Patent Application
20200345304
The present invention relates generally to graphic displays, and specifically to displays related to the temperature and force measured by a catheter.
PCT/US2012/059131 patent application to Ghaffari et al., whose disclosure is incorporated herein by reference, describes an apparatus for medical diagnosis. The disclosure provides a series of screen shots of an example graphical user interface demonstrating a variety of conditions simulated with the apparatus.
U.S. Patent Application 2003/0153905 to Edwards, et al. whose disclosure is incorporated herein by reference, describes systems for ablation of hollow organs. The disclosure describes a temperature map in which the temperature data may be used to monitor and control ablation.
U.S. Patent Application 2006/0253116 to Avitall, et al. whose disclosure is incorporated herein by reference, describes catheters, systems, and methods for performing medical procedures such as tissue ablation. The disclosure describes a graphical representation of an internal anatomical structure, which may be displayed in a display window of a monitor.
U.S. Patent Application 2007/0293792 to Sliwa, et al. whose disclosure is incorporated herein by reference, describes prostate probe systems comprising either a force or pressure sensor mounted on or in a rectally insertable probe or a temperature sensor mounted on or in a rectally insertable probe, or both. The disclosure describes a thermographic or temperature mapping capability.
U.S. Patent Application 2012/0226130 to De Graff, et al. whose disclosure is incorporated herein by reference, describes systems that integrate stretchable or flexible circuitry, including arrays of active devices for enhanced sensing, diagnostic, and therapeutic capabilities.
The disclosure describes a graphical presentation and mapping functionality.
U.S. Patent Application 2012/0232388 to Curra, et al. whose disclosure is incorporated herein by reference, describes ultrasound systems and methods for real-time noninvasive spatial temperature estimation. The disclosure claims that strain and spectral information can be compounded and correlated with both strain-based and spectral-based temperature calibration maps.
U.S. Patent Application 2013/0079650 to Turgeman, et al. whose disclosure is incorporated herein by reference, describes a graphic user interface for physical parameter mapping. The disclosure describes receiving a selection from a user of a value in a parameter sub-range and displaying a candidate location for further measurement.
Endosense, of Geneva, Switzerland, produce a “Tactisys Quartz” system. The system is claimed to allow visualization of contact force between a catheter tip of the system and a heart wall.
U.S. Pat. No. 9,980,652 to Govari, et al. whose disclosure is incorporated herein by reference, describes a method for displaying information, including receiving measurements, with respect to an invasive probe inside a body of a subject, of probe parameters consisting of a force exerted by the probe on tissue of the subject and temperatures measured by sensors of the probe. The method further includes, responsively to the measurements, displaying in a single map on a display screen a graphical representation of a distribution of the temperatures in a vicinity of the probe and superimposing thereon a vector representation of the force.
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.
An embodiment of the present invention provides a method for displaying information, including:
receiving measurements, with respect to an invasive probe inside a body of a subject, of probe parameters consisting of a force exerted by the probe on tissue of the subject and temperatures measured by sensors of the probe; and
responsively to the measurements, displaying in a single map on a display screen a graphical representation of a distribution of the temperatures in a vicinity of the probe and superimposing thereon a vector representation of the force,
wherein the single map includes a color map based on an auto-adjust color scale.
In some embodiments, the auto-adjust color scale includes a selected color that represents a maximum temperature equal to a maximum measured temperature increased by a predetermined number of degrees.
In some embodiments, the auto-adjust color scale includes a selected color that represents a minimum temperature equal to a measured tissue temperature before ablation.
Typically, the vector representation includes a first indication of a magnitude of the force and a second indication of a force-direction of the force.
In a disclosed embodiment the vector representation includes an arrow, the first indication includes a width of the arrow, and the second indication includes a combination of a length of the arrow and a direction of the arrow.
In a further disclosed embodiment the vector representation includes an arrow and a text box associated with the arrow, the first indication includes text within the text box, and the second indication includes a combination of a length of the arrow and a direction of the arrow.
In a yet further disclosed embodiment the vector representation includes a first circle having a first center, the graphical representation of the distribution includes a second circle having a second center, the first indication includes a diameter of the first circle, and the second indication consists of a combination of a distance between the first and second centers and a direction therebetween.
In an alternative embodiment the method includes calculating a center of the graphical representation, and displaying the center in the single map.
There is further provided, according to an embodiment of the present invention embodiment of the present invention, apparatus for displaying information, including: a probe, configured to be inserted into a body of a subject;
a force sensor attached to the probe, coupled to provide a force signal indicative of a force exerted by the probe on tissue of the subject;
temperature sensors attached to the probe, coupled to provide temperature signals of temperatures in a vicinity of the probe;
a display screen; and
a processor coupled to receive the force signal and the temperature signals, to display in a single map on the display screen a graphical representation of a distribution of the temperatures, and to superimpose thereon a vector representation of the force,
wherein the single map includes a color map based on an auto-adjust color scale.
