Patent Publication Number: US-2022225925-A1

Title: Automatic shaving of an anatomical map during ablation to expose internal points of interest

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation-in-part of U.S. patent application Ser. No. 17/151,825, titled “Automatic Mesh Reshaping Of An Anatomical Map To Expose Internal Points Of Interest,” filed Jan. 19, 2021, whose disclosure is incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to electroanatomical (EA) mapping, and particularly to automatic editing of cardiac EA maps. 
     BACKGROUND OF THE INVENTION 
     Software-based editing tools for assisting in the interpretation of a mapped cavity of an organ were previously proposed in the patent literature. For example, in the field of dentistry, U.S. Patent Application Publication 2006/0286501 describes using a computer to create a plan for repositioning an orthodontic patient&#39;s teeth. The computer receives an initial digital data set representing the patient&#39;s teeth at their initial positions and a final digital data set representing the teeth at their final positions. The computer then uses the data sets to generate treatment paths along which the teeth will move from the initial positions to the final positions. In some embodiments, the individual tooth models include data representing hidden tooth surfaces, such as roots imaged through x-ray, CT scan, or MRI techniques. Tooth roots and hidden surfaces also can be extrapolated from the visible surfaces of the patient&#39;s teeth. 
     As another example, U.S. Patent Application Publication 2017/0325891 describes methods directed at generating a three-dimensional surface representation of an anatomic structure such as a heart cavity. More specifically, the three-dimensional surface representation of the anatomic structure is constrained relative to one or more anchor portions corresponding to received input regarding the location of anatomic features of the anatomic structure. The resulting three-dimensional surface representation includes salient features of the anatomic structure and, therefore, can be useful as visualization tool during any of various different medical procedures, including, for example, cardiac ablation. 
     SUMMARY OF THE INVENTION 
     An embodiment of the present invention that is described hereinafter provides a method including receiving or generating a volume map of at least a portion of a cavity of an organ of a body including a plurality of mapped locations, and a point cloud of locations in the cavity marked for treatment. The volume map is updated by removing a portion of the mapped locations, so that the locations marked for treatment fall on a surface of the volume map. Using the updated volume map, a map of at least a portion of the cavity is generated, the map including the locations marked for treatment. The map is displayed to user. 
     In some embodiments, removing the portion of the mapped locations includes identifying one or more of the locations marked for treatment that fall in an interior of the volume map, and removing the portion so that the identified locations marked for treatment fall on the surface of the volume map. 
     In some embodiments, identifying a location marked for treatment that falls in the interior of the volume map includes determining that a vector, from the location marked for treatment to a respective projected location on the surface, is opposite to an outward-pointing normal to the surface at the projected location. 
     In an embodiment, the locations marked for treatment are locations on a cardiac wall tissue, and are marked for ablation. 
     In another embodiment, generating the map includes generating an electroanatomical (EA) map of at least a portion of the wall tissue. 
     In some embodiments, removing the portion of the mapped locations includes projecting the locations marked for treatment to respective locations on the surface of the volume map, and removing the portion of the volume map that includes a surface connecting the locations marked for treatment with the projected locations. 
     In some embodiments, removing the surface connecting the locations marked for treatment with the projected locations includes removing a surface defined as a surface between a first curve generated by interconnecting the locations marked for treatment, and a second curve generated by interconnecting the projected locations. 
     In other embodiments, removing the portion of the volume includes defining, between each location marked for treatment and a respective projected location on the surface, a respective distance embedded in the surface, and defining the removed portion based on the distance. 
     In an embodiment, defining the removed portion of volume map includes defining a sphere having a diameter corresponding to the distance. 
     In another embodiment, wherein displaying the map to the user includes presenting one or more icons at the locations marked for treatment. 
     There is additionally provided, in accordance with another embodiment of the present invention, a system including a memory and a processor. The memory is configured to store a plurality of mapped locations acquired in a cavity of an organ of a body, and a point cloud of locations in the cavity marked for treatment. The processor is configured to (i) receive or generate a volume map of at least a portion of the cavity including the plurality of mapped locations, (ii) update the volume map by removing a portion of the mapped locations, so that the locations marked for treatment fall on a surface of the volume map, (iii) using the updated volume map, generate a map of at least a portion of the cavity, including the locations marked for treatment, and (iv) display the map to user. 
