Biosense Webster (Israel) Patente

Methods and systems of mapping electrophysiological signals in a heart using a catheter having an ultra-high density electrode array are disclosed. The disclosed technology can include a method including navigating a medical probe to a target location in a patient's heart; receiving electrophysiological signals from at least some of the electrodes of the plurality of electrodes; identifying, based on the electrophysiological signals and the location signal, an earliest activation point identified as having the earliest activation time; identifying, based on the electrophysiological signals and the location signal, a plurality of points closest to the earliest activation point having an activation time less than a predetermined time duration from the earliest activation time; and generating an electro-anatomical map of the heart based on data corresponding to the plurality of points, the electro-anatomical map representing the location of the earliest activation point for subsequent ablation.

Methods may include receiving, at a computing device, at least one coordinate set associated with a catheter tip. Methods may include receiving, at the computing device, at least one three-dimensional (3D) model of a heart. Methods may include determining, based on at least the at least one 3D model, an endocardial surface of the heart. Methods may include determining, based on at least the at least one 3D model, an epicardial surface of the heart. Methods may include causing a vector to be projected from the catheter tip. The vector may intersect the endocardial surface at a first point. The vector may intersect the epicardial surface at a second point. Methods may include determining, using at least the first point and the second point, a tissue thickness. Methods may include causing, via a display, output of an indication of the tissue thickness.

A system includes a catheter, an electrocardiogram (ECG) system, and a processor. The catheter is configured to apply pacing to given tissue location inside a ventricle of heart of patient. The ECG system is configured to acquire a set of ECG signals generated in response to the pacing, wherein electrodes of the ECG system attached to the patient define respective directions in space relative to an origin located in the heart. The processor is configured to (i) calculate respective set of signal differences between the acquired set of ECG signals and reference set of ECG signals, (ii) calculate corresponding set of deviation vectors along the respective directions in space, the deviation vectors having amplitudes corresponding to the respective signal differences, (iii) using the deviation vectors, calculate direction vector from the given location to new ventricle location at which to apply the pacing, and (iv) indicate calculated direction vector to user.

A catheter is presented having a planar end effector with elongated ablation electrodes configured to provide electrical signals to achieve IRE in target tissue. The planar end effector can be aligned along a longitudinal axis of a shaft of the catheter and configured to flex away from the longitudinal axis when making contact with tissue. Bipolar electrical signals can be applied between the elongated ablation electrodes in various pair combinations to achieve PFA. The end effector may also include diagnostic electrodes configured to receive electrical signals from tissue to map tissue, pairs of tissue contact electrodes to determine which portions of the end effector are in contact with tissue, or reference electrodes configured to measure blood voltage.

A medical apparatus includes a probe, which includes an insertion tube configured for insertion into a body cavity of a patient, and a distal assembly, which is connected distally to the insertion tube and includes a plurality of electrodes, which are configured to contact tissue within the body cavity. The apparatus further includes an electrical signal generator, which is configured to apply electrical pulses to a group of two or more of the electrodes with an amplitude sufficient to irreversibly electroporate the tissue contacted by the electrodes in the group, and a controller, which is coupled to measure a change in an electrical impedance between an electrode in the group and a further electrode as a result of application of the electrical pulses and to output a measure of ablation of the tissue responsively to the measured change in the electrical impedance.

The disclosed technology includes a medical probe comprising a tubular shaft extending along a longitudinal axis of the medical probe. The medical probe further comprises an expandable basket assembly coupled to the distal end of the tubular shaft. The basket assembly comprises a plurality of spines and a plurality of electrodes. The electrode comprises an electrode body that defines a lumen therethrough such that the respective spine extends through the lumen. The basket assembly comprises an electrically insulative jacket disposed between each respective spine and each respective electrode. Each electrode body and electrically insulative jacket comprises a substantially circular cross-sectional shape.