In some embodiments, the processor is configured such that the auto-adjust color scale includes a selected color that represents a maximum temperature equal to a maximum measured temperature increased by a predetermined number of degrees.
In some embodiments, the processor is configured such that the auto-adjust color scale includes a selected color that represents a minimum temperature equal to a measured tissue temperature before ablation.
The present disclosure will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings, in which:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
These and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%. In addition, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
In the following description, like elements in the drawings are identified by like numerals, and the like elements are differentiated as necessary by appending a letter to the identifying numeral.
Apparatus 12 is controlled by a system processor 46, which is located in an operating console 48 of the apparatus. During the procedure, processor 46 typically tracks a location and an orientation of distal end 22 of the probe, using any method known in the art. For example, processor 46 may use a magnetic tracking method, wherein magnetic transmitters external to patient 18 generate signals in coils positioned in the distal end. The Carto® system produced by Biosense Webster, of Diamond Bar, Calif., uses such a tracking method.
The software for processor 46 may be downloaded to the processor in electronic form, over a network, for example. Alternatively or additionally, the software may be provided on non-transitory tangible media, such as optical, magnetic, or electronic storage media. The track of distal end 22 is typically displayed on a three-dimensional representation 60 of the heart of patient 18 on a screen 62.
In order to operate apparatus 12, processor 46 communicates with a memory 50, which has a number of modules used by the processor to operate the apparatus. Thus, memory 50 comprises a temperature module 52, an ablation module 54, and a force module 56, the functions of which are described below. Memory 50 typically comprises other modules, such as a tracking module for operating the tracking method used by processor 46, and an irrigation module allowing the processor to control irrigation provided for distal end 22. For simplicity, such other modules, which may comprise hardware as well as software elements, are not illustrated in
Processor 46 uses results of measurements of temperature and force, acquired by modules 52 and 56, to display on screen 62 a combined force-temperature map 64. Embodiments of force-temperature map 64 are described in more detail below.
An electrical conductor 74 conveys radio-frequency (RF) electrical energy from ablation module 54 (
Temperature sensors 78 are mounted within conductive cap electrode 24A at locations that are arrayed around the distal tip of the probe, both axially and circumferentially. In this example, cap 24A contains six sensors, with one group in a distal location, close to the tip, and the other group in a slightly more proximal location. This distribution is shown only by way of example, however, and greater or smaller numbers of sensors may be mounted in any suitable locations within the cap. Sensors 78 may comprise thermocouples, thermistors, or any other suitable type of miniature temperature sensor. These sensors are connected by leads running through the length of insertion tube 70 to provide temperature signals to temperature module 52.
In a disclosed embodiment cap 24A comprises a side wall 73 that is relatively thick, on the order of 0.5 mm thick, in order to provide the desired thermal insulation between temperature sensors 78 and the cooling fluid inside a central cavity 75 of the tip. The cooling fluid exits cavity 75 through apertures 72. Sensors 78 are mounted on rods 77, which are fitted into longitudinal bores 79 in side wall 73. Rods 77 may comprise a suitable plastic material, such as polyimide, and may be held in place at their distal ends by a suitable glue 81, such as epoxy. U.S. patent application Ser. No. 13/716,578, which is incorporated herein by reference, describes a catheter having temperature sensors mounted in a similar configuration to that described above. The arrangement described above provides an array of six sensors 78, but other arrangements, and other numbers of sensors, will be apparent to those having ordinary skill in the art, and all such arrangements and numbers are included within the scope of the present invention. Another arrangement of sensors 78 is described in U.S. patent application Ser. No. 13/716,578, referenced above.
In addition to the temperature sensors, distal end 22 comprises a force sensor 90, which is configured to measure the force exerted by the distal end on tissue contacted by the distal end. Force sensor 90 generates signals in response to the measured force, and the signals are transferred to force module 56, which operates the sensor and which calculates a value for the magnitude, as well as a value for the direction, of the force exerted. The direction of the force exerted is measured with respect to an axis 92, typically the axis of symmetry, of distal end 22.
In the description herein, distal end 22 is assumed to define a set of xyz orthogonal axes, where axis 92 corresponds to the z axis of the set, and orthogonal x and y axes are in any convenient xy plane orthogonal to the z axis. For simplicity, the xy plane is herein assumed to correspond to the plane defined by circle 86, the origin of the xyz axes is assumed to be the center of the circle.
