Wire connections in intraluminal ultrasound imaging devices and systems

Abstract

An intraluminal imaging device includes a flexible elongate member configured to be positioned within a body lumen of a patient. The flexible elongate member includes a plurality of coaxial cables. Each of the plurality of coaxial cables includes a conductive shield. The intraluminal imaging device also includes an ultrasound imaging assembly positioned at a distal portion of the flexible elongate member and in communication with the plurality of coaxial cables. The ultrasound imaging assembly includes a transducer array configured to obtain ultrasound data and a conductive pad. The conductive shield of each of the plurality of coaxial cables is mechanically and electrically coupled to the conductive pad. Related devices, systems, and methods are also provided.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to ultrasound imaging systems, and more particularly to wire connections for imaging catheters, such as intracardiac echocardiography (ICE) catheters. BACKGROUND

[0002] Diagnostic and therapeutic ultrasound catheters have been designed for use within many areas of the human body. In the cardiovascular system, a common diagnostic ultrasound method is intraluminal ultrasound imaging, with intracardiac echocardiography (ICE) being a specific example of intraluminal imaging. Typically, a single rotating transducer or an array of transducer elements is used to transmit ultrasound waves at the distal end of the catheter. The same transducer is used to receive echoes from the tissue. Signals generated from the echoes are transmitted to a console, which can allow for processing, storage, display, or manipulation of ultrasound-related data.

[0003] Intraluminal imaging catheters, such as ICE catheters (e.g., Siemens Acunav, St. Jude ViewFlex), are commonly used to image the heart and surrounding structures, for example, to guide and facilitate medical procedures such as transseptal catheterization, left atrial occlusion, atrial fibrillation ablation, and valve repair. Commercially available ICE catheters have a distal end that can be articulated through a steering mechanism located in a handle at the proximal end of the catheter. For example, an intraluminal imaging catheter, such as an ICE catheter, can be inserted through the femoral or jugular vein and steered within the heart to acquire images necessary for the safety of a medical procedure as it enters the anatomy.

[0004] ICE catheters must meet national and / or international requirements that dictate that the distal tip of the catheter must not separate when various sized tensile pull loads are applied, primarily dependent on the diameter of the catheter. This can ensure that the catheter can be safely removed from the patient without breaking and leaving the tip inside the heart or vasculature. Since ICE catheters must be very narrow, and the distal catheter assembly houses many transducers, circuitry, and other electrical components, it is difficult to achieve the necessary tensile strength within the extremely limited space. SUMMARY

[0005] Embodiments of the present disclosure relate to wire connections for imaging catheters, such as intracardiac echocardiography (ICE) catheters. A need exists for a simple, compact, stronger method and apparatus to connect the ultrasound imaging assembly of an ICE catheter to the elongate wire that carries it. To achieve a stronger mechanical coupling, a significant amount of solder can be applied to form a mechanical and electrical joint between the shield layers of multiple coaxial cables and ground pads located on an interposer board within the ultrasound imaging assembly. The center conductors of these coaxial cables can be joined to corresponding conductive pads elsewhere on the interposer board and can provide signal communication between the ultrasound imaging assembly and a computer. Single conductor cables can be connected to the interposer board at other locations within the ultrasound imaging assembly. The joint of the shield layers of the coaxial cables to the ground pads on the interposer board provides a common ground signal for all of the center conductor signals of the coaxial cables and provides a strong physical connection between the catheter cables and the ultrasound imaging assembly, making it easier to achieve the necessary tensile strength of an intracardiac echocardiography (ICE) catheter.

[0006] According to an exemplary aspect of the present disclosure, a luminal imaging device is provided. The luminal imaging device includes a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member including a plurality of coaxial cables, wherein each of the plurality of coaxial cables includes a conductive shield layer; and an ultrasound imaging assembly positioned at a distal portion of the flexible elongate member and in communication with the plurality of coaxial cables, the ultrasound imaging assembly including a transducer array configured to obtain ultrasound data; and a first conductive pad, wherein the conductive shield layer of each of the plurality of coaxial cables is mechanically and electrically coupled to the first conductive pad.

[0007] In some aspects, the intraluminal imaging device further comprises a solder block positioned on the first conductive pad, wherein the conductive shield of each of the plurality of coaxial cables is mechanically and electrically coupled to the first conductive pad by the solder block. In some aspects, the solder block is positioned around a perimeter of the plurality of coaxial cables. In some aspects, the solder block is configured to support a tensile load of at least 15 N. In some aspects, each of the plurality of coaxial cables includes an insulating jacket surrounding the conductive shield, the conductive shield includes an exposed portion free of the insulating jacket, and the exposed portion of the conductive shield and a corresponding dimension of the first conductive pad are equal. In some aspects, each of the plurality of coaxial cables includes a center conductor and an insulating layer surrounding the center conductor, the conductive shield is positioned around the insulating layer, and the solder block is positioned between the conductive shield and the insulating layer. In some aspects, the plurality of coaxial cables includes a first row of coaxial cables and a second row of coaxial cables, the first row of coaxial cables is positioned on the first conductive pad, and the second row of coaxial cables is positioned on the first row of coaxial cables. In some aspects, the solder block is positioned between the first row of coaxial cables and the second row of coaxial cables. In some aspects, each of the plurality of coaxial cables is spaced apart, wherein the solder block is positioned between each of the plurality of coaxial cables. In some aspects, the first conductive pad comprises an electrical ground for the plurality of coaxial cables. In some aspects, each of the plurality of coaxial cables includes a center conductor, wherein the ultrasound imaging assembly comprises a plurality of second conductive pads, the center conductor of each of the plurality of coaxial cables is mechanically and electrically coupled to a respective one of the plurality of second conductive pads, and the center conductor is configured to transmit electrical signals to and from the ultrasound imaging assembly. In some aspects, the flexible elongate member comprises a plurality of single-conductor cables positioned on the plurality of coaxial cables, the ultrasound imaging assembly comprises a plurality of third conductive pads configured to be mechanically and electrically coupled to the plurality of single-conductor cables, and the plurality of single-conductor cables are configured to transmit electrical signals to and from the ultrasound imaging assembly. In some aspects, the flexible elongate member comprises a catheter configured to be positioned within a heart of a patient. In some aspects, the ultrasound imaging assembly further comprises a circuit board in communication with the transducer array, the first conductive pad is positioned on a surface of the circuit board.

[0008] According to example aspects of the present disclosure, a system is provided. The system includes: an intraluminal imaging device including: a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member including a plurality of coaxial cables, wherein each of the plurality of coaxial cables includes a conductive shield; and an ultrasound imaging assembly positioned at a distal portion of the flexible elongate member and in communication with the plurality of coaxial cables, the ultrasound imaging assembly including: a transducer array configured to obtain ultrasound data; and a conductive pad, wherein the conductive shield of each of the plurality of coaxial cables is mechanically and electrically coupled to the conductive pad; and a computer in communication with the intraluminal imaging device and configured to generate an ultrasound image based on the ultrasound data.

[0009] Other aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. BRIEF DESCRIPTION OF DRAWINGS

[0010] Illustrative explanatory embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:

[0011] FIG. 1A is a schematic diagram of an intraluminal imaging system according to embodiments of the present disclosure.

[0012] FIG. 1B is a schematic diagram of a catheter according to embodiments of the present disclosure.

[0013] FIG. 2 is a perspective view of a catheter cable according to embodiments of the present disclosure.

[0014] FIG. 3A is a cross-sectional view of a catheter body according to embodiments of the present disclosure.

[0015] FIG. 3B is a cross-sectional view of a catheter cable according to embodiments of the present disclosure.

[0016] FIG. 4 is a perspective view of a distal ultrasound assembly of an intraluminal imaging device according to embodiments of the present disclosure.

[0017] FIG. 5 is a flowchart of a method of assembling an intraluminal imaging device according to embodiments of the present disclosure.

[0018] FIG. 6A is a top view of an interposer before connecting catheter cables according to embodiments of the present disclosure.

[0019] FIG. 6B is a cross-sectional view of the interposer along section line 6B-6B in FIG. 6A

[0020] FIG. 7 ​is a perspective view of a coaxial cable according to embodiments of the disclosure with each layer partially exposed.

