WO2017087578A1

WO2017087578A1 - Lung isolation devices, systems, and methods for use

Info

Publication number: WO2017087578A1
Application number: PCT/US2016/062366
Authority: WO
Inventors: Benjamin Goggio COHN; Ryan J.F. VAN WERT; Arthur Wai SUNG
Original assignee: The Board Of Trustees Of The Leland Stanford Jr. University
Priority date: 2015-11-16
Filing date: 2016-11-16
Publication date: 2017-05-26

Abstract

Apparatus, systems, and methods are provided for isolating and/or accessing a patient's lung, e.g., to perform a biopsy or other procedure within the lung. For example, an isolation device may be introduced into an airway of a lung, and an expandable member on the isolation device may be expanded to isolate a region of the lung distal to the expandable member. One or more ultrasound images of the isolated region, e.g., after at least partially filling the isolated region with ultrasound conducting fluid and/or removing air from the isolated region, and, optionally, a procedure may be performed on tissue adjacent the isolated region.

Description

LUNG ISOLATION DEVICES, SYSTEMS, AND METHODS FOR USE

RELATED APPLICATION DATA

The present application claims benefit of co-pending provisional application Serial No. 62/256,011, filed November 16, 2015, the entire disclosure of which is expressly incorporated by reference herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND

DEVELOPMENT

This invention was made with Government support under contract TR001085 awarded by the National Institutes of Health. The Government has certain rights in the invention.

FIELD OF THE INVENTION

The present invention relates to apparatus, systems, and methods for performing procedures within a patient's body, e.g., to provide access and/or isolate a region of a patient's lung, e.g., to facilitate ultrasound imaging, monitoring and/or assessing treatment of lesions, localizing a lesion before surgical removal, performing a biopsy, and/or performing other procedures 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 cancer and other diseases are typically diagnosed through biopsy or sampling lung tissue. 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, a lung nodule. When the nodule lies in the periphery, significant limitations are present. If one chooses high-yield transthoracic needle biopsy, pneumothorax, or lung collapse, occurs thirty percent (30%) of the time from puncturing the chest wall. If one chooses an endobronchial method, airway navigation aids can be unreliable in localizing the lesion on the small scale, and no direct image-guided sampling is available.

One improvement could be the use of real time ultrasound to sample lung nodules. Ultrasound-guided biopsy is a well-established procedure used in anatomy such as liver and breast, as well as other disciplines. Currently, however, within the lung, ultrasound is only usable in very limited cases, such as when the nodule is touching an airway wall or diseased lungs have filled with fluid, because air does not conduct ultrasound. Expanding the use of ultrasound in lung would be useful for improved sampling of lung lesions.

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 isolating and/or accessing body lumens within a patient's body, e.g., to facilitate introducing one or more imaging, biopsy, and/or treatment devices, and more particularly to devices, systems, and methods for isolating and/or otherwise accessing a patient's lung, e.g., to perform a biopsy, to perform ultrasound image guidance for localization, to monitor treatment and/or assess treatment of lesions, to localize a lesion before surgical removal, and/or to perform other procedures.

For example, the apparatus and methods described herein may create and/or maintain favorable ultrasound imaging conditions within a patient's lung and/or may facilitate introducing an imaging/biopsy device and/or other tool. Additionally, improved ultrasound imaging may be useful to monitor treatment procedures and as well as surgeries. For example, thermal ablation procedures in lung are plagued by high recurrence rates, which may be caused by poor confirmation of necrosis at the tumor margin. Ultrasound imaging may be able to better assess treatment success. In another example, to perform a wedge resection or segmentectomy, a surgeon may use palpation to confirm the location of a lesion. This technique is not always reliable for smaller, non-solid lesions. High-quality ultrasound imaging may negate the need for intraoperative palpation and provide more accurate localization. In an exemplary method, favorable ultrasound imaging conditions may be created within a region of a lung through a sequence that includes isolating at least one airway and then performing one or more additional steps, such as (i) insufflation of one hundred percent (100%) oxygen or other blood-absorbabie gas; (li) active or passive deflation of the segment; and (iii) introduction of a liquid, e.g. , water, saline, and the like, to at least partially or completely fill the airway or alveoli. These techniques may be repeated multiple times, alone or in combination. Each step may be performed for a pre-specified amount of time, although the order may vary and/or certain steps may be omitted.

In exemplary embodiments, isolation and/or access devices may be provided that attach to a bronchoscope, that are inserted through a working channel of a bronchoscope, or that are separate from a bronchoscope.

In one exemplary embodiment, an access sheath may be provided that fits over at least part of a bronchoscope and/or other guide instrument, which may be passed through the airways of a lung to reach a point in the bronchial tree close to a region of interest. The sheath may be flexible or rigid. Once the distal terminus of the bronchoscope and/or guide instrument has reached a desired position in the airway, the sheath may be left in place and/or the guide instrument may be withdrawn. Optionally, the sheath may have an airtight seal at its proximal end, distal end, or both ends. Optionally, the seal may be adjustable, e.g., in diameter, and/or may be created using a non-porous, semi-flexible material such as rubber or silicone, and the like. The seal may act as a connector to the guide instrument to allow advancement of the sheath along with the guide instrument into a patient's body. Other connectors to the guide instrument may include straps or hooks at the distal end of the device.

Optionally, the sheath may include a balloon at the distal end, e.g., for airway isolation. In addition or alternatively, the sheath may include an access port, e.g., for injection of gas, liquid, and/or other fluid, application of a valve, and/or application of suction. The sheath may be variable in diameter, e.g., to facilitate introduction and/or deployment within a body lumen. In addition or alternatively, the sheath may include a curved or otherwise deflected tip to allow for easier traversal of the airways.

Optionally, the device may have one or more interior lumen configurations. For example, once the bronchoscope/guide instrument is removed, one or more interior lumens may be accessed. These lumens may be facilitated in many ways, including but not limited to flexible, pre-stressed and shape-memory materials. The interior lumens may have variable diameters.

In another exemplary embodiment, an access sheath may include an outer tubular member and an extendable inner member to access narrower airways within a lung. For example, one or more balloons may be provided on the sheath, e.g., on a distal tip of the outer member, the inner lumen, or both. Optionally, a connecting mechanism may be provided between the inner and outer members to allow for joint and/or separate movement when desired. The connection between the inner and outer members may be facilitated by a clip or pressure fit system.

In addition or alternatively, the sheath may include an airtight seal at its proximal end, distal end, or both ends. The seal may be adjustable in diameter and/or may be created using a non-porous, semi-flexible material, such as rubber or silicone, and the like. The seal may act as a connector to the guide instrument to allow advancement of the sheath along with the guide instrument. Other connectors to the guide instrument may include straps or hooks at the distal end of the device. Optionally, the device may include one or more access ports, e.g., for injection of gas, liquid, and/or other fluid, application of a valve, and/or application of suction. The sheath may be variable in diameter. Optionally, the inner and/or outer members may include deflected tips to allow for easier traversal of the airways.

