BIOPSY DEVICES, SYSTEMS, AND METHODS FOR USE

Apparatus, systems, and methods are provided for performing a biopsy within a patient's lung using an access sheath or catheter including a distal portion sized for introduction into an airway of a lung. An ultrasound imaging device is deployable from the distal portion for imaging tissue adjacent the body lumen, and a needle or other biopsy may be advanced from the distal portion into surrounding tissue, e.g., to obtain a tissue sample.

FIELD OF THE INVENTION

The present invention relates to apparatus, systems, and methods for accessing body lumens within a patient's body, e.g., to perform a biopsy, and more particularly to biopsy devices and systems and methods for using such devices to access a patient's lung and/or to perform a biopsy within a patient's lung.

BACKGROUND

Lung cancer is the leading cause of cancer mortality in the United States. Early diagnosis is key: survival rates rise from 17% to 52% if the cancer is detected at an early stage. Until recently, no effective framework for lung cancer screening was in place. However, a recent landmark study showed a dramatic reduction in lung cancer mortality by screening at-risk individuals using low-dose CT scans. These findings prompted the United States Preventative Services Task Force (USPSTF) to recommend annual screening for high-risk individuals.

Lung biopsy is a medical procedure used to obtain a sample of tissue in order to diagnose various diseases. Current methods for obtaining a lung biopsy include surgical procedures, image-guided biopsy or aspiration, or biopsy via a bronchoscope. In many instances, there is a desire to obtain tissue from a specific area of interest in the lungs, for example, within a lung nodule. Current technologies facilitate navigation of a bronchoscope to a region of interest with various degrees of accuracy, but there remain limitations to such procedures. Many limitations are due to the fact that navigation methods utilize fixed computed tomography images, but do not account for real-time variations in functional lung anatomy including normal respiration patterns. In addition, bronchoscopes may have design limitations that limit the size of biopsy and/or imaging instruments that may be introduced because of the relatively small working channel available to introduce instruments through the bronchoscope to an area of interest.

Accordingly, apparatus, systems, and methods that facilitate accessing a patient's lung and/or facilitate performing a biopsy within a lung would be useful.

SUMMARY

The present invention is directed to apparatus, systems, and methods for accessing body lumens within a patient's body, e.g., to perform a biopsy, and more particularly to biopsy devices and systems and methods for using such devices to access a patient's lung and/or to perform a biopsy within a patient's lung. For example, the devices and methods herein may facilitate directing biopsy tools in real-time to an area of interest, e.g., using imaging tools and/or a working channel that allows relatively larger instruments to be introduced into the area of interest.

In an exemplary embodiment, an access sheath or catheter is provided that is configured to fit over at least part of a bronchoscope and/or other guide instrument and that may be introduced through one or more airways within a patient's lung to reach a target location, e.g., within the bronchial tree close to a region of interest, e.g., a target biopsy site. Generally, the sheath includes an elongate tubular member including a proximal end, a distal end sized for introduction into a patient's body, and one or more lumens extending therebetween. In exemplary embodiments, the guide instrument may include one or more locatable guides, e.g., components of electromagnetic navigation systems, radio-opaque wires advanced using fluoroscopic guidance, and/or other navigation systems that may be used to guide the guide instrument to a desired location in the airway.

During use, with the sheath placed over a bronchoscope and/or other guide instrument, the bronchoscope/guide instrument and sheath may be introduced into a patient's lung until a distal portion thereof has reached a desired location in an airway. The bronchoscope and/or guide instrument may then be removed, leaving the sheath in place. In this way, the sheath may serve as a conduit through which other devices or objects of interest may be introduced into the region of interest. The sheath may be substantially rigid, semi-rigid, or flexible along its length, and optionally, may have a variable diameter, e.g., may be folded on itself at one or more regions to accommodate various diameters of the instrument(s) it surrounds.

In another exemplary embodiment, an expandable access sheath is provided that is configured to be introduced through a working channel of a bronchoscope, e.g., in a contracted or collapsed configuration, and deployable within an airway, e.g., in an expanded configuration. This may be achieved in various ways. For example, the sheath may be resiliently biased to a generally cylindrical or other expanded configuration, and may be folded on itself, rolled, and the like to adopt the contracted configuration, e.g., using one or more creases, pleats, folds, weakened regions, and the like to facilitate compressing the sheath. In addition or alternatively, the material of the sheath may be pre-stressed or may include spring or shape-memory materials that expand upon deployment towards the expanded configuration but may be resiliently compressed to the contracted configuration for delivery. In another embodiment, the sheath may be formed from flexible material that may expand in the cross-sectional dimension when an internal portion of the sheath, e.g., an annular wall or lumen, is subjected to increased pressure from a gas or liquid. In still another embodiment, the sheath may include a plurality of support struts that may reorient themselves between the contracted and expanded configurations. For example, the struts may initially be oriented substantially parallel to a longitudinal axis of the sheath to adopt the contracted configuration and, when deployed, transition to be substantially perpendicular to the longitudinal axis and/or peripherally to expand the wall of the sheath towards the expanded configuration.

During use, the sheath may be inserted into the bronchoscope in the contracted configuration before introduction, and the sheath and bronchoscope may be introduced into the patient's body substantially simultaneously. Alternatively, a distal end of the bronchoscope may be introduced first and then a distal portion of the sheath may be advanced through the bronchoscope until disposed adjacent the distal end. The distal portion of the sheath may remain adjacent the distal end of the bronchoscope or it may be advanced beyond the distal end, e.g., into more distal airways within the lung. Such advancement may be guided by any of the navigation methods described herein, if desired, with or without an associated guide instrument. Once the desired position has been reached, the bronchoscope and any associated guide instruments may be withdrawn, leaving the sheath in place. The sheath may automatically expand upon withdrawal of the bronchoscope or may be selectively expanded by the user.

Optionally, the distal portion of the sheath may include one or more anchoring elements to secure the distal portion relative to a desired location in the airway. In an exemplary embodiment, the anchoring element may include a balloon or other expandable member, which may be inflated or otherwise expanded to be in apposition with the airway walls. Optionally, the balloon surface may be smooth or contain various surface variations configured to increase the purchase of the balloon to the airway wall. Such surface variations may include one or more ridges, bumps, or other macro or microscopic patterns. In addition or alternatively, the balloon surface may be coated with an adhesive substance and/or with a viscous or “sticky” liquid. In an alternative embodiment, the anchoring element may include one or more hooks and/or needles, which may or may not be barbed. Such hooks and/or needles may be deployed by slightly retracting the sheath such that the anchoring elements contact the airway wall, or by other mechanical actuators, such as a pull wire, pull string, spring mechanism, and the like. Removal may be achieved through similar mechanisms.

Once deployed, any of the sheaths herein may be used to introduce one or more instruments together, sequentially, or in other combinations, e.g., a desired biopsy device, imaging device, and the like to achieve a desired task. Exemplary instruments may include one or more biopsy forceps, biopsy needles, biopsy brushes, fiber optic cameras, infrared cameras, microscopic visualization devices, other tissue sampling devices, ultrasound imaging devices including radial or convex endobronchial ultrasound (“EBUS”) devices, and optical computed tomography imaging devices.

In an exemplary embodiment, a system may be provided that includes an access sheath or delivery catheter in combination with one or both of a real-time imaging device and a directable biopsy device, which may be deployed near a region of interest in the airway. In an exemplary device, the imaging device may be a radial endobronchial ultrasound (EBUS) probe, and the biopsy device may be a biopsy needle. The sheath may include one or more channels or lumens extending between proximal and distal regions of the sheath, and including one or more ports or outlets in the distal portion. For example, the sheath may include an instrument lumen including a ramped surface adjacent an outlet in the distal portion, e.g., to direct a biopsy device or other instrument deployed from the outlet laterally relative to the sheath, e.g., to a desired location in the lung parenchyma.

