Devices, systems, and methods for placing medical devices within a body lumen.

Abstract

The present invention provides an elongated member for positioning a medical device at a target site within a body lumen. [Solution] The elongated member may include one or more articulated joints for maneuvering, one or more transducers for positioning, and one or more lumens for delivering the instrument to a target site. Some embodiments, in particular, relate to medical devices that guide an operator to a target site, confirm the location of the target site, enable a biopsy to be taken from the target site, and / or deliver treatment to the target site. For example, a position tracking sensor may be used to guide the medical device to the target site, a phased array sensor may be used to confirm proper positioning at the target site, and a biopsy needle inserted through a lumen may be used to take a sample from the target site.

Description

Technical Field

[0001] The present disclosure generally relates to the field of medical devices. In particular, the present disclosure relates to devices, systems, and methods for facilitating the placement of an elongate member at a target site within a body lumen.

Background Art

[0002] Various medical devices are placed within body lumens for diagnostic or therapeutic purposes. For example, an endoscopy is a procedure that uses an endoscope to view inside the body. Typically, an endoscopy procedure utilizes an elongate member (e.g., an endoscope) to access, examine, or interact with the interior of a hollow organ or body cavity of the body for diagnostic or therapeutic purposes. An endoscope typically has a direct visualization function for observing inside the body and / or may be equipped with an ultrasonic observation function. Such an endoscope has an outer diameter that allows the endoscope to be inserted into a larger body lumen (e.g., the GI tract or trachea) having a specific diameter. For example, a bronchoscope, which is a type of endoscope, can be used to visualize the inside of the airway up to a specific generation of airway having a diameter capable of accommodating the diameter of the bronchoscope for diagnostic and therapeutic purposes. The bronchoscope is inserted into the airway via the mouth, nose, or tracheostomy, etc. Thereby, a physician can examine the patient's airway for abnormalities such as foreign bodies, bleeding, tumors, or inflammation. In some cases, a biopsy may also be performed from inside the lung. In certain higher-generation airways, the diameter of the airway becomes too narrow to accommodate a conventional endoscope, which presents a challenge for improved devices having means for accurately navigating, finding, and biopsying tissue within these smaller airways or other lumens of minimum diameter.

Summary of the Invention

[0003] This summary is provided to introduce, in a simplified form, a selection of concepts that will be further explained in the detailed description below. This summary is not intended to necessarily identify the main or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter.

[0004] In one embodiment, the present disclosure relates to an apparatus comprising an elongated member, a lumen, and a first transducer. The elongated member may include an outer surface, a proximal end, a distal end, and at least one articulated joint positioned between the proximal and distal ends. The lumen may have a first opening adjacent to the proximal end of the elongated member and a second opening adjacent to the distal end of the elongated member. The first transducer may include a phased array sensor positioned adjacent to the distal end of the elongated member.

[0005] In some embodiments, the field of view of the phased array sensor extends from the outer surface of an elongated member. In various embodiments, a second opening of the lumen is located on the outer surface of the elongated member. In various such embodiments, the lumen includes a slanted section configured to orient the instrument into the field of view of the phased array sensor as the instrument extends through the lumen and out of the second opening of the lumen. In some such embodiments, the slanted section includes bends of multiple radii. Many embodiments include a second transducer including a position tracking sensor. In many such embodiments, the position tracking sensor includes a magnetic tunnel junction. Some such embodiments include a third transducer including an optical imaging sensor. In various further such embodiments, at least one of the first transducer, the second transducer, and the third transducer is mounted on a flexible circuit board. Some embodiments include a second transducer including an optical imaging sensor. In some such embodiments, the field of view of the phased array sensor extends from the outer surface of an elongated member, and the field of view of the optical imaging sensor extends from the distal end of the elongated member. In some such embodiments, the optical imaging sensor is mounted on the distal end of an elongated member. In various embodiments, at least one articulated joint comprises a first articulated joint and a second articulated joint, where the direction of articulation of the first articulated joint is perpendicular to the direction of articulation of the second articulated joint. In many embodiments, at least one articulated joint comprises a first articulated joint and a second articulated joint, where the second opening of the lumen is located between the first and second articulated joints. In some embodiments, the first portion of the phased array sensor is located proximal to the second opening of the lumen, and the second portion of the phased array sensor is located distal to the second opening of the lumen.

[0006] In another embodiment, the disclosure relates to a system comprising an elongated member, a lumen, a first transducer, and a controller. The elongated member may include an outer surface, a proximal end, and a distal end. The lumen may have a first opening adjacent to the proximal end of the elongated member and a second opening adjacent to the distal end of the elongated member. The first transducer may include a phased array sensor positioned adjacent to the distal end of the elongated member. The controller may be communicatively coupled to the first transducer and configured to generate an image based on signals received from the first transducer.

[0007] In some embodiments, the field of view of the phased array sensor extends from the outer surface of an elongated member. In various embodiments, the second opening of the lumen is located on the outer surface of the elongated member. In many embodiments, at least one articulated joint comprises a first articulated joint and a second articulated joint, wherein the direction of articulation of the first articulated joint is perpendicular to the direction of articulation of the second articulated joint.

[0008] In yet another aspect, the present disclosure relates to a method, the method comprising inserting an elongated member into a body lumen, the elongated member comprising an outer surface, a proximal end, a distal end, at least one articular joint positioned between the proximal and distal ends, and a lumen having a first opening adjacent to the proximal end of the elongated member and a second opening adjacent to the distal end of the elongated member, the method comprising generating a first image using a first transducer, the first transducer comprising a phased array sensor positioned adjacent to the distal end of the elongated member, the method comprising extending a tool outside the second opening of the lumen based on the image, the second opening of the lumen located on the outer surface of the elongated member.

[0009] In some embodiments, the method includes activating one of at least one articulated joints to navigate to a target site. In various embodiments, the method includes generating a second image using a first transducer, the second image being generated before the first image, and the method includes rotating an elongated member based on the second image to align a second opening of the lumen with the target site.

[0010] In yet another aspect, the disclosure relates to a method, the method comprising mounting first and second transducers to a flexible circuit board, and positioning the first transducer relative to the second transducer using a low-pressure epoxy potting process to manufacture a transducer subassembly comprising the first transducer, the second transducer, and at least a portion of the flexible circuit board.

[0011] In some embodiments, the method includes forming a lens mounting mechanism on a transducer subassembly in a low-pressure epoxy potting process. In some such embodiments, the method includes forming a transducer lens and mounting the transducer lens to the transducer subassembly in a molding process. [Brief explanation of the drawing]

[0012] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each of the identical or substantially identical components shown is usually represented by a single number. It will be understood that the various drawings contained herein may omit some components, show some components, and / or present some components as transparent to facilitate the illustration and description of components that might otherwise appear hidden. For clarity, not all components are labeled in all drawings, nor are all components of each embodiment shown where it is not necessary to illustrate them to enable those skilled in the art to understand this disclosure. [Figure 1] Figure 1 shows an exemplary medical device according to one or more embodiments disclosed herein. [Figure 2A] Figures 2A to 2C show various exemplary forms of elongated members according to one or more embodiments disclosed herein. [Figure 2B] Figures 2A to 2C show various exemplary forms of elongated members according to one or more embodiments disclosed herein. [Figure 2C] Figures 2A to 2C show various exemplary forms of elongated members according to one or more embodiments disclosed herein. [Figure 3A] Figures 3A and 3B show various exemplary configurations of articulated joints according to one or more embodiments disclosed herein. [Figure 3B] Figures 3A and 3B show various exemplary configurations of articulated joints according to one or more embodiments disclosed herein. [Figure 4] Figure 4 shows various exemplary embodiments of a transducer according to one or more embodiments disclosed herein. [Figure 5A]Figures 5A to 5C show various exemplary forms of elongated members according to one or more embodiments disclosed herein. [Figure 5B] Figures 5A to 5C show various exemplary forms of elongated members according to one or more embodiments disclosed herein. [Figure 5C] Figures 5A to 5C show various exemplary forms of elongated members according to one or more embodiments disclosed herein. [Figure 6] Figure 6 shows various exemplary forms of controllers for medical devices according to one or more embodiments disclosed herein. [Figure 7] Figure 7 shows an exemplary process flow according to one or more embodiments disclosed herein. [Figure 8] Figure 8 shows an exemplary computing architecture according to one or more embodiments disclosed herein. [Modes for carrying out the invention]

