System and method for shape tracking of object in body subject to deformation

Abstract

The subject matter of the invention is a system and method for shape tracking of an object in a body subject to deformation. An in vivo probe having a flexible portion is configured with one or more integrated EM loops of conductive elements wherein the EM loop, when exposed to one or more external magnetic fields, is configured to generate a voltage signal indicative of a position of the EM loop, such as when the EM loop is subjected to an external force that causes deformation. With respect to a plurality of EM loops at different locations on the flexible portion of the probe, a set of such voltage signals from each EM loop enables a system configured to receive and process the voltage signals to determine coordinates of the EM loop in a local coordinate system and track in real-time a shape in space representing deformation of the probe.

Description

[0001] priority

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 524,144, filed on June 29, 2023, entitled “System And Method For Shape Tracking Of Intrabody Object Subject To Deformation,” the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to detecting the position of a flexible object placed within a living body, and particularly to sensing multiple conductive elements on a flexible electrophysiology probe or device to track its shape and deformation in space in real time. Background Art

[0004] In many medical procedures, it is necessary to track the position of internal objects such as sensors, tubes, catheters, dispensing devices, and implants. Well-established, highly accurate systems for determining the position and orientation of internal objects have been developed based on magnetic field sensing. These systems utilize sensors attached to internal objects to measure the relative strength of externally generated magnetic fields and derive the position of the object from these measurements. For example, methods for magnetic-based position sensing are disclosed in U.S. Patents Nos. 5,391,199, 5,433,489, and 6,788,967 to Ben-Haim, 6,690,963 to Ben-Haim et al., 5,558,091 to Acker et al., 6,172,499 to Ashe, and 6,177,792 to Govari, all of which are incorporated herein by reference in their respective disclosures.

[0005] Position sensing systems that utilize impedance-based measurements may also have been developed. In such systems, the impedance between electrodes fixed to an object in the body and electrodes placed on the surface of the body is measured. The system then derives the position of the object in the body from the impedance measurements. For example, methods for impedance-based position sensing are disclosed in U.S. Pat. No. 5,983,126 to Wittkampf, U.S. Pat. No. 6,456,864 to Swanson, and U.S. Pat. No. 5,944,022 to Nardella, all of which are incorporated herein by reference.

[0006] For example, hybrid position sensing systems and methods combining magnetic and electrical position sensing technologies are disclosed in U.S. Patent Publication No. 20070016007 to Govari. In these systems, a magnetic position sensor provides an accurate position reference for calibrating less accurate electrical impedance-based measurements. To this end, a hybrid probe (such as a catheter) including a three-axis magnetic position sensor and one or more electrodes is used to correlate magnetic position measurements with impedance-based measurements. Such a system alleviates the need for multiple magnetic position sensors and therefore benefits from both magnetic position sensing and impedance-based sensing.

[0007] However, for catheters with relatively large distal assemblies, particularly those presenting a 3-D configuration, magnetic-based, impedance-based, or hybrid position sensing only provides a "point" position of the corresponding sensor, rather than the position of the 3-D configuration as a whole (particularly as a structure with segments connected by joints). In addition, because magnetic position sensors (whether single-axis or multi-axis) are structurally rigid, they are not suitable for mounting on flexible portions of catheters to detect flexure or deformation, including flexible distal end assemblies or those that bend at the interface with the shaft. Because magnetic position sensors are mounted on the rigid portion of the catheter shaft, they do not sense changes in the position of the distal assembly due to bending. Therefore, magnetic position sensors are not typically used to detect deformations in the distal assembly, for example, deformations caused by bending or buckling when pressed against the ventricular wall.

[0008] Accordingly, Applicants recognize the need for a system and method that can sense and track the shape or volume of an in vivo device (e.g., an electrophysiology catheter, particularly one having a 3-D distal component) in space as well as its shape and deformation and / or real-time deformation when the distal component is subjected to external forces (such as when the distal component comes into contact with tissue). Summary of the invention

[0009] An in vivo flexible probe adapted to deform when subjected to an external force includes one or more integrated electromagnetic (EM) loops of a conductive element that respond to one or more magnetic fields to provide electrical signals indicating the position of the probe in space and its shape (including its real-time deformation). The EM loop, which may be carried on or embedded in a flexible distal assembly and / or a flexible shaft of the probe, is configured to generate a voltage signal in response to a magnetic flux that induces a current through the EM loop. When the configuration of the EM loop changes due to deformation, the voltage signal of the EM loop changes accordingly in response to the deformation. In the case where a sufficient number of EM loops are positioned at different locations of the flexible portion of the probe, a collection of such responsive voltage signals may enable a system configured to receive and process the voltage signals to determine the position coordinates of the EM loop in a local coordinate system and track the shape of the flexible probe in real time.

[0010] In some embodiments, an in-vivo probe includes: a deformable portion; and a flexible electromagnetic loop positioned on the deformable portion, the flexible electromagnetic loop configured to generate an induced voltage in response to an external magnetic field.

[0011] In some embodiments, the intracorporeal probe further comprises a distal electrode assembly, and the deformable portion comprises a deformable portion of the distal electrode assembly.

[0012] In some embodiments, the intracorporeal probe further comprises a shaft, and the deformable portion comprises a portion of the shaft.

[0013] In some embodiments, the intracorporeal probe further comprises a distal electrode assembly, a shaft, and an interface therebetween, and the deformation comprises a portion of the interface.

[0014] In some embodiments, the flexible electromagnetic loop includes conductive ridges.

[0015] In some embodiments, the flexible electromagnetic loop includes a conductive coating.

[0016] In some embodiments, the flexible electromagnetic loop includes electrical traces.

[0017] In some embodiments, the flexible electromagnetic loop includes a flex circuit.

[0018] In some embodiments, the flexible electromagnetic loop is configured to generate different induced voltages when the deformable portion undergoes a deformation that changes the flexible magnetic loop from a neutral configuration to a deformed configuration.

[0019] In some embodiments, the induced voltage indicates a position of the flexible electromagnetic loop.

[0020] In some embodiments, the flexible electromagnetic loop is configured to generate the induced voltage in response to a first external magnetic field of a first frequency, and to generate a second induced voltage in response to a second external magnetic field of a second frequency.

[0021] In some embodiments, an in-vivo probe includes: a deformable portion; and a plurality of flexible electromagnetic loops, each of the plurality of flexible electromagnetic loops being in a different position on the deformable portion, each flexible electromagnetic loop being configured to generate a corresponding induced voltage in response to an external magnetic field.