Optionally, the inner member may have different interior lumen configurations. For example, once the bronchoscope/guide instrument is removed, one or more interior lumens may be accessed. These lumens may be facilitated in many ways, including but not limited to flexible, pre-stressed, and shape-memory materials. The interior lumens may have variable diameters.

In another exemplary embodiment, an isolation device, e.g., an expandable sheath or plug device, may be deployed through a working channel of a bronchoscope. The geometry of the isolation device may allow compression to a collapsed condition, e.g., folding, rolling, and the like, to minimize diameter prior to advancing the isolation device through the working channel, and allow for expansion to an expanded condition, e.g., once deployed from a distal tip of the bronchoscope. The diameter minimization and re-expansion may be achieved in various ways, including, but not limited to, specific geometries that facilitate expansion, pre-stressed materials, spring or shape-memory materials that expand at deployment to a larger cross-sectional area, flexible materials that expand in cross-sectional dimension when an internal portion of the isolation device is subjected to increased pressure by gas or liquid, and/or support struts that are initially substantially parallel to conduit walls of the isolation device in a collapsed condition and expand in cross-sectional dimension, e.g., to be relatively perpendicular to the conduit walls, in the expanded condition.

Optionally, the sheath may include a balloon on its distal end to facilitate airway expansion. The balloon may include one or more features, e.g., a rough texture, an adhesive substance, or the presence of knobs or ridges to facilitate anchoring to the airway wall as the bronchoscope is extracted. Optionally, the device may include an access port, e.g., for injection of gas, liquid, and/or other fluid, application of a valve, and/or application of suction. The sheath may be variable in diameter. The device may have different interior lumen configurations.

Optionally, once the device emerges from the working channel, one or more interior lumens may be accessed. These lumens may be facilitated in many ways, including but not limited to flexible materials, pre-stressed materials, and/or shape-memory materials. The interior lumens may have variable diameters.

In another exemplary embodiment, an isolation device may be provided as an attachment to a bronchoscope or other guide instrument, which may create an airtight seal within the lung. The device may be placed on the exterior of a bronchoscope or guide instrument prior to insertion. The seal may be created by a balloon or a non-porous rigid, semi-flexible, or flexible material such as rubber, silicone, mesh with a non-porous covering, and the like. The device may be deployed at the region of interest, and the guide instrument may be removed while the device remains in place, or the guide instrument may be advanced through the device while the device remains in place.

Optionally, to provide low-friction translation of tools and non-slippage of the deployed device, special attributes of the tool channel and its covering may be provided. The tool channel may be covered to allow easy tool passage while forbidding airflow to proximal airways. The tool channel cover may include a rubber film with or without a small aperture, quick-sealing micro-bead gel/plasma, a mechanical hatch or other valve that opens when a tool is inserted and closes when removed, one or more objects that rotate about a set axis, such as ball bearings or miniature conveyor belts, and the like. Optionally, these rotating objects may have an elastic coating made of rubber or other materials to ensure an airtight seal. The tool channel may include a combination of any of the aforementioned elements. The tool channel itself may possess one or more of the aforementioned elements. The operator may control the function of the device with leads that pass air to inflate balloons, that conduct torque and/or that force the device to open, close, or rotate.

A separate tool may be used to facilitate deployment or retrieval of the device. The tool may be passed through the working channel of a bronchoscope, within an interior lumen of a guide instrument, or alongside the instrument. The device may have a seal that allows exchange of instruments while prohibiting airflow across the device.

In another exemplary embodiment, the isolation device is a deployable plug that facilitates airway isolation while allowing tool and/or guide instrument insertion. It may be introduced through the working channel of the bronchoscope, through the interior lumen of another guide instrument, or alongside the bronchoscope/guide instrument. Once the device is deployed, other tools and/or guide instruments may be inserted through the inner portions of the device. To allow for low-friction translation of tools and non-slippage of the deployed device, special attributes of the tool channel and its covering may be provided.

For example, the tool channel may be covered to allow easy tool passage while forbidding airflow to distal airways. The tool channel cover may include one or more of a rubber or other elastic film with or without a small aperture, quick-sealing micro-bead gel/plasma, a mechanical hatch or other valve that opens when a tool is inserted and closes when removed, one or more objects that rotate about a set axis, such as ball bearings or miniature conveyor belts, and the like. Optionally, these rotating objects may have an elastic coating made of rubber or other materials to ensure an airtight seal. The tool channel may include a combination of the aforementioned elements. The tool channel itself may include one or more of the aforementioned elements.

Optionally, the isolation device may be collapsible and expandable. The collapsible behavior may be orchestrated in various ways including, but not limited to, specific geometries that facilitate expansion, such as folding or rolling, pre-stressed materials, spring or shape-memory materials that automatically expand at deployment to a larger cross- sectional area, flexible material that expand in the cross-sectional dimension when the internal portion of the sheath is subjected to increased pressure by a gas or liquid, support struts that are initially substantially parallel to the airways or guide instrument walls, yet, when deployed transition to being relatively perpendicular thus expanding the cross- sectional dimension.

To create the seal, outer portions of the isolation device may include a balloon or non-porous material. The extreme outer portions may include a substance, texture, and/or exposed structures that allows for adherence to airway walls. Optionally, the isolation device may include one or more ports, e.g., to allow for balloon inflation, expanding the device, collapsing the device, or easy retrieval of the isolation device.

In another exemplary embodiment, an isolation device may include a bronchoscope, traditional endobronchial ultrasound scope (EBUS) or other scope or instrument, including one or more isolation balloons, e.g., on a distal end of the scope. Traditional optical bronchoscopes do not include a balloon. Although endobronchial ultrasound scopes may include a balloon, the purpose of such a balloon is to couple the probe to the tracheal wall. The isolation balloon may be fixed on the distal tip, or translatable along the external edge of the scope.

For example, an operator may navigate the scope to the most distal extent possible within a lung and inflate the balloon to isolate the airway. Next, the operator may use the working channel to deploy tools and/or other instruments, aerate with oxygen, apply suction or passive deflation, or inject fluid. With a translatable balloon, a proximal isolation site may be chosen, the balloon inflated to achieve isolation, and then the scope may be advanced further to distal airways, while the balloon remains at its proximal location.

In another exemplary embodiment, an isolation device may include one or more special balloons that allow for tool insertion while maintaining an airtight seal on the airway walls. For example, if the isolation device is a relatively a small-diameter sheath with a balloon on its distal tip, it may be advantageous to insert a tool alongside the sheath, not through its interior, and advance the tool towards distal airways. If the balloon were not modified, then the tool would need to be inserted adjacent to the airway wall, and the balloon inflated in the interior of the airway. This configuration may lead to difficult tool translation, balloon rupture, and/or air leaks.