[0013] This disclosure generally relates to medical devices for positioning an elongated member at a target site within a body lumen, such as for obtaining a biopsy from a peripheral airway. In various embodiments, the elongated member may include one or more articulated joints for maneuvering, one or more transducers for positioning, and one or more lumens for delivering the instrument to the target site. Some embodiments particularly relate to medical devices that guide an operator to a target site, confirm the location of the target site, enable a biopsy to be taken from the target site, and / or deliver a treatment to the target site. For example, a position tracking sensor (e.g., a guidance or tunnel magnetoresistance (TMR) sensor) may be used to guide the medical device to the target site, a phased array sensor (e.g., a phased array of ultrasound image sensors) may be used to confirm proper positioning at the target site, and a biopsy needle inserted through a lumen may be used to obtain a sample from the target site. In some such examples, the medical device may also include an optical imaging sensor to assist in guiding the medical device to the target site and / or confirming proper positioning at the target site. In addition, one or more of these features may be combined into an elongated member of sufficiently small dimensions to access a narrow peripheral lumen. In some embodiments, the medical device allows a therapeutic probe (e.g., an ablation probe) to be delivered to or placed inside a target site, such as a lesion. In some such embodiments, the therapeutic probe may be inserted through the lumen to deliver the treatment to the target site after a biopsy needle has been inserted through the lumen to take a sample for confirmation. These and other embodiments are described and claimed.

[0014] Medical devices for positioning elongated components at target sites within body lumens face numerous challenges, including external dimensions that limit access to narrow lumens. For example, endobronchial ultrasound (EBUS) scopes are often too large (e.g., OD greater than 4 mm) to reach the peripheral portions of body lumens where suspected cancerous nodules are commonly located (e.g., peripheral airways). Electromagnetic (EM) bronchoscopy can be used to locate target sites (e.g., suspected cancerous nodules in the periphery of the airway). However, errors such as those introduced into the patient's position during surgery by metal strain and preoperative computed tomography (CT) scans can hinder confirmation of proper placement at the target site. Therefore, operators typically rely on other techniques, such as reusable single-element (rotating) ultrasound probes, used in conjunction with EM bronchoscopy to confirm proper placement at the target site. However, these probes are unmaneuverable and can obstruct the entire lumen (e.g., the working channel), requiring removal of the probe before the instrument (e.g., biopsy needle) can be inserted into the lumen. Furthermore, device replacement can contribute to tip movement, and removal of the ultrasound probe can make it impossible to confirm the position of the elongated member after the instrument has been inserted, leading to several challenges such as reduced biopsy diagnostic accuracy or inaccurate probe placement during treatment. Inaccurate probe placement during treatment (e.g., ablation probe) may prevent the operator from achieving expected treatment outcomes, such as target margins. Such limitations can dramatically reduce the usefulness and applicability of medical devices for positioning elongated members at target sites, potentially contributing to limited-functioning and inefficient devices. With these considerations in mind, a variety of advantageous medical outcomes can be achieved with the devices, systems, and methods of this disclosure.

[0015] The following detailed description should be read with reference to the drawings that illustrate exemplary embodiments. The present disclosure is not limited to the specific embodiments described, and such embodiments may vary. The terms used herein are for the purpose of describing only the specific embodiments and are not intended to limit beyond the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Finally, embodiments of the present disclosure may be described specifically with reference to medical devices and systems and procedures for treating the gastrointestinal system, but it should be understood that such medical devices and methods may be used to treat tissues such as the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc. Structures and configurations, and methods of deployment, may find utility beyond the treatments discussed herein for stabilizing, maintaining, and / or assisting fluid flow paths.

[0016] As used herein, "proximal end" refers to the end of the device that is closest to the user (such terms as medical professional or clinician or technician or operator or physician, etc., are used interchangeably herein without intent to limit, including an automated control system, etc.) along the device when introducing the device into the patient, and "distal end" refers to the end of the device or object that is furthest from the user along the device during implantation, placement, or delivery.

[0017] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of "and / or" unless the content clearly dictates otherwise.

[0018] As used herein, the conjunction "and" includes each of the structures, components, features, etc. thus connected, unless the context clearly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. thus connected, alone and in any combination and number, unless the context clearly indicates otherwise.

[0019] All numerical values are assumed to be modified by the term "about" herein, whether or not explicitly indicated. The term "about" in the context of a numerical value generally refers to a range of numbers that a person of ordinary skill in the art would consider to be equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) can be understood from the context of this specification and are assumed to have their ordinary customary definitions consistent with the context of this specification, unless otherwise specified. The recitation of a numerical range or value by endpoints includes all numbers within that range including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5), and their fractions.

[0020] Note that references herein to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such recitation does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Additionally, when a specific feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that such feature, structure, and / or characteristic may be used in relation to other embodiments as well, whether or not explicitly described, unless the contrary is explicitly stated.

[0021] It should be understood that the disclosures contained herein are illustrative and descriptive only, and not limiting. Where used herein, the terms “comprise,” “comprising,” or any other variation thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements may include, but not only, other elements not expressly enumerated, or elements specific to such process, method, article, or apparatus. The term “exemplary” is used herein in the sense of “example,” not “ideal.” Endoscopes and endoscopic systems are referred to herein, but references to endoscopes, endoscopic systems, or endoscopic examinations should not be construed as limiting the possible uses of the disclosed embodiments. For example, the disclosed embodiments may be used in combination with a duodenoscope, bronchoscope, ureteroscope, colonoscope, catheter, diagnostic or therapeutic tool or device, or other types of medical devices or systems.

[0022] The following references are to the drawings, where similar reference numbers are used throughout to refer to similar elements. Numerous specific details are included in the following description for illustrative purposes to provide a complete understanding. However, it will be apparent that novel embodiments can be implemented without these specific details. In other examples, well-known structures and devices are shown in block diagram form to facilitate their description. The intent is to encompass all modifications, equivalents, and substitutions within the claims.

[0023] Figure 1 shows a medical device 100 according to one or more embodiments disclosed herein. The medical device 100 may include an elongated member 102 and a controller 110. The elongated member 102 may include one or more articulated joints 104, one or more lumens 106, and one or more transducers 108. As will be described in more detail below, the medical device 100 can provide functionality that enables guidance to a target site, confirmation of position at the target site, and delivery of the instrument to the target site. In some embodiments, Figure 1 may include one or more components that are identical or similar to one or more other components of the Disclosure. Furthermore, one or more components of Figure 1, or embodiments thereof, may be incorporated into other embodiments of the Disclosure without departing from the scope of the Disclosure, or excluded from embodiments described. For example, an embodiment of the medical device 100 may exclude the controller 110 without departing from the scope of the Disclosure. Furthermore, one or more components or embodiments of other embodiments of the Disclosure may be incorporated into one or more components of Figure 1 without departing from the scope of the Disclosure. The embodiments are not limited to this context.

[0024] In various embodiments, the medical device 100 can enable reliable and precise access to the peripheral portion of a body lumen, such as a peripheral airway. In many embodiments, access to the peripheral portion of a body lumen may be used to obtain a biopsy of a target tissue (e.g., a suspected cancerous nodule) or to deliver treatment or therapy to the target tissue. Therefore, the elongated member 102 can have an external shape small enough to fit within the peripheral portion of a body lumen, while still providing one or more of the following: real-time localization of the elongated member 102, real-time imaging within the peripheral portion of a body lumen, maneuverability of the elongated member 102, and delivery of the instrument to a target site without interfering with real-time localization or real-time imaging.

[0025] In some embodiments, the outer diameter of the elongated member 102 may not exceed 5 mm. In other embodiments, the outer diameter (OD) of the elongated member 102 may not exceed 4.2 mm. In some embodiments, the elongated member 102 may include a tapered portion near its distal end to facilitate navigation into and / or entry into small-diameter body lumens, such as peripheral airways. One or more devices or embodiments of this specification may have and / or be configured to be used for diagnostic or therapeutic purposes, such as one or more of the pulmonary, cardiac, endoscopic, and urological applications. In various embodiments, the external shape of the elongated member may be equidiameteral with non-traumatic (e.g., rounded) edges. Embodiments of the medical device 100 can be used in a variety of applications, such as peripheral lung navigation, peripheral lung biopsy, peripheral lung ultrasound reconstruction, and peripheral lung treatment.

