Flexible tips for intracavitary imaging devices and related devices, systems, and methods

Abstract

An intracavity imaging device is provided. The device includes a flexible elongate member configured to be inserted into a patient's lumen, the flexible elongate member having a proximal portion and a distal portion. The device includes an ultrasound imaging assembly disposed in the distal portion and configured to acquire ultrasound imaging data while positioned in the patient's lumen. The device includes a tip member disposed in the distal portion of the flexible elongate member, the tip member including a cavity configured to be filled with an adhesive adjacent to the ultrasound imaging assembly to couple the tip member and the ultrasound imaging assembly. The tip member may include a first material and a second material. The tip member may include a linear outer diameter and a varying wall thickness, or a varying outer diameter and a constant wall thickness.

Description

Technical Field

[0001] Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 595,744, filed Dec. 7, 2017, which is incorporated herein by reference in its entirety.

[0002]

[0001] This disclosure generally relates to intravascular ultrasound imaging, and more particularly to the structure of intravascular imaging devices. For example, an intravascular imaging device may include a flexible tip at a distal end of a flexible elongate member.

Background Art

[0003]

[0002] Intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool for evaluating diseased blood vessels within the human body, such as arteries, to determine the need for treatment, guide an intervention, and / or evaluate the effectiveness of the intervention. An IVUS device that includes one or more ultrasound transducers is passed into a blood vessel and guided to the area to be imaged. The transducer emits ultrasonic energy to generate an image of the blood vessel of interest. The ultrasonic waves are partially reflected by discontinuities arising from tissue structures (such as the various layers of the blood vessel wall), red blood cells, and other features of interest. The echoes from the reflected waves are received by the transducer and sent to an IVUS imaging system. The imaging system processes the received ultrasonic echoes to generate a cross-sectional image of the blood vessel in which the device is placed.

[0004]

[0003] Solid-state (also known as synthetic aperture) IVUS catheters are one of two types of IVUS devices commonly used today, the other being the rotating IVUS catheter. A solid-state IVUS catheter comprises a scanner assembly containing an array of ultrasonic transducers, which are distributed around the periphery of the scanner assembly along with one or more integrated circuit controller chips mounted adjacent to the transducer array. The controllers select individual transducer elements (or sets of elements) to transmit ultrasonic pulses and to receive ultrasonic echo signals. Stepping through a sequence of transmit-receive pairs allows a solid-state IVUS system to synthesize the effects of mechanically scanned ultrasonic transducers without moving any 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 while 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 using simple electrical cables and standard detachable electrical connectors, rather than the complex rotary electrical interfaces required for rotary IVUS devices. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005]

[0004] It is difficult to manufacture intravascular imaging devices that efficiently traverse physiological functions within the human body. In this regard, the distal components of imaging devices may be assembled in a way that excessively enlarges the outer circumference, making navigation through smaller diameter vessels difficult. Ensuring robust mechanical connections between components can also be difficult. [Means for solving the problem]

[0006]

[0005] Intracavitary imaging devices are inserted into the human body to acquire information about the state of various anatomical structures within it. For example, intracavitary imaging devices such as intravascular ultrasound (IVUS) devices can be introduced into the body through blood vessels and then guided to an area of ​​anatomical interest. Intracavitary imaging devices commonly encounter various obstacles as they travel through the body. To address this, the anterior end of the intracavitary imaging device is equipped with a tip member to facilitate the navigation of the intracavitary imaging device through the body. The shape of the outer contour of the tip member is conical, and its diameter decreases from the anterior end to the posterior end of the tip member. The anterior end of the tip member is formed using a material that has greater flexibility than the material used to form the posterior end of the tip. The tip member is connected to the intracavitary imaging device by applying adhesive around each of its outer contours. To minimize the effect of the adhesive on the outer contours of the tip member and the intracavitary imaging device, a cavity is formed at the proximal end of the tip member to receive the adhesive. The cavity functions to provide both connection and sealing between the intracavitary imaging device and the tip member. The contour and flexible properties of the tip component assist the intracavitary imaging device in navigating obstacles when it is being guided within the body. Advantageously, the embodiments described herein advantageously minimize the outer diameter of the imaging assembly while achieving robust and efficient assembly and operation.

[0007]

[0006] In an exemplary embodiment, an intracavitary imaging device is provided. The device includes a flexible elongated member configured to be inserted into a patient's lumen, the flexible elongated member having a proximal portion and a distal portion; an ultrasound imaging assembly positioned in the distal portion and configured to acquire ultrasound imaging data while positioned in the patient's lumen; and a tip member positioned in the distal portion of the flexible elongated member, adjacent to the ultrasound imaging assembly and having a cavity configured to be filled with an adhesive to bond the tip member and the ultrasound imaging assembly.

[0008]

[0007] In some embodiments, the cavity has a connecting region in the proximal portion of the tip member, and the cavity has a smaller outer diameter than the proximal portion of the tip member. In some embodiments, the cavity has a linear outer diameter. In some embodiments, the cavity further has an inclined outer diameter. In some embodiments, the distal portion of the tip member has an intersection region configured to intersect with the occlusion of the lumen, and the outer diameter of the intersection region decreases along the longitudinal axis of the flexible slender member. In some embodiments, the intersection region of the tip member has a linear outer diameter. In some embodiments, the intersection region of the tip member has a curved outer diameter. In some embodiments, the distal end of the tip member is formed in a shape that facilitates intersection with the occlusion. In some embodiments, the distal end of the tip member has a linear outer diameter. In some embodiments, the distal end of the tip member has a curved outer diameter. In some embodiments, the distal end of the tip member is provided with a reinforcing device. In some embodiments, the reinforcing device has a first color, and the tip member has a second color different from the first color. In some embodiments, the proximal portion of the tip member is made of a first material, and the distal portion of the tip member is made of a second material. In some embodiments, the tip member has an internal diameter extending therein, which is related to a lumen, and this internal diameter has an engaging function configured to contact at least a portion of an ultrasonic imaging assembly located within the lumen.