The disclosed technology includes a distal tip of a medical probe. The distal tip includes spines extending radially outward from a longitudinal axis of the end effector in an expanded configuration, a membrane connected to the spines, a first flexible circuit disposed on a first surface of the membrane proximate each of the plurality of spines, a second flexible circuit disposed on a second surface of the membrane proximate each of the plurality of spines, a plurality of first pairs of electrodes disposed on the first flexible circuit proximal to one another and a spine of the plurality of spines, and a plurality of second pairs of electrodes disposed on the second flexible circuit proximal to one another and a spine of the plurality of spines such that the first and second pairs of electrodes define a mirror image configuration.

The disclosed technology includes an end effector of a medical probe. The end effector includes spines and a membrane. The spines are coupled to a distal portion of a tubular member, with each spine including a proximal spine end coupled to the distal portion of the tubular member and a free distal end. The membrane and spines are fixed relative to each other to define a single member. The membrane defines a plurality of leaves, each of which, in an expanded configuration, extending curvilinearly outward and being separated from adjacent free distal ends of adjacent leaves of the plurality of leaves. Each leaf includes flexible circuits including electrodes.

In one embodiment, a catheter apparatus is configured to be inserted into a body part of a living subject, and including an elongated deflectable element including a distal end, an expandable basket assembly disposed at the distal end and comprising a plurality of splines and a plurality of electrodes disposed on the splines, an irrigation channel disposed in the elongated deflectable element, and an inflatable balloon disposed in the expandable basket assembly and including a plurality of irrigation holes in fluid connection with the irrigation channel.

An apparatus includes an elongate shaft assembly and a processor. The elongate shaft assembly includes a distal portion having an end effector and a tip member. The end effector has a flex circuit with a plurality of electrodes extending angularly about the distal portion of the shaft assembly and spaced longitudinally apart from each other along the distal portion of the shaft assembly. The tip member is positioned distal to the end effector and is more flexible than the distal portion of the shaft assembly. The processor is electrically coupled with the flex circuit and is configured to select one or more electrodes of the plurality of electrodes to activate. The processor is further configured to activate the one or more selected electrodes to apply electrical energy to tissue to thereby ablate the tissue.

An apparatus includes an elongate shaft assembly, an end effector, and a flexible circuit. The end effector includes one or more electrodes. The flexible circuit includes a flexible substrate and a trace. The flexible substrate includes a proximal portion, an intermediate portion, and a distal portion. The proximal portion of the flexible substrate is positioned proximal to the end effector. The intermediate portion extends along the distal portion of the shaft assembly and is positioned proximal to the end effector. The trace extends along at least the intermediate portion of the flexible substrate. A portion of the trace defines a position sensor that is configured to generate a signal in the presence of an alternating magnetic field and is configured to flex with the distal portion of the shaft assembly. The position sensor length is at least approximately 10 times greater than the outer diameter of the shaft assembly.

An apparatus includes an elongate flexible shaft and an end effector. The shaft has a proximal end and a distal end. The end effector is positioned at a distal end of the shaft. The end effector includes a body, an electrode, and a bonding material. The electrode defines one or more laterally oriented openings. The bonding material secures the electrode to the body. A portion of the bonding material is disposed in at least one of the one or more laterally oriented openings.

A computer-implemented method provides real-time visual feedback of intraluminal catheter engagement within a luminal organ of a patient. A catheter with electrodes on a distal end assembly is positioned in the organ, and a three-dimensional (3D) model of the internal surface is generated and rendered as a 3D anatomical map. For each electrode, a proximity value indicative of distance to a tissue wall is determined based at least on measured impedance and translated into a graphical attribute value. A continuous proximity visualization feature is formed by sequencing the graphical attributes according to electrode positions, representing proximity variations. The feature is projected onto the 3D anatomical map, creating an integrated graphical representation displayed on a computer display. The visualization is dynamically updated in response to impedance changes, providing real-time feedback on catheter contact with the tissue wall.

