Signal leakage for electromagnetic tracking of intraluminal device inside patient body

Abstract

An apparatus includes one or more processors that communicate with an intraluminal device using an electrical signal while the intraluminal device is positioned inside a patient body. The electrical signal is associated with operation of the intraluminal device to perform intraluminal sensing or treatment inside the patient body. The processor(s) receive a position and / or an orientation of the intraluminal device. The position and / or the orientation is determined based on an electromagnetic tracking signal generated by an electromagnetic field sensor. The electromagnetic tracking signal is representative of a signal leakage of the electrical signal. The processor(s) provide, to a display, an output based on the position and / or the orientation of the intraluminal device.

Description

2024PF00686SIGNAL LEAKAGE FOR ELECTROMAGNETIC TRACKING OF INTRALUMINAL DEVICE INSIDE PATIENT BODYTECHNICAL FIELD

[0001] The subject matter described herein relates to an apparatuses (e.g. devices, systems, ), and methods for tracking of an intraluminal device using leakage of signals for the ordinary operation of the intraluminal device (e.g., signals for intraluminal sensing or treatment, not dedicated tracking signals). This passive electromagnetic tracking system has particular but not exclusive utility for intravascular and intracardiac devices (e.g., intracardiac echocardiography or ICE catheter).BACKGROUND

[0002] During intraluminal procedures, such as intracardiac echography (ICE), it may be desirable to know the position of an intraluminal device, such as the imaging element of an ICE catheter. This can be achieved using radiopaque markers on the device, which may for example show up on live X-ray images. However, this may be insufficient to provide 3 degree-of-freedom (3-DOF) position information (e.g., X, Y, and Z position), or 6 degree-of-freedom (6-DOF) position and / or orientation information (e.g., X, Y, and Z position, plus pitch, yaw, and roll orientation).

[0003] In some cases, dedicated electromagnetic (EM) tracking sensors may be included in the intraluminal instrument. In many versions of EM tracking systems, the dedicated EM tracking sensors require electrical wire connection to the tracking system for power and / or signal communication.

[0004] Recently, some versions of EM tracking systems (e.g., FreeNav) have emerged that use dedicated EM tracking sensors (referred to as “tags”) that do not require an electrical wire connection to the tracking system. These passively tracked systems rely on a perturbation of the magnetic field caused by the “tag” to determine the tag’s location

[0005] Existing techniques for EM tracking require integration of dedicated tracking sensors into the device itself. If the sensor is wired, the wires must also be integrated, which can increase diameter of the intraluminal device. Integration of dedicated tracking components (sensor, wire) increases the complexity and expense of the device and may also create additional failure modes.

[0006] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included2024PF00686for technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound.SUMMARY

[0007] Disclosed is a passive electromagnetic tracking system. Signal leakage occurs from electronics (e.g., an unshielded portion) at the distal of an intraluminal sensing or treatment device (e.g., an intracardiac echocardiography (ICE) catheter), as a byproduct of its normal function. For example, the signals are for operation of the intraluminal device for intraluminal sensing (e.g., intraluminal ultrasound imaging) or intraluminal treatment. The signals are not dedicated electromagnetic tracking signals. This signal leakage is usually considered a problem, and efforts are typically made reduce it. As described herein, the signal leakage is beneficially used for electromagnetic tracking. The signal leakage can be sensed as electromagnetic perturbations by an electromagnetic field receiver, which indicates the position (X, Y, and / or Z) and / or the orientation (roll, pitch, and / or yaw) of the intraluminal device.

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of the passive electromagnetic tracking system, as defined in the claims, is provided in the following written description of various embodiments of the disclosure and illustrated in the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:

[0010] Figure l is a schematic diagram of an intraluminal imaging system, according to aspects of the present disclosure.

[0011] Figure 2 is a perspective view of the imaging assembly positioned for coupling, according to aspects of the present disclosure.

[0012] Figure 3A is a perspective view of the imaging component, according to aspects of the present disclosure.

[0013] Figure 3B is a cross-sectional view of the imaging component, taken along the line 301 of Fig. 3A, according to aspects of the present disclosure.2024PF00686

[0014] Figure 4 is a perspective view of the interposer with a bond wire and the electrical cable coupled in position, according to aspects of the present disclosure.

[0015] Figure 5 is a cross-sectional view of the interposer and the imaging component coupled in position, taken along line 402 of Figure 4, according to aspects of the present disclosure.

[0016] Figure 6A is a schematic, diagrammatic representation, in block diagram form, of an example wired electromagnetic tracking system with a dedicated, wired tracking element, according to aspects of the present disclosure.

[0017] Figure 6B is a schematic, diagrammatic representation, in block diagram form, of an example wireless electromagnetic tracking system with a dedicated, wireless tracking element, according to aspects of the present disclosure.

[0018] Figure 7 is a schematic, diagrammatic representation, in block diagram form, of an example passive electromagnetic tracking system with signal leakage from the ordinary operation of other components, according to aspects of the present disclosure.

[0019] Figure 8 is a schematic, diagrammatic, side view of an example endoluminal or intraluminal device, according to aspects of the present disclosure.

[0020] Figure 9 is a schematic top view of an example electronic circuit such as an interposer or ASIC, according to aspects of the present disclosure.

[0021] Figure 10 is a schematic top view of an example electronic circuit such as an interposer or ASIC, according to aspects of the present disclosure.

[0022] Figure 11 is a schematic, side cross-sectional view of an example electronic circuit according to aspects of the present disclosure.

[0023] Figure 12 is a schematic, diagrammatic representation, in block diagram form, of an example intraluminal imaging system that incorporates a passive electromagnetic tracking system, according to aspects of the present disclosure.

[0024] Figure 13 is a schematic, diagrammatic representation, in block diagram form, of an example intraluminal imaging system that incorporates a passive electromagnetic tracking system, according to aspects of the present disclosure.

[0025] Figure 14 is a schematic, diagrammatic representation, in block diagram form, of an example intraluminal imaging system that incorporates a passive electromagnetic tracking system, according to aspects of the present disclosure.

[0026] Figure 15 is a schematic diagram of a processor circuit, according to aspects of the present disclosure.2024PF00686DETAILED DESCRIPTION

[0027] In accordance with at least one embodiment of the present disclosure, a passive electromagnetic tracking system is provided which permits tracking of an intraluminal (e.g., intracardiac) device, without the need for dedicated electromagnetic tracking sensors (wired or wireless) on the device itself.

[0028] Certain portions of the ultrasonic transducer circuitry can produce spurious electromagnetic signals (e.g., signal leakage). In some versions of EM tracking systems with a dedicated sensor, these spurious signals or signal leakage interfere with the ability to correctly determine the sensor’s position, and hence, the position of the device itself. Several strategies exist to mitigate this EM interference, such as moving the sensor away from the source of the noise, shielding the circuitry so that signal leakage no longer interferes with the sensors, actively or passively filtering out the spurious signals, etc.

