Positioning devices, methods, and systems

Embodiments include devices, methods, and systems for positioning devices. An exemplary method comprises: moving a distal end of a tube into a body, the tube including a lumen and a shaft in the lumen, the shaft having a transducer; sending a first signal to the transducer; passing, with the transducer, in response to the first signal, a wave energy into the body; receiving, with the transducer, a reflected portion of the wave energy; generating, with the transducer, a second signal in response to the reflected portion of the wave energy; determining, with a processor, an indicia of the body in response to the second signal; and identifying, with the indicia, a targeted issue in the body; positioning the distal end of the tube at the targeted tissue in response to the indicia; and removing a portion of the targeted tissue with the distal end of the tube.

TECHNICAL FIELD

Aspects of the present disclosure generally relate to positioning devices, methods, and procedures. In particular, aspects relate to using wave energy to position a medical device in a body.

BACKGROUND

Lung cancer is among the leading causes of cancer deaths worldwide, in part, because most new cases are not presented until later stages of development (e.g., at Stage III or IV). Screening for lung cancer reduces mortality by allowing a greater percentage of new cases to be presented at early stages (e.g., at Stage I or II) where the cancerous tissue can be more easily removed. Many screening procedures comprise, for example, identifying tissues that are suspected to be cancerous (e.g., a lung nodule >8 mm), and performing a lung biopsy on the identified tissue to confirm the presence and/or staging of cancer. In many cases, the lung biopsy is performed by placing a biopsy needle into the lung, and using a series of X-rays to position the biopsy needle at the identified tissue.

There are many problems with known procedures. For example, multiple X-rays may be required to position the biopsy needle, exposing both the patient and the physician to high amounts of radiation. This problem is of particular concern to physicians, and their technicians, who may perform more than one lung biopsy per day, and potentially hundreds per year. Moreover, because each X-ray captures a still image, and multiple X-rays are required to locate the biopsy needle in three dimensions, the physician cannot position the biopsy needle in real-time. Numerous starts and stops are thus required to position the needle, increasing operating times and the potential of damaging non-targeted tissues.

Aspects of the positioning devices, methods, and systems disclosed herein may solve one or more these problems and/or address other missing aspects of the prior art.

SUMMARY

Aspects of the present disclosure relate to positioning devices, methods, and systems. Numerous aspects are now described.

One aspect of this disclosure is a positioning system. An exemplary system may comprise: a tube including a distal end with a tissue penetrating feature and one or more lumens extending through the tube; a shaft positioned in a first lumen of the one or more lumens; a transducer coupled to the shaft, the transducer being configured to generate a wave energy in response to a first signal, receive a reflected portion of the wave energy, and generate a second signal in response to the reflected portion of the wave energy; and one or more processors in communication with the transducer, the one or more processors being configured to generate the first signal, receive the second signal, and output indicia of the body in response to the second signal. In this system, a wave energy impedance of the tube may be similar to a wave energy impedance of the shaft, and the indicia may include a location of a targeted tissue in the body.

According to this aspect, the shaft may be movably positioned in the tube. A distal end of the shaft may include a tissue penetrating feature. The transducer may be mounted on an exterior surface of the shaft, or within an interior of the shaft. In some aspects, the transducer may include, for example, a cylindrical body extending along a central longitudinal axis, a proximal end opposite of a distal end along the central longitudinal axis, an array of side-looking transducers on the cylindrical body, an array of forward-looking transducers on the distal end, and an array of rearward-looking transducers on the proximal end. The array of forward-looking transducers may be movably mounted to the distal end of the cylindrical body. For example, the array of forward-looking transducers may be rotatable about the central longitudinal axis of the cylindrical body, as may any other array described herein. A lumen may extend through the shaft and the transducer. The array of side-looking transducers may be configured to generate a first wave energy, the array of forward-looking transducers may be configured to generate a second wave energy, and the second wave energy may be more focused than the first wave energy. In some aspects, the wave energy may be acoustic energy. For example, the transducer may include at least one piezoelectric ultrasound transducer, and the first and second signals may be electrical signals.

In other aspects, the indicia may include a graphical representation of the body. The one or more processors may be configured to determine, for example, a condition of the targeted tissue from the indicia. In still other aspects, the or more lumens may include a second lumen, and the system may comprise an elongated tool positioned in the second lumen. For example, the elongated tool may be movably positioned in the second lumen and include a working end composed of a shape-memory material that assumes a pre-determined shape when extended distally out of the second lumen.