A solution to these problems is a balloon that includes one or more channels for tool passage while the balloon is inflated. A channel may be created by inflation of a secondary balloon within a primary balloon. The secondary balloon may or may not be a non- compliant or semi-compliant balloon that inflates in a cylindrical or conical shape. A channel may or may not have a material that creates an airtight seal on the proximal, distal, or both ends of the channel. Alternatively, a channel may be created by inflation of a balloon that is engineered to inflate in a nonhomogeneous manner. This behavior may or may not be achieved by the use of balloon material of varying stiffness, multiple materials with varying stiffness, and/or one material that is constrained to inflate in certain areas. This may be considered as two balloons inflating and joining to create a channel. Multiple sets of balloons may join together to create multiple channels. Additionally, these new balloon configurations may appear on the exterior to sheaths/instruments, within the interior lumen(s) of any sheaths/instruments, or on the exterior/interior of deployable plugs.

In another exemplary embodiment, an attachment to the proximal end of the device may be provided that includes a connector that allows for easy switching between active and passive deflation. For example, at times, it is desirable to switch back and forth between active suction and passive deflation using a Heimlich valve. For example, if trapped air is disrupting the ultrasound image, removing the trapped air will improve the image quality. However, one may not want to continue with active suction and remove injected fluid, and so one may use passive deflation, such as a Heimlich valve. This process may be repeated multiple times, and, optionally, more fluid may be injected as well. The connector may have a suction port, one or more internal lumens and/or one-way valves, and a switching mechanism, such as toggle switch or twisting mechanism that opens and closes interior lumens to direct airflow. Many switching mechanisms and internal configurations exist and are feasible, but the key element remains easy switching between active and passive deflation.

In accordance with one embodiment, a method is provided for ultrasound imaging within a lung that includes introducing an isolation device into an airway of a lung;

expanding an expandable member on the isolation device to isolate a region of the lung distal to the expandable member; introducing an ultrasound conducting fluid into the isolated region; and acquiring one or more ultrasound images of the isolated region.

In accordance with another embodiment, a method is provided for performing a procedure within a lung that includes introducing an isolation device into an airway of a lung; expanding an expandable member on the isolation device to isolate a region of the lung distal to the expandable member; acquiring one or more ultrasound images of the isolated region; and performing a procedure on tissue adjacent the isolated region.

In accordance with still another embodiment, a system is provided for ultrasound imaging within a lung of a bod}^' that includes a bronchoscope comprising a distal end sized for introduction into an airway of a lung; an isolation device carried on the bronchoscope and comprising an expandable member expandable between a contracted condition to facilitate introduction into the airway and an enlarged condition to isolate a region of the lung distal to the expandable member; a source of blood-absorbable gas connectable to the isolation device to deliver the gas into the isolated region; and a source of ultrasound conducting fluid connectable to the isolation device to at least partially fill the isolated region with the fluid. Optionally, the system may include one or more additional devices, such as an ultrasound imaging device, a biopsy device, and/or a treatment device sized for introduction through a passage of the isolation device into the isolated region.

In accordance with yet another embodiment, a system is provided for ultrasound imaging within a lung of a body that includes a bronchoscope comprising a distal end sized for introduction into an airway of a lung and a working channel; an isolation device comprising an elongate sheath compressible to a collapsed condition for introduction into the working channel and expandable to an expanded condition when deployed within an airway, the isolation device further comprising an expandable member carried on a distal end of the sheath that is expandable between a contracted condition to facilitate introduction into the airway and an enlarged condition to isolate a region of the lung distal to the expandable member; a source of blood-absorbable gas connectable to the isolation device to deliver the gas into the isolated region; and a source of ultrasound conducting fluid connectable to the isolation device to at least partially fill the isolated region with the fluid.

In accordance with still another embodiment, a system is provided for performing a procedure within a lung of a body that includes a bronchoscope comprising a distal end sized for introduction into an airway of a lung and a working channel ; and an isolation device compressible to a collapsed condition for introduction into the working channel and expandable to an expanded condition when deployed within an airway sized to engage a wall of the airway to isolate a region of the lung distal to the expandable member.

In accordance with another embodiment, a device is provided for isolating a region of an airway within a lung that includes a sleeve comprising a proximal end and a distal end and including a passage extending between the proximal and distal ends; one or more lines extending from the proximal end of sleeve, the one or more lines comprising an infusion lumen including a port connectable a source of fluid and communicating with the passage; and an expandable member mounted on an outer surface of the sleeve, the expandable member expandable between a contracted condition to facilitate introduction into the airway and an enlarged condition to isolate a region of the lung distal to the expandable member.

In accordance with yet another embodiment, a device is provided for isolating a region of an airway within a lung that includes an elongate member comprising a proximal end and a distal end sized for introduction into an airway of a lung; and a balloon mounted on the distal end and extending only partially around a circumference of the distal end, thereby defining a longitudinal gap between opposite edges of the balloon, the balloon expandable from a contracted condition to an enlarged condition wherein a channel is formed between the edges of the balloon to accommodate receiving one or more instruments therethrough.

In accordance with still another embodiment, a device is provided for isolating a region of an airway within a lung that includes an elongate member comprising a proximal end and a distal end sized for introduction into an airway of a lung; and a balloon mounted on the distal end and extending around a circumference of the distal end and including proximal and distal ends, the balloon comprising a relatively inelastic strip of material extending between the balloon proximal and distal ends and relatively elastic material on either side of the relatively inelastic strip and extending at least partially around the circumference, the balloon expandable from a contracted condition to an enlarged condition wherein the relatively elastic expands more than the inelastic strip to cause the strip to roll and form a channel extending between the balloon proximal and distal ends for receiving one or more instruments therethrough.

In accordance with yet another embodiment, a device is provided for isolating a region of an airway within a lung that includes a bronchoscope comprising a shaft including a proximal end, a distal end sized for introduction into an airway of a lung and terminating in a distal tip, a working channel, and an imaging element for imaging beyond the distal tip; and an expandable member mounted on the distal end and movable from a distal position adjacent the distal tip to a proximal position, the expandable member expandable from a contracted condition to accommodate introduction of the bronchoscope distal end into an airway to an enlarged condition for engaging a wall of the airway to isolate a region distally beyond the balloon.

In accordance with another embodiment, a method is provided for isolating a region of an airway within a lung that includes introducing a distal end of a bronchoscope into an airway within a lung, the bronchoscope carrying an expandable member in a contracted condition on the distal end; expanding the expandable member within the airway to engage a wall of the airway and isolate a region distally beyond the expandable member; advancing the bronchoscope with the expandable expanded and engaging the wall of the airway, thereby directing the distal end into a distal airway within the lung; and introducing one or more instruments from a working channel of the bronchoscope into the distal airway to perform a procedure.

Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be better understood from the following detailed description when read in conjunction with the accompanying drawings. It will be appreciated that the exemplary apparatus shown in the drawings are not necessarily drawn to scale, with emphasis instead being placed on illustrating the various aspects and features of the illustrated embodiments.

FIGS. 1 A-1D show an exemplary embodiment of an isolation device positioned within a patient's lung and demonstrating an exemplary method for creating favorable ultrasound conditions.

FIG. 2A shows an exemplary embodiment of an isolation sheath removably fitted over a bronchoscope.

FIG. 2B shows an exemplary method in which the isolation sheath of FIG. 2A is positioned within a patient's lung, e.g., to guide a biopsy device to a region of interest.

FIG. 3A shows another exemplary embodiment of an isolation sheath removably fitted over a bronchoscope.

FIG. 3B shows an exemplary method in which the isolation sheath of FIG. 3 A is positioned within a patient's lung to guide a biopsy device to a region of interest.

FIGS. 4 A and 4B show an exemplary embodiment of an expandable isolation sheath in a collapsed and expanded conditions, respectively.

FIGS. 4C and 4D show the isolation sheath of FIGS. 4 A and 4B being introduced through a working channel of an bronchoscope in the collapsed condition (FIG. 4C) and deployed in the expanded condition after removing the bronchoscope (FIG. 4D).

FIG. 5A shows an exemplary embodiment of an isolation and/or access balloon device.

FIG. 5B shows the balloon device of FIG. 5 A mounted to a bronchoscope.

FIGS. 5C and 5D show an exemplary method in which the bronchoscope-balloon device of FIG. 5B are introduced into a patient's lung.

FIGS. 5E1 and 5E2 are top and side details, respectively, showing an exemplary embodiment of low-friction elements that may be provided on the balloon device of FIG. 5 A to facilitate introduction of a tool through the balloon device.

FIGS. 5F1 and 5F2 are details showing rotation of the low-friction elements of FIGS. 5E1 and 5E2 during introduction of a tool through the balloon device.

FIGS. 5G1 and 5G2 are side and cross-sectional details, respectively, showing an exemplary embodiment of a hatch or valve that may be provided on the balloon device of FIG. 5 A to facilitate introduction of a tool through balloon device.

FIGS. 6 A and 6B show an exemplary embodiment of an isolation and/or access plug in a collapsed and expanded conditions, respectively.

FIGS. 6C-6E show an exemplary method for introducing the plug of FIGS. 6 A and

6B into a patient's lung to facilitate introduction of a tool through the plug.

FIGS. 6F and 6G show an alternative embodiment of an isolation and/or access plug introduced into a patient's lung to facilitate introduction of a tool through the plug.

FIGS. 7 A and 7B show a distal end of another exemplary embodiment of an isolations sheath including a balloon thereon that extends only partially around the distal end with the balloon in collapsed and expanded conditions, respectively.

FIG. 7C is a cross-section of the access sheath of FIG. 7B taken across 7C-7C.

FIG. 7D shows the access sheath of FIGS. 7A and 7B introduced into a patient's lung to facilitate introduction of an imaging catheter into the lung.

FIGS. 8 A and 8B show a distal end of yet another exemplary embodiment of an isolation sheath including a balloon thereon in collapsed and expanded conditions, respectively.

FIG. 8C is a cross-section of the access sheath of FIG. 8B taken across 8C-8C to show an access channel formed by the balloon in the expanded condition.

FIG. 8D is a cross-section of an alternative embodiment of a balloon that forms a plurality of access channels in an expanded condition.

FIG. 9 is a perspective view of an embodiment of a bronchoscope including an isolation balloon on a distal end thereof and a pilot balloon coupled to a proximal end thereof.

FIG. 10A is a perspective view of another embodiment of a bronchoscope including a translatable isolation balloon on a distal end thereof.

FIG. 10B shows an exemplary method wherein the bronchoscope of FIG. 10A is introduced into a patient' lung and the isolation balloon remains stationary within the lung during translation of the bronchoscope.

FIG. 11 A is a side view of a connector device that may be provided on an access device.

FIG. 1 I B and 1 1 C show operation of the connector device of FIG. 11 A in active suction and passive suction modes, respectively.

FIGS. 12A and 12B show an alternative embodiment of a connector device including a switch for opening and closing a valve of the connector device.

The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1A-1 D show an exemplary embodiment of an isolation and/or access sheath or catheter 10 for accessing a body lumen within a patient's body, e.g., an airway 92 within the patient's lung 90, e.g., to image tissue, perform a biopsy, provide ultrasound imaging guidance, monitor and/or assess treatment of lesions, localize lesions before surgical removal, and/or perform other medical procedures. As described elsewhere herein, the sheath 10 may be part of a system for accessing and/or performing a procedure within the lung 90, e.g. , including one or more other devices that may be introduced into and/or deployed via the sheath 10, such as a bronchoscope, a biopsy device or instrument, a treatment device, such as an ablation device, surgical tool, and the like, and/or an imaging device (not shown).

As best seen in FIG. 1 A, the sheath 10 generally includes a proximal end or portion 12, a distal end or portion 14 sized for introduction into a patient's body, and one or more lumens 16 extending therebetween, thereby defining a central longitudinal axis 18. In addition, the sheath 10 may include a balloon or other expandable member 20 on the distal end 14 that is expandable from a contracted or delivery condition to an enlarged condition, e.g., sized to engage and/or otherwise seal against a sidewall of an airway 92.

For example, as shown, the sheath 10 may include a central or working lumen 16a communicating between a first port 52a on a handle or hub 50 coupled to the proximal end 12 and one or more outlets 15a on the distal end 14. In an exemplary embodiment, the first port 52a may include one or more valves (not shown) that provide a fluid-tight seal yet accommodate introducing one or more instruments into the central lumen 16a. In addition, the handle 50 may include a second side port 52b also communicating with the central lumen 16a to which one or more sources of fluid and/or vacuum may be coupled, as described elsewhere herein. Alternatively, the sheath 10 may include a separate infusion and/or aspiration lumen (not shown) that extends adjacent the central lumen 16a, and one or more additional ports (also not shown) may be provided for coupling source(s) of fluid and/or vacuum to the separate lumen.

Finally, the sheath 10 may include an inflation lumen (not shown), e.g.,

communicating between a third port 52c on the handle 50 and an interior of the balloon 20. Optionally, one or more connectors, e.g., Luer lock fittings (not shown), may be provided on any of the ports 52, e.g., to facilitate connecting and/or removing various sources to the ports 52. In another option, the inflation port 52c may include a pilot balloon (as may any of the embodiments herein), e.g., which may expand when a predetermined pressure is introduced into the inflation lumen, e.g., to provide a visual confirmation when the balloon 20 has been sufficiently expanded within an airway 92.