The disclosed technology includes a flexible circuit for an end effector of a medical probe. The flexible circuit comprises a flexible substrate layer, a plurality of electrodes, and a stiffening layer. The stiffening layer is disposed on the first side of the flexible substrate layer and in the first zone of the flexible circuit such that a first thickness of a first zone of the flexible circuit is greater than a second thickness of the second zone of the flexible circuit, the thickness being measured along the vertical axis, and such that a first flexural rigidity of the first zone is greater than a second flexural rigidity of a second zone of the flexible substrate layer.

Disclosed is a medical probe comprising an elongated shaft extending along a longitudinal axis and a distal electrode disposed at a distal end of the elongated shaft, the distal electrode configured to deliver ablative energy to tissue. The medical probe includes an outer sleeve disposed at least partially around the elongated shaft and a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis. Each planar member of the plurality of planar members comprises a framework coupled to an outer surface member and an inner surface member opposite the outer surface member. Each of the inner and outer surface members includes a plurality of electrodes diametrically disposed on the inner surface member and outer surface member and the outer sleeve is configured to move axially along the elongated shaft to move the plurality of planar members axially with respect to the distal electrode.

An apparatus includes a flexible catheter shaft, one or more electrodes, and one or more position sensors, at least one of the one or more position sensors being positioned on the distal portion of the catheter shaft, the one or more position sensors being configured to provide a signal indicating respective positions of the one or more position sensors in three-dimensional space in response to a magnetic field. The flexible catheter shaft includes a lumen in fluid communication with an open distal end of the shaft. The lumen is configured to receive a guidewire and to communicate a therapeutic fluid out through the open distal end. The shaft has an outer diameter ranging from approximately 0.67 mm to approximately 1.33 mm. At least one of the one or more electrodes is operable to apply electrical energy to tissue.

A catheter system for use with a catheter with a distal assembly supporting a plurality of electrodes adapted to sense electrical signal in heart tissue and a force sensor configured to generate first contact signals representative of a contact force acting on the distal assembly. The system includes an ablation power generator configured to energize the plurality of electrodes, an impedance circuitry configured to generate second contact signals representative of the electrodes in contact with tissue, a processor configured to receive the first and second contact signals and generate switch signals in response thereto, and a switch circuitry configured to connect in response to the switch signals solely selected electrodes in contact with tissue to the ablation power generator in forming one or more composite electrodes.

The disclosed technology includes an end effector comprising a plurality of spines extending along a longitudinal axis to define a basket assembly, the plurality of spines configured to bow radially outward from the longitudinal axis to define a radius of curvature with respect to the longitudinal axis and to transition between an expanded configuration and a collapsed configuration. Each spine of the plurality of spines can include a section extending radially outward from the radius of curvature defined by a remainder of each spine. The end effector can further include at least one electrode disposed on the section for each spine of the plurality of spines.

The disclosed technology includes an end effector comprising at least one flexible circuit extending along a longitudinal axis having a substrate supporting at least one electrical trace and at least one electrode. Portions of the substrate may be reinforced by forming the electrical trace with a plurality of bends and/or by providing a plurality of bends in the substrate. Additionally, portions of the substrate may include multiple layers, each layer having electrical traces which are offset from one another.

The disclosed technology includes an end effector of a medical device. The end effector includes a framework, a flexible circuit including electrodes, an insulative material, and skids. The framework and flexible circuits are disposed on the insulative material. The insulative material includes a first surface disposed a first height from the framework in a height direction of the end effector and includes a first dynamic coefficient of friction. The skids are disposed on the insulative material, each skid comprising a second surface disposed a second height from the framework in the height direction and including a second dynamic coefficient of friction, lower than the first dynamic coefficient of friction. The first surface and the skids are disposed in the height direction such that the first height and each respective second height are one of equal or the respective second height is greater than the first height.