[0021] FIG. 8A is a perspective view of a coaxial cable according to embodiments of the disclosure with each layer partially exposed. FIG. 6A is a top view of a midplate of the

[0022] FIG. 8B is a top view of a midplate of the FIG. 8A is a cross-sectional view of the

[0023] FIG. 9A is a perspective view of a coaxial cable according to embodiments of the disclosure with each layer partially exposed. FIG. 6A is a top view of a midplate of the

[0024] FIG. 9B is a top view of a midplate of the FIG. 9A is a cross-sectional view of the

[0025] FIG. 10A is a perspective view of a coaxial cable according to embodiments of the disclosure with each layer partially exposed. FIG. 6A is a top view of a midplate of the

[0026] FIG. 10B is a cross-sectional view of a midplate according to embodiments of the disclosure with a first and second row of coaxial cables connected and a third row of top center conductor cables positioned above the coaxial cables.

[0027] FIG. 11 is a perspective view of a midplate according to embodiments of the disclosure with a first and second row of coaxial cables connected and a third row of top center conductor cables positioned above the coaxial cables.

[0028] FIG. 12 is a schematic diagram of a processor circuit according to embodiments of the disclosure. DETAILED DESCRIPTION

[0029] For the purpose of facilitating an understanding of the principles of this disclosure, reference will now be made to the embodiments illustrated in the accompanying drawings, and these embodiments will be described using specific language. Nevertheless, it should be understood that this disclosure is not intended to limit its scope. Any changes and further modifications to the apparatus, systems, and methods, as well as any other applications of the principles of the invention, are fully contemplated and included within this disclosure, as will be readily apparent to those skilled in the art to which this disclosure pertains. For example, while this disclosure describes intraluminal imaging, it should be understood that it is not intended to be limited to that application. Specifically, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of this disclosure. However, for the sake of brevity, various repetitions of these combinations will not be described separately.

[0030] FIG. 1A This is a schematic diagram of an imaging system 100 according to an embodiment of the present disclosure. The system 100 may include an intraluminal ultrasound imaging device 110, a control and processing system 130 (e.g., a console including a computer), and a patient interface module (PIM) 131 extending between the device 110 and the control and processing system 130.

[0031] The ultrasound imaging device 110 may include a catheter 101, which in FIG. 1B The details are shown in more detail below. The catheter 101 may include one or more flexible, elongated members that are sized and shaped, structurally arranged, and / or otherwise configured to be positioned within a patient's body lumen. In some embodiments, the catheter 101 includes an ultrasound imaging assembly 102, a catheter body or shaft 201, a catheter cable 203, a handle 120, a guide tube 124, a connector 209, and one or more printed circuit board assemblies (PCBAs) 207. The catheter cable 203 may have a small-diameter construction and a low profile, and is sized to pass through or through the catheter shaft 201, handle 120, and / or guide tube 124. The cable 203 may be electrically and / or mechanically coupled to the ultrasound imaging assembly 102 located at the distal portion of the catheter shaft 201 and to the PCBA 207 located at the proximal portion of the catheter 101.

[0032] In some embodiments, one or both of the catheter body / shaft 201 and the catheter cable 203 may be referred to as a flexible elongated member. The catheter shaft 201 is sized and shaped, structurally arranged and / or otherwise configured to be positioned within a patient's body lumen (e.g., a vascular system, such as a blood vessel or a chamber of the heart). A corresponding portion of the catheter cable 203 extends within the catheter shaft 201, handle 120, guide tube 124, and connector 209. An imaging assembly 102 may be attached to the distal end of the catheter shaft 201. The catheter shaft 201 may include a lumen through which the catheter cable 203 can pass.FIG. 2 The proximal end 204 of the catheter shaft 201 shown in FIG. 1 can be connected to the handle 120, for example, through a resilient strain relief. The handle 120 can be used to steer and manually control the ultrasound imaging device 110. The ultrasound imaging device 110 can include an imaging assembly 102 having ultrasound transducer elements and associated circuitry. The handle 120 can include an actuator 116, a clutch 114, and other steering control components for steering the ultrasound imaging device 110. Steering can include deflecting the distal end of the catheter cable 203, as described in greater detail herein.

[0033] The catheter cable 203 can pass through one or more of the catheter shaft 201, the handle 120, the conduit 124, and the connector 209. In some embodiments, during assembly, the catheter cable 203 passes through a lumen within the catheter body 201, the handle 120, and the conduit 124. In some embodiments, the conduit 124 is a component distinct from the cable 203. For example, the conduit can be a tubing material in which the cable 203 extends. In other embodiments, the conduit 124 can be a coating that defines an outer surface of the cable 203. The coating can reinforce the cable 203 for exposure to direct contact and / or handling by an operator of the catheter 101. The catheter cable 203 can be terminated at the PCBA 207 within the connector 209. The catheter cable 203 can be electrically and mechanically coupled to the imaging assembly 102 and can include a plurality of wires.

[0034] The handle 120 can be connected to the conduit 124 through another strain relief. The conduit 124 can be configured to provide suitable configurations to interconnect the control and processing system 130 with the monitor 132 and the imaging assembly 102. The control and processing system 130 can be used to process, store, analyze, and manipulate data, and the monitor 132 can be used to display the acquired signals produced by the imaging assembly 102. The control and processing system 130 can include a processor circuit having one or more processors in communication with a memory. The memory can be a non-transitory computer readable storage medium. The memory can store instructions or program code that, when executed by the processor, cause the processing circuit to perform one or more functions described herein. The control and processing system 130 can be operable to facilitate the functions of the intraluminal imaging system 100 described herein. For example, the processor can execute computer readable instructions stored on a non-transitory, tangible computer readable medium. The control and processing system 130 can include one or more input devices, such as a keyboard and any suitable command control interface devices. The monitor 132 can be any suitable display device, such as a liquid crystal display (LCD) panel, or the like.

[0035] In operation, a physician or clinician can advance the catheter 101 into a lumen, such as a blood vessel, body lumen, or portion of the cardiac anatomy. By controlling the actuators 116 and / or clutch 114 on the control handle 120, the physician or clinician can steer the catheter 101 to a position near a region of interest to be imaged. For example, one actuator can deflect the distal end of the imaging assembly 102 and catheter cable 203 in a left-right plane, while another actuator can deflect the distal end of the imaging assembly 102 and catheter cable 203 in an anterior-posterior plane. The clutch 114 can provide a locking mechanism to lock the position of the actuators 116 and effectively lock the deflection of the imaging assembly 102 while imaging the region of interest.

[0036] The imaging process can include activating the ultrasound transducer elements on the imaging assembly 102 to generate ultrasound energy. A portion of the ultrasound energy is reflected by the region of interest and surrounding anatomy, and ultrasound echo signals are received by the ultrasound transducer elements. The guide tube 124 can be used to transmit the received echo signals to the control and processing system 130, where ultrasound images are reconstructed and displayed on the monitor 132. In some embodiments, the processing system 130 can control the activation of the ultrasound transducer elements and the reception of the echo signals. In some embodiments, the control and processing system 130 and monitor 132 can be part of the same system.

[0037] While some embodiments of the present disclosure relate to an imaging device, an ultrasound imaging device, or an intraluminal imaging device, it should be understood that the ultrasound imaging device 110 and system 100 can generally be used to image any suitable anatomical structure / tissue within a blood vessel, structure, lumen, and / or patient, including any number of anatomical locations and tissue types, including but not limited to: organs, including the liver, heart, kidney, gall bladder, pancreas, lung; ducts; intestines; nervous system structures, including the brain, dural sac, spinal cord, and peripheral nerves; urinary tract; and valves of the blood, chambers or other portions of the heart, and / or other systems of the body. In addition to natural structures, the imaging device 110 can be used to examine artificial structures, such as but not limited to heart valves, stents, shunts, filters, and other devices. For example, the ultrasound imaging device 110 can be positioned within a fluid-filled or surrounded structure, including natural and artificial structures, such as within a patient. The blood vessel, structure, lumen, and anatomical structure / tissue can include a blood vessel, such as an artery or vein of the patient’s vasculature, including the cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and / or any suitable lumen within the body.

[0038] The system 100 can be referred to as an imaging system, an ultrasound imaging system, an intraluminal imaging system, and / or combinations thereof. Although the present disclosure refers to an ICE catheter, any suitable intraluminal imaging device is contemplated, such as an intravascular ultrasound (IVUS) device, an optical coherence tomography (OCT) device, an intracardiac echocardiography (ICE) device, a transesophageal echocardiography (TEE) device, an intravascular photoacoustic (IVPA) imaging device, and / or any suitable internal imaging device. Intraluminal devices having a flexible elongate member, such as a catheter, a guidewire, and / or a guide catheter, are contemplated.