Generally, the sheath 10 is formed from material that is sufficiently flexible to allow the sheath 10 to be placed over a shaft of a bronchoscope, stylet, or other guide instrument (not shown), which may be used to introduce the sheath 10 into a lung 90 or other region within a patient's body. For example, a distal end of the guide instrument may be inserted through the first port 52a into the central lumen 16a and advanced to the distal end 14 to support the sheath 10 during introduction into a patient's body. Alternatively, the sheath 10 may have sufficient rigidity, e.g., a semi-rigid or rigid proximal portion and a flexible distal portion, to allow the sheath 10 to be introduced into the patient's body without a bronchoscope and/or other guide instrument. In a further alternative, the sheath 10 may be collapsible such that the sheath 10 may be introduced through a working channel of a bronchoscope in a collapsed condition and deployed to an enlarged condition within an airway 92, as described elsewhere herein.

During use, the distal end 14 of the sheath 10 may be introduced into one or more airways 92 of a patient's lung and positioned at a desired location, e.g., proximal to a nodule or set of alveolar sacs 94 intended to be isolated, as shown in FIG. 1 A. For example, the sheath 10 may be placed over the shaft of a bronchoscope 6, e.g., similar to the sheaths shown in FIGS. 2A and 2B, and the sheath 10 and bronchoscope 6 may be introduced together into the patient's body, e.g., using conventional methods. The bronchoscope 6 may include an imaging element on its distal end (not shown), which may provide direct visualization of the body lumen into which the bronchoscope 6 is introduced, e.g., to allow the user to visually monitor introduction of the sheath 10. Alternatively, the sheath 10 may be collapsed and introduced through a working channel 7 of a bronchoscope 6, e.g. , similar to the sheath shown in FIGS. 4C and 4D.

With reference to FIGS. 1 C and I D, once the distal end 14 of the sheath 10 is positioned at a desired location, e.g., within an airway 92 of the lung 90, the bronchoscope may be removed, leaving the sheath 10 to provide access into the airway 92 from outside the patient's body. One or more instruments may then be introduced through the sheath 10 into the airway 92, e.g. , to perform one or more procedures.

For example, once the distal end 14 is positioned at a desired location, e.g., upstream of the desired alveolar sacs 94, the balloon 20 may be inflated or otherwise expanded (either before or after removing the bronchoscope 6) to engage the wall of the airway 92 to provide a substantially fluid-tight seal, thereby isolating the segment including the alveolar sacs 94 from other regions of the lung 90 and/or regions outside the patient's body. For example, a source of inflation media, e.g., a syringe carrying saline or other fluid therein, may be coupled to the first port 52a and used to inflate the balloon 20 to engage the wall of the airway 92.

In an exemplary embodiment, the balloon 20 may be formed from elastic or compliant material, e.g., such that the balloon 20 may expand to engage and conform to the airway 92 to seal the airway 92 without substantially dilating the wall. Optionally, the balloon 20 may include one or more features to enhance engagement and/or sealing with the wall of the airway 92, e.g., an adhesive or sticky material, a plurality of frictional knobs or other elements on the outer surface, and the like. Alternatively, a mechanically expandable member, e.g. , including a membrane covering an expandable frame (not shown), may be provided instead of the balloon 20, which may be selectively expanded and/or collapsed using an actuator (also not shown) on the handle 50.

Turning to FIG. I B, with the alveolar sacs 94 isolated, the isolated region may be ventilated with a blood-absorbable gas, e.g., oxygen or alternatively hydrogen or helium, e.g., via the central lumen 16a and outlet 15a. This causes the alveolar sacs to become inflated and the oxygen then diffuses into the blood stream. As shown in FIG. 1 C, due to the absorption of the oxygen, the alveolar sacs 94 collapse, whereupon active and/or passive deflation may be applied to maintain the alveolar sacs 94 collapsed. For example, suction may be applied, e.g., by coupling a source of vacuum (not shown) to the first port 52a and applying a vacuum via the central lumen 16a and outlet 15a to aspirate any remaining gas within the isolated region. Alternatively, both active and passive deflation may be used, e.g., using a Heimlich valve or a connector device, such as those shown in FIGS. 1 1 A-12B, as described elsewhere herein.

Turning to FIG. I D, with little to no gas present within the airway 92 distal to the balloon 20, fluid 96, e.g. , water, saline, or other biocompatible liquid, may be introduced into the airway 92, e.g. , via the central lumen 16a and outlet 15a, to at least partially or entirely fill the isolated segment, thereby allowing for a clear ultrasound image to be created. Optionally, additional suction may then be applied to remove any residual gas, if desired. For example, an ultrasound imaging device (not shown) may be introduced into the central lumen 16a and through the outlet 15a into the fluid-filled region and ultrasound imaging may be used to identify one or more target locations within the isolated region, e.g., for biopsy or treatment. For example, once a target site has been identified, a biopsy device (not shown) may be advanced through the sheath 10 (after removing the imaging device or through a lumen of the imaging device, not shown), e.g., to obtain a tissue sample from an area of interest adjacent the airway 92. Alternatively, other procedures may be performed via the sheath 10 and/or otherwise within the isolated region. For example, an ablation device or surgical tool (not shown) may be introduced through a lumen of the imaging device, through the central lumen 16a of the sheath 10, or otherwise introduced into the isolated region to destroy or remove one or more lesions (not shown). Optionally, such procedures may be performed while using the imaging device for guidance and/or localization, to monitor the treatment, and/or asses a previous treatment. Further details and features of exemplary embodiments of sheaths, biopsy devices, imaging device, and systems including such devices are described in International Publication No. WO 2015/ 153931, the entire disclosure of which is expressly incorporated by reference herein.

After sufficient imaging, biopsy, and/or other treatment, the fluid may be aspirated from the isolated region, e.g. , via the central lumen 16a and outlet 15a, whereupon the balloon 20 may be deflated and the sheath 10 may be removed from the lung 90.

Turning to FIG. 2A, an embodiment of an isolation and/or access sheath 110 is shown that may be positioned over a bronchoscope 6. Similar to the previous embodiment, the sheath 1 10 generally includes a proximal end 112 (that remains outside the patient's body), a distal end 1 14 sized for introduction into the patient's body, one or more lumens 1 16 extending therebetween, and a balloon 120 carried on the distal end 1 14. A first port 152a may be provided on the proximal end 112 that includes one or more seals or one-way tool insertion valves (not shown), which may provide a substantially airtight and/or fluid- tight seal of a central lumen 1 16a of the sheath 1 10, e.g., between the proximal end 112 of the sheath 1 10 and the bronchoscope 6, e.g., to prevent ambient air from reaching the lungs during introduction of the sheath 1 10.

The balloon 120 may be carried on the distal end 114 of the sheath 1 10, e.g., at its distal tip adjacent outlet 115a to enable isolation of a target segment of an airway, as previously described. One or more suction/aeration/injection ports 152b may be provided on the proximal end 1 12 that communicate with the central lumen 1 16a, and a balloon inflation port 152c may be provided on the proximal end 1 12 that communicate with an inflation lumen (not shown), similar to the previous embodiment.

