System and method for shape tracking of intrabody object subject to deformation

Abstract

To provide an intrabody probe.SOLUTION: An intrabody probe with a flexible portion is configured with one or more integrated EM loops of electrically conductive elements. When exposed to one or more external magnetic fields, the EM loops generate voltage signals that are indicative of positions of the EM loops, e.g., when the EM loops are subjected to an external force that results in deformation. With multiple EM loops at different locations on the flexible portion of the probe, a collection 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 loops in a local coordinate system and track a shape in a space representative of probe deformation in real time.SELECTED DRAWING: Figure 2B

Description

[Technical field]

[0001] (Priority) This application claims the benefit of U.S. patent application Ser. No. 63 / 524,144, entitled “System And Method For Shape Tracking Of Intrabody Object Subject To Deformation,” filed Jun. 29, 2023, the disclosure of which is incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates generally to detecting the location of a flexible object placed within a living body, and specifically to sensing multiple conductive elements on a flexible electrophysiological probe or device to track the shape and deformation of the flexible electrophysiological probe or device in space in real time. [Background technology]

[0003] Tracking the position of internal body objects such as sensors, tubes, catheters, dispensing devices and implants is required in many medical procedures. Well-established high-precision systems for determining the position and orientation of internal body objects have been developed based on magnetic field sensing. These systems utilize sensors affixed to the internal body objects to measure the relative strength of externally generated magnetic fields and derive the object's position from these measurements. Methods for magnetic-based position sensing are disclosed, for example, in U.S. Pat. Nos. 5,391,199, 5,433,489 and 6,788,967 (Ben-Haim), 6,690,963 (Ben-Haim et al.), 5,558,091 (Acker et al.), 6,172,499 (Ashe), and 6,177,792 (Govari), the entire disclosures of which are incorporated herein by reference.

[0004] Position sensing systems have also been developed that utilize impedance-based measurements. In such systems, impedance is measured between electrodes fixed to the internal object and electrodes placed on the body surface. The system then derives the position of the internal object from the impedance measurements. Methods for impedance-based position sensing are disclosed, for example, in U.S. Pat. Nos. 5,983,126 (Wittkampf), 6,456,864 (Swanson), and 5,944,022 (Nardella), the entire disclosures of which are incorporated herein by reference.

[0005] Hybrid position sensing systems and methods combining magnetic and electrical position sensing techniques are disclosed, for example, in US Patent Application Publication No. 20070016007 (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 equipped with a three-axis magnetic position sensor and one or more electrodes, is used to correlate the magnetic position measurements with the impedance-based measurements. This type of system alleviates the need for multiple magnetic position sensors and thus benefits from both magnetic position sensing and impedance-based sensing.

[0006] However, for catheters with relatively large distal tip assemblies, especially those that present a 3D configuration, magnetic, impedance-based, or hybrid position sensing only provides a "point" location of the corresponding sensor, but not the 3D configuration as a whole, especially as a structure with segments connected by joints. Furthermore, because magnetic position sensors, whether single-axis or multi-axis, are structurally rigid, the sensors are not suitable for mounting on flexible portions of a catheter to detect bending or deformation, including distal tip assemblies that bend at the interface with a flexible distal tip assembly or shaft. Because magnetic position sensors are mounted on rigid portions of the catheter shaft, they do not sense changes in the position of the distal assembly due to bending. Thus, magnetic position sensors are typically not used to detect deformation of the distal assembly due to bending or bending, for example, when pressed against the wall of a heart chamber. Summary of the Invention [Problem to be solved by the invention]

[0007] Accordingly, applicants have recognized a need to provide a system and method that can sense and track in real time the shape or volume in space of an intracorporeal device, such as an electrophysiological catheter, particularly having a 3D distal assembly, and its shape and deformation, and / or deformation when the distal assembly is subjected to an external force, such as when the distal assembly comes into contact with tissue. [Means for solving the problem]

[0008] An internal flexible probe adapted to deform when subjected to an external force includes one or more integrated electromagnetic (EM) loops of conductive elements that provide electrical signals indicative of the probe's position and shape in space, including its deformation, in real time, in response to one or more magnetic fields. The EM loops, which may be carried or embedded on the flexible distal assembly and / or flexible shaft of the probe, are configured to generate voltage signals in response to 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 correspondingly in response to the deformation. With a sufficient number of EM loops positioned at different locations of the flexible portion of the probe, collection of such response voltage signals may enable a system configured to receive and process the voltage signals to determine location coordinates of the EM loop in a local coordinate system and track a shape representative of the flexible probe in real time.

[0009] In some embodiments, the intracellular probe comprises 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.

[0010] In some embodiments, the intracellular probe further comprises a distal electrode assembly, and the deformable portion comprises a deformable portion of the distal electrode assembly.

[0011] In some embodiments, the intracellular probe further comprises a shaft, and the deformation portion comprises a portion of the shaft.

[0012] In some embodiments, the intracellular probe further comprises a distal electrode assembly, a shaft, and an interface between the distal electrode assembly and the shaft, the deformation including a portion of the interface.

[0013] In some embodiments, the flexible electromagnetic loop includes a conductive spine.

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

[0015] In some embodiments, the flexible electromagnetic loop includes an electrical trace.

[0016] In some embodiments, the flexible electromagnetic loop comprises a flex circuit.

[0017] In some embodiments, when the deformable portion experiences a deformation that changes the flexible magnetic loop from a neutral configuration to a deformed configuration, the flexible electromagnetic loop is configured to generate a different induced voltage.

[0018] In some embodiments, the induced voltage is indicative of the location of the flexible electromagnetic loop.

[0019] In some embodiments, the flexible electromagnetic loop is configured to generate an induced voltage in response to a first external magnetic field at a first frequency and to generate a second induced voltage in response to a second external magnetic field at a second frequency.

[0020] In some embodiments, the intracellular probe comprises a deformable portion and a plurality of flexible electromagnetic loops, each at a different position on the deformable portion, each flexible electromagnetic loop configured to generate a respective induced voltage in response to an external magnetic field.

[0021] In some embodiments, at least one of the flexible electromagnetic loops includes a conductive spine.

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

[0023] In some embodiments, at least one of the flexible electromagnetic loops includes an electrical trace.

