Reinforcing layer for intraluminal imaging device

Abstract

An intraluminal imaging device includes a flexible elongate member configured to be positioned within a body lumen of a patient. The flexible elongate member includes a proximal portion and a distal portion. The imaging device further includes an ultrasound scanner assembly configured to obtain ultrasound imaging data while positioned within the body lumen. The ultrasound scanner assembly is coupled to the distal portion of the flexible elongate member and positioned distally of the distal portion. The distal portion of the flexible elongate member includes a first polymer having a first stiffness. The imaging device further includes a reinforcement layer extending over and in direct contact with only a region of the distal portion of the flexible elongate member. The reinforcement layer includes a second polymer having a second, different stiffness.

Description

Technical Field

[0001] This disclosure generally relates to intraluminal imaging devices, and particularly to intraluminal imaging devices including a reinforcing layer that extends over and directly contacts a region of a flexible, elongated member on its distal side. For example, the reinforcing layer can change the stiffness of the region, allowing it to bend to a certain radius of curvature without kinking. 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 their effectiveness. An IVUS device, comprising one or more ultrasound transducers, is delivered into the blood vessel and guided to the area to be imaged. The transducers emit ultrasound energy to create an image of the vessel of interest. Ultrasound waves are reflected by discontinuities caused by tissue structures (e.g., layers of the vessel wall), red blood cells, and other features of interest. The transducers receive the echoes from the reflected waves and transmit them to the IVUS imaging system. The imaging system processes the received ultrasound echoes to produce a cross-sectional image of the blood vessel at the location where the device is placed.

[0003] Phased array (also known as synthetic aperture) IVUS catheters are a commonly used type of IVUS device. A phased array IVUS catheter carries a scanner assembly comprising an array of ultrasound transducers positioned and distributed around its periphery or circumference, and one or more integrated circuit controller chips mounted near the transducer array. The controller selects individual acoustic elements (or groups of elements) to emit acoustic energy pulses and receive ultrasound echo signals corresponding to the emitted ultrasound energy. By sequentially performing a transmit-receive pair sequence, the phased array IVUS system is able to synthesize the effect of mechanically scanning ultrasound transducers without moving parts (hence the term 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 injury, and no additional housing between rotating elements and the vascular lumen is required.

[0004] IVUS catheters must be stiff enough to be maneuverable, allowing clinicians to advance them through the tortuous paths of the body's vascular system. However, to facilitate navigation through these tortuous paths, the catheter must also be flexible. For example, the catheter may need to be flexible enough to bend near turns within the vascular system. Balancing catheter stiffness and flexibility can be challenging and can be further complicated by attempts to limit kinking of the catheter during bends. Summary of the Invention

[0005] This document discloses an intraluminal imaging device (e.g., intravascular ultrasound or IVUS imaging device) capable of navigating through tortuous vascular systems (e.g., coronary vascular systems). The device includes a flexible elongated member (e.g., a catheter) and an imaging assembly (e.g., a scanner assembly) for acquiring intraluminal image data. A reinforcement layer is coupled to and extends over a region within the distal portion of the flexible elongated member, near the imaging assembly. For example, this region may be close to the junction between the flexible elongated member and the imaging assembly. The reinforcement layer can transfer the stiffness (e.g., flexibility) of the flexible elongated member (e.g., an outer member of the flexible elongated member) to the imaging assembly, which may be more rigid than the flexible elongated member. By coupling the reinforcement layer to this region, the column strength of this region can be increased, and the region can better resist kinking when bending. For this purpose, the reinforcement layer can reduce the radius of curvature to which the intraluminal imaging device can bend without kinking, allowing the imaging device to navigate through sharper turns without kinking. Furthermore, with the increase in longitudinal strength in this region, intraluminal imaging devices can maintain sufficient strength to be propelled through the vascular system.

[0006] In one exemplary aspect, an intraluminal imaging device includes a flexible, elongated member configured to be positioned within a patient's body lumen. The flexible, elongated member may include a proximal portion and a distal portion. The intraluminal imaging device may also include an ultrasound scanner assembly configured to acquire ultrasound imaging data when positioned within the body lumen. The ultrasound scanner assembly may be coupled to and positioned distal to the distal portion of the flexible, elongated member. The distal portion of the flexible, elongated member comprises a first polymer having a first stiffness. The intraluminal imaging device may also include a reinforcing layer extending only over a region of the distal portion of the flexible, elongated member and in direct contact only with that region. The reinforcing layer may comprise a second polymer having a different second stiffness.

[0007] In some aspects, the region and the reinforcing layer can be coupled via thermal reflow. In some aspects, the region can be spaced proximally from the distal end of the distal portion of the flexible elongated member. In some aspects, the region can be spaced at least 1 mm from the distal end of the distal portion of the flexible elongated member.

[0008] In some aspects, the second hardness can be less than the first hardness. In some aspects, the reinforcing layer can comprise a thermoplastic elastomer. In some aspects, the reinforcing layer can comprise a thickness greater than or equal to 0.001 inches.

[0009] In some aspects, the ultrasound scanner assembly can include a conductor interface. A proximal portion of the reinforcement layer can extend over the conductor interface. In some aspects, the intraluminal imaging device can include a plurality of conductors coupled to a proximal portion of the conductor interface. The reinforcement layer can extend over the plurality of conductors.

[0010] In some aspects, the distal end of the flexible elongated member includes an outwardly flared opening. In some aspects, the region is spaced proximally from the outwardly flared opening. In some aspects, the endoluminal imaging device is a rapid-exchange catheter including a guidewire inlet. The guidewire inlet can be located within the distal portion of the flexible elongated member. The region can be positioned distal to the guidewire inlet.

[0011] In some aspects, the intraluminal imaging device includes an additional reinforcement layer that extends only over an additional region of the distal portion of the flexible elongated member and is in direct contact only with that additional region. The additional reinforcement layer may include a third hardness different from the first hardness.

[0012] In some aspects, the flexible elongated member can be configured to bend to a certain radius of curvature within a tortuous vascular system. The reinforcing layer is configured to reduce the radius of curvature to which the region of the flexible elongated member can bend within the tortuous vascular system without kinking.

[0013] In one exemplary aspect, an intravascular ultrasound (IVUS) imaging catheter includes a catheter body configured to be positioned within a patient's blood vessel. The catheter body may include a proximal portion and a distal portion. The IVUS imaging catheter may also include an ultrasound scanner assembly. The ultrasound scanner assembly may include a circumferential array of acoustic elements configured to acquire ultrasound imaging data when positioned within the blood vessel. The ultrasound scanner assembly is coupled to and positioned distal to the distal portion of the catheter body. The distal portion of the catheter body may include a first polymer having a first stiffness. The IVUS imaging catheter may include a reinforcing layer extending only over and in direct contact with a region of the distal portion of the catheter body, the reinforcing layer including a second polymer having a second stiffness different from the first stiffness, such that the region can bend within a tortuous portion of the blood vessel without kinking.

[0014] Other aspects, features, and advantages of this disclosure will become apparent from the following detailed description. Attached Figure Description

[0015] Illustrative embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

[0016] Figure 1A This is a schematic diagram of an intraluminal imaging system based on various aspects of this disclosure.

[0017] Figure 1B This is a schematic diagram of a processor circuit according to an embodiment of the present disclosure.

