Intracardiac echography catheter with integrated electromagnetic sensor

Abstract

An apparatus includes an intraluminal catheter, such as an intracardiac echocardiography (ICE) catheter. The intraluminal catheter includes a catheter shaft that can be advanced through a patient body. The intraluminal catheter includes a pullwire that causes deflection of a distal portion of the catheter shaft. The intraluminal catheter includes a pullwire crown and a crown sleeve, both positioned at the distal portion. The pullwire crown is mechanically coupled to the pullwire, and the crown sleeve is mechanically coupled to the pullwire crown. The intraluminal catheter includes one or multiple electromagnetic tracking sensors that identify a position and orientation of the distal portion. The one or multiple electromagnetic tracking sensors are positioned in a pre-defined spatial arrangement with the crown sleeve.

Description

INTRACARDIAC ECHOGRAPHY CATHETER WITH INTEGRATED ELECTROMAGNETIC SENSORTECHNICAL FIELD

[0001] The subject matter described herein relates to devices, systems, and methods for integrating one or multiple electromagnetic (EM) sensors in an intraluminal catheter (e.g., an intracardiac echography or ICE catheter, which obtains ultrasound images while positioned within a patient’s heart). The EM sensor(s) can be integrated into the intraluminal catheter’s crown sleeve, which is a component in the mechanism for deflecting the intraluminal catheter’s distal portion using pullwires.BACKGROUND

[0002] Intracardiac echocardiography (ICE) catheters include an ultrasound imaging sensor at the end of a catheter, which can be introduced into a patient’s heart via, for example, a blood vessel in the leg. ICE catheters may be used in many complex structural heart disease interventions, including mitral valve repair and replacement procedures, tricuspid valve repair and replacement procedures, left atrial appendage (LAAO) occlusion, intra-atrial septum crossing, and more. One method for echocardiography has been transesophageal echo (TEE). However, ICE has distinct advantages over TEE for some procedure types, as well as physician preference.

[0003] One of the limitations of ICE has been the learning curve to understand catheter position relative to anatomy in a complex and moving three-dimensional (3D) structure, such as the heart. As a result, a second physician, acting as a navigator, has been required for complex procedures, and in some cases, physicians will opt to use both TEE and ICE, adding to the cost of the procedure and burden to the patient. The ICE learning curve is made challenging because, while traditionally TEE views would be constrained to the perspective from the esophagus, an ICE catheter can be oriented anywhere within the blood volume of the heart, making the views less intuitive.

[0004] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for 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

[0005] Disclosed is an intraluminal catheter (e.g., an intracardiac echography or ICE catheter) with integrated electromagnetic (EM) sensor(s). The one or multiple EM sensors interact with an electromagnetic field to allow 6-degree-of-freedom (6-DOF) determination of the catheter’s position and orientation. Because of that, the EM sensors can be referred to as EM tracking sensors. The integration of EM sensors into an ICE catheter advantageously improves a user’s ability to navigate the ICE catheter, because the EM sensors provide information about the ICE catheter’s position and orientation.

[0006] The intraluminal catheter may, for example, include one 6-DOF sensor or two 5-DOF sensors. Each 5-DOF sensor can output signals representative of the X, Y, and Z position, along with the pitch and yaw of the intraluminal catheter. Using the signals output by the 5-DOF sensors (positioned at an angle to one another), a computer can determination the roll of the intraluminal catheter.

[0007] The one or multiple EM sensors can have a pre-defined, known, and / or fixed physical / spatial relationship to the crown sleeve of the intraluminal catheter, which is part of the mechanism related to the pullwires allowing the distal end of the intraluminal catheter to be deflected. Examples of a pre-defined, known, and / or fixed physical / spatial relationship include the one or multiple EM sensors being partially or fully positioned / received within the crown sleeve, partially or fully positioned around the crown sleeve, partially or fully longitudinally and / or radially overlapping the crown sleeve, etc., and / or combinations thereof. Providing the EM tracking sensors in a pre-defined, known, and / or fixed physical / spatial relationship to the crown sleeve advantageously allows the EM sensors to be added to the distal portion of the ICE catheter in space that is occupied by the crown sleeve. This avoids the need to find new space at the distal portion of the intraluminal catheter just for the EM tracking sensors, because space at the distal portion of the intraluminal catheter is limited (e.g., the diameter of an ICE catheter should be small enough to be advanced inside a blood vessel).

[0008] One general aspect includes an apparatus an intraluminal catheter that may include: a catheter shaft configured to be advanced through a patient body, a pullwire configured to cause deflection of a distal portion of the catheter shaft, a pullwire crown positioned at the distal portion and mechanically coupled to the pullwire, a crown sleeve positioned at the distal portion and mechanically coupled to the pullwire crown, and a first electromagnetic tracking sensorpositioned in a pre-defined spatial arrangement with the crown sleeve and configured to identify a position and orientation of the distal portion.

[0009] Implementations may include one or more of the following features. In some aspects, the crown sleeve may include: a sidewall extending between an inner surface and an outer surface; and a first opening in the sidewall, where the pre-defined spatial arrangement may include the first electromagnetic tracking sensor being positioned within the first opening. In some aspects, the first opening may include a hole positioned between the inner surface and the outer surface such that the sidewall completely surrounds a perimeter of the hole. In some aspects, the first opening may include a channel in the outer surface. In some aspects, the first opening may include a gap extending completely through the inner surface and the outer surface. In some aspects, the crown sleeve may include a proximal end and a distal end, where the first opening may include a through-hole extending completely between the proximal end and the distal end of the crown sleeve. In some aspects, the crown sleeve may include a proximal end and a distal end, where the opening may include a blind hole extending from the proximal end to a location along a length of the crown sleeve proximal of the distal end. In some aspects, the crown sleeve may include a second opening in the sidewall; and the intraluminal catheter may include a second electromagnetic tracking sensor positioned within the second opening. In some aspects, the first opening and the second opening are angled relative to one another, where at least one of the first opening or the second opening is angled relative to a longitudinal axis of the crown sleeve. In some aspects, the first electromagnetic tracking sensor and the second electromagnetic tracking sensor each may include a five-degrees-of-freedom (5-DOF) sensor. In some aspects, a length of the first electromagnetic tracking sensor completely fits within a length of the crown sleeve. In some aspects, at least one of: a proximal end of the first electromagnetic tracking sensor is positioned proximal of a proximal end of the crown sleeve; or a distal end of the first electromagnetic tracking sensor is positioned distal of a distal end of the crown sleeve.

[0010] In some aspects, the crown sleeve may include a first portion and a second portion, where the first portion may include one of a projection or a recess, where the second portion may include the other of the projection or the recess, and where the projection is received within the recess to mechanically couple the first portion and the second portion. In some aspects, the first portion and the second portion may include an identical structure as one another, where the first portion and the second portion are rotated relative to one another when mechanically coupled. Insome aspects, the pullwire crown may include a ring and a post extending from the ring, where the crown sleeve may include a second opening configured to receive the post to mechanically coupled the crown sleeve and the pullwire crown, and where the second opening is circumferentially spaced from the first opening.

[0011] In some aspects, the intraluminal catheter is an intracardiac echocardiography (ICE) catheter, where the catheter shaft is configured to be advanced through a blood vessel of the patient and into a heart of the patient, where the intraluminal catheter may include an ultrasound transducer array positioned at the distal portion and configured to obtain ultrasound images of the heart. In some aspects, the crown sleeve may include a lumen, where intraluminal catheter further may include a first plurality of electrical lines electrically coupled to the ultrasound transducer array and configured to carry signals associated with the ultrasound images, where the first plurality of electrical lines is positioned within the lumen of the crown sleeve. In some aspects, the intraluminal catheter further may include a second plurality of electrical lines electrically coupled to the first electromagnetic tracking sensor and configured to carry signals associated with the position and orientation of the distal portion, where the second plurality of electrical lines are not positioned within the lumen of the crown sleeve. In some aspects, the first electromagnetic tracking sensor may include a magnetostrictive material, where the first electromagnetic tracking sensor is a passive sensor that is not electrically coupled to an electrical line carrying signals associated with the position and orientation of the distal portion. In some aspects, the pre-defined spatial arrangement may include the first electromagnetic tracking sensor being positioned around the crown sleeve.

[0012] One general aspect includes an apparatus with an intracardiac echocardiography (ICE) catheter that may include a catheter shaft configured to be advanced through a blood vessel of a patient and into a heart of the patient. The catheter shaft may include: a proximal portion; a distal portion; a pullwire configured to cause deflection of the distal portion of the catheter; and a tip housing positioned coupled to the distal portion. The tip housing may include: an ultrasound transducer array configured to obtain ultrasound images of the heart while the tip housing is positioned within the heart; a pullwire crown mechanically coupled to the pullwire; and a crown sleeve mechanically coupled to the pullwire crown. The crown sleeve may include: a sidewall; a first opening in the sidewall; and a first electromagnetic tracking sensor positionedwithin the first opening and configured to identify a position and orientation of the ultrasound transducer array inside the heart.

[0013] In some aspects, the first opening in the sidewall is positioned proximate to a location where a first rounded portion of the sidewall and a first planar portion of the sidewall meet.

[0014] One general aspect includes an apparatus an intraluminal catheter that may include: a catheter shaft configured to be advanced through a patient body. The catheter shaft may include: a proximal portion; a distal portion; a pullwire configured to cause deflection of the distal portion of the catheter shaft; and a tip housing positioned coupled to the distal portion, where the tip housing may include: a pullwire crown mechanically coupled to the pullwire; and a crown sleeve. The crown sleeve may include: a sidewall; one or more first openings in the sidewall; one or more second openings in the sidewall, where the one or more second openings receive the pullwire crown to mechanically couple the crown sleeve and the pullwire crown; and at least one electromagnetic tracking sensor received by the one or more first openings and configured to identify a position and orientation of the tip housing inside the patient body.

[0015] One general aspect includes an apparatus with an intracardiac echocardiography (ICE) catheter. The ICE catheter may include: a catheter shaft configured to be advanced through a blood vessel of a patient and into a heart of the patient. The catheter shaft may include: a proximal portion; a distal portion; a pullwire configured to cause deflection of the distal portion of the catheter; and a tip housing positioned coupled to the distal portion. The tip housing may include: an ultrasound transducer array configured to obtain ultrasound images of the heart while the tip housing is positioned within the heart; a pullwire crown mechanically coupled to the pullwire; and a crown sleeve mechanically coupled to the pullwire crown; and an electromagnetic tracking sensor positioned around the crown sleeve, where electrical magnetic tracking sensor configured to identify a position and orientation of the ultrasound transducer array inside the heart.

[0016] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.

[0017] 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 ICE catheter with electromagnetic sensor(s), 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

[0018] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:

[0019] Fig. 1 a schematic diagram of an intra-cardiac echocardiography (ICE) imaging system according to embodiments of the present disclosure.

[0020] Fig. 2 is a schematic diagram of a portion of an ICE device according to embodiments of the present disclosure.

[0021] Fig. 3 is a schematic diagram illustrating deflections of an ICE device according to embodiments of the present disclosure.

[0022] Fig. 4 is a top view showing an intraluminal imaging device with electromagnetic position tracking capabilities being used during an intraluminal imaging procedure according to embodiments of the present disclosure.

[0023] Fig. 5 is a schematic diagram illustrating an interconnection within an ICE device between a tip assembly and a flexible elongate member according to embodiments of the present disclosure.

[0024] Fig. 6A is a perspective view of a crown element according to embodiments of the present disclosure.

[0025] Fig. 6B is a bottom view of a crown element according to embodiments of the present disclosure.