The disclosed technology includes a flexible circuit for an end effector of a medical probe. The flexible circuit includes a flexible substrate, electrodes, and a first sensing loop. The flexible substrate defines tines extending along a longitudinal axis. The electrodes are disposed on each of the tines. The first sensing loop is disposed on the flexible substrate. The first sensing loop forms one or more coils that generate a current that is indicative of a position of the one or more coils when the one or more coils is subjected to a magnetic field. The first sensing loop includes two segments disposed on respective tines extending generally parallel to the longitudinal axis and converging towards each other on a tine disposed on the longitudinal axis.

Examples presented herein generally include systems and methods which can contact electrodes to cardiac tissue while sensing electrical potential from fluids near the tissue. The electrodes in contact with the tissue can be carried by an end effector and can be used to sense and/or ablate the tissue they contact. A reference electrode can be insulated by a shaft connected to the end effector so that the reference electrode can sense the electrical potentials from the fluids near the tissue while being prevented, by the shaft geometry, from contacting the cardiac tissue. In some examples, the reference electrode can be tubular, having an inner surface that is configured to contact and sense electrical potentials from the fluids and an electrically insulated outer surface. Configured as such, the reference electrode can serve as an extension of an irrigation tube extending through the shaft.

The present disclosure provides a flexible circuit strip for use in a catheter assembly. The flexible circuit strip comprises a first insulating layer, a second insulating layer and a third insulating layer, each having an elongated shape and bonded together such that the second insulating layer is between the first and third insulating layers; a conductive trace layer positioned between the first and second insulating layers, the conductive trace layer including longitudinal circuit traces for carrying electrical signals; electrodes positioned along a length of an outer surface of the first insulating layer and electrically connected to the circuit traces; and a longitudinal hollow channel formed between any two of the first, second and third layers, the longitudinal hollow channel being configured to receive an elongated support element.

A catheter assembly is configured for preventing the occurrence of at least one hotspot during operation of the catheter assembly. The catheter assembly includes a shaft and an end effector. The shaft is designed to be guided into a lumen through a delivery sheath. The electrode is printed on a substrate and is configured to deliver energy to an ablation site. The bottom surface of the electrode is coupled to the substrate and the arcuate element(s) are coupled to the upper surface of the electrode. The arcuate element(s) have a curved upper surface and extend over respective location(s). The arcuate element(s) reduce the intensity of the electrical field at their respective locations to below the arcing level when the electrode is operated in the blood, thereby preventing the occurrence of hotspots during operation.

Medical catheterization is carried out by introducing a catheter into a heart, sliding the catheter through a sheath that encloses a multi-electrode probe into a chamber of the heart. The sheath is retracted to expose the probe. As the sheath is retracted the exposed probe expands into a spiral configuration, and the electrodes contact the endocardial surface of the chamber at multiple contact points.

A method includes receiving an anatomical map of wall tissue of at least portion of a cardiac chamber. Locations are received, of electrodes of a catheter inside the cardiac chamber during application of ablation. At least some of the locations of the electrodes are projected onto surface of the map. Shortest paths are found between pairs of projected locations of adjacent electrodes. Some of the paths are indicated with first indications representing continuous ablation, when paths have path lengths that are below a given threshold path length. Others of the paths are indicated with second indications representing ablation gaps based on catheter geometry. Grid ablation tags are generated according to first and second indications and ablation model. The grid ablation tags are superimposed over anatomical map to generate ablation map and are graphically encoded according to the first and second indications. The graphically encoded ablation map is presented to users.

In one example, an apparatus includes an ablation energy generator to conduct ablative energy to an electrode of a catheter, a processor configured to compute a first force signal acting on tissue by a distal end assembly of the catheter based on a first magnetic signal received by a first magnetic field sensor of the distal end assembly from a magnetic transmitter coil of a distal end of the catheter during ablation of tissue by the electrode, compute a second force signal acting on tissue by the distal end assembly based on a second magnetic signal received by a second magnetic field sensor of the distal end assembly from a magnetic transmitter coil disposed in a location pad, compute a third force signal based on the first and second force signal, and render to a display a force value or an ablation index value computed from the third force signal.