     There is additionally yet provided, in accordance with another embodiment of the present invention, a method including receiving or generating (i) a volume map of at least a portion of a cavity of an organ of a body including a plurality of mapped locations, and (ii) ablation locations inside the cavity. The volume map is updated by removing a portion of the mapped locations, so that the ablation locations inside the cavity fall on a surface of the volume map. Using the updated volume map, a map of at least a portion of the cavity is generated, that includes the ablation locations located on a surface of the updated volume map. The map is displayed to a user. 
     In some embodiments, receiving or generating the ablation locations inside the cavity includes, during an ablation procedure, receiving positions of an ablation catheter, and obtaining an average position of the ablation catheter by averaging the catheter positions received over a given time duration of the ablation procedure. 
     In some embodiments, removing the portion of the mapped locations for each average position includes (a) projecting the average position to the surface, to find a closest location on the surface to the average position, (b) defining a body of revolution about an axis defined by a line connecting the average position and its closest location on the surface, and (c) removing the portion that falls inside the body of revolution so that the average position falls on a surface of the volume map. 
     In an embodiment, the body of revolution is one of a cone and an ellipsoid. 
     In another embodiment, removing the portion includes causing the average position of the catheter to fall on a surface of the volume map by generating a differentiable surface at the average position. 
     In yet another embodiment, receiving or generating the ablation locations includes tracking the ablation catheter with a position tracking system. 
     In some embodiments, displaying the map to the user includes presenting an icon at each average position. 
     In some embodiments, generating the map includes generating an electroanatomical (EA) map. 
     There is additionally yet provided, in accordance with another embodiment of the present invention, a system including a memory and a processor. The memory is configured to store (i) a volume map of at least a portion of a cavity of an organ of a body including a plurality of mapped locations, and (ii) ablation locations inside the cavity. The processor is configured to (a) update the volume map by removing a portion of the mapped locations, so that the ablation locations inside the cavity fall on a surface of the volume map, (b) using the updated volume map, generate a map of at least a portion of the cavity, including the ablation locations located on a surface of the updated volume map, and (c) display the map to a user. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which: 
         FIG. 1  is a schematic, pictorial illustration of a system for electroanatomical (EA) mapping and ablation, in accordance with an embodiment of the present invention; 
         FIG. 2  is a volume-rendered semi-transparent EA map of a left atrium showing locations marked for ablation and respective projected locations on a surface of the EA map, in accordance with an embodiment of the present invention; 
         FIG. 3  is a flow chart that schematically illustrates a method for exposing locations of a cardiac cavity marked for ablation, in accordance with an embodiment of the present invention; 
         FIGS. 4A and 4B  are volume-rendered non-transparent maps of a cardiac cavity showing respectively a surface that hides icons of locations for ablation, and the mesh reshaped surface with the icons exposed at locations marked for ablation, in accordance with embodiments of the present invention; 
         FIGS. 5A and 5B  are schematic drawings that show a removal of a volume of an EA map to have an average position of an ablation catheter falling on an adjusted surface of the EA map, in accordance with an embodiment of the present invention; and 
         FIG. 6  is a flow chart that schematically illustrates a method for exposing locations of a cardiac cavity during ablation, in accordance with an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Overview 
     A cavity of an organ of a patient, such as a cardiac cavity, also called hereinafter cardiac chamber, can be mapped (e.g., electroanatomically mapped) using a mapping catheter having one or more suitable sensors, such as electrodes, fitted at its distal end for mapping within the organ. Using location signals generated by the various sensors, a processor may calculate the sensor locations within the organ (e.g., the locations of sensing electrodes inside the cardiac cavity). Using the calculated locations, the processor may further derive an anatomical map of the cavity surface. In case of a cardiac cavity (e.g., cardiac chamber), the processor may derive an electroanatomical (EA) map of the cavity surface. In some embodiments, such an EA map also graphically indicates arrhythmogenic locations over the cavity wall tissue that should be ablated for treatment of arrhythmia. 
