Ultrasonic imaging and backscattering system and method

Abstract

An ultrasound imaging and backscatter system includes an ICE ultrasound catheter having an ultrasound pMUT transducer array disposed within a distal end of the ultrasound catheter and including a plurality of transducer array elements disposed on a substrate. One end of the catheter shaft is connected to the handle assembly and the other end is connected to the ultrasonic transducer array. The catheter shaft accommodates an electronic flexible cable in communication with the signal trace and directs each of the plurality of transducer array elements to transmit and receive an ultrasound beam, receives at least one signal from the plurality of transducer array elements, and constructs at least one image characterizing one or more tissue components of the scanned object. An ultrasound imaging system is used to measure tissue thickness, tissue scar, and lesion assessment for left atrium, right atrium, left ventricle, and right ventricle tissue wall characteristics and other intracardiac tissue anomalies.

Description

Technical Field

[0001] This disclosure generally relates to the field of ultrasound imaging systems. More specifically, some embodiments relate to piezoelectric transducers (PZTs), piezoelectric micromachined ultrasound transducers (pMUTs), or micro-electromechanical (MEMS) ultrasound catheters connected to ultrasound imaging and backscattering systems, in combination with mapping, ablation, or other intracardiac devices, for measuring tissue wall features of the left and right atria and ventricles, as well as assessing tissue thickness, scarring, and lesions of other intracardiac tissue abnormalities. Background Technology

[0002] Cardiovascular disease remains a leading cause of death in industrialized countries, with ischemic heart disease (IHD) and its sequelae being significant contributors. For many years, non-invasive imaging techniques have played a crucial role in the detection, risk stratification, and management of patients with IHD. However, existing techniques have certain limitations that hinder their effectiveness in accurately assessing myocardial structure and composition.

[0003] Myocardial ischemia, caused by an imbalance between oxygen supply and consumption, initiates a series of pathological changes known as the ischemic cascade. While existing imaging methods are valuable, they have limitations in visualizing early ultrastructural changes in the myocardium, which occur as early as 10 to 15 minutes after ischemia. Furthermore, the ability to accurately identify and quantify cellular and vasogenic edema (a non-specific response to acute injury) remains limited.

[0004] Unresolved complications arising from ischemia, such as severe arrhythmias, cardiogenic shock, and myocardial rupture, necessitate the development of improved imaging techniques to enhance diagnosis and management. Furthermore, non-invasive methods are needed to effectively assess the chronic phase of ischemic heart disease, a major contributing factor to congestive heart failure. Advances in imaging techniques are required to address these limitations and provide more comprehensive information about myocardial structure and composition.

[0005] Arrhythmogenic right ventricular cardiomyopathy / dysplasia (ARVC / D) is characterized by non-ischemic ventricular arrhythmias originating from the right ventricle and is a significant cause of sudden death, particularly in young adults and athletes. The pathology of ARVC / D involves progressive atrophy of the right ventricular myocardium and its replacement by fibrofatty tissue. However, current imaging techniques have limited sensitivity in accurately assessing the extent and characteristics of right ventricular fibrofatty tissue.

[0006] Recent advances in digital signal processing have opened up new possibilities for echocardiography, allowing for the assessment of myocardial structure based on the acoustic properties of tissues through sound reflection. Nevertheless, further development in this field is needed to optimize the assessment of myocardial ultrastructure and composition using digital signal processing techniques.

[0007] Therefore, there is a need for non-invasive systems and methods that can accurately detect and quantify the acoustic properties of myocardial tissue, thereby providing valuable information for the diagnosis and risk assessment of cardiovascular diseases. Summary of the Invention

[0008] As an introduction, preferred embodiments described below are disclosed, including an easy-to-use ultrasound imaging and backscattering system. The ultrasound imaging and backscattering system includes an ultrasound catheter having a longitudinal axis, a proximal end, and a distal end. Furthermore, an ultrasound transducer array is disposed within the distal end of the ultrasound catheter. The ultrasound transducer array includes a plurality of transducer array elements arranged on a substrate. It can be noted that the plurality of transducer array elements correspond to micro-electromechanical (MEMS) based piezoelectric micromachined ultrasound transducers (pMUTs). Additionally, the ultrasound imaging and backscattering system includes a catheter shaft, one end of which is connected to a handle assembly, and the other end is connected to the ultrasound transducer array. The catheter shaft surrounds an electronic flexible cable that communicates with at least one signal trace and is configured to: guide each of a plurality of transducer array elements to transmit and receive ultrasound beams relative to the heart via the at least one signal trace, the ultrasound beams having a bandwidth including a predetermined fundamental mode vibration of each of the plurality of transducer array elements, such that a single array element can transmit and receive multiple fundamental mode vibrations simultaneously; receive at least one signal from the plurality of transducer array elements based on at least one of the transmitted and received ultrasound beams, and construct at least one image of at least a portion of the heart based on the at least one signal.

[0009] Furthermore, the ultrasound imaging and backscattering system includes an imaging device coupled to an ultrasound catheter using a custom dongle. The custom dongle is coupled to a handle assembly using an inserter and a planar circuit board. The custom dongle is configured to transmit ultrasound transmission pulses and ultrasound reception waveforms between the ultrasound catheter and the imaging device. Additionally, the ultrasound imaging and backscattering system includes a steering control unit located within the handle assembly for hinged engagement of the distal tip of the ultrasound catheter and alignment of the surface of the ultrasound transducer array toward an internal view, including an anterior or posterior position of the heart. It can be noted that the distal tip of the ultrasound catheter is coated with a material to provide electrical isolation and transmission of the ultrasound signal.

[0010] In one embodiment, a method for characterizing one or more tissue components of a scanned object in a patient is disclosed. The method includes the steps of: positioning a catheter having a piezoelectric micromachined ultrasound transducer intracardiac echocardiographic (pMUT ICE) catheter near a region of interest (ROI) of the scanned object. Furthermore, the method includes receiving a reflected signal from the pMUT ICE catheter; scanning the ROI; and determining one or more signal characteristics of the ROI based on the reflected signal. Subsequently, the one or more signal characteristics are associated with predetermined signal characteristics of tissue components similar to the scanned object. The predetermined signal characteristics include classification criteria stored in a data structure. Additionally, the method includes identifying one or more tissue components. The one or more tissue components include tissue scarring, lesion assessment, and tissue thickness measurement. In one embodiment, tissue thickness corresponds to the thickness of the left ventricle, right ventricle, left atrium, or right atrium.

[0011] In one embodiment, the reflected signal includes a plurality of backscattered scan lines, and the determining step includes determining the signal characteristics of a plurality of segments from the plurality of scan lines.

[0012] In one embodiment, the method further includes measuring the wall structure used in conjunction with ICE imaging ablation and mapping catheters.

