Electrical wire connections in intraluminal ultrasound imaging devices and systems - Patent Application 20070122997

Abstract

The 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 shielding layer. 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 acquire ultrasound data and a conductive pad. The conductive shielding layer 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] FIELD OF THE DISCLOSURE

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

[0002]

[0002] Diagnostic and therapeutic ultrasound catheters are designed for use inside many areas of the human body. In the cardiovascular system, a common diagnostic ultrasound method is intraluminal ultrasound imaging with intracardiac echocardiography (ICE), 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 tip of the catheter. The same transducer is used to receive echoes from the tissue. Signals generated from the echoes are transmitted to a console that allows for processing, storage, display, or manipulation of the ultrasound-related data.

[0003]

[0003] Intraluminal imaging catheters, such as ICE catheters (e.g., Siemens Acunav, St. Jude ViewFlex), are generally used to image the heart and surrounding structures to guide and facilitate medical procedures, such as transseptal luminal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair. Commercially available ICE catheters have a distal end that can be articulated by a steering mechanism located on a handle at the proximal end of the catheter. For example, an intraluminal imaging catheter, such as an ICE catheter, is inserted through the femoral or jugular vein and steered in the heart when accessing anatomical structures to obtain images necessary for the safety of the medical procedure. Summary of the Invention [Problem to be solved by the invention]

[0004]

[0004] ICE catheters must meet national and / or international requirements that stipulate that the distal tip of the catheter must not separate when subjected to tensile loads of varying magnitudes, depending primarily on the diameter of the catheter. This ensures that the catheter can be safely removed from the patient's body without breaking and leaving the tip within the heart or vasculature. Because ICE catheters are necessarily very thin and the distal catheter assembly houses many transducers, circuits, and other electrical components, achieving the required tensile strength in a very confined space is difficult. [Means for solving the problem]

[0005]

[0005] Embodiments of the present disclosure are directed to electrical wire connections for imaging catheters, such as intracardiac echocardiography (ICE) catheters. There is a need for a simpler, smaller, and more robust method and apparatus for connecting the ultrasound imaging assembly of an ICE catheter to the elongated wire that carries the assembly. To achieve a stronger mechanical bond, sections of solder can be applied to form mechanical and electrical bonds between the shielding layers of several coaxial cables and grounding pads located on an interposer within the ultrasound imaging assembly. The center conductors of these coaxial cables are bonded to corresponding conductive pads elsewhere on the interposer, providing signal communication between the ultrasound imaging assembly and a computer. A single-conductor cable is connected to the interposer elsewhere within the ultrasound imaging assembly. Bonding the shielding layers of the coaxial cables to the grounding pads on the interposer provides a common ground signal for all center conductor signals of the coaxial cables, providing a robust physical connection between the catheter cable and the ultrasound imaging assembly and making it easier to achieve the required tensile strength of the intracardiac echocardiography (ICE) catheter.

[0006] According to an exemplary aspect of the present disclosure, there is provided an endoluminal imaging device comprising: a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member comprising a plurality of coaxial cables, each of the plurality of coaxial cables comprising a conductive shielding layer; 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 comprising: a transducer array configured to acquire ultrasound data; and a first conductive pad to which the conductive shielding layer of each of the plurality of coaxial cables is mechanically and electrically coupled.

[0007] In some embodiments, the intraluminal imaging device further includes a solder portion positioned on the 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 via the solder portion. In some embodiments, the solder portion is positioned around an outer periphery of the plurality of coaxial cables. In some embodiments, the solder portion is configured to support a tensile load of at least 15 N. In some embodiments, each of the plurality of coaxial cables includes an insulating jacket around the conductive shield layer, the conductive shield layer including an exposed portion not including the insulating jacket, and corresponding dimensions of the exposed portion of the conductive shield layer and the first conductive pad are equal. In some embodiments, each of the plurality of coaxial cables includes a center conductor and an insulating layer around the center conductor, the conductive shield layer being positioned around the insulating layer, and the solder portion is positioned between the conductive shield layer and the insulating layer. In some embodiments, the plurality of coaxial cables comprises a first row of coaxial cables and a second row of coaxial cables, the first row of coaxial cables being positioned on the first conductive pads and the second row of coaxial cables being positioned on the first row of coaxial cables. In some embodiments, a solder portion is positioned between the first row of coaxial cables and the second row of coaxial cables. In some embodiments, each of the plurality of coaxial cables is spaced apart and a solder portion is positioned between each of the plurality of coaxial cables. In some embodiments, the first conductive pad comprises an electrical ground for the plurality of coaxial cables. In some embodiments, each of the plurality of coaxial cables comprises a center conductor, and the ultrasound imaging assembly comprises a plurality of second conductive pads, the center conductor of each of the plurality of coaxial cables being mechanically and electrically coupled to a corresponding one of the plurality of second conductive pads, the center conductor being configured to carry electrical signals to and from the ultrasound imaging assembly.In some embodiments, the flexible elongate member comprises a plurality of single-conductor cables positioned over the plurality of coaxial cables, and 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, the plurality of single-conductor cables being configured to carry electrical signals to and from the ultrasound imaging assembly. In some embodiments, the flexible elongate member comprises a catheter configured to be positioned within the patient's heart. In some embodiments, the ultrasound imaging assembly further comprises a circuit board in communication with the transducer array, and the first conductive pad is positioned on a surface of the circuit board.

[0008] According to an exemplary aspect of the present disclosure, there is provided a system comprising: an endoluminal imaging device comprising: a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member comprising a plurality of coaxial cables, each of the plurality of coaxial cables comprising a conductive shielding layer; 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 comprising: a transducer array configured to acquire ultrasound data; and a conductive pad to which the conductive shielding layer of each of the plurality of coaxial cables is mechanically and electrically coupled; and a computer in communication with the endoluminal imaging device and configured to generate an ultrasound image based on the ultrasound data.

[0009]

[0009] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

[0010]

[0010] Exemplary embodiments of the present disclosure are described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0011] [Figure 1A]

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

[0012] 1 is a schematic diagram of a catheter according to an embodiment of the present disclosure. [Figure 2]

[0013] FIG. 1 is a perspective view of a catheter cable according to an embodiment of the present disclosure. [Figure 3A]

[0014] 1 is a cross-sectional view of a catheter body according to an embodiment of the present disclosure. FIG. [Figure 3B]

[0015] FIG. 1 is a cross-sectional view of a catheter cable according to an embodiment of the present disclosure. [Figure 4]

[0016] FIG. 1 is a perspective view of a distal ultrasound assembly of an intraluminal imaging device according to an embodiment of the present disclosure. [Figure 5]

[0017] FIG. 10 is a flowchart diagram of a method for assembling an endoluminal imaging device according to an embodiment of the present disclosure. [Figure 6A]

[0018] FIG. 1B is a top view of an interposer before a catheter cable is connected thereto, according to an embodiment of the present disclosure. [Figure 6B]

[0019] 6B is a cross-sectional view of the interposer taken along section line 6B-6B in FIG. 6A before a catheter cable is connected thereto, according to an embodiment of the present disclosure. [Figure 7]

[0020] FIG. 1 is a perspective view of a coaxial cable with layers partially exposed, according to an embodiment of the present disclosure. [Figure 8A]

[0021] FIG. 6B is a top view of the interposer of FIG. 6A with a first row of coaxial cables connected thereto, according to an embodiment of the present disclosure. [Figure 8B]

[0022] 8B is a cross-sectional view of the interposer taken along section line 8B-8B in FIG. 8A with a first row of coaxial cables connected thereto, according to an embodiment of the present disclosure. [Figure 9A]

[0023] 6B is a top view of the interposer of FIG. 6A with first and second rows of coaxial cables connected thereto, according to an embodiment of the present disclosure. [Figure 9B]