[0018] Figure 2 This is a schematic view of the scanner components in a flat configuration on top, according to various aspects of this disclosure.

[0019] Figure 3 It is in accordance with various aspects of this disclosure that the configuration is arranged around the support member in a rolled-up configuration. Figure 2 The image shows a schematic perspective view of the scanner components.

[0020] Figure 4 This is an illustrated cross-sectional side view of a scanner assembly in a rolled-up configuration surrounding a support member, according to various aspects of this disclosure.

[0021] Figure 5A This is a schematic side view of an intraluminal imaging apparatus curved along the radius of curvature according to at least one embodiment of the present disclosure.

[0022] Figure 5B This is a schematic side view of an intraluminal imaging apparatus curved along the radius of curvature according to at least one embodiment of the present disclosure.

[0023] Figure 5C This is a schematic side view of an intraluminal imaging apparatus curved along the radius of curvature according to at least one embodiment of the present disclosure.

[0024] Figure 6 This is an illustrated cross-sectional side view of the distal portion of an intraluminal imaging apparatus according to at least one embodiment of the present disclosure.

[0025] Figure 7 It is from at least one embodiment of this disclosure Figure 6 The illustrated cross-sectional view of section 7-7.

[0026] Figure 8A This is an illustrative schematic diagram of an intraluminal imaging apparatus according to at least one embodiment of the present disclosure.

[0027] Figure 8B This is an illustrative schematic diagram of an intraluminal imaging apparatus according to at least one embodiment of the present disclosure.

[0028] Figure 9This is an illustrated cross-sectional side view of the distal portion of an intraluminal imaging apparatus according to at least one embodiment of the present disclosure.

[0029] Figure 10 This is a flowchart of a method for assembling an intraluminal imaging device according to at least one embodiment of the present disclosure. Detailed Implementation

[0030] To facilitate an understanding of the principles of this disclosure, the embodiments illustrated in the accompanying drawings will now be described using specific language. Nevertheless, it should be understood that this disclosure is not intended to limit its scope. Any changes and further modifications to the described devices, systems, and methods, as well as any other applications of the principles of this disclosure, are readily apparent to those skilled in the art and are included within its scope. In particular, it is entirely conceivable 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, numerous iterations of these combinations will not be described separately.

[0031] Figure 1A This is a schematic diagram illustrating an ultrasound imaging system 100 according to various aspects of this disclosure. The ultrasound imaging system 100 can be an intraluminal imaging system. In some instances, system 100 can 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 can be an ultrasound imaging device. In some instances, device 102 can be an IVUS imaging device (e.g., a solid-state IVUS device).

[0032] At a high level, 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 device. The ultrasound energy is reflected by tissue structures in the medium (e.g., blood vessel 120 or another body lumen surrounding the scanner assembly 110), and the ultrasound echo signals are received by the transducer array 124. In this respect, device 102 can be sized, shaped, or otherwise configured to be positioned within a patient's body lumen. PIM 104 transmits the received echo signals to a console or computer 106, where an ultrasound image (potentially including flow information) is reconstructed and displayed on a monitor 108. Processing system 106 can include a processor and memory. Processing system 106 is capable of operating features that facilitate the IVUS imaging system 100 described herein. For example, processing system 106 can run computer-readable instructions stored on a non-transient tangible computer-readable medium.

[0033] PIM 104 facilitates signal communication between the processing system 106 and the scanner assembly 110 included in the IVUS device 102. This communication includes the following steps: (1) sending... Figure 2 The integrated circuit controller chips 206A, 206B included in the scanner assembly 110 provide commands to select one or more specific transducer array elements or one or more acoustic elements to be used for transmission and reception, (2) provide transmission trigger signals to the integrated circuit controller chips 206A, 206B included in the scanner assembly 110 to activate the transmitter circuitry to generate electrical pulses to excite the selected one or more transducer array elements 212, and / or (3) receive the amplified echo signal received from the selected one or more transducer array elements 212 via an amplifier included on the integrated circuit controller chips 206 of the scanner assembly 110. In some embodiments, the PIM 104 performs preliminary processing of the echo data before relaying the data to the console 106. In an example of such an embodiment, the PIM 104 performs amplification, filtering, and / or aggregation of the data. In an embodiment, PIM 104 also supplies high-voltage and low-voltage DC power to support the operation of device 102, which includes circuitry within scanner assembly 110.

[0034] Processing system 106 receives echo data from scanner assembly 110 via PIM 104 and processes the data to reconstruct an image of the tissue structure in the medium surrounding scanner assembly 110. Console 106 outputs image data such that an image of blood vessel 120 (e.g., a cross-sectional image of blood vessel 120) is displayed on monitor 108. Blood vessel 120 can represent both naturally occurring fluid-filled or surrounded structures and artificially created fluid-filled or surrounded structures. Blood vessel 120 can be inside a patient. Blood vessel 120 can be a blood vessel, such as an artery or vein of a 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, lungs), tubes, intestines, nervous system structures (including the brain, dura mater, spinal cord, and peripheral nerves), urinary tract, and valves in the blood, ventricles, 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 man-made structures, such as, but not limited to, heart valves, stents, shunts, filters and other devices.

[0035] In some embodiments, the IVUS device includes features similar to those of conventional solid-state IVUS catheters, such as those available from Royal Philips Public Company Limited. The conduits and those disclosed in U.S. Patent 7,846,101 are incorporated herein by reference in their 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 is capable of including multiple conductors, including one, two, three, four, five, six, seven, or more conductors 218. Figure 2 Additionally, in some embodiments, the IVUS device 102 includes multiple transmission harnesses, each comprising multiple conductors with different dimensions (e.g., gauges), insulation materials, and / or other structural and electrical characteristics. It should be understood that any suitable gauge wire can be used for conductor 218. In embodiments, cable 112 can include a four-conductor transmission line arrangement using, for example, 41AWG gauge wire. In embodiments, cable 112 can include a seven-conductor transmission line arrangement using, for example, 44AWG gauge wire. In some embodiments, 43AWG gauge wire can be used.

[0036] The transmission harness 112 passes through or connects to cable 113, which terminates at a PIM connector 114 at the proximal end of device 102. PIM connector 114 electrically couples the transmission harness 112 to PIM 104 and physically couples the IVUS device 102 to PIM 104. In embodiments, IVUS device 102 also includes a guidewire exit 116. Thus, in some instances, the IVUS device is a quick-change catheter. Guidewire exit 116 allows for distal insertion of guidewire 118 to guide device 102 through blood vessel 120.

[0037] In an embodiment, processing system 106 generates flow data by processing echo signals from IVUS device 102 into Doppler power or velocity information. Processing system 106 can also generate B-mode data by applying envelope detection and logarithmic compression to the modulated echo signals. Processing system 106 is also capable of generating images of various views (e.g., 2D and / or 3D views) based on the flow data or B-mode data. Processing system 106 is also capable of performing various analyses and / or evaluations. For example, processing system 106 can apply virtual histology (VH) technology to, for example, analyze or evaluate plaque within a blood vessel (e.g., vessel 120). Images can be generated to display reconstructed color-coded histological maps of plaque components superimposed on a cross-sectional view of the blood vessel.