[0013] In one embodiment, a system is disclosed. The system includes a catheter comprising a piezoelectric micromechanical ultrasound transducer intracardiac echocardiography (pMUT ICE) catheter configured to scan a region of interest. Furthermore, the system includes a computing device in communication with the catheter. The computing device is configured to: receive reflected signals from the pMUT ICE catheter; determine one or more signal characteristics of the region of interest from the reflected signals; associate the one or more signal characteristics with predetermined signal characteristics of tissue components of an object similar to the scanned object, wherein the predetermined signal characteristics include classification criteria stored in a data structure; and identify one or more tissue components. The one or more tissue components include tissue scarring, lesion assessment, and tissue thickness measurement. In one embodiment, tissue thickness corresponds to the thickness of the left ventricle, right ventricle, left atrium, or right atrium.

[0014] In one embodiment, an ultrasonic conduit is disclosed. The ultrasonic conduit includes a body having a longitudinal axis and a distal end. Furthermore, an ultrasonic transducer array is disposed within the distal end of the body. The ultrasonic transducer array includes a plurality of transducer array elements arranged on a substrate. It can be noted that the plurality of transducer array elements correspond to microelectromechanical (MEMS) based piezoelectric micromechanical ultrasonic transducers (pMUTs). Furthermore, each of the plurality of transducer array elements includes individual elements of multiple diameters. Furthermore, the ultrasonic transducer array is connected in series between at least one signal trace and a common ground. Furthermore, each transducer array element includes a plurality of transducers, wherein a first group of two or more transducers is in the first transducer array element, and a second group of two or more transducers is in the first transducer array element. Furthermore, each of the plurality of transducer array elements is connected in parallel. Furthermore, at least one first electrode is connected between at least one piezoelectric layer and a signal conductor, and at least one second electrode is connected between at least one piezoelectric layer and a ground conductor.

[0015] In one embodiment, an intracardiac echocardiography (ICE) imaging and backscattering system is disclosed. The ICE imaging system includes an ultrasound catheter having a longitudinal axis, a proximal end, and a distal end. Furthermore, a microelectromechanical system (MEMS)-based piezoelectric micromechanical ultrasound transducer (pMUT) array is disposed within the distal end of the ultrasound catheter. The MEMS-based pMUT array includes a plurality of MEMS-based pMUT array elements disposed on a substrate. Additionally, the ultrasound imaging and backscattering system includes an electronic flexible cable, one end of which is connected to a handle assembly, and the other end of which is connected to the MEMS-based pMUT array. The electronic flexible cable communicates with at least one signal trace and is configured to: guide each of the plurality of MEMS-based pMUT array elements to transmit and receive ultrasound beams relative to the heart via the at least one signal trace; receive at least one signal from the plurality of MEMS-based pMUT array elements based on the transmitted and received ultrasound beams; and construct at least one image of at least a portion of the heart based on the at least one signal.

[0016] In one embodiment, the MEMS-based pMUT array includes multiple pMUT cells of different diameters to achieve a bandwidth greater than 55%.

[0017] In an alternative embodiment, a steerable ICE catheter with 64 or 96 parallel drive elements is disclosed. The ICE catheter employs phased array technology and is manufactured in 8 or 10 French (Fr) sizes, operating in a frequency range of 5–10 MHz. The ICE catheter enables pulsed-wave and continuous-wave Doppler imaging, as well as color flow imaging. These imaging capabilities are particularly useful for assessing pulmonary vein (PV) blood flow during atrial fibrillation (AF) ablation procedures. The “front view” of the ICE catheter represents its neutral position in the right atrium (RA), and comprehensive imaging of both the right and left sides of the heart can be easily achieved by performing a series of maneuvers.

[0018] In an alternative embodiment, the present invention relates to advancements in ablation catheters, particularly in the fields of high-power, short-duration (HPSD) RF delivery, single-shot RF balloons, cryoablation, and electroporation. Lesion formation using modern RF ablation catheters involves two simultaneous phases: resistive heating and conductive heating. Resistive heating occurs when the catheter tip directly contacts the tissue, resulting in superficial lesions. Conductive heating, on the other hand, is time-dependent and penetrates deep into the tissue, causing transmural lesions.

[0019] In one embodiment, a cryoablation method is disclosed as an alternative to RF ablation, utilizing heat extraction for ablation purposes. Cryoablation is a pioneering balloon platform designed for pulmonary vein isolation (PVT). Cryoablation methods employ a single-shot delivery technique to achieve effective ablation. Conventional cryotherapy involves extracting heat from adjacent tissue using pressurized nitric oxide to reach extremely low temperatures up to -80°C. Cell death is caused by the formation of ice crystals, which further damage occurs as these crystals expand during thawing. It can be noted that point-by-point ablation is time-consuming and requires highly skilled physicians. However, balloon-based ablation allows for rapid and easy PV isolation in a single shot.

[0020] In one embodiment, the present invention relates to electroporation, a non-thermal ablation technique that uses an electric field to create nanopores in the cell membranes of specific cardiac tissue cells by exposing them to a high-voltage field. When sufficient voltage is applied, electroporation causes irreversible effects, leading to apoptosis and alternative fibrosis. The exact timeline of these changes, occurring over days to weeks, is not fully understood. Irreversible electroporation is also commonly referred to as pulsed field ablation.

[0021] In one embodiment, the present invention relates to mapping catheters for field use, particularly basket or high-density contact mapping catheters. High-density mapping catheters offer several potential benefits. While basket mapping enables rapid, simultaneous contact mapping of chambers, providing comprehensive mapping density, it has limitations in terms of local resolution. In contrast, this newer mapping technique allows the catheter puncture to spread against the endocardial surface, thereby facilitating precise high-density contact mapping to accurately locate and characterize the origin of focal atrial tachycardias (AT). Furthermore, the ability to locate multiple electrodes in specific areas of the endocardium has proven advantageous, particularly in the left atrium (LA) and for mapping complex focal AT.

[0022] In one embodiment, the present invention relates to catheter mapping and ablation as a superior treatment option compared to antiarrhythmic drugs. The cornerstone of AF mapping and ablation is pulmonary vein isolation (PVI), which involves the electrical isolation of the pulmonary veins (PV) from the left atrium. Catheter mapping and ablation are used as an alternative treatment option, exceeding the efficacy of antiarrhythmic drugs. In AF ablation procedures, intracardiac echocardiography (ICE) plays a crucial role in performing transseptal puncture, mapping the junction between the left atrium and pulmonary veins, monitoring catheter placement, and identifying potential surgical complications. Establishing a strong endothelial contact between the ablation catheter and the endocardial surface is an important step in ensuring successful delivery of effective ablation of the lesion.

[0023] Other features and aspects of this disclosure will become apparent from the following description and accompanying drawings. Attached Figure Description

[0024] The accompanying drawings illustrate various embodiments of the system, method, and various aspects of this disclosure. Those skilled in the art will understand that the element boundaries (e.g., boxes, groups of boxes, or other shapes) shown in the figures represent one example of various boundaries representing the disclosed invention. In some examples, one element may be designed as multiple elements, or multiple elements may be designed as one element. In other examples, an element shown as an internal component of one element may be implemented as an external component in another element, and vice versa. Furthermore, elements may not be drawn to scale. A non-limiting and non-exhaustive description of this disclosure is described with reference to the following drawings. Components in the figures are not necessarily drawn to scale; instead, the emphasis is on the principles illustrated.