In an exemplary embodiment, the biopsy needle is a hollow needle attached to or otherwise carried on a hollow conduit or other shaft that travels through the instrument lumen to a proximal portion of the sheath. The distal end of the shaft may then be attached to a needle for purposes of aspiration during a biopsy procedure. During use, the needle and radial EBUS probe may be rotated by the operator to select the region of interest around the airway. The needle may be made of a flexible material, such as Nitinol, silicone, other flexible plastic or pre-stressed material. The radial EBUS probe includes one or more ultrasound transducers, which may or may not be encapsulated with a balloon, which may be filled with an ultrasound-conductive substance, in order to secure the probe against the airway wall and/or enhance acoustically coupling the transducer(s) with adjacent tissue during a biopsy procedure.

In an alternate embodiment, a catheter may be provided that includes a conduit attached to a needle such that the needle exits from a distal portion of the catheter at a desired angle. During use, a physician or other user of the catheter may control the advancement and retraction of the needle and/or the rotational orientation of the needle. The catheter may include one or more clips or other connectors, which may be used to affix the catheter to an imaging device, such as a radial EBUS probe. The connector(s) may permit rotational motion of the catheter relative to the ultrasound probe or may rotationally fix the catheter and probe to one another.

In yet an alternate embodiment, any of the sheaths or catheters may include a balloon or other expandable member on the distal portion, e.g., proximal to the outlet for the biopsy needle. During use, the balloon may be inflated to isolate a region of the airway, e.g., to permit the distal airway to be filled with ultrasound-conducting fluid, such as water or saline solution, via a lumen of the sheath. When the balloon is inflated, the fluid may be substantially isolated from the rest of the airways. The fluid may be delivered through the same lumen used to deliver other instruments or an additional lumen may be provided in the sheath to deliver the fluid and/or to aspirate air or other fluid within the airway.

For example, in yet another exemplary embodiment, the balloon on the distal portion of the sheath may be used to collapse a segment of the lung by first creating a seal within the airway at the position of the balloon and then applying a suction force to remove air from the region beyond the balloon. The suction may or may not be applied using one of the other lumens, e.g., a working or instrument lumen, or an additional aspiration lumen may be provided in the sheath for this purpose. Such collapse may facilitate biopsy, ablation, cryotherapy, and/or other diagnostic or therapeutic procedure in the collapsed segment of the lung.

In yet another embodiment, a biopsy device is provided that includes a hollow flexible or rigid catheter with real-time imaging capability that includes an imaging device, such as an ultrasound probe. In an exemplary embodiment, the catheter may include a lumen extending between proximal and distal ends of the catheter that contain the electrical wiring for operating the ultrasound probe, and a structural component capable of manipulating the position of the ultrasound probe relative to the catheter. In exemplary embodiments, the lumen may have a variety of cross-sectional shapes, e.g., circular, oval, rectangular, concave, and the like, the lattermost may be configured to match the inner or outer contour of the catheter. Once positioned in an airway adjacent to a region of interest to be sampled, the ultrasound probe may be advanced relative to the catheter. In this way, the catheter may be used to deploy a biopsy instrument to the region of interest to obtain a desired sample under real-time visualization with the ultrasound probe.

In accordance with another embodiment, a biopsy device is provided that includes a hollow flexible or rigid catheter with real-time imaging capability and a biopsy device. In an exemplary embodiment, the catheter may include an instrument lumen extending between proximal and distal ends of the catheter for receiving, positioning, deploying, and/or otherwise manipulating the biopsy device. In exemplary embodiments, the instrument lumen may have a variety of cross-sectional shape, e.g., circular, oval, rectangular, concave, and the like, the lattermost to match the inner or outer contour of the catheter. Once positioned in an airway adjacent to a region of interest to be sampled, the biopsy device may be advanced relative to the catheter. In this way, the catheter may be used to deploy an imaging instrument, such as an ultrasound probe to the region of interest to facilitate real-time visualization of the biopsy device during the sampling process. An exemplary biopsy device may be formed from a shape memory material that deploys to a semi-circular shape to advance into the area of interest.

In accordance with yet another embodiment, a biopsy device is provided that includes a plurality of segments formed from material whose rigidity and/or stiffness may be modified when energy or other modifying force is applied. Such materials include piezoelectric materials, heat-sensitive materials, and/or any other material subject to material property change when electromagnetic energy or other force is applied.

In accordance with still another embodiment, a fiducial marker is provided that includes at least two parts. The first part is an object made of a biocompatible material of sufficient size and firmness to be palpated through a desired segment of tissue. The second is a visible light source of sufficient intensity to permeate a desired segment of tissue.

In one embodiment, the fiducial marker may include a biocompatible metal segment and an LED light source. The LED light source may powered by a battery included with the fiducial marker, of from an alternate power source, including an external power source, which may deliver power to the marker via wired or wirelessly transmitted electromagnetic energy. The light source may only become apparent with the application of external electromagnetic energy to the region of interest.

In accordance with another embodiment, an ultrasound probe is provided that includes at least one transducer which may be configured to operate in at least two dimensions or modes in order to obtain a desired image. For example, the transducer may be operated in a first mode where the transducer is rotated about a central axis in order to produce radial ultrasound image slices. In addition or alternatively, the transducer may be operated in a second mode where the transducer is directed in a cyclic manner axially along the central axis, which, when processed by an algorithm known to one skilled in the art, may produce a two dimensional image of the area of interest. Such a linear image may be used for real-time visualization of, for example, a biopsy device or other instrument, which may be advanced in the same plane as the ultrasound transducer.

When utilizing such an ultrasound device capable of sequentially producing both radial and linear images, the user may wish to select an area of interest on the radial images, to be subsequently visualized using the linear mode. In such cases, the user interface and device functionality may permit the user to mark the area of interest on the radial image. In turn, when switched to linear mode, the ultrasound transducer is aligned with that area of interest thus forming a linear image of the area of interest.

In any of the embodiments described herein, there may be digitally produced guide lines or other indicators, e.g., presented on a display to the user after processing and/or analysis by a controller coupled to the transducer, to assist the user in advancing a biopsy instrument under image-guidance. Such guiding indicators may be produced based on actual or calculated trajectories as by the user or through calculations performed by the device itself.

In accordance with yet another embodiment, a tubular device is provided that includes at least one of an inflatable balloon, a working channel through which a biopsy device or other instrument may be advanced, and an ultrasound transducer. The tubular device may be advanced in an airway to a desired position, and then the balloon may be inflated, e.g., to compress adjacent lung tissue. Such compression may reduce the quantity of air in the tissue, facilitating improved transmission of ultrasound waves and, in turn, image quality. Optionally, the tubular device may include a plurality of balloons, e.g., on different distal branches, which may be advanced into adjacent airways in order to increase the compressive effects.

In accordance with still another embodiment, a sheath is provided that includes at least one of a working channel through which a biopsy device or other instrument may be advanced, and an ultrasound transducer. The sheath, and/or one of its constituent components has a directable terminal segment, whose purpose when actuated is to compress adjacent lung tissue in order to reduce air content and improve ultrasound image quality. The directable terminal portion may be linear, curvilinear, circular, or any other configuration to achieve the desired effect.