[0024] 9B is a cross-sectional view of the interposer taken along section line 9B-9B in FIG. 9A with first and second rows of coaxial cables connected thereto, according to an embodiment of the present disclosure. [Figure 10A]

[0025] 6B is a top view of the interposer of FIG. 6A with the first and second rows of coaxial cables connected and the center conductor cable of the third, upper row positioned above the coaxial cables, according to an embodiment of the present disclosure. [Figure 10B]

[0026] 1 is a cross-sectional view of an interposer with first and second rows of coaxial cables connected and a third, upper row of center conductor cables positioned above the coaxial cables, according to an embodiment of the present disclosure. [Figure 11]

[0027] 1 is a perspective view of an interposer with first and second rows of coaxial cables connected and a third, top row of center conductor cables positioned above the coaxial cables, according to an embodiment of the present disclosure. FIG. [Figure 12]

[0028] FIG. 2 is a schematic diagram of a processor circuit according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012]

[0030] To promote an understanding of the principles of the present disclosure, reference will be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. However, it will be understood that no limitation on the scope of the present disclosure is intended. Any changes and further modifications to the described devices, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one skilled in the art to which the present disclosure pertains, are fully contemplated and included within the present disclosure. For example, while the present disclosure has been described with respect to intraluminal imaging, it will be understood that it is not intended to be limited to this application. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment of the present disclosure may be combined with features, components, and / or steps described with respect to other embodiments. However, for the sake of brevity, many iterations of these combinations will not be individually described.

[0013]

[0031] 1A is a schematic diagram of an imaging system 100 according to an embodiment of the present disclosure. System 100 includes 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 device 110 and control and processing system 130.

[0014]

[0032] The ultrasound imaging device 110 includes a catheter 101, which is shown in more detail in FIG. 1B . The catheter 101 includes one or more flexible elongate members 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 conduit 124, a connector 209, and one or more printed circuit board assemblies (PCBAs) 207. The catheter cable 203 has a small diameter and low profile configuration sized to be threaded through or through the catheter shaft 201, the handle 120, and / or the conduit 124. The cable 203 may be electrically and / or mechanically coupled to the ultrasound imaging assembly 102 at a distal portion of the catheter shaft 201 and coupled to the PCBA 207 at a proximal portion of the catheter 101.

[0015]

[0033] In some embodiments, one or both of the catheter body / shaft 201 and the catheter cable 203 are referred to as flexible elongate members. The catheter shaft 201 is sized, shaped, structurally arranged, and / or otherwise configured to be positioned within a patient's body lumen (e.g., a blood vessel or the vasculature, such as a chamber of the heart). Portions of the catheter cable 203 extend within the catheter shaft 201, the handle 120, the conduit 124, and the connector 209. The imaging assembly 102 is attached to the distal end of the catheter shaft 201. The catheter shaft 201 includes a lumen through which the catheter cable 203 passes. The proximal end 204 of the catheter shaft 201, illustrated in FIG. 2, is attached to the handle 120, for example, by an elastic strain relief device. The handle 120 is used for operation of the ultrasound imaging device 110 and for manual control of the ultrasound imaging device 110. The ultrasound imaging device 110 includes an imaging assembly 102 having ultrasound transducer elements and associated circuitry. The handle 120 includes the actuator 116, clutch 114, and other steering control components for steering the ultrasound imaging device 110. As described in more detail herein, steering includes bending the distal end of the catheter cable 203.

[0016]

[0034] The catheter cable 203 passes 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 is threaded through lumens in the catheter body 201, the handle 120, and the conduit 124. In some embodiments, the conduit 124 is a separate component from the cable 203. For example, the conduit may be a tube through which the cable 203 extends. In other embodiments, the conduit 124 may be a covering that defines the outer surface of the cable 203. The covering may strengthen the cable 203 against exposure to direct contact and / or handling by an operator of the catheter 101. The catheter cable 203 terminates at a PCBA 207 within the connector 209. The catheter cable 203 is electrically and mechanically coupled to the imaging assembly 102 and includes multiple electrical wires.

[0017]

[0035] The handle 120 is connected to the conduit 124 via another strain relief device. The conduit 124 is configured to provide a suitable configuration for interconnecting the control and processing system 130 and the monitor 132 to the imaging assembly 102. The control and processing system 130 is used to process, store, analyze, and manipulate data, and the monitor 132 is used to display acquired signals generated by the imaging assembly 102. The control and processing system 130 may include a processor circuit having one or more processors in communication with a memory. The memory may be a non-transitory computer-readable storage medium. The memory may 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 is operable to facilitate the features of the intraluminal imaging system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-transitory tangible computer-readable medium. The control and processing system 130 may include one or more input devices, such as a keyboard and any suitable command and control interface device. The monitor 132 is any suitable display device, such as a liquid crystal display (LCD) panel.

[0018]

[0036] In operation, a physician or clinician advances catheter 101 into a lumen, such as a blood vessel, a body lumen, or a portion of the cardiac anatomy. By controlling actuators 116 and / or clutch 114 on handle 120, the physician or clinician steers catheter 101 to a position near an area of ​​interest to be imaged. For example, one actuator deflects imaging assembly 102 and the distal end of catheter cable 203 in the left-right plane, while the other actuator deflects imaging assembly 102 and the distal end of catheter cable 203 in the front-to-back plane. Clutch 114 provides a locking mechanism to lock the position of actuator 116, and effectively the deflection of imaging assembly 102, while imaging the area of ​​interest.

[0019]

[0037] The imaging process involves activating ultrasound transducer elements on the imaging assembly 102 to produce ultrasound energy. A portion of the ultrasound energy is reflected by the area of ​​interest and surrounding anatomical structures, and ultrasound echo signals are received by the ultrasound transducer elements. Conduits 124 are used to transfer the received echo signals to a control and processing system 130, where an ultrasound image is reconstructed and displayed on a monitor 132. In some embodiments, the processing system 130 may control the activation of the ultrasound transducer elements and the reception of the echo signals. In some embodiments, the control and processing system 130 and the monitor 132 are part of the same system.

[0020]

[0038] Although some embodiments of the present disclosure refer to an imaging device, an ultrasound imaging device, or an intraluminal imaging device, it is understood that the ultrasound imaging device 110 and system 100 are generally used to image vessels, structures, lumens, and / or any suitable anatomical structure / tissue within a patient's body, such as, but not limited to, organs such as the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures such as the brain, the dural sac, spinal cord, and peripheral nerves; the urinary tract; and any number of anatomical locations and tissue types, such as blood, valves within the ventricles or other parts of the heart, and / or other systems of the body. In addition to natural structures, the imaging device 110 is 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 both natural and artificial structures filled with or surrounded by fluid, such as within a patient's body. The vessels, structures, lumens, anatomical structures / tissues may include blood vessels, such as arteries or veins, of a patient's vascular system, such as the cardiovascular system, peripheral vascular system, neurovascular system, renal vascular system, etc., and / or any suitable lumen within the body.

[0021]

[0039] System 100 may be referred to as an imaging system, an ultrasound imaging system, an intraluminal imaging system, and / or combinations thereof. While this 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.

[0022]

[0040] System 100 may be used to image vessels and structures in vivo in a variety of applications, such as transseptal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair. While system 100 is described in the context of an endoluminal imaging procedure, system 100 is suitable for use with any catheterization procedure. Additionally, imaging assembly 102 may include any suitable physiological sensors or components for diagnosis, treatment, and / or therapy. For example, imaging assembly 102 may include an imaging component, an ablation component, a cutting component, a morcellation component, a pressure sensing component, a flow sensing component, a temperature sensing component, and / or combinations thereof. In some embodiments, endoluminal imaging system 100 may be used to generate two-dimensional and three-dimensional images.

