Medical imaging device and system

Abstract

The present invention generally relates to medical imaging devices, such as real-time visualization and diagnostic and / or therapeutic tool assemblies, which may include an ergonomic handle and a catheter configured for dual function use during a medical procedure. By way of non-limiting example, the medical device may be configured for use with a probe, such as a probe disposed at the distal end of a catheter and delivered inside a bronchoscope working channel to provide real-time visualization (e.g., radial ultrasound imaging) and manipulation (e.g., diagnostic biopsy sampling) of pulmonary nodules in the peripheral region of the lung. As disclosed herein, in various embodiments, one or more components of the medical imaging device may be configured to position a catheter inside a peripulmonary region using a first tool / implement (e.g., a biopsy needle) while maintaining real-time visualization of pulmonary nodules (e.g., with a second tool / implement, such as a radial ultrasound probe).

Description

This application is a divisional application of invention patent application 202080036082.9. Related Applications

[0001] Pursuant to Section 119 of Title 35 of the United States Code, this application claims priority to U.S. Provisional Patent Application No. 62 / 849,311, filed on May 17, 2019, entitled "Device for accessing the peripheral area of ​​the lung for direct visualization with tool attachment," the entire contents of which are incorporated herein by reference.

[0002] Pursuant to Section 119 of Title 35 of the United States Code, this application claims priority to U.S. Provisional Patent Application No. 62 / 849,649, filed on May 17, 2019, entitled “Device for Providing an Adjustable Mechanism for Radial Ultrasonic Orifices and Irrigation Orifices,” the entire contents of which are incorporated herein by reference.

[0003] Pursuant to Section 119 of Title 35 of the United States Code, this application claims priority to U.S. Provisional Patent Application No. 62 / 849,307, filed on May 17, 2019, entitled “Radial Ultrasonic Needle Biopsy Device,” the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present disclosure generally relates to the technical field of medical devices. Specifically, the present disclosure relates to devices, systems and methods for applying imaging, and more specifically, the present disclosure relates to devices, systems and methods for integrating imaging (such as ultrasound imaging) and biopsy or other diagnostic and / or therapeutic capabilities in the same device. Background Art

[0005] Typically, endoscopic imaging can be performed to determine the internal features of one or more target anatomical structures. Often, imaging is used for positioning / locating purposes, such as during diagnostic procedures. For example, an ultrasound imaging device can be inserted into the working channel of an endoscope to image the target anatomical structure so that the tool can be positioned through the endoscope for surgery, such as biopsy of a lung nodule. In this example, once the endoscope is positioned, the ultrasound imaging device can be removed from the working channel, and if the endoscope is properly positioned, a needle can be inserted into the working channel to biopsy a lung nodule. The key points of this process may include: when the probe is being exchanged with the needle (for example, when direct visualization with a bronchoscope cannot be positioned at the nodule), the position of the nodule is maintained, the orientation of the needle relative to the nodule and / or the bronchoscope is controlled, and the biopsy needle must be driven into the nodule tissue without the benefit of real-time imaging.

[0006] A biopsy is a group of medical diagnostic tests used to determine the structure and composition of tissues or cells. During a biopsy procedure, cells or tissues are sampled from an organ or other body part to allow them to be analyzed (e.g., under a microscope). Typically, if an abnormality is found by superficial examination (such as palpation or radiography), a biopsy may be performed to determine the nature of the suspected abnormality.

[0007] With these factors in mind, a variety of beneficial medical outcomes can be achieved through the devices, systems, and methods of the present disclosure. Summary of the invention

[0008] In one aspect, the present disclosure relates to a medical device comprising a plunger assembly, a flushing orifice assembly, and a handle body connecting the plunger assembly to the flushing orifice assembly. The plunger assembly may be coupled to a first tool and configured to move the first tool in a distal direction and a proximal direction. The flushing orifice assembly may be coupled to a second tool and configured to rotate at least partially around the longitudinal axis of the second tool. In some embodiments, the flushing orifice assembly may be configured to rotate at least 180 degrees around the longitudinal axis of the second tool. In various embodiments, the first tool may include a biopsy needle and the second tool may include a radial ultrasound probe. In several embodiments, the plunger assembly and the flushing orifice assembly may be parallel to each other in the handle body. In many embodiments, the medical device may include a bifurcated joint in the handle body. In many such embodiments, the bifurcated joint may connect the plunger assembly to the first lumen of a double lumen catheter and connect the flushing orifice assembly to the second lumen of the double lumen catheter. In various embodiments, the double lumen catheter may include a braided layer and a return layer. In some embodiments, the second tool may include an imaging sensor configured to communicate with an imaging controller via a hub assembly. In some such embodiments, the imaging sensor is connected to the hub assembly via a proximal drive cable having a first diameter and a distal drive cable having a second diameter, and the first diameter is greater than the second diameter. In several embodiments, an impedance compensator connects the distal drive cable to the proximal drive cable. In many embodiments, the medical device may include a probe and a double-lumen catheter. In many such embodiments, the probe may include an imaging window and a marker, and the double-lumen catheter may connect the handle body to the probe, wherein the double-lumen catheter includes a braided layer, wherein the braided layer is configured to rotate the probe axially inside the body cavity with the axial rotation of the handle body. In various embodiments, the medical device may include an imaging sensor extending into the probe through the first lumen of the double-lumen catheter, the imaging sensor may be configured to generate an image of the body cavity via the imaging window, and the image of the body cavity may include an indication of the marker. In various such embodiments, the probe includes a side orifice and the indication of the marker in the body cavity image indicates the orientation of the side orifice in the body cavity image. In some such embodiments, the side orifice and the marker are oriented on the probe at intervals of 180 degrees. In several embodiments, the medical device may include a biopsy needle extending through a second lumen of the dual lumen catheter into the probe, wherein the biopsy needle is configured to exit the probe through a side port upon actuation of an actuation member included on the handle body. In multiple embodiments, the medical device may include a biopsy needle extending through a second lumen of the dual lumen catheter into the probe, wherein the biopsy needle is configured to exit the probe through a side port included in the handle assembly at an angle relative to the imaging window upon actuation of the actuation member. In some embodiments, the medical device may include a dual lumen catheter having a first lumen and a second lumen.In some perspective views of this embodiment, the first tool is arranged in the first lumen and the second tool is arranged in the second lumen. In various embodiments, the medical device may include a probe attached to the distal end of a double lumen catheter, wherein the probe includes a third lumen aligned with the first lumen of the double lumen catheter and a fourth lumen aligned with the second lumen of the double lumen catheter. In various such embodiments, the probe is attached to the distal end of the double lumen catheter via a reflux process. In one or more embodiments, the medical device may include an imaging controller, which is connected to an imaging sensor via a hub assembly and a coaxial cable. In some embodiments, the handle body includes at least two mirrored ergonomic contours.

[0009] On the other hand, the present disclosure relates to a system; the system includes a handle assembly, a probe and a dual-lumen catheter. The handle assembly may include a flushing port and the probe may include an imaging window and a marker. The dual-lumen catheter may connect the handle assembly to the probe. In addition, the dual-lumen catheter may include a braided layer configured to rotate the probe axially inside the body cavity as the handle assembly rotates axially. In some embodiments, the system may include an imaging sensor extending into the probe through a first lumen of the dual-lumen catheter, and the imaging sensor is configured to generate an image of the body cavity via an imaging window, wherein the image of the body cavity includes an indication of a marker. In many embodiments, the probe includes a side orifice, and the indication of the marker in the body cavity image indicates the orientation of the side orifice in the body cavity image. In one or more embodiments, the side orifice and the marker are oriented at intervals of 180 degrees on the probe. In many embodiments, the system includes a biopsy needle extending into the probe through a second lumen of the dual-lumen catheter, wherein the biopsy needle is configured to leave the probe via the side orifice as an actuation of an actuation member included in the handle assembly is actuated.

[0010] In yet another aspect, the present disclosure relates to a system comprising a handle assembly, a probe, and a dual lumen catheter. The handle assembly may include a bifurcated joint and the probe may include an imaging window and a marker. The dual lumen catheter may connect the bifurcated joint to the probe and is configured to rotate the probe axially within the body cavity as the handle assembly rotates axially.

[0011] In yet another aspect, the present disclosure is directed to an apparatus comprising a processor and a memory containing instructions that, when executed by the processor, cause the processor to perform one or more of the following. In some embodiments, the memory may contain instructions for causing the processor to control one or more aspects of an imaging sensor, such as generating an image based on signals received from the imaging sensor.

[0012] In yet another aspect, the present disclosure relates to a method. The method may include one or more of: inserting a medical imaging device through a working channel of a bronchoscope; extending the medical imaging device beyond a distal end of the bronchoscope; generating an image with the medical imaging device; aligning the medical imaging device to perform a biopsy of a nodule based on the image; and performing a biopsy of the nodule based on the image. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Non-limiting embodiments of the present disclosure are described below by way of example and with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component illustrated is generally represented by a single numeral. For clarity, not every component is labeled in each drawing, nor is every component of each embodiment shown, wherein illustration is not necessary for a person skilled in the art to understand the present disclosure. In the drawings:

[0014] Figure 1 An exemplary medical imaging apparatus according to one or more embodiments described herein is illustrated.

[0015] Figure 2A-2C The diagrams illustrate various aspects of an exemplary medical imaging apparatus according to one or more embodiments described herein.

[0016] Figure 3A-3H Various aspects of an exemplary probe for a medical imaging device are illustrated according to one or more embodiments described herein.

[0017] Figure 4A-4C An exemplary handle assembly for a medical imaging device according to one or more embodiments described herein is illustrated.

[0018] Figure 5A-5E Various aspects of an exemplary handle assembly according to one or more embodiments described herein are illustrated.

[0019] Fig. 6A and Figure 6B Various internal components of an exemplary handle assembly are illustrated according to one or more embodiments described herein.

[0020] Figure 7A-7D Various aspects of an exemplary bifurcated joint for a handle assembly are illustrated according to one or more embodiments described herein.

[0021] Figure 8A-8J Various aspects of an exemplary flushing orifice assembly for a handle assembly are illustrated according to one or more embodiments described herein.