     Typically, therefore, before a cardiac ablation procedure, the cardiac chamber is mapped, to (i) obtain a volume representation of the cardiac chamber anatomy, and (ii) acquire a point cloud of locations in the cardiac chamber to be marked for ablation. At least some of the locations marked for ablation are typically located along a curve. For example, in a fast anatomical mapping (FAM) of a cardiac chamber, point locations for ablation on an inner surface of the cavity are drawn using acquired EA data. Subsequently, a physician may ablate the locations along the curve to block an aberrant electrophysiological signal, as in the case of isolating a pulmonary vein ostium in a left atrium. 
     However, erroneous catheter locations may also be acquired and automatically added to a FAM-constructed cavity surface during FAM reconstruction. Examples of such undesired data points include cavity wall locations distorted by being pushed outward by the catheter, as well as incorrect wall locations due to respiration-induced movement. 
     The accumulation of such undesired locations affects the accuracy of the reconstructed EA map. To address these inaccuracies, during or after acquisition, a physician, or a specialist helping the physician, may manually edit the surface that is generated from the acquired points to correct for the errors. This manual editing typically involves erasing locations and/or removing (“shaving”) entire portions from the computed surface. However, this manual editing is a time-consuming process. 
     Moreover, in some cases erroneous catheter locations may obstruct or hide markings that point to wall tissue locations selected for treatment, such as cardiac wall tissue locations selected for ablation. Typically, while locations for ablation are marked (e.g., overlaid) on the map as icons (e.g., “visitags”), some of the icons may become invisible because they appear inside the chamber, rather than on its outer surface, due to the above, or other, mapping errors. 
     Embodiments of the present invention use an underlying assumption that the mapped locations marked for treatment (e.g., ablation) are correct, and that any obstruction of such marks by other locations on the cavity wall is due to erroneous mapping of the wall tissue. Such mapping errors cause locations marked for treatment to erroneously appear inside the chamber. This results in icons (e.g., visitag icons) pointing at these locations being hidden in a typical, non-transparent view of the map of the cavity of the organ. 
     To overcome such errors, a processor corrects the mapping of the cavity so that the locations marked for treatment fall on the cavity wall. In an embodiment, the processor receives or generates an EA map of at least a portion of a volume of a cardiac cavity, and a point cloud of locations marked for treatment (e.g., ablation). The processor identifies that one or more of the locations marked for treatment fall in an interior of the volume, and in response updates the volume by removing a portion of the mapped locations, so that the locations marked for treatment fall on a surface of the volume of the chamber map. Using the updated EA mapping data, the processor generates a map of at least a portion of the cavity, comprising the locations marked for treatment, and displays the map to user. 
     In another embodiment, to remove a portion of the mapped locations, the processor projects the locations marked for treatment onto a modeled surface of the cavity. The processor then joins the locations marked for treatment by a first spline, and joins the projected locations by a second spline. A “ball rolling” algorithm is then used: A “ball,” having a variable radius found by connecting respective locations marked for treatment and projected locations, is “rolled” along the two splines, and anatomical locations in the chamber volume and surface are removed from the cloud. The chamber surface is then reconstructed using the updated data set to reveal the original locations marked for treatment (e.g., to make their icons visible in an external view of the model). In general, a shape other than ball can be used, such as of an ellipsoid having a variable width and diameter. 
     In an additional embodiment, the processor starts exposing positions for ablation (an action referred to as “shaving” the EA map) immediately when ablation starts. One purpose of this shaving is to have the ablation sites always correspond to locations on the surface of the EA map (rather than erroneously falling inside a blood volume of the EA map due to mapping errors). 
     This embodiment has two essential differences with regard to the above:
         1—There is no need to wait for the visitag icons to be created.   2—The shaving process can affect the ablation positions, as the map is changing during ablation.       

     In this embodiment, the processor receives (or generates) an EA map of at least a portion of a volume of a cardiac chamber, and further receives ablation catheter positions during ablation. While performing the ablation, the processor averages the ablation catheter positions over a recent pre-defined time duration (over 5 seconds, for example). Several criteria, such as electrode-tissue touch quality and catheter stability, can be taken into account as filters for deciding on averaging positions within the time duration. 