[0023]

[0041] 1A , the PIM 131 provides a physical and electrical connection between the ultrasound imaging device 110 and the control and processing system 130. Some embodiments of the present disclosure do not include the PIM 131. In other embodiments, the PIM 131 communicatively interposes between the ultrasound imaging device 110 and the processing system 130. In some instances, the PIM 131 may 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 are configured to mechanically and electrically couple the ultrasound imaging device 110, the PIM 131, and the control and processing system together. The system 100 includes a connector junction 111 comprising the proximal connector 209 of the ultrasound imaging device 110 and the distal connector of the PIM 131.

[0024]

[0042] In some embodiments, the control and processing system 130 includes one or more computers, processors, and / or computer systems. The control and processing system 130 is also 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 through the PIM 131 to the ultrasound imaging device 110 and to the control and processing system 130. The control and processing system 130 includes one or more processors and / or memory modules that form processing or processor circuits that process the electrical signals and generate and output a graphical representation of the imaging data (e.g., an ultrasound image) on the monitor 132. One or more electrical conductors in the ultrasound imaging device 110 and the PIM 131 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 controls imaging using the ultrasound imaging device 110 via a control interface 134 of the control and processing system 130. Electrical signals representing commands from the control and processing system 130 are sent to the ultrasound imaging device 110 via connectors and / or cables at the PIM 131 and the ultrasound imaging device 110. The control and processing system 130 is portable and includes wheels or other mechanisms to facilitate easy transportation by a user.

[0025]

[0043] In some embodiments, one or more components of the ultrasound imaging device 110 are disposable components. For example, a user, such as a physician, obtains the catheter 101 and / or ultrasound imaging device 110 in sterile packaging. In some embodiments, the ultrasound imaging device 110 is disposed of after a single use. In other embodiments, the ultrasound imaging device 110 may be sterilized and / or reprocessed for more than one use. The PIM 131 is a reusable component used in multiple procedures. For example, the PIM 131 may be cleaned between individual procedures, such as by treating it with a germicide to kill bacteria. In some embodiments, the PIM 131 does not need to be sterilized before a medical procedure. For example, the PIM 131 may be sufficiently remote from the patient that use of the unsterilized PIM 131 is safe for the patient. The sterile-to-non-sterile connection at the connector assembly 111 between the ultrasound imaging device 110 and the PIM 131 allows for a safe operating environment while saving costs by allowing reuse of expensive equipment.

[0026]

[0044] FIG. 2 is a perspective view of the catheter cable 203 described above with respect to FIG. 1B. The catheter cable 203 is a flexible, elongated body 206 containing multiple communication cables that enable communication of imaging data and / or command signals between the processing system 130 and the catheter 101. The communication cables may be electrical wires. Each individual electrical wire may include a bare single conductor surrounded by one or more insulating and / or shielding layers. Each individual electrical wire may be a coaxial wire including a central conductor surrounded by one or more insulating layers and a conductive shielding layer also surrounded by one or more insulating or protective layers. Multiple electrical wires may be collectively surrounded by one or more insulating and / or shielding layers. The insulating layers, in some cases, are formed of any suitable material, such as plastic or polymer. The shielding layers, in some cases, are formed of any suitable material, such as metal. For example, a woven fabric layer 211, such as an RFI braid, may surround the electrical wires. The cable 203 extends between the ultrasound imaging assembly 102 located at the distal portion 202 and the PCBA 207 located at the proximal portion 204. A 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., glued or bonded) to the distal end 202. During manufacturing, the imaging assembly 102 is coupled to the catheter cable 203 before the cable 203 is threaded through the catheter body or shaft. In some embodiments, the catheter cable 203 is approximately 4 feet long. In other embodiments, the catheter cable 203 is between 1 and 6 feet long, between 3 and 5 feet long, and / or other suitable lengths, both greater and less.

[0027]

[0045] FIG. 3A illustrates a cross-sectional view of a catheter shaft 201. The catheter shaft 201 is sized, shaped, structurally arranged, and / or otherwise configured to be positioned within a patient's body lumen during an imaging procedure. The catheter cable 203 is configured to be disposed within an internal lumen 332 of the catheter shaft 201 (as shown in FIGS. 2 and 3B). The catheter shaft 201 includes several pull wire lumens 336 disposed within the catheter shaft 201. The pull wires positioned within the lumens 336 control the movement (deflection of the distal tip) of the catheter shaft and / or the distal portion of the imaging assembly 102. In some embodiments, the catheter shaft 201 has an outer diameter between approximately 1 mm and approximately 3 mm, including values ​​both larger and smaller than this. In an exemplary embodiment, the catheter shaft 201 has an outer diameter of approximately 1.422 mm (+ / - 0.025 mm).

[0028]

[0046] FIG. 3B illustrates a cross-sectional view of the catheter cable 203. During assembly, the catheter cable 203 (e.g., the PCBA 207 and flexible elongate body 206) is threaded or passed through the catheter shaft 201. The PCBA 207 can be configured to interface directly or indirectly with a 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 approximately 1 mm and approximately 3 mm, including values ​​both larger and smaller than this. In an exemplary embodiment, the catheter cable 203 has a diameter of approximately 1.3 mm (+ / - 0.07 mm). In some embodiments, the catheter cable 203 includes a polymer layer 342, a shielding layer 344, and several electrical wires 346. The electrical wires 346 are disposed within the shielding layer 342, which is disposed within the polymer layer 342. Electrical wires 346 are used to communicate signals from the imaging assembly 102 to the proximal end 204 and ultimately to the processing system 130. In some embodiments, as illustrated in FIG. 2, the shielding layer 342 can be a woven fabric layer 211 disposed around the polymer layer 342. The electrical wires 346 connect the imaging assembly 102 to the proximal connector 209 (e.g., PCBA 207).

[0029]

[0047] 4 is a perspective view of an imaging assembly 102 according to an embodiment of the present disclosure. After assembly, the imaging assembly 102 is positioned at a distal portion of the catheter shaft 201. The imaging assembly 102 is also positioned at a distal portion of the cable 203. The imaging assembly 102 includes an ultrasound transducer array 262 including several transducer elements and a microbeamformer IC 304 that may be coupled to the transducer array 262. Electrical wires 346 of the cable 203 are mechanically and electrically coupled to the imaging assembly 102. In some embodiments, the electrical cable 203 is further coupled to the microbeamformer IC 304 via an interposer 310. In some embodiments, the interposer 310 is connected to the microbeamformer IC 304 through wire bonds 320. The wires 346 of the cable 203 communicate directly or indirectly with the transducer array 262, the IC 304, and / or the interposer 310. In some embodiments, interposer 310 is a circuit board or any other suitable component. In some embodiments, wires 346 comprise three groups: a first set of coaxial cables 402, a second set of coaxial cables 404, and a third set of standard single conductor cables 406.

[0030]

[0048] In some embodiments, the transducer array 262 includes ultrasound imaging transducers that are flip-chip mounted directly to the microbeamformer IC 304. The transmitters and receivers of the ultrasound imaging transducers are on the microbeamformer IC 304 and are attached directly to the transducer. In some examples, a number of the acoustic elements terminate in the microbeamformer IC 304.

[0031]

[0049] In some embodiments, transducer array 262 includes more than 800 imaging elements, and electrical cable 203 includes a total of 12 or fewer signal lines. In some embodiments, electrical cable 203 includes a total of 30 or fewer lines, including signal lines, power lines, control lines, etc. In some embodiments, transducer array 262 includes a one-dimensional or two-dimensional array of between 32 and 1000 imaging elements. For example, the array may include 32, 64, 128, 256, 512, 640, 768, 812, or any other suitable number of imaging elements. For example, a one-dimensional array has 32 imaging elements. A two-dimensional array has 32, 64, or more imaging elements. In some embodiments, 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. A one-dimensional array may be configured to generate a two-dimensional image. A two-dimensional array may be configured to generate a two-dimensional and / or three-dimensional image.