[0009]

[0008] In an exemplary embodiment, an intracavitary imaging device is provided. The device includes a flexible elongated member configured to be inserted into the lumen of a patient, the flexible elongated member having a proximal portion and a distal portion; an ultrasound imaging assembly positioned in the distal portion and configured to acquire ultrasound imaging data while positioned in the lumen of a patient; and a tip member of the distal portion of the flexible elongated member, having a first material in the distal portion of the tip member and a second material in the proximal portion of the tip member.

[0010]

[0009] In some embodiments, the first material has less rigidity than the second material such that the distal portion of the tip member has greater flexibility than the proximal portion of the tip member. In some embodiments, the device further includes a transition region between the proximal and distal portions, the transition region consisting of the first material and the second material.

[0011]

[0010] In an exemplary embodiment, an intracavitary imaging device is provided. The device includes a flexible elongated member configured to be inserted into a patient's lumen, the flexible elongated member having a proximal portion and a distal portion; an ultrasound imaging assembly positioned in the distal portion and configured to acquire ultrasound imaging data while positioned in the patient's lumen; and a tip member of the distal portion of the flexible elongated member, having a proximal portion and a distal portion, the proximal portion of the tip member having a linear outer diameter and a varying wall thickness, and the distal portion of the tip member having a varying outer diameter and a constant wall thickness.

[0012]

[0011] In some embodiments, the thickness of the proximal portion of the chip member is greater than the thickness of the distal portion of the chip member.

[0013]

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

[0014]

[0013] Exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings. [Brief explanation of the drawing]

[0015] [Figure 1]

[0014] This is a schematic diagram of an imaging system according to an aspect of the present disclosure. [Figure 2]

[0015] This is a schematic top view of a scanner assembly having a flat configuration according to an aspect of the present disclosure. [Figure 3]

[0016] This is a schematic side view of a scanner assembly with a wrapped configuration around a support member according to an aspect of the present disclosure. [Figure 4]

[0017] A schematic side cross-sectional view of a distal portion of an intravascular device according to an aspect of the present disclosure. [Figure 5a]

[0018] A schematic side cross-sectional view of a tip member joint of an endoluminal device according to an aspect of the present disclosure. [Figure 5b]

[0019] A schematic side cross-sectional view of a tip member joint of an endoluminal device according to an aspect of the present disclosure. [Figure 5c]

[0020] A schematic side cross-sectional view of a tip member of an endoluminal device according to an aspect of the present disclosure. [Figure 6a]

[0021] A perspective view of a tip member of an endoluminal device according to an aspect of the present disclosure. [Figure 6b]

[0022] A schematic side cross-sectional view of a tip member and an imaging assembly according to an aspect of the present disclosure. [Figure 7]

[0023] A schematic side cross-sectional view of a tip member of an endoluminal device according to an aspect of the present disclosure. [Figure 8]

[0024] A schematic side cross-sectional view of a tip member of an endoluminal device according to an aspect of the present disclosure. [Figure 9]

[0025] A side view of a tip member having an inclined type cross-sectional profile according to an aspect of the present disclosure. [Figure 10]

[0026] A side view of a tip member having a sloped type cross-sectional profile according to an aspect of the present disclosure. [Figure 11]

[0027] A side view of a tip member having a stepped type cross-sectional profile according to an aspect of the present disclosure. [Figure 12]

[0028] A schematic side cross-sectional view of a tip member having a chamfered distal end according to an aspect of the present disclosure.. [Figure 13]

[0029] A schematic side cross-sectional view of a tip member having a radially distal end according to an aspect of the present disclosure. [Figure 14]

[0030] This is a schematic side cross-sectional view of a tip member having a reinforced radial distal end according to an aspect of the present disclosure. [Modes for carrying out the invention]

[0016]

[0031] To facilitate understanding of the principles of this disclosure, references are made to embodiments shown in the drawings, and specific terminology is used to describe them. Nevertheless, it is understood that no limitation on the scope of this disclosure is intended. Any changes and further modifications to the devices, systems and methods described, and any further applications of the principles of this disclosure, are fully assumed and included within this disclosure, as would be commonly conceived by those skilled in the art to which this disclosure relates. For example, while the systems described are in relation to cardiovascular imaging, it is understood that they are not intended to be limited to this application. The systems are equally well suited to any application requiring imaging within a limited cavity. In particular, it is fully assumed that features, components and / or steps described in relation to one embodiment may be combined with features, components and / or steps described in relation to other embodiments of this disclosure. However, for the sake of simplification, many repetitions of these combinations are not described separately.

[0017]

[0032] Figure 1 is a schematic diagram of an intracavitary imaging system 100 according to an aspect of the present disclosure. For example, the system 100 may be an intracavitary ultrasound imaging system or an intravascular ultrasound (IVUS) imaging system. The imaging system 100 includes an intracavitary ultrasound imaging device 102 such as a catheter, guidewire, or guidecatheter, a patient interface module (PIM) 104, a processing system or console 106, and a monitor 108.