[0022] Fig. 9illustrates various aspects of an exemplary imaging controller according to one or more embodiments described herein; Fig.10 Illustrated is one embodiment of an exemplary computing architecture 1000 that may be suitable for implementing the various embodiments described above.

[0022] Figures 11A-11L Various exemplary handle assemblies according to one or more embodiments described herein are illustrated. DETAILED DESCRIPTION

[0024] In various embodiments, the present disclosure generally relates to a medical imaging device, such as a real-time visualization and diagnostic and / or therapeutic tool assembly (e.g., an assembly with radial ultrasound imaging and biopsy needle capabilities), which may include an ergonomic handle and a catheter configured for dual-function use during a medical procedure (e.g., bronchoscopy). By way of non-limiting example, the medical device may be configured for use with a probe, such as a probe that is disposed at the distal end of a catheter and is delivered inside a bronchoscope working channel to provide real-time visualization (e.g., radial ultrasound imaging) and manipulation (e.g., diagnostic biopsy sampling) of pulmonary nodules in a peripheral lung region. As disclosed herein, in various embodiments, one or more components of the medical imaging device may be configured to position the catheter inside a peripheral lung region with a first tool / instrument (e.g., a biopsy needle) while maintaining real-time visualization of pulmonary nodules (e.g., with a second tool / instrument, such as a radial ultrasound probe). Additionally or alternatively, the assembly may be configured to enable a medical professional to approach, lock, and / or manipulate a tool / instrument attached thereto with a single hand.

[0025] Although embodiments of the present disclosure are described with specific reference to components, systems, and methods designed to provide dual-function real-time visualization and diagnostic sampling of pulmonary nodules within the peripulmonary region, it should be understood that such components, systems, and methods can be used to visualize and manipulate a variety of tissues within a variety of different body cavities and / or body passages for diagnostic and / or therapeutic purposes. In various embodiments described herein, direct visualization may refer to video imaging using an endoscope, and real-time visualization may refer to imaging using an instrument (e.g., a radial ultrasound probe) inserted through a working channel of an endoscope and beyond the distal end of the endoscope. In addition or alternatively, in one or more embodiments described herein, direct visualization may refer to imaging that applies a visible light spectrum (video images), and real-time visualization may refer to imaging that does not apply a visible light spectrum (e.g., ultrasound imaging or infrared imaging).

[0026] The present disclosure is not limited to the specific embodiments described. The terms used herein are only used for the purpose of describing the specific embodiments, and are not intended to limit whether it exceeds the scope of the attached claims. Unless otherwise specified, all technical terms used in this article have the same meaning as those commonly understood by those skilled in the art to which the present disclosure belongs.

[0027] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the terms "include" and / or "comprise" or "have" and / or "contain" when used herein specify the presence of stated features, regions, steps, elements and / or components, but do not exclude the presence and addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups thereof.

[0028] As used herein, the term "distal" refers to the end farthest from the medical professional when the device is introduced into a patient, while the term "proximal" refers to the end closest to the medical professional when the device is introduced into a patient.

[0029] Generally with reference to the symbols and nomenclature used herein, one or more parts of the following detailed description may be given in the form of program steps performed on a computer or computer network. These program descriptions and diagrams are used by those skilled in the art to communicate their work content to other technical personnel in the field in the most effective manner. The steps here are generally considered to be a self-consistent order of operations that lead to a desired result. These operations are operations that require physical manipulation of physical quantities. Usually, although not necessarily, these quantities are in the form of electrical signals, magnetic signals, and optical signals that can be stored, transmitted, combined, compared, or otherwise manipulated. Mainly due to commonly used reasons, it is sometimes proven convenient to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, etc. However, it should be noted that all of these and similar terms should be related to appropriate physical quantities and are merely convenient labels applicable to these quantities.

[0030] In addition, these manipulations are often referred to with terms (such as adding or comparing) that are usually associated with mental operations performed by a human operator. However, this ability of a human operator is not necessary, or in most cases, it is desirable to constitute a part of one or more embodiments in any operation described herein. On the contrary, these operations are machine operations. Useful machines for implementing the operation of various embodiments include general-purpose digital computers that are selectively activated or configured by a computer program stored internally written according to the teachings herein, and / or include special devices for the desired purpose. Various embodiments also relate to devices or systems for performing these operations. These devices can be specially made for the desired purpose or can include a general-purpose computer. Based on the description given, the required structure for a variety of these machines will be apparent.

[0031] Reference is now made to the accompanying drawings, in which similar reference numerals are used to refer to similar elements in all the drawings. In the following description, for the purpose of explanation, many specific details are stated to provide a detailed understanding thereof. However, it is apparent that these novel embodiments can be implemented without these specific details. In other cases, well-known structures and devices are shown in block diagram form to facilitate their description. It is intended to cover all modifications, equivalents and substitutes within the scope of the claims.

[0032] Figure 1 The medical imaging device 100 according to one or more embodiments described herein is illustrated. In general, the medical imaging device 100 may include a probe 102, a handle assembly 104, and a hub assembly 106. The probe 102 may be connected to the handle assembly 104 via a dual lumen catheter 108, which handle assembly and other features facilitate efficient and reliable use of first and second medical instruments / tools 116-1, 116-2 in conjunction with the medical imaging device 100. For example, the first tool 116-1 may include a biopsy needle and the second tool 116-2 may include a radial ultrasound probe. The medical imaging device 100 may include a distal end 145 at the probe 102 and a proximal end at the hub assembly 106. The handle assembly 104 may include a tool lock 110, an actuation member 112, and an irrigation port 114. When the tool lock 110 is unlocked, the actuation member 112 may manipulate the first tool 116-1 between multiple positions. In one or more embodiments, the hub component 106 can interact with logic and / or control circuitry to operate at least the tool 116-2. For example, the tool 116-2 can include one or more sensors for imaging, which can interact with a controller via the hub component 106 (e.g., Fig. 9 In many embodiments, Figure 1One or more components illustrated in or described with respect to the EMBODIMENTS 100 may be identical or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0033] In various embodiments, the probe 102 can be inserted into a body cavity for diagnostic and / or therapeutic purposes. For example, the medical imaging device 100 can be used to image and / or biopsy a nodule inside a patient's body cavity. In some embodiments, the medical imaging device 100 can be used as a stand-alone device for insertion into a body cavity. However, in additional or alternative embodiments, the medical imaging device 100 can be configured to extend through a working channel of another medical device (e.g., a duodenoscope, an endoscope, a ureteroscope, a bronchoscope, a colonoscope, an arthroscope, a cystoscope, a hysteroscope, etc.). For example, the medical imaging device 100 can be inserted via a bronchoscope to biopsy lung tissue.

[0034] In many embodiments, the medical imaging device 100 can be modular (including one or more modular components), for example, to facilitate efficient manufacturing, selectable tools, and / or reliable operation. In several embodiments, the first tool 116-1 and the second tool 116-2 can have a parallel configuration within the handle assembly 104. In several such embodiments, the parallel configuration can facilitate reliable and intuitive one-handed operation using either hand. For example, the tool lock 110 can provide ambidextrous operation (see, e.g., Figure 5C-5E ).

[0035] The flushing orifice can facilitate the provision of fluid to the proximal distal end 145, such as via the lumen of tool 116-2. In several embodiments, a fluid (saline) can be introduced via the flushing orifice 114. In some embodiments, a fluid that assists in imaging (such as a conductive medium that replaces another less conductive medium) can be introduced via the flushing orifice 114. For example, saline can be introduced to the distal end of the medical device 100 via the flushing orifice 114 to enhance the propagation of sound waves from an ultrasound sensor (such as tool 116-2 inside the probe 102), such as compared to air. In some embodiments, the flushing orifice can be used to direct other types of fluids for various other diagnostic or therapeutic purposes.

[0036] The proximal portion of the dual lumen catheter 108 and the tool 116-2 (e.g., between the irrigation port 114 and the hub assembly 106) can have the same or different diameters. In some embodiments, a common diameter can be achieved by the fact that the proximal portion of the tool 116-2 has a larger diameter drive cable than the distal portion of the tool 116-2 extending through the dual lumen catheter 108.

[0037] Figure 2A-2CThe diagram illustrates various aspects of a medical imaging device 100 according to one or more embodiments described herein. More specifically, Figure 2A Axial displacement and rotation of one or more of the probe 102, the handle assembly 104, the tool 16-1, and the tool 116-2 are illustrated. Figure 2B Axial displacement and rotation between the irrigation orifice 114 and the handle body 243 are illustrated. Figure 2C The diagram illustrates axial rotation of tool 116-2 at the distal end 145 and proximal end 155 of the medical imaging device 100. In the embodiments described herein, components of the medical imaging device 100 can be rotated and / or translated in a reliable, intuitive, unique and advantageous manner. For example, an embodiment may include an adjustable and leak-proof irrigation orifice assembly configured for use in a bronchial radial ultrasound system to provide real-time imaging and targeting of difficult-to-access lung nodules. For example, the medical imaging device 100 may extend beyond the distal end of a bronchoscope to access lung passages that are narrower than the distal end that the bronchoscope can access. In this case, for example, the medical imaging device may be configured to extend beyond the distal end of the bronchoscope by 15 centimeters or more. In addition, the adjustable irrigation orifice assembly may include an adjustable ultrasound probe and / or irrigation orifice configured to allow a physician to position / reposition components of the bronchial radial ultrasound system (e.g., ultrasound probe, irrigation orifice, and / or probe assembly) proximally / distally (e.g., along the longitudinal axis), laterally (e.g., along the radial axis), and / or axially (e.g., about or around the longitudinal axis) within the peripulmonary region while maintaining a leak-proof seal for simultaneous irrigation of fluid through the lumen of the radial ultrasound probe. In many embodiments, Figure 2A-2C One or more components illustrated or described in the drawings may be identical or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0038] Reference Figure 2A, the probe 102 may include an imaging window 222, a side port 220, a marker 224, and the handle assembly 104 may include an actuation member 112. In addition, the lumens 218-1, 218-2 (or lumens 218) may extend generally between the distal end 245 of the probe 102 and the proximal end 255 of the handle assembly 104. More specifically, the first lumen 218-1 may include a distal opening at the side port 220, and the second lumen 218-2 may include a distal opening in or at the distal end 245. In some embodiments, one or more of the lumens 218 may be covered or sealed at the distal end. For example, the lumen 218-2 may be covered by a balloon at the distal end 245. In various embodiments, the first tool 116-1 may be disposed in the first lumen 218-1 and the second tool 116-2 may be disposed in the second lumen 218-2. In one or more embodiments, the second tool 116-2 may include an imaging sensor. In one or more such embodiments, the first tool 116 - 1 can include a biopsy needle.

