Curved circuit board for intraluminal ultrasound imaging assembly

Abstract

An intraluminal ultrasound imaging device includes a flexible elongate member and an ultrasound imaging assembly coupled with a distal portion of the flexible elongate member. The ultrasound imaging assembly includes a flexible substrate having a scanner body portion, one or more control circuits mounted on the scanner body portion, and one or more transducer elements mounted on the scanner body portion. The ultrasound imaging assembly further includes an attachment portion extending proximally from the scanner body portion. The attachment portion defines a path that curves in a first direction and a different second direction and includes a plurality of conductive traces in electrical communication with the one or more control circuits. The plurality of conductive traces follow the curved path of the attachment portion, and each conductive trace includes a pattern that curves relative to the curved path of the attachment portion.

Description

Technical Field

[0001] This disclosure generally relates to intraluminal ultrasound imaging, and more particularly to the structure of an ultrasound imaging assembly located at the distal portion of a catheter or guidewire. For example, a flexible substrate of an ultrasound imaging assembly includes strain relief features that increase its flexibility so as to allow bending after the substrate has been wound into a cylindrical shape (e.g., during navigation through a tortuous path through the human vascular system). Background Technology

[0002] Intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool to assess diseased blood vessels (e.g., arteries) within the body to determine treatment needs, guide interventions, and / or evaluate treatment effectiveness. An IVUS device, comprising one or more ultrasound transducers, is inserted into the blood vessel and guided to the area to be imaged. The transducers emit ultrasound energy to produce an image of the vessel of interest. Ultrasound waves are partially reflected due to discontinuities caused by tissue structures (e.g., different layers of the vessel wall), red blood cells, and other features of interest. The echoes from the reflected waves are received by the transducers and transmitted along the path to the IVUS imaging system. The imaging system processes the received ultrasound echoes to produce a cross-sectional image of the blood vessel in which the device is positioned.

[0003] Solid-state (also known as synthetic aperture) IVUS catheters are one of two types of IVUS devices commonly used today, the other being rotating IVUS catheters. Solid-state IVUS catheters carry a scanner assembly comprising an array of ultrasound transducers distributed around its periphery and one or more integrated circuit controller chips mounted adjacent to the transducer array. The controller selects individual acoustic elements (or groups of elements) to emit ultrasound pulses and receive ultrasound echo signals. By sequentially executing a series of transmit-receive pairs, a solid-state IVUS system can synthesize the effects of mechanically scanning ultrasound transducers without moving parts (hence the name solid-state). Because there are no rotating mechanical elements, the transducer array can be positioned in direct contact with blood and vascular tissue with minimal risk of vascular trauma. Furthermore, the absence of rotating elements simplifies the electrical interface. Solid-state scanners can be directly wired to the imaging system via simple cables and standard detachable electrical connectors, unlike the complex rotating electrical interfaces required by rotating IVUS devices.

[0004] Several challenges exist with existing solid-state devices. Cables are attached to the flexible circuitry of the IVUS imaging assembly, close to the electronics. Attaching cables at such close proximity can potentially impair the operation of the electronics. The cable connections also increase the rigid length of the distal portion of the catheter, reducing its ability to traverse tortuous blood vessels without damaging the electrical traces. Furthermore, the rigidity difference between the distal imaging assembly and the flexible catheter body creates weak points in the IVUS imaging device's structure, making them prone to kinking and bending. The stress and strain at these kinks and bends increase the likelihood of material failure, as well as breakage of the electrical conductors and connections to the flexible circuitry. Ensuring that the conductive traces formed in the flexible circuitry remain operable during manufacturing is also a challenge. Assembling solid-state IVUS devices sometimes involves winding the flexible circuitry around the periphery of the catheter. Due to the increased thickness of some sections of the flexible circuitry, these steps can be difficult to automate in a reproducible manner during manufacturing. Summary of the Invention

[0005] This document describes an intraluminal imaging device, such as an intravascular ultrasound (IVUS) imaging catheter. The ultrasound imaging assembly located at the distal portion of the catheter includes a flexible substrate wound into a substantially cylindrical shape. The flexible substrate has a distal portion and a proximal portion, on which an acoustic element is positioned, and the proximal portion includes a solder pad to which an electrical conductor is attached. Electrical traces formed on the flexible substrate connect the ultrasound imaging assembly to the solder pads. When the catheter is subjected to bending, strain generated on the flexible substrate can cause one or more electrical traces to break, leading to malfunction of the imaging catheter. Disclosed are the flexible substrate and the electrical traces, which include strain relief features to minimize the likelihood of trace breakage when the catheter is bent.

[0006] The flexible circuit board disclosed herein has specific, but not exclusive, utility for endoluminal medical devices (e.g., catheters and guidewires). One general aspect of the flexible circuit board includes an endoluminal ultrasound imaging device. The endoluminal ultrasound imaging device also includes a flexible elongated member configured to be positioned within a patient's body lumen; and an ultrasound imaging assembly coupled to a distal portion of the flexible elongated member and comprising: a flexible substrate including a scanner body portion and an attachment portion extending proximally from the scanner body portion, wherein the attachment portion defines a bending path including a first curved portion bending in a first direction and a second curved portion bending in a different second direction; one or more control circuits mounted on the scanner body portion; one or more transducer elements mounted on the scanner body portion and communicating with the one or more control circuits; and a plurality of conductive traces disposed on the attachment portion, wherein the plurality of conductive traces are electrically communicating with the one or more control circuits, wherein the plurality of conductive traces follow the bending path of the attachment portion, and each conductive trace includes a pattern bending relative to the bending path of the attachment portion. Other embodiments in this regard may include appropriate computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0007] Implementations may include one or more of the following features. In some embodiments, the bending path includes a horseshoe shape. In some embodiments, the bending path includes a serpentine shape. In some embodiments, the pattern of each conductive trace includes a sinusoidal shape. In some embodiments, the pattern of each conductive trace includes a braided shape. In some embodiments, the pattern of each conductive trace includes a redundant zigzag pattern that is periodically interconnected. In some embodiments, the flexible elongated member includes an inner member, wherein a proximal region of the attachment portion is attached to the inner member, and a middle region of the attachment portion is separated from the inner member, such that the middle region of the attachment portion is configured to move relative to the inner member. In some embodiments, the width of the proximal region of the attachment portion is greater than the width of the middle region of the attachment portion. In some embodiments, the flexible elongated member further includes an outer member positioned around the inner member and the attachment portion of the flexible substrate, wherein the outer member holds the attachment portion of the flexible substrate in a wound configuration, such that the attachment portion is arranged around at least a portion of the periphery of the inner member and located within an annular space between the inner member and the outer member. In some embodiments, the proximal region of the attachment portion includes a plurality of electrical contacts coupled to a plurality of conductive traces, wherein a plurality of conductors are electrically connected to a plurality of conductive traces via the plurality of electrical contacts. In some embodiments, a plurality of conductors extend within an annular space between an inner member and an outer member. In some embodiments, the flexible elongated member includes a longitudinal axis, and the proximal region of the attachment portion includes a rectangular shape and is aligned with the longitudinal axis. In some embodiments, the region of the attachment portion located between a first curved portion and a second curved portion is oriented at an angle of 60-90 degrees relative to the longitudinal axis. In some embodiments, a scanner body portion is positioned around a rigid tubular member. In some embodiments, the attachment portion is positioned proximal to one or more transducer elements and one or more control circuits. In some embodiments, the attachment portion extends proximal to the rigid tubular member. In some embodiments, the width of the scanner body portion is greater than the width of the attachment portion.