[0018]

[0033] The IVUS device 102 emits high levels of ultrasound energy from a transducer array 124 contained 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, such as blood vessels 120 surrounding the scanner assembly 110, and the ultrasound echo signal is received by the transducer array 124. The PIM 104 transmits the received echo signal to a console or computer 106, where the ultrasound image (including flow information) is reconstructed and displayed on a monitor 108. The console or computer 106 may include a processor and memory. The computer or computing device 106 is operable to facilitate the features of the imaging system 100 described herein. For example, the processor is capable of executing computer-readable instructions stored in a non-temporary, tangible computer-readable medium.

[0019]

[0034] The PIM 104 facilitates the communication of signals between the console 106 and the scanner assembly 110 included in the IVUS device 102. This communication includes the steps of (1) providing instructions to the integrated circuit controller chips 206A and 206B, shown in Figure 2, included in the scanner assembly 110, to select specific transducer array elements to be used for transmission and reception; (2) providing the integrated circuit controller chips 206A and 206B included in the scanner assembly 110 with a transmit trigger signal to activate the transmitter circuit to generate an electrical pulse and excite the selected transducer array elements; and / or (3) receiving the amplified echo signal received from the selected transducer array elements via an amplifier included in the integrated circuit controller chip 126 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 one embodiment, the PIM 104 also supplies high-voltage and low-voltage DC power to assist the operation of the device 102, which includes the circuitry within the scanner assembly 110.

[0020]

[0035] Console 106 receives echo data from scanner assembly 110 via PIM 104 and processes the data to reconstruct an image of tissue structure in the medium surrounding scanner assembly 110. For example, device 102 may be formed, structurally positioned, and / or otherwise configured to be sized and shaped to be positioned in a lumen 120 of the patient's body. For example, in some embodiments, the body lumen 120 may be a blood vessel. Console 106 outputs image data so that an image of the body lumen 120, such as a cross-sectional image of a blood vessel 120, is displayed on monitor 108. Lumen 120 represents both natural and artificial structures that are filled with or surrounded by fluid. Lumen 120 is located within the patient's body. Lumen 120 is a blood vessel, such as an artery or vein, in the patient's vascular system, including the cardiovascular system, peripheral vascular system, neurovascular system, renal vascular system, etc., and / or any other suitable lumen in the body. For example, device 102 is used to examine any number of anatomical locations and types of tissue, including, but not limited to, organs such as the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures such as the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and valves in the blood, the ventricles or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 is also used to examine artificial structures such as heart valves, stents, shunts, filters, and other devices, but not limited to these.

[0021]

[0036] In various embodiments, the intracavitary imaging device 102 and / or imaging assembly 110 may acquire imaging data related to intravascular ultrasound (IVUS) imaging, forward-view intravascular ultrasound (FL-IVUS) imaging, intravascular photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), forward-view ICE (FLICE), transesophageal echocardiography (TEE), optical coherence tomography (OCT), and / or other appropriate imaging modalities. The system 100 and / or device 102 may also be configured to acquire physiological data related to pressure, flow rate, temperature, fractional flow reserve (FFR) determination, functional measurement determination, coronary flow reserve (CFR) determination, radiographic imaging, angiography, fluoroscopy, computed tomography (CT), magnetic resonance imaging (MRI), intravascular pulpography, and / or other types of physiological data.

[0022]

[0037] In some embodiments, the IVUS device has some features similar to conventional solid-state IVUS catheters, such as the EagleEye® catheter available from Volcano Corporation and disclosed in U.S. Patent No. 7,846,101, which is incorporated herein by reference in whole. For example, the IVUS device 102 includes a scanner assembly 110 near the distal end of the device 102 and a transmission line bundle 112 extending along the longitudinal body of the device 102. The transmission line bundle or cable 112 may include multiple conductors, including one, two, three, four, five, six, seven or more conductors 218 (Figure 2). It is understood that any suitable gauge wire may be used as the conductors 218. In one embodiment, the cable 112 may include a transmission line configuration of four conductors, for example, using 41 AWG gauge wire. In one embodiment, the cable 112 may include a transmission line configuration of seven conductors, for example, using 44 AWG gauge wire. In some embodiments, 43AWG gauge wire may be used.

[0023]

[0038] The transmitting line bundle 112 terminates at a PIM connector 114 at the proximal end of the device 102. The PIM connector 114 electrically connects the transmitting line bundle 112 to the PIM 104 and physically connects the IVUS device 102 to the PIM 104. In one embodiment, the IVUS device 102 further includes a guidewire exit port 116. Thus, in some cases, the IVUS device is a rapid-exchange catheter. The guidewire exit port 116 allows a guidewire 118 to be inserted toward the distal end in order to advance the device 102 through the blood vessel 120.

[0024]

[0039] Figure 2 is a top view of a portion of an ultrasonic scanner assembly 110 according to an embodiment of the present disclosure. The assembly 110 includes a transducer array 124 formed in a transducer region 204 and a transducer control logic die 206 (including dies 206A and 206B) formed in a control region 208, with a transition region 210 positioned between them. The transducer control logic die 206 and transducer 212 are mounted on a flex circuit 214, which is shown in a flat configuration in Figure 2. Figure 3 shows the wound configuration of the flex circuit 214. The transducer array 202 is a non-limiting example of a medical sensor element and / or a medical sensor element array. The transducer control logic die 206 is a non-limiting example of a control circuit. The transducer region 204 is positioned adjacent to the distal portion 221 of the flex circuit 214. The control region 208 is positioned adjacent to the proximal portion 222 of the flex circuit 214. The transition region 210 is located between the control region 208 and the transducer region 204. The dimensions of the transducer region 204, the control region 208, and the transition region 210 (e.g., lengths 225, 227, 229) may vary in various embodiments. In some embodiments, lengths 225, 227, and 229 may be substantially the same, or the length 227 of the transition region 210 may be greater than the lengths 225 and 229 of the transducer region and the control region, respectively. Although the imaging assembly 110 is described as including a flexible circuit, it is understood that the transducers and / or controllers may be arranged in other configurations, including configurations without a flexible circuit, to form the imaging assembly 110.

