Wire connections in ultrasound imaging devices, systems and methods

Abstract

A system includes an intraluminal device configured to be positioned in a body cavity of a patient, the intraluminal device including a proximal portion and a distal portion, wherein the intraluminal device further includes: a sensor disposed at the distal portion; a proximal connector, the proximal connector including a printed circuit board assembly (PCBA) configured to interface with a user console and disposed at the proximal portion; and a plurality of wires connecting the sensor and the proximal connector, wherein the plurality of wires are terminated on the PCBA at an angle such that the PCBA and the wires terminated thereon together can be configured to form a 2 mm 2 or smaller cross-section.

Description

Technical Field

[0001] The present disclosure relates generally to ultrasound imaging systems, and in particular to electrical wiring connections for imaging catheters, such as intracardiac echocardiography (ICE) catheters. Background Art

[0002] Diagnostic and therapeutic ultrasound catheters have been designed for use in many areas of the human body. In the cardiovascular system, a common diagnostic ultrasound method is intraluminal ultrasound imaging using intracardiac echocardiography (ICE) as a specific example of intraluminal imaging. Typically, a single rotating transducer or an array of transducer elements is used to transmit ultrasound at the tip of the catheter. The same transducer is used to receive echoes from tissue. The signals generated based on the echoes are transmitted to a console that allows 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 generally used to image the heart and surrounding structures, for example, to guide and facilitate medical procedures, such as transseptal puncture, left atrial appendage occlusion, atrial fibrillation ablation, and valve repair. Commercially available ICE catheters have a distal end that can be articulated by a steering mechanism in a handle located at the proximal end of the catheter. For example, an intraluminal imaging catheter, such as an ICE catheter, can be inserted through a femoral or jugular vein while accessing the anatomical structure, and steered in the heart to acquire images necessary for the safety of the medical procedure.

[0004] The ICE catheter may include an imaging assembly connected to the distal portion of the catheter and an electrical wire that transmits an electrical signal representing a command or ultrasound data. Generally speaking, the imaging assembly is larger than the lumen of the catheter so that the imaging core cannot pass through or through the lumen. Therefore, the wire passes through the catheter before the imaging core is attached to the catheter wire. However, the catheter may be damaged during manipulation after the imaging assembly is attached. For example, manufacturing steps related to the imaging assembly (such as precise alignment, bonding, wire bonding, and coating) may cause damage to the fragile catheter. In addition, the wires and imaging assembly require multiple testing steps to ensure quality after being assembled. Summary of the invention

[0005] The present disclosure provides an ultrasonic imaging system. The ultrasonic imaging system can include a catheter assembly. The catheter assembly can include a distal portion, a proximal portion, and a cable extending between the distal portion and the proximal portion. The cable includes multiple wires for electrical signal communication between the ultrasonic imaging assembly at the distal portion and the electronic components (such as a printed circuit board (PCB)) at the proximal portion. The PCB can be a part of a low-profile proximal connector that is sized and shaped for passing through a catheter body after the wire is attached. In this regard, the wire can be attached to the connector at an angle relative to the orientation of the connector. The angled connection advantageously allows a more robust interconnection that is less prone to damage when the PCB and the wire pass through the entire length of the catheter body during manufacturing. This can reduce waste and help alleviate manufacturing problems. The interconnection also allows testing of electrical connections during assembly of the catheter.

[0006] The present disclosure provides a system, which may include: an intraluminal device, which is configured to be positioned in a body cavity of a patient, the intraluminal device including a proximal portion and a distal portion, wherein the intraluminal device further includes: a sensor, which is disposed at the distal portion; a proximal connector, which includes a printed circuit board assembly (PCBA), the printed circuit board assembly is configured to be connected to a user console interface and is disposed at the proximal portion; and a plurality of wires connecting the sensor and the proximal connector, wherein the plurality of wires are terminated on the PCBA at an angle so that the PCBA and the wires terminated thereon can be configured together to form a 2 mm 2 or smaller cross-section.

[0007] In some aspects, the intraluminal device further comprises a sheath disposed around at least a portion of the plurality of wires and terminated on the PCBA. In some aspects, the sheath is braided. In some aspects, the length of the sheath before termination at the PCBA is not disposed around the plurality of wires, such that the length of the sheath runs parallel to the length of the wires. In some aspects, the sheath is terminated on the PCBA at a location distal to the termination of the plurality of wires. In some aspects, the plurality of wires are arranged to be foldable when the intraluminal device passes through a catheter body. In some aspects, the angle is between 10 degrees and 80 degrees relative to the orientation of the PCBA. In some aspects, the angle is between 30 degrees and 60 degrees relative to the orientation of the PCBA. In some aspects, each of the plurality of wires is welded to a contact of the PCBA. In some aspects, the plurality of wires are welded along one or more lines extending along the length of the PCBA. In some aspects, the wires are welded along a single line along the length of the PCBA. In some aspects, the plurality of wires pass through an opening distal to the proximal portion of the intraluminal device. In some aspects, the intraluminal device comprises a braided outer portion, wherein the opening is in the braided outer portion. In some aspects, a proximal end of the braided outer portion is coupled to a distal end of the PCBA.