[0039] The system 100 can be used for a variety of applications, such as transseptal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair, and can be used to image blood vessels and structures in vivo. Although the system 100 is described in the context of an intraluminal imaging procedure, the system 100 is suitable for use with any catheterization procedure. Moreover, the imaging assembly 102 can include any suitable physiological sensor or component for diagnosis, treatment, and / or therapy. For example, the imaging assembly can include imaging components, ablation components, cutting components, morcellating components, pressure sensing components, flow sensing components, temperature sensing components, and / or combinations thereof. In some embodiments, the intraluminal imaging system 100 is used to generate two-dimensional and three-dimensional images.

[0040] Referring back to FIG. 1A The PIM 131 can provide physical and electrical connections between the ultrasound imaging device 110 and the control and processing system 130. Some embodiments of the present disclosure omit the PIM 131. In other embodiments, the PIM 131 is communicatively interposed between the ultrasound imaging device 110 and the processing system 130. In some cases, the PIM 131 can be referred to as a patient interface cable. For example, the proximal connector 209 of the ultrasound imaging device 110, the distal connector of the PIM, and / or the proximal connector of the PIM can be configured to mechanically and electrically couple the ultrasound imaging device 110, the PIM 131, and the control and processing system together. The system 100 can include a connector hub 111 that includes the proximal connector 209 of the ultrasound imaging device 110 and the distal connector of the PIM 131.

[0041] In some embodiments, the control and processing system 130 can include one or more computers, processors, and / or computer systems. The control and processing system 130 can also be referred to as a console. In some embodiments, the PIM 131 is in mechanical and electrical communication with the control and processing system 130 such that electrical signals are transmitted to the ultrasound imaging device 110 and to the control and processing system 130 through the PIM 131. The control and processing system 130 can include one or more processors and / or memory modules forming processing circuitry or processor circuitry, which can process the electrical signals and generate and output graphical representations of the imaging data (e.g., ultrasound images) on a monitor 132. One or more electrical conductors of the ultrasound imaging device 110 and the PIM 131 can facilitate communication between the control and processing system 130 and the ultrasound imaging device 110. For example, a user of the control and processing system 130 can control imaging using the ultrasound imaging device 110 through a control interface 134 of the control and processing system 130. Electrical signals representing commands from the control and processing system 130 can be transmitted to the ultrasound imaging device 110 via connectors and / or cables in the PIM 131 and the ultrasound imaging device 110. The control and processing system 130 can be transportable and can include wheels or other devices to facilitate easy transport by a user.

[0042] In some embodiments, one or more components of the ultrasound imaging device 110 can be a single-use component. For example, a user such as a physician can obtain the catheter 101 and / or the ultrasound imaging device 110 in sterile packaging. In some embodiments, the ultrasound imaging device 110 can be discarded after a single use. In other embodiments, the ultrasound imaging device 110 can be sterilized and / or reprocessed for use more than once. The PIM 131 can be a reusable component that is used in multiple operations. For example, the PIM 131 can be cleaned between operations, for example, treated with a disinfectant to kill bacteria. In some embodiments, the PIM 131 can not need to be sterilized prior to a medical operation. For example, the PIM 131 can be spaced sufficiently from a patient such that it is safe for the patient to use the PIM 131 that is not sterilized. The sterile-non-sterile connection at the connector assembly 111 between the ultrasound imaging device 110 and the PIM 131 can allow for a safe operating environment while saving costs by allowing reuse of expensive equipment.

[0043] FIG. 2 is above with respect to FIG. 1BA perspective view of the described catheter cable 203. The catheter cable 203 is a flexible elongate body 206 that includes a plurality of communication cables allowing for communication of imaging data and / or command signals between the processing system 130 and the catheter 101. The communication cables can be electrical wires. Individual wires can include a single bare conductor surrounded by one or more insulating layers and / or shielding layers. Individual wires can also be coaxial wires that include a central conductor surrounded by one or more insulating layers and a conductive shield layer that is also surrounded by one or more insulating layers or protective layers. Multiple wires can be collectively surrounded by one or more insulating layers and / or shielding layers. The insulating layers can be formed of any suitable material, such as plastic or polymer in some cases. The shielding layers can be formed of any suitable material, such as metal in some cases. For example, a woven layer 211, such as RFI braid, can surround the wires. The cable 203 extends between the ultrasound imaging assembly 102 disposed at the distal portion 202 and the PCBA 207 disposed at the proximal portion 204. The flexible elongate body 206 extends between the distal end 202 and the proximal end 204. In some embodiments, the imaging assembly 102 is electrically and / or mechanically coupled (e.g., adhered or engaged) with the distal end 202. During manufacturing, the imaging assembly 102 can be coupled to the catheter cable 203, which is then threaded through the catheter body or shaft. In some embodiments, the catheter cable 203 is about 4 feet long. In other embodiments, the catheter cable 203 is between 1 and 6 feet long or between 3 and 5 feet long, and / or other suitable values that are larger or smaller.

[0044] FIG. 3A A cross-sectional view of the catheter shaft 201 is shown. The catheter shaft 201 is sized and shaped, structurally arranged, and / or otherwise configured to be positioned within a body lumen of a patient during an imaging operation. The catheter cable 203 (shown in FIG. 2 and 3B ) can be configured to be disposed within an internal lumen 332 of the catheter shaft 201. The catheter shaft 201 can include a plurality of pull wire lumens 336 disposed within the catheter shaft 201. The pull wires positioned within the lumens 336 control movement of the distal portion of the catheter shaft and / or the imaging assembly 102 (deflection of the distal tip). In some embodiments, the outer diameter of the catheter shaft 201 is between about 1 mm and 3 mm, including larger and smaller values. In an exemplary embodiment, the catheter shaft 201 has an outer diameter of about 1.422 (+ / - 0.025 mm).

[0045] FIG. 3BA cross-sectional view of the catheter cable 203 is shown. The catheter cable 203 (e.g., the PCBA 207 and the flexible elongate body 206) can pass through or by the catheter shaft 201 during assembly. The PCBA 207 can be configured to connect directly or indirectly with the user console. For example, the PCBA 207 can communicate directly or indirectly with the console or processing system 130 and / or the PIM 131 FIG. 1A ) in some embodiments, the catheter cable 203 has a diameter between about 1 mm and about 3 mm, including greater and smaller values. In an exemplary embodiment, the catheter cable 203 has a diameter of about 1.3 mm (+ / - 0.07 mm). In some embodiments, the catheter cable 203 can include a polymer layer 342, a shielding layer 344, and a plurality of electrical wires 346. The electrical wires 346 can be disposed within the shielding layer 342, which can be disposed within the polymer layer 342. The electrical wires 346 can be used to transmit signals from the imaging assembly to the proximal end 204 and ultimately to the processing system 130. In some embodiments, the shielding layer 342 can be a woven layer 211 disposed around the polymer layer 342, as shown in FIG. 2 . The electrical wires 346 connect the imaging assembly 102 and the proximal connector 209 (e.g., the PCBA 207).

[0046] FIG. 4 is a perspective view of the imaging assembly 102 according to embodiments of the present disclosure. The imaging assembly 102 is positioned at a distal portion of the catheter shaft 201 after assembly. The imaging assembly 102 is also positioned at a distal portion of the cable 203. The imaging assembly 102 can include an ultrasound transducer array 262, which includes a plurality of transducer elements, and a microbeamformer IC 304 that can be coupled to the transducer array 262. The electrical wires 346 of the cable 203 are mechanically and electrically coupled to the imaging assembly 102. In some examples, the cable 203 is also coupled to the microbeamformer IC 304 through an interposer 310. In some examples, the interposer 310 is connected to the microbeamformer IC 304 through wire bonds 320. The electrical wires 346 of the cable 203 are in direct or indirect communication with the transducer array 262, the IC 304, and / or the interposer 310. In some embodiments, the interposer 310 can be a circuit board or any other suitable component. In some embodiments, the electrical wires 346 include three groups: a first group of coaxial cables 402, a second group of coaxial cables 404, and a third group of standard single-conductor cables 406.

[0047] In some embodiments, the transducer array 262 includes ultrasonic imaging transducers flip-chip mounted directly onto the microwave beamformer IC 304. The transmitters and receivers of the ultrasonic imaging transducers are located on the microwave beamformer IC 304 and are attached directly to the transducers. In some examples, the termination of the large number of acoustic elements is accomplished at the microwave beamformer IC 304.