[0039] In the illustrated embodiment, the probe 102 includes an imaging window 222 and a marker 224. In many embodiments, the imaging window 222 may refer to one or more portions of the probe 102 that are substantially transparent to the imaging energy wavelength, while the marker 224 may refer to one or more portions of the probe that are relatively opaque to the imaging energy wavelength. The marker 244 may comprise any medium that absorbs the imaging energy wavelength (e.g., ultrasound). For example, a metal or metal alloy (e.g., stainless steel or nickel-titanium alloy) may be used. In some embodiments, a non-metal may be used, such as an air pocket embedded in the wall of the imaging window. Additionally or alternatively, in various embodiments, the marker 244 may be radiopaque, such as to appear in X-ray and / or fluorescence imaging.

[0040] In such an embodiment, the marker 244 may be positioned to indicate in the generated image where the first tool 116-1 will be positioned when the actuating member 112 is moved distally along the axial displacement 226-2, resulting in the axial displacement 226-1 of the tool 116-1, resulting in the tool 116-1 extending from the side orifice 220. In order to position the probe 102 based on the generated image, the handle assembly 104 may be rotated along the axial rotation 228-1, resulting in the probe 102 being rotated along the axial rotation 228-2. For example, the handle assembly 104 may be rotated to align the side orifice 220 with the target nodule based on the indication of the marker 224 in the generated image. In some such instances, once aligned, the actuating member 112 may be moved distally, resulting in the distal end of the first tool 116-1 contacting and / or penetrating the target nodule. In various embodiments, the marker may be embedded in the wall of the lumen (e.g., the wall of the second lumen 218-2). As will be appreciated, device rotation (e.g., markings and radial orientation of the needle) can enable more efficient biopsy of eccentric nodules, for example, when the biopsy target tissue has an asymmetric shape with irregular margins, does not extend around the entire circumference of the body cavity, etc., where needle control or orientation and position may be more important.

[0041] As an example, the marker 224 can be oriented around the perimeter of the imaging window at a known angle relative to the side orifice 220. In this case, for example, when a lung nodule is targeted for core biopsy, the marker 224 can be oriented on the radial ultrasound image at a known angle relative to the predetermined biopsy site so that the needle leaving the side orifice 220 will be correctly aligned with the biopsy site. In another such example, the marker 224 can be oriented on the radial ultrasound image across 180 degrees from the predetermined biopsy site. In many embodiments, the known angle relative to the predetermined biopsy site can be configured to provide an allowable deviation. For example, the marker 224 can be oriented on the radial ultrasound image at an angle of 180 ± 35 degrees relative to the predetermined biopsy site.

[0042] Reference Figure 2B , the handle assembly 104 may have a distal end 245 and a proximal end 255 and include a handle body 243 and a flushing orifice 114. In many embodiments, the flushing orifice 114 may have one or more of a distal axial rotation 230, a proximal axial rotation 232, and a proximal / distal displacement 234. In several embodiments, the flushing orifice 114 may rotate approximately 270 degrees without contacting the plunger assembly and / or the handle body. In many embodiments, the rotation of the flushing orifice 114 may allow the flushing orifice 114 to be positioned so that the proximal drive cable does not interfere with use, thereby facilitating ease of one-handed control. In various embodiments, the flushing orifice 114 may rotate up to 360 degrees without any interfering structures. Referring to Figure 2C, the second tool 116-2 can extend from the hub assembly 106 through the irrigation port 114 to the distal end 245 of the probe 102. In various embodiments, the axial rotation 236-2 via the hub assembly 106 can result in an axial rotation 236-1 in the probe 102. In various such embodiments, the axial rotation 236-1 can enable the tool 116-2 to generate a 360-degree image and / or can allow the tool 116-2 to be rotationally oriented as needed to align the side port 220 and the tool 116-1 with a predetermined target site. As will be discussed in more detail below, for example, with respect to Fig. 9 , the hub assembly 106 may be connected to an imaging controller that enables the tool 116 - 2 to be rotated via the assembly 106 .

[0043] Figure 3A-3H The diagram illustrates various aspects of an exemplary probe 302 for a medical imaging device according to one or more embodiments described herein. More specifically, Figure 3A The diagram illustrates a perspective view of the probe 302 and Figure 3B A cross-sectional view of the probe 302 is illustrated. Figure 3C The cannula 342 is illustrated along with a distal engagement point 346 of the probe 302 . Figure 3D The sleeve 342 and distal junction 346 are illustrated along with the marker 344 and tubular member 354 . Figure 3E An end cap 340 of the probe 302 is illustrated. Figure 3F A front perspective view of the probe 302 is illustrated. Figure 3G Braid 360 is illustrated as being applied to a dual lumen catheter 308 . Figure 3H An exemplary image 362 generated by the probe 302 is illustrated (see, e.g., Fig. 9 ). In the embodiments described herein, the components of the probe 302 can facilitate the targeting of specific tissues in a reliable, intuitive, unique and advantageous manner. For example, an embodiment may include an end cap 340 disposed on the distal end of the dual-lumen catheter 308. In addition, the end cap 340 can be aligned with each lumen in the catheter 308 so that the needle 316-1 can leave the side orifice 320 and the ultrasound sensor 316-2 to utilize the imaging window 322 and the marker 344. In many embodiments, when the needle 316-1 leaves the side orifice 320, the marker 344 can provide an indication and / or estimate of the position of the needle 316-1. This, along with other features, can provide a technique that improves efficiency, accuracy and / or reliability for biopsy. For example, a real-time image with a marker 344 can allow a user to determine where and from what angle the biopsy needle will radially leave the side orifice and / or biopsy the tissue before starting, which is particularly useful for biopsy of eccentric nodules. Each embodiment is not limited to this context.

[0044] Biopsies can be performed in a number of organs, tissues, and body parts (superficial and deep), and a variety of techniques may be applied depending on the tissue or body part to be sampled, the location, size, shape, and other characteristics of the abnormality, the number of abnormalities, and patient preference. FNA (fine needle aspiration) is typically performed to sample deep tissues (such as the kidney) using a fine-gauge needle (22 or 25 gauge) inserted percutaneously or endoscopically under ultrasound guidance (ultrasound-guided fine needle aspiration (US-FNA)). In contrast, surgical biopsies are typically performed as open procedures and can be excisional (removal of the entire lesion) or incisional (removal of a piece of the lesion).

[0045] Surgical biopsies generally allow for the removal of more tissue than fine needle biopsies and are therefore less prone to misdiagnosis. Open surgical procedures can be significantly more expensive than needle biopsies, can require more time for recovery, require sutures, can leave disfiguring scars, can require anesthesia, can have a small risk of death, and can result in bleeding, infection, and wound healing problems.

[0046] However, fine needle biopsies can have their own risks: the relatively small amount of sampled tissue may not be representative of the region of interest from which the sample is being taken, particularly when the region of interest is difficult to image or the nodule is very small, very hard, and / or eccentric. Additional difficulties arise in the case of ultrasound-guided fine needle biopsies: fine-gauge biopsy needles are typically stiffer and less prone to deflection than the catheter-based endoscopic ultrasound transducers used to guide them in some ultrasound-guided fine needle aspiration (US-FNA) procedures. Thus, while the transducer can be guided to the site of interest, it cannot be accurately sampled if the needle is too stiff to guide the same path through the tissue. Additionally, current methods involve "blind" actuation of the biopsy needle, which can result in damage to non-target tissue or false-negative results if healthy tissue proximal to the intended suspected tissue site is accidentally sampled.

[0047] The difficulties of fine needle biopsy are magnified in the case of sampling of lung nodules, where the respiratory rhythm causes the nodule, probe, and needle to move relative to each other. It is particularly desirable in this environment to be able to visualize the nodule and needle in real time during the patient's breathing to ensure accurate needle tracking and sampling. Therefore, one or more embodiments and / or features herein may solve or minimize these problems.

[0048] Reference Figure 3A , the probe 302 may include an end cap 340 coupled to the dual lumen catheter 308 (e.g., via overmolding and / or through-reflow bonding), a needle 316-1 extending from a side port 320, an imaging window 322, a marker 344, a cannula 342, and an imaging sensor 316-2. Figure 3BAs shown in the cross-sectional view in , the probe 302 may include a first lumen 318-1 and a second lumen 318-2, a needle 316-1 having a guide needle 352 extending therethrough, an imaging sensor 316-2 with a distal cable 356, a side port 320 with a ramp 348, an imaging window 322, a cannula 342, a marker 344, a distal joint 346, and a strain relief portion 350.

[0049] Reference Figure 3C , the distal junction 346 may include a portion of the first and second lumens 318. The distal junction 346 may include a side orifice 320 and a ramp 348. In various embodiments, the angle of the ramp 348 may be between 0 and 90 degrees relative to the longitudinal axis in the proximal direction. In many embodiments, a higher angle may improve nodule (e.g., eccentric lesions) targeting, but make needle actuation more difficult. For example, the greater the angle of the bevel (ramp) 348, the greater the longitudinal force required to actuate the needle along the ramp 348 and extend from the side orifice 320. In addition, a larger angle would require the needle to extend more from the side orifice 320 to enter the field of view of the imaging sensor 316-2, thereby limiting the applicability of body cavities with larger diameters. Conversely, a lower angle would require the probe 302 to be located closer to the target nodule, making it difficult to obtain a biopsy sample from an eccentric nodule and / or from a position lower below the surface of the target nodule. Therefore, the angle of the ramp may be selected based on the specific application. In one or more embodiments, the ramp angle may be greater than or equal to 3 degrees and less than or equal to 20 degrees. For example, the angle of the ramp 348 may be 15 degrees. The distal joint 346 and / or the sleeve 342 may comprise a metal or a metal alloy (e.g., a nickel-titanium alloy). In some embodiments, the sleeve 342 is laser cut. In many embodiments, the sleeve 342 may provide one or more of rigidity, restraint, structure, and flexibility. Figure 3D , the tubular member 354 can extend into the cannula 342. In various embodiments, the tubular member 354 can comprise a portion of a double lumen catheter. Figure 3D Also shown in FIG. 344 are markers 344. The markers 344 may comprise any medium that absorbs the imaging energy wavelength (e.g., ultrasound). For example, a metal or metal alloy (e.g., stainless steel or nickel titanium alloy) may be used. In some embodiments, a non-metal (e.g., air) may be used. For example, the marker 344 may comprise an air pocket or a plurality of air bubbles squeezed into the wall of the imaging window.