Force sensor 90 may comprise any convenient sensor of force or pressure known in the art. By way of example, herein force sensor 90 is assumed to operate by measuring the deflection, parallel to z axis 92 and orthogonal to the axis, i.e., in an xy plane, of a cylindrically shaped spring 94. The deflection of spring 94 may be measured by transmitting an alternating magnetic field from a magnetic transmitter 96 located in proximity to the distal end of the spring, and measuring the received magnetic field in magnetic receivers 98 located at the proximal end of the spring. Typically transmitter 96 and receivers 98 are coils, transmitter 96 being located on axis 92, and receivers 98 being distributed symmetrically around the axis. In force sensor 90 there are three receivers 98 (two are shown in the figure). Operating signals between force module 90 and the transmitter and the receivers are transferred by conductors 100, and enable the force module to generate a unique value for the magnitude of a given force, as well as a unique value for the direction of the force with respect to the xyz axes of distal end 22. Force sensors similar to force sensor 90 are described in U.S. Patent Applications 2009/0306650 to Govari et al., 2011/0130648 to Beeckler et al., and 2012/0253167 to Bonyak et al., all of which are incorporated herein by reference.
Typically, distal end 22 contains other functional components, which are outside the scope of the present disclosure and are therefore omitted for the sake of simplicity. For example, the distal end of the probe may contain steering wires, as well as sensors of other types, such as a position sensor. Probes containing components of these kinds are described, for example, in U.S. Patent Applications 2009/0306650 and 2011/0130648, referenced above.
As stated above, 2D map 100 is a 2D projection of a 3D distribution of temperatures. One type of projection that may be used, based on angles subtended by a line through the origin of the xyz axes to the z-axis (
2D map 100 is typically a color map showing the different temperatures of the external surface of electrode 24A, and a legend 104 may be displayed with the map showing values of the temperatures for the different colors. (In the figures different colors are schematically illustrated by different shadings.) In some embodiments the numerical values measured by each of sensors 78 may also be displayed on map 100. For simplicity, the display of such numerical values is not illustrated in
In the color map of
The legend 205 may represent a fixed color scale implemented by the processor 46 and the temperature module 52 where selected colors are fixedly assigned to selected temperatures or range of temperatures between a minimum temperature and a maximum temperature, as shown, for example, in Table I below. When the three distal thermocouples TCD measure a first common temperature or common temperature range (used interchangeably herein), a center 214 of the color map 200 reveals a color representative of the first measured temperature according to the fixed color scale. When the three proximal thermocouples TCP measure a second common temperature, a periphery 203 circumscribed by bounding circle 202 reveals a color representative of the second common temperature according to the fixed color scale. In between the center 214 and the periphery 203, the processor 46 may use interpolation and extrapolation from the first and second temperature measurements according to the fixed color scale to complete the color map 200, in forming a generally continuous temperature gradient that is azimuthally symmetrical about the center 214, in creating a, for example, a “bullseye,” in
However, because tissue temperature response to ablation can be proportional to tissue thickness, where thinner tissue exhibits lesser temperature response or sensitivity and thicker tissue exhibits greater temperature response or sensitivity, a fixed color scale may not provide a sufficient temperature range to accommodate the different thicknesses of tissue being ablated. When a majority, if not all, of the measured temperatures falls outside of the minimum and maximum temperatures of the fixed color scale, the color map becomes “saturated,” where the color map shows no or very little discernible color differentiation, such as shown in
In the sample auto-adjusted color scale above, because the color red is to consistently designate a temperature 5 degrees higher than the maximum measured temperature, the color map never shows red, and the “warmest” color(s) representing the highest measured temperatures are only dark orange or light orange, with lower measured temperatures being represented by the remaining colors, so as to avoid saturation, as shown in
In some embodiments, the minimum of the auto-adjust color scale is consistently equal to the initial tissue temperature prior to ablation, as shown in Table II. Such setting of a static minimum temperature and a dynamic maximum temperature for the auto-adjust color scale avoids saturation of the bullseye color map which assists the physician during ablation by improving temperature response and providing high definition EGMs. According to the setting of the target temperature and the maximum temperature achieved would translate into the different colors on the bullseye color map. It is understood that Tables I and II above are merely non-limiting embodiments.
Moreover, in some embodiments, it is understood that a dynamic temperature range for an auto-adjust color scale that is responsive to the maximum measured tissue temperature being measured throughout the ablation procedure allows the bullseye color map to continually display one or more selected colors, including, e.g., red as representing heating so that the physician can always see where the ablation tip electrode is heating, by how much and the amount of tip electrode that is being heated at the maximum temperature. Furthermore, in some embodiments, dynamic temperature range may be deactivated if a particular force, as measured by the force module 56 (
Representation 108 comprises a variable length arrow 120 representing the direction of the force exerted by distal end 22, which has been drawn on map 110. Arrow 120 has a start point corresponding with the center of circle 112, and an end point corresponding to the angle subtended by the distal end force to the z-axis, so that a length of the arrow is a function of the angle of the force measured with respect to the z-axis. Thus in
In order to represent the magnitude of the force in representation 108, in a disclosed embodiment a width of arrow 120 is varied according to the magnitude. By varying the width of the arrow, representation 108 is a complete vector representation of the magnitude and the direction of the force exerted by distal end 22.
