Intraluminal ultrasound assemblies having a variety of material support members and related devices, systems, and methods

Abstract

The present invention provides intravascular imaging probes including a variety of material support members or bases, as well as related devices, systems, and methods. According to one embodiment, a lumenal intravascular ultrasound imaging catheter includes a flexible elongate member configured to be positioned within a body lumen of a patient, a support member coupled to a distal portion of the flexible elongate member, and an ultrasound scanner assembly positioned about the support member. The support member includes a hollow interior member comprising a first material, and a first annular member positioned about a periphery of the hollow interior member at a proximal portion of the hollow interior member. The first annular member extends radially outward from the hollow interior member and comprises a second material different from the first material.

Description

Technical Field

[0001] This disclosure generally relates to the structural arrangement of intravascular ultrasound devices, and more particularly to intravascular ultrasound devices having support members formed of various materials to provide structural support and other mechanical properties to the device. 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) in the body to determine the necessity of treatment, guide interventions, and / or evaluate their 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 form an image of the vessel of interest. Ultrasound waves are reflected by discontinuities caused by tissue structures (e.g., different layers of the vessel wall), red blood cells, and other features of interest. The echoes of the reflected waves are received by the transducers and transmitted to the IVUS imaging system. This imaging system processes the received ultrasound echoes to produce a cross-sectional image of the blood vessel in which the device is placed.

[0003] Solid-state (also known as integrated aperture) IVUS catheters are one of two commonly used IVUS devices 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 transducer elements (or groups of elements) to transmit ultrasound pulses and receive ultrasound echo signals. By single-stepping through a series of transmit-receive pairs, a solid-state IVUS system synthesizes the effects of mechanically scanning ultrasound transducers without any 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, minimizing the risk of vascular damage. 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 for rotating IVUS devices).

[0004] When designing an IVUS device, it is important to consider practical limitations such as manufacturability, reliability, flexibility, and mechanical properties. The expectation is that the ultrasound catheter assembly will generate high-quality raw image signals for a signal processing system located outside the body (where the intravascular ultrasound transducer assembly is inserted for imaging). However, there is concern about limiting the number of components, as increased complexity increases manufacturing costs and reduces the yield of the intravascular ultrasound catheter assembly. The device is expected to be sufficiently flexible and structurally supported to navigate the tortuous regions of the vascular system without damaging the electronic components of the IVUS device.

[0005] A conventional IVUS device includes a support member, also known as a base or monolithic piece, formed from a metal tube. The ultrasound imaging assembly is positioned on or around the support member. The support member provides structural support, rigidity, radiopaqueness, and other properties for the scanner assembly. Conventional support members have several drawbacks. For example, manufacturing techniques available for metals (such as milling, welding, etc.) limit the geometry of the support members that can be produced. Similarly, steel cannot reflow with polymers and cannot effectively scatter or attenuate ultrasound waves. Therefore, the structure of a conventional support member can limit the mechanical and / or acoustic performance of the IVUS device. Summary of the Invention

[0006] This application provides an improved intravascular imaging probe comprising a multi-material support member or base as part of an imaging assembly located at the distal portion of an IVUS catheter. The support member is formed of multiple (i.e., two, three, or more) materials with varying structural complexities. The base may include a cylindrical hollow core or a hypo tube incorporating polymer features that are overmolded, assembled, or otherwise directly coupled to the hollow core. The multi-material structure allows features to be directly molded or coupled to the support structure, which can improve and / or simplify the manufacturing process and provide more varied geometries exhibiting improved mechanical and / or acoustic properties. In some aspects, the multi-material base may have a rigid structure to prevent any stress applied to the sensor components and a more flexible structure to increase the resilience and maneuverability of the IVUS catheter.

[0007] According to one embodiment of this disclosure, an endoluminal ultrasound imaging catheter includes: a flexible elongated member configured to be positioned within a patient's body cavity; and a support member coupled to a distal portion of the flexible elongated member. In some embodiments, the support member includes: a hollow internal member comprising a first material; and a first annular member positioned around the periphery of the hollow internal member at a proximal portion of the hollow internal member, wherein the first annular member extends radially outward from the hollow internal member and comprises a second material different from the first material. In some embodiments, the endoluminal ultrasound imaging catheter further includes an ultrasound scanner assembly positioned around the first annular member of the support member, wherein the ultrasound scanner assembly is configured to acquire ultrasound imaging data of the body cavity.

[0008] In some embodiments, the hollow internal member comprises a cylindrical shape. In some embodiments, the hollow internal member comprises a constant outer surface and a constant inner surface. In some embodiments, the hollow internal member comprises an outer surface having a first groove, and the first groove is formed at a proximal portion of the hollow internal member such that a second material of the first annular member is positioned within the first groove. In some embodiments, the first material of the hollow internal member comprises a metal, and the second material of the first annular member comprises a polymer. In some embodiments, the second material is overmolded onto the hollow internal member. In some embodiments, the first annular member comprises an annular shape. In some embodiments, the first annular member comprises a polygonal shape. In some embodiments, the hollow internal member and the first annular member are joined at a proximal portion of the hollow internal member by an adhesive. In some embodiments, the adhesive comprises a polymeric material.

[0009] In some embodiments, the support member further includes a sleeve member positioned around the periphery of the hollow internal member at a central portion of the hollow internal member. In some embodiments, the sleeve member is positioned distal to the first annular member. In some embodiments, the sleeve member comprises a third material. In some embodiments, the hollow internal member includes an outer surface having a second groove. In some embodiments, the second groove is formed at a central portion of the hollow internal member such that the sleeve member is positioned within the second groove to form a continuous outer profile with the hollow internal member. In some embodiments, the third material of the sleeve member comprises a polymer. In some embodiments, the support member further includes a second annular member positioned around the periphery of the hollow internal member at a distal portion of the hollow internal member. In some embodiments, the second annular member extends radially outward from the hollow internal member. In some embodiments, an ultrasound scanner assembly is positioned around the second annular member.

[0010] In some embodiments, the second annular member comprises a second material and has an annular shape. In some embodiments, the support member further comprises a distal tubular member extending distally to the hollow inner member, and the second annular member and the distal tubular member comprise a flexible third material. In some embodiments, the first annular member, the sleeve member, and the second annular member form an integral component positioned around the periphery of the hollow inner member. In some embodiments, the sidewalls of the hollow inner member comprise at least one of grooves or through holes.