[0038] In an embodiment, the processing system 106 can apply a blood flow detection algorithm to determine the movement of blood flow, for example, by repeatedly acquiring image data of a target area (e.g., blood vessel 120) and determining the movement of blood flow based on that image data. The blood flow detection algorithm operates on the principle that signals measured from vascular tissue are relatively static between different acquisitions, while signals measured from blood flow change at a characteristic rate corresponding to flow velocity. Therefore, the blood flow detection algorithm can determine the movement of blood flow based on changes in signals measured from the target area between repeated acquisitions. To repeatedly acquire image data, the processing system 106 can control the device 102 to emit repeated pulses at the same aperture.

[0039] 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 also be implemented in any suitable ultrasound imaging system, including synthetic aperture ultrasound, phased array ultrasound, or any other array-based ultrasound imaging system. For example, 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 when positioned near and / or in contact with the patient's skin. In some embodiments, the ultrasound imaging device can be a transthoracic echocardiography (TTE) imaging device.

[0040] An ultrasonic transducer array in an ultrasonic imaging device 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 can include 2 to 10,000 acoustic elements, such as 2, 4, 64, 128, 500, 812, 3,000, 9,000, and / or larger or smaller numbers of acoustic elements. In some instances, the transducer elements of the array can be arranged in any suitable configuration, such as linear arrays, planar arrays, curved arrays, wavy arrays, circular arrays, ring 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 uniformly or independently controlled and activated. This array can be configured to acquire one-dimensional, two-dimensional, and / or three-dimensional images of the patient's anatomy.

[0041] 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 electronic circuitry (e.g., are electrically coupled to electronic circuitry). For example, the electronic circuitry may include one or more transducer control logic dies. 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 may include a multiplexer circuit (MUX).

[0042] Figure 1B This is a schematic diagram of a processor circuit 150 according to an embodiment of the present disclosure. The processor circuit 150 can... Figure 1A The processor circuitry 150 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 or indirectly with each other, for example, via one or more buses.

[0043] Processor 160 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, an FPGA, another hardware device, a firmware device, or any combination thereof, configured to perform the operations described herein. Processor 160 may 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 combined with a DSP core, or any other such configuration.

[0044] Memory 164 may include cache memory (e.g., 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 storage devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In embodiments, memory 164 includes a non-transient computer-readable medium. Memory 164 may store instructions 166. Instructions 166 may include, when executed by processor 160, causing processor 160 to perform actions described herein with reference to processing system 106 and / or imaging device 102 (…). Figure 1A Instructions describing operations. 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(s). 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 multiple computer-readable statements.

[0045] The communication module 168 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect data communication between the processor circuitry 150, the imaging device 102, and / or the display 108. In this respect, the communication module 168 can be an input / output (I / O) device. In some instances, the communication module 168 facilitates direct data communication between the processor circuitry 150 and / or the processing system 106. Figure 1A Direct or indirect communication between various components.

[0046] Figure 2 This is a schematic top view of a portion of the flexible component 200 according to various aspects of this disclosure. The flexible component 200 includes a transducer array 124 formed in a transducer region 204 and transducer control logic dies 206 (including dies 206A and 206B) formed in a control region 208, with a transition region 210 disposed therebetween.

[0047] The transducer control logic die 206 is mounted on a flexible substrate 214 in which the transducer 212 has been previously integrated. The flexible substrate 214 is... Figure 2 The middle part is shown as a flat structure. Although Figure 2 The diagram shows six control logic chips 206, 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.

[0048] A flexible substrate 214, on which transducer control logic die 206 and transducer 212 are mounted, provides structural support and interconnection for electrical coupling. The flexible substrate 214 can be constructed comprising a flexible polyimide material (e.g., KAPTON). TM (DuPont trademark) thin film layer. Other suitable materials include polyester film, polyimide film, polyethylene naphthalate film or polyetherimide film, liquid crystal polymer, other flexible printed semiconductor substrates, and such as (A registered trademark of UbeIndustries) and Products such as (EIdu Pont's registered trademark). 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 wrap around the support member 230 ( Figure 3 Therefore, the thickness of the thin film layer on the flexible substrate 214 is typically related to the curvature of the ultimately assembled flexible component 200. In some embodiments, the thin film layer is between 5 micrometers and 100 micrometers, wherein some specific embodiments are between 5 micrometers and 25.1 micrometers, for example, 6 micrometers.

[0049] The transducer control logic die 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 dimensional dimensions (e.g., lengths 225, 227, 229) of the transducer region 204, control region 208, and transition region 210 may differ. 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.

[0050] The control logic die 206 is not necessarily homogeneous. In some embodiments, a single controller is designated as the master control logic die 206A and includes a communication interface for a transmission harness 112, which can act as an electrical communication bus between the processing system (e.g., processing system 106) and the flexible component 200. Therefore, the master control circuitry may include control logic units that decode control signals received via the transmission harness 112, transmit control responses via the transmission harness 112, amplify echo signals, and / or transmit echo signals via the transmission harness 112. The remaining controllers are slave controllers 206B. Slave controller 206B may include control logic units that drive transducers 212 to emit ultrasonic signals and select transducers 212 to receive echoes. In the depicted embodiment, the master controller 206A does not directly control any transducer 212. In other embodiments, the master controller 206A drives the same number of transducers 212 as the slave controllers 206B, or drives a reduced number of transducers 212 compared to the slave controllers 206B. In an exemplary embodiment, a single master controller 206A and eight slave controllers 206B are provided with eight transducers, which are assigned to each slave controller 206B.

[0051] To electrically interconnect the control logic die 206 with the transducer 212, in one embodiment, the flexible substrate 214 includes conductive traces 216 formed in a thin film layer, the conductive traces 216 carrying signals between the control logic die 206 and the transducer 212. Specifically, the conductive traces 216 providing communication between the control logic die 206 and the transducer 212 extend along the flexible substrate 214 within the transition region 210. In some instances, the conductive traces 216 can also facilitate electrical communication between the master controller 206A and the slave controller 206B. The conductive traces 216 can also provide a set of conductive pads that contact the conductors 218 of the transmission harness 112 when the conductors 218 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, electroplating, and etching. In this embodiment, the flexible substrate 214 includes a chromium adhesive layer. The width and thickness of the conductive traces 216 are selected to provide appropriate conductivity and flexibility when the flexible substrate 214 is rolled up. At this point, an exemplary range for the thickness of the conductive traces 216 and / or conductive pads is between 1 and 5 micrometers. For example, in this embodiment, 5-micrometer conductive traces 216 are spaced 5 micrometers apart. The width of the conductive traces 216 on the flexible substrate can be further determined by the width of the conductors 218 to be coupled to the traces / pads.

[0052] In some embodiments, the flexible substrate 214 may include a conductor interface 220 (e.g., a solder pad). The conductor interface 220 may be a location on the flexible substrate 214 where conductors 218 of the transmission harness 112 are coupled to the flexible substrate 214. For example, bare conductors of the transmission harness 112 are electrically coupled to the flexible substrate 214 at the conductor interface 220. The conductor interface 220 may be a protrusion extending from the body of the flexible substrate 214. In this respect, the body of the flexible substrate 214 may be collectively referred to as 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 in other portions of the flexible substrate 214 (e.g., the distal portion 221), or the flexible substrate 214 may not have the conductor interface 220. The dimensional dimension (e.g., width 224) of the protrusion or conductor interface 220 can be smaller than the dimensional dimension (e.g., width 226) of the body of the flexible substrate 214. In some embodiments, the substrate forming the conductor interface 220 is made of the same (or one or more) materials as the flexible substrate 214 and / or has similar flexibility to the flexible substrate 214. In other embodiments, the conductor interface 220 is made of a different material and / or is more rigid than the flexible substrate 214. For example, the conductor interface 220 can be made of plastic, thermoplastic, polymer, rigid polymer (including polyoxymethylene (e.g., ...). It is made of materials such as polyetheretherketone (PEEK), nylon, liquid crystal polymer (LCP) and / or other suitable materials.