A catheter includes a shaft assembly, an end effector, and a flexible circuit. The end effector is positioned at a distal end of the shaft assembly and includes a tip member. The tip member is operable to apply electrical energy to tissue. The tip member defines a bore, which has an inner sidewall. The flexible circuit includes a thermocouple positioned within the bore of the tip member. The thermocouple is configured to sense a temperature of the tip member. The flexible circuit further includes a deformable feature that resiliently urges the thermocouple toward the inner sidewall of the bore.

A method includes receiving an anatomical map of wall tissue of at least a portion of a cardiac chamber, the map comprising different anatomical regions. A plurality of ablation points generated by a multi-electrode catheter during an ablation instance can be received. Using a classification algorithm that considers catheter shape data, an anatomical region is identified and all of the ablation points can be classified as belonging to the identified anatomical region. Respective ablation tags can also be presented on the anatomical map according to the classified ablation points and catheter shape data.

A medical probe can include electrodes for ablation and sensing proximity to tissue and/or monitoring electrical signals within the cardiovascular system to identify aberrant conductive tissue sites that are responsible for an arrhythmia. The electrodes can be oriented on an end effector assembly, such as a basket assembly, such that one side of an electrode is positioned to contact tissue and the opposite side is inhibited from contacting tissue. To enable both efficient delivery of energy as well as high sensitivity for ECG sensing an impedance reducing coating can be positioned on the tissue contacting side and an impedance increasing coating can be applied on the opposite side. The impedance increasing coating of an IRE electrode can be thin enough to allow energy to be delivered through the coating during ablation. An RF electrode an have sufficient mass to carry electrical energy for thermal ablation.

In one exemplary mode, an apparatus includes a catheter including an electrode to provide an intracardiac electrogram (IEGM) signal and a signal used to sense impedance, an ablation energy generator configured to conduct ablative energy to the electrode of the catheter based on user input, a controller configured to sample the IEGM signal from the electrode before and after a given ablation, and sense impedance between the electrode and tissue, and a processor configured to compare the sensed impedance with a TPI threshold to determine a contact status of the electrode with respect to the tissue, render to a display an indication of the determined contact status, compute a change in the IEGM signal due to the given ablation, and adjust the TPI threshold for subsequent ablations based on the computed change in the IEGM signal due to the given ablation of the tissue with the electrode.

Catheterization of the heart is carried out using a framework formed by a plurality of electrically conducting wire loops. The wire loops are modeled as polygons, each subdivided into a plurality of triangles,. The wire loops are exposed to magnetic fluxes at respective frequencies, and signals read from the loops. Theoretical magnetic fluxes in the polygons are computed as sums of theoretical magnetic fluxes in the triangles thereof, The location and orientation of the framework in the heart is determined by relating the computed theoretical magnetic fluxes to the signals.

A catheter system is for use with a catheter with an expandable balloon member of a conic configuration with a maximum radius delineating between a distal portion and a proximal portion, the balloon member including a plurality of circumferential flexible circuits disposed thereon in the distal portion of the balloon member, the balloon member defining a longitudinal axis, each ablation flexible circuit extending circumferentially around the longitudinal axis with a different respective radius at a different respective location along the longitudinal axis wherein a circumferential flexible circuit with a conforming radius for contact with tissue is selectively energized to create a complete circumferential lesion around tubular region of the heart.

In one embodiment, a medical system, includes a catheter to be inserted into a chamber of a heart of a living subject, and including catheter electrodes configured to contact tissue at respective locations within the chamber of the heart, a display, and processing circuitry to receive signals from the catheter, and in response to the signals assess a respective quality of contact of each of the catheter electrodes with the tissue in the heart, and render to the display respective intracardiac electrograms traces representing electrical activity in the tissue that is sensed by the catheter electrodes at the respective locations, while modifying a visual feature of at least some of the traces responsively to the respective quality of contact of the catheter electrodes with the tissue of the heart at the respective locations.

