embodiment of the present invention;
• FIGS. 64A is a fragmentary perspective view illustrating the proximal end of the tip assembly according to another embodiment of the invention in which an adhesive is used to provide support to the tip assembly;
• FIG. 64B is a schematic view illustrating control of the proximal end of the tip assembly according to the embodiment ofFIG. 64A;
• FIGS. 65A is a fragmentary perspective view illustrating the distal end of the tip assembly according to another embodiment of the invention in which an adhesive is used to provide support to the tip assembly;
• FIG. 65B is a schematic view illustrating control of the distal end of the tip assembly according to the embodiment ofFIG. 65A;
• FIG. 66 is a perspective view of a distal tip assembly illustrating an exemplary location where superelastic channels may be located in the distal tip assembly;
• FIG. 67 illustrates a cross sectional view of the distal tip assembly shown inFIG. 66;
• FIG. 68 is a perspective view of a portion of one exemplary implementation of a superelastic channel;
• FIG. 69 is a perspective view of a portion of another exemplary implementation of a superelastic channel;
• FIG. 70 is an elevational view of a superelastic channel;
• FIG. 71 is a schematic view illustrating a configuration for controlling the proximal end of a tip assembly having a superelastic channel using a pull wire; and
• FIG. 72 is a schematic view illustrating the distal end of the tip assembly according to another embodiment of the invention in which a superelastic channel is used to impart a bias to the orientation of the tip assembly.
DETAILED DESCRIPTION
• In this description, various aspects and features of the present invention will be described. One skilled in the art will appreciate that the features may be selectively combined in a device depending on the particular application. Furthermore, any of the various features may be incorporated in a catheter and associated method of use for mapping and/or ablation procedures.
• Catheter Overview
• Reference is now made toFIG. 1, which illustrates an overview of a mapping and/or ablation catheter system for use in electrophysiology procedures, in accordance with the present invention. The system includes acatheter100 having aflexible shaft110, acontrol handle120, and aconnector130. When used in mapping applications, theconnector130 is used to allow signal wires running from mapping electrodes at a distal end of thecatheter100 to be connected to a device for recording signals, such as arecording device160. When used in ablation applications,connector130 is used to allow signal wires running from ablation electrodes at the distal end of thecatheter100 to be connected to a device for generating ablation energy, such asablation energy generator170. As will be described further in detail below, the distal end of thecatheter100 may include separate mapping and/or ablation electrodes, or may alternatively include electrodes that are adapted for both mapping and ablation.
• Acontroller150 is electrically connected toconnector130 viacable115. In one embodiment,controller150 may be a QUADRAPULSE RF CONTROLLER™ device available from C. R. Bard, Inc., Murray Hill, N.J.Ablation energy generator170 may be connected tocontroller150 viacable116.Recording device160 may be connected tocontroller150 viacable117. When used in an ablation application,controller150 is used to control ablation energy, provided byablation energy generator170, tocatheter100. When used in a mapping application,controller150 is used to process signals fromcatheter100 and provide these signals torecording device160. Although illustrated as separate devices,recording device160,ablation energy generator170, andcontroller150 may be incorporated into a single device. It should further be appreciated that although bothablation energy generator170 andrecording device160 are illustrated inFIG. 1, either or both of these devices may be incorporated in the catheter system in accordance with the present invention.
• Theshaft110 of thecatheter100 is, in one embodiment, approximately six French in diameter, although it should be appreciated that many diameters are possible, and the diameter ofshaft110 may be smaller or larger depending on the particular application and/or combination of features incorporated into thecatheter100. Attached to adistal end112 of theshaft110 is a distalend tip assembly140 having aproximal end142 that is attached to thedistal end112 of theshaft110, and adistal end144 having one or more electrodes146 (SeeFIG. 2). The length of thetip assembly140 may be approximately 7 to 8 cm in length, although other lengths may be suitably employed, as the present invention is not limited to any particular length. Further, and as will be subsequently described, the number and placement of electrodes along thedistal end144 of thetip assembly140 may vary depending upon the application. For example, for mapping applications, a plurality of low profile electrodes may be preferred, whereas for ablations applications a lesser number of higher profile electrodes may be preferred. Embodiments of the present invention may include as few as one electrode, which may be movably attached to thedistal end144 of thetip assembly140, or may alternatively include a plurality of fixed electrodes, for example 20 or 20 more, spaced apart along thedistal end142 of thetip assembly140. Further, the construction of the electrode orelectrodes146 may vary, as known to those skilled in the art.
• According to one aspect of the present invention, and as shown in detail inFIG. 3, theproximal end142 of thetip assembly140 includes an approximately ninetydegree bend148 relative to a longitudinal axis (L) of theshaft110, which may be active, or fixed, and thedistal end144 of thetip assembly140 includes an arcuate curve that is oriented orthogonally to the longitudinal axis of theshaft110. As used in association with the approximately ninetydegree bend148, the term “active” is herein defined to mean that the portion of theproximal end142 of thetip assembly140 where thebend148 is formed is capable of movement, relative to the longitudinal axis (L) of theshaft110 between approximately zero degrees and approximately ninety degrees via manipulation of a remotely controlled actuator (e.g.,actuators122,124 disposed on the handle120). The term “fixed,” as used in association with the approximately ninetydegree bend148, is herein defined to mean that the approximately ninetydegree bend148 is permanently formed in theproximal end142 of thetip assembly140, such that the approximately ninety degree bend retains its shape at body temperatures.
• According to a further aspect of the present invention, the radius (or alternatively, the diameter) of curvature of the arcuately curveddistal end144 may be adjustable by operation of an actuator (e.g.,actuators122,124) disposed on thehandle120. The combination of the approximate ninety degree bend followed by an arcuate curve that is adjustable in diameter permits thecatheter100 to be uniquely suited for mapping and/or ablation procedures in difficult endocardial sites, such as, for example, within a blood vessel, such as a pulmonary vein, or an ostium of a blood vessel, such as the ostium of a pulmonary vein. For example, in both mapping and ablation procedures, the approximately ninety degree bend permits pressure, applied to thehandle120, to be translated to thedistal end144 of thetip assembly142, to thereby urge thedistal end144 of thetip assembly140 tight against the endocardial site. The adjustable radius of curvature of the arcuate curve can be used to apply an outwardly radial pressure to further force thedistal end144 of thetip assembly140 tight against the endocardial site, or to adjust to endocardial sites of different diameters (e.g. that of an adult or large animal, or a small child or small animal), or both. This ability to urge thedistal end144 of the tip assembly tight against an endocardial site is advantageous in mapping procedures to better localize the source of the cardiac arrhythmia, and may be used in ablation procedures to focus the ablation energy on the selected endocardial site. Further, because the radius of curvature of thedistal end144 of the tip assembly can be adjusted to different diameters, the catheter may be used with either an adult (or large animal) or a child (or small animal), as “one size fits all.” This ability to accommodate a range of sizes can reduce the number of distinctly sized catheters that need to be stocked by the manufacturer or the care provider.
• Disposed on thehandle120 are one ormore actuators122,124 that may be used for a variety of purposes. Each of theactuators122,124 is mechanically coupled to at least one cable that extends to thetip assembly140 and which may be used to change the shape, orientation, or both the shape and orientation of the tip assembly. In the embodiment depicted inFIG. 1, thehandle120 includes two different actuators, athumbwheel actuator122 and aslide actuator124. In one embodiment, thethumbwheel actuator122 may be used to change the orientation of thetip assembly140 in two opposing directions, and theslide actuator124 may be used to enlarge and decrease the radius of curvature of the arcuately curveddistal end144 of thetip assembly140. As will be described in detail further below, the operation of theactuators122,124 may be reversed, such that thethumbwheel actuator122 is used to control the radius of curvature, and theslide actuator124 is used to control the orientation of thetip assembly140 relative to the shaft110 (e.g., to provide steering). Moreover, as described further in detail below, the present invention is not limited to two distinct control actuators, as embodiments of the present invention may include only a single actuator that controls only one degree of movement (for example, increasing the radius of curvature of the arcuately curved distal end144), or may include several actuators, each capable of controlling two degrees of movement.
• The Tip Assembly
• FIGS. 2-4 illustrate a distal end tip assembly according to one embodiment of the present invention. According to this embodiment, theproximal end142 of thetip assembly140 includes an approximately ninetydegree bend148 relative to the longitudinal axis of theshaft110, followed by an arcuately curveddistal end144. In the embodiment depicted inFIGS. 2-4, the approximately ninetydegree bend148 is fixed, that is, permanently formed in theproximal end142 of thetip assembly140, such that the approximately ninetydegree bend148 retains its shape at body temperatures. In other embodiments, the approximately ninetydegree bend148 may be active, that is, movable between approximately zero and approximately ninety degrees relative to the longitudinal axis (L) of theshaft110 via a pull or push cable attached to one of theactuators122,124 on thehandle120, as described further below with respect toFIG. 21.
• In each embodiment, the region of thetip assembly140 that includes the approximately ninetydegree bend148 is preferably biased in a curved position relative to the longitudinal axis (L) of theshaft110, although the degree of bias may vary. Specifically, in embodiments featuring a fixed bend, thebend148 is permanently formed in theproximal end142 of thetip assembly140 at an angle of approximately ninety degrees, such that while capable of being straightened for introduction into a vessel, such as for example, through the use of a sheath/dilator, thedistal end144 of thetip assembly140 springs back in its unrestrained state to rest in a plane that is approximately perpendicular to the longitudinal axis (L) of theshaft110. In embodiments featuring an active bend, only a slight amount of bend, for example, a few degrees, is permanently formed in theproximal end142 of thetip assembly140. This slight amount of bend in theproximal end142 of thetip assembly140 is sufficient to ensure that thedistal end144 of thetip assembly140 bends in a predetermined direction relative to the longitudinal axis (L) of theshaft110, as described more fully below. However, in all embodiments, thedistal end144 of thetip assembly140 is permanently biased in an arcuate shape to facilitate increases and/or decreases in the radius of curvature of thedistal end144 of thetip assembly140 in a known and controlled manner.
• Disposed on the arcuately curveddistal end144 of thetip assembly140 are a plurality of ring-shapedelectrodes146 spaced uniformly apart along thedistal end144 and a distalend tip electrode147. Although illustrated as being uniformly spaced apart on thedistal end144 of thetip assembly140, theelectrodes146 may alternatively be grouped in pairs, with the distance between each electrode of a pair being closer than the distance between electrodes of adjacent pairs. For example, each ring electrode may be approximately 1 mm in length, with pairs of electrodes being spaced approximately 2 mm apart on center, and with electrodes of adjacent pairs being spaced apart by approximately 8 mm. Furthermore, although theelectrodes146 illustrated inFIG. 2 are shown as being low profile ring electrodes that conform to the surface of thedistal end144 of thetip assembly140, they may also be raised in profile. Indeed, as described further in detail below, embodiments of the present invention may be used with any type of electrode that is suitable for use in endocardial or epicardial mapping and/or ablation procedures, as the present invention is not limited to the number, the construction, or placement of electrodes on thedistal end144 of thetip assembly140.
• According to an embodiment of the present invention, thetip assembly140 may be made from an elastomeric or polymeric thermodynamic bio-compatible material, such as PEBAX, that is bonded onto thedistal end112 of theflexible shaft110, which may also be made from an elastomeric or polymeric thermodynamic bio-compatible material. Examples of materials that may be used to form theflexible shaft110 and thetip assembly140 are well known in the art, and are described, for example, in commonly assigned U.S. Pat. Nos. 5,383,852, 5,462,527, and 5,611,777, which are hereby incorporated by reference in their entirety.
• According to one embodiment of the present invention theflexible shaft110 may be made from a material that is stiffer than the material used to form theproximal end142 of thetip assembly140, and thetip assembly140 may be formed from a variety of bio-compatible materials that have different degrees of stiffness. For example, in one embodiment, theflexible shaft110 is made from a material having a hardness of approximately 60 Shore D, theproximal end142 of the tip assembly is made from a material having a hardness of approximately 45-50 Shore D, and the arcuately curveddistal end144 is made from a material having a hardness of approximately 40 Shore D. The increased stiffness of theshaft110 permits pressure applied to thehandle120 to be more directly translated to thetip assembly140. Further, the intermediate stiffness of theproximal end142 of thetip assembly140 permits movement (i.e., steering) of the tip assembly140 (described further below) while ensuring that pressure applied to thehandle120 is translated via theshaft110 to thedistal end144 of thetip assembly140 to urge thedistal end144 of thetip assembly140 tight against an endocardial site. Such enhanced contact is advantageous in both mapping and ablation procedures. Further, the relative flexibility of the material from which thedistal end144 of thetip assembly140 is formed permits the diameter of the arcuately curveddistal end144 of thetip assembly140 to be changed (increased, decreased, or both) via manipulation of one of theactuators122,124 on thehandle120. In another embodiment, theflexible shaft110 is made from a material having the same degree of hardness as theproximal end142 of the tip assembly, for example, 45050 Shore D, but theflexible shaft110 has a larger diameter, and is thus stiffer than theproximal end142.
• To further enhance contact with the endocardial site, theproximal end142 of thetip assembly140 may be stiffened, for example with an outer stiffening tube (not shown), just ahead (i.e., proximally) of the approximately ninetydegree bend148. For example, where thetip assembly140 includes a fixed bend of approximately ninety degrees, the material forming the approximately ninetydegree bend148 may be sufficiently stiffer than that from which thedistal end144 is formed, to further enhance contact with an endocardial or epicardial site.
• Although embodiments of the present invention are not limited to any particular length, in one embodiment of the present invention, the length of the flexible shaft is approximately one meter, the length of theproximal end140 of the tip assembly is approximately 4.5 cm, the length of thedistal end144 of the tip assembly is approximately 6.5 cm, and the length of the approximately ninety degree bend portion is approximately 0.7 cm. It should of course be appreciated that lengths of the different portions of the catheter may be varied, dependent upon the endocardial or epicardial site of interest.
• As shown inFIG. 3, thetip assembly140 may be movable (i.e., steerable) in one or more directions perpendicular to the longitudinal axis of theshaft110. For example, as illustrated in the embodiment ofFIG. 3, thetip assembly140 is capable of movement in two opposite directions (shown as the Z axis) relative to the longitudinal axis of the shaft via manipulation of one of theactuators122,124 on the handle120 (FIG. 1). In other embodiments, the tip assembly may be moved in only a single direction (e.g., in the positive Z direction), or in a number of different directions (e.g., in the positive and negative Z directions, and the positive and negative Y directions).
• As also shown inFIG. 3, and according to one aspect of the present invention, the radius (or alternatively, the diameter) of curvature of the arcuately curveddistal end144 of thetip assembly140 may be changed from a first diameter D1 to a second diameter D2. Preferably, the radius of curvature of the arcuately curveddistal end144 of thetip assembly140 may be increased and decreased via manipulation of one of theactuators122,124 disposed on thehandle120. This ability to both increase and decrease the radius of curvature of thedistal end144 of thetip assembly140 permits asingle tip assembly140 to be used in a wide variety of applications and with a wide variety of patients (from adults or large animals to children or small animals), as it can be adjusted to different diameters to suit the requirements of the patient and the particular medical procedure. It also permits a radially outward force, or alternatively, a radially inward force, to be applied to an endocardial or epicardial site.
• According to one embodiment of the present invention, the diameter of the arcuately curved distal end of the tip assembly is approximately 20 mm in a resting state (corresponding to a neutral position of theactuator122,124 that controls the radius of curvature of thedistal end144 of the tip assembly140), but may be decreased to a diameter of approximately 5 mm and increased to a diameter of approximately 50 mm via manipulation of one of theactuators122,124. According to this embodiment, the diameter of approximately 20 mm corresponds to an approximately closed circle shown inFIGS. 2 and 3. The diameter of approximately 50 mm corresponds approximately to a semicircle, shown in phantom inFIG. 3, and the diameter of approximately 5 mm corresponds to more than one complete circle (i.e., a spiraling of the distal end) as shown inFIG. 4. Although the present invention is not limited to any particular diameter for thedistal end144 of thetip assembly140, these dimensions permit thecatheter100 to be well suited for use in mapping and/or ablation procedures relating to blood vessels where focal triggers may be present, such as a pulmonary vein. For example, a diameter of approximately 5 to 50 mm permits the tip assembly to be used for mapping and/or ablation procedures relating to the ostium of a pulmonary vein where focal triggers for cardiac arrhythmias may frequently be encountered. These dimensions also permit asingle tip assembly140 to be used in either large or small humans or animals, and for a wide variety of different procedures. It should be appreciated that the above-described dimensions for the diameter of the arcuately curved distal end of the tip assembly correspond to a radius of curvature that is one half that of the indicated diameter (i.e., a diameter of 50 mm corresponds to a radius of curvature of 25 mm, etc.).