[0025]

[0040] Although only a limited number of ultrasonic transducers are shown in Figure 2 for clarity, the transducer array 124 may include any number and types of ultrasonic transducers 212. In one embodiment, the transducer array 124 includes 64 individual ultrasonic transducers 212. In a further embodiment, the transducer array 124 includes 32 ultrasonic transducers 212. Other numbers are also conceivable and provided. With respect to the types of transducers, in one embodiment, the ultrasonic transducer 124 is a piezoelectric microfabricated ultrasonic transducer (PMUT) made using polymer piezoelectric material on a microelectromechanical system (MEMS) substrate, for example, as disclosed in whole in U.S. Patent No. 6,641,540, which is incorporated herein by reference. In an alternative embodiment, the transducer array includes piezoelectric zirconate transducers (PZT), such as bulk PZT transducers, capacitive microfabricated ultrasonic transducers (cMUT), single-crystal piezoelectric materials, other suitable ultrasonic transmitters and receivers, and / or combinations thereof.

[0026]

[0041] The scanner assembly 110 includes various transducer control logics, which, in the shown embodiment, are divided into individual control logic dies 206. In various examples, the control logic of the scanner assembly 110 performs the following: decoding control signals sent by the PIM 104 via cable 112, driving one or more transducers 212 to emit ultrasonic signals, selecting one or more transducers 212 to receive reflected echoes of the ultrasonic signals, amplifying the signals representing the received echoes, and / or transmitting signals to the PIM via cable 112. In the shown embodiment, the scanner assembly 110 having 64 ultrasonic transducers 212 divides the control logic across nine control logic dies 206, five of which are illustrated in Figure 2. In other embodiments, designs incorporating other numbers of control logic dies 206, including eight, nine, sixteen, seventeen, and more, are utilized. Generally, the control logic dies 206 are characterized by the number of transducers they can drive, with exemplary control logic dies 206 driving 4, 8, and / or 16 transducers.

[0027]

[0042] The control logic dies are not necessarily homogeneous. In some embodiments, one controller is designated as the master control logic die 206A and includes a communication interface for cable 112. Thus, the master control circuit includes control logic that decodes the control signals received via cable 112, transmits control responses via cable 112, amplifies the echo signals, and / or transmits the echo signals via cable 112. The remaining controllers are slave controllers 206B. The slave controllers 206B include control logic that drives transducers 212 to emit ultrasonic signals and selects transducers 212 to receive echoes. In the illustrated embodiment, the master controller 206A does not directly control any of the transducers 212. In other embodiments, the master controller 206A drives the same number of transducers 212 as the slave controllers 206B, or drives one set of transducers 212, fewer than the slave controllers 206B. In an exemplary embodiment, one master controller 206A and eight slave controllers 206B are provided, and eight transducers are assigned to each slave controller 206B.

[0028]

[0043] The flex circuit 214, to which the transducer control logic die 206 and transducer 212 are mounted, provides structural support and interconnects the electrical coupling. The flex circuit 214 is configured to include a film layer of flexible polyimide material such as KAPTON® (a trademark of Du Pont). Other suitable materials include polyester film, polyimide film, polyethylene naphthalate film, or polyetherimide film, other flexible printed semiconductor substrates, and products such as Upilex® (a registered trademark of Ube Industries) and TEFLON® (a registered trademark of Du Pont). In the planar configuration shown in Figure 2, the flex circuit 214 has an overall rectangular shape. In some cases, as illustrated and described herein, the flex circuit 214 is configured to be wrapped around a support member 230 to form a tubular annular body (Figure 3). Thus, the thickness of the film layer of the flex circuit 214 generally relates to the degree of curvature of the final assembled scanner assembly 110. In some embodiments, the film layer is between 5 μm and 100 μm, and in some specific embodiments, it is between 12.7 μm and 25.1 μm.

[0029]

[0044] In one embodiment, to electrically interconnect the control logic die 206 and the transducer 212, the flex circuit 214 further includes conductive wiring 216 formed on a film layer for carrying signals between the control logic die 206 and the transducer 212. In particular, the conductive wiring 216 providing communication between the control logic die 206 and the transducer 212 extends along the flex circuit 214 within a transition region 210. In some cases, the conductive wiring 216 may also facilitate electrical communication between a master controller 206A and a slave controller 206B. The conductive wiring 216 may also provide a pair of conductive pads that contact the conductors 218 of the cable 112 when the conductors 218 of the cable 112 are mechanically and electrically coupled to the flex circuit 214. Suitable materials for the conductive wiring 216 include copper, gold, aluminum, silver, tantalum, nickel, and tin, which are deposited onto the flex circuit 214 by processes such as sputtering, plating, and etching. In one embodiment, the flexible circuit 214 includes a chromium adhesive layer. The width and thickness of the conductive wiring 216 are selected to provide appropriate conductivity and elasticity when the flexible circuit 214 is wound. In this regard, exemplary ranges of the thickness of the conductive wiring 216 and / or conductive pads are between 10 and 50 μm. For example, in one embodiment, 20 μm conductive wiring 216 are spaced apart by 20 μm of space. The width of the conductive wiring 216 on the flexible circuit 214 is further determined by the width of the conductor 218 coupled to the wiring / pad.

