Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/984,953, which is herein incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates to invasive medical devices. More particularly, this invention relates to ablation of tissue using such devices. 
         [0004]    2. Description of the Related Art 
         [0005]    Ablation of body tissue using electrical energy is known in the art. The ablation is typically performed by applying alternating currents, for example radiofrequency energy, to the electrodes, at a sufficient power to destroy target tissue. Typically, the electrodes are mounted on the distal tip of a catheter, which is inserted into a subject. The distal tip may be tracked in a number of different ways known in the art, for example by measuring magnetic fields generated at the distal tip by coils external to the subject. 
         [0006]    A known difficulty in the use of radiofrequency energy for cardiac tissue ablation is controlling local heating of tissue. There are tradeoffs between the desire to create a sufficiently large lesion to effectively ablate an abnormal tissue focus, or block an aberrant conduction pattern, and the undesirable effects of excessive local heating. If the radiofrequency device creates too small a lesion, then the medical procedure could be less effective, or could require too much time. On the other hand, if tissues are heated excessively then there could be local charring effects, coagulum, and or explosive steam pops due to overheating. Such overheated areas can develop high impedance, and may form a functional barrier to the passage of heat. The use of slower heating provides better control of the ablation, but unduly prolongs the procedure. 
         [0007]    Steam pops or microbubble formation can occur during RF ablation when tissue temperatures exceed 100 C. While tactile and audible cues are used for their detection, background lab noise and catheter movement may confound identification. Steam pops are particularly hazardous. For example, during RF ablation, steam pops caused by tissue overheating may result in cardiac perforation. The present disclosure deals with recognition of impending steam pops in time to take corrective action, e.g., controlling the power output of the ablator. 
         [0008]    Previous attempts to recognize steam pops include the use of phonocardiography. For example, the document  Detection of microbubble formation during radiofrequency ablation using phonocardiography , Kotini et al., EP Europace Volume 8, Issue 5 Pp. 333-335 proposes detection of characteristic signatures prior to steam pops using a computer-based phonocardiography system. 
         [0009]    In another approach, the document  Steam Pop Prediction and Detection During Radiofrequency Ablation , Holmes et al., Circulation 2011 124:A13330 describes an Electrical Coupling Index (ECI), in which resistive and reactive impedance between the ablation catheter and tissue. The ECI was displayed as a continuous waveform during ablation. A steam pop prediction algorithm is said to have predicted 92% of all steam pops at least 3 seconds before they occurred. The negative predictive value of the steam pop prediction algorithm is stated as 98%. 
         [0010]    U.S. Pat. No. 8,147,484 to Lieber et al. discloses real-time optical measurements of tissue reflection spectral characteristics while performing ablation. The technique involves the radiation of tissue and recapturing of light from the tissue to monitor changes in the reflected optical intensity as an indicator of steam formation in the tissue for prevention of steam pop. Observation is made to determine whether measured reflectance spectral intensity (MRSI) increases in a specified time period followed by a decrease at a specified rate in the MRSI. If there is a decrease in the MRSI within a specified time and at a specified rate, then formation of a steam pocket is inferred. 
       SUMMARY OF THE INVENTION 
       [0011]    According to disclosed embodiments of the invention, high frequency fluctuations in optical reflectivity measured by optical sensors near the tip of a catheter predict an imminent occurrence of steam pops, i.e., within a few seconds. Without being bound by any particular theory, the following discussion is offered to facilitate understanding of the invention: a possible reason for this phenomenon relates to optical properties of a developing steam pocket or microbubbles within the target tissue. 
         [0012]    There is provided according to embodiments of the invention an apparatus, including a power generator of ablative electrical energy and an insertion tube configured for insertion into proximity with tissue in a body of a patient. The insertion tube has an electrical conductor for conveying the ablative electrical energy to the tissue, a conductive cap attached to the distal end of the insertion tube and coupled electrically to the electrical conductor, and at least one optical fiber terminating in proximity to an outer surface of the conductive cap. The optical fiber conveys optical radiation to the tissue while the power generator is activated and receives reflected optical radiation. An optical module measures the received reflected optical radiation, and a processor linked to the optical module analyzes the reflected optical radiation. 