• Although the radius of curvature of thedistal end144 of thetip assembly140 described with respect toFIG. 3 is preferably capable of being increased or decreased, the present invention is not so limited. For example, in certain embodiments, the radius of curvature may be changed in only first direction (e.g., increased), while in other embodiments, the radius of curvature may only be changed in a second direction (e.g., decreased). However, in each of the above described embodiments, thedistal end144 of thetip assembly140 is preferably permanently biased into an arcuate shape in its resting state so that the increase and/or decrease in the radius of curvature is achieved in a known and controlled manner.
• Steering and Control of the Tin Assembly
• FIG. 11 is an enlarged end elevational view of the distalend tip assembly140 ofFIG. 2. As shown inFIG. 11, in one embodiment of the present invention, thedistal end144 of thetip assembly140 includes a pair ofcables1110a,1110bthat may be used to change the radius (or alternatively, the diameter) of curvature of thedistal end144 of the tip assembly from a first diameter to a second diameter. In the embodiment illustrated inFIG. 11, the tip assembly includes acore1120 that includes a plurality of lumens, including acentral lumen1125, and fourcoaxial lumens1128a-ddisposed about thecentral lumen1125. Thecentral lumen1125 is used to hold one or more electrically conductive wires (not shown inFIG. 11) that are attached torespective electrodes146,147 disposed along thedistal end144 of thetip assembly140. The fourcoaxial lumens1128a-dmay be used to hold cables that control the orientation of thetip assembly140 relative to theshaft110, and that control the radius of curvature of thedistal end144 of thetip assembly140. As illustrated inFIG. 11, twocables1110aand1110bextend along the length of thedistal end144 of thetip assembly140, while the two other cables (not shown) terminate prior to thedistal end144. In the embodiment depicted inFIG. 11, the ends of the twocables1110aand1110bare tied together and potted with an epoxy adjacent the most distal end of thetip assembly140. In this embodiment, thecables1110aand1110bare used to control the radius of curvature of thedistal end144 of thetip assembly140.
• Although the tip assembly is described as including acore1120 that includes a plurality oflumens1125 and1128a-d, it should be appreciated that the tip assembly may be constructed in other ways. For example, U.S. Pat. Nos. 5,383,852, 5,462,527, and 5,611,777 describe alternative constructions for the distal end of a catheter, some of which include a central lumen that holds both the electrode wires and the pull cables. This alternative construction of the distal end tip assembly may also be used with embodiments of the present invention, as the present invention is not limited to any particular construction.
• FIGS. 12 and 13 illustrate how the radius of curvature of thedistal end144 of thetip assembly140 may be changed via manipulation of thecables1110a,1110bthat are attached to one or more of theactuators122,124 on the handle120 (FIG. 1). In the embodiment illustrated,cables1110aand1110dare pull cables that may be formed, for example, from stainless steel wire or any other suitable material. Where thecatheter100 is to be used in an environment where large magnetic fields may be present, for example, in an MRI chamber, each of the cables (and indeed, theelectrodes146,147) may be made from non-ferromagnetic materials. For example, the electrodes may be made from electrically conductive non-ferromagnetic materials such as platinum, silver, or gold, while the cables may be made from composite materials, such as carbon fiber, or KEVLAR™, or a multiplicity of ultra-high molecular weight polyethelene filaments. It should be appreciated that thecables1110aand1110bmay alternatively be used as push cables, although the use of push cables generally requires a more rigid and oftentimes larger diameter cable than that required for a pull cable, which is operative under tension, rather than compression. As an example, the diameter of the pull cables may be in the range of 0.003 to 0.004 inches.
• As shown inFIGS. 12 and 13, tension applied tocable1110bresults in a decrease in the diameter of curvature of thedistal end144 of the tip assembly140 (and a corresponding slack in thecable1110a), while tension applied tocable1110aresults in an increase in the diameter of curvature of thedistal end144 of thetip assembly140.
• FIG. 14 is a side elevational view of the distal end of afinished catheter100 prior to shaping with any one of the jigs described with respect toFIGS. 5-10 below. According to one embodiment of the present invention, thetip assembly140 may be formed from several different sections that are bonded together and to theshaft110. The formation of the tip assembly in sections permits greater control of the diameter and stiffness of various sections. As illustrated inFIG. 14, these sections may include aproximal section1420 that is bonded to theflexible shaft110, anintermediate section1480 which may be shaped to bend approximately ninety degrees relative to theshaft110 and which is bonded to theproximal section1420, and adistal section1440 that is bonded to theintermediate section1480 and which includes a plurality of electrodes and a distal end tip orcap electrode147,
• FIG. 15 is a cross sectional view of the distalend tip assembly140 ofFIG. 14 taken along line15-15 inFIG. 14. According to one embodiment of the present invention, thetip assembly140 comprises a tubularproximal section1420 and a tubulardistal section1440 aligned coaxially with theshaft110. Between theproximal section1420 and thedistal section1440 is anintermediate section1480 that may be shaped to bend approximately ninety degrees relative to theshaft110. As illustrated, in one embodiment, theproximal section1420 may be of approximately the same outer diameter as theshaft110, and thedistal section144 and theintermediate section1480 can also be of approximately the same outer diameter, but a slightly smaller diameter than theproximal section1420 and theshaft110. In other embodiments, the various sections forming thetip assembly140 may be of the same outer diameter as theshaft110.
• In the illustrated embodiment, thedistal section1440 of thetip assembly140 terminates in a distal end orcap electrode147 which is also coaxially aligned with theshaft110 andsections1420,1440, and1480. A threadedcollar1520 is secured to the distal end ofdistal section1440 to retain theelectrode cap147. It should be appreciated that other embodiments need not include the threadedcollar1520 and the distal end orcap electrode147, and may for example, instead utilize a non-conductive cap.
• Shaft110 may include asingle lumen1525 which extends the length of theshaft110 from the distal end of thehandle120. The single-lumen1525 may be used to house thepull cables1128a-dand theelectrode wires1510. Each pull cable and each electrode wire preferably includes a sheath.
• The electrical portion of thetip assembly140 may include a plurality spaced ring-type electrodes146 along with a distal end orcap electrode147. The electrodes provide signal information on heart potentials to the remote recording device160 (FIG. 1) used by the electrophysiologist. The ring-type electrodes146 and thecap electrode147 are electrically connected torespective signal wires1510. Thesignal wires1510 are routed through the length of thecore1120 through acentral lumen1125 in each of the proximal1420, intermediate1480, and distal1440 sections, as illustrated inFIGS. 15, 16, and17 and attached to arespective electrode146,147. Thesignal wires1510 are preferably electrically insulated from each other and therefore may all share a single lumen as shown. Thesignal wires1510 extend proximally through thehandle120 to theconnector130 which enables theelectrodes146 and147 to be easily coupled electrically to therecording device160. In the illustrated embodiment, the twopull cables1110aand1110bthat extend nearly the length of thetip assembly140 are used to control the radius of curvature of thedistal section1440. The other twopull cables1110cand1110dare used to control bending of thetip assembly140 in a plane that is perpendicular to the longitudinal axis (L) of the shaft110 (SeeFIG. 14). As shown inFIGS. 15, 16, and17, thepull cables1110cand1110dterminate proximally of theintermediate section1480. In one embodiment, each of thepull cables1110cand1110dterminates in aball1530 which may be made from any suitable material, and which is larger in diameter than thelumens1128cand1128din which the pull cables are housed. For example, each of thepull cables1110cand1110dmay be passed through a hole in the ball (not shown) and the end tied to prevent the cable from coming loose. Other methods of terminating thecables1110cand1110dare described in the aforementioned patents, for example, by tying the ends of thecables1110cand1110dtogether at a distal end ofproximal section1420.
• It should be appreciated that an additional pair of pull cables may also be provided to control bending of thetip assembly140 in a plane that is perpendicular to the longitudinal axis of theshaft110 and perpendicular to the other plane of motion provided bypull cables1110cand1110d. Thus, depending upon the number of pull cables and the number of actuators disposed on thehandle120, the radius of curvature of the distal end of thetip assembly140 may be increased or decreased, and the orientation of thetip assembly140 may be changed in two different directions in each of two orthogonal planes (e.g., a Y plane and a Z plane) that are perpendicular to the longitudinal axis of the shaft.
• Theproximal section1420 includes acentral lumen1125 for passing all of theelectrode wires1510 to the intermediate1480 and distal1440 sections, and for passing two of thepull cables1110aand1110b. Theproximal section1440 also includes twoproximal cable lumens1128cand1128dwhich passpull cables1110cand1110dfrom thelumen1525 in theshaft110 through the length of theproximal section1420.Proximal cable lumens1128cand1128dmay contain respective stiffening wires1710 (FIG. 17) to reduce axial twisting ofproximal section1420. Theproximal section1420 includes a reduced diameter proximal end so that theproximal section144 may be mated to the distal end of the shaft, within the distal end of theshaft110.
• Theintermediate section1480 is thermally bonded to the distal end of theproximal section1420 and the proximal end of thedistal section1440. Theintermediate section1480 includes two reduced diameter ends so that it may snugly nest inside the proximal and distal sections. Theintermediate section1480 includes twocable lumens1128aand1128band acentral lumen1125. Additional lumens may also be included, as described further below. Pullcables1110aand1110bfrom the centralproximal section lumen1125 are routed to the outwardly disposed cable lunens1128aand1128b, respectively, at a point just past the distal end of thecentral lumen1125 of theproximal section1420. A small transition space is provided between the lumens of the intermediate and proximal sections to permit thepull cables1110a,1110bto be radially displaced.
• Thedistal section1440 is thermally bonded to the distal end of theintermediate section1480 and has approximately the same outer diameter as theintermediate section1480. The distal end of theintermediate section1480 is recessed within thedistal section1440 to provide a smooth transition between the two sections. Thedistal section1440 also includes twocable lumens1128aand1128band acentral lumen1125. Thedistal section1440 may also include additional lumens (shown inFIG. 16), that may be used, for example, to house a control wire for a sliding electrode, to house an irrigation line, to house a wire for a localization sensor, etc. The ends of thepull cables1110aand1110bemanating from the outwardlydisposed cable lumens1128aand1128b, respectively, may be tied together and/or potted with an epoxy. Theelectrode wires1510 from thecentral lumen1125 are fed through radial apertures in thecore1120 and soldered or welded (or bonded with a conductive epoxy) onto an undersurface of thering electrodes146, as illustrated inFIGS. 15A and 16. The wire for the distal end or cap electrode may be fed through thecentral lumen1125 and soldered, welded, or epoxied onto thecap electrode147.
• In the embodiment illustrated inFIG. 15, each of the plurality ofring electrodes146 are recessed within the outer circumferential surface of the distal section to provide a low profile. However, for certain procedures, such as ablation, it may be preferable to have the outer surface of one or more of theelectrodes1546 protrude above the outer circumferential surface of the distal section, such as illustrated inFIG. 15A, and illustrated in phantom inFIG. 16. It should be appreciated that a variety of different types of electrodes may be used with the tip assembly depicted inFIG. 15, as the present invention is not limited to any particular type, or construction of electrode.
• Various configurations can be used to locate and anchor the pull cables within the shaft and the proximal, intermediate and distal sections of the tip assembly. In general, it is preferable to conduct the pull cables as close as possible to the outer circumference of the section controlled by the cables in order to increase the bending moment. For this reason, the controlling cables for both the proximal and distal sections are directed to outer lumens, i.e.,lumens1128cand1128dandlumens1128a,1128b. However, prior to reaching the section that is controlled by the cables, the cables are preferably centrally routed, for example incentral lumen1125, so that manipulation of cables controlling movement of more distal sections of the catheter do not affect the orientation of more proximal sections of the catheter. The illustrated construction has been found to be an optimal arrangement from the points of view of manufacturing ease and function. Other arrangements, however, can also be used. For example, the pull cables can be conducted through the proximal, intermediate, and distal sections exclusively through outer lumens. Examples of other arrangements for the pull cables within thetip assembly140 are described in the aforementioned U.S. Pat. Nos. 5,383,852, 5,462,527, and 5,611,777.
• According to one embodiment of the invention, control of thedistal end144 of thetip assembly140 may be provided using an individual pull cable together with a superelastic material. A superelastic material may be any material that exhibits a “springback effect” such that it will to return to its original position after undergoing a substantial deformation. The superelastic material may be formed of a metal alloy or a compound containing metals and, in one example, may have an elasticity that is approximately ten times greater than that of stainless steel. While it should be appreciated that any superelastic material may be used in accordance with this embodiment, in one example a superelastic wire is used.
• One exemplary superelastic material that may be used is a compound comprising nickel and titanium. In particular, a nitinol material may be used. Nitinol is a family of intermetallic materials that contain a nearly equal mixture of nickel and titanium and exhibit the properties of shape memory and superelasticity. Nitinol may be set in a particular shape, and will return or “spring back” to that shape after deformation. To set the desired undeformed shape of the superelastic wire, the wire may be constrained in the desired shape and an appropriate heat treatment may be applied. For example, thedistal end144 of thetip assembly140 of thecatheter100 may be placed in a jig, such as the jigs described in connection withFIGS. 5-10, and heated until the shape of the superelastic wire is set. A temperature of 400-500 degrees Celsius over a period of 1-5 minutes may be sufficient to set the shape.
• Nitinol exhibits its optimum superelastic behavior at body temperature, and thus is well-suited for use in a catheter inserted into a body. Nitinol is also well-suited for use within a catheter because it is non-ferromagnetic, and thus will not interfere with MRI imaging, and produces a fluoroscopic image comparable to stainless steel.
• FIG. 38 is an enlarged elevational view of the distalend tip assembly140 ofFIG. 2 implemented in accordance with one embodiment of the invention. As shown inFIG. 38, thedistal end144 of thetip assembly140 includes asuperelastic wire3810 that may be used withcable1110ato change the radius of curvature of the tip assembly from a first radius to a second radius. As illustrated inFIG. 38, pullcable1110aandsuperelastic wire3810 extend along the length of thedistal end144 of thetip assembly140 throughlumens1128aand1128b, respectively, and are tied together and potted with an epoxy adjacent the most distal end of thetip assembly140.
• A number of variations are possible for thedistal end144 of thetip assembly140 illustrated inFIG. 38. For example, although thesuperelastic wire3810 is shown extending along the length of thedistal end144 of thetip assembly140 throughlumen1128b, thesuperelastic wire3810 may be disposed in other portions of thecatheter100. For example, thesuperelastic wire3810 may be housed within thecentral lumen1125 or another lumen, or may be embedded within thecore1120 of thetip assembly140. Further, although thesuperelastic wire3810 is shown anchored at the most distal end of thetip assembly140 and tied together with thecable1110a, this arrangement is not necessary.Superelastic wire3810 need not be anchored since, as described above, the wire is formed from a material that exhibits a “springback effect” such that it has a tendency to return to its original position once deformed. It follows that thesuperelastic wire3810 also need not be tied to thecable1110a, which may instead be independently anchored at thedistal end144 of thetip assembly140.
• Thesuperelastic wire3810 may extend through any portion of thecatheter100 sufficient to bias thedistal end144 of thetip assembly140 in a desired arcuate shape. For example, the wire may originate at the control handle120 of thecatheter100, or may originate at a more distal location. For example, thesuperelastic wire3810 may occupy only that portion of thecatheter100 that may form the arcuate shape (i.e., thedistal end144 of the tip assembly140). Further, thesuperelastic wire3810 may extend through another portion of thecatheter100 to bias thecatheter100 in an additional orientation. The use ofsuperelastic wire3810 to bias thecatheter100 in different ways at different portions of the catheter will be discussed in more detail below.
• FIGS. 39A and 39B illustrate how the radius of curvature of thedistal end144 of thetip assembly140 may be changed via manipulation of thecable1110athat is attached to anactuator122,124 on the handle120 (FIG. 1). It should be appreciated that, because only one pull wire is used to change the radius of curvature, only one pull wire is attached to actuator122 or124 in accordance with this embodiment. As shown inFIG. 39A,superelastic wire3810 is biased to form an arcuate curve and causes thedistal end144 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110a. When tension is applied tocable1110a, as shown inFIG. 39B, the radius of curvature of thedistal end144 of thetip assembly140 increases.
