FIELD OF THE INVENTIONThe present invention relates generally to invasive probes, and specifically to estimating tissue thickness based on location and contact force measurements received from an invasive probe.
BACKGROUND OF THE INVENTIONA wide range of medical procedures involve placing objects, such as sensors, tubes, catheters, dispensing devices and implants, within a patient's body. Position sensing systems have been developed for tracking such objects. Magnetic position sensing is one of the methods known in the art. In magnetic position sensing, magnetic field generators are typically placed at known positions external to the patient. A magnetic field sensor within the distal end of a probe generates electrical signals in response to these magnetic fields, which are processed in order to determine the position coordinates of the distal end of the probe. These methods and systems are described 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 1996/005768, and in U.S. Patent Application Publications 2002/0065455 A1, 2003/0120150 A1 and 2004/0068178 A1, whose disclosures are all incorporated herein by reference.
When placing a probe within the body, it may be desirable to have the distal tip of the probe in direct contact with body tissue. The contact can be verified, for example, by measuring the contact pressure between the distal tip and the body tissue. U.S. Patent Application Publications 2007/0100332, 2009/0093806 and 2009/0138007, whose disclosures are incorporated herein by reference, describe methods of sensing contact pressure between the distal tip of a catheter and tissue in a body cavity using a force sensor embedded in the catheter.
Some probes include both a force sensor and a position sensor. U.S. patent application Ser. No. 13/152,423, whose disclosure is also incorporated herein by reference, describes a method for detecting tenting in tissue (due to a force exerted by the distal tip of the probe on the tissue) using location and force measurements received from a probe that includes a position sensor and a force sensor.
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.
SUMMARY OF THE INVENTIONAn embodiment of the present invention provides a method, including:
pressing a distal end of a medical probe against a wall of a body cavity;
receiving from the probe first measurements of a force exerted by the distal end on the wall;
receiving from the probe second measurements indicating a displacement of the wall in response to the force; and estimating a thickness of the wall based on the first and
the second measurements.
Typically the probe includes a catheter.
In a disclosed embodiment the method includes, prior to pressing the distal end of the probe against the wall, initializing one or more calibration matrices, each of the calibration matrices associated with a type of tissue. Typically, the type of tissue is selected from a list comprising artery tissue and endocardial tissue.
Initializing a given calibration matrix may include storing a force value, a displacement value, and an associated thickness value to each element of the calibration matrix.
In a further disclosed embodiment estimating the thickness of the wall includes identifying, in a given calibration matrix, a given element of the calibration matrix having a given force value corresponding to the first measurements and a given displacement value corresponding to the second measurements, and retrieving the thickness value from the identified matrix element.
Estimating the thickness of the wall may include interpolating between the thickness values stored in two calibration matrix elements. In one embodiment the method includes, subsequent to initializing the one or more calibration matrices and prior to estimating the thickness of the wall, selecting a given calibration matrix associated with the type of tissue corresponding to the wall of the body cavity. In another embodiment, the method includes, prior to selecting the given calibration matrix, identifying the type of tissue based on a location of the distal end.
In an alternative embodiment receiving the second measurements indicating the displacement includes receiving first position measurements from the probe indicating a first location of the probe upon the probe engaging the wall, receiving second position measurements indicating a second location of the probe upon the distal end exerting the force on the wall, and calculating a distance between the first and the second locations.
There is also provided, according to an embodiment of the present invention, medical apparatus, including:
a probe having a distal end configured for insertion into a body cavity having a wall, the probe including:
a force sensor in the distal end, configured to generate a first signal indicative of a force exerted by the distal end on the wall; and
a position sensor in the distal end, configured to generate a second signal indicative of a location of the distal end within the body cavity; and
a processor, which is coupled to receive and process the first and second signals from the probe so as to estimate a thickness of the wall.