[0032]

[0050] In some embodiments, the electrical cables 203 of the imaging assembly 102 are directly coupled to the microbeamformer IC 304 of the imaging assembly 102. In some embodiments, the microbeamformer IC 304 is located directly below the transducer array 262 and electrically connected to it. The elements of the transducer array 262 are piezoelectric or micromachined ultrasound transducer (MUT) elements. In some embodiments, the piezoelectric elements are attached to the IC 304 by flip-chip mounting of an acoustic layer assembly, which includes sawing into individual elements. The MUT elements are flip-chip mounted as a unit or grown directly on the microbeamformer IC 304. In some embodiments, the cable bundle terminates in an interposer 310 of a suitable material, such as a rigid or flexible printed circuit assembly. The interposer 310 is then connected to the microbeamformer IC 304 via any suitable means, such as wire bonds 320.

[0033]

[0051] In some embodiments, the microbeamformer IC 304 and the interposer 310 are coupled to an elongated acoustic backing member 410. For example, adhesive bonding is used. In other embodiments, the microbeamformer IC 304 and the interposer 310 are mechanically fastened, solvent bonded, UV bonded, ultrasonically welded, or coupled using any other suitable method. The acoustic backing 410 extends from the distal tip of the microbeamformer IC 304 to the proximal end of the interposer 310.

[0034]

[0052] The stiffening member 412 is coupled to the acoustic backing 410. The stiffening member 412 has a similar shape to the acoustic backing 410 and similarly extends from the distal tip of the microbeamformer 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 is constructed of any suitable material. In an exemplary embodiment, the stiffening member 412 is made of stainless steel. In other embodiments, the stiffening member is made of electroless nickel plating, titanium, carbon fiber, magnesium, high specific strength steel, other steel alloys, or other suitable materials.

[0035]

[0053] The interposer 310 houses various electrical components 420. The electrical components 420 are positioned between the distal ends of the cables 326 and the wire bonds 320, and are disposed on the top surface of the interposer 310. In some embodiments, the electrical components 420 are used to generate, transport, amplify, attenuate, record, or smooth signals to and from the transducer array 262. The electrical components 420 are additionally used to sense one or more characteristics of the physiology within which the endoluminal imaging device is positioned, such as temperature. It is fully contemplated that the electrical components 420 perform any other function while positioned on the imaging assembly 102. The electrical components may consist of both passive and active components, such as, but not limited to, resistors, capacitors, inductors, transistors, operational amplifiers, thermistors, or any other suitable electrical components.

[0036]

[0054] The interposer 310 also includes ground pads 430. The ground pads 430 are thin, conductive layers of material positioned on the top surface of the interposer 310. The ground pads 430 may be located on a proximal portion of the interposer 310. The first set of coaxial cables 402 and the second set of coaxial cables 404 are mechanically and electrically coupled to the ground pads 430. As discussed in more detail herein, this connection is achieved by soldering the exposed shield layer (e.g., exposed shield layer 710 in FIG. 7 ) of each coaxial cable in the first set 402 and the second set 404 such that the cables are mechanically and electrically joined to the ground pads 430. In some embodiments, coaxial cables are preferred over single-conductor cables because they more effectively transmit fast-switching, high-frequency signals and reduce noise. In some embodiments, the coaxial cable may be configured to carry control signals from the computer 130 to the ultrasound imaging assembly 102 and / or to carry image data from the ultrasound imaging assembly 102 to the computer 130 .

[0037]

[0055] FIG. 5 is a flowchart diagram of a method 500 for assembling an endoluminal imaging device 101 in accordance with an embodiment of the present disclosure. Method 500 may include connecting an ultrasound imaging assembly 102 to a catheter cable 346. As shown, method 500 includes several enumerated steps, but embodiments of method 500 may include additional steps before, after, and between the enumerated steps. In some embodiments, one or more of the enumerated steps may be omitted, performed in a different order, or performed simultaneously. The steps of method 500 may be performed by the manufacturer of the endoluminal imaging device 101, the manufacturer of a subassembly including the ultrasound imaging assembly 102 or the catheter cable 346, and / or the manufacturer of any other component discussed in this disclosure. Method 500 is described with reference to FIGS. 6A-11, which are schematic diagrams of various components of the ultrasound imaging assembly 102 and the cable 346 during various steps of manufacturing. For example, FIGS. 6A-11 show assembly steps for various components of device 110, such as the connection between ultrasound imaging assembly 102 and cable 346.

[0038]

[0056] In step 505, the method 500 includes obtaining an interposer 310 having ground pads 430 disposed on a surface, such as a top surface or upper surface, of the interposer 310. A schematic top view of an exemplary interposer 310 with the ground pads 430 positioned on a proximal portion 620 of the interposer 310 is shown in FIG. 6A , in accordance with an embodiment of the present disclosure. Various components of the ultrasound imaging assembly 102 may be coupled to the interposer 310. In some embodiments, the interposer 310 is 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 ICs 304. The circuit board may include conductive traces formed on and / or within it. The interposer substrate may be formed of any suitable semiconductor material, such as a silicon (Si) substrate or a germanium (Ge) substrate. In some embodiments, interposer 310 includes a compound semiconductor, such as silicon carbide (SiC), silicon germanium (SiGe), or silicon germanium carbide (SiGeC). As shown in FIG. 6A , conductive pads 602, 604, and 606 are disposed on the top surface of interposer 310. Electrical component 420 is also disposed on the top surface of interposer 310. Electrical component 420 can be of any particular type, as previously described. Conductive pads 602, 604, and 606 are positioned along the length of interposer 310 between ground pad 430 and electrical component 420. Conductive pad 602 has a proximal end 610 and a distal end 611. Conductive pad 604 also has a proximal end 612 and a distal end 613. Additionally, ground pad 430 has a proximal end 451 and a distal end 450. Electrical component 420 is positioned at a location distal from conductive pads 602, 604, and 606. Wire bonds 320 are also positioned on the top surface of interposer 310 and are disposed at a distal portion 625 of interposer 310. The placement of conductive pads 602, 604, and 606, electrical component 420, and / or wire bonds 320 in the embodiment shown in FIG. 6A is merely exemplary.Any of these features may be located anywhere on interposer 310.

[0039]

[0057] Interposer 310 may have dimensions 352, 354, and 356, which may be any suitable size. Dimension 352 may be a width, dimension 354 may be a length, and dimension 356 may be a depth. In some embodiments, width 352 of interposer 310 is between approximately 1 mm and approximately 3 mm, including both larger and smaller values. In an exemplary embodiment, width 352 of interposer 310 is approximately 2.31 mm (+ / - 0.100 mm). In some embodiments, length 354 of interposer 310 is between approximately 8 mm and approximately 15 mm, including both larger and smaller values. In an exemplary embodiment, length 354 of interposer 310 is approximately 11.5 mm (+ / - 0.100 mm). Depth 356 of interposer 310 is between approximately 0.10 mm and approximately 0.40 mm, including both larger and smaller values. In an exemplary embodiment, the depth 356 of the interposer 310 is approximately 0.25 mm (+ / - 0.100 mm).

[0040]

[0058] The ground pad 430 may have dimensions 432, 434, and 436, which may be any suitable size. Dimension 434 may be a width, dimension 432 may be a length, and dimension 436 may be a depth. Generally, the width 434 of the ground pad 430 is similar to or smaller than the width 352 of the interposer 310. The width 434 may be the same as the width 352. As described in more detail herein, the length 432 of the ground pad 430 is generally the same as the length 712 of the exposed shield layer 710 of the coaxial cable 700 illustrated in FIG. 7 . The length 432 of the ground pad 430 may be any suitable length that allows for space for other components on the interposer 310 and produces the necessary bond between the cable 346 and the interposer 310. In some embodiments, the length 432 of the ground pad 430 is between approximately 0.5 mm and approximately 1.0 mm, including values ​​both greater and less than this. In an exemplary embodiment, the length 432 of the ground pad 430 is approximately 0.69 mm (+ / - 0.050 mm). In some embodiments, the width 434 of the ground pad 430 is between approximately 1.0 mm and approximately 3.0 mm, including both larger and smaller values. In an exemplary embodiment, the width 434 of the ground pad 430 is approximately 1.85 mm (+ / - 0.050 mm).