         [0013]    According to an aspect of the apparatus, analyzing the reflected optical radiation includes recognizing a characteristic signature in the reflected optical radiation indicative of an impending steam pop event. 
         [0014]    According to another aspect of the apparatus, the characteristic signature comprises a high frequency pattern in a second derivative of the reflected optical radiation with respect to time. 
         [0015]    According to one aspect of the apparatus, the processor is configured for recognizing the high frequency pattern by performing a Fourier transform on the second derivative thereof and identifying spectral peaks exceeding 0.5 Hz in a spectrum of the Fourier transform. 
         [0016]    According to a further aspect of the apparatus, the processor is configured for obtaining additional reflected optical radiation when the ablation power generator is deactivated, performing an additional Fourier transform on the second derivative of the additional reflected optical radiation and subtracting the additional Fourier transform from the Fourier transform. 
         [0017]    There is further provided according to embodiments of the invention a method that is carried out by the above-described apparatus. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0018]    For a better understanding of the present invention, reference is made to the detailed description of the invention, by way of example, which is to be read in conjunction with the following drawings, wherein like elements are given like reference numerals, and wherein: 
           [0019]      FIG. 1  is a pictorial illustration of a system for performing ablative procedures, which is constructed and operative in accordance with a disclosed embodiment of the invention; 
           [0020]      FIG. 2  is a schematic, perspective illustration of a catheter cap in accordance with an embodiment of the invention; 
           [0021]      FIG. 3  is a schematic end view showing the interior of the cap shown in  FIG. 2 , in accordance with an embodiment of the invention; 
           [0022]      FIG. 4  is a schematic sectional view taken along line  4 - 4  of  FIG. 3 , in accordance with an embodiment of the invention; 
           [0023]      FIG. 5  is a schematic sectional view taken along line  5 - 5  of  FIG. 3 , in accordance with an embodiment of the invention; 
           [0024]      FIG. 6  schematically illustrates paths taken by light to/from windows in the cap shown in  FIG. 2 , in accordance with an embodiment of the invention; 
           [0025]      FIG. 7  is a group of four exemplary tracings of reflectance data in accordance with an embodiment of the invention; 
           [0026]      FIG. 8  is a group of four exemplary tracings of reflectance data in accordance with an embodiment of the invention; 
           [0027]      FIG. 9  is a group of four exemplary tracings of reflectance data in accordance with an embodiment of the invention; and 
           [0028]      FIG. 10  illustrates FFT plots of the second derivative tracings shown in  FIG. 9 , in accordance with an embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0029]    In the following description, numerous specific details are set forth in order to provide a thorough understanding of the various principles of the present invention. It will be apparent to one skilled in the art, however, that not all these details are necessarily needed for practicing the present invention. In this instance, well-known circuits, control logic, and the details of computer program instructions for conventional algorithms and processes have not been shown in detail in order not to obscure the general concepts unnecessarily. 
         [0030]    Turning now to the drawings, reference is initially made to  FIG. 1 , which is a pictorial illustration of a system  10  for performing ablative procedures on a heart  12  of a living subject, which is constructed and operative in accordance with a disclosed embodiment of the invention. The system comprises a catheter  14 , which is percutaneously inserted by an operator  16  through the patient&#39;s vascular system into a chamber or vascular structure of the heart. The operator  16 , who is typically a physician, brings the catheter&#39;s distal tip  18  into contact with the heart wall at an ablation target site. Electrical activation maps may then be prepared, according to the methods disclosed in U.S. Pat. Nos. 6,226,542, and 6,301,496, and in commonly assigned U.S. Pat. No. 6,892,091, whose disclosures are herein incorporated by reference. Although the embodiment described with respect to  FIG. 1  is concerned primarily with cardiac ablation; the principles of the invention may be applied, mutatis mutandis, to other catheters and probes and to body tissues other than the heart. 