[0024] In some embodiments, at least one of the flexible electromagnetic loops includes a flex circuit.

[0025] In some embodiments, the flexible electromagnetic loop is configured to generate an induced voltage that is indicative of the location of the loop in a local coordinate system.

[0026] In some embodiments, when the deformable portion transitions from a neutral configuration to a deformed configuration, the flexible electromagnetic loop is configured to generate an induced voltage that is indicative of a deformation of the loop in a local coordinate system.

[0027] In some embodiments, each of the plurality of flexible electromagnetic loops is configured to generate a respective induced voltage in response to a first external magnetic field at a first frequency and to generate a respective second induced voltage in response to a second external magnetic field at a second frequency.

[0028] In some embodiments, each of the plurality of flexible electromagnetic loops is configured to generate a respective induced voltage when subjected to an external force that causes deformation of the respective loop, and the collection of the respective induced voltages of the plurality of loops represents a deformed shape of the deformable portion.

[0029] In some embodiments, an intracellular probe comprises a deformable portion and first and second conductive elements, the first and second conductive elements configured as flexible electromagnetic loops on the deformable portion, a first terminal of the first conductive element configured to carry a first induced voltage when exposed to a magnetic field, a second terminal of the second conductive element configured to carry a second induced voltage when exposed to a magnetic field, and a connection point configured to provide a voltage difference between the first and second induced voltages.

[0030] In some embodiments, the probe includes an electrophysiology catheter having a flexible end effector, the flexible end effector including a deformable portion.

[0031] In some embodiments, the probe includes an electrophysiology catheter having a flexible shaft, the flexible shaft including a deformable portion.

[0032] In some embodiments, the end effector includes a first spline and a second spline configured as the first conductive element and the second conductive element.

[0033] In some embodiments, the first conductive element and the second conductive element include a first conductive coating and a second conductive coating on the end effector.

[0034] In some embodiments, the intracellular probe further comprises a flexible printed circuit board affixed to the end effector, the printed circuit board including a first electronically conductive element and a second electronically conductive element.

[0035] In some embodiments, the first conductive element and the second conductive element are affixed to an outer surface of the shaft.

[0036] In some embodiments, the shaft includes a sidewall and the first and second conductive elements include first and second wires embedded in the sidewall.

[0037] In some embodiments, the first conductive element includes a non-linear segment.

[0038] In some embodiments, at least the first conductive element extends circumferentially around the shaft.

[0039] In some embodiments, the 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 affixed to a different location on the deformable portion, and each loop includes a first conductive element, a second conductive element, a first terminal of the first conductive element configured to carry a first induced voltage when exposed to a magnetic field, and a second terminal of the second conductive element configured to carry a second induced voltage when exposed to a magnetic field. The at least the connection point is configured to provide a voltage difference between the first induced voltage and the second induced voltage of each loop. The system further includes a display and a processor, the processor configured to (i) receive the voltage difference of each loop from the at least one connection point, (ii) determine coordinates of each loop relative to a local coordinate system, and (iii) drive the display to display a shape as a visual representation of the deformable portion based on a set of coordinates of each loop.

[0040] In some embodiments, the deformable portion includes an electrode, and the system further includes an RF generator configured to energize the electrode for ablation of tissue.

[0041] In some embodiments, the deformable portion includes a flexible end effector.

[0042] In some embodiments, the deformable portion comprises a flexible shaft.

[0043] In some embodiments, the deformable portion includes an end effector having first and second splines configured as the first and second conductive elements.

[0044] In some embodiments, the first conductive element and the second conductive element include a first conductive coating and a second conductive coating on the end effector.

[0045] In some embodiments, the system further comprises a flexible printed circuit board affixed to the end effector, the printed circuit board including the first electronically conductive element and the second electronically conductive element.

[0046] In some embodiments, the first conductive element and the second conductive element are affixed to an outer surface of the shaft.

[0047] In some embodiments, the shaft includes a sidewall and the first and second conductive elements include first and second wires embedded in the sidewall.

[0048] In some embodiments, the display shows a visual representation of the shape in real time.

[0049] In some embodiments, the 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 affixed 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 configured to carry a first induced voltage when exposed to a magnetic field, and a second terminal of the second conductive element configured to carry a second induced voltage when exposed to a 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 further includes a display and a processor, the processor configured to (i) receive the voltage difference of each loop from the at least one connection point, (ii) determine coordinates of each loop relative to a local coordinate system, (iii) identify a shape of the deformable portion based on a set of 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]

[0050] These and other features and advantages of the present invention will be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which it is understood that in certain drawings, selected structures and features are not shown in order to better illustrate remaining structures and features. [Figure 1] FIG. 1 is a schematic diagram of a system in accordance with an implementation of the disclosed subject matter. [Figure 2A] 2 is a perspective view of an intracellular probe for use with the system of FIG. 1 in a first configuration prior to deployment from a guide sheath in accordance with an implementation of the disclosed subject matter. [Figure 2B] 2B is a perspective view of the intracellular probe of FIG. 2A in a second configuration after deployment from a guide sheath. [Diagram 3] 2C is a top view of the end effector of the intracellular probe of FIG. 2B in a neutral configuration in accordance with an implementation of the disclosed subject matter. [Figure 4] FIG. 13 is a top view of an end effector in a neutral configuration according to an alternative implementation of the disclosed subject matter. [Diagram 5] FIG. 2C is a front perspective view of the end effector of FIG. 2B in a deformed configuration when subjected to an external force. [Figure 6] FIG. 13 is a side view of a basket end effector in a neutral configuration in accordance with an implementation of the disclosed subject matter. [Figure 7] FIG. 13 is a side view of a balloon end effector in a neutral configuration in accordance with an implementation of the disclosed subject matter. [Figure 8A] FIG. 1 is a front perspective view of a balloon catheter according to an implementation of the disclosed subject matter with a balloon end effector. [Figure 8B] FIG. 8B is a top view of a first substrate of the PCB of the balloon end effector of FIG. 8A. [Figure 8C] FIG. 8B is a top view of the second substrate of the PCB of the balloon end effector of FIG. 8A. [Figure 9A] FIG. 1 is a side view of a shaft with an EM loop according to a first implementation of the disclosed subject matter in a neutral configuration. [Figure 9B] FIG. 13 is a side view of a shaft with an EM loop according to a second implementation of the disclosed subject matter in a deflected configuration. [Figure 9C] FIG. 13 is a side view of a shaft with an EM loop according to a third implementation of the disclosed subject matter in a deflected configuration. [Figure 9D] FIG. 13 is a side view of a shaft with an EM loop according to a fourth implementation of the disclosed subject matter in a neutral configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0051] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.