[0025] Various embodiments will be described below with reference to the accompanying drawings, which are provided for illustration and not to limit the scope of this disclosure in any way, wherein similar names denote similar elements, and wherein:

[0026] Figure 1 and Figure 2An existing imaging system for acquiring two-dimensional image information is shown;

[0027] Figure 3 A schematic diagram of an ultrasound imaging system according to an embodiment of the present disclosure is shown;

[0028] Figure 4 A schematic diagram showing a front view of an ultrasound catheter and a custom dongle according to an embodiment of the present disclosure is provided.

[0029] Figure 5 A schematic diagram of an ultrasonic catheter according to an embodiment of the present disclosure is shown, wherein a steering control unit is used to divert the distal tip to an anterior position and a posterior position;

[0030] Figure 6 Multichannel electronic communication between an imaging device and an ultrasonic transducer array of an ultrasonic catheter according to an embodiment of the present disclosure is illustrated.

[0031] Figure 7 A cross-sectional view of the distal end of an ultrasonic catheter having a plurality of transducer array elements according to an embodiment of the present disclosure is shown.

[0032] Figures 8A-8B A schematic diagram of a human heart having ventricles and diaphragmatic walls is shown according to an embodiment of the present disclosure;

[0033] Figure 9 A block diagram of signal analyzer logic according to an embodiment of the present disclosure is shown;

[0034] Figure 10 A schematic diagram illustrating the signal flow of a signal analyzer logic according to an embodiment of the present disclosure is shown;

[0035] Figure 11 A graph illustrating the received RF signal according to an embodiment of the present disclosure is shown;

[0036] Figure 12 A cross-sectional view of the ventricular wall according to an embodiment of the present disclosure is shown. Detailed Implementation

[0037] The components of the embodiments generally described and illustrated in the accompanying drawings can be arranged and designed in a wide variety of different configurations. Therefore, as shown in the figures, the following more detailed description of various embodiments is not intended to limit the scope of this disclosure, but merely represents various embodiments. Although various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated otherwise.

[0038] Some embodiments of this disclosure will now be discussed in detail, illustrating all the features of this disclosure. The words “comprising,” “having,” “containing,” and “including,” and other forms thereof, are meant to have equivalent meanings and are open to interpretation, because one or more items of any of these words are not intended to be an exhaustive list of such items, nor are they intended to be limited to the one or more items listed.

[0039] It should also be noted that, unless the context otherwise requires, the singular forms “a,” “an,” and “the” used herein and in the appended claims include plural references. While any systems and methods similar to or equivalent to those described herein may be used in practice or testing of embodiments of this disclosure, preferred systems and methods are now described. The terms “proximal” and “distal” are terms of opposite direction. For example, the distal end of a device or component is the end of the component furthest from the physician during normal use. The proximal end refers to the opposite end, or the end closest to the physician during normal use.

[0040] Embodiments of the present disclosure will now be described more fully with reference to the accompanying drawings, in which the same numerals denote the same elements, and exemplary embodiments are illustrated. However, embodiments of the present disclosure may be embodied in alternative forms and should not be construed as limited to the embodiments described herein. The examples described herein are non-limiting examples, merely examples of other possible examples.

[0041] Figure 1 and Figure 2 A prior art imaging system 100 is illustrated. The imaging system 100 can be used in conjunction with another imaging modality, such as X-ray, fluoroscopy, magnetic resonance imaging, computed tomography, or an optical system, for diagnosis and / or treatment. It can be noted that the imaging modality scans the patient to generate images to assist the physician. Furthermore, the imaging system 100 provides an ultrasound transmission pulse 102 and an ultrasound receiving path 202 for connection to an ultrasound transducer (not shown). The ultrasound transmission pulse 102 can transmit ultrasound signals from the imaging system 100 to an object such as a patient's heart. Furthermore, the ultrasound receiving path 202 can create waveforms based at least on the ultrasound signals. The imaging system 100 can then convert the received ultrasound signals or ultrasound information into a two-dimensional (2D) image of the object or a portion of the object.

[0042] Figure 3 A schematic diagram of an ultrasound imaging and backscattering system 300 according to an embodiment of the present disclosure is shown. Figure 3 Combination Figures 4-12 B is described.

[0043] The ultrasound imaging and backscattering system 300 can be performed for electrophysiology (EP). The ultrasound imaging and backscattering system 300 can be combined with another imaging modality (such as X-ray, fluoroscopy, magnetic resonance imaging, computed tomography, or optical systems) for diagnosis and / or treatment. Both imaging modalities can scan the patient to generate images to assist the physician. Data from different modalities can be aligned by locating markers in the image of the other modality that have a known spatial relationship to the ultrasound scan. In other embodiments, the ultrasound imaging and backscattering system 300 can use catheters without markers and / or without other imaging modalities. In one embodiment, the ultrasound imaging and backscattering system 300 can utilize an array of microelectromechanical (MEMS) transducers defined as piezoelectric micromechanical ultrasound transducers (pMUTs) or other types of MEMS transducers interconnected using matching flexible circuitry. In one embodiment, the ultrasound imaging and backscattering system 300 can correspond to an intracardiac echocardiography (ICE) imaging system. In one embodiment, the ultrasound imaging and backscattering system 300 can correspond to an intravascular MEMS ultrasound transducer utilizing high-density flexible circuitry for all transmission and electrical interconnection. In one embodiment, the ultrasound imaging and backscattering system 300 analyzes spectral backscattered radio frequency (RF) data. In one embodiment, the ultrasound imaging and backscattering system 300 can be used to treat patients with cystic fibrosis (CF). It can be noted that the use of high-density flexible circuitry enables highly repeatable and stable transmission and return signals. Furthermore, the high-density flexible circuitry transmission lines can transmit electrical energy from one end of the ultrasound imaging and backscattering system 300 to the other distal end.

[0044] Reference Figure 3 The ultrasound imaging and backscattering system 300 may include an imaging device 302 coupled to an ultrasound catheter 304 via a communication channel 306. In one embodiment, the communication channel 306 may be a custom dongle having cable and bus connections or multiple connections. Hereinafter, the communication channel 306 may be referred to as a custom dongle 306.

[0045] An ultrasound catheter 304 can be positioned within a cavity of a patient's heart, and an imaging device 302 can receive at least one signal from the ultrasound catheter 304. The at least one signal can be transmitted from the ultrasound catheter 304 to the imaging device 302 via a custom dongle 306. Furthermore, the imaging device 302 may include an image processor 308, a transmit beamformer 310, a receive beamformer 312, a signal analyzer 316, and a display 314.

