Abstract:
A method includes providing an elongated probe having a longitudinal axis and a distal end, and capable of rotation of the distal end about the longitudinal axis in mutually opposite first and second directions. While an operator manipulates the probe within a body of a patient, the rotation that is applied to the distal end is sensed automatically. An alert is issued to the operator upon sensing that the rotation is in the second direction, but not when the sensed rotation is in the first direction.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates generally to medical probes, and particularly to methods and systems for sensing and indicating probe rotation. 
       BACKGROUND OF THE INVENTION 
       [0002]    Certain catheterization procedures, such as pulmonary vein mapping and ablation, are sometimes performed using Lasso catheters. For example, U.S. Pat. No. 6,973,339, whose disclosure is incorporated herein by reference, describes a method for electrical mapping of a pulmonary vein of a heart. The method includes introducing into the heart a catheter having a curved section and a base section, the base section having a distal end attached to a proximal end of the curved section. At a location on the curved section, a first position signal is generated having fewer than six dimensions of position and orientation information. At a vicinity of the distal end of the base section, a second position signal is generated having six dimensions of position and orientation information. The method also includes measuring, at one or more locations on the curved section, an electrical property of the pulmonary vein. Lasso catheters are also described in U.S. Patent Application Publications 2010/0168548 and 2010/0222859, whose disclosures are incorporated herein by reference. 
       SUMMARY OF THE INVENTION 
       [0003]    An embodiment of the present invention that is described herein provides a method, which includes providing an elongated probe having a longitudinal axis and a distal end, and capable of rotation of the distal end about the longitudinal axis in mutually opposite first and second directions. While an operator manipulates the probe within a body of a patient, the rotation that is applied to the distal end is sensed automatically. An alert is issued to the operator upon sensing that the rotation is in the second direction, but not when the sensed rotation is in the first direction. 
         [0004]    In some embodiments, the distal end includes a hook-shaped curve in a plane that is oriented obliquely with respect to the longitudinal axis. In an embodiment, the probe includes a lasso cardiac catheter. In a disclosed embodiment, automatically sensing the rotation includes receiving a signal from a sensor coupled to the probe, and determining the rotation based on the received signal. In another embodiment, receiving the signal includes accepting the signal from a position sensor that generates the signals responsively to an externally-generated magnetic field. In yet another embodiment, receiving the signal includes accepting the signal from an acceleration sensor that generates the signal responsively to an angular acceleration of the probe. In an embodiment, the sensor is coupled to the distal end of the probe. 
         [0005]    In some embodiments, sensing the rotation includes measuring an impedance between at least one sensor coupled to the distal end and one or more electrodes attached to the body of the patient, and calculating the rotation based on the measured impedance. In an embodiment, issuing the alert includes displaying a visual alert on a monitor display viewed by the operator. 
         [0006]    In another embodiment, issuing the alert includes sounding an audible alarm to the operator. 
         [0007]    In a disclosed embodiment, the method includes detecting an entanglement of the distal end with tissue in the body, and issuing a notification of the entanglement to the operator. Detecting the entanglement may include detecting a deviation of a shape of the distal end from a reference shape. In an embodiment, the probe is designated for operation in atria of a heart of the patient, and the method includes measuring a location of the probe and alerting the operator upon detecting that the probe is located in a ventricle of the heart. 
         [0008]    There is additionally provided, in accordance with an embodiment of the present invention, apparatus including a processor and an output device. The processor is connected to an elongated probe that has a longitudinal axis and a distal end and is capable of rotation of the distal end about the longitudinal axis in mutually opposite first and second directions. The processor is configured to automatically sense the rotation that is applied to the distal end while an operator manipulates the probe within a body of a patient, and to issue an alert upon sensing that the rotation is in the second direction, but not when the sensed rotation is in the first direction. The output device is configured to present the alert to the operator. 