[0029] What is described below is advantageously utilizing these spurious signals or signal leakage for EM tracking. What is tracked is the perturbation in the magnetic field generated by the spurious signals emitted by the transducer electronics, as part of their normal function (e.g., for intraluminal sensing and / or intraluminal treatment). The present disclosure eliminates the need to mitigate spurious electromagnetic signals emanating from the ultrasound transducer electronics. Rather than trying to eliminate the signal leakage, as is may be typically done, the signal leakage is unconventionally used for the beneficial purpose of tracking. This advantageously removes the need to integrate a dedicated EM tracking sensor into the intraluminal device. Compared to wired EM tracking sensors, this also removes the need to integrate a dedicated electrical wire connection into the intraluminal device. Both of these improvements may make the tracked ultrasound transducer easier and less expensive to manufacture.

[0030] One object of the present disclosure is the use of otherwise extraneous electrical / electromagnetic noise as the source signal that can be tracked using an electromagnetic tracking system. The present disclosure aids substantially in the treatment and prophylaxis of disease by intraluminal medical devices within the body, by improving the ability to track these devices, without the need for wired sensors or wireless electromagnetic tags. Implemented on an intraluminal electronic device in communication with an electromagnetic sensing system, the passive electromagnetic tracking system disclosed herein provides practical improvements in the treatment and prophylaxis of disease. This improved tracking methodology transforms a device with wired or wireless EM tracking sensors into one that can be tracked on its own, without a dedicated EM tracking sensor. This2024PF00686unconventional approach improves the functioning of the intraluminal sensing system or intraluminal treatment system, by improving the tracking of the intraluminal device.

[0001] The passive electromagnetic tracking system may be implemented as a process at least partly viewable on a display, and operated by a control process executing on a processor that accepts user inputs from a keyboard, mouse, or touchscreen interface, and that is in communication with one or more intraluminal electronic devices. In that regard, the control process performs certain specific operations in response to different inputs or selections made at different times. Certain outputs of the passive electromagnetic tracking system may be printed, shown on a display, or otherwise communicated to human operators. Certain structures, functions, and operations of the processor, display, sensors, and user input systems are known in the art, while others are recited herein to enable novel features or aspects of the present disclosure with particularity.

[0031] These descriptions are provided for exemplary purposes only, and should not be considered to limit the scope of the passive electromagnetic tracking system. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0032] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one embodiment may be combined with the features, components, and / or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0033] Figure 1 is a schematic diagram of an intraluminal imaging system 100, according to aspects of the present disclosure. The system 100 may include an intraluminal imaging device 110, a connector 124, a control and processing system 130, such as a console and / or a computer, and a monitor 132. The intraluminal imaging device 110 includes an imaging assembly 102 at the tip of a flexible elongate member 108, and a handle 120. The flexible elongate member 108 includes a distal portion 104 and a proximal portion 106. The2024PF00686distal end of the distal portion 104 is attached to the imaging assembly 102. The proximal end of the proximal portion 106 is attached to the handle 120 for example, by a resilient strain reliever 112, for manipulation of the intraluminal imaging device 110 and manual control of the intraluminal imaging device 110. The imaging assembly 102 can include an imaging core with ultrasound transducer elements and associated circuitry. The handle 120 can include actuators 116, a clutch 114, and other steering control components for steering the intraluminal imaging device 110, such as deflecting the imaging assembly 102 and the distal portion 104, as described in greater details herein.

[0034] The handle 120 is connected to the connector 124 via another strain reliever 118 and a connection cable 122. The connector 124 may be configured in any suitable configurations to interconnect with the control and processing system 130 and the monitor 132 for processing, storing, analyzing, manipulating, and displaying data obtained from signals generated by the imaging core at the imaging assembly 102. The control and processing system 130 can include one or more processors, memory, one or more input devices, such as keyboards and any suitable command control interface device. The control and processing system 130 can be operable to facilitate the features of the intraluminal imaging system 100 described herein. For example, the one or more processor can execute computer readable instructions that may be stored on the non-transitory tangible computer readable medium. The monitor 132 can be any suitable display device, such as liquid-crystal display (LCD) panel or the like. The control and processing system 130 can be referred to as an apparatus as defined herein. In further examples, the control and processing system 130 (or apparatus) can include one or more other parts of the system 100 as described and defined herein such as for example, the intraluminal imaging device 110 and / or the monitor 132.

[0035] In operation, a physician or a clinician advances the flexible elongate member 108 into a vessel within a heart anatomy. The physician or clinician can steer the flexible elongate member 108 to a position near the area of interest to be imaged by controlling the actuators 116 and the clutch 114 on the handle 120. For example, one actuator 116 may deflect the imaging assembly 102 and the distal portion 104 in a left-right plane and the other actuator 116 may deflect the imaging assembly 102 and the distal portion 104 in an anterior-posterior plane, as discussed in greater details herein. The clutch 114 provides a locking mechanism to lock the positions of the actuators 116 and in turn the deflection of the flexible elongate member while imaging the area of interest.

[0036] The imaging process may include activating the ultrasound transducer elements on the imaging assembly 102 to produce ultrasonic energy. A portion of the ultrasonic energy is2024PF00686reflected by the area of interest and the surrounding anatomy, and the ultrasound echo signals are received by the ultrasound transducer elements. The connector 124 transfers the received echo signals to the control and processing system 130 where the ultrasound image is reconstructed and displayed on the monitor 132. In some embodiments, the processing system 130 can control the activation of the ultrasound transducer elements and the reception of the echo signals. In some embodiments, the control and processing system 130 and the monitor 132 may be part of the same system.

[0037] The system 100 may be utilized in a variety of applications such as transseptal lumen punctures, left atrial appendage closures, atrial fibrillation ablation, and valve repairs and can be used to image vessels and structures within a living body. Although the system 100 is described in the context of intraluminal imaging procedures, the system 100 is suitable for use with any catheterization procedure, e.g., ICE. In addition, the imaging assembly 102 may include any suitable physiological sensor or component for diagnostic, treatment, and / or therapy. For example, the imaging assembly can include an imaging component, an ablation component, a cutting component, a morcellation component, a pressure-sensing component, a flow-sensing component, a temperature-sensing component, and / or combinations thereof.

[0038] In some aspects, the intraluminal imaging device 110 includes a flexible elongate member 108 that can be positioned within a vessel. The flexible elongate member 108 has a distal portion 104 and a proximal portion 106. The intraluminal imaging device 110 includes an imaging assembly 102 that is mounted within the distal portion 104 of the flexible elongate member 108.

[0039] In some aspects, the intraluminal imaging system 100 is used for generating two-dimensional (2D) and three-dimensional (3D) images. In some aspects, the intraluminal imaging system 100 is used for generating x-plane images at two different viewing directions perpendicular to each other. In some aspects, the x-plane images are at two different viewing directions that are not perpendicular to each other.