[0046] Image processor 308 can be configured to generate a two-dimensional (2D) image based on data received from ultrasound catheter 304. In one embodiment, image processor 308 can be configured to receive a focus signal from receiving beamformer 312. Image processor 308 can render data to construct an image or image sequence. In one embodiment, the image can be a three-dimensional (3D) representation, such as a two-dimensional image rendered from a viewing direction selected by the user or processor. In one embodiment, image processor 308 can be a detector, filter, processor, application-specific integrated circuit, field-programmable gate array, digital signal processor, control processor, scan converter, 3D image processor, graphics processing unit, analog circuit, digital circuit, or a combination thereof. Image processor 308 can receive beamforming data and can generate an image for display on display 314. It can be noted that the generated image is associated with a two-dimensional (2D) scan. Alternatively, the generated image can be a three-dimensional (3D) representation.

[0047] Image processor 308 can be programmed for hardware-accelerated 2D reconstruction. Image processor 308 can store processing data of at least one signal and image sequences in memory. In one embodiment, the memory may be a non-transitory computer-readable storage medium. Instructions for implementing the processes, methods, and / or techniques discussed herein are provided on a computer-readable storage medium or memory (such as a cache, buffer, RAM, removable media, hard disk drive, or other computer-readable storage medium). Non-transitory computer-readable storage media include various types of volatile and non-volatile storage media. The functions, actions, or tasks shown in the figures or described herein are performed in response to one or more sets of instructions stored in or on a computer-readable storage medium. Functions, actions, or tasks are independent of a particular type of instruction set, storage medium, processor, or processing strategy, and can be performed by software, hardware, integrated circuits, firmware, microcode, etc., operating individually or in combination.

[0048] The transmitting beamformer 310 can be configured to transmit an electrical signal or electrical pulse toward the ultrasonic catheter 304 in the form of at least one signal. The receiving beamformer 312 can be configured to receive an electrical signal or electrical pulse from the ultrasonic catheter 304. In one embodiment, the transmitting beamformer 310 and the receiving beamformer 312 can facilitate transmitting beamforming techniques to focus energy onto the receiver, thereby improving the signal-to-noise ratio (SNR) of at least one signal, which is then sent to the image processor 308.

[0049] Display 314 can be configured to display an image or image sequence on a screen during or after data rendering by image processor 308. The image can be a three-dimensional (3D) representation, such as a two-dimensional image rendered from a viewing direction selected by the user or processor. Alternatively, the image can be one or more two-dimensional images representing planes in a volume. In one embodiment, display 314 can be part of imaging device 302 or a remote display, such as a networked display. In one embodiment, display 314 can be a cathode ray tube (CRT), liquid crystal display (LCD), projector, plasma display, or other display device now known or developed in the future.

[0050] The ultrasound catheter 304 can electronically communicate with the imaging device 302 to transmit and receive ultrasound signals to and from the arterial walls of the vascular system. In one embodiment, the ultrasound catheter 304 can be configured to visualize standard echocardiographic views of the heart, such as, in a standard version, the right atrium. The ultrasound catheter 304 can be used for transseptal catheterization for various percutaneous interventions, including left atrial catheter ablation and atrial septal defect closure, as an effective alternative to surgical interventions. Furthermore, the ultrasound catheter 304 may include a body 318 having a longitudinal axis 320, a proximal end 322, a distal end 324, a handle assembly 326, a steering control unit 328, a distal tip 330, and a dongle cable 332.

[0051] Handle assembly 326 can be positioned between the proximal end 322 and the distal tip 330 of the ultrasonic catheter 304. Furthermore, a steering control unit 328 can be located within the handle assembly 326. The steering control unit 328 can be provided for hinged engagement of the distal tip 330 of the ultrasonic catheter 304. Additionally, the steering control unit 328 can align the surfaces of the ultrasonic transducer array (not shown) to different positions relative to the ultrasonic catheter 304. Furthermore, the steering control unit 328 can include a steering handle 334 and a housing 336, the housing 336 surrounding an actuator (not shown) and a steering hub (not shown). It can be noted that internal friction occurs between the actuator and the steering hub, and between the actuator and the housing 336, causing the ultrasonic catheter 304 to maintain its adjusted configuration without operator intervention. The steering handle 334 can be rotated to facilitate positioning of the distal tip 330 of the ultrasonic catheter 304. Figure 5The image illustrates movement of the distal tip 330 caused by the steering control unit 328. In one embodiment, the steering handle 334 can be rotated to position the distal tip 330 within a chamber of the patient's heart. In one embodiment, the steering control unit 328 may include a set of steering lines controlled by a steering actuator to bidirectionally articulate the distal segment of the ultrasound catheter 304. It can be noted that the steering handle 334 can rotate from 0 degrees to... The catheter shaft 338 can be coupled at one end to the handle assembly 326 and at the other end to the distal tip 330 of the ultrasonic catheter 304. Furthermore, the catheter shaft 338 can surround an electronic flexible cable (not shown) and multiple steering cables (not shown). In one embodiment, the electronic flexible cable can be a stainless steel cable. One end of the electronic flexible cable can be coupled to the handle assembly 326 and the other end to the ultrasonic transducer array. This can be combined later. Figure 6 A- Figure 7 Describes electronic flexible cables and multiple steering cables. Furthermore, it combines... Figure 4 Description of ultrasound catheter 304.

[0052] Reference Figure 4 The ultrasonic conduit 304 may include an ultrasonic transducer array 402, a substrate 404, an inserter 406, and a planar circuit board 408. The ultrasonic transducer array 402 may be disposed within the distal tip 330 of the ultrasonic conduit 304. In one embodiment, the ultrasonic transducer array 402, substrate 404, inserter 406, and planar circuit board 408 may correspond to flexible printed electronics for transmission from the distal end 324 of the ultrasonic conduit to a dongle cable 332 or directly to an ultrasonic imaging and backscattering system 300. The ultrasonic transducer array 402 may be disposed above the substrate 404 facing the distal end 328 of the ultrasonic conduit 304. It can be noted that the ultrasonic transducer array 402 may correspond to a MEMS-based pMUT array. A handle assembly 326 may be coupled to the proximal end 322 of the ultrasonic conduit 304 using the inserter 406 and the planar circuit board 408. In one embodiment, the handle assembly 326 may be coupled to the dongle cable 332 using a conduit handle (not shown) and the inserter 406. (This will be discussed later.) Figure 6 B to Figure 6 D describes the catheter handle. It can be noted that the inserter 406 can be coupled to the custom dongle 306 facing the handle assembly 326, and the planar circuit board 408 can be coupled to the proximal end 322 of the ultrasound catheter 304 facing the handle assembly 326.