[0030]

[0045] In some embodiments, the flex circuit 214 may include a conductor interface 220. The conductor interface 220 may be a location in the flex circuit 214 such that a conductor 218 of the cable 112 is coupled to the flex circuit 214. For example, the bare conductor of the cable 112 is electrically coupled to the flex circuit 214 at the conductor interface 220. The conductor interface 220 may be a tab extending from the main body of the flex circuit 214. In this regard, the main body of the flex circuit 214 collectively refers to the transducer region 204, the controller region 208, and the transition region 210. In the shown embodiment, the conductor interface 220 extends from the proximal portion 222 of the flex circuit 214. In other embodiments, the conductor interface 220 is located in another part of the flex circuit 214, such as the distal portion 221, or the flex circuit 214 does not have a conductor interface 220. The dimensions of the tab or conductor interface 220, such as a width of 224, may be smaller than the dimensions of the main body of the flex circuit 214, such as a width of 226. In some embodiments, the substrate forming the conductor interface 220 is made of the same material as the flex circuit 214 and / or has similar flexibility. In other embodiments, the conductor interface 220 is made of a different material than the flex circuit 214 and / or is relatively more rigid than the flex circuit 214. For example, the conductor interface 220 may be made of plastics, thermoplastics, polymers, hard polymers, etc., including polyoxymethylene (e.g., DELRIN®), polyetheretherketone (PEEK), nylon, and / or other suitable materials. As will be described in more detail herein, the support members 230, flex circuit 214, conductor interface 220, and / or conductors 218 can be configured in various ways to facilitate the efficient manufacturing and operation of the scanner assembly 110.

[0031]

[0046] In some cases, the scanner assembly 110 transitions from a flat configuration (Figure 2) to a rolled or more cylindrical configuration (Figures 3 and 4). For example, in some embodiments, techniques such as those disclosed in one or more of U.S. Patent No. 6,776,763, titled "ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME," and U.S. Patent No. 7,226,417, titled "HIGH RESOLUTION INTRAVASCULAR ULTRASOUND TRANSDUCER ASSEMBLY HAVING A FLEXIBLE SUBSTRATE," each of which is incorporated herein by reference in its entirety, are utilized.

[0032]

[0047] As shown in Figures 3 and 4, the flex circuit 214 is positioned around the support member 230 in a wound configuration. Figure 3 is a schematic side view of the flex circuit 214 in a wound configuration around the support member 230 according to an aspect of the present disclosure. Figure 4 is a schematic side cross-sectional view of the distal portion of the intravascular device 110, including the flex circuit 214, support member 230, and tip member 304, according to an aspect of the present disclosure.

[0033]

[0048] In some cases, the support member 230 may be referred to as a single structure. The support member 230 may be made of a metallic material such as stainless steel, or of a non-metallic material such as plastic or polymer, as described in U.S. Provisional Patent Application No. 61 / 985,220, filed April 28, 2014, entitled “Pre-Doped Solid Substrate for Intravascular Devices,” which is incorporated herein by reference in its entirety. The support member 230 may be a ferrule having a distal portion 262 and a proximal portion 264. The support member 230 may define a lumen 236 extending longitudinally. The lumen 236 is formed to communicate with the exit port 116 and to receive a guidewire 118 (Figure 1). The support member 230 may be manufactured by any suitable process. For example, the support member 230 may be machined by removing material from a base material to form the support member 230, or it may be molded by an injection molding process, etc. In some embodiments, the support member 230 is formed integrally as a single structure, while in other embodiments, the support member 230 may be formed of various components such as ferrules and stands 242, 244 that are fixedly connected to one another.

[0034]

[0049] Vertically extending stands 242 and 244 are provided on the distal and proximal portions 262 and 264 of the support member 230, respectively. The stands 242 and 244 lift and support the distal and proximal portions of the flex circuit 214. In this regard, portions of the flex circuit 214, such as the transducer portion 204, may be spaced apart from the central body portion of the support member 230 that extends between the stands 242 and 244. The stands 242 and 244 may have the same outer diameter or different outer diameters. For example, the distal stand 242 may have a larger or smaller outer diameter than the proximal stand 244. To improve acoustic performance, any cavities between the flex circuit 214 and the surface of the support member 230 are filled with backing material 246. The liquid backing material 246 may be introduced between the flex circuit 214 and the support member 230 through passages 235 in the stands 242 and 244. In some embodiments, suction is applied through one of the stands 242, 244 via a passage 235, while liquid backing material 246 is supplied between the flex circuit 214 and the support member 230 via the other passage 235 of the stands 242, 244. The backing material can be cured to allow it to solidify and harden. In various embodiments, the support member 230 includes three or more stands 242, 244, or only one of the stands 242, 244, or neither stand. In this regard, the support member 230 may have a large-diameter distal portion 262 and / or a large-diameter proximal portion 264 formed to lift and support the distal and / or proximal portions of the flex circuit 214.

[0035]

[0050] In some embodiments, the support member 230 may be substantially cylindrical. Other shapes of the support member 230 are also conceivable, including geometric, non-geometric, symmetrical, and asymmetrical cross-sectional profiles. In other embodiments, various parts of the support member 230 may have various shapes. For example, the proximal portion 264 may have an outer diameter larger than the outer diameter of the distal portion 262, or the outer diameter of 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 in accordance with the change in outer diameter. In other embodiments, the inner diameter of the support member 230 remains constant regardless of the change in outer diameter.