         [0031]    Areas determined to be abnormal by evaluation of the electrical activation maps can be ablated by application of thermal energy, e.g., by passage of radiofrequency electrical current through wires in the catheter to one or more electrodes at the distal tip  18 , which apply the radiofrequency energy to the myocardium. The energy is absorbed in the tissue, heating it to a point (typically above 60° C.) at which it permanently loses its electrical excitability. When successful, this procedure creates non-conducting lesions in the cardiac tissue, which disrupt the abnormal electrical pathway causing the arrhythmia. Alternatively, other known methods of applying ablative energy can be used, e.g., ultrasound energy, as disclosed in U.S. Patent Application Publication No. 2004/0102769, whose disclosure is herein incorporated by reference. The principles of the invention can be applied to different heart chambers, and to mapping in sinus rhythm, and when many different cardiac arrhythmias are present. 
         [0032]    The catheter  14  typically comprises a handle  20 , having suitable controls on the handle to enable the operator  16  to steer, position and orient the distal end of the catheter as desired for the ablation. To aid the operator  16 , the distal portion of the catheter  14  contains position sensors (not shown) that provide signals to a positioning processor  22 , located in a console  24 . The console  24  typically contains an ablation power generator  25 . The catheter  14  may be adapted to conduct ablative energy to the heart using any known ablation technique, e.g., radiofrequency energy, ultrasound energy, and laser energy. Such methods are disclosed in commonly assigned U.S. Pat. Nos. 6,814,733, 6,997,924, and 7,156,816, which are herein incorporated by reference. 
         [0033]    The positioning processor  22  is an element of a positioning subsystem of the system  10  that measures location and orientation coordinates of the catheter  14 . 
         [0034]    In one embodiment, the positioning sub-system comprises a magnetic position tracking arrangement that determines the position and orientation of the catheter  14  by generating magnetic fields in a predefined working volume its vicinity and sensing these fields at the catheter. The magnetic position tracking arrangement typically comprises a set of external radiators, such as field generating coils  28 , which are located in fixed, known positions external to the patient. The field generating coils  28  are driven by field generators (not shown), which are typically located in the console  24 , and generate fields, typically electromagnetic fields, in the vicinity of the heart  12 . 
         [0035]    In an alternative embodiment, a radiator in the catheter  14 , such as a coil, generates electromagnetic fields, which are received by sensors (not shown) outside the patient&#39;s body. 
         [0036]    Some position tracking techniques that may be used for this purpose are described, for example, in the above-noted U.S. Pat. No. 6,690,963, and in commonly assigned U.S. Pat. Nos. 6,618,612 and 6,332,089, and U.S. Patent Application Publications 2004/0147920, and 2004/0068178, whose disclosures are all incorporated herein by reference. Although the positioning sub-system shown in  FIG. 1  uses magnetic fields, the methods described below may be implemented using any other suitable positioning system, such as systems based on electromagnetic fields, acoustic or ultrasonic measurements. 
         [0037]    As noted above, the catheter  14  is coupled to the console  24 , which enables the operator  16  to observe and regulate the functions of the catheter  14 . Console  24  includes a processor, preferably a computer with appropriate signal processing circuits. The processor is coupled to drive a monitor  30 . The signal processing circuits typically receive, amplify, filter and digitize signals from the catheter  14 , including signals generated by the above-noted sensors and a plurality of sensing electrodes (not shown) located distally in the catheter  14 . The digitized signals are received and used by the console  24  to compute the position and orientation of the catheter  14  and to analyze the electrical signals from the electrodes. The information derived from this analysis may be used to generate an electrophysiological map of at least a portion of the heart  12  or structures such as the pulmonary venous ostia, for diagnostic purposes such as locating an arrhythmogenic area in the heart or to facilitate therapeutic ablation. 
         [0038]    An optical module  40  provides optical radiation, typically from, but not limited to, a laser, an incandescent lamp, an arc lamp, or a light emitting diode (LED), for transmission from distal tip  18  to the target tissue. The module receives and analyzes optical radiation returning from the target tissue and acquired at the distal end, as described below. 