[0052] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates suitable dimensional tolerances that allow a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value, e.g., "about 90%" may refer to a range of values ​​of 71% to 99%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in human patients represents a preferred embodiment, it is not intended to limit the system or method to human use.

[0053] Please refer to FIG. 1, which shows an exemplary catheter-based electrophysiology mapping and ablation system (10). The system (10) includes multiple catheters that are percutaneously inserted by a physician (24) through a patient's vascular system and into a cavity or vasculature of a heart (12). Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart (12). One or more catheters can then be inserted into the delivery sheath catheter to reach the desired location within the heart 12. The multiple catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter (14) configured to sense IEGMs is illustrated herein. The physician 24 can place a distal tip 28 of the catheter 14 in contact with the heart wall to sense a target site in the heart 12. For ablation, physician 24 can similarly place the distal end of the ablation catheter in contact with a target site for tissue ablation.

[0054] Catheter 14 is an exemplary catheter including one, and preferably multiple, electrodes 26, optionally distributed across multiple splines 22 at distal tip 28, configured to sense IEGM signals. Catheter 14 may further include a position sensor 29 embedded in or near distal tip 28 for tracking the position and orientation of distal tip 28. Optionally and preferably, position sensor 29 is a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0055] The magnetic-based position sensor 29 may be operated in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the distal tip 28 of the catheter 14 may be tracked based on the magnetic fields generated by the location pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 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.

[0056] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a location reference for the location pads 25 as well as impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based location tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0057] The recorder 11 records and displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes 26 on the catheter 14. The recorder 11 may include pacing functionality for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0058] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal tip 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 unipolar or bipolar high voltage direct current pulses, such as may be used to effect irreversible electroporation (IRE), or combinations thereof.

[0059] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, the 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, a number of catheters, location pads 25, body 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 implementing real-time calculation of catheter location and performing ECG calculations.

[0060] The workstation (55) includes a memory, a processor unit with memory or storage device having suitable operating software stored therein, and user interface capabilities. The workstation (55) may optionally provide multiple functions including: (1) modeling endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map (20) for display on a display device (27), (2) displaying activation sequences (or other data) compiled from recorded electrograms (21) in a representative visual representation or image superimposed on the rendered anatomical map (20) on the display device (27), (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers, and (4) displaying sites of interest, such as locations where ablation energy has been applied, on the display device (27). One commercially available product embodying elements of the system (10) is available as the CARTO™ 3 system, available from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0061] As shown in Figures 2A-2B, the catheter assembly (100) includes a handle assembly (110), a catheter (120) extending distally from the handle assembly (110), an end effector (200) located at a distal end of the catheter (120), and a deflection drive actuator (114) associated with the handle assembly (110). The deflection drive actuator (114) is rotatable relative to a casing (112) of the handle assembly (110) to thereby deflect the end effector (200) and the distal portion (120) of the catheter away from a central longitudinal axis (LA) defined by a proximal portion of the catheter (120). A variety of suitable components that may be coupled with the deflection drive actuator (114) and the catheter (120) to provide such functionality will be apparent to those of skill in the art in view of the teachings herein.

[0062] The catheter (120) includes an elongated flexible shaft (122) and an outer sheath (124). The shaft (122) is coaxially and 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 variations, the outer sheath (124) is an integral component of the catheter (120). In some other variations, the sheath (124) is a component of a separate instrument and the catheter (120) is inserted into the sheath (124). In either scenario, the shaft (122) and outer sheath (124) may transition between two arrangements, including a first arrangement as shown in FIG. 2A in which the outer sheath (124) is positioned distally relative to the shaft (122) such that the end effector (200) is housed within the outer sheath (124), and a second arrangement as shown in FIG. 2B in which the outer sheath (124) is positioned proximally relative to the shaft (122) such that the end effector (200) is exposed to the outer sheath (124). In some variations, the shaft (122) translates relative to the handle assembly (110) to achieve different longitudinal positioning relative to the outer sheath (124). In some other variations, the outer sheath (124) translates relative to the handle assembly (110) to achieve different longitudinal positioning relative to the shaft (122).

[0063] The catheter 120 and end effector 200 may be in the state shown in Figure 2A when the catheter 120 is introduced into the body of a patient (PA) and during transition from the insertion site to the target cardiac vascular region within the patient (PA). Once the catheter 120 and end effector 200 reach the target cardiac vascular region within the patient (PA), the outer sheath 124 may be retracted proximally to expose the end effector 200, thereby allowing the end effector 200 to achieve the expanded, deployed state shown in Figure 2B.

[0064] As shown in Figures 2B and 3, the end effector (200) is secured to the distal end of the shaft (122) of the catheter (120) via a proximal coupling member (230). The end effector (200) of this embodiment includes a plurality of splines (210) extending distally from the proximal connector 230. As an interface 213 with the proximal connector 230, a proximal portion of each spline (210) extends distally and diverges outwardly away from a central longitudinal axis (LA) defined by the proximal portion of the catheter (120). A longitudinal intermediate portion of each spline (210) is generally parallel to the central longitudinal axis (LA). A distal portion of each spline converges back toward the central longitudinal axis (LA). For example, the distal end of each spline may be distally joined to a distal joint (220) in the form of a ball (FIG. 3), or alternatively, each spline may be formed from a linear spline bent into a U-shape such that the distal and proximal ends converge at a proximal connector 230 (FIG. 4). Each spline (210) may also include multiple electrodes (212) spaced apart from one another along the length of the spline (210) (FIG. 3). In some variations, the electrodes (212) are operable to provide EP signals from tissue for EP mapping. Additionally or alternatively, the electrodes (212) may be operable to ablate tissue. The splines (210) may also include various other features, such as temperature sensors.