Another aspect of this disclosure is a positioning method. An exemplary method may comprise: moving a distal end of a tube into a body passageway, the tube including a lumen extending therethrough and a shaft positioned in the lumen, the shaft having a transducer; sending a first signal to the transducer; passing, with the transducer, in response to the first signal, a wave energy into the body passageway through the tube and the shaft; receiving, with the transducer, a reflected portion of the wave energy; generating, with the transducer, a second signal in response to the reflected portion of the wave energy; and determining, with a processor, an indicia of the body passageway in response to the second signal; identifying, with the indicia, a targeted issue in the body passageway. In some aspects, the method may comprise positioning the distal end of the tube at the targeted tissue in response to the indicia; and removing a portion of the targeted tissue with the distal end of the tube.

According to this aspect, the indicia may include a graphical representation of the body, and the method may comprise determining a location of the targeted tissue with the graphical representation. The method may comprise determining a size of the targeted tissue with the indicia. For example, the wave energy may be acoustic energy, and the method may comprise determining, with the processor, a condition of the targeted tissue based on the reflected portion of the acoustic energy. In other aspects, the indicia may include a boundary of the targeted tissue, and the method may comprise determining, with the processor, whether the distal end of the tube has penetrated the boundary.

Yet another aspect of this disclosure is another positioning method. This method may comprise: moving a distal end of a tube in a lung, the tube including a lumen extending therethrough and a shaft positioned in the lumen, the shaft having a transducer mounted therein; sending and receiving, with the transducer, a wave energy through the tube and the shaft; generating, with a processor, using a reflected portion of the wave energy, indicia of the lung; locating, with the indicia, a lung nodule in the lung; guiding, with the indicia, the distal end of the tube into the lung nodule; and removing a portion of the nodule with the distal end of the tube.

According to this aspect, the method may comprise guiding, with the indicia, a distal end of the shaft towards the lung nodule. For example, the indicia may include a graphical representation of the lung (or a portion of the lung), and the method may comprise identifying, with one or more processors, a location of the lung nodule on the graphical representation. The method may comprise determining, from the indicia, a distance between the distal end of the tube and a proximal surface of the lung nodule. The distal end of the shaft may include a tissue penetrating portion, and the method may comprise: moving the tissue penetrating portion of the shaft into the lung nodule; and determining whether the nodule is solid-filled based upon the reflected portion of wave energy. In some aspects, the distal end of the tube may include a tissue penetrating portion, and the method may comprise: determining whether the density of the lung nodule exceeds a pre-determined maximum density; and moving the tissue penetrating portion of the tube into the nodule if the pre-determined maximum density is exceeded. In still other aspects, the shaft may include an echogenic indicator, and the method may comprise determining a location of the echogenic indicator with the indicia. For example, the shaft may include a central longitudinal axis, the echogenic indicator may be offset from the central longitudinal axis, and the method may comprise determining a rotational position of the shaft with the indicia based on the location of the indicator relative to the central longitudinal axis.

Aspects of a positioning device are also disclosed with reference the methods and systems described above. Numerous exemplary devices, methods, and systems are now described in detail below, each including aspects relating to the use of wave energy as a means for positioning a medical device in a body (e.g., in a lung) to identify and confirm the location of a material in the body (e.g., a tumor in the lung), the material having an impedance distinguishable from healthy tissue of the body (e.g., healthy lung tissue).

It may be understood that both the foregoing summary and the following detailed descriptions are exemplary and explanatory only, neither being restrictive of the inventions claimed below.

DETAILED DESCRIPTION

Aspects of the present disclosure are now described with reference to exemplary positioning devices, methods, and systems. Some aspects are described with reference to a medical procedure (e.g., a lung biopsy), wherein a sensor (e.g., a transducer) is positioned in a body (e.g., in a lung) to identity a targeted tissue in the body (e.g., a solid-filled lung nodule), and guide a needle (e.g., a biopsy needle) toward the targeted tissue. Any reference to a particular procedure, such as a lung biopsy; a particular sensor, such as a transducer; a particular body, such as a lung; or a particular instrument, such as a biopsy needle, is provided for convenience and not intended to limit this disclosure unless claimed. Accordingly, the concepts disclosed herein may be used with any analogous device, method, or system—medical or otherwise.