[0053] like Figures 3-4As shown, the catheter shaft 338 can be coupled between the handle assembly 326 and the ultrasonic transducer array 402. An electronic flexible cable within the catheter shaft 338 can receive at least one signal from the ultrasonic transducer array 402, and the received signal can be transmitted back to the imaging device 302 via a custom dongle 306. One end of the electronic flexible cable can be coupled to the handle assembly 326, and the other end is coupled to the ultrasonic transducer array 402. It can be noted that the ultrasonic transducer array 402 can receive electrical signals from the imaging device 302 via the custom dongle 306 and the electronic flexible cable. It can also be noted that the ultrasonic transducer array 402 can transmit at least one signal back to the imaging device 302 for further analysis of the at least one signal for image generation. Furthermore, the ultrasonic catheter 304 can be coupled to the ultrasonic imaging device 302 using a dongle cable 332.

[0054] Reference Figure 5 According to an embodiment of the present disclosure, a schematic diagram of an ultrasonic catheter 304 is disclosed, wherein the distal tip 330 is rotated to a forward position 502 and a rear position 504 using a steering control unit 328.

[0055] A steering control unit 328 may be positioned within a handle assembly 326 for hinged engagement of the distal tip 330 of the ultrasound catheter 304 and for aligning the surface of the ultrasound transducer array 402 toward an internal view including an anterior position 502 or a posterior position 504 of the heart. It may be noted that the distal tip 330 of the ultrasound catheter 304 may correspond to the tip of the catheter shaft 338 of the ultrasound catheter 304. Furthermore, the ultrasound transducer array 402 may be disposed within the distal tip 330 of the ultrasound catheter 304. It may be noted that the cable connecting the distal end 324 of the catheter handle to the distal tip 330 may be the catheter shaft 338. In one embodiment, the ultrasound transducer array 402 may be positioned toward an internal view including an anterior position 502 and a posterior position 504 of the heart. The distal tip 330 of the ultrasound catheter 304 may be bent toward the distal end 324. In one embodiment, the distal tip 330 of the ultrasound catheter 304 may be coated with a material to provide electrical isolation and transmission of ultrasound signals. Furthermore, the catheter shaft 338, which communicates between the distal tip 330 and the distal end 324 of the ultrasonic catheter 304, can send electrical signals or pulses to the distal tip 330 of the ultrasonic catheter 304, and the ultrasonic transducer array 402 can send echoes to the imaging device 302 via the catheter shaft 338 and the custom dongle 306.

[0056] Furthermore, the ultrasonic catheter 304 may include multiple steering cables 506, which can be rotated to a front position 502 and a rear position 504 using a steering control unit 328, such as... Figure 5As shown. Multiple steering cables 506 can be housed within a catheter shaft 338. In one embodiment, at least two of the multiple steering cables 506 can be rotated towards at least two distal tips using a steering control unit 328 via an ultrasonic transducer array. Furthermore, the catheter shaft 338, having a Pebax material gradient stiffness gauge 508, is oriented towards the distal tip 330 of the ultrasonic catheter 304. It can be noted that the Pebax material gradient stiffness gauge 508 can be hard and rigid towards the proximal end 322 of the catheter shaft 338, and can be more flexible towards the distal end 324. In one embodiment, the catheter shaft 338 can be more flexible towards the distal end 324 by at least 6 to 8 inches. It can be noted that the distal tip 330 can have a softer Pebax material. Furthermore, the multiple steering cables 506 can be configured to bend or tilt the distal tip 330 when the steering handle of the steering control unit 328 is rotated clockwise or counterclockwise. It can be noted that when inserted into the heart, the actuator of the steering control unit 328 can pull the steering cables among the multiple steering cables 506. The steering cables of the plurality of steering cables 506 can then bend the distal tip 330 toward an anterior and posterior position within the heart. In one embodiment, a steering control unit 328 can be used to bend at least two of the plurality of steering cables 506.

[0057] In one embodiment, the multiple steering cables 506 may be made of synthetic materials (such as nylon or similar synthetic fibers) or plastic materials (such as polyurethane, Teflon®, Kynar®, Kevlar®, polyethylene, multi-strand nylon, or gel-spun polyethylene fibers). For example, the multiple steering cables 506 may be multi-strand Spectra® brand nylon line (10 lb test) sold as Spiderwire® fishing line.

[0058] Reference Figure 6 According to embodiments of this disclosure, multi-channel electronic communication between an ultrasonic imaging device 302 and an ultrasonic PMUT transducer array 402 is disclosed. The ultrasonic transducer array 402 may include a plurality of transducer array elements 602 disposed on a substrate 404. Furthermore, each of the plurality of transducer array elements 602 may provide a wide bandwidth of a separately focused beam. As previously described, the ultrasonic transducer array 402 may be coupled to the ultrasonic imaging device 302 using a dongle cable 332. The MEMS-based ultrasonic transducer array 402 disposed within the distal end 324 of an ultrasonic conduit 304 may transmit at least one signal to the imaging device 302 via a flexible electronic cable 602 within the conduit shaft 338. The at least one signal may be an acoustic echo transmitted from the ultrasonic transducer array 402. It can be noted that the acoustic echo of the acoustic energy may be received from the surface of the ultrasonic transducer array 402 and at an image processor 308.

[0059] Furthermore, multiple steering cables 506 can be configured to guide each of the multiple transducer array elements 602 via at least one signal trace to transmit and receive ultrasound beams. The ultrasound beams can have a bandwidth including a predetermined fundamental mode vibration of each of the multiple transducer array elements 602, such that a single array element can simultaneously transmit and receive multiple fundamental mode vibrations. It can be noted that the multiple transducer array elements 602 can transmit and receive ultrasound beams relative to the heart or at least a portion of the heart. Furthermore, an electronic flexible cable 602 within the catheter shaft 338 can be configured to receive at least one signal from the multiple transducer array elements 602 based on at least one of the transmitted and received ultrasound beams. The imaging device 302 can also be configured to construct at least one image of at least a portion of the heart based on at least one signal. It can be noted that the electronic flexible cable can be configured to transmit beamformer 310 and receive beamformer 312 to display two-dimensional (2D) image information of the heart or at least a portion of the heart.

[0060] In one embodiment, the plurality of transducer array elements 602 may correspond to a microelectromechanical (MEMS)-based piezoelectric micromechanical ultrasonic transducer (pMUT). The catheter shaft 338 may be coupled at one end to the handle assembly 326 and at the other end to the ultrasonic transducer array 402. An electronic flexible cable 602 within the catheter shaft 338 may communicate with at least one signal trace. It can be noted that the electronic flexible cable 602 may also communicate via a custom dongle 306 with a transmit beamformer 310 and a receive beamformer 312 to display two-dimensional (2D) image information of the heart to be scanned.

[0061] Reference Figure 7 According to an embodiment of the present disclosure, a cross-sectional view of the distal end 324 of an ultrasonic catheter 304 having an ultrasonic pMUT transducer array 402 having a plurality of transducer array elements 602 is disclosed.