• If the positions of the pull cable and the superelastic wire are reversed, an opposite effect results. For example,FIGS. 41A and 41B illustratesuperelastic wire3810 disposed on the outer portion of arcuate curve of thedistal end144, thus having a greater radius of curvature thanpull wire1110bdisposed on the inner portion of the arcuate curve. As shown inFIG. 41 A,superelastic wire3810 is biased to form an arcuate curve and causes thedistal end144 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110b. When tension is applied tocable1110b, as shown inFIG. 41B, the radius of curvature of thedistal end144 of thetip assembly140 decreases.
• FIGS. 43A and 43B illustrate a configuration similar to that shown inFIGS. 41A and 41B. However, rather than being biased in an arcuate curve,superelastic wire3810 is biased linearly and causes thedistal end144 of thetip assembly140 to assume a linear orientation when no tension is applied to pullcable1110b(seeFIG. 43A). When tension is applied tocable1110b, as shown inFIG. 43B, the radius of curvature of thedistal end144 of thetip assembly140 decreases, causing thedistal end144 of thetip assembly140 to assume an arcuate curve.
• According to another embodiment of the invention, adhesive may be introduced into the catheter100 (FIG. 1) and cured in a configuration such that it imparts a bias on thecatheter100 or tends to retain a portion of thecatheter100 in a particular position or shape. For example, the adhesive may be injected into a lumen of thecatheter100, e.g., by means of a syringe, and a portion of thecatheter100 may be placed in a jig, such as the jigs described in connection withFIGS. 5-10. The jig holds thecatheter100 in a desired position while the adhesive cures so that thecatheter100 with the cured adhesive is biased in a particular orientation. According to another aspect of the invention, the adhesive may be used in connection with a pull cable to provide control of the tip assembly140 (FIG. 1). Epoxy and silicone are two exemplary adhesives that may be used in accordance with the present embodiment. Other adhesives that are compatible with the catheter material and that impart a bias or that tend to retain their shape when cured may also be used. Various configurations of thecatheter100 including an adhesive to provide a bias will be described below.
• FIG. 45 is an enlarged elevational view of the distalend tip assembly140 ofFIG. 2 implemented in accordance with the present embodiment of the invention. As shown inFIG. 45, thedistal end144 of thetip assembly140 includes adhesive4510 withinlumen1128bthat has been cured in an arcuate shape. When used withcable1110a, the adhesive4510 may be used to change the radius of curvature of the tip assembly from a first radius to a second radius, as will be described.
• It should be appreciated that while the adhesive4510 is shown extending along the length of thedistal end144 of thetip assembly140 throughlumen1128b, the adhesive4510 may be disposed in other portions of thecatheter100. For example, the adhesive4510 may be disposed within thecentral lumen1125 or another lumen of thetip assembly140. Further, the adhesive4510 may extend through any portion of thecatheter100 sufficient to bias thedistal end144 of thetip assembly140 is a desired arcuate shape. For example, the adhesive4510 may extend from the control handle120 of thecatheter100, or may originate at a more distal location or may occupy only that portion of thecatheter100 that may form the arcuate shape (i.e., thedistal end144 of the tip assembly140). In addition, the adhesive4510 may extend through another portion of thecatheter100 and be cured to bias thecatheter100 in an additional orientation. The use of adhesive4510 to bias thecatheter100 in different ways at different portions of the catheter will be discussed in more detail below.
• FIGS. 46A and 46B illustrate how the radius of curvature of thedistal end144 of thetip assembly140 may be changed via manipulation of thecable1110athat is attached to anactuator122,124 on the handle120 (FIG. 1). It should be appreciated that, because only one pull wire is used to change the radius of curvature, only one pull wire is attached to actuator122 or124 in accordance with this embodiment. As shown inFIG. 46A, adhesive4510 is biased to form an arcuate curve and causes thedistal end144 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110a. When tension is applied tocable1110a, as shown inFIG. 46B, the radius of curvature of thedistal end144 of thetip assembly140 increases.
• If the positions of the pull wire and the adhesive are reversed, an opposite effect results. For example,FIGS. 48A and 48B illustrate adhesive4510 disposed on the outer portion of arcuate curve of thedistal end144, thus having a greater radius of curvature thanpull wire1110bdisposed on the inner portion of the arcuate curve. As shown inFIG. 48A, adhesive4510 is biased to form an arcuate curve and causes thedistal end144 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110b. When tension is applied tocable1110b, as shown inFIG. 48B, the radius of curvature of thedistal end144 of thetip assembly140 decreases.
• FIGS. 50A and 50B illustrate a configuration similar to that shown inFIGS. 48A and 48B. However, rather than being biased in an arcuate curve, adhesive4510 is biased linearly and causes thedistal end144 of thetip assembly140 to assume a linear orientation when no tension is applied to pullcable1110b(seeFIG. 50A). When tension is applied tocable1110b, as shown inFIG. 50B, the radius of curvature of thedistal end144 of thetip assembly140 decreases, causing thedistal end144 of thetip assembly140 to assume an arcuate curve.
• FIGS. 52 and 53 illustrate an alternative embodiment of the invention in which the pull wire described above is omitted. Thus, the adhesive is used to bias a portion of thecatheter100 in a fixed configuration. As shown inFIG. 52, adhesive4510 may be included in thedistal end144 of thetip assembly140 and cured to bias thedistal end144 in an arcuate shape. As shown inFIG. 53, the adhesive may additionally or alternatively be included in theproximal end142 of thetip assembly140 and cured to bias theproximal end142 with an approximately ninetydegree bend148. As discussed above, the adhesive4510 inFIGS. 52 and 53 may be introduced into a desired lumen of thecatheter100, e.g., via a syringe, and cured in a jig, such as those ofFIGS. 5-10, to effect the bias on thecatheter100. We have found that providing an adhesive in thetip assembly140 as illustrated inFIGS. 52 and 53 tends to prevent the curve from relaxing during storage or in use.
• FIGS. 65A and 65B illustrate another embodiment of the invention in which adhesive is used within the catheter to provide support to the arcuate curve of thedistal end144 of thetip assembly140. To provide such support, adhesive is introduced into the catheter and cured while the catheter is retained in a particular position or shape. The adhesive may be injected into one or more lumens of the catheter, e.g., by means of a syringe, and a portion of the catheter may be placed in a jig, such as the jigs described in connection withFIGS. 5-10. The jig holds the catheter in a desired position while the adhesive cures. As shown inFIGS. 65A and 65B, adhesive6410 is disposed withinlumens1128c-d, which may also contain electrode wires or other wires. Although the adhesive6410 is shown disposed withinlumens1128c-d, the adhesive6410 may alternatively be disposed in a central lumen or another lumen not occupied by pull cables. The adhesive6410 may be epoxy, silicone, or other material that tends to retain a catheter in a particular shape when the material in the catheter is cured while the catheter is in a particular position.
• As shown inFIG. 65B, pullcables1110a-bmay be used to control the position of theproximal end144 of thetip assembly140. In the figure, tension is applied to thepull cable1110band not applied to thepull cable1110a, such that an arcuate curve having a particular radius of curvature formed. The adhesive6410, which may be cured in a curved configuration, provides support to the catheter structure such that the pull cables are able to effect the desired radius of curvature. Without the adhesive6410, the ability of thepull cables1110a-bto effect a desired radius of curvature may degrade over time.
• Active Bend
• As noted above, the approximately ninety degree bend in the distalend tip assembly140 may be either fixed (e.g., permanently formed with the use of a jig, such asjigs500,700, and900, described in detail with respect toFIGS. 5-10 below), or active (e.g., movable between approximately zero and approximately ninety degrees relative to the longitudinal axis of theshaft110 of the catheter100) through the use of anactuator122,124 disposed on thehandle120.FIGS. 21 and 21A illustrate an embodiment of the present invention that includes such an “active bend.”
• As shown inFIG. 21, in one embodiment, the distalend tip assembly140 includes aproximal section2120, anintermediate section2180 that may be actively bent via manipulation of a control cable (FIG. 21A) attached to an actuator (e.g., actuator122) on the control handle120 to be approximately perpendicular to the longitudinal axis of theshaft110, and adistal section2140 having a radius of curvature that can be adjusted via manipulation of a control cable attached to an actuator (e.g., actuator124) on thehandle120. Thedistal section2140 includes one ormore electrodes146,147 disposed along a length of thedistal section2140.
• As shown inFIG. 21A, which is a cross section of theproximal section2120 of thetip assembly140 taken alongline21A-21A inFIG. 21, thecables1110cand1110dthat control bending of theintermediate section2180 may be formed from a single cable that is wrapped around a reduced diameter end of theproximal section2120 and that is recessed within the intermediate section2128 in a manner similar to that described with respect toFIG. 12 in U.S. Pat. No. 5,383,852. In general, the cable will be wrapped about that portion of the tip assembly that is immediately prior to the point at which bending is to occur. In this embodiment, tension applied tocable1110cresults a bending of thedistal section2140 of thetip assembly140 in a downward direction (as seen inFIG. 21) to orient the arcuately curveddistal section2140 in a plane that is perpendicular to the longitudinal axis of theshaft110, and tension applied tocable1110dresults in the bending of thedistal section2140 of thetip assembly140 in an upward direction (as seen inFIG. 21) to return to its position along the longitudinal axis of the shaft. Because thehandle120 may be rotated one hundred and eighty degrees, the ability to bend the distal section in an opposite direction is unnecessary, but may be provided, if desired. It should be appreciated that in other embodiments, only a single control wire may be used.
• To accommodate such an active curve, the material from which theintermediate section2180 is formed should be less stiff than the material from which theshaft110 is formed so that bending occurs in theintermediate section2180. Preferably, the material from which the distal section is formed is less stiff than that from which the intermediate section is formed to permit the radius of curvature of thedistal section2140 to be changed without altering the orientation of the intermediate andproximal sections2180 and2120, respectively.
• To facilitate bending in a known and controlled manner, theintermediate section2180 may be permanently biased to have a bend of a few degrees relative to the longitudinal axis (L) of theshaft110. Because theintermediate section2180 is permanently biased a few degrees away from the longitudinal axis (L) of theshaft110, tension applied tocable1110c, for example, results in bending of theintermediate section2180 in the plane of the bend toward a ninety degree angle with the longitudinal axis (L) of theshaft110. Tension applied to the opposing cable, for example1110d, results in bending of theintermediate section2180 in the plane of the bend back toward the longitudinal axis (L) of theshaft110. Because theintermediate section2180 is biased a few degrees away from the longitudinal axis (L) of theshaft110 in a particular direction, any bending of theintermediate section2180 occurs in the plane aligned in the same direction as that bend in a known and controlled manner. Were theintermediate section2180 not biased in a particular direction, bending could occur in any direction.
• Other manners of biasing thetip assembly142 are also possible. In one embodiment, the principles applied inFIGS. 39, 41, and43 to effect control of the arcuate curve of thedistal end144 of thetip assembly140 using asuperelastic wire3810 may be applied to effect control of the ninetydegree bend148 of theproximal end142 of thetip assembly140.FIGS. 40A and 40B illustrate how the bend angle of theproximal end142 of thetip assembly140 may be changed via manipulation of acable1110dthat may be attached to anactuator122,124 on the handle120 (FIG. 1). As shown inFIG. 40A,superelastic wire3810 is biased to form a bend having an angle of approximately ninety degrees (in one embodiment) with respect to the longitudinal axis of thecatheter100 and causes theproximal end142 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110d. When tension is applied tocable1110d, as shown inFIG. 40B, the bend angle of theproximal end142 of thetip assembly140 decreases.
• If the positions of the pull wire and the superelastic wire are reversed, the bend angle of theproximal end142 of thetip assembly140 may be increased from the bias position of the superelastic wire. For example,FIGS. 42A and 42B illustratesuperelastic wire3810 disposed on the outer portion of theproximal end142 with respect to the bend, and apull cable1110cdisposed on the inner portion. As shown inFIG. 41A,superelastic wire3810 is biased to form an acute bend angle and causes thedistal end144 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110c. When tension is applied tocable1110c, as shown inFIG. 42B, the angle of the bend ofproximal end142 increases to approximately ninety degrees (in one embodiment).
• FIGS. 44A and 44B illustrate a configuration similar to that shown inFIGS. 42A and 42B. However, rather than being biased to form a bend angle,superelastic wire3810 is biased linearly and causes theproximal end142 of thetip assembly140 to assume a linear orientation when no tension is applied to pullcable1110c(seeFIG. 44A). When tension is applied tocable1110c, as shown inFIG. 44B, the angle of the bend ofproximal end142 increases to approximately ninety degrees in one embodiment. It should be appreciated that although the bend is described as increasing to approximately ninety degrees, other bend angles are also possible.
• The principles applied inFIGS. 46, 48, and50 to effect control of the arcuate curve of thedistal end144 of thetip assembly140 using adhesive4510 may also be applied to effect control of the ninetydegree bend148 of theproximal end142 of thetip assembly140.FIGS. 47A and 47B illustrate how the bend angle of theproximal end142 of thetip assembly140 may be changed via manipulation of acable1110dthat may be attached to anactuator122,124 on the handle120 (FIG. 1). As shown inFIG. 47A, adhesive4510 is biased to form a bend having an angle of approximately ninety degrees with respect to the longitudinal axis of thecatheter100 and causes theproximal end142 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110d. When tension is applied tocable1110d, as shown inFIG. 47B, the bend angle of theproximal end142 of thetip assembly140 decreases.
• If the positions of the pull wire and the adhesive are reversed, the bend angle of theproximal end142 of thetip assembly140 may be increased from the bias position of the adhesive. For example,FIGS. 49A and 49B illustrate adhesive4510 disposed on the outer portion of theproximal end142 with respect to the bend, and apull cable1110cdisposed on the inner portion. As shown inFIG. 49A, adhesive4510 is biased to form an acute bend angle and causes thedistal end144 of thetip assembly140 to assume such a shape when no tension is applied to pullcable1110c. When tension is applied tocable1110c, as shown inFIG. 49B, the angle of the bend ofproximal end142 increases to approximately ninety degrees.
• FIGS. 51A and 51B illustrate a configuration similar to that shown inFIGS. 49A and 49B. However, rather than being biased to form a bend angle, adhesive4510 is biased linearly and causes theproximal end142 of thetip assembly140 to assume a linear orientation when no tension is applied to pullcable1110c(seeFIG. 51A). When tension is applied tocable1110c, as shown inFIG. 51B, the angle of the bend ofproximal end142 increases to approximately ninety degrees.
• FIGS. 64A and 64B illustrate another embodiment of the invention in which adhesive is used within the catheter to provide support to the ninetydegree bend148 of theproximal end142 of thetip assembly140. To provide such support, adhesive is introduced into the catheter and cured while the catheter is retained in a particular position or shape. The adhesive may be injected into one or more lumens of the catheter, e.g., by means of a syringe, and a portion of the catheter may be placed in a jig, such as the jigs described in connection withFIGS. 5-10. The jig holds the catheter in a desired position while the adhesive cures. As shown inFIGS. 64A and 64B, adhesive6410 is disposed withinlumens1128c-d, which may also contain electrode wires or other wires. Although the adhesive6410 is shown disposed withinlumens1128c-d, the adhesive6410 may alternatively be disposed in a central lumen or another lumen not occupied by pull cables. The adhesive6410 may be epoxy, silicone, or other material that tends to retain a catheter in a particular shape when the material in the catheter is cured while the catheter is in a particular position.
• As shown inFIG. 64B, pullcables1110c-dmay be used to control the position of theproximal end142 of thetip assembly140. In the figure, tension is applied to thepull cable1110cand not applied to thepull cable1110d, such that a bend having an angle of approximately ninetydegrees148 is formed. The adhesive6410, which may be cured in a bent configuration, provides support to the catheter structure such that the pull cables are able to effect a desired bend angle. Without the adhesive6410, the ability of thepull cables1110c-dto effect a desired bend angle may degrade over time.
• Superelastic Channels
• FIGS. 66-72 illustrate a further embodiment of the invention according to which a superelastic channel may be used to impart a bias to a portion of the catheter having a particular configuration, such that the portion will “spring back” to the configuration after being deformed. In one example, a superelastic channel may be incorporated within a portion of a lumen of the catheter to bias the catheter in a particular configuration while allowing a catheter component (e.g., a pull cable, wire, or fluid conduit), or multiple such catheter components, to pass through the portion of the lumen. In another example, a superelastic channel may be incorporated within the catheter, but not within a lumen. For instance, the channel may form part of the exterior sheath of the catheter, or may be an interior channel that at least partially encloses many structures (e.g., lumens) in the catheter.
• In one example, illustrated inFIGS. 66-67, superelastic channels6620a-bare included in the portion of thetip assembly140 that includesbend148, which is described herein as being an approximately ninety degree bend, but which may have an angle that is greater or less than ninety degrees. The channels6620a-bare included withinlumens1128aand1128b, respectively, and extend from a location6610aat theproximal end142 of thetip assembly140 to alocation6610batelectrode146b. Thus, in one example, channels6620a-bextend from theproximal end142 of thetip assembly140 to a portion of thedistal end144 of thetip assembly140, which may be biased to form a curve. The channels6620a-bmay be held in place by thelumens1128a-bthemselves, or may be adhered to the lumens, e.g., with epoxy between each channel and lumen near location6610a. The channels6620a-bbias the portion of thecatheter spanning locations6610aand6610bto form the configuration of ninetydegree bend148 and to “spring back” to the configuration after being deformed. Thus, channels6620a-bform a resilient bend angle intip assembly140. It should be appreciated, however, that channels6620a-bmay be used in connection with other biasing mechanisms (e.g., heating in a jig) and/or resiliency mechanisms (e.g., superelastic wires) to achieve the desired bias or resiliency.
