Endobronchial Ultrasound-Guided Needle Biopsy (EBUS-TBNA) Bronchoscope

Abstract

A pMUT-guided ultrasound bronchoscope is disclosed. The pMUT-guided ultrasound bronchoscope includes an insertion tube having a proximal section and a distal section. A handle is connected to the proximal section, and a distal tip is connected to the distal section of the insertion tube. The handle includes a working channel inlet port for inserting fluids and biopsy tools into a working channel extending through the insertion tube and exiting near the distal tip. A suction button is configured to control a valve disposed adjacent to the suction port to control suction when the suction port is connected to a suction device.

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of ultrasound catheters. More specifically, embodiments relate to a piezoelectric micromachined ultrasound transducer (pMUT)-ultrasound pulmonary bronchoscopic needle biopsy (EBUS-TBNA) or TBNA bronchoscope for performing bronchial lymph node biopsies. [Background technology]

[0002] The lung is the most common site where cancer can form, with 2.09 million new cases and 1.76 million deaths attributed to lung cancer worldwide in 2018. More than three-quarters of lung cancer patients are not identified until after the disease has spread to distant or localized locations, at which point the 5-year survival rate ranges from 5.5% to 33.4%. Prompt diagnosis and accurate staging are crucial to the treatment and survival of lung cancer patients. Achieving such an accurate and early diagnosis is difficult, and the associated costs are often prohibitive, especially in low-resource areas. In these types of cases, diagnosis and staging can only be achieved by performing a lymph node (LN) biopsy and subsequent classification of the lymph node as benign or malignant.

[0003] Traditional diagnostic modalities for mediastinal and pulmonary lesions have involved noninvasive or minimally invasive approaches utilizing exfoliative cytology. These include procedures such as transbronchial needle aspiration (TBNA) or Wang needle biopsy, and computed tomography (CT)-guided percutaneous fine-needle aspiration (PCA). TBNA and Wang needle biopsy are both examples of diagnostic procedures. Diagnostic tissue can also be obtained through these procedures, in addition to less invasive surgical techniques such as mediastinoscopy and thoracoscopy. Endobronchial ultrasound-guided needle biopsy (EBUS-TBNA), also known as EBUS fine-needle aspiration, is a relatively new method for obtaining samples from the lung and / or mediastinum using a thin-gauge (22G or less) needle. This unique approach potentially goes beyond simple sampling of lung parenchyma because it incorporates the use of traditional bronchoscopy and ultrasound imaging, both of which have been used for decades.

[0004] The effectiveness of EBUS fine-needle aspiration in sparing patients from more invasive procedures, such as EBUS for lung cancer staging as an alternative to mediastinoscopy, and its ability to facilitate appropriate treatment have contributed to the procedure's growing popularity. A bronchoscopic sampling procedure known as catheter biopsy is used to diagnose peripheral lung lesions. Endobronchial ultrasound, also known as EBUS, has found widespread use and has opened up new horizons for ultrasound-guided lymph node sampling. Recent studies have shown that the diagnostic value of EBUS in determining whether cancer has spread to lymph nodes has demonstrated a pooled sensitivity of 90% and a pooled specificity of 99%.

[0005] Alternatively, local intravenous anesthesia can be used while performing EBUS fine-needle aspiration. An anesthesiologist must be present to supervise monitoring of the patient's ECG, pulse oximetry, and blood pressure throughout the procedure. EBUS fine-needle aspiration can be accomplished by inserting a flexible bronchoscope containing an ultrasound probe through a laryngeal mask. The bronchoscope is then guided through the trachea and bronchial tree toward the correct location in the mediastinum. The lesion is punctured with a needle inserted into the bronchoscope through the bronchial wall, allowing tissue to be aspirated. To obtain a sufficient sample, it may be necessary to puncture the lymph node or mass three to four times, and this procedure can be repeated for multiple lymph nodes during the same session. The aspirate is then smeared onto a slide and simultaneously sent to the pathology laboratory for further cytology. However, visualization during the procedure is limited, increasing the risk of puncturing different areas of interest to obtain biopsy samples.