[0008] One general aspect includes an intravascular ultrasound (IVUS) imaging catheter. In some embodiments, the IVUS imaging catheter further includes a flexible elongated member configured to be positioned within a patient's blood vessel, the flexible elongated member including a longitudinal axis. In some embodiments, the IVUS imaging catheter further includes an ultrasound scanner assembly coupled to a distal portion of the flexible elongated member and including: a flexible substrate including a scanner body portion and an attachment portion extending proximally from the scanner body portion; a plurality of control circuits mounted on the scanner body portion; a plurality of transducer elements mounted on the scanner body portion and communicating with the plurality of control circuits, wherein the plurality of transducer elements are arranged in a circumferential arrangement around the longitudinal axis; and a plurality of conductive traces disposed on the attachment portion and electrically communicating with the plurality of control circuits. In some embodiments, the attachment portion includes a first curved portion bending along a first direction and a second curved portion bending along a different second direction, the first and second curved portions defining a bending path. In some embodiments, the plurality of conductive traces follow the bending path. In some embodiments, each conductive trace includes a pattern of bending relative to the bending path.

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

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

[0011] Figure 1 This is a schematic diagram of an intraluminal imaging system based on various aspects of this disclosure.

[0012] Figure 2 This is a schematic view of the top of a scanner component in a flat configuration, according to various aspects of this disclosure.

[0013] Figure 3 It is in the winding structure surrounding the support member according to various aspects of this disclosure. Figure 2 A schematic perspective view of the scanner component shown.

[0014] Figure 4 This is a schematic cross-sectional side view of a scanner assembly with a coiled structure surrounding a support member, according to various aspects of this disclosure.

[0015] Figure 5 This is a front view of an ultrasound imaging assembly according to various aspects of this disclosure, wherein the distal portion of the flexible substrate is in a wound configuration surrounding a support member.

[0016] Figure 6 This is a schematic view of a flexible circuit attachment portion that is wound around an inner component and positioned within an outer component, according to various aspects of this disclosure.

[0017] Figure 7 This is a schematic view of a flexible substrate in an unwound state according to at least one embodiment of the present disclosure.

[0018] Figure 8 This is a front view of a flexible circuit in which the inner components of a support member and a flexible elongated member are cylindrically wound according to at least one embodiment of the present disclosure.

[0019] Figure 9 This is a schematic view of a curved, flexible circuit attachment portion that is wound around an inner member and positioned within an outer member, according to at least one embodiment of the present disclosure.

[0020] Figure 10 This is a schematic representation of the electrical traces of a flexible circuit attachment portion according to at least one embodiment of the present disclosure.

[0021] Figure 11 It is a schematic representation of the traces of a hexagonal pattern of a flexible circuit attachment portion according to at least one embodiment of the present disclosure.

[0022] Figure 12 It is a schematic representation of the horseshoe-shaped or sinusoidal pattern of electrical traces of a flexible circuit attachment portion according to at least one embodiment of the present disclosure.

[0023] Figure 13 It is a schematic representation of the traces of a plurality of zigzag patterns of a flexible circuit attachment portion according to at least one embodiment of the present disclosure.

[0024] Figure 14 This is a schematic representation of a plurality of electrical traces of a flexible circuit attachment portion according to at least one embodiment of the present disclosure.

[0025] Figure 15 This is a schematic representation of the traces of multiple brick patterns on a flexible circuit attachment portion according to at least one embodiment of the present disclosure.

[0026] Figure 16 This is a top view of the curved middle region of a flexible circuit attachment portion in a flattened state according to at least one embodiment of the present disclosure.

[0027] Figure 17 This is a top view of the curved middle region of a flexible circuit attachment portion in a flattened state according to at least one embodiment of the present disclosure.

[0028] Figure 18 This is a top view of a curved flexible circuit connection portion in a flattened state according to at least one embodiment of the present disclosure.

[0029] Figure 19 This is a top view of a curved flexible circuit connection portion in a flattened state according to at least one embodiment of the present disclosure.

[0030] Figure 20 This is a schematic diagram of a processor circuit according to various aspects of this disclosure. Detailed Implementation

[0031] This article describes an intraluminal imaging device, such as an intravascular ultrasound (IVUS) imaging catheter. The ultrasound imaging component located at the distal portion of the catheter includes a flexible substrate. The flexible substrate has a distal portion and a proximal portion. An acoustic element is positioned on the distal portion, and the proximal portion includes a solder pad to which an electrical conductor is attached. Electrical traces formed on the flexible substrate connect the ultrasound imaging component to the solder pad. As part of the manufacturing process, the flexible substrate is rolled into a cylindrical shape around a rigid tubular body or sleeve. Furthermore, a proximal attachment portion of the flexible substrate is coupled to a flexible intracatheter component. The proximal attachment portion has electrical contacts or pads that connect to electrical conductors extending along the length of the catheter body. However, the catheter may be subjected to bending during manufacturing, during normal handling, or during navigation through anatomical structures such as the tortuous path of the human vascular system. This bending causes strain on the flexible substrate, particularly at the proximal attachment portion, which can then lead to the breakage of one or more electrical traces, resulting in malfunction of the imaging catheter. What is disclosed is a flexible substrate and an electrical trace, which includes strain relief features to minimize the chance of the electrical trace breaking when the conduit is bent.

[0032] For the purpose of facilitating an understanding of the principles of this disclosure, reference will now be made to embodiments illustrated in the accompanying drawings, and these embodiments will be described using specific language. However, it should be understood that there is no intention to limit the scope of this disclosure. Any changes and further modifications to the described apparatus, systems, and methods, as well as any further application of the principles of this disclosure, are fully contemplated and included within this disclosure, as would typically occur to those skilled in the art to which this disclosure pertains. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment can be combined with features, components, and / or steps described with respect to other embodiments of this disclosure. However, for the sake of brevity, multiple repetitions of these combinations will not be described separately.

[0033] Figure 1This is a schematic diagram of an ultrasound imaging system 100 according to various aspects of the present disclosure. The ultrasound imaging system 100 may be an intraluminal imaging system. In some cases, system 100 may be an intravascular ultrasound (IVUS) imaging system. System 100 may include an intraluminal imaging device 102 (e.g., a catheter, guidewire, or guiding catheter), a patient interface module (PIM) 104, a processing system or console 106, and a monitor 108. The intraluminal imaging device 102 may be an ultrasound imaging device. In some instances, device 102 may be an IVUS imaging device, such as a solid-state IVUS device.

[0034] At a high level, the IVUS device 102 emits ultrasound energy or ultrasound signals from a transducer array 124 included in a scanner assembly or scanner body 110 mounted near the distal end of the catheter assembly. The ultrasound energy is reflected by tissue structures (such as blood vessels 120 or other body lumens) in the medium surrounding the scanner assembly or scanner body 110, and the ultrasound echo signals are received by the transducer array 124. In this respect, the device 102 may be sized, shaped, or otherwise configured to be positioned within a patient's body lumen. The PIM 104 transmits the received echo signals to a console or computer 106, where ultrasound images (including flow information) are reconstructed and displayed on a monitor 108. The console or computer 106 may include a processor and memory. The computer or computing device 106 may be operable to facilitate the features of the IVUS imaging system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-transitory tangible computer-readable medium.