[0050] Reference Figure 3E , the end cap 340 can accommodate Figure 3D. The marker 344 can be arranged in the marker pocket 357 and the side orifice 320 can be aligned with the orifice window 359. In some embodiments, the marker pocket 357 can include an air pocket in the wall of the end cap 340. In addition, the end cap 340 includes an imaging window 322 and a strain relief 350. In one or more embodiments, the imaging window 322 can be the same or similar material as the rest of the end cap 340. In various embodiments, the strain relief 350 can limit the bending caused by the marker 344 and / or the distal joint 346. In various embodiments, a gap is left between the end cap 340 and the braid layer 360 and the return layer 361 to allow greater flexibility.

[0051] like Figure 3F As shown in FIG. 3 , the double lumen catheter 308 may include a tubular member 354 having two lumens, a braided layer 360, and a return layer 361 above the braided material 360. Figure 3G As shown in, braid 360 may have overlapping, braided, two lines per band, two up / two down and / or cross patterns. Based on the specific application of medical imaging devices, other patterns, braiding conditions, materials, etc. can be envisioned. In various embodiments, the number of crosses of braid 360 per inch can be between 25 and 140. In some embodiments, the angles of different braided strands to each other can be between 60 degrees and 120 degrees (such as 90 degrees). In many embodiments, with regard to the combination of flexibility and strength, the pattern of braid 360 can be selected. In various embodiments, braid 360 can be braided stainless steel or nickel-titanium alloy. In several embodiments, braid 360 can provide torsional strength to double-lumen catheters. In several such embodiments, the torsional strength provided by braid 360 can enable the rotation of the handle to be converted into the rotation of the distal end. In many embodiments, the rotation of the handle can cause the distal end (e.g., probe) to rotate at a known ratio. For example, the rotation of the handle can cause a 1:1 or approximately 1:1 distal end rotation. In addition, the ability to rotate the handle and cause rotation at the distal end can facilitate targeting of nodules (such as eccentric nodules) based on real-time images indicated by markers. In many embodiments, the end cap 340 can be connected to the double lumen catheter 308 via a reflow and / or secondary molding process. In many embodiments, in addition or alternatively, the double lumen catheter 308 can have a braided layer (such as braid 360). In some embodiments, the braid 360 can use up to 356 different strands. For example, some embodiments can use 64 different strands.

[0052] Figure 3H An exemplary image 362 generated by the probe 302 is illustrated (see, e.g., Fig. 9 ). Image 362 may include marker 344, needle 316-1, and nodule 364. Figure 3HAs shown in , in the generated image (e.g., ultrasound image), the marker 344 can provide an indication and / or estimate of the position of the needle 316-1 when the needle leaves the side aperture 320. This, along with other features, can provide an improved efficiency, accuracy and / or reliability technique for performing biopsies (e.g., positioning the biopsy needle to the tip to optimize the efficiency and reliability of sampling). In the illustrated embodiment, the needle 316-1 is extended to indicate that it can provide an indication on the image that is compared to the marker.

[0053] In various embodiments, the marker 344 can be oriented around the circumference of the imaging window at a known angle relative to the side aperture 320. In such a case, for example, when targeting a nodule 364 (e.g., an eccentric or concentric lung nodule) to perform a core biopsy, the marker 344 can be oriented on the image 362 (e.g., a radial ultrasound image) at a known angle relative to the intended biopsy site so that a needle exiting the side aperture 320 will be properly aligned with the biopsy site. For example, in the illustrated embodiment, the marker 344 can be oriented on the image 362 at an angle of 180±35 degrees relative to the intended biopsy site (i.e., the nodule 364).

[0054] Figure 4A-4C An exemplary handle assembly 404 for a medical imaging device according to one or more embodiments described herein is illustrated. More specifically, Figure 4A The figure illustrates a side view of the handle assembly 404, Figure 4B The figure illustrates a bottom view of the handle assembly 404, and Figure 4C A top view of handle assembly 404 is illustrated. In embodiments described herein, components of handle assembly 404 may facilitate intuitive, ergonomic, and / or one-handed operation to target specific tissues in a reliable, intuitive, and unique and advantageous manner. For example, handle assembly 404 may include one or more ergonomic contours, gripping ribs, ergonomic protrusions, component positioning, and / or configurations to provide convenient, comfortable, and accurate minimized operation. For example, tool lock 410 may provide ambidextrous operation and / or bilateral access for one-handed use (e.g., a thumb may access tool lock 410 while rotating the handle). In another example, gripping ridge 444 and gripping ribs 446, 447 may provide a non-slip surface on actuation member 412. In many embodiments, Figure 4A-4C One or more components illustrated or described in the drawings may be the same or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0055] Reference Figure 4A, the handle assembly 404 may have a distal end 445 and a proximal end 455, and include a handle body 443, an actuation stop 442, an actuation member 412 with a gripping rib 446 and a gripping ridge 444, a tool lock 410, an ergonomic protrusion 448, strain reliefs 450-1, 450-2, a plunger assembly 440, and a flushing orifice assembly 452. Figure 4B , the handle assembly 404 may include one or more ergonomic contours 454-1, 454-2, 454-3, 454-4, a tool lock 410, and gripping ribs 447. Figure 4C , the handle assembly 404 may include a displacement gauge 457, a Luer lock head 458, and a cap 460. In some embodiments, the cap 460 may be a stylet cap, and / or the Luer lock head 458 may be a syringe connector. In various embodiments, one or more of the ergonomic contours 454, gripping ribs 446, 447, ergonomic protrusions 448, and / or gripping ridges 444 may be symmetrical, complementary, and / or mirrored. In addition, one or more surfaces may include textures and / or coatings to promote or resist friction.

[0056] Various handle assembly embodiments described herein may include one or more of a modular assembly, a bifurcated joint, a linear needle orientation, a manual slide (e.g., actuation member 112), a needle lock (e.g., tool lock 110), an integral flushing orifice (e.g., flushing orifice assembly 452), a syringe attachment, and a dual strain relief (e.g., strain relief 450-1, 450-2). The medical imaging device may include two separate modules: a needle module and an ultrasound module. The two modules may be assembled separately and connected together inside the handle body 443. In various embodiments, one or more of these modules may be interchangeable. For example, the needle module may be replaced by a module with different tools (e.g., other diagnostic and / or therapeutic medical tools). Before being introduced into a double-lumen catheter, the needle line and the ultrasound line may be brought together inside a bifurcated joint (e.g., bifurcated joint 664). The bifurcated joint may determine the bending radius of the ultrasound line. The needle module (e.g., plunger assembly 640) may be axially aligned with the lumen (e.g., lumen 218-1), for example to reduce the force required to actuate the needle. In other words, the needle module may extend linearly into the first lumen of the dual lumen catheter.

[0057] In various embodiments, one or more features of the medical imaging device can provide tactile confirmation. In some embodiments, the extended handle profile and short transition curve can provide a more comfortable and obvious gripping position and / or accommodate a wider range of hand sizes. For example, the handle assembly 404 can accommodate adult hand sizes ranging from 5% of a female hand to 95% of a male hand. The displacement meter 457 (e.g., a graduated stroke depth corresponding to the needle leaving the ramp and the side port) can be easily read from a variety of viewing angles, such as by partially wrapping around the plunger. In some embodiments, the soft-touch surface treatment on the actuating member 412 can produce a contrasting feel to the handle body 443 and / or match the distal handle surface treatment. Some members may include a textured secondary molded piece covered with rubber and / or color accents, such as on the actuating member gripping ridge 444. In some embodiments, this feature and other features can provide an improved thumb grip and / or visual travel indication. In some embodiments, the handle body may have a smooth / semi-bright surface treatment. Various embodiments may include a horizontal groove texture on the tool lock 410, for example, for ergonomic details and / or a sense of precision. Several embodiments include a textured surface treatment around the tool lock 410 to create a tactile contrast, for example, for intuitive use. The actuation stop 442 (or handle) and / or the gripping ridge 444 can provide 360 ​​degrees of tactile registration. In some embodiments, during actuation, the actuation stop 442 and / or the gripping ridge 444 can provide a boundary for hand position and / or hand protection. In addition, the actuation stop 442 and / or the gripping ridge 444 can provide a non-visual indication of hand position. Various embodiments may include a soft touch surface treatment on the distal portion of the handle body 443 and / or a lightly rubberized texture.

[0058] Several embodiments may include a solid color band wrapped around the handle body to indicate that the ultrasonic zone is exposed when the actuation member 412 is moved distally. In several such embodiments, the band may include slight texture variations and / or an ultrasonic icon disposed nearby. In one or more embodiments, additional part breaks on the strain relief connection may allow for separate rotation.