     The processor then calculates a location (e.g., point) on the surface that is closest to the average ablation catheter position found above. The processor defines a cone or an ellipsoid that starts (i.e., has its head) at the average catheter position and has its axis along the line that connects the average catheter position and its projection to the map surface (the closest point found above). The cone/ellipsoid has a predefined opening angle. 
     Finally, the processor removes the EA map volume falling inside the cone/ellipsoid built above, and corrects the EA map surface accordingly, to have an average position of an ablation catheter falling on the adjusted surface of the EA map. 
     By exposing hidden landmarks (e.g., icons) of locations marked for treatment, the disclosed technique may assist the physician to improve the quality of complicated diagnostic tasks performed during diagnostic catheterizations, such as marking (e.g., by visitag icons) tissue locations mapped for ablation. Another advantage of the disclosed technique is reducing the editing time of portions of the EA map, e.g., when done manually for this purpose. 
     System Description 
       FIG. 1  is a schematic, pictorial illustration of a system  21  for electroanatomical (EA) mapping and ablation, in accordance with an embodiment of the present invention.  FIG. 1  depicts a physician  27  using a Pentaray® EA mapping catheter  29  to perform an EA mapping of a heart  23  of a patient  25  and/or an electrical ablation. Catheter  29  comprises, at its distal end, one or more arms  20 , which may be mechanically flexible, each of which is coupled with one or more electrodes  22 . During the mapping procedure, electrodes  22  acquire and/or inject unipolar and/or bipolar signals from and/or to the tissue of heart  23 . To perform ablation, electrodes  22  are connected (e.g., switched) to an ablation waveform generator (not shown) in a console  30 . 
     During mapping, a processor  28  in console  30  receives diagnostic signals via an electrical interface  35 , and uses information contained in these signals to construct an EA map  40  that processor  28  stores in a memory  33 . During and/or following the procedure, processor  28  may display EA map  40  on a display  26 . User controls  32  of a user interface  100  enable physician  27  to communicate with processor  28  and command editing and/or highlighting portions of EA map  40 . Controls  32  may include, for example, a trackball and control knobs, as well as a keyboard. Other elements of user interface  100  may include touch screen functionality of display  26 . 
     During the procedure, a tracking system is used to track the respective locations of sensing electrodes  22 , such that each of the signals may be associated with the location at which the signal was acquired. For example, the Active Catheter Location (ACL) system, made by Biosense-Webster (Irvine Calif.), which is described in U.S. Pat. No. 8,456,182, whose disclosure is incorporated herein by reference, may be used. In the ACL system, a processor estimates the respective locations of the electrodes based on impedances measured between each of the sensing electrodes  22 , and a plurality of surface electrodes  24 , that are coupled to the skin of patient  25 . For example, three surface electrodes  24  may be coupled to the patient&#39;s chest, and another three surface electrodes may be coupled to the patient&#39;s back. (For ease of illustration, only one surface electrode is shown in  FIG. 1 .) Electric currents are passed between electrodes  22  inside heart  23  of the patient and surface electrodes  24 . Processor  28  calculates an estimated location of all electrodes  22  within the patient&#39;s heart based on the ratios between the resulting current amplitudes measured at surface electrodes  24  (or between the impedances implied by these amplitudes) and the known locations of electrodes  24  on the patient&#39;s body. The processor may thus associate any given impedance signal received from electrodes  22  with the location at which the signal was acquired. 
     The example illustration shown in  FIG. 1  is chosen purely for the sake of conceptual clarity. Other tracking methods can be used, such as those based on measuring voltage signals. Other types of sensing catheters, such as the Lasso® Catheter (produced by Biosense Webster) or a basket catheter may equivalently be employed. Contact sensors may be fitted at the distal end of EA mapping catheter  29 . As noted above, other types of electrodes, such as those used for ablation, may be utilized in a similar way and fitted to electrodes  22  for acquiring the needed location data. Thus, an ablation electrode used for collecting location data is regarded, in this case, as a sensing electrode. In an optional embodiment, processor  28  is further configured to indicate the quality of physical contact between each of the electrodes  22  and an inner surface of the cardiac chamber during measurement. 