The directional terms “proximal” and “distal,” and their respective initials “P” and “D,” are used to describe relative components and features of the present disclosure. Proximal refers to a position closer to the exterior of the body or a user, whereas distal refers to a position closer to the interior of the body or further away from the user. Appending the initials P or D to an element number signifies the element's proximal or distal location. Unless claimed, these directional terms and initials are provided for convenience and not intended to limit the present disclosure to a particular direction or orientation. As used herein, the terms “comprises,” “comprising,” or like variation, are intended to cover a non-exclusive inclusion, such that a device or method that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent thereto. Unless stated otherwise, the term “exemplary” is used in the sense of “example” rather than “ideal.”

The relative terms “echogenic” and “anechoic” are used to describe characteristics of certain “materials” in the present disclosure. The term materials may include any organic or non-organic material, including body fluids and tissues. The term echogenic may be attributed to materials with a higher resistance or impedance to a wave energy (also referred to as wave energy impedance), meaning that at least a portion of the wave energy will be reflected off such materials. For example, an echogenic material may produce internal echoes, such as reflections of ultrasound waves. Air and metal, for example, may be considered echogenic materials in some ultrasound applications. The term echogenic may also be used to describe a relative difference between two materials. For example, an internal echo may be produced by a first material (e.g., air) and a second material (e.g., metal) in response to wave energy. If a magnitude of each echo is different, then those materials may be described as echogenic with respect to one another. Conversely, the term anechoic may be attributed to materials with a lower resistance or impedance to wave energy (or low wave energy impedance), meaning that at least a portion of the wave energy will pass through such materials. Healthy lung tissue and certain polymers, for example, may be considered anechoic materials in some ultrasound applications. The term anechoic may also be used to described a relative similarity between two materials. For example, if the magnitude of an echo produced by a first material (e.g., lung tissue) is equal to a magnitude produced by a second material (e.g., a polymer), then those materials may be described as being anechoic with respect to one another. Unless claimed as such, neither of these relative terms, echogenic or anechoic, is intended to be absolute.

The term “indicia” is used in this disclosure to mean any real-time indication of a particular characteristic of a body. One form of indicia is a data model that is generated in response to one or more electrical signals and usable to determine characteristics of the body, such as the location and/or size of a cavity in the body, the location of its boundaries, and the location of a targeted tissue in the cavity. The data model may, for example, be created by an operator or processor, and used by the operator as a real-time guide to position a medical device in the body. Another form of indicia is a two- or three-dimensional graphical representation of the body that is generated in response to the one or more electrical signals, or with the data model. The graphical representation may also be used by the operator as a real-time guide to position a medical device in the body.

One aspect of the present disclosure is an exemplary device10configured to generate indicia of a body. As shown inFIG.1A, device10may comprise a tube20with a lumen22extending therethrough, a shaft40in lumen22, and a transducer50in shaft40. Transducer50may generate a wave energy (e.g., acoustic energy, laser energy, vibratory energy, or the like) that is passed into the body through tube20, shaft40, and/or a fluid (e.g., saline). According to this disclosure, a reflected portion of the wave energy is returned to transducer50from the interior surfaces of the body. Transducer50ofFIGS.1A-Bgenerates an electric signal in response to the reflected portion of the wave energy. This electric signal may, in turn, be used to generate indicia of the body.

Tube20ofFIG.1Ais an elongated element that extends along a central longitudinal axis X-X from a distal end20D. A lumen22extends through tube20in a direction parallel to axis X-X, although tube20may include any number of lumens22extending therethrough. The distal end20D of tube20ofFIG.1Ahas a penetrating feature24configured to penetrate the surfaces of the body. For example, penetrating feature24may be an edge of distal end20D that has been sharpened to remove a portion of tissue from a body when distal end20D is positioned at the tissue and moved in a linear and/or rotational direction relative thereto. The structure and uses for penetrating feature24may include any cutting and/or piercing implementations associated with biopsy needles, including blades, sharpened points, and the like.

Shaft40is an elongated element that extends in a direction parallel to axis X-X. InFIG.1A, shaft40is movably positioned in lumen22. Shaft40may be positioned for translational movement (i.e., movement in a proximal-distal direction along axis X-X) and/or rotational movement (i.e., movement about axis X-X). A distal end40D of shaft40ofFIG.1Aincludes a penetrating feature44configured to penetrate the interior surfaces of the body. Penetrating feature44ofFIG.1includes a distal point that is formed on distal end40D and configured to penetrate tissue when moved out of lumen22in a direction parallel to axis X-X. Any aspect of penetrating feature24of tube20may be used with penetrating feature44of shaft40.