FIG. 2B shows the sheath 1 10 positioned within an airway 92 of a lung 90 after the bronchoscope 6 has been removed. For example, with the bronchoscope 6 positioned through the central lumen 1 16a of the sheath 110 (e.g., as shown in FIG. 2 A), the distal end 1 14 of the sheath 110 and the bronchoscope 6 may be introduced together into a patient's lung 90 and positioned until the balloon 120 is located at a desired location within the airway 92 adjacent a desired segment. The bronchoscope 6 may then be withdrawn, e.g., with the seal of the first port 152a slidably engaging the bronchoscope 6 during withdrawal and substantially closing the central lumen 1 16a upon removal of the bronchoscope 6. One or more procedures may then be performed via the sheath 1 10, e.g., ultrasound imaging, biopsy, removing or treating lesions, and/or other procedure, as described elsewhere herein.

Turning to FIG. 3 A, another embodiment of an isolation and/or access sheath device 208 is shown that includes outer and inner sheaths or tubular members 210, 230, which may be carried on a bronchoscope 6. Generally, the outer and inner sheaths 210, 230 include proximal ends 212, 232, distal ends 214, 234, and one or more lumens 216, 236 extending therebetween, similar to other embodiments herein. The outer sheath 210 includes a balloon or other expandable member 220 on its distal end 214, which may be selectively expanded to isolate a region of an airway 92, similar to other embodiments herein. In addition, the outer sheath 210 includes one or more ports and/or valves, e.g., a first axial port 252a communicating with the outer lumen 216 and including one or more valves or seals (not shown), a second side port 252b communicating with the outer lumen 216, e.g., for introducing fluids and/or applying suction, and a third port 252c communicating with an inflation lumen (not shown) for expanding the balloon 220, similar to other embodiments herein.

The inner sheath 230 may be sized to be slidably received within the outer lumen 236 and may have a length longer than the outer sheath 210, e.g., such that the proximal and distal ends 232, 234 of the inner sheath 230 may extend beyond the proximal and distal ends 212, 214 of the outer sheath 210. For example, in a retracted position, shown in FIG. 3 A, the inner sheath distal end 234 may be disposed adjacent the outer sheath distal end 214 while the inner sheath proximal end 232 may be spaced proximally from the outer sheath proximal end 212. The inner sheath 230 may be advanceable distally, e.g., to direct the inner sheath distal end 234 distally away from the balloon 220, as shown in FIG. 3B and described further below. Optionally, one or both of the sheaths 210, 230 may include a handle or hub (not shown) on the proximal ends 212, 234, e.g., to facilitate manipulation of the sheath device 210 and/or manipulation of the inner sheath 210 relative to the outer sheath 230, and/or limit advancement of the inner sheath 210, as desired.

During use, the sheath 208 may be loaded or otherwise provided over a shaft 8 of the bronchoscope 6, e.g., such that an imaging element of the bronchoscope is disposed beyond the sheath distal ends 214, 234. For example, the shaft 8 may be introduced through a port 254 on the inner sheath proximal end 232 into the inner lumen 236 and the bronchoscope 6 advanced until the sheath device 208 is fully seated on the shaft 8.

Once properly prepared, the bronchoscope 6 and sheath device 208 may be introduced into a lung 90 and positioned within an airway 92 adjacent to a desired region to be isolated. The balloon 220 may be expanded to engage the wall of the airway 92 to isolate the region distal to the balloon 220 and the bronchoscope 6 may be removed (either before or after expanding the balloon 220).

Optionally, gas and/or liquid may be introduced and/or suction applied to the isolated region via the central lumen 216 of the outer sheath 210, and/or one or more instruments may be introduced through the inner lumen 236 into the isolated region, similar to other embodiments herein. However, in this embodiment, as shown in FIG. 3B, at any time, the inner sheath 230 may be advanced to introduce the inner sheath distal end 234 into one or more distal airways, e.g. , given the smaller diameter or profile of the inner sheath 230. This may facilitate introducing other instruments into smaller passages, e.g. , an imaging device, biopsy device, treatment device, and the like, into distal airway(s) to perform a procedure, similar to other embodiments herein.

Turning to FIGS. 4A and 4B, an embodiment of a collapsible sheath 310 is shown that is deployable from a collapsed or delivery condition, shown in FIG. 4A, to an enlarged or deployed condition, shown in FIG. 4B. Similar to other embodiments herein, the sheath 310 generally includes a proximal end 312 including one or more ports 352, a distal end 314 carrying a balloon or other expandable member 320, and one or more lumens 316 extending between the proximal and distal ends 312, 314. For example, the sheath 310 may include a central or working lumen 316 communicating between a first axial port 352a and one or more outlets 315 beyond the balloon 320.

Unlike the previous embodiments, the sheath 310 may be rolled, folded, or otherwise directed into a contracted condition, e.g., having a clover-like geometry, as shown in FIG. 4A, or a spiral geometry, as shown in FIG. 4B. The sheath 310 may be biased to the enlarged condition, i.e. , to unroll, unfold, or otherwise open, but may be directed to and/or constrained in the contracted condition to facilitate introduction. Once released or deployed, the sheath 310 may resiliently expand back towards the enlarged condition. Alternatively, the sheath 310 may not be biased but may be selectively compressed, e.g. , manually or otherwise, and expanded, e.g., by inserting an expansion tool (not shown) or fluid into the working lumen 316.

During use, as shown in FIG. 4C, a bronchoscope 6 or other tubular delivery device may be introduced into a lung 90 and positioned within a desired airway 92. Once properly positioned, the sheath 310 may be introduced through a working channel 7 of the bronchoscope 6 in the contracted condition. For example, the sheath 310 may be introduced into the working channel 7 until the distal end 314 is positioned adjacent the distal end of the bronchoscope 6, whereupon the bronchoscope 6 may be retracted to deploy the sheath 310. Alternatively, the sheath 310 may be advanced distally to deploy the distal end 314 from the working channel 7.

As shown in FIG. 4C, as the distal end 314 of the sheath 310 exits the working channel 7, the distal end 314 may automatically expand towards the enlarged condition, e.g., until the sheath 310 is fully deployed, as shown in FIG. 4D. At any desired time, the entire bronchoscope 6 may be removed entirely from the airway 92 and lung 90. With the bronchoscope 6 removed, the balloon 320 may be expanded within the airway 92 and one or more procedures may be performed, similar to other embodiments herein.

Turning to FIGS. 5A and 5B, another embodiment of an isolation and/or access device 410 is shown that includes a relatively short collar or sleeve including a proximal end 412 and a distal end 414 sized such that the entire isolation device 410 may be introduced into an airway 92 within a lung 90, e.g. , having a length between about five and fifty millimeters (5-50 mm). The isolation device carries a balloon 420, which may extend at least partially between the proximal and distal ends 412, 414, e.g. , along most of the length of the device 410.