[0059] Figure 5A-5E The figure illustrates various aspects of an exemplary handle assembly 504 for a medical imaging device according to one or more embodiments described herein. More specifically, Figure 5A The handle assembly 504 is illustrated in an unactuated configuration 500A and Figure 5B The handle assembly 504 is illustrated in an actuated configuration 500B. In various embodiments, the actuation member 512 can be moved distally to cause a tool (eg, a biopsy needle) to exit the side port of the probe, as indicated by the markers in the image. Figure 5C-5EThe operation of the tool lock 510 of the handle assembly 504 is illustrated. In the embodiments described herein, the components of the handle assembly 504 can facilitate intuitive, ergonomic and / or one-handed operation to target specific tissues in a reliable, intuitive and unique and advantageous manner. For example, the handle assembly 504 can apply intuitive movements for grasping, locking, unlocking and actuating to provide convenient, comfortable, accurate and minimal operation. In many embodiments, Figure 5A-5E One or more components illustrated in or described with respect to the present invention may be the same or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0060] Reference Figure 5A , when the distal end of the actuating member 512 is proximal to the tool lock 510, the handle assembly 504 is in the unactuated configuration 500A. In the unactuated configuration 500A, the tool lock can be engaged or disengaged. The unlocking motion 562-1 can be used to center the tool lock 510 so that in the actuating motion 562-2, the actuating member can be moved distally on either side of the tool lock 510 to place the handle assembly 504 in the actuated configuration 500B (see, e.g., Figure 5B ). The positioning of the tool lock will be discussed in more detail below with reference to section line 565. In many embodiments, the tool lock 510 can provide a visual indicator of the locked state of the plunger assembly. The ultrasonic flushing orifice valve (e.g., the flushing orifice assembly) can be incorporated into the handle assembly and / or the handle body design. In several embodiments, the flushing orifice is located and / or can be located away from the user's gripping area. In various embodiments, the medical imaging device can use two syringes (e.g., one for ultrasonic flushing and the other for needle aspiration and / or suction). In many embodiments, the syringe can be attached to the medical imaging device with a stopcock Luer lock fitting and / or a one-way valve. For example, the one-way valve can be located between the flushing orifice and the syringe connector (e.g., Luer lock). The handle assembly can include integral strain reliefs at the distal and proximal ends of the handle body (see, e.g., strain reliefs 450-1, 450-2). In some embodiments, a distal strain relief (e.g., strain relief 450-1 can be used as another gripping space).

[0061] Reference Figure 5C-5E, in addition to the unactuated configuration 500A and the actuated configuration 500B, the handle assembly 504 may have positions 500C, 500D, and 500E. In position 500C, the tool lock 510 may be in a first locked position wherein the actuating member 512 is prevented from moving distally (away from the page). Similarly, in position 500D, the tool lock 510 may be in a second locked position wherein the actuating member 512 is prevented from moving distally (away from the page). In position 500E, the tool lock 510 may be in an unlocked position wherein the actuating member 512 is not prevented from moving distally (away from the page). This arrangement may allow actuation of the tool lock 510 from either side of the handle, based on which side is closer to the user's fingers. Additionally, because the distal direction is in the Figure 5C-5E The drawing is in the direction away from the page, so it will be appreciated that although the flushing orifice would be visible, it is not shown for simplicity.

[0062] Fig. 6A and Figure 6B The diagram illustrates various internal components of an exemplary handle assembly 604 for a medical imaging device according to one or more embodiments described herein. More specifically, Fig. 6A The diagram illustrates a first cross-sectional view of a handle assembly 604 having a distal end 645 and a proximal end 655, and Figure 6B A second cross-sectional view of the handle assembly 604 is illustrated. In the illustrated embodiment, the handle assembly 604 includes a handle body 659 (which includes and / or is connected to a bifurcated joint 664), a tool lock 610, an actuating member 612, a plunger assembly 640, an irrigation orifice assembly 652, and a noise compensator 670. In the embodiments described herein, the components of the handle assembly 604 facilitate intuitive, ergonomic, and / or one-handed operation, thereby targeting specific tissues in a reliable, intuitive, unique, and advantageous manner. For example, the handle assembly 504 can apply intuitive motion to grasping, locking, unlocking, and actuation to provide convenient, comfortable, accurate, and minimized operation. In various embodiments, the noise compensator 670 can be used to reduce electrical noise in the distal and / or proximal drive cables. For example, the noise compensator 670 can be an electronic choke, such as a passive electrical component that suppresses high-frequency noise in an electronic circuit. In some embodiments, one or more of the noise compensators 670 can use a ferrite (such as a ferrite ceramic). In many embodiments, Fig. 6A and Figure 6B One or more components illustrated in or described with respect to the invention may be the same or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0063] Figure 7A-7DThe figure illustrates various aspects of an exemplary bifurcated joint 764 for a medical imaging device 700 according to one or more embodiments described herein. More specifically, Fig. 7A A cross-sectional view of the bifurcated joint 764 along with the handle body 743 is illustrated. Figure 7B A bifurcated joint 764 is illustrated. Figure 7C and Fig.7D A cross-sectional view of a forked joint 764 is illustrated. In various embodiments, the forked joint 764 can connect the needle 716-1 to a first lumen of the dual-lumen catheter 708 and connect the tubing 744 carrying a portion of the distal drive cable 756 to a second lumen of the dual-lumen catheter 708. In many embodiments, the forked joint 764 can prevent fluid leakage within the handle body 743 when fluid is allowed to enter the dual-lumen catheter. In various embodiments described herein, the components of the forked joint 764 can facilitate convenient, reliable, efficient, and leak-proof operation in a unique and advantageous manner. For example, the forked joint 764 can reduce or minimize the bend in the tubing 744 to limit the bend in a drive cable (e.g., an ultrasonic drive cable). In another example, the forked joint 764 includes a needle support 742 to prevent the needle 716-1 from bending, such as when it is pushed distally by the plunger assembly. In many embodiments, Figure 7A-7D One or more components illustrated or described in the drawings may be the same or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0064] Reference Fig. 7A , the fork joint 764 can be disposed in the handle body 743 and include the needle support 742. More generally, the fork joint 764 can be a component of a medical imaging device that guides the first tool and the second tool into the first lumen and the second lumen of the double lumen catheter. In many embodiments, the fork joint 764 can align the first tool and the second tool for insertion into the double lumen catheter 708 while limiting the amount of required bending. For example, the fork joint 764 can prevent either tool from bending more than 20 degrees. In another case, the fork joint 764 can limit the bending of the drive cable of the medical imaging device to less than 15 degrees. In many embodiments, the minimum radius of curvature for the drive cable can be 3 inches.

[0065] The medical imaging device 700 may also include a strain relief 750-1. The strain relief 750-1 or one or more other strain reliefs described herein may limit bending of the dual lumen catheter 708 or other portions along the length of the tool lumen (e.g., tubing 744) (e.g., limiting bending to more than 25 degrees). In some embodiments, tubing 744 may include a polymer tube such as PEEK (polyetheretherketone) or nylon tubing. In several embodiments, the bifurcated joint 764 supports parallel alignment of the plunger assembly and the flushing orifice assembly in the handle assembly, resulting in an ergonomic and intuitive feel.

[0066] Reference Figure 7B , the dual lumen catheter 708 can be connected at the catheter support 748 into the bifurcated joint 764, the tubing 744 can be connected at the tubing support 749 into the bifurcated joint 764, and the needle 716-1 can be connected into the needle support 742. In many embodiments, the needle support 742 can prevent the needle from kinking, folding, bending, and / or breaking. The bifurcated joint 764 can also include mounting portions (supports) 754-1, 754-2, 754-3 (or mounting portions 754) and / or recesses 753-1, 753-2 (or recesses 753) on both sides. In many embodiments, the mounting hole 754 can be used to attach the bifurcated joint 764 to the handle body 743. As previously described, in one or more embodiments, the handle body 743 can connect one or more components of the medical imaging device, such as by serving as one or more of a mounting point, a housing, a structure, etc. Additionally or alternatively, the bifurcated junction 764 can include one or more viewing windows 752-1, 752-2 (or viewing windows 752). In various embodiments, the viewing windows 752 can allow for visual confirmation of the contents of the lumen as they pass through the bifurcated junction.

[0067] Figure 7C A cross-sectional view of a forked joint 764 is included. Figure 7C, the braided layer 360 and the tubular member (not labeled) begin proximal to the notch 752, and the return layer 361 on the dual lumen catheter begins at the distal end of the bifurcated joint 764. In addition or alternatively, the tubing 744 terminates between the viewing window 752 and the tubing support 746. The needle support 742 terminates at a position close to the end of the tubing 744. In several embodiments, the first lumen of the bifurcated joint, close to the distal side of the needle support 42, includes a joint taper 762-1. In various embodiments, the second lumen of the bifurcated joint, close to the distal side of the tubing 744, includes a joint taper 762-2. In some embodiments, the joint taper 762 facilitates one or more of the following: maintaining the connected tubing / needle support, limiting the bend radius, and improving fluid flow (such as preventing leakage or reducing turbulence). In the medical imaging device 700, the needle 716-1 can pass through the first lumen of the bifurcated joint 764 and the distal drive cable 756 can pass through the second lumen of the bifurcated joint 764. Fig.7D The handle body 743 is shown with the strain relief 750 - 1 removed leaving the strain relief pocket 751 .

[0068] Figure 8A-8J The diagram illustrates various aspects of an exemplary irrigation port assembly 852 for a medical imaging device according to one or more embodiments described herein. More specifically, Fig. 8A A cross-sectional view of the flushing orifice assembly 852 is illustrated. Figure 8B and Figure 8C The diagram illustrates axial displacement of the irrigation orifice assembly 852 in the distal direction and the proximal direction, respectively. Fig.8D Axial rotation of the flushing orifice assembly 852 is illustrated. Fig. 8E Various aspects of the flushing orifice assembly 852 are illustrated. Figure 8F The various components of the flushing orifice assembly 852 are illustrated. Figure 8G Flow path 861 from flushing orifice 814 into conduit 844 is illustrated. Figure 8H and Figure 8I Various aspects of the flushing orifice assembly 852 including the stabilizer 823 and the bearing 868 - 2 are illustrated. Figure 8JThe diagram illustrates an impedance compensator 843 disposed between the distal drive cable 856 and the proximal drive cable. In the embodiments described herein, the components of the flushing orifice assembly 852 can facilitate convenient, reliable, efficient, and leak-proof operation in a unique and advantageous manner. For example, the flushing orifice assembly 852 can rotate independently of the proximal drive cable 856 and the distal drive cable 858 while maintaining a seal with the conduit 844 that facilitates the introduction of fluid into the conduit 844 around the distal drive cable 856. In another example, the impedance compensator 843 matches the impedance between the distal drive cable 856 and the proximal drive cable 858. In many embodiments, in Figure 8A-8J One or more components illustrated or described in the drawings may be the same or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0069] Reference Fig. 8A , the irrigation orifice assembly 852 may include bearings 868-1, 868-2, a seal 869, a sliding bracket 823, a proximal surface feature 880, a strain relief 850-2, a lip seal 866, an orifice member 872, an irrigation orifice 814, a port interface 882, a flow connector 876, a flow chamber 874 with a tapered portion 825, a distal surface feature 878, a proximal portion of the conduit 844, a portion of the distal drive cable 856, and a portion of the proximal drive cable 858. One or more components described herein (e.g., the port interface 882) may be formed by molding, extrusion, and / or machining steps (e.g., secondary molding, injection molding, vacuum forming, cold extrusion, lathing, etc.).