There is also provided, according to an embodiment of the present invention, a computer software product, operated in conjunction with a probe that is configured for insertion into a body cavity of a patient and that includes a position sensor for measuring a position of a distal end of the probe inside the body cavity and a force sensor for measuring a force between the distal end and a wall of the body cavity, the product including a non-transitory computer-readable medium, in which program instructions are stored, which instructions, when read by a computer, cause the computer to receive from the probe, while pressing the distal end against the wall, first measurements of a force exerted by the distal end on the wall, to receive from the probe second measurements indicating a displacement of the wall in response to the force, and to estimate a thickness of the wall based on the first and the second measurements.
BRIEF DESCRIPTION OF THE DRAWINGSThe disclosure is herein described, by way of example only, with reference to the accompanying drawings, wherein:
FIG. 1 is a schematic pictorial illustration of a medical system that is configured to estimate tissue thickness, in accordance with an embodiment of the present invention;
FIG. 2 is a schematic side view showing details of the distal portion of a pressure-sensitive catheter, in accordance with an embodiment of the present invention;
FIG. 3 is a flow diagram that schematically illustrates a method of calibrating the catheter, in accordance with an embodiment of the present invention;
FIGS. 4A and 4B are schematic detail illustrations of tissue displacements due to a force exerted by the distal portion of the catheter on the tissue, in accordance with an embodiment of the present invention; and
FIG. 5 is a flow diagram that schematically illustrates a method of estimating tissue thickness based on location and force measurements received from the catheter, in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTSOverviewVarious diagnostic and therapeutic procedures, such as cardiac ablation and intracardiac electrical mapping, use an invasive probe, such as a catheter, whose distal tip is fitted with at least one electrode. The electrode is typically operated when the probe is pressed against a wall (also referred to herein as tissue) of a body cavity. In these procedures, it is usually important to ascertain both the precise location of the probe in the body cavity, and the force that the distal tip is exerting on the body cavity wall. Therefore, some catheters comprise position sensors for ascertaining the location of the distal tip and force sensors for measuring the force exerted by the probe on intra-body tissue, such as the endocardium.
During an ablation procedure, in embodiments of the present invention the thickness of the tissue being ablated is monitored. Applying (by the distal tip) too much force to thin tissue may cause perforation, and on the other hand, applying too little force to thicker tissue may be inefficient in isolating the tissue area electrically.
As an operator presses the distal tip of a probe against a body cavity wall, embodiments of the present invention provide methods and systems for estimating a thickness of the body cavity wall, based on location and force measurements received from sensors within the probe. The received force measurements indicate a force applied by the distal tip against the body cavity wall, and the position measurements indicate a displacement of the wall in response to the applied force. As explained in detail hereinbelow, the tissue thickness can be estimated by locating an entry in a calibration matrix with force and displacement values that correspond to the force and the displacement measurements received from the probe. Tissue thickness measurements incorporating embodiments of the present invention may be used by medical systems to replace or complement other known methods of tissue thickness measurement, such as magnetic resonance imaging (MRI) or computerized tomography (CT).
System DescriptionFIG. 1 is a schematic pictorial illustration of amedical system20 that is configured to estimate tissue thickness, in accordance with an embodiment of the present invention.System20 may be based, for example, on the CARTO™ system, produced by Biosense Webster Inc. (Diamond Bar, Calif.).System20 comprises aprobe22, such as a catheter, and acontrol console24. In the embodiment described hereinbelow, it is assumed thatprobe22 is used for diagnostic or therapeutic treatment, such as for mapping electrical potentials in aheart26 or performing ablation of heart tissue. Alternatively,probe22 may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs.
Anoperator28, such as a cardiologist, insertsprobe22 through the vascular system of apatient30 so that a distal end ofprobe22 enters a chamber ofheart26.Operator28advances probe22 so that adistal tip34 ofprobe22 engages endocardial tissue at a desired location or locations.Probe22 is typically connected by a suitable connector at its proximal end to console24.