[0035] PIM 104 facilitates signal communication between IVUS console 106 and scanner assembly 110 included in IVUS device 102. This communication includes the following steps: (1) sending... Figure 2The integrated circuit controller chips 206A and 206B included in the scanner assembly 110 provide commands to select specific transducer array elements or acoustic elements for transmission and reception, (2) provide transmission trigger signals to the integrated circuit controller chips 206A and 206B included in the scanner assembly 110 to activate transmitter circuitry to generate electrical pulses for exciting the selected transducer array elements, and / or (3) receive amplified echo signals received from the selected transducer array elements via an amplifier on the integrated circuit controller chip 206 included in the scanner assembly 110. In some embodiments, the PIM 104 performs preliminary processing of the echo data before transferring the data to the console 106. In examples of such embodiments, the PIM 104 performs data amplification, filtering, and / or aggregation. In one embodiment, the PIM 104 also provides high-voltage and low-voltage DC power to support the operation of the device 102, which includes circuitry located within the scanner assembly 110.

[0036] IVUS console 106 receives echo data from scanner assembly 110 via PIM 104 and processes the data to reconstruct images of tissue structures located in the medium surrounding scanner assembly 110. Generally, device 102 can be used within any suitable anatomical structure and / or body lumen of a patient. Processing system 106 outputs image data such that an image of a tube or lumen 120, such as a cross-sectional IVUS image of lumen 120, is displayed on monitor 108. Lumen 120 can represent a structure filled or surrounded by fluid, including both natural and artificial structures. Lumen 120 can be within the patient's body. Lumen 120 can be a blood vessel, such as an artery or vein in the patient's vascular system, including the cardiac vascular system, peripheral vascular system, neurovascular system, renal vascular system, and / or any other suitable lumen within the body. For example, device 102 can be used to examine any number of anatomical locations and tissue types, including but not limited to: organs, including the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures, including the brain, dura mater, spinal cord, and peripheral nerves; the urinary tract; and valves within the blood vessels, chambers, or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 can also be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0037] In some embodiments, the IVUS device includes features similar to those of a conventional solid-state IVUS catheter, such as those available from Volcano Corporation. The conduits and those disclosed in U.S. Patent No. 7,846,101, which is incorporated herein by reference in its entirety. For example, IVUS device 102 includes a scanner assembly 110 near the distal end of device 102 and a transmission harness 112 extending along the longitudinal body of device 102 within a flexible elongated member 120. It should be understood that any suitable wire gauge can be used for transmission harness 112. In one embodiment, transmission harness 112 may include a four-conductor transmission line arrangement with wires having, for example, 41 American Wire Gauge (AWG) gauge. In one embodiment, cable 112 may include a seven-conductor transmission line arrangement using, for example, 44 AWG gauge wires. In some embodiments, 43 AWG gauge wires may be used.

[0038] The transmission harness 112 is terminated in the PIM connector 114 at the proximal end of the device 102. The PIM connector 114 electrically connects the transmission harness 112 to the PIM 104 and physically connects the IVUS device 102 to the PIM 104. In one embodiment, the IVUS device 102 also includes a guidewire exit port 116. Thus, in some instances, the IVUS device is a quick-change catheter. The guidewire exit port 116 allows the guidewire 118 to be inserted distally to guide the device 102 through the tube 120.

[0039] In one embodiment, the image processing system 106 generates flow data by processing echo signals from the IVUS device 102 into Doppler power or velocity information. The image processing system 106 can also generate B-mode data by applying envelope detection and logarithmic compression to the conditioned echo signals. The processing system 106 can also generate images in various views, such as 2D and / or 3D views, based on the flow data or B-mode data. The processing system 106 can also perform various analyses and / or evaluations. For example, the processing system 106 can apply virtual histology (VH) techniques, such as analyzing or evaluating plaques within a tube (e.g., tube 120). Images can be generated to display a reconstructed color-coded histological map formed by plaque components superimposed on a cross-sectional view of the tube.

[0040] In one embodiment, the processing system 106 may apply a blood flow detection algorithm (e.g., ChromaFlo) to determine the movement of blood flow, for example, by repeatedly acquiring image data of a target region (e.g., tube 120) and determining the movement of blood flow based on the image data. The blood flow detection algorithm works by recognizing that the signal measured from vascular tissue is relatively static between acquisitions, while the signal measured from blood flow changes at a characteristic rate corresponding to the flow velocity. Therefore, the blood flow detection algorithm can determine the movement of blood flow based on the changes in the signal measured from the target region between repeated acquisitions. To repeatedly acquire image data, the processing system 106 may control the device 102 to emit repetitive pulses at the same aperture.

[0041] An ultrasonic transducer array in an ultrasonic imaging apparatus comprises an array of acoustic elements configured to emit ultrasonic energy and receive echoes corresponding to the emitted ultrasonic energy. In some cases, the array may include any number of ultrasonic transducer elements. For example, the array may include values ​​between 2 and 10,000 acoustic elements, including values ​​such as 2, 4, 64, 128, 500, 812, 3,000, 9,000, and / or other values ​​greater or smaller. In some cases, the transducer elements of the array may be arranged in any suitable configuration, such as linear arrays, planar arrays, curved arrays, circumferential arrays, annular arrays, phased arrays, matrix arrays, one-dimensional (1D) arrays, 1.x-dimensional arrays (e.g., 1.5D arrays), or two-dimensional (2D) arrays. An array of transducer elements (e.g., one or more rows, one or more columns, and / or one or more orientations) can be controlled and activated uniformly or independently. This array can be configured to acquire one-dimensional, two-dimensional, and / or three-dimensional images of the patient's anatomy.

[0042] The ultrasonic transducer elements may include piezoelectric / piezoresistive elements, piezoelectric micromechanical ultrasonic transducer (PMUT) elements, capacitive micromechanical ultrasonic transducer (CMUT) elements, and / or any other suitable type of ultrasonic transducer element. The ultrasonic transducer elements of this array communicate with (e.g., are electrically connected to) electronic circuitry. For example, the electronic circuitry may include one or more transducer control logic chips. The electronic circuitry may include one or more integrated circuits (ICs), such as application-specific integrated circuits (ASICs). In some embodiments, one or more ICs may include a microwave beamformer (μBF). In other embodiments, one or more ICs include a multiplexer circuit (MUX).

[0043] Figure 2 This is a schematic top view of a portion of a scanner assembly or scanner body 110 formed on a flexible substrate 214 according to various aspects of the present disclosure. The scanner assembly or scanner body 110 includes a transducer array 124 formed in a transducer region 204 and transducer control logic chips 206 (including chips 206A and 206B) formed in a control region 208, with a transition region 210 disposed therebetween. In some embodiments, the scanner assembly or scanner body 110 is substantially rectangular in a flat, unwound configuration.

[0044] A transducer control logic chip 206 is mounted on a flexible substrate 214, and a transducer 212 has previously been integrated into the flexible substrate 214. The flexible substrate 214 is... Figure 2 The middle part is shown as having a flat structure. Although Figure 2Six control logic chips 206 are shown, but any number of control logic chips 206 can be used. For example, one, two, three, four, five, six, seven, eight, nine, ten or more control logic chips 206 can be used.