[0040] Before continuing, it should be noted that the examples described above are provided for purposes of illustration, and are not intended to be limiting. Other devices and / or device configurations may be utilized to carry out the operations described herein.

[0041] Figure 2 is a perspective view of the imaging assembly 102 positioned for coupling, according to aspects of the present disclosure. The imaging assembly 102 is illustrated with the imaging core 262 in position within the tip member 200. The imaging core 262 is coupled to the electrical cable 266 via the electrical interconnection 264. The electrical cable 266 extends through the alignment portion 244 and the interface portion 2462024PF00686of the inner cavity 250. The electrical cable 266 can further extend through the flexible elongate member 108 as shown in Figure 1.

[0042] The tip member 200 can also include other features, for example, a guidewire lumen, holes, or other geometry to accommodate additional devices or features such as pressure sensors, drug delivery mechanisms, and / or any suitable interventional features.

[0043] Figure 3A is a perspective view of the imaging component 320, according to aspects of the present disclosure. The imaging component 320 is a planar component including an acoustic layer 322, an integrated circuit (IC) layer 326, and a backing layer 328. The IC layer 326 is positioned between the acoustic layer 322 and the backing layer 328. In some other aspects, the backing layer 328 may be between the acoustic layer 322 and the IC layer 326 with electrical connections made through the backing layer 328.

[0044] The backing layer 328 is composed of an acoustically absorptive material so that the backing layer 328 can absorb or deaden the ultrasonic waves coming from the back of the acoustic layer 322. For example, the backing layer 328 may be composed of an epoxy material. In some embodiments, the backing layer 328 may have a longer length than IC layer 326. The portion 329 of the backing layer 328 extending beyond the IC layer 326 may function as an alignment agent for aligning the interposer 330 (see Figure 4) to the imaging component 320. The imaging component 320 has a width 308. The ultrasound signal may propagate in the direction as shown by the dashed arrows.

[0045] Figure 3B is a cross-sectional view of the imaging component 320, taken along the line 301 of Fig. 3A, according to aspects of the present disclosure. Visible are the acoustic layer 322, an integrated circuit (IC) layer 326, backing layer 328. The acoustic layer 322 includes an array of ultrasound transducer elements 324. The ultrasound transducer elements 324 are composed of piezoelectric material and acoustic matching layers. In alternative aspects, the ultrasound transducer elements 324 may be capacitive micromachined ultrasound transducers (cMUTs). Exemplary transducers for ICE have a typical thickness of approximately 0.28 mm in the piezoelectric material to enable an 8 megahertz (MHz) ultrasound signal to be generated and transmitted at a typical velocity of 1500 meter per second (m / sec) through blood. The transducer elements 324 can be of various thicknesses ranging approximately from 0.56 mm to 0.19 mm to generate sufficient penetration depth in tissue imaging. In general, the thickness of the transducers can be adjusted for the frequency of sound in the transmission medium for the desired penetration depth in any tissue imaging. Image intensity can be adjusted by the driving voltage on the transducers. In some embodiments, the acoustic layer 322 may include a linear array of about 32 to about 1282024PF00686ultrasound transducer elements 324 for two-dimensional (2D) imaging. In some other embodiments, the acoustic layer 322 may include a matrix of about 200 to about 2000 ultrasound transducer elements 324 for three-dimensional (3D) imaging.

[0046] The IC layer 326 includes logic and / or circuits configured to multiplex control signals, for example, generated by the processing system 130 (see Figure 1), and transfer the control signals to corresponding ultrasound transducer elements 324. The controls signals can control the emission of ultrasound pulses and / or the reception of echo signals. In the reverse direction, the logic and / or circuits are configured to receive ultrasound echo signals reflected by target tissue and received by the ultrasound transducer elements 324. The logic and / or circuits convert the ultrasound echo signals into electrical signals and transfer the electrical signals through the interposer 330 (see Figure 4) and the electrical cable 266 (see Figure 2) to the processing system 130 for processing and / or display. The logic and / or circuits can be further configured to perform signal conditioning before transferring the signals. Signal conditioning may include filtering, amplification, and beamforming. In some aspects, beamforming can be performed to reduce the number of signal channels. For example, the number of signal channels may be between about 4 to about 128, with some particular aspects, of about 8. In some aspects, the IC layer 326 may have a longer length than the acoustic layer 322. The portion 325 of the IC layer 326 extending beyond acoustic layer 322 may include a plating layer 327 for wirebonding to the interposer 330, as described in greater detail herein. The plating layer 327 may be composed of any suitable material such as gold, aluminum, copper, silver, or Electroless Nickel Electroless Palladium Immersion Gold (ENEPIG).

[0047] The acoustic layer 322 has a length 302. The IC layer 326 has a length 304 which is greater than length 302. The backing layer 328 has a length 306 which is greater than length 304.

[0048] Figure 4 is a perspective view of the interposer 330 with a bond wire 410 and the electrical cable 266 coupled in position, according to aspects of the present disclosure. In Figure 4, the imaging component 320 is coupled to the interposer 330, for example, using wirebonding technology such as thermal compression wirebonding. As described above, the IC layer 326 of the imaging component 320 may generate a number of signal channels for transferring ultrasound echo signals to the electrical cable 266 for image generation. In an embodiment, the interposer 330 connects each signal channel output by the IC layer 326 of the imaging component 320 via a bond wire 410. The bond wire 410 may be composed of any suitable materials such as gold, aluminum, or copper.2024PF00686

[0049] Surface-mount components 420 are mounted to the interposer 330 as described below. The conductors of the electrical cable 266 connect to the electrical traces of the interposer 330 under the cover of a protector 344.

[0050] Figure 5 is a cross-sectional view of the interposer 330 and the imaging component 320 coupled in position, taken along line 402 of Figure 4, according to aspects of the present disclosure. The ultrasound transducer elements 324 in the acoustic layer 322 emit ultrasound signals (shown as solid arrows) and receive ultrasound echo signals (shown as dashed arrows) reflected by surrounding vasculature when in use. The logics and / or circuits of the IC layer 326 convert and process the ultrasound echo signals into electrical signals and transfer the electrical signals to the electrical cable 266 via the bond wires 410, the conductive contact pads 512, and the conductive lines 522 of the interposer 330.

[0051] As shown in Figure 5, one end of each bond wire 410 is bonded to one of the first plurality of conductive contact pads 512a. The opposite end of each bond wire 410 is bonded to the plating layer 327 of the IC layer 326. For example, the plating layer 327 may include a plurality of contact pads coupled to the signal channel outputs.