[0062] The distal end 324 of the ultrasonic catheter 304 may be provided with an ultrasonic transducer array 402 having multiple transducer array elements 602. Furthermore, each of the multiple transducer array elements 602 may have multiple individual transducers 702 arranged in a manner that provides a wide bandwidth for a single focused beam. In one embodiment, the ultrasonic transducer array 402 may be composed of a pMUT array comprising individual elements of different diameters. In one embodiment, to achieve a wider bandwidth using the pMUT array, pMUT units of multiple diameters can be integrated into a single element. It can be noted that by arranging pre-shaped pMUTs of different diameters, a wider bandwidth can be achieved through the complex interactions between the individual pMUT elements. In one embodiment, pMUT units of multiple diameters can achieve a bandwidth greater than 55%. For example, in 3 elements, there are 5 different dome diameters, and each array has a different size, such as 300. .

[0063] Furthermore, the ultrasound transducer array 402 may correspond to a pMUT, and multiple transducer array elements 602 may correspond to multiple pMUT elements. In one embodiment, multiple pMUT elements can be guided to transmit and receive ultrasound beams having a bandwidth including predetermined fundamental mode vibrations of each of the multiple pMUT elements, such that a single pMUT element can transmit and receive multiple fundamental mode vibrations simultaneously. Additionally, an electronic flexible cable 602 within the catheter shaft 338 receives at least one signal from the multiple pMUT elements. It can be noted that at least one signal may correspond to at least one ultrasound beam. At least one signal can be sent to an ultrasound imaging device 302 for further processing in an image processor 308. The image processor 308 can construct at least one image of the heart. It can be noted that multiple pMUT elements can be used to create individually focused beams.

[0064] In an alternative embodiment, the ultrasound transducer array 402 may include a cap portion presenting a circular cross-section. It can be noted that the characteristics of the ultrasound transducer array 402 are typical of ultrasound imaging catheters. Due to the severe space constraints imposed by the small diameter of intracardiac catheters, ultrasound transducer arrays are typically limited to linear phased arrays consisting of several individual transducer elements, such as 64 transducers or elements. The transducers have flat surfaces from which sound can be emitted and echoes received. As is well known in the art, the individual transducer elements are pulsed by an ultrasound control system such that the emitted sound waves are constructively combined into a main beam. By varying the timing of the pulse emitted by each transducer element, the ultrasound imaging and backscattering system 300 can render the individual beams into a focused image that can sweep across an arc to obtain a 2D image. Therefore, the ultrasound transducer array 402 emits ultrasound along a plane perpendicular to the transducer array surface. Therefore, the ultrasound transducer array 402 emits sound along a plane perpendicular to the components.

[0065] Reference Figures 8A-8B A cross-sectional image of a heart 800 is disclosed, wherein an ultrasound catheter 304 is located within the right atrium 802 of the heart 800. The distal tip 330 of the ultrasound catheter 304 can be inserted into the right atrium 802 via the inferior vena cava (not shown). Two normalized views can be used to perform appropriate imaging of the interatrial septum (IAS) 804 and its adjacent structures. Movement of the distal tip 330 of the ultrasound catheter 304 within the right atrium 802 can be controlled by a steering control unit 328. A steering handle 334 of the steering control unit 328 can be rotated to position the distal tip 330 of the ultrasound catheter 304 within the patient's heart 800. In one embodiment, the steering handle 334 can be turned clockwise to position the distal tip 330 of the ultrasound catheter 304 in a posterior view of the right atrium 802. In another embodiment, the steering handle 334 can be turned counterclockwise to position the distal tip 330 of the ultrasound catheter 304 in a frontal view of the right atrium 802. Furthermore, the clockwise or counterclockwise movement of the steering handle 334 allows the imaging window to move from the rear view to the front view, and vice versa.

[0066] Furthermore, the flexible sheath can be introduced into the patient's vascular structure via the femoral vein (not shown) to properly position the ultrasound transducer array 402 for imaging the right atrium 802 and the mitral valve 806 (bicuspid valve). Using fluorescence imaging to monitor the position of the ultrasound catheter 304, the clinician can advance the distal end 324 of the ultrasound catheter 304 into the right atrium 802. To guide the ultrasound catheter 304 through bends in the patient's vascular structure, the clinician can rotate the steering handle 334 clockwise or counterclockwise to allow the imaging window to move toward the posterior position 504, including the internal view of the anterior position 502, and vice versa. Once the distal tip 330 of the ultrasound catheter 304 is in the right atrium 802, the clinician can rotate the steering handle 334 to introduce an acute-angle bend in the flexible sheath to guide the ultrasound transducer array 402 through the tricuspid valve 808 and into the right ventricle 810, as shown. Figure 8A As shown. In this position, the field of view of the ultrasound transducer array 402 may include the right ventricle 810, IAS 804, left ventricle 812, left atrium 814, mitral valve 806, and a portion of the left ventricular wall. In one embodiment, the right ventricle 810 and the right ventricular wall can be imaged when the ultrasound transducer array 402 is guided by rotating the steering handle 180 degrees clockwise. It can be noted that the clinician can twist the ultrasound catheter 304 when... Figures 8A-8B When the ultrasound catheter 304 is located within the heart 800, the transducer array 402 can swing around its axis, which may damage the tricuspid valve 808 or cause the ultrasound transducer array 402 to impact the IAS 804. Figure 8B A vertical short-axis view is shown to visualize the internal portions of the IAS 804. The internal portions of the IAS 804 include the aorta 816, the IAS 804, and the bicuspid valve 818 facing the left ventricle 812.

[0067] In one exemplary embodiment, a standard view is obtained by placing an ultrasound catheter 304 in the middle of the right atrium 802 and positioning the ultrasound transducer array 402 in a neutral position facing the tricuspid valve 808. The standard view provides imaging of the right atrium 802, the tricuspid valve 808, and the right ventricle 810, and typically provides an oblique or short-axis view of the aortic valve.

[0068] Furthermore, when the ultrasound catheter 304 can be rotated clockwise, the aortic valve and the right ventricular outflow tract 810 are visible along their long axis. In this view, the tricuspid valve, closer to the ultrasound transducer array 402 or its distal tip 330, is the non-coronary valve (closely related to the membranous septum and the para-His bundle region), while the right coronary valve is opposite (it is the most anterior part of the aortic valve, directly located in the infundibulum of the right ventricular outflow tract 810 and posterior to the pulmonary valve). The left ventricle 812 is visible anterior to most of the septum of the right atrium 802, and the opening of the coronary sinus becomes apparent. In this view, the long axis of the left ventricular outflow tract 812 is identified, and the posterior wall of the left ventricle 812 is located directly below the non-coronary valve.

[0069] In addition, the extra clockwise rotation of the ultrasound catheter 304 allows visualization of the bicuspid valve 818 and IAS 804, with the left atrial appendage located anteriorly and the coronary sinus posteriorly. The left atrial appendage 814 is examined for thrombi at its opening, and color Doppler ultrasound can be used to assess bicuspid regurgitation.