         [0009]    The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which: 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a schematic, pictorial illustration of a system for cardiac catheterization that uses position tracking, in accordance with an embodiment of the present invention; 
           [0011]      FIG. 2  is a diagram showing recommended and non-recommended directions of rotation of a lasso catheter, in accordance with an embodiment of the present invention; 
           [0012]      FIG. 3  is a schematic pictorial view of a system for cardiac catheterization, in accordance with an embodiment of the present invention; 
           [0013]      FIGS. 4A and 4B  are diagrams showing a scheme for detecting tip entanglement in a lasso catheter, in accordance with an embodiment of the present invention; and 
           [0014]      FIG. 5  is a flow chart that schematically illustrates a method for controlling rotation of a catheter, in accordance with an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Overview 
       [0015]    When a physician manipulates a catheter inside a patient&#39;s body, the physician often rotates the catheter about the catheter&#39;s longitudinal axis. In some catheter types, however, one direction of rotation (clockwise or counterclockwise) may be recommended, while the opposite direction should be avoided. For example, some lasso catheters have a hook-like, curved distal end in a plane that is approximately perpendicular to the longitudinal axis of the catheter. In a catheter of this sort, one direction of rotation may cause the distal end to engage or hook onto tissue, while rotation in the opposite direction is typically safer. 
         [0016]    Embodiments of the present invention that are described herein provide methods and systems for assisting an operator (e.g., physician) in choosing the recommended direction of rotation. In some embodiments, a processor senses the direction of rotation applied to the distal end of the catheter, for example using a position sensor fitted in the catheter. The processor determines whether or not the catheter is being rotated in the recommended direction, and notifies the operator accordingly. 
         [0017]    For example, the processor may display an indication of the sensed rotation direction on a monitor display or other output device. Additionally or alternatively, the processor may produce a visual and/or audible indication as to whether the sensed direction of rotation is the recommended direction. Using such indications, the operator is able to choose the direction of rotation so as to reduce the risk of tissue damage by the catheter and/or disruption of the catheterization procedure. 
         [0018]    In other disclosed embodiments, the processor detects events in which the tip of the catheter&#39;s distal end is entangled or hooked onto tissue, and generates an appropriate alert. The processor typically detects such an event by identifying a change in the shape of the catheter, e.g., by detecting a change in the distance between position sensors fitted in the distal end. 
       System Description 
       [0019]      FIG. 1  is a schematic, pictorial illustration of a system  20  for cardiac catheterization that uses position tracking, in accordance with an embodiment of the present invention. In the present example, system  20  uses magnetic position tracking. Alternatively, however, system  20  may use other suitable position tracking technologies, such as impedance-based position tracking. System  20  may be based, for example, on the CARTO™ system, produced by Biosense-Webster Inc. (Diamond Bar, Calif.). In system  20 , a physician  24  (or other operator) inserts a catheter  28  (or other elongated probe) into the body of a patient  30 . 
         [0020]    Catheter  28  has a proximal end that is handled by the physician, and a distal end  36  that is navigated through the patient body. The physician moves the distal end of the catheter by manipulating the proximal end. In particular, the physician may rotate the proximal end about the longitudinal axis of the catheter, and this rotation is in turn applied to the distal end. 
         [0021]    In the present example, distal end  36  has a Lasso shape. In a typical lasso catheter, the distal end has an end section that is formed so as to define an arc that is oriented obliquely relative to the longitudinal axis of the catheter. One or more electrodes, e.g., potential sensing electrodes and/or ablation electrodes, may be disposed along the end section. Lasso catheters may be used, for example, for sensing electrical potentials at multiple points that lie on an arc surrounding an anatomical structure, such as the ostium of a pulmonary vein, and/or for ablating tissue along such an arc. 
         [0022]    Example lasso catheters are described in U.S. patent application Ser. No. 12/649,417, filed Dec. 30, 2009; and in U.S. patent application Ser. No. 12/975,787, filed Dec. 22, 2010, which are assigned to the assignee of the present patent application and whose disclosures are incorporated herein by reference. 
         [0023]    Catheter  28  is connected to a control console  44  using a cable  32 . In the embodiment described herein, catheter  28  is inserted into the patient&#39;s heart and used for ablation and/or for creating electrophysiological maps of one or more heart chambers. Alternatively, catheter  28  may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs. 
         [0024]    In the example of  FIG. 1 , console  44  uses magnetic position sensing to determine position coordinates of distal end  36  inside the heart. (As noted above, the disclosed techniques are not limited to magnetic position tracking. In alternative embodiments, console  44  may use any other suitable position tracking technique, for example impedance-based techniques, to track distal end  36 .) 
         [0025]    To determine the position coordinates, a driver circuit in console  44  drives field generators  40  to generate magnetic fields within the body of patient  30 . Typically, field generators  40  comprise coils, which are placed at known positions below the patient&#39;s torso. One or more magnetic position sensors (not shown in the figure) within distal end  36  of catheter  28  generate electrical signals in response to these magnetic fields. 