In accordance with an exemplary embodiment, a system is provided for performing a procedure within a patient's lung that includes an elongate tubular member including a proximal portion, a distal portion sized for introduction into a body lumen of a lung, and one or more lumens extending between the proximal and distal portions, thereby defining a longitudinal axis. An ultrasound imaging device is deployable from the distal portion for imaging tissue adjacent the body lumen, and an expandable member on the distal portion is configured to expand within the body lumen to isolate a region of the body lumen beyond the distal portion. A source of vacuum may be coupled to the proximal portion and communicating via a lumen of the tubular member with a port in the distal portion for aspirating fluid within region of the body lumen beyond the distal portion to collapse the body lumen around the imaging device.

In accordance with another exemplary embodiment, a method is provided for performing a procedure within a patient's lung that includes introducing a distal portion of an elongate tubular member into a body lumen of a lung; deploying an ultrasound imaging device from the distal portion within the body lumen; expanding an expandable member on the distal portion within the body lumen to isolate a region of the body lumen beyond the distal portion; aspirating fluid within the body lumen via the tubular member to at least partially collapse the body lumen around the imaging device; and activating the imaging device to identify a target tissue site adjacent the body lumen.

In accordance with still another embodiment, a method is provided for performing a procedure within a patient's lung that includes introducing a distal portion of an elongate tubular member into a body lumen of a lung; deploying an ultrasound imaging device from the distal portion within the body lumen; expanding an expandable member on the distal portion within the body lumen to isolate a region of the body lumen beyond the distal portion; delivering acoustic coupling fluid into the region of the body lumen beyond the expandable member via the tubular member; and activating the imaging device to identify a target tissue site adjacent the body lumen, the fluid enhancing acoustic coupling between the imaging device and tissue surrounding the body lumen.

In accordance with yet another embodiment, a method is provided for performing a procedure within a patient's lung that includes introducing a distal portion of an elongate tubular member into a body lumen of a lung; expanding an expandable member on the distal portion within the body lumen to distend a wall of the body lumen and compress lung tissue adjacent the wall to remove air within the tissue; and activating an imaging device within the balloon to acquire images of tissue adjacent the body lumen.

In accordance with another embodiment, a method is provided for performing a procedure within a patient's lung that includes introducing a distal portion of an elongate tubular member into a body lumen of a lung; manipulating the distal portion to position a first leg of the distal portion within a first branch of the body lumen and a second leg of the distal portion within a second branch adjacent the first branch; expanding expandable members on the first and second legs to compress lung tissue between the first and second branches; and activating an imaging device on the first leg to acquire images of the compressed lung tissue.

In accordance with still another embodiment, a method is provided for performing a procedure within a patient's lung that includes introducing a distal portion of an elongate tubular member into a body lumen of a lung; directing the distal portion to a deflected configuration to compress lung tissue adjacent the body lumen; and activating an imaging device on the distal portion to acquire images of the compressed lung tissue.

In accordance with yet another embodiment, a system is provided for accessing a body lumen within a patient's lung that includes a bronchoscope comprising a shaft sized for introduced into a patient's lung and a working channel; and an access sheath comprising a proximal portion, a distal portion, and one or more lumens extending therebetween, at least the distal portion being expandable from a contracted condition sized for introduction into the working channel of the bronchoscope to an expanded condition larger than the shaft.

In accordance with still another embodiment, a system is provided for performing a biopsy within a patient's lung that includes an elongate tubular member comprising a proximal portion, a distal portion sized for introduction into a body lumen of a lung, a central working lumen extending from the proximal portion to an outlet in the distal portion, thereby defining a longitudinal axis, and an accessory lumen disposed adjacent the working lumen; an ultrasound imaging device comprising a shaft slidably disposed within the accessory lumen, and an imaging element carried on a distal end of the shaft, the shaft movable axially between a retracted position wherein the imaging element is at least partially disposed within the working lumen and a deployed position wherein the imaging element is spaced apart from the distal portion of the tubular member; and a needle disposed within the working lumen of the tubular member and comprising a tip that is advanceable from the outlet of the working lumen when the imaging element is spaced apart from the distal portion, wherein the imaging element comprises a ramped proximal surface disposed adjacent to and aligned with the outlet of the working lumen in the deployed position for directing the tip of the needle laterally relative the longitudinal axis when the tip is advanced from the outlet.

Although discussed with particular applicability to accessing and/or performing procedures within a lung, it should be apparent to those skilled in the art that any of the devices, systems, and methods herein may be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels, the gastrointestinal system and constituent digestive tract, the bile and pancreatic duct, the genitourinary system and constituent urethra, bladder, ureters, the nervous system and constituent blood vessels, and the ventricular system.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings,FIGS. 1A-1Dshow an exemplary embodiment of an access sheath or catheter10for accessing a body lumen with a patient's body, e.g., an airway92within the patient's lung90(shown inFIGS. 1C and 1D), e.g., to image tissue, perform a biopsy, and/or other medical procedure. As described elsewhere herein, the sheath10may be part of a system for accessing and/or performing a procedure within the lung90, e.g., including one or more other devices that may be introduced into and/or deployed from the sheath10, such as a biopsy device or instrument20(shown inFIG. 1D) and/or an imaging device (not shown).

As best seen inFIG. 1B, the sheath10generally includes a proximal end or portion12, a distal end or portion14, and one or more lumens16extending therebetween, thereby defining a central longitudinal axis18. For example, the sheath10may include one or more of an instrument or working lumen, an imaging device lumen, an aspiration or infusion lumen, and the like, as described further elsewhere herein.

Generally, the sheath10is formed from material that is sufficiently flexible to allow the sheath10to be placed over a shaft7of a bronchoscope6, as shown inFIG. 1, which may be used to introduce the sheath10into the lung90. Alternatively, the sheath10may have sufficient rigidity, e.g., a semi-rigid or rigid proximal portion and a flexible distal portion, to allow the sheath10to be introduced into the patient's body without the bronchoscope and/or other guide instrument.

As shown inFIG. 1B, optionally, the sheath10may include an elastic band13on the proximal end12, which may be used to secure the sheath10temporarily to the bronchoscope6during delivery. Alternatively, the sheath10may include a handle or hub (not shown) on the proximal end12, which may include one or more side ports (also not shown) communicating with respective lumens16in the sheath10, as described elsewhere herein.

During use, the sheath10may be placed over the shaft7of the bronchoscope6, as shown inFIG. 1A, and the sheath10and bronchoscope6may be introduced into the patient's body together, e.g., using conventional methods. For example, the bronchoscope6may include an imaging element on its distal end (not shown), which may provide direct visualization of the body lumen into which the bronchoscope6is introduced. Once the distal portion14of the sheath10is positioned at a desired location, e.g., within an airway92of the lung90, as shown inFIGS. 1C and 1D, the bronchoscope6may be removed, leaving the sheath10to provide access into the airway92from outside the patient's body.

As shown inFIG. 1D, with the sheath10deployed within the airway92in the desired position, one or more instruments, e.g., a biopsy device20, may be advanced through the sheath10to perform a procedure, e.g., to obtain a tissue sample from an area of interest94adjacent the airway92. Further details and features of exemplary embodiments of sheaths, biopsy devices, imaging device, and systems including such devices are described further elsewhere herein.

Turning toFIGS. 2A-2C, an alternate embodiment of an access sheath110is shown, which may be expandable from a contracted or collapsed configuration, e.g., shown inFIG. 2A, to an expanded configuration, e.g., as shown inFIG. 2C. For example, the sheath110may be configured to be folded, rolled, or otherwise compressed to reduce its cross-sectional dimension in order to allow at least the distal portion114of the sheath110to be introduced through a working channel of the bronchoscope6. Once received in the bronchoscope6, the distal portion114may extend from the shaft7of the bronchoscope6or may be disposed within the working channel, e.g., adjacent the distal end of the shaft7.