     Other catheter types may be used for ablation and EA mapping, such as a balloon catheter and a basket catheter. 
     Processor  28  typically comprises a general-purpose computer with software programmed to carry out the functions described herein. In particular, processor  28  runs a dedicated algorithm as disclosed herein, including in  FIG. 3 , that enables processor  28  to perform the disclosed steps, as further described below. The software may be downloaded to the computer in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory. 
     Automatic Mesh Reshaping of an Anatomical Map for Internal Points of Interest 
       FIG. 2  is a volume-rendered semi-transparent EA map  200  of a left atrium showing locations marked for ablation ( 202 ) and respective projected locations  204  on a surface of the EA map, in accordance with an embodiment of the present invention. 
       FIG. 2  shows a map for clarity and simplicity of presentation only. The disclosed process does not necessarily require generating such an initial map. Rather, acquisition data comprising locations is received in a processor, and the processor applies the disclosed steps to the mapped volume. 
     As seen, mapped locations marked for ablation  202  are each along a circumference of an ostium  222  of a pulmonary vein. The mapped location may define a contour (not shown) along which a subsequent ablation is performed to isolate an arrhythmia. 
     As noted above, errors in map  200  may cause icons of locations  202  to be hidden in a non-transparent view. 
     In one embodiment of the disclosed technique, the processor identifies only locations  202  marked for treatment that fall in an interior of the mapped volume by determining if a vector between each location  202  marked for treatment and its respective projected surface location  204  is opposing an outward-pointing normal to the surface of the cavity at the projected location. Subsequently, the processor projects locations  202  to surface locations  204 , in order to subsequently generate a map in which icons of locations  202  are visible, as described below. 
     In another embodiment, the processor projects all points marked for treatment, without attempting to identify which of the locations is internal. If a point is already on the surface, then the rolled ball diameter, or local volume to remove, will be zero or negligible. 
     While the shown cavity is of a left atrium, the description holds for cavities of other organs and for different treatments than ablation. 
       FIG. 3  is a flow chart that schematically illustrates a method for exposing locations of a cardiac cavity marked for ablation, in accordance with an embodiment of the present invention. The algorithm, according to the presented embodiment, carries out a process that begins with processor  28  receiving an EA map of at least a portion of a volume of a cardiac chamber, and a point cloud of locations marked for ablation, at a data receiving step  302 . At this stage some of the location marked for ablation may comprise hidden icons. 
     Next, processor  28  projects the locations marked for ablation to respective locations on a surface of the chamber map volume, at a data projection step  304 . 
     At a data connection step  306 , processor  28  joins locations marked for ablation by a first spline, and joins the respective projected locations found in step  304  by a second spline. 
     Next, at a point cloud updating step  308 , processor  28  generates an updated volume by automatically removing portions of the volume that comprise a surface connecting the locations marked for ablation with the projected locations. For example, the processor “rolls” a ball having a variable diameter (or “rolls” the aforementioned ellipsoid) along the two splines and removes from the chamber map volume the intersection between the chamber volume and the rolled ball, or ellipsoid. 
     At an EA map generation step  310 , using the updated mapped data, or chamber volume map, processor  28  generates an EA map, such as map  440  below, of the portion of the cardiac cavity comprising visible icons that mark ablation locations. 
     Finally, at a map displaying step  312 , processor  28  presents the EA map to a user. 
     The example flow chart shown in  FIG. 3  is chosen purely for the sake of conceptual clarity. For example, in alternative embodiments, the cavity is of an organ other than a heart. 
     Reshaped Mesh of an Anatomical Map 
       FIGS. 4A and 4B  are volume-rendered non-transparent EA maps  400  and  440  of a cardiac cavity showing, respectively, a surface  405  that hides ( 402 ) icons of locations for ablation, and the mesh reshaped surface with the icons ( 404 ) exposed at locations marked for ablation, in accordance with embodiments of the present invention. 
