1. Field of the Invention
This invention relates to cardiac catheterization. More particularly, this invention relates to determination of contact of a catheter with cardiac tissue.
2. Description of the Related Art
Cardiac arrhythmias, such as atrial fibrillation, occur when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythm.
Procedures for treating arrhythmia include surgically disrupting the origin of the signals causing the arrhythmia, as well as disrupting the conducting pathway for such signals. By selectively ablating cardiac tissue by application of energy via a catheter, it is sometimes possible to cease or modify the propagation of unwanted electrical signals from one portion of the heart to another. The ablation process destroys the unwanted electrical pathways by formation of non-conducting lesions.
Verification of physical electrode contact with the target tissue is important for controlling the delivery of ablation energy. Attempts in the art to verify electrode contact with the tissue have been extensive, and various techniques have been suggested. For example, U.S. Pat. No. 6,695,808 describes apparatus for treating a selected patient tissue or organ region. A probe has a contact surface that may be urged against the region, thereby creating contact pressure. A pressure transducer measures the contact pressure. This arrangement is said to meet the needs of procedures in which a medical instrument must be placed in firm but not excessive contact with an anatomical surface, by providing information to the user of the instrument that is indicative of the existence and magnitude of the contact force.
As another example, U.S. Pat. No. 6,241,724 describes methods for creating lesions in body tissue using segmented electrode assemblies. In one embodiment, an electrode assembly on a catheter carries pressure transducers, which sense contact with tissue and convey signals to a pressure contact module. The module identifies the electrode elements that are associated with the pressure transducer signals and directs an energy generator to convey radiofrequency energy to these elements, and not to other elements that are in contact only with blood.
A further example is presented in U.S. Pat. No. 6,915,149. This patent describes a method for mapping a heart using a catheter having a tip electrode for measuring local electrical activity. In order to avoid artifacts that may arise from poor tip contact with the tissue, the contact pressure between the tip and the tissue is measured using a pressure sensor to ensure stable contact.
U.S. Patent Application Publication 2007/0100332 describes systems and methods for assessing electrode-tissue contact for tissue ablation. An electromechanical sensor within the catheter shaft generates electrical signals corresponding to the amount of movement of the electrode within a distal portion of the catheter shaft. An output device receives the electrical signals for assessing a level of contact between the electrode and a tissue.
Impedance-based methods for assessing catheter-tissue contact that are known in the art typically rely on measurement of the magnitude of the impedance between an electrode on the catheter and a body-surface electrode. When the magnitude is below some threshold, the electrode is considered to be in contact with the tissue. This sort of binary contact indication may be unreliable, however, and is sensitive to changes in the impedance between the body-surface electrode and the skin.
U.S. Patent Application Publication Nos. 2008/0288038 and 2008/0275465, both by Sauarav et al., which are herein incorporated by reference, describe an electrode catheter system, which may comprise an electrode adapted to apply electric energy. A measurement circuit adapted to measure impedance may be implemented between the electrode and ground as the electrode approaches a target tissue. A processor or processing units may be implemented to determine a contact condition for the target tissue based at least in part on reactance of the impedance measured by the measurement circuit. In another embodiment, the contact condition may be based on the phase angle of the impedance.
U.S. Patent Application Publication No. 2013/0172875 to Govari et al., entitled “Contact Assessment Based on Phase Measurement”, which is herein incorporated by reference, describes displaying intra-operative phase determinations of an electrical current passing between the ablation electrode and another electrode as an indicator of contact force between an ablation electrode and target tissue.
Today contact force catheters are commercially available, for example the THERMOCOOL® SMARTTOUCH™ Catheter, produced by Biosense Webster, Inc., 3333 Diamond Canyon Road, Diamond Bar, Calif. 91765.
There is provided according to embodiments of the invention a method, which is carried out by inserting a probe having a contact force sensor into a cavity in a body of a subject, the cavity having a blood pool and an endocardial surface, generating an image of the blood pool, removing a portion of the blood pool from the image to retain a remaining portion of the blood pool thereon, making a determination from the image that the distal segment of the probe is within the remaining portion of the blood pool, and responsively to the determination manually zeroing the contact force sensor.
According to one aspect of the method, the removed portion of the blood pool is adjacent the endocardial surface.
According to a further aspect of the method, the removed portion of the blood pool is adjacent another probe.