[0006] Therefore, there is a need for improved EBUS devices for bronchoscopic biopsy with clear bronchoscopic visualization and ultrasound imaging techniques to identify the location of lymph nodes or masses of interest. Summary of the Invention

[0007] By way of preamble, the preferred embodiment described below discloses an easy-to-use piezoelectric micromachined ultrasound transducer (pMUT)-guided ultrasound bronchoscope. The pMUT-guided ultrasound bronchoscope includes an insertion tube having a proximal section and a distal section. The insertion tube is inserted into a patient and directed toward a region of interest. A handle is connected to the proximal section, and a distal tip is connected to the distal section of the insertion tube. The handle includes a working channel inlet port for inserting fluids and biopsy tools into a working channel extending through the insertion tube and exiting near the distal tip. A suction button is provided and configured to control a valve disposed adjacent to the suction port to control suction when the suction port is connected to a suction device. Furthermore, the handle includes a flexion extension level for adjusting the position and orientation of the distal tip when directed toward a region of interest.

[0008] Furthermore, the distal tip is disposed with an ultrasound transducer array having transmit and receive circuitry. Note that the distal tip is coated with a material that provides electrical insulation and transmission of ultrasound signals. The ultrasound transducer array includes a flexible interconnect between the transmit and receive circuitry and the ultrasound transducer array. Note that the ultrasound transducer array corresponds to a microelectromechanical (MEMS)-based piezoelectric micromachined ultrasound transducer (pMUT) or other MEMS-based transducer. Further, the ultrasound transducer array is coupled to an imaging device using a dedicated dongle, and the dedicated dongle is configured to communicate ultrasound transmit pulses and ultrasound receive waveforms. The ultrasound transducer array includes multiple transducer array elements having transducer cells with multiple diameters to achieve a wide bandwidth. Note that each of the multiple transducer array elements is a linear phased array. The multiple transducer array elements generate individual focused beams.

[0009] According to another aspect of the present invention, a piezoelectric micromachined ultrasound transducer (pMUT)-guided ultrasound bronchoscope is disclosed. The pMUT-guided ultrasound bronchoscope includes an insertion tube having a proximal section and a distal section. The insertion tube is inserted into a patient and directed toward a region of interest. A handle is connected to the proximal section, and a distal tip is connected to the distal section of the insertion tube. The handle includes a working channel inlet port for inserting fluids and a biopsy tool into a working channel extending through the insertion tube and exiting near the distal tip. Note that the biopsy tool includes a biopsy needle extending from the working channel through the insertion tube and exiting near the distal tip. A suction button is provided and configured to control a valve disposed adjacent to the suction port to control suction when the suction port is connected to a suction device. Furthermore, the handle includes a flexion extension level for adjusting the position and orientation of the distal tip when directed toward a region of interest. The pMUT-guided ultrasound bronchoscope further includes an ultrasound transducer array having transmit / receive circuitry and disposed at the distal tip of the distal section of the insertion tube, the ultrasound transducer array configured to communicate via the transmit / receive circuitry, and a biopsy needle positioned above the ultrasound transducer array, extending through the insertion tube and exiting near the distal tip. [Brief explanation of the drawings]

[0010] The accompanying drawings illustrate systems, methods, and various embodiments of various aspects of the present disclosure. Those skilled in the art will understand that element boundaries (e.g., boxes, groups of boxes, or other shapes) depicted in the figures represent one example of various boundaries that represent 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 of another element, and vice versa. Additionally, elements may not be drawn to scale. A non-limiting and non-exhaustive description of the present disclosure is described with reference to the following drawings. The components in the figures are not necessarily to scale, with emphasis instead being placed on the principles illustrated.