Transducer50ofFIG.1Amay be mounted on, mounted in, or otherwise coupled to shaft40at, for example, a location adjacent distal end40D. As shown, transducer50may include any means for generating and receiving wave energy. For example, transducer50may be configured to: generate one or more wave energies in response to a first electrical signal; receive a reflected portion of the wave energies (if present); and generate a second electrical signal in response thereto. Exemplary wave energies may include acoustic energy, laser energy, and the like, such as those energies typically used for ultrasound, lidar, radar, sonar, and the like. The first and second electrical signals may be modified (e.g., pulsed) according to any existing method so as to maximize the capability of a particular wave energy.

In one aspect, the wave energy is acoustic energy, and transducer50includes at least one array (e.g., a two- or three-dimensional array) of piezoelectric ultrasound transducers configured to generate an ultrasonic wave (e.g., a pulse or train of pulses) in response to the first electrical signal, and generate the second electrical signal in response to a reflected portion of the ultrasonic wave. A frequency of the ultrasound wave may be selected based upon a desired combination of accuracy and depth. For example, if greater accuracy is desired, then a higher frequency may be used; whereas, if greater depth is required, then a lower frequency may be used. In some aspects, the frequency may be approximately 5 MHz or lower; between approximately 5 and 20 MHz; between approximately 10 and 30 MHz; at least 40 MHz; approximately between 20 and 60 MHz; or approximately 60 MHz or lower. Any suitable intermediate and/or comparable frequency values and/or ranges may be used. In some aspects, a plurality of transducers50may used, wherein, responsive to one or more signals, a first portion is configured to optimize accuracy and a second portion is configured to optimize depth.

An exemplary transducer50is illustrated inFIG.1Bas having a cylindrical body52with a distal end52D opposite of a proximal end52P. As shown, an array of forward transducers53is mounted on distal end52D, while an array of side-looking transducers54are mounted on body52, and an array of rearward-looking transducers55is mounted on proximal end52P. Each array53,54, and55may include a plurality of transducers that, individually or in combination, generate the wave energy in response to the first electrical signal, and generate the second electrical signal in response to the reflected portion of the wave energy. Each second electrical signal may be used to generate indicia of the body. Arrays53,54, and55also may be arranged to enhance the indicia. For example, locating forward (53), side (54) and rearward (55) arrays on opposing proximal and distal ends52P and52D of body52may provide for an accurate, three-dimensional representation of the body no matter the proximal-distal location of transducer50relative to tube20, shaft40, and/or an interior surface of the body. Although a cylindrical transducer with forward, side, and rearward-looking transducers is shown inFIG.1B, other suitable shapes and configurations may be used.

Numerous types of indicia may be generated with device10. For example, the second electrical signal from transducer50may be used to generate indicia including geometric data concerning the body, such as the size, shape, and orientation of a cavity in the body. In other aspects, the indicia may further include targeting data concerning the identification and location of a targeted tissue in the body relative to said geometric data. For example, different tissues in the body (e.g., healthy lung or liver tissue versus cancerous lung or liver tissue) may have different wave energy impedances. These differences may be determined from the second electrical signals and used to generate indicia including, in one aspect, a graphical representation of the body that distinguishes between the targeted tissues and other, non-targeted tissues. Using similar comparative methods, the indicia may likewise be used to determine, for example, the relative sizes of each targeted tissue, the density and/or porosity of said tissues, the relative locations of a plurality of said tissues, optimized paths thereto and therebetween, and the like.

Another aspect of the present disclosure is now described with reference to a system100including a device110that, like device10, may be used to generate indicia of a body, depicted as a lung1inFIG.2A. In one aspect, system100is used to perform a biopsy on a lung nodule3in lung1. System100includes a device110that is similar to device10, but within the100series of numbers. For example, device110ofFIG.2A, similar to device10ofFIG.1A, includes a tube120with a lumen122, a shaft140in lumen122, and a transducer150mounted on, in, or otherwise coupled to shaft140. Like reference numbers are used to describe like elements of devices10and110wherever possible. System100further includes a processor160in communication with transducer150.