• Many variations on the configuration shown inFIGS. 66-67 are possible to achieve a resilient bend angle intip assembly140 using superelastic channels. For example, channels6620a-bmay occupy any of thelumens1128a-ddescribed herein, or one or more additional lumens. Further, although two channels are illustrated, a single channel or greater than two channels (e.g., three, four, five, or more) may alternatively be employed. In addition, while channels6620 are disposed betweenlocations6610aand6610binFIGS. 66-67, this configuration is merely exemplary, and channels6620 may span a portion of the catheter of a different size or location. Optionally, the portion of the catheter atbend148 may be formed of a material having a lower durometer than adjacent portions of the catheter. Making the region atbend148 softer enhances the effect of the superelastic channel by allowing a greater degree of responsiveness to the bias imparted by the superelastic channel.
• FIGS. 68-69 illustrate exemplary configurations for the superelastic channels described above.FIG. 68 illustrates asuperelastic channel6810 having a cylindrical shape with an inner surface diameter Di and an outer surface diameter Do.FIG. 69 illustrates asuperelastic channel6910 having a rectangular shape with an length Li between opposite inner surfaces and a length Lo between opposite outer surfaces. In one example, inner surface diameter Di or length Li may be approximately 0.01-0.011 inch, and outer surface diameter Do or length Lo may be approximately 0.014-0.015 inch. It should be appreciated that the superelastic channels described herein may assume a variety of shapes and are not limited to those shown inFIGS. 68-69. For example, the channels may be shaped as a spring, an oval-shaped tube, a multi-sided tube (e.g., a pentagonal or octagonal tube), or another hollow shape.Superelastic channels6810 and6910 may be formed of any of the exemplary superelastic materials described herein, such as nitinol or another compound comprising nickel and titanium. In one example,superelastic channels6810 and6910 are formed of string-tempered stainless steel.
• Pullcables6820 or6920 are shown disposed withinsuperelastic channels6810 and6910, respectively. To facilitate movement of the pull cables within their respective channels, the pull cables and/or channels may include low-friction material, such as teflon. For example,FIG. 68 illustrates a low-friction coating6830 adhered to the interior ofsuperelastic channel6810 to facilitate movement ofpull cable6820. Alternatively,channel6810 itself may be formed of a low-friction material.FIG. 69 illustrates a low-friction coating6930 adhered to the exterior ofpull cable6920 to facilitate movement ofpull cable6920. Thecoating6930 may be included on the entirety of thepull cable6920, or on the portion of the pull cable that contacts channel6910 only. Alternatively, pullcable6920 may itself may be formed of a low-friction material, either wholly or in-part.
• It should be appreciated that although pull cables are shown passing through the superelastic channels illustrated inFIGS. 68-69, the invention is not limited in this respect. As discussed previously, other catheter components, such as wires or fluid conduits, may pass through the superelastic channel. Alternatively, the channel may be much larger, and may form part of the exterior sheath of the catheter, or may be an interior channel that encloses many structures (e.g., lumens) in the catheter.
• FIG. 70 illustrates an exemplary shape of a superelastic channel before the channel is incorporated into the body of a catheter.Superelastic channel7010 includes a proximal leg7010a, adistal leg7010b, and abend7010cthat joins the proximal and distal legs. In one example, thebend7010chas a radius of approximately 0.25 inch, andlegs7010a-bform anangle7020 between 60° and 110° (e.g., approximately 80°), although other dimensions are possible. Further, whilechannel7010 is illustrated as being substantially planar,distal leg7010bmay have a curvature. In one example, such curvature corresponds to the curvature of a portion of thedistal end144 of thetip assembly140. To set the desired undeformed shape of the superelastic channel, the channel may be constrained in the desired shape and an appropriate heat treatment may be applied in a manner similar to that described in connection with the superelastic cables discussed herein.
• While the description ofFIGS. 66-70 contemplates the use of superelastic channels to form a “fixed bend” in thetip assembly140, superelastic channels may also be used in connection with an active bend (i.e., a bend controlled via manipulation of an actuator).FIG. 71 illustrates asuperelastic channel7110 included in theproximal end142 of thetip assembly140 to form a resilient curve atbend148, wherein apull cable1110dis further included to allow controlled manipulation of thebend148. The configuration ofFIG. 71 is similar to that described in connection with FIGS.40A-B, except that a superelastic channel is used rather than a superelastic wire. Further, thesuperelastic channel7110 illustrated occupies only a portion of thetip assembly140, although alternatively the superelastic channel may extend further into or to the end of thetip assembly140. Manipulation of thebend148 ofFIG. 71 viapull cable1110dmay occur in the same manner as described in connection with FIGS.40A-B.
• Although the superelastic channels described above are used to form a resilient curve at ninetydegree bend148, it should be appreciated that the invention is not limited in this respect. Superelastic channels may be included in other portions of the catheter where it is desired to impart a bias. For example,FIG. 72 illustrates a configuration wherein asuperelastic channel7210 is used to bias thedistal end144 in an arcuate curve. Thesuperelastic channel7210 may be incorporated within a lumen of the catheter, with a wall of the catheter, or elsewhere within the catheter. The arcuate shape may be fixed, as shown inFIG. 72, such that the arcuate curve is not manipulable via a pull cable. Alternatively, an active curve may be achieved by including a pull cable (e.g., in a lumen on the inner portion of the curve) manipulable to control the radius of the curve. Manipulation of the curve ofFIG. 72 may occur in the same manner as described in connection with FIGS.39A-B.
• Electrode Configurations
• As noted above, embodiments of the present invention are not limited to a particular construction, type, or number of electrodes disposed along the distal end of the tip assembly. For example, embodiments of the present invention may include a plurality of low-profilering type electrodes146 disposed along the distal end of thetip assembly140, such as shown inFIG. 2, with or without a distal end orcap electrode147. Alternatively, a plurality of raised profile ring type electrodes may be used, such as theelectrode1546 illustrated inFIG. 15A, with or without a distal end orcap electrode147. Alternatively still, a combination of raised and low profile electrodes may be used.
• Where multiple mapping electrodes are used, pairs of mapping electrodes146 (FIG. 2) may be used to determine a location of lowest conductivity on the septal wall, or a preferred location to puncture the septal wall during a transeptal procedure. Each of themapping electrodes146 may detect a voltage signal, which is transmitted tocontroller150 via cable115 (FIG. 1). Voltage may be measured instantaneously or continuously by each of theelectrodes146. Continuous voltage measurements generate an electrogram (a voltage signal that changes with time) for each electrode. The voltage detected by each electrode may be determined with respect to a reference electrode, termed a unipolar voltage measurement, or may be determined with respect to another electrode of a pair, termed a bipolar voltage measurement. Thus, a pair of mapping electrodes may generate two unipolar electrograms, each with respect to a reference electrode located elsewhere on thecatheter100, or a single bipolar electrogram representing the voltage between each pair of electrodes. As unipolar and bipolar voltage measurement are well understood by those skilled in the art, further discussion is omitted herein.
• It should be appreciated that the electrodes may be constructed from a variety of materials, including non ferromagnetic materials such as gold, platinum, and silver, or they may be constructed from a conductive epoxy. The electrodes may be individual electrodes, or may be continuous electrodes, similar in construction to a coiled spring wrapped about the distal end of the tip assembly. The electrodes may be fixed in position along the distal end of the tip assembly, or alternatively, may be movable along a length of the distal end of the tip assembly. An example of such a movable electrode is now described with respect toFIG. 18.
• As shown inFIG. 18, thedistal end144 of thetip assembly140 may include amovable electrode1846 that is movable between a first position and a second position spaced apart along a length of thedistal end144 of thetip assembly140. In the embodiment illustrated, themovable electrode1846 slides along a length of thedistal end144 than spans approximately 360 degrees, and when used for ablation, may be used to form a circular lesion. The very distal end of the tip assembly may include acap electrode1847, or alternatively, the cap may be made from a non-conductive material and may simply serve to terminate the very distal end of the tip assembly. Where acap electrode1847 is used, an insulating spacer may be placed proximally of the cap electrode to prevent themovable electrode1846 from electrically contacting thecap electrode1847.
• As shown inFIG. 19, which is a cross sectional side view of the distal end of the tip assembly inFIG. 18 taken along line19-19, theelectrode1846 may be attached to a cylindrically-shapedplastic slider1910 that that can slide back and forth along a length of thedistal end144 of the tip assembly. In the embodiment shown, the distal end of a metal push/pull wire1920 is welded to an outer surface of theelectrode1846, with the proximal end of the push/pull1920 wire being attached to anactuator122,124 on thehandle120. The push/pull wire1920 may be disposed within thecentral lumen1125 from thehandle120 to theintermediate section1480 of the tip assembly140 (FIG. 15), wherein it then passes through one of theouter lumens1110c,1110dof the distal section. The distal end of the push/pull wire1920 emanates through aslit1930 in thecore1120. It should be appreciated that in embodiments where it is desired that the push/pull wire1920 not be electrically connected to the electrode, the push/pull wire1920 may be attached to theplastic slider1910, rather than to theelectrode1846. It should also be appreciated that the push/pull wire1920 need not be made from metal, as non-conducting materials may also be used, as known to those skilled in the art.
• FIG. 20 is a cross sectional end view of distal end of the tip assembly illustrated inFIG. 19, taken along line20-20.FIG. 20 illustrates theslit1930 in thecore1120 through which the push/pull wire1920 protrudes, with the remaining elements having already been described. Further details of the sliding electrode described with respect toFIGS. 18-20 are provided in commonly assigned U.S. Pat. No. 6,245,066, which is hereby incorporated by reference in its entirety.
• The Handle
• A handle assembly in accordance with one embodiment of the invention, is shown inFIGS. 22-33. The handle configuration shown in these drawings uses rotational movement of thethumbwheel actuator122 to selectively control the tension applied to thepull cables1110cand1110dwhich control the orientation of thetip assembly140 relative to the longitudinal axis of theshaft110, and linear movement of theslide actuator124 to selectively control the tension applied to pullcables1110aand1110bthat control the radius of curvature of thedistal end144 of thetip assembly140. Referring toFIG. 22, thehandle120 comprises a housing having aleft section2200L and aright section2200R. These twosections2200L and2200R are somewhat semicircular in cross section and have flat connecting surfaces which may be secured to each other along a common plane to form a complete housing for thehandle120. The outer surfaces of thehandle120 are contoured to be comfortably held by the user.
• Awheel cavity2210 is formed within theright section2200R of thehandle120. Thewheel cavity2210 includes a planarrear surface2211 which is generally parallel to the flat connecting surface of thehandle120. Thethumb wheel actuator122 is a generally circular disc having acentral bore2216, an integrally formedpulley2218, and upper and lower cable anchors2220. Upper and lower cable guides2221 serve to retain thecables1110cand1110dwithin a guide slot orgroove2223 formed in a surface of the integrally formedpulley2218. In the embodiment illustrated, thethumbwheel122 rotates about asleeve2228 inserted in thecentral bore2216. Thethumbwheel122 is held in position by ashoulder nut2224 that mates with a threadedinsert2229 in the planarrear surface2211 of theright section2200R of thehandle120. To provide friction that permits the thumbwheel to maintain its position even when tension is applied to one of thecables1110c,1110d, afriction disk2226 is provided between theshoulder nut2224 and thethumbwheel122. Tightening of theshoulder nut2224 increases the amount of friction applied to thethumbwheel122.
• A peripheral edge surface2222 of thethumb wheel122 protrudes from a wheel access opening so that thethumb wheel122 may be rotated by the thumb of the operator's hand which is used to grip thehandle120. To ensure a positive grip between thethumb wheel122 and the user's thumb, the peripheral edge surface2222 of thethumb wheel122 is preferably serrated, or otherwise roughened. Different serrations on opposite halves ofthumb wheel122 enable the user to “feel” the position of the thumb wheel.
• Theleft section2200L supports part of the mechanism for selectively tensioning each of the twopull cables1110aand1110bthat control the radius of curvature of thedistal end144 of thetip assembly140. To accommodate the protruding portion of thethumb wheel122, theleft handle section2200L includes a wheel access opening similar in shape to the wheel access opening of theright handle section2200R. It also includes anelongated slot2230 in its side surface.
• Aslider2232 is provided with aneck portion2242 which fits snugly within theslot2230. Theslider2232 includes aforward cable anchor2235 and arear cable anchor2236 for anchoring thepull cables1110aand1110b. Pullcable1110bis directly attached to theforward cable anchor2235 and becomes taught when theslider2232 is moved toward the distal end of thehandle120. Pullcable1110ais guided by areturn pulley2238 prior to being attached to therear cable anchor2236 and becomes taught when theslider2232 is moved toward the proximal end of thehandle120. Thereturn pulley2238 is rotatably attached to apulley axle2239 which is supported in a bore (not shown) in the flat surface of theright handle section2200R. Thereturn pulley2238 may include a groove (not shown) to guidepull cable1110a. In the illustrated embodiment, acable guide2205 is attached to theright handle section2200R to guide thecables1110a-1110dand prevent their entanglement with one another. As shown,cables1110aand1110bare routed up and over thecable guide2205, whilecables1110cand1110dare routed through a gap2206 in thecable guide2205. Grooves may be formed in a top surface of thecable guide2205 to keepcables1110aand1110bin position, although they could alternatively be routed through holes formed in thecable guide2205, or by other suitable means.
• Aslider grip2252 is attached to theneck portion2242 of theslider2232 and positioned externally of thehandle120. Theslider grip2252 is preferably ergonomically shaped to be comfortably controlled by the user. Together, theslider2232 and theslider grip2252 form theslide actuator124 depicted inFIG. 1.Preload pads2254 are positioned between the outer surface of theleft handle section2200L and the slider grip2252 (shown inFIGS. 22 and 25). By tightening thescrews2260 that attach theslider grip2252 to theslider2232, friction is applied to theslider2232 and thus, to thepull cables1110a,1110b.Preload pads2237 may also be placed on a surface of theslider2232 for a similar purpose.
• A dust seal2234 (FIGS. 22 and 26) having an elongated slit and preferably made from latex is bonded along theslot2230 within theleft handle section2200L. Theneck portion2242 of theslider2232 protrudes through the slit of thedust seal2234 so that the slit only separates adjacent to theneck portion2242. Otherwise, the slit remains “closed” and functions as an effective barrier preventing dust, hair and other contaminants from entering thehandle120. Further details of thehandle122 are described in U.S. Pat. Nos. 5,383,852, 5,462,527, and 5,611,777.
• According to a further aspect of the present invention, each of the thumbwheel actuator and the slide actuator may include means for imparting a first amount of friction on at least one pull cable to which the actuator is attached when the actuator is in a first position, and for imparting a second and greater amount of friction on the at least one pull cable when the actuator is moved away from the first position. According to this aspect of the present invention, the first position may correspond to a neutral position of the actuator wherein the tip assembly is aligned with the longitudinal axis of the shaft, or a neutral position of the actuator wherein the radius of curvature of the distal end of the tip assembly is neither being actively reduced or increased, and the second position may correspond to a position of the actuator that is other than the neutral or rest position.
• As should be appreciated by those skilled in the art, it is desirable that the actuators for changing the orientation of the tip assembly and for controlling the radius of curvature of the distal end of the tip assembly remain in a fixed position, once actuated. Conventionally, this has been achieved by providing a sufficient amount of friction between the actuator and another surface on thehandle122 to resist movement of the actuator unless a certain amount of force is applied to the actuator. For example, inFIG. 22, by tighteningshoulder nut2224 that holds the thumbwheel in position, a greater amount of force must be applied to the thumbwheel to rotate the thumbwheel from one rotational position to another. Similarly, and with respect to theslide actuator124, by tightening the twoscrews2260 that hold theslider grip2252 in position against an undersurface of the handle section, a greater amount of force must be applied to theslide actuator124 to move theslide actuator122 from one position to another.