[0065] The splines (210) may be formed from a resilient material (such as, for example, Nitinol) such that the splines (210) may be resiliently biased to assume the configurations shown in Figures 2B, 3, and 4. In some variations, the end effector (200) defines a generally flat configuration when the splines (210) are in the illustrated state, with the plane defined by the end effector (200) extending along and laterally from the longitudinal axis (LA). The splines are also deformable such that the spines may be accommodated within the outer sheath (124), as shown in Figure 2A. Thus, the splines may be deformed inwardly toward the longitudinal axis (LA) along the plane defined by the end effector (200) to accommodate within the sheath (124). In addition to deforming and expanding along a plane defined by the end effector (200) to transition between the state shown in Figure 2A and the states shown in Figures 2B and 3, the splines may also deform along 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).

[0066] The proximal coupling member (230) may take any other suitable form. In some embodiments, the coupling member (230) comprises a cylindrical plastic (e.g., polyether ether ketone (PEEK), etc.) component. In some embodiments, the cylindrical plastic is flexible and deformable. The proximal end of the spine (210) may be secured to the coupling member (230) via adhesive, overmolding, welding, epoxy, or in any other suitable manner. Similarly, the distal end of the flexible shaft (122) may be secured to the coupling member (230) via adhesive, overmolding, welding, epoxy, or in any other suitable manner. In some variations, the distal end of the flexible shaft (122) is secured to the proximal end (and in some embodiments the distal end) of the spine (210) within the coupling member (230), and in addition, these components are secured to the coupling member (230). The coupling member (230) of this example further includes a ring electrode (240). In some variations, the ring electrode (240) is used to provide a reference signal from the patient's blood, while the electrode (210) provides an EP mapping signal from the patient's tissue. Alternatively, the ring electrode (240) may be used for any other suitable purpose(s). In some variations, the ring electrode (240) is omitted.

[0067] In some variations, the workstation 55 (FIG. 1) is also operable to receive EM loop signals indicative of position and / or shape from the catheter assembly (100), as described in more detail below. In such variations, the workstation 55 is also operable 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 location pads (25) may include coils that generate alternating magnetic fields within a predetermined working volume that includes the heart (H). Each generator may also drive the coils at a different frequency.

[0068] The display device (27) is coupled to the workstation (55) and is operable to render an image of the patient's anatomy. Such an image may be based on a set of images (e.g., CT or MRI scans, 3D maps, etc.) acquired pre-operatively or intra-operatively. The view of the patient's anatomy provided via the display device (27) may also change dynamically based on signals indicative of the position and / or shape of the catheter assembly (100), as described further below. For example, as the end effector (200) of the catheter (120) moves within the patient (PA), corresponding position and / or shape data from the catheter may cause the workstation (55) to update the view of the patient's anatomy in the display device (27) in real time to depict the region of the patient's anatomy surrounding the end effector (200) as it moves within the patient (PA). Additionally, the workstation 55 may drive the display device 27 to indicate the location of the abnormal conductive tissue site as detected by EP mapping by the end effector 200. By way of example only, the workstation 55 may drive the display device 27 to superimpose the location of the abnormal conductive tissue site onto the image of the patient's anatomy, such as by superimposing an illuminated dot, crosshairs, or some other type of visual indication of the abnormal conductive tissue site.

[0069] The workstation (55) may also advantageously drive the display device (27) to superimpose the current position and / or shape of the end effector (200), shaft (122), including any deformations experienced by the catheter (100) of its flexible portion, onto the image of the patient's anatomy, such as by superimposing a graphical representation of such deformations. Such superimposed visual indications may also move within the image of the patient's anatomy on the display device (27) in real time as the physician moves the end effector (200) within the patient (PA), 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 images provided via the display device (27) may effectively provide a video that tracks the position and / or shape of the catheter within the patient (PA) and its deformations, without necessarily having any optics (i.e., a camera) viewing the end effector (200). In the same view, the display device 27 may simultaneously visually indicate the location of the abnormal conductive tissue sites detected via EP mapping, such that a physician (PH) may view the display device 27 and observe the real-time position and / or shape of the catheter elements in relation to images of the mapped abnormal conductive tissue sites and adjacent anatomical structures within the patient (PA).

[0070] This embodiment may include a fluid source including a bag containing saline or some other suitable irrigation fluid. The conduit includes a flexible tube further coupled to a pump operable to selectively drive fluid from the fluid source to the catheter assembly. In some variations, the conduit, fluid source, and pump are omitted entirely. In variations in which these components are included, the end effector may be configured to transfer irrigation fluid from the fluid source to a target site within a patient. Such irrigation may be performed according to the teachings of any of the various patent references cited herein, or in any other suitable manner that will be apparent to one of ordinary skill in the art in view of the teachings herein.

[0071] The catheter embodiment shown in Figures 3 and 4 includes one or more electromagnetic (EM) loops of conductive material formed on or otherwise integrated into one or more flexible portions of the catheter that can deform when subjected to an external force. For example, as shown in Figure 4, 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 from a linear spline that is curved or bent on itself such that its distal end converges with its proximal end at an interface (213) with the distal end of the shaft. Each of the spline loops occupies a different location on the end effector (200), and each loop can generate a voltage signal based on the magnetic flux through the respective loop at the location of the respective loop. A voltage reading of each loop can be provided at a respective connection point (C1, C2, C3).

[0072] According to implementations of the disclosed subject matter, each EM loop is exposed to one or more alternating magnetic fields around the heart (H) of the patient (PA) generated by one or more magnetic field generators (32) of the location pads (25). Each loop may generate a voltage quantity 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 flux of the at least one alternating magnetic field, and the voltage signal may be measured from a voltage contact that is part of the loop or is external to the loop. For example, with multiple magnetic fields generated at different frequencies, each magnetic field may induce a respective voltage in each loop such that the processor may ascertain the position and orientation of each loop in a defined 3D coordinate system with a collection of such respective voltages of the loops at different locations on the catheter.

[0073] The processor may construct an electromagnetic map of the heart based on any ECG signals (indicating electrical activity of the cardiac tissue) and the voltages induced in the loops (indicating the respective locations of the loops and the source of the ECG signals). Such a map may be displayed on the display 18.