For example, during use, the compressed sheath110may be loaded into the working channel of the bronchoscope6and then the bronchoscope6may be introduced into the patient's body, e.g., until the shaft7is positioned at a desired location in the airway92. Alternatively, the bronchoscope6may be introduced first to position the shaft7within the airway92and then the distal portion114of the sheath110may be loaded into the working channel and advanced through the bronchoscope6until disposed within the airway92, e.g., deployed from the shaft7or disposed within the shaft7adjacent the distal end.

The bronchoscope6may then be removed and the sheath110expanded within the airway92, as shown inFIG. 2C. For example, as the bronchoscope6is removed, the distal portion114and then the remainder of the sheath110may resiliently return towards the expanded configuration. Optionally, in the expanded configuration, the sheath110may have a diameter or other maximum outer cross-section larger than the bronchoscope6, which may maximize the available lumen space of the sheath110within the airway92, e.g., for introducing one or more instruments via the sheath110thereafter.

FIGS. 3A-3Cshow exemplary embodiments of expandable sheaths110that may be provided. In each of these embodiments, the sheath110may be directed to the contracted configuration (shown inFIGS. 3A(1),3B(1),3C(1)) yet resiliently biased to return to the expanded configuration (shown inFIGS. 3A(2),3B(2),3C(2) when no longer constrained, e.g., by the bronchoscope6. Optionally, one or more clips, wires, or other constraints (not shown) may be provided to maintain the sheath110in the contracted configuration such that, upon removal of the constraint(s), the sheath110may become biased to expand. Alternatively, the bronchoscope6or other introduction device (not shown) may be sufficient to constrain the sheath110in the contracted configuration during delivery.

For example,FIGS. 3A(1) and3A(2) show an exemplary sheath110ain contracted and expanded configurations, respectively. The sheath110amay be made from flexible material having some degree of shape memory. Along the longitudinal dimension of the sheath110a, a crease111amay be provided that facilitates folding the sheath110ainto itself, e.g., while maintaining a roughly circular shape in the contracted configuration and facilitating advancement through the working channel of the bronchoscope6. Once no longer constrained by the working channel of the bronchoscope6(or by any constraints to maintain the compressed shape), the sheath110aautomatically deploys to its fully expanded configuration, e.g., with the residual crease111apossibly remaining visible along its length, e.g., substantially parallel to the longitudinal axis118aof the sheath110a.

FIGS. 3B(1) and3B(2) show another exemplary sheath110bmade from material having some degree of shape memory, having a total of six (6) creases111b, which when folded, e.g., in alternating fashion, permit the sheath110bto assume its contracted configuration that facilitates passage through the bronchoscopy6or other device designed to position the sheath110bin the desired location. Once no longer constrained by the working channel of the bronchoscope6, (or other constraint(s)), the sheath110bresiliently expands towards the expanded configuration, thereby providing an increased cross-sectional dimension. The creases111bmay remain visible along the length of the sheath110b, e.g., as shown inFIG. 3B(2).

FIGS. 3C(1) and3C(2) show yet another exemplary sheath110C, which includes a shape memory frame, e.g., formed from Nitinol or other elastic or superelastic material. In the embodiment shown, the frame111cincludes four longitudinal struts113c(although optionally other numbers of struts may be provided), e.g., joined by several transverse connectors115c, e.g., spaced apart from one another along the length of the sheath110c.

The frame111cmay be entirely covered around the periphery of the sheath110cwith a membrane117c, e.g., formed from relatively thin plastic or other polymer, fabric, and/or other flexible material. In the contracted configuration, the transverse connectors115cmay extend substantially parallel or near-parallel to the longitudinal struts113c. Optionally, the sheath110cmay be rolled, folded, or otherwise compressed further along its longitudinal axis or otherwise modified or folded to further reduce the outer profile of the sheath110cin the contracted configuration. Upon being deployed or released, the frame111cmay resiliently return towards its original expanded configuration, thereby opening the membrane117cto provide one or more lumens extending along the sheath110c.

Turning toFIGS. 4A and 4B, a distal portion214of another exemplary embodiment of an access sheath or catheter210is shown that includes a pair of channels or lumens216that extend from the proximal end of the catheter210to respective ports or outlets217in the distal portion214. Each lumen216may communicate with a hub on the proximal end (not shown), e.g., including a port allowing a corresponding device to be inserted into (and removed from) the lumen216and advanced, e.g., until deployed from the outlet217. Alternatively, each lumen216may communicate to an actuator on a hub or handle on the proximal end (also not shown) such that the actuator may be used to deploy or retract the device disposed within the lumen216.

The first or imaging lumen216ais sized to receive an ultrasound probe or other real-time imaging instrument240, while the second or working lumen216bis sized to receive a needle or other biopsy device220, e.g., as shown inFIG. 4B. As shown, the first lumen216amay be disposed concentrically relative to the central longitudinal axis218of the distal portion214, e.g., such that the outlet217ais aligned with the central axis218and the imaging instrument240is substantially centered when deployed from the distal portion214.

The second lumen216bmay extend adjacent to the first lumen216a, e.g., offset from the central axis218, and the outlet217bmay be located on a side wall of the distal portion214. The second lumen216bmay include a ramped surface219badjacent the outlet217b, e.g., such that the second lumen216bchanges direction at a specific angle relative to the central axis218. Thus, a biopsy device220deployed from the outlet217bmay extend laterally relative to the central axis218and the distal portion214. The catheter210may be manufactured with various angulations to achieve the desired directionality of the biopsy device220when deployed.

Similar to other embodiments herein, the catheter210may be substantially rigid, semi-rigid, or flexible, e.g., having a variable rigidity along its length, e.g., being more rigid at the proximal portion to facilitate advancement, rotation, and/or other manipulation of the distal portion214from outside the patient's body, and being flexible at the distal portion214to facilitate introduction through tortuous anatomy. Optionally, the distal portion214may be biased to a predetermined shape, e.g., a simple curve or other curvilinear shape, yet may be resiliently deflected towards other shapes, e.g., to adopt the shape of a bronchoscope or other guide instrument used to deliver the catheter210and/or to facilitate introduction of the catheter210independent of a guide instrument, if desired.

With reference toFIG. 4B, during use, the distal portion214may be positioned within an airway or other body lumen92, e.g., in conjunction with a bronchoscope or other guide instrument (not shown), similar to other embodiments herein. Once positioned at a desired location, an imaging device240, e.g., a radial EBUS probe, may be inserted into the first lumen216aand deployed from the outlet217ainto the body lumen92. The imaging device240may be activated and manipulated, e.g., axially relative to the distal portion214, to best visualize the area of interest. Optionally, the imaging device240may be rotatable relative to the distal portion214, e.g., if the imaging device240is directional or the entire distal portion214may be rotated to direct the imaging device240.

Once a target site94is identified, e.g., for biopsy, a biopsy device, e.g., biopsy needle220, may be deployed from the outlet217bof the second lumen216b. For example, using real-time images from the imaging device240, the distal portion214may be rotated and/or directed axially to align the target site94with the outlet217bof the second lumen216b. The biopsy needle220may be introduced into the second lumen216b, e.g., via a port on the proximal end (not shown), before or after positioning the distal portion214. By moving the catheter210and biopsy device220axially relative to each other and relative to the airway92and area of interest94, the needle220may be situated such that the needle220enters the area of interest (407) when advanced from the outlet217bthrough the wall of the airway92. Similarly, the distal portion214of the catheter210may be rotated about the central axis218to further direct the needle220towards the area of interest94.