[0026] Fig. 6C is a side view of a crown element according to embodiments of the present disclosure.

[0027] Fig. 7 is a side view of a crown element with a pullwire in position according to embodiments of the present disclosure.

[0028] Fig. 8 A is a perspective view of a sleeve element according to embodiments of the present disclosure.

[0029] Fig. 8B is a top view of a sleeve element according to embodiments of the present disclosure.

[0030] Fig. 9 is a top view of a sleeve element according to embodiments of the present disclosure.

[0031] Fig. 10 is a perspective view of a tip assembly and a sleeve element positioned for coupling according to embodiments of the present disclosure.

[0032] Fig. 11 is a schematic, diagrammatic view of an ICE catheter procedure room, according to embodiments of the present disclosure.

[0033] Fig. 12A is a schematic, diagrammatic view of the distal portion of an ICE catheter, according to embodiments of the present disclosure.

[0034] Fig. 12B is a schematic, diagrammatic view of the distal portion 104 of an ICE catheter, according to embodiments of the present disclosure.

[0035] Fig. 13 is a cross-sectional view of a lined variable braided differential durometer multi-lumen catheter shaft according to embodiments of the present disclosure.

[0036] Fig. 14 is a top side perspective view of an example two-piece crown sleeve, according to embodiments of the present disclosure.

[0037] Fig. 15A is a top front perspective view of an example crown sleeve half, according to embodiments of the present disclosure.

[0038] Fig. 15B is a top front perspective view of an example crown sleeve half, according to embodiments of the present disclosure.

[0039] Fig. 16 is a top view or end view of the proximal end of two crown sleeve halves which can be fitted together to define a central lumen, according to embodiments of the present disclosure.

[0040] Fig. 17 is a top view or end view of the proximal end of the two crown sleeve halves of Fig. 16, according to embodiments of the present disclosure.

[0041] Fig. 18 is a partly exploded side perspective view of an ICE catheter that includes a two-piece crown sleeve, according to embodiments of the present disclosure.

[0042] Fig. 19 is a top view or end view of the proximal end of a two-piece crown sleeve, according to embodiments of the present disclosure.

[0043] Fig. 20 is a top view or end view of the proximal end of the two-piece crown sleeve of Fig. 19 inserted into the tip member, according to embodiments of the present disclosure.

[0044] Fig 21 is a top view or end view of the proximal end of the two-piece crown sleeve of Fig. 19 inserted into the tip member, according to embodiments of the present disclosure.

[0045] Fig. 22 is a side view of the two-piece crown sleeve of Fig. 19 inserted into the tip member, according to embodiments of the present disclosure.

[0046] Fig. 23 is a top view or end view of the proximal end of the two-piece crown sleeve of Fig. 19 inserted into the tip member, according to embodiments of the present disclosure.

[0047] Fig. 24 is a top side perspective cross-sectional view of the crown sleeve of Figure 14, taken along section line 24-24, according to aspects of the present disclosure.

[0048] Fig. 25A is a top side perspective cross-sectional view of at least a portion of the crown sleeve of Figure 24, according to aspects of the present disclosure.

[0049] Fig. 25B is a top side perspective cross-sectional view of at least a portion of the crown sleeve of Figure 24, according to aspects of the present disclosure.

[0050] Fig. 26 is a top side perspective cross-sectional view of a portion of an example crown sleeve with an EM sensor inserted, according to aspects of the present disclosure.

[0051] Fig. 27 is a side view of an assembled ICE catheter with electromagnetic sensor, according to aspects of the present disclosure.

[0052] Fig. 28 is an end view of a blind hole or through-hole in a crown sleeve half, according to aspects of the present disclosure.

[0053] Fig. 29A is a side perspective view of an example crown sleeve, according to aspects of the present disclosure.

[0054] Fig. 29B is an end view of the proximal end of the crown sleeve of Fig. 29A, according to aspects of the present disclosure.

[0055] Fig. 30 is an end side perspective view of an example crown sleeve, according to aspects of the present disclosure.

[0056] Fig. 31 is a perspective view of a fully assembled tip assembly, according to embodiments of the present disclosure.

[0057] Fig 32A is a side perspective view of an example crown sleeve surrounded by an electromagnetic sensor, according to aspects of the present disclosure.

[0058] Fig 32B is an end perspective view of the proximal end of the crown sleeve and electromagnetic sensor of Figure 32 A, according to aspects of the present disclosure.

[0059] Fig. 33 is a schematic diagram of a processor circuit, according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0060] EM sensors can be integrated into an intraluminal catheter, such as an ICE catheter. This advantageously helps overcome the learning curve difficulty for ICE catheters, because the EM sensors provide information about the ICE catheter’s position and orientation. In some aspects, the intraluminal catheter includes a mechanism related to pullwires for deflection of the catheter’s distal portion. One part of this mechanism is an anchor segment or crown sleeve, which is located at the distal portion of the intraluminal catheter. The crown sleeve is mechanically coupled to a pullwire crown because legs or posts of the pullwire crown are received and bonded within (e.g., adhesive, thermal, etc.) slots of the crown sleeve. The pullwire crown is mechanically coupled to the pullwires because the pullwires are, e.g., knotted around the pullwire crown.

[0061] The crown sleeve can be modified to include one or two openings into which one or two EM sensors can be inserted, respectively. Adhesive can be provided in the opening(s) to affix the EM sensor(s) to the crown sleeve. This positions the EM sensor(s) in a pre-defined, known, and / or fixed physical / spatial relationship with the crown sleeve. Pre-defined, known, and / or fixed can refer to the fact that the physical / spatial relationship between the EM sensor(s) and the crown sleeve is permanently established by the intraluminal catheter’s manufacturer during manufacturing of the intraluminal catheter. A user of the intraluminal catheter (e.g., a physician) cannot change the physical / spatial relationship between the EM sensor(s) and the crown sleeve. Examples of the pre-defined, known, and / or fixed physical / spatial relationship are illustrated in the drawings and include the EM sensor(s) being (partially or fully) positioned / received within the crown sleeve, the EM sensor(s) being (partially or fully) positioned around the crown sleeve, the EM sensor(s) (partially or fully) longitudinally and / or radially overlapping the crown sleeve, etc., and / or combinations thereof.

[0062] Some aspects include integrating one 6-DOF sensor into the intraluminal catheter. Some aspects include integrating two 5-DOF sensors into the intraluminal catheter. The two 5- DOF sensors can be positioned at some offset angle so that they do not run parallel to each other. This is so a computer can, using the signals output by the two 5-DOF sensors, determine the relative position / orientation of the two sensors with respect to one another, and with respect to the electromagnetic field, and calculate a full 6-DOF pose, which includes the X, Y, and Z position, as well as the pitch, yaw, and roll orientation.

[0063] In some aspects, the EM sensor(s) are each connected to the computer by a pair of wires (e.g., a twisted pair) running down the catheter shaft. For example, the computer can be an ultrasound console that provides user control of the ICE catheter and display for ultrasound images obtained by the ICE catheter. In another example, the computer is a separate workstation providing user control and display related to the electromagnetic field and / or EM sensors. The pair of wires (e.g., the twisted pair) either terminates into the same connector as the ultrasound imaging signals from the ICE catheter (connected to the ultrasound console) or the ICE catheter’s cable bifurcates into a second connector for the EM signals (connected to the separate workstation).

[0064] In some aspects, the EM sensor is a magnetostrictive material, which is a material disrupting the electromagnetic field. This disruption can be tracked with high fidelity. Some magnetostrictive materials have been shown to act in this way in the presence of an electromagnetic field. The below table summarizes a selection of magnetostrictive materials in which a primary material is sputter coated with a layer of the secondary material. This list is not comprehensive.Table 1 : Magnetostrictive Responses of Different Materials

[0065] The present disclosure substantially improves the technical field of intracardiac medical procedures related to the diagnosis, prophylaxis, and treatment of cardiac and vascular diseases. For example, integrating electromagnetic sensor(s) into the ICE catheter improves the clinician’s understanding of the position and orientation of the ICE catheter, such that the ICE images can be interpreted more quickly and accurately.

[0066] Aspects of the ICE catheter with electromagnetic sensor(s) may be implemented as a process at least partially 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 electromagnetic sensors. 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 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 embodiments of the present disclosure with particularity.

[0067] These descriptions are provided for exemplary purposes only, and should not be considered to limit the scope of the ICE catheter with electromagnetic sensor(s). Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0068] Embodiments of the present disclosure relate to ultrasound imaging using an intracardiac echocardiography (ICE) catheter, which is described, for example, in U.S. Publication No. 2019 / 0307420, filed September 29, 2017, entitled “Pullwire crown and crown sleeve for catheter assembly”, U.S. Publication No. 2019 / 0274658, filed September 25, 2017, entitled “Intracardiac echocardiography (ICE) catheter tip assembly”, U.S. Publication No. 2019 / 0282204, filed October 3, 2017, entitled “Intra-cardiac echocardiography interposer”, U.S. Publication No. 2020 / 0214670, filed September 26, 2017 entitled “Intraluminal imaging devices with a reduced number of signal channels”, U.S. Publication No. 2021 / 0321986, filed September 28, 2019, entitled “Imaging plane control and display for intraluminal ultrasound, and associated devices, systems, and methods”, U.S. Publication No. 2021 / 0275136, filed September 25, 2019,entitled “Lined variable braided differential durometer multi-lumen shaft with a cross-shaped inner profile”, U.S. Publication No. 2021 / 0307721, filed September 28, 2017, entitled “X-plane and 3d imaging for asymmetric apertures”, U.S. Publication No. 2021 / 0128110, filed July 9, 2019, entitled “Electrical wire connection in ultrasound imaging devices, systems, and methods”, U.S. Publication No. 2022 / 0296211, filed June 8, 2022, entitled “Control handle for steerable medical devices”, and U.S. Publication No. 2023 / 0052311, filed January 5, 2021, entitled “Electrical wire connection in intraluminal ultrasound imaging devices and system”, each of which is incorporated by reference herein in its entirety.

[0069] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the aspects 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. For example, while the ICE system is described in terms of cardiovascular imaging, it is understood that it is not intended to be limited to this application. The system is equally well suited to any application requiring imaging within a confined cavity. 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.

[0070] Fig. 1 is a schematic diagram of an intra-cardiac echocardiography (ICE) imaging system 100 according to embodiments of the present disclosure. The system 100 may include an ICE device 110 (e.g., an ICE catheter and / or other intraluminal imaging device), a connector 124, a control and processing system 130, such as a console and / or a computer, and a monitor 132. The ICE device 110 may include a tip assembly 102, a flexible elongate member 108, and a handle 120. The flexible elongate member 108 may include a distal portion 104 and a proximal portion 106. The distal end of the distal portion 104 may be attached to the tip assembly 102. The proximal end of the proximal portion 106 may be attached to the handle 120. For example, in some instances a resilient strain relief 112 couples the proximal portion 106 to the handle 120.The handle 120 may be used for manipulation of the ICE device 110 and / or manual control of the ICE device 110. The handle 120 can include actuators 116, a clutch 114, and other steering control components for steering the ICE device 110, such as deflecting the tip assembly 102 and the distal portion 104. In some aspects, the ICE device 110 may include steering and / or control mechanisms similar to those described in U.S. Patent No. 11,464,481, which is hereby incorporated by reference in its entirety. The tip assembly 102 may include an imaging array, imaging core, and / or imaging sensor with a plurality of ultrasound transducer elements and associated circuitry.