         [0026]    A processor  48  in console  44  processes these signals in order to determine the position coordinates of distal end  36 , typically including both location and orientation coordinates. Magnetic position tracking methods of this sort are described in detail in U.S. Pat. Nos. 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612 and 6,332,089, in PCT International Publication WO 96/05768, and in U.S. Patent Application Publications 2002/0065455, 2003/0120150 and 2004/0068178, whose disclosures are all incorporated herein by reference. 
         [0027]    Based on the signals received from catheter  28 , processor  44  drives a display  52  to present physician  24  with a map of cardiac electrophysiological activity, as well as providing visual feedback regarding the position of distal end  36  in the patient&#39;s body and status information and guidance regarding the procedure that is in progress. 
         [0028]    Processor  48  typically comprises a general-purpose computer, with suitable front end and interface circuits for receiving signals from catheter  28  and controlling the other components of console  44 . Processor  48  may be programmed in software to carry out the functions that are described herein. The software may be downloaded to processor  48  in electronic form, over a network, for example, or it may be provided on non-transitory tangible media, such as optical, magnetic or electronic memory media. Alternatively, some or all of the functions of processor  48  may be carried out by dedicated or programmable digital hardware components. 
       Recommended and Non-Recommended Rotation Directions of a Lasso Catheter 
       [0029]      FIG. 2  is a diagram showing recommended and non-recommended directions of rotation of a lasso catheter, in accordance with an embodiment of the present invention. The figure shows distal end  36  of catheter  28 , which has a hook-like shape. The two possible directions of rotation about the longitudinal axis of the catheter are marked with arrows. One direction of rotation of distal end  36  is defined as a recommended direction that should be used whenever possible. The opposite direction of rotation is defined as a non-recommended direction that should be avoided as much as possible. 
         [0030]    In the example of  FIG. 2 , the bottom arrow marks the non-recommended direction of rotation. Because of the shape of distal end  36 , rotating the catheter in this direction may cause the tip of the distal end to hook or engage onto tissue. As a result, damage may be caused to the tissue and/or the catheter, and the catheterization procedure may be disrupted. The top arrow marks the recommended direction of rotation. Rotating the catheter in this direction is likely to be safe and free of the above-described complications. 
         [0031]    The distal end configuration of  FIG. 2  is chosen purely by way of example. In alternative embodiments, the disclosed techniques can be used with any other suitable catheter having recommended and non-recommended directions of rotation for any reason. For example, a catheter having a semi-rigid crescent-shaped distal end, or a catheter whose distal end comprises multiple arms, may entangle in tissue unless rotated in a particular recommended direction. 
       Notification of Non-Recommmended Catheter Rotation 
       [0032]      FIG. 3  is a schematic, pictorial illustration of certain elements of system  20 , in accordance with an embodiment of the present invention.  FIG. 3  shows catheter  28  and some of console  44  in greater detail. In the present embodiment, a handle  56  is fitted at the proximal end of catheter  28 . The handle is used for maneuvering the catheter by the physician, and in particular for rotating the catheter about its longitudinal axis. A connector  62  connects catheter  28  to cable  32 . A magnetic position sensor  66  is fitted in distal end  36  of catheter  28 , in order to carry out magnetic position tracking of the distal end by system  20 , as explained above. Sensor  66  is typically fitted at or near the end of the catheter shaft, i.e., at the root of the catheter distal end. 
         [0033]    In some embodiments, processor  48  senses the rotation that the physician applies to catheter  28 . In an example embodiment, processor  48  senses the rotation based on the signals produced by magnetic position sensor  66  in the distal end. In a typical application of this sort, system  20  measures the location and orientation coordinates of distal end  36  using the magnetic position tracking methods described above. In particular, processor  48  tracks the orientation of the distal end based on the signals produced by sensor  66 , and calculates the rotation angle or the rate of rotation of the catheter. 
         [0034]    In an alternative embodiment, sensor  66  comprises an acceleration sensor. In this embodiment, the signals are indicative of the angular acceleration of the catheter about its longitudinal axis. Processor  48  processes (e.g., integrates) these signals so as to estimate the rotation angle or rate of rotation applied to the catheter. 
         [0035]    In alternative embodiments, processor  48  may sense the catheter rotation based on inputs from two or more sensors, e.g., based on multiple sensors that are disposed along the lasso loop of the distal end. Such sensors may comprise simple (e.g., single-axis) sensors that do not necessarily each produce rotation information. 