[0022] In some embodiments, at least one of the flexible electromagnetic loops includes a conductive ridge.

[0023] In some embodiments, at least one of the flexible electromagnetic loops includes a conductive coating.

[0024] In some embodiments, at least one of the flexible electromagnetic loops includes an electrical trace.

[0025] In some embodiments, at least one of the flexible electromagnetic loops comprises a flex circuit.

[0026] In some embodiments, the flexible electromagnetic loop is configured to generate an induced voltage indicative of a position of the loop in a local coordinate system.

[0027] In some embodiments, the flexible electromagnetic loop is configured to generate an induced voltage indicative of deformation of the loop in a local coordinate system when the deformable portion transitions from a neutral configuration to a deformed configuration.

[0028] In some embodiments, each of the plurality of flexible electromagnetic loops is configured to generate the respective induced voltage in response to a first external magnetic field of a first frequency, and to generate a respective second induced voltage in response to a second external magnetic field of a second frequency.

[0029] In some embodiments, each of the plurality of flexible electromagnetic loops is configured to generate a corresponding induced voltage when subjected to an external force that causes deformation of the corresponding loop, and a collection of the corresponding induced voltages of the plurality of loops represents the deformed shape of the deformable portion.

[0030] In some embodiments, an intrabody probe includes: a deformable portion; and a first conductive element and a second conductive element, the first conductive element and the second conductive element configured as a flexible electromagnetic loop on the deformable portion. The intrabody probe also includes: a first terminal of the first conductive element, the first terminal configured to transmit a first induced voltage when exposed to a magnetic field; a second terminal of the second conductive element, the second terminal configured to transmit a second induced voltage when exposed to the magnetic field; and a connection point, the connection point configured to provide a voltage difference between the first induced voltage and the second induced voltage.

[0031] In some embodiments, the probe comprises an electrophysiology catheter having a flexible end effector comprising the deformable portion.

[0032] In some embodiments, the probe comprises an electrophysiology catheter having a flexible shaft comprising the deformable portion.

[0033] In some embodiments, the end effector includes a first spline and a second spline configured as the first and second conductive elements.

[0034] In some embodiments, the first and second conductive elements include first and second conductive coatings located on the end effector.

[0035] In some embodiments, the intracorporeal probe further comprises a flexible printed circuit board attached to the end effector, the printed circuit board comprising the first conductive element and the second conductive element.

[0036] In some embodiments, the first and second conductive elements are attached to an outer surface of the shaft.

[0037] In some embodiments, the shaft includes a sidewall, and the first and second conductive elements include first and second wires embedded in the sidewall.

[0038] In some embodiments, the first conductive element includes a non-linear segment.

[0039] In some embodiments, at least the first conductive element extends circumferentially around the shaft.

[0040] In some embodiments, a system includes: a magnetic field generator configured to generate a magnetic field; and a catheter. The catheter includes a deformable portion, a plurality of flexible electromagnetic loops, and at least a connection point. Each of the plurality of flexible electromagnetic loops is attached to a different location on the deformable portion, wherein each loop includes: a first conductive element; a second conductive element; a first terminal of the first conductive element, the first terminal configured to transmit a first induced voltage when exposed to the magnetic field; and a second terminal of the second conductive element, the second terminal configured to transmit a second induced voltage when exposed to the magnetic field. The at least connection point is configured to provide a voltage difference between the first induced voltage and the second induced voltage of each loop. The system also includes a display and a processor configured to: (i) receive the voltage difference of each loop from the at least one connection point; (ii) determine the coordinates of each loop relative to a local coordinate system; and (iii) drive the display based on the set of the coordinates of each loop to display a shape as a visual representation of the deformable portion.

[0041] In some embodiments, the deformable portion includes an electrode, and the system further includes an RF generator configured to power the electrode for ablation of tissue.

[0042] In some embodiments, the deformable portion includes a flexible end effector.

[0043] In some embodiments, the deformable portion comprises a flexible shaft.

[0044] In some embodiments, the deformable portion includes an end effector having first and second splines, the first and second splines being configured as the first and second conductive elements.

[0045] In some embodiments, the first and second conductive elements include first and second conductive coatings located on the end effector.

[0046] In some embodiments, the system further includes a flexible printed circuit board attached to the end effector, and the printed circuit board includes the first conductive element and the second conductive element.

[0047] In some embodiments, the first and second conductive elements are attached to an outer surface of the shaft.

[0048] In some embodiments, the shaft includes a sidewall, and the first and second conductive elements include first and second wires embedded in the sidewall.

[0049] In some embodiments, the display displays the shape as a visual representation in real time.

[0050] In some embodiments, a system includes: a magnetic field generator configured to generate a magnetic field; and a catheter. The catheter includes a deformable portion, a plurality of flexible electromagnetic loops, and at least a first connection point. Each of the plurality of flexible electromagnetic loops is attached to the deformable portion at a different location, and each loop includes: a first conductive element; a second conductive element; a first terminal of the first conductive element, the first terminal configured to transmit a first induced voltage when exposed to the magnetic field; and a second terminal of the second conductive element, the second terminal configured to transmit a second induced voltage when exposed to the magnetic field. The at least connection point is configured to provide a voltage difference between the first induced voltage and the second induced voltage of each loop. The system also includes a display and a processor, the processor being configured to: (i) receive the voltage difference of each loop from the at least one connection point; (ii) determine the coordinates of each loop relative to a local coordinate system; (iii) identify the shape of the deformable portion based on the set of the coordinates of each loop; and (iv) drive the display to display the shape as a visual representation of the deformable portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] These and other features and advantages of the present invention will be better understood by referring to the following detailed description when considered in conjunction with the accompanying drawings. It should be understood that selected structures and features are not shown in certain drawings in order to provide a better view of the remaining structures and features.

[0052] Figure 1 is a schematic illustration of a system according to a specific implementation of the disclosed subject matter.

[0053] Figure 2A is a device for use with a first configuration prior to deployment from a guide sheath according to a specific implementation of the disclosed subject matter. Figure 1A perspective view of an in vivo probe for use with the system.

[0054] Figure 2B is in a second configuration after being deployed from the introducer sheath Figure 2A Perspective view of the in vivo probe.