[0048] In some examples, the transducer array 262 includes more than 800 imaging elements, and the cable 203 includes a total of 12 or fewer signal lines. In some examples, the cable 203 includes a total of 30 or fewer lines, including signal lines, power lines, and control lines. In some examples, the transducer array 262 includes a one- or two-dimensional array of between 32 and 1000 imaging elements. For example, the array can include 32, 64, 128, 256, 512, 640, 768, 812, or any other suitable number of imaging elements. For example, a one-dimensional array can have 32 imaging elements. A two-dimensional array can have 32, 64, or more imaging elements. In some examples, the number of signal lines is between 10 and 20, for example, 12 signal lines, 16 signal lines, or any other suitable number of signal lines. The one-dimensional array can be configured to generate two-dimensional images. The two-dimensional array can be configured to generate two-dimensional and / or three-dimensional images.

[0049] In some examples, the cable 203 of the imaging assembly 102 is directly coupled to the microbeamformer IC 304 of the imaging assembly 102. In some embodiments, the microbeamformer IC 304 is located directly beneath and electrically connected to the transducer array 262. The elements of the transducer array 262 can be piezoelectric or micro-machined ultrasonic transducer (MUT) elements. In some examples, the piezoelectric elements are attached to the IC 304 by flip-chip mounting of an assembly including an acoustic layer sawn into individual elements. The MUT elements can be flip-chip mounted or grown directly on top of the microbeamformer IC 304 as a unit. In some examples, the cable bundle can be terminated to an interposer 310 of a suitable material, such as a rigid or flexible printed circuit assembly. The interposer 310 can then be connected to the microbeamformer IC 304 by any suitable means, such as wire bonds 320.

[0050] In some embodiments, the microbeamformer IC 304 and the interposer 310 are coupled to an elongated acoustic backing material member 410. For example, adhesive bonding can be used. In other embodiments, the microbeamformer IC 304 and the interposer 310 can be mechanically fastened, solvent bonded, UV bonded, ultrasonically welded, or coupled using any other suitable method. The acoustic backing 410 can extend from the distal end of the microbeamformer IC 304 to the proximal end of the interposer 310.

[0051] A stiffening member 412 is coupled to the acoustic backing 410. The stiffening member 412 can have a similar shape as the acoustic backing 410 and extend from the distal tip of the microwave beamformer IC 304 to the proximal end of the interposer 310. The stiffening member 412 provides additional rigidity and structure to the imaging assembly 102. The stiffening member 412 can be constructed of any suitable material. In an exemplary embodiment, the stiffening member 412 is made of stainless steel. In other embodiments, the stiffening member can be made of electroless nickel, titanium, carbon fiber, magnesium, high strength steel, other alloy steels, or other suitable materials.

[0052] The interposer 310 houses various electrical components 420. The electrical components 420 can be positioned between the distal terminal of the cable 326 and the wire bond 320 and disposed on the top surface of the interposer 310. In some embodiments, the electrical components 420 can be used to generate, transmit, amplify, attenuate, record, or smooth signals in and out of the transducer array 262. The electrical components 420 can additionally be used to sense one or more characteristics of the physiological structure in which the intraluminal imaging device is positioned, such as temperature. It is fully contemplated that the electrical components 420 can provide any other functionality when positioned on the imaging assembly 102. The electrical components can be composed of passive and active components, including but not limited to resistors, capacitors, inductors, transistors, operational amplifiers, thermistors, or any other suitable electrical components.

[0053] The interposer 310 can also include a ground pad 430. The ground pad 430 can be a thin layer of conductive material positioned on the top surface of the interposer 310. The ground pad 430 can be disposed at the proximal portion of the interposer 310. The first set of coaxial cables 402 and the second set of coaxial cables 404 can be mechanically and electrically coupled to the ground pad 430. This connection can be achieved by brazing the exposed shield layer of each coaxial cable in the first set 402 and the second set 404 (e.g., the exposed shield layer 710 of FIG. 7), such that the cables are mechanically and electrically joined to the ground pad 430, as will be discussed in greater detail herein. In some embodiments, coaxial cables can be preferred over single conductor cables because they more effectively transmit high frequency signals for fast switching and reduce noise. In some embodiments, the coaxial cables can be configured to transmit control signals from the computer 130 to the ultrasound imaging assembly 102 and / or transmit image data from the ultrasound imaging assembly 102 to the computer 130. FIG. 7

[0054] FIG. 5 ​is a flowchart of a method 500 of assembling the intraluminal imaging device 101 according to embodiments of the present disclosure. The method 500 can include connecting the ultrasound imaging assembly 102 to the catheter cable 346. As shown, the method 500 includes a number of enumerated steps, but embodiments of the method 500 can include additional steps before, after, or in between the enumerated steps. In some embodiments, one or more of the enumerated steps can be omitted, performed in a different order, or performed concurrently. The steps of the method 500 can be performed by the manufacturer of the intraluminal imaging device 101, the manufacturer of subassemblies including the ultrasound imaging assembly 102 or the catheter cable 346, and / or the manufacturer of any other components discussed in the present disclosure. The method 500 will be described with reference to FIGS. 6A-11 FIGS. 1-4, FIGS. 6A-11 are schematic illustrations of various components of the ultrasound imaging assembly 102 and the cable 346 during various steps of manufacture. For example, FIGS. 6A-11 illustrate assembly steps of various components of the device 110, such as the connection between the ultrasound imaging assembly 102 and the cable 346.

[0055] At step 505, the method 500 includes obtaining the interposer 310 having the ground pad 430 disposed on a surface (e.g., a top or upper surface) thereof. According to embodiments of the present disclosure, FIG. 6A illustrates a schematic top view of an exemplary interposer 310 with the ground pad 430 positioned at the proximal portion 620 of the interposer 310. Various components of the ultrasound imaging assembly 102 can be coupled to the interposer 310. In some embodiments, the interposer 310 can be a circuit board that facilitates electrical communication between one or more components of the device 101, such as the cable 346, the transducer array 262, and / or the IC 304. The circuit board can include conductive traces formed on a surface and / or interior thereof. The interposer can be formed of any suitable semiconductor material, such as a silicon (Si) substrate or a germanium (Ge) substrate. In some embodiments, the interposer 310 can include a compound semiconductor, such as silicon carbide (SiC), silicon germanium (SiGe), silicon germanium carbide (SiGeC). As FIG. 6AAs shown, the conductive pads 602, 604, and 606 can be disposed on a top surface of the interposer 310. The electrical component 420 can also be disposed on the top surface of the interposer 310. The electrical component 420 can be any particular type as previously described. The conductive pads 602, 604, and 606 can be positioned along a length of the interposer 310 between the ground pad 430 and the electrical component 420. The conductive pad 602 can have a proximal end 610 and a distal end 611. The conductive pad 604 can also have a proximal end 612 and a distal end 613. Additionally, the ground pad 430 can have a proximal end 451 and a distal end 450. The electrical component 420 can be positioned at a location distal of the conductive pads 602, 604, or 606. The wire bond 320 can also be positioned on the top surface of the interposer 310 and disposed at a distal portion 625 of the interposer 310. FIG. 6A The arrangement of the conductive pads 602, 604, and 606, the electrical component 420, and / or the wire bond 320 in the illustrated embodiment is merely illustrative. Any of these features can also be positioned at any location on the interposer 310.

[0056] The interposer 310 can include dimensions 352, 354, and 356, which can be any suitable dimensions. The dimension 352 can be a width, the dimension 354 can be a length, and the dimension 356 can be a depth. In some embodiments, the width 352 of the interposer 310 can be between about 1 mm and about 3 mm, including greater and lesser values. In an exemplary embodiment, the width 352 of the interposer 310 is about 2.31 mm (+ / - 0.100 mm). In some embodiments, the length 354 of the interposer 310 can be between about 8 mm and about 15 mm, including greater and lesser values. In an exemplary embodiment, the length 354 of the interposer 310 is about 11.5 mm (+ / - 0.100 mm). The depth 356 of the interposer 310 can be between about 0.10 mm and about 0.40 mm, including greater and lesser values. In an exemplary embodiment, the depth 356 of the interposer 310 is about 0.25 mm (+ / - 0.100).

