Abstract:
A system that interfaces with a workstation endocardial mapping system allows for the rapid and successful ablation of cardiac tissue. The system allows a physician to see a representation of the physical location of a catheter in a representation of an anatomic model of the patient&#39;s heart. The workstation is the primary interface with the physician. A servo catheter having pull wires and pull rings for guidance and a servo catheter control system are interfaced with the workstation. Servo catheter control software may run on the workstation. The servo catheter is coupled to an RF generator. The physician locates a site for ablation therapy and confirms the location of the catheter. Once the catheter is located at the desired ablation site, the physician activates the RF generator to deliver the therapy.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. application Ser. No. 12/638,814 (“the &#39;814 application”), filed 15 Dec. 2009, now pending, which is a continuation of U.S. application Ser. No. 11/139,908 (“the &#39;908 application”), filed 27 May 2005, now U.S. Pat. No. 7,632,265 (“the &#39;265 patent”), issued 15 Dec. 2009, which claims priority to U.S. provisional application No. 60/575,741 (“the &#39;741 application”), filed 28 May 2004, now expired. The &#39;814, &#39;908, and &#39;741 applications and the &#39;265 patent are hereby incorporated by reference in their entirety as though fully set forth herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    a. Field of the Invention 
         [0003]    The present invention relates generally to radio frequency ablation catheter systems and more particularly to an interactive and automated catheter for producing lesions to treat arrhythmias in the atrium of a patient&#39;s heart. 
         [0004]    b. Background Art 
         [0005]    Many atrial arrhythmias are caused by anatomical accessory pathways in the heart, which provide spurious conduction paths. Conduction of electrical depolarization&#39;s along these pathways within a chamber gives rise to arrhythmias. Although drugs have been used to treat such arrhythmias for many years, cardiac ablation, or destruction of localized regions of tissue, can provide a permanent cure for the patient. For this reason cardiac ablation is preferred in many instances. This treatment is especially preferred for patients that experience detrimental effects from drugs. 
         [0006]    Cardiac ablation has traditionally been a tedious procedure performed under fluoroscopy by a physician who sequentially maps the electrical potentials within the heart using a manually directed EP catheter. Once an appropriate site has been selected identified and selected for ablation, RF energy is delivered to the site. Ablation energy is typically delivered through the same catheter used to “map”. The purpose of the ablation is to destroy a small bolus of tissue at the location. This tissue lesion can no longer conduct and the arrhythmia is interrupted and the arrhythmia stops. 
         [0007]    One common intervention is ablation around the annulus or the ostium of the pulmonary vein that is located in the left atrium. However, navigating to this location reliably and sequentially and delivering electrical energy is an extremely tedious procedure requiring substantial amount of skill and time to complete successfully. 
         [0008]    For this reason there is a continuing need to improve catheter technology. 
       BRIEF SUMMARY OF THE INVENTION 
       [0009]    The present invention provides a system that allows for the automated rapid and successful ablation of cardiac tissue. The overall system interfaces with an Endocardial Solutions Ensite “work station” endocardial mapping system of the type sold by Endocardial Solutions, Inc. of St. Paul, Minn., or other equivalent devices. 
         [0010]    The “Ensite” system is preferred as it includes a “NavX” feature that allows the physician to see a representation of the physical location of his catheter in a presentation of an anatomic model of the patient&#39;s heart. 
         [0011]    The system includes a “servo catheter” and a servo catheter control system that are interfaced with the work station. The work station is the primary interface with the physician and it is anticipated that the servo catheter control software will run on the work station. The servo catheter will also be coupled to a conventional RF generator. 