[0074] Advantageously, when the flexible portion of the catheter is subjected to an external force that causes deformation, the loops in the flexible portion undergo deformation as they transition from a neutral configuration to a deformed configuration, and such transition changes the respective induced voltages as a result of the change in the respective magnetic flux. With reference to Fig. 5, the catheter 100 is manipulated into contact with tissue such that the end effector 200 is no longer parallel to the longitudinal axis LA defined by the shaft 122, but extends at an angle with deformation, e.g., at interface 213, which transitions from a neutral configuration as shown in Fig. 2B to a deformed or bent configuration as shown in Fig. 5. Also, with each spline loop L1, L2, L3 occupying its respective position on the end effector 200, each spline loop may undergo deformation that affects and alters the magnetic flux detected by each loop, thereby altering the respective voltage signals induced by the magnetic field.

[0075] 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 as a result of an external force causing deformation of the interface 213. It will be appreciated that for a flexible end effector of any configuration, coverage of the structure of the end effector with sufficient multiple EM loops on and / or within the surface of the end effector, each at a different position or location on the end effector, whether in 2D or 3D, allows 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 in space defined by a local coordinate system and any deformations it undergoes.

[0076] If multiple alternating magnetic fields are generating magnetic flux at different frequencies, the voltage signal (and its change) due to the movement and deformation of the loop is measured at each frequency to provide a signal indicative of such movement and deformation.

[0077] From the embodiment of end effector (200) of Figure 3, each spline (210) can form a loop with any other spline (either having a conductive material configuration or acting as a substrate to which a conductive material is applied or integrated). For example, spline (210a) may form a first loop (L1) through distal joint (220) with spline (210b), spline (210a) may form a second loop (L2) through distal joint (220) with spline (210c), and spline (210b) and spline (210c) may form a third loop (L3) through distal joint (220). It should be understood that an infinite number of different loops may be created and designated from coupling different splines, each of which may generate a separate voltage signal based on the magnetic field generated by the magnetic field generators (32) of the location pads (25) at the location of the end effector (200), with a voltage reading provided at the voltage measurement area or connection point (222). Thus, depending on the location of the splines (or conductive elements thereon) on the end effector (200) and the designation and identification of the splines used to create the loop, the guidance and drive system 10 may detect the location of the loop (and thus the catheter 100) along with any deformations in its shape of the catheter, including any deformations in the shape of the end effector and the interface with the end effector, shaft, and / or voltage measured at the connection point (222). To that end, one or more connection points 22 may be voltage contacts, such as conductive pads or wired connections, that are coupled to the guidance and drive system (10) via cable 30 where the loop voltage signal is received and processed by the first driver module (14).

[0078] At the connection point of the pair of first and second splines that approximately converge to form a loop, a first terminal of the first conductive element carries a first voltage induced by the magnetic field through the loop, and a second terminal of the second conductive element carries a second voltage induced by the magnetic field through the loop. The pair of first and second conductive elements collectively carry the voltage difference induced across the first and second conductive elements that form the loop to a differential amplifier (not shown). The output from the amplifier represents the position and / or shape of the loop. It will be appreciated that depending on the loop of interest, the voltage difference may be measured for any number of splines (and their respective conductive elements) that form the loop.

[0079] 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 therefore, collectively, the shape of the end effector and shaft in which the loops reside. With multiple loops configured at different locations on the interface with the end effector and shaft, the multiple loops collectively connect the entire structure of the end effector and interface. 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.

[0080] Coupled to the processor of the console (12), the display device (27) of FIG. 1 can render an image of the patient's anatomy based on a set of images (e.g., CT or MRI scans, 3D maps, etc.) acquired pre-operatively or intraoperatively. The view of the patient's anatomy provided through the display device (27) can also change dynamically based on voltage signals from the loop of the catheter (100). For example, as the end effector of FIG. 5 moves and / or deforms within the patient, the corresponding voltage signals can cause the processor of the console (12) to update the patient's anatomy in the display device (27) in real time to depict the area of ​​the patient's anatomy surrounding the end effector as it moves or deforms within the patient. Additionally, the workstation (55) can drive the display device (27) to show the location of abnormal conductive tissue sites as detected by electrophysiological (EP) mapping using the electrodes 212 on the end effector (200) or as otherwise detected (e.g., using a dedicated EP mapping catheter).

[0081] The workstation (55) may also drive the display device (27) to superimpose the current location of the end effector along with its shape onto the image of the patient's anatomy, such as by superimposing an illuminated graphic representation or other form of visual indication representing the shape. Such superimposed visual indication may also move within the image of the patient anatomy on the display device (27) in real time as the physician moves the end effector within the patient (PA), thereby providing the operator with real time visual feedback regarding the position and shape of the end effector within the patient (PA) as it moves within the patient, particularly as the end effector advances into a tissue wall, applying external forces to the end effector and deforming and changing the shape of the end effector. If the spline is located in an area of ​​the end effector or shaft that deforms as a result of an external force, the deformation is also displayed in real time. Thus, the image provided via the display device (27) may effectively provide a video that tracks the position and shape of the end effector within the patient (PA) without necessarily having optics (i.e., a camera) to view the end effector. In the same view, the display device 27 may simultaneously visually indicate the location of the abnormal conductive tissue site detected via EP mapping, such that the physician (PH) may look at the display device 27 and observe the real-time position and shape, including any deformations, of the end effector in relation to the image of the mapped abnormal conductive tissue site and adjacent anatomical structures within the patient (PA).

[0082] In some embodiments, the splines can be arranged to define a basket end effector (400) of any suitable shape, such as the spheroidal basket shown in Figure 6. Figure 6 shows an embodiment in which the conductive elements of the splines 412 are printed onto the splines. For example, each of the conductive elements may include a conductive paint that is painted onto the spline. In other embodiments, the conductive elements comprise wires affixed to the surface of the spline. In yet other embodiments, the splines themselves are constructed from a conductive material.

[0083] As part of its structural framework, the basket end effector (400) includes a number 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 every other spline via the hub (450), the combination of any two selected splines and their respective conductive elements can form an EM loop (e.g., L1, L2, L3), and a voltage difference induced by a magnetic field across the first and second conductive elements forming the loop can be measured at a 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 in that the pair of splines forming each loop need not be adjacent splines. An amplifier switch box (415) proximal to the basket end effector (400), which receives the voltage signal via leads (417), may be configured to amplify the voltage difference between selected splines of the loop and provide an output to a processor in the console (12) via cable (30), such output advantageously indicating the position and / or shape of the selected loop. With multiple loops, each at different positions and / or locations, 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, allows 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 end effector and any deformations it undergoes.