[0008] The present disclosure provides a cable assembly for a catheter. The cable assembly defines a length between a proximal portion and a distal portion of the cable assembly. The cable assembly may include: a sensor disposed at the distal portion; a printed circuit board assembly (PCBA) disposed at the proximal portion; and a cable connecting the sensor and the PCBA and including a plurality of wires, wherein the plurality of wires are angled relative to the PCBA so that the PCBA and the wires together form a 2 mm 2 or smaller cross-section.

[0009] In some aspects, the wire is configured to move from a first position when disposed in the shaft of the catheter to a second position when extending from the shaft of the catheter.

[0010] The present disclosure provides a method for assembling an intraluminal ultrasound imaging device, which may include: coupling a distal portion of a cable to an ultrasound transducer configured to obtain imaging data of a patient's body cavity, the cable comprising a plurality of wires; and coupling a proximal portion of the cable to a printed circuit board assembly (PCBA), wherein the plurality of wires are terminated at an angle relative to an orientation of the PCBA; and after attaching the cable to the ultrasound transducer and the PCBA, passing the PCBA and the cable through a catheter shaft; and coupling the PCBA to a proximal connector configured to communicate with a patient interface module (PIM).

[0011] In some aspects, attaching the PCBA to the proximal connector includes connecting the PCBA to another PCBA within the proximal connector. In some aspects, passing the PCBA and the cable through the catheter shaft includes folding the wire toward the PCBA. In some aspects, the angle is between 10 degrees and 80 degrees relative to the orientation of the PCBA. In some aspects, the angle is between 30 degrees and 60 degrees relative to the orientation of the PCBA. In some aspects, coupling the proximal portion of the cable to the PCBA includes soldering each of the plurality of wires to a contact of the PCBA. In some aspects, coupling the proximal portion of the cable to the PCBA includes soldering the plurality of wires along a single line extending across the PCBA. In some aspects, the method further includes passing the plurality of wires through an opening distal to the proximal end of the cable. In some aspects, the cable includes a braided outer portion, and wherein passing the plurality of wires through the opening includes passing the plurality of wires through an opening in the braided outer portion. In some aspects, the method further includes attaching a proximal end of the braided outer portion of the cable to a distal end of the PCBA.

[0012] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, in which:

[0014] Figure 1A is a schematic diagram of an intraluminal imaging system according to an embodiment of the present disclosure.

[0015] Figure 1B is a schematic diagram of a catheter according to an embodiment of the present disclosure.

[0016] Figure 2 is a perspective view of a conduit cable according to an embodiment of the present disclosure.

[0017] Figure 3Ais a cross-sectional view of a catheter body according to an embodiment of the present disclosure.

[0018] Figure 3B is a cross-sectional view of a catheter cable according to an embodiment of the present disclosure.

[0019] Figure 4 is a perspective view of a distal ultrasound assembly of an intraluminal imaging device according to an embodiment of the present disclosure.

[0020] Figure 5 is a perspective view of a proximal portion of a catheter cable according to an embodiment of the present disclosure.

[0021] Fig. 6A is a top view of a transition section of a catheter cable according to an embodiment of the present disclosure.

[0022] Figure 6B is a top view of wires of a transition section of a conduit cable according to an embodiment of the present disclosure.

[0023] Figure 7 is a perspective view of a radio frequency immune (RFI) braid of a transition section and a proximal portion of a catheter cable according to an embodiment of the present disclosure.

[0024] Figure 8 is a perspective view of a portion of a PCB at a proximal portion of a catheter cable according to an embodiment of the present disclosure.

[0025] Fig. 9 is a view of the proximal end of a catheter cable attached to a connector according to an embodiment of the present disclosure.

[0026] Fig.10 is a flow chart illustrating a method of assembling an intraluminal ultrasound imaging device according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0027] For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the accompanying drawings and specific language will be used to describe the same. However, it should be understood that limitations on the scope of the present disclosure are not intended. Any changes and other modifications to the described devices, systems and methods, as well as any other applications of the principles of the present disclosure, are fully contemplated and included in the present disclosure as would be generally expected by a person skilled in the art to which the present disclosure relates. For example, although the ICE system is described in terms of intraluminal imaging, it should be understood that it is not intended to be limited to the present application. Specifically, it should be fully contemplated that the features, components and / or steps described with respect to one or more embodiments may be combined with the features, components and / or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, many iterations of these combinations will not be described separately.