[0026] In some embodiments, transducer 108 may generally refer to a device that converts energy from one form to another. In many embodiments, each transducer may operate to convert one or more electrical signals into one or more physical quantities (e.g., energy, force, torque, light, motion, position, etc.) and / or convert one or more physical quantities into one or more electrical signals. For example, a transducer may include one or more of the following: imaging sensors, phased array sensors, position sensors, light-emitting diodes, pressure sensors, actuators, induction sensors, TMR sensors, optical fiber sensors, electromagnetic position sensors, etc.

[0027] Figures 2A to 2C show various aspects of the elongated member 202 according to one or more embodiments disclosed herein. More specifically, Figure 2A includes a cross-sectional view of the distal portion of the elongated member 202 in combination with the fixture 220, Figure 2B includes a perspective view of the distal portion of the elongated member 202 including the machined component 224, and Figure 2C includes another perspective view of the distal portion of the elongated member 202 including the transducer subassembly 226. The elongated member 202 has a proximal end 210, a distal end 212, an outer surface 214, and includes articulated joints 204a, 204b, lumens 206a, 206b, 206c, transducers 208a, 208b, 208c, openings 216a, 216b, inclined section 218, light 222, and lens mounting mechanisms 228a, 228b. In some embodiments, Figures 2A, 2B, and / or 2C may include one or more components that are identical or similar to one or more other components of the Disclosure. For example, elongated member 202 may be identical or similar to elongated member 102. Furthermore, one or more components, or embodiments thereof, of Figures 2A, 2B, and / or 2C may be incorporated into other embodiments of the Disclosure or excluded from the embodiments described without departing from the scope of the Disclosure. For example, an embodiment of elongated member 202 may exclude transducer 208b without departing from the scope of the Disclosure. Furthermore, one or more components, or embodiments thereof, of other embodiments of the Disclosure may be incorporated into one or more components of Figures 2A, 2B, and / or 2C without departing from the scope of the Disclosure. Embodiments are not limited to this context.

[0028] Referring to Figure 2A, the distal end 212 of the elongated member 202 may include a transducer 208a for lateral or radial imaging, a transducer 208b for forward imaging, and a transducer 208c for electromagnetic position sensing. In some embodiments, multiple electromagnetic position sensors may be arranged along the length of the elongated member 202. For example, position sensing transducers may be located in multiple sections of the elongated member 202 separated by articulated joints 204a, 204b, making it easier to determine the movement or position of the sections relative to each other (e.g., by the controller 110). In some embodiments, optical fiber shape sensing may be utilized. For example, one or more optical fibers may extend along one or more portions of the length of the elongated member 202. In such examples, the shape of the elongated member can be determined using the effect on light passing through one or more optical fibers (e.g., reflection, refraction, absorption, polarity, etc.). In some embodiments, optical fiber shape sensing may be used to continuously determine the shape along the entire length of the elongated member 202.

[0029] The opening 216a may be located on the outer surface 214 of the elongated member 202, and the lumen 206a may terminate at the opening 216a. In various embodiments, the lumen 206a may have a working channel. In the illustrated embodiment, the instrument 220 is inserted through the lumen 206a and extends outward from the opening 216a. In various embodiments, the lumen 206a may be sized to accommodate an instrument having an outer diameter of at least 1.067 mm (e.g., a 19-gauge needle). The inclined portion 218 may be configured to direct the instrument 220 into the field of view of the transducer 208a when the instrument 220 extends outward from the opening 216a through the lumen 206a.

[0030] In various embodiments, the angle of the inclined portion 218 may be 0 to 90 degrees with respect to the longitudinal axis of the elongated member 202. In many embodiments, a larger angle may improve nodule targeting (e.g., eccentric lesions) but may make operation more difficult. For example, a larger angle of the inclined portion 218 requires a greater longitudinal force to extend the instrument 220 above the inclined portion 218 and outside the opening 216a. Furthermore, a larger angle requires the needle to extend further outward from the elongated member 202 to enter the field of view of the transducer 208a, which may limit applicability to body lumens with larger diameters. Conversely, a lower angle requires the elongated member 202 to be positioned closer to the target nodule, which may make it difficult to obtain biopsy samples from eccentric nodules and / or further below the surface of the target nodule. Therefore, the inclination angle may be selected based on the specific application. In one or more embodiments, the inclination angle may be between 3 degrees and 20 degrees. For example, the angle of the inclined portion 218 may be 15 degrees. In another example, the angle of the inclined portion 218 may be 10 degrees.

[0031] Referring to Figure 2B, the openings 216b and 216c may be located at the distal end 212 of the elongated member 202. Furthermore, lumen 206b may terminate at opening 216b, and lumen 206c may terminate at opening 216c. In some embodiments, lumens 206a and 206b may provide suction and / or fluid channels at the distal end 212 of the elongated member 202. In the illustrated embodiment, opening 216b is provided with a suction port (e.g., for removing mucus from the surface of transducer 208b), light 222 is located at opening 216c, and a wire for light 222 extends through lumen 206c. It will be understood that light 222 may occlude opening 216c or be integrally formed within the elongated member 202 (e.g., as part of an epoxy potting process). In some embodiments, lumen 206c may provide an encapsulation wire for light 222. In various embodiments, instead of using the opening 216b as an intake port, another light may be placed in the opening 216b. The light 222 may include a light-emitting diode that emits light at a frequency that the transducer 208b can detect. For example, the transducer 208b may include an optical imaging sensor, and the light 222 may emit visible light.

[0032] Some portions of the elongated member 202 are removed or transparent in Figure 2B to better show the lumens 206a, 206b, 206c and the machined components 224. In some embodiments, a flexible and / or elastic member extends from the proximal end of the machined component 224 to the proximal end 210 of the elongated member 202. In some such embodiments, the flexible and / or elastic member may include the illustrated portions of the lumens 206a, 206b, 206c. In some embodiments, the machined component 224 may form portions of the lumens 206a, 206b, 206c that extend from the proximal end of the machined component 224 to the openings 216a, 216b, 216c. The machined component 224 can provide a single bending radius for a tool (e.g., instrument 220) to pass out of the opening 216a of the outer surface 214 at a predetermined angle and / or controlled distance from the face of the transducer 208a. In various embodiments, the transducer 208a may include a phased array for emitting and detecting ultrasonic pulses.

[0033] In some embodiments, the transducer subassembly 226 may comprise a portion of an elongated member 202 distal to the articulated joint 204. In various embodiments, the transducer subassembly 226 may include one or more lens mounting mechanisms. The lens mounting mechanism portion can provide anchors for mounting lenses (e.g., for phased array sensors). In the illustrated embodiment, the lens mounting mechanisms 228a, 228b are located on either side of the transducer 208a. The lens mounting mechanisms 228a, 228b may include rails with one or more openings for receiving corresponding portions of lenses or lens brackets. The lenses may be constructed from imaging-compatible materials such as silicone for ultrasound imaging.

[0034] Referring to Figure 2C, the opening 216a and transducer 208a may be operated via articulated joints 204a and 204b. In various embodiments, the opening 216a may be located between articulated joints 204a and 204b, and the transducer 208a may be located between articulated joint 204a and distal end 212. The portion of the elongated member 202 distal to articulated joint 204a may be referred to as the transducer subassembly 226. As will be described in more detail below with reference to Figures 3A and 3B, etc., the articulated joints 204a and 204b can provide the elongated member 202 with dual-mode maneuverability, allowing the transducer subassembly 226 to be moved independently of the opening 216a. In many embodiments, a handle may be attached to the proximal end 210 of the elongated member 202. As will be explained in more detail below with respect to Figures 5A to 5C, in many such embodiments, the handle may allow the operator to actuate the articulated joints 204a and 204b.