[0045] A flexible substrate 214, on which transducer control logic chip 206 and transducer 212 are mounted, provides structural support and interconnections for electrical connections. The flexible substrate 214 can be configured to include components such as KAPTON... TM (A trademark of DuPont) flexible polyimide materials formed into film layers. Other suitable materials include polyester films, polyimide films, polyethylene naphthalate films or polyetherimide films, liquid crystal polymers, other flexible printed semiconductor substrates, and others such as… (A registered trademark of Ube Industries) and Products bearing the registered trademark of EIdu Pont. Figure 2 In the flat configuration shown, the flexible substrate 214 has a generally rectangular shape. As shown and described herein, in some instances, the flexible substrate 214 is configured to be wound around the support member 230. Figure 3 Therefore, the thickness and flexibility of the film layer on the flexible substrate 214 are generally related to the degree of bending of the finally assembled flexible component 110. In some embodiments, the film layer is between 5 μm and 100 μm, and in some specific embodiments it is between 5 μm and 25.1 μm, for example, 6 μm.

[0046] The transducer control logic chip 206 is a non-limiting example of a control circuit. A transducer region 204 is disposed at the distal portion 221 of the flexible substrate 214. A control region 208 is disposed at the proximal portion 222 of the flexible substrate 214. A transition region 210 is disposed between the control region 208 and the transducer region 204. In different embodiments, the dimensions (e.g., lengths 225, 227, 229) of the transducer region 204, the control region 208, and the transition region 210 can vary. In some embodiments, lengths 225, 227, and 229 can be substantially similar, or the length 227 of the transition region 210 can be less than lengths 225 and 229, and the length 227 of the transition region 210 can be greater than the length 225 of the transducer region and the length 229 of the controller region, respectively.

[0047] The control logic chip 206 is not necessarily of the same type. In some embodiments, a single controller is designated as the master control logic chip 206A and includes a communication interface for a transmission harness or cable 112 (which may serve as an electrical conductor, such as electrical conductor 218) between the processing system (e.g., processing system 106) and the flexible scanner assembly 110. Therefore, the master control circuitry may include control logic for decoding control signals received via the cable or transmission harness 112, transmitting control responses via cable 142, amplifying echo signals, and / or transmitting echo signals via the cable or transmission harness 112. The remaining controllers are slave controllers 206B. Slave controller 206B may include control logic for driving transducers 212 to emit ultrasonic signals and selecting transducers 212 to receive echoes. In the depicted embodiment, the master controller 206A does not directly control any transducers 212. In other embodiments, the master controller 206A drives the same number of transducers 212 as the slave controller 206B or drives a reduced set of transducers 212 compared to the slave controller 206B. In an exemplary embodiment, a single master controller 206A and eight slave controllers 206B are provided with eight transducers assigned to each slave controller 206B.

[0048] To electrically interconnect the control logic chip 206 and the transducer 212, in one embodiment, the flexible substrate 214 includes conductive traces 216 formed in a film layer that transmit signals between the control logic chip 206 and the transducer 212. Specifically, the conductive traces 216 providing communication between the control logic chip 206 and the transducer 212 extend along the flexible substrate 214 within a transition region 210. In some instances, the conductive traces 216 may also facilitate electrical communication between a master controller 206A and a slave controller 206B. The conductive traces 216 may also provide a set of conductive pads that contact the conductors 218 of the cable 142 when the conductors 218 of the cable 142 are mechanically and electrically coupled to the flexible substrate 214. Suitable materials for the conductive traces 216 include copper, gold, aluminum, silver, tantalum, nickel, and tin, and can be deposited on the flexible substrate 214 by processes such as sputtering, plating, and etching. In one embodiment, the flexible substrate 214 includes a chromium adhesion layer. The width and thickness of the conductive trace 216 are selected to provide appropriate conductivity and flexibility when the flexible substrate 214 is rolled up. In this regard, an exemplary range for the thickness of the conductive trace 216 and / or conductive pad is between 1 and 5 μm. For example, in one embodiment, 5 μm conductive traces 216 are spaced 5 μm apart. The width of the conductive trace 216 on the flexible substrate may be further determined by the width of the conductor 218 to be coupled to the trace / pad. The transmission harness or cable 112 may include multiple conductors, including one, two, three, four, five, six, seven, or more conductors 218.

[0049] In some embodiments, the flexible substrate 214 may include a conductor interface 220. In some cases, the conductor interface 220 may be referred to as an attachment portion, connection portion, tail, end, solder joint, bend, etc. The conductor interface 220 (also referred to as attachment portion 220) may be a location on the flexible substrate 214 where the conductor 218 of the cable 142 is coupled to the flexible substrate 214. For example, the bare conductor of the cable 142 is electrically coupled to the flexible substrate 214 at the conductor interface 220. The conductor interface 220 may be a tab extending from the body of the flexible substrate 214. In this respect, the body of the flexible substrate 214 may collectively refer to the transducer region 204, the controller region 208, and the transition region 210. In the illustrated embodiment, the conductor interface 220 extends from the proximal portion 222 of the flexible substrate 214. In other embodiments, the conductor interface 220 is located at other portions of the flexible substrate 214, such as the distal portion 221, or the flexible substrate 214 may not have the conductor interface 220. The dimensions of the tab or conductor interface 220 (e.g., width 224) may be smaller than the dimensions of the body of the flexible substrate 214 (e.g., width 226). In some embodiments, the substrate forming the conductor interface 220 is made of the same material as the flexible substrate 214 and / or is flexible, similar to the flexible substrate 214. In other embodiments, the conductor interface 220 is made of a different material than the flexible substrate 214 and / or is more rigid than the flexible substrate 214. For example, the conductor interface 220 may be made of plastic, thermoplastic, polymer, rigid polymer, etc., including polyoxymethylene (e.g., Polyetheretherketone (PEEK), nylon, liquid crystal polymer (LCP) and / or other suitable materials.

[0050] Figure 3 A perspective view of an ultrasound scanner assembly 110 with a coiled construction according to various aspects of this disclosure is shown. In some instances, assembly 110 is derived from a flat construction (e.g., as...). Figure 2 As shown, it is transformed into a wound structure or a more cylindrical structure (e.g., as shown). Figure 3 (as shown in the illustration). For example, in some embodiments, techniques disclosed in one or more of the following U.S. patents, such as U.S. Patent No. 6,776,763 entitled "ULTRASONIC TRANSDUCERARRAY AND METHOD OF MANUFACTURING THE SAME" and U.S. Patent No. 7,226,417 entitled "HIGH RESOLUTION INTRAVASCULAR ULTRSOUND SENSING ASEMBLY HAVING A FLEXIBLESUBSTRATE", either of which is incorporated herein by reference in its entirety.

[0051] In some embodiments, the transducer element 212 and / or controller 206 may be positioned in an annular configuration about the longitudinal axis 250 of the support member 230, such as a circular or polygonal configuration. It should be understood that the longitudinal axis 250 of the support member 230 may also be referred to as the longitudinal axis of the scanner assembly 110, the flexible elongated member 121, and / or the intraluminal imaging device 102. For example, the cross-sectional profile of the imaging assembly 110 at the transducer element 212 and / or controller 206 may be circular or polygonal. Any suitable annular polygonal shape can be achieved, such as pentagons, hexagons, heptagons, octagons, nonagons, decagons, etc., based on the number of controllers / transducers, the flexibility of the controllers / transducers, etc. In some examples, multiple transducer controllers 206 may be used to control multiple ultrasound transducer elements 212 to obtain imaging data associated with the blood vessel 120.