[0028] Figure 1A1 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 (eg, a console including a computer), and a patient interface module (PIM) 131 extending between the device 110 and the control and processing system 130.

[0029] Ultrasonic imaging device 110 may include a catheter 101. Figure 2 1. The catheter 101 is shown in more detail in FIG. The catheter 101 may include one or more flexible elongated members that are sized and shaped, structurally arranged and / or configured to be positioned in a body cavity of a patient. 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 may have a small diameter configuration and be sized to pass through or sneak through the catheter shaft 201, the handle 120, and / or the conduit 124. The cable may be electrically and / or mechanically coupled to the ultrasound imaging assembly 102 at the distal portion of the catheter shaft 201 and the PCBA 207 at the proximal portion of the catheter 101.

[0030] In some embodiments, one or both of the catheter body / shaft 201 and the catheter cable 203 can be referred to as a flexible elongated member. The catheter shaft 201 is sized and shaped, structurally arranged and / or configured to be positioned in a body cavity (e.g., a vascular system (such as a blood vessel) or a chamber of the heart) of a patient. The corresponding portion of the catheter cable 203 extends in the catheter shaft 201, the handle 120, the pipeline 124 and the connector 209. The imaging assembly 102 can be attached to the distal end of the catheter shaft 201. The catheter shaft 201 can include a lumen through which the catheter cable 203 can pass. The proximal end 204 of the catheter shaft 201 can be attached to the handle 120, for example, by an elastic strain release. The handle 120 can be used for the manipulation of the ultrasonic imaging device 110 and the manual control of the ultrasonic imaging device 110. The ultrasonic imaging device 110 can include an imaging assembly 102 having an ultrasonic transducer element and associated circuits. The handle 120 may include an actuator 116, a clutch 114, and other steering controls for steering the ultrasound imaging device 110. Steering may include deflecting a distal end of a catheter cable 203, as described in greater detail herein.

[0031] 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 sneaks through the lumen within the catheter body 201, the handle 120, and the conduit 124. In some embodiments, the conduit 124 is a component that is distinct from the cable 203. For example, the conduit can be a tube within which the cable 203 extends. In other embodiments, the conduit 124 can be a coating that defines the outer surface of the cable 203. The coating can strengthen the cable 203 so as to be exposed 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 multiple wires.

[0032] The handle 120 can be connected to the pipe 124 via another strain relief. The pipe 124 can be configured to provide a suitable structure for connecting the control and processing system 130 and the monitor 132 to each other to 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 obtained signals generated by the imaging assembly 102. The control and processing system 130 can include one or more processors, memory, one or more input devices (such as keyboards) and any suitable command control interface device. The control and processing system 130 can be operable to facilitate the features of the intraluminal imaging system 100 described herein. For example, the processor can execute computer-readable instructions stored on a non-transient tangible computer-readable medium. The monitor 132 can be any suitable display device, such as a liquid crystal display (LCD) panel, etc.

[0033] In operation, a physician or clinician can advance the catheter 101 into a lumen (such as a blood vessel), a body cavity, or a portion of a cardiac anatomical structure. By controlling the actuator 116 and / or the clutch 114 on the handle 120, the physician or clinician can manipulate 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 the catheter cable 203 in a left-right plane, and another actuator can deflect the distal end of the imaging assembly 102 and the catheter cable 203 in an anterior-posterior plane. The clutch 114 can provide a locking mechanism that locks the position of the actuator 116 and, in effect, locks the deflection of the imaging assembly 102 when imaging the region of interest.

[0034] The imaging process may include activating the ultrasonic transducer elements on the imaging assembly 102 to generate ultrasonic energy. A portion of the ultrasonic energy is reflected by the region of interest and surrounding anatomical structures, and an ultrasonic echo signal is received by the ultrasonic transducer elements. The conduit 124 may be used to transmit the received echo signal to the control and processing system 130, where an ultrasonic image is reconstructed and displayed on a monitor 132. In some embodiments, the processing system 130 may control the activation of the ultrasonic transducer elements and the reception of the echo signals. In some embodiments, the control and processing system 130 and the monitor 132 may be part of the same system.

[0035] Although some embodiments of the present disclosure refer to imaging devices, ultrasound imaging devices, or intraluminal imaging devices, it should be understood that the ultrasound imaging device 110 and system 100 can generally be used to image vessels, structures, lumens, and / or any suitable anatomical structures / tissues within the body of a patient, including any number of anatomical locations and tissue types, including but not limited to organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures, including the brain, dural sac, spinal cord, and peripheral nerves; urinary tract; and valves within the blood, chambers or other parts 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 (both natural and artificial) such as within the body of a patient. The vessels, structures, lumens and / or anatomical structures / tissues can include a blood vessel, such as an artery or vein of a patient's vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and / or any suitable lumen within the body.