[0055] Figure 3 is in a neutral configuration according to a specific implementation of the disclosed subject matter Figure 2B Top plan view of the end effector of the in vivo probe.

[0056] Figure 4 is a top plan view of an end effector in a neutral configuration according to an alternative implementation of the disclosed subject matter.

[0057] Figure 5 It is in a deformed configuration when subjected to external forces. Figure 2B Front perspective view of the end effector.

[0058] Figure 6 is a side view of a basket end effector in a neutral configuration according to an implementation of the disclosed subject matter.

[0059] Figure 7 is a side view of a balloon end effector in a neutral configuration according to an implementation of the disclosed subject matter.

[0060] Fig. 8A is a front perspective view of a balloon catheter having a balloon end effector according to an implementation of the disclosed subject matter.

[0061] Figure 8B yes Fig. 8A A top plan view of the first substrate of the balloon end effector PCB.

[0062] Figure 8C yes Fig. 8A A top plan view of the second substrate of the balloon end effector PCB.

[0063] Fig.9A is a side view of a shaft with an EM loop in a neutral configuration according to a first implementation of the disclosed subject matter.

[0064] Fig. 9B is a side view of a shaft with an EM loop in a deflected configuration according to a second implementation of the disclosed subject matter.

[0065] Fig. 9C is a side view of a shaft with an EM loop in a deflected configuration according to a second implementation of a third implementation of the disclosed subject matter.

[0066] Fig.9Dis a side view of a shaft with an EM loop in a neutral configuration according to a fourth implementation of the disclosed subject matter. DETAILED DESCRIPTION

[0067] The following specific embodiments should be read in conjunction with the accompanying drawings, wherein the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0068] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the enumerated value, for example, "about 90%" may refer to a range of values ​​of 71% to 99%. In addition, as used herein, the terms "patient", "recipient", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment.

[0069] refer to Figure 1 , which shows an exemplary catheter-based electrophysiological mapping and ablation system (10). The system (10) includes a plurality of catheters that are inserted by a physician (24) through the patient's vascular system percutaneously into a chamber or vascular structure of a heart (12). Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart (12). One or more catheters may then be inserted into the delivery sheath catheter to reach a desired location in the heart (12). The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter (14) configured for sensing IEGM is shown herein. The physician (24) may place the distal end (28) of the catheter (14) in contact with the heart wall for sensing a target site in the heart (12). For ablation, the physician (24) may similarly place the distal end of the ablation catheter in contact with the target site for ablating tissue.

[0070] The catheter (14) is an exemplary catheter that includes one and preferably multiple electrodes (26) optionally distributed on multiple splines (22) at a distal tip (28) and configured to sense IEGM signals. The catheter (14) may further include a position sensor (29) embedded in or near the distal tip (28) for tracking the position and orientation of the distal tip (28). Optionally and preferably, the position sensor (29) is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0071] A magnetic-based position sensor (29) can operate with a positioning pad (25) that includes a plurality of magnetic coils (32) configured to generate a magnetic field in a predetermined working space. The real-time position of the distal tip (28) of the catheter (14) can be tracked based on the magnetic field generated by the positioning pad (25) and sensed by the magnetic-based position sensor (29). Details of magnetic-based position sensing technology are described in U.S. Patents 5,5391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091.

[0072] The system (10) includes one or more electrode patches (38) positioned in contact with the skin of a patient (23) to establish a position reference for impedance-based tracking of a positioning pad (25) and electrodes (26). For impedance-based tracking, current is directed to the electrodes (26) and sensed at the electrode skin patches (38) so that the position of each electrode can be triangulated via the electrode patches (38). Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0073] The recorder (11) records and displays electrograms (21) captured using surface ECG electrodes (18) and intracardiac electrograms (IEGMs) captured using electrodes (26) of the catheter (14). The recorder (11) may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0074] The system (10) may include an ablation energy generator (50) adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0075] The patient interface unit (PIU) (30) is an interface configured to establish electrical connectivity between catheters, other electrophysiological equipment, a power source, and a workstation (55) for controlling the operation of the system (10). The electrophysiological equipment of the system (10) may include, for example, multiple catheters, positioning pads (25), surface ECG electrodes (18), electrode patches (38), an ablation energy generator (50), and a recorder (11). Optionally and preferably, the PIU (30) further includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0076] The workstation (55) includes a memory, a processor unit having a memory or storage device storing appropriate operating software, and user interface capabilities. The workstation (55) can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering the model or anatomical map (20) for display on a display device (27); (2) displaying an activation sequence (or other data) compiled from recorded electrograms (21) as representative visual markers or images superimposed on the rendered anatomical map (20) on the display device (27); (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (4) displaying sites of interest on the display device (27), such as where ablation energy has been applied. A commercial product embodying elements of the system (10) can be purchased as the CARTO™ 3 system from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0077] like FIG. 2A to FIG. 2BAs shown, the catheter assembly (100) includes a handle assembly (110), a catheter (120) extending distally from the handle assembly (110), an end actuator (200) located at the distal end of the catheter (120), and a deflection drive actuator (114) associated with the handle assembly (110). The deflection drive actuator (114) can be rotated relative to the housing (112) of the handle assembly (110) to deflect the end actuator (200) and the distal portion of the catheter (120) away from the central longitudinal axis (LA) defined by the proximal portion of the catheter (120). Various suitable components that can be coupled to the deflection drive actuator (114) and the catheter (120) to provide such functionality will be apparent to those skilled in the art in view of the teachings herein.

[0078] The catheter (120) includes an elongated flexible shaft (122) and an outer sheath (124). The shaft (122) is coaxial and is slidably disposed within the outer sheath (124). The end effector (200) is positioned at the distal end of the shaft (122). The proximal end of the catheter (120) extends distally from the nozzle member (116) of the handle assembly (110). In some versions, the outer sheath (124) is an integral component of the catheter (120). In some other versions, the sheath (124) is a component of another instrument, and the catheter (120) is inserted into the sheath (124). In either case, the shaft (122) and the outer sheath (124) can be transformed between two arrangements, including as Figure 2A A first arrangement is shown, in which the outer sheath (124) is positioned distally relative to the shaft (122) such that the end effector (200) is contained within the outer sheath (124); and Figure 2B A second arrangement is shown in which outer sheath (124) is positioned proximally relative to shaft (122) such that end effector (200) is exposed relative to outer sheath (124). In some versions, shaft (122) translates relative to handle assembly (110) to achieve a different longitudinal positioning relative to outer sheath (124). In some other versions, outer sheath (124) translates relative to handle assembly (110) to achieve a different longitudinal positioning relative to shaft (122).