[0070] As previously described, the flushing orifice assembly 852 may be adjustable in both the proximal and distal directions. Figure 8B The diagram illustrates an orifice assembly 852 that includes a slide bracket 823, a conduit 844, and an orifice member 872 in a distal-most position, and Figure 8C The orifice assembly 852 is illustrated, and the orifice assembly 852 includes a sliding bracket 823, a pipe 844, and an orifice member 872 in the most proximal position. In many embodiments, the pipe 844 can be supported by a slideway inside the orifice member 872 when it moves proximally and distally relative to the longitudinal axis of the device. The sliding bracket 823 can be connected to a short pile or mounting point on the handle body. In various embodiments, adjustment along the sliding bracket 823 can be used to calibrate the position of the imaging sensor relative to the imaging window, such as during manufacturing. In some embodiments, the end user may be able to adjust along the sliding bracket 823.

[0071] Reference Figure 8D-Figure 8EIn one embodiment, the flushing orifice assembly 852 of the present disclosure may include a housing 810 defining a flow chamber 874. An ultrasonic orifice 812 (e.g., a first orifice) may be formed within or extend through a proximal portion of the housing 810. In various embodiments, the ultrasonic orifice 812 may be coextensive with the flow chamber 874 (e.g., substantially aligned with the flow chamber 874, etc.). The flushing orifice 814 (e.g., a second orifice) defining the fluid passage 115 (through which) may be disposed along (e.g., attached to, integrally formed with, etc.) a middle portion of the housing 810. A fitting 816 may be disposed around a distal portion of the housing 810. In various embodiments, the housing 810 can be configured to rotate 360° (e.g., move axially) within the fitting 816 to change the position of the irrigation orifice 814 relative to the longitudinal axis of the irrigation orifice assembly 852 (e.g., move proximally or distally) and / or rotate a radial ultrasound probe (described below) extending through the housing 810 (e.g., change the axial position of the probe). The outer surface of the distal portion of the housing can include distal surface features 818 that are configured to frictionally engage with a corresponding inner surface of the fitting 816. By way of non-limiting example, the surface features can include a rubber seal or O-ring that is configured to maintain or lock the axial position of the housing 810 relative to the fitting 816 until a threshold level of rotational force is applied to the housing 810 (e.g., a sufficient amount of force applied by a physician's hand). In various embodiments, the outer surface of the housing 810 and / or the irrigation port 814 can include a non-slip surface (e.g., overmolded or coated with rubber, etc.) to provide the physician with an adequate grip to manipulate the housing 810, such as when wearing wet gloves, etc. A sliding bracket 823 (e.g., an arm or protrusion) can extend from the outer surface of the accessory 816 to secure or lock the housing of the probe assembly within a handle body (e.g., handle body 743) of a medical imaging device utilizing radial ultrasound and needle biopsy capabilities.

[0072] In one embodiment, a first seal 869 (e.g., an O-ring, etc.) may be disposed inside the distal portion of the flow chamber 874 (e.g., proximal to the distal opening of the housing 810) and a second seal 124 may be disposed inside the proximal portion of the flow chamber 874 (e.g., distal to the proximal opening of the housing 810). The first seal 869 and the second seal 880-1 may be configured to prevent fluid introduced (e.g., flushed) through the fluid channel 1815 of the flushing orifice 814 from leaving the flow chamber 874 (e.g., flowing / leaking distally beyond the first seal 1869 or flowing / leaking proximally beyond the second seal 124). The bearing 126 may be disposed inside the proximal portion of the flow chamber 874 proximal to the second seal 124. In various embodiments, the housing 810 and the ultrasonic orifice 812 may be configured to receive a proximal portion of a tool (e.g., a radial ultrasonic probe) therethrough. The bearing 126 may be configured to receive an outer surface of the radial ultrasound probe 130 to support / facilitate rotation of the radial ultrasound probe within the housing 810 .

[0073] Figure 8F and Figure 8G Various components of the flushing orifice assembly 852 are illustrated, such as components related to fluid flow. Figure 8F The flushing orifice assembly 852 includes a conduit 844 , an orifice member 872 , a proximal surface feature 880 , a bearing 868 - 2 , a stabilizer 823 , a lip seal 866 , a flow orifice 857 , a flow channel 859 , a flow chamber 874 , a distal drive cable 856 , and a conduit 844 . Figure 8G The flow path 861 of the fluid introduced via the flushing orifice 814 is illustrated. Thus, the flow path 861 can enter via the flushing orifice 814, fill the flow chamber 874, follow the flow channel 859 of the orifice member 842, enter the flow orifice 857 of the orifice member 872, and advance into the tubing 844 around the distal drive cable 856. In various embodiments, the lumen and / or flow members described herein can be designed to operate at a pressure of at least 43 pounds per square inch. This pressure level can vary, as determined by design and / or performance requirements.

[0074] Figure 8H The stabilizer 823, lip seal 866, and bearing 868-2 are illustrated, and Figure 8I The stabilizer 823 and the bearing 868-2 are illustrated. In various embodiments, the stabilizer 823 can extend through one or more of the bearing 868-2 and the lip seal 866. The drive cable can extend through the stabilizer 823. In many embodiments, the stabilizer can prevent loss of stability during rotation of the drive cable.

[0075] Reference Figure 8J, the proximal side of the stabilizer 823, the impedance compensator 843 can connect the distal drive cable 856 to the proximal drive cable 858. In several embodiments, the proximal and distal drive cables together with the imaging sensor can be rotated at up to 2000 or more revolutions per minute (rpm). For example, the imaging sensor (and the drive cable) can rotate at a speed of 1800 rpm. In various embodiments, the impedance compensator 843 can accommodate the diameter variation between the distal drive cable 856 and the proximal drive cable 858. In many embodiments, the impedance compensator rotates with the distal and proximal drive cables 856, 858. In one or more embodiments, the impedance compensator 843 includes a printed circuit board (PCB). In many embodiments, the lumen of the distal drive cable 856 has a uniform size to prevent kinking or winding of the distal drive cable. In some embodiments, the diameter variation between the proximal drive cable and the distal drive cable prevents signal degradation. For example, if the proximal drive cable is as small as the distal drive cable, an unacceptable signal degradation level will occur. In some embodiments, electromagnetic emission (e.g., noise) reduction can be achieved, for example, using lower signal voltages, by making the proximal drive cable 856 have a larger diameter than the distal drive cable 858. In several embodiments, one or more of the stabilizer 823 and the impedance compensator 843 can be filled with epoxy, for example, to prevent fluid from leaking around the distal drive cable 856 and through the stabilizer 823 into the impedance compensator 843.

[0076] Fig. 9Various internal components of an exemplary imaging controller 990 according to one or more embodiments described herein are illustrated. The ultrasound controller 990 may include a logic circuit 992, a memory 994, an input / output (I / O) 996, and a user interface 998. As previously described, the imaging controller 990 may be connected to the imaging sensor 916-2 via a proximal drive cable 958 connected between the hub assembly 906 and the impedance compensator 943 and a distal drive cable 956 connected between the impedance compensator 943 and the imaging sensor 916-2. In the embodiments described herein, the components of the imaging control 990 may facilitate intuitive, accessible, dynamic monitoring and control of the imaging sensor 916-2 in a reliable, assessable, unique and advantageous manner. For example, the imaging controller 990 may control one or more of the calibration, frequency, resolution, translation, interpretation, integration, analysis, and / or display of images generated by one or more medical imaging devices described herein. In one or more embodiments, the imaging controller 990 may apply one or more of history, context, user input, and sensor data to control various aspects of the medical imaging device. For example, the historical data may include sensor data and / or imaging data from previous steps. In some such embodiments, the historical data may be annotated based on user input. In many embodiments, Fig. 9 One or more components illustrated or described in the drawings may be the same or similar in structure, function, and / or appearance to one or more other components described herein. The embodiments are not limited to this context.

[0077] In various embodiments, the proximal drive cable 958 and the distal drive cable 956 may include multiple wires. In some embodiments, the drive cables may be coaxial cables. In various embodiments, the drive cables may provide one or more of power, torque, and communication between the imaging sensor and the imaging controller.

[0078] One or more of the components, devices and / or technologies described herein can be used as part of a system to facilitate the use performance of medical surgery (e.g., peripheral lung nodule biopsy) in a safe, efficient and reliable manner. In many embodiments, the novel system may include one or more medical devices that can locate and find patient-specific anatomical structures, locate flexible and elongated components for entering patient-specific anatomical structures, and enter patient-specific anatomical structures in a safe, accurate and reliable manner. In these and other ways, the components / techniques described herein can improve patient care, enhance user experience, reduce learning curves, improve success rates, and / or reduce adverse outcomes through more efficient and better-functioning implementations of medical devices with advantageous features. In many embodiments, one or more of the advantageous features can lead to several technical effects and advantages relative to conventional devices and technologies, including improved capabilities and improved adaptability. In various embodiments, one or more of the aspects, technologies and / or components described herein can be implemented using one or more computing devices in practical applications, thereby providing additional and useful functions to one or more computing devices, thereby leading to more capable, better-functioning, and improved computing devices. Furthermore, one or more of the aspects, techniques and / or components described herein may be used to improve one or more technology areas including imaging, endoscopy, cannulation, diagnosis, processing, imaging, robotics, embedded systems, and / or control systems.