[0084] Referring to FIG. 7, in some embodiments, the balloon end effector (500) has as a conductive element a flexible printed circuit board (PCB) (502) affixed to the outer surface (501), the PCB (502) providing 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 a catheter shaft (522) coupled to the cable (30), and the processor analyzes the output for 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 array to also function as ablation electrodes, for example when energized by an RF generator (507) connected proximally to the balloon end effector (500).

[0085] 8A, 8B, and 8C, in some embodiments, a catheter (1000) includes a shaft (1010) and a deformable balloon (1012) configured with a number of flexible printed circuit boards (PCBs) (1014) disposed on an outer surface of the deformable balloon (1012). In the illustrated embodiment, each PCB (1014) is configured with a distal "leaf" portion (1016) and a proximal "stem" portion (1018) located along a respective length of the balloon (1012) and extending between a distal end (1022D) and a proximal end (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 measurements, as described in U.S. Patent Application Publication No. 2023 / 0028867, entitled Accurate Tissue Proximity, U.S. Patent Application Publication No. 2022 / 0183748(A1), entitled Accurate Tissue Proximity, U.S. Patent Application Publication No. 2020 / 0177504(AI), entitled Tissue Proximity Indication Based on a Subset of Electrodes, and U.S. Patent Application Publication No. 2020 / 0129089, entitled Combined Active Current Location (ACL) and Tissue Proximity Indication (TPI) System, the contents of all of which are incorporated herein by reference.

[0086] In the illustrated embodiment, the first layer (1026) provides an outer trace electrode (1030) on its outward facing surface, and the second layer (1028) provides an inner electrode (1032) on its inward facing surface, which together are configured for impedance measurement for TPI. The trace electrode (1030) is configured as a "fishbone" having a longitudinal portion (1013L) and lateral finger portions (1030F). The lateral finger portions increase the circumferential or equatorial contact surface of the trace electrode, while the gap between adjacent finger portions allows the balloon to deflate / inflate. The inner electrode (1032) is located below the longitudinal portion (1013L).

[0087] The second layer (1028) also provides one or more electromagnetic sensors configured as one or more EM loops (1034) that provide location orientation of the balloon (1012) and location orientation of balloon deformation in response to the magnetic field generators (32) of the location pad (25) (FIG. 1). In some embodiments, balloon deformation (including inflation and deflation) as detected by the EM loops is used to measure pressure changes within the balloon, e.g., indicative of balloon contact with tissue, e.g., the ostium of a pulmonary vein.

[0088] Electrical connections that transmit electrical signals between the trace electrodes (1030), the inner electrodes (1032), and the EM loops (1034) extend along each stem portion (1018) of each layer (1026, 1028) of each PCB.

[0089] 9A, in some embodiments, the EM loop (L) extends axially on the outer surface (623) of the catheter shaft (622) and is configured to detect bending or deformation of the shaft, particularly at locations proximal and adjacent to the end effector (600). The EM loop (L) is coupled to a lead (617) such that an EM loop signal is transmitted proximally through the shaft (622) and received by a processor of the console (12) via cable (30).

[0090] 9B, in some embodiments, the EM loop (L) is configured with one or more nonlinear segments (LN) on the outer surface (723) of the catheter shaft (722) to minimize mechanical strain when the catheter shaft is bent. For example, the nonlinear segments (LN) configured as zigzags can accommodate elongation and / or compression of the conductive elements of the EM loop when the shaft (722) is deflected or otherwise deformed, such as when the end effector (700) contacts tissue. From the EM loop (L), the leads (717) extend proximally through the catheter shaft (722) and are coupled to the processor of the console (12) via the cable (30).

[0091] 9C, in some embodiments, multiple EM loops (e.g., loops LA, LB) are each configured circumferentially around the outer surface (823) of the catheter shaft (822), each with a respective pair of leads (817A, 817B) that extend proximally through the shaft and are coupled to a processor of the console (12) via cable (30). In some embodiments, the plane defined by each EM loop is angularly offset from the diameter D of the shaft (822) (see, e.g., angles θ and β). In some embodiments, the EM loops overlap as shown in FIG. 8D, although it will be understood that the EM loops need not overlap.

[0092] Referring to FIG. 9D, in some embodiments, the catheter shaft (922) has a sidewall (907) configured with embedded conductive elements (909), e.g., conductive wires (903) that extend continuously or are electrically coupled in at least a portion of the shaft (922). The wires (903) may be configured in any suitable configuration, e.g., an angularly offset spiral that extends distally in a counterclockwise direction, and an angularly offset spiral that extends proximally in an opposite clockwise direction, with the ends coupled to a cable 30 for transmitting any EM loop signals to a processor in the console (12). Coverage of the structure of the shaft (922) with sufficient multiple EM loops on and / or within the shaft (922), each at a different position or location on the end effector, allows the processor to monitor and track not only the position and orientation of the shaft (922), but also the overall shape and any deformations it undergoes.

[0093] Structural conductive materials such as splines or embedded wires may include, for example, copper, stainless steel, and nitinol. Materials with shape memory may be advantageous to maintain contact between electrodes carried on the splines and the tissue surface.

[0094] After the processor of the console (12) analyzes the voltage measurement signals generated by one or more EM loops on the catheter end effector, shaft, and / or interface, the system obtains apparent coordinates representing the apparent shape of any of these catheter elements in a local coordinate system. The processor may then apply a model of the mechanical properties of any of these catheter elements to the apparent coordinates. The processor may then calculate a cost function for the shapes that may be assumed by any of these catheter elements in the patient's body. The processor may then identify and select shapes of any of these deformed catheter elements in response to the cost function. The processor may then generate a set of corrected coordinates representing the corrected shape of any of these catheter elements. The processor using the corrected coordinates may drive the display device (27) to display a more accurate representation of any of these catheter elements. In this regard, the processor may apply a catheter mechanics algorithm that defines the parameters of the catheter by combining a priori known properties such as the neutral shape of the catheter, the bending and / or flexibility, the dimensions of any of these catheter elements, etc. Such catheter dynamics algorithms are described in U.S. Patent Application Publication No. 2021 / 0345902, entitled “Catheter Shape and Position Detection Using Flexible Magnetic Sensor,” the entire disclosure of which is incorporated herein by reference.