[0057] The ground pad 430 can include dimensions 432, 434, and 436, which can be any suitable dimensions. The dimension 434 can be a width, the dimension 432 can be a length, and the dimension 436 can be a depth. Generally, the width 434 of the ground pad 430 is similar to or less than the width 352 of the interposer 310. The width 434 can be the same as the width 352. The length 432 of the ground pad 430 can generally be similar to or less than the length 354 of the interposer 310. The length 432 can be the same as the length 354. The depth 436 of the ground pad 430 can generally be similar to or less than the depth 356 of the interposer 310. The depth 436 can be the same as the depth 356. FIG. 7The exposed shielding layer 710 of the coaxial cable 700 shown has the same length 712, which will be discussed in more detail herein. The length 432 of the ground pad 430 can be any suitable length to allow space for other components on the interposer plate 310 and to create the necessary connection between the cable 346 and the interposer plate 310. In some embodiments, the length 432 of the ground pad 430 can be between about 0.5 mm and about 1.0 mm, including larger and smaller values. In an exemplary embodiment, the length 432 of the ground pad 430 is about 0.69 mm (+ / - 0.050 mm). In some embodiments, the width 434 of the ground pad 430 can be between about 1.0 mm and about 3.0 mm, including larger and smaller values. In an exemplary embodiment, the width 434 of the ground pad 430 is about 1.85 mm (+ / - 0.050 mm).

[0058] Now for reference FIG. 6B The diagram shows the intermediate plate 310 and the ground pad 430 along... FIG. 6A A schematic sectional view of section lines 6B-6B in the diagram. (See diagram for example.) FIG. 6B As shown, the ground pad 430 is a generally rectangular thin conductive material disposed on the interposer 310. In some embodiments, the depth 436 of the ground pad 430 can be between about 0.010 mm and about 0.100 mm, including larger and smaller values. In an exemplary embodiment, the depth 436 of the ground pad 430 is about 0.025 mm (+ / - 0.005 mm). FIG. 6B In this embodiment, the ground pad 430 is shown recessed into a corresponding cavity on the top surface of the interposer 310, such that the top surface of the ground pad 430 is flat, flush, or continuous with the top surface of the interposer 310. This configuration represents an illustrative embodiment. It should be understood that the ground pad 430 may be disposed on the top of the interposer 310 without a cavity, such that the ground pad 430 protrudes from the upper surface of the interposer 310 by a distance approximately equal to the depth 436 of the ground pad 430. Alternatively, the ground pad 430 may be recessed into the interposer 310 to a depth greater than the depth 436, such that the upper surface of the ground pad 430 is located below the upper surface of the interposer 310. The precise orientation of the ground pad 430 relative to the interposer 310 can be of any particular type.

[0059] Refer again FIG. 5 At step 510, method 500 includes obtaining a first set of coaxial cables. FIG. 7 The diagram illustrates an illustrative example of one embodiment of a coaxial cable that can be included in the first set of coaxial cables. The coaxial cable 700 comprises four basic layers. It is fully contemplated that... FIG. 7Additional layers can be added to those shown in the middle. For example, layers that provide additional strength, rigidity, protection, increased electrical conductivity, or any other functionality can be added to the coaxial cable 700. For example, an inner shield layer and an outer shield layer can be provided. The inner shield layer and / or the outer shield layer can be electrically and mechanically coupled to other components within the ultrasound imaging assembly 102. For simplicity, only four layers are shown and discussed in detail herein.

[0060] The center conductor cable 720 can be positioned along an axial center of the cable 700. The center conductor 720 can include a plurality of electrically conductive, elongated wires that are twisted around one another or otherwise coupled to one another, or can include a single electrically conductive, elongated wire. The center conductor 720 can transmit signals from the control and processing system 130 to the ultrasound image assembly 102 or from the ultrasound imaging assembly 102 to the control and processing system 130. The coaxial cable 700 is provided in such a way that a distal portion of the center conductor 720 of the length 722 is exposed by removing layers of the cable 700. The cable 700 can be obtained with this distal portion of the center conductor 720 already exposed. The length 722 of the distal portion of the center conductor 720 can be any suitable length. The length 722 will typically have similar dimensions to the conductive pads 602 or 604 in order to enable electrical and mechanical engagement of the distal end of the center conductor 720 with the conductive pads 602 or 604, as will be discussed in greater detail herein.

[0061] An insulating layer 715 can be provided around the center conductor 720. The insulating layer 715 can extend primarily from a proximal end of the center conductor 720 to a distal end thereof. The purpose of the insulating layer 715 can be to insulate the center conductor 720 from other layers of the cable 700 and from the surrounding environment, such that the center conductor 720 is not in electrical communication with any elements other than those intended at either end of the center conductor 720. As previously mentioned, the insulating layer 715 is not provided around the distal portion of the center conductor 720 to allow for electrical and mechanical engagement of the distal end of the center conductor 720 with the conductive pads 602 or 604. As FIG. 7 As shown, a further outer layer of the cable 700 is removed to expose a length 717 of the insulating layer 715. The length 717 can be any suitable length. Typically, the length 717 can be approximately equal to the distance from the proximal end 610 of the conductive pad 602 to the distal end 450 of the ground pad 430 for the first set of coaxial cables 700a. For the second set of cables 700b, the length 717 is approximately equal to the distance from the proximal end 612 of the conductive pad 604 to the distal end 450 of the ground pad 430, further accounting for any displacement of the coaxial cable 700b that occurs due to being positioned on the cable 700a, as will be discussed herein.

[0062] The shielding layer 710 may be positioned around the insulation layer 715, extending primarily from the proximal end of the insulation layer 715 to its distal end. The purpose of the shielding layer 710 may be to establish an electrical ground relative to the center conductor 720 and to provide electrical communication with the control and processing system 130 and the ultrasonic imaging assembly 102. Similar to the exposed distal portion of the center conductor 720 and the exposed distal portion of the insulation layer 715, the outer layer or sheath 705 of the coaxial cable 700 is partially removed to expose the distal portion of the shielding layer 710. As previously described, the length 712 of the exposed distal portion of the shielding layer 710 typically has the same or similar length as the width 432 of the grounding pad 430. However, the length 712 of the exposed distal portion of the shielding layer 710 can be any suitable length.

[0063] An outer layer or sheath 705 is configured to surround the shielding layer 710, extending primarily from the proximal end to the distal end of the shielding layer 710. The purpose of the sheath 705 may be to insulate the shielding layer 710 from the general environment and ensure that the shielding layer 710 communicates only electrically with the control and processing system 130 and the ultrasound imaging assembly 102. As previously described, removing the sheath 705 exposes... FIG. 7 The distal portion of the shielding layer 710 with a length of 712 is shown.

[0064] Refer again FIG. 5 At step 515, method 500 includes mechanically and electrically connecting the center conductor 720a of the first set of coaxial cables 700a to conductive pads 602 on the interposer plate 310. FIG. 8A As shown, the first group of coaxial cables 700a are basically similar to each other. FIG. 8A Eight such coaxial cables positioned on the intermediate plate 310 are illustrated; however, it is entirely conceivable that any number of coaxial cables 700a could be included in this first group. The first group of coaxial cables 700a may include only one coaxial cable 700a, two, four, eight, sixteen, or more coaxial cables 700a.

[0065] like FIG. 8A As shown, the center conductor 720a of each coaxial cable 700a is mechanically and electrically bonded to a corresponding conductive pad 602 positioned on the interposer plate 310. Because FIG. 8A Eight coaxial cables 700a are shown, so the interposer 310 has eight conductive pads 602 positioned on the interposer 310 near the ground pad 430. As mentioned above, this number is merely illustrative. Electrical and mechanical connections can be achieved by any suitable method (including, but not limited to, the use of solder).

[0066] Refer again FIG. 5In step 520, method 500 includes brazing the shielding layer 710a of the coaxial cable 700a to the grounding pad 430. In some embodiments, applying as... FIG. 8B The extensive solder block 810 shown mechanically and electrically bonds the shielding layer 710a of the coaxial cable 700a to the grounding pad 430. Since each shielding layer 710a of the coaxial cable 700a will carry an equivalent electrical ground corresponding to the signal carried by each center conductor 720a of the coaxial cable 700a, each shielding layer 710a of the coaxial cable 700a can communicate electrically with each other and with the grounding pad 430. The grounding pad 430 provides electrical grounding for multiple coaxial cables 700a and multiple coaxial cables 700b, as described in more detail herein. In addition to establishing electrical connections between the shielding layers 710a, the solder block 810 provides a mechanical connection between the coaxial cable 700a and the interposer plate 310, resulting in a significantly stronger connection between the conduit cable 346 and the ultrasound imaging assembly 102 than conventional methods.