         [0012]    In use the physician will locate site for ablation therapy and then he will confirm the location of the catheter which will automatically navigate to the lesion site desired by the physician. Once the catheter is located at that desired point or site the physician will activate the RF generator to deliver the therapy. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    Throughout the several drawings identical reference numerals indicate identical structure wherein: 
           [0014]      FIG. 1  is a schematic representation of the overall system; 
           [0015]      FIG. 2  is a schematic representation of a portion of the overall system; 
           [0016]      FIG. 3  is a schematic representation of an image displayed by the system; 
           [0017]      FIG. 4A  is a flow chart representation of a method of the system; 
           [0018]      FIG. 4B  is a flow chart representation of a method of the system; 
           [0019]      FIG. 5  is a representation of a servo catheter of the system; and, 
           [0020]      FIG. 6  is a representation of a servo catheter of the system. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0021]    Overview 
         [0022]    For purposes of this disclosure the NavX features of the Ensite system as sold by ESI of St Paul Minn., allows for the creation of a chamber geometry reflecting the chamber of interest within the heart. In a preferred embodiment a mapping catheter is swept around the chamber by the physician to create a geometry for the chamber. Next the physician will identify fiducial points in the physical heart that are used to create a base map of the heart model. This base map may be merged with a CT or MRI image to provide an extremely high resolution, highly detailed anatomic map image of the chamber of the heart. Or in the alternative the base map may be used for the method. The physician identifies regions of this model heart for ablation by interacting with a computer terminal and for example using a mouse to lay down a collection of target points which he intends to ablate with RF energy. 
         [0023]    In summary the servo catheter is also interfaced with the Ensite system and makes use of the NavX catheter navigation and visualization features of NavX. In operation the physician navigates the servo catheter to the approximate location of the therapy and a relatively complicated control system is invoked that navigates the servo catheter tip to various locations sequentially identified by the physician. Once in place and after its position is verified the physician will activate the RF generator to provide the ablation therapy. 
         [0024]    Servo Catheter 
         [0025]    The catheter has a number of attributes that permit the device to carry out this function. An illustrative and not limiting prototype version of the device is seen in  FIG. 5  and  FIG. 6 . The catheter  100  has been constructed with eight pull wires (of which  4  are shown for clarity) and two associated pull rings labeled  102  and  104  in the figures. 
         [0026]    The pull wires typified by pull wire  106  and  108  are manipulated by servo mechanisms, such as stepper or driven ball screw slides illustrated in  FIG. 1 . These mechanisms displace the wire with respect to the catheter body  110  and under tension pull and shape the catheter in a particular direction. The use of multiple wires and multiple pull rings allows for very complex control over the catheter&#39;s position, shape and stiffness, all of which are important to carry out the ultimate therapy desired by the physician. Multiple pull rings and multiple individual wires permits control over the stiffness of the catheter which is used to conform the shape of the catheter so that the entire carriage may be advanced on a ball screw to move the catheter against the wall of the heart. 
         [0027]    At least one force transducer  112  is located within the catheter provide feedback to the control system to prevent perforation of the heart and to otherwise enhance the safety of the unit. Preferably the force transducer takes the form of a strain gauge  112  coupled to the control system via connection  120 . 
         [0028]    The catheter distal tip will carry an ablation electrode  124  coupled via a connection not shown to the RF generator as is known in the art. It is preferred to have a separate location electrode  126  for use by the Ensite system as is known in the art. Once again no connection is shown to simply the figure for clarity. 
         [0029]    As seen in  FIG. 6  pulling on pull wire  108  deflects the distal tip while pulling on pull wire  106  deflects the body  110  of the catheter. Since each wire is independent of the others the computer system may control both the stiffness and deflection of the catheter in a way not achieved by physician control of the wires. In general the physician will use a joystick of other input device to control the catheter. However, this control system also invokes many of the automated procedures of the servo catheter and is not strictly a direct manipulator. 
         [0030]    Although robotic control has made great headway in surgery most conventional systems use a stereotactic frame to position the device and the coordinate systems with respect to the patient. One challenge of the current system is the fact that the target tissue is moving because the heart is beating and the catheter within the heart is displaced and moved by heart motion as well so that there is no permanently fixed relationship between the catheter and its coordinate system, the patient and its coordinate system, and the patient and its coordinate system at the target site. This issue is complicated by and exacerbated by the fact that the map may not be wholly accurate as well, so the end point or target point&#39;s location in space is not well resolved. 