An electrode combination for an end effector of a catheter may include a reference electrode and a sensing electrode positioned such that the reference electrode is recessed in relation to the sensing electrode so that the reference electrode is inhibited from contacting tissue while the sensing electrode is in contact with tissue. The reference electrode can function to detect far-field electromagnetic noise while the sensing electrode receives electrical signals from tissue and may also receive signals from far-field electromagnetic noise. Electrocardiograms of the electrical signals from tissue can be generated by subtracting, or otherwise compensating for, the far-field noise received by the sensing electrode based on the far-field electromagnetic noise received by the reference electrode. Preferably, the reference electrode and the sensing electrode have the same surface area as each other.

Disclosed herein are medical devices configured and sized to be positioned within a subject. Medical devices may comprise a flexible circuit comprising at least two conductive layers. A first conductive layer may be disposed on a first surface of the flexible circuit and a second conductive layer is disposed on a second surface opposite the first surface such that electrical energy is capable of being conducted through the flexible circuit to the first conductive layer and the second conductive layer. Medical devices may comprise an electro acoustic module (EAM) disposed at or adjacent a distal region of the flexible circuit, the EAM coupled to the flexible circuit to define a distal tip of the medical device. The at least two conductive layers create trace routes via the flexible circuit to the EAM.

A method for performing a medical procedure, consisting of providing a probe, having a known spring constant, for insertion into a patient, the probe having electrodes and a position sensor at respective locations along the probe, and recording relative location coordinates of the electrodes and the position sensor when the probe is in an unrestrained state. While the probe is in the patient and deformed by contact with patient tissue, recording changes in the relative location coordinates of the electrodes in contact with the tissue and the position sensor, and computing a probe shape in a deformed state, in response to the recorded changes. In response to the known spring constant and the computed probe shape, computing a respective force exerted by the tissue on each of the electrodes, and controlling electrical signals through the electrodes from the tissue responsively to the computed respective force on the electrodes.

A catheter includes: a shaft for insertion into an organ of a patient, and first and second position sensors. The shaft includes: (a) an inner shaft, which is configured to be deflected relative to an axis of the shaft, and (b) an outer shaft, which is coupled to a distal tip of the catheter and is configured to be: (i) coaxially disposed around the inner shaft, (ii) deflected together with the inner shaft, and (iii) rotated about the axis relative to the inner shaft. The first position sensor is coupled to the distal tip and is configured to produce a first signal, and the second position sensor is coupled to the inner shaft, and is configured to produce a second signal.

A composite correlation score associated with a selected spatial location in the heart is determined based on a plurality of individual correlation values, each of which is based on a correlation between a signal associated with a selected electrode positioned at the selected spatial location and a signal associated with another one of the plurality of electrodes when the selected electrode is positioned at the selected spatial location. Composite correlation scores associated other selected spatial locations in the heart are determined the same way. An electro-anatomical map of the heart is displayed which depicts information representative of the composite correlation score determined for the selected spatial locations, including information indicating that a spatial location is a suspected trigger of AF.

A guiding sheath assembly includes an elongate shaft and a control handle (910) proximal of the elongate shaft. The control handle has a longitudinal axis, and includes a control handle housing (912) and at least one shuttle (914a, 914b) configured for translation along the longitudinal axis. The guiding sheath assembly also includes at least one actuator element (921a, 921b) extending along at least one side of the elongate shaft and having a proximal end portion responsive to translation of the at least one shuttle in at least a proximal direction. The guiding sheath assembly further includes at least one deflection sensor assembly (920a, 920b) secured to the control handle housing and configured to generate one or more signals indicative of an articulation state of the elongate shaft based on a longitudinal position of the at least one shuttle.