[0067] FIG. 8B According to an embodiment of this disclosure, the intermediate plate 310 is along... FIG. 8A The cross-sectional view along sections 8B-8B shows the first row of coaxial cables 700a connected. As previously described, eight coaxial cables 700a are shown positioned on the upper surface of the grounding pad 430. A center conductor 720a is shown at the axial center of each coaxial cable. An insulating layer 715a is positioned around each center conductor 720a. A shielding layer 710a is positioned around each insulating layer 715a. A layer of solder 812, which passes through the shielding layer 710a during the soldering process, is shown between the insulating layer 715a and the shielding layer 710a. The solder 812 may be part of or substantially similar to a solder block 810. The shielding layer 710a may be made of a braided conductive material to allow the solder to pass through the layer. Alternatively, the shielding layer 710a may be made of any suitable conductive material that allows the solder to pass through the layer. In other embodiments, the shielding layer 710a may not be porous at all and may not allow solder to pass through the layer, but still provide a strong mechanical connection. The shielding layer 710a is at least semi-porous to allow solder to pass through the layer, and the resulting entangled connection ensures a stronger mechanical connection between the solder block 810 and the shielding layer 710a, and subsequently between the first set of coaxial cables 700a and the interposer 310.

[0068] Without a solder mass as described in the present application, the connection between the distal tip of an ICE catheter having an ultrasonic imaging assembly and the more proximal portion of the ICE catheter (e.g., the catheter shaft) is relatively weak. For example, the distal tip and the catheter shaft are attached at a polymer-polymer interface between the polymer housing of the distal tip and the polymer forming the catheter shaft. The center conductors of the electrical cables are also attached to their respective conductive pads for electrical communication. However, these connections are weak and cannot withstand greater pulling forces (e.g., at least 15 N). Advantageously, as described in the present disclosure, the shielding layers of the plurality of coaxial cables are mechanically coupled to the ground pad 430 by solder, providing a strong mechanical connection between the electrical wires 346 and the ultrasonic imaging assembly 102. The solder mass connection thus provides a stronger connection point between the distal end and the more proximal portion of the ICE catheter (e.g., stronger than the polymer-polymer interface and the center conductor-conductive pad connections). The presently disclosed methods and apparatus advantageously meet the minimum peak pull force requirements in ISO 10555, as well as other national and international requirements regarding peak pull force for intracardiac echocardiography (ICE) catheters having a catheter shaft diameter greater than 1.85 mm. In some embodiments, the catheter shaft 201 FIG. 3A ) has a diameter of 9 Fr (3 mm). For example, the solder mass 810 is configured to support a tensile load of at least 15 N. For example, the solder mass 810 is configured to support a tensile load of between about 1 N and about 60 N, between about 15 N and about 60 N, and / or other greater or lesser values.

[0069] The solder mass 810 takes on the same general shape as the ground pad 430, as the solder will infiltrate all conductive surfaces it comes into contact with and avoid mechanical engagement with non-conductive surfaces. For example, the solder mass can have a general shape of a rectangular or polygonal prism, with a generally rectangular or polygonal cross-sectional profile. In some embodiments, the interposer 310 is composed of a non-conductive material, such that the solder mass 810 only engages with the ground pad 430 and the shielding layers 710a. Furthermore, the insulating layers 715a and the jacket 705a of the coaxial cables 700a are composed of non-conductive materials, such that the solder mass 810 also does not electrically or mechanically engage with these elements, causing the solder 810 to retain a general shape similar to that of the ground pad 430.

[0070] Referring again to FIG. 5 , at step 525, the method 500 includes obtaining a second set of coaxial cables 700b. The second set of coaxial cables 700b can be substantially similar to the first set of coaxial cables 700a. An illustrative example of one embodiment of a coaxial cable 700 of this second set 700b is shown in FIG. 6. FIG. 7

[0071] ​The second set of coaxial cables 700b can differ from the first set of coaxial cables 700a in the length 717 of the insulating layer 715. Referring again to FIG. 6A , the length 717 of the insulating layer 715 of the coaxial cables 700b can have substantially the same length as the distance between the proximal end 604b of the conductive pad 604 and the distal end 430a of the ground pad 430. Because the cables 700b can be positioned above the first set of coaxial cables 700a, the length 717 of the insulating layer 715 of the coaxial cables 700b can be slightly longer than this distance due to the positional offset of the cables 700b.

[0072] Referring again to FIG. 5 , at step 530, the method 500 includes mechanically and electrically coupling the center conductor 720b of the second set of coaxial cables 700b to the conductive pad 604 on the interposer 310. As FIG. 9A illustrated, the second set of coaxial cables are positioned on top of the first set of coaxial cables 700a. Like the cables 700a, the coaxial cables 700b are each substantially similar to one another. FIG. 9A Eight such coaxial cables 700b are illustrated positioned on the interposer 310 and eight coaxial cables 700a are illustrated positioned below the coaxial cables 700b. Thus, FIG. 9A sixteen coaxial cables 700 are illustrated positioned on the interposer 310, however, it is fully contemplated that any number of coaxial cables 700 can be included. Similarly, the second set of coaxial cables 700b can include only one coaxial cable 700b, two, four, eight, sixteen, or more coaxial cables 700b.

[0073] As FIG. 9A illustrated, the center conductor 720b of each coaxial cable 700b is mechanically and electrically joined to a respective conductive pad 604 positioned on the interposer 310. Because FIG. 9A eight coaxial cables 700b are illustrated, the interposer 310 displays eight conductive pads 604. As noted, this number is merely illustrative. In some embodiments, a conductive pad 602 can be positioned between the conductive pad 604 and the ground pad 430. This orientation allows the second set of coaxial cables 700b to be positioned above the first set of coaxial cables 700a, thereby forming two rows of coaxial cables, as FIG. 9BThe coaxial cables 700a and 700b are arranged in two rows overlapping each other, and the conductive pads 602 and 604 are arranged in corresponding two rows, allowing all of the cables 346 to be terminated and mechanically and electrically coupled to the interposer 310 in a smaller space on the interposer 310 than traditional methods. This configuration of two or more rows of coaxial cables as disclosed in the present invention makes the entire ultrasound imaging assembly 102 shorter, which allows the intraluminal catheter assembly 101 to be more easily maneuvered within a patient's heart, vasculature, or other lumen within the patient's body. The mechanical and electrical engagement between the center conductor 720b and the conductive pad 604 can be achieved by any suitable method, including but not limited to the use of solder.

[0074] Referring again to FIG. 9A , the proximal portions of the first set of coaxial cables 700a and the second set of coaxial cables 700b are depicted as offset from each other such that the second set of coaxial cables 700b appears to be terminated at some location distal of the proximal termination of the first set of coaxial cables 700a. Although this orientation can be used in embodiments of the present disclosure, for pedagogical purposes, this staggering of the proximal terminations of the coaxial cables is depicted so that even in FIG. 9A the second set of coaxial cables 700b completely obscures the view of the first set of coaxial cables 700a, the first set of coaxial cables 700a is shown to be positioned below the second set of coaxial cables 700b.

[0075] Referring again to FIG. 5 , at step 535, the method 500 includes soldering the shield 710b of the coaxial cable 700b to the ground pad 430. In some embodiments, the solder mass 810 applied to the shield 710a of the first set of coaxial cables 700a is extended to further cover the shield 710b of the second set of coaxial cables 700b and the shield 710a of the first set of coaxial cables 700a. In this manner, the shield 710b of the second set of coaxial cables 700b is mechanically and electrically coupled to both the shield 710a of the first set of coaxial cables 700a and the ground pad 430. Since each shield 710a and 710b of the coaxial cables 700a and 700b carries an equivalent electrical ground to the signals carried by each center conductor 720a and 720b of the coaxial cables 700a and 700b, each shield 710a and 710b of the coaxial cables 700a and 700b can be in electrical communication with each other and with the ground pad 430. In addition to establishing an electrical connection between the shields 710a, 710b and the ground pad 430, the solder mass 810 provides a mechanical connection between the coaxial cables 700a, 700b and the interposer 310, making the connection between the catheter cables 346 and the ultrasound imaging assembly 102 significantly stronger than traditional methods.