[0011] Various embodiments are described below in accordance with the accompanying drawings, which are provided to illustrate, but not in any way limit, the scope of the present disclosure, and in which like designations refer to like elements. [Figure 1] FIG. 1 illustrates a top view of an exemplary application of a piezoelectric micromachined ultrasound transducer (pMUT) bronchoscopy-guided ultrasound-transduced needle biopsy (EBUS-TBNA) bronchoscope for evaluation of a patient's lungs, according to an embodiment of the present disclosure. [Figure 2] FIG. 2 shows a side view of a pMUT-EBUS-TBNA bronchoscope delivered to a patient's bronchus according to an embodiment of the present disclosure. [Figure 3] FIG. 3 shows a schematic diagram of several locations of a pMUT-EBUS-TBNA bronchoscope for examination of bronchial lymph nodes, according to an embodiment of the present disclosure. [Figure 4] FIG. 4 shows a schematic diagram of a pMUT-EBUS-TBNA bronchoscope inserted into a bronchial lymph node according to an embodiment of the present disclosure. [Figure 5] FIG. 5 shows a schematic close-up view of the insertion tube of a pMUT-EBUS-TBNA bronchoscope inserted into a bronchial lymph node according to an embodiment of the present disclosure. [Figure 6] FIG. 6 shows a schematic diagram of an ultrasound imaging system according to an embodiment of the present disclosure. [Figure 7] FIG. 7 shows a cross-sectional view of the distal end of a pMUT-EBUS-TBNA bronchoscope having an ultrasound transducer array with multiple transducer array elements according to an embodiment of the present disclosure. [Figure 8] FIG. 8 shows a side view of a pMUT-EBUS-TBNA bronchoscope according to an embodiment of the present disclosure. [Figure 9] FIG. 9 shows a side view of a distal section of an insertion tube with a biopsy needle and ultrasound transducer array extending from a working channel exit port according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012] The components of the embodiments as generally described and illustrated in the figures herein can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments as represented in the figures is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0013] Next, several embodiments of the present disclosure that exhibit all the features of the present disclosure will be described in detail. The words "comprising," "having," "containing," and "including," and other forms thereof, are equivalent in meaning and are intended to be open-ended in that the item or items following any one of these words are not meant to be an exhaustive listing of such item or items, or to be limited to only the listed item or items.

[0014] It should also be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context dictates otherwise. Although systems and methods similar or equivalent to those described herein may be used in the practice or testing of embodiments of the present disclosure, preferred systems and methods are described herein. The terms "proximal" and "distal" are opposite terms. For example, the distal end of a device or component is the end of the component farthest from the practitioner during normal use. The proximal end refers to the opposite end, or the end closest to the practitioner during normal use.

[0015] Embodiments of the present disclosure will be described more fully below with reference to the accompanying drawings, in which like numerals represent like elements throughout the several views and in which exemplary embodiments are shown. However, embodiments of the present disclosure may be embodied in alternative forms and should not be construed as limited to the embodiments set forth herein. The example set forth herein is not limiting and is merely one example among many other possible examples.

[0016] FIG. 1 illustrates a top view of an exemplary application of a piezoelectric micromachined ultrasound transducer (pMUT) bronchoscopy-guided needle biopsy (EBUS-TBNA) bronchoscope 100 for evaluation of the lungs of a patient 102, according to one embodiment of the present disclosure.

[0017] The pMUT-EBUS-TBNA bronchoscope 100 may be provided by an operator to perform lung evaluations. In one embodiment, the operator may be a pulmonologist, interventional pulmonary surgeon, or physician. The pMUT-EBUS-TBNA bronchoscope 100 is a technique for performing bronchoscopy or biopsies of the lungs or lymph nodes. The pMUT-EBUS-TBNA bronchoscope 100 is a minimally invasive procedure performed under direct ultrasound visualization to enable sampling of mediastinal lymph nodes via a fine-gauge aspiration needle (not shown). The pMUT-EBUS-TBNA bronchoscope 100 has low morbidity and has demonstrated utility in diagnosing mediastinal lymphadenopathy secondary to malignancies, lymphoma, and sarcoidosis. The pMUT-EBUS-TBNA bronchoscope 100 allows the operator to obtain tissue or fluid samples from the lungs and surrounding lymph nodes without traditional surgery. The fluid samples may be used to diagnose and stage lung cancer, detect infections, and identify inflammatory diseases affecting the lungs, such as cancers like sarcoidosis or lymphoma.