• Although this conventional approach is straightforward, it results in the sane amount of friction being applied to the actuator(s) in all positions, and not merely those positions that deviate from a neutral or rest position. Thus, in use, it can be difficult to ascertain whether the orientation of the tip assembly or the radius of curvature of the distal end of the tip assembly is in a neutral state, without visually looking at the handle. This can be problematic, as the user of the catheter would need to divert his or her attention to visually inspect the position of the actuator(s). Further, Applicants have determined that the frictional force imparted by the mechanisms that maintain the cables and actuators in a fixed position can significantly decrease over time, for example, while stacked on the shelf, oftentimes requiring that the mechanisms used to impart such friction (e.g., the shoulder nut and the screws) be tightened prior to use. It is believed that this phenomena is due to material creep associated with the various materials used to form the actuator mechanisms. This decrease in frictional force is especially apparent where the catheter has been brought to elevated temperatures during a sterilization cycle, as the materials from which the handle and the control mechanisms are formed have a tendency to yield at elevated temperatures. Although the various mechanisms may be tightened after sterilization, such tightening may contaminate the sterile nature of the catheter, and is undesirable in a clinical setting.
• According to a further aspect of the present invention, each of the thumbwheel actuator and the slide actuator may include means for imparting a first amount of friction on at least one pull cable to which the actuator is attached when the actuator is in a first position, and for imparting a second and greater amount of friction on the at least one pull cable when the actuator is moved away from the first position. This difference in the frictional force can be perceived by the user to alert the user as to when the actuator is in a neutral or rest position, without visually inspecting the actuator. Further, because the frictional forces on the actuating mechanisms are reduced in a neutral or rest position, the catheter may be sterilized with the actuator(s) in a neutral or rest position, thereby reducing yielding of the actuation mechanism during sterilization.
• According to one embodiment that is directed to the thumbwheel actuator, the means for imparting different amounts of friction may include a plurality of detents formed in the planar rear surface of the handle housing that cooperate with corresponding plurality of detents in a lower surface of the thumbwheel. In this embodiment, each of the plurality of detents in the lower surface of the thumbwheel receives a ball or bearing that sits partially within the respective detent. In a first neutral position, each of the balls also rest within a respective detent in the rear surface of the handle and exert a first amount of friction on the thumbwheel and the pull cables attached thereto. But, as the thumbwheel is rotated, the balls ride outside the detent in the rear surface of the handle onto the elevated surface above, thereby exerting a second and greater amount of friction on the thumbwheel and the pull cables attached thereto. According to one embodiment, this second amount of friction is sufficient to prevent the thumbwheel from returning to its neutral position.FIGS. 22, 26,27, and28 illustrate one implementation of a means for imparting different amounts of friction for athumbwheel actuator122 according to this embodiment of the present invention.
• As shown inFIGS. 22, 26,27, and28, the planarrear surface2210 of theright section2200R includes a plurality ofdetents2212 formed therein. A corresponding number ofdetents2215 are provided in an undersurface of the thumbwheel122 (FIGS. 26-28). Within each of the plurality ofdetents2215 in the undersurface of the thumbwheel is a ball orbearing2214. The balls or bearing may be made from any suitable material, such as stainless steel, or may alternatively be made from a hard plastic. The balls orbearings2214 may be fixed in position for example, with an epoxy, or permitted to rotate within thedetents2215. It should be appreciated that the balls orbearings2214 may alternatively be seated within thedetents2212 in the planarrear surface2211 of the right section of thehandle2200R. In a neutral or rest position, for example, corresponding to an orientation of the tip assembly that is parallel to the longitudinal axis of the shaft, each of the plurality of balls rests within acorresponding detent2212 in the planarrear surface2211. Such a resting or neutral state is depicted inFIG. 27 which is a schematic cross sectional view of the thumbwheel ofFIG. 22. As may be appreciated, this neutral or rest position corresponds to a position of reduced friction on thethumbwheel122 in which thefriction disk2226 is compressed to only a small degree, and thus, to a reduced frictional force on the pull cables that are attached to the thumbwheel.
• As thethumbwheel122 is rotated from this neutral or rest position, theballs2214 ride up and out of theirrespective detents2212 and along thepath2265 indicated inFIG. 22. In this second position wherein each of the balls contacts the elevated planarrear surface2211, a second and greater amount of friction is imparted to the thumbwheel, and thus, the pull cables attached thereto, that tends to prevent the thumbwheel from moving to another position without further rotational force applied to the thumbwheel.FIG. 28 is a schematic cross sectional view of the thumbwheel ofFIG. 22 illustrating a state in which the thumbwheel is in a position other than the neutral or rest position. As can be seen inFIG. 28, each of theballs2214 rests upon the elevated planarrear surface2211 and thefriction disk2226 is compressed relative to that shown inFIG. 27. As shown best inFIG. 22, each of thedetents2212 in the planarrear surface2211 may include lead in/lead out sections2267 that are gradually tapered to the level of the planarrear surface2211 to facilitate smooth movement of theballs2214 out of and into thedetents2212.
• Although the present invention is not limited to the number ofdetents2212,2215 incorporated into the handle and the thumbwheel, Applicants have found that three detents spaced equally about a circumference of the planarrear surface2211 and thethumbwheel122 distributes stress evenly about thethumbwheel122 and permits a sufficient amount of rotation before anotherdetent2212 is encountered. Furthermore, although the present invention is not limited to the amount of force applied to the thumbwheel to change the position of the thumbwheel, Applicants have empirically determined that a force of approximately 4 to 8 pounds is sufficient to resist any forces on the pull cables. Moreover, this amount of force is sufficient so that the thumbwheel cannot be moved inadvertently, and does not require great strength by the user. This amount of force also accounts for any yielding during storage and/or sterilization.
• Although this embodiment of the present invention has been described in terms of a plurality of detents in a surface of the handle and a corresponding number of detents that hold a ball or bearing in an undersurface of the thumbwheel, the present invention is not so limited. For example, and as discussed above, the detents in theplanar surface2211 of thehandle120 may hold the balls orbearings2214 and not the thumbwheel. Moreover, it should be appreciated that other means of imparting different frictional forces on the thumbwheel may be readily envisioned. For example, rather than detents, the rearplanar surface2211 may be contoured to include a plurality of ramps (for example, three ramps). The undersurface of thethumbwheel122 may include a corresponding plurality of complementary shaped ramps such that when thethumbwheel122 is in a neutral or rest position, a minimum of friction is imparted, and as thethumbwheel122 is rotated, the heightened surface of the ramps on the undersurface of thethumbwheel122 contacts a heightened surface of the ramps in the planar surface. As thethumbwheel122 is rotated further, addition friction is imparted.
• According to another embodiment that is directed to the slide actuator, the means for imparting different amounts of friction may include a ramp disposed on or formed within thehandle120. In this embodiment, the apex of the ramp corresponds to a neutral position of theslide actuator122. In this neutral position, a minimum amount of friction is applied to theslider2232 and thepull cables1110a,1110battached thereto. As theslider2232 is moved forward or backward away from the neutral position, theslider2232 is pushed toward the thumbwheel and an interior surface of the housing to impart a great amount of friction on the slider and the pull cables attached thereto: As with the thumbwheel, this second amount of friction is sufficient to prevent the slider from returning to its neutral position.
• FIGS. 23, 24, and26 illustrate one implementation of a means for imparting different amounts of friction for aslide actuator124. As shown in these Figures, the is undersurface of theleft section2200L includes aramp2610. The ramp may be integrally formed within theleft section2200L of thehandle120, or alternatively, theramp2610 may be separate from the handle and attached thereto. As illustrated inFIG. 26 which is a schematic cross sectional view of theslide actuator124 shown inFIGS. 1 and 22, theramp2610 includes a central section of decreased thickness and proximal and distal sections that increase in thickness away from the central section until flush with the undersurface of the left section. The top surface of theslider2232 that contacts the undersurface of theleft section2200L of the handle may have a complementary shape to the ramp as shown inFIGS. 23 and 24. In the position shown inFIG. 23, the slide actuator is in a neutral or rest position corresponding to a first radius of curvature of the distal end of the tip assembly. The twoscrews2260 force theslider grip2252 and theslider2232 closer to one another and compress thepreload pads2254 therebetween. In the neutral or rest position shown inFIGS. 23 and 25, thepreload pads2254 are compressed to only a minimal extent. However, as theslider2232 is moved away from the neutral or resting position, the shape of the ramp2610 (and the slider2332) imparts an additional frictional force that tends to separate theslider2232 from theslider grip2252, thereby compressing thepreload pads2254 to a greater extent, as illustrated inFIG. 24. This additional frictional force resists theslide actuator124 from changing position, absent further force on theslide actuator124.
• Although this embodiment of the present invention has been described in terms of a ramp formed within or disposed on an undersurface of thehandle122, the present invention is not so limited. For example, the ramp may alternatively be formed on an outer surface of the handle and provide similar functionality. Other means for imparting different frictional forces on the slide actuator may be readily envisioned by those skilled in the art.
• Although the above described embodiments for imparting a varying amount of friction on at least one pull cable have been described with respect to a catheter in which the diameter of curvature of the distal end, or the orientation of the distal end of the tip assembly, can be changed by manipulation of an actuator attached to the pull cable, the present invention is not so limited. For example, the means for imparting a varying amount of friction may also be used with a push/pull cable and a movable electrode described above. Alternatively, the means for imparting a varying amount of friction may be used to impart varying amounts of friction to a cable that is used to deploy a braided conductive member in the manner described in co-pending and commonly assigned U.S. patent application Ser. No. 09/845,022, entitled APPARATUS AND METHODS FOR MAPPING AND ABLATION IN ELECTROPHYSIOLOGY PROCEDURES, filed Apr. 27, 2001, and incorporated herein by reference. Accordingly, it should be appreciated that this embodiment of the present invention may be used to impart varying amounts of friction on any cable that controls movement of one portion of the catheter with respect to another.
• FIG. 29A illustrates another handle that may be used with embodiments of the present invention. In the embodiment depicted inFIG. 29A, thehandle120 includes threeactuators122,124, and124afor controlling movement of thetip assembly140. For example, thethumbwheel actuator122 may be used to change the orientation of thetip assembly140 relative to the longitudinal axis of theshaft110 of thecatheter100 in one or two different directions depending on the number of cables attached thereto. Thefirst slide actuator124 may be used to increase and/or decrease the radius of curvature of thedistal end144 of thetip assembly140. The second slide actuator124amay be used to control the orientation of the of thetip assembly140 relative to the longitudinal axis of theshaft110 of thecatheter100 in one or two different direction of movement that are orthogonal to the directions provided by use of thethumbwheel actuator122. Alternatively, the second slide actuator124A may be used to move a sliding electrode (SeeFIG. 18) proximally and distally along the distal end of the tip assembly. Alternatively still, thethumbwheel actuator122 or thefirst slide actuator124 may be used for changing the orientation of the tip assembly or the radius of curvature of the distal end in a first direction, and the second slide actuator124amay be used for changing the orientation of the tip assembly or the radius of curvature in the opposite direction. Alternatively still, thefirst slide actuator124 may be used for controlling an active bend (seeFIG. 21), thethumbwheel actuator122 may be used for changing the radius of curvature of the distal end of the tip assembly, and the second slide actuator124amay be used for changing the orientation of the tip assembly in a first and/or second direction (e.g., for steering of the proximal end of the tip assembly.)
• FIG. 29B illustrates another handle that includes a third actuator. In the embodiment illustrated inFIG. 29B, the third actuator is a plunger-type actuator126 that is conventionally used for a variety of different purposes in the medical industry. In the illustrated embodiment, the plunger-type actuator may be used to move a sliding electrode proximally and distally along the distal end of the tip assembly, with thethumbwheel122 and slide124 actuators being used for steering of the proximal end of the tip assembly and changing the radius of curvature of the distal end of the tip assembly, respectively, or vice versa. Although the use of a handle having up to three different actuators has been described, it should be appreciated that more than three different actuators may be provided. For example, a thumbwheel actuator, two slide actuators, and a plunger-type actuator may be used to control an active bend, a sliding electrode, changing the radius of curvature of the distal end, and steering of the proximal end of the tip assembly.
• FIGS. 30-32 illustrate a control handle for a catheter according to another embodiment of the present invention. As illustrated inFIG. 31, a surface of thehandle120 may include a plurality of ribs ordetents3010 to provide tactile feedback to a user. For example, as theslider grip2252 is moved proximally and distally on the handle, this movement can be felt by the user. Such feedback permits the user to understand that the radius of curvature of the distal end of the tip assembly, or the orientation of the tip assembly has been changed, without requiring the user to visually perceive the movement of theslider grip2252. In the embodiment illustrated inFIG. 31, the plurality of ribs are formed integrally with thehandle120 and disposed on an outer surface thereof. To prevent thepreload pads2254 from catching on the ribs ordetents3010, a hard thin layer of material such as plastic may be applied to the surface of the preload pads that contact the outer surface of thehandle120. In the embodiment shown, the leading and trailing edges of thepads2254 are also curved away from the outer surface of thehandle120 to avoid rough movement.
• FIG. 32 illustrates an alternative embodiment of thehandle120 that includes a plurality of ribs ordetents3010 that are formed integrally with thehandle120 and disposed on an inner surface of thehandle120. As thepreload pads2252 do not directly contact the ribs ordetents3010, a hard layer such as that described above with respect toFIG. 31 is not necessary. With each of the embodiments described above, it should be appreciated that the ribs ordetents3010 should be large enough to provide tactile feedback to the user, but not so large as to be disturbing to the user, or to result in rough and abrupt movement of theslide actuator124 when moved from one position to another. Applicants have empirically determined that a protrusion of the ribs ordetents3010 approximately 1 mm above, or below the surface of the handle meets these objectives. Although the use of ribs or detents has been described with respect to providing feedback to a user on movement of the distal end of the catheter, the present invention is not so limited. For example, the ribs or detents may be used to provide feedback relating to movement of a movable electrode, or a braided conductive mesh. Accordingly, the use of tactile features for providing feedback to a user may be used wherever it is useful to provide feedback to a user on the movement of one portion of the catheter with respect to another.
• According to another embodiment of the present invention, a handle for use with a catheter having an elongated shaft and a tip assembly is provided. According to this embodiment, the handle may include graphical indicia indicative of a radius of curvature of a distal end of the tip assembly. This embodiment is now described with respect toFIG. 33.
• As shown inFIG. 33, thehandle120 of thecatheter100 can includegraphical indicia3310 that identifies the radius of curvature of the distal end of the tip assembly. In the embodiment shown, thegraphical indicia3310 are disposed on thehandle120 adjacent to theslide actuator124, which in this embodiment controls the radius of curvature of the distal end of the tip assembly. As illustrated, thegraphical indicia3310 identify the diameter of curvature in centimeters, with a position of two centimeters corresponding to a neutral position of the slide actuator. Movement of theslide actuator124 distally on thehandle120 increases the radius of curvature of the distal end of the tip assembly, and movement of theslider124 proximally on thehandle120 decreases the radius of curvature. Although not illustrated inFIG. 33, thegraphical indicia3310 may also identify the number of circles formed by the distal end of the tip assembly. For example, a first numeric indicator can precede each of the illustrated numeric indicators to identify the number of circles formed by the distal end of the tip assembly. For example, an indicator of 2.1 can indicate two complete circles of the distal end of the tip assembly with a diameter of 1 cm, with an indicator of 1.2 indicating one complete circle of the distal end of the tip assembly with a diameter of 2 cm. Alternatively, the number of circles formed by the distal end of the tip assembly may be placed on the other side of theslide actuator124. Other representations of both the diameter of curvature and the number of circles formed by the distal end of the tip assembly may be readily envisioned. It should be appreciated that the graphical indicia permit a user to roughly determine the diameter of an endocardial or epicardial site without recourse to other instrumentation, other than the catheter itself.
• Although the provision of graphical indicia has been described with respect to theslide actuator124, it should be appreciated that a similar provision may be made for thethumbwheel actuator122. In general, although the provision of graphical indicia may associated with thethumbwheel122 may not be very useful when related to the orientation of the tip assembly, the operation of thethumbwheel122 and theslide actuator124 may be reversed, such that thethumbwheel122 is used to control the radius of curvature of the distal end of the tip assembly, and theslide actuator124 is used to control the orientation of the tip assembly. Where thethumbwheel122 is used to control the radius of curvature of the distal end of the tip assembly,graphical indicia3010 may be provided on the thumbwheel at different rotational positions (e.g., at zero degrees, at thirty degrees, as sixty degrees, etc. to serve a similar purpose.