[0035] Figures 3A and 3B show various embodiments of articulated joints 304a, 304b of an elongated member 302 according to one or more embodiments disclosed herein. More specifically, Figure 3A includes a top view of the distal portion of the elongated member 302 having an opening 316, and Figure 3B includes a side view of the distal portion of the elongated member 302. The elongated member 302 extends along a longitudinal axis 314 and includes a proximal end 310, a distal end 312, a distal steering assembly 318 having a transducer subassembly 320, and articulated joints 304a, 304b. The articulated joints 304a, 304b may be located between the proximal end 310 and the distal end 312, and the opening 316 may be located between the articulated joints 304a, 304b. The articulated joint 304a includes a direction of articulation 306, and the articulated joint 304b includes a direction of articulation 308. In various embodiments, the direction of articulation 306 may be perpendicular to the direction of articulation 308. The articulated joints 304a, 304b may be configured to allow the movement of the transducer subassembly 320 independently of the distal steering assembly 318. In some embodiments, Figure 3A and / or Figure 3B may include one or more components that are identical or similar to one or more other components of the present disclosure. For example, articulated joint 304a may be identical or similar to articulated joint 204a, and articulated joint 304b may be identical or similar to articulated joint 204b. Furthermore, one or more components of Figure 3A and / or Figure 3B, or embodiments thereof, may be incorporated into other embodiments of the present disclosure or excluded from the embodiments described without departing from the scope of the present disclosure. Furthermore, one or more components or embodiments of other embodiments of the present disclosure may be incorporated into one or more components of Figure 3A and / or Figure 3B without departing from the scope of the present disclosure. For example, transducers 208a, 208b may be incorporated into the elongated member 302 without departing from the scope of the present disclosure. Embodiments are not limited to this context.

[0036] In various embodiments, the articulated joints 304a, 304b may enable dual-mode maneuverability. Dual-mode maneuverability allows for separate maneuverability of the transducer subassembly 320, independent of the portion of the elongated member 302 including the opening 316 between the articulated joints 304a, 304b, in addition to bidirectional maneuverability of the distal steering assembly 318. The additional flex points of the transducer subassembly 320 allow the elongated member 302 to travel around a narrower bending radius and offset the additional length of the transducer subassembly 320 due to the size constraints of one or more of the transducers within the transducer subassembly 320 (for example, due to the length of a phased array sensor having 48 ultrasonic elements). In various embodiments, the additional flex points may allow one or more transducers within the transducer subassembly 320 to contact or be embedded in the wall of a body lumen. As described above, in the illustrated embodiment, the transducer subassembly 320 can flex in a direction perpendicular to (e.g., offset by 90 degrees from) the steering of the entire distal steering assembly 318. However, in other embodiments, the transducer subassembly 320 may flex in the same direction as the steering of the entire distal steering assembly 318.

[0037] In some embodiments, the articulated joints 304a and / or 304b may bend only in a first direction beyond the longitudinal axis 314. For example, articulated joint 304a may bend in a certain direction beyond the longitudinal axis 314 (for example, towards the top of the page in Figure 3B) without bending in the opposite direction beyond the longitudinal axis 314 (for example, towards the bottom of the page in Figure 3B). As will be described in more detail below with respect to Figure 5C and the like, the elongated member may include one or more hard stops to restrict the movement of the articulated joint to a predetermined range. In some embodiments, restricting the movement of the articulated joint to a predetermined range ensures that the components do not get in the way of functioning properly and / or that the instrument can still be inserted through the lumen of the elongated member without damaging itself or the instrument.

[0038] Figure 4 shows various embodiments of exemplary transducers 404a, 404b according to one or more embodiments disclosed herein. The illustrated embodiments include a side view of a transducer subassembly 414 of an elongated member 402 having an outer surface 408, a proximal end 410, a distal end 412, a field of view 406a, a transducer 404b with a field of view 406b, and the transducers. Thus, the transducers 404a, 404b may be imaging sensors. For example, transducer 404a may be a phased array sensor of at least two elements, and transducer 404b may be an optical imaging sensor. In various embodiments, transducer 404a may enable lateral or radial imaging, and transducer 404b may enable forward imaging. In some embodiments, the field of view 406a of transducer 404b may extend from the outer surface 408 of the elongated member 402, and the field of view 406b of transducer 404b may extend from the distal end 412 of the elongated member 402. In some embodiments, the field of view 406a may be orthogonal to the field of view 406b. In various embodiments, transducer 404c may include a position tracking sensor such as an electromagnetic position sensor (e.g., an induction sensor or TMR sensor). In some embodiments, Figure 4 may include one or more components that are identical or similar to one or more other components of the present disclosure. For example, transducer 404a may be identical or similar to transducer 208a, and transducer 404b may be identical or similar to transducer 208b. Furthermore, one or more components of Figure 4, or embodiments thereof, may be incorporated into other embodiments of the present disclosure or excluded from the embodiments described without departing from the scope of the present disclosure. For example, field of view 406a may be incorporated into transducer 208a, and field of view 406b may be incorporated into transducer 208b. Furthermore, one or more components or embodiments of other embodiments of the present disclosure may be incorporated into one or more components of Figure 4 without departing from the scope of the present disclosure.For example, the lumen 206a having an opening 216a may be incorporated into an elongated member 402. The embodiments are not limited to this context.

[0039] In various embodiments, one or more of the transducers 404a, 404b, and 404c may be mounted on a flexible circuit board. In various such embodiments, two or more of the transducers 404a, 404b, and 404c may be mounted on a common flexible circuit board. For example, transducers 404b and 404c may be mounted on a common flexible circuit board. In some such examples, transducer 404b may include a forward-facing optical imaging sensor (e.g., a camera), and transducer 404c may include a TMR-based position sensor. In some embodiments, one or more of the transducers 404a, 404b, and 404c may be mounted on a flexible circuit board that at least partially encloses the transducer subassembly 414, such as being close to the outer diameter of the transducer subassembly. In various embodiments, the flexible circuit board is at least partially encapsulated with potting material or the like. In some embodiments, a low-pressure epoxy potting method may be used.

[0040] In many embodiments, the transducer 404c may be a 6-degree-of-freedom (DOF) sensor. In various embodiments, the transducer 404c may be cylindrical with a length of less than 9 mm and a diameter of less than 1.5 mm. In one embodiment, the transducer 404c may include a cylindrical TMR sensor with a length of 8 mm and a diameter of 0.65 mm. In some embodiments, the transducer 404c may include or be mounted on a semicircular or "C"-shaped flexible circuit board. In various embodiments, the transducer 404c may be mounted either inside or outside the transducer subassembly 414. In many embodiments, the configuration and dimensions of the components of the elongated member 402 may allow the elongated member 402 to access peripheral body lumens such as peripheral airways. For example, an outer diameter of less than 2 mm, such as 1.5 mm, may be suitable for peripheral airways. However, different appropriate dimensional ranges and limits may be applicable depending on the desired application.

[0041] In many embodiments, the flexible circuit board of transducer 404c may at least partially enclose the transducer subassembly 414, for example, by being embedded in the transducer subassembly in close proximity to its outer diameter. In some embodiments, the flexible circuit included in or to which transducer 404c is attached may be the same as or different from the flexible circuit to which one or more other transducers are attached. In one embodiment, the flexible circuit may include connection pads that allow signals from other transducers to cross the flexible circuit board.

[0042] In some embodiments, the flexible circuit may be molded according to available space and size constraints. In various embodiments, the flexible circuit may be manufactured in a flat configuration and formed into a desired shape using a second potting application. In other embodiments, the flexible circuit may be manufactured with a target end shape. In some embodiments, the transducer 404c may be reflowed into an elongated member 402. For example, the ability to mold a transducer 404c with a 6-DOF sensor and wrap the transducer 404c around the outer shape of a transducer subassembly 414 allows the transducer 404c to be reflowed into an elongated member 402, thus avoiding the occupancy of excess space at the tip and / or cross-sectional area of ​​the device.

[0043] In some embodiments, the elongated member 402 may be manufactured as a single-use device (SUD). Therefore, various epoxy, polymer, and / or composite materials can be used, for example, as a substitute for metal in some of the components. In many embodiments, the transducer subassembly 414 may be manufactured using a low-pressure epoxy potting process to accommodate the transducer 404b (e.g., a forward-facing camera) and the transducer 404c (e.g., a TMR-based position sensor). In many such embodiments, a mechanism for securely mounting the transducer lens (e.g., lens mounting mechanisms 228a, 228b) may also be included in the design of the low-pressure epoxy component. In various embodiments, the transducer lens (e.g., for lens mounting mechanisms 228a, 228b) may be formed by a molding process, e.g., silicone or other ultrasonic imaging-compatible material molding process. In some embodiments, the low-pressure epoxy potting process may be the first step in a two-part manufacturing process, and the lens formation may be the second step in a two-part manufacturing process.