Optionally, the imaging device240may include a processor and display (not shown), e.g., a radial EBUS system, and the processor may analyze the images acquired by the imaging device240to present one or more markers on the display to indicate the location, direction, and/or orientation of the needle220with respect to the area of interest94. Thus, the catheter210may be used to perform a biopsy or otherwise acquire a sample of tissue from the area of interest94using the needle220, which may then be analyzed to aid in diagnosis and/or treatment of the patient.

Optionally, one or more balloons or other expandable members may be provided on one or more components of the system to facilitate performing a biopsy or other procedure. For example,FIGS. 5A and 5Bshow an alternative embodiment of a catheter210′ generally similar to the catheter210shown inFIGS. 4A and 4B. For example, the catheter210′ generally includes a proximal portion (not shown), a distal portion214′ sized for introduction into a patient's body, and a plurality of channels or lumens216′ that extend from the proximal end of the catheter210′ to respective ports or outlets217′ in the distal portion214.′ The first or imaging lumen216a′ is sized to receive an ultrasound probe or other real-time imaging instrument240,′ while the second or working lumen216b′ is sized to receive a needle or other biopsy device220,′ e.g., as shown inFIG. 5B.

In addition, the catheter210′ includes a balloon or other expandable member230′ on the distal portion214,′ e.g., proximal to the outlet217b′ of the working lumen216b.′ The catheter210′ may include an inflation lumen216c′ extending from a port on the proximal end (not shown) to a side port217c′ communicating with an interior of the balloon230,′ as shown inFIG. 5A, e.g., for inflating and/or collapsing the balloon230.′ The balloon230′ may include an annular membrane and the like, e.g., formed from compliant or semi-compliant material, and attached at its ends to the distal portion214,′ e.g., by bonding with adhesive, sonic welding, fusing, and the like.

The balloon230′ may be expanded within an airway92or other body lumen, e.g., as shown inFIG. 5B, to substantially fix the distal portion214′ within the airway92. For example, the balloon230′ may be expanded after positioning the distal portion214′ to orient the outlet217b′ towards the area of interest92, e.g., based on images from the imaging device240,′ before deploying the needle220′ into the area of interest94to prevent migration of the distal portion214′ during deployment, e.g., similar to the procedures described with reference to the catheter210shown inFIGS. 4A and 4B.

In addition or alternatively, the balloon230′ may substantially isolate the region of the airway92beyond the balloon230′ and/or beyond the distal portion214,′ e.g., from the region of the airway92proximal to the balloon214.′ For example, with the balloon214′ inflated, one or more fluids, e.g., water, saline solution, and/or other ultrasound conductive fluid, may be injected into the region beyond the balloon214′ to enhance acoustically coupling the imaging device240′ to tissue surrounding the airway92. Optionally, one or more other compounds, e.g., sclerosing material, may be injected into the region in addition to or instead of ultrasound conductive fluid. Such fluid(s) may be injected through one of the first and second lumens217′ or through a dedicated infusion lumen having one or more outlet ports (not shown) on the distal portion214.′

In addition or alternatively, fluid within the region of the airway92beyond the balloon230′ may be aspirated using the catheter214.′ For example, with the balloon230′ substantially isolating the region, a suction force may be applied to the region of the airway92, e.g., using a source of vacuum (not shown) coupled to the proximal end of the catheter214′ and one of the lumens216,′ to at least partially collapse the airway92and/or the surrounding tissue, which may enhance acoustically coupling the imaging device240′ to the surrounding tissue.

Optionally, as shown inFIG. 5B, the imaging device240′ may also include a balloon or other expandable member246,′ which may be expanded when the imaging device240′ is deployed from the distal portion214.′ The balloon246′ may be used to substantially fix the imaging device240′ and/or substantially center the imaging device240′ relative to the airway92, e.g., while allowing the catheter214′ to be manipulated further before deploying the needle device220′ into the area of interest94.

It should be noted that these exemplary embodiments of the catheter210,210′ and associated devices may be introduced into an airway92to access adjacent parenchyma. However, such catheters may also be used to access an area of interest in any area of the body that is adjacent to a lumen, for example, a lumen within the gastrointestinal system, biliary system, pancreas, and cardiovascular system.

Turning toFIGS. 6A and 6B, an exemplary biopsy needle device320is shown that may be used in cooperation with any of the embodiments of catheters and access sheaths described elsewhere herein. Generally, the needle device320includes a catheter or other elongate member including a proximal end (not shown) and a distal portion324sized for introduction through a working or instrument lumen of an access sheath (not shown). The distal portion324may carry a needle325that terminates in a pointed, beveled, and/or other sharpened tip. The external surface of the distal portion324of the needle325may be smooth. However, the interior region of the needle325is hollow and the interior surface includes one or more helical threads327. The thread(s)327may be configured such that, when a simultaneous forward and rotational force is applied to the distal portion324, the needle325may be advanced into an area of interest (not shown), thereby directing tissue from the area of interest into the hollow region engaging the thread(s)327. The needle325may then be withdrawn, e.g., by directing the distal portion324by pulling proximally from the proximal end without rotation, thereby separating the tissue within the hollow region of the needle325from the area of interest with the internal thread(s)327retaining the tissue to remain in situ during the removal process.

The needle325may be relatively short compared to the catheter, e.g., having a length between about two and fifty millimeters, which may facilitate advancing the needle device320through the access sheath, even if oriented in a sharply curving shape through body lumens of the patient's body, without substantial risk of skiving, catching, or otherwise damaging the lumen wall of the access sheath. Optionally, multiple needle devices may be inserted into the access sheath, used to acquire tissue sample, and removed sequentially, e.g., to obtain multiple samples using the same access sheath at the same or different locations.

Turning toFIG. 7, another exemplary embodiment of a catheter310is shown that generally includes a proximal end (not shown), a distal portion314sized for introduction into a body lumen, and a pair of lumens216extending therebetween, similar to other embodiments herein. For example, a first lumen316amay extend along the distal portion314to an outlet317agenerally aligned with a central longitudinal axis318of the catheter310, e.g., for deploying a real-time imaging instrument such as endobronchial ultrasound or other imaging device (not shown). A second lumen316bis also provided within the distal portion314that may be located near the outer circumference of the catheter310and terminates at an outlet317bin a side wall of the distal portion314, e.g., for receiving a biopsy device (not shown). At least a portion of the second lumen316bhas a helical shape, e.g., within the distal portion314and may transition to an axial orientation proximal to the distal portion314. In this configuration, a needle or other biopsy device introduced through the second lumen316bmay be deployed laterally relative to the central axis318and may also extend diagonally.

During use, as shown inFIG. 8, the distal portion314may be positioned within an airway or other body lumen92adjacent to an area of interest94, similar to other embodiments herein. A radial EBUS probe or other imaging device340may be deployed from the first lumen into the airway92, e.g., to obtain images of the tissue surrounding the airway92. A biopsy needle device320′ may be introduced into the second lumen316b, which may include a distal portion324′ having a curvature that matches that of the helical region of the second lumen316b. The distal portion324′ may be coupled to a flexible catheter or other elongate member (not shown) that extends through the catheter310to the proximal end. The needle device320′ may thus be advanced under real-time visualization of the EBUS probe340into the area of interest94. Optionally, the needle device320′ and/or imaging device340may include features similar to other embodiments herein.

Turning toFIGS. 9A-9C, another exemplary embodiment of a biopsy device420is shown that may be delivered using any of the access sheaths, catheters, and systems herein to perform a biopsy, e.g., within a patient's lung or other tissue. Generally, the biopsy device420includes a catheter or other elongate shaft422including a proximal portion (not shown), a distal portion424sized for introduction through a lumen of an access sheath, and an expandable capture structure430carried on the distal portion424, which is movable between a compressed configuration (shown inFIG. 9A) intended to advance the distal portion424at least partially into an area of interest within a tissue structure and a deployed configuration (shown inFIG. 9B) intended to capture a tissue sample from the area of interest. The distal portion424may terminate in a pointed, beveled, or other sharpened tip425to facilitate puncturing through tissue.