[0052] In some instances, support member 230 may be referred to as a single piece. Support member 230 may be made of a metallic material (e.g., stainless steel) or a non-metallic material (e.g., plastic or polymer), as described in U.S. Provisional Application No. 61 / 985,220 ('220'), filed April 28, 2014, entitled "Pre-Doped Solid Substrate for Intravascular Devices," the entire contents of which are incorporated herein by reference. Support member 230 may be a collar having a distal flange or portion 232 and a proximal flange or portion 234. Support member 230 may be tubular in shape and define a lumen 236 extending longitudinally therethrough. Lumen 236 may be sized and shaped to receive guidewire 118. Support member 230 may be manufactured using any suitable process. For example, support member 230 may be machined and / or electrochemically machined or laser milled (e.g., by removing material from a blank to shape support member 230), or molded (e.g., by injection molding).

[0053] Figure 4A schematic cross-sectional side view of the distal portion of an intraluminal imaging apparatus 102 according to various aspects of this disclosure is shown, including a flexible substrate 214 and a support member 230. In some instances, the support member 230 may be referred to as a monolithic piece. The support member 230 may be made of a metallic material (e.g., stainless steel) or a non-metallic material (e.g., plastic or polymer), as described in U.S. Provisional Application No. 61 / 985,220, filed April 28, 2014, entitled “Pre-Doped Solid Substrate for Intravascular Devices,” the entire contents of which are incorporated herein by reference. The support member 230 may be a collar having a distal portion or flange 232 and a proximal portion or flange 234. The support member 230 may define a lumen 236 extending along a longitudinal axis. The lumen 236 communicates with an inlet / outlet port 116 and is sized and shaped to receive a guidewire 118 (e.g., as shown in the image). Figure 1 (As shown in the diagram). The support member 230 can be manufactured according to any suitable process. For example, the support member 230 can be machined and / or electrochemically processed or laser milled (e.g., by removing material from a blank to shape the support member 230), or molded (e.g., by injection molding). In some embodiments, the support member 230 can be integrally formed as a monolithic or single-piece structure, while in other embodiments, the support member 230 can be formed from different components, such as collars and supports 242, 244, which are fixedly connected to each other. In some cases, the support member 230 and / or one or more of its components can be fully integrated with the internal component or guide wire component 256. In some cases, the internal component 256 and the support member 230 can be joined as one, for example, in the case of a polymer support member.

[0054] Vertically extending supports 242 and 244 are respectively disposed at the distal portion 232 and proximal portion 234 of the support member 230. Supports 242 and 244 lift and support the distal and proximal portions of the flexible substrate 214. In this respect, multiple portions of the flexible substrate 214, such as transducer portion 204 (or transducer region 204), may be spaced apart from the central body portion of the support member 230 extending between supports 242 and 244. Supports 242 and 244 may have the same outer diameter or different outer diameters. For example, the distal support 242 may have a larger or smaller outer diameter than the proximal support 244, and may also have specific features for rotational alignment and control chip placement and connection. To improve acoustic performance, any cavity between the surfaces of the flexible substrate 214 and the support member 230 is filled with a backing material 246. The liquid backing material 246 may be introduced between the flexible substrate 214 and the support member 230 via channels 235 in supports 242 and 244. In some embodiments, suction can be applied via a channel 235 of one of the supports 242, 244, while liquid backing material 246 is supplied between the flexible substrate 214 and the support member 230 via a channel 235 of the other of the supports 242, 244. The backing material can be cured to solidify and solidify. In various embodiments, the support member 230 includes more than two supports 242, 244, includes only one of the supports 242, 244, or includes none of the supports. In this respect, the support member 230 may have an enlarged distal portion 232 and / or an enlarged proximal portion 234, which are sized and shaped to lift and support the distal and / or proximal portions of the flexible substrate 214.

[0055] In some embodiments, the support member 230 may be substantially cylindrical. Other shapes of the support member 230 are also contemplated, including geometrical, non-geometrical, symmetrical, and asymmetrical cross-sectional profiles. The shape of the support member 230 may be referred to with reference to its cross-sectional profile, as used herein. In other embodiments, different portions of the support member 230 may be shaped differently. For example, the proximal portion 234 may have a larger outer diameter than the distal portion 232 or the central portion extending between the distal portion 232 and the proximal portion 234. In some embodiments, the inner diameter of the support member 230 (e.g., the diameter of the lumen 236) may increase or decrease accordingly with a change in the outer diameter. In other embodiments, the inner diameter of the support member 230 remains the same despite a change in the outer diameter.

[0056] The internal member 256 and the proximal external member 254 are coupled to the proximal portion 234 of the support member 230. The internal member or guidewire member 256 and / or the proximal external member 254 may include flexible elongated members. The internal member 256 may be received within the proximal flange 234, terminated within the support member 230, or extend completely through the support member 230 and project outward through the distal portion or flange 232. The proximal external member 254 abuts against and contacts the flexible substrate 214. The distal member 252 is coupled to the distal portion 232 of the support member 230. For example, the distal member 252 is positioned around the distal flange 232. The distal member 252 may abut against and contact the flexible substrate 214 and the support 242. The distal member 252 may be the most distal component of the intraluminal imaging device 102.

[0057] One or more adhesives may be applied between various components at the distal portion of the intraluminal imaging device 102. For example, one or more of the flexible substrate 214, support member 230, distal member 252, internal member 256, and / or proximal external member 254 may be bonded together by adhesives.

[0058] The flexible substrate 214 includes a conductor interface 220, which may also be referred to as an attachment portion. The attachment portion 220 may have the form of a tail or leg extending proximally to the scanner portion of the flexible substrate 214. The attachment portion extends within an annular space formed by the inner member 256 and the outer member 254 and is coupled to the inner member 256. In some embodiments, the attachment portion 220 is attached, soldered, adhered, or otherwise connected to the inner member 256 at one or more attachment locations. As described below, in some embodiments, the attachment portion 220 includes a plurality of curved portions. The curved segments of the attachment portion 220 may at least partially wrap around the inner member 256. In an exemplary embodiment, at least a portion of the curved segments is not attached or affixed to the inner member 256, such that the curved segments of the attachment portion 220 are allowed to move and flex relative to the inner member 256 as the device 102 is assembled or navigated through the vascular system.

[0059] Figure 5This is a front view of an ultrasound imaging assembly 110 according to various aspects of the present disclosure, wherein the distal portion of the flexible substrate 214 is in a wound configuration surrounding a support member 230. The flexible scanner assembly 110 has been wound around the support member 230 (e.g., a sleeve, metal tube, monolith, or other suitable structure) such that the control region 208, transition region 210, and transducer region 204 have taken on a cylindrical shape around the support member 230. In some cases, the control region 208, transition region 210, and transducer region 204 may be referred to as the distal portion of the flexible substrate 214 or the scanner body portion. Also visible is a conductor interface or attachment portion 220, which includes conductive traces 216 and conductive fusion solder pads or brazing pads 520 for attaching conductors 218 forming cables 112 to these pads. In some cases, the conductor interface 220 may be referred to as the proximal portion of the flexible substrate 214. Conductive traces 216 in the conductor interface or attachment portion 220 establish electrical communication between the solder pad 520 and the controller region 208. To prevent thermal damage to the scanner assembly 110 when the conductor 218 is soldered or brazed to the conductive pad 520, the conductor interface 220 protrudes a certain distance away from the control region 208 of the scanner assembly 110.