[0052] In some aspects, surface-mount components 420 are mounted on the second plurality of conductive pads 512b. For example, one or more of the surface-mount component 420 can be mounted onto surfaces of one or more of the second plurality of conductive pads 512b via soldering or conductive epoxy. Some examples of the surfacemount components 420 may include capacitors, thermistors, resistors, diodes, transistors, and / or inductors. Thus, the interposer 330 may include various surface-mount components 420 to provide additional functionalities such as power regulation.

[0053] The interposer 330 provides several benefits. The interposer 330 can facilitate stable interconnect between the imaging component 320 and the electrical cable 340. The interposer 330 can form the conductive lines 522 with high density and high precision. As described above, the conductive lines 522 can have widths between about 1 pm to about 50 pm and spaced apart by about 1 pm to about 50 pm, whereas typical PCBs and / or flex circuits have traces with widths between about 25 pm to about 100 pm and spaced apart by about 25 pm to about 100 pm. As such, the interposer 330 is suitable for use in a catheter assembly. In addition, the inclusion of the EPENIG conductive contact pads 512 in the top layer of the interposer 330 allows the interposer 330 to be soldered to the electrical cable 340 and wire-bonded to the imaging component 320. The interposer 330 can include additional functionalities by including surface-mount components 420 soldered to the EPENIG conductive contact pads 512. In some aspects, unshielded conductive lines 522 may serve as2024PF00686antennas that leak or radiate spurious electromagnetic signals that can be detected and tracked by the passive electromagnetic tracking system, as described below.

[0054] The electrical cable 266 is coupled to the third plurality of conductive contact pads 512c of the interposer 330, for example, using soldering. As described above, the electrical cable 266 carries the signal channel outputs (e.g., the beamformed or multiplexed ultrasound echo signals) of the IC layer 326 to the processing system 130. The electrical cable 266 includes a plurality of conductors or conductive elements 342. For example, each signal channel output is carried by one conductive element 342. In addition, one or more of the conductive elements 342 can carry control signals for controlling the ultrasound transducer elements 324. For example, the control signals may be generated by the processing system 130 or other interface modules positioned between the processing system 130 and the intraluminal device 110. Further, one or more of the conductive elements 342 can carry power for powering the imaging component 320. The conductive elements 342 can be soldered to the third plurality of conductive contact pads 512c using any suitable soldering material (e.g., tin, lead, and / or zinc). The electrical cable 340 is coupled to a protector 344 protecting the portions of the conductive elements that are positioned on the surface of the interposer 330.

[0055] Figures 6A and 6B describe tracking an intraluminal device using electromagnetic fields.

[0056] Figure 6A is a schematic, diagrammatic representation, in block diagram form, of an example wired electromagnetic tracking system 600A with a dedicated, wired tracking element, according to aspects of the present disclosure. An endoluminal device or intraluminal device 610 includes a working element 620, such as intraluminal sensor (e.g., imaging sensor, such as ultrasound transducer array), an intraluminal treatment device (e.g., radio frequency ablation electrodes, cutting electrodes), etc. In some instances, the endoluminal device 610 may also include electronic components 630 for operation of the working element. The endoluminal device 610 can include electrical wires and / or electrical traces that carry dedicated signals 625 for operation of the working element 620. The endoluminal device 610 also includes dedicated, wired sensor(s) 640 for electromagnetic tracking, such as one or more tracking coil(s). The tracking coils 640 receive an electromagnetic field 655 from an electromagnetic field generator 650 (e.g., transmitter), and produce electromagnetic tracking signals 645 that are sent (e.g., along a wire 647) to a tracking system 660, which interprets the tracking signals 645 and determines a tracked location 665. The wire 647 runs inside the endoluminal device 610 (e.g., inside the catheter2024PF00686body) and also outside of the endoluminal device 610 (e.g., inside an electrical cable connected to the endoluminal device 610.) The tracking system 660 may include a processor circuit.

[0057] Figure 6B is a schematic, diagrammatic representation, in block diagram form, of an example wireless electromagnetic tracking system 600B with a dedicated, wireless tracking element, according to aspects of the present disclosure. As in Figure 6A, endoluminal device or intraluminal device 610 includes a working element 620, such as intraluminal sensor (e.g., imaging sensor, such as ultrasound transducer array), an intraluminal treatment device (e.g., radio frequency ablation electrodes, cutting electrodes), etc. In some instances, the endoluminal device 610 may also include electronic components 630 for operation of the working element. The endoluminal device 610 can include electrical wire(s) and / or electrical trace(s) that carry dedicated signals 625 for operation of the working element 620. The endoluminal device 610 also includes dedicated, wireless sensor 640 (e.g., an electromagnetic tag) for electromagnetic tracking. The tag 640 receives an electromagnetic field 655 from an EM field generator and sensor 680 (e.g., a transmitter and receiver), and returns a field perturbation 657 that is sensed by the EM field generator and sensor 680 to decode EM tracking signals 645, which are received by an EM data interface 690 that determines the tracked location 665. The EM data interface 690 may include a processor circuit.

[0058] In both Figures 6A and 6B, the components for EM tracking are solely for EM tracking, and are not related to operation the working element (e.g., a transducer array, RF electrodes, etc.). Similarly, signals from the components for EM tracking are dedicated to carrying the information for EM tracking (not related to signals from operation of the working element, e.g., command signals to control working element, power signals to power working element, data signals from working element, etc.)

[0059] Block diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, any of the blocks described herein may optionally include an output to a user of information relevant to the step, and may thus represent an improvement in the user interface over existing art by providing information (whether static or dynamically updated) that is not otherwise available. Similarly, block diagrams may show a particular arrangement of components, modules, services, steps, processes, or layers, resulting in a particular data flow. It is understood that some aspects of the systems disclosed herein may include additional components, that some components shown may be absent from2024PF00686some aspects, and that the arrangement of components may be different than shown, resulting in different data flows, power flows, or signal flows, while still performing the methods described herein.

[0060] Figure 7 is a schematic, diagrammatic representation, in block diagram form, of an example passive electromagnetic tracking system 700 with signal leakage from the ordinary operation of other components, according to aspects of the present disclosure. In the example shown in Figure 7, an endoluminal device 710, such as an ICE catheter, includes a transducer array 720, as well as electronic components 730 for the operation of the transducer array. Examples of electronic components 730 include an integrated circuit (e.g., an ASIC), conductive wires, conductive traces on a substrate (e.g., a rigid substrate or a flexible substrate), surface mount electronics / components (e.g., capacitors, thermistors, resistors, diodes, transistors, and / or inductors), etc. The electronic components 730 carry signals 740 dedicated for the operation of the transducer array 720. Examples of signals 740 include power signals, control signals, data signals, as described in Figure 8. In some aspects, the signals 740 can be generated by discharging of capacitors (e.g., capacitors 420 in Figure 4). These signals 740 produce signal leakage 750, which can be detected as electromagnetic perturbations by an electromagnetic field sensor 760 (e.g., an EM receiver). In some aspects, an electromagnetic field generator is not needed because the signal leakage itself (e.g., the signal leakage presents as electrical signal(s) / field(s), magnetic signal(s) / field(s), and / or EM signal(s) / field(s),) can be sensed by the EM receiver 760. In some aspects, the signal leakage 750 can be spurious or unstable electrical field(s), magnetic field(s), and / or EM field(s). In some aspects, the signal leakage 750 can have a periodic nature, such as when the actual signals 740 are also periodic. The EM field sensor 760 can be an electrical field sensor (electrical field receiver), a magnetic field sensor (magnetic field receiver), or a combination thereof (EM field receiver).