According to an additional aspect of the method, boundaries of the remaining portion of the blood pool are 3 mm from another probe in the cavity and 10 mm from the endocardial surface.
According to a further aspect of the method, boundaries of the remaining portion of the blood pool are 6 mm from another probe in the cavity and 13 mm from the endocardial surface.
There is further provided according to embodiments of the invention a method that is carried out by inserting a probe having a contact force sensor into a cavity in a body of a subject, the cavity having a blood pool and an endocardial surface. The method is further carried out by generating a first image of the blood pool, generating a second image to define an excluded region of the blood pool, generating subtraction images by subtracting the second image from the first image to define a zero-qualified region of the blood pool, and while generating the subtraction images navigating the probe within the cavity, until the distal portion is within the zero-qualified region.
Another aspect of the method includes making a determination from the subtraction images that the distal portion is within the zero-qualified region, and responsively to the determination enabling manual zeroing of the contact force sensor.
According to still another aspect of the method, a boundary of the other excluded region is at least 6 mm from another probe.
According to an additional aspect of the method, the first image and the subtraction images include the other probe.
There is further provided according to embodiments of the invention an apparatus, including a probe, configured for insertion into a body cavity having a blood pool, the probe including a contact force sensor for measuring a force applied to the contact force sensor and location sensors for detecting a location of the probe in the body cavity, and a processor, which is configured to receive a plurality of measurements from the contact force sensor. The processor is operative for generating an image of the blood pool, removing a portion of the blood pool from the image to retain a remaining portion of the blood pool thereon, and presenting a location of a distal segment of the probe on the image.
According to yet another aspect of the apparatus, the processor is operative for making a determination from the image that the distal segment of the probe is within the remaining portion of the blood pool, and responsively to the determination enabling manual zeroing of the contact force sensor.
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:
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.
In a medical ablation procedure, such as ablation of heart tissue, it is extremely useful to be able to measure the force applied to the tissue while the tissue is being ablated. This is because the force applied is a key parameter governing the amount of tissue ablated for a given ablation energy input to the tissue. The ablation is typically provided by a probe comprising an ablation electrode at its distal end. To accurately measure a force exerted by the distal tip on the endocardium, the force sensor incorporated into the distal end of the probe is typically calibrated to a “zero level,” also referred to herein as a baseline. The baseline is determined from measurements generated by the force sensor when the distal tip has minimal contact with any surface (and therefore there is essentially no effective force exerted on the distal tip). The baseline may be determined using the techniques disclosed in U.S. Patent Application Publication No. 2012/0108988 to Ludwin et al., which is herein incorporated by reference. Once the baseline is identified, the measurements from the force sensor can be used to provide a value of the force exerted.
But such force sensors known in the art typically drift. Even if the force exerted on the sensor is constant, readings from the sensor change. Such drift may be compensated for by zeroing the sensor periodically, typically before applying ablation energy. However, the zeroing of the sensor should only be applied if the sensor is not contacting or in proximity to tissue or other catheters, i.e., the sensor is in a state where the force on it is effectively zero.
The force sensor is assumed to be in a zeroed state if over at least a predetermined interval of time force readings from the sensor change by less than a predetermined force limit. To ensure that the sensor is in the zeroed state, the probe having the force sensor is typically also assumed to change its location during the predetermined time interval by more than a predetermined location threshold.
Commonly assigned application Ser. No. 14/010,697, entitled “Determining Non-Contact State for a Catheter”, whose disclosure is herein incorporated by reference, teaches how to detect a zeroed state for the sensor, and to calibrate a zero-force point for the force sensor. In order to auto-zero the sensor, received signals from the sensor are checked to detect a situation wherein the sensor is in a first zeroed state, then in a non-zeroed state (such as if the sensor indicates it is touching tissue), and then in a second zeroed state. Once such a situation is detected, force readings from the second zeroed state may be used as calibration values that zero the sensor.
The sensor is in a zeroed state where the force on it is effectively zero (such a state is typically achieved if the sensor is surrounded by blood in the heart chamber, and is not contacting a heart wall and the probe is not in proximity to another probe. Changes in proximity between probes may reduce the accuracy of the calibration values referred to above. In such cases, a probe may be assumed to be in the zeroed state if, in addition to the force condition described above, a measured value of the change in proximity to another probe is less than a predetermined proximity change threshold. In general, there is a high probability of accurately auto-zeroing the sensor when the sensor does not contact tissue. In addition, there is an extremely high probability of not auto-zeroing the sensor when the sensor does contact tissue.