[0071] The handle 120 may be connected to the connector 124 via a strain relief 118 and an electrical cable 122. The connector 124 may be configured in any suitable configurations (including wired and / or wireless communications) to interconnect with the 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 tip assembly 102. The 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 processing system 130 can be operable to facilitate the features of the system 100 described herein. For example, the processor can execute computer readable instructions 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.

[0072] In operation, a physician or a clinician advances the flexible elongate member 108 into a vessel within a heart anatomy. The tip assembly 102 and the flexible elongate member 108 may be shaped and sized for insertion into vessels of a patient body. The flexible elongate member 108 may be composed of any suitable material, such as Pebax® poly ether block amides. The distal portion 104 and the proximal portion 106 may be tubular in shape and may include a primary lumen and one or more pullwire lumens extending longitudinally along the flexible elongate member 108. The primary lumen may be sized and shaped to accommodate an electrical cable interconnecting the tip assembly 102 and the connector 124 for transferring data (e.g., echo signals) obtained from the transducer elements. In some aspects, the primary lumen can be sized and shaped to accommodate other components for diagnostic and / or therapy procedures. The pullwire lumens may be sized and shaped to accommodate pullwires, for example, extending from the distal portion 104 to the handle 120. The pullwires may be coupledto the actuators 116 and / or the clutch 114 such that the flexible elongate member 108 and the tip assembly 102 are deflectable based on actuations of the actuators 116 and / or the clutch 114. In some instances, the primary lumen may be sized and shaped to facilitate alignment of the pullwire lumens. In addition, the tubular body of the flexible elongate member 108 may include a lined variable braided reinforcement layer configured to provide flexibility and kink resistance.

[0073] Dimensions of the flexible elongate member 108 can vary in different aspects. Generally, the flexible elongate member 108 may be positioned within any lumen or area within a patient body. In some instances, the flexible elongate member 108 may be sized and / or shaped for positioning with one or more particular lumens and / or target areas with the patient body. In some aspects, the flexible elongate member 108 can be a catheter having an outer diameter between about 8 and about 12 French (Fr) and can have a total length between about 80 centimeters (cm) to about 120 cm, where the proximal portion 106 can have a length between about 70 cm to about 118 cm and the distal portion 104 can have a length between about 2 cm to about 10 cm. While aspects described herein may refer to the ICE device 110, the concepts of the present disclosure may be applied to other types of intraluminal imaging devices, including IVUS, OCT, and / or other imaging modalities.

[0074] The physician or clinician can steer the flexible elongate member 108 to a desired position within the patient body. In this regard, the desired position may be near an area of interest to be imaged by the ICE device 110. In some aspects, the physician or clinician steers the flexible elongate member 108 by controlling the actuators 116 and the clutch 114 on the handle 120. For example, one actuator 116 may deflect the tip assembly 102 and the distal portion 104 in a left-right plane and the other actuator 116 may deflect the tip assembly 102 and the distal portion 104 in an anterior-posterior plane. The clutch 114 may provide a locking mechanism to lock the positions of the actuators 116 and, in turn, the deflection of the flexible elongate member 108 while imaging the area of interest.

[0075] The imaging process may include activating the ultrasound transducer elements of the tip assembly 102 to produce ultrasonic energy. A portion of the ultrasonic energy may be reflected by the area of interest and the surrounding anatomy. The ultrasound echo signals may be received by the ultrasound transducer elements. The connector 124 may transfer the received echo signals to the processing system 130. The processing system 130 may process the received echo signals to generate the ultrasound image(s) and output the image(s) to the monitor 132 fordisplay. In some aspects, the processing system 130 may control the activation of the ultrasound transducer elements and / or the repletion of the echo signals. In some aspects, the processing system 130 and the monitor 132 may be part of the same system.

[0076] 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 patient body. Although the system 100 is described in the context of ICE catheterization procedures, the system 100 is suitable for use with any catheterization procedure, including structural heart, cardiac, peripheral, and / or otherwise. In addition, the tip assembly 102 may include any suitable physiological sensor, component, and / or functional element for diagnosis, treatment, and / or therapy, such as pressure sensor(s), flow sensor(s), force sensor(s), doppler sensor(s), etc. The physiological sensors may be provided in addition to and / or in lieu of the imaging element(s). Thus, the handle 120 can be used to guide articulation and / or positioning of any type of functional element included in the distal portion 104 of the ICE device 110.

[0077] Fig. 2 is a schematic diagram of a portion of the ICE device 110 according to embodiments of the present disclosure. The tip assembly 102 and the flexible elongate member 108 are shaped and sized for insertion into vessels of a patient body. The flexible elongate member 108 can be composed of any suitable material, such as poly ether block amides. Polyether block amides are commonly manufactured under the tradename Pebax®. The distal portion 104 and the proximal portion 106 may be tubular in shape and may include a primary lumen and one or more pullwire lumens extending longitudinally along the flexible elongate member 108.

[0078] In some aspects, the tip assembly 102 and / or the distal portion 104 of the flexible elongate member 108 includes one or more electromagnetic position sensors or electromagnetic tracking sensors 140. The electromagnetic position sensors 140 may be a five degree of freedom (5-DOF) sensor. In some aspects, the electromagnetic position sensors 140 may be an electrical inductor (e.g., coil or other suitable structure). The electromagnetic position sensors 140 may be placed in a known mechanical position within the ICE device 110. More than one electromagnetic position sensor 140 can be utilized to gain a sixth degree of freedom (6-DOF). In this regard, all relevant guidance positions and orientations may be captured with 6-DOF, including X, Y, Z, roll, pitch, and yaw. For example, in some instances the electromagneticposition sensors 140 may have a length between about 1.5 mm and about 20 mm and a diameter between about 0.2 mm and about 0.8 mm, or other suitable dimensions. In some particular applications in accordance with the present disclosure, the electromagnetic position sensors 140 may include a coil having a length of approximately 2.5 mm and a diameter of approximately 0.3 mm, though any other suitable combinations of length and diameter (or width and height) may be utilized. Further, in some instances the electromagnetic position sensors 140 may be made of a material (or combination of materials) suitable for measuring characteristics of an electromagnetic field (e.g., magnetic field flux, magnetic field differential etc.).

[0079] The electromagnetic position sensors 140 may be in a known, fixed position relative to a target of the ICE device 110 that is to be tracked. For example, the electromagnetic position sensors 140 may have a known position relative to the imaging core, the distal portion of the flexible elongate member, another electromagnetic position sensor, the distal most tip, a boundary and / or middle of the tip assembly, a boundary and / or middle of the imaging core, a radiopaque marker, and / or other aspects or components of the ICE device 110. For example, as shown in Fig. 2, the electromagnetic position sensor 140 within the tip assembly 102 is spaced from the electromagnetic position sensor 140 within the distal portion 104 of the flexible elongate member 108 by a fixed distance 208. Similarly, the electromagnetic position sensor 140 within the tip assembly 102 may be spaced from the imaging core (e.g., proximal end, distal end, or middle) and / or a distal most tip of the ICE device 110 by a known distance. Further, the relative positional orientations of the electromagnetic positions sensors 140 may be known. For example, in some aspects the electromagnetic position sensor 140 within the tip assembly 102 may extend substantially colinear with or parallel to the electromagnetic position sensor 140 within the distal portion 104 of the flexible elongate member 108. In other aspects, the electromagnetic position sensor 140 within the tip assembly 102 may extend substantially perpendicular to the electromagnetic position sensor 140 within the distal portion 104 of the flexible elongate member 108. In yet other aspects, the electromagnetic position sensor 140 within the tip assembly 102 may extend at an oblique angle relative to the electromagnetic position sensor 140 within the distal portion 104 of the flexible elongate member 108. Similar orientation approaches may be used for two or more electromagnetic position sensors 140 within the tip assembly 102 and / or within the distal portion 104 of the flexible elongate member 108. In this regard, the known, but different orientations of the electromagnetic position sensors 140 maybe utilized to determine the location and / or orientation of the tip assembly 102 and / or an associated imaging core during a medical procedure utilizing magnetic fields produced by an electromagnetic field generator of a position tracking system.

[0080] The primary lumen of the ICE device 110 may be sized and shaped to accommodate a pair of wires extending from each of the electromagnetic position sensors 140 to the proximal portion 106 of the flexible elongate member 108. The primary lumen may be further sized and shaped to accommodate a plurality of wires (e.g., an electrical cable) interconnecting an imaging core of the tip assembly 102 to the handle 120 and / or the connector 124 for transferring echo signals obtained from the transducer elements of the imaging core to the processing system 130. In some aspects, the primary lumen can be shaped and sized to accommodate other components for diagnostic and / or therapy procedures.

[0081] The pullwire lumens may be sized and shaped to accommodate pullwires, for example, extending from the distal portion 104 to the handle 120. The pullwires may be coupled to the actuators 116 and the clutch 114 such that the flexible elongate member 108 and the tip assembly 102 are deflectable based on actuations of the actuators 116 and the clutch 114. In an embodiment, the primary lumen is shaped to facilitate alignment of the pullwire lumens. In addition, the tubular body of the flexible elongate member 108 may include a lined variable braided reinforcement layer configured to provide flexibility and kink resistance. The arrangements and configurations of the pullwires, the primary lumen, the pullwire lumens, the tip assembly 102, and the lined variable braided reinforcement layer are described in greater details herein. Dimensions of the flexible elongate member 108 can vary in different aspects. In some aspects, the flexible elongate member 108 can be a catheter having an outer diameter between about 8 and about 12 French (Fr) and can have a total length 206 between about 80 centimeters (cm) to about 120 cm, where the proximal portion 106 can have a length 204 between about 70 cm to about 118 cm and the distal portion 104 can have a length 202 between about 2 cm to about 10 cm.

[0082] Fig. 3 is a schematic diagram illustrating deflections planes of the ICE device 110 according to embodiments of the present disclosure. In some aspects, the orientation of the flexible elongate member 108 shown in Fig. 2 may be referred to as a neutral position. In Fig. 3, the tip assembly 102 and the distal portion 104 of the flexible elongate member 108 may be deflected from the neutral position to one or more other positions. As shown, the tip assembly102 and the distal portion 104 can be deflected along a first plane as shown by the solid arrows and a second plane as shown by the dotted arrows. In Fig. 3, the first plane is represented by an x-y plane and the second plane is represented by an x-z plane. For example, the x-y plane may correspond to a left-right plane and the x-z plane may correspond to an anterior-posterior plane for imaging the heart anatomy.

[0083] Fig. 4 is a top view showing an intraluminal imaging device with electromagnetic position tracking capabilities being used during an intraluminal imaging procedure according to embodiments of the present disclosure. In this regard, the intraluminal imaging device (e.g., ICE catheter, IVUS catheter, OCT device, and / or other imaging device) may be inserted into a body of a patient 400. For example, a distal portion of the intraluminal imaging device can be positioned within any suitable lumen with the body of a patient. In some instances, the distal portion of the intraluminal imaging device is advanced through the femoral or jugular artery when accessing the anatomy of the patient 400 and steered to the heart to acquire images for associated medical procedures. For example, as shown in Fig. 4, a distal portion of an ICE device 110 having an imaging core or assembly may be inserted into a femoral artery of the patient 400 on an operating table 410 and advanced to a desired location within the body. In some instances, at least a section of the proximal portion 106 of the ICE device 110 may remain outside of the patient 400, as shown.