Tube120ofFIG.2Ahas a distal end120D, a distal end portion121, and a proximal end portion123arranged linearly along a central longitudinal axis X-X. Distal end120D has a penetrating feature124similar to penetrating feature24described above. A lumen122extends through end portions121and123of tube120along axis X-X. At least the distal end portion121may be composed of an anechoic material having a wave energy impedance similar to that of a body tissue and/or a fluid. According to one aspect of system100, the anechoic material is a biocompatible and/or polymeric material (e.g., a polyetheretherketone or PEEK) having an acoustic impedance similar to that of the body tissue and/or fluid. These acoustic impedances be approximately equal, or within a range of approximately 10% to 20% of each other. For example, the polymeric material may have an acoustic impedance proximate to that of a healthy tissue (e.g., a lung tissue having an acoustic impedance of about 1.8×105kg/(M2*s)) and/or biocompatible fluid (e.g., a water-based solution having an acoustic impedance of about 1.52×106kg/(M2*s).

Shaft140is movably positioned in lumen122. A section view of tube120and shaft140is shown inFIG.2C. As shown, for example, an exterior diameter of shaft140is offset from an interior diameter of lumen122to define an annular channel126. Shaft140may be composed of an anechoic material having a wave energy impedance similar to that of the distal end121of tube120and/or the aforementioned fluid. For example, shaft140may be composed of a PEEK tuned to match a body tissue and/or a saline. According to this aspect, the wave energy impedance of tube120, shaft140, and the fluid may render any of those elements fully or partially anechoic. For example, the impedance of tube120and shaft140may be tuned to match the impedance of a body tissue when exposed to a specific type of wave energy. In some aspects, a proximal end portion tube120may be composed of the same anechoic material as distal end portion121of tube120.

Tube120and shaft140may include one or more echogenic markers. For example, as shown inFIG.2A, a first echogenic marker125may separate the distal and proximal end portions121and123of shaft120. First marker125is depicted as a metallic annulus mounted between end portions121and123. A second echogenic marker145may be included on shaft140. For example, as shown inFIGS.2B-C, second echogenic marker145is depicted as one or more metallic strips mounted on shaft140. These first and second markers125and145may, for example, be used individually or in combination to determine the disposition of shaft140relative to tube120. For example, because markers125and145are made of an echogenic material (e.g., a metal), they may be highlighted on a graphical representation generated from the indicia so that a physician may move (e.g., rotate or steer) shaft140by a precise amount (e.g., an incremental distance or angle) relative to tube120, in real-time, by comparing the relative positions of markers125and145.

An exemplary transducer150is depicted inFIGS.2A-C. As shown inFIG.2B, transducer150, like transducer50, may have a cylindrical body with a distal end152D opposite of a proximal end152P. A section view of shaft140and transducer150is depicted inFIG.2C. Shaft140and transducer150ofFIG.2Ccooperate to define a shaft lumen146extending through shaft140in a direction parallel to axis X-X. Similar to above, an array of forward-looking transducers153is mounted on distal end152D, while an array of side-looking transducers154is mounted on body152, and array of rearward-looking transducers155is mounted on proximal end152P. Transducer150may be configured to match the capabilities of transducer50. For example, as above, each array153,154, and155may be configured to generate a wave energy upon application of a first electrical signal, and generate a second electrical signal upon receiving a reflected portion of the wave energy.

The wave energy impedance of tube120and shaft140may determine the location of transducer150. For example, if tube120and shaft140are made of similar anechoic materials (e.g., PEEK), then the distal end portion121of tube120may be used to pierce a body tissue, meaning that transducer150may be located anywhere on or within shaft140and/or tube120because a majority of the wave energy will pass through each element. Alternatively, if distal end portion121of tube120is made of an echogenic material (e.g., stainless steel), then transducer150should be located on a portion of shaft140that is extendable from tube120to expose transducer150, else a majority of the wave energy will not escape tube120.

In system100, the capabilities of transducer150may be modified by shaft lumen146to permit addition of new arrays, sensors, tools, and the like. In some aspects, at least forward-looking array153ofFIG.2Bmay include, for example, a toroidal transducer configured to generate a wave energy that is more intense and/or focused in a direction parallel to axis X-X, thereby improving the quality of indicia generated with system100. In some aspects, the array of side-looking transducers154may be configured to generate a first wave energy, the array of forward-looking transducers155may be configured to generate a second wave energy, and the second wave energy is more focused than the first wave energy, thereby improving the quality of the indicia along axis X-X. Additional arrays may be added to the interior surfaces of lumen146for like effect.