[0011] In some embodiments, the intraluminal ultrasound imaging catheter further includes: a proximal tubular member coupled to a proximal portion of the hollow internal member and extending proximally into the hollow internal member; and a distal end member coupled to a distal end portion of the hollow internal member and extending distally into the hollow internal member, wherein the distal end member includes: an annular portion positioned around the periphery of the hollow internal member at the distal portion of the hollow internal member, wherein the annular portion extends radially outward from the hollow internal member; and a tapering portion extending distally into the annular portion, wherein the proximal tubular member and the distal end member comprise a polymer material.

[0012] According to another embodiment of this disclosure, an endoluminal ultrasound imaging system includes: an endoluminal ultrasound imaging catheter comprising: a flexible elongated member configured to be positioned within a patient's body lumen; a support member coupled to a distal portion of the flexible elongated member, wherein the support member includes: a hollow internal member of a metal comprising a first material; a polymer ring positioned around the periphery of the hollow internal member at a proximal portion of the hollow internal member, wherein the polymer ring extends radially outward from the hollow internal member; an ultrasound scanner assembly positioned around the polymer ring of the support member, wherein the ultrasound scanner assembly is configured to acquire ultrasound imaging data of the body lumen; and processor circuitry in communication with the endoluminal ultrasound imaging catheter, wherein the processor circuitry is configured to generate an endoluminal ultrasound image using the ultrasound imaging data and output the endoluminal ultrasound image to a display.

[0013] Other aspects, features, and advantages of this disclosure will become apparent from the following detailed description. Attached Figure Description

[0014] Illustrative embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

[0015] Figure 1A This is a schematic diagram of an intraluminal imaging system based on various aspects of this disclosure.

[0016] Figure 1B This is a schematic diagram of a processor circuit according to an embodiment of the present disclosure.

[0017] Figure 2 This is a schematic view of the top of a scanner assembly in a flat configuration, according to various aspects of this disclosure.

[0018] Figure 3 It is in the winding structure surrounding the support member according to various aspects of this disclosure. Figure 2 An illustrative perspective view of the scanner components shown.

[0019] Figure 4This is a schematic cross-sectional side view of a scanner assembly in a coiled configuration surrounding a support member, according to various aspects of this disclosure.

[0020] Figure 5A This is a perspective view of the base of a scanner assembly according to various aspects of this disclosure, the base comprising a cylindrical hollow core and two polymer rings attached around its periphery.

[0021] Figure 5B It is taken along section line 5-5 according to various aspects of this disclosure. Figure 5A The base shown is a perspective cross-sectional view.

[0022] Figure 6A This is a perspective view of the base of a scanner assembly according to various aspects of the present disclosure, the base including a cylindrical hollow core, and two polymer rings and polymer internal components attached around the periphery of the hollow core.

[0023] Figure 6B It is taken along section line 6-6 according to various aspects of this disclosure. Figure 6A The base shown is a perspective cross-sectional view.

[0024] Figure 7A This is a perspective view of the base of a scanner assembly according to various aspects of the present disclosure, the base including a cylindrical hollow core with through holes and two polymer rings attached around the periphery of the hollow core.

[0025] Figure 7B It is taken along section line 7-7 according to various aspects of this disclosure. Figure 7A The base shown is a perspective cross-sectional view.

[0026] Figure 8A This is a perspective view of the base of a scanner assembly according to various aspects of this disclosure, the base including a cylindrical hollow core and two polymer rings and internal components attached around its periphery.

[0027] Figure 8B It is taken along section line 8-8 according to various aspects of this disclosure. Figure 8A The shown is a perspective cross-sectional side view of the base.

[0028] Figure 8C Based on multiple aspects of this disclosure Figure 9A The base shown is an enlarged graphical cross-sectional view along section line 8-8.

[0029] Figure 9A This is a perspective view of the base of a scanner assembly according to various aspects of this disclosure, the base including a cylindrical hollow core, with two polymer rings and two flexible portions partially passing through each end of the core and surrounding its periphery.

[0030] Figure 9B It was cut along section line 9-9. Figure 9A The shown is a perspective cross-sectional side view of the base.

[0031] Figure 10A This is a perspective view of the base of a scanner assembly according to various aspects of the present disclosure, the base including a cylindrical hollow core with two polymer rings attached around its periphery and flexible portions positioned at each end of the core.

[0032] Figure 10B It was cut along section line 10-10. Figure 10A The shown is a perspective cross-sectional side view of the base.

[0033] Figure 11 This is a cross-sectional side view of the base of a scanner assembly according to various aspects of the present disclosure, the base including a cylindrical hollow core having a protrusion extending radially outward around the periphery of the cylindrical hollow core, and a polymer ring positioned on and around the protrusion.

[0034] Figure 12 This is a flowchart of a method for forming a base of various materials for a scanner assembly according to various aspects of this disclosure. Detailed Implementation

[0035] For the purpose of facilitating an understanding of the principles of this disclosure, reference will now be made to the embodiments shown in the accompanying drawings, and the embodiments described therein will be used in specific language. However, it should be understood that there are no limitations on 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 the scope of this disclosure, as would typically occur to those skilled in the art to which this disclosure relates. Specifically, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the invention. However, for the sake of brevity, various repetitions of these combinations will not be described separately.

[0036] Figure 1A This 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.

[0037] At a high level, the IVUS device 102 emits ultrasound energy or ultrasound signals from a transducer array 124 included in a scanner assembly 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 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.

[0038] PIM 104 facilitates signal communication between IVUS console 106 and scanner component 110 included in IVUS device 102. This communication includes the following steps: (1) sending... Figure 2 The 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 126 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.

[0039] 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. Console 106 outputs image data such that an image of blood vessel 120, such as a cross-sectional image of blood vessel 120, is displayed on monitor 108. Blood vessel 120 can represent structures filled or surrounded by fluid, including both natural and artificial ones. Blood vessel 120 can be inside a patient. Blood vessel 120 can be a vessel that serves 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, 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.

[0040] In some embodiments, the IVUS device includes features similar to those of a conventional solid-state IVUS catheter, such as those available from Koninklijke Philips NV. 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. The transmission harness or cable 112 may include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors 218 (…). Figure 2 It should be understood that any suitable wire gauge can be used for conductor 218. In one embodiment, cable 112 may include a four-conductor transmission line arrangement using, for example, 41 American Wire Gauge (AWG) wire. In one embodiment, cable 112 may include a seven-conductor transmission line arrangement using, for example, 44 AWG wire. In some embodiments, 43 AWG wire may be used.