[0018] A fine-gauge aspiration needle is inserted through the trachea toward the lymph node. The pMUT-EBUS-TBNA bronchoscope 100 allows needle aspiration to be performed on the lymph node using a bronchoscope (not shown) inserted through the mouth. The pMUT-EBUS-TBNA bronchoscope 100 can provide real-time imaging of the airways, blood vessels, lungs, and lymph node surfaces. Note that an endoscope (not shown) can be mated with an ultrasound processor (not shown), and a fine-gauge aspiration needle can be guided through the patient's trachea. In one embodiment, the pMUT-EBUS-TBNA bronchoscope 100 can provide improved images, allowing the operator to easily visualize hard-to-reach areas or regions of interest and access more and smaller lymph nodes for biopsy with an aspiration needle than through traditional mediastinoscopy.

[0019] FIG. 2 shows a side view of a pMUT-EBUS-TBNA bronchoscope 100 delivered to the bronchi of a patient 102 according to an embodiment of the present disclosure. The pMUT-EBUS-TBNA bronchoscope 100 may include a handle 202 connected to an insertion tube (not shown) via a flexible shaft 204. The pMUT-EBUS-TBNA bronchoscope 100 may be positioned at an angle to face or face of the patient 102 when the insertion tube is inserted into the trachea via the mouth. In one embodiment, the flexible shaft 204 may be made from a material selected from a group of materials, such as, but not limited to, polymer, carbon fiber, aluminum, or other elastic materials. The insertion tube may include a proximal section and a distal section. The insertion tube may be inserted into the patient's trachea and may be guided and directed toward a region of interest 206 by the handle 202. The pMUT-EBUS-TBNA bronchoscope 100 may include a distal tip 208 located on the distal section of the insertion tube. Note that the distal tip 208 of the insertion tube may be directed toward the region of interest. Additionally, the distal tip 208 of the insertion tube may be positioned proximate one or more bronchial lymph nodes 210. The one or more bronchial lymph nodes 210 may be detected using ultrasound imaging techniques. Additionally, the distal tip 208 of the insertion tube may be provided with a biopsy needle (not shown) for extracting tissue samples from the one or more bronchial lymph nodes 210. The insertion tube is described in detail below in conjunction with Figures 3-4 of this disclosure.

[0020] Additionally, the pMUT-EBUS-TBNA bronchoscope 100 may include a flexion / extension lever 212 positioned on the handle 202. The flexion / extension lever 212 may be configured to adjust the position and orientation of the distal tip 208 when pointed toward the region of interest. In one embodiment, the handle 202 may be manipulated by the operator to adjust the position of the distal tip 208, along with the biopsy needle, toward the proximal side of one or more bronchial lymph nodes 210. In one exemplary embodiment, the operator uses their left hand to hold the handle 202 of the pMUT-EBUS-TBNA bronchoscope 100 and insert the flexible shaft 204 into the trachea through the mouth of the patient 102, and then uses their right hand to manipulate the flexion / extension lever 212 when the distal tip 208 is close to one or more bronchial lymph nodes 210.

[0021] 3 and 4 show schematic diagrams of several locations on the pMUT-EBUS-TBNA bronchoscope 100 for examination of one or more bronchial lymph nodes 210 according to one embodiment of the present disclosure.

[0022] The pMUT-EBUS-TBNA bronchoscope 100 may include a flexible shaft 204 that is inserted via the trachea toward the lungs or one or more bronchial lymph nodes 210. The flexible shaft 204 may include one or more detachable segments (not shown). The one or more detachable segments may be assembled according to one or more bronchial lymph nodes 210 in different lobes of the lungs of the patient 102. For example, when the right lower lobe (RLL) of the patient 102 is accessed for lymph node biopsy, five detachable segments of the flexible shaft 204 are used.

[0023] Additionally, the pMUT-EBUS-TBNA bronchoscope 100 may include one or more insertion tubes 302 disposed at the distal tip 208. Each of the one or more insertion tubes 302 may include a proximal section 304 and a distal section 306. The proximal section 304 of each of the one or more insertion tubes 302 may be coupled to the flexible shaft 204 at one or more detectable sections. In one embodiment, the one or more insertion tubes 302 may be provided for accessing multiple biopsies or multiple lung samples from one or more bronchial lymph nodes 210. Thus, the pMUT-EBUS-TBNA bronchoscope 100 may be employed to access multiple biopsies from one or more bronchial lymph nodes 210 located in different locations or lobes of the patient's 102 lungs. Additionally, the one or more insertion tubes 302 may include one or more biopsy needles (not shown) for extracting biopsy samples from one or more bronchial lymph nodes 210. It should be noted that one or more biopsy needles may be positioned on the distal section 306 of each of one or more insertion tubes 302 .