A sensor may be provided in lumen146. For example, a sensor may be placed on an interior surface of lumen146to track the location of shaft140(or marker145) relative to tube120(or marker125) as it passes by said sensor along axis X-X. Other elongated elements, such as a guide wire, an optical cable, or an elongated tool, may be delivered to lung1through shaft lumen146.

A portion of transducer150may be movably mounted in lumen146. For example, as shown inFIG.3, forward-looking array153of transducer150may be a rotational planar transducer that is movably mounted on a distal surface192of a platform190. An actuator194may extend proximally from platform190for receipt in lumen146. Actuator194may be operable in lumen146to move platform190. For example, actuator194may include a motor that is operable with the interior surfaces of lumen146to move platform190, or a portion that extends through lumen146for manual operation by application of force to a proximal end of actuator194. In either instance, forward-looking array153is rotatable about axis X-X to modify the indicia. Similar modifications may be made to side-looking array154and/or rearward-looking array155without departing from this disclosure. For example, each array153,154, and155may be independently rotatable about axis X-X.

Processor160is in communication with transducer150and may include one or more processors that are local (e.g., an element of device10) and/or remote (e.g., an internet connected server) thereto. Any wired or wireless means may be used to facilitate communication between processor160and transducer150. InFIG.2A, for example, a set of conductors162extend between transducer150and processor160. Conductors162may include, for example, at least one conductor162extending between processor160and each array153,154, and155to deliver the first electrical signal from processor160to array153-155; and deliver the second electrical signal from arrays153-155to processor160.

Processor160outputs indicia of lung1in response to the second electrical signals. For example, as illustrated inFIG.2A, the wave energy may be an acoustic energy7, and lung1may include a plurality of air-filled lung nodules2and a plurality of solid-filled lung nodules3. Because the acoustic impedance of each air-filled nodule2may be lower than the acoustic impedance of each solid-filled nodule3, the magnitude of acoustic energy reflected from an air-filled nodule2may be less than the magnitude of acoustic energy reflected from a solid-filled nodule3. These magnitude difference are reflected in the second electrical signals, which may then be analyzed by processor160to output the indicia. To continue the previous example, processor160may use the magnitude of each second electrical signal to generate a graphical representation of lung1, and the respective differences between each magnitude to locate one or more solid-filled lung nodules3on the graphical representation. An operator may, thus, use the representation as a real-time guide to position distal end120D of device110at one of the solid-filled nodules3.

Using other comparative methods, processor160may likewise be used to determine, for example, the size of a particular solid-filled nodule3, the location of a plurality of nodules3in lung1, a condition (e.g., the density) of a particular nodule3, and the like. Still other capabilities may be realized with system100. For example, because each of tube120, shaft140, and the fluid have as similar wave energy impedance, transducer150may be “always-on” because the indicia output by processor160is not affected by the position of shaft140relative to tube120. In this regard, there is no need to position the distal end140D of shaft140at a point distal of the distal end120D of tube120, as shown inFIG.2A. As a further example, because of shaft lumen146, processor160may be in communication with another element extending through lumen146, such as a laser source coupled to an optical fiber that extends through lumen146to direct a wave energy (i.e., laser energy) towards one of the solid-filled nodules3.

Still other aspects of the present disclosure are described with reference to a device210. As shown inFIG.4A, device210, like devices10(FIG.1A) and110(FIG.2A), may be used to generate indicia of a body. Like element numbers are used to describe like components of device210wherever possible, but within the200series of numbers. For example, device210ofFIG.4A, similar to device10ofFIG.1A, includes a tube220with a first lumen222A, a shaft240in first lumen222A, and a transducer250in or on shaft240. In contrast to above, tube220includes a second lumen222B, and an elongated tool280in second lumen222B.

For tube220, first lumen222A extends through tube220along first axis X1-X1, while second lumen222B extends through tube220along a second longitudinal axis X2-X2that is parallel to first longitudinal axis X1-X1. A section view of tube220is provided inFIG.4B. As shown, lumen222A and axis X1-X1are offset from lumen222B and axis X2-X2along a lateral axis Y-Y. Shaft240is movable in first lumen222A relative to axis X1-X1, like shafts40and140described above. Transducer250is mounted in, on, or otherwise coupled to shaft240ofFIG.4Aand configured to generate wave energy and responsive electrical signals like those described for transducers50and150. At least a distal end portion221of tube220and/or shaft240may be composed of an anechoic material with a wave energy impedance similar to a fluid, such as saline. As shown inFIG.4A, the distal end220D of tube220has a penetrating feature224.