[0041]

[0059] Referring now to FIG. 6B, a schematic cross-sectional view of interposer 310 and ground pad 430 is shown taken along section line 6B-6B in FIG. 6A. As shown in FIG. 6B, ground pad 430 is a generally rectangular, thin, conductive material disposed on interposer 310. In some embodiments, ground pad 430 has a depth 436 between approximately 0.010 mm and approximately 0.100 mm, including values ​​both greater and less than this. In an exemplary embodiment, ground pad 430 has a depth 436 of approximately 0.025 mm (+ / - 0.005 mm). In FIG. 6B, ground pad 430 is shown recessed within a corresponding cavity in the top surface of interposer 310 such that the top surface of ground pad 430 is uniform, flush, or continuous with the top surface of interposer 310. This configuration represents one exemplary embodiment. It will be appreciated that ground pad 430 may be disposed on interposer 310 without a recessed cavity, such that ground pad 430 protrudes from the upper side of interposer 310 a distance generally equal to depth 436 of ground pad 430. Alternatively, ground pad 430 may be recessed within interposer 310 to a depth greater than depth 436, such that the upper side of ground pad 430 is below the upper side of interposer 310. The exact orientation of ground pad 430 relative to interposer 310 may be of any particular type.

[0042]

[0060] Referring again to FIG. 5 , in step 510, the method 500 includes obtaining a first set of coaxial cables. An illustrative example of one embodiment of the coaxial cables included in this first set of coaxial cables is illustrated in FIG. 7 . The coaxial cable 700 includes four basic layers. It is fully contemplated that additional layers may be added to the coaxial cable 700 beyond those illustrated in FIG. 7 . For example, layers providing additional strength, rigidity, protection, improved conductivity, or any other functionality may be added to the coaxial cable 700. For example, an inner shielding layer and an outer shielding layer may be provided. The inner shielding layer and / or the outer shielding layer may be electrically and mechanically coupled to other components within the ultrasound imaging assembly 102. For simplicity, only four layers are illustrated and discussed in detail herein.

[0043]

[0061] The center conductor cable 720 is positioned along the axial center of the cable 700. The center conductor 720 may comprise multiple conductive elongated wires twisted or otherwise coupled together, or may comprise a single conductive elongated wire. The center conductor 720 carries signals from the control and processing system 130 to the ultrasound imaging assembly 102 or from the ultrasound imaging assembly 102 to the control and processing system 130. The coaxial cable 700 is provided such that a layer of the cable 700 is removed to expose a length 722 of the distal portion of the center conductor 720. The cable 700 may 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 may be any suitable length. As described in more detail herein, the length 722 is generally a similar dimension to the conductive pad 602 or 604 to enable electrical and mechanical bonding of the distal end of the center conductor 720 to the conductive pad 602 or 604.

[0044]

[0062] An insulating layer 715 is disposed around the center conductor 720. The insulating layer 715 extends primarily from the proximal end to the distal end of the center conductor 720. The purpose of the insulating layer 715 is to insulate the center conductor 720 from the other layers of the cable 700 and from the surrounding environment so that the center conductor 720 does not electrically communicate with any elements other than those intended at either end of the center conductor 720. As previously mentioned, the insulating layer 715 is not disposed around the distal portion of the center conductor 720 to allow electrical and mechanical bonding of the distal end of the center conductor 720 to the conductive pads 602 or 604. As shown in FIG. 7 , the outer layer of the cable 700 is further removed to expose a length 717 of the insulating layer 715. The length 717 may be any suitable length. Generally, length 717 is approximately equal to the distance from proximal end 610 of conductive pad 602 to distal end 450 of ground pad 430 for first set of coaxial cables 700a. For second set of cables 700b, length 717 is approximately equal to the distance from proximal end 612 of conductive pad 604 to distal end 450 of ground pad 430, further including any displacement of coaxial cables 700b as a result of being positioned over cables 700a, as discussed herein.

[0045]

[0063] The shielding layer 710 is positioned around the insulating layer 715 and extends primarily from the proximal end to the distal end of the insulating layer 715. The purpose of the shielding layer 710 is to establish an electrical ground for the center conductor 720, which is in electrical communication with the control and processing system 130 and the ultrasound imaging assembly 102. As with the exposed distal portion of the center conductor 720 and the exposed distal portion of the insulating layer 715, the outer layer or jacket 705 of the coaxial cable 700 is partially removed to expose the distal portion of the shielding layer 710. As previously mentioned, the length 712 of this exposed distal portion of the shielding layer 710 is generally the same or similar to the length 432 of the ground pad 430. However, the length 712 of the exposed distal portion of the shielding layer 710 may be any suitable length.

[0046]

[0064] An outer layer or jacket 705 is disposed around the shielding layer 710 and extends primarily from the proximal end to the distal end of the shielding layer 710. The purpose of the jacket 705 is to insulate the shielding layer 710 from the general environment and ensure that the shielding layer 710 is in electrical communication only with the control and processing system 130 and the ultrasound imaging assembly 102. As previously mentioned, the jacket 705 is removed to expose a distal portion of the shielding layer 710 by a length 712, as illustrated in FIG.

[0047]

[0065] Referring again to FIG. 5, in step 515, the method 500 includes mechanically and electrically coupling the center conductors 720a of the first set of coaxial cables 700a to the conductive pads 602 on the interposer 310. As illustrated in FIG. 8A, the coaxial cables 700a in the first set are substantially similar to one another. While FIG. 8A shows eight such coaxial cables positioned on the interposer 310, it is fully contemplated that any number of coaxial cables 700a may be included in this first set. The first set of coaxial cables 700a may include only one coaxial cable 700a, two, four, eight, sixteen, or more coaxial cables 700a.

[0048]

[0066] As shown in Figure 8A, the center conductor 720a of each coaxial cable 700a is mechanically and electrically bonded to a corresponding conductive pad 602 located on the interposer 310. Because eight coaxial cables 700a are shown in Figure 8A, the interposer 310 has eight conductive pads 602 located near the ground pads 430 on the interposer 310. As stated, this number is merely exemplary. The electrical and mechanical bonding may be achieved by any suitable method, such as, but not limited to, using solder.

[0049]

[0067] 5, in step 520, method 500 includes soldering shield layer 710a of coaxial cable 700a to ground pad 430. In some embodiments, a portion of solder 810, illustrated in FIG. 8B, is applied to mechanically and electrically join shield layer 710a of coaxial cable 700a to ground pad 430. Because each shield layer 710a of coaxial cable 700a carries an identical electrical ground for the signal carried by each center conductor 720a of coaxial cable 700a, each shield layer 710a of coaxial cable 700a is in electrical communication with each other's ground pad 430. As described in more detail herein, ground pad 430 provides an electrical ground for multiple coaxial cables 700a and multiple coaxial cables 700b. In addition to establishing an electrical connection between the shielding layers 710a, the solder portion 810 provides a mechanical connection between the coaxial cable 700a and the interposer 310 so that the connection between the catheter cable 346 and the ultrasound imaging assembly 102 is significantly stronger than conventional methods.