         [0039]    Typically, the system  10  includes other elements, which are not shown in  FIG. 1  for the sake of simplicity. For example, the system  10  may include an electrocardiogram (ECG) monitor, coupled to receive signals from one or more body surface electrodes, to provide an ECG synchronization signal to the console  24 . The system  10  typically also includes a reference position sensor, either on an externally-applied reference patch attached to the exterior of the subject&#39;s body, or on an internally-placed catheter, which is inserted into the heart  12  maintained in a fixed position relative to the heart  12 . Conventional pumps and lines for circulating liquids through the catheter  14  for cooling the ablation site are provided. 
         [0040]    One system that embodies the above-described features of the system  10  is the CARTO® 3 System, available from Biosense Webster, Inc., 3333 Diamond Canyon Road, Diamond Bar, Calif. 91765. This system may be modified by those skilled in the art to embody the principles of the invention described herein. 
         [0041]    Some embodiments of the present invention that are described hereinbelow provide irrigated ablation electrodes with fiberoptic elements and optional embedded temperature sensors that provide accurate tissue temperature assessment. Such electrodes typically comprise a conductive cap, which is attached to the distal tip  18  ( FIG. 1 ) of the catheter  14 . A cooling fluid flows out through an array of perforations in the electrode to irrigate the tissue under treatment. Further details of these embodiments are disclosed in commonly assigned application Ser. No. 14/090,614 entitled Irrigated Catheter Tip with Temperature Sensor and Optic Fiber Arrays, which is herein incorporated by reference. 
         [0042]    Reference is now made to  FIG. 2 , which is a schematic, perspective illustration of a catheter cap  100 , in accordance with an embodiment of the invention. Cap  100  comprises a side wall  74  that is on the order of 0.4 mm thick, in order to provide the desired thermal insulation between optional temperature sensors  48  and the irrigation fluid inside a central cavity  76  of the tip. Irrigation fluid exits cavity  76  through apertures  46 . 
         [0043]    Reference is now made to  FIG. 3 , which is a schematic end view showing the interior of the cap  100 , in accordance with an embodiment of the invention. Reference is also made to  FIG. 4  and to  FIG. 5 , which are schematic sectional views taken respectively along the lines  4 - 4  and  5 - 5  of  FIG. 3 , in accordance with an embodiment of the invention. Three through longitudinal bores  102  and three blind longitudinal bores  106  are formed in side wall  74 . As shown in  FIG. 3 , the three sets of bores  72 ,  102 ,  106  may be distributed symmetrically around an axis  110  of cap  100 . However, the bores are not necessarily distributed symmetrically around axis  110 . Optional sensors  48  are mounted in hollow tubes  78 , which are filled with a suitable glue, such as epoxy and fitted into longitudinal bores  72  in side wall  74 . Tubes  78  may comprise a suitable plastic material, such as polyimide, and may be held in place by a suitable glue, such as epoxy. This arrangement provides an array of six sensors  48 , with possible advantages of greater ease of manufacture and durability. 
         [0044]    As best seen in  FIG. 4 , each through longitudinal bore  102  terminates in an opening  114  in the outer surface of wall  74 , and a transparent window  116  is placed in the opening. A fiber optic  118  is inserted into each of the through bores. In some embodiments, temperature sensors  48  may not be installed in wall  74 , and only fiber optics  118  are incorporated into the wall. Such an embodiment enables determination of tissue contact with the cap, and/or characterization of the tissue in proximity to the cap, by methods described below. 
         [0045]    As best seem in  FIG. 5 , there is a respective opening  120 , in the outer surface of wall  74 , to each blind bore  106 , and a transparent window  124  is placed in each opening  120 . A fiber optic  128  is inserted into each of the blind bores. Windows  116 ,  124  act as seals preventing fluid external to the outer surface of cap  100  from penetrating into the bores containing the fiber optics. Windows  116 ,  124  may be formed by filling openings  114 ,  120  with an optically transparent glue or epoxy. In some embodiments, the material of the windows may be filled with a scattering agent to diffuse light passing through the windows. 
         [0046]    Alternatively, the windows may be formed from an optical quality flat or lensed material, and may be secured to their openings with glue. 