[0041] 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 rapid-change catheter. The guidewire exit port 116 allows the guidewire 118 to be inserted distally to guide the device 102 through the blood vessel 120.

[0042] In one embodiment, image processing system 106 generates flow data by processing echo signals from IVUS device 102 into Doppler power or velocity information. Image processing system 106 can also generate B-mode data by applying envelope detection and logarithmic compression to the conditioned echo signals. 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. Processing system 106 can also perform various analyses and / or evaluations. For example, processing system 106 can apply virtual histology (VH) techniques, such as analyzing or evaluating plaque within a blood vessel (e.g., vessel 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 blood vessel.

[0043] 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., blood vessel 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 the vascular tissue is relatively static between acquisitions, while the signal measured from the 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.

[0044] While this disclosure describes embodiments relating to intravascular ultrasound (IVUS) imaging using intravascular catheters or guidewires, it should be understood that one or more aspects of this disclosure can be implemented in any suitable ultrasound imaging system, including synthetic aperture ultrasound imaging systems, phased array ultrasound imaging systems, or any other array-based ultrasound imaging system. For example, multiple aspects of this disclosure can be implemented in endovascular ultrasound imaging systems using intracardiac (ICE) echocardiography catheters and / or transesophageal echocardiography (TEE) probes, and / or in external ultrasound imaging systems using ultrasound probes configured to image near and / or in contact with the patient's skin. In some embodiments, the ultrasound imaging device may be a transthoracic echocardiography (TTE) imaging device.

[0045] 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 instances, 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 ​​larger or smaller. In some instances, 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. The array can be configured to acquire one-dimensional, two-dimensional, and / or three-dimensional images of the patient's anatomy.

[0046] 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 array of ultrasonic transducer elements communicates with (e.g., is 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).

[0047] Figure 1BThis is a schematic diagram of a processor circuit 150 according to an embodiment of the present disclosure. The processor circuit 150 can... Figure 1A This is implemented in the processing system 106 and / or imaging device 102. As shown, the processor circuitry 150 may include a processor 160, a memory 164, and a communication module 168. These components may communicate directly with each other or indirectly, for example, via one or more buses.

[0048] Processor 160 may include a central processing unit (CPU), digital signal processor (DSP), ASIC, controller, field-programmable gate array (FPGA), other hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 160 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.

[0049] Memory 164 may include cache memory (e.g., the cache memory of processor 160), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In one embodiment, memory 164 includes a non-transitory computer-readable medium. Memory 164 may store instructions 166. Instructions 166 may include instructions that, when executed by processor 160, cause processor 160 to perform the functions of the processing system 106 and / or imaging apparatus 101 mentioned herein. Figure 1A The operation described is described in the instruction 166. Instruction 166 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" can refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instruction" and "code" can include a single computer-readable statement or many computer-readable statements.

[0050] The communication module 168 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuitry 150, the imaging device 102, and / or the display 108. In this respect, the communication module 168 may be an input / output (I / O) device. In some instances, the communication module 168 facilitates direct or indirect communication of data between the processor circuitry 150 and / or the processing system 106. Figure 1A Direct or indirect communication between various components.

[0051] Figure 2This is a schematic top view of a flexible component 200 according to several aspects of the present disclosure. The flexible component 200 includes a transducer array 124 formed in a transducer region 204 and a transducer control logic chip 206 (including chips 206A and 206B) formed in a control region 208, with a transition region 210 disposed therebetween.

[0052] 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 2 Six 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.

[0053] 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 film layers formed from flexible polyimide materials such as KAPTON™ (a trademark of DuPont). 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 of the film layer on the flexible substrate 214 is 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.

[0054] 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 lengths 225 and 229 of the transducer region and the controller region, respectively.

[0055] The control logic chips 206 are 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 cable 142, which may serve as an electrical conductor, such as conductor 112, between the processing system (e.g., processing system 106) and the flexible component 200. Therefore, the master control circuitry may include control logic for decoding control signals received via cable 142, transmitting control responses via cable 142, amplifying echo signals, and / or transmitting echo signals via cable 142. 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 illustrated 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.

[0056] 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 wound. In this regard, an exemplary range for the thickness of the conductive trace 216 and / or the conductive pad is between 1 and 5 μm. For example, in one embodiment, a 5 μm conductive trace 216 is spaced 5 μm apart. The width of the conductive trace 216 on the flexible substrate can be further determined by the width of the conductor 218 to be coupled to the trace / pad.

[0057] In some embodiments, the flexible substrate 214 may include a conductor interface 220. The conductor interface 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 a conductor interface 220. The size of the tab or conductor interface 220 (e.g., width 224) may be smaller than the size 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.

[0058] Figure 3 A perspective view of an apparatus 102 having an ultrasound scanner assembly 110 in a wound configuration is shown. In some instances, the assembly 110 is derived from a flat configuration ( Figure 2 ) transforms into a coiled structure or a more cylindrical structure. Figure 3 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 TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME” and U.S. Patent No. 7,226,417 entitled “HIGH RESOLUTION INTRAVASCULARULTRSOUND SENSING ASEMBLY HAVING A FLEXIBLE SUBSTRATE”, either of which is incorporated herein by reference in its entirety.

[0059] In some embodiments, transducer element 212 and / or controller 206 may be positioned in an annular configuration about the longitudinal axis 250 of support member 230, such as a circular or polygonal configuration. It should be understood that support member 230 may include or be referred to as a base. It should also be understood that the longitudinal axis 250 of support member 230 may also be referred to as the longitudinal axis of scanner assembly 110, flexible elongated member 121, and / or device 102. For example, the cross-sectional profile of imaging assembly 110 at 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 blood vessel 120.

[0060] In some instances, support member 230 may be referred to as a monolithic piece or a base. 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 an injection molding process).

[0061] Now for reference Figure 4 The diagram illustrates a schematic cross-sectional side view of the distal portion of an intraluminal imaging device 102 according to various aspects of the present disclosure, including a flexible substrate 214 and a support member 230. In some instances, the support member 230 may be referred to as a monolith or a base. 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 262 and a proximal portion 264. The support member 230 may define a lumen 236 extending along a longitudinal axis LA. The lumen 236 communicates with an inlet / outlet port 116 and is sized and shaped to receive a guidewire 118. Figure 1AThe 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 one-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 member 256. In some cases, the internal member 256 and the support member 230 can be joined as one, for example, in the case of a polymer support member.