In addition, the device 410 includes a central passage 416 extending between the proximal and distal ends 412, 414, e.g. , sized to receive an instrument, such as the imaging device 4 shown in FIG. 5D. Optionally, one or more valves or seals (not shown) may be provided within the passage 416, e.g. , at or adjacent to the proximal end 412, which may resiliently close to seal the passage 416, yet open to accommodate introducing one or more instruments therethrough.

In addition, one or more tubes or lumens 452 may extend from the proximal end 412, e.g., an infusion/suction tube 452b communicating with the passage 416, an inflation tube 452c communicating with an interior of the balloon 420, and the like. The tubes 452b, 452c may have a diameter substantially smaller than the sleeve of the device 410 and a length substantially longer than the sleeve, i.e. , such that the tubes 452b, 452c may extend from the airway 92 entirely out of the patient's body. Thus, sources of gas, fluid, and/or suction (not shown) may be coupled to the infusion/suction tube 452b and a source of inflation media (also not shown) may be coupled to the inflation tube 452c, thereby allowing delivery of fluids and/or applying suction distally beyond the device 410, similar to other embodiments herein.. Optionally, the tubes may include one or more connectors, e.g., Luer lock fittings (not shown), a pilot balloon, and the like, also similar to other embodiments herein.

During use, as shown in FIG. 5B, the device 410 may be mounted on, attached to, or otherwise carried on a shaft 8 of a bronchoscope 6 or other guide instrument. Once the device 410 is secured to the bronchoscope 6, the shaft 8 may be introduced into a lung 90 and positioned within a desired airway 92, whereupon the balloon 420 may be expanded to engage the wall of the airway 92. With the balloon 420 engaging the wall of the airway 92, the bronchoscope 6 may be removed, leaving the device 410 secured within the airway 92, thereby isolating a region distal to the device 410, as shown in FIG. 5C. One or more fluids may be introduced into the isolated region and/or an imaging device 4 may be introduced through the passage 416 into the isolated region to acquire ultrasound images. One or more procedures, such as a biopsy, imaging, and/or treatment, may then be performed at desired sites within or adjacent to the isolated region.

Optionally, the device 410 may include one or more low-friction elements, e.g., within or adjacent the passage 416, which may facilitate removing the bronchoscope 6 and/or introducing one or more instruments, such as the imaging device 4. For example, FIGS. 5E1 and 5E2 show a plurality of internal elements 460 that allow for low-friction tool introduction and/or withdrawn through the passage 416. In this embodiment, the internal elements are akin to one or more conveyor belts that rotate with tool translation. FIGS. 5F1 and 5F2 show the rotating behavior of the belts 416 that may occur with translation of a tool 4 axially through the passage 416.

It will be appreciated that other low-friction elements may be provided within the passage 416. For example, a plurality of bearings (not shown) may be spaced apart around an inner surface of the device 410 such that a tool inserted through the passage 416 slidably engages the bearings. In addition or alternatively, a lubricious coating may be provided on an inner surface defining the passage. FIGS. 5G1 and 5G2 show an alternate embodiment of an isolation balloon device 410' that includes a hatch, flapper, or other valve 462' that may be provided across passage 416' that may open when a tool 4 is inserted and automatically close when the tool 4 is removed.

Turning to FIGS. 6 A and 6B, another embodiment of an isolation and/or access device is shown, namely an isolation plug 510 that may be deployed through a

bronchoscope 6 or other delivery device. Generally, the isolation plug 510 includes a proximal end 512, a distal end 514, and a passage 516 extending therebetween. The plug 510 may include one or more seals, e.g., within the passage 516 and/or adjacent on the proximal end 512, e.g., to substantially seal the passage 416, yet accommodate introducing one or more instruments through the plug 510.

The plug 510 may be collapsible and/or expandable, e.g., biased to an expanded condition, as shown in FIG. 6B, yet resiliently compressible to a collapsed condition, as shown in FIG. 6A, e.g., by rolling, folding, or otherwise compressing the plug 510.

Alternatively, the plug 510 may be formed from a compressible material, e.g., foam and the like, which may be compressible to the collapsed condition for delivery and resiliently expand upon deployment. As shown, the plug 510 has a frustoconical shape, e.g. , with the proximal end 512 having a larger diameter or cross-section than the distal end 514. It will be appreciated that other tapered or substantially uniform diameter plugs may be provided, as desired, that may be delivered in a collapsed condition and deployed such that the plug expands and engages the wall of the airway 92 to provide a substantially fluid-tight seal.

During use, a bronchoscope 6 or other tubular delivery device including a working channel 7 may be introduced into a lung 90 and positioned within a desired airway 92, as shown in FIG. 6C. The plug 510, in its collapsed condition, may be introduced through the working channel 7 and deployed within the airway 92 to isolate a region beyond the plug 510, whereupon the bronchoscope 6 may be removed, as shown in FIG. 6D. For example, a plunger or other advancement tool (not shown) may be introduced into or otherwise advanced within the working channel 7 behind the plug 510 to direct the plug through the working channel 7 or, conversely, the bronchoscope 6 may be retracted relative to the plunger to hold the plug 510 in a desired location within the airway 92 until the plug 510 is deployed.

Optionally, as shown in FIG. 6C, a tether or other elongate element 570 may be coupled to the plug 510 to ensure that the plug 510 is properly deployed within the airway 92 and/or to allow retrieval of the plug 510. In another option, the tether 570 may be releasable from the plug 510 such that the tether 570 is removed after the plug 510 is properly deployed to isolate a region beyond the airway 92.

Once the plug 510 is properly deployed within the airway 92, as shown in FIG. 6E, an imaging device 4 (or other instrument) may be introduced into the airway 92 and directed through the passage 516 of the plug 510 into the isolated region. One or more procedures, e.g., ultrasound imaging, obtaining a biopsy, treating tissue, and the like via the passage 516, similar to other embodiments herein. Upon completing the procedure(s), the plug 510 may be retrieved or otherwise removed from the lung 90. For example, if a tether remains coupled to the plug 510, a bronchoscope or other tubular retrieval device (not shown) may be introduced into the airway 92 and the tether retracted to pull the plug 510 into the working channel or other lumen of the retrieval device. Alternatively, a tool may be introduced that may engage and at least partially collapse the plug 510 to disengage the plug 510 from the wall of the airway 92 and allow withdrawal into a retrieval device (not shown). Turning to FIGS. 6E and 6F, an alternate embodiment of an isolation plug 510' is shown that has a "cup" or "plunger" configuration, which may be deployed from a bronchoscope 6 or other delivery device using a deploying catheter 5. The plug 510' may be compressible to facilitate introduction through the working channel 7 of the

bronchoscope 6 and resiliently expandable to the deployed condition shown in FIG. 6E. As shown in FIG. 6F, the plug 510' may become inverted after the sides remain fixed and the deploying catheter 5 is advanced. Given the convex shape of the inverted plug 510', a tool (not shown) introduced through the catheter 5 may be introduced adjacent the leading edge of the plug 510', which may be useful in directing subsequent tools or injected fluids in a desired direction, e.g., when a bifurcation is present.