[0084] Advancing the distal portion to the intraluminal imaging device to the desired location within the patient 400 may include steering the distal portion of the intraluminal imaging device using one or more steering mechanisms of the handle. One or more components of a steering mechanism can include pulley(s) coupled to the pullwire segment(s), axle(s), and / or actuation control member(s). The actuation control members can be coupled to the pullwire segments via the pulleys such that movement of the actuation control members causes corresponding deflection of the distal portion of the flexible elongate member. A clutch mechanism may include a clutch control member, a clutch cam, a clutch spring, and frictional members. The clutch control member can be moved to increase or decrease the compression force on the clutch cam. The clutch cam in turn applies the suitable compression force on the clutch spring. The frictional members may be positioned adjacent to and / or in contact with the actuation control members. The actuation control members may be urged into contact with the frictional members in response to the control force. Increased contact slows down the rate ofreturn to the non-deflected state. Decreased contact speeds up the rate of return to the nondeflected state. In this manner, a user may control the rate at which the distal portion of the intraluminal imaging device returns to a non-deflected state using the clutch mechanism.

[0085] Advancing the distal portion to the intraluminal imaging device to the desired location within the patient 400 may also include tracking the position and / or orientation of the distal portion and / or tip assembly of the intraluminal imaging device. In this regard, the intraluminal imaging device may include one or more electromagnetic position sensors as described previously. An electromagnetic field generator 420 may generate electromagnetic fields 430 that are used to determine the position and / or orientation of the electromagnetic position sensors and, thereby, the associated position and / or orientation of one or more aspects of the intraluminal imaging device. In this regard, the position and / or orientation of the electromagnetic position sensors may be determined by measuring an induced current produced in the electromagnetic position sensors by the electromagnetic fields 430. In this regard, a pair of wires may carry a signal corresponding to the induced current from the electromagnetic position sensors to a proximal portion and / or the handle of the intraluminal imaging device.

[0086] In use, the pair of wires extending from the electromagnetic position sensors may act as antennae and pick up undesired signals or noise (e.g., due to electromagnetic interference, the electromagnetic fields 430 generated by the electromagnetic field generator 420, or otherwise). A method for attempting to eliminate noise in this context is to twist the pair of wires around one another. In this regard, twisted pair cables may include two insulated copper wires twisted around each other. In theory, any external electromagnetically induced noise should be carried equally on both wires such that the receiving system can subtract one signal from the other to cancel out the noise. Aspects of reducing electromagnetic noise reduction are described in U.S. Provisional Application No. 63 / 641,441, filed May 2, 2023, titled “Intraluminal Imaging Devices With Electromagnetic Position Tracking And Reduced Electromagnetic Noise Interference”, which is incorporated by reference herein in its entirety.

[0087] Fig. 5 is a schematic diagram illustrating an interconnection within the ICE device 110 between the tip assembly 102 and the flexible elongate member 108 according to embodiments of the present disclosure. As shown, the interconnection between the tip assembly 102 and the distal portion 104 of the flexible elongate member 108 includes a crown element 520 and a sleeve element 540. The crown element 520 is coupled to the distal end of the distalportion 104. The sleeve element 540 is coupled to the crown element 520 and the proximal end of the tip assembly 102. The tip assembly 102 includes an imaging core 562 encased in a tip member 560. For example, the imaging core 562 is a planar element. The tip assembly 102 can include an alignment portion (not shown) shaped to facilitate alignment during manufacturing, as described in greater detail herein. The imaging core 562 is connected to an electrical cable 566 via an electrical interconnection 564. The electrical cable 566 extends longitudinally along the flexible elongate member 108. The crown element 520 and the sleeve element 540 are fitted around the electrical cable 566.

[0088] A more detailed view of the crown element 520 is illustrated in Fig. 6A and dimensions of the crown element 520 are illustrated in Figs. 6B and C. The crown element 520 functions as an anchor for pullwires 507 such that the tip assembly 102 and the distal portion 104 may be deflectable upon actuations of the pullwires 507 in the proximal direction as shown in Figs. 3 and 4 and described in greater detail herein. The anchoring of the pullwires 507 to the crown element 520 is illustrated in Fig. 7. The sleeve element 540 functions as an alignment agent to align the crown element 520 and the pullwires 507 such that the deflection may provide predictable or predetermined articulation views as described in greater detail herein. A more detailed view of the sleeve element 540 is illustrated in Fig. 8A. The alignment between the sleeve element 540 and the tip assembly 102 is illustrated in Fig. 10.

[0089] In an embodiment, the flexible elongate member 108 may include a lined variable braided enforcement layer to provide flexibility and kink resistance as described in greater detail herein. In such an embodiment, the interconnection further includes a braid containment 504 positioned between an anchoring segment 503 and the distal end of the flexible elongate member 108. The braid containment 504 may be composed of material such as polyethylene terephthalate (PET) or any suitable material. The anchoring segment 503 can be composed of similar material as the flexible elongate member 108. The braid containment 504 functions as a termination for the braided reinforcement layer. The braid containment 504 encases the termination of the materials (e.g., stainless steel wires) of the braided reinforcement layer to prevent exposure of the materials outside of the ICE device 110. The structure of the flexible elongate member 108 and the braided reinforcement layer are described in greater detail herein. The anchoring segment 503 couples the braid containment 504 to the crown element 520 and thesleeve element 540 to allow for thermal reflow when bonding the components at the interconnection.

[0090] The interconnection may further include support members 508 and 509, which are thin sleeves, to provide protection over connections of different components. The support members 508 and 509 may be composed of any suitable polymeric material. As shown, the support member 508 is positioned over the connections among the sleeve element 540, the tip assembly 102, the crown element 520, and the anchoring segment 503. The support member 509 is positioned over the connections among the braid containment 504, the anchoring segment 503, and the distal portion 104 of the flexible elongate member 108.

[0091] Fig. 6A is a perspective view of the crown element 520 according to embodiments of the present disclosure. Fig. 6B is a bottom view of the crown element 520 according to embodiments of the present disclosure. Fig. 6C is a side view of the crown element 520 taken along the line 601 of Fig. 6B according to embodiments of the present disclosure. The crown element 520 includes an annular ring 522 and support legs or posts 528 and 529. The crown element 520 is composed of a material dissimilar or incompatible with the material of the flexible elongate member 108. For example, the crown element 520 is composed of a thermoset material such as metal or plastic polymer. The annular ring 522 includes a top surface 524 and a bottom surface 526. The posts 528 and 529 are positioned about radially opposite of each other on the annular ring 522 and extend about perpendicularly from the bottom surface 526. Each of the posts 528 and 529 has a hole 530 positioned at an end of each of the posts 528 and 529, respectively, away from the annular ring 522 and along a central axis of the posts 528 and 529, respectively. A pair of pullwires such as the pullwires 507 can be secured to the crown element 520, one at each of the posts 528 and 529. The edges of the annular ring 522 are curved or rounded, for example, with small radii, to eliminate breakage of the pullwires during multiple actuations.

[0092] Dimensions of the crown element 520 can vary in different embodiments depending on the dimensions of the flexible elongate member 108. In some embodiments, the annular ring 522 can have an outer radius 611 between about 5 FR and about 11 FR and an inner radius 612 between about 4 FR and about 10 FR. Each of the posts 528 and 529 can have a height 613 between about 1 mm and 3 mm and a width 614 between about 0.25 mm and 1.5 mm. Each hole 530 can have a radius 615 between about 0.05 mm and .7 mm. In some embodiments, the outerradius 611 can be less than the outer diameter of the flexible elongate member 108 while the inner radius 612 can be greater than the radius of the primary lumen of the flexible elongate member 108.

[0093] Fig. 7 is a side view of the crown element 520 taken along the line 601 of Fig. 6B with a pullwire 700 similar to the pullwires 507 in position according to embodiments of the present disclosure. The pullwire 700 can be composed of metal, hard plastic, or any suitable material. As shown, the pullwire 700 is anchored or mechanically coupled to the crown element 520 by forming a knot 710 at the post 528 creating segments 721 and 722 separated by the post 528. The post 528 provides connection security and stability when the segments 721 and 722 are actuated. The separation of the segments 721 and 722 by the post 528 allows actuations of the segments 721 and 722 to be independent of each other, and thus provides consistent bending of the ICE device 110 over multiple actuations of the segments 721 and 722. For example, an actuation of the segment 721 deflects the ICE device 110 in one direction and actuation of the segment 722 deflects the ICE device 110 in another direction. Another pullwire similar to the pullwires 700 and 507 can be anchored to the crown element 520 at the other post 529 using similar mechanisms to provide deflection of the ICE device 110 along a different plane. Thus, the crown element 520 enables independent and consistent actuations of the pullwire segments. In addition, the head 711 of the knot 710 is placed at the inner wall of the crown element 520 to minimize the amount of dissimilar material outside of the crown element 520 that can weaken the joint between the crown element 520 and the sleeve element 540 after bonding.

[0094] Fig. 8A is a perspective view of the sleeve element 540 according to embodiments of the present disclosure. Fig. 8B is a top view of the sleeve element 540 according to embodiments of the present disclosure. The sleeve element 540 has a tubular body and includes flat outer surface portions 542 and 544 and curved outer surface portions 546 and 548. The sleeve element 540 is composed of a material compatible to the flexible elongate member 108 and the tip assembly 102. For example, the sleeve element 540 can be composed of a plastic polymer. The flat outer surface portions 542 and 544 have about the same surface area. The curved outer surface portions 546 and 548 have about the same surface area. The flat outer surface portion 542 is adjacent to the curved outer surface portions 546 and 548. The flat outer surface portion 544 is adjacent to the curved outer surface portions 546 and 548. The flat outer surface portions 542 and 544 are about radially opposite of each other. The sleeve element 540further includes slots 551 and 552 extending longitudinally along the tubular body. The slot 551 is positioned proximal to the flat outer surface portion 542 and curved outer surface portion 546. The slot 552 is positioned proximal to the flat outer surface portion 544 and curved outer surface portion 548.

[0095] During assembly or manufacturing, the posts 528 and 529 of the crown element 520 are fitted into the slots 551 and 552, respectively, and thermally bonded. Since the pullwires are anchored at the posts 528 and 529 and the posts 528 and 529 are fitted into the slots 551 and 552, respectively, the positioning of the slots 551 and 552 relative to the flat outer surface portions 542 and 544 can facilitate alignment of the pullwires to the imaging core 562 such that actuations of the pullwires can provide consistent articulation views, as described in greater detail herein.

[0096] Dimensions of the sleeve element 540 can vary in different embodiments depending on the dimensions of the flexible elongate member 108. For example, the outer diameter 814 may be smaller than the inner diameter of the proximal opening 568 of the tip member 560 such that the sleeve element 540 may be fitted into the proximal opening 568 of the tip member 560. The widths 813 of the slots 551 and 552 may be greater than the widths 614 of the posts 528 and 529 such that the posts 528 and 529 may be inserted into the slots 551 and 552, respectively. For example, the material of the sleeve element 540 may be pliable and may conform to the inserted posts 528 and 529.

[0097] Fig. 9 is a top view of a sleeve element 900 according to embodiments of the present disclosure. The sleeve element 900 can be employed by the ICE device 110 in place of the sleeve element 540. The sleeve element 900 is similar to the sleeve element 540, but has a curved outer surface 910 without any flat portion as in the sleeve element 540. The sleeve element 900 can include slots 921 and 922 similar to the slots 551 and 552, which can be used for fitting the posts 528 and 529, respectively, when bonded with the crown element. The sleeve element 900 can be used when the tip assembly 102 does not include an alignment portion for alignment. In some embodiments, a sleeve element can be shaped to have an outer surface portion different from remaining outer surface to allow for alignment, where the outer surface portion can be in any shape suitable for alignment.