[0053] Figure 3 The illustration shows a perspective view of device 102, where the scanner component 200 is in a rolled-up configuration. In some instances, component 200 is in a flat configuration (…). Figure 2 ) transforms into a rolled-up structure or a more cylindrical structure. Figure 3 For example, in some embodiments, techniques disclosed in U.S. Patent 6,776,763 entitled “ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THESAME” and U.S. Patent 7,226,417 entitled “HIGH RESOLUTION INTRAVASCULAR ULTRASOUNDSENSING ASSEMBLY HAVING AFLEXIBLE SUBSTRATE” are utilized, the entire contents of each of these patents being incorporated herein by reference.

[0054] In some embodiments, transducer element 212 and / or controller 206 can be positioned in an annular configuration (e.g., circular or polygonal configuration) about the longitudinal axis 250 of support member 230. It should be understood that the longitudinal axis 250 of support member 230 can also be referred to as the longitudinal axis of scanner assembly 200, flexible elongated member 121, and / or device 102. For example, the cross-sectional profile of imaging assembly 200 at transducer element 212 and / or controller 206 can be circular or polygonal. (E.g., based on the number of controllers / transducers, the flexibility of the controllers / transducers, etc.) Any suitable annular polygonal shape (including pentagons, hexagons, heptagons, octagons, nonagons, decagons, etc.) can be implemented. In some examples, multiple transducer controllers 206 can be used to control multiple ultrasound transducer elements 212 to obtain imaging data associated with blood vessel 120.

[0055] In some instances, support member 230 may be referred to as a monolith. Support member 230 may be constructed of a metallic material (e.g., stainless steel) or a non-metallic material (e.g., plastic or polymer) (such as the plastic or polymer described in U.S. Provisional Application ('220) US 61 / 985220, filed April 28, 2014, “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 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, the support member 230 can be machined and / or electrochemically machined or laser milled (e.g., by removing material from the blank to form the support member 230), or molded (e.g., by injection molding process).

[0056] Figure 4This is a schematic cross-sectional side view of the distal portion (including the flexible substrate 214 and support member 230) of an intraluminal imaging device 102 according to various aspects of this disclosure. In some instances, the support member 230 may be referred to as a monolith. The support member 230 may be constructed of a metallic material (e.g., stainless steel) or a non-metallic material (e.g., plastic or polymer) (such as the plastic or polymer described in U.S. Provisional Application US 61 / 985220, filed April 28, 2014, “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 116 and is sized and shaped to receive a guidewire 118. Figure 1A The support member 230 can be manufactured according to any suitable process. For example, the support member 230 can be machined and / or electrochemically machined or laser milled (e.g., by removing material from a blank to form the support member 230), or molded (e.g., by an injection molding process). In some embodiments, the support member 230 can be integrally formed as a single structure, while in other embodiments, the support member 230 can be formed from different components (e.g., collars and supports 242, 244) fixedly coupled 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 combined as a single unit, as is the case, for example, in the case of a polymer support member.

[0057] Vertically extending supports 242 and 244 are provided at the distal and proximal portions 262 and 264 of the support member 230, respectively. Supports 242 and 244 elevate and support the distal and proximal portions of the flexible substrate 214. At this point, portions of the flexible substrate 214 (e.g., transducer portions or region 204) can be spaced apart from the central body portion of the support member 230 extending between supports 242 and 244. Supports 242 and 244 can have the same or different outer diameters. For example, the distal support 242 can have a larger or smaller outer diameter than the proximal support 244, and can also have special 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. Liquid backing material 246 can 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 a liquid backing material 246 is fed 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 solidified to allow for curing and setting. In various embodiments, the support member 230 may include two or more supports 242, 244, include only one of the supports 242, 244, or exclude either 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.

[0058] In some embodiments, the support member 230 can be substantially cylindrical. Other shapes of the support member 230 are also contemplated, including geometrical, non-geometric, symmetrical, asymmetrical, and cross-sectional profiles. When used herein, the shape of the support member 230 may refer to the cross-sectional profile of the support member 230. In other embodiments, different portions of the support member 230 can be of various shapes. For example, the proximal portion 264 can have an outer diameter larger than that of 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) can increase or decrease accordingly with a change in the outer diameter. In other embodiments, while the outer diameter changes, the inner diameter of the support member 230 remains constant.

[0059] The inner member 256 and the outer member 254 (e.g., an outer shaft) are coupled to the proximal portion 264 of the support member 230. The inner member 256 and / or the outer member 254 can be included in a flexible elongated member (e.g., flexible elongated member 121). For example, the illustrated inner member 256 and / or the outer member 254 can represent the distal end of the flexible elongated member 121. For this purpose, the coupling between the inner member 256 and / or the outer member 254 and the support member 230 can represent the engagement between the flexible elongated member 121 and the scanner assembly 110. The inner member 256 can be received within the proximal flange 234. The outer member 254 abuts 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 can abut and contact the flexible substrate 214 and the support 242. The distal component 252 can be the most distal component of the intraluminal imaging device 102.

[0060] One or more adhesives can be disposed between the 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 external member 254 can be coupled to each other via adhesives.

[0061] Conductor interface 220 is positioned near the end of substrate 214 and provides electrical contact for transmission harness 112. As described above, transmission harness 112 may include a plurality of conductors configured to transmit signals to and from electronic components positioned on the substrate. The conductors of transmission harness 112 are sized, shaped, and otherwise configured to be positioned within space 266 between outer member 254 and inner member 256.

[0062] As described above, the available space within the elongated body of the conduit (e.g., within the external member 254) is limited. One method for positioning the conductors of the transmission harness 112 within the limited space of the conduit is to use a single set of small-gauge wires or strips that span the entire length of the conduit from the scanner assembly to the PIM. The conductors of the harness 112 can be bundled together to form one or more twisted pairs, quads, stranded bundles, or other conductor arrangements. In some embodiments, one or more conductors are untwisted, such that the conductors extend parallel to one or more conductors or stranded bundles of conductors.

[0063] It should be understood that although the embodiments described below include IVUS imaging catheters, the structural features and / or arrangements described herein are contemplated for use with other types of intraluminal devices, including sensing catheters, guiding catheters, imaging probes, sensing probes, or any other suitable type of device.

[0064] As described herein, the endovascular imaging device 102 may include a scanner assembly 110 that may be coupled to an external member 254 (e.g., a flexible elongated member), such as a catheter body. Furthermore, in some embodiments, the scanner assembly 110 may be more rigid than the external member 254. For example, the flexible substrate 214, electrical and / or acoustic components coupled to the flexible substrate 214 (e.g., one or more integrated circuit controller chips 206, transducer array 124, etc.), and / or support member 230 may not be as easily bent as the external member 254. Therefore, when the endovascular imaging device 102 is navigated (e.g., manipulated) through a patient's vascular system, the scanner assembly 110 can more easily maintain its shape, while the external member 254 can be bent or deformed, such as... Figures 5A-5C As shown.