[0050]

[0068] FIG. 8B is a cross-sectional view of the interposer 310 along section line 8B-8B in FIG. 8A with a first row of coaxial cables 700a connected thereto, according to an embodiment of the present disclosure. As previously described, eight coaxial cables 700a are shown disposed on the top surface of the ground pad 430. A center conductor 720a is shown at the axial center of each coaxial cable. Positioned around each center conductor 720a is an insulating layer 715a. A shielding layer 710a is shown positioned around each insulating layer 715a. Between the insulating layer 715a and the shielding layer 710a is a layer of solder 812 that passed through the shielding layer 710a during the soldering process. The solder 812 is part of, or substantially similar to, the solder portion 810. The shielding layer 710a is composed of a conductive material that is braided to allow the solder to pass through the layer. Alternatively, the shielding layer 710a is composed of any suitable conductive material that allows solder to pass through the layer. In yet other embodiments, the shielding layer 710a is not porous at all and does not allow solder to pass through the layer, but still provides a robust mechanical connection. The shielding layer 710a is at least semi-porous to allow solder to pass through the layer, such that the resulting twisted connection ensures a stronger mechanical connection between the solder portions 810 and the shielding layer 710a, and therefore between the first set of coaxial cables 700a and the interposer 310.

[0051]

[0069] Without the solder portions described herein, the connection between the distal tip of the ICE catheter with the ultrasound imaging assembly and the more proximal portion of the ICE catheter, such as the catheter shaft, would be relatively weak. For example, the distal tip and 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 cables are also attached to respective conductive pads for electrical communication. However, these connections are weaker and cannot handle larger pull forces (e.g., at least 15 N). Advantageously, mechanically coupling the shield layers of multiple coaxial cables to the ground pads 430 via solder portions as described herein provides a strong mechanical connection between the electrical wires 346 and the ultrasound imaging assembly 102. Thus, the solder portion connection provides a stronger connection point (e.g., stronger than the polymer-polymer interface and center conductor-conductive pad connection) between the distal tip and the more proximal portion of the ICE catheter. The disclosed methods and apparatus advantageously meet the minimum peak tensile force requirements of ISO 10555, among various national and international peak tensile force requirements for intracardiac echocardiography (ICE) catheters having catheter shaft diameters 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 portion 810 is configured to support a tensile load of at least 15 N. For example, the solder portion 810 is configured to support a tensile load between approximately 1 N and approximately 60 N, between approximately 15 N and approximately 60 N, and / or other values ​​both greater and less than this.

[0052]

[0070] Because the solder wicks by capillary action across the conductive surfaces it contacts and avoids mechanical bonding with non-conductive surfaces, solder portion 810 has the same overall shape as ground pad 430. For example, the solder portion may have the overall shape of a rectangular or polygonal cylinder having a generally rectangular or polygonal cross-sectional profile. In some embodiments, interposer 310 is constructed of a non-conductive material such that solder portion 810 bonds only with ground pad 430 and shield layer 710a. In addition, insulation layer 715a and jacket 705a of coaxial cable 700a are constructed of a non-conductive material such that solder portion 810 does not electrically or mechanically bond with these elements, resulting in solder portion 810 maintaining an overall shape similar to ground pad 430.

[0053]

[0071] 5, in step 525, method 500 includes obtaining a second set of coaxial cables 700b, which are substantially similar to the first set of coaxial cables 700a. An illustrative example of one embodiment of the coaxial cables 700 in this second set 700b is illustrated in FIG.

[0054]

[0072] The second set of coaxial cables 700b differs from the first set of coaxial cables 700a by 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 is the same overall length as the distance between the proximal end 604b of the conductive pad 604 and the distal end 430a of the ground pad 430. Due to the offset in the location of the cables 700b due to their positioning above the first set of coaxial cables 700a, the length 717 of the insulating layer 715 of the coaxial cables 700b is slightly longer than this distance.

[0055]

[0073] Referring again to FIG. 5, at step 530, method 500 includes mechanically and electrically coupling center conductors 720b of a second set of coaxial cables 700b to conductive pads 604 on interposer 310. As illustrated in FIG. 9A, the second set of coaxial cables 700b are positioned above the first set of coaxial cables 700a. Like cables 700a, coaxial cables 700b are each substantially similar to one another. FIG. 9A shows eight such coaxial cables 700b positioned on interposer 310 and eight coaxial cables 700a positioned below coaxial cables 700b. Thus, while FIG. 9A shows 16 coaxial cables 700 positioned on interposer 310, it is fully contemplated that any number of coaxial cables 700 may be included. Similarly, the second set of coaxial cables 700b may include only one coaxial cable 700b, two, four, eight, sixteen, or more coaxial cables 700b.

[0056]

[0074] As shown in FIG. 9A , the center conductor 720b of each coaxial cable 700b is mechanically and electrically bonded to a corresponding conductive pad 604 located on the interposer 310. Because eight coaxial cables 700b are shown in FIG. 9A , the interposer 310 has eight conductive pads 604. As stated, this number is merely exemplary. In some embodiments, the conductive pad 602 is located between the conductive pad 604 and the ground pad 430. This arrangement allows a second set of coaxial cables 700b to be positioned above the first set of coaxial cables 700a, resulting in two rows of coaxial cables, as shown in FIG. 9B . Arranging the coaxial cables 700a and 700b in two rows above each other, with the conductive pads 602 and 604 arranged in two corresponding rows, allows all of the cables 346 to terminate at the interposer 310 and be mechanically and electrically coupled to the interposer 310 in less space than conventional methods on the interposer 310. This two or more row configuration of coaxial cables disclosed in the present invention allows for a shorter overall ultrasound imaging assembly 102, making it easier to manipulate the intraluminal catheter assembly 101 within the heart, vasculature, or other lumen within a patient. The electrical and mechanical bond between the center conductor 720b and the conductive pad 604 may be achieved by any suitable method, such as, but not limited to, using solder.

[0057]

[0075] 9A , the proximal portions of the first set of coaxial cables 700 a and the second set of coaxial cables 700 b are shown offset from one another so that the second set of coaxial cables 700 b appear to terminate at a location distal to the proximal ends of the first set of coaxial cables 700 a. While this orientation is utilized in embodiments of the present disclosure, this offset in the proximal ends of the coaxial cables is shown primarily for illustrative purposes to illustrate that the first set of coaxial cables 700 a is positioned below the second set of coaxial cables 700 b in FIG. 9A , even though the second set of coaxial cables 700 b completely obscures the first set of coaxial cables 700 a.

[0058]

[0076] 5, in step 535, method 500 includes soldering shielding layers 710b of coaxial cables 700b to ground pads 430. In some embodiments, the portion of solder 810 applied to the shielding layers 710a of the first set of coaxial cables 700a is extended to further encompass the shielding layers 710b of the second set of coaxial cables 700b and the shielding layers 710a of the first set of coaxial cables 700a. In this manner, the shielding layers 710b of the second set of coaxial cables 700b are mechanically and electrically bonded to both the shielding layers 710a of the first set of coaxial cables 700a and the grounding pads 430. Because each shield layer 710a and 710b of the coaxial cables 700a and 700b carries an equivalent electrical ground for the signals carried by each center conductor 720a and 720b of the coaxial cables 700a and 700b, the respective shield layers 710a and 710b of the coaxial cables 700a and 700b are in electrical communication with each other's ground pads 430. In addition to establishing an electrical connection between the shield layers 710a, 710b and the ground pads 430, the solder portions 810 provide a mechanical connection between the coaxial cables 700a, 700b and the interposer 310 such that the connection between the catheter cable 346 and the ultrasound imaging assembly 102 is significantly stronger than conventional methods.

[0059]

[0077] 9B is a cross-sectional view of the interposer 310 along section line 9B-9B in FIG. 9A with a first row of coaxial cables 700a and a second row of coaxial cables 700b bonded to the ground pad 430, according to an embodiment of the present disclosure. As previously described, eight coaxial cables 700a are shown disposed along the upper surface of the ground pad 430. Additionally, 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 includes a shielding layer 710b that is at least semi-porous, allowing a small amount of solder 812 to pass through the shielding layer 710b, ensuring a stronger mechanical connection between the solder portions 810 and the shielding layer 710b, and therefore between the second set of coaxial cables 700b, the first set of coaxial cables 700a, and the interposer 310.