In the presentation of single map 64 on screen 62, an operator of the system may choose to display all, some, or none of the xyz axes and the angular circles. By way of example, in the examples illustrated herein, angular circles, but not the xyz axes, are displayed.
Single maps 64A and 64B have the same temperature distribution, and the force is in the same direction (approximately 40.degree. to the z-axis and −70.degree. to the x-axis). However, the magnitudes of the force in the two maps is different, the difference being presented on screen 62 as different widths of an arrow 120A in map 64A and an arrow 120B in map 64B. Usually a width of the arrow representing the force is configured to be proportional to, and typically directly proportional to, a magnitude of the force.
Rather than using an arrow to represent the force exerted by distal end 22, representation 128 uses a circle 130. A center 132 of the circle, measured with respect to center 114 and the xy axes, represents the direction of the force exerted by the distal end.
In order to represent the magnitude of the force in representation 128, in a disclosed embodiment a diameter of circle 130 is varied according to the magnitude. By varying the diameter of the circle, representation 128 is a complete vector representation of the magnitude and the direction of the force exerted by distal end 22.
Single maps 64C and 64D have the same temperature distribution, and the force is in the same direction (approximately 40.degree. to the z-axis and −70.degree. to the x-axis), as is indicated by the same positions of centers 132A and 132B in their respective circles. However, the magnitudes of the force in the two maps is different, the difference being presented on screen 62 as different diameters of a circle 130A in map 64C and a circle 130B in map 64D. Usually a diameter of the circle representing the force is configured to be proportional to, and typically directly proportional to, a magnitude of the force.
Rather than using a variable length arrow having a variable width (as described above for representation 108) to represent the force exerted by distal end 22, representation 138 uses a variable length arrow 140 with a constant width. Except that it is invariant with regard to width, arrow 140 is generally similar to arrow 120 (
In order to represent the magnitude of the force in representation 138, in a disclosed embodiment a text box 142 is “attached” to arrow 140 and a value corresponding to the force magnitude is entered into the text box. By way of example, text box 142 is attached to the head of arrow 140, but in other embodiments text box 142 may be in any convenient position with respect to the arrow. Text within the text box gives a magnitude of the force, so that representation 138 is a complete vector representation of the force on distal end 22.
Single maps 64E and 64F have the same temperature distribution, and the force is in the same direction (approximately 40.degree. to the z-axis and −70.degree. to the x-axis), as is indicated by the same directions and lengths of arrows 140A and 140B. However, the magnitudes of the force in the two maps are different, the difference being presented on screen 62 as a text box 142A in map 64E and as a text box 142B in map 64F. Thus, for example, the force in map 64E is 2 g, and the force in map 64F is 3 g.
By presenting the force (in magnitude and direction) together with the temperature distribution in a single map, embodiments of the present invention facilitate the ablation process performed by a physician, by enabling the physician to see the relative alignment between the force and the temperature distribution. For example, during the ablation process, the physician may desire that the force is directed to the hottest part of the temperature distribution, so that the force “aligns” with the temperature. This is typically the desired state during ablation of a single region. Alternatively, the physician may desire that the force is directed in a particular direction away from the hottest part of the temperature distribution. This is typically the desired state during ablation along a line. Embodiments of the present invention facilitate these types of alignment by allowing the physician to mark a “center” of the temperature, which enables the physician to compare the direction of the force, and the “direction” of the temperature distribution.
A center of the temperature distribution is calculated by any means known in the art. For example, the center may correspond to a weighted center of gravity of regions of the distribution, where the weights are according to the temperatures of each of the regions. In map 64L a temperature distribution center 150 is indicated by an X on the map; in map 64M a temperature distribution center 152 is indicated by cross-hairs on the map. In map 64L the force direction is shown as aligning with temperature distribution center 150, in a “bullseye” type of display, which may be the desired situation for ablation of a single region. In contrast, in map 64M the force does not align with temperature distribution center 152, and this may be the desired situation for ablation along a line.
The preceding description has been presented with reference to certain exemplary embodiments of the invention. Workers skilled in the art and technology to which this invention pertains will appreciate that alterations and changes to the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this invention, and that the drawings are not necessarily to scale. Moreover, it is understood that any one feature of an embodiment may be used in lieu of or in addition to feature(s) of other embodiments. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the accompanying drawings. Rather, it should be read as consistent with and as support for the following claims which are to have their fullest and fairest scope.
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/843,223 filed May 3, 2019, the entire content of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62843223 | May 2019 | US |