[0036]

[0051] The proximal inner member 256 and the proximal outer member 254 are coupled to the proximal portion 264 of the support member 230. The proximal inner member 256 and / or the proximal outer member 254 may be flexible elongated members extending from the proximal portion of the intravascular device 102, such as the proximal connector 114, to the imaging assembly 110. For example, the proximal inner member 256 may be received within the proximal flange 234. The proximal outer member 254 abuts against and contacts the flex circuit 214. The tip member 304 is coupled to the distal portion 262 of the support member 230. As will be further discussed herein, the tip member 304 may be a flexible component that defines the most distal portion of the intravascular device 102. For example, the tip member 304 is positioned around the distal flange 232. The tip member 304 abuts against and contacts the flex circuit 214 and the stand 242. The tip member 304 may be the most distal component of the intravascular device 102. The tip member 304 functions to facilitate the translational movement of the intraluminal device 300 through any number of anatomical structures encountered in the patient, including but not limited to lesions and small-radius vessels.

[0037]

[0052] Figures 5a and 5b show embodiments of the intracavitary device 300 including a joint 302, which facilitates the connection between the imaging assembly 110, which is a scanner assembly in certain embodiments, and the tip member 304. Figure 5a is a side view of the joint 302 of the imaging assembly 110 and the tip member 304. Figure 5b is a side cross-sectional view of the joint 302 of the imaging assembly 110 and the tip member 304. For clarity, the proximal portion of the intracavitary device 300 is shown on the left side of Figures 5a and 5b, and the more distal portion is shown on the right side.

[0038]

[0053] The intraluminal device 300 may, in some embodiments, be analogous to the intravascular device 102. Referring to Figures 5a and 5b, the joint 302 of the imaging assembly 110 and the tip member 304 includes an adhesive 306 located in a connecting region 308 positioned between the proximal portion 310 of the tip member 304 and the distal end 312 of the imaging assembly 110. The adhesive 306 functions to mechanically connect the imaging assembly 110 and the tip member 304. Furthermore, the adhesive 306 functions to provide an hermetically sealed bond between the tip member 304 and the distal end 312 of the imaging assembly 110. As will be further discussed herein, the connecting region 308 is configured to receive the adhesive 306 while limiting the overall diameter of the tip member 304 and the joint 302. One or more adhesives 306 are expected to be located in the connecting region 308. The adhesive 306 is placed within the connecting region 308 such that a limited amount of adhesive 306 overlaps the imaging assembly 110 and the proximal portion 310 of the chip member 304. Figure 5b provides an example of a support member 230 and an inner member 256 extending through the connecting region 308 into the proximal portion 310 of the chip member 304.

[0039]

[0054] Referring next to Figure 5c, a cross-sectional view of the tip member 304 is presented. The tip member 304 includes a lumen 314 extending between the wall portions 316 of the tip member 304 along the longitudinal axis 318 between the connecting region 308, the proximal portion 310, and the distal portion 320. As will be further discussed herein, it will be understood that the lengths and geometric contours of the connecting region 308, the proximal portion 310, and the distal portion 320, respectively, vary depending on the functional purpose of the tip member 304. Figure 5c shows the wall portion 316 sloping linearly from the proximal portion 310 to the distal portion 320. However, as will be further described herein, the wall portion 316 may be curved. The wall portion 316 and the lumen 314 define the inner diameter 322 of the tip member 304. The engaging functional portion 324 is positioned along the inner diameter 322 to secure the support member 230 within the proximal portion 310. The engaging portion 324 is expected to include, but is not limited to, any number of fastening mechanisms and methods known in the art, such as surface treatment, grooves, and threads, for fixing the support portion 230 to the inner diameter 322 of the tip member 304.

[0040]

[0055] The tip member 304 also includes the intersection region 326, which is defined as the area of ​​the tip member 304 that includes the largest outer diameter of the contour of the tip member 304, and is generally located in the proximal portion 310 or the connecting region 308.

[0041]

[0056] The connecting region 308 is located within the joint 302 between the proximal portion 310 of the tip member 304 and the imaging assembly 110. The connecting region 308 includes a cavity 328 for receiving adhesive 306 used to facilitate the mechanical connection between the imaging assembly 110 and the tip member 304. The cavity 328 is configured to receive the adhesive 306 for the mechanical connection while simultaneously functioning to minimize the crossing region 326 of the tip member 304. However, the addition of adhesive 306 to the connecting region 308 is expected to increase the overall diameter of the tip member 304, which becomes the de facto location of the crossing region 326. As previously discussed, this is particularly true when it is desired to create an overlap of adhesive 306 at the joint 302 between the imaging assembly 110 and the tip member 304. As shown in Figure 5c, the cavity 328 of the connecting region 308 is defined by the linear inclination of the wall portion 316 extending from the proximal portion 310 toward the imaging assembly 110, forming an annular triangular cross-section. However, as will be discussed further herein, the cavity 328 may be defined by any number of geometric shapes that facilitate minimizing the intersection region 326 of the tip member 304.

[0042]

[0057] Continuing to refer to Figure 5c, the wall portion 316 is again shown to slope linearly from the proximal portion 310 of the tip member 304 toward the distal portion 320 of the tip member. In this configuration, the outer diameter 330 of the tip member 304 gradually decreases along the longitudinal axis 318 from the proximal portion 310 toward the distal portion 320. The most distal position of the distal portion 320 is the distal end 332, which is the first point of contact between the tip member 304 of the intraluminal device 300 and any obstacle along the path of the intraluminal device 300, as will be discussed further herein.