[0060] Cable 112 includes a flexible elongated member (e.g., flexible elongated member 121, for example in...) Figure 1 Multiple conductors 218 extending along the length of the portion shown in the diagram. The proximal region of the attachment portion includes multiple electrical contacts or solder pads 520, which are connected to multiple conductive traces 216. The multiple conductors 218 are electrically connected to the multiple conductive traces 216 via the multiple electrical contacts or solder pads 520. A cable 112 formed by the multiple electrical conductors 218 is connected to an inner component 256 and an outer component (e.g., outer component 254, for example in...). Figure 4 Extending within the annular space between (as shown in the diagram). The proximal region of the attachment portion comprises a generally rectangular shape and is aligned with the longitudinal axis of the flexible elongated member. The scanner body portion or scanner assembly 110 of the device (e.g., device 102, for example in) Figure 1 (As shown) is positioned around the rigid tubular member or support member 230. The attachment portion 220 extends proximally to the rigid tubular member, one or more transducer elements of the transducer region 204, and one or more control circuits of the control region 208.

[0061] Figure 6This is a schematic view of a flexible circuit attachment portion 220 that is wound around an inner member (not shown) and positioned within an outer member 254, according to various aspects of this disclosure. When the outer member 254 is bent (e.g., when navigating a tortuous path through the human vascular system), the attachment portion 220 experiences a low-stress region 610, a medium-stress region 620, and a high-stress region 630.

[0062] Figure 7 This is a schematic view of a flexible substrate 214 in an unwound or flattened state according to at least one embodiment of the present disclosure. Visible are the transducer region 204, transition region 210, and control region 208 of the scanner body portion 110, and an attachment portion or solder pad 720 extending proximally from the scanner body portion 110 and including a plurality of conductive traces 216 connecting a plurality of solder pads 520 to one or more control circuits in the control region 208. The attachment portion 720 is substantially rectangular and substantially aligned with the longitudinal axis 750 of the flexible elongated member (e.g., the longitudinal axis of the internal member 256, for example in...). Figure 5 (As shown in the diagram) Alignment, and includes a proximal portion 730, a middle portion 735, and a distal portion 740 where the solder pads are located. The middle portion 735 defines the bending path, in Figure 7 In the example shown, the curved path includes a first curved portion 736a along a first direction and a second curved portion 736b along a second (e.g., opposite) direction, thereby forming a curved portion 737. More or fewer curved portions may be provided instead of or as supplements. Such a curved path may be described, for example, as a C-shape, D-shape, S-shape, horseshoe shape, serpentine shape, sinusoidal shape, zigzag shape, braided shape, or strain-relieved shape. The first curved portion 736a and the second curved portion 736b may, for example, each be oriented at an angle of 60-90 degrees relative to the longitudinal axis 750.

[0063] In some embodiments, the conductive trace 216 follows a curved path along the attachment portion 720. In some embodiments, the width of the proximal region 730 of the attachment portion 720 is greater than the widths of the intermediate region 735 and the distal region 740. In some embodiments, the width 226 of the scanner body portion 110 is greater than the width 224 of the attachment portion 720.

[0064] Figure 8 It is a cylindrically wound member 230 and an inner member 256 surrounding a flexible elongated member, according to at least one embodiment of the present disclosure. Figure 7 A schematic view of the flexible circuit 214. In Figure 8In the example shown, the proximal region 730 of the attachment portion 720 is attached to the inner member (e.g., using adhesive, sealant, or heat shrink tubing), while the distal region 740 of the attachment portion 720 is attached to the scanner body portion 110, which is attached to the support member 230. However, in some embodiments, at least the intermediate region 735 of the attachment portion 720 is separated from the inner member 256 and is capable of flexing, stretching, rotating, or translating relative to the inner member 256, for example, when the inner member 256 is bent. Such bending may occur, for example, when a flexible, elongated member navigates a tortuous path through the human vascular system or other anatomical systems. In some embodiments, the outer tubular member, for example... Figure 4 The external member 254 shown is positioned around the attachment portion 720 and adjacent to the proximal end of the scanner body portion 110. Therefore, the attachment portion 720 is positioned within an annular space defined by the internal member 256 and the external member 254.

[0065] Figure 9 This is a schematic view of a curved, flexible circuit attachment portion 720, wound around an inner member 256 (not shown) and positioned within an outer member 254, according to at least one embodiment of this disclosure. Because the outer member 254 is bent to... Figure 6 As shown (e.g., when navigating a winding path through the human vascular system), the attachment portion 720 experiences a low-stress region 610 and a medium-stress region 620. In this example, with Figure 6 The attachment portion 220 shown in the example is different. Figure 9 The attachment portion 720 does not show a high-stress area. This is possible because the curved (e.g., horseshoe-shaped) shape of the intermediate region 735 of the attachment portion 720 makes it possible for the intermediate region 735 to bend, flex, rotate, and translate relative to the inner member 256 (not shown).

[0066] Figure 10 This is a schematic representation of the trace 216 of the flexible circuit attachment portion 220 or attachment portion 720 according to at least one embodiment of the present disclosure. The dark portion 1010 represents the bending of the attachment portion 220 or 720 around the Y-axis after it has been wound around the X-axis (e.g., wound around the inner member 256, for example as...). Figure 5 As shown, and bent within the outer member 254, for example, as Figure 6As shown in the diagram, this is the area where the electrical trace 216 is subjected to breakage. Because the electrical trace 216 is of uniform width, it is capable of breaking along its entire width, thereby disrupting the electrical continuity between the proximal side 1030 and the distal side 1040 of the attachment portion 220. This breakage of electrical continuity can cause the device to malfunction. Furthermore, since the electrical trace 216 is straight, it does not include any strain relief features, and therefore is also capable of breaking at any point along its length. Therefore, the dark portion 1010 covers the entire electrical trace 216.

[0067] The electrical traces may be, for example, a layer 1060 of 1 to 5 micrometers thick formed of copper, nickel, or gold or combinations thereof, deposited on top of an attachment layer 1070 of 200 to 600 nanometers thick (e.g., titanium or tungsten or combinations thereof).

[0068] Figure 11 This is a schematic representation of a hexagonal pattern of electrical traces 1116 of a flexible circuit attachment portion 720 according to at least one embodiment of the present disclosure. The electrical traces 1116 include a plurality of openings 1110 (e.g., hexagonal openings) that define two distinct, interconnected paths 1120a and 1120b (e.g., hexagonal or zigzag paths). The darker areas 1010 represent regions of the electrical traces 1116 that experience breakage when the attachment portion 720 is bent (e.g., to an angle θ around the Y-axis, as shown). Due to the non-uniform width of the electrical traces 216 and the inclusion of two independent, interconnected paths 1120a and 1120b, it is capable of breaking only in straight areas across its entire width. In other areas, the openings 1110 and the interconnected, alternating zigzag paths 1120a and 1120b serve as strain-relieving features, making it impossible for any breakage occurring when the attachment portion 720 is wound and bent to traverse the entire width of the electrical traces 1116. Therefore, the darker area 1010 represents the possibility of a break occurring only within a certain portion of each path, thus making it possible for a break in the electrical trace 1116 to not completely interrupt the electrical continuity between the proximal 1030 and distal 1040 of the attachment portion 720. If electrical continuity can be maintained even when the attachment portion 720 is bent, then when faced with the same degree of bending, Figure 11 The 1116 trace wire can be compared to Figure 10 The 216 trace wire is more durable.

[0069] Because it can be more robust, the electrical trace may, in some cases, include a conductive layer of copper, nickel, or gold, or may consist only of a metallic attachment layer, such as titanium, tungsten, or a combination thereof. The metallic mass of trace 216 must be sufficient to transmit any desired electrical signal without overheating. However, within this constraint, since thin metallic traces may be more flexible and / or stretchable than thick metallic traces, it may be advantageous to minimize the mass, width, or thickness of trace 216 to minimize the chance of breakage.