[0070] In one embodiment, most catheters used in endovascular applications (especially those with ultrasound transducers) have a diameter of at least approximately 10 French kilometres. The electronics and wiring required for ultrasound transducer arrays make reducing the size of such catheters to below approximately 10 French kilometres impractical and expensive. However, reducing the catheter diameter is beneficial, and technological advancements allow for further reduction in the size of electronic and control structures. The bundled arrangement of coaxial cables, steering and pivot cables, and steering and pivoting mechanisms, as described in more detail below, makes it possible to effectively reduce the diameter to below approximately 10 French kilometres, to 4, 6, or 8 French kilometres, or even 3 French kilometres (approximately 1 mm).

[0071] Reference Figure 9 A signal analyzer logic 902 for processing and analyzing radiofrequency ultrasound data is disclosed. It should be understood that the signal analyzer logic 902 can be embodied as a component of an ultrasound imaging console, an ablation system console, or as a component of a separate system that receives raw radiofrequency data from an ultrasound catheter 304. If the radiofrequency data is in analog form, a digital-to-digital converter 904 can be provided to digitize the data. Signal processing logic 906 is configured to process each individual beam of the ultrasound data and transform it into a format that can be analyzed. To reduce processing time, object boundary detection 908 can be used to determine the boundary locations of the scanned object.

[0072] After boundary detection, the individual beam data is transformed. In some embodiments, boundary detection can be performed after the transformation. Transformation logic 910 can be configured to transform the remaining individual beam data into a suitable format for analysis. Generally, the transformed format should match the same format used to construct the predetermined signal characteristics of the object components. In one embodiment, transformation logic 910 can transform the data into a power spectrum of frequency versus power output. Various transformation algorithms include Fourier transform, Welch periodograms, and autoregressive modeling. Other types of transformations can include transforming the data into wavelets, which provide an image with frequency and time information. For example, other signal processing techniques can include wavelet decomposition or curvelet decomposition to deliver parameters relevant to the distinction between tissue types, while being unaffected by the system transmission capabilities of the imaging system and probe. Another transformation involves using impedance instead of frequency, which gives an image of acoustic impedance. In this format, different tissue components have different impedance characteristics, which provide different signal reflections.

[0073] Further reference Figure 9 The spectrum analysis logic 912 can analyze the power spectrum of individual beam data to determine its spectral characteristics 914. As previously mentioned, spectral characteristics or parameters may include maximum power, frequency at maximum power, minimum power, frequency at minimum power, slope, y-intercept, mid-band fit, and integral backscatter. The spectral parameters 914 are then fed into classification logic 916, which attempts to classify the spectral parameters associated with a particular individual beam segment against spectral parameters previously measured from known tissue composition. As mentioned above, signal analysis techniques need not be limited to spectrum analysis and autoregressive coefficients, but may require the use of wavelet decomposition or curvelet decomposition to deliver parameters that can be used by the classification logic 916 to distinguish tissue types.

[0074] In one embodiment, the classification data structure 918 may include a statistical classification of measured or observed spectral characteristics (and / or other characteristics) associated with a specific type of tissue and / or ablated tissue components. In one embodiment, the classification data structure 918 is generated in advance from laboratory studies that correlate ultrasound data analysis of ablated tissue samples with their corresponding tissue sections.

[0075] Reference Figure 10A method 1000 for analyzing ultrasound signals and identifying tissue composition types corresponding to the signals is disclosed. The elements shown refer to "process blocks" and represent computer software instructions or sets of instructions that cause a computer or processor to perform one or more actions and / or make decisions. Alternatively, a process block may represent a function and / or action performed by a functionally equivalent circuit, such as a digital signal processor circuit, an application-specific integrated circuit (ASIC), or other logic device. The figure does not depict the syntax of any particular programming language. Rather, it illustrates functional information that a person skilled in the art can use to fabricate circuits, generate computer software, or use a combination of hardware and software to perform the illustrated processing. It should be understood that electronic and software applications may involve dynamic and flexible processes, such that the blocks shown can be executed in a different order than that shown, and / or the blocks can be combined or separated into multiple components. They can also be implemented using various programming methods, such as machine language, procedural, object-oriented, artificial intelligence, or other techniques. This applies to all methods described herein.

[0076] In other embodiments, the steps of method 1000 can be used to analyze imaging signals received from another imaging modality and identify the type of tissue component corresponding to the signal. In some embodiments, instead of receiving ultrasound data and analyzing ultrasound imaging characteristics (such as spectral characteristics), system 100 can receive imaging data specific to a particular type of imaging modality and analyze imaging characteristics particularly associated with the type of imaging modality used based on relevant secondary parameters.

[0077] First, at step 1005, the analysis can begin when RF ultrasound data can be received. The RF ultrasound data can be received in real time during or after the scan. Furthermore, at step 1010, the RF ultrasound data can be digitized. In one embodiment, if the RF ultrasound data is still in its original radio frequency form, it can be digitized. In one embodiment, the digitized data is analyzed along separate beams in one or more segments. Figure 10 The example illustrates the analysis of a piece of data. Although... Figure 10 Not shown, but the process is repeated for each segment of an individual beam, and for other individual beams, until completion or until the process stops. Optionally, the process may allow for changes to the characteristics of how individual beams are segmented, such as defining various sizes and segment spacings.

[0078] Subsequently, at step 1015, the boundaries of the target object are determined along the beam data. For the individual beam being analyzed, a boundary detection algorithm can be used to identify the boundaries of the target object, and the analysis can be focused on the individual beam data corresponding to the target object. Since the scan in this example is not within a blood vessel, the individual beams passing through the target object may cross two or more walls of the object. For example, the region of interest for the scan is a vascular object, such as the carotid body. The boundary detection algorithm can identify the boundaries of the carotid body and / or adjacent vessels. Many individual beams may cross two walls of the carotid body. Therefore, boundary detection will attempt to search for and identify at least two boundaries along the individual beams. Many different boundary detection methods are available, including analyzing the signal characteristics of the scan lines, reconstructing images from ultrasound data, and detecting boundaries from image data, among others. If necessary, individual beam data outside the boundaries of the target object can be ignored or removed from the analysis.

[0079] Individual beams can be segmented and analyzed segment by segment. Furthermore, at step 1020, the beam data is transformed into power spectrum data. In one embodiment, signal data from a segment is transformed into power spectrum form. Subsequently, at step 1025, spectral characteristics are determined. These spectral characteristics can be determined from the power spectrum, which may include their intercepts, maximum power, mid-band fit, minimum power, frequencies at maximum and minimum power, slope of the regression line, integral backscatter, and / or other characteristics in the power spectrum. Other characteristics can be determined using wavelet decomposition or curvelet decomposition techniques. The spectral characteristics and / or other characteristics of the individual beam data are then compared with corresponding predetermined characteristics of known tissue components to determine which type of component best matches the individual beam spectral characteristics. Tissue components may include tissue scars, lesion assessments, and tissue thickness measurements.