[0044] Figures 5A to 5C illustrate various aspects of the elongated member 502 according to one or more embodiments disclosed herein. More specifically, Figure 5A includes a cross-sectional view of the distal portion of the elongated member 502, which includes a distal steering assembly 538 with a transducer subassembly 536 combined with a biopsy needle 520; Figure 5B includes a cross-sectional view of the distal portion of the elongated member 502 in a cutting plane 540; and Figure 5C includes a perspective view of the distal portion of the elongated member 502. The elongated member 502 has a proximal end 510, a distal end 512, and an outer surface 514, and includes articulated joints 504a, 504b, 504c, lumens 506a, 506b, a phased array sensor 508a, an optical imaging sensor 508b, a position tracking sensor 508c, an opening 516, inclined sections 518 with bending radii 522a, 522b, a hard stop 524, steering wires 526a, 526b, a pull wire 528, a suction channel 530, working members 532a, 532b, and a tapered section 534. In some embodiments, Figures 5A, 5B, and / or 5C may include one or more components that are identical or similar to one or more other components of the present disclosure. For example, the transducer subassembly 536 may be similar to the transducer subassembly 320. Furthermore, one or more components or embodiments thereof of Figures 5A, 5B, and / or 5C may be incorporated into other embodiments of the Disclosure or excluded from embodiments described without departing from the scope of the Disclosure. For example, an embodiment of the elongated member 502 may exclude the optical imaging sensor 508b without departing from the scope of the Disclosure. Furthermore, one or more components or embodiments thereof of other embodiments of the Disclosure may be incorporated into one or more components of Figures 5A, 5B, and / or 5C without departing from the scope of the Disclosure. For example, the light 222 may be incorporated into the elongated member 502 without departing from the scope of the Disclosure. Embodiments are not limited to this context.

[0045] In general, the arrangement of the components of the elongated member 502 may be similar to that of the elongated member 202. Additionally or alternatively, the elongated member 502 includes or shows a tapered portion 534 on the outer surface 514, a third articulated joint 504c, an inclined portion 522 having two bending radii 518a, 522b, a hard stop 524, steering wires 526a, 526b, a pull wire 528, a suction channel 530, and working members 532a, 532b. Some embodiments may include a phased array sensor 508a, but omit the optical imaging sensor 508b and / or position tracking sensor 508c. Various embodiments may include an opening for a biopsy needle 520 at the distal end 512 of the elongated member 502 instead of the opening 516.

[0046] As mentioned above, the inclination angle may be between 3 degrees and 20 degrees. For example, the angle of the inclined portion 518 may be 15 degrees. In another example, the angle of the inclined portion 518 may be 10 degrees. However, in the inclined portion 518, the total angle of the inclined portion may be divided between the bending radii 522a and 522b. For example, the bending radius 522b may bend by an angle of 7.5 degrees from the longitudinal axis of the elongated member 502, and the bending radius 522a may bend by another 7.5 degrees, with a total angle of 15 degrees. In another example, the bending radius 522b may bend by an angle of 4 degrees from the longitudinal axis of the elongated member 502, and the bending radius 522a may bend by another 6 degrees, with a total angle of 10 degrees.

[0047] In various embodiments, the inclined section 518 may include at least two different bending radii to allow instruments with a larger diameter (e.g., 19G biopsy needles) to exit the opening 516 from the surface of the phased array sensor 508a at a predetermined angle and / or a controlled distance. In many embodiments, the phased array sensor 508a may include at least two adjacent elements (e.g., ultrasound imaging elements). In some embodiments, the number of adjacent elements in the phased array sensor 508a may be adjusted to optimize the length of the transducer subassembly 536 to the target image size. For example, reducing the number of elements in the phased array shortens the length of the transducer subassembly but also narrows the image. In some examples, different embodiments may include different numbers of adjacent elements, allowing the operator to choose based on personal preference. In various embodiments, the phased array sensor 508a may include elements on the proximal and distal sides of the opening 516. In some such embodiments, a controller (e.g., controller 610) can be used to make physically separated elements function as a single continuous array that provides an image including the distal and proximal regions of the aperture 516.

[0048] In some embodiments, the phased array sensor 508a may be mounted on a rotatable collar. In some such embodiments, the phased array sensor 508a may be used to generate a 360-degree radial image. In various embodiments, the rotatable collar may include a plurality of conductive rings to maintain conductive and / or communication coupling between the phased array sensor 508a and a controller (e.g., controller 110). In some embodiments, a fluid reservoir and / or delivery port, such as an expandable balloon, may be included in or around the transducer subassembly 536. In some such embodiments, fluid may be introduced into the fluid reservoir or body lumen via the fluid delivery port to improve coupling between the phased array sensor 508a and the body lumen. In various embodiments, the fluid coupling may be used in a body lumen of a larger diameter where the transducer subassembly 536 is not pressed against the wall of the body lumen.

[0049] In various embodiments, one or more of the articulated joints 504a, 504b, 504c may enable dual-mode maneuverability. Dual-mode maneuverability allows for bidirectional steering of the distal steering assembly 538, as well as separate maneuverability of the transducer subassembly 536, independent of the rest of the distal steering assembly 538 (including the opening 516 between the articulated joints 504a, 504b). Steering wires 526a, 526b may be used to actuate the articulated joint 504b. A pull wire 528 may be used to flex the transducer subassembly 536 independently of the rest of the distal steering assembly 538. More generally, the pull wire 528 may comprise a flex wire. In many embodiments, a handle may be attached to the proximal end 510 of the elongated member 502. In many such embodiments, the handle may include one or more control functions that allow an operator to adjust the articulated joint. Some embodiments may include a steering mechanism that may include lock and / or tension control functions. In some embodiments, locking and / or tension control functions may allow the transducer subassembly 536 to remain in place without requiring the operator to keep their fingers on the steering mechanism. In one embodiment, the deflection of the transducer subassembly 536 may be controlled by a push mechanism (as opposed to a pull or tension mechanism).

[0050] Referring to Figure 5B, a cross-sectional view is shown of the elongated member 502 viewed toward its distal end 512 in the cutting plane 540. The suction channel 530 may terminate at the distal end of the elongated member 502. In various embodiments, the suction channel 530 may be used to remove mucus from the surface of the optical imaging sensor 508b. In some embodiments, the suction channel 530 may have a diameter of 0.7 to 1 mm, such as 0.889 mm.

[0051] Referring to Figure 5C, the deflection of the transducer subassembly 536 can be limited by the hard stop 524. In some embodiments, the actuators 532a, 532b may include rods for articulating the transducer subassembly 536. In one or more embodiments, the actuators 532a, 532b may be made of stainless steel. In various embodiments, when there is no external input, the transducer subassembly 536 may be aligned with the rest of the distal steering assembly 538. For example, a series of wires may be attached (e.g., welded) between the transducer subassembly 536 and the rest of the distal steering assembly 538. In such an example, when the tension of the pull wire 528 is released, the transducer subassembly 536 can return to its nominal straight position. In one embodiment, the series of wires may be replaced by pins and springs (e.g., torsion springs, tension springs, or compression springs) that facilitate return to the nominal straight position when an external force (e.g., pushing / pulling force) is removed from the flexing wire. In various embodiments, one or more of the wires (e.g., pull wire 528, steering wires 526a, 526b) may be covered with braid and reflow polymer to prevent pinch points or foreign matter intrusion (e.g., Bowden cable). Some embodiments can utilize a braid with a small number of wires (few picks) and / or loosely packed (not densely packed). The braid may provide a scaffold for reflowing the polymer to produce a smooth outer surface without affecting flexibility and / or flex, while preventing pinch points.

[0052] Figure 6 shows various aspects of the controller 610 of a medical device 600 according to one or more embodiments disclosed herein. In the illustrated embodiments, the medical device 600 includes the controller 610 and an elongated member 602. The controller 610 includes logic circuits 604, memory 606, input / output (I / O) 608, and a user interface 612. In various embodiments, the controller 610 can enable interaction with and control of components of the elongated member 602. For example, the controller 610 can generate and present an image based on signals received from a transducer in response to a signal transmitted by the controller 610 to the transducer. In some embodiments, Figure 6 may include one or more components that are identical or similar to one or more other components of the Disclosure. For example, the elongated member 602 may be identical or similar to the elongated member 502. Furthermore, one or more components, or aspects thereof, of Figure 6 may be incorporated into other embodiments of the Disclosure or excluded from the embodiments described herein without departing from the scope of the Disclosure. For example, the controller 610 may be used with the elongated member 202 without departing from the scope of the disclosure. Furthermore, one or more components or embodiments of other embodiments of the disclosure may be incorporated into one or more components of Figure 6 without departing from the scope of the disclosure. For example, the transducer 108 may be incorporated into the elongated member 602 without departing from the scope of the disclosure. Embodiments are not limited to this context.