         [0047]    In one embodiment, each fiber optic  118  or each fiber optic  128  is a single fiber optic, typically having a diameter of approximately 175 μm. In an alternative embodiment each fiber optic  118  or each fiber optic  128  comprises a bundle of substantially similar fiber optics, typically having a bundle diameter also of approximately 175 μm. Implementing the fiber optics as bundles increases the flexibility of cap  100  with respect to more proximal regions of the catheter  14  ( FIG. 1 ). 
         [0048]    Such an increase in flexibility is advantageous if cap  100  is connected to the more proximal regions of the catheter by a spring whose deflections are measured for the purpose of measuring a force on the cap, since the increased flexibility means there is little or no change in the spring deflection for a given force. A spring that may be used to join the cap  100  to the more proximal regions of the catheter is described in U.S. patent application Ser. No. 12/627,327, to Beeckler et al., whose disclosure is incorporated herein by reference. 
         [0049]    Optical module  40  ( FIG. 1 ) is configured to be able to provide optical radiation to any one of fiber optics  118  and  128 , for transmission from any of the associated windows  116 ,  124  in order to irradiate tissue in proximity to cap  100 . Simultaneously, the optical module  40  is able to acquire, via any or all of the windows, radiation returning from the irradiated tissue. 
         [0050]    The array of windows  116 ,  124 , and their associated fiber optics, enables embodiments of the present invention to employ a number of different methods, using optical radiation, for determining characteristics of the irradiated tissue, as well as the proximity of cap  100 , or a region of the cap, with respect to the tissue. By way of example, three such methods are described below, but those having ordinary skill in the art will be aware of other methods, and all such methods are included within the scope of the present invention. 
         [0051]    A first method detects contact of any one of windows  116 ,  124 , and consequently of the catheter, with tissue. Optical radiation of known intensity is transmitted through each fiber optic, so as to exit from the optic&#39;s window. The intensity of the radiation returning to the window is measured while cap  100  is not in contact with tissue, typically while the cap is in the blood of heart  12  ( FIG. 1 ). Optical module  40  may use these intensities as reference values of the optical radiation. 
         [0052]    For any given window, a change in the value from the window&#39;s reference value, as measured by the module, may be taken to indicate that the window is in contact with tissue. 
         [0053]    A second method measures characteristics of tissue being irradiated by the optical radiation. Reference is now made to  FIG. 6 , which schematically illustrates paths taken by light to/from windows in the cap  100  ( FIG. 2 ), in accordance with an embodiment of the invention. 
         [0054]    As illustrated in  FIG. 6 , for all six windows  116 ,  124  there are a total of 21 different paths, comprising 6 paths  150  where radiation from a given window returns to that window, and 15 paths  160  where radiation from a given window returns to a different window. The change of optical radiation for a given path or group of paths depends on characteristics of tissue in the path or group of paths, so that measurements of the change in all of the paths provide information related to characteristics of the tissue in proximity to cap  100 . 
         [0055]    For example, the change in all of the paths may be measured by sequentially transmitting, in a time multiplexed manner, optical radiation from each of the windows  116 ,  124 , and measuring the returning radiation. A first transmission from a first window in such a sequence provides values for five paths  160  plus a return path  150  to the first window. A second transmission from a second window provides values for four new paths  160  plus return path  150  to the second window. A third transmission from a third window provides values for three new paths  160  plus return path  150  to the third window. A fourth transmission from a fourth window provides values for two new paths  160  plus return path  150  to the fourth window. A fifth transmission from a fifth window provides values for one new path  160  to the sixth window, and return path  150  to the fifth window). A sixth and final transmission from a sixth window provides one return path  150  through the sixth window. 
         [0056]    Optical module  40  ( FIG. 1 ) may measure the changes of all the paths, and, using a calibration procedure, may derive from the changes optical characteristics of tissue within the paths. Such characteristics may include an overall level of ablation of tissue, or an amount and/or type of necrotic tissue, in the paths or the characteristic signature indicative of impending steam pop events described below. 
         [0057]    A third method uses changes of levels of optical radiation returning to either or both windows  116 ,  124 , such as are described in the two methods, to make an estimate of the wall thickness of tissue being illuminated by the optical radiation. 