[0076] FIG. 9BThe interposer 310 according to embodiments of the present disclosure is along FIG. 9A a cross-sectional view of the cross-section line 9B-9B in FIG. 7B, where the first row of coaxial cables 700a and the second row of coaxial cables 700b are joined to the ground pad 430. As previously described, eight coaxial cables 700a are shown disposed along the upper surface of the ground pad 430. In addition, eight coaxial cables 700b are shown disposed along the upper surface of the first set of coaxial cables 700a. Similar to the first set of coaxial cables 700a, the second set of coaxial cables 700b can include a shield layer 710b that is at least semi-porous to allow a small amount of solder 812 to pass through the shield layer 710b and ensure a stronger mechanical connection between the solder mass 810 and the shield layer 710b and subsequently between the second set of coaxial cables 700b, the first set of coaxial cables 700a, and the interposer 310.

[0077] The solder mass 810 still maintains the same general shape as the ground pad 430 because the solder will soak into all conductive surfaces it comes into contact with and avoid mechanical bonding with non-conductive surfaces. In some embodiments, the interposer 310 is constructed of a material such that the solder mass 810 only joins with the ground pad 430 as well as the shield layers 710a and 710b. In addition, the insulating layers 715b and the jacket 705b of the coaxial cables 700b are constructed of a non-conductive material such that the solder mass 810 does not electrically or mechanically join with these elements either. The solder mass 810 has a width similar to the width 434 of the ground pad 430 and a length similar to the length 432 of the ground pad 430. The vertical depth of the solder mass 810 is largely dependent on the dimensions and positions of the coaxial cables 700a and 700b. The vertical depth of the solder mass 810 can be between about 0.25 mm and about 0.75 mm, including greater and lesser values. In an exemplary embodiment, the vertical depth of the solder mass 810 is about 0.50 mm (+ / - 0.10 mm). The solder mass completely or partially surrounds the perimeters of each coaxial cable. For example, in a cross-section of the coaxial cable, the solder mass can completely or partially surround one or more coaxial cables. The solder mass 810 extends within the lateral and vertical space between adjacent coaxial cables. For example, the solder mass 810 will fill the space between coaxial cables positioned to the left and right of each other within the same group and will fill the space between coaxial cables positioned above and below each other within the first set of coaxial cables 700a and the second set of coaxial cables 700b. In the disclosed exemplary embodiment, the solder mass 810 is positioned between the first row of coaxial cables 700a and the second row of coaxial cables 700b. The solder mass 810 is also positioned between each coaxial cable within the first set of coaxial cables 700a and between each coaxial cable within the second set of coaxial cables 700b. The solder mass 810 is also positioned between the first set of coaxial cables 700a and the ground pad 430.

[0078] Referring again to FIG. 5Method 500 describes, in steps 515 and 520, mechanically and electrically joining the center conductor 720a to the conductive pad 602 prior to mechanically and electrically joining the shield layer 710a to the ground pad 430. Similarly, method 500 describes, in steps 530 and 535, mechanically and electrically joining the center conductor 720b to the conductive pad 604 prior to mechanically and electrically joining the shield layer 710b to the ground pad 430. However, this particular order of connecting the center conductor 720a or 720b of the coaxial cable 700a or 700b prior to connecting the shield layer 710a or 710b to the ground pad 430 is not required. The shield layer 710a or 710b can be mechanically and electrically joined to the ground pad 430 prior to joining the center conductor 720a or 720b to the conductive pad 602 or 604.

[0079] Referring again to FIG. 5 At step 540, method 500 includes obtaining a set of single conductor cables 1000. The single conductor cables 1000 can be substantially similar to single conductor cables well known to those skilled in the art. FIG. 10A A third set of five such single conductor cables are shown positioned above the first set of coaxial cables 700a and the second set of coaxial cables 700b. In some embodiments, the single conductor cables 1000 are primarily composed of two layers. However, it is contemplated that additional layers can be added in other embodiments of the present application that provide additional functionality. For example, layers that provide additional strength, rigidity, protection, increased conductivity, or any other functionality can be added to the single conductor cables 1000. As FIG. 10A shown, a single conductor 1010 extends along the interior of the single conductor cable 1000. The single conductor 1010 can be used to transmit signals from the control and processing system 130 to the ultrasonic imaging assembly 102 or from the ultrasonic imaging assembly 102 to the control and processing system 130. For example, the single conductor 1010 can be a power line or a thermistor sense lead. In such embodiments, the single conductor 1010 can carry a power signal or a thermistor signal. The single conductor 1010 can also be used for any number of other suitable applications.

[0080] An insulating layer 1005 is disposed around the single conductor 1010. The insulating layer 1005 extends primarily from the proximal end of the single conductor 1010 to its distal end. The purpose of the insulating layer 1005 can be to insulate the single conductor 1010 from the general environment and to ensure that the single conductor 1010 only electrically communicates with the control and processing system 130 and the ultrasonic imaging assembly 102 as intended. As FIG. 10AAs shown, the insulating layer 1005 is removed to expose the distal portions of the single conductors 1010. The single conductor cable 1000 can be obtained in a manner that exposes the distal portions of the single conductors 1010, or the single conductor cable 1000 can be alternatively modified after the cable 1000 is obtained so that the single conductors 1010 are exposed as shown. Although the present disclosure only illustrates two layers comprising the single conductor cable 1000, as previously mentioned, many additional layers providing different functionality can be included in the single conductor cable 1000.

[0081] Referring again to FIG. 5 At step 545, the method 500 includes mechanically and electrically coupling the single conductor cable 1000 to the conductive pads 606 so that the single conductor cable 1000 is positioned over the first set of coaxial cables 700a and the second set of coaxial cables 700b. As FIG. 10A As shown, the single conductor cables 1000 are substantially similar to one another. FIG. 10A Five such single conductor cables 1000 are illustrated positioned on the interposer 310, however, it is fully contemplated that any number of single conductor cables 1000 can be included in the set. The single conductor cable 1000 can include only one single conductor cable 1000, two, four, eight, 16, hundreds, or more single conductor cables 1000.

[0082] As FIG. 10A As shown, the single conductors 1010 of each single conductor cable 1000 are mechanically and electrically joined to a respective conductive pad 606 positioned on the interposer 310. Because FIG. 10A Because five single conductor cables 1000 are shown, the interposer 310 shows five corresponding conductive pads 606 positioned proximate the conductive pads 604. As mentioned above, this number is illustrative only. In some embodiments, the conductive pads 602 are positioned between the conductive pads 604 and the ground pads 430, and the conductive pads 604 are positioned between the conductive pads 606 and the conductive pads 602. This orientation allows the second set of coaxial cables 700b to be positioned over the first set of coaxial cables 700a, and the single conductor cables 1000 to be positioned over the first set of coaxial cables 700a and the second set of coaxial cables 700b to form two rows of coaxial cables 700a and 700b and one row of single conductor cables 1000, as FIG. 10BThe conductor pads 602, 604, and 606 can be positioned at any location on the interposer 310. Mechanical and electrical engagement between the single conductor 1010 and the ground pad 606 can be achieved by any suitable method, including but not limited to the use of solder, adhesive, insulating tape, wire gel connectors, grease-filled connectors, rubber welding, heat shrink, or any other suitable form of mechanical and electrical connection. It is also contemplated that the single conductor cable 1000 need not be positioned over the first set of coaxial cables 700a and the second set of coaxial cables 700b. They can be positioned in any suitable manner on either side of or below the coaxial cables. It should be noted that the solder block 810 that encapsulates the first set of coaxial cables 700a and the second set of coaxial cables 700b does not encapsulate the single conductor cable 1000. Because the insulating layer 1005 extends along the entire single conductor 1010 except near the distal end of the single conductor 1010 that is engaged to the conductive pad 606, the solder of the solder block 810 will not be drawn to the single conductor cable 1000.

[0083] Referring again to FIG. 1 FIG. 10A , the proximal portions of the first set of coaxial cables 700a, the second set of coaxial cables 700b, and the single conductor cable 1000 are shown offset from one another such that the second set of coaxial cables 700b appears to terminate at a location distal of the proximal termination of the first set of coaxial cables 700a, and the single conductor cable 1000 appears to terminate at a location distal of the proximal termination of the second set of coaxial cables 700b. While this orientation can be used in embodiments of the present disclosure, this staggering of the proximal terminations of the coaxial cables is shown for teaching purposes, similar to the staggering of the first set of coaxial cables 700a and the second set of coaxial cables 700b described with respect to FIG. 9A FIG. 2.