[0036] System 100 can be represented as an imaging system, an ultrasound imaging system, an intraluminal imaging system, and / or a combination 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, elongated member, such as a catheter, a guidewire, and / or an induction catheter are contemplated.

[0037] The system 100 can be used in a variety of applications, such as transseptal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair, and can be used to image 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. In addition, the imaging assembly 102 can include any suitable physiological sensor or component for diagnosis, treatment, and / or treatment. For example, the imaging assembly can include an imaging component, an ablation component, a cutting component, a fragmentation component, a pressure sensing component, a flow sensing component, a temperature sensing component, and / or a combination thereof. In some embodiments, the intraluminal imaging system 100 is used to generate two-dimensional and three-dimensional images.

[0038] Come back for reference Figure 1A , the PIM 131 can provide a physical and electrical connection 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 intermediated between the ultrasound imaging device 110 and the processing system 130. In some instances, the PIM 131 can be represented 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 may include a connector joint 111, which includes the proximal connector 209 of the ultrasound imaging device 110 and the distal connector of the PIM 131.

[0039] In some embodiments, the control and processing system 130 may include one or more computers, processors and / or computer systems. The control and processing system 130 may 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 so that electrical signals are transmitted from the ultrasound imaging device 110 through the PIM 131 and reach the control and processing system 130. The control and processing system 130 may include one or more processors and / or memory modules that form processing circuits that can process electrical signals and output graphical representations of imaging data on the monitor 132. One or more electrical conductors of the ultrasound imaging device 110 and the PIM 131 may 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 may control imaging using the ultrasound imaging device 110 via the control interface 134 of the control and processing system 130. Electrical signals representing commands from the control and processing system 130 may 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 may be transportable, and may include wheels or other devices to facilitate easy transportation by a user.

[0040] In some embodiments, one or more components of the ultrasound imaging device 110 may be disposable components. For example, a user (such as a physician) may obtain the catheter 101 and / or the ultrasound imaging device 110 in a sterilized package. In some embodiments, the ultrasound imaging device 110 may be discarded after a single use. In other embodiments, the ultrasound imaging device 110 may be sterilized and / or reprocessed to be used more than once. The PIM 131 may be a reusable component used in multiple procedures. For example, the PIM 131 may be cleaned between individual procedures, such as by using a disinfectant to kill bacteria. In some embodiments, the PIM 131 may not be required to be sterilized before a medical procedure. For example, the PIM 131 may be sufficiently spaced apart from the patient so that the use of the non-sterile PIM 131 is safe for the patient. The sterile-non-sterile connection at the connector assembly 111 between the ultrasound imaging device 110 and the PIM 131 may allow a safe operating environment while saving costs by allowing expensive equipment to be reused.

[0041] Figure 2 It is above about Figure 1B1. A perspective view of a catheter cable 203 is depicted. The catheter cable 203 is a flexible, elongated body 206 that includes a plurality of communication cables that allow communication of imaging data and / or command signals between the processing system 130 and the catheter 101. The communication cables can be wires. Individual wires can include a bare conductor surrounded by one or more insulating layers and / or shielding layers. Multiple wires can be collectively surrounded by one or more insulating layers and / or shielding layers. The insulating layer can be made of any suitable material, in some instances, such as plastic or polymer. The shielding layer can be made of any suitable material, in some instances, such as metal. For example, a braid 211 (such as an 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 at the proximal portion 204. The flexible, elongated 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 bonded) to the distal end 202. During manufacturing, the imaging assembly 102 can be coupled to the catheter cable 203 before the cable 203 is advanced 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 or between 3 and 5 feet long, and / or other suitable values ​​greater and lesser.

[0042] Figure 3A A cross-sectional view of a catheter shaft 201 is shown. The catheter shaft 201 is sized and shaped, structurally arranged and / or configured to be positioned within a body cavity of a patient during an imaging procedure. A catheter cable 203 (eg, Figure 2 and 3B 332) can be configured to be disposed within an interior lumen 332 of the catheter shaft 201. The catheter shaft 201 may 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 catheter shaft 201 has an outer diameter between about 1 mm and about 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).