[0079] The catheter (120) and the end effector (200) may be in the following situations: Figure 2A The states shown are: when the catheter (120) is introduced into the patient (PA); and during transport from the insertion site to the target cardiovascular region in the patient (PA). Once the catheter (120) and the end effector (200) reach the target cardiovascular region in the patient (PA), the outer sheath (124) can be retracted proximally to expose the end effector (200), thereby allowing the end effector (200) to achieve Figure 2BShown in the expanded, unfolded state.

[0080] like Figure 2B and Figure 3 As shown, the end effector (200) is fixed to the distal end of the shaft (122) of the catheter (120) via a proximal coupling member (230). The end effector (200) of this example includes a plurality of splines (210) extending distally from the proximal connector 230. As an interface 213 with the proximal connector 230, the proximal portion of each spline (210) extends distally and diverges outward away from the central longitudinal axis (LA) defined by the proximal portion of the catheter (120). The longitudinal middle portion of each spline (210) is generally parallel to the central longitudinal axis (LA). The distal portion of each spline converges rearwardly toward the central longitudinal axis (LA). For example, the distal end of each spline is distally coupled to a distal coupling member 220 ( Figure 3 ), or alternatively, each spline may be formed by a linear spline bent into a U-shape so that the distal end and the proximal end converge at the proximal connector 230 ( Figure 4 Each spline (210) further comprises a plurality of electrodes (212) spaced apart from one another along the length of the ridge (210) ( Figure 3 ). In some versions, electrodes (212) may be operable to provide EP signals from tissue for EP mapping. Additionally or in the alternative, electrodes (212) may be operable to ablate tissue. Splines (210) may also include various other features, such as a temperature sensor, etc.

[0081] The splines (210) may be formed of an elastic material (e.g., Nitinol, etc.) such that the splines (210) may be elastically biased to present Figure 2B , Figure 3 and Figure 4 In some versions, when splines (210) are in the illustrated configuration, end effector (200) defines a generally planar configuration, wherein a plane defined by end effector (200) is along longitudinal axis (LA) and extends transversely from longitudinal axis (LA). The splines are also deformable such that the splines may be contained within outer sheath (124), such as Figure 2A As shown. The splines may thus deform inwardly toward the longitudinal axis (LA) along the plane defined by the end effector (200) to fit within the sheath (124). In addition to deforming and expanding along the plane defined by the end effector (200) to Figure 2A The status shown is the same as Figure 2B and Figure 3 In addition to transitioning between the states shown, the splines may also deform in a direction transverse to the plane defined by the end effector (200). Such deformation may occur when the end effector (200) is pressed against tissue ( Figure 5 ).

[0082] The proximal coupling member (230) may take any suitable form. In some embodiments, the coupling member (230) includes a cylindrical plastic (e.g., polyetheretherketone (PEEK) or the like) component. In some embodiments, the cylindrical plastic is flexible and deformable. The proximal end of the ridge (210) may be securely secured to the coupling member (230) via an adhesive, overmolding, welding, epoxy, or in any other suitable manner. Similarly, the distal end of the flexible shaft (122) may be securely secured to the coupling member (230) via an adhesive, overmolding, welding, epoxy, or in any other suitable manner. In some versions, in addition to these components being securely secured to the coupling member (230), the distal end of the flexible shaft (122) is securely secured to the proximal end (and in some embodiments, the distal end) of the spline (210) within the coupling member (230). The coupling member (230) of this example also includes a ring electrode (240). In some versions, ring electrode (240) is used to provide a reference signal from the patient's blood, while electrode (210) provides an EP mapping signal from the patient's tissue. Alternatively, ring electrode (240) may be used for any other suitable purpose. In some variations, ring electrode (240) is omitted.

[0083] In some versions, the workstation (55) ( Figure 1 ) can also be operated to receive EM loop signals indicating position and / or shape from the catheter assembly (100), as will be described in more detail below. In this type of formula, the workstation 55 can also be operated to process the EM loop signals (including voltage signals) to thereby determine the position and / or shape of the end effector (200) or other components of the catheter assembly (100) within the patient (PA). The positioning pad (25) can include a coil that generates an alternating magnetic field in a predetermined working volume that accommodates the heart (H). Each generator can also drive the coil at different frequencies.

[0084] The display device (27) is coupled to the workstation (55) and is operable to present an image of the patient's anatomical structure. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D mapping diagrams, etc.). The view of the patient's anatomical structure provided by the display device (27) may also be dynamically changed based on a signal indicating the position and / or shape of the catheter assembly (100), as further described below. For example, as the end effector (200) of the catheter (120) moves within the patient (PA), the corresponding position and / or shape data from the catheter may cause the workstation (55) to update the patient's anatomical structure view in the display device (27) in real time, so as to depict the patient's anatomical structure around the end effector (200) as the end effector (200) moves within the patient (PA). In addition, the workstation (55) may drive the display device (27) to display the position of the abnormal conductive tissue site detected by EP mapping using the end effector (200). By way of example only, workstation (55) may drive display device (27) to superimpose the location of abnormal conductive tissue sites on an image of the patient's anatomy, such as by superimposing illuminated dots, crosshairs, or some other form of visual indication of abnormal conductive tissue sites.

[0085] The workstation (55) may also advantageously drive the display device (27) to superimpose the current position and / or shape of the end effector (200), the shaft (122) (including any deformation experienced by the flexible portion of the catheter (100)) on the image of the patient's anatomy, such as by superimposing a graphical representation of such deformation. As the physician moves the end effector (200) within the patient (PA), such superimposed visual indications may also move in real time within the image of the patient's anatomy on the display device (27), thereby providing the operator with real-time visual feedback regarding the position and / or shape of the catheter (100) within the patient (PA) as the end effector (200) moves within the patient (PA). Thus, the image provided by the display device (27) may effectively provide a video tracking the position and / or shape of the catheter and its deformation within the patient (PA), without necessarily having any optical instrument (i.e., camera) viewing the end effector (200). In the same view, the display device (27) may simultaneously visually indicate the location of abnormal conductive tissue sites detected by EP mapping. Thus, the physician (PH) may view the display device (27) to observe the real-time positioning and / or shape of the catheter element relative to the mapped abnormal conductive tissue site and relative to an image of adjacent anatomical structures within the patient (PA).