Elongated tool280is movable in second lumen222B relative to axis X2-X2in a translational and rotational manner. For example, the distal end220D of tube220may be placed adjacent tissue (e.g., tissue3ofFIG.2A) so that a distal end280D of tool280may be moved distally to engage the tissue. Tool280ofFIG.4Ahas a working end284configured to perform a procedure on the tissue. In one aspect, working end284is composed of a shape-memory metal that forms a pre-determined shape when end284is extended distally from, and thus unrestrained by, lumen222B. The pre-determined shape of end284illustrated inFIG.4Amay position a tip286of working end284adjacent a tissue along an axis transverse to axis X1-X1and/or X2-X2.

All or at least portions of elongated tool280may have a wave energy impedance similar to that of tube220, shaft240, and/or the fluid, allowing the wave energy to pass through each of those elements. If composed of a metal, then working end284may have a different wave energy impedance so that the position of tip286may be determined from the indicia. For example, in a graphical representation generated from the indicia, using the wave energy, working end284and tip286may be distinguishable from the body, a targeted tissue in the body, and the remainder of device210, each of which may have a wave energy impedance different from that of tip286.

Various echogenic markers may be provided on tube220, shaft240, and/or tool280so that the relative locations of these elements may be determined from the indicia.FIG.4A, for example, shows a tube220with a first echogenic marker225separating the distal end portion221of tube220from the remainder of tube220. In one aspect, first marker225is a metal annulus. Shaft240ofFIG.4Aincludes a plurality of second echogenic markers227A-C extending along a length thereof. Either of markers227A-C and287A-C may be a plurality of metal strips spaced apart longitudinally on shaft240or tool280at regular intervals. Accordingly, the indicia may be used to determine a distance between distal end220D of tube220and transducer250by comparing the distance between marker225and one of markers227A-C. An operator may, for example, use the indicia to determine an extension depth for shaft240by comparing, in real-time, the distance between first marker225and one or more of the second markers227A-C.

The operator may also use the indicia to determine a distance between distal end220D of tube220and portions of tool280. As shown inFIG.4A, for example, tool280may include a plurality of third echogenic markers287A-C extending along a length thereof. An operator may, thus, use the indicia to determine an extension depth for tool280by comparing, in real-time, the distance between first marker225and one or more of third markers287A-C. In some aspects, the distance between marker225and one of markers287A-C ofFIG.4Amay be used to determine whether working end284has been extended from second lumen222B and/or assumed its pre-determined shape. For example, a first distance between the distal-most marker287A and the intermediate marker287B may be used to determine whether tip286has been extended out of second lumen222B, while a second distance between intermediate marker287B and the proximal-most marker287C may be used to determine whether working end284has assumed its pre-determined shape. In some aspects, the pre-determined shape of working end284may be configured so that each (e.g., incremental) movement of tool280along axis X2-X2moves tip286by a corresponding (e.g., incremental) amount in a direction transverse to axis X2-X2.

Other aspects of the present disclosure include exemplary methods of using devices10,110, and210. An exemplary method300is shown inFIG.4and now described with reference to device10ofFIGS.1A-B. The illustrated method comprises: preparing device10, which includes tube20, shaft40, and transducer50(310); moving distal end20D of tube20into an body (320); sending a first electrical signal to transducer50(330); passing a wave energy into the body with transducer50in response to the first electrical signal (340); receiving a reflected portion of the wave energy with transducer50(350); generating a second electrical signal in response to the reflected portion of the wave energy (360); and determining indicia of the body with the first and second electrical signals (370). Method300may optionally include positioning, for example, the distal end20D of the tube20in the body in response to the indicia (380).

Preparing device10(310) may include any methods necessary to generate the indicia, such as sterilization, providing power, enabling communications, and the like. Moving distal end20D (320) may likewise include any methods necessary to access the body, including invasive and non-invasive surgical methods, and/or methods of imaging guidance. Sending the first electrical signal to transducer50(330) may be performed by a processor, such as processor160ofFIG.2A. A wave energy may then be generated by transducer50and passed into the body in response to the first electrical signal (340). For example, as described above, transducer50may be a piezoelectric actuator that generates an acoustic wave energy by oscillating in response to the first electrical signal. A reflected portion of the wave energy may be returned to transducer50from the interior surfaces of the body. Thus, method300at350further includes receiving a reflected portion of wave energy with transducer50.