[0065] Now go to Figures 5A-5C , Figures 5A-5C The illustration shows an example of an intraluminal imaging device 102 curved along a radius of curvature of 300°. For illustrative purposes, Figure 5A and Figure 5B A simplified example of an intraluminal imaging device 102 is illustrated, which includes a scanner assembly 110 and an external component 254. Figure 5C The exemplary endovascular imaging device 102 illustrated in the figure includes a scanner assembly 110, an external component 254, a transmission harness 112, and a conductor interface 220. Additionally, the radius of curvature 300 may correspond to a bend (e.g., a curve or other tortuosity) in the patient's vascular system. More specifically, the radius of curvature 300 may correspond to the radius of curvature to which the endovascular imaging device 102 may bend in order to navigate through a tortuous vascular system (e.g., the cardiac vascular system).

[0066] like Figure 5AAs shown, bending of the intraluminal imaging device 102 along the radius of curvature 300 may cause a kink 310 in the external member 254, which may not be as rigid as the scanner assembly 110. In some cases, the kink 310 may prevent the intraluminal imaging device 102 from advancing through the patient's vascular system. Additionally or alternatively, the kink 310 may cause imaging malfunctions, electronic malfunctions, and / or mechanical malfunctions of the intraluminal imaging device 102. For example, the external member 254 may exert pressure on one or more conductors of the transmission harness 112 via the kink 310, which may damage or destroy these conductors. As a result, communication of power signals, data signals, and / or control signals with the scanner assembly 110 may be prevented, which may interrupt operations performed at the scanner assembly 110 (e.g., intraluminal imaging).

[0067] Therefore, in some embodiments, the reinforcing layer 320 (e.g., a wall or coating) can be used to reinforce the external member 254, such as Figure 5B and Figure 5C As shown. In some embodiments, for example, the reinforcing layer 320 may be a polymer, such as a thermoplastic elastomer (e.g., ...). (ARKEMA's registered trademark), which can be coupled to the outer member 254 via thermal reflow. That is, for example, the reinforcing layer 320 and the outer member 254 can be heated (e.g., melted) so that the material of the reinforcing layer 320 is fused (e.g., bonded) together with the material of the outer member 254.

[0068] The reinforcing layer 320 advantageously provides a transition in stiffness (e.g., flexibility) from the outer member 254 to the scanner assembly 110. For example, a region of the outer member 254 lacking the reinforcing layer 320 may have a first hardness, a region of the outer member 254 coupled to the reinforcing layer 320 via thermal reflow may have a second hardness greater than the first hardness, and the scanner assembly 110 may have a third hardness greater than the second hardness. Materials with relatively high hardness may have relatively low flexibility (e.g., high stiffness), and vice versa. In some embodiments, regions of the outer member 254 having the first hardness may be adjacent to regions of the outer member 254 having the second hardness (e.g., regions reinforced by the reinforcing layer) and the scanner assembly 110, and regions of the outer member 254 having the second hardness may be between regions of the outer member 254 having the first hardness and the scanner assembly 110, such that the outer member 254 includes a stiffness variation adjacent to the scanner assembly 110.

[0069] Additionally, in some embodiments, the reinforcing layer 320 can alter the stiffness of the outer member 254 by having a relatively lower stiffness (e.g., measured stiffness) than the outer member 254. Specifically, the reinforcing layer 320 can be selected to create regions with a stiffness less than the scanner assembly 110 and greater than the stiffness of another region in the outer member lacking the reinforcing layer 320. For this purpose, the reinforcing layer 320 (e.g., having a stiffness less than that of the outer member 254) can be selected to advantageously provide a change (e.g., a gradual decrease) in stiffness of the intraluminal imaging device 102 proximal to the scanner assembly 110. Due to the respective material properties (e.g., stiffness / flexibility) of the reinforcing layer 320, the outer member 254, and the scanner assembly 110, the reinforcing layer 320 will not extend the stiffness length of the scanner assembly 110, even though it is additional material surrounding the outer member 254. In the illustrative example, the measured hardness of the outer component 254 may be 70 Shore D, while the measured hardness of the reinforcing layer 320 may be 55 Shore D.

[0070] By coupling the reinforcing layer 320 to the region of the outer member 254 via thermal reflow, the longitudinal strength and stiffness of the region of the outer member 254 can be increased, and the outer member 254 can be more resistant to kinking when bent. For example, for with Figure 5A The case shown has the same radius of curvature of 300. Figure 5B The intraluminal imaging device 102 shown can be bent without kinking. In other words, as shown, the external member 254 reinforced by the reinforcing layer 320 will not kink 310. Therefore, the reinforcing layer 320 can reduce the radius of curvature to which the intraluminal imaging device 102 can be bent without kinking, allowing the imaging device 102 to navigate through sharper turns without kinking. Furthermore, with the increase in longitudinal strength of the region of the external member 254, the intraluminal imaging device 102 can maintain sufficient strength to be propelled through the vascular system.

[0071] Figure 5C The illustration shows that by applying a reinforcing layer 320 to the outer member 254, the conductor interface 220 and the transmission harness 112 can remain undamaged when the intraluminal imaging device 102 is bent along a radius of curvature 300. That is, for example, because the outer member 254 is not kinked, it does not exert pressure (e.g., compression) on the conductor interface 220 or the transmission harness 112. Therefore, in addition to the intraluminal imaging device 102 being able to navigate through a tortuous bend without kinking, the scanner assembly 110 can also remain functional during such navigation. In other words, the intraluminal imaging device 102 can remain functional when it is navigated through a bend at least with the illustrated radius of curvature 300.

[0072] Figure 6 This is an illustrated cross-sectional side view of the distal portion 350 of an exemplary intraluminal imaging apparatus (e.g., intraluminal imaging apparatus 102) according to various aspects of this disclosure. Specifically, Figure 6 The illustration shows the distal portion of an outer member 254 (e.g., an outer shaft), which is reinforced by a reinforcing layer 320 and includes an outwardly flared opening 400. In some embodiments, the outwardly flared opening 400 may be sized to receive a scanner assembly 110. For example, the proximal end of the scanner assembly 110 may be wider than the non-flared portion of the outer member 254, and in such cases, the outwardly flared opening 400 may be shaped to increase the diameter of the outer member 254 from a first diameter to a second diameter to accommodate the diameter of the scanner assembly 110. Additionally or alternatively, the outwardly flared opening 400 may be shaped to receive a conductor interface 220. While the conductor interface 220 is illustrated as having a regular shape (e.g., one or more planar profiles), the conductor interface 220 may alternatively be implemented as an irregular shape and / or curved along a curved path. Examples of conductor interfaces are disclosed in U.S. Patent Application US 63 / 056172, filed July 24, 2020, entitled “CURVED CIRCUIT SUBSTRATE FOR INTRALUMINAL ULTRASOUND IMAGING ASSEMBLY,” the entire contents of which are incorporated herein by reference. Additionally, in some embodiments, adhesive 404 may be used to couple external member 254 to scanner assembly 110. For example, as shown, adhesive 404 may fill the space between the outwardly flared opening 400 and scanner assembly 110. In other embodiments, such as Figure 4 As shown, the external component 254 can maintain a relatively constant diameter.