• Although the provision of graphical indicia has been described with respect to providing feedback to a user on the radius of curvature of the distal end of the catheter, it should be appreciated that other uses may be readily envisioned. For example, the use of graphical indicia may be used to identify the state of deployment of a braided mesh that is disposed at the distal end of the catheter, or to identify the location of a movable electrode that is disposed on the distal end of the catheter.
• Temperature Sensing and Localization
• Temperature sensing refers to a number of techniques whereby the temperature in the vicinity surroundingdistal end144 of thetip assembly140 may be measured. Measuring temperature is important, particularly during ablation procedures, so as to avoid overheating or charring tissue. The catheter of the present invention can provide for measuring the temperature of thedistal end144 of thetip assembly140 and the mapping electrodes disposed thereon at the same time. The temperature of thedistal end144 can then be used to provide feedback for control ofablation energy generator170 and the temperature of the mapping electrodes can be monitored to be certain that the tissue that is being ablated is in fact being destroyed or rendered non-electrically conductive.
• In a further embodiment of the invention, one or more of the plurality of ring or band-type electrodes146 may be replaced with a ring or band-shaped temperature sensor. Reference is now made toFIG. 34, which illustrates a ring-shapedablation electrode146 and a ring-shapedtemperature sensor3410.Temperature sensor3410 may be a thermocouple, thermistor, or any other device for sensing temperature. Thetemperature sensor3410 detects the heat of the tissue during ablation by ring or band-shapedablation electrode146. Temperature sensing is important during ablation because overheated tissue may explode or char, releasing debris into the bloodstream.Ablation electrode146 is connected to connector130 (FIG. 1) viawire3420, which in turn connects to ablationenergy generator170; ring-shapedtemperature sensor3410 is connected toconnector130 viawire3430, which in turn connects tocontroller150. Ring-shapedelectrode146 can serve as both a reference electrode and an ablation electrode, and may be switched between applications by thecontroller150 or by a human operator.
• A temperature sensor or sensors, such as, but not limited to one or more thermocouples may be attached to thecatheter100 for temperature sensing during ablation procedures. The temperature sensor may be in contact with the heart tissue or, alternately, may not be in contact with the heart tissue. In other embodiments, temperature sensors may be disposed within one or more of themapping electrodes146,147, for example in a hole drilled within the electrode. One skilled in the art will appreciate that more than one temperature sensor may be used in any particular configuration ofcatheter100.
• Localization refers to a number of techniques whereby the location ofcatheter100 in a patient can be determined. Apparatus and methods for localization can be incorporated intocatheter100.
• Referring again toFIG. 34, thedistal end144 of thetip assembly140 may include anelectromagnetic sensor3450 that may be used for localization.Electromagnetic sensor3450, may be fixed within thetip assembly140 of thecatheter100 using any suitable mechanism, such as glue or solder. Theelectromagnetic sensor3450 generates signals indicative of the location of the electromagnetic sensor. Awire3440 electrically connects theelectromagnetic sensor3450 to thecontroller150, allowing the generated signals to be transmitted to thecontroller150 for processing.
• In addition to theelectromagnetic sensor3450 fixed in the distal end of thetip assembly140, a second electromagnetic sensor (not shown) may be provided that is fixed relative to the patient. The second electromagnetic sensor is attached, for example, to the patient's body, and serves as a reference sensor. A magnetic field is also provided, which is exposed to the electromagnetic sensors. Coils within each electromagnetic sensor generate electrical currents when exposed to the magnetic field. The electrical current generated by the coils of each sensor corresponds to a position of each sensor within the magnetic field. Signals generated by the reference electromagnetic sensor andelectromagnetic sensor3450 fixed to the catheter are analyzed by thecontroller150 to ascertain a precise location ofelectromagnetic sensor3450.
• Further, the signals can be used to generate a contour map of the heart. The map may be generated by contacting thedistal end144 of thetip assembly140 with the heart tissue at a number of locations along the heart wall. At each location, the electric signals generated by the electromagnetic sensors are transmitted to thecontroller150, or to another processor, to determine and record a location of the distal end of the tip assembly. The contour map is generated by compiling the location information for each point of contact. This map may be correlated with heart signal data, measured by one or more electrodes on the distal end of the tip assembly, for each location to generate a map of both the shape and electrical activity of the heart. Signals generated by the electromagnetic sensors may also be analyzed to determine a displacement of the distal end of the tip assembly caused by heartbeat. Further details of performing localization using electromagnetic sensors is provided in U.S. Pat. No. 5,694,945, which is hereby incorporated by reference in its entirety.
• As an alternative to the use of electromagnetic sensors other conventional techniques, such as ultrasound or magnetic resonance imaging (MRI) can also be used for localization of tip assembly. Details of performing localization using ultrasound are provided in U.S. Pat. Nos. 6,212,027 and 5,820,568, which are hereby incorporated by reference in their entirety. Moreover, an impedance-based sensor can also be incorporated into the tip assembly. In an impedance-based system, several, such as three, high frequency signals are generated along different axes. The catheter electrodes may be used to sense these frequencies, and with appropriate filtering, the strength of the signal and thus the position of the catheter can be determined. Details of an impedance based system are provided in U.S. Pat. No. 5,983,126, which is hereby incorporated by reference in its entirety.
• One skilled in the art will appreciate that the construction ofcatheter100 may be optimized to make use of the various localization techniques.
• According to another embodiment of the invention, multiple electromagnetic sensors may be included in thetip assembly140 of thecatheter100.FIG. 54 illustrates first and second electromagnetic sensors3450aand3450bdisposed within thedistal end144 of thetip assembly140 includingelectrodes4410aand4410b.Wires4420aand4420belectrically connect the electromagnetic sensors3450aand3450bto thecontroller150 ofFIG. 1, andwires4430aand4430belectrically connect theelectrodes4410aand4410bto thecontroller150. In the example shown, the first and second electromagnetic sensors3450aand3450bare located beneathelectrodes4410aand4410b, respectively. Thus, the first and second location electromagnetic3450aand3450bmay be used in indicate a location of the first andsecond electrodes4410aand4410b. It should be appreciated that the electromagnetic sensors may alternatively be disposed adjacent corresponding electrodes, or in another proximal location. Further, there need not be any correspondence between the electromagnetic sensors and particular electrodes as the sensors may be placed in any desired location on thetip assembly140.
• According to a further embodiment of the invention, an electromagnetic sensor may be included in or near a movable electrode, such as themovable electrode1846 described in connection withFIGS. 18 and 19.FIG. 55 illustrates amovable electrode assembly4510 includingmovable electrode1846, aslider4520, and an electromagnetic sensor3450c.Slider4520 may be similar to the cylindrically-shapedplastic slider1910 described in connection withFIG. 19. As shown, theslider4520 may accommodate the electromagnetic sensor3450cwithin theslider4520 itself, although the sensor may alternatively be included on the surface of the slider. Alternatively still, the electromagnetic sensor3450cmay be included within themovable electrode1846. Themovable electrode assembly4510 operates as described previously, and is movable along theslit1930.Wire4530, which may pass throughslit1930, electrically connects the electromagnetic sensor3450cto thecontroller150 ofFIG. 1. Thewire4530 may be insulated, and may be coupled to the push/pull wire1920 shown inFIG. 19.
• It should be appreciated that the electromagnetic sensor3450cmay be used with one or more additional sensors such as electromagnetic sensors3450aand3450bdescribed in connection withFIG. 54. It should also be appreciated that theelectromagnetic sensors3450a-cmay be implemented as described for theelectromagnetic sensor3450, or alternative localization techniques may be used in place of theelectromagnetic sensors3450a-c, such as the ultrasound, MRI, and impedance-based sensor localization techniques described in connection withelectromagnetic sensor3450.
• Fluid Delivery
• As thecatheter100 described herein may be used in connection with medical imaging and/or fluoroscopy, it may be desirable to deliver a contrast agent (e.g., a bolus of x-ray contrast agent or radio-opaque dye) to the cardiovascular system during an electrophysiology procedure. Further, it may be desirable to administer drugs such as antithrombogenic agents directly to the cardiovascular system during a catheter procedure.FIGS. 56 and 58 illustrate one embodiment of a structure to deliver fluids, such as drugs and contrast agents, that may be incorporated into embodiments of thecatheter100 described herein. As shown, thetip assembly140 includes a first and secondfluid delivery lumens4640 and4610. The firstfluid delivery lumen4640 is disposed within thecentral lumen1125 of thecatheter100, while the secondfluid delivery lumen4610 is embedded within thecore1120 of thecatheter100. The secondfluid delivery lumen4610 may be any of thecoaxial lumens1128a-ddescribed previously, or may be an additional lumen. The first and secondfluid delivery lumens4640 and4610 may have respective dimensions chosen to provide, either individually or in combination, an adequate flow of fluid therethrough. For example, in one implementation, the combined cross-sectional area of the fluid delivery lumens may be chosen to be equivalent to a cylindrical lumen having a diameter between approximately 0.025 inch and approximately 0:039 inch.Opening4650 on thedistal tip147 of thecatheter100 andopening4620 on the circumferential surface of thecatheter100 are respectively provided for the first and second fluid delivery lumens.Opening4620 includes anangled surface4630 to direct the direction of fluid exit from thecatheter100.
• FIGS. 57 and 59 illustrate another embodiment of a structure to deliver fluids. As shown, an externalfluid delivery lumen4710 may be coupled to the external surface of thecatheter100. Thelumen4710 may be sized and shaped to provide a desired fluid flow, without exceeding desired dimensions for catheter size. In the embodiment ofFIGS. 47 and 49, thelumen4710 is disposed on side of thecatheter100. Alternatively,lumen4710 may surround the periphery of thecatheter100 such that it is coaxial therewith. One or more external lumens, such aslumen4710, may be provided to deliver fluids, and may be combined with one or more internal fluid delivery lumens, such as those discussed in connection withFIGS. 46 and 48. Each lumen may deliver fluid independently, or may be joined with one or more other lumens at the proximal end of thecatheter100. The joining of lumens enables a single injection of fluid (e.g., via syringe) to provide fluid to a plurality of lumens.
• FIGS.62A-B illustrate a further embodiment of a structure to deliver fluids. InFIG. 62A, a fluid injection manifold6210 is shown coupled to thecatheter100 to allow a syringe or other fluid injection device (e.g., a power injector) to introduce fluid into the one or morefluid delivery lumens6220, which transport fluid along thecatheter100. The one or morefluid delivery lumens6220 may be joined at a proximal opening6260 in the fluid injection manifold before diverging into separate lumens. Thefluid delivery lumen6220 shown may transport fluids, such as the drugs or contrast agents described above, from the fluid injection manifold6210 to adistal opening6250, where fluid may exit thecatheter100. In the embodiment of FIGS.62A-B, thedistal opening6250 is disposed on aproximal portion6230 of thecatheter100 having a larger diameter than adistal portion6240 of the catheter and is perpendicular to the longitudinal axis ofcatheter100.
• It should be appreciated that a number of variations are possible for the fluid delivery structures described above, and that other manners of fluid delivery are possible. For example, a sheath or introducer, via which thecatheter100 may be inserted into the body, may include fluid delivery means.FIG. 63 illustrates asheath2120 having theshaft110 of acatheter100 disposed therein. Thesheath2120 includes at least onefluid delivery lumen6330 to transport fluids, such as the drugs or contrast agents described above, from afluid injection manifold6310 to adistal opening6350. Thefluid injection manifold6310 is provided with aproximal opening6360 to allow a syringe or other fluid injection device (e.g., a power injector) to introduce fluid into the one or morefluid delivery lumens6330, which may be joined at theproximal opening6360. Fluid may exit thesheath2120 through one or moredistal openings6350 disposed at the distal end of the sheath.
• FIGS. 60 and 61 illustrate the delivery of fluid from thecatheter100 into the heart. InFIG. 50, thecatheter100 is shown traversing the septal wall of the heart from theright atrium3610 into theleft atrium3620.Fluid5010 is ejected from the tip of thedistal end144 of thecatheter100 into theleft atrium3620. As discussed above, fluid5010 may be a drug or a contrast agent. InFIG. 61,fluid5010 is ejected from anopening4620 in the proximal end of thetip assembly140 into theleft atrium3620. Although thefluid5010 is shown being injected into theleft atrium3620 in bothFIGS. 60 and 61, it should be appreciated that the fluid5010 may alternatively be injected into thepulmonary vein3710, into another blood vessel, or into theright atrium3610 or ventricles.
• Methods for Making the Tip Assembly
• FIGS. 5-10 illustrate a number of different jigs that may be used to form a tip assembly having a fixed bend of approximately ninety degrees followed by an arcuately curved distal end. Each of these jigs may be used with a finished catheter (i.e., a catheter which is already fully assembled, and including ahandle120 andelectrodes146,147 disposed on the distal end of the tip assembly140), a partially finished tip assembly (i.e., atip assembly140 that includeselectrodes146,147, that is not yet attached toshaft110 and the handle120 (FIG. 1)), or an unfinished tip assembly140 (i.e., atip assembly140 without anyelectrodes146,147).
• FIGS. 5 and 6 illustrate afirst jig500 that is formed from a hollow tube. In one embodiment, the hollow tube is formed from hypodermic stainless steel tubing, although other materials, such as a high temperature plastics such as TEFLON, DELRIN, etc., may alternatively be used. The material from which thejig500 is formed should be thermally stable, such that its shape does not change when subjected to temperature in the range of 200-400 degrees Fahrenheit. In one embodiment, the tube used to form thejig500 has an outer diameter of approximately 0.83 inches and an inner diameter of approximately 0.72 inches to accommodate atip assembly140 that is approximately 6 French in diameter, although these dimensions may be varied to accommodate different diameter tip assemblies. For example, to accommodate a tip assembly that is 10 French in diameter, a larger diameter tube would be used. As shown inFIG. 5, the distal end of thejig500 is formed in a circle having an inner diameter of approximately 0.44 inches and an outer diameter of approximately 0.61 inches. Although the present invention is not limited to any particular dimensions, these dimensions may be used to form atip assembly140 in which the diameter of curvature of thedistal end144 in a resting state is approximately 20 mm. Further, and as described in more detail below, these dimensions are selected to account for a certain amount of rebounding (approximately fifteen to twenty percent) in thetip assembly140 after removal from the jig. Although embodiments of the present invention are not limited to a tip assembly having a diameter of curvature of approximately 20 mm in a resting state, this size advantageously permits the catheter to be used for mapping and/or ablation procedures within a blood vessel, such as a pulmonary vein. It should be appreciated that for other endocardial or epicardial sites, other dimensions may be used.
• As shown inFIG. 6, thejig500 has a firststraight region510, followed by acurved region520 having an approximately ninety degree bend relative to thestraight region510, and terminates in an arcuately shapedcurved region530 defining approximately a circle (i.e., spanning approximately 360 degrees). In one embodiment, thestraight region510 is approximately 0.125 inches in length, and thecurved region520 has aninner radius515 of approximately 0.2 inches. It should be appreciated that other dimensions may be used to impart a different shape to the tip assembly, and to accommodate tip assemblies having a different outer diameters (e.g., a 10 French diameter tip assembly).
• According to one embodiment of the present invention, thetip assembly140 is inserted into thestraight region510 of thejig500 and thedistal end144 of thetip assembly140 is advanced until the very distal end of thetip assembly140 is adjacent the distal end of thejig500. Thejig500 and thetip assembly140 are then heated at a predetermined temperature for a predetermined time to permanently shape thetip assembly140. Applicants have found that heating thejig500 and thetip assembly140 at a temperature of approximately 200 to 400 degrees Fahrenheit for approximately thirty minutes to an hour is sufficient to permanently shape thetip assembly140 to the desired shape. It should be appreciated that the lower the temperature, the greater amount of time is needed to permanently shape thetip assembly140, and that the time and temperature to which thetip assembly140 and thejig500 are heated may vary dependent upon the materials used to form thetip assembly140 and thejig500. It should further be appreciated that because catheters may be sterilized prior to use or after use, the temperature to which thetip assembly140 and thejig500 is heated should be approximately 20 degrees Fahrenheit above the temperature at which the catheter is sterilized. This helps to prevent thetip assembly140 from returning to its original shape during sterilization. During sterilization, a retainer may be used to hold thetip assembly140 in the desired shape.
• After heating thetip assembly140 and thejig500 for the predetermined time at the predetermined temperature, thetip assembly140 and thejig500 are allowed to cool, and thetip assembly140 is removed from thejig500. After removal, Applicants have found the arcuately curveddistal end144 of thetip assembly140 tends to rebound by approximately fifteen to twenty percent, but that further rebounding at temperatures similar to those of human body temperature does not occur. Further, by modifying the materials from which thetip assembly140 is formed, and by controlling the temperature and the time at which thetip assembly140 is shaped, rebounding to less than three percent is expected. It should be appreciated that because a certain amount of rebounding is to be expected, the dimensions of thejig500 should be sized to accommodate the expected amount of rebounding.