         [0036]    Further alternatively, processor  48  may measure or estimate the rotation applied to catheter  28  based on any other suitable sensor and using any other suitable method, e.g., by measuring the impedance between each of the lasso electrodes and patches attached to the patient body. Note that the disclosed techniques are in no way limited to use in magnetic position tracking systems such as system  20 . For example, the methods described herein can be used with an acceleration sensor at the proximal end or at the distal end, without a position tracking system of any kind. 
         [0037]    Based on the sensed rotation, processor  48  notifies the physician whether or not the catheter is being rotated in the recommended or in the non-recommended direction. The identification of one rotation direction as recommended and the other as non-recommended is typically predefined in processor  48 . In some embodiments, processor  48  presents an indication of the sensed direction of rotation to physician  24 . In some embodiments, processor  48  indicates whether or not the present direction of rotation is the recommended direction. 
         [0038]    In the example embodiment of  FIG. 3 , processor  48  displays on display  52  an alphanumeric field  67  showing “OK” when the catheter is rotated in the recommended direction, and “WRONG” when the catheter is rotated in the non-recommended direction. In another embodiment, processor  48  displays an arrow  68 , whose direction indicates the direction of rotation of the catheter. In an example embodiment, the arrow is displayed in a manner that indicates whether the direction of rotation is recommended or not. For example, an arrow indicating the non-recommended direction may be colored red, while an arrow indicating the recommended direction may be colored green. Alternatively, processor  48  may present any other suitable indication, e.g., using a suitable alphanumeric or graphical indication. 
         [0039]    In some embodiments, processor  48  generates an alert when the catheter is rotated in the non-recommended direction. Any suitable type of alert and any suitable output device for generating the alert can be used, e.g., displaying a visual alert on display  52  or sounding an audible alert using a loudspeaker or other audio output device. Based on the indication generated by processor  48 , physician  24  is able to prefer the recommended direction of rotation whenever possible. 
         [0040]    In some embodiments, processor  48  detects events in which the tip of distal end  36  becomes entangled with tissue (either because the catheter was rotated in the non-recommended direction or for any other reason). Example methods for detecting catheter tip entanglement are described further below. Upon detecting tip entanglement, processor  48  issues an alert to the physician. Any suitable type of alert and any suitable type of output device can be used for this purpose, such as the examples given above for the rotation direction alert. In the example of  FIG. 3 , processor  48  displays a warning icon  69  on display  52 . 
         [0041]    Additional aspects of measuring catheter rotation and indicating the rotation to an operator are addressed in U.S. patent application Ser. No. 12/851,085, entitled “Catheter Entanglement Indication,” which is assigned to the assignee of the present patent application and whose disclosure is incorporated herein by reference. 
       Detection and Notification of Catheter Tip Entanglement 
       [0042]    In some cases, the tip of distal end  36  may become stuck or engaged in tissue, an event that may risk the patient and/or the catheter. For example, the tip of a lasso catheter may hook onto the heart&#39;s papillary muscle. As another example, one or more tips of a multi-arm catheter may hook onto the heart&#39;s papillary muscle or a heart valve. Events of this sort are all referred to herein as “tip entanglement.” In some embodiments, processor  48  detects tip entanglement by identifying a change or abnormality in the shape of the catheter distal end. 
         [0043]      FIGS. 4A and 4B  are diagrams showing a scheme for detecting entanglement of distal end  36  in tissue, in accordance with an embodiment of the present invention.  FIG. 4A  shows the normal shape of distal end  36 .  FIG. 4B  shows distal end  36  when a tip  71  of the distal end is entangled in tissue  72 . 
         [0044]    As can be seen in the figure, the tip entanglement causes a change or abnormality in the shape of the lasso loop. Processor  48  typically detects the tip entanglement by identifies this abnormality, i.e., by identifying that the shape of the distal end deviates from the normal baseline shape by more than a tolerable amount. 
         [0045]    In an example embodiment, a position sensor  70  is fitted on the lasso loop, typically more than half-way toward tip  71 . In this embodiment, processor  48  measures the positions of sensors  66  and  70  using the methods described above, and calculates the distance between the two sensors. If the distance exceeds a reference distance (e.g., the distance under normal conditions as seen in  FIG. 4A ) by more than a predefined threshold, processor  48  concludes that the distal tip is entangled. 