[0098] Fig. 10 is a perspective view of the tip assembly 102 and the sleeve element 540 positioned for coupling according to embodiments of the present disclosure. The tip assembly 102 is illustrated with the imaging core 562 in position within the tip member 1700. Theimaging core 562 is coupled to the electrical cable 566 via the electrical interconnection 564. The electrical cable 566 extends through the alignment portion 1844 and the interface portion 1846 of the inner cavity 1800 and sleeve element 540. The electrical cable 566 can further extend through the flexible elongate member 108 as shown in Fig. 5. During manufacturing, the interface portion 1846 can extend over and cover a portion of the sleeve element 540, the crown element 520, and the flexible elongate member 108, thus improving the bonding strength.

[0099] As shown, the tip member 1700 is oriented such that the alignment members 1830 and 1832 are aligned to the flat outer surface portions 542 and 544 of the sleeve element 540. As described above, the sleeve element 540 includes the flat outer surface portions 542 and 544 and the slots 551 and 552, which are configured to couple to the crown element 520 in a particular orientation associated with the positioning of the pullwires 700 and 740. Thus, the sleeve element 540, the alignment members 1830 and 1832, and the crown element 520 can be conjunctively designed to allow coupling of the sleeve element 540, the alignment members 1830 and 1832, and the crown element 520 in a particular orientation. As such, the sleeve element 540, the alignment members 1830 and 1832, and the crown element 520 can be consistently aligned during manufacturing without additional alignment measurement or adjustment. Since the alignment members 1830 and 1832 are oriented in a pre-defined relation with the ultrasound beam propagation direction of the imaging core 562 and the pullwires 700 and 740 are configured to provide steering of the tip assembly 102, the actuations of the pullwires 700 and 740 can provide consistent articulation view for imaging. It should be noted that the alignment keying of the sleeve element 540 and the alignment members 1830 and 1832 can be alternatively configured as determined by a person of ordinary skill in the art to achieve similar functionalities.

[0100] Fig. 11 is a schematic, diagrammatic view of an ICE catheter procedure room 1100 (e.g., catheterization laboratory or cath lab, operating room, etc.), according to embodiments of the present disclosure. Visible are the flexible elongate member 108 and handle 120 of the ICE catheter 110, along with the cable 122, connector 124, console or processor 130, and display or monitor 132. Also visible are a patient interface module (PIM) cable 1110, patient table 1120, patient table controls 1125, electromagnetic field generator 1130, EM field generator coupling box 1140, cable T-junction or Y-junction 1150, EM field generator cable 1160, EM sensor data cable 1170, EM field generator computer 1180, EM field generator computer monitor 1190, twoboom monitors 1192 and 1194, and an X-ray machine 1196. The cable T-junction or Y-junction 1150 allows signals to and from the electromagnetic sensors (located near the distal tip of the flexible elongate member 108) to be routed to the EM field generator computer via the EM sensor data cable 1170, while ultrasound signals from the transducer array (also located near the distal tip of the flexible elongate member 108) are routed to the ultrasound console 130 via the PIM cable 1110.

[0101] In an example, the patient table 1120 can move (e.g., longitudinally), and the EM field generator 1130 (which, in some aspects, may also serve as an EM field sensor) is coupled to patient table and thus moves along with the movement of the patient table). Example EM field generators and EM field sensors may include devices manufactured by Northern Digital Inc., Polhemus, Radwave, and FreeNav. In this regard, the ICE catheter 110 may include one or more electromagnetic position sensors as described herein. The electromagnetic field generator 1130 may generate electromagnetic fields 430 that are used to determine the position and / or orientation of the electromagnetic position sensors and, thereby, the associated position and / or orientation of one or more aspects of the intraluminal imaging device. In this regard, the position and / or orientation of the electromagnetic position sensors may be determined by measuring an induced current or voltage produced in the electromagnetic position sensors by the electromagnetic fields 430.

[0102] Readings from the EM sensors are transmitted through the EM field generator coupling box 1140 and the EM sensor data cable 1170 to the EM field generator computer 1180, which may for example be or include a processor circuit with a processor and memory, a user interface (keyboard, mouse, touchscreen / touchpad, joystick, trackball, etc.), and display 1190. The display 1190 may for example show the position and orientation of the ICE catheter tip assembly with regard to a 3D heart model and / or a heart-centric coordinate system. The EM field generator computer 1180 may be the same or different from the ultrasound console 130. The display 1190 of the EM field generator computer 1180 may be the same or different that the display 132 of the ultrasound console 130.

[0103] The PIM cable 1110 establishes communication between the ICE catheter 110 and the ultrasound console 130, as described for example in U.S. Publication No. 2020 / 0275909, filed September 7, 2018, entitled “Connectors for patient interface module and ultrasound imaging device”, which is incorporated by reference herein in its entirety. The ultrasound console 130may be or include a processor circuit with a processor and memory, a user interface (keyboard, mouse, touchscreen / touchpad, joystick, trackball, etc.), and display 132. The display 132 may for example show ultrasound images of the inside of the heart, generated by the tip assembly of the ice catheter 110.

[0104] The boom displays 1192, 1194 may mirror the displays 1190 and / or 132, or may show the output of the X-ray machine 1196 (e.g., a live fluoroscopic image stream), or combinations thereof. For example, the boom displays 1192, 1194 may show ultrasound images, fluoroscopic images, a 3D heart model, and / or the ICE catheter pose (6-DOF position and orientation), whether co-registered or otherwise.

[0105] The coordinates of the ICE catheter (e.g., in a heart model coordinate system) can be registered to the patient (e.g., in a patient coordinate system) through the use of one or more patient reference sensors 1199, such as a skin patch which contains another EM sensor tracked within the electromagnetic volume.

[0106] Fig. 12A is a schematic, diagrammatic view of the distal portion 104 of an ICE catheter 110, according to embodiments of the present disclosure. The flexible elongate member 108 can also be referred to as a body (e.g., catheter body), catheter shaft, etc. The flexible elongate member 108 includes the proximal portion 106 terminating at a proximal end and a distal portion 104 terminating at a distal end. The tip assembly 102 is positioned at and coupled to the distal portion 104 (e.g., distal end) of the flexible elongate member 108. Visible within the tip housing 1210 are a transducer array 1220, application-specific integrated circuit (ASIC) 1230, and interposer 1240, along with the pullwires 507, pullwire crown 520, crown sleeve 540, and two 5-DOF sensors 140. The tip housing 1210 includes an inner surface 1250 that defines an inner volume 1270.

[0107] Electrical lines 514 form the electrical cable 566. The electrical lines 514 may for example be coaxial cables, and there may be between 1 and 65 electrical lines or between 16 and 30 electrical lines, such as 17, 20, 21, and / other values both larger and smaller. The transducer array 1220, integrated circuit (e.g., ASIC) 1230, and / or interposer 1240 are in electrical communication with one another and with the ultrasound console. Electrical lines 514 carry power and / or command signals from the ultrasound console to the transducer array 1220, integrated circuit (e.g., ASIC) 1230, and / or interposer 1240 for operation of the transducer array 1220 to obtain ultrasound image data. Electrical lines 514 carry signals representative of theobtained ultrasound image data from the transducer array 1220, integrated circuit (e.g., ASIC) 1230, and / or interposer 1240 to the ultrasound console, which further processes the ultrasound image data to generate 2D and / or 3D ultrasound images and outputs the 2D and / or 3D ultrasound images to a display.

[0108] A 5-DOF sensor 140 can be an active sensor (e.g., powered, having bidirectional communication), such as 5-DOF sensors available from Northern Digital Inc. The 5-DOF sensors 140 can receive power and / or command signals from the EM field generator computer and / or the EM field generator (e.g., via the EM field generator coupling box) for operation of the 5-DOF sensor to obtain X, Y, Z position and pitch and yaw orientation of the tip housing (e.g., position and orientation that the transducer array is facing and / or emitting ultrasound energy, which allows a user to understand the anatomy that is shown in the ultrasound images). The 5- DOF sensors 140 can transmit signals representative of an induced current or voltage produced in the 5-DOF sensors by the electromagnetic fields 430 (see Fig. 4) to the EM field generator computer. The EM field generator computer can generate a X, Y, Z position and pitch and yaw orientation based on the induced current or voltage. In the example shown in Figure 12A, the 5- DOF sensors 140 are connected to electrical lines or conductors 1260. For example, each 5-DOF sensor can be electrically coupled two conductors 1260 (e.g., a twisted pair).

[0109] In other aspects, a 5-DOF sensor 140 can be a passive sensor (e.g., not powered, and with no communication, thus connected to no conductors carrying signals associated with the position and orientation of the distal portion of the ICE catheter), such as a passive sensor formed of magnetostrictive material. Magnetostrictive or magneto- elastic materials include for example terfenol-D, permendur, nickel, and / or alloys of nickel, cobalt, iron, and / or aluminum (e.g., cobalt and nickel, aluminum and iron (lul4 Alfer), Co-Ni, Ni-Co ferrite). In the absence of a strong magnetic field, magnetic dipoles within the magnetostrictive material are randomly or quasi-randomly oriented in a relaxed state. In the presence of a magnetic field, magnetic dipoles within the magnetostrictive material align or partially align with the magnetic field. This results in an elongated state, wherein, the magnetoelastic material increases in length and decreases in width. In an oscillating magnetic field, the magnetostrictive material can oscillate between the relaxed state and the elongated state. The use of magnetostrictive materials in position sensing is described for example in U.S. Provisional Application No. 63 / 464,320, filed May 5, 2023, entitled “Ultrasound And Magnetic Field Used With Magneto-Elastic Material For DeterminingTissue Engagement By Medical Device”, which is incorporated by reference herein in its entirety. The electromagnetic fields 430 (see Fig. 4) generated by the EM field generator cause a magnetostrictive response in the magnetostrictive material. The magnetostrictive response causes a change in the electromagnetic fields 430 (e.g., perturbations in the electromagnetic fields). In some aspects, the EM field generator can be also be an EM field sensor and / or a distinct EM field sensor can be in communication with EM field generator computer. The EM field sensor can detect the changes in the electromagnetic field 430 caused by the magnetostrictive material. The EM field sensor transmits signals representative of the changes in the electromagnetic field 430 caused by the magnetostrictive material to the EM field generator computer, which processes the signal to determine the X, Y, and Z position and pitch and yaw orientation.

[0110] The two 5-DOF sensors allow for determination of the roll orientation (e.g., the sixth degree of freedom, thus enabling 6-DOF sensing). In particular, two 5-DOF sensors can be angled relative to one another by a pre-determined, fixed, and / or known angle. The angle can be between 15 degrees and 60 degrees, include values such as 20 degrees, and / or other suitable values both larger and smaller. The EM field generator computer can receive the signals representative of the induced current or voltage from both 5-DOF sensors. Based on the difference in the signals from the two 5-DOF sensors, and the known angle between them, the EM field generator computer can determination the roll orientation (the sixth DOF).

[0111] Pullwires that can cause deflection of the tip housing 1210 and / or distal portion 104 of the catheter shaft 500, as shown in Fig. 3. Any suitable number of pullwires may be used, including 1, 2, 3, 4, or more pullwires. For example, 2 pull wires may be used - each with knot at the pullwire crown, to form 2 pull segments each, so that there are total of 4 pullwire segments (as shown below in Figure 14).

[0112] Fig. 12B is a schematic, diagrammatic view of the distal portion 104 of an ICE catheter 110, according to embodiments of the present disclosure. The flexible elongate member 108 can also be referred to as a body (e.g., catheter body), catheter shaft, etc. The flexible elongate member 108 includes the proximal portion 106 terminating at a proximal end and a distal portion 104 terminating at a distal end. The tip assembly 102 is positioned at and coupled to the distal portion 104 (e.g., distal end) of the flexible elongate member 108.