[0086] This example may include a fluid source of this example, the fluid source including a bag containing saline or some other suitable irrigation fluid. The conduit includes a flexible tube, which is further coupled to a pump that is operable to selectively drive the fluid from the fluid source to the catheter assembly. In some variations, the conduit, fluid source, and pump are completely omitted. In a version that includes these components, the end effector can be configured to deliver irrigation fluid from the fluid source to a target site in the patient's body. Such irrigation can be provided in accordance with the teachings of any of the various patent references cited herein; or in any other suitable manner that will be apparent to a person skilled in the art with reference to the teachings herein.

[0087] exist Figure 3 and Figure 4 The embodiment of the catheter shown in FIG. 1 includes one or more electromagnetic (EM) loops made of conductive material formed on or otherwise integrated into one or more flexible portions of the catheter that are deformable when subjected to external forces. For example, Figure 4 As shown, extending from the distal end of the shaft are splines (210) that form closed EM spline loops (L1, L2, L3). Each spline loop is formed by a linear spline that is bent or bent on itself so that its distal end and its proximal end converge at an interface (213) with the distal end of the shaft. Each of the spline loops occupies a different position on the end effector (200), and each loop can generate a voltage signal based on the magnetic field flux through the corresponding loop at the location of the corresponding loop. The voltage reading of each loop can be provided at the corresponding connection point (C1, C2, C3).

[0088] According to a specific implementation of the disclosed subject matter, each EM loop is subjected to one or more alternating magnetic fields near the heart (H) of the patient (PA) generated by one or more field generators (32) of a positioning mat (25). Each loop can generate a voltage amount based on the magnetic field at the location of the loop. A console (12) having a processor receives a voltage signal generated by each EM loop in response to the magnetic flux of at least one alternating magnetic field, wherein the voltage signal can be measured from a voltage contact that is part of the loop or external to the loop. With respect to multiple magnetic fields generated, for example, at different frequencies, each magnetic field can induce a corresponding voltage in each loop, so that the processor can determine the position and orientation of each loop in a defined 3-D coordinate system, wherein the collection of such corresponding voltages of the loops is in different locations on the catheter.

[0089] The processor can construct an electromagnetic map of the heart based on any ECG signals (which indicate the electrical activity of the heart tissue) and the voltage induced in the loop (which indicates the respective locations of the loop and the source of the ECG signals). Such a map can be displayed on display 18.

[0090] Advantageously, when the flexible portion of the catheter is subjected to an external force causing deformation, the loops in the flexible portion undergo deformation as they transition from a neutral configuration to a deformed configuration, wherein such transition changes their respective induced voltages due to a change in the respective magnetic fluxes. Figure 5 , the catheter 100 has been manipulated into contact with tissue so that the end effector 200 is no longer parallel to the longitudinal axis LA defined by the shaft 122, but extends at a certain angle, wherein a deformation occurs at, for example, the interface 213, which is changed from Figure 2B The neutral configuration shown is transformed into Figure 5 And with each spline loop L1, L2, L3 occupying a corresponding position on the end effector 200, each spline loop may undergo a deformation that affects and changes the magnetic flux detected by each loop, thereby changing the corresponding voltage signal induced by the magnetic field.

[0091] When the processor of the console (12) detects changes in the voltage signals of the spline loops L1, L2, L3, these changes indicate that the spline loops have been deformed due to the external force that caused the deformation of the interface 213. It should be understood that for any configuration of flexible end effector (whether 2-D or 3-D), the coverage of the structure of the end effector with sufficient multiple EM loops on the surface and / or in the interior of the end effector (each EM loop at a different position or location on the end effector) enables the processor to monitor and track not only the position and orientation of the end effector, but also the overall shape of the end effector and any deformation it undergoes in the space defined by the local coordinate system.

[0092] Where multiple alternating magnetic fields are generating magnetic flux at different frequencies, the voltage signal (and changes therein) due to movement and deformation of the loop is measured at the corresponding frequencies to provide a signal indicative of such movement and deformation.

[0093] from Figure 3As can be seen from the embodiment of the end effector (200) of the embodiment of the invention, each spline 210 (e.g., a structure having a conductive material or as a substrate to which a conductive material is applied or integrated) can form a loop with any other spline. For example, spline (210a) can form a first loop (L1) with spline (210b) via a distal coupling (220), and spline (210a) can form a second loop (L2) with spline (210c) via a distal coupling (220), and spline (210b) and spline (210c) can form a third loop (L3) via a distal coupling (220). It should be understood that numerous different loops can be generated and specified by coupling different splines, wherein each of these loops can generate a different voltage signal based on the magnetic field generated by the field generator (32) of the positioning pad (25) at the location of the end effector (200), wherein the voltage reading is provided at the voltage measurement area or connection point (222). Thus, depending on the location of the spline (or the conductive element thereon) on the end effector (200) and the name and identification of the spline used to generate the loop, the guide and drive system 10 is able to detect the location of the loop (and therefore the catheter 100) along with the shape of the end effector and any deformation of that shape of the catheter, including any deformation of the end effector, shaft and / or interface, through the voltage measured at the connection point (222). To this end, one or more of the connection points 22 can be a voltage contact (such as a conductive pad or a wired connection) that is coupled to the guide and drive system (10) via a cable 30, through which the first driver module (14) receives and processes the loop voltage signal.

[0094] At the connection point of a pair of first and second splines that generally converge to form a loop, a first terminal of the first conductive element transmits a first voltage induced by the magnetic field through the loop, and a second terminal of the second conductive element transmits a second voltage induced by the magnetic field through the loop. The pair of first and second conductive elements collectively transmit a voltage difference induced across the first and second conductive elements forming the loop to a differential amplifier (not shown). The output from the amplifier represents the position and / or shape of the loop. It should be understood that, depending on the loop of interest, the voltage difference may be measured for any plurality of splines (and their corresponding conductive elements) forming the loop.

[0095] The processor of the console (12) is operable to process the loop voltage signals, thereby determining the position of each loop and the deformation of each loop, and thus collectively determining the shape of the end effector and shaft in which the loop resides. With respect to multiple loops configured at different locations on the end effector and the interface with the shaft, the multiple loops collectively connect the overall structure and interface of the end effector. Advantageously, the more loops configured at different locations on the catheter, the more completely the system can track the position and complete shape of the catheter in space.