[0079] In several embodiments, the components described herein may provide a specific and detailed way to render, interpret, convert, analyze, monitor, and / or characterize images generated by the medical imaging device, such as via imaging sensor 316-2 (see, e.g., Figure 3B In several such embodiments, these specific and detailed modes may include, for example, controlling, monitoring, and / or interacting with one or more of the sensors, connectors, working channels, and user interfaces to facilitate one or more endoscopic procedures. In one example, these specific and detailed modes may simplify lung surgery so that medical professionals can quickly learn to safely and reliably biopsy target nodules.

[0080] In many embodiments, one or more of the components described herein may be embodied as a set of rules that improve computer-related technology by allowing functions that could not previously be performed by a computer that facilitates improved technical results to be achieved. In many embodiments, the functions allowed are related to medical imaging devices and / or steps. For example, the functions allowed may include generating a combined image containing features of a body cavity wall and features outside the body cavity wall based on a first image generated by a first imaging mode and a second image generated by a second imaging mode. In some embodiments, the functions allowed may include a sensor positioned inside the focal area of ​​another sensor with one or more connectors, for example to facilitate image generation using the sensor. In various embodiments, the functions allowed may include using one or more connectors to locate and / or approach the target of cannulation.

[0081] Fig.10 An embodiment of an exemplary computing architecture 1000 that may be suitable for implementing various embodiments as described above is illustrated. In various embodiments, the computing architecture 1000 may include or be embodied as a part of an electronic device and / or a medical device. In some embodiments, the computing architecture 1000 may be, for example, a representative of one or more components described herein. In some embodiments, the computing architecture 1000 may be, for example, a representative of a computing device that implements or applies one or more parts of the components and / or techniques described herein (such as an imaging controller 990, a logic circuit 992, a memory 994, an I / O 996, and / or a user interface 998). The embodiments are not limited to this context.

[0082] The terms "system" and "component" and "module" as used in various embodiments herein may refer to computer-related entities, hardware, a combination of hardware and software, software, or software in execution, examples of which are provided by the exemplary computing architecture 1000. For example, a component may be, but is not limited to: a process running on a processor, a processor, a hard drive, a plurality of storage drives (optical and / or magnetic storage media), an object, an executable file, a thread of execution, a program, and / or a computer. As an example, both an application running on the controller 106 and the controller 106 may be a component. One or more components may exist within a process and / or a thread of execution, and a component may be confined to a computer and / or distributed between one or more computers. In addition, the components may be connected to each other in communication via various types of communication media to coordinate the operations. The coordination may include a one-way or two-way exchange of information. For example, the components may transmit information in the form of signals transmitted on the communication medium. The information may be embodied as signals assigned to various signal lines. In this assignment, each message is a signal. However, another embodiment may alternatively apply a data message. Such a data message may be sent over various connections. Exemplary connections include parallel interfaces, serial interfaces, and bus interfaces.

[0083] The computing architecture 1000 includes various common computing elements, such as one or more processors, multi-core processors, coprocessors, memory units, chipsets, controllers, peripherals, interfaces, oscillators, timing devices, video cards, audio cards, multimedia input / output (I / O) elements, power supplies, etc. However, the various embodiments are not limited to implementation by the computing architecture 1000.

[0084] like Fig.10 As shown in FIG. 1 , computing architecture 1000 includes a processing unit 1004, a system memory 1006, and a system bus 1008. Processing unit 1004 may be any of a variety of commercially available processors, including but not limited to: and processor: Applications, embedded security processors; and and Processors; IBM and Cell Processor: Core(2) and Processor: and similar processors. Dual microprocessors, multi-core processors, and other multi-processor architectures may also be used as the processing unit 1004 .

[0085] The system bus 1008 provides an interface for system components, including but not limited to: a system memory 1006 connected to the processing unit 1004. The system bus 1008 can have several types of bus structures, which can further be interconnected to a memory bus (with or without a memory controller), a peripheral bus, and a local bus using any of a variety of commercially available bus architectures. Interface adapters can be connected to the system bus 1008 via a slot architecture. Exemplary slot architectures can include but are not limited to: accelerated graphics port (AGP), card bus, (Extended) Industry Standard Architecture ((E)ISA), Micro Channel Architecture (MCA), network user bus, peripheral component interconnect (Extended) (PCI (X)), serial bus, Personal Computer Memory Card International Association (PCMCIA), etc.

[0086] The system memory 1006 may include various types of computer-readable storage media in the form of one or more higher speed memory cells, such as read-only memory (ROM), random access memory (RAM), dynamic random access memory (DRAM), double data rate DRAM (DDRAM), synchronous dynamic random access memory (SDRAM), static random access memory (SRAM), programmable read-only memory (PPRM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory (e.g., one or more flash memory arrays), polymer memory (e.g., ferroelectric polymer memory), bidirectional memory, phase change or ferroelectric memory, silicon oxide-nitride-oxide-silicon (SONOS) memory, magnetic or optical cards, arrays of devices (e.g., redundant array of independent disks (RAID) drives), solid-state storage devices (e.g., USB memory), solid-state drives (SSDs), and any other type of storage media suitable for storing information. Fig.10 In the illustrated embodiment shown in , the system memory 1006 can include non-volatile memory 1010 and / or volatile memory 1012. In some embodiments, the system memory 1006 can include main memory. A basic input / output system (BIOS) can be housed in the non-volatile memory 1010.

[0087] The computer 1002 may include various types of computer-readable storage media in the form of one or more lower-speed storage units, including an internal (or external) hard disk drive (HDD) 1014, a floppy disk drive (FDD) 1016 that reads or writes from a removable disk 1018, and an optical drive 1020 (e.g., a CD-ROM or DVD) that reads or writes from a removable optical disk 1022. The HDD 1014, FDD 1016, and optical drive 1020 may be connected to the system bus 1008 via a HDD interface 1024, a FDD interface 1026, and an optical drive interface 1028, respectively. The HDD interface 1024 for external drive embodiments may include at least one or both of a universal serial bus (USB) and an Institute of Electrical and Electronics Engineers (IEEE) 994 interface technology. In various embodiments, these types of memory may not be included in the main memory or system memory.

[0088] The drives and associated computer-readable media provide volatile and / or nonvolatile storage of data, data structures, computer-executable instructions, etc. For example, several program modules may be housed in the drives and storage units 1010, 1012, including an operating system 1030, one or more application programs 1032, other program modules 1034, and program data 1036. In one embodiment, one or more application programs 1032, other program modules 1034, and program data 1036 may include or embody various techniques, applications, and / or components as described herein.

[0089] A user may enter commands and information into the computer 1002 through one or more wired / wireless input devices, such as a keyboard 1038 and a pointing device such as a mouse 1040. Other input devices may include a microphone, an infrared (IR) remote control, a radio frequency (RF) remote control, a game controller, a stylus, a card reader, a communication stick, a fingerprint reader, a glove, a graphics tablet, a joystick, a keyboard, a retina reader, a touch screen (e.g., capacitive, resistive, etc.), a trackball, a touch pad, a sensor, a stylus, etc. These and other input devices are often connected to the processing unit 1004 through an input device interface 1042, which is coupled to the system bus 1008 but may be connected using other interfaces, such as a parallel port, an IEEE 994 serial port, a game port, a USB port, an IR port, etc.

[0090] A monitor 1044 or other type of display device is also connected to the system bus 1008 via an interface, such as a video adapter 1046. The monitor 1044 may be internal or external to the computer 1002. In addition to the monitor 1044, computers typically include other peripheral output devices (such as speakers, printers, etc.).

[0091] Computer 1002 can utilize logical connection and operate in network environment via wired and / or wireless communication with one or more remote computers (such as remote computer 1048).In various embodiments, one or more interactions described herein can occur via network environment.Remote computer 1048 can be workstation, server computer, router, personal computer, portable computer, microprocessor-based entertainment device, peer device or other common network node, and generally includes many or all elements described about computer 1002, although memory / storage device 1050 is illustrated for simplicity and clarity.Depicted logical connection includes wired / wireless connection with local area network (LAN) 1052 and / or larger network (such as wide area network (WAN) 1054).Such LAN and WAN network environment are common in office and company, and simplify enterprise computer network (such as intranet), all these networks can be connected to global communication network (such as Internet).

[0092] When used in a LAN networking environment, the computer 1002 is connected to the LAN 1052 via a wired and / or wireless communication network interface or adapter 1056. The adapter 1056 may facilitate wired and / or wireless communication with the LAN 1052, which may also include a wireless access point disposed thereon for communicating with the wireless functionality of the adapter 1056.

[0093] When used in a WAN networking environment, the computer 1002 may include a modem 1058, or be connected to a communications server on the WAN 1054 or have other means for establishing communications over the WAN 1054, such as via the Internet. The modem 1058 (which may be internal or external and wired and / or wireless) is connected to the system bus 1008 via the input device interface 1042. In a networked environment, program modules depicted with respect to the computer 1002, or portions thereof, may be located in the remote memory / storage device 1050. It should be appreciated that the network connections shown are exemplary and other methods of establishing a communications link between the computers may be used.

[0094] The computer 1002 is operable to communicate with wired and wireless devices or entities using the IEEE 802 family of standards, such as wireless devices that are operable to arrange online communications (e.g., IEEE 802.16 over-the-air modulation techniques). This includes at least Wi-Fi (or Wireless Fidelity), WiMax (Worldwide Interoperability for Microwave Access), and Bluetooth. TMWireless technology, etc. Therefore, the communication can be a predetermined structure, like a conventional network or simply a point-to-point communication between at least two devices. Wi-Fi networks use radio technology called IEEE 802.11x (a, b, g, n, etc.) to provide secure, reliable, and fast wireless connections. Wi-Fi networks can be used to connect computers to each other, to the Internet, and to wired networks (these networks use IEEE 802.3 related media and functions).