         [0031]    Operation Overview 
         [0032]    Turning to  FIG. 1  there is shown a patient&#39;s heart  10  in isolation. A series of patch electrodes are applied to the surface of the patient (not shown) typified by patch  12 . These are coupled to an Ensite catheter navigation system  14  which locates the tip of the Servo catheter  16  in the chamber  18  of the patient&#39;s heart. The Ensite system is capable of using this catheter or another catheter to create a map of the chamber of the heart shown as image  20  on monitor  22  of a computer system. In operation the physician interacts with the model image  20  and maps out and plans an RF ablation intervention that is applied to the Servo catheter  16  through its proximal connection to the Servo catheter interface box  24 . The interface box allows RF energy from generator  26  to enter the catheter upon the command of the physician and ablate tissue in the cardiac chamber. Critical to the operation of the servo catheter is the translation mechanism  28 , which provides a carriage for translating the catheter proximal end advancing or retracting the catheter from the chamber as indicated by motion arrow  30 . An additional group of sensors and actuators or other servo translation mechanism  32  are coupled to the proximal end of the catheter  16  to allow the device to be steered automatically by software running on the Ensite  14  workstation. 
         [0033]    Thus, in brief overview, the physician navigates the catheter into the chamber of interest, identifies locations of interest within that chamber which he desires to ablate, then the Servo mechanism moves the catheter to various locations requested by the physician and once in position the physician administers RF radiation to provide a therapeutic intervention. 
         [0034]      FIG. 2  shows the interaction of the physician with the heart model. The locations for ablation are shown on the map  20  as X&#39;s  32  which surround an anatomic structure that may be, for example, the pulmonary vein  34 . These locations are typically accessed on the map image through a mouse or other pointer device  36  so that the physician may act intuitively with the model. As is clear from the Ensite operation manual the catheter  16  may also be shown on the image to facilitate planning of the intervention. Turning to  FIG. 3  the servo catheter  16  has been activated and the catheter has been retracted slightly as indicated by arrow  41  and has been manipulated to come into contact with the cardiac tissue at location  40 . In this instance the physician is in a position to perform his ablation. 
         [0035]    The control system to achieve this result is shown in  FIG. 4A  and  FIG. 4B  which are two panels of a software flow chart describing software executed by the Ensite work station. 
         [0036]    Turning to  FIG. 4   a , initially the catheter is placed in the desired heart chamber as seen in  FIG. 2  by the positioning of catheter  16  as represented on the Ensite work station within the chamber of the heart  20 . This process occurs after the creation of the chamber geometry. In block  202  the Ensite system determines the location of the location ring of catheter  16  in the chamber and in process  204  a small motion is initiated by the operation of the steppers  32  controlling the various pull wires of the catheter. The Ensite system tracks the motion of the location electrode and establishes a relationship between the operation of the various pull wires and motion in the chamber. It is important to note that this process eliminates the need to keep track of the X, Y, Z references of the body and the catheter. In process  206  the physician manipulates the joystick or other control mechanism and places the target location, for example target location  32 , around an anatomic feature of interest, for example the OS of the pulmonary vein. The user then activates a “go” command on the workstation and the catheter  16  automatically navigates to the location  32  by measuring the difference between its current position and the desired location position in block  210 . If it is within 0.5 millimeters or so, the process stops in block  212 . However, if the catheter is farther away from the target location than 0.5 millimeters, the process defaults to step  212  wherein a displacement vector is calculated in process  212 . In process  214  the displacement vector is scaled and in process  216  an actuation vector is computed to drive the catheter toward the location. In process  218  the actuation vector is applied to the pull wires  32  and to the carriage  28  to move the catheter tip toward the desired location. After a short incremental motion in process  220  a new location for the catheter is computed and the process repeats with comparison step  210 . It is expected that in most instances the algorithm will converge and the catheter will move smoothly and quickly to the desired location. However, after a certain number of tries if this result is not achieved it is expected that an error condition will be noted and the physician will reposition the catheter manually and then restart the automatic algorithm.