[0062] Vertically extending supports 242 and 244 are respectively disposed at the distal and proximal portions 262 and 264 of the support member 230. Supports 242 and 244 elevate 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 portions or regions 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 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 the 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 regard, the support member 230 may have an enlarged distal portion 262 and / or an enlarged proximal portion 264, which are sized and shaped to lift and support the distal and / or proximal portions of the flexible substrate 214.

[0063] 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 264 may have a larger outer diameter than the distal portion 262 or the central portion extending between the distal portion 262 and the proximal portion 264. 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.

[0064] The proximal internal member 256 and the proximal external member 254 are coupled to the proximal portion 264 of the support member 230. The proximal internal member 256 and / or the proximal external member 254 may include flexible elongated members. The proximal internal member 256 may be received within the proximal flange 234. The proximal external member 254 abuts against and contacts the flexible substrate 214. The distal member 252 is coupled to the distal portion 262 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.

[0065] 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, proximal internal member 256 and / or proximal external member 254 may be bonded to each other by adhesives. Figure 2 The component 110 shown can be activated according to a pulse sequence or a scan sequence to form a coherent ultrasonic energy beam, thereby generating an image.

[0066] As described above, conventional IVUS imaging devices may include a support member or base, also referred to as a monolithic component or housing, formed from a metal tube and providing structural support, rigidity, radiopaqueness, and other properties for the IVUS device. Conventional bases have many drawbacks. For example, manufacturing techniques available for metals (such as milling, welding, etc.) limit the types of bases and mechanical features that can be produced. Similarly, some metals cannot be reflowed with polymers and / or cannot effectively scatter or attenuate ultrasound waves. This disclosure describes exemplary embodiments of bases formed from a variety of materials that combine various mechanical and / or acoustic properties to improve the performance of the IVUS device. In particular, the materials and construction of the bases described herein are selected to enhance or improve properties and characteristics such as strength, flexibility, operability, elasticity, acoustic performance, processability, and / or radiopaqueness. It should be understood that although the embodiments discussed below are described with respect to IVUS imaging catheters, it is understood that these embodiments can be used with any suitable device configured for insertion into a patient's body lumen.

[0067] Figure 5-11 illustrates various structural arrangements and embodiments of various material support members or bases for IVUS imaging catheters according to multiple aspects of this disclosure. The base includes a hollow internal member formed of a first material, and one or more structures (e.g., rings, sleeves, flexible components) formed of one or more different materials. It should be understood that the support members or bases described below can be used with scanner assemblies, such as… Figure 1A The scanner assembly 110 shown is included. In some aspects, the scanner assembly may include, or be referred to as, an ultrasonic transducer array, flexible circuitry, ultrasonic transducers, acoustic components, and / or integrated circuits coupled to a substrate. The scanner assembly may be positioned around the periphery of the base and coupled to other components of the conduit, including flexible inner components, flexible outer components, and / or flexible end components.

[0068] Figure 5A It is configured to work with scanner components (e.g., scanner component 110). Figure 1A , Figure 2 A perspective view of a base 500 used together, the base 500 including a hollow cylindrical member 502, and two polymer rings 504, 506 attached around the periphery of the hollow cylindrical member 502. Figure 5B It was cut along section line 5-5. Figure 5AThe illustrated base 500 is shown as a perspective cross-sectional side view. In one exemplary embodiment, the hollow cylindrical member 502, also referred to as a hollow internal member, cylindrical core member, core, metal core, or tube, may comprise or be formed of a metallic material. However, in other embodiments, the hollow cylindrical member 502 may comprise a polymer, ceramic, or other type of material. In some aspects, the two rings 504, 506 may be referred to as annular members. In the illustrated embodiment, the two rings 504, 506, or annular members, comprise a circular shape. In other embodiments, the annular members 504, 506 comprise polygonal shapes, elliptical shapes, and / or combinations thereof. For example, in some embodiments, the annular members 504, 506 comprise rectangular, hexagonal, octagonal, nonagonal, and / or any other suitable shape. The two rings 504, 506 may comprise, or may be formed of, a polymer-based material. In one exemplary embodiment, the metallic material of the cylindrical member 502 or the hollow core includes stainless steel. However, other metallic materials can also be used, including non-transparent materials such as platinum and iridium, tungsten, aluminum and / or nickel-titanium.

[0069] The hollow core 502 can provide structural support and / or protection for electrical components and sensitive materials on the scanner assembly. The hollow core 502 may include cylindrical and / or annular cross-sectional shapes. In some aspects, Figure 5A and 5B The hollow core 502 shown includes a generally cylindrical shape. The generally cylindrical shape may be continuous or may include grooves, through-holes, or other features. Although in Figure 5A Hollow core 502 includes a cylindrical shape, but hollow core 502 may include other profiles or shapes, such as polygons, rectangles, triangles, ellipses, and / or combinations thereof. In the illustrated embodiment, hollow core 502 includes a constant shape and constant inner and outer diameters from proximal end 510 to distal end 512. However, in some embodiments, hollow core 502 includes one or more non-constant diameters, profiles, shapes, thicknesses, surfaces, or other features from proximal end 510 to distal end 512. In some embodiments, hollow core 502 may include a portion or length of an extruded tube.

[0070] In the illustrated embodiment, the dimensions of the hollow core 502 include: an inner diameter 508 ranging from 0.0217 to 0.0227 inches; an outer diameter 514 ranging from 0.0247 to 0.0257 inches; a thickness 518 ranging from 0.0027 to 0.0037 inches; and a length 516 ranging from 0.234 to 0.271 inches. It should be understood that the dimension ranges listed above are exemplary and may include other values, larger and smaller than those listed. Two polymer rings 504, 506 are attached around the periphery of the hollow core 502. The polymer rings 504, 506 comprise a structure formed of a material different from that of the core 502 and project radially outward from the periphery of the core 502. Each polymer ring 504 and 506 comprises a cylindrical, circular, and / or annular shape. In some aspects, the rings 504, 506 may be described as gaskets. However, in other embodiments, one or both of the polymer rings 504 and 506 may include other shapes or profiles, including polygons such as octagons, nonagons, rectangles, triangles, or any combination thereof. The dimensions of each polymer ring 504 and 506 include: an inner diameter 514 ranging from 0.018 to 0.030 inches; an outer diameter 522 ranging from 0.030 to 0.050 inches; and a width 520 ranging from 0.002 to 0.030 inches. In some aspects, the dimensions and values ​​provided herein are applicable to catheters accommodating guidewires up to 0.014 inches. However, it should be understood that these values ​​are merely exemplary and are not intended to limit the scope of this disclosure. For example, the dimensions provided herein may be modified to accommodate guidewires or intraluminal devices of other sizes. For example, in some embodiments, the dimensions and values ​​provided herein may be modified to accommodate guidewires up to 0.035 inches. In some embodiments, the support member is configured for applications that do not use a guidewire. Other ranges are also contemplated. For example, one or more exemplary dimensions provided above may be increased or decreased depending on different diagnostic applications. For example, one or more dimensions provided above (e.g., upper and / or lower limits) may be modified by a factor of 0.5, 1.5, 2, 3, 5, or any other suitable multiplier. In various embodiments, the endovascular device may be used in coronary vascular systems, peripheral vascular systems, intracardiac applications, endoscopic applications, etc. The numerical values ​​of the proposed and / or other dimensions of the endovascular device may be selected based on the relatively large or small size of the body lumen in which the endovascular device is to be positioned.