[0073] As described herein, the reinforcing layer 320 may be formed of a polymer. For example, the reinforcing layer 320 may include polyimide, polyamide, thermoplastic elastomer (such as... Or PTFE). Specifically, the reinforcing layer 320 can be formed of a material that can be coupled (e.g., bonded) to the outer member 254 via thermal reflow (e.g., thermal bonding and / or thermal fusion). Furthermore, as described above, the reinforcing layer 320 can be selected to create a region in the outer member 254 with a hardness less than the hardness of the scanner assembly 110 and greater than the hardness of another region in the outer member lacking the reinforcing layer 320, such that the stiffness of the intraluminal imaging device 102 transitions from a relatively low stiffness (e.g., corresponding to the outer member 254) to a relatively high stiffness (e.g., corresponding to the imaging assembly 110) from proximal to distal. For this purpose, in some embodiments, a material with a hardness less than that of the outer member 254 can be selected for the reinforcing layer 320. In some cases, for example, the measured hardness of the reinforcing layer 320 can be less than or equal to 55 Shore D (e.g., 55D), while the measured hardness of the external component 254 can be greater than or equal to 55 Shore D (e.g., 70D). Additionally, in some cases, the outer member 254 and the reinforcing layer may comprise the same material, for example, the same type of thermoplastic elastomer having correspondingly different hardnesses. For example, the outer member 254 may be made of a material having a first measured hardness. Formed, and the reinforcing layer 320 can be made of materials having a second measured hardness. form.

[0074] like Figure 6As shown, the reinforcing layer 320 may extend over a region of the outer member 254. Specifically, the reinforcing layer 320 may extend to a length 420 corresponding to the length of the region. As an illustrative example, the length 420 may be between 5 millimeters (mm) and 15 mm, including values ​​such as 5 mm, 7 mm, 9 mm, 10 mm, 12 mm, and 15 mm, or other values ​​larger and smaller. In some embodiments, the region of the reinforcing layer 320 and / or the outer member 254 coupled to the reinforcing layer 320 may be spaced apart from the distal end 421 of the outer member 254. For example, length 422 may represent the distance between the reinforcing layer 320 and the outwardly flared opening 400, while length 424 may represent the distance between the reinforcing layer 320 and the distal end 421 of the outer member 254. In some embodiments, length 422 and / or length 424 may be greater than or equal to 1 mm. Specifically, length 422 and / or length 424 may be approximately between 1.0 mm and 1.5 mm. For this purpose, the reinforcement layer 320 may be spaced 1.0 mm to 1.5 mm from the outwardly flared opening 400 of the proximal external member, and / or the reinforcement layer 320 may be spaced 1.0 mm to 1.5 mm from the distal end 421. In some embodiments, spaced the reinforcement layer 320 from the outwardly flared opening 400 (e.g., up to length 422) can minimize the diameter of the intraluminal imaging device 102 at the coupling site between the external member 254 and the scanner assembly 110 (e.g., at the outwardly flared opening 400). Additionally, in some embodiments, the thickness of the reinforcement layer 320 may be greater than or equal to 0.001 inches. For example, the thickness may be between 0.001 inches and 0.005 inches. In particular, the thickness of the reinforcement layer 320 may be selected such that the outer diameter of the region of the external member reinforced by the reinforcement layer 320 does not exceed the outer diameter of the scanner assembly 110. Section 7-7 shows a cross-section through the distal portion of the intraluminal imaging device 102. Figure 7 The cross-section is shown in more detail below.

[0075] As shown, the location and extent of the reinforcing layer 320 can be defined at least partially by lengths 420, 422, and / or 424. Furthermore, the reinforcing layer 320 can be further defined by thickness and material, and it can have a certain degree of stiffness. In some embodiments, a combination of one or more parameters (e.g., lengths 420, 422, and / or 424, thickness, and / or material) can be selected for the reinforcing layer 320 to cause the intraluminal imaging device 102 to exhibit certain properties. In particular, one or more parameters can be selected such that the intraluminal imaging device 102 can bend to a specific radius of curvature without kinking (e.g., at the external member 254). For example, one or more parameters can be selected such that the intraluminal imaging device can bend to a smaller radius of curvature without kinking compared to an intraluminal imaging device lacking the reinforcing layer 320. Additionally, one or more parameters can be selected such that the external member 254 can support the mass of the scanner assembly 110 and / or the mass of the intraluminal imaging device 100 distal to the external member 254. For example, one or more parameters can be selected to provide longitudinal strength that enables the intraluminal imaging device 100 to navigate (e.g., to propel) through the tortuous vascular system.

[0076] In the illustrated embodiment, the extent and positioning of the reinforcement layer 320, influenced by one or both of lengths 420, 422, and / or 424, create a proximal portion 430 of the reinforcement layer extending over the conductor interface 220. More specifically, the illustrated reinforcement layer 320 extends over a portion of the conductor interface 220 where one or more conductors of the transmission harness 112 can be physically and / or electrically coupled to the conductor interface 220. Therefore, the reinforcement layer 320 further extends over at least a portion of one or more conductors of the transmission harness 112. Because the conductor interface 220 can affect the stiffness (e.g., flexibility) of the intraluminal imaging device 102, the reinforcement layer 320 can alter the stiffness of the external member 254 at the proximal end of the conductor interface 220. Specifically, the reinforcement layer 320 can be positioned so that the connection between the transmission harness 112 and the connector interface 220 is not interfered with (e.g., pinched off) by bending of the external member 254 during the navigation of the intraluminal imaging device 102 within the patient's vascular system.

[0077] Figure 7 It comes from Figure 6A schematic cross-sectional perspective view of section 7-7 is provided. As shown, an inner member 256 is visible, the interior of which defines a lumen 236. The cross-sectional perspective view of section 7-7 also includes an outer member 254, the interior of which defines a space 266. A conductor interface 220 is positioned within space 266 and includes a reinforcing layer 320 of thickness 450 directly coupled to the outer member 254. As described herein, the thickness 450 may be greater than or equal to approximately 0.001 inches. Furthermore, although the reinforcing layer 320 is illustrated as a single layer, it will be appreciated that the reinforcing layer 320 may comprise a multi-layer stack having a combined total thickness of 450.

[0078] like Figures 8A-8B As illustrated, the reinforcement layer 320 may be coupled to the flexible elongated member 121 of the intraluminal imaging device 102 at the distal portion 500 of the flexible elongated member, which may include an external member 254 (e.g., an external shaft of the flexible elongated member), as described herein. Figure 8A This is an illustrative schematic diagram of an exemplary intraluminal imaging device 102, which includes a flexible elongated member 121 having a proximal portion 480 and a distal portion 500. Figure 8A As further shown, in some embodiments, the flexible elongated member 121 may be a quick-exchange catheter. For this purpose, the flexible elongated member 121 may include a guidewire inlet 510 and a guidewire outlet 520 positioned within the distal portion 500 of the flexible elongated member. In some cases, the guidewire outlet 520 may be positioned at the distal end of the distal member 252. Furthermore, a reinforcement layer 320 may be coupled to the flexible elongated member 121 distal to the guidewire inlet 510. That is, for example, the reinforcement layer 320 may be positioned between the guidewire inlet 510 and the scanner assembly 110 within the distal portion 500 of the flexible elongated member.