[0096] coupled to a processor of the console (12) Figure 1 The display device (27) can present an image of the patient's anatomy based on a collection of images obtained preoperatively or intraoperatively (e.g., CT or MRI scans, 3-D maps, etc.). The view of the patient's anatomy provided by the display device (27) can also change dynamically based on a voltage signal from the loop of the catheter (100). For example, as Figure 5 As the end effector of the end effector (200) moves and / or deforms in the patient's body, the corresponding position voltage signal can cause the processor of the console (12) to update the patient's anatomical structure view in the display device (27) in real time to depict the patient's anatomical structure around the end effector as the end effector moves or deforms in the patient's body. In addition, the workstation (55) can drive the display device (27) to display the location of abnormal conductive tissue sites detected by electrophysiological (EP) mapping using electrodes 212 on the end effector (200) or detected in other ways (for example, using a dedicated EP mapping catheter, etc.).

[0097] The workstation (55) may also drive the display device (27) to superimpose the current position of the end effector along with its shape on the image of the patient's anatomy, such as by superimposing an illuminated graphic representing the shape or some other form of visual indication. As the physician moves the end effector within the patient (PA), this superimposed visual indication may also move in real time within the image of the patient's anatomy on the display device (27), thereby providing the operator with real-time visual feedback regarding the position and shape of the end effector within the patient (PA) as the end effector moves within the patient (PA), particularly in the case where the end effector is advanced into a tissue wall, which applies an external force to the end effector to deform the end effector and change the shape of the end effector. In the case where the spline is located in an area of ​​the end effector or shaft that is deformed by the external force, the deformation is also displayed in real time. Thus, the image provided by the display device (27) may effectively provide a video tracking the position and shape of the end effector within the patient (PA) without necessarily having any optical instrument (i.e., camera) viewing the end effector. In the same view, the display device (27) can simultaneously visually indicate the location of the abnormal conductive tissue site detected by EP mapping. Therefore, the physician (PH) can watch the display device (27) to observe the real-time positioning and / or shape (including any deformation) of the end effector relative to the mapped abnormal conductive tissue site and relative to the image of the adjacent anatomical structure in the patient (PA).

[0098] In some embodiments, the splines may be arranged to define a basket end effector (400) of any suitable shape, such as Figure 6 Spherical basket shown. Figure 6An embodiment of a spline 412 is shown in which the conductive elements are printed onto the spline. For example, each conductive element may include a conductive paint applied to the spline. In other embodiments, the conductive elements include wires attached to the surface of the spline. In other embodiments, the spline itself is composed of a conductive material.

[0099] As part of its structural framework, the basket end effector (400) includes a plurality of splines (412) whose proximal ends extend from a proximal coupling member (430) and whose distal ends converge at a hub (450). Because each spline is connected to all other splines via the hub (450), the combination of any two selected splines and their corresponding conductive elements can form an EM loop (e.g., L1, L2, L3), wherein a voltage difference induced by a magnetic field across the first and second conductive elements forming the loop can be measured at the connection point (430) located on the proximal coupling member. Notably, each loop (L1, L2, L3) need not be identical in shape and size to one another, as the pair of splines forming each loop need not be adjacent splines. An amplifier switch box (415) receiving a voltage signal via leads (417) on the proximal side of the basket end effector (400) can be configured to amplify the voltage difference between selected splines of the loop and provide an output to a processor of the console (12) via cables (30), wherein such output advantageously indicates the position and / or shape of the selected loop. With respect to multiple loops, each at a different position and / or location, the coverage of the structure of the basket end effector (400) with sufficient multiple EM loops on the surface (each at a different position or location on the end effector) enables the processor to monitor and track not only the position and orientation of the basket end effector (400), but also the overall shape of the basket end effector and any deformation it undergoes.

[0100] refer to Figure 7 In some embodiments, the balloon end effector (500) has a flexible printed circuit board (PCB) 502 attached to an outer surface (501) as a conductive element, wherein the PCB 502 provides an array (A1, A2) of electrodes 511 connected by leads (514) forming an EM loop (L). The signal output of the loop (L) is received by a processor of the console (12) via leads (517) extending proximally through the catheter shaft (522) coupled to the cable (30), wherein the processor analyzes the output of the position and / or shape of the loop (L). In some embodiments, the EM loop (L) includes a resistor (513) between the two arrays (A1, A2), which allows the electrodes (511) of the arrays to also be used as ablation electrodes, such as powered by, for example, an RF generator (507) connected proximally to the balloon end effector (500).

[0101] refer to Fig. 8A , Figure 8B and Figure 8C In some embodiments, the catheter (1000) includes a shaft (1010) and a deformable balloon (1012) configured with a plurality of flexible printed circuit boards (PCBs) (1014) disposed on an outer surface of the balloon (1012). In the illustrated embodiment, each PCB (1014) is configured to have a distal "leaf" portion (1016) and a proximal "stem" portion (1018) disposed along a respective longitudinal direction of the balloon (1012) to extend between the distal and proximal ends (1022D, 1024P) of the balloon (1012). Each PCB (1014) includes a first or outer substrate (1026) having one or more electrical / electromagnetic sensors and a second or inner substrate (1028) having one or more electrical / electromagnetic sensors. In some embodiments, the outer layer (1026) provides one or more electrodes configured for tissue proximity indication (TPI) via impedance measurement, as described in: U.S. Publication 2023 / 0028867, entitled Accurate Tissue Proximity; U.S. Publication 2022 / 0183748A1, entitled Accurate Tissue Proximity; U.S. Publication 2020 / 0177504AI, entitled Tissue Proximity Indication Based on a Subset of Electrodes; and U.S. Publication 2020 / 0129089, entitled Combined Active Current Location (ACL) and Tissue Proximity Indication (TPI) System, the entire contents of which are incorporated herein by reference.

[0102] In the illustrated embodiment, the first layer (1026) provides an outer trace electrode (1030) on an outwardly facing surface and the second layer (1028) provides an inner electrode (1032) on an inwardly facing surface, which together are configured for impedance measurement of TPI. The trace electrode (1030) is configured as a "fishbone shape" having a longitudinal portion (1013L) and a transverse finger portion (1030F). The transverse finger portion increases the circumferential or equatorial contact surface of the trace electrode, while the gaps between adjacent finger portions allow for balloon deflation / inflation. The inner electrode (1032) is located below the longitudinal portion (1013L).