[0095] The above description is provided in relation to the presently preferred embodiment of the present invention. Those skilled in the art and technology to which the present invention pertains will recognize that modifications and variations may be made to the described structure without significantly departing from the principles, spirit, and scope of the present invention. Any feature or configuration disclosed in one embodiment may be incorporated in place of or in addition to other features of any other embodiment, as necessary or appropriate. As will be appreciated by those skilled in the art, the drawings are not necessarily to scale. Thus, the above description should not be read in relation to the exact configurations described and illustrated in the accompanying drawings, but rather in accordance with and in support of the following claims, which are to have their fullest and fairest scope.

[0096] [Embodiment] (1) An intra-body probe, comprising: A deformable portion; 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. (2) An intracorporeal probe as described in embodiment 1, further comprising a distal electrode assembly, wherein the deformable portion includes a deformable portion of the distal electrode assembly. (3) An intracellular probe as described in embodiment 1, further comprising a shaft, the deformable portion comprising a portion of the shaft. (4) The intracorporeal probe of embodiment 1, further comprising a distal electrode assembly, a shaft, and an interface between the distal electrode assembly and the shaft, wherein the deformation comprises a portion of the interface. (5) An intracorporeal probe as described in embodiment 1, wherein the flexible electromagnetic loop includes a conductive spine.

[0097] (6) The intrabody portion of embodiment 1, wherein the flexible electromagnetic loop includes a conductive coating. (7) The intrabody portion of embodiment 1, wherein the flexible electromagnetic loop includes an electrical trace. (8) The intrabody portion of embodiment 1, wherein the flexible electromagnetic loop comprises a flex circuit. (9) An intracorporeal probe as described in embodiment 1, wherein the flexible electromagnetic loop is configured to generate a different induced voltage when the deformable portion experiences a deformation that changes the flexible magnetic loop from a neutral configuration to a deformed configuration. (10) The internal body portion of embodiment 9, wherein the induced voltage indicates the location of the flexible electromagnetic loop.

[0098] (11) The intrabody portion described in embodiment 1, wherein the flexible electromagnetic loop is configured to generate the induced voltage in response to a first external magnetic field at a first frequency and to generate a second induced voltage in response to a second external magnetic field at a second frequency. (12) An intra-body probe, comprising: A deformable portion; and a plurality of flexible electromagnetic loops, each at a different position on the deformable portion, each flexible electromagnetic loop configured to generate a respective induced voltage in response to an external magnetic field. (13) The intracorporeal probe of embodiment 12, wherein at least one of the flexible electromagnetic loops includes a conductive spine. (14) The intracorporeal probe of embodiment 12, wherein at least one of the flexible electromagnetic loops includes a conductive coating. (15) The intracorporeal probe of embodiment 12, wherein at least one of the flexible electromagnetic loops includes an electrical trace.

[0099] (16) The intracorporeal probe of embodiment 12, wherein at least one of the flexible electromagnetic loops includes a flex circuit. (17) The intracorporeal probe of embodiment 12, wherein the flexible electromagnetic loop is configured to generate an induced voltage indicative of a location of the loop in a local coordinate system. (18) An intracorporeal probe as described in embodiment 12, wherein the flexible electromagnetic loop is configured to generate an induced voltage indicative of a deformation of the loop in a local coordinate system when the deformable portion transitions from a neutral configuration to a deformed configuration. (19) An intracorporeal probe as described in embodiment 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 at a first frequency and to generate a respective second induced voltage in response to a second external magnetic field at a second frequency. (20) An intracorporeal probe as described in embodiment 17, wherein each of the plurality of flexible electromagnetic loops is configured to generate a respective induced voltage when subjected to an external force that causes deformation of the respective loop, and the collection of the respective induced voltages of the plurality of loops represents a deformed shape of the deformable portion.

[0100] (21) An intracellular probe, comprising: A deformable portion; a first conductive element and a second conductive element, the first conductive element and the second conductive element being configured as a flexible electromagnetic loop on the deformation portion; a first terminal of the first conductive element configured to carry a first induced voltage when exposed to a magnetic field; a second terminal of the second conductive element configured to carry a second induced voltage when exposed to the magnetic field; a connection point configured to provide a voltage difference between the first induced voltage and the second induced voltage. (22) The intracorporeal probe of embodiment 21, wherein the probe comprises an electrophysiological catheter having a flexible end effector, the flexible end effector comprising the deformable portion. (23) The intracorporeal probe of embodiment 21, wherein the probe comprises an electrophysiological catheter having a flexible shaft, the flexible shaft comprising the deformable portion. (24) The intracorporeal probe of embodiment 21, wherein the end effector includes a first spline and a second spline configured as the first conductive element and the second conductive element. (25) The intracellular probe of embodiment 21, wherein the first conductive element and the second conductive element comprise a first conductive coating and a second conductive coating on the end effector.

[0101] (26) The intracellular probe of embodiment 22, further comprising a flexible printed circuit board attached to the flexible end effector, the printed circuit board including a first electronically conductive element and a second electronically conductive element. (27) The intracorporeal probe of embodiment 21, wherein the first conductive element and the second conductive element are affixed to an outer surface of the shaft. (28) The intracorporeal probe of embodiment 23, wherein the shaft includes a side wall, and the first conductive element and the second conductive element include a first wire and a second wire embedded in the side wall. (29) The intracellular probe of embodiment 28, wherein the first conductive element includes a nonlinear segment. (30) The intracorporeal probe of embodiment 28, wherein the first conductive element extends circumferentially around the shaft.

[0102] (31) A system comprising: a magnetic field generator configured to generate a magnetic field; A catheter comprising: A deformable portion; a plurality of flexible electromagnetic loops, each of the plurality of flexible electromagnetic loops being affixed to a different location on the deformed portion, each loop including a first conductive element, a second conductive element, a first terminal of the first conductive element configured to carry a first induced voltage when exposed to the magnetic field, and a second terminal of the second conductive element configured to carry a second induced voltage when exposed to the magnetic field; at least one connection point configured to provide a voltage difference between the first induced voltage and the second induced voltage of each loop; and A display and a processor, the processor comprising: (i) receiving the voltage difference for each loop from the at least one node; (ii) determining the coordinates of each loop relative to a local coordinate system; (iii) a system configured to drive the display to display a shape as a visual representation of the deformable portion based on the set of coordinates of each loop. (32) The system of embodiment 31, wherein the deformable portion includes an electrode, and the system further includes an RF generator configured to energize the electrode for tissue ablation. (33) The system of embodiment 31, wherein the deformable portion includes a flexible end effector. (34) The system of embodiment 31, wherein the deformable portion comprises a flexible shaft. (35) The system of embodiment 31, wherein the deformable portion includes an end effector having a first spline and a second spline configured as the first conductive element and the second conductive element.