[0060]

[0078] Because the solder wicks by capillary action across the conductive surfaces it contacts while avoiding mechanical bonding with non-conductive surfaces, solder portion 810 still retains the same overall shape as ground pad 430. In some embodiments, interposer 310 is constructed of a material such that solder portion 810 bonds only with ground pad 430 and shield layers 710a and 710b. In addition, insulation layer 715b and jacket 705b of coaxial cable 700b are constructed of a non-conductive material such that solder portion 810 does not electrically or mechanically bond with these elements either. Solder portion 810 has a width similar to width 434 of ground pad 430 and a length similar to length 432 of ground pad 430. The vertical depth of solder portion 810 is highly dependent on the dimensions and location of coaxial cables 700a and 700b. The vertical depth of the solder portion 810 is between approximately 0.25 mm and approximately 0.75 mm, including both greater and lesser depths. In an exemplary embodiment, the vertical depth of the solder portion 810 is approximately 0.50 mm (+ / - 0.10 mm). The solder portion completely or partially surrounds the outer circumference of each of the coaxial cables. For example, in a cross-section of the coaxial cables, the solder portion may completely or partially surround one or more of the coaxial cables. The solder portion 810 extends into the lateral and vertical spaces between adjacent coaxial cables. For example, the solder portion 810 fills the spaces between coaxial cables positioned left to right in the same set, and fills the spaces between coaxial cables positioned above and below in the first set of coaxial cables 700a and the second set of coaxial cables 700b. In the disclosed exemplary embodiment, solder portions 810 are positioned between the first row of coaxial cables 700a and the second row of coaxial cables 700b. Solder portions 810 are also positioned between each coaxial cable in the first set of coaxial cables 700a and between each coaxial cable in the second set of coaxial cables 700b. Solder portions 810 are also positioned between the first set of coaxial cables 700a and the ground pads 430.

[0061]

[0079] 5 , method 500 describes, at steps 515 and 520, mechanically and electrically bonding center conductor 720a to conductive pad 602 before mechanically and electrically bonding shield layer 710a to ground pad 430. Similarly, method 500 describes, at steps 530 and 535, mechanically and electrically bonding center conductor 720b to conductive pad 604 before mechanically and electrically bonding shield layer 710b to ground pad 430. However, this particular order of connecting center conductor 720a or 720b of coaxial cable 700a or 700b before connecting shield layer 710a or 710b to ground pad 430 is not required. Shield layer 710a or 710b may be mechanically and electrically bonded to ground pad 430 before center conductor 720a or 720b is bonded to conductive pad 602 or 604.

[0062]

[0080] Referring again to FIG. 5 , at step 540, the method 500 includes obtaining a set of single conductor cables 1000. The single conductor cables 1000 are substantially similar to single conductor cables well known to those skilled in the art. FIG. 10A shows a third set of five such single conductor cables 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, in other embodiments of the present invention, it is contemplated that additional layers may be added to provide additional functionality. For example, layers providing additional strength, rigidity, protection, improved conductivity, or any other functionality may be added to the single conductor cable 1000. As shown in FIG. 10A , a single conductor 1010 extends along the inside of the single conductor cable 1000. The single conductor 1010 is used to transmit signals from the control and processing system 130 to the ultrasound imaging assembly 102 or from the ultrasound imaging assembly 102 to the control and processing system 130. For example, the single conductor 1010 may be a power line or a thermistor sensing lead. In such an embodiment, the single conductor 1010 may carry a power signal or a thermistor signal. The single conductor 1010 may also be used for any number of other suitable applications.

[0063]

[0081] An insulating layer 1005 is disposed around the single conductor 1010. The insulating layer 1005 extends primarily from the proximal end to the distal end of the single conductor 1010. The purpose of the insulating layer 1005 is to insulate the single conductor 1010 from the general environment and ensure that the single conductor 1010 communicates electrically only with the control and processing system 130 and the ultrasound imaging assembly 102 as intended. As shown in FIG. 10A , the insulating layer 1005 is removed to expose a distal portion of the single conductor 1010. The single conductor cable 1000 may be obtained to expose the distal portion of the single conductor 1010, or alternatively, the single conductor cable 1000 may be modified after obtaining the cable 1000 to expose the single conductor 1010 as shown. While this disclosure shows only two layers making up the single conductor cable 1000, as previously discussed, many additional layers performing different functions may be included in the single conductor cable 1000.

[0064]

[0082] 5, in step 545, method 500 includes mechanically and electrically coupling single conductor cables 1000 to conductive pads 606 such that single conductor cables 1000 are positioned over the first set of coaxial cables 700a and the second set of coaxial cables 700b. As illustrated in FIG. 10A, the single conductor cables 1000 are substantially similar to one another. While FIG. 10A shows five such single conductor cables 1000 positioned on interposer 310, it is fully contemplated that any number of single conductor cables 1000 may be included in the set. The single conductor cables 1000 may include only one single conductor cable 1000, two, four, eight, sixteen, hundreds, or more single conductor cables 1000.

[0065]

[0083] 10A , the single conductor 1010 of each single conductor cable 1000 is mechanically and electrically bonded to a corresponding conductive pad 606 located on the interposer 310. Because five single conductor cables 1000 are shown in FIG. 10A , the interposer 310 has five corresponding conductive pads 606 located near the conductive pads 604. As stated, this number is merely exemplary. In some embodiments, the conductive pad 602 is positioned between the conductive pad 604 and the ground pad 430, and the conductive pad 604 is positioned between the conductive pad 606 and the conductive pad 602. This arrangement allows for a second set of coaxial cables 700b to be positioned above the first set of coaxial cables 700a, and for single conductor cable 1000 to be positioned above both the first set of coaxial cables 700a and the second set of coaxial cables 700b, resulting in two rows of coaxial cables 700a and 700b and one row of single conductor cables 1000, as shown in FIG. 10B. However, conductive pads 602, 604, and 606 may be positioned anywhere on interposer 310. The mechanical and electrical bond between single conductors 1010 and ground pads 606 is achieved by any suitable method, such as, but not limited to, using 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 single conductor cable 1000 need not be positioned above first set of coaxial cables 700a and second set of coaxial cables 700b. They may be positioned on either side of or below the coaxial cables in any suitable manner. It is noted that solder portion 810, which encapsulates first set of coaxial cables 700a and second set of coaxial cables 700b, does not encapsulate single conductor cable 1000. Because insulating layer 1005 extends along the entire single conductor 1010 except for the distal end of single conductor 1010 that is bonded to conductive pad 606, the solder of solder portion 810 is not wicked into single conductor cable 1000 by capillary action.

[0066]

[0084] Referring again to FIG. 10A , the first set of coaxial cables 700 a, the second set of coaxial cables 700 b, and the proximal portion of single conductor cable 1000 are shown offset from one another such that second set of coaxial cables 700 b appear to terminate at a location distal to the proximal terminations of first set of coaxial cables 700 a, and single conductor cable 1000 appears to terminate at a location distal to the proximal terminations of second set of coaxial cables 700 b. While this orientation is utilized in embodiments of the present disclosure, this offset in the proximal terminations of the coaxial cables, like the offset between first set of coaxial cables 700 a and second set of coaxial cables 700 b described in connection with FIG. 9A , is shown primarily for illustrative purposes. FIG. 10A shows the apparatus of the present disclosure after all of the previously described coaxial and single conductor cables have been connected to interposer 310.