[0024] Additionally, the flexible shaft 204 may include one or more spherical joints (not shown) for connecting one or more detachable segments. The one or more spherical joints may be connected at different lengths to provide redirection for the flexible shaft 204 when inserted inside the trachea of ​​the patient 102. For example, a flexible shaft longer than 30 centimeters (cm) has five segments with four detachable segments and therefore four spherical joints. In one embodiment, the one or more spherical joints may include mating joints such as, but not limited to, ball joints, bearing joints, spherical joints, and U-joints. In another embodiment, the one or more spherical joints may be made from a material selected from the group of carbon fiber, stainless steel, titanium, and other non-conductive and non-corrosive materials.

[0025] Additionally, the pMUT-EBUS-TBNA bronchoscope 100 may include one or more ultrasound transducer arrays 308 disposed on the distal section 306 of each of the one or more insertion tubes 302. The one or more ultrasound transducer arrays 308 may be integrated into the distal tip 208 of the pMUT-EBUS-TBNA bronchoscope 100. In one embodiment, the one or more ultrasound transducer arrays 308 may provide detailed mapping and imaging of one or more endobronchial lymph nodes 210 when the one or more insertion tubes 302 and flexible shaft 204 are inserted into the trachea of ​​the patient 202. The one or more ultrasound transducer arrays 308 may provide detailed imaging of the target lymph nodes from which a biopsy sample needs to be extracted. The one or more ultrasound transducer arrays 308 are described in detail in connection with Figures 6-7 of the present disclosure.

[0026] FIG. 5 shows a close-up schematic view of the insertion tube 502 of the pMUT-EBUS-TBNA bronchoscope 100 inserted into one of one or more bronchial lymph nodes 210 according to an embodiment of the present disclosure.

[0027] The insertion tube 502 of the pMUT-EBUS-TBNA bronchoscope 100 can be inserted into one of the one or more bronchial lymph nodes 210 to extract a biopsy sample. The insertion tube 502 can include a working channel exit port 504 positioned on the proximal section 304 of the insertion tube 502. The working channel exit port 504 can be provided with a biopsy needle 506 extending on the distal section 306 of the insertion tube 502. The biopsy needle 506 can be manipulated by the handle 202 to extract a sample from one of the one or more bronchial lymph nodes 210.

[0028] Additionally, the pMUT-EBUS-TBNA bronchoscope 100 may include one or more ultrasound transducer arrays 308 disposed at the distal tip 208 of the flexible shaft 204. The one or more ultrasound transducer arrays 308 may transmit ultrasound signals to one of the one or more bronchial lymph nodes 210 and may receive echo signals that may be transmitted to an external system for image construction and mapping of one of the one or more bronchial lymph nodes 210. The structure and arrangement of the one or more ultrasound transducer arrays 308 are described in connection with FIGS.

[0029] FIG. 6 shows a schematic diagram of an ultrasound imaging system 600 according to an embodiment of the present disclosure. The ultrasound imaging system 600 may utilize one or more ultrasound transducer arrays 308 interconnected using a matching flexible circuit. In one embodiment, the one or more ultrasound transducer arrays 308 may be microelectromechanical (MEMS) transducer arrays defined as piezoelectric micromachined ultrasound transducers (pMUTs) or other types of MEMS transducers. Note that the ultrasound imaging system 600 uses a high-density flexible circuit, which may enable highly repeatable and stable transmit and return signals. Additionally, the high-density flexible circuit transmission lines may transmit electrical energy from one end of the ultrasound imaging system 600 to the other distal end.

[0030] The ultrasound imaging system 600 may include an imaging device 602 linked to the pMUT-EBUS-TBNA bronchoscope 100 via a communication channel 604. The imaging device 602 may include a display 606, an image processor 608, a receive beamformer 610, a transmit beamformer 612, and a dongle 614. The pMUT-EBUS-TBNA bronchoscope 100 may be positioned within one or more bronchial lymph nodes 210 of the patient 102, and the imaging device 602 may receive at least one signal from one or more ultrasound transducer arrays 308. The at least one signal may be communicated to the imaging device 602 via an electronic flex cable (not shown) connected to the dongle 614.