[0084] FIG. 10B is an interposer 310 according to embodiments of the present disclosure along FIG. 10AThe cross-sectional view along section lines 10B-10B shows a first row of coaxial cables 700a and a second row of coaxial cables 700b connected, with a third row of top center conductor cables 1000 positioned above the first and second rows of coaxial cables 700a and 700b. Solder blocks 810 surround the first and second rows of coaxial cables 700a and 700b and mechanically and electrically connect them to a ground pad 430. As previously described, each coaxial cable in the first group of coaxial cables 700a includes a center conductor 720a, an insulation layer 715a, and a shielding layer 710a. Similarly, each coaxial cable in the second group of coaxial cables 700b includes a center conductor 720b, an insulation layer 715b, and a shielding layer 710b. Solder 812, which may be part of or substantially similar to solder block 810, may be positioned between the insulation layer 715a and shielding layer 710a of the first set of coaxial cables 700a and between the insulation layer 715b and shielding layer 710b of the second set of coaxial cables 700b. As previously described, each of the single conductor cables 1000 includes a single conductor 1005 and an insulation layer 1010. It should also be noted that, as FIG. 3B The cable 346 shown is arranged in a circular manner within the conduit cable 203. At a point near the proximal portion 620 of the intermediate plate 310, the cable 346 is arranged as follows: FIG. 10B The diagram shows three or more rows. FIG. 10B The currently disclosed device is shown after all the previously mentioned coaxial cables and single-conductor cables have been connected to the interposer 310. In some embodiments, the length and / or width of the solder block 810 may be equal to the length 432 and / or width 434 of the ground pad 430, respectively. In some embodiments, the length and / or width of the solder block 810 may be less than the length 432 and / or width 434 of the ground pad 430, respectively. The height of the solder block 810 may depend on the volume of solder used to connect the ground pad 430, the first set of coaxial cables 700a, and the second set of coaxial cables 700b.

[0085] FIG. 11 This is a perspective view of an interposer plate 310, in which the conduit cable 346 includes a first set of coaxial cables 700a, a second set of coaxial cables 700b, and a third set of single-conductor cables 1000, which are mechanically and electrically connected to corresponding conductive pads 602, 604, and 606 and a ground pad 430. Solder blocks 810 mechanically and electrically connect the first set of coaxial cables 700a and the second set of coaxial cables 700b to the ground pad 430. Electrical components 420 can be positioned distal to the ground pads 602, 604, and 606. FIG. 11 The currently disclosed device is shown after all the previously mentioned coaxial cables and single-conductor cables have been connected to the intermediate plate 310.

[0086] It should be noted that while the figures and related descriptions of the present disclosure depict three sets of cables 346, the first set of coaxial cables 700a, the second set of coaxial cables 700b, and one set of single conductor cables 1000 are arranged into three rows, any number of sets of cables can be used. For example, only one set arranged into one row can be used and mechanically and electrically joined to the interposer 310 according to embodiments of the present disclosure. Further, two sets, four sets, five sets, ten sets, or more sets of cables can be mechanically and electrically joined to the interposer 310 according to the present disclosure. Further, the single conductor cables 1000 can be positioned in the same row or set as the first set of coaxial cables 700a or the second set of coaxial cables 700b. The single conductor cables can be in the same row or set as any other type of cable used in the present disclosure.

[0087] FIG. 12 is a schematic diagram of a processor circuit 150 according to embodiments of the present disclosure. The processor circuit 150 can be implemented in the intraluminal ultrasound imaging device 110, the control and processing system 130, and / or the PIM 131. FIG. 1A As shown, the processor circuit 150 can include a processor 160, a memory 164, and a communication module 168. These elements can communicate with each other directly or indirectly, for example via one or more buses.

[0088] The processor 160 can include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, a FPGA, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 160 can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0089] The memory 164 can include cache memory (e.g., of the processor 160), random access memory (RAM), magneto resistive 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 drive, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, the memory 164 includes a non-transitory computer-readable medium. The memory 164 can store instructions 166. The instructions 166 can include, when executed by the processor 160, instructions to cause the processor 160 to perform one or more of the methods, functions, or operations described herein with respect to the intraluminal ultrasound imaging device 110, the control and processing system 130, and / or the PIM 131. FIG. 1Ainstructions 166 can 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" can refer to one or more programs, routines, sub-routines, functions, procedures, etc. "Instructions" and "code" can include a single computer-readable statement, or many computer-readable statements.

[0090] The communication module 168 can include any electronic and / or logic circuitry to facilitate direct or indirect communication of data between the processor intraluminal ultrasound imaging device 110, the control and processing system 130 (including the monitor 132 and the control interface 134), and / or the PIM 131. In this regard, the communication module 168 can be an input / output (I / O) device. In some cases, the communication module 168 facilitates direct or indirect communication between various elements of the processor circuitry 150 and / or the system 100.

[0091] Those skilled in the art will realize that the aforementioned apparatus, systems, and methods can be modified in various ways. Accordingly, persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In this regard, although illustrative embodiments have been shown and described, a wide range of modifications, changes and substitutes are contemplated in the foregoing disclosure. It should be understood that such variations can be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.

Claims

1. An intraluminal imaging device, comprising: a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member including a plurality of coaxial cables, wherein each of the plurality of coaxial cables includes a conductive shield; an ultrasound imaging assembly positioned at a distal portion of the flexible elongate member and in communication with the plurality of coaxial cables, the ultrasound imaging assembly including: a transducer array configured to obtain ultrasound data; and a first conductive pad, wherein the conductive shield of each of the plurality of coaxial cables is mechanically and electrically coupled to the first conductive pad; and a solder block positioned on the first conductive pad, wherein the conductive shield of each of the plurality of coaxial cables is mechanically and electrically coupled to the first conductive pad and to each other via the solder block; wherein each of the plurality of coaxial cables further includes a center conductor and an insulating layer surrounding the center conductor, the conductive shield is positioned around the insulating layer, and the solder block is positioned between the conductive shield and the insulating layer of each coaxial cable.

2. The intraluminal imaging device of claim 1, wherein, The solder block is positioned around a perimeter of the plurality of coaxial cables.

3. The intraluminal imaging device of claim 1, wherein, The solder block is configured to support a tensile load of at least 15 N.

4. The intraluminal imaging device of claim 1, wherein, each of the plurality of coaxial cables includes an insulating jacket surrounding the conductive shield, wherein the conductive shield includes an exposed portion free of the insulating jacket, and wherein a corresponding dimension of the exposed portion of the conductive shield and the first conductive pad is equal.

5. The intraluminal imaging device of claim 1, wherein, The plurality of coaxial cables includes a first row of coaxial cables and a second row of coaxial cables, wherein the first row of coaxial cables is positioned on the first conductive pad, and wherein the second row is positioned on the first row of coaxial cables.

6. The intraluminal imaging device of claim 5, wherein, The solder block is positioned between the first row of coaxial cables and the second row of coaxial cables.

7. The intraluminal imaging device of claim 1, wherein, Each of the plurality of coaxial cables is spaced apart, wherein the solder block is positioned between each of the plurality of coaxial cables.

8. The intraluminal imaging device of claim 1, wherein, The first conductive pad includes an electrical ground for the plurality of coaxial cables.

9. The intraluminal imaging device of claim 1, wherein the ultrasound imaging assembly includes a plurality of second conductive pads, wherein the center conductor of each of the plurality of coaxial cables is mechanically and electrically coupled to a corresponding one of the plurality of second conductive pads, and wherein the center conductor is configured to transmit electrical signals to and from the ultrasound imaging assembly.

10. The intraluminal imaging device of claim 9, wherein the flexible elongate member includes a plurality of single conductor cables positioned on the plurality of coaxial cables, wherein the ultrasound imaging assembly includes a plurality of third conductive pads configured to be mechanically and electrically coupled to the plurality of single conductor cables, and wherein the plurality of single conductor cables are configured to transmit the electrical signals to and from the ultrasound imaging assembly.

11. The intraluminal imaging device of claim 1, wherein, The flexible elongate member includes a catheter configured to be positioned within a heart of the patient.

12. The intraluminal imaging device of claim 1, wherein, The ultrasound imaging assembly further includes a circuit board in communication with the transducer array, the first conductive pad positioned on a surface of the circuit board.

13. An intraluminal imaging system, comprising: the intraluminal imaging device of claim 1, and a computer in communication with the intraluminal imaging device and configured to generate an ultrasound image based on the ultrasound data.

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