[0113] In the example shown in Figure 12B, the tip housing 1210 includes a single 6-DOF sensor 1310. The single 6-DOF sensor 1310 can be an active (powered, bidirectional communication) sensor, such as 6-DOF sensor available from Northern Digital Inc. The 6-DOF sensor 1310 can receive power and / or command signals from the EM field generator computer and / or the EM field generator (e.g., via the EM field generator coupling box) to obtain X, Y, Z position and pitch, yaw, roll orientation of the tip housing (e.g., position and orientation of that transducer array is facing and / or emitting ultrasound energy, which allows a user to understand the anatomy that is shown in the ultrasound images. The 6-DOF sensor 1310 can transmit signals representative of an induced current or voltage produced in the 6-DOF sensor 1310 by the electromagnetic fields 430 (see Fig. 4) to the EM field generator computer. The EM field generator computer can generate a X, Y, Z position, and roll, pitch, and yaw orientation based on the induced current or voltage. The 6-DOF sensor 1310 is connected to electrical lines or conductors 1260. For example, the 6-DOF sensor 1310 can be electrically coupled four conductors 1260 (e.g., two twisted pairs).

[0114] Fig. 13 is a cross-sectional end view of a body 500 with additional components of the intraluminal imaging device shown according to embodiments of the present disclosure. In some aspects, the body 500 may be utilized in intracardiac echocardiography (ICE) catheters, intravascular ultrasound (IVUS) catheters, and / or other imaging devices having electromagnetic position tracking capabilities. For example, the body 500 may form part or all of flexible elongate member 108 of the ICE device 110, including the distal portion 104 and / or the proximal portion 106, or sections thereof. The body 500 and / or flexible elongate member 108 can also be referred as a catheter body and / or a catheter shaft.

[0115] The body or catheter shaft 500 may be tubular in shape with a tubular wall 502 and a primary lumen 1308. The primary lumen 1308 may extend between a proximal end and a distal end, for example, along a central longitudinal axis of the body 500. As shown, the primary lumen 1308 may have a cross-shaped cross-sectional profile. In this regard, the primary lumen 1308 may include arms 510 extending from a central lumen. The cross-shaped profile may be rounded (as shown in FIG. 13) or rectangular, for example. In some aspects, the primary lumen 1308 may have other cross-sectional profiles, including geometrical, non-geometrical, and / or combinations thereof. Further, the cross-section profile of the primary lumen 1308 may change along the length of the body 500 in some instances. The dimensions of the primary lumen 1308 can besized to allow components (e.g., a printed circuit board (PCB), a coaxial cable, a plurality of wires, etc.) to be introduced through the primary lumen 1308 during assembly, and thus may improve handling responsiveness during operation.

[0116] The body or catheter shaft 500, including tubular wall 502, may be formed of any suitable material. In some aspects, the tubular wall 502 may be composed of a high durometer polymeric material at a distal segment and a low durometer polymeric material at a proximal segment. For example, the high durometer polymeric material may have a durometer between 63D-80D and include materials such as Pebax® 72D or a suitable nylon. The low durometer polymeric material may have a durometer between 30D to 55D and include materials such as Pebax® 35D, Pebax® 45D, or a suitable nylon. The differing durometer of the tubular wall 502 between the distal segment and the proximal segment may create a sharp transition or a high stiff-to-flex ratio in the body 500. Thus, the body 500 can be relatively rigid at the proximal segment, but substantially pliable or flexible at the distal segment. The steerability of the body 500, the amount of force to bend the body 500, and / or the locality of the bend force and / or actuations may depend on the durometer of the body 500. A sharp transition may improve the steerability, the amount of force, and / or the locality of the force when the body 500 is in use. In some aspects, the tubular wall 502 may have a common or continuous durometer (e.g., between 30D and 80D) along its length. In some aspects, the tubular wall 502 may include multiple changes in durometer along its length.

[0117] The body 500 may further include a plurality of secondary lumens 506 extending longitudinally through a length of the tubular wall 502. The secondary lumens 506 may be shaped and sized to accommodate pullwires 507. Thus, the secondary lumens 506 may also be referred to as pullwire lumens. The secondary lumens 506 are positioned within the tubular wall 502 radially spaced apart by an angle of about 90 degrees. The arms 510 of the cross-shaped cross section of the primary lumen 1308 may define the angular positions of the secondary lumens 506 within the body 500. For example, the secondary lumens 506 may be positioned between adjacent arms 510. The primary lumen 1308 and the secondary lumens 506 can be lined with a lubricious lining material 1309 such as a polytetrafluoroethylene (PTFE) or other suitable material. The lining material 1309 may create surfaces with less friction for threading, delivery, and actuations of the pullwires or any other suitable diagnostic sensor assembly. In addition, the lining material 1309 can function as a support structure to prevent the primary lumen 1308and / or the secondary lumens 506 from collapsing. Further, the lining material 1309 can function as a barrier to protect abrasion caused by shifting or actuations of the pullwires and / or threading of the diagnostic sensor assembly.

[0118] The body 500 further includes a braided layer 504 embedded within the tubular wall 502. The braided layer 504 includes a distal portion, a proximal portion, and a transition portion between the distal portion and the proximal portion. The braided layer 504 can be composed of any suitable material and geometry. For example, the braided layer 504 may include stainless steel flat wires, which may provide optimal usage of radial space and additional strength. The braided layer 504 has braids with pitches that vary along a length of the tubular wall 502. The braids can include any suitable braid pattern. The braid pattern may be selected to improve torque transmission (e.g., a 1 : 1 ratio from the proximal end to the distal end), pushability, and / or kink resistance.

[0119] The braids at the distal portion may be configured to have a higher per inch count (PIC) than the braids at the proximal portion, for example, by about two times. The higher PIC at the distal portion provides a great flexibility to the distal segment. The lower PIC at the proximal portion creates a stiffer support for the proximal segment. For example, the distal portion has a first PIC, the proximal portion has a second PIC, and the transition portion has a varying PIC that varies smoothly from the first PIC to the second PIC. As shown, the distal portion of the braided layer 504 is aligned to the distal segment 104 of the tubular wall 502, the proximal portion of the braided layer 504 is aligned to the proximal segment 106 of the tubular wall 502, and the transition portion extends across a coupling point at which the low durometer distal segment 104 meets the high durometer proximal segment 106. The transition portion can extend a length, for example, between about 5 mm to about 20 mm. The smooth varying braid pitches in the short transition portion can alleviate the weak kink point resulting from the abrupt transition between the low durometer distal segment 104 and the high durometer proximal segment 106.

[0120] Dimensions of the tubular wall 502 can vary in different embodiments. In some embodiments, the tubular wall 502 may be a 9 Fr catheter. Thus, the tubular wall 502 can have an outer diameter 1320 of about 3 mm. The distal segment 104 (Figs. 1-3) can have a length between about 70 mm to about 81 mm. The length may vary based on a required bend radius for the tubular wall 502. The proximal segment 106 can have a length between about 872 mm to877 mm. The dimensions of the cross-shaped primary lumen 1308 can be sized to allow components (e.g., a printed circuit board (PCB) and / or a coaxial cable) to be threaded through the lumen 1308 during assembly instead of using the coaxial cable as an anchor as in some configurations, and thus may improve handling responsiveness during operation. The low durometer material used in in the distal segment 104 and the braided layer 504 allows the tubular wall 502 to deflect up to a bend radius (e.g., as shown Fig. 3) of between about 13 mm to about 14 mm instead of about 27 mm to about 28 mm.

[0121] In this regard, the braid 504 may partially and / or fully surround wires 512 extending from the one or more electromagnetic position sensors along a length of the flexible elongate member. For example, as shown in Fig. 13, two pairs of wires 512 are shown. Each of the pairs of wires 512 is coupled to a corresponding electromagnetic position sensor. In some aspects, the wires 512 include an outer insulating layer. In some instances, the parameters (e.g., thickness, durometer, etc.) of the insulation layer and / or the twists per inch of the wires 512 may be selected based on desired flexibility and / or dielectric properties, which may be optimized for the specific applications and / or procedures, including limiting particular type(s) and / or frequencies of electromagnetic interference. The electromagnetic position sensors may have a known position relative to the imaging core, the distal portion of the flexible elongate member, another electromagnetic position sensor, the distal most tip, a boundary and / or middle of the tip assembly, a boundary and / or middle of the imaging core, a radiopaque marker, and / or other aspects or components of the intraluminal imaging device. In some aspects, the braid 504 may partially and / or fully surround a plurality of wires 514 extending from the imaging core to the proximal portion of the flexible elongate member. For example, as shown in Fig. 13, a bundle of wires 514 is shown extending from the imaging core to the proximal portion of the flexible elongate member. The bundle of wires 514 includes twenty wires, but it is understood that the wires 514 may include any suitable number of wires, including between 1 and 65, between 16 and 30, or other suitable number. Further, the wires 514 may be part of or form a cable or otherwise be grouped or bundled together. For example, the wires 514 can be grouped with a insulative sheath or conduit 516 to form the cable 566 of Figure 5.

[0122] Fig. 14 is a top side perspective view of an example two-piece crown sleeve 1400, according to embodiments of the present disclosure. In the example shown in Figure 14, the crown sleeve 1400 is similar to the crown sleeve 540 of Fig. 8 A, but is assembled from twosubstantially identical halves 1410, e.g., one half is a rotated version of the other half (e.g., rotated around a central, longitudinal axis 1420). As with crown sleeve 540, crown sleeve 1400 includes two slots or blind openings 1430 in the proximal face or proximal end 1460, that are sized and shaped to receive the support legs or posts 528, 529 of the pullwire crown or crown element 520 (see Fig. 6A). The posts 528, 529 may be bonded to the blond openings 1430 (e.g., thermally bonded, adhesively bonded, etc.).

[0123] However, unlike crown sleeve 540, the crown sleeve 1400 of Figure 14 includes two openings that are angled through-holes 1440, and that are sized and shaped to receive the 5-DOF EM sensors 140 (see Fig. 2), and that extend from the proximal end 1460 to the distal end 1465 of the crown sleeve 1400 such that the entire length of the 5-DOF sensor can be received. Thus, the distal end of the 5-DOF sensor may be proximal of the distal end of the crown sleeve 1400, and the proximal end of the 5-DOF sensor may be distal of the proximal end of the crown sleeve 1400, such that the crown sleeve completely surrounds the electromagnetic tracking sensor and the perimeter of the through-hole, and is positioned between the electromagnetic tracking sensor and the tip housing. However, in some instances, the distal end of the 5-DOF sensor may protrude distally from the distal end of the crown sleeve 1400, such that electromagnetic tracking sensor is positioned between the crown sleeve and the tip housing, and / or the proximal end of the 5-DOF sensor may protrude proximally from the proximal end of the crown sleeve 1400. The two slots or blind openings 1430 are radially spaced from the central lumen 1470, and are circumferentially spaced from one another by approximately 180 degrees, as are the two through-holes 1440.

[0124] The two halves 1410 are snapped together (e.g., mechanically coupled) with snap fittings 1450, each comprising a snap post or snap projection and a snap post receiver or snap recess, as described below in Fig. 15. An adhesive or thermal bond may, instead or in addition, be used to join the two halves 1410. The inner surfaces 1480 of the two halves 1410 together define a central lumen 1470, through which the cable 566 (see Fig. 5) can pass. The outer surfaces 1485 and inner surfaces 1480 together define a sidewall 1490 whose outer surface includes two rounded portions and two planar portions, as described above in Figure 8A. The slots or blind openings 1430 and the through- holes 1440 are positioned completely within the sidewall 1490.