[0070] Figure 12 This is a schematic representation of a repeating horseshoe or sinusoidal pattern of electrical traces 1216 in a flexible circuit attachment portion 720 according to at least one embodiment of the present disclosure. The traces 1216 include a plurality of 180-degree horseshoe bends 1220 that define a single path for the traces 1216. Darker areas 1010 represent regions of the traces 1216 that experience breakage when the attachment portion 720 is bent. Because the width of the traces 1216 is uniform, it is possible for it to break across its entire width in some areas. In other areas, the horseshoe bends 1220 serve as strain-relieving features, making it less likely that breakage will occur in some (uncolored) areas 1050 of the trace when the attachment portion 720 is wound and bent. Therefore, darker areas 1010 represent the possibility of breakage occurring only within some portions of the path, making it less likely that a breakage in the traces 1116 would completely disrupt the electrical continuity between the proximal 1030 and distal 1040 of the connection region 720.

[0071] Figure 13 This is a schematic representation of a plurality of zigzag-patterned electrical traces 1316 of a flexible circuit attachment portion 720 according to at least one embodiment of the present disclosure. Each trace 1316 includes a plurality of zigzag bends 1320 that define a single path for each trace 1216. Each zigzag bend includes a rounded corner 1325, which is likely desirable because cracks in the conductive trace 1316 are less likely to form and propagate at the rounded corner 1325 compared to at sharp, angled corners. In some embodiments, each conductive line 1316 leads to a single electrical contact or solder pad. In some embodiments, the plurality of zigzag traces 1316 form a single conductor path consisting of a plurality of redundant, commonly extending traces leading to a single solder pad.

[0072] Figure 14This is a schematic representation of a plurality of electrical traces 1416 of a flexible circuit attachment portion 720 according to at least one embodiment of the present disclosure. Each electrical trace 1416 includes a plurality of bends 1320 that combine sinusoidal and zigzag arrangements with rounded corners. Each electrical trace 1416 also includes a plurality of openings 1410 that define two redundant but interconnected paths 1420a and 1420b for each electrical trace 1416. In some embodiments, the openings 1410 have rounded corners or zigzag or sinusoidal shapes, or combinations thereof.

[0073] Figure 15 This is a schematic representation of multiple brick-patterned electrical traces 1516 of a flexible circuit attachment portion 720 according to at least one embodiment of the present disclosure. In some aspects, the brick-patterned electrical traces 1516 may be referred to as a braided pattern of electrical traces. Each of the electrical traces 1516 includes a plurality of zigzag portions 1520 and (e.g., rectangular) openings 1510, which define two redundant but interconnected paths 1420a and 1420b for each electrical trace 1516. Thus, the pattern formed by alternating curved portions comprises a redundant zigzag pattern that is periodically interconnected. In some embodiments, the zigzag portions 1520 and openings 1510 have sharp corners, as shown. In other embodiments, the zigzag portions 1520 and / or openings 1510 have rounded corners or sinusoidal shapes, or combinations thereof.

[0074] Figure 16This is a top view of a curved intermediate region 735 of a flexible circuit attachment portion 720 in a planarized (unwound) state according to at least one embodiment of the present disclosure. The intermediate region 735 has strain-relieved bends 737, resulting in a shape that can be described differently as a C-shape, horseshoe shape, serpentine shape, strain-relieved portion, or others. In some cases, multiple C-shapes may be used, facing the same direction or different directions. It should be understood that other numbers of bends may be used instead of or supplemented to result in a shape that can be described differently as a sinusoidal shape, S-shape, or others. In some embodiments, other strain-relieved shapes of the intermediate region 735 may be used instead of or supplemented, including but not limited to dogleg, zigzag, lightning bolt, or polygonal shapes. The intermediate region 735 of the flexible circuit connection also includes a plurality of sinusoidal conductive traces 1216 along the contour or bending path of the intermediate region 735, each including a plurality of 180-degree strain-relief bends 1220, or combinations of other bends resulting in a sinusoidal shape. The conductive traces 1216 alternate or bend relative to the bending path of the intermediate region 735 of the attachment portion 720. The combination of the strain-relief bends 1220 in the traces 1216 and the strain-relief shape of the intermediate region 735 can minimize the risk of wire breakage that could cause a failure more than any one of these features alone.

[0075] Figure 17 This is a top view of the curved intermediate region 735 of the flexible circuit attachment portion 720 in a flattened (unwound) state according to at least one embodiment of the present disclosure. Figure 16 As in the example, the intermediate region 735 has a strain-relief bend 737, or a series of bends, resulting in a shape forming the intermediate region 735, which may be described differently as a C-shape, a horseshoe shape, a strain-relief bend, or others. In some embodiments, other strain-relief shapes of the intermediate region 735 may be used instead of or as a supplement, including but not limited to S-shapes, sine shapes, dogleg shapes, zigzag shapes, lightning bolt shapes, or polygons.

[0076] The intermediate region 735 of the flexible circuit connection also includes a plurality of conductive traces 1716 along the shape of the intermediate region 735. Each conductive trace 1716 includes a plurality of strain-relief V-shaped shapes 1720. Each V-shaped shape 1720 includes a V-shaped opening 1710 that defines two redundant but interconnected paths 1720a and 1720b. Thus, the pattern formed by alternating curved portions comprises a redundant zigzag pattern that is periodically interconnected. In one example, the V-shaped shapes 1720 and the V-shaped openings 1710 are rounded such that they do not include sharp corners that could promote the initiation or propagation of cracks in the traces 1716. In some embodiments, the V-shaped shape 1720 of a given conductive trace 1716 faces the opposite direction to the V-shaped shape 1720 of an adjacent trace 1716.

[0077] Figure 17 The illustrated arrangement includes strain relief features located in the intermediate region 735 of the attachment portion 720 and in traces 1716 along the contour of the intermediate region 735. The traces 1716 also include multiple redundant, interconnected paths 1720a and 1720b. In some embodiments, the width and thickness of the paths are sufficient to transmit the electrical signals required to operate the scanner body 110, but not large enough to significantly increase the risk of crack formation and propagation. In one example, the width of the traces 1716 is between 14 and 20 micrometers, spaced 14 to 20 micrometers apart. In another example, the width of the traces 1716 is 14 micrometers, spaced 16 to 18 micrometers apart. The traces may, for example, be 2 micrometers thick. This combination of features can advantageously minimize the risk of failure-causing fracture occurring across the entire width of any electrical trace 1716. It should be noted that the strain relief characteristics of the above features are size-independent and effective compared to the larger and smaller devices described herein.

[0078] Figure 18 This is a top view schematic diagram of a bent flexible circuit connection portion 1820 in a planarized (unwound) state according to at least one embodiment of the present disclosure. The scanner portion 110 and the connection portion 1820 of the flexible substrate 214 are visible. Figure 18 In the example shown, the connecting portion 1820 includes a first bend or curve portion 1830a and a second bend or curve portion 1830b, which form a dogleg or zigzag pattern. The connecting portion 1820 also includes a first longitudinal portion 1840a and a second longitudinal portion 1840b. The first longitudinal portion 1840a and the second longitudinal portion 1840b are substantially parallel. The curve portions 1830a and 1830b are configured such that when the flexible circuit is wound around the cylindrical body and attached to the distal portion of the flexible elongated member of the conduit, the first longitudinal portion 1840a and the second longitudinal portion 1840b extend longitudinally along the flexible elongated member.