[0043]

[0058] Figures 6a and 6b show an enlarged perspective view and a schematic cross-sectional view, respectively, of the joint 302 of the imaging assembly 110 and the tip member 304. Figure 6a shows a support member 230 of the imaging assembly 110 extending to the proximal portion 310 through the connecting region 308 of the tip member 304. The cavity 328 is shown as an annular configuration having a trapezoidal cross-section. In contrast to the linear inclinations depicted in Figures 5a-5c, in Figure 6a, the tip member 304 is shown to have a partially curved contour that decreases from the proximal portion 310 to the distal portion 320 along the longitudinal axis 318. The distal end 332 of the distal portion 320 includes a reinforcing device 334, which in certain embodiments is a reinforcing ring positioned between the inner diameter 322 and the lumen 314 of the tip member 304. As will be further discussed herein, the reinforcing device 334 functions to provide rigidity to the distal portion 320 of the tip member 304. This rigidity prevents deformation of the tip member 304 when it encounters relatively rigid obstacles along the path of the intraluminal device 300.

[0044]

[0059] Figure 6b depicts a configuration of the tip member 304 having a linear contour that decreases from a proximal portion 310 to a distal portion 320 along the longitudinal axis 318, similar to those shown in Figures 5a-5c. However, this configuration shows an annular cavity 328 containing adhesive 306, which has a rectangular cross-section, in contrast to the triangular and trapezoidal cross-sections described previously. It will be understood that the tip member 304 may be constructed from any number of combinations of the geometric shape contour and the cross-section of the cavity 328.

[0045]

[0060] Figure 7 shows a side cross-sectional view of the tip member 304, where the tip member 304 is manufactured using an injection molding process. This process is performed to control the flexibility of the tip member 304. The process includes the steps of molding the distal portion 320 using a flexible first material 336 and molding the proximal portion 310 using a second material 338 having less flexibility than the first material 336. This configuration provides greater flexibility to the distal portion 320 of the tip member 304, which is beneficial for navigating obstacles encountered along the path of the intra-luminal device 300. In addition, this configuration provides an optimized transition to the proximal portion 310 of the tip member 304, which has less flexibility and is connected to a rigid imaging assembly 110. The first material 336 is selected from any number of materials having flexible properties, including but not limited to plastics, polymers, elastomers, polyether block amides, Pebax® (e.g., Pebax® 5533) and / or other suitable materials. Furthermore, the second material 338 is selected from any number of materials having less flexibility than the selected first material 336. The process is configured to control the amounts of the first material 336 and the second material 338 injected into the distal portion 320 and the proximal portion 310, respectively, and ultimately determine the flexibility of the tip member 304. For example, Figure 7 illustrates a larger amount of the first material 336 in the tip member 304, but depending on the desired degree of stiffness of the tip member 304, the injection molding process may be modified to increase the amount of the second material 338 in the proximal portion 310.

[0046]

[0061] The tip member 304 in Figure 7 includes features similar to the tip member 304 presented in Figure 5c, but also includes a transition region 340 formed from both the first material 336 and the second material 338 and positioned between the proximal portion 310 and the distal portion 320. The transition region 340 includes an interlocking assembly 342, which functions to create a bond between the first material 336 and the second material 338. The interlocking assembly 342 uses any number of methods or devices, including but not limited to ribs or interface regions with a rough texture, to secure the first material 336 and the second material 338. Although Figure 7 illustrates the use of two materials in the injection molding process that forms the tip member 304, it will be understood that the molding process may use any number of materials with different degrees of flexibility.

[0047]

[0062] Figure 8 shows a side cross-sectional view of the tip member 304, where the proximal portion 310 has a constant diameter 330 while the thickness of the wall portion 316 of the tip member 304 varies along the longitudinal axis 318, and the distal portion 320 has a varying diameter 330 while the thickness of the wall portion 316 of the tip member 304 is constant along the longitudinal axis 318. Similar to the tip member 304 described with reference to Figure 7, the tip member 304 presented in Figure 8 has similar features to the tip member 304 presented in Figure 5c, except for the geometric shape of the lumen 314. It will be understood that the shape of the lumen 314 can be derived from any number of linear or nonlinear geometric shapes as desired. The tip member 304 presented in Figure 8 demonstrates an alternative method for controlling the flexibility of the tip member 304 by using one material rather than multiple materials (e.g., the first material 336 and the second material 338 discussed with reference to Figure 7). By increasing the thickness of the wall portion 316 along the proximal portion 310 and decreasing the thickness of the wall portion 316 along the distal portion 320 around the lumen 314, the tip member 304 is configured to be flexible in the distal portion 320 and less flexible in the proximal portion 310.

[0048]