[0103] The second layer (1028) also provides one or more electromagnetic sensors configured as one or more EM loops (1034) that respond to the positioning pad (25) ( Figure 1 ) provides a positional orientation of the balloon (1012) and balloon deformation. In some embodiments, balloon deformation (including inflation and deflation) as detected by the EM loop is used to measure pressure changes within the balloon, indicating, for example, contact of the balloon with tissue (e.g., with the ostium of a pulmonary vein).

[0104] Electrical connections for transmitting electrical signals to and from the trace electrodes (1030), inner electrodes (1032), and EM loops (1034) extend along respective stem portions (1018) of each layer (1026, 1028) of each PCB.

[0105] refer to Fig.9A In some embodiments, the EM loop (L) is configured to extend axially on the outer surface (623) of the catheter shaft (622) to detect bending or deformation of the shaft, particularly at a location proximal to and adjacent to the end effector (600). The EM loop (L) is coupled to the lead (617) so that the EM loop signal is transmitted proximally through the shaft (622) and received by the processor of the console (12) via the cable (30).

[0106] refer to Fig. 9B In some embodiments, the EM loop (L) is configured with one or more nonlinear sections (LN) on the outer surface (723) of the catheter shaft (722) to minimize mechanical strain when the catheter shaft is bent. When the shaft (722) is deflected or otherwise deformed, such as when the end effector (700) contacts tissue, the nonlinear sections (LN) configured, for example, in a zigzag shape can accommodate the stretching and / or compression of the conductive elements of the EM loop. The lead (717) extends proximally from the EM loop (L) through the catheter shaft (722) and is coupled to a processor of the console (12) via a cable (30).

[0107] Reference Fig. 9C In some embodiments, a plurality of EM loops (e.g., loops LA, LB) are each circumferentially disposed around an outer surface (823) of a catheter shaft (822), each having a corresponding pair of leads (817A, 817B) extending proximally through the shaft and coupled to a processor of a console (12) via a cable (30). In some embodiments, a plane defined by each EM loop is angularly offset from a radius D of the shaft (822) (e.g., see angle In some embodiments, the EM loops are overlapping, such as Fig.9D, although it should be understood that the EM loops may be non-overlapping.

[0108] refer to Fig.9D In some embodiments, the catheter shaft (922) has a sidewall (907) configured with an embedded conductive element (909), such as a conductive wire (903) extending continuously or electrically coupled in at least a portion of the shaft (922). The wire (903) can be configured in any suitable configuration, such as a counterclockwise, angularly offset spiral extending distally and a clockwise, oppositely angularly offset spiral extending proximally, with its ends coupled to a cable 30 for transmitting EM loop signals to a processor of the console (12). The coverage of the structure of the shaft (922) with sufficient multiple EM loops on the surface and / or in the interior of the shaft (922), each EM loop at a different location or position on the end effector, enables the processor to monitor and track not only the position and orientation of the shaft (922), but also the overall shape of the shaft and any deformation it undergoes.

[0109] Structural conductive materials such as splines or embedded wires may include, for example, copper, stainless steel, and nitinol. Materials with shape memory may advantageously maintain contact between electrodes carried on the splines and the tissue surface.

[0110] After the processor of console (12) analyzes the voltage measurement signal generated by one or more EM loops on the end effector, shaft and / or interface of catheter, the system obtains the apparent coordinates representing the apparent shape of any one of these catheter elements in the local coordinate system. The processor can then apply the model of the mechanical characteristics of any one of these catheter elements to the apparent coordinates. Then, the processor can calculate the cost function relative to the shape that can be presented by any one of these catheter elements in the patient's body. The processor can then identify and select the shape of any one of these deformed catheter elements in response to the cost function. Then, the processor can generate a correction coordinate set representing the correction shape of any one of these catheter elements. The processor using the correction coordinates can drive a display device (27) to display a more accurate representation of any one of these catheter elements. In this regard, the processor can apply a catheter mechanics algorithm, which defines the parameters of the catheter by combining pre-known characteristics, such as its neutral shape, bendability and / or flexibility, the size of any one of these catheter elements. Such catheter mechanics algorithms are described in U.S. Publication No. 2021 / 0345902, entitled “Catheter Shape and Position Detection Using Flexible Magnetic Sensor,” the entire contents of which are incorporated herein by reference.

[0111] The foregoing description has been presented with reference to the presently preferred embodiments of the invention. Those skilled in the art to which the invention pertains will appreciate that changes and modifications may be made to the structures described without intentionally departing from the principles, spirit and scope of the invention. Any feature or structure disclosed in one embodiment may be incorporated as needed or appropriate to replace or supplement other features of any other embodiment. As will be appreciated by those of ordinary skill in the art, the drawings are not necessarily drawn to scale. Therefore, the above-described specific embodiments should not be interpreted as being suitable only for the precise structures described and shown in the drawings, but rather should be interpreted as being consistent with and supporting the following claims, which have a full and fair scope of the invention.

Claims

1. An in-vivo probe, comprising: A deformable portion; and A flexible electromagnetic loop is positioned on the deformable portion, the flexible electromagnetic loop being configured to generate an induced voltage in response to an external magnetic field. 2 . The intracorporeal probe of claim 1 , further comprising a distal electrode assembly, and the deformable portion comprises a deformable portion of the distal electrode assembly.

3. The intracorporeal probe of claim 1 further comprising a shaft, and wherein the deformable portion comprises a portion of the shaft.

4. The intracorporeal probe of claim 1 further comprising a distal electrode assembly, a shaft, and an interface therebetween, and the deformation comprises a portion of the interface.

5. The intracorporeal probe according to claim 1, wherein: The flexible electromagnetic loop includes conductive ridges.

6. The intracorporeal probe according to claim 1, wherein: The flexible electromagnetic loop includes a conductive coating.

7. The intracorporeal probe according to claim 1, wherein: The flexible electromagnetic loop includes electrical traces.

8. The intracorporeal probe according to claim 1, wherein: The flexible electromagnetic loop includes a flexible circuit.

9. The intracorporeal probe according to claim 1, wherein: The flexible electromagnetic loop is configured to generate different induced voltages when the deformable portion undergoes a deformation that changes the flexible magnetic loop from a neutral configuration to a deformed configuration.

10. The intracorporeal probe according to claim 9, wherein: The induced voltage indicates the position of the flexible electromagnetic loop.