[0079] Figure 8B This is an illustrative schematic diagram of an exemplary intraluminal imaging device 102, in which the flexible elongated member 121 is implemented as an integral exchange catheter. More specifically, in the illustrated example, a guidewire inlet 510 is positioned at the proximal end 540 of the flexible elongated member (e.g., within the proximal portion 480). In this way, the flexible elongated member 121 can be implemented such that it extends along a guidewire (e.g., guidewire 118) from the proximal end 540 to the distal end 550 of the flexible elongated member. Figure 8B As further shown, in embodiments where the flexible elongated member 121 is an integral exchangeable conduit, the reinforcing layer 320 may be positioned in the distal portion 500 of the flexible elongated member. In particular, the reinforcing layer 320 may be spaced apart from and close to the scanner assembly 110.

[0080] In some embodiments, such as Figure 9 As shown, the intraluminal imaging device 102 may include multiple reinforcement layers. Figure 9 This is an illustrated cross-sectional side view of the distal portion 350 of an exemplary intraluminal imaging apparatus (e.g., intraluminal imaging apparatus 102) according to various aspects of this disclosure. Specifically, Figure 9 The illustration shows a first reinforcing layer 320a extending over and coupled to a first region of the outer member 254, and a second reinforcing layer 320b extending over and coupled to a second region of the outer member 254. As shown, when the outer member 254 is engaged with the scanner assembly 110 (e.g., positioned at a distal region of the flexible elongated member 121), the first reinforcing layer 320a and the second reinforcing layer 320b can be positioned near the scanner assembly 110. As described below, one or more parameters associated with the reinforcing layers 320a-320b can be selected, which can affect the characteristics (e.g., stiffness) of the outer member 254. Because the parameters of the first reinforcing layer (e.g., 320a) and the second reinforcing layer (e.g., 320b) and the relationship between their respective parameters can be tuned, the effect on this characteristic can be adjusted more finely in some cases. For example, reinforcement layers 320a-320b can finely adjust the flexibility of the outer member 254 compared to a single reinforcement layer. Additionally, for illustrative purposes, embodiments are illustrated and described with one or two reinforcement layers. However, it will be appreciated that any suitable number of reinforcement layers can be included in the intraluminal imaging device 102.

[0081] In some embodiments, reinforcing layers 320a-320b can transform the stiffness of the external member 254 near the scanner assembly 110. Furthermore, reinforcing layers 320a-320b can transform stiffness uniformly or non-uniformly with respect to each other. That is, for example, reinforcing layers 320a-320b may include similar features or may be different from each other. For example, the lengths of the first reinforcing layer 320a and the second reinforcing layer 320b may be equal, or, as shown, the first reinforcing layer 320a and the second reinforcing layer 320b may have different lengths (e.g., they may extend over regions of different lengths). For example, the shown length 420a of the first reinforcing layer 320a is less than the length 420b of the second reinforcing layer 320b. It will be appreciated that in other embodiments, length 420a may be greater than length 420b. Additionally, reinforcing layers 320a-320b may be composed of the same or different materials. For example, in some embodiments, reinforcing layers 320a-320b may comprise the same type of polymer (e.g., thermoplastic elastomer), or may comprise different types of polymers. Additionally, the hardness of reinforcing layers 320a-320b may be the same or different. In some cases, the hardness of each reinforcing layer in reinforcing layers 320a-320b may be less than the hardness of the outer member 254. Furthermore, the thickness of reinforcing layers 320a-320b may be the same or different.

[0082] As further shown in the figure, the reinforcing layers 320a-320b may be spaced apart from each other. For example, the reinforcing layers 320a-320b may be separated by a distance of up to 600. Alternatively, in some embodiments, the reinforcing layers 320a-320b may be adjacent to each other. Additionally, in some embodiments, one or both of the reinforcing layers 320a-320b may be positioned such that these layers extend at the proximal end of the conductor interface 220. For example, in the illustrated embodiment, the second reinforcing layer 320b extends at the proximal end of the conductor interface 220. Furthermore, as referenced... Figure 6 The length 422 between the distal end of the first reinforcing layer 320a and the outwardly expanding opening 400 and / or the length 424 between the distal end of the first reinforcing layer 320a and the distal end 421 of the outer member 254 can be selected to affect certain characteristics of the outer member 254 (e.g., stiffness).

[0083] Figure 10 This is a flowchart of a method 700 for assembling an intraluminal imaging device according to various aspects of this disclosure. As shown, method 700 includes a number of enumerated steps, but embodiments of method 700 may include additional steps before, after, or between the enumerated steps. In some embodiments, one or more of the enumerated steps may be omitted, one or more of the enumerated steps may be performed in a different order, or one or more of the enumerated steps may be performed simultaneously.

[0084] At step 710, method 700 may include applying a reinforcing layer to a distal portion of the flexible elongated member. For example, the reinforcing layer (e.g., reinforcing layer 320 (FIG. 5)) may be applied to an external member (e.g., external member 254) positioned at the distal portion of the flexible elongated member (e.g., flexible elongated member 121). In some embodiments, applying the reinforcing layer to the distal portion of the flexible elongated member may involve wrapping a layer of material around the flexible elongated member and / or positioning a sleeve around the distal portion of the flexible elongated member. Additionally or alternatively, applying the reinforcing layer may involve depositing the layer, coating the layer, etc., on the distal portion of the flexible elongated member.

[0085] In some embodiments, the flexible elongated member and / or the reinforcing layer may be prepared before the reinforcing layer is applied to the flexible elongated member. For example, the flexible elongated member and / or the reinforcing layer may be cleaned (e.g., wiped with alcohol) or otherwise prepared for coupling. Additionally, the reinforcing layer applied to the flexible elongated member may be selected to modify one or more properties of the flexible elongated member. For example, a region of the flexible elongated member coupled to the reinforcing layer may bend to a radius of curvature different from the radius of curvature to which the region may bend without kinking when it is not coupled to the reinforcing layer. In particular, the reinforcing layer may be selected and / or positioned such that when the region is coupled to the reinforcing layer, the region may bend to a smaller radius of curvature than the radius of curvature to which the region may bend without kinking when it is not coupled to the reinforcing layer (e.g., forming a sharper turn). Therefore, as described herein, applying a reinforcing layer to a flexible elongated member can involve positioning the reinforcing layer such that it is spaced apart from the distal end of the flexible elongated member (e.g., spaced apart from the distal end of an external member at the distal portion of the flexible elongated member). Furthermore, applying the reinforcing layer can involve applying a reinforcing layer having a specific length, thickness, hardness, etc. As an illustrative example, the reinforcing layer may have a length of 7 mm, a thickness greater than or equal to 0.001 inches, a measured hardness less than or equal to 55 Shore D, or a combination thereof. Additionally or alternatively, the characteristics of the reinforcing layer (including positioning) can be selected such that when the flexible elongated member is engaged (e.g., coupled) with an imaging assembly (e.g., scanner assembly 110), the reinforcing layer extends proximally at the conductor interface (e.g., conductor interface 220). Additionally, the characteristics of the reinforcing layer can be selected such that the hardness of the reinforcing layer is less than the hardness of the region in the flexible elongated member to which the reinforcing layer is applied.