Turning now to the drawings, reference is initially made to
Areas determined to be abnormal, for example 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 about 50° 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. The principles of the invention can be applied to different heart chambers to treat many different cardiac arrhythmias.
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 processor 22, located in a console 24. The processor 22 may fulfill several processing functions as described below.
Ablation energy and electrical signals can be conveyed to and from the heart 12 through one or more ablation electrodes 32 located at or near the distal tip 18 via cable 34 to the console 24. Pacing signals and other control signals may be conveyed from the console 24 through the cable 34 and the electrodes 32 to the heart 12. Sensing electrodes 33, also connected to the console 24 are disposed between the ablation electrodes 32 and have connections to the cable 34.
Wire connections 35 link the console 24 with body surface electrodes 30 and other components of a positioning sub-system for measuring location and orientation coordinates of the catheter 14. The processor 22, or another processor (not shown) may be an element of the positioning subsystem. The electrodes 32 and the body surface electrodes 30 may be used to measure tissue impedance at the ablation site as taught in U.S. Pat. No. 7,536,218, issued to Govari et al., which is herein incorporated by reference. A temperature sensor (not shown), typically a thermocouple or thermistor, may be mounted on or near each of the electrodes 32.
The console 24 typically contains one or more ablation power generators 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-produced light 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.
In one embodiment, the positioning subsystem 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 and sensing these fields at the catheter, using field generating coils 28. The positioning subsystem U.S. Pat. No. 7,756,576, which is hereby incorporated by reference, and in the above-noted U.S. Pat. No. 7,536,218.
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 29. 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 location sensing electrodes (not shown) located distally in the catheter 14. The digitized signals are received and used by the console 24 and the positioning system to compute the position and orientation of the catheter 14 and to analyze the electrical signals from the electrodes.
During the procedure, contact force between the distal tip 18 or ablation electrode 32 and the wall 37 may be measured using a position sensor in conjunction with the processor 22, or by any of the other techniques described above for verifying physical electrode contact with the target tissue.
Typically, the system 10 includes other elements, which are not shown in the figures 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, so as to provide an ECG synchronization signal to the console 24. As mentioned above, the system 10 typically also includes a reference position sensor, either on an externally-applied reference patch attached to the exterior of the subject'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. The system 10 may receive image data from an external imaging modality, such as an MRI unit or the like and includes image processors that can be incorporated in or invoked by the processor 22 for generating and displaying images that are described below.
Reference is now made to
Reverting to
The operator-assisted manual zeroing visualization procedure may alert the operator or even disable his ability to perform manual contact force zeroing when the catheter is detected, e.g., by the processor 22 in areas that are not suitable for zeroing, i.e., are not highlighted on the map displayed on the monitor 29.
Reference is now made to
Reference is now made to
At initial step 61 catheterization of a cardiac chamber is accomplished conventionally. A contact force catheter and optionally other catheters are introduced into a cardiac chamber.
Next, at step 63, a definition of the blood pool of the cardiac chamber is displayed as a first image.
Next, at step 65, The blood pool is redrawn to exclude a first region of the blood pool adjacent the endocardial surface of the cardiac chamber, referred to herein as a first excluded region. Typically, the first excluded region is about 10 mm away from any tissue due to contraction and expansion of the heart. Furthermore, each catheter within the chamber other than the contact force catheter is surrounded by a respective spherical proximity zone, which constitutes a second excluded region. Steps 63, 65 may be accomplished using the procedures described in the above-mentioned application Ser. No. 14/010,697. A second image may be generated in which the first excluded region and the second included regions are highlighted.
Next, at step 67, the first excluded region and the second exclusion regions defined on the second image in step 65 are subtracted from the first image that was produced in step 63, using standard image processing routines. A subtraction image is generated. The portion of the blood pool that remains on the subtraction image is referred to herein as a zero-qualified region, because it is suitable for manually zeroing the contact force sensor.
Referring again to
Next, at decision step 71, it is determined by evaluation of the new images if the catheter is in the zero-qualified region that was established at step 67. If the determination is negative, then control returns to step 69 and the catheter is repositioned.
If the determination at decision step 71 is affirmative then control proceeds to final step 73. The operator zeroes the contact force sensor, and the procedure ends.
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
The procedure shown in
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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