Console24 typically uses magnetic position sensing to determine position coordinates ofdistal end32 insideheart26. To determine the position coordinates, adriver circuit36 inconsole24drives field generators38 to generate magnetic fields within the body ofpatient30. Typically,field generators38 comprise coils, which are placed below the patient's torso at known positions external topatient30. These coils generate magnetic fields in a predefined working volume that containsheart26. Amagnetic field sensor62 withindistal end32 of probe22 (sensor62 is shown in more detail inFIG. 2) generates electrical signals in response to these magnetic fields. Asignal processor40 processes these signals in order to determine the position coordinates ofdistal end32, typically including both location and orientation coordinates. The method of position sensing described hereinabove is implemented in the above-mentioned CARTO™ system and is described in detail in the patents and patent applications cited above.
Signal processor40 typically comprises a general-purpose computer, with suitable front end and interface circuits for receiving signals fromprobe22 and controlling the other components ofconsole24.Processor40 may be programmed in software to carry out the functions that are described herein. The software may be downloaded to console24 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 ofprocessor40 may be carried out by dedicated or programmable digital hardware components.
An input/output (I/O)interface42 enablesconsole24 to interact withprobe22. Based on the signals received from probe22 (viainterface42 and other components of system20),processor40 drives adisplay44 to presentoperator30 with animage46 showing the position ofdistal end32 in the patient's body, as well as status information and guidance regarding the procedure that is in progress.
In the present embodiment,processor40 monitors measurements received fromposition sensor62 and aforce sensor64 within distal end32 (force sensor64 is shown in more detail inFIG. 2) during periods in which the catheter is believed to be pressing against endocardial tissue ofheart26. As explained hereinbelow, whendistal tip34 is pressing against the endocardial tissue,processor40 can determine the thickness of the tissue based on measurements received from the probe's position and force sensors.
Processor40 storesdata representing image46 in amemory48. In some embodiments,operator28 can manipulateimage46 using one ormore input devices50.
Alternatively or additionally,system20 may comprise an automated mechanism (not shown) for maneuvering and operatingprobe22 within the body ofpatient30. Such mechanisms are typically capable of controlling both the longitudinal motion (advance/retract) ofprobe22 and transverse motion (deflection/steering) ofdistal end32 of the probe. In such embodiments,processor40 generates a control input for controlling the motion ofprobe22 based on the signals provided by the magnetic field sensor in the probe.
AlthoughFIG. 1 shows a particular system configuration, other system configurations can also be employed to implement embodiments of the present invention, and are thus considered to be within the spirit and scope of this invention. For example, the methods described hereinbelow may be applied using position transducers of types other than the magnetic field sensor described above, such as impedance-based or ultrasonic position sensors. The term “position transducer” as used herein refers to an element mounted onprobe22 which causesconsole24 to receive signals indicative of the coordinates of the element. The position transducer may thus comprise a receiver on the probe, which generates a position signal to the control unit based on energy received by the transducer; or it may comprise a transmitter, emitting energy that is sensed by a receiver external to the probe. Furthermore, the methods described hereinbelow may similarly be applied in therapeutic and diagnostic applications using not only catheters, but also probes of other types, both in the heart and in other body organs and regions.
FIG. 2 is a schematic sectional view ofdistal end32 ofprobe22, in accordance with an embodiment of the present invention. Specifically,FIG. 2 shows functional elements ofdistal end32 used for therapeutic and/or diagnostic activity. An electrode60 (e.g., an ablation electrode) atdistal tip34 of the probe is typically made of a metallic material, such as a platinum/iridium alloy or another suitable material. Alternatively, multiple electrodes (not shown) along the length of the probe may be used for this purpose.
Position sensor62 transmits a signal to console24 that is indicative of the location coordinates ofdistal end32.Position sensor62 may comprise one or more miniature coils, and typically comprises multiple coils oriented along different axes. Alternatively,position sensor62 may comprise either another type of magnetic sensor, an electrode which serves as a position transducer, or position transducers of other types, such as impedance-based or ultrasonic position sensors. AlthoughFIG. 2 shows a probe with a single position sensor, embodiments of the present invention may utilize probes with more than one position sensor.