         [0058]    Although a number of particular implementation examples have been shown and described above, alternative implementations of the principles embodied in these examples will be apparent to those skilled in the art after reading the foregoing description and are considered to be within the scope of the present invention. 
       EXAMPLES 
       [0059]    Examination of reflectance data (intensity with respect to time) indicates that 668.7 nm showed the largest difference between steam pop events and situations in which steam pops did not occur. In the following examples, the graphs on the left side of the figure show intensity over time at 668.7 nm. Time is arbitrary on the scale. However, the data is representative of a 60-second ablation performed at random powers and forces, with 5 seconds of data recorded postablation. The graphs at the right side of the following figures show the second derivative (d 2 I/dt 2 ) of the reflectance data over time. 
         [0060]    Reference is now made to  FIG. 7 , which is a group of four exemplary tracings of reflectance data in accordance with an embodiment of the invention. Intensity was tuned by increasing binning ( 8 ) and integration (100 ms) to maximize the dynamic range. In the upper three tracings, undulations in signal were evident, for example in the region indicated by arrow  162  in tracing  164 . In these three tracings, steam pop events were indicated by arrows  161 ,  163 ,  165 . There are marked fluctuations in the corresponding tracing  166  of the second derivative, Steam pop prediction was highly correlated with a high frequency signal (exceeding 0.5 Hz) for d 2 I/dt 2 . In contrast, the lowermost set of tracings  168 ,  170  describes an ablation in which no steam pop occurred. It is evident that the signal fluctuations precede the steam pop event. 
         [0061]    Reference is now made to  FIG. 8 , which is a group of four exemplary tracings of reflectance data in accordance with an embodiment of the invention. In this series, intensity was tuned to get usable signal with short integration (30 ms) and as little binning at possible for lesion-assessment testing. Undulations in signal were less evident but still appeared with the second derivative. Steam pop events were indicated by arrows  167 ,  169 . Steam pop prediction was highly correlated with high frequency signal for d 2 I/dt 2 . 
         [0062]    Reference is now made to  FIG. 9 , which is a group of four exemplary tracings of reflectance data in accordance with an embodiment of the invention. Intensity was tuned to get a usable signal with a short integration (10 ms) and as little binning at possible for lesion-assessment testing. Undulations in signal were less evident than on the preceding figures, but still appeared together with a chaotic appearance of the second derivative tracings. Steam pop events were indicated by arrows  171 ,  173 ,  175 . Steam pop prediction had less correlation (˜79%) with the high frequency signal for d 2 I/dt 2  than that of the previous examples. 
       Conversion to Frequency Domain. 
       [0063]    Converting the time-based tracings shown in  FIGS. 7-9  to the frequency domain using a Fourier transfer technique, e.g., a Fast Fourier Transform (FFT) technique, reveals characteristic spectra indicative of an impending steam pop. Reference is now made to  FIG. 10 , which illustrates FFT plots of the second derivative tracings shown at the right side of  FIG. 9 , in accordance with an embodiment of the invention. Graphs  172 ,  174  illustrate high frequency spectral peaks indicative of impending steam pop events. Peaks having frequencies exceeding 0.5 Hz are significant. Graphs  176 ,  178  show a low frequency spectral pattern (less than 0.5 Hz), indicating that steam pop events are not imminent. It is conjectured that the high frequency events correlate with formation of microbubbles in the tissue, followed by their movement and collapse within the top layer of the tissue. When enough microbubbles are present, they can conglomerate and form one large bubble that can rupture (pop) and perforate the tissue. 
         [0064]    Evaluating the FFT is useful as it can differentiate between fluctuations in optical intensity resulting from changes in contact force between the catheter and the ablation site and those caused by microbubbles. 
         [0065]    It is desirable to perform an FFT on a reflectance reading obtained while ablation is not occurring, e.g., prior to initiation of ablation. A 5-10 second window for this reading is satisfactory. Then the pre-ablation spectrum is subtracted from the FFT obtained during the ablation procedure. It is assumed that catheter movement during the 5-10 second window is representative of catheter movement during ablation. The subtraction procedure largely eliminates artifact due to catheter movement. 
         [0066]    It will be appreciated by persons skilled in the art 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 that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

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