[0125] Fig. 15A is a top front perspective view of an example crown sleeve half 1410, according to embodiments of the present disclosure. The crown sleeve half 1410 includes two blind opening halves 1530, which can be matched with blind opening halves 1530 of another crown sleeve half 1410 to form the slots or blind openings 1430. The crown sleeve half 1410 also includes one angled through hole 1440, which extends from the proximal end to the distal end of the crown sleeve half, and forms an angle a with the vertical or longitudinal axis. The crown sleeve half also includes a snap post 1550 and snap post receiver 1555 (e.g., a blind opening sized and shaped to receive a snap post 1550). The snap post 1550 and snap post receiver 1555 on this crown sleeve half 1410 can be respectively matched with a snap post receiver 1555 and snap post 1550 on another crown sleeve half 1410 to form the snap fittings 1450.

[0126] In the example shown in Figure 15A, the through hole 1440 has a diameter DTI, while the central lumen 1470 has a diameter DLI, the sidewall 1490 has a thickness Ti, and the crown sleeve half 1410 has an outer diameter Dcsi. DTI can be determined based on the size (e.g., diameter) of the electromagnetic sensor. Ti is dependent on DTI, is greater than DTI, and is sized to allow the imaging core cable to pass through the inner diameter. DLI is sized to allow the imaging core cable to fit through. Dcsi is dependent on the inner diameter of the tip. In an example, DTI is between 0.2 mm and Ti minus the thickness of the crown sleeve, DLI is between 1 mm and 2 mm, Ti is between 0.2 mm and 0.75 mm, and / or Dcsi is between 2 mm and 3.5 mm. In this example, the cross-sectional shape of the through-hole 1440 is circular. In other examples, the cross-sectional shape of the through- hole 1440 may be non-circular (e.g., elliptical, polygonal, etc.). In other example, the cross-sectional shape of the through-hole 1440 may include combinations of circular and non-circular (e.g., elliptical, polygonal, etc.).

[0127] Fig. 15B is a top front perspective view of an example crown sleeve half 1410, according to embodiments of the present disclosure. The crown sleeve half 1410 of Figure 15B is similar to that of Figure 15 A, except that the diameter of the through-hole 1440 is now DT2, which is larger than DTI, e.g., to accommodate a larger EM sensor. This change necessitates a thicker sidewall 1490 with a thickness T2, which in turn drives a smaller lumen diameter DL2, if the outer diameter of the crown sleeve half is held to the same value of Dcsi. Another consequence of this change is that the through-hole 1440 is closer to the outer surface of the crown sleeve half 1410 at the proximal surface of the crown sleeve half 1410.

[0128] Fig. 16 is a top view or end view of the proximal end of two crown sleeve halves 1410 which can be fitted together to define a central lumen 1470, according to embodiments of the present disclosure. As described above, each crown sleeve half includes a through-hole 1440 and two blind opening halves 1530, which can be matched with the blind opening halves 1530 of the other crown sleeve half 1410 to form the slots or blind openings 1430 of Fig. 14. Also visible are the two alignment flats or -planar portions 1610, along with two curved portions or rounded portions 1620. The through holes 1440 are positioned proximate to where the alignment flats 1610 meet the curved portions 1620.

[0129] Fig. 17 is a top view or end view of the proximal end of the two crown sleeve halves 1410 of Fig. 16, according to embodiments of the present disclosure. Unlike Fig. 16, the through holes 1440 have been filled by the two 5 -DOF EM sensors 140, which are bonded in place with a layer of adhesive 1710. The 5-DOF EM sensors are thus held in position, at a known angle to one another, by the crown sleeve, thus providing a pre-defined spatial arrangement between the pullwire and the tip housing for the deflection of the distal portion.

[0130] Fig. 18 is a partly exploded side perspective view of an ICE catheter that includes a two-piece crown sleeve, according to embodiments of the present disclosure. Visible are two crown sleeve halves 1410, two 5-DOF EM sensors, two twisted-pair wire sets 512, the electrical cable 566 and its component wires 514, and the support member 508.

[0131] Fig. 19 is a top view or end view of the proximal end of a two-piece crown sleeve 1400, according to embodiments of the present disclosure. Visible are the crown sleeve halves 1410, blind openings 1430, angled through-holes 1440, 5-DOF EM sensors 140, adhesive 1710, alignment flats 1610, and central lumen 1470. When the two halves 1410 are assembled together to form the crown sleeve 1400 (e.g., by snapping the snap fittings together), the wires 514, without their surrounding sheath, pass through the central lumen 1470 of the crown sleeve 1400.

[0132] Fig. 20 is a top view or end view of the proximal end of the two-piece crown sleeve 1400 of Fig. 19 inserted into the tip member 560, according to embodiments of the present disclosure. Visible are the crown sleeve halves 1410, blind openings 1430, angled through-holes 1440, 5-DOF EM sensors 140, adhesive 1710, wires 514, and central lumen 1470. The crown sleeve 1400 is inserted into the tip member 560 such that the alignment flats 1610 of the crown sleeve align with the alignment flats 1830, 1832 of the tip member 560, as described above in Figure 10, while the curved portions 1620 of the crown sleeve 1400 align with curved portions2010 of the tip member 560, to provide the pre-defined spatial arrangement between the EM sensors 140, the pullwires, and the tip assembly of the ICE catheter.

[0133] Fig 21 is a top view or end view of the proximal end of the two-piece crown sleeve 1400 of Fig. 19 inserted into the tip member 560, according to embodiments of the present disclosure. Visible are the crown sleeve halves 1410, blind openings 1430, angled through-holes 1440, twisted-pair wires 512, electrical wires 514, electrical cable 566, central lumen 1470, and one alignment flat 1610. The twisted pair wired 512 are not located in the central lumen 1470 of the crown sleeve 1400, but enter the through-holes 1440 to connect to the 5-DOF EM sensors.

[0134] Fig. 22 is a side view of the two-piece crown sleeve 1400 of Fig. 19 inserted into the tip member 560, according to embodiments of the present disclosure. Visible are the twistedpair wires 512, electrical cable 566, one alignment flat 1610, the pullwire crown 520, pullwires 507, and support member 508. In a next assembly step, the pullwire crown 520 will be attached to the crown sleeve 1400 as described above.

[0135] Fig. 23 is a top view or end view of the proximal end of the two-piece crown sleeve 1400 of Fig. 19 inserted into the tip member 560, according to embodiments of the present disclosure. Visible are the crown sleeve halves 1410, blind openings 1430, angled through-holes 1440, 5-DOF EM sensors 140, adhesive 1710, wires 514, and central lumen 1470. As in Figure 20, the crown sleeve 1400 has been inserted into the tip member 560 such that the alignment flats 1610 of the crown sleeve align with the alignment flats 1830, 1832 of the tip member 560, as described above in Figure 10. However, in addition, the posts 528, 529 of the pullwire crown 520 have been inserted into the blind openings 1430, thus assembling the pullwire crown (and the pullwires knotted to it) to the tip member 560, and therefore making the tip member steerable via the pullwires as described above in Figs. 3 and 7.

[0136] Fig. 24 is a top side perspective cross-sectional view of the crown sleeve 1400 of Figure 14, taken along section line 24-24, according to aspects of the present disclosure. The sidewall 1490 of the crown sleeve 1400 extends radially between the outer surface 1485 and the inner surface 1480. Visible are the two through-holes 1440, and one of the two blind slots 1430, along with two EM sensors 140 and their twisted-pair wires 512, and one pullwire crown post 528. In the example shown in Figure 24, the pullwire crown post 528 is fully inserted to the bottom of the blind slot 1430, and the EM sensors 140 are inserted into the through-holes such that the EM sensor 140 is positioned completely within the through-hole 1440 (e.g., the distalend 2410 of the EM sensor 140 is proximal of the distal end 1465 of the crown sleeve 1400, and the proximal end 2420 of the EM sensor 140 is positioned distal of the proximal end 1460 of the crown sleeve 1400.

[0137] Fig. 25A is a top side perspective cross-sectional view of at least a portion of the crown sleeve 1400 of Figure 24, according to aspects of the present disclosure. The sidewall 1490 of the crown sleeve 1400 extends radially between the outer surface 1485 and the inner surface 1480. Visible are one two through-hole 1440, and one blind slot 1430, along an EM sensors 140 and its twisted-pair wires 512, and one pullwire crown post 528. In the example shown in Figure 25A, the pullwire crown post 528 is fully inserted to the bottom of the blind slot 1430, and the EM sensors 140 are inserted into the through-holes such that the EM sensor 140 is positioned completely within the through-hole 1440 (e.g., the distal end 2410 of the EM sensor 140 is flush with the distal end 2510 of the crown sleeve 1400, and the proximal end 2420 of the EM sensor 140 is flush with the proximal end 2520 of the crown sleeve 1400.

[0138] Fig. 25B is a top side perspective cross-sectional view of at least a portion of the crown sleeve 1400 of Figure 24, according to aspects of the present disclosure. The sidewall 1490 of the crown sleeve 1400 extends radially between the outer surface 1485 and the inner surface 1480. Visible are one two through-hole 1440, and one blind slot 1430, along an EM sensors 140 and its twisted-pair wires 512, and one pullwire crown post 528. In the example shown in Figure 25A, the pullwire crown post 528 is fully inserted to the bottom of the blind slot 1430, and the EM sensors 140 are inserted into the through-holes such that the EM sensor 140 is not positioned completely within the through-hole 1440 (e.g., the distal end 2410 of the EM sensor 140 is distal of the distal end 2510 of the crown sleeve 1400, and the proximal end 2420 of the EM sensor 140 is proximal of the proximal end 2520 of the crown sleeve 1400.

[0139] Fig. 26 is a top side perspective cross-sectional view of a portion of an example crown sleeve 1400 with an EM sensor 140 inserted, according to aspects of the present disclosure. The sidewall 1490 of the crown sleeve 1400 extends radially between the outer surface 1485 and the inner surface 1480. In the example shown in Fig. 26, the hole 2640 is a blind hole rather than a through-hole, with the hole 2640 starting from the proximal end 2520 of the crown sleeve 1400 but extending only to the blind distal end 2620 of the hole 2640 (proximal of the distal end 2510 of the crown sleeve 1400), rather than extending all the way through the distal end 2510 of the crown sleeve 1400. The distal end 2410 of the EM sensor 140 can beadjacent to, in contact with, spaced from, and / or proximate to the blind distal end 2620 of the hole 2640. In the illustrated example, the proximal end 2420 of the sensor 140 is flush with the proximal end 2520 of the crown sleeve 1400. In other examples, the proximal end 2420 of the EM sensor 140 is proximal of the proximal end 2520 of the crown sleeve 1400.

[0140] Fig. 27 is a side view of an assembled ICE catheter with electromagnetic sensor, according to aspects of the present disclosure. Visible are the flexible elongate member or catheter shaft 108, pullwires 507, twisted pair wires 512, pullwire crown 520, pullwire crown post 528, crown sleeve 1400, EM sensors 140, and tip housing 1210.

[0141] As in Fig. 25B, the distal end of the EM sensor 140 extends distal of the distal end of crown sleeve and the distal end of the through-hole the for EM sensor in the crown sleeve 1400, and the proximal end of the EM sensor extends proximal of the proximal end of crown sleeve and proximal end of the through-hole for the EM sensor in the crown sleeve, although other configurations are possible as described above. The twisted pair wires 512 start from the proximal end of the EM sensor 140 and extend proximally in the ICE catheter (e.g., extends proximally from crown sleeve 1400 through the catheter shaft 108.