In an alternative embodiment, the roles ofposition sensor62 andmagnetic field generators38 may be reversed. In other words,driver circuit36 may drive a magnetic field generator indistal end32 to generate one or more magnetic fields. The coils ingenerator38 may be configured to sense the fields and generate signals indicative of the amplitudes of the components of these magnetic fields.Processor40 receives and processes these signals in order to determine the position coordinates ofdistal end32 withinheart26.
Force sensor64 measures a force applied bydistal tip34 to the endocardial tissue ofheart26 by conveying a signal to the console that is indicative of the force exerted by the distal tip on the intra-body tissue. In one embodiment, the force sensor may comprise a magnetic field transmitter and receiver connected by a spring indistal end32, and may generate an indication of the force based on measuring the deflection of the spring. Further details of this sort of probe and force sensor are described in U.S. Patent Application Publications 2009/0093806 and 2009/0138007, whose disclosures are incorporated herein by reference. Alternatively,distal end32 may comprise another type of force sensor.
Tissue Thickness EstimationPrior to performing a medical procedure such as cardiac ablation,probe22 is typically calibrated using embodiments described hereinbelow. During a medical procedure,processor40 can utilize the calibration data in order to estimate tissue thickness based on force and displacement measurements received from probe22 (i.e., when the probe is pressing against a wall of a body cavity).
FIG. 3 is a flow diagram that schematically illustrates a method of calibratingprobe22, andFIGS. 4A and 4B are schematic detail views of displacements92 in body cavity walls in response to a force exerted bydistal tip34, in accordance with an embodiment of the present invention. In the description herein, different body cavity walls90 and different displacements92 may be separately identified by appending a letter to the identifying numeral, so that body cavity walls90 comprise abody cavity wall90A and abody cavity wall90B, and displacements92 comprise adisplacement92A, also indicated by Δx1inFIG. 4A, and adisplacement92B, also indicated by Δx2inFIG. 4B. Calculating Δx1and Δx2is described in detail hereinbelow.
In an initial step70,operator28 selects a first body cavity wall90 having a first known thickness. In a force application step72, the operatorfirst positions probe22 so thatdistal tip34 engages the selected body cavity wall, and then presses the distal tip against the wall. Pressingdistal tip34 against body cavity wall90 causes displacement92 of wall90 in response to the force exerted by the distal tip on the wall.
Asoperator28positions probe22,position sensor62 outputs a signal indicative of locations ofdistal tip34. Additionally, as the operator pressesdistal tip34 against the selected body cavity wall,force sensor64 outputs a signal indicative of the force exerted by the distal tip on the wall. Both the position and the force signals, providing respective location and force measurements, are conveyed tomedical system20.
Whenoperator28 pressesdistal tip34 against the selected body cavity wall,processor40 collects, in a first collection step74, a first signal fromsensor64 indicating a force exerted by the distal tip against the wall.Processor40 also collects, in asecond collection step76, a second signal fromsensor62 indicating locations ofdistal tip34. The locations indicated by the signal comprise a first location comprising wheredistal tip34 initially engages the selected body cavity wall and a second location comprising a location of the distal tip after the operator presses the distal tip against the wall. Displacement92 comprises a distance between the first location and the second location.
In acalibration step78,processor42 creates a calibration matrix entry based on the collected position and force measurements. To create the calibration matrix element,processor42 maps the known thickness of body cavity wall90 against the location measurements received from position sensor and the force measurements received fromforce sensor64. Therefore, each calibration matrix element typically comprises a force value, a displacement value, and an associated thickness value. Alternatively, the thickness, force and displacement values may be stored as a range of values. For example, for a range between 1.8 and 2.0, the range of values can be stored in the calibration matrix as a lower and an upper threshold (e.g., 1.8, 2.2) of the range, or as the midpoint of the range and the value to be added to and subtracted from the midpoint (2.0, 0.2).