[0053] In various embodiments, the controller 610 can implement one or more functions disclosed herein. For example, instructions stored in member 606 can be executed by logic circuit 604 to operate phased array sensor 508a and generate an image on user interface 612 based on signals received from phased array sensor 508a. In many embodiments, the controller 610 can automate one or more functions. Logic circuit 604 can send and receive signals from transducers of elongated member 602 via I / O 608. In many embodiments, logic circuit 604 may generate metadata for signals received from transducers. In many such embodiments, the metadata may correspond to signals from one or more other transducers of elongated member 602. For example, the position of elongated member 602 indicated by an EM tracking sensor may be associated as metadata with an image from a phased array of ultrasonic imaging sensors.

[0054] In some embodiments, the logic circuit 604 may perform image processing. For example, it may combine multiple images generated by transducer 406a to create a composite image of the inside of the body. In some embodiments, the logic circuit 604 can perform mapping, such as by using data from multiple transducers to generate a composite image. For example, position data (e.g., in 6DOF) can be combined with images to generate a composite image. In some embodiments, metadata associated with an image may indicate the position of the imaging sensor (e.g., in 6DOF) when the imaging sensor captured the image. In various embodiments, multiple images can be combined to generate a radial image. In various such embodiments, multiple radial images can be combined to generate a composite image of the inside of the body.

[0055] In one or more embodiments, data from a preoperative scan may be stored in memory 606 and / or utilized by logic circuit 604. In some embodiments, logic circuit 602 may use the preoperative data in conjunction with surgical data (e.g., sensor data received from the elongated member 602) to determine the position of the elongated member 602. For example, logic circuit 604 can determine the position of the elongated member 602 by matching landmarks identified in the preoperative image with elements in the image generated via the elongated member 602.

[0056] In some embodiments, the logic circuit 602 may perform motion compensation. For example, the logic circuit 602 may compensate for respiratory motion. In various embodiments, motion compensation can facilitate the matching of surgical data with preoperative data (e.g., from computed tomography (CT) scans). For example, motion compensation may allow surgical images to be overlaid on preoperative images.

[0057] In various embodiments, the logic circuit 602 may perform one or more of the following: object detection, distance estimation, and object classification. In various such embodiments, the logic circuit 602 may identify tumors from multiple ultrasound images, determine the distance to the tumors based on the multiple ultrasound images, and classify the tumors based on their size, location, and distance. In some embodiments, the logic circuit 602 may classify tumors by utilizing data from preoperative scans, such as by matching the tumors to landmarks identified in the preoperative images. For example, a target nodule for biopsy located in the peripheral part of the lung may be identified by comparing an object detected in the ultrasound image with one or more preoperative images containing the target nodule. In many embodiments, object detection and classification may be used for boundary detection, such as to identify airway bifurcations.

[0058] In many embodiments, the logic circuit 602 may generate a three-dimensional model of one or more internal body parts. In some embodiments, one or more techniques described herein may be used to generate three-dimensional models of transducer data, preoperative data, composite images, metadata, images, locations, objects, distances, object classifications, etc. In various embodiments, the three-dimensional model may include the location of an elongated member 602.

[0059] In various embodiments, the operator can cause the logic circuit 604 to perform various functions by providing inputs via the user interface 612. In some embodiments, image generation may be controlled via the user interface 612. In one or more embodiments, object classification may be controlled via the user interface 612. For example, the user can add or remove classifications by selecting objects in an image presented via the user interface 612. In some embodiments, the logic circuit may determine the distance between two points identified in an image presented via the user interface 612. For example, the logic circuit 602 may determine the distance between two objects selected by the user in an image. In many embodiments, an output may be presented to the operator via the user interface 612. For example, a three-dimensional model of a part of the body's interior may be presented via the user interface 612.

[0060] In many embodiments, additional and / or updated functionality can be integrated into the controller 610 by storing the additional and / or updated instructions in memory 606 (for example, as software). In one or more embodiments, the controller 610 may be connected to a network (for example, the Internet, a local area network, a personal area network, or inductive coupling). In one or more such embodiments, the controller 610 may be updated and / or provide additional functionality by receiving instructions over the network.

[0061] In some embodiments, the controller 610 can automate one or more functions. In many embodiments, the controller 610 may automate functionality by using feedback loop-based data from one or more transducers to control one or more of the same or other transducers. For example, data from a position sensor may be used to control one or more actuators located at an actuation joint. In such an example, the feedback loop may be used to automate the navigation and / or positioning of the elongated member 602 to a target site. In some embodiments, the elongated member 602 may have a wire for controlling an articulated joint that extends to its proximal end. In some such embodiments, a servo motor coupled to the wire and operable by the controller 610 may use data from one or more transducers (e.g., 208b and / or 208c) to enable automatic steering of the elongated member. In one embodiment, an electromagnetic position sensor may be located along the length of the elongated member, such as at an articulated joint.

[0062] In various embodiments, CT scans and mapping can be used to determine the approximate location of a target site (e.g., a target lesion) and a virtual map of the corresponding part of the body (e.g., the lungs). In various such embodiments, the controller 610 may utilize CT scans and / or mapping in conjunction with data from the transducer to automate navigation to the target site. In one or more embodiments, biopsy acquisition may be at least partially automated. For example, imaging data (e.g., from 208a) may be utilized by the controller 610 in conjunction with a needle actuator to acquire a biopsy of the target tissue. In various embodiments, the controller 610 may automate biopsy acquisition using a suction device. In some embodiments, the controller 610 may acquire samples from various locations at the target site (e.g., via feathering). In many embodiments, the controller 610 may track and record the location of each biopsy. In many such embodiments, data from the biopsy locations may be used to determine characteristics of the target site, such as the size and boundaries of the lesion. In some embodiments, various automated functions may be controlled or directed via the user interface 612. For example, the target location for biopsy may be identified via a touchscreen based on real-time images from one or more imaging transducers. In another example, the direction of acquisition of the branched lumen may be identified based on user input.

[0063] Figure 7 shows a process flow 700 according to one or more embodiments disclosed herein. In various embodiments, one or more parts of the process flow 700 may be performed by or using components disclosed herein. For example, blocks 708-718 may be performed using medical device 100 or medical device 600. Embodiments are not limited to this context.

[0064] In the illustrated embodiment, the process flow 700 can begin in block 702. In block 702, “Preoperative Imaging,” preoperative imaging can be performed. For example, preoperative imaging may be performed to determine the location of a target site (e.g., a potentially cancerous nodule) within the peripheral airway. Preoperative imaging may utilize one or more external imaging techniques, such as X-ray (e.g., as part of a CT scan), magnetic resonance imaging (MRI), and ultrasound imaging. Proceeding to block 704, “Preoperative Planning,” preoperative planning can be performed. For example, a treatment plan (e.g., a route) for obtaining a biopsy of the target site can be formulated. In some embodiments, preoperative planning may include providing one or more preoperative images to controller 110 or controller 610.

[0065] The system can proceed to block 706, “Patient Preparation,” to perform patient preparation. For example, the patient may be sedated and positioned to receive the elongated member. In many embodiments, the patient may be positioned based on their position during preoperative imaging. In block 708, “Inserting the Elongated Member,” the elongated member can be inserted into the patient. For example, the distal end of the elongated member 102 may be inserted into the patient through the nose or mouth, etc. By proceeding to block 710, “Navigating to the Target Site Using a Position Tracking Sensor,” the distal end of the elongated member can be navigated to the target site using a position tracking sensor. For example, a position tracking sensor 508c equipped with a TMR sensor can be used to navigate to the target site. In various embodiments, the position tracking sensor 508c may include a TMR 6-DOF sensor. In some embodiments, the controller 110 or controller 610 can use the preoperative images in conjunction with feedback from one or more position tracking sensors (e.g., position tracking sensor 508c) to provide guidance for navigating to the target site. In some embodiments, articulated joints (e.g., articulated joints 504a, 504b, 504c) can be used to manipulate an elongated member and enable navigation to a target location based on position tracking sensors.