[0043] Figure 3B A cross-sectional view of the catheter cable 203 is shown. The catheter cable 203 (e.g., PCBA 207 and flexible elongated body 206) can be passed through or through the catheter shaft 201 during assembly. The PCBA 207 can be configured to communicate directly or indirectly with a user console. For example, the PCBA 207 can communicate with a console or processing system 130 and / or PIM 131 ( Figure 1A) directly or indirectly. In some embodiments, the catheter cable 203 has a diameter between about 1 mm and about 3 mm, including larger 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 may include a polymer layer 342, a shielding layer 344, and a plurality of wires 346. The wires 346 may be disposed within the shielding layer 342, and the shielding layer 342 may be disposed within the polymer layer 342. The wires 346 may be used to communicate signals from the imaging component to the proximal end 204, and ultimately to the processing system 130. In some embodiments, the shielding layer 342 can be a braided layer 211 disposed around the polymer layer 342, such as Figure 2 Wires 346 connect the imaging assembly 102 and the proximal connector 209 (eg, PCBA 207).

[0044] Figure 4 is a perspective view of an imaging assembly 102 according to an embodiment 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 including a number of transducer elements and a microwave beamformer IC 304 that can be coupled to the transducer array 262. The electrical wires 346 of the cable 203 are mechanically and / or electrically coupled to the imaging assembly 102. In some examples, the electrical cable 203 is further coupled to the microwave beamformer IC 304 through an intermediate piece 310. In some examples, the intermediate piece 310 is connected to the microwave beamformer IC 304 through a wire bond 320. Wires 346 of cable 203 communicate directly or indirectly with transducer array 262 , IC 304 , and / or middleware 310 .

[0045] In some embodiments, the transducer array 262 includes an ultrasound imaging transducer that is flip-chip mounted directly to the microbeamformer IC 304. The transmitter and receiver of the ultrasound imaging transducer are on the microbeamformer IC 304 and are attached directly to the transducer. In some examples, the large termination of the acoustic elements is done at the microbeamformer IC 304.

[0046] In some examples, the transducer array 262 includes more than 800 imaging elements, and the electrical cable 203 includes a total of 12 signal lines or less. In some examples, the electrical cable 203 includes a total of 30 lines or less, which includes signal lines, power lines and control lines. In some examples, the transducer array 262 includes a one-dimensional or two-dimensional array of imaging elements from 32 to 1000. For example, the array can include 32, 64, 128, 256, 512, 640, 768 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. A one-dimensional array can be configured to generate a two-dimensional image. A two-dimensional array can be configured to generate a two-dimensional and / or three-dimensional image.

[0047] In some examples, 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 microbeamforming IC 304 is located directly below the transducer array 262 and is electrically connected to them. The elements of the transducer array 262 can be piezoelectric or micromachined 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 as a unit or grown directly on top of the microbeamforming IC 304. In some examples, the cable bundle can be terminated directly to the microbeamforming IC 304, or can be terminated to an intermediate 310 of suitable material, such as a rigid or flexible printed circuit assembly. The intermediate 310 can then be connected to the microbeamforming IC 304 via any suitable means (such as wire bonding) 320.

[0048] Figure 52 is a perspective view of the proximal portion 204 of the catheter cable 203. In some embodiments, the proximal portion 204 includes a proximal portion 511 of the flexible elongated body 206 that communicates with the PCBA 207 and a transition portion 530 connecting the proximal portion 511 and the connector 520. The connector 520 can be in the form of the PCBA 207. The transition portion 530 can include a plurality of wires 522 attached to a substrate 524 of the connector 520. In some embodiments, the substrate 524 can have a length L1 of approximately 1.2 inches. The length L1 can be between 1 and 1.25 inches, between 0.5 and 1.5 inches, or between 1.2 and 1.4 inches, and / or other values ​​greater and less. The substrate 524 can have a width W1 of approximately 0.08 inches. The width W1 can be between 0.05 and 0.10 inches, between 0.075 and 0.085 inches, or between 0.07 and 0.09 inches, and / or other values ​​greater and less. The base 524 generally extends lengthwise or longitudinally without a large width. The small size of the base 524 and thin wires 522 can provide a smaller PCBA 207 within the connector 520 and allow the proximal end 204 to pass through a catheter after assembly.

[0049] Fig. 6A yes Figure 5 An enlarged view 700 of the transition portion 530 is shown. The wires 522 can be seen extending from the flexible elongated body 206 to the base 524. In some embodiments, the transition portion 530 includes 21 wires 522. In other embodiments, 10-15, 15-20, 20-25, 30-50, and / or other numbers of wires 522 are included in the transition portion 530. The wires 522 can pass from the imaging assembly 102 through the body 206 to the PCBA 207. In some embodiments, the wires 522 are attached to the base 524 at an angle.