[0142] Fig. 28 is an end view of a blind hole or through-hole 2840 in a crown sleeve half, according to aspects of the present disclosure. Although the through-hole 1440 of Figs. 15A- 15B is circular in cross-section, the blind hole or through-hole 2840 of Figure 28 is non-circular, with two curved portions 2850 and two flat or planar portions 2860, to accommodate a non- cylindrical EM sensor. The cross-sectional profile for the EM sensor opening (e.g., the blind hole or though-hole 1440, 2640, 2840) can dependent on the shape of EM sensor (e.g., a cross- sectional profile of the EM sensor that is circular, elliptical, polygonal, non-circular, and / or combinations thereof).

[0143] Fig. 29A is a side perspective view of an example crown sleeve 2900, according to aspects of the present disclosure. In some aspects, the diameter DEM of the EM sensors 140 is such that it cannot be accommodated by the thickness Ti of the sidewall 1490 (see Fig. 15 A). In such cases, the through-holes 1440 of Figs. 15A-15B may be replaced with openings that are open channels 2940 that are angled to one another, and that extend completely from the proximal face to the distal face of the crown sleeve 2900. The EM sensors 140 may for example be attached into the channels 2940 with an adhesive or thermal bond.

[0144] Fig. 29B is an end view of the proximal end of the crown sleeve of Fig. 29 A, according to aspects of the present disclosure. Visible are the blind slots or blind openings 1430, open channels 2940, central lumen 1470, and EM sensors 140. In the example shown in Fig. 29B, the sensors 140 are 5-DOF sensors that are angled with respect to one another and to the longitudinal axis of the crown sleeve 2900, such that 6-DOF pose information can be computed.

[0145] Fig. 30 is an end side perspective view of an example crown sleeve 3000, according to aspects of the present disclosure. In the example shown in Fig. 30, the opening to accommodate the EM sensor is neither a through-hole, a blind hole, or a channel, but a circular gap 3040 in the crown sleeve 3000 that extends completely through the inner surface 3050 and the outer surface 3060 of the crown sleeve 3000, so that the crown sleeve 3000 is not continuous around its perimeter. Thus, the crown sleeve 3000 can accommodate a single large EM sensor, such as a 6DOF sensor. In this configuration, the gap interrupts the perimeter of the crown sleeve, and the electromagnetic tracking sensor may be immediately adjacent to the tip housing.

[0146] Fig. 31 is a perspective view of a fully assembled tip assembly 102, according to embodiments of the present disclosure. The tip assembly 102 is illustrated with the transducer array 1220 in position within the tip member 1700. Visible are the pullwires 507, pullwire crown 520, crown sleeve 1400, EM sensor 140, electrical lines or coaxial cables 514, interposer (circuit board) 1240, a stiffener 3110 (e.g., metal, to prevent the tip assembly 1700 from bending), an ASIC 1230, and acoustic backing material 3120. In the example shown in Fig. 31, the EM sensor 140 extends for a significant distance distally from the distal end of the crown sleeve. Depending on the implementation, the EM sensor 140 may be one of two 5-DOF sensors, or may be a single 6 DOF sensor.

[0147] Fig 32A is a side perspective view of an example crown sleeve 3200 surrounded by an electromagnetic sensor 3210, according to aspects of the present disclosure. In the example shown in Fig. 32A, the EM sensor 3210 is generally cylindrical in shape, though it is shown with a diagonal camber at its proximal and distal ends. This camber may for example allow for an angle between the two sensors that is required to get the 6th degree of freedom (rotation about the long axis of the device). The EM sensor 3210 may for example include a canted coil 3220 wrapped around a polymer (e.g., polyimide) tube 3230 and embedded in a fixation material 3240 such as an epoxy. With the EM sensor 3210 surrounding the crown sleeve 3200, there is no need for the crown sleeve 3200 to include through-holes, blind holes, channels, or gaps toaccommodate the EM sensors. In the example shown in Figure 32A, the EM sensor 3210 extends both proximally and distally of the crown sleeve 3200, such that the electromagnetic tracking sensor is located between the tip housing and the crown sleeve. In the example shown in Fig. 32A, the polymer tube 3230 includes alignment flats 3250 that are aligned with the alignment flats 1610 of the crown sleeve 3200 that may be used to "clock" or align the canted coil 3220 relative to the crown sleeve 3200. Also visible are the central lumen 1470 and one of the two blind slots 1430 in the crown sleeve 3200.

[0148] Fig 32B is an end perspective view of the proximal end of the crown sleeve 3200 and electromagnetic sensor 3210 of Figure 32A, according to aspects of the present disclosure. The crown sleeve 3200 includes two crown sleeve halves 3260, a central lumen 1470, and two blind slots 1430. With the EM sensor 3210 surrounding the crown sleeve 3200, there is no need for the crown sleeve 3200 to include through-holes, blind holes, channels, or gaps to accommodate the EM sensors. Thus, the crown sleeve 3200 includes only the central lumen 1470 and the blind slots 1430 to accommodate the pullwire crown, with no other openings being necessary.

[0149] Also visible are the canted coil 3220 and epoxy 3240, the polymer tube 3230, alignment flats 1610, and alignment flats 3250.

[0150] Fig. 33 is a schematic diagram of a processor circuit 3350, according to embodiments of the present disclosure. The processor circuit 3350 may be implemented in the ICE imaging system 100, the ICE procedure room 1100, 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 3350 may include a processor 3360, a memory 3364, and a communication module 3368. These elements may be in direct or indirect communication with each other, for example via one or more buses.

[0151] The processor 3360 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 3360 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 3360 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality ofmicroprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0152] The memory 3364 may include a cache memory (e.g., a cache memory of the processor 3360), random access memory (RAM), magnetoresistive RAM (MRAM), read-only 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 3364 includes a non-transitory computer-readable medium. The memory 3364 may store instructions 3366. The instructions 3366 may include instructions that, when executed by the processor 3360, cause the processor 3360 to perform the operations described herein. Instructions 3366 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.

[0153] The communication module 3368 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 3350, and other processors or devices. In that regard, the communication module 3368 can be an input / output (I / O) device. In some instances, the communication module 3368 facilitates direct or indirect communication between various elements of the processor circuit 3350 and / or the system 100 or procedure room 1100. The communication module 3368 may communicate within the processor circuit 3350 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 communicationsmay be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystem.

[0154] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the EM sensor(s)) 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) , 3GUMTS (universal mobile telecommunications system), 4G, long term evolution (LIE), 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.

[0155] A number of variations are possible on the examples and embodiments described above. For example, sensors may be integrated onto the catheter and their data exported to a workstation external of the ultrasound console, or integrated with the ultrasound console. More than two sensors may be employed, in order to get 3D pose in high fidelity, or the sensors may include magnetostrictive materials in addition to powered electromagnetic sensors. EM sensors could be detected in the catheter by simple X-ray or CT technologies. The technology described herein may be used for electromagnetic sensing, intracardiac echography (ICE), or for the assessment and / or treatment of structural heart disease and / or vascular disease.

[0156] 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.

[0157] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, 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, particularlyas to the position, orientation, or use of the ICE catheter with electromagnetic sensor(s). 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.

[0158] The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the ICE catheter with electromagnetic sensor(s) 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.

[0159] 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.

Claims

CLAIMSWhat is claimed is:

1. An apparatus, comprising: an intraluminal catheter comprising: a catheter shaft configured to be advanced through a patient body; a pullwire configured to cause deflection of a distal portion of the catheter shaft; a pullwire crown positioned at the distal portion and mechanically coupled to the pullwire; a crown sleeve positioned at the distal portion and mechanically coupled to the pullwire crown; and a first electromagnetic tracking sensor positioned in a pre-defined spatial arrangement with the crown sleeve and configured to identify a position and orientation of the distal portion.

2. The apparatus of claim 1, wherein the crown sleeve comprises: a sidewall extending between an inner surface and an outer surface; and a first opening in the sidewall, wherein the pre-defined spatial arrangement comprises the first electromagnetic tracking sensor being positioned within the first opening.

3. The apparatus of claim 2, wherein the first opening comprises a hole positioned between the inner surface and the outer surface such that the sidewall completely surrounds a perimeter of the hole.

4. The apparatus of claim 2, wherein the first opening comprises a channel in the outer surface.

5. The apparatus of claim 2, wherein the first opening comprises a gap extending completely through the inner surface and the outer surface.

6. The apparatus of claim 2, wherein the crown sleeve comprises a proximal end and a distal end, wherein the first opening comprises a through-hole extending completely between the proximal end and the distal end of the crown sleeve.

7. The apparatus of claim 2, wherein the crown sleeve comprises a proximal end and a distal end, wherein the opening comprises a blind hole extending from the proximal end to a location along a length of the crown sleeve proximal of the distal end.

8. The apparatus of claim 2, wherein the crown sleeve comprises a second opening in the sidewall; and wherein the intraluminal catheter comprises a second electromagnetic tracking sensor positioned within the second opening.

9. The apparatus of claim 8, wherein the first opening and the second opening are angled relative to one another, wherein at least one of the first opening or the second opening is angled relative to a longitudinal axis of the crown sleeve.

10. The apparatus of claim 8, wherein the first electromagnetic tracking sensor and the second electromagnetic tracking sensor each comprise a five-degrees-of-freedom (5-DOF) sensor.

11. The apparatus of claim 1, wherein a length of the first electromagnetic tracking sensor completely fits within a length of the crown sleeve.

12. The apparatus of claim 1, wherein at least one of: a proximal end of the first electromagnetic tracking sensor is positioned proximal of a proximal end of the crown sleeve; ora distal end of the first electromagnetic tracking sensor is positioned distal of a distal end of the crown sleeve.

13. The apparatus of claim 1, wherein the crown sleeve comprises a first portion and a second portion, wherein the first portion comprises one of a projection or a recess, wherein the second portion comprises the other of the projection or the recess, and wherein the projection is received within the recess to mechanically couple the first portion and the second portion.

14. The apparatus of claim 13, wherein the first portion and the second portion comprise an identical structure as one another, and wherein the first portion and the second portion are rotated relative to one another when mechanically coupled.

15. The apparatus of claim 1, wherein the pullwire crown comprises a ring and a post extending from the ring, wherein the crown sleeve comprises a second opening configured to receive the post to mechanically coupled the crown sleeve and the pullwire crown, and wherein the second opening is circumferentially spaced from the first opening.

16. The apparatus of claim 1, wherein the intraluminal catheter is an intracardiac echocardiography (ICE) catheter, wherein the catheter shaft is configured to be advanced through a blood vessel of the patient and into a heart of the patient, wherein the intraluminal catheter comprises an ultrasound transducer array positioned at the distal portion and configured to obtain ultrasound images of the heart.

17. The apparatus of claim 16, wherein the crown sleeve comprises a lumen,wherein intraluminal catheter further comprises a first plurality of electrical lines electrically coupled to the ultrasound transducer array and configured to carry signals associated with the ultrasound images, wherein the first plurality of electrical lines is positioned within the lumen of the crown sleeve.

18. The apparatus of claim 17, wherein the intraluminal catheter further comprises a second plurality of electrical lines electrically coupled to the first electromagnetic tracking sensor and configured to carry signals associated with the position and orientation of the distal portion, wherein the second plurality of electrical lines is not positioned within the lumen of the crown sleeve.

19. The apparatus of claim 1, wherein the first electromagnetic tracking sensor comprises a magnetostrictive material, wherein the first electromagnetic tracking sensor is a passive sensor that is not electrically coupled to an electrical line carrying signals associated with the position and orientation of the distal portion.

20. The apparatus of claim 1, wherein the pre-defined spatial arrangement comprises the first electromagnetic tracking sensor being positioned around the crown sleeve.

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