[0031] The image processor 608 may be configured to generate two-dimensional (2D) images according to data received from the pMUT-EBUS-TBNA bronchoscope 100. In one embodiment, the image processor 608 may be configured to receive focused signals from the receive beamformer 610. The image processor 608 may render the data to construct an image or a series of images. In one embodiment, the image may be a three-dimensional (3D) representation, such as a two-dimensional image rendered from a viewpoint selected by a user or a processor. In one embodiment, the image processor 608 may be a detector, filter, processor, application specific integrated circuit, field programmable gate array, digital signal processor, control processor, scan converter, three-dimensional image processor, graphics processing unit, analog circuit, digital circuit, or combination thereof. The image processor 608 may receive the beamformed data and generate an image for display on the display 606. It should be noted that the generated image is associated with a two-dimensional (2D) scan. Alternatively, the generated image may be a three-dimensional (3D) representation.

[0032] The image processor 608 may be programmed for hardware-accelerated two-dimensional reconstruction. The image processor 608 may store processed data of at least one signal and a series of images 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 in a computer-readable storage medium or memory, such as a cache, buffer, RAM, removable media, a hard 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, operations, or tasks illustrated in the figures or described herein are performed in response to one or more instruction sets stored in a computer-readable storage medium. The functions, operations, or tasks are independent of the particular type of instruction set, storage medium, processor, or processing strategy and may be performed by software, hardware, integrated circuits, firmware, microcode, etc., operating alone or in combination.

[0033] The pMUT-EBUS-TBNA bronchoscope 100 may be in electronic communication with an imaging device 602 for transmitting ultrasound signals to and receiving ultrasound signals from one or more bronchial lymph nodes 210. In one embodiment, the pMUT-EBUS-TBNA bronchoscope 100 may be configured to visualize a standard view of one or more bronchial lymph nodes 210 in the lungs of the patient 102, e.g., in a standard version, the right and left lobes may be visualized.

[0034] FIG. 7 shows a cross-sectional view of a distal tip 208 of a pMUT-EBUS-TBNA bronchoscope having one or more ultrasound transducer arrays 308 with multiple transducer array elements 702, according to an embodiment of the present disclosure.

[0035] The one or more ultrasound transducer arrays 308 may comprise a plurality of transducer array elements 702 disposed at the distal tip 208 of the pMUT-EBUS-TBNA bronchoscope 100. Furthermore, each of the plurality of transducer array elements 702 may have a plurality of individual transducer cells 704 arranged to provide a wide bandwidth of the individual focused beams. In one embodiment, the one or more ultrasound transducer arrays 308 may be constructed from a pMUT-based array including individual elements of different diameters. In one embodiment, to achieve a wider bandwidth in a pMUT-based array, multiple diameters of pMUT cells may be integrated into a single element. Note that by arranging preformed pMUT cells with different diameters, a wider bandwidth may be realized through complex interactions between the individual pMUT elements. In one embodiment, multiple diameter pMUT cells may achieve a bandwidth greater than 55%. For example, with three elements, there may be five different dome diameters, each array of a different size, such as 300 μm.

[0036] Furthermore, one or more of the ultrasound transducer arrays 308 may correspond to a pMUT, and the plurality of transducer array elements 702 may correspond to a plurality of pMUT elements. In one embodiment, the plurality of transducer array elements 702 may be oriented to transmit and receive ultrasound beams having a bandwidth that includes a predetermined fundamental mode vibration of each of the plurality of transducer array elements 702, such that a single transducer array element may simultaneously transmit and receive multiple fundamental mode vibrations. Furthermore, an electronic flex cable within the flexible shaft 204 receives at least one signal from the plurality of transducer array elements 702. Note that the at least one signal may correspond to at least one ultrasound beam. The at least one signal may be transmitted to the imaging device 602 for further processing in the image processor 608. The image processor 608 may construct at least one image of one or more bronchial lymph nodes 210. Note that multiple transducer array elements 702 may be used to generate individual focused beams. In one embodiment, the plurality of transducer array elements 702 are arranged in a linear fashion. In the second embodiment, the plurality of transducer array elements 702 are arranged in a cylindrical shape.