         [0046]    As another example, processor  48  may detect tip entanglement by identifying that the lasso loop deviates from a single plane, e.g., by identifying that the lasso electrodes (or position sensors fitted along the lasso loop) are not all on the same plane. These conditions are typically regarded as indicating entanglement provided that the catheter is out of its sheath, i.e., in its expanded position. 
         [0047]    One possible way for processor  48  to detect that the catheter&#39;s lasso loop deviates from a single plane is to find a point on the lasso loop that is closest to tip  71 , excluding the most distal section (e.g., half) of the loop from the search. If the distance between this point and the catheter tip is above some threshold, processor may conclude that the loop deviates from a single plane. 
         [0048]    In alternative embodiments, processor  48  may detect tip entanglement using any other suitable method. As explained above, in response to detecting tip entanglement processor  48  typically issues an alert. 
         [0049]      FIG. 5  is a flow chart that schematically illustrates a method for preventing rotation of a catheter in a non-recommended direction, in accordance with an embodiment of the present invention. The method begins with physician  24  maneuvering catheter  28  in the body of patient  30  as part of a medical procedure, at a catheter manipulation step  80 . In particular, the physician applies rotation to the catheter with respect to the catheter&#39;s longitudinal axis. 
         [0050]    Processor  48  senses the direction of the rotation applied to the catheter during the procedure, at rotation sensing step  84 . Any suitable measurement method and sensor, such as the schemes described above, can be used. 
         [0051]    Processor  48  checks whether the sensed direction of rotation is the recommended direction or the non-recommended direction, at a direction checking step  88 . If the sensed rotation is in the recommended direction, processor  48  displays an “OK” indication to physician  24  on display  52 , at a recommended direction indication step  92 . If, on the other hand, the sensed rotation is in the non-recommended direction, processor  48  displays an alert indication, at a non-recommended direction indication step  96 . 
         [0052]    Processor  48  then checks whether tip  71  of distal end  36  is entangled in tissue, at an entanglement checking step  100 . Processor  48  may detect tip entanglement, for example, by measuring the distance between sensors  66  and  70  ( FIGS. 4A and 4B ). If no tip entanglement is detected, the method loops back to step  80  above. If tip entanglement is detected at step  100 , processor  48  issues an entanglement alert, at an entanglement alerting step  104 . The method then loops back to step  80  above. 
         [0053]    In some embodiments, processor  48  detects that the lasso catheter is rotated in the non-recommended direction using the following method: The Lasso loop is approximated by a plane. A normal to this plane is the axis around which the lasso rotation is measured and filtered. For a counter-clockwise (CCW) loop, the non-recommended rotation direction can be defined as the difference between the current value of the rotation angle, and the minimal value of the rotation angle until the present time. If this difference exceeds some positive threshold, processor  48  concludes that the catheter is being rotated in the non-recommended direction. For a clockwise (CW) loop, the non-recommended rotation direction can be defined as the difference between the current value of the rotation angle, and the maximal value of the rotation angle until the present time. If this difference is below some negative threshold, processor  48  concludes that the catheter is being rotated in the non-recommended direction. 
         [0054]    In some embodiments, system  20  comprises an electrophysiological mapping system that enables the physician to generate maps of the four heart chambers (i.e., the two atria and the two ventricles), and indicate the catheter location within the heart. Some catheters are designed for use only in the atria, and it is highly recommended not to place them in a ventricle. When using such catheters, processor  48  of system  20  may issue an alert when the measured catheter position indicates that it is located in a ventricle. 
         [0055]    Although the embodiments described herein mainly address lasso catheters, the methods and systems described herein can also be used with other types of medical probes having recommended and non-recommended directions of rotation. Although the embodiments described herein refer mainly to rotation of a medical probe, the disclosed techniques can be used for recommending the direction of rotation in other devices. 
         [0056]    Although the embodiments described herein refer mainly to detecting deformation in a lasso loop of a catheter in order to identify entanglement of the lasso tip, the disclosed techniques can be used to detect deformation of various other medical instruments, such as in procedures that involve insertion of flexible medical instruments into the heart, the spine, the epidural space, the brain or any other organ. For example, the disclosed techniques can be used to verify the direction of a temperature probe, which is inserted into the esophagus in order to measure heating of the side of the esophagus that is adjacent to the heart. In this application it is important to verify that the probe is indeed pointed toward the heart. 
         [0057]    It will thus be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art. Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated documents in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.