[0066] In block 712, "Generating an image using a phased array sensor," an image can be generated using a phased array sensor. For example, the controller 610 can generate an image based on feedback from the phased array sensor 508a. In block 714, "Adjusting the position based on an image generated using a phased array sensor," the position of the elongated member can be adjusted based on an image generated using a phased array sensor. For example, the placement of the elongated member may be fine-tuned to finally position it for the operation of a biopsy needle inserted through the lumen of the elongated member. In block 716, "Collecting a biopsy sample," a biopsy sample can be collected. For example, the biopsy needle 520 may extend from the opening 516 on the outer surface 514 of the elongated member 502 to acquire a tissue sample. In block 718, "Confirming the tissue sample," the tissue sample can be confirmed. For example, the biopsy needle 520 may be removed from the lumen 506a to visually confirm that a tissue sample has been acquired.

[0067] In some embodiments, tissue samples(s) are collected and sent to a pathology laboratory for diagnosis. In various embodiments, a rapid spot assessment (ROSE) can be performed, such as with a pathologist present to analyze the tissue samples and determine the diagnosis. In various such embodiments, real-time confirmation may allow the biopsy needle to be replaced with a therapeutic probe that can be used to treat the target site. The therapeutic probe may include or utilize one or more of the following ablation modalities: radio frequency (RF) waves, microwaves, cryogenics, fluids, irreversible electroporation (IRE), or other ablation modalities. In some embodiments, the therapeutic probe may be used to deliver a therapeutic agent, such as a chemosphere, to the target site.

[0068] Figure 8 shows a computing architecture 800 according to one or more embodiments disclosed herein. The computing architecture 800 may be suitable for implementing various embodiments as described above. In various embodiments, the computing architecture 800 may include or be implemented as part of an electronic device and / or medical device. In some embodiments, the computing architecture 800 may represent, for example, one or more components described herein. In some embodiments, the computing architecture 800 may represent a computing device that implements or utilizes one or more parts of the components and / or techniques described herein, such as, for example, controller 110, transducer 108, controller 610, logic circuit 604, memory 606, I / O 608, and / or user interface 612. Embodiments are not limited to this context.

[0069] Where used in various embodiments of this specification, the terms “system,” “component,” and “module” can refer to computer-related entities that are either hardware, a combination of hardware and software, software, or running software, examples of which are provided by the exemplary computing architecture 800. For example, a component may be, but is not limited to, a process running on a processor, a processor, a hard disk drive, multiple storage drives (of optical and / or magnetic storage media), an object, an executable file, an execution thread, a program, and / or a computer. For example, both an application running on controller 110 and controller 110 may be components. One or more components may reside within a process and / or an execution thread, and components may be localized on one computer and / or distributed between two or more computers. Furthermore, components may be coupled together communicatively by various types of communication media to coordinate their operation. Coordination may include unidirectional or bidirectional exchange of information. For example, components may communicate information in the form of signals communicated over a communication medium. Information may be realized as signals assigned to various signal lines. In such an assignment, each message is a signal. However, further embodiments may alternatively employ data messages. Such data messages may be transmitted over various connections. Exemplary connections include parallel interfaces, serial interfaces, and bus interfaces.

[0070] Computing architecture 800 includes a variety of common computing elements, such as one or more processors, multicore processors, coprocessors, memory units, chipsets, controllers, peripherals, interfaces, oscillators, timing devices, video cards, audio cards, multimedia input / output (I / O) components, and power supplies. However, embodiments are not limited to implementations of computing architecture 800.

[0071] As shown in Figure 8, the computing architecture 800 comprises a processing unit 804, system memory 806, and a system bus 808. The processing unit 804 can be any of a variety of commercially available processors, including, but not limited to, AMD® Athlon®, Duron®, and Opteron® processors, ARM® application, embedded, and secure processors, IBM® and Motorola® DragonBall® and PowerPC® processors, IBM and Sony® Cell processors, Intel® Celeron®, Core(2)Duo®, Itanium®, Pentium®, Xeon®, and XScale® processors, and similar processors. Dual microprocessors, multi-core processors, and other multiprocessor architectures can also be used as the processing unit 804.

[0072] The system bus 808 provides an interface to the processing unit 804 for system components, including but not limited to the system memory 806. The system bus 808 can be any of several types of bus structures that can further interconnect to the memory bus (with or without a memory controller), peripheral bus, and local bus using any of the various commercially available bus architectures. Interface adapters can be connected to the system bus 808 via slot architectures. Exemplary slot architectures may include, but are not limited to, Accelerated Graphics Port (AGP), CardBus, Industry Standard Architecture ((E)ISA), Microchannel Architecture (MCA), NuBus, Peripheral Component Interconnect (Extensions) (PCI(X)), PCI Express, and the International Personal Computer Memory Card Association (PCMCIA).

[0073] The system memory 806 may include various types of computer-readable storage media in the form of one or more high-speed memory units, such as read-only memory (ROM), random access memory (RAM), dynamic RAM (DRAM), double-data-rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory (e.g., one or more flash arrays), polymer memory such as ferroelectric polymer memory, ovonic memory, phase-change or ferroelectric memory, silicon-oxide-nitride-oxide-silicon (SONOS) memory, magnetic or optical cards, arrays of devices such as RAID (Redundant Array of Independent Disks) drives, solid-state memory devices (e.g., USB memory, solid-state drives (SSDs)), and any other type of storage medium suitable for storing information. In the exemplary embodiment shown in Figure 8, the system memory 806 may include non-volatile memory 810 and / or volatile memory 812. In some embodiments, system memory 806 may include main memory. The basic input / output system (BIOS) can be stored in non-volatile memory 810.

[0074] Computer 802 may include various types of computer-readable storage media in the form of one or more low-speed memory units, including an internal (or external) hard disk drive (HDD) 814, a magnetic floppy disk drive (FDD) 816 for reading from or writing to a removable magnetic disk 818, and an optical disk drive 820 for reading from or writing to a removable optical disk 822 (e.g., a CD-ROM or DVD). The HDD 814, FDD 816, and optical disk drive 820 can be connected to the system bus 808 by HDD interface 824, FDD interface 826, and optical drive interface 828, respectively. The HDD interface 824 for external drive implementation may include at least one or both of the Universal Serial Bus (USB) and the Institute of Electrical and Electronics Engineers (IEEE) 994 interface technology. In various embodiments, these types of memory may not be included in main memory or system memory.

[0075] The drive and associated computer-readable media provide volatile and / or non-volatile storage of data, data structures, computer-executable instructions, etc. For example, an operating system 830, one or more application programs 832, other program modules 834, and multiple program modules including program data 836 can be stored in the drive and memory units 810, 812. In one embodiment, one or more application programs 832, other program modules 834, and program data 836 may include or implement, for example, various techniques, applications, and / or components described herein.

[0076] The user can input commands and information to the computer 802 via one or more wired / wireless input devices, such as a keyboard 838 and a pointing device such as a mouse 840. Other input devices may include a transducer 108, a phased array sensor 508a, an optical imaging sensor 508b, a position tracking sensor 508c, a microphone, an infrared (IR) remote control, a radio frequency (RF) remote control, a gamepad, a stylus pen, a card reader, a dongle, a fingerprint reader, a glove, a graphics tablet, a joystick, a keyboard, a retina reader, a touchscreen (e.g., capacitive, resistive, etc.), a trackball, a trackpad, a sensor, a stylus, and the like. These and other input devices are often connected to the processing unit 804 via an input device interface 842 coupled to the system bus 808, but can also be connected via other interfaces such as a parallel port, an IEEE994 serial port, a game port, a USB port, or an IR interface.

[0077] Monitor 844 or other types of display devices are also connected to the system bus 808 via interfaces such as the video adapter 846. Monitor 844 may be located inside or outside the computer 802. In addition to Monitor 844, the computer typically includes other peripheral output devices such as speakers and printers.

[0078] Computer 802 can operate in a networked environment using logical connections via wired and / or wireless communication to one or more remote computers, such as remote computer 848. In various embodiments, one or more interactions described herein may occur via a networked environment. Remote computer 848 may be a workstation, server computer, router, personal computer, portable computer, microprocessor-based entertainment device, peer device, or other common network node, and typically includes many or all of the elements described with respect to computer 802, but for brevity only, the memory / storage device 850 is shown. The shown logical connections include wired / wireless connections to a local area network (LAN) 852 and / or a larger network, such as a wide area network (WAN) 854. Such LAN and WAN networking environments are common in offices and companies, facilitating enterprise-scale computer networks such as intranets, all of which may be connected to global communication networks, such as the Internet.