[0071] The material of each polymer ring 504, 506 may include polymer-based materials, polymer-based composites, polymer-based materials reinforced with metallic components or coatings, and / or any combination thereof. The material of each polymer ring 504, 506 may include conductive, radiopaque, and / or acoustic properties. The polymer rings 504, 506 provide support for the scanner assembly when it is wound into a cylindrical shape. The polymer rings 504, 506 may be attached to the hollow core 502 by overmolding, interference fit, adhesive, or any other suitable attachment method. In one embodiment, the polymer rings 504, 506 are formed by extruding tubing, cutting a length of tubing, and sliding the cut portion of the tubing across the hollow core 502. Two polymer rings 504, 506 may be secured to the hollow core 502 by applying an adhesive at the ring-cylinder interface 524. The adhesive may include polymers, metals, composite-based materials, or any combination thereof. The hollow core 502 and the polymer rings 504 and 506 may include patterned surfaces with various geometric features and sizes to improve the attachment of the rings 504 and 506 to the hollow core 502.

[0072] Figure 6A This is a perspective view of a base 600 of a scanner assembly according to an embodiment of the present disclosure. In some aspects, the base 600 includes a... Figure 5A and Figure 5B The base 500 has similar or identical features, including a cylindrical hollow core 502, and two polymer rings 504, 506 positioned around the periphery of the hollow core 502. (Reference) Figure 6A and 6B The base 600 also includes a polymer internal member 602 positioned between polymer rings 504 and 506 and attached around the periphery of the hollow core 502. In some respects, the polymer internal member 602 may be referred to as a sleeve member or a sheath. Figure 6B It was cut along section line 6-6. Figure 6A The diagram shows a perspective cross-sectional side view of the base 600. The base 600 includes a cylindrical hollow core 502 with two polymer rings 504, 506. In some aspects, the hollow core 502 and / or the polymer rings 504, 506 may include... Figure 5A and Figure 5B The base shown is similar to or the same size as the 500. Figure 6A and Figure 6B In the illustrated embodiment, the base 600 further includes an internal member 602 formed between two polymer rings 504, 506, such as Figure 6AAs shown. The internal component 602 has: a length 604, which may range from 9 to 10 inches; and a thickness 606, which may range from 0.0045 to 0.006 inches. The base 600 also includes a diameter, which may be similar to or equal to the outer diameter 514 of the base 500. In the illustrated embodiment, the internal component 602 is formed with two polymer rings 504, 506 into an integral assembly 608, which is overmolded onto the cylindrical hollow core 502. The internal component may comprise the same material as the polymer rings 504, 506, or may comprise a different material. The integral assembly 608 forms an attachment or interface 624 with the cylindrical hollow core 502. In some embodiments, the integral assembly 608 is formed by injection molding. In other embodiments, the integral assembly 608 is formed by extruding tubing, cutting into segments, and machining to form the rings 504, 506 and positioning the integral assembly 608 on the hollow core 502. The integral component 608 can be attached to the hollow core 502 using an interference fit, adhesive, and / or any other suitable attachment method. Adhesives may include polymers, metals, and / or composite-based materials. In other embodiments, the internal member 602 may be formed as a separate member independent of the rings 504, 506, thereby forming a separate attachment or interface with the hollow core 502. In some embodiments, the internal member 602 and / or the integral component 608 includes patterned inner and / or outer surfaces having various geometric features and dimensions. Including the internal member 602 on the hollow core 502 facilitates easier attachment of multiple features (e.g., polymer rings 504, 506) to the base 600 and allows for control of the spacing between the multiple features. Although in the illustrated embodiment, the internal member 602 (also referred to as a sleeve member) includes a circular or cylindrical shape, the internal member 602 may include other shapes or profiles, including polygons, ellipses, and / or combinations thereof.

[0073] Figure 7A This is a perspective view of the base 700 of the scanner assembly, which includes a cylindrical hollow core 502 and two polymer rings 504, 506 and an internal through hole 702 arranged around the periphery of the hollow core. Figure 7B It was cut along section line 7-7. Figure 7A The figure shows a perspective sectional side view of the base 700. The base 700 may include features similar to or identical to those of the base 500 shown in Figure 5. (Reference) Figure 7A and Figure 7B The base 700 includes a cylindrical hollow core 502, and two polymer rings 504 and 506 are positioned around the periphery of the hollow core 502. The base 700 may include... Figure 5A and Figure 5B The base shown is similar to or the same size as the 500. Figure 7A and 7BThe base 700 shown also includes through holes or grooves 702 disposed around the periphery of the cylindrical hollow core 502. The cylindrical hollow core 502 may include one, two, three, four, five, ten, fifteen, twenty, or any other suitable number of through holes 702, including larger and smaller ones. Each through hole 702 includes a diameter 704. In some embodiments, the diameter of each through hole 702 is the same. In other embodiments, the diameter of at least one of the through holes 702 is different from the diameter of another of the through holes 702. The presence of through holes 702 around the periphery of the cylindrical hollow core 502 can serve as mechanical interference points to aid in the positioning and attachment of other materials to the base 700. In some embodiments, the base 700 includes grooves instead of holes, such that the grooves do not extend entirely through the sidewalls of the hollow core 502.

[0074] Further, refer to Figure 7B The hollow core 502 includes a groove 706 extending inward from the outer surface of the hollow core 502, at least partially surrounding the periphery of the hollow core 502. In some aspects, including the groove 706 on the outer surface of the cylindrical hollow core 502 can facilitate improved attachment or connection of the polymer rings 504, 506 to the cylindrical hollow core 502. For example, the groove 706 can improve the engagement of the polymer rings 504, 506 with the hollow core 502, and / or retain the polymer rings 504, 506 at their respective respective longitudinal positions on the hollow core 502. As described above, in some embodiments, the polymer rings 504, 506 are overmolded onto the hollow core 502 such that the polymer material of the rings 504, 506 at least partially fills the groove 706.