[0050] For example, Figure 6BAnother enlarged view of the wire 522 attached to the base 524 is shown. In some embodiments, the wire 522 is attached at an angle α with reference to the orientation of the base 524. For example, the angle α can be measured between 15 and 45 degrees, between 20 and 30 degrees, between 15 and 60 degrees, between 30 and 60 degrees, between 10 and 80 degrees, or between 0 and 90 degrees, including values ​​such as 30 degrees, 45 degrees, 60 degrees, and / or other values ​​greater and lesser. The wire 522 can be attached at an angle α to allow the wire 522 to fold when the proximal end 204 passes through the catheter shaft 201. The wire 522 is configured to move from a first position when placed in the shaft 201 to a second position when extending out of the shaft 201. Specifically, the wire 522 can be folded upward in the direction of the base 524 during compression (e.g., within the shaft 201) so that they are not damaged or separated from the base 524. When the assembly is positioned outside the shaft 201, the wires 522 can be folded down away from the PCBA. The plurality of wires 522 can be welded along one or more lines extending the length of the PCBA 207. For example, the plurality of wires 522 can be welded along a single line extending across the substrate 524 of the PCBA 207. Each wire 522 is welded or adhered to a corresponding conductive portion (e.g., a contact) of the substrate 524 at the joint 712. The wires 522 can include a bare conductor welded at the joint 712, the first insulating layer 714, and the second insulating layer 716. The wires 522 can be connected to a ground on the substrate 524, such as a ground strip 806 of the substrate 524. The ground strip 806 can be formed of any suitable metal, such as silver, copper, gold, or aluminum. For example, the wires 522 can be welded or adhered to the ground strip 806 along the first insulating layer 714. The insulating layers 714 and / or 716 can include a polymer material. In some embodiments, the substrate 524 includes an isolated portion 720 that is not filled with the bonding portion 712. This can allow space for the wires 522 to fold upward during the sneak pass procedure. In some embodiments, the wires 522 are terminated on the substrate 524 so that the wires 522 extend from the substrate 524 at a distance of 1.4 mm or less. In other embodiments, the wires 522 extend from the substrate at a distance of 2.0 mm, 1.5 mm, 1.4 mm, 1 mm, or other distances. In some embodiments, the PCBA 207 and the wires 522 terminated thereon can be configured to form a 2 mm 2 In other embodiments, the wires 522 extending from the base 524 form a 5 mm cross-sectional area. 2 , 3mm 2 , 1.5mm 2 , 1mm 2 or smaller cross-sectional area.

[0051] Figure 7Another view of the transition portion 530 is shown. The catheter cable 203 can include a braided outer portion (or sheath) surrounding a plurality of wires. For example, the braided outer portion can be a radio frequency immune (RFI) braid. In some embodiments, the RFI braid 750 extends from the flexible elongated body 206 to the substrate 524 of the PCBA 207. The RFI braid 750 can include a braided material formed by one or more fibers 752. In some instances, the fibers 752 include metal. The RFI braid 750 can provide electrical shielding for the connector 520, as well as strengthening the connection between the flexible elongated body 206 and the substrate 524.

[0052] like Figure 7 As shown, a portion of the RFI braid 750 is not disposed around the wires 522 before they are terminated on the substrate 524, such that a portion of the RFI braid 750 runs parallel to a portion of the length of the wires 522. In some embodiments, the RFI braid 750 surrounds a portion of the wires 522, and the wires 522 pass through enlarged holes or openings 754 in the braiding process of the RFI braid 750. The opening 754 is located distal to the proximal end of the flexible elongated body 206. The proximal end of the RFI braid 750 that does not enclose the wires 522 can be attached to the distal end of the substrate 524 at the joint 756. The sheath or RFI braid 750 is terminated on the PCBA 207 at a location distal to the termination of the wires 522. The RFI braid 750 can be welded, adhered, or bonded to the substrate 524. For example, during a threading operation in assembly, the substrate 524 may be subjected to pulling the proximal end 204 (e.g., during Figure 8 The RFI braid 750 may be configured to resist a force of 1.5 pounds applied to the proximal end 204. In other embodiments, the RFI braid 750 may be configured to resist a force of 1, 2, 3, 5 pounds, and / or other values ​​greater and lesser.

[0053] Figure 8 Shows Figure 5 524. The proximal portion 800 can be attached to the connector after the proximal end 204 is advanced through the catheter. In some embodiments, the proximal portion 800 includes a low-profile surface mount connector 810 that can include several miniaturized connectors 803 on the substrate 524. The miniaturized connectors 803 can be attached to a corresponding connector without the need for soldering or adhesive bonding, such as Fig. 9 As shown. In some embodiments, the proximal portion 800 may include a row of pads suitable for use with a male type connector (which may also be mounted to the base 524) and / or an elastomeric type connector. The proximal portion 800 may include an opening 808 that may be used during a passing operation. For example, an instrument may be passed through the opening 808 and used to pull the base 524 through the length of the catheter body 201.