[0086] At step 720, method 700 may involve thermally reflowing (e.g., bonding and / or fusion) the reinforcing layer with the flexible elongated member (e.g., with an external member of the flexible elongated member). More specifically, method 700 may involve coupling the reinforcing layer with a region of the flexible elongated member (e.g., a region within the distal portion of the flexible elongated member) via thermal reflow (e.g., thermal bonding). For this purpose, the materials of the reinforcing layer and the region of the flexible elongated member may be heated (e.g., melted) such that the reinforcing layer and the region of the flexible elongated member are fused together. For example, in some embodiments, thermally reflowing the reinforcing layer may involve using a thermal split die bonder that can heat the reinforcing layer and / or the region. As an illustrative example, the reinforcing layer and / or the region may be heated to a temperature of 375°F for 15 seconds to affect the thermal reflow.

[0087] At step 730, method 700 may involve engaging a distal portion of a flexible elongated member to a proximal portion of a scanner assembly (e.g., scanner assembly 110). More specifically, method 700 may involve engaging a distal portion of a flexible elongated member to a proximal portion of the scanner assembly, the distal portion including an area to which a reinforcing layer is coupled and extends. Engaging the distal portion of the flexible elongated member to the proximal portion of the scanner assembly may involve sliding an outwardly flared opening at the distal end of the flexible elongated member onto the proximal portion of the scanner assembly. This engagement may also involve applying an adhesive such that the flexible elongated member is securely coupled to the scanner assembly. For example, an adhesive may be applied between the flexible elongated member and the scanner assembly within the outwardly flared opening. Additionally or alternatively, any other suitable method for engaging the flexible elongated member to the scanner assembly may be employed, such as thermal coupling, press fit, interference fit, clamping, etc.

[0088] Although the joining of the distal portion of the flexible elongated member to the proximal portion of the scanner assembly is illustrated and described herein as occurring after the application of a reinforcing layer and coupling (e.g., fusion) to the flexible elongated member via thermal reflow, the embodiments are not limited thereto. For example, in some embodiments, the reinforcing layer may be applied and / or coupled to the flexible elongated member via thermal reflow after joining the flexible elongated member to the scanner assembly. Additionally, it will be appreciated that the flexible substrate of the scanner assembly (e.g., flexible substrate 214) may be wound around a support member (e.g., support member 230) prior to joining the flexible elongated member to the scanner assembly.

[0089] Those skilled in the art will recognize that this disclosure advantageously provides an intraluminal imaging system capable of achieving both maneuverability and flexibility in navigating an imaging component through the human vascular system. In particular, the intraluminal imaging system enables the imaging component to traverse tortuous vascular systems by preventing portions of the imaging component from twisting along sharp bends. The logical operations constituting embodiments of the technology described herein are referred to differently as operations, steps, objects, elements, components, regions, etc. Furthermore, it should be understood that these logical operations may occur in any order unless otherwise expressly stated or the language of the claims inherently requires a specific order.

[0090] It should also be understood that the described techniques can be used in a variety of different applications, including but not limited to human medicine, veterinary medicine, education, and examination. All directional references (e.g., up, down, inside, outside, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal) are used for identification purposes only to help the reader understand the claimed subject matter and do not create limitations, particularly regarding the location, orientation, or use of the endoluminal imaging system. Unless otherwise stated, connection references (e.g., attachment, coupling, connection, and engagement) should be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. Therefore, a connection reference does not necessarily mean that two elements are directly connected and fixed to each other. The term “or” should be interpreted as “and / or”, not “exclusive or”. The word “comprising” does not exclude other elements or steps, and the words “a” or “an” do not exclude multiple. Unless otherwise stated in the claims, the values ​​recorded should be interpreted as illustrative only and should not be considered limiting.

[0091] Those skilled in the art will recognize that the above-described apparatus, system, and method can be modified in various ways. Therefore, those skilled in the art will realize that the embodiments covered by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, although exemplary embodiments have been shown and described, various modifications, alterations, and substitutions are conceived 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 claims be interpreted broadly in a manner consistent with this disclosure.

Claims

1. An intraluminal imaging device, comprising: A flexible, elongated member configured to be positioned within a patient's body lumen, the flexible, elongated member comprising a proximal portion and a distal portion; An ultrasound scanner assembly configured to acquire ultrasound imaging data when positioned within the body lumen, wherein the ultrasound scanner assembly is coupled to and positioned distal to the distal portion of the flexible elongated member, wherein the distal portion of the flexible elongated member comprises a first polymer having a first stiffness; and A reinforcing layer that extends only on and directly contacts only the region of the distal portion of the flexible elongated member, wherein the reinforcing layer comprises a second polymer having a different second hardness.

2. The device according to claim 1, wherein, The region and the reinforcement layer are coupled via thermal reflow.

3. The device according to claim 1, wherein, The region is spaced apart from the distal end of the distal portion of the flexible elongated member on the proximal side.

4. The device according to claim 3, wherein, The region is spaced at least 1 mm from the distal end of the distal portion of the flexible elongated member.

5. The device according to claim 1, wherein, The second hardness is less than the first hardness.

6. The device according to claim 1, wherein, The reinforcing layer comprises a thermoplastic elastomer.

7. The device according to claim 1, wherein, The reinforcement layer has a thickness of 0.001 inches or more.

8. The device according to claim 1, wherein, The ultrasound scanner assembly includes a conductor interface, wherein a proximal portion of the reinforcement layer extends over the conductor interface.

9. The device of claim 8, further comprising a plurality of conductors coupled to a proximal portion of the conductor interface, wherein, The reinforcing layer extends over the plurality of conductors.

10. The device according to claim 1, wherein, The distal end of the flexible elongated member includes an outwardly flared opening.

11. The device according to claim 10, wherein, The region is separated from the outwardly expanding opening on the proximal side.

12. The device according to claim 1, wherein, The intraluminal imaging device is a rapid-exchange catheter including a guidewire inlet, wherein the guidewire inlet is disposed within the distal portion of the flexible elongated member, and wherein the region is located distal to the guidewire inlet.

13. The device of claim 1, further comprising an additional reinforcing layer extending only over an additional region of the distal portion of the flexible elongated member and in direct contact only with said additional region, wherein, The additional reinforcement layer includes a third hardness, which is different from the first hardness.

14. The device according to claim 1, wherein, The flexible elongated member is configured to bend to a certain radius of curvature within a tortuous vascular system, and wherein the reinforcing layer is configured to reduce the radius of curvature to which the region of the flexible elongated member can bend within the tortuous vascular system without kinking.

15. An intravascular ultrasound (IVUS) imaging catheter, comprising: A catheter body configured to be positioned within a patient's blood vessel, the catheter body comprising a proximal portion and a distal portion; An ultrasound scanner assembly comprising a circumferential array of acoustic elements configured to acquire ultrasound imaging data when positioned within the blood vessel, wherein the ultrasound scanner assembly is coupled to and positioned distal to the distal portion of the catheter body, wherein the distal portion of the catheter body comprises a first polymer having a first rigidity; and A reinforcing layer extends only over and directly contacts the distal portion of the catheter body, wherein the reinforcing layer comprises a second polymer having a second hardness less than the first hardness, such that the region can bend within the tortuous portion of the blood vessel without kinking.

Images