[0075] Figure 8A This is a perspective view of the base 800 of the scanner assembly, which includes a cylindrical hollow core 502 with two polymer rings 504, 506, and an acoustic component 802, also referred to as a sleeve component or internal component, positioned around the center or intermediate portion of the core 502, extending at least partially around its periphery. This intermediate portion or segment is positioned between the distal and proximal portions or segments of the hollow core 502. Figure 8B It was cut along section line 8-8. Figure 8A The side view of the perspective section of the base 800 shown. Figure 8C It is a section taken along line 8-8. Figure 8A An enlarged schematic cross-sectional view of the base 800 shown illustrates recesses 706 and 808. The base 800 may include... Figure 5A and Figure 5B The base 500 shown has some similar or identical features and dimensions, including the hollow core 502 and polymer rings 504, 506. Figure 8A-8CThe illustrated base 800 is formed with an internal member 802 disposed between two polymer rings 504, 506. In the illustrated embodiment, the length 804 of the internal member 802 extends approximately from the center of the cylindrical hollow core 502 to a position near the polymer rings 506. The internal member 802 can be positioned on the outer surface of the cylindrical hollow core 502 by overmolding, coating, doping, or positioning a sleeve on the hollow core 502. For example, in some embodiments, the hollow core 502 is placed in a mold, and the internal member 802 is molded onto the outer surface of the hollow core 502. In other embodiments, a polymer sleeve is positioned on the hollow core 502 and secured to the hollow core 502 by an adhesive. The adhesive may include polymers, metals, composite-based materials, or combinations thereof. The adhesive can improve the bonding at the surface of the formation interface 808 between the internal member 802 and the cylindrical hollow core 502. Although in the illustrated embodiment, the inner member 802 (also referred to as the sleeve member) includes a circular or cylindrical shape, the inner member 802 may include other shapes or profiles, including polygons, ellipses, and / or combinations thereof.

[0076] refer to Figure 8B and 8C Interface 808 includes a groove in the outer surface of the cylindrical hollow core 502, within which an inner member 802 is positioned such that the outer surface of the inner member 802 is flush with the outer surface 526 of the cylindrical hollow core 502, thereby forming a smooth or continuous outer profile of the combined hollow core 502 and inner member 802. In this respect, the inner member 802 is continuous with the proximal and distal portions of the hollow core 502 such that they together form a continuous outer surface. The grooves 808, 706 are formed such that they do not extend into the lumen 528 of the hollow core 502. In other embodiments, the cylindrical hollow core 502 does not have grooves, and the inner member 802 is positioned on the outer surface of the cylindrical hollow core 502 such that it is not flush with the outer surface 526 of the cylindrical hollow core 502. In some aspects, including the inner member 802 can provide improved acoustic characteristics and performance (e.g., backscattering and / or attenuation) of the scanner assembly. The material and thickness 810 of the internal component 802 can be selected to achieve the desired acoustic properties at the distal portion 512 of the base 800. For example, the thickness 810 can range from 0.0004 to 0.006 inches, and the material can include polymer materials, such as... Or polyimide.

[0077] Alternatively, additional matching material may be included at the interface between the surfaces of the internal member 802 and the cylindrical hollow core 502 to improve acoustic energy transmission between the scanner assembly 110 and the base 800. The internal member 802 may also serve as an impact absorber for impacts applied to the scanner assembly by external or internal forces.

[0078] Figure 9A This is a perspective view of the base 900 of the scanner assembly, which includes a cylindrical hollow core 502, two polymer rings 504 and 506, a flexible member 901 positioned at a proximal end 510, and a flexible member 903 positioned at a distal end 512 of the hollow core 502 and surrounding its periphery. The flexible member 901 may be referred to as the proximal tubular member, and the flexible member 903 may be referred to as the distal tubular member 903. Figure 9B It was cut along section line 9-9. Figure 9A The diagram shows a perspective cross-sectional view of the base 900. The base 900 may include some features and dimensions similar to or the same as those of the base 500 in FIG. 5, including a hollow core 502 and polymer rings 504 and 506. Figure 9A and Figure 9B The base 900 shown also includes opposing flexible members 901 and 903 on the proximal end 510 and distal end 512 of the cylindrical hollow core 502, respectively. Flexible member 901 includes a tapered portion 902a and a cylindrical portion 906a, which together form a flexible member 901 as an integral component. Similarly, flexible member 903 includes a tapered portion 902b and a cylindrical portion 906b, which together form a flexible member 903 as an integral component. Figure 9A and Figure 9B The tapered portions 902a and 902b shown include tapering of the outer surfaces of the flexible members 901 and 903, such that the inner diameter of each of the flexible members 901 and 903 remains constant or substantially constant along its length, while the outer diameter decreases along its length. In other embodiments, the tapered portions 906a and 906b include tapering of both the outer and inner surfaces of the flexible members 901 and 903. In other embodiments, the flexible member comprises a cylindrical shape along its entire length and does not include the tapered portions.

[0079] Flexible components 901 and 903 are coupled or attached to the hollow core 502 near their respective ends and near the respective polymer rings 504 and 506. Each of the cylindrical portions 906a and 906b includes an outer diameter 514, ranging from 0.036 to 0.037 inches, and may be substantially equal to the diameter of the hollow core 502. Each of the cylindrical portions 906a and 906b includes a length 908, ranging from 0.030 to 0.033 inches. Tapered portions 902a and 902b have an end diameter 912, which may be smaller than the diameter 514 of the hollow core 502, and ranges from 0.021 to 0.022 inches. The tapered portion has a length 910, ranging from 0.10 to 0.030 inches. The thinner sidewalls and smaller diameter 912 increase flexibility at each end 510, 512. In some respects, the dimensions and values ​​provided herein are applicable to catheters accommodating guidewires up to 0.014 inches. However, it should be understood that these values ​​are exemplary only and are not intended to limit the scope of this disclosure. For example, the dimensions provided herein can be modified to accommodate guidewires or intraluminal devices of other sizes. For example, in some embodiments, the dimensions and values ​​provided herein can be modified to accommodate guidewires up to 0.035 inches. Other ranges are also contemplated. For example, one or more exemplary dimensions provided above may be increased or decreased depending on different diagnostic applications. For example, one or more dimensions provided above may be modified by 0.5 times, 1.5 times, 2 times, 3 times, 5 times, or any other suitable multiple.