[0061] In other aspects, an EM generator and sensor (e.g., a transmitter and receiver) is used both to generate electrical field(s), magnetic field(s), and / or EM field(s) (e.g., a stable, well-defined EM field) and sense perturbations in the generated field by the signal leakage 750. The component 760 can be an electrical field generator and / or sensor (electrical field transmitter and / or receiver), a magnetic field generator and / or sensor (magnetic field transmitter and / or receiver), or a combination thereof (EM field transmitter and / or receiver).

[0062] The EM field sensor 760 produces EM tracking signals 770 that are interpreted by an EM data interface 780 to yield a tracked position and / or orientation 790. The position and / or orientation 790 can include any one or any multiple of X, Y, and / or Z and / or any one2024PF00686or any multiple of yaw, pitch, and / or roll. The EM data interface 780 may include a processor circuit.

[0063] In the example shown in Figure 7, the dedicated component 640 for electromagnetic tracking has been removed (indicated by “x”), as it is not necessary for the functioning of the passive electromagnetic tracking system 700. Rather, the passive electromagnetic tracking system 700 performs 3-degree-of-freedom (3-DOF) EM position tracking, 5-degree-of-freedom EM position and orientation (e.g., pose) tracking, and / or 6-degree-of-freesom (6-DOF) position and orientation (e.g., pose) tracking, using signal leakage from ordinary operation of other components (e.g., leakage of signals used in ordinary operation of the transducer array 720 for ultrasound imaging).

[0064] Figure 8 is a schematic, diagrammatic, side view of an example endoluminal or intraluminal device 800, according to aspects of the present disclosure. The device 800 includes a catheter body 108 attached to a handle 120 and controlled by an electrical cable 122. Shielded conductors 820 may pass through the electrical cable 122, handle 120, and catheter body 108. Shielded conductors may not produce significant electromagnetic signal leakage. However, the device 800 also includes a catheter tip 810 which includes unshielded conductors 830 which carry signals from the shielded conductors 820 to the transducer array 322. The shielded conductors 820 and unshielded conductors 830 may carry a variety of signals (e.g., signals 740 of Fig. 7), including carrying high-voltage power signals 840, low-voltage power signals 850, and control signals 860 to the transducer array 322, and carrying data signals 870 (e.g., ultrasound imaging signals) from the transducer array to the console or control and processing system 130 (see Figure 1).

[0065] Low voltage signals can be in the range of, e.g., 1 to 5 volts, and may be used for powering electronic components (e.g., an application-specific integrated circuit (ASIC)). High voltage signals can be in the range of, e.g., 0 V to 70 V, and may be used for activating or driving a piezoelectric material in the transducer array to emit ultrasound energy.Examples of control signals, power signals, data signals may be found for example in U.S. Patent No. 11,911,217, entitled “Intraluminal Imaging Devices with a Reduced Number of Signal Channels”, filed September 26, 2017, incorporated by reference as though fully set forth herein. Depending on the implementation, the conductors 820, 830 may be electrical wires and / or conductive traces disposed on or inside of a substrate.

[0066] The signals 840, 850, 860, and 870, and particularly the high-voltage signals 840, produce leakage electromagnetic fields 880, which can be detected in order to track the position of the catheter tip 810. The signal leakage 880 can be from the unshielded portion2024PF00686830 of the intraluminal device 800. The unshielded portion 830 can include unshielded conductors and / or unshielded electronic components. For example, the signal leakage 880 can be from capacitor discharge (e.g., capacitors 420 of Fig. 4), which can occur during ordinary operation of the intraluminal device (e.g., ordinary operation of ultrasound transducer array for ultrasound imaging).

[0067] Figure 9 is a schematic top view of an example electronic circuit 900 such as an interposer or ASIC, according to aspects of the present disclosure. The electronic circuit 900 includes a substrate 910, which may for example be a rigid substrate (e.g., a printed circuit board (PCB), wafer, or chip) or a flexible substrate (e.g., a polymer film). In the example shown in Figure 9, the substrate 910 has a generally rectangular shape, with a long axis or longitudinal axis 920 and a short axis or lateral axis 930.

[0068] The electronic circuit 900 also includes unshielded conductors 940 extending along the long axis 920. These unshielded conductors may or may not extend completely between the left and right (short) edges of the substrate 910; they could extend only partially between the left and right (short) edges. Signal leakage electromagnetic fields 950 from the unshielded conductors 940 can be detected by the passive electromagnetic tracking system. The unshielded conductors 940 may carry signals for analog and / or digital electronics, but the higher voltage for analog electronics may make a larger contribution to the signal leakage electromagnetic fields 950. In some cases, using only conductors extending in the longitudinal direction 920, the tracking may be 3-DOF (e.g., X, Y, and Z position) or 5-DOF (e.g., X, Y, Z, yaw, and pitch). In some aspects, the signal leakage EM field(s) 950 could appear as a spot emission, so that X, Y, and Z position are localized, and there may be a projection of the signal leakage EM field(s) 950 perpendicular to the substrate 910.

[0069] Figure 10 is a schematic top view of an example electronic circuit 900 such as an interposer or ASIC, according to aspects of the present disclosure. The electronic circuit 900 includes a substrate 910 with a long axis or longitudinal axis 920 and a short axis or lateral axis 930. In the example shown in Figure 10, unshielded conductors 1040 running in the lateral direction 930 (e.g., along the short axis) may extend completely between the top and bottom (long) edges of the substrate 910, or may extend only partway between the top and bottom (long) edges. The unshielded conductors 1040 running in the lateral direction 930 create signal leakage electromagnetic fields 1050 at a different orientation than the signal leakage electromagnetic fields 950 of Figure 9. In some cases, using only conductors extending in the lateral direction 930, the tracking may be 3-DOF or 5-DOF. In some aspects, the signal leakage EM field(s) 1050 could appear as a spot emission, so that X, Y,2024PF00686and Z position are localized, and there may be a projection of the signal leakage EM field(s) perpendicular to the substrate 910.