[0079] When used in a LAN networking environment, computer 802 is connected to LAN 852 via a wired and / or wireless network interface or adapter 856. Adapter 856 can facilitate wired and / or wireless communication to LAN 852 and may also include a wireless access point located thereto to communicate with the wireless capabilities of adapter 856.

[0080] When used in a WAN networking environment, computer 802 may include a modem 858, or be connected to a communication server on the WAN 854, or have other means for establishing communication via the WAN 854, such as the Internet. The modem 858 may be internal or external, wired and / or wireless, and connect to the system bus 808 via an input device interface 842. In a networked environment, the program modules or parts thereof shown in relation to computer 802 may be stored in a remote memory / storage device 850. The illustrated network connection is illustrative, and it will be understood that other means can be used to establish communication links between computers.

[0081] Computer 802 is operable to communicate with wired and wireless devices or entities using standards of the IEEE 802 family, such as wireless devices configured to operate wirelessly (e.g., IEEE 802.16 wireless modulation technology). This includes, among other things, at least Wi-Fi (or Wireless Fidelity), WiMAX, and Bluetooth® wireless technologies. Thus, communication may be a predefined structure, similar to conventional networks, or simply ad-hoc communication between at least two devices. Wi-Fi networks provide secure, reliable, and high-speed wireless connectivity using wireless technologies called IEEE 802.11x (a, b, g, n, etc.). Wi-Fi networks can be used to connect computers to each other, to the Internet, and to wired networks (using IEEE 802.3 related media and functions).

[0082] Various embodiments may be implemented using hardware elements, software elements, or a combination of both. 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, application programs, system programs, machine programs, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, procedures, software interfaces, application program interfaces (APIs), instruction sets, computing code, computer code, code segments, computer code segments, words, values, symbols, or any combination thereof. Whether an embodiment is implemented using hardware and / or software elements may vary depending on any number of factors such as desired computing speed, power level, thermal tolerance, processing cycle budget, input data rate, output data rate, memory resources, data bus speed, and other design or performance constraints.

[0083] One or more aspects of at least one embodiment may be implemented by representative instructions stored on a machine-readable medium representing various logics within a processor (e.g., a logic circuit), which, when read by a machine, cause the machine to create logic for performing the techniques described herein. Such representations, known as "IP cores," may be stored on a tangible machine-readable medium and supplied to various customers or manufacturing facilities to be loaded into manufacturing machines that actually produce logic or processors. Some embodiments may be implemented using a machine-readable medium or article that can store instructions or sets of instructions that, when performed by a machine (e.g., a logic circuit), cause the machine to perform the methods and / or operations according to the embodiment. Such a machine may include, for example, any preferred processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, logic circuit, etc., and may be implemented using any preferred combination of hardware and / or software. Machine-readable media or articles may include, for example, any suitable type of memory unit, memory device, memory article, memory medium, storage device, storage article, storage medium and / or storage unit, such as memory, removable or non-removable media, erasable or non-erasable media, writable or rewritable media, digital or analog media, hard disks, floppy disks, compact disc read-only memory (CD-ROM), recordable compact discs (CD-R), rewritable compact discs (CD-RW), optical discs, magnetic media, magneto-optical media, removable memory cards or discs, various types of digital multipurpose discs (DVDs), tapes, cassettes, etc. Instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, cryptographic code, etc., implemented using any suitable high-level, low-level, object-oriented, visual, compiled and / or interpreted programming language.

[0084] The preceding discussions are presented for illustrative and explanatory purposes, with broad applicability, and are not intended to limit this disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, ideas, and scope of this disclosure. In particular, it will be apparent to those skilled in the art that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from its concepts, ideas, scope, or characteristics. For example, various features of this disclosure are grouped together into one or more aspects, embodiments, or configurations for the purpose of streamlining this disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of this disclosure can be combined in alternative aspects, embodiments, or configurations. While this disclosure is presented with respect to embodiments, it should be understood that various distinct features of the subject matter do not all need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with numerous modifications, or modifications to the structure, arrangement, proportions, materials, components, etc., used in the implementation of this disclosure, without departing from the principles, technical ideas, or scope of this disclosure, or particularly adapted to specific environmental and operating requirements. For example, an element shown as being formed as a whole may consist of multiple parts, or an element shown as multiple parts may be formed as a whole; the operation of an element may be reversed or modified; and the size or dimensions of an element may be modified. Similarly, while an operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations or actions or procedures should be performed. In addition, other forms of implementation are within the scope of the following claims. In some cases, the operations described in the claims may be performed in a different order, and the desired result may still be achieved.Accordingly, the embodiments currently disclosed should be considered in all respects to be illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or any specific embodiment or configuration described or illustrated herein. In consideration of the foregoing, individual features of any embodiment may be used, either separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0085] In the foregoing description and the following claims, it will be understood that: The terms “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions that are both conjunctive and disjunctive in their function. Terms such as “a,” “an,” “the,” “first,” and “second” do not exclude plurals. For example, the term “a” or “an” entity, as used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. References to all directions (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements from one another, and do not limit the elements relevant in particular with respect to the position, orientation, or use of this disclosure. References to connections (e.g., attached, joined, connected, and joined) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative movement between elements. Thus, references to connections do not necessarily imply that two elements are directly connected and have a fixed relationship with respect to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0086] The following claims are incorporated by reference into this detailed description, and each claim stands independently as a distinct embodiment of the present disclosure. In the claims, the term “equipped with / possesses” does not exclude the presence of other elements or steps. In addition, individual features may be included in different claims, but they may be advantageously combined, and inclusion in different claims does not mean that the combination of features is unfeasible and / or unfavorable. In addition, singular references do not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should never be construed as limiting the claims.

[0087] All devices and / or methods disclosed and claimed herein can be manufactured and performed without undue experimentation in light of this disclosure. While the devices and methods of this disclosure are described in relation to preferred embodiments, it will be apparent to those skilled in the art that modifications can be applied to the devices and / or methods disclosed herein, as well as to the steps or sets of steps of the methods, without departing from the concepts, art, and scope of this disclosure. All such similar substitutes and modifications that are apparent to those skilled in the art shall be deemed to be within the scope of the art, scope, and concepts of this disclosure as defined by the appended claims.

Claims

1. An elongated member having an outer surface, a proximal end, a distal end, and at least one articulated joint positioned between the proximal end and the distal end, A lumen having a first opening adjacent to the proximal end of the elongated member and a second opening adjacent to the distal end of the elongated member, A first transducer comprising a phased array sensor positioned close to the distal end of the elongated member, A device equipped with the following features.

2. The apparatus according to claim 1, wherein the field of view of the phased array sensor extends from the outer surface of the elongated member.

3. The apparatus according to claim 1 or 2, wherein the second opening of the lumen is located on the outer surface of the elongated member.

4. The apparatus according to claim 3, wherein the lumen includes a tilted portion configured to direct the device into the field of view of the phased array sensor when the device extends through the lumen and out of the second opening of the lumen.

5. The apparatus according to claim 4, wherein the inclined portion includes bends of multiple radii.

6. The apparatus according to any one of claims 1 to 5, further comprising a second transducer including a position tracking sensor.

7. The apparatus according to claim 6, wherein the position tracking sensor comprises a magnetic tunnel junction.

8. The apparatus according to claim 6 or 7, further comprising a third transducer including an optical imaging sensor.

9. The apparatus according to claim 8, wherein at least one of the first transducer, the second transducer, and the third transducer is mounted on a flexible circuit board.

10. The apparatus according to any one of claims 1 to 5, further comprising a second transducer including an optical imaging sensor.

11. The apparatus according to claim 10, wherein the field of view of the phased array sensor extends from the outer surface of the elongated member, and the field of view of the optical imaging sensor extends from the distal end of the elongated member.

12. The apparatus according to claim 10 or 11, wherein the optical imaging sensor is mounted on the distal end of the elongated member.

13. The apparatus according to any one of claims 1 to 12, wherein the at least one articular joint comprises a first articular joint and a second articular joint, and the direction of articular movement of the first articular joint is perpendicular to the direction of articular movement of the second articular joint.

14. The apparatus according to any one of claims 1 to 13, wherein the at least one articulated joint comprises a first articulated joint and a second articulated joint, and the second opening of the lumen is located between the first articulated joint and the second articulated joint.

15. The apparatus according to any one of claims 1 to 14, wherein the first portion of the phased array sensor is positioned near the second opening of the lumen, and the second portion of the phased array sensor is positioned distal to the second opening of the lumen.

Images