As shown inFIGS. 9A and 9B, the capture structure430includes a plurality of struts432including first ends432aattached to or otherwise coupled to the distal portion424and second free ends432b, and a sheeting material or membrane434carried by the struts432. Although four struts432are shown, the capture structure430may include two, three, or more struts, as desired. The struts432may be formed from elastic, superelastic, and/or shape memory material, e.g., Nitinol, such that the free ends432bof the struts432are biased to the deployed configuration shown inFIG. 9B, yet resiliently compressed inwardly towards the distal portion424to the compressed configuration.

As shown inFIG. 9B, with the struts432in the deployed configuration, the membrane434may be opened to define an open proximal end434aand a closed distal end434badjacent the distal tip425. The membrane may be formed from a variety of materials, e.g., biocompatible plastic, fabric, and the like, which may be nonporous or porous. In an alternative embodiment, if sufficient numbers of struts are provided, the membrane may be omitted and/or a mesh or other porous structure may be carried by the struts to capture tissue within the capture structure430.

Optionally, the capture structure430may include one or more actuator elements, e.g., to facilitate collapsing the capture structure430after capturing a tissue sample. For example, as shown inFIGS. 9B and 9C, a plurality of flexible or rigid wires, strings, or other filaments436may be coupled to the free ends432bof the struts432that enter one or more openings438in the distal portion424and extend through a lumen426to the proximal end of the biopsy device420.

Turning toFIGS. 10A-10D, an exemplary method is shown for using the biopsy device420ofFIGS. 9A-9C, e.g., to obtain a tissue sample within lung tissue94adjacent an airway92. The distal portion424of the biopsy device420may be loaded into an access sheath, catheter, or other delivery device (not shown), e.g., within the biopsy lumen216bof the catheter210shown inFIGS. 4A-4B, with the capture structure430in the compressed configuration shown inFIG. 10A. After positioning the delivery device within the airway adjacent an area of interest, e.g., using ultrasound imaging and/or other guidance (e.g., similar to the methods used to position and/or orient the outlet217bof the catheter210shown inFIGS. 4A-4Btowards the area of interest94), the distal portion424may be deployed from the delivery device, e.g., laterally into the area of interest94, by advancing the proximal end of the biopsy device420from outside the patient's body. The sharpened distal tip425may facilitate easy advancement into the tissue of the area of interest94with the capture structure430remaining substantially in the compressed configuration, as shown inFIG. 10A.

Turning toFIG. 10B, once the capture structure430is fully inserted into the tissue94, the capture structure430may be deployed by partially retracting the capture structure430within the area of interest94. This action may cause the free ends432bof the struts432to engage tissue and move outwardly relative to the distal portion424, thereby expanding the membrane434as shown. Optionally, the expansion and/or other manipulation of the capture structure430may be monitored, e.g., using an imaging device within the airway92and/or using external imaging, e.g., fluoroscopy, ultrasound, MRI, and the like, to ensure that the membrane434expands and target tissue is located between the open proximal end434aand the airway92.

As shown inFIG. 10C, the capture structure430may then be closed around the captured tissue, e.g., by pulling the control filaments436to draw the free ends432bof the struts432inwardly and close the membrane434around the captured tissue. As shown inFIG. 10D, the closed capture structure430may then be retracted out of the area of interest94, e.g., back into the lumen of the delivery device and removed from the patient's body.

Turning toFIGS. 11A and 11B, another exemplary embodiment of a biopsy device520is shown that includes a shaft522including a proximal end (not shown) and a distal portion524that terminates in a needle tip525. The shaft522may be formed from a plurality of segments coupled sequentially to one another such that a rigidity of the shaft522may be selectively modified, e.g., using piezoelectric principles. As shown, the shaft522includes several segments522amade from piezoelectric material, with adjacent segments separated by layers of insulating material522b. A plurality of wires or other conductive elements527, e.g., positive wires527aand negative wires527bmay be coupled to each segment, which may be used to selectively apply current to respective segments to modify their material properties when desired.

As shown inFIG. 11B, during use, an access sheath, catheter, or other delivery device510(shown in phantom) may be introduced into an airway92, similar to other embodiments herein, that includes a working channel or lumen516including a ramped surface519, e.g., defining a right angle, adjacent an outlet517through which the biopsy device520may pass. With the segments522adisposed within the working lumen516, no current is applied, e.g., such that the segments522aare in a relatively flexible or semi-rigid state relative to one another, which may facilitate advancing the distal portion524through the delivery device (particularly if the delivery device has several bends from being introduced through tortuous anatomy). As each segment522aadvances around the ramped surface519, electric current may be applied to the segments522a, thereby causing the segments522ato become substantially rigid relative to one another. Thus, the distal portion524of the biopsy device520that exits the outlet517may adopt a substantially rigid state, allowing the needle tip525to be penetrated into tissue and/or otherwise directed into an area of interest without risk of buckling, e.g., to obtain a tissue sample within a recess within the needle tip525.

When the distal portion524is retracted back into the working lumen516, electric current may be removed from the segments522aas they enter the lumen516, thereby returning the segments522ato a flexible or semi-rigid state. A variety of mechanisms and systems may be used to determine the sequence and timing of applying electric current to each segment. For example, a controller, e.g., in a handle in the proximal end (not shown) of the biopsy device520or otherwise disposed externally to the patient, may be coupled to the wires527to selectively apply current to desired segments522automatically, e.g., in response to one or more position sensors or other feedback elements in the delivery device510, e.g., adjacent the outlet517or ramped surface519, that indicate when individual segments exit or enter the outlet517or are adjacent the ramped surface519. Alternatively, with relative lengths known, the controller may activate the segments based on the extent and/or time that the biopsy device is inserted into the delivery device. In a further alternative, the user may manually activate desired segments to provide desired rigidity to the shaft522.

Turning toFIG. 12, an exemplary embodiment of a fiducial marker580is shown that may be used in conjunction with any of the systems and methods herein. Generally, the fiducial marker580includes a rigid component582, e.g., a shaft configured to be palpated through a desired portion of tissue, and a light source584coupled to the shaft582. In one embodiment, the shaft582may include a biocompatible metal segment and the light source584may be an LED light source configured to emit visible light. The light source582may be powered by a battery or other power source (not shown) within the marker580, or alternately by an external power source, which may deliver power to the marker580wirelessly, e.g., using an external induction device (not shown), or by an external wired power source. For example, the light source584may be selectively activated by placing an external electromagnetic energy source adjacent to a tissue region within which the marker580has been implanted, e.g., using conventional devices and methods.

Turning toFIGS. 13A-13C, another exemplary embodiment of a system608for imaging and/or performing a biopsy within a patient's lung or other region is shown that includes an access sheath or catheter610, a biopsy device620, and an imaging device640, which may be constructed similar to other embodiments herein. Generally, the catheter610includes a proximal end or portion (not shown), a distal end or portion614, and one or more channels or lumens616extending from the proximal end to the distal portion614. For example, the catheter610may include a working lumen616bcommunicating with an outlet617bsized to receive a needle or other biopsy device620, e.g., as shown inFIG. 13C, which may be similar to any of the biopsy devices described elsewhere herein.