[0054] Fig. 9 A proximal portion 204 of a catheter cable 203 is shown attached to a connector 902 at a proximal portion of a catheter 101. The cable 203 can pass through an opening 904 at a distal portion of the connector 902. The connector 902 includes a PCBA 906 that includes one or more electronic components. A PCBA 207 at the proximal portion of the cable 203 is electrically and mechanically coupled to the PCBA 906. For example, a surface mount connector 810 at a proximal portion 800 of the PCBA 207 engages with a corresponding connector on the PCBA 906. The connector 902 is configured to interface with a PIM 131 ( Figure 1A ) mechanically and electrically communicate. In this way, electrical signals can be communicated between the processing system 130 and the ultrasound imaging assembly 102 via the cable 203 and the PIM 131.

[0055] Fig.10 A flow chart illustrating a method 1000 of assembling an ultrasound imaging device, such as the ultrasound imaging device 110 shown in FIGS. 1-2 , is provided. The method 1000 includes several enumerated steps, but embodiments of the method 1000 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 in parallel.

[0056] At step 1002, method 1000 may include attaching a distal portion of a catheter cable to an ultrasound imaging assembly. In some embodiments, the catheter cable is similar to the flexible elongated body 206 ( Figure 2 ). The catheter cable may include one or more wires and an outer layer. The (one or more) wires of the catheter cable can be mechanically and / or electrically coupled to the ultrasound imaging assembly after attachment. The ultrasound imaging assembly can be disposed at a distal portion of the catheter cable. The attachment can be direct or indirect. For example, the cable can be directly coupled to an intermediate piece that is coupled to an ultrasound transducer array and / or an IC. The catheter cable can be welded, bonded, adhered, or attached to the imaging assembly.

[0057] At step 1004, method 1000 may include attaching a proximal portion of the catheter cable to the PCBA(s). Figure 2 , 5 , 6A, 6B, 7 and 8 illustrate the proximal portion of the catheter cable and the PCBA. In some embodiments, the wires of the catheter cable are terminated at corresponding conductive portions of the PCBA substrate. In some embodiments, one or more portions of the PCBA can be a flexible substrate. In some embodiments, one or more portions of the PCBA can be a rigid substrate. The proximal connector can be configured to be attached to a PIM or cable that is ultimately connected to a processing system. In some embodiments, the wire substrate of the catheter cable is connected via a foldable connection (such as Figure 5-9 The foldable connection shown in Figure 1008 is attached to the PCBA. The wire can be attached to the substrate at an angle. In some embodiments, the catheter cable includes an RFI braid that is mechanically connected to the substrate (e.g., welded, bonded, adhered and / or otherwise attached). The wires can pass through holes in the RFI braid so that they extend between the RFI braid and the substrate. The portion of the RFI braid without wires is attached to the substrate. This structural arrangement advantageously allows the PCBA and the attached catheter cable to be pulled through the catheter body during assembly (step 1008), so that the substrate can pass through the catheter in the case of damaging the electrical interconnection between the wire and the PCBA. For example, the wire can be folded toward the substrate to minimize the outer profile, size and / or diameter of the proximal portion of the catheter cable. In addition, the mechanical attachment between the RFI braid and the substrate allows the pulling force to be transferred to the RFI braid rather than the wire interconnection. The PCBA substrate can include a low-profile surface mount connector.

[0058] At step 1006, method 1000 may optionally include testing a catheter assembly including the wires of the catheter cable, an ultrasonic imaging assembly (e.g., a transducer array and / or an IC) and a proximal PCBA. For example, the test can ensure that an electrical signal representing a command from a console is transmitted from the proximal PCBA to the ultrasonic transducer array at the distal portion via the wire. The test can also ensure that an electrical signal representing ultrasonic imaging data is transmitted from the ultrasonic transducer array to the proximal PCBA. The test may include checking the alignment of the wires, PCBA and ultrasonic imaging assembly, and the quality of the welding, bonding, wire bonding, and / or coating of the components. Step 1006 can be performed at any point during the assembly process, and can be repeated as needed to ensure that electrical communication is not damaged due to manufacturing steps. The test of the catheter assembly can avoid waste by preventing faulty components from being paired with expensive components before detection. The ability to test the entire catheter assembly before transportation and installation can further simplify the manufacturing steps.

[0059] At step 1008, method 1000 may include passing the catheter cable through or through the length of the catheter shaft. In some embodiments, the proximal PCBA also passes through the catheter shaft. For example, the proximal PCBA at the proximal portion of the cable can be inserted into the lumen at the distal end of the catheter shaft. Instruments can be used to connect to the proximal PCBA (e.g., at the distal end of the catheter shaft). Figure 8 The proximal PCBA and the catheter cable can be pulled within the lumen over the length of the catheter shaft from the distal portion of the catheter shaft to the proximal portion of the catheter shaft. In some embodiments, the cable can pass from the proximal portion of the catheter shaft to the distal portion of the catheter shaft. Step 1008 can include folding the wires of the cable toward the base to reduce the diameter of the proximal portion of the cable (e.g., the wires connected to the PCBA). Step 1008 can also include transferring the pulling force on the proximal PCBA to the RFI braid rather than the wires. Method 1000 can also include passing the catheter cable through a handle of the catheter and / or through a conduit extending from the handle to the proximal connector.