In afirst comparison step80, if additional calibration for the selected body cavity wall is needed to calibrate the selected body cavity wall, then in a promptingstep82,console24prompts operator28 to change the force applied bydistal tip34 against the selected body cavity wall (i.e., apply lower or greater force), and the method continues with step72. For example, to accurately calibrate a given body cavity wall,processor40 may need to collect at least a defined number of force (and displacement) values, within a range typically used during a given medical procedure. If no additional calibration for the selected body cavity wall is needed, then in asecond comparison step84,console24prompts operator28 to determine if there is an additional body cavity wall to be calibrated.
If an additional body cavity wall is needed to calibrateprobe22, then in aselection step86,console24prompts operator28 to select a different body cavity wall90 having a different known thickness, and the method continues with step72. The method ends when there are no additional body cavity walls needed for calibratingprobe22.
In some embodiments,operator28 can decide if additional calibration is desired in the comparison steps described supra (i.e., insteps80 and84). In alternative embodiments, a software application executing onprocessor40 can determine if further calibration is desired.
During calibration,operator28 may select a variety of different types of body cavity walls90, since different types of tissue may generate different calibration tables. For example, a specific part of the endocardium may generate a calibration matrix that differs from a calibration matrix for an artery, typically because of different elasticities of the different tissues. Sets of calibration matrices for different types of tissue can be created using the steps described hereinabove, wherein a given calibration matrix is associated with a given tissue type. In some embodiments, the set of calibration matrices can be stored tomemory48. Alternatively, the calibration matrices can be stored to a memory coupled to probe22 (not shown).
In the examples shown inFIGS. 4A and 4B,operator28 applies the same force vector F, as measured byforce sensor64, orthogonally towalls90A and90B having different thicknesses (T1and T2respectively). As described supra,processor40 can measure the displacement in the tissue by identifying a first location ofdistal tip34 when the distal tip first engages the given tissue, and identifying a second location when the force applied by the distal tip on the given tissue is F. The difference between the first location and the second location (i.e., the displacement) is Δx1inFIG. 4A and Δx2inFIG. 4B. As illustrated in the examples shown in the Figures, there is a relation between tissue thickness and tissue displacement. In other words, given the same force vector F applied bydistal tip34, the resulting displacement Δx1in thinbody cavity wall90A is typically greater than the displacement Δx2in thickbody cavity wall90B.
FIG. 5 is a schematic flow diagram that schematically illustrates a method of estimating tissue thickness based on position and force measurements conveyed byprobe22, in accordance with an embodiment of the present invention. In aninitial step100,operator28 positionsdistal end32 within a given body cavity (e.g., heart26) and pressesdistal tip34 against a given body cavity wall90. As explained supra, there may be multiple of calibration matrices defined for different types of tissue that can be encountered during a medical procedure. Therefore, prior to pressingdistal tip34 against a given body cavity wall90,operator28 may identify, usinginput devices50, the type of tissue in the body cavity. In response to the operator identifying the type of tissue,processor40 can select a given calibration matrix that is associated with the identified tissue. In an alternative embodiment,processor40 can identify the type of tissue based on the location ofdistal tip34.
Whileoperator28 pressesdistal tip34 against the given body cavity wall,processor40 collects, in afirst collection step102, a first signal fromsensor64 indicating a force exerted by the distal tip against the wall.Processor40 also collects, in asecond collection step104, a second signal fromsensor62 indicating locations ofdistal tip34. The locations indicated by the signal comprise a first location wheredistal tip34 initially engages the given body cavity wall, and a second location comprising a location of the distal tip after the operator presses the distal tip against the wall. As explained supra, displacement92 (in response to the applied force) comprises the distance between the first location and the second location.
In an estimation step106,processor40 identifies an element in the calibration matrix that has force and displacement values corresponding to the collected force and the displacement measurements, and retrieves a thickness value from the identified calibration matrix element, and the method ends. In instances where corresponding values for the collected force and displacement measurements are not explicitly found in the calibration matrix,processor40 can estimate the thickness by calculating a thickness based on an interpolation between two force and/or displacement values found in the calibration matrix.
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 subcombinations 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.