The imaging device640generally includes a shaft642including a proximal end, e.g., within the proximal end of the catheter610(not shown), and a distal end644carrying an imaging element650, e.g., including one or more piezoelectric transducers or other ultrasound imaging elements (not shown) within a housing. The shaft642may include one or more lumens or other regions that contain one or more wires or other conductive elements and/or components (also not shown) needed to operate the imaging element650.

The shaft642may be slidably disposed within an imaging lumen616a, which may be relatively small compared to the working lumen616b, such that the imaging element650may be movable between a proximal or retracted position (shown inFIG. 13A) and a distal or deployed position (shown inFIGS. 13B and 13C). In the retracted position, the imaging element650may be at least partially received within the working lumen616a(e.g., as shown inFIG. 13A), e.g., to provide a transition for introduction of the distal portion614, while in the deployed position, the imaging element650may be spaced apart from a distal tip615, e.g., to provide a ramped surface619adjacent the outlet617bof the working lumen616b.

During use, the distal portion614of the catheter610may be introduced into a patient's body, e.g., into an airway in a lung (not shown), similar to other embodiments herein, but with the imaging element650in the retracted position shown inFIG. 13A. Optionally, the imaging device640may include a rounded or other substantially atraumatic tip (not shown), which may facilitate introduction of the catheter610. Once positioned within a desired airway or other body lumen, the imaging element650may be deployed, as shown inFIG. 13B, and activated as desired, e.g., to provide real-time imaging to facilitate positioning the imaging element650and/or the ramped surface619adjacent an area of interest (not shown). Thus, the distal portion614of the catheter610and/or imaging element650may be manipulated axially and/or rotated as desired, e.g., to image an area of interest and/or direct the ramped surface619towards the area of interest.

Once positioned as desired, a biopsy device, e.g., a needle device620, may be deployed from the working lumen616bout the outlet617b. As shown inFIG. 13C, as the tip625of the needle device620exits the outlet617b, the tip625may slidably contact the ramped surface619, thereby deflecting the tip625and directed the needle device620laterally relative to the catheter610. For example, the needle device620may be introduced into the catheter610, advanced from the outlet617binto an area of interest adjacent the airway to perform a biopsy, similar to other embodiments herein.

Turning toFIGS. 14A-14C, still another embodiment of a system708for imaging and/or performing a biopsy within a patient's lung or other region is shown that includes an access sheath or catheter710, a biopsy device720, and an imaging device740, which may be constructed similar to other embodiments herein. Generally, the catheter710includes a proximal end or portion (not shown), a distal end or portion714, and one or more channels or lumens716extending from the proximal end to the distal portion714. For example, the catheter710may include a working lumen716bsized to receive the imaging device740, which may be generally aligned with a central axis of the catheter710e.g., as shown inFIG. 14C.

The biopsy device720generally includes a shaft722including a proximal end, e.g., within the proximal end of the catheter710(not shown), and a distal end724carrying a biopsy element, e.g., a set of forceps728. The shaft722may include one or more lumens or other regions that contain one or more rods, wires or other actuator elements and/or components (also not shown) for operating the forceps728.

The shaft722may be slidably disposed within an accessory lumen716a, which may be relatively small compared to the working lumen716b, such that the forceps728may be movable between a proximal or retracted position (shown inFIG. 14A) and a distal or deployed position (shown inFIGS. 14B and 14C). In the retracted position, the forceps728may be at least partially received within the working lumen716b(e.g., as shown inFIG. 13A), e.g., to provide a transition for introduction of the distal portion714, while in the deployed position, the forceps728may be spaced apart from a distal tip715.

During use, the distal portion714of the catheter710may be introduced into a patient's body, e.g., into an airway in a lung (not shown), similar to other embodiments herein, but with the forceps728in the retracted position shown inFIG. 14A. Optionally, the forceps728may include rounded or other substantially atraumatic tips (not shown), which may facilitate introduction of the catheter710. Once positioned within a desired airway or other body lumen, the forceps728may be deployed, as shown inFIG. 14B.

The imaging device740may then be deployed from the working lumen716b, e.g., to provide real-time imaging to facilitate positioning the forceps728during a procedure. For example, one or more of the distal portion714of the catheter710, the forceps728, and/or imaging device740may be manipulated axially and/or rotated as desired, e.g., individually or together, to image an area of interest and/or direct the forceps728to an area of interest adjacent the airway to perform a biopsy, similar to other embodiments herein.

Turning toFIGS. 15A and 15B, an exemplary embodiment of an ultrasound imaging device840is shown, which may be used in conjunction with any of the systems and methods herein, e.g., for imaging within an airway or other body lumen92. Generally, the imaging device840includes a shaft or other elongate member842including a proximal end (not shown), and a distal end844carrying one or more imaging elements, e.g., an ultrasound transducer850oriented to acquire images laterally, e.g., substantially perpendicular to a longitudinal axis of the shaft842. The shaft842may be sufficiently flexible to facilitate introduction into the airway92, e.g., via an access sheath, catheter, or other delivery device (not shown), and have sufficient column and torsional strength such that torsional and linear forces (e.g., as represented by arrows852and856) may be transmitted to the distal end844from the proximal end.

The imaging device840may be coupled to a controller, e.g., at the proximal end (not shown), which may be used to activate the transducer850in one of two modes of operation. For example, in a first mode, a rotational force852may be applied to the shaft842to rotate the transducer850and acquire radial ultrasound images, e.g., within an image slice plane854shown inFIG. 15A. In a second mode, the rotational force852may be stopped and an axial force856may be applied to direct the shaft842proximally and distally, e.g., to move the transducer850back and forth axially within the airway92and acquire linear ultrasound images, e.g., along a desired two-dimensional linear axis858shown inFIG. 15B.

In an exemplary method, a user may manipulate the imaging device840while the transducer850is rotating to localize a region of interest, e.g., to acquire annular image slices of a tissue region adjacent the airway92. Once the region is identified, the transducer850may be used to acquire images in the second, linear mode, e.g., to acquire linear or axial wedge-shaped images more suitable for real-time visualization of a biopsy device (not shown) being directed into the region.

Turning toFIGS. 16A and 16B, another exemplary embodiment of an ultrasound imaging device940is shown that may be introduced into an airway92within a lung90, e.g., to image tissue adjacent the airway92, similar to other embodiments herein. Generally, the imaging device940includes a shaft or other elongate member942including a proximal end (not shown), a distal end or portion944sized for introduction into a body lumen, and an imaging transducer950carried on the distal portion944. In addition, the distal portion944carries a balloon952thereon, e.g., surrounding the transducer950, which may be used to compress tissue adjacent the body lumen and/or otherwise enhance imaging. The balloon952may be formed from compliant material, e.g., such that the size of the balloon952expands in proportion to the amount of fluid introduced into the balloon952and/or conforms to surrounding anatomy. Alternatively, the balloon952may be formed from semi-compliant or non-compliant material, e.g., such that the balloon952expands to a predetermined size and/or shape. A source of inflation media, e.g., an acoustic-coupling fluid (not shown), may be coupled to the proximal end of the imaging device940and communicate via a lumen (also not shown) with an interior of the balloon952.

During use, the distal portion944may be introduced into an airway92with the balloon952collapsed, e.g., similar to other embodiments herein, until the transducer950is disposed adjacent to aerated lung tissue96. The balloon952may then be inflated, e.g., with an acoustic-coupling fluid, until the balloon952distends the wall of the airway92, thereby compressing the adjacent lung tissue96and reducing the air content within the tissue, which may improve the quality of ultrasound images of the lung tissue96obtained using the transducer950.