[0080] The presence of flexible components 901 and 903 advantageously allows for a gradual transition in hardness from the rigid stainless steel cylindrical member 502 to the flexible conduit, reducing the likelihood of kinking or damage to the conduit within the lumen. The flexible member 901 at the proximal end 510 of the base 900 can be connected or joined to the internal and / or external components of the conduit using one or more techniques (including thermal bonding, adhesives, interference fits, etc.), and can serve to relieve strain and / or provide a rigidity transition. The flexible member 903 at the distal end 512 of the base 900 can be connected or joined to the hollow core 502 using one or more techniques (including overmolding, thermal bonding, adhesives, doping, coating, interference fits, etc.), and can serve to provide a hardness transition at the conduit tip. Figure 9A and 9BIn the illustrated embodiment, flexible components 901, 903 are attached to a cylindrical hollow core 502 at each end 510, 512, such that the inner diameter 508 of the cylindrical hollow core 502 is constant or unchanging along its respective length. The attachment of flexible components 901, 903 to the hollow core 502 forms interfaces 914, 916, which include corresponding mating surfaces between the metal core 502 and the flexible components 901, 903. In some aspects, the interfaces or attachments of the flexible components 901, 903 may include other features, including grooves, channels, holes, textured surfaces, and / or tapered surfaces that improve mechanical strength and engagement. The base 900 advantageously comprises a variety of materials that improve the functionality and mechanical properties of the device. For example, in some embodiments, a molded flexible component (e.g., 903) overlaid on the hollow core 502 may replace the above. Figure 1A The separated distal end members are shown. In some embodiments, the surface finish of the internal lumen of the flexible members 901, 903 may be selected to minimize friction with the guidewire.

[0081] Figure 10A This is a perspective view of the base 1000 of the scanner assembly, which includes a cylindrical hollow core 502 and a polymer ring 504 and a flexible component 1003 positioned around the periphery of the hollow core 502. Figure 10B It was cut along section line 10-10. Figure 10A The diagram shows a perspective cross-sectional view of the base 1000. The base 1000 may include components related to... Figure 9A and 9B The base 900 has similar or identical features and / or dimensions, including a hollow core 502 and an annular member 504. Figure 10A and Figure 10B In one embodiment, the base 1000 has a flexible member 1002 formed at a proximal end 510 and a flexible member 1003 formed at a distal end 512, wherein the flexible members include different geometries. In this respect, the flexible member 1003 includes a generally cylindrical body comprising an annular or cylindrical portion 1004 forming an integral part and a tapered or conical portion 1006. The flexible member 1003 may be referred to as a distal end member. In some embodiments, the cylindrical portion 1004 may include a shape and size similar to that of the polymer ring 504. For example, in some embodiments, the cylindrical portion 1004 includes an outer diameter similar to or the same as that of the polymer ring 504. The flexible member 1003 includes a length 1012, and the cylindrical portion 1004 is positioned around the distal portion of the hollow core 502, while the tapered portion 1006 extends distally into the hollow core 502. Flexible component 1003 includes variable thicknesses 1013, 1015, and 1016 along its length 1012, while maintaining a constant cross-sectional inner diameter 508 (e.g., Figure 10A and 10B(As shown). In this respect, the tapered portion includes a tapered outer surface such that the inner diameter 508 is constant along the length 1012. It should be understood that in some embodiments, the inner surface may be tapered. In some embodiments, the outer surface is tapered, while the thickness (1013, 1015, 1016) of the flexible member 1003 is constant along its length.

[0082] refer to Figure 10B The flexible component 1003 can be attached to the outer surface of the cylindrical hollow core 502 by overmolding, mechanical attachment, interference fit, and / or adhesive, and can fit within and / or around features (including protrusions 1014) of the hollow inner component 502. For example, the flexible component 1003 may include a slot or groove in the inner surface of the flexible component 1003 configured to fit on or around the protrusions 1014 of the hollow inner component to hold the flexible component 1003 in place. Unique attachment interfaces can improve the adhesion of the flexible component 1003 to the hollow inner component 502 and achieve similar functional objectives as those described above for other structures explained in Figures 5-9. The flexible component 1003 includes an inner lumen 1020 communicating with or extending from the lumen of the core component 502 and can be configured to receive a guidewire.

[0083] At the proximal end 510, the base 1000 includes a flexible member 1002. In the illustrated embodiment, the flexible member 1002 includes a generally cylindrical body defining a lumen 1022, the body including a constant diameter that remains constant along its length and an external profile that remains constant or constant along its length. The distal portion of the flexible member 1002 is formed or positioned around the proximal end of the cylindrical hollow core 502, and the flexible member 1002 is formed with an optimized, constant thickness 1018 and length 1010 to achieve flexibility, radiation impermeability, acoustic properties, and other performance characteristics to meet desired functional objectives.

[0084] Figure 11 This is a perspective cross-sectional side view of the scanner assembly's base 1100, which includes a cylindrical hollow core 502, wherein a polymer ring 504 is attached around its periphery using locking features or protrusions 1101. Figure 11 In the base 1100, the polymer ring 504 is attached to the surface of the cylindrical hollow core 502 by positioning the polymer ring 504 on a corresponding protrusion 1102. The protrusion 1102 can be positioned, locked, or press-fitted into a corresponding groove or slot in the inner surface of the polymer ring 504. In some embodiments, Figure 11 The attachment shown can be achieved by forming a protrusion 1102 on the hollow core 502 and covering the protrusion with a molded polymer ring 504. This structural connection method can be applied to any of the structural embodiments given above.

[0085] To manufacture the various base embodiments disclosed herein, several different conventional and non-conventional manufacturing techniques can be used based on the base's material, features, and structure, including injection molding, casting, 3D printing, laser cutting and texturing, extrusion, micromachining, co-molding, reflow, electron beam melting, and / or other suitable techniques. It should be understood that limitations on any particular manufacturing technique are not intended and should not be implied from the teachings of the disclosed principles.