[0070] Figure 11 is a schematic, side cross-sectional view of an example electronic circuit 1100 according to aspects of the present disclosure. The electronic circuit 1100 includes an interposer 330 bonded to an example integrated circuit 326 by a bond wire 410. In the example shown in Figure 11, both the interposer 330 and the integrated circuit 326 include unshielded conductors 940 extending in the longitudinal direction (e.g., to the left and right of the page) and unshielded conductors 1040 extending in the lateral direction (e.g., into and out of the page). The conductive traces 940, 1040 can be on the top side of, on the bottom side of, or within the middle layers of their respective substrates. The combination of longitudinally extending and laterally extending unshielded conductors (e.g., conductors extending in two different, directions) additionally allow for the sixth degree of freedom (roll) to be determined, thereby resulting in a full 6-DOF position and / or orientation. In some aspects, there may be a projection of the signal leakage EM field(s) 950 perpendicular to the substrate 910 and EM field(s) 1050 perpendicular to the substrate 910, which can allow calculation of the one or more of the three rotational DOFs (roll, pitch, yaw).

[0071] The unshielded conductors 940 produce leakage fields 950 at a first orientation, and the unshielded conductors 1040 produce leakage fields 1050 at a second orientation, such that a 6-DOF position and / or orientation can be determined by the EM field sensor 760 (see Fig. 7). In the example shown in Figure 11, the leakage fields 950, 1050 generated by the interposer 330 are stronger (e.g., of greater magnitude) than the leakage fields 950, 1050 generated by the integrated circuit 326, because the interposer 330 is carrying analog signals at a higher voltage, whereas the integrated circuit 326 is carrying digital signals at a lower voltage. Thus, the interposer 330 will provide a greater contribution to the detectable EM field than the integrated circuit 326 will.

[0072] Figure 12 is a schematic, diagrammatic representation, in block diagram form, of an example intraluminal imaging system 1200 that incorporates a passive electromagnetic tracking system 700, according to aspects of the present disclosure. The intraluminal imaging system 1200 includes an external imaging device 1210 (e.g., an X-ray scanner, CAT scanner, MRI scanner, etc.) operated by an external imaging console 1220 that includes a processor circuit 1224, display 1222, and input device 1226. The intraluminal imaging system 1200 also includes an ultrasound imaging console 130 that incorporates a processor circuit 134, display 132, and input device 136. The ultrasound imaging console 130 is attached to an ICE catheter 710 by a patient interface module (PIM) cable 1230. Aspects of2024PF00686the PIM cable 1230 may be described for example in U.S. Publication No. 2020 / 0275909, filed September 7, 2018, entitled “Connectors for patient interface module and ultrasound imaging device”, and U.S. Publication No. 2021 / 0128110, filed July 9, 2019, entitled “Electrical wire connection in ultrasound imaging devices, systems, and methods”, each of which is incorporated by reference as though fully set forth herein.

[0073] The ICE catheter 710 includes a transducer array 720, as well as electronic components 730 for normal operation of the transducer array 720. The electronic components 730 may include unshielded wires or traces. The ICE catheter 710 can be introduced into the body of a patient 1240 in order to image the interior of the heart 1250. The patient 1240 is positioned on a patient table or bed 1260 which includes an electromagnetic field sensor (e.g., a receiver) 760. The electromagnetic field sensor detects stray electromagnetic fields (e.g., signal leakage) emitted by the electronic components 730, and conveys readings to an EM data interface 780, which includes a processor circuit 784 to determine a position and / or orientation (e.g., any one or any multiple positions of X, Y, and / or Z; any one or any multiple orientations of yaw, pitch, and / or roll) and convey it to the external imaging console 1220 for display on the display 1222 In some aspects, the EM field sensor 760 may also serve as an EM field generator (e.g., a transmitter).

[0074] Aspects of the ICE catheter may be described for example in U.S. Publication No.2022 / 0409171, filed August 30, 2022, entitled “Intra-cardiac echocardiography interposer”, U.S. Publication No. 2019 / 0247018, filed September 26, 2017, entitled “Radiopaque arrangement of electronic components in intra-cardiac echocardiography (ICE) catheter”, U.S. Publication No. 2023 / 0052311, filed January 5, 2021, entitled “Electrical wire connection in intraluminal ultrasound imaging devices and system”, U.S. Publication No. 2024 / 0188931, filed February 26, 2024, entitled “Intraluminal imaging devices with a reduced number of signal channels”, U.S. Publication No. 2022 / 0409171, filed August 30, 2022, entitled “Intra-cardiac echocardiography interposer”, and U.S. Publication No.2021 / 0128110, filed July 9, 2019, entitled “Electrical wire connection in ultrasound imaging devices, systems, and methods”, each of which is incorporated by reference as though fully set forth herein.

[0075] Figure 13 is a schematic, diagrammatic representation, in block diagram form, of an example intraluminal imaging system 1300 that incorporates a passive electromagnetic tracking system 700, according to aspects of the present disclosure. An ultrasound imaging console 130 sends signals 740 for the operation of the transducer array 720 to the ICE catheter 710, which includes electronic components 730 (e.g., unshielded wires and traces)2024PF00686for the operation of the transducer array 720. The transducer array 720 generates ultrasound imaging signals 1360, which are received by the ultrasound imaging console 130 to produce an ultrasound image 1370. On a display 132, a screen display 1370 is shown that includes a graphical representation 1380 of the ultrasound image data.

[0076] The electronic components 730 create signal leakage electromagnetic fields 750 that are received by the EM field sensor 760 (e.g., a receiver) and converted to EM tracking signals 770, which are received by the EM data interface and converted into a tracked 3-DOF position, 5-DOF position and orientation (e.g., pose), or 6-DOF position and orientation (e.g., pose), which is then passed to the external imaging console 1220.

[0077] The external imaging console 1220 receives external imaging signals 1310 from the external imaging device 1210. The external imaging console 1220 conveys the external image 1320 and the tracked position and / or orientation 790 to the display 1222, where a screen display 1330 includes the external image 1320, with graphical representation 1350 of the tracked position and / or orientation 790 (e.g., a marker 1350 indicating the tracked position and / or orientation 790).

[0078] In this way, a clinician operating the intraluminal imaging system 1300 can keep visual track of the position and / or orientation of the ICE catheter’s imaging component, relative to other anatomy such as the skeleton of the patient, in order to aid interpretation of the ultrasound image 1370, and thus facilitate the diagnosis, treatment, and prophylaxis of disease.

[0079] Figure 14 is a schematic, diagrammatic representation, in block diagram form, of an example intraluminal imaging system 1400 that incorporates a passive electromagnetic tracking system 700, according to aspects of the present disclosure. Like the intraluminal imaging systems 700, 1200 and 1300, the intraluminal imaging system 1400 includes an ICE catheter 710 with electronic components 730 for controlling the transducer array 720. The electronic components 730 produce signal leakage 750 at a first frequency fi, which is received by the EM field sensor 760 and converted into EM tracking signals 770 for frequency fi, which are then received by the EM data interface 780 and converted into a tracked position and / or orientation 790 for the ICE catheter 710.