[0080] In one embodiment, predetermined tissue characteristics are constructed as a classification tree, generated from statistical analysis of how the characteristics relate to the type of tissue component. Subsequently, at step 1030, the spectral characteristics are processed using the classification tree. Individual beam spectral characteristics are then processed through the tree, traversing branches based on how the spectral characteristics satisfy conditions for branch nodes. The tree is traversed to the leaf nodes that identify the type of tissue component. Subsequently, at step 1035, the type of component is characterized. The spectral characteristics of individual beam segments are then characterized as the type of this component. In one embodiment, method 1000 may also output an assessment score of the observed ablation level within the tissue component.

[0081] refer to Figure 11A graph illustrating the received RF signal is disclosed. It can be noted that the data for a single beam 1150, or RF signal, is plotted as a voltage varying over time. The single beam 1150 can be analyzed in segments represented by multiple windows, such as window 1155. In this embodiment, the data within window 1155 is transformed into a power spectral density plot. The signal characteristics of the single beam 1150 from window 1155 are determined by the power spectrum. Signal characteristics (also referred to in this case as spectral characteristics) may include y-intercept, maximum power, mid-band fit, minimum power, frequencies at maximum and minimum power, regression slope, integral backscatter, or combinations of these or other characteristics.

[0082] Reference Figure 12 A cross-sectional view of the ventricular wall 1248 is disclosed. The ventricular wall 1248 includes the myocardium 1250, epicardium 1252, endocardium 1254, and a scarred region 1256 caused by myocardial fibrosis. Identification of wall cardiomyopathy may include: Transthyretin amyloid cardiomyopathy (ATTR-CM) occurs when amyloid accumulates and forms deposits in the left ventricular wall. These amyloid deposits harden the ventricular wall, preventing the ventricles from filling with blood and reducing their ability to pump blood out of the heart. Myocardial fibrosis is defined as an increased amount of collagenous scar tissue within the heart. Hypertrophic cardiomyopathy (HCM) is a disease characterized by thickening (hypertrophy) of the myocardium. Thickened myocardium makes it more difficult for the heart to pump blood.

[0083] While certain specific structures embodying various embodiments of the invention have been shown and described herein, those skilled in the art will understand that various modifications and rearrangements of the components can be made without departing from the spirit and scope of the basic inventive concept, and that such modifications and rearrangements are not limited to the specific forms shown or described herein, except as indicated by the scope of the appended claims.

Claims

1. An ultrasound imaging and backscattering system, comprising: An ultrasonic catheter, which has a longitudinal axis, a proximal end, and a distal end; An ultrasonic pMUT transducer array disposed within the distal end of the ultrasonic conduit, wherein the ultrasonic pMUT transducer array includes a substrate and a plurality of transducer array elements disposed on the substrate; and A catheter shaft, one end of which is connected to a handle assembly and the other end to the ultrasonic transducer array, wherein the catheter shaft houses a flexible electronic cable that communicates with at least one signal trace and is configured to: Each of the plurality of transducer array elements is guided to send and receive ultrasound beams relative to the heart via the at least one signal trace; Based on transmitting and receiving at least one of the ultrasonic beams, at least one signal is received from the plurality of transducer array elements; and Based on the at least one signal, construct at least one image of at least a portion of the heart.

2. The ultrasound imaging and backscattering system according to claim 1, wherein, The ultrasonic transducer array corresponds to a microelectromechanical (MEMS) based piezoelectric micromechanical ultrasonic transducer (pMUT).

3. A method for characterizing one or more tissue components of a scanned object within a patient, the method comprising: Position the catheter with a piezoelectric micromechanical ultrasound transducer intracardiac echocardiography (pMUT ICE) catheter near the region of interest of the scanned object; Receive reflected signals from the pMUT ICE conduit; Scan the region of interest; One or more signal characteristics of the region of interest are determined based on the reflected signal; The one or more signal characteristics are associated with predetermined signal characteristics of tissue components of an object similar to the scanned object, wherein the predetermined signal characteristics include classification conditions stored in a data structure; as well as Identify one or more tissue components, including tissue scarring, lesion assessment, and measurement of tissue thickness.

4. The method according to claim 3, wherein, The identification of one or more tissue components is the identification of myocardial scarring.

5. The method according to claim 4, wherein, The myocardial scar is an accumulation of fibrotic tissue.

6. The method according to claim 4, wherein, The myocardial scar is caused by the formation of excess tissue.

7. The method according to claim 3, wherein, The lesion was assessed as endocarditis and inflammation of the cardiac endocardium.

8. The method according to claim 3, wherein, The lesion assessment targets the diaphragm or other cardiac chamber walls.

9. The method according to claim 3, wherein, The tissue thickness corresponds to the thickness of the left ventricle, right ventricle, left atrium, or right atrium.

10. The method according to claim 3, wherein, The reflected signal includes multiple backscattered scan lines, and the determining step includes determining the signal characteristics of multiple segments from the multiple scan lines.

11. The method of claim 3, further comprising measuring the wall structure used in conjunction with ICE imaging ablation and mapping catheters.

12. A system comprising: The catheter includes a piezoelectric micromechanical ultrasonic transducer intracardiac echocardiography (pMUTICE) catheter configured to scan regions of interest; A computing device that communicates with the conduit and is configured to: Receive reflected signals from the pMUT ICE conduit; One or more signal characteristics of the region of interest are determined based on the reflected signal; The one or more signal characteristics are associated with predetermined signal characteristics of one or more tissue components of an object similar to the scanned object, wherein the predetermined signal characteristics include classification conditions stored in a data structure; as well as Identify one or more tissue components, including tissue scarring, lesion assessment, and measurement of tissue thickness.

13. The system according to claim 12, wherein, The reflected signal includes multiple backscatter scan lines, and the computing device is configured to determine the signal characteristics of multiple segments based on the multiple backscatter scan lines.

14. An intracardiac echocardiography (ICE) imaging and backscattering system, comprising: An ultrasonic catheter, which has a longitudinal axis, a proximal end, and a distal end; A microelectromechanical (MEMS)-based piezoelectric micromechanical ultrasonic transducer (pMUT) array is disposed at the distal end of the ultrasonic conduit, wherein the MEMS-based pMUT array includes a substrate and a plurality of MEMS-based pMUT array elements disposed on the substrate; and An electronic flexible cable, one end of which is connected to the handle assembly and the other end to the MEMS-based pMUT array, wherein the electronic flexible cable communicates with at least one signal trace and is configured to: Each of the plurality of MEMS-based pMUT array elements is guided to send and receive ultrasound beams relative to the heart via the at least one signal trace; Based on transmitting and receiving at least one of the ultrasonic beams, at least one signal is received from the plurality of MEMS-based pMUT array elements; and Based on the at least one signal, construct at least one image of at least a portion of the heart.

15. The ICE imaging and backscattering system according to claim 14, wherein, The MEMS-based pMUT array comprises multiple pMUT cells of different diameters to achieve a bandwidth greater than 55%.

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