[0086] The structure of the above embodiments can be selected based on the size, functional objectives, and / or type of the scanner assembly. Therefore, any advantageous structural arrangement with appropriate length, width, and height can be adopted, which can include not only the circular / cylindrical and semi-circular shapes discussed herein, but also triangular, conical, polygonal, and linear shapes. The base can include any number of polymer rings, such as one, two, three, five, ten, or any other suitable number, including larger and smaller numbers. Furthermore, the base can include various combinations of the above features. All exemplary variations of the base in Figures 5-11 can be coupled to the scanner assembly. The base advantageously incorporates various material properties and structures that can improve the performance characteristics of various catheters and intraluminal devices. In this respect, although... Figure 5A-11 The embodiments shown are described with respect to IVUS imaging catheters, but it should be understood that the aforementioned support members or bases can be used for a variety of intraluminal devices, including intracardiac echocardiography (ICE) catheters, optical coherence tomography (OCT) catheters, sensing catheters, guiding catheters, sensing guidewires, or any other suitable type of intraluminal device.

[0087] Figure 12 A flowchart illustrating an exemplary method 1200 for forming a scanner assembly with a base made of various materials is shown. At step 1202, method 1200 includes defining the geometry of the base for the type of scanner to be used and the intended functional goals. As shown in Figures 5-11, various structural geometries can be used to construct the base based on the intended function.

[0088] At step 1204, method 1200 includes selecting an appropriate material for each component of the base. The material selection is based on the expected performance required by the scanner assembly, such as rigidity, opacity, flexibility, acoustics, processability, moldability, and combinations thereof.

[0089] At step 1206, method 1200 includes defining the number of flexible components to be attached to the hollow core, which will produce the intended function of the scanner assembly. Step 1206 may include adding two or more polymer rings, a combination of two polymer rings and a flexible internal member, a polymer ring and a flexible component as a guidewire, or any combination thereof.

[0090] At step 1208, method 1200 includes selecting a suitable manufacturing process to produce each component of the multi-material base, such as selecting micromachining to form a hollow core component, selecting an overmolding process to form a polymer ring on the hollow core component, and any other suitable manufacturing process corresponding to each component of the base.

[0091] At step 1210, method 1200 includes connecting all components to form a multi-material base. For example, in some embodiments, flexible components may be placed into grooves formed on the surface of the hollow core component, the flexible components may be press-fitted into the hollow core component, or they may be applied by overmolding, as shown in Figures 5-11. At step 1210, once the multi-material base is formed, it can be coupled to the scanner assembly.

[0092] Those skilled in the art will recognize that the above-described devices, systems, and methods can be modified in various ways. Therefore, those skilled in the art will appreciate that the embodiments covered by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, although illustrative embodiments have been shown and described, extensive modifications, variations, 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 this disclosure. Therefore, a broad interpretation of the appended claims, consistent with this disclosure, is appropriate.

Claims

1. An intraluminal ultrasound imaging catheter, comprising: A flexible, slender member configured to be positioned within the patient's body cavity. A support member, which is connected to the distal portion of the flexible elongated member, wherein the support member comprises: Including hollow internal components of the first material; and A first annular member is positioned around the periphery of the hollow internal member at a proximal portion of the hollow internal member, wherein the first annular member extends radially outward from the hollow internal member, and the first annular member comprises a second material different from the first material; and An ultrasound scanner assembly positioned around the first annular member of the support member, wherein the ultrasound scanner assembly is configured to acquire ultrasound imaging data of the body lumen. The supporting member further includes a sleeve member, which is positioned around the periphery of the hollow internal member at the middle portion of the hollow internal member. The sleeve component is positioned distal to the first annular component, and The sleeve component includes a third material.

2. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The hollow internal component has a cylindrical shape.

3. The intraluminal ultrasound imaging catheter according to claim 2, wherein, The hollow internal component includes a fixed outer surface and a fixed inner surface.

4. The intraluminal ultrasound imaging catheter according to claim 2, in, The hollow internal component includes an outer surface with a first groove. The first groove is formed at the proximal portion of the hollow internal component, such that the second material of the first annular component is positioned within the first groove.

5. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The first material of the hollow internal component includes metal, and the second material of the first annular component includes polymer.

6. The intraluminal ultrasound imaging catheter according to claim 5, wherein, The second material is molded onto the hollow internal component.

7. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The first annular component has an annular shape.

8. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The first annular component has a polygonal shape.

9. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The hollow internal component and the first annular component are joined by an adhesive at the proximal portion of the hollow internal component.

10. The intraluminal ultrasound imaging catheter according to claim 9, wherein, The adhesive comprises a polymer material.

11. The intraluminal ultrasound imaging catheter according to claim 1, in, The hollow internal component includes an outer surface with a second groove. The second groove is formed at the middle portion of the hollow internal component, such that the sleeve component is positioned within the second groove to form a continuous outer contour with the hollow internal component.

12. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The third material of the sleeve component includes a polymer.

13. The intraluminal ultrasound imaging catheter according to claim 1, in, The supporting member further includes a second annular member, which is positioned around the periphery of the hollow internal member at the distal portion of the hollow internal member. The second annular member extends radially outward from the hollow internal member. The ultrasound scanner assembly is positioned around the second annular member.

14. The intraluminal ultrasound imaging catheter according to claim 13, in, The second annular component includes the second material, and The second annular component has an annular shape.

15. The intraluminal ultrasound imaging catheter according to claim 13, in, The support member further includes a distal tubular member extending distally to the hollow internal member, and The second annular member and the distal tubular member comprise a flexible third material.

16. The intraluminal ultrasound imaging catheter according to claim 13, wherein, The first annular member, the sleeve member, and the second annular member form an integral component positioned around the periphery of the hollow internal member.

17. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The sidewalls of the hollow internal component include at least one of grooves or through holes.

18. The intraluminal ultrasound imaging catheter according to claim 1, wherein, The intraluminal ultrasound imaging catheter also includes: A proximal tubular member, which is connected to the proximal portion of the hollow internal member and extends proximal to the hollow internal member; and A distal end member, which is coupled to the distal portion end of the hollow internal member and extends distally into the hollow internal member, wherein the distal end member comprises: An annular portion, positioned around the periphery of the hollow internal member at a distal portion of the hollow internal member, wherein the annular portion extends radially outward from the hollow internal member; and The tapering portion extends distally to the annular portion. The proximal tubular member and the distal end member are made of polymer material.

19. An intraluminal ultrasound imaging system, comprising: The intraluminal ultrasound imaging catheter according to any one of claims 1 to 18; and A processor circuit that communicates with the intraluminal ultrasound imaging catheter, wherein the processor circuit is configured to generate an intraluminal ultrasound image using the ultrasound imaging data and output the intraluminal ultrasound image to a display.

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