• The jig ofFIGS. 5 and 6 may be used to impart a desired shape to thetip assembly140 of a finished catheter or to a partially finished tip assembly. For example, in the described embodiment, the length of thestraight region510 is relatively short to permit thetip assembly140 of a finished catheter to be inserted into thejig500 without damaging theelectrodes146,147. This can be advantageous in a manufacturing setting, as finished catheters can be shaped as desired after construction and testing, and prior to shipment to an end user. This may allow fewer distinct catheters to be stocked by the manufacturer of the catheter. Alternatively, in a hospital setting, the ability to shape a finished catheter can allow fewer catheters to be stocked at the hospital, with each of the catheters being capable of being shaped as desired, prior to use.
• For use with partially finished tip assemblies, the length of thestraight region510 may be lengthened, with any excess material being cut to length as desired. Moreover, with partially finished tip assemblies, the distal end of thejig500 may form more than one complete circle, or may form a helical shape.
• Although thejig500 depicted inFIGS. 5 and 6 was used to receive a tip assembly, it should be appreciated that a solid wire of a similar shape may alternatively be used. For example, the hollow stock from which the tip assembly is formed may be fed onto a solid wire having the desired shape, and then heated at an elevated temperature to produce the desired shape. The formed stock can then be removed from the wire, cut to the desired length, and finished in a conventional manner.
• FIGS. 7 and 8 illustrate a second jig that may also be used to form a tip assembly having the desired shape. In particular, the jig ofFIGS. 7 and 8 may be used to permanently shape the distal end of a catheter so that it includes an approximately ninety degree bend followed by an arcuately curved section. According to this embodiment, thejig700 includes acylindrical mandrel740 and acylindrical retainer750. Thecylindrical mandrel740 and thecylindrical retainer750 may be formed from any suitable high temperature materials, such as stainless steel, aluminum, anodized aluminum, or high temperature plastics. In one embodiment, themandrel740 has an outer diameter of approximately 0.75 inches and is approximately 2.5 inches long, and theretainer750 has an inner diameter that is slightly greater than the outer diameter of themandrel740, so that themandrel740 can be fit within. Although the present invention is not limited to these dimensions, the above-identified dimensions may be used to shape the distal end tip assembly of a catheter so that it is uniquely suited for use inside a blood vessel, such as a pulmonary vein, and to accommodate an anticipated amount of rebounding after removal of the distal end tip assembly from the jig. It should be appreciated that for applications relating to other endocardial sites, other dimensions may be suitably employed.
• As shown inFIGS. 7 and 8, themandrel740 has a passageway to receive atip assembly140 that includes a firststraight region710, acurved region720 having an approximately ninety degree bend relative to thestraight region710, and an arcuately shapedcurved region730 defining a circle. The passageway may be formed in a conventional manner, for example with a milling machine. In one embodiment, thestraight region710 is approximately 1.9 inches in length, and thecurved region720 has aninner radius715 of approximately 0.2 inches; the depth of the passageway is approximately 0.068 inches and the width is approximately the same. The described dimensions are selected to shape a tip assembly that is well suited for use within a blood vessel such as a pulmonary vein, although it should be appreciated that other dimensions may be suitably employed for use with different anatomical structures and for different applications. Again, the dimensions of themandrel740 and theretainer750 should be selected to accommodate the expected amount of rebounding. In the embodiment shown, the arcuately shapedcurved region730 is spaced apart from the end of themandrel740 to facilitate insertion of themandrel740 into theretainer750.
• According to one embodiment of the present invention, atip assembly140 is placed into the passageway, and themandrel740 and thetip assembly140 are inserted into theretainer750. Theretainer750 acts to hold thetip assembly140 in place within the passageway of themandrel740. Thejig700 and thetip assembly140 are then heated at a predetermined temperature for a predetermined time to permanently shape thetip assembly140 in a manner similar to that described above with respect to thefirst jig500. Because of the larger thermal mass of thejig700 relative to thejig500, Applicants have found that a longer time may be needed to shape thetip assembly140 than with thefirst jig500, for example, about 20 additional minutes. To lessen the amount of time required to shape thetip assembly140, themandrel740 may be hollowed out, for example. After heating thetip assembly140 and thejig700 for the predetermined time at the predetermined temperature, thetip assembly140 and thejig700 are allowed to cool, and then thetip assembly140 is removed from thejig700.
• As with the jig ofFIGS. 5 and 6, thejig700 may be used to impart a desired shape to thetip assembly140 of a finished catheter or to a partially finished tip assembly. Indeed, because thetip assembly140 is placed within the passageway rather than being threaded through it, thejig700 is particularly well suited for use with a finished tip assembly, as damage to the finished tip assembly resulting from contact with the jig can be avoided.
• FIGS. 9 and 10 illustrate another jig that may be used to form atip assembly140 having an approximately ninety degree bend followed by an arcuately curved distal end. According to this embodiment, thejig900 includes a disk-shapedmandrel940 and acircular cover950. The disk-shapedmandrel940 and thecircular cover950 may again be formed from any suitable high temperature materials, such as stainless steel, aluminum, anodized aluminum, or high temperature plastics. Thecover950 is removably attached to themandrel940 by afastener960, such as a threaded screw, that is passed through anaperture980 in thecover950. Themandrel940 may include a threaded aperture to receive thefastener960. Attached to themandrel940 is atubular extension970 that may be made from any suitable material, and which is attached, for example, with a high temperature epoxy or by welding to the mandrel. Thetubular extension970 may be used to support theproximal end142 of thetip assembly140 without substantially increasing the thermal mass of thejig900.
• As shown inFIGS. 9 and 10, themandrel940 has a passageway to receive atip assembly140 that includes a firststraight region910, acurved region920 having an approximately ninety degree bend relative to thestraight region910, and an arcuately shapedcurved region930 defining a circle. The arcuately shapedcurved region930 may be formed by milling an annular groove in a top surface of themandrel940, while thestraight region910 may be formed by drilling a through hole through a section of arcuately shapedcurved region930, for example. A ninety degree bend is formed at the intersection of the annular groove and the through hole. In one embodiment, the arcuately shapedcurved region930 has an outer diameter of approximately 0.5 inches and the annular groove has a width of approximately 0.07 inches. The above-described dimensions are selected to shape the tip assembly so that it is well suited for use within a blood vessel such as a pulmonary vein, although it should be appreciated that other dimensions may be suitably employed for use with different anatomical structures and for different applications. The depth of the groove should be sufficiently greater than the outer diameter of thetip assembly140 so that the bend in thetip assembly140 takes place over a length of thetip assembly140. For example, in one embodiment, the depth of the groove is approximately twice the width of the groove to avoid an immediate ninety degree bend in thetip assembly140. Such an immediate bend could interfere with operation of the control cables that are used to adjust the radius of curvature of thedistal end144 of thetip assembly140. Again, the dimensions of themandrel940 should be selected to accommodate the expected amount of rebounding, and the desired dimensions and shape of thetip assembly140.
• According to one embodiment of the present invention, atip assembly140 is threaded through thetubular extension970 and thestraight region910 of themandrel940, and thedistal end144 of thetip assembly140 is placed into the annular groove in themandrel940. Thecover950 is then fastened to themandrel940. Thecover950 acts to hold thetip assembly140 in place within the passageway of themandrel940. Thejig900 and thetip assembly140 are then heated at a predetermined temperature for a predetermined time to permanently shape thetip assembly140 in a manner similar to that described above with respect to the first and second jigs. After heating thetip assembly140 and thejig900 for the predetermined time at the predetermined temperature, thetip assembly140 and thejig900 are allowed to cool, and then thetip assembly140 is removed from thejig900.
• As with the previously describedjigs500 and700, thejig900 may be used to impart a desired shape to thetip assembly140 of a finished catheter or to a partially finished tip assembly. Because the distal end of the tip assembly is inserted straight ahead into themandrel940, rather than along a curved path, thejig900 is also particularly well suited for use with a finished tip assembly, as damage to the finished tip assembly resulting from contact with the jig can be avoided.
• Although thejigs500,700, and900 ofFIGS. 5-10 have been illustrated and described as being useful in forming a tip assembly having a fixed bend of approximately ninety degrees followed by an arcuately curved distal end, it should be appreciated that each of these jigs may also be used or modified for use with a tip assembly including an active bend, such as described above with respect toFIG. 19. For example, for creating a permanent bias of a few degrees relative to thestraight regions510,710, and910, the approximately ninety degree bend may have a larger radius that may be varied according to the intended use of the tip assembly. As noted above with respect toFIG. 19, by permanently biasing the intermediate section2180 (FIG. 19) away from thestraight regions510,710, and910, bending takes place in a known and controlled manner. Moreover, it should be appreciated that rather than terminating in acurved region530,730,930 that spans approximately 360 degrees in a single plane (e.g., a circle), thecurved region530,730, and930 may be formed in a helical shape.
• Methods of Use
• As discussed above, the catheter system of the invention may be used in mapping and/or ablation applications. In one embodiment of the invention, the mapping or ablation is performed in the heart of a patient. In the mapping application, multiple signals may be received from the heart tissue via multiple electrodes on the catheter. Each electrode may measure a continuous signal (i.e., electrogram) from the heart tissue. The continuous signal may represent the voltage of the heart tissue in contact with the electrode, with respect to a reference voltage, as it changes with time. The reference voltage may be obtained using a dedicated reference electrode or another measurement electrode. The quality of the signal received by each electrode improves as both the size of the electrode and the isolation of the electrode increases.
• Preferably, multiple electrodes are employed, such that multiple electrograms may be obtained simultaneously. This allows for multiple data points, which can result in a more precise mapping of the heart signal and a shorter required measurement time. A shorter measurement time advantageously reduces the x-ray exposure to patients and physicians during fluoroscopy, when employed during the catheter procedure.
• The mapping function of the catheter can be used for a number of different applications. For example, in one application, the catheter may be used to measure the conductivity at various points of the septal wall, which separates the left and right sides of the heart, to determine a preferred sight for puncture of the septal wall. In another application, the conductivity of the heart tissue may be measured between adjacent electrodes in contact with the heart tissue to determine the continuity of a lesion formed by ablation. In still another application, the catheter may used to identify electrical signals within the heart that are characteristic of a number of heart conditions. For example, the focus site of an arrhythmia (e.g., atrial fibrillation, AV nodal tachycardia or tachycardia resulting from Wolff-Parkinson-White syndrome).
• Reference is now made toFIG. 35, which illustrates a method of insertion of thecatheter100 into apatient3510 in accordance with an embodiment of the present invention. Thecatheter100 is inserted into the patient via a blood vessel, e.g., subclavian vein, jugular vein, or femoral vein. InFIG. 35, thecatheter100 is shown entering afemoral vein3520 via an incision3530 in the thigh of thepatient3510. Thecatheter100 may be introduced into the vein using a sheath/dilator (not shown). The sheath/dilator may be anchored at the incision site, for example by stitching the sheath/dilator to the patient's skin at the area of incision3530. From the incision site3530 in thefemoral vein3520, thecatheter100 may be advanced independently, or through a sheath/dilator, up theinferior vena cava3540 into the right atrium of the heart.
• Reference is now made toFIG. 36, which illustrates a diagram of a cross-sectional view of the heart taken along line36-36 inFIG. 35. Thecatheter100 is shown entering theright atrium3610 via theinferior venacava3540. For passage of thecatheter100 into the left atrium,3620 the distal end of thecatheter100 may be passed trans-septally through theseptal wall3630. In one method, apuncture3640 in theseptal wall3630 is made at the foramen ovale, an area of the septal wall having a decreased thickness and decreased conductivity relative to other areas of the septal wall. As described previously, electrodes on the distal end of thecatheter100 may be used to locate the foramen ovale, or another preferred site to puncture theseptal wall3630. As shown inFIG. 36, the distal end of thetip assembly140 of thecatheter100 traverses theseptal wall3630 from theright atrium3610 and enters theleft atrium3620. The distal end of thecatheter100 may be used for mapping and/or ablation procedures in theleft atrium3620 or may be maneuvered into the pulmonary vein(s) for mapping and/or ablation. It should be appreciated that the catheter may also be used to perform mapping and/or ablation in the right heart, in the ventricles, or in any other area of the heart or blood vessels of the circulatory system, and that thecatheter1 need not pass through the septal wall to enter these areas.
• Referring now toFIG. 37, which is an expanded view ofFIG. 36, in one embodiment of the present invention, once inside theleft atrium3620, the distal end of thecatheter100 may be advanced towards the ostium of one of thepulmonary veins3710. In this embodiment, the radius of curvature of thedistal end144 of thetip assembly140 is remotely adjusted to snugly fit against the annular walls of thepulmonary vein3710 by is manipulation of theactuator122,124 (FIG. 1) that controls the radius of curvature of thedistal end144 of thetip assembly140. In this position, the graphical indicia3310 (FIG. 33) on thehandle120 may be used to give the user an indication of the diameter of the ostium of the pulmonary vein at this location. Mapping may be performed, as can ablation.
• Because of the approximately ninety degree bend in thetip assembly140, pressure applied to thehandle120 is translated via the shaft to force the arcuately curveddistal end144 of thetip assembly140 tightly against the ostium of thepulmonary vein3710. In this position, the user may also apply pressure to the actuator (e.g., the slide actuator124) that controls the radius of curvature of thedistal end144 of thetip assembly140 to also apply an outwardly radial pressure that further forces thedistal end144 of thetip assembly140 tight against the ostium of thepulmonary vein3710. Mapping may then be performed to locate a focal trigger or triggers of atrial fibrillation. It should be appreciated that the ability to force thedistal end144 of thetip assembly140 tightly against the inner circumferential surface of a blood vessel, such as the ostium of a pulmonary vein, enhances the ability to accurately locate a focal trigger or triggers of atrial fibrillation.
• Should ablation be determined to be an effective solution, ablation energy may then be provided by the ablation energy generator170 (FIG. 1) to create a circular lesion around the circumference of the ostium of thepulmonary vein3710. By controlling which electrodes (disposed on the distal end of the tip assembly, but not shown) are used to provide such ablation energy, a full circumferential lesion or a partial circumferential lesion may be created. Further, by monitoring of the temperature of at the site (for example, by using one or more temperature sensors disposed along thedistal end144 of the tip assembly140), care may be exercised to ensure that charring is prevented and that the appropriate temperatures necessary for ablation are achieved. After ablation, the mapping electrodes may then be used to verify that the electrical conductivity of the tissue has been destroyed.
• One advantage of using a catheter according to the invention in the described method is that only a single catheter is necessary to (1) determine the location of the foramen ovate for passage through the septal wall, (2) perform any desired mapping procedures, and (3) perform any desired ablation procedures. This avoids the need for changing catheters during procedures as between, for example, mapping and ablation procedures. It may also reduce the number of removal and reinsertion operations needed during a patient's electrophysiology study and treatment procedure. Further, because the radius of curvature of the distal end of the tip assembly may be remotely altered within the endocardial site, the catheter may be used on any sized patient from an infant or small animal to an adult or large animal, as “one size fits all.” Moreover, should the size of a blood vessel or other anatomical structure be different than that which was anticipated, it is not necessary to remove the catheter and insert another more appropriately sized catheter. As noted above, this ability to be used with any sized patient can also reduce the need for a manufacturer or a care provider to stock a number of differently sized catheters.
• The various configurations of the catheter illustrated in the figures are exemplary. One skilled in the art will appreciate that the number, size, orientation, and configuration of the mapping electrodes and the ablation electrodes, as well as various diameters and lengths of the catheter can be provided depending upon the particular application.
• Having thus described at least one illustrative embodiment of the invention, various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description is by way of example only and is not intended as limiting. The invention is limited only as defined in the following claims and the equivalents thereto.