[0080] However, in the example of Figure 14, the intraluminal imaging system 1400 also includes a radio frequency (RF) ablation catheter 1410, which includes ablation electrodes 1420 that emit signal leakage 1450 at a different, frequency fz, which are received by the EM field sensor 760 and converted into EM tracking signals 1470 for frequency fz, which are received by the EM data interface 780 and converted into a tracked position and / or2024PF00686orientation 1490 for the RF ablation catheter. Accordingly, the EM field sensor 760 and / or the EM data interface 780 can use the different frequencies of signal leakages to distinguish between and / or separately track the position and / or orientation of different intraluminal devices.

[0081] The ICE catheter 710 and / or the RF ablation catheter 1410 are examples of intraluminal devices that can be tracked inside of the patient body. Other types of kinds of intraluminal devices, extraluminal devices (outside of the patient body; inside the patient body, but outside a particular body lumen), etc., can also be tracked using signal leakage. The devices can for sensing and / or treatment.

[0082] Figure 15 is a schematic diagram of a processor circuit 1550, according to aspects of the present disclosure. The processor circuit 1550 may be implemented in the system 100, the system 700, the system 1200, the system 1300, or the system 1400, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to implement the method. As shown, the processor circuit 1550 may include a processor 1560, a memory 1564, and a communication module 1568. These elements may be in direct or indirect communication with each other, for example via one or more buses.

[0083] The processor 1560 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general-purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. The processor 1560 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 1560 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0084] The memory 1564 may include a cache memory (e.g., a cache memory of the processor 1560), random access memory (RAM), magnetoresistive RAM (MRAM), readonly memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, the memory 1564 includes a non-transitory computer-readable medium. The2024PF00686memory 1564 may store instructions 1566. The instructions 1566 may include instructions that, when executed by the processor 1560, cause the processor 1560 to perform the operations described herein. Instructions 1566 may also be referred to as code. The terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc. “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements. It is noted that in this context and in embodiments where the operations are performed by more than one processor, each of these processors can execute a subset of the instructions referred to herein such that the combination of subsets of instructions performed by the more than one processor cause an entire set of operations to be performed. The disclosed operations and methods may thus be implemented in a distributed processing environment using multiple processors in communication for example using communication means as described herein below.

[0085] The communication module 1568 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 1550, and other processors or devices. In that regard, the communication module 1568 can be an input / output (I / O) device. In some instances, the communication module 1568 facilitates direct or indirect communication between various elements of the processor circuit 1550 and / or the system 100, 700, 1200, 1300, or 1400. The communication module 1568 may communicate within the processor circuit 1550 through numerous methods or protocols. Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter-Integrated Circuit (I2C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol. Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystem.

[0086] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the2024PF00686intraluminal device) may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G / GSM (global system for mobiles) , 3G / UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G. For example, a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches. The controller may be configured to communicate with a remote server, or a local device such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.

[0087] As will be readily appreciated by those having ordinary skill in the art after becoming familiar with the teachings herein, the passive electromagnetic tracking system advantageously permits electromagnetic tracking of an intraluminal device, in real time, without requiring any modifications to the device itself. This disclosure can be applied to any ultrasound device, or any device that incorporated electronics that emit electromagnetic interference as a normal part of their function, whether intraluminal or otherwise. Such devices can be tracked using an electromagnetic tracking system as described herein.

[0088] A number of variations are possible on the examples and embodiments described above. For example, different devices can be used than those disclosed herein, and the signal leakage can come from any components therein, including but not limited to wires, traces, resistors, capacitors, diodes, inductors, transistors, integrated circuits, or other electronic components, whether surface-mounted to a substrate or located within the substrate.

[0089] An exemplary of aspects of the present disclosure include apparatus including one or more processors configured to: communicate with an intraluminal device using an electrical signal while the intraluminal device is positioned inside a patient body, wherein the electrical signal is associated with operation of the intraluminal device to perform intraluminal sensing or treatment inside the patient body; receive a position and / or orientation of the intraluminal device, wherein the position and / or orientation is determined based on an electromagnetic tracking signal generated by an electromagnetic field sensor, wherein the electromagnetic tracking signal is representative of a signal leakage of the electrical signal; and provide, to a display, an output based on the position and / or orientation of the intraluminal device.2024PF00686

[0090] In an aspect, the electrical signal is not a dedicated signal for tracking the position and / or orientation of the intraluminal device. In an aspect, the apparatus further includes the intraluminal device. In an aspect, the intraluminal device comprises an intracardiac echocardiography (ICE) catheter. In an aspect, the intraluminal device comprises an ultrasound transducer array and the intraluminal sensing comprises ultrasound imaging. In an aspect, the electrical signal comprises a high voltage signal configured to drive the ultrasound transducer array to emit ultrasound energy. In an aspect, the intraluminal device comprises one or more unshielded electronic components configured to cause the signal leakage. In an aspect, the one or more unshielded electronic components comprises at least one of an unshielded wire or an unshielded conductive trace configured to carry the electrical signal. In an aspect, the one or more unshielded electronic components comprises: at least one of a first unshielded wire or a first unshielded conductive trace extending in a first direction; and at least one of a second unshielded wire or a second unshielded conductive trace extending in a different, second direction. In an aspect, the position and / or orientation of the intraluminal device comprises a six-degrees-of-freedom (6-DOF) pose (e.g., position and orientation). In an aspect, the electrical signal comprises a voltage between 0 and 70 volts. In an aspect, the electrical signal comprises an analog signal. In an aspect, the apparatus further includes the electromagnetic field sensor, and the electromagnetic field sensor is configured to sense the signal leakage and generate the electromagnetic tracking signal based on sensing the signal leakage. In an aspect, the one or more processors is configured to: receive the electromagnetic tracking signal from the electromagnetic field sensor; and determine the position and / or orientation of the intraluminal device based on the electromagnetic tracking signal. In an aspect, the one or more processors is configured to: obtain an extraluminal image of the patient body; and overlay a graphical representation of the position and / or orientation of the intraluminal device on the extraluminal image, wherein the output comprises the extraluminal image and the graphical representation of the position and / or orientation overlaid on the extraluminal image.

[0091] Accordingly, the logical operations making up the embodiments of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may occur, or be performed or arranged, in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language.

[0092] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise,2024PF00686counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the passive electromagnetic tracking system. Connection references, e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term “or” shall be interpreted to mean “and / or” rather than “exclusive or.” The word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

[0093] The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the passive electromagnetic tracking system as defined in the claims. Although various embodiments of the claimed subject matter have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter.

[0094] Still other embodiments are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular embodiments and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the following claims.