     As seen in  FIG. 4A , almost all the icons marking locations  402  for ablation on two ostia of a pulmonary vein of a left atrium are hidden under surface  405 . In  FIG. 4B , on the other hand, the regenerated surface  410  exposes respective locations, as shown by icons  404 . 
     A physician may use map  440  to perform the required ablation. 
     Shaving of an Anatomical Map During Ablation 
       FIGS. 5A and 5B  are schematic drawings that show a removal of a volume ( 512 ,  522 ) of an EA map to have an average position ( 504 ,  514 ) of an ablation catheter falling on an adjusted surface ( 520 ,  530 ) of the EA map, in accordance with an embodiment of the present invention. 
       FIG. 5A  shows an EA map of portion of a volume of a cardiac chamber, with the interior and exterior of the chamber volume marked on, being separated by a surface  502  of the volume mapped. Further shown is an average position  504  of the ablation catheter during a very recent last pre-defined time range during which the catheter was applying ablation. As seen, the average position  504  falls inside the volume, rather than on the surface of the map. Such error occurs, for example, when, during mapping, the mapping catheter is pushed to strong against cavity wall, and the mapped location therein doesn&#39;t represent there a nominal shape of the cardiac chamber. This case is better seen in  FIG. 5B , where the surface of the EP map has a bulge at a surface location  516 . 
     Also shown in  FIG. 5A , is a closest point  506  on the surface of the volume to the average ablation catheter position  504 . The processor defines a body of revolution (e.g., a cone  510 ) with its axis  508  goes along the line that connects the average catheter position  504  and its projection to the map surface (the closest point  506  found above). The cone has a predefined opening angle. To expose position  504 , all the EA map volume  512  defined inside the cone built above is removed. The EA map has an adjusted surface  520 , where the average position  504  of an ablation catheter falls on adjusted surface  520  of the EA map. 
       FIG. 5B  shows another case of an average position  514  of the ablation catheter while applying ablation. As noted above, also the average position  514  falls inside the volume. A closest point  516  on the surface of the volume defines with position  514  an axis  518  of a body of revolution (e.g., a cone  511 ) To expose position  514 , all the EA map volume  522  defined inside the cone built above is removed. The EA map of  FIG. 5B  has an adjusted surface  530 , where the average position  514  of an ablation catheter falls on adjusted surface  530  of the EA map. 
       FIGS. 5A and 5B  were brought by way of example. Other types of bodies of revolution may be used, such as made by an exponential curve, power law curves, etc. or combination of, to, for example, have the processor generating a smooth adjusted surface (e.g., a differentiable surface at the average position). 
       FIG. 6  is a flow chart that schematically illustrates a method for exposing locations of a cardiac cavity during ablation, in accordance with an embodiment of the present invention. The processor starts the exposing (e.g., shaving) immediately when ablation starts, and there is no need to wait for the visitag icons to be created. Moreover, the shaving process can affect the ablation positions, as the map is changing during ablation. 
     The algorithm, according to the presented example, carries out a process that begins with processor  28  receiving an EA map of at least a portion of a volume of a cardiac chamber, and ablation catheter positions during an ablation, at a data receiving step  602 . 
     While performing ablation, the processor averages the ablation catheter positions during a last pre-defined time range (over 5 seconds, for example), at a catheter position averaging step  604 . 
     Next, the processor then calculates the closest location on the surface to the average ablation catheter position found above, at finding a closest surface position step  606   
     The processor defines next a body of revolution (e.g., a cone or an ellipsoid), as defined in  FIGS. 5A and 5B  above, at a body of revolution defining step  608 . 
     Next, the processor removes all the EA map volume defined inside the cone/ellipsoid built above, at an EA volume removal step  610 . 
     At an EA map correction step  612 , the processor corrects the EA map surface so that the average position of the catheter falls on a surface of the EA map. 
     Finally, at a map displaying step  614 , processor  28  presents the adjusted EA map to a user. 
     The flowchart of  FIG. 6  is brought by way of example and in brief for clarity. Additional steps may be including, such removing catheter positions that were deemed unstable or with bad contact with tissue. The average position may be tagged with an icon as an ablated position on the cavity wall. 
     It will 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.