11. The intracorporeal probe according to claim 1, wherein: The flexible electromagnetic loop is configured to generate the induced voltage in response to a first external magnetic field of a first frequency, and to generate a second induced voltage in response to a second external magnetic field of a second frequency.

12. An in-vivo probe, comprising: A deformable portion; and A plurality of flexible electromagnetic loops are each in a different position on the deformable portion, each flexible electromagnetic loop being configured to generate a respective induced voltage in response to an external magnetic field.

13. The intracorporeal probe according to claim 12, wherein: At least one of the flexible electromagnetic loops includes a conductive ridge.

14. The intracorporeal probe according to claim 12, wherein: At least one of the flexible electromagnetic loops includes a conductive coating.

15. The intracorporeal probe according to claim 12, wherein: At least one of the flexible electromagnetic loops includes an electrical trace.

16. The intracorporeal probe according to claim 12, wherein: At least one of the flexible electromagnetic loops includes a flex circuit.

17. The intracorporeal probe according to claim 12, wherein: The flexible electromagnetic loop is configured to generate an induced voltage indicative of a position of the loop in a local coordinate system.

18. The intracorporeal probe according to claim 12, wherein: The flexible electromagnetic loop is configured to generate an induced voltage indicative of deformation of the loop in a local coordinate system when the deformable portion transitions from a neutral configuration to a deformed configuration.

19. The intracorporeal probe according to claim 17, wherein: Each of the plurality of flexible electromagnetic loops is configured to generate the respective induced voltage in response to a first external magnetic field of a first frequency, and to generate a respective second induced voltage in response to a second external magnetic field of a second frequency.

20. The intracorporeal probe according to claim 17, wherein: Each of the plurality of flexible electromagnetic loops is configured to generate a respective induced voltage when subjected to an external force causing deformation of the respective loop, and a collection of the respective induced voltages of the plurality of loops represents a deformed shape of the deformable portion.

21. An in-vivo probe, comprising: A deformable portion; a first conductive element and a second conductive element, wherein the first conductive element and the second conductive element are configured as a flexible electromagnetic loop on the deformable portion; a first terminal of the first conductive element, the first terminal being configured to transmit a first induced voltage when exposed to a magnetic field; a second terminal of the second conductive element, the second terminal being configured to transmit a second induced voltage when exposed to the magnetic field; and A connection point is configured to provide a voltage difference between the first induced voltage and the second induced voltage.

22. The intracorporeal probe according to claim 21, wherein: The probe includes an electrophysiology catheter having a flexible end effector including the deformable portion.

23. The intracorporeal probe according to claim 21, wherein: The probe comprises an electrophysiology catheter having a flexible shaft including the deformable portion.

24. The intracorporeal probe according to claim 21, wherein: The end effector includes first and second splines configured as the first and second conductive elements.

25. The intracorporeal probe according to claim 21, wherein: The first and second conductive elements include first and second conductive coatings on the end effector.

26. The intracorporeal probe according to claim 22, wherein: The intra-body probe also includes a flexible printed circuit board attached to the flexible end effector, the printed circuit board including the first conductive element and the second conductive element.

27. The intracorporeal probe according to claim 21, wherein: The first conductive element and the second conductive element are attached to an outer surface of the shaft.

28. The intracorporeal probe of claim 23, the shaft comprising a sidewall, and the first and second conductive elements comprising first and second wires embedded in the sidewall.

29. The intracorporeal probe according to claim 28, wherein: The first conductive element includes a non-linear segment.

30. The intracorporeal probe according to claim 28, wherein: The first conductive element extends circumferentially around the shaft.

31. A system comprising: a magnetic field generator configured to generate a magnetic field; A catheter, the catheter comprising: A deformable portion; a plurality of flexible electromagnetic loops, each of the plurality of flexible electromagnetic loops being attached to a different location on the deformable portion, wherein each loop comprises: a first conductive element; a second conductive element; a first terminal of the first conductive element, the first terminal being configured to transmit a first induced voltage when exposed to the magnetic field; and a second terminal of the second conductive element, the second terminal configured to transmit a second induced voltage when exposed to the magnetic field; at least a connection point configured to provide a voltage difference between the first induced voltage and the second induced voltage for each loop; Display, and A processor configured to: (i) receiving said voltage difference of each loop from at least one connection point; (ii) determining the coordinates of each loop relative to the local coordinate system; and (iii) driving the display based on the set of coordinates for each loop to display a shape as a visual representation of the deformable portion.

32. The system of claim 31, wherein: The deformable portion includes an electrode, and the system further includes an RF generator configured to energize the electrode for ablation of tissue.

33. The system of claim 31, wherein: The deformable portion includes a flexible end effector.

34. The system of claim 31, wherein: The deformable portion includes a flexible shaft.

35. The system of claim 31, wherein: The deformable portion includes an end effector having first and second splines, the first and second splines being configured as the first and second conductive elements.

36. The system of claim 31, wherein: The first and second conductive elements include first and second conductive coatings on the end effector.

37. The system of claim 31, wherein: The system also includes a flexible printed circuit board attached to the end effector, and the printed circuit board includes the first conductive element and the second conductive element.

38. The system of claim 31, wherein: The first conductive element and the second conductive element are attached to an outer surface of the shaft.

39. The system of claim 34, wherein: The shaft includes a sidewall, and the first and second conductive elements include first and second wires embedded in the sidewall.

40. The system of claim 31, wherein: The display displays the shape as a visual representation in real time.

41. A system comprising: A magnetic field generator and a catheter for generating a magnetic field, the catheter comprising a deformable portion, a plurality of flexible electromagnetic loops, and at least a first connection point, each of the plurality of flexible electromagnetic loops being attached to the deformable portion at a different location, each loop comprising: a first conductive element; a second conductive element; a first terminal of the first conductive element, the first terminal being configured to transmit a first induced voltage when exposed to the magnetic field; and a second terminal of the second conductive element, the second terminal being configured to transmit a second induced voltage when exposed to the magnetic field, the at least connection point being configured to provide a voltage difference between the first induced voltage and the second induced voltage of each loop, the system also comprising a display and a processor, the processor being configured to: (i) receive the voltage difference for each loop from the at least one connection point; (ii) determine the coordinates of each loop relative to a local coordinate system; (iii) identify the shape of the deformable portion based on the coordinates of each loop; and (iv) drive the display to display the shape as a visual representation of the deformable portion.

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