[0060] At step 1010, method 1000 may include attaching a PCBA at a proximal portion of the catheter cable to a PCBA within a proximal connector. In some embodiments, a low-profile surface mount connector of the proximal connector is attached to a corresponding connector on a PCBA within the proximal connector. In other embodiments, the PCBA at the proximal portion of the catheter cable and / or wires is soldered, adhered, and / or coupled to one or more electronic components within the proximal connector.

[0061] Those skilled in the art will recognize that the apparatus, system and method described above can be modified in various ways. Therefore, it will be appreciated by those of ordinary skill in the art that the embodiments covered by the present disclosure are not limited to the specific exemplary embodiments described above. In this respect, although illustrative embodiments have been shown and described, various modifications, changes and substitutions 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. Therefore, it is appropriate for the appended claims to be understood broadly and in a manner consistent with the present disclosure.

Claims

1. A system comprising: An intraluminal device configured to be positioned in a body cavity of a patient, the intraluminal device comprising a proximal portion and a distal portion, wherein the intraluminal device further comprises: a catheter shaft and a catheter cable configured to be sneaked through or threaded through the catheter shaft during assembly; a sensor disposed at the distal portion; a proximal connector including a printed circuit board assembly (PCBA) configured to interface with a user console and disposed at the proximal portion, wherein a base of the PCBA has a length; and a plurality of wires connecting the sensor and the proximal connector, wherein the plurality of wires are attached to the substrate of the printed circuit board assembly at an angle relative to the length orientation of the substrate, thereby allowing the wires to fold upward in the direction of the substrate during compression in the catheter shaft so that the printed circuit board assembly and the wires terminated thereon together can be configured to form a 2 mm 2 or smaller cross-section.

2. The system according to claim 1, wherein: The intraluminal device also includes a sheath configured to surround at least a portion of the plurality of wires and terminated on the printed circuit board assembly.

3. The system according to claim 2, wherein: The sheath is braided.

4. The system according to claim 2, wherein: A length of the sheath prior to termination at the printed circuit board assembly is not disposed around the plurality of wires such that the length of the sheath extends parallel to the length of the wires.

5. The system according to claim 2, wherein: The jacket is terminated on the printed circuit board assembly at a location distal to the terminations of the plurality of wires.

6. The system according to claim 1, wherein: The angle is between 10 degrees and 80 degrees oriented relative to the length of the substrate of the printed circuit board assembly.

7. The system according to claim 1, wherein: The angle is between 30 degrees and 60 degrees relative to the length orientation of the substrate of the printed circuit board assembly.

8. The system according to claim 1, wherein: Each of the plurality of wires is soldered to a contact of the printed circuit board assembly.

9. The system according to claim 1, wherein: The plurality of wires are soldered along one or more lines extending along the length of the printed circuit board assembly.

10. The system according to claim 1, wherein: The wires are soldered along a single line along the length of the printed circuit board assembly.

11. The system according to claim 1, wherein: The plurality of electrical wires pass through an opening distal to the proximal portion of the intraluminal device.

12. The system according to claim 11, wherein: The intraluminal device comprises a braided outer portion, wherein the opening is in the braided outer portion.

13. The system according to claim 12, wherein: A proximal end of the braided outer portion is coupled to a distal end of the printed circuit board assembly.

14. A method for assembling an intraluminal ultrasound imaging device, comprising: coupling a distal portion of a cable to an ultrasound transducer configured to obtain imaging data of a body cavity of a patient, the cable comprising a plurality of wires; and coupling the proximal portion of the cable to a printed circuit board assembly (PCBA), the substrate of the PCB assembly having a length, wherein the plurality of wires are attached to the substrate at an angle oriented relative to the length of the substrate; and After attaching the cable to the ultrasound transducer and the PCB assembly, threading or sneaking the PCB assembly and the cable through a catheter shaft at an angle that allows the wires to fold upward in the direction of the base by being compressed within the catheter shaft; and The printed circuit board assembly is coupled to a proximal connector configured to interface with a patient interface module (PIM).

15. The method of claim 14, further comprising passing the plurality of wires through an opening distal to the proximal end of the cable, wherein The cable includes a braided outer portion, and wherein passing the plurality of wires through the opening includes passing the plurality of wires through the opening in the braided outer portion.

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