[0095] Various embodiments may be implemented using hardware elements, software elements, or a combination of the two. Examples of hardware elements may include: processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, etc.), integrated circuits, application specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), logic gates, registers, semiconductor devices, chips, microchips, chipsets, etc. Examples of software may include software components, programs, applications, computer programs, applications, system programs, machine programs, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, steps, software interfaces, application program interfaces (APIs), instruction sets, computing codes, computer codes, code segments, computer code segments, words, values, symbols, or any combination thereof. Determining whether to use hardware elements and / or software elements to perform an embodiment may vary according to any number of factors, such as desired computing rates, power levels, heat tolerance, processing cycle budgets, input data rates, output data rates, memory resources, data bus speeds, and other design or performance constraints.

[0096] One or more aspects of at least one embodiment may be performed by representative instructions stored on a machine-readable medium, which represents various logics (e.g., logic circuits) inside a processor, which, when read by a machine, cause the machine to make logic to perform the techniques described herein. Such representations, referred to as "IP cores," may be stored in tangible, machine-readable media and provided to various customers or manufacturing equipment to be loaded into manufacturing machines that actually make logic or processors. Some embodiments may be implemented, for example, using a machine-readable medium or object, which may store instructions or instruction sets that, if executed by a machine (e.g., logic circuits), may cause the machine to perform methods and / or operations according to the embodiments if these instructions or instruction sets are executed by the machine. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, logic circuit, etc., and may be implemented using any suitable combination of hardware and / or software. The machine-readable medium or object may include, for example, any suitable type of storage unit, storage device, memory object, storage medium, storage device, storage object, storage medium and / or storage unit, such as memory, removable or non-removable media, erasable or non-erasable media, erasable or rewritable media, digital or analog media, hard disk, floppy disk, compact read-only memory (CD-ROM), compact disk-rewritable (CD-R), compact disk-rewritable (CD-RW), optical disk, magnetic media, magneto-optical media, removable memory cards or disks, various types of digital versatile discs (DVD), magnetic tapes, cassettes, etc. The instructions may include any suitable type of code executed using any suitable high-level, low-level, object-oriented, visual, compiled and / or interpreted programming language, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, etc.

[0097] Figures 11A-11L Various exemplary handle assemblies according to one or more embodiments described herein are illustrated. More specifically, Fig.11A The diagram illustrates a first handle assembly, Fig. 11B The diagram illustrates a second handle assembly, Fig. 11C The diagram illustrates a third handle assembly, Fig.11D The diagram illustrates a fourth handle assembly, Fig.11E The diagram illustrates a fifth handle assembly, Fig.11F The diagram illustrates a sixth handle assembly, Fig.11G The figure illustrates a seventh handle assembly, Fig.11H The figure illustrates an eighth handle assembly, Fig.11I The figure illustrates a ninth handle assembly, Fig.11J The figure illustrates a tenth handle assembly, Figure 11KAn eleventh handle assembly is illustrated, and Fig.11L The twelfth handle assembly is illustrated. Various aspects and features of one or more of the handle assemblies may be determined and / or combined based on a specific application without departing from the scope of the present disclosure. For example, features of the handle assembly may be selected based on hand dominance or size. The embodiments are not limited to this context.

[0098] like Fig. 11B As shown in , in various embodiments, the distal strain relief piece can flow out of the body while maintaining a clean bottom profile. In addition or alternatively, clean geometric intersections can be used to create partial breaks and / or visual hierarchy. In some embodiments, the needle module (e.g., plunger assembly) can enter the handle body in a downward position. In many embodiments, the sliding button (e.g., actuating member) may include engraved finger ridges. In addition, the sliding button may be included on both sides of the handle body. In one or more embodiments, the gripping area can visually extend into the strain relief piece. The tool lock (sliding piece below the flushing orifice) may include a graphic logo. The gripping area can be textured and / or covered with rubber.

[0099] like Fig. 11C As shown in , in various embodiments, the strain relief can be integrated into the overmolded side grip. In addition, the tool lock (the component on the face with the small circle in the middle) can be actuated from front to back (e.g., similar to Figure 5C-5E ). In addition, the displacement meter can be positioned to be easily read during actuation. In many embodiments, components (such as displacement meters) can be colored differently to improve visibility. For example, color changes can be used to visually separate functional modules (e.g., plunger components and flushing orifice components). Fig.11D As shown in , in some embodiments, the tool lock (the knob on the opposite side of the flushing port located below the gripping rib) can be mechanically locked / unlocked using a rotational motion. Fig.11E As shown in , in various embodiments, a distinct needle assembly may provide easy access to a stylet (eg, via a stylet cap). Additionally or alternatively, the actuation member may include a textured (eg, cross-hatched) surface.

[0100] like Fig.11F As shown in , several embodiments may include a molded slide (actuating member) with a protruding central ridge that may improve grip and / or accessibility. Additionally or alternatively, the handle on the distal end on the flushing orifice side may include a rubber-covered ergonomic gripping area with a sculpted gripping detail. In several embodiments, the handle body may be tapered toward the distal end, for example to provide a more natural gripping area. As shown in Fig.11G As shown in , various embodiments may include a twist lock (e.g., a rotatable disk below the flushing orifice). Fig.11F As shown in , many embodiments may include a recessed tool lock, such as to prevent accidental actuation. In addition or alternatively, each embodiment may include a faceted gripping area (e.g., flushing port assembly side).

[0101] One or more components described herein may be made of elastomers and / or polymers (e.g., polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), high-density polyethylene (HDPE), nylon, polyetheretherketone (PEEK), silicone, thermoplastics, plastics, etc.). Various components described herein may be made of metals (e.g., stainless steel, titanium, aluminum, alloys, etc.). For example, the port interface 882 may be made of a polymer and the housing 810 may be made of a nickel-titanium alloy. In another example, the end cap 340 may be made of a polymer while the distal joint 348 and the sleeve 342 are made of stainless steel. In yet another example, the braid 360 may be made of a metal while the return layer 361 comprises a polymer. Other medical imaging-related techniques, features and / or components that may be used herein are disclosed in U.S. non-provisional patent application entitled “DEVICE FOR ACCESSING AREA PERIPHERAL TO THE LUNGS FOR DIRECT VISUALIZATION USING A TOOL ATTACHMENT” filed on the same date with attorney docket number 8150.0581 (the entire contents of which are incorporated herein by reference) and / or U.S. non-provisional patent application entitled “DEVICE FOR PROVIDING ADJUSTABLE MECHANISM FOR RADIAL ULTRASOUND ORIFICES AND IRRIGATION ORIFICES” filed on the same date with attorney docket number 8150.0600 (the entire contents of which are incorporated herein by reference).

[0102] The medical device of the present disclosure is not limited to bronchoscopes, and may include a variety of medical devices for approaching body passages (including, for example, catheters, ureteroscopes, duodenoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc.). In addition, in some embodiments, references to endoscopy, endoscopic, endoscopes, etc. may generally refer to any medical device inserted into a body cavity. In one or more embodiments, a body passage may be entered to perform a biopsy step. For example, a bronchoscope may be inserted into a patient in order to perform a lung nodule biopsy step (the location of the lung nodule may have been previously determined, such as based on virtual mapping and / or radiology). Once the bronchoscope is positioned, a medical imaging device may be inserted through a working channel and exceed the distal end (e.g., 15 cm) of the bronchoscope. An imaging sensor may then be activated inside the airway to provide real-time imaging of a lung nodule. Based on real-time imaging and marker indications of the lung nodule, the imaging device may be positioned so that a lung nodule is biopsied. Once positioned, the biopsy needle may be actuated one or more times to remove one or more core samples inside the hollow biopsy needle. In addition, aspiration and attraction through the needle can be used to remove the sample from the hollow biopsy needle. In addition, one or more steps of this process can be repeated at the same location or other locations of the nodule and / or at other locations of the same lung airway or other airways of the lung if necessary.

[0103] According to the present disclosure, all devices and / or methods disclosed and claimed herein can be made and performed without undue experimentation. Although the devices and methods have been described using the preferred embodiments of the present disclosure, it is obvious to those skilled in the art that changes can be made to the devices and / or methods and in the steps or in the order of the steps of the methods described herein without departing from the concept, spirit and scope of the present disclosure. All such similar substitutions and modifications that are obvious to those skilled in the art are considered to be within the spirit, scope and concept of the present disclosure as defined by the appended claims.

Claims

1. A medical device comprising: a plunger assembly coupled to a first tool, the plunger assembly being configured to move the first tool in a distal direction and a proximal direction: a flushing orifice assembly coupled to a second tool, the flushing orifice assembly being configured to rotate at least partially about a longitudinal axis of the second tool; and A handle body connects the plunger assembly to the flush orifice assembly. 2 . The medical device of claim 1 , wherein the irrigation port assembly is configured to rotate at least 180 degrees about the longitudinal axis of the second tool.

3. The medical device of any one of claims 1-2, wherein the first tool comprises a biopsy needle and the second tool comprises a radial ultrasound probe.

4. The medical device of any one of claims 1-3, wherein the plunger assembly and the flushing orifice assembly are parallel to each other in the handle body.

5. The medical device of any one of claims 1-4, comprising a bifurcated joint in the handle body, wherein the bifurcated joint connects the plunger assembly to a first lumen of a dual lumen catheter and connects the flushing orifice assembly to a second lumen of the dual lumen catheter. The medical device of claim 5 , wherein the double lumen catheter comprises a braid layer and a return layer.

7. The medical device of any one of claims 1-6, wherein the second tool comprises an imaging sensor configured to be communicatively coupled to an imaging controller via a hub assembly.

8. The medical device of claim 7, wherein the imaging sensor is coupled to the hub assembly via a proximal drive cable having a first diameter and a distal drive cable having a second diameter, the first diameter being greater than the second diameter.

9. The medical device of claim 8, wherein an impedance compensator connects the distal drive cable to the proximal drive cable.

10. The apparatus according to any one of claims 1 to 9, further comprising: a probe having an imaging window and a marker; and The handle body is connected to a dual lumen catheter of the probe, wherein the dual lumen catheter includes a braid, wherein the braid is configured to cause axial rotation of the probe within a body cavity in response to axial rotation of the handle body.

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