[0095] Additional embodiments or clauses.Clause 1. An apparatus, comprising:one or more processors configured to:communicate with an intraluminal device using an electrical signal while the intraluminal device is positioned inside a patient body, wherein the electrical signal is associated with operation of the intraluminal device to perform intraluminal sensing or treatment inside the patient body;receive at least one of a position or an orientation of the intraluminal device, wherein at least one of the position or the orientation is determined based on an electromagnetic tracking signal generated by an electromagnetic field sensor, wherein2024PF00686the electromagnetic tracking signal is representative of a signal leakage of the electrical signal; andprovide, to a display, an output based on at least one of the position or the orientation of the intraluminal device.Clause 2. The apparatus of clause 1, wherein the electrical signal is not a dedicated signal for tracking at least one of the position or the orientation of the intraluminal device.Clause 3. The apparatus of clause 1, further comprising the intraluminal device.Clause 4. The apparatus of clause 3, wherein the intraluminal device comprises an intracardiac echocardiography (ICE) catheter.Clause 5. The apparatus of clause 3,wherein the intraluminal device comprises an ultrasound transducer array, and wherein the intraluminal sensing comprises ultrasound imaging.Clause 6. The apparatus of clause 5, wherein the electrical signal comprises a high voltage signal configured to drive the ultrasound transducer array to emit ultrasound energy.Clause 7. The apparatus of claim 1, wherein the intraluminal device comprises one or more unshielded electronic components configured to cause the signal leakage.Clause 8. The apparatus of clause 7, wherein the one or more unshielded electronic components comprises at least one of an unshielded wire or an unshielded conductive trace configured to carry the electrical signal.Clause 9. The apparatus of clause 7, wherein the one or more unshielded electronic components comprises:at least one of a first unshielded wire or a first unshielded conductive trace extending in a first direction; andat least one of a second unshielded wire or a second unshielded conductive trace extending in a different, second direction.2024PF00686Clause 10. The apparatus of clause 9, wherein at least one of the position or the orientation of the intraluminal device comprises a six-degrees-of-freedom (6-DOF) pose.Clause 11. The apparatus of clause 1, wherein the electrical signal comprises a voltage between 0 and 70 volts.Clause 12. The apparatus of clause 1, wherein the electrical signal comprises an analog signal.Clause 13. The apparatus of clause 1,further comprising the electromagnetic field sensor,wherein the electromagnetic field sensor is configured to sense the signal leakage and generate the electromagnetic tracking signal based on sensing the signal leakage.Clause 14. The apparatus of clause 13, wherein the one or more processors is configured to:receive the electromagnetic tracking signal from the electromagnetic field sensor; and determine at least one of the position or the orientation of the intraluminal device based on the electromagnetic tracking signal.Clause 15. The apparatus of clause 1,wherein the one or more processors is configured to:obtain an extraluminal image of the patient body; andoverlay a graphical representation of at least one of the position or the orientation of the intraluminal device on the extraluminal image, wherein the output comprises the extraluminal image and the graphical representation of at least one of the position or the orientation overlaid on the extraluminal image.

Claims

2024PF00686CLAIMSWhat is claimed is:

1. An apparatus, comprising:one or more processors configured to:communicate with an intraluminal device using an electrical signal while the intraluminal device is positioned inside a patient body, wherein the electrical signal is associated with operation of the intraluminal device to perform intraluminal sensing or treatment inside the patient body;receive at least one of a position or an orientation of the intraluminal device, wherein at least one of the position or the orientation is determined based on an electromagnetic tracking signal generated by an electromagnetic field sensor, wherein the electromagnetic tracking signal is representative of a signal leakage of the electrical signal; andprovide, to a display, an output based on at least one of the position or the orientation of the intraluminal device.

2. The apparatus of claim 1, wherein the electrical signal is not a dedicated signal for tracking at least one of the position or the orientation of the intraluminal device.

3. The apparatus of claim 1 or 2, further comprising the intraluminal device.

4. The apparatus of any one of claims 1 to 3, wherein the intraluminal device comprises an intracardiac echocardiography (ICE) catheter.

5. The apparatus of any one of the claims 1 to 3,wherein the intraluminal device comprises an ultrasound transducer array, and wherein the intraluminal sensing comprises ultrasound imaging.

6. The apparatus of any one of the claims 1 to 5, wherein the electrical signal comprises a high voltage signal configured to drive the ultrasound transducer array to emit ultrasound energy.2024PF006867. The apparatus of any one of claims 1 to 6, wherein the intraluminal device comprises one or more unshielded electronic components configured to cause the signal leakage, optionally, wherein the one or more unshielded electronic components comprises at least one of an unshielded wire or an unshielded conductive trace configured to carry the electrical signal.

8. The apparatus of any one of claims 1 to 6, wherein the intraluminal device comprises one or more unshielded electronic components configured to cause the signal leakage, optionally, wherein the one or more unshielded electronic components comprises:at least one of a first unshielded wire or a first unshielded conductive trace extending in a first direction; andat least one of a second unshielded wire or a second unshielded conductive trace extending in a different, second direction.

9. The apparatus of any one of claims 1 to 8, wherein at least one of the position or the orientation of the intraluminal device comprises a six-degrees-of-freedom (6-DOF) pose.

10. The apparatus of any one of claims 1 to 9, wherein the electrical signal comprises a voltage between 0 and 70 volts and / or wherein the electrical signal comprises an analog signal.

11. The apparatus of one of claims 1 to 10,further comprising the electromagnetic field sensor,wherein the electromagnetic field sensor is configured to sense the signal leakage and generate the electromagnetic tracking signal based on sensing the signal leakage.

12. The apparatus of claim 11, wherein the one or more processors is configured to: receive the electromagnetic tracking signal from the electromagnetic field sensor; and determine at least one of the position or the orientation of the intraluminal device based on the electromagnetic tracking signal.

13. The apparatus of one of claims 1 to 12,wherein the one or more processors is configured to:obtain an extraluminal image of the patient body; and2024PF00686overlay a graphical representation of at least one of the position or the orientation of the intraluminal device on the extraluminal image,wherein the output comprises the extraluminal image and the graphical representation of at least one of the position or the orientation overlaid on the extraluminal image.

14. A method carried out by one or more processors, the method comprising:communicating with an intraluminal device using an electrical signal while the intraluminal device is positioned inside a patient body, wherein the electrical signal is associated with operation of the intraluminal device to perform intraluminal sensing or treatment inside the patient body;receiving at least one of a position or an orientation of the intraluminal device, wherein at least one of the position or the orientation is determined based on an electromagnetic tracking signal generated by an electromagnetic field sensor, wherein the electromagnetic tracking signal is representative of a signal leakage of the electrical signal; andproviding, to a display, an output based on at least one of the position or the orientation of the intraluminal device.

15. Computer readable instructions which, when executed by the one or more processors, cause the one or more processors to execute the method of claim 14.

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