[0103] (36) The system of embodiment 31, wherein the first conductive element and the second conductive element comprise a first conductive coating and a second conductive coating on the end effector. (37) The system of embodiment 31, wherein the system further comprises a flexible printed circuit board attached to the end effector, the printed circuit board including a first electronically conductive element and a second electronically conductive element. (38) The system of embodiment 31, wherein the first conductive element and the second conductive element are affixed to an outer surface of the shaft. (39) The system of embodiment 34, wherein the shaft includes a sidewall, and the first conductive element and the second conductive element include a first wire and a second wire embedded in the sidewall. (40) The system of embodiment 31, wherein the display displays a visual representation of the shape in real time.

[0104] (41) A system comprising: A system comprising a magnetic field generator for generating a magnetic field and a catheter, 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 affixed to the deformable portion at a different location, each loop including a first conductive element, a second conductive element, a first terminal of the first conductive element configured to carry a first induced voltage when exposed to the magnetic field, and a second terminal of the second conductive element configured to carry 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 further comprises a display and a processor, the processor configured to (i) receive the voltage difference of each loop from the at least one connection point, (ii) determine coordinates of each loop relative to a local coordinate system, (iii) identify a 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.

Claims

1. An intracellular probe, comprising: A deformable portion; 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.

2. The intracellular probe of claim 1 , further comprising a distal electrode assembly, the deformable portion comprising a deformable portion of the distal electrode assembly.

3. The intracellular probe of claim 1 , further comprising a shaft, the deformable portion comprising a portion of the shaft.

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

5. The intrabody probe of claim 1 , wherein the flexible electromagnetic loop includes a conductive spine.

6. The body portion of claim 1 , wherein the flexible electromagnetic loop includes a conductive coating.

7. The body portion of claim 1 , wherein the flexible electromagnetic loop comprises an electrical trace.

8. The intrabody portion of claim 1 , wherein the flexible electromagnetic loop comprises a flex circuit.

9. The intracellular probe of claim 1 , wherein the flexible electromagnetic loop is configured to generate a different induced voltage when the deformable portion experiences a deformation that changes the flexible magnetic loop from a neutral configuration to a deformed configuration.

10. The internal body portion of claim 9 , wherein the induced voltage is indicative of the location of the flexible electromagnetic loop.

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

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

13. The intracellular probe of claim 12 , wherein at least one of the flexible electromagnetic loops includes a conductive spine.

14. The intracellular probe of claim 12 , wherein at least one of the flexible electromagnetic loops includes a conductive coating.

15. The intracellular probe of claim 12 , wherein at least one of the flexible electromagnetic loops includes an electrical trace.

16. The intracellular probe of claim 12 , wherein at least one of the flexible electromagnetic loops comprises a flex circuit.

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

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

19. 20. The intracorporeal probe of 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 at a first frequency and to generate a respective second induced voltage in response to a second external magnetic field at a second frequency.

20. 20. The intracorporeal probe of 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 that causes deformation of the respective loop, and the collection of the respective induced voltages of the plurality of loops represents a deformed shape of the deformable portion.

21. An intracellular probe, comprising: A deformable portion; a first conductive element and a second conductive element, the first conductive element and the second conductive element being configured as a flexible electromagnetic loop on the deformation portion; a first terminal of the first conductive element configured to carry a first induced voltage when exposed to a magnetic field; a second terminal of the second conductive element configured to carry a second induced voltage when exposed to the magnetic field; a connection point configured to provide a voltage difference between the first induced voltage and the second induced voltage.

22. The intracellular probe of claim 21 , wherein the probe comprises an electrophysiology catheter having a flexible end effector, the flexible end effector including the deformable portion.

23. The intracellular probe of claim 21 , wherein the probe comprises an electrophysiology catheter having a flexible shaft, the flexible shaft including the deformable portion.

24. The intracellular probe of claim 21 , wherein the end effector includes first and second splines configured as the first and second conductive elements.

25. The intracellular probe of claim 21 , wherein the first and second conductive elements comprise first and second conductive coatings on the end effector.

26. The intracellular probe of claim 22 , further comprising a flexible printed circuit board affixed to the flexible end effector, the printed circuit board including a first electronically conductive element and a second electronically conductive element.

27. The intracellular probe of claim 21 , wherein the first conductive element and the second conductive element are affixed to an outer surface of the shaft.

28. 24. The intracellular probe of claim 23, wherein the shaft includes a sidewall, and the first and second conductive elements include first and second wires embedded in the sidewall.

29. 30. The intracellular probe of claim 28, wherein the first conductive element comprises a nonlinear segment.

30. 30. The intracellular probe of claim 28, wherein the first conductive element extends circumferentially around the shaft.

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

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

33. The system of claim 31 , wherein the deformable portion comprises a flexible end effector.

34. The system of claim 31 , wherein the deformable portion comprises a flexible shaft.

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

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

37. 32. The system of claim 31, further comprising a flexible printed circuit board affixed to the end effector, the printed circuit board including a first electronically conductive element and a second electronically conductive element.

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

39. 35. 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. 32. The system of claim 31, wherein the display displays a visual representation of the shape in real time.

41. 1. A system comprising: A system comprising: a magnetic field generator for generating a magnetic field; and a catheter. The catheter comprises 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 affixed to the deformable portion at a different location, each loop including a first conductive element, a second conductive element, a first terminal of the first conductive element configured to carry a first induced voltage when exposed to the magnetic field, and a second terminal of the second conductive element configured to carry a second induced voltage when exposed to the magnetic field, the at least a connection point configured to provide a voltage difference between the first induced voltage and the second induced voltage of each loop. The system further comprises 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 coordinates of each loop relative to a local coordinate system, (iii) identify a 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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