FIGS. 16C and 16Dshow an alternative embodiment of an ultrasound imaging device940′ that includes a shaft or other elongate member942′ including a proximal end (not shown) and a distal portion that includes a first leg944a′ and a second leg944b,′ with each leg944′ carrying a balloon952.′ The second leg944b′ may also include an imaging transducer950,′ e.g., within an interior of the second balloon952b.′ During use, the first and second legs944′ may be introduced into the patient's body together with the balloons952′ collapsed, e.g., using an access sheath, catheter, or other delivery device, similar to other embodiments herein. The legs944′ may then be directed into adjacent branches of the airway92, e.g., using separate stylets, guidewires, or other guide instruments (not shown), such that the balloons952′ are disposed generally on opposite sides of a tissue region96. The balloons952′ may then be inflated, e.g., with an acoustic-coupling fluid, until the balloons952′ distend the wall of the airway92and/or compress the lung tissue96between the branches, e.g., to reduce air content within the tissue, which again may improve the quality of ultrasound images of the lung tissue96obtained using the transducer950′ carried on the second leg944b.′

Turning toFIGS. 17A and 17B, yet another exemplary embodiment of an imaging device940″ is shown that may be introduced into an airway92adjacent to aerated lung tissue96. Generally, the imaging device940″ includes a shaft942″ including a proximal end (not shown) and a distal portion944″ carrying an imaging element950,″ e.g., similar to other embodiments herein. Unlike other embodiments, the distal portion944″ may be steerable or otherwise directable between one or more shapes. For example, in a relaxed, straightened, or other first state, the distal portion944″ may be introduced into the airway92, e.g., using similar methods to other embodiments herein, and the imaging element950″ may be positioned adjacent an area of interest adjacent the airway92, e.g., including aerated lung tissue96.

As shown inFIG. 17B, the distal portion944″ may then be directed to a curved, bent, deflected, or other second state, thereby distorting a portion93of the airway92and compressing the adjacent lung tissue96to reduce the air content and improve ultrasound image quality. In an exemplary embodiment, the imaging device940″ may include one or more steering wires, cables, or other elements (not shown) that are slidably received within a lumen in the distal portion944″ and coupled adjacent the distal tip945″ such that actuation of the steering element(s) causes the distal portion944″ to bend to a desired shape. In another embodiment, a stylet or other pre-shaped member, e.g., having a bent, curved, or other pre-shaped distal region, may be inserted into a lumen of the imaging device940″ and advanced into the distal portion944″ to cause the distal portion944″ to at least partially adopt the shape of the stylet.

In a further alternative, the distal portion944″ may be biased to a bent, curved, or other deflected shape, and a stylet or other guide member may be inserted into the imaging device940″ to at least partially straighten the distal portion944″ and/or otherwise facilitate introduction of the distal portion944″ into the airway92. Once positioned as desired, the stylet may be removed, whereupon the distal portion944″ may move towards its deflected shape to bend the portion93of the airway92and/or otherwise compress the aerated tissue96. In this alternative, the stylet may be reintroduced after imaging and/or other procedures to facilitate withdrawal of the distal portion944.″

In any of these embodiments, after imaging the tissue96, a procedure may be performed within the airway92. For example, a biopsy device (not shown) may be introduced into the airway92(e.g., via the same device used to introduce the imaging device940″ or independently of the imaging device940″) and used to perform a biopsy within the tissue96while imaging the tissue96and/or biopsy device.

Turning toFIGS. 18A and 18B, still another exemplary embodiment of an access device or catheter1010is shown for performing a medical procedure, e.g., accessing, imaging, and/or performing a biopsy, similar to other embodiments herein. Generally, the catheter1010includes a proximal end (not shown), a distal end or portion1014sized for introduction into an airway or other body lumen92, and one or more lumens1016extending between the proximal end and the distal portion1014, generally similar to other embodiments herein. For example, the catheter1010includes a working channel or lumen1016acommunicating with an outlet1017ain a side wall of the distal portion1014, e.g., through which one or more biopsy devices may be advanced.

In addition, the catheter1010includes an imaging element, e.g., ultrasound transducer1040, and a balloon1030surrounding or otherwise overlying the transducer1040, both carried on the distal portion1014. The balloon1030may be formed from materials such that the balloon1030is biased to a predetermined shape upon expansion, e.g., by molding the balloon material into the predetermined shape and/or including support materials within the material. The balloon1030may be coupled to an actuating element1038, e.g., an elongate rod and the like, which may be manipulated to alter the shape of the balloon1030upon expansion. In addition, the balloon1030may be empty, partially filled, or completely filled with ultrasound-conductive fluid to modify the shape of the balloon1030and/or acoustically couple the transducer1040to surrounding tissue.

During use, the distal portion1014may be introduced into an airway92, similar to other embodiments herein, and positioned adjacent an area of interest, e.g., while using the transducer1040to obtain images of the area. As desired, after partially or fully inflating the balloon1030, the actuator element1039may be manipulated by the user to cause the balloon1030to change to a desired shape.

For example, a wall1031of the balloon1030may be disposed adjacent the outlet1017aof the working lumen1016aand may be supported to provide a ramped surface for guiding a biopsy device (not shown) advanced through the working lumen10106a. For example, the actuating element1038may be manipulated to change the shape of the balloon1030, thereby changing the orientation of the wall1031to a position desired by the user. In addition or alternatively, the wall1031of the balloon1030may include one or more materials whose properties may be modified, e.g., by applying energy thereto, to change a shape and/or rigidity of the wall1031. For example, the wall1031may include piezoelectric material that may be actuated from the proximal end of the catheter1010to change the shape and/or rigidity of the wall1031. This manipulation may facilitate real-time adjustment of the trajectory of a biopsy device placed in the working channel1016aand deployed from the outlet1017a, e.g., to access an area of interest visualized using ultrasound.

Turning toFIG. 19A, another exemplary embodiment of an access device or catheter1110is shown for performing a medical procedure, e.g., accessing, imaging, and/or performing a biopsy, similar to other embodiments herein. Generally, the catheter1110includes a proximal end (not shown), a distal end or portion1114sized for introduction into an airway or other body lumen, and one or more lumens1116extending between the proximal end and the distal portion1114, generally similar to other embodiments herein. For example, the catheter1110includes a working channel or lumen1116acommunicating with an outlet1117ain a side wall of the distal portion1114, e.g., through which one or more biopsy devices may be advanced.

In addition, the catheter1110includes an imaging element, e.g., ultrasound transducer1140, and a balloon1130surrounding or otherwise overlying the transducer1040, both carried on the distal portion1014, similar to other embodiments herein. In addition, the distal portion1114may also include a pair of lumens1116bthat receive respective wires or other conductive elements1142for operating the transducer1140. As can be seen inFIGS. 19B-19D, the location of the wire lumens1116bmay change along the length of the distal portion1114, e.g., to minimize a profile of the distal portion1114yet accommodate the wire lumens1116band the working lumen1116a. For example, as can be seen inFIG. 19C, the wire lumens1116bmay be disposed on either side of the working lumen1116aalong a region of the distal portion1114and then may be disposed immediately adjacent one another, e.g., to accommodate the outlet1117aof the working lumen1116a. The wire lumens1116bmay extend separately to the proximal end of the catheter1110or may be merge into a single wire lumen (not shown) at a desired location along the length of the catheter1110.

It should be noted that the present examples provide for use of the proposed embodiments and associated instruments in the airway to access adjacent parenchyma. However, such a catheter may also be used to access an area of interest in any area of the body that is adjacent to a lumen. This includes, but is not limited to the gastrointestinal system, biliary system, pancreas, and the cardiovascular system. It should further be reiterated that any of the exemplary embodiments may be utilized alone or in combination with each other to create further novel embodiments.

It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.