[0079] Figure 19 This is a top view schematic diagram of a bent flexible circuit connection portion 1920 in a planarized (unwound) state according to at least one embodiment of the present disclosure. The scanner portion 110 and the connection portion 1920 of the flexible substrate 214 are visible. Figure 19 In the example shown, the connecting portion 1920 includes a curved portion 1930 that forms a rounded zigzag pattern (also known as a serpentine pattern).

[0080] Figure 20 This is a schematic diagram of processor circuitry 2050 according to various aspects of this disclosure. Processor circuitry 2050 may be implemented in the ultrasound imaging system 100, or in other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as required to implement this method. As shown, processor circuitry 2050 may include processor 2060, memory 2064, and communication module 2068. These components may communicate directly with each other or indirectly, for example, via one or more buses.

[0081] Processor 2060 may include any combination of a central processing unit (CPU), digital signal processor (DSP), ASIC, controller, or general-purpose computing device, simplified instruction set computing (RISC) device, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other related logic device, including mechanical and quantum computers. Processor 2060 may also include another hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 2060 may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors cooperating with a DSP core, or any other such configuration.

[0082] Memory 2064 may include cache memory (e.g., cache memory of processor 2060), 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 storage devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In one embodiment, memory 2064 includes a non-transitory computer-readable medium. Memory 2064 may store instructions 2066. Instructions 2066 may include instructions that, when executed by processor 2060, cause processor 2060 to perform the operations described herein. Instructions 2066 may also be referred to as code. The terms “instruction” and “code” should be interpreted broadly to include any type of computer-readable statement. For example, the terms “instruction” and “code” may refer to one or more programs, routines, subroutines, functions, procedures, etc. “Instruction” and “code” may include a single computer-readable statement or a number of computer-readable statements.

[0083] The communication module 2068 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect data communication between the processor circuitry 2050 and other processors or devices. In this regard, the communication module 2068 may be an input / output (I / O) device. In some cases, the communication module 2068 facilitates direct or indirect communication between the processor circuitry 2050 and / or various components of the ultrasound imaging system 100. The communication module 2068 can communicate within the processor circuitry 2050 via a variety of methods or protocols. Serial communication protocols may include, but are not limited to, US SPI, I... 2 C. Serial and parallel communication may be carried out using methods or protocols such as RS-232, RS-485, CAN, Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communication may be bridged via UART, USART, or other suitable subsystems.

[0084] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the ultrasound device) can be accomplished using any suitable wireless or wired communication technology, such as cable interfaces (e.g., USB, micro USB, Lightning, or FireWire), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections (e.g., 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G). For example, Bluetooth Low Energy (BLE) radios can be used to establish connections to cloud services for data transfer and for receiving software patches. The controller can be configured to communicate with remote servers or local devices (e.g., laptops, tablets, or handheld devices) and may include a display capable of showing status variables and other information. Information can also be transmitted over physical media, such as USB flash drives or memory sticks.

[0085] Those skilled in the art, upon familiarity with the teachings herein, will recognize that the apparatus, systems, and methods described above can be modified in various ways. Therefore, those skilled in the art will understand that the embodiments covered by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, while illustrative embodiments have been shown and described, a wide range of modifications, alterations, and substitutions are contemplated in the foregoing disclosure. It should be understood that such changes can be made to the foregoing without departing from the scope of this disclosure. Therefore, it is appropriate that the appended claims be interpreted broadly and in a manner consistent with this disclosure.

Claims

1. An intraluminal ultrasound imaging device, comprising: A flexible, slender member configured to be positioned within a patient's body cavity; as well as An ultrasound imaging assembly, which is connected to the distal portion of the flexible elongated member and includes: A flexible substrate includes a scanner body portion and an attachment portion extending proximally from the scanner body portion, wherein the attachment portion defines a bending path, the bending path including a first curved portion bending in a first direction and a second curved portion bending in a different second direction; One or more control circuits are mounted on the scanner body portion; One or more transducer elements, which are mounted on the scanner body and communicate with the one or more control circuits; and A plurality of conductive traces are disposed on the attachment portion, wherein the plurality of conductive traces are in electrical communication with the one or more control circuits, wherein the plurality of conductive traces are along the bending path of the attachment portion, and each conductive trace includes a pattern bending relative to the bending path of the attachment portion.

2. The intraluminal ultrasound imaging device according to claim 1, wherein, The conductive trace includes multiple openings that define two distinct, periodically interconnected conductive paths.

3. The intraluminal ultrasound imaging device according to claim 1, wherein, The curved path includes a horseshoe shape or a serpentine shape.

4. The intraluminal ultrasound imaging device according to claim 1, wherein, The pattern of each conductive trace includes a sinusoidal shape.

5. The intraluminal ultrasound imaging device according to claim 2, wherein, The pattern of each conductive trace includes a braided shape.

6. The intraluminal ultrasound imaging device according to claim 2, wherein, The pattern of each conductive trace comprises a redundant zigzag pattern that is periodically interconnected.

7. The intraluminal ultrasound imaging device according to claim 1, wherein, The flexible elongated member includes an inner member, wherein a proximal region of the attachment portion is attached to the inner member, and a middle region of the attachment portion is separated from the inner member, such that the middle region of the attachment portion is configured to move relative to the inner member.

8. The intraluminal ultrasound imaging device according to claim 7, wherein, The width of the proximal region of the attachment portion is greater than the width of the middle region of the attachment portion.

9. The intraluminal ultrasound imaging device according to claim 7 or 8, wherein, The flexible elongated member further includes an external member positioned around the attachment portion of the inner member and the flexible substrate, wherein the external member holds the attachment portion of the flexible substrate in a wound configuration such that the attachment portion is arranged around at least a portion of the periphery of the inner member and located within an annular space between the inner member and the external member.

10. The intraluminal ultrasound imaging device according to claim 9, wherein, The intraluminal ultrasound imaging device also includes multiple conductors that extend along the length of the flexible elongated member. The proximal region of the attachment portion includes a plurality of electrical contacts connected to the plurality of conductive traces. The plurality of conductors are electrically connected to the plurality of conductive traces via corresponding electrical contacts.

11. The intraluminal ultrasound imaging device according to claim 10, wherein, The plurality of conductors extend within the annular space between the inner component and the outer component.

12. The intraluminal ultrasound imaging device according to claim 7 or 8, wherein, The flexible elongated member includes a longitudinal axis, and the proximal region of the attachment portion includes a rectangular shape and is aligned with the longitudinal axis.

13. The intraluminal ultrasound imaging device according to claim 12, wherein, The region of the attachment portion located between the first curved portion and the second curved portion is oriented at an angle of 60-90 degrees relative to the longitudinal axis.

14. The intraluminal ultrasound imaging device according to claim 1, wherein, The intracavitary ultrasound imaging device also includes a rigid tubular component, and the main body of the scanner is positioned around the rigid tubular component.

15. The intraluminal ultrasound imaging device according to claim 14, wherein, The attachment portion extends proximal to the rigid tubular member.

16. The intraluminal ultrasound imaging device according to claim 14 or 15, wherein, The width of the main body of the scanner is greater than the width of the attached portion.

17. An intravascular ultrasound imaging system, comprising: Intraluminal ultrasound imaging apparatus according to any one of claims 1 to 16; Patient interface module; Processing system; and A monitor for displaying ultrasound information output by the processing system; The intraluminal ultrasound imaging device can be connected to the processing system through the patient interface module.

Images