Claims (48)

1. An electrophysiology catheter comprising:

a handle having a distal end and a proximal end, the handle including an actuator;

a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle;

a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft, and the tip assembly including a wire formed of a superelastic material and shaped to bias the tip assembly in a first orientation; and

a cable, attached to the actuator and the tip assembly, that extends through the shaft, the cable being adapted to change an orientation of the tip assembly from the first orientation in response to movement of the actuator.

2. The electrophysiology catheter ofclaim 1, wherein:

the wire is shaped to bias the distal end of the tip assembly in a first orientation including an arcuately curved shape having a bias radius of curvature; and

the cable is adapted to change a radius of curvature of the distal end of the tip assembly to a radius of curvature larger than the bias radius of curvature in response to movement of the actuator.

3. The electrophysiology catheter ofclaim 2, wherein:

the wire has a radius of curvature smaller than or equal to a radius of curvature of the cable.

4. The electrophysiology catheter ofclaim 2, wherein the wire is shaped to bias the distal end of the tip assembly in a first orientation including an arcuately curved shape spanning at least three hundred and sixty degrees.

5. The electrophysiology catheter ofclaim 1, wherein:

the wire is shaped to bias the distal end of the tip assembly in a first orientation including an arcuately curved shape having a bias radius of curvature; and

the cable is adapted to change a radius of curvature of the distal end of the tip assembly to a radius of curvature smaller than the bias radius of curvature in response to movement of the actuator.

6. The electrophysiology catheter ofclaim 5, wherein:

the cable has a radius of curvature smaller than or equal to a radius of curvature of the wire.

7. The electrophysiology catheter ofclaim 5, wherein the distal end of the tip assembly curves at least three hundred and sixty degrees in response to movement of the actuator.

8. The electrophysiology catheter ofclaim 1, wherein:

the wire is shaped to bias the proximal end of the tip assembly in a first orientation including a bend having a bias angle of approximately ninety degrees relative to the longitudinal axis of the shaft; and

the cable is adapted to change an angle of the bend of the proximal end of the tip assembly to an angle smaller than the bias angle in response to movement of the actuator.

9. The electrophysiology catheter ofclaim 8, wherein:

the wire is disposed in an inner portion of the tip assembly and the cable is disposed in an outer portion of the tip assembly with respect to the angle of the bend of the proximal end of the tip assembly.

10. The electrophysiology catheter ofclaim 1, wherein:

the wire is shaped to bias the proximal end of the tip assembly in a first orientation including a bend having a bias angle relative to the longitudinal axis of the shaft; and

the cable is adapted to change an angle of the bend of the proximal end of the tip assembly to an angle of approximately ninety degrees relative to the longitudinal axis of the shaft in response to movement of the actuator.

11. The electrophysiology catheter ofclaim 10, wherein:

the wire is disposed in an outer portion of the tip assembly and the cable is disposed in an inner portion of the tip assembly with respect to the angle of the bend of the proximal end of the tip assembly.

12. The electrophysiology catheter ofclaim 1, wherein:

the wire is shaped to bias the distal end of the tip assembly in a linear orientation; and

the cable is adapted to deform the wire so that the wire forms arcuate curve at the distal end of the tip assembly in response to movement of the actuator.

13. The electrophysiology catheter ofclaim 1, wherein:

the wire is shaped to bias the proximal end of the tip assembly in a linear orientation; and

the cable is adapted to deform the wire so that the wire forms a bend of approximately ninety degrees with respect to the longitudinal axis of the tip assembly at the proximal end of the tip assembly in response to movement of the actuator.

14. The electrophysiology catheter ofclaim 1, wherein the wire is formed of a nickel titanium compound.

15. The electrophysiology catheter ofclaim 14, wherein the wire is formed of nitinol.

16. An electrophysiology catheter comprising:

a handle having a distal end and a proximal end, the handle including an actuator;

a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle; and

a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the tip assembly including an adhesive cured in a configuration to bias the tip assembly in a first orientation.

17. The electrophysiology catheter ofclaim 16, wherein the first orientation includes a bend at the proximal end of the tip assembly having an angle of approximately ninety degrees relative to the longitudinal axis of the shaft.

18. The electrophysiology catheter ofclaim 16, wherein the first orientation includes an arcuately curved shape at the distal end of the tip assembly.

19. The electrophysiology catheter ofclaim 16, further comprising:

a first cable, attached to the actuator and the tip assembly, that extends through the shaft, the first cable being adapted to change an orientation of the tip assembly from the first orientation in response to movement of the actuator.

20. The electrophysiology catheter ofclaim 19, wherein:

the first orientation includes an arcuately curved shape at the distal end of the tip assembly having a bias radius of curvature; and

the first cable is adapted to change a radius of curvature of the distal end of the tip assembly to a radius of curvature larger than the bias radius of curvature in response to movement of the actuator.

21. The electrophysiology catheter ofclaim 20, wherein the first orientation includes an arcuately curved shape spanning at least three hundred and sixty degrees.

22. The electrophysiology catheter ofclaim 19, wherein:

the first orientation includes an arcuately curved shape at the distal end of the tip assembly having a bias radius of curvature; and

the first cable is adapted to change a radius of curvature of the distal end of the tip assembly to a radius of curvature smaller than the bias radius of curvature in response to movement of the actuator.

23. The electrophysiology catheter ofclaim 22, wherein the distal end of the tip assembly curves at least three hundred and sixty degrees in response to movement of the actuator.

24. The electrophysiology catheter ofclaim 20, wherein:

a second cable is adapted to change a radius of curvature of the distal end of the tip assembly to a radius of curvature smaller than the bias radius of curvature in response to movement of the actuator.

25. The electrophysiology catheter ofclaim 16, wherein:

the first orientation includes a bend at the proximal end of the tip assembly having a bias angle of approximately ninety degrees relative to the longitudinal axis of the shaft; and

the first cable is adapted to change an angle of the bend of the proximal end of the tip assembly to an angle smaller than the bias angle in response to movement of the actuator.

26. The electrophysiology catheter ofclaim 25, wherein:

the adhesive is disposed in an inner portion of the tip assembly and the first cable is disposed in an outer portion of the tip assembly with respect to the angle of the bend of the proximal end of the tip assembly.

27. The electrophysiology catheter ofclaim 25, further including a second cable adapted to change an angle of the bend of the proximal end of the tip assembly to an angle of approximately ninety degrees relative to the longitudinal axis of the shaft in response to movement of the actuator.

28. The electrophysiology catheter ofclaim 16, wherein:

the first orientation includes a bend having a bias angle relative to the longitudinal axis of the shaft; and

the first cable is adapted to change an angle of the bend of the proximal end of the tip assembly to an angle of approximately ninety degrees relative to the longitudinal axis of the shaft in response to movement of the actuator.

29. The electrophysiology catheter ofclaim 28, wherein:

the adhesive is disposed in an outer portion of the tip assembly and the first cable is disposed in an inner portion of the tip assembly with respect to the angle of the bend of the proximal end of the tip assembly.

30. The electrophysiology catheter ofclaim 16, wherein:

the first orientation includes a linear orientation along the longitudinal axis of the shaft at the distal end of the tip assembly; and

the first cable is adapted to form an arcuate curve at the distal end of the tip assembly in response to movement of the actuator.

31. The electrophysiology catheter ofclaim 16, wherein:

the first orientation includes a linear orientation along the longitudinal axis of the shaft at the proximal end of the tip assembly; and

the first cable is adapted to form a bend of approximately ninety degrees with respect to the longitudinal axis of the tip assembly at the proximal end of the tip assembly in response to movement of the actuator.

32. An electrophysiology catheter comprising:

a handle having a distal end and a proximal end, the handle including an actuator;

a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle;

a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the tip assembly including an adhesive cured in a configuration to support the tip assembly in a first orientation including an arcuately curved shape at the distal end of the tip assembly having a first radius of curvature;

a first cable, attached to the actuator and the tip assembly, that extends through the shaft, the first cable being adapted to change an orientation of the tip assembly from the first orientation to a second orientation including an arcuately curved shape at the distal end of the tip assembly having a second radius of curvature larger than the first radius of curvature in response to movement of the actuator; and

a second cable, attached to the actuator and the tip assembly, that extends through the shaft, the second cable being adapted to change the orientation of the tip assembly from the second orientation to the first orientation in response to movement of the actuator.

33. An electrophysiology catheter comprising:

a handle having a distal end and a proximal end, the handle including an actuator;

a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle;

a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft and the tip assembly including an adhesive cured in a configuration to support the tip assembly in a first orientation including a bend at the proximal end of the tip assembly having a first angle of approximately ninety degrees relative to the longitudinal axis of the shaft;

a first cable, attached to the actuator and the tip assembly, that extends through the shaft, the first cable being adapted to change an orientation of the tip assembly from the first orientation to a second orientation including a bend at the proximal end of the tip assembly having a second angle relative to the longitudinal axis that is smaller than the first angle in response to movement of the actuator; and

a second cable, attached to the actuator and the tip assembly, that extends through the shaft, the second cable being adapted to change the orientation of the tip assembly from the second orientation to the first orientation in response to movement of the actuator.

34. The electrophysiology catheter ofclaim 33, wherein the first angle is approximately ninety degrees.

35. The electrophysiology catheter ofclaim 16, wherein the adhesive is epoxy.

36. The electrophysiology catheter ofclaim 16, wherein the adhesive is silicone.

37. A method of shaping a tip assembly of a catheter, comprising acts of:

injecting an adhesive into a lumen of the catheter that extends along the tip assembly of the catheter; and

curing the adhesive by maintaining a portion of the tip assembly of the catheter in a fixed position for a time sufficient to allow the adhesive to bias the tip assembly in a particular orientation.

38. The method ofclaim 37, wherein the act of curing the adhesive includes maintaining a proximal end of the tip assembly in a bent shape having an angle of approximately ninety degrees.

39. The method ofclaim 37, wherein the act of curing the adhesive includes maintaining a distal end of the tip assembly in an arcuately curved shape.

40. The method ofclaim 37, wherein the act of curing the adhesive includes maintaining a portion of the tip assembly in a linear shape.

41. The method ofclaim 37, wherein the act of injecting the adhesive includes injecting epoxy into the lumen of the catheter.

42. The method ofclaim 37, wherein the act of injecting the adhesive includes injecting silicone into the lumen of the catheter.

43. The method of any of claimsclaim 37, wherein the act of curing the adhesive includes heating the tip assembly of the catheter at a predetermined temperature.

44-73. (canceled)

74. A flexible shaft of a catheter device, the shaft comprising:

a catheter body having a proximal end and a distal end and a longitudinal axis that extends along a length of the catheter body; and

a channel formed of a superelastic material and shaped to bias a portion of the catheter body in a first orientation.

75-94. (canceled)

95. An electrophysiology catheter, comprising:

a handle having a distal end and a proximal end, the handle including an actuator;

a flexible shaft having a proximal end and a distal end and a longitudinal axis that extends along a length of the shaft, the proximal end of the shaft being attached to the distal end of the handle;

a tip assembly having a proximal end and a distal end, the proximal end of the tip assembly being attached to the distal end of the shaft, and the tip assembly including

a channel formed of a superelastic material and shaped to bias the tip assembly in a first orientation; and

a cable, attached to the actuator and the tip assembly and extending through the channel, the cable being adapted to change an orientation of the tip assembly from the first orientation in response to movement of the actuator.

96-101. (canceled)

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