The wave energy may be sent and received through portions of tube20and shaft40. To enhance the indicia, each of tube20and shaft40may have a similar wave energy impedance so that the wave energy may be passed through tube20and shaft40without distortion. For example, moving distal end20D of tube20into a body (320) may further comprise moving shaft40relative to tube20until distal end20D of tube20is distal of distal end40D of shaft40. Because tube20and shaft40share a common wave energy impedance, the quality of any indicia generated from the second electrical signal may be similar no matter the position of distal ends20D and40D.

Generating a second electrical signal in response to the reflected portion of the wave energy (360) may be performed by transducer50. If transducer50includes arrays53,54, and55, as described above, and each array53,54, and55generates a plurality of second electrical signals, then generating the second electrical signal (360) may further comprise combining the plurality of second signals. Determining an indicia of the body with the first and second signals (370) may be performed by a processor that, as described above, analyzes the first and second signals, performs various calculations therewith, and outputs the indicia. These determinations (370) may further include determining a magnitude and/or timing of each second electrical signal, comparing the magnitudes and/or timing of each second signal, and identifying a targeted tissue in the body based upon such comparisons. Similar comparative methods be used to determine, for example, the size of the targeted tissue, the location of a plurality of such tissues, a condition of said tissues (e.g., density or porosity), and the like. Aspects of the wave energy may be varied to support these determinations. For example, method300may further include identifying the boundaries of the body with a first wave energy generated by transducer50, and identifying a targeted tissue in the body with a second wave energy generated by transducer50.

Although not required, method300ofFIG.4may further include positioning distal end20D of the tube20adjacent a targeted tissue in the body (e.g., healthy lung tissue and/or a lung tumor) in response to the indicia (380). Distal end40D of shaft40may be similarly positioned. In some aspects, distal end20D is positioned by a machine in response to indicia including a data model; while in other aspects, distal end20D is positioned by a human in response to indicia including a graphical representation of the body. Distal ends20D and/or40D may be positioned at the targeted tissue in this manner. Method300may further comprise: confirming that distal end20D, for example, is positioned at the targeted tissue, and performing a procedure on the targeted tissue. An exemplary procedure may, for example, including removing shaft40from lumen22, and performing an aspiration biopsy on the targeted tissue.

Aspects of method300may be modified for use with system100. For example, each of tube120and shaft140may have a similar wave energy impedance to the fluid so that the wave energy may be passed through tube120, shaft140, and/or the fluid without distortion. In other aspects of method300, the first electrical signal may be sent by processor160at330, the second electrical signal may be received at processor160at360, and processor160may be used to determine the indicia at370. Because of processor160, any number of additional determination steps may be included in method300, including those described herein. Echogenic markers125and145of system100(FIGS.2Aand C) may also be used with method300. For example, method300at370and380may comprise determining indicia including a distance between distal end120D of tube120and a solid-filled lung nodule3, and moving first echogenic marker125on tube120relative to second echogenic marker145on shaft140by an amount equal to said distance. In other aspects, method300may further include removing shaft140from tube120, and either removing fluid from lung1, or performing an aspiration biopsy on solid-filled lung nodule3.

Still other aspects of method300may be modified for use with device220. For example, positioning the distal end220D of tube220(380) may further include positioning the distal end280D of tool280at the targeted tissue. The indicia determined at370of method300may be used to guide working end284of tool280. For example, method300may further comprise determining a distance between tip286and a targeted tissue, and moving tube220and/or tool280to ensure that tip286will be moved toward the targeted tissue when working end284forms its pre-determined shape. Additional echogenic markers may be placed on tube220and/or tool280to facilitate such movements.

The various aspects of method300may be performed in any order. Moreover, in some aspects, method300may comprise less than all of the described aspects without departing from this disclosure. For example, the aspects of method300at310and/or380ofFIG.4may be omitted. Method300also may be modified to accommodate the various capabilities and structures of devices10,110, and/or210described herein, each possible variation being part of this disclosure.

While principles of the present disclosure are disclosed herein with reference to illustrative aspects for particular applications, the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, aspects, and substitution of equivalents all fall in the scope of the aspects disclosed herein. Accordingly, the present disclosure is not to be considered as limited by the foregoing description.