[0063] Figures 9, 10, and 11 present various types of cross-sectional contours of the tip member 304, including different geometric shapes, which are used as needed to facilitate translational movement through or around difficult anatomical structures. In Figure 9, a side view of the tip member 304 having a beveled cross-sectional contour is presented. The beveled cross-sectional contour has a small outer diameter 330 at the distal portion 320, which gradually increases in a linear inclination with respect to the longitudinal axis 318 until it reaches the proximal portion 310. The proximal portion 310 includes a contour section where the inclination becomes zero. The use of the tip member 304 having a beveled cross-sectional contour is advantageous in situations such as crossing tight curves in the vascular system or other body lumens, where a thin, flexible tip edge transitions continuously to a thicker, less flexible proximal edge. In Figure 10, a side view of the tip member 304 having a beveled cross-sectional contour is presented. Similar to the bevel-type cross-sectional contour, the inclined-type cross-sectional contour also has a smaller outer diameter 330 at the distal portion 320, which gradually increases along the longitudinal axis 318 toward the proximal portion 310. However, instead of increasing linearly, the outer diameter 330 increases along a curvilinear slope from the distal portion 320 to the proximal portion 310. The use of a tip member 304 with an inclined-type cross-sectional contour is advantageous in situations such as intersecting a partial or complete occlusion within a vascular system or other body lumen, where the bevel of the tip acts as a wedge. Figure 11 shows a side view of a tip member 304 having a stepped-type cross-sectional contour. Similar to the bevel and inclined-type cross-sectional contours in Figures 9 and 10, the stepped-type cross-sectional contour has a smaller diameter 330 at the distal portion 320 than at the proximal portion 310. However, in the stepped cross-sectional profile, a smaller diameter 330 is maintained at zero slope throughout the distal portion 320 until it encounters the proximal portion 310, where it increases to a larger diameter 330 along a curvilinear slope. The use of a tip member 304 with a stepped cross-sectional profile is advantageous in situations such as crossing a stent in the vascular system or other body lumens, where it is desirable for the distal portion to be flexible to avoid pressing the guidewire and the tip edge against the stent struts.It will be understood that the lengths of the distal portion 320 and proximal portion 310 of the contour of each tip member 304, as well as their respective inclinations and radii, are optimized for general use or specific clinical scenarios.

[0049]

[0064] Figures 12, 13, and 14 present various types of distal end 332 of the tip member 304 having contours with different geometric shapes, which are used as needed to prevent deformation of the tip member 304 when encountering obstacles. For assistance in the guidewire 118 loading process, the tip member 304 is given a first color and the distal end 332 is given a second color. As previously discussed, the distal end 332 is located at the most distal position of the distal portion 320. In Figure 12, a side section view of the tip member 304 having a chamfered distal end is presented. The distal end 320 has an outer diameter 344 that slopes linearly from the wall portion 316 of the tip member 304 toward the edge portion 346 of the distal end 332. The use of a tip member 304 having a chamfered distal end 332 is advantageous when the device traverses a geometric shape (e.g., an occlusion or stent) in the vascular system or other body lumen that could catch on the tip. Figure 13 shows a side section of a tip member 304 having a radial distal end 332. The distal end 332 has an outer diameter 348 that curves inward from the wall 316 of the tip member 304 toward the edge 346 of the distal end 332. The use of a tip member 304 having a radial distal end 332 is advantageous when the device traverses a curve in the vascular system or other body lumen (particularly in a rigid segment of a guidewire), where additional thickness of the material is required to prevent deformation of the tip material. Figure 14 shows a side section of a tip member 304 having a reinforcement device 334. The reinforcement device 334 is positioned around the outer diameter 350 of the lumen at the edge 346 of the distal end 332. To distinguish it from the tip member 304, the reinforcement device 334 is also given a second color. It will be understood that the reinforcement device 334 is used with any geometric contour of the distal end 332.

Claims

1. A flexible, elongated member inserted into the patient's lumen, comprising a proximal portion and a distal portion, An ultrasound imaging assembly positioned in the distal portion acquires ultrasound imaging data while being positioned within the lumen of the patient, An intracavitary imaging device comprising a tip member disposed at the distal portion of the flexible elongated member, The intracavitary imaging device is characterized in that the tip member comprises an annular cavity having an opening on a surface adjacent to the ultrasonic imaging assembly, which is filled with an adhesive that bonds the tip member and the ultrasonic imaging assembly to provide an airtight seal.

2. The intracavitary imaging device according to claim 1, wherein the cavity has a connecting region in the proximal portion of the tip member, and the cavity has an outer diameter smaller than the outer diameter of the proximal portion of the tip member.

3. The intracavitary imaging device according to claim 2, wherein the cavity has parallel outer diameters.

4. The intracavitary imaging device according to claim 2, wherein the cavity has an inclined outer diameter.

5. The intracavitary imaging device according to claim 2, wherein the distal portion of the tip member has a distal end that intersects with the occlusion portion of the lumen, and the outer diameter of the distal end decreases along the longitudinal axis of the flexible slender member.

6. The intracavitary imaging device according to claim 5, wherein the distal end of the tip member has an outer diameter that decreases linearly.

7. The intracavitary imaging device according to claim 5, wherein the distal end of the tip member has an outer diameter that decreases in a curve.

8. The intracavitary imaging device according to claim 5, wherein the distal end of the tip member is formed in a shape that facilitates intersection with the occluded portion by having an outer diameter that decreases linearly or curvilinearly at the distal end of the tip member.

9. The intracavitary imaging device according to claim 8, wherein the distal end of the tip member is provided with a reinforcing device.

10. The intracavitary imaging device according to claim 9, wherein the reinforcement device has a first color, and the tip member has a second color different from the first color.

11. The intracavitary imaging device according to claim 2, wherein the proximal portion of the tip member is made of a first material, and the distal portion of the tip member is made of a second material.

12. The intracavitary imaging device according to claim 11, wherein the first material has less rigidity than the second material such that the distal portion of the tip member has greater flexibility than the proximal portion of the tip member.

13. The intracavitary imaging device according to claim 12, further comprising a transition region between the proximal and distal portions of the tip member, wherein the transition region comprises a first material and a second material.

14. The intracavitary imaging device according to claim 1, wherein the tip member comprises a proximal portion and a distal portion, the proximal portion of the tip member having a constant outer diameter and a varying wall thickness along the longitudinal axis of the flexible slender member, and the distal portion of the tip member having a varying outer diameter and a constant wall thickness along the longitudinal axis, and optionally, the wall thickness of the proximal portion of the tip member is greater than the wall thickness of the distal portion of the tip member.

Images