[0037] FIG. 8 shows a side view of a pMUT-EBUS-TBNA bronchoscope 100 according to an embodiment of the present disclosure. The pMUT-EBUS-TBNA bronchoscope 100 may include a handle 202 and an insertion tube 502 having a proximal section 304 and a distal section 306. The proximal section 304 of the insertion tube 502 may be connected to the handle 202 via a flexible shaft 204. The distal section 306 is positioned between the distal tip 208 and the proximal section 304. Additionally, the handle 202 may include a working channel inlet port 802, a suction port 804, and a suction button 806. The working channel inlet port 802 may be integrated into the handle 202 on the flexible shaft 204 side. In one embodiment, the working channel inlet port 802 may be employed to insert fluids and / or tools into a working channel (not shown) that extends through the insertion tube 502 and exits near the distal tip 208.

[0038] Additionally, the suction button 806 may be configured to control a valve adjacent the suction port 804 to control suction when the suction port 804 is connected to a suction device (not shown). In one embodiment, once the insertion tube 502 is inserted inside the trachea of ​​the patient 102, the suction button 806 is pressed or the suction port 804 is activated to aspirate obstructions such as mucus, blood, etc.

[0039] As described above, the handle 202 may include a flexion-extension lever 212. The flexion-extension lever 212 may be configured to adjust the location and orientation of the distal tip 208 when directed toward one or more bronchial lymph nodes 210. Additionally, the distal tip 208 of the pMUT-EBUS-TBNA bronchoscope 100 may include one or more ultrasound transducer arrays 308. The one or more ultrasound transducer arrays 308 may continuously transmit ultrasound signals as the handle 202 manipulates the insertion tube 502 to generate different images of the surrounding lymph nodes.

[0040] FIG. 9 shows a side view of the distal section 306 of the insertion tube 502 with a biopsy needle 506 and an ultrasound transducer array 308 extending from a working channel exit port 504 according to an embodiment of the present disclosure.

[0041] The biopsy needle 506 may extend from the working channel exit port 504 toward one of the one or more bronchial lymph nodes 210. One or more ultrasound transducer arrays 308 disposed on the distal tip 208 may be configured to transmit ultrasound signals to the surrounding lymph nodes, and the imaging device 602 may receive at least one signal to generate an image of the surrounding lymph nodes. The physician / surgeon may make a real-time diagnosis and extract a biopsy sample from the infected lymph node using the biopsy needle 506.

[0042] In one embodiment, pMUT-EBUS-TBNA bronchoscope 100 may be designed to allow delivery of distal tip 208 to one of one or more bronchial lymph nodes 210 or the bronchi of patient 102. In another embodiment, pMUT-EBUS-TBNA bronchoscope 100 is designed with good pushing, torqueing, and steering capabilities to allow an operator to easily manipulate distal tip 208 to a desired location and orientation.

[0043] In one embodiment, the transducer array elements may have one or more different shapes. As used herein, the term "proximal and distal sections" refers to tubes or shafts in which one or more transducer elements are disposed. The insertion tube 502 and flexible shaft 204 are not limited in size or shape and can be configured in expanded and unexpanded or compact states. As used herein, the term "proximal and distal sections" refers to a wire-like shaft capable of interfacing with the transducer array elements. Additionally, the distal tip 208 is not limited to any size or dimension.

[0044] Other embodiments of the present invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims. In addition, where this application recites method or procedure steps in a particular order, it is intended that the order in which some steps are performed be changed, or even advantageous in certain circumstances, and that particular steps of the method or procedure claims described herein below are not to be construed as order-specific unless such order-specificity is expressly recited in the claims.

Claims

1. an insertion tube having a proximal section and a distal section; a handle connected to the proximal section; a distal tip connected to the distal section of the insertion tube; Equipped with The handle is a working channel inlet port for inserting fluids and biopsy tools into a working channel extending through the insertion tube and exiting near the distal tip; a suction button configured to control a valve disposed adjacent the suction port to control suction when the suction port is connected to a suction device; A piezoelectric micromachined ultrasound transducer (pMUT)-guided ultrasound bronchoscope comprising:

2. The pMUT-guided ultrasound bronchoscope of claim 1 , wherein the insertion tube is inserted into a patient and directed toward a region of interest.