[0067]

[0085] 10B is a cross-sectional view of the interposer 310 along section line 10B-10B in FIG. 10A with the first and second rows of coaxial cables 700a, 700b connected together and the third, upper row of center conductor cables 1000 positioned above the first and second rows of coaxial cables 700a, 700b, according to an embodiment of the present disclosure. Solder portions 810 encase the first and second rows of coaxial cables 700a, 700b, mechanically and electrically coupling them to the ground pad 430. As previously described, each coaxial cable in the first set of coaxial cables 700a includes a center conductor 720a, an insulating layer 715a, and a shielding layer 710a. Similarly, each coaxial cable in the second set of coaxial cables 700b includes a center conductor 720b, an insulating layer 715b, and a shielding layer 710b. Solder 812, which is part of or substantially similar to solder portion 810, is positioned between insulation layer 715a and shielding layer 710a for the first set of coaxial cables 700a, and between insulation layer 715b and shielding layer 710b for the second set of coaxial cables 700b. As previously described, each single conductor cable 1000 includes a single conductor 1005 and insulation layer 1010. Note also that the cables 346 illustrated in FIG. 3B are arranged in a circular configuration within catheter cable 203. At a point proximal to the proximal portion 620 of interposer 310, the arrangement of cables 346 transitions to three or more rows, as illustrated in FIG. 10B. FIG. 10B shows the device of the present disclosure after all of the previously described coaxial and single conductor cables have been connected to interposer 310. In some embodiments, the length and / or width of the solder portion 810 may be equal to the length 432 and / or width 434, respectively, of the ground pad 430. In some embodiments, the length and / or width of the solder portion 810 may be less than the length 432 and / or width 434, respectively, of the ground pad 430. The height of the solder portion 810 may depend on the volume of solder used to couple the ground pad 430, the first set of coaxial cables 700a, and the second set of coaxial cables 700b.

[0068]

[0086] 11 is a perspective view of interposer 310 with catheter cable 346 disposed thereon, comprising first set of coaxial cables 700a, second set of coaxial cables 700b, and third set of single conductor cables 1000 mechanically and electrically coupled to corresponding conductive pads 602, 604, and 606, and ground pad 430. Solder portions 810 mechanically and electrically couple first set of coaxial cables 700a and second set of coaxial cables 700b to ground pad 430. Electrical component 420 is positioned distal to ground pads 602, 604, and 606. FIG. 11 shows the device of the present disclosure after all of the aforementioned coaxial and single conductor cables have been connected to interposer 310.

[0069]

[0087] Although the figures and related description of this disclosure show three sets of cables 346, namely, a first set of coaxial cables 700a, a second set of coaxial cables 700b, and a set of single conductor cables 1000 arranged in three rows, it is noted that any number of sets of cables may be used. For example, according to embodiments of the present disclosure, only one set arranged in one row may be used and mechanically and electrically coupled to the interposer 310. In addition, according to the present disclosure, two, four, five, ten, or more sets of cables may be mechanically and electrically coupled to the interposer 310. In addition, the single conductor cable 1000 may 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 cable may be in the same row or set as any other type of cable used in the present disclosure.

[0070]

[0088] 12 is a schematic diagram of a processor circuit 150, according to an embodiment of the present disclosure. The processor circuit 150 may be implemented in the intraluminal ultrasound imaging device 110, the control and processing system 130, and / or the PIM 131 of FIG. 1A. As shown, the processor circuit 150 includes a processor 160, a memory 164, and a communication module 168. These elements communicate with each other directly or indirectly, for example, via one or more buses.

[0071]

[0089] Processor 160 includes a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, an FPGA, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. Processor 160 may be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0072]

[0090] The memory 164 may include cache memory (e.g., cache memory of the processor 160), 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 devices, hard disk drives, 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 stores instructions 166. The instructions 166 include instructions that, when executed by the processor 160, cause the processor 160 to perform the operations described herein with reference to the intraluminal ultrasound imaging device 110, the control and processing system 130, and / or the PIM 131 (FIG. 1A). The instructions 166 may also be referred to as code. The terms "instructions" and "code" should be interpreted broadly to include any type of computer-readable statement. For example, the terms "instructions" and "code" refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" include a single computer-readable statement or many computer-readable statements.

[0073]

[0091] The communications module 168 may include any electronic and / or logic circuitry that facilitates the direct or indirect communication of data between the 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 communications module 168 may be an input / output (I / O) device. In some cases, the communications module 168 facilitates direct or indirect communication between the processor circuit 150 and / or various elements of the system 100.

[0074]

[0092] Those skilled in the art will appreciate that the above-described devices, systems, and methods may be modified in various ways. Therefore, those skilled in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. In this regard, while exemplary embodiments have been shown and described, a wide range of modifications, changes, and substitutions are contemplated in the foregoing disclosure. It will be understood that such variations can be made to the foregoing without departing from the scope of the present disclosure. It is therefore appropriate that the appended claims be broadly construed in a manner consistent with the present disclosure.

Claims

1. a flexible elongate member positioned within a body lumen of a patient, the flexible elongate member comprising a plurality of coaxial cables, each of the plurality of coaxial cables comprising a conductive shielding layer; a handle coupled to the flexible elongate member and manipulated by a user to manually control the flexible elongate member within the patient's body lumen; 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 comprising: a transducer array for acquiring ultrasound data; a first conductive pad to which the conductive shield layer of each of the plurality of coaxial cables is mechanically and electrically coupled; the ultrasound imaging assembly comprising: a solder portion positioned on the first conductive pad, the conductive shield layer of each of the plurality of coaxial cables being mechanically and electrically coupled to the first conductive pad via the solder portion; Equipped with the conductive shield layer is comprised of a braided conductive material that is at least semi-porous to allow solder to pass through the layer; An intraluminal imaging device, wherein the solder portion supports a tensile load of at least 15 N generated while the flexible elongate member is being manually controlled.

2. The intraluminal imaging device of claim 1 , wherein the solder portions are positioned around an outer periphery of the plurality of coaxial cables.

3. each of the plurality of coaxial cables includes an insulating jacket around the conductive shield layer; the conductive shield layer has an exposed portion that is free of the insulating jacket; The intraluminal imaging device of claim 1 , wherein corresponding dimensions of the exposed portion of the conductive shielding layer and the first conductive pad are equal.

4. Each of the plurality of coaxial cables includes a center conductor and an insulating layer surrounding the center conductor; the conductive shielding layer is positioned around the insulating layer; The intraluminal imaging device of claim 1 , wherein the solder portion is positioned between the conductive shielding layer and the insulating layer.

5. the plurality of coaxial cables comprises a first row of coaxial cables and a second row of coaxial cables; the first row of coaxial cables is positioned over the first conductive pads; The intraluminal imaging device of claim 1 , wherein the second row of coaxial cables is positioned above the first row of coaxial cables.

6. The intraluminal imaging device of claim 5 , wherein the solder portion 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, and the solder portion is positioned between each of the plurality of coaxial cables.

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

9. each of the plurality of coaxial cables includes a center conductor; and the ultrasound imaging assembly includes a plurality of second conductive pads; 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; The endoluminal imaging device of claim 1 , wherein the center conductor carries electrical signals to and from the ultrasound imaging assembly.

10. the flexible elongate member comprises a plurality of single conductor cables positioned over the plurality of coaxial cables; the ultrasound imaging assembly includes a plurality of third conductive pads mechanically and electrically coupled to the plurality of single conductor cables; The endoluminal imaging device of claim 9 , wherein the plurality of single conductor cables carry the electrical signals to and from the ultrasound imaging assembly.

11. The intraluminal imaging device of claim 1 , wherein the flexible elongate member comprises a catheter positioned within the patient's heart.

12. The endoluminal imaging device of claim 1 , wherein the ultrasound imaging assembly further comprises a circuit board in communication with the transducer array, and the first conductive pad is located on a surface of the circuit board.

13. The intraluminal imaging device of claim 1 ; a computer in communication with the intraluminal imaging device that generates an ultrasound image based on the ultrasound data; A system comprising:

Images