3. The pMUT-guided ultrasound bronchoscope of claim 1 , wherein the handle comprises a flexion / extension lever that adjusts the position and orientation of the distal tip when directed toward a region of interest.

4. The pMUT-guided ultrasound bronchoscope of claim 1 , wherein the biopsy tool includes a biopsy needle that extends through the insertion tube and exits near the distal tip.

5. The pMUT-guided ultrasound bronchoscope of claim 1 , wherein the distal tip is disposed within an ultrasound transducer array having transmit and receive circuitry.

6. The pMUT-guided ultrasound bronchoscope of claim 5 , wherein the ultrasound transducer array includes a flexible interconnect between the transmit / receive circuitry and the ultrasound transducer array.

7. The pMUT-guided ultrasound bronchoscope of claim 5 , wherein the ultrasound transducer array corresponds to a microelectromechanical (MEMS)-based piezoelectric micromachined ultrasound transducer (pMUT).

8. The pMUT-guided ultrasound bronchoscope of claim 1 , wherein the distal tip is coated with a material that provides electrical insulation and transmission of ultrasound signals.

9. The pMUT-guided ultrasound bronchoscope of claim 5 , wherein the ultrasound transducer array is coupled to an imaging device using a dedicated dongle, the dedicated dongle being configured to communicate ultrasound transmit pulses and ultrasound receive waveforms.

10. The pMUT-guided ultrasound bronchoscope of claim 1 , wherein the ultrasound transducer array comprises a plurality of transducer array elements having transducer cells of multiple diameters to achieve a wide bandwidth.

11. The pMUT-guided ultrasound bronchoscope of claim 10 , wherein each of the plurality of transducer array elements is a linear phased array, and the plurality of transducer array elements generate individual focused beams.

12. an insertion tube having a proximal section and a distal section; a handle connected to the proximal section; a distal tip connected to the distal section of the insertion tube; an ultrasound transducer array having transmit and receive circuitry and disposed at the distal tip of the distal section of the insertion tube; Equipped with The handle is a working channel inlet port for inserting fluids and biopsy tools into a working channel extending through the insertion tube and exiting near the distal tip; a suction button configured to control a valve disposed adjacent the suction port to control suction when the suction port is connected to a suction device; Equipped with The piezoelectric micromachined ultrasound transducer (pMUT)-guided ultrasound bronchoscope, wherein the ultrasound transducer array is configured to communicate via the transmit and receive circuitry.

13. The pMUT-guided ultrasound bronchoscope of claim 12 , wherein the insertion tube is inserted into a patient and directed toward a region of interest.

14. The pMUT-guided ultrasound bronchoscope of claim 12 , wherein a biopsy needle is positioned above the ultrasound transducer array, extends through the insertion tube, and exits near the distal tip.

15. The pMUT-guided ultrasound bronchoscope of claim 12 , wherein the ultrasound transducer array includes a flexible interconnect between the transmit and receive circuitry and the ultrasound transducer array.

16. The pMUT-guided ultrasound bronchoscope of claim 12 , wherein the ultrasound transducer array corresponds to a microelectromechanical (MEMS)-based piezoelectric micromachined ultrasound transducer (pMUT).

17. The pMUT-guided ultrasound bronchoscope of claim 12 , wherein the distal tip is coated with a material that provides electrical insulation and transmission of ultrasound signals.

18. The pMUT-guided ultrasound bronchoscope of claim 12 , wherein the ultrasound transducer array is coupled to an imaging device using a dedicated dongle, the dedicated dongle configured to communicate ultrasound transmit pulses and ultrasound receive waveforms.

19. The pMUT-guided ultrasound bronchoscope of claim 12 , wherein the ultrasound transducer array comprises a plurality of transducer array elements having transducer cells of multiple diameters to achieve a wide bandwidth.

20. The pMUT-guided ultrasound bronchoscope of claim 19 , wherein each of the plurality of transducer array elements is a linear phased array, and the plurality of transducer array elements generate individual focused beams.

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