Turning to FIGS. 7A-7C, another exemplary embodiment of an isolation and/or access device 610 is shown that includes an elongate sheath or tubular member including a proximal end (not shown), a distal end 614 sized for introduction into a patient's body, a lumen 616 extending therebetween, and a special balloon 620 that allows for tool insertion while maintaining airway isolation. As shown, the balloon material extends only partially around a circumference of the distal end 614, i.e., thereby defining a longitudinal gap 622 between opposite edges 624 of the balloon 624. Given that there is a circumferential region without any balloon material, when the balloon 620 is inflated, a channel 626 is formed between the edges 624 of the balloon 620, as best seen in FIG. 7C.

For example, as shown in FIG. 7D, the distal end 614 of the device 610 may be introduced into an airway 92 of a lung 90, similar to other embodiments herein, and the balloon 620 may be expanded to isolate a region distal to the balloon 620. Given the channel 626, an instrument, such as imaging device 4, may be introduced into airway 92 adjacent the device 610 (i.e., outside the lumen 616) and directed through the channel 626 into the isolated region. For example, if the balloon 620 is formed from elastic or compliant material, the side edges 624 of the balloon 620 may expand to engage one another, as shown in FIG. 7B, to seal the channel 626, yet the balloon 620 may elastically deform to accommodate the imaging device 4 (or other instrument) being introduced through the channel 626, as shown in FIG. 7D.

Alternatively, as shown in FIGS. 8A and 8B, a balloon 620' may be provided on an isolation device 610' (otherwise similar to the device 610) that utilizes materials of differing stiffness. For example, most of the balloon 620' may be formed from elastic or compliant material while a longitudinal section 628' may be formed from inelastic or less compliant material. Given that most of the balloon 620' is formed from less stiff material, most of the balloon inflates to a greater extent than the suffer material of the section 628', thereby causing the section to roll and form a channel 626'. By modifying the construction of the balloon 626' as desired, the channel 626' may be modified to maintain an airtight seal at the distal tip of the device 610' . FIG. 8D shows another alternate embodiment of a balloon 620" that includes multiple channels 626," e.g., formed by multiple longitudinal sections 628" of balloon material that is more stiff than adjacent regions of the balloon 620. " Thus, in this alternative, multiple instruments may be introduced adjacent the isolation device and beyond the balloon 620" simultaneously, via separate channels 626. "

It will be appreciated that a balloon similar to the balloons 620, 620,' and 620" may be provided on any of the other isolation devices described herein. For example, by providing a balloon including one or more channels similar to 626, 626,' 626," multiple instruments may be introduced simultaneously into an isolated region. For example, one instrument, e.g. , an imaging device, may be introduced through the central lumen of a sheath, while one or more additional instruments, e.g., an ablation device, surgical tool, and the like, may be introduced outside the sheath and inserted through a channel 626, 626, ' 626" in the balloon 620, 620,' 620" to perform a procedure on tissue within or adjacent the isolated region. The imaging device may provide guidance for localization of the tool(s), may be used to monitor and/or assess treatment of lesions or other tissue structures, and/or to localize a lesion before surgical removal.

Turning to FIG. 9, another embodiment of an isolation and/or access device 710 is shown that includes a bronchoscope including a proximal end 712, a distal end 714, and a balloon 720 carried on the distal end 714, e.g., adjacent a distal tip of the scope. The device 710 may include a side port 752c communicating with an inflation lumen (not shown) extending along the scope and communicating with an interior of the balloon 710.

Optionally, a pilot balloon may be provided on the port 752c to check inflation amount and/or a connector (not shown) may be provided for coupling a source of inflation media to the port 752c, similar to other embodiments herein.

During use, the distal end 714 of the device 710 may be introduced into an airway (not shown), whereupon the balloon 720 may be expanded to isolate a region beyond the balloon 720. One or more instruments may then be introduced through the working channel (not shown) of the bronchoscope to image and/or perform a procedure within the isolated region, similar to other embodiments herein. Alternatively, as shown in FIG. 10 A, an isolation device 710' may be provided that includes a bronchoscope with a translatable balloon 720' carried on a distal end 714' of the device 710. ' For example, the balloon 720' may be carried on a sleeve or other structure slidably mounted on the bronchoscope, which may be movable axially between a distal position, e.g., adjacent a distal tip, and a proximal location. During use, the distal end 714' may be introduced into an airway 92, and the balloon 720' expanded to engage the wall of the airway 92 and/or isolate a region beyond the balloon 720,' as shown in FIG. 10B.

Thereafter, the bronchoscope may be advanced further, e.g., to introduce the distal end 714' into distal airways while the isolation balloon 720' remains in place and one or more instruments may be introduced through the working channel 716' into the isolated region to perform a procedure, similar to other embodiments herein.

Turning to FIGS. 11 A-11 C, an exemplary embodiment of a connector device 860 is shown that may be provided on a proximal end of an isolation device (not shown), such as any of the embodiments described herein. For example, the connector device 860 may include a first end 862, which may be coupled to an infusion or suction port (not shown) of an isolation device that communicates with a lumen and one or more outlets on the isolation device. Optionally, the first end 862 may include a connector, such as a Luer lock fitting (not shown), which may facilitate connecting and/or removing the connector device 860 from the isolation device.

The connector device may include two lumens 864 communicating with the first end

862, namely a first lumen 864a communicating with a suction port 866 via a one-way valve 865, and a second lumen 864b communicating with a passive one-way valve 868, which may allow the connector device 860 to be easily switched between active and passive deflation.

For example, as shown in FIG. 1 IB, a suction catheter 870 may be connected to the suction port 866 to provide active suction to the first end 862. For example, with the suction catheter 870 connected, to the suction port 866, air selectively flows through the one-way valve 865 to the suction port 866, thereby continuously aspirating fluid through the first end 862 (i. e., from a lumen of the isolation device and, consequently, from an isolated region of an airway, not shown).

FIG. l l C shows the connecting device 860 switched to a passive deflation configuration. In this configuration, the suction port 866 is twisted or otherwise opened up to airflow into the suction port from ambient air, thereby closing the one-way valve 865. Consequently, airflow is directed from the first end 862 out to the ambient environment through the second lumen 864b and the passive one-way valve 868. For example, if liquid is introduced to fill the isolated region, residual gas within the isolated region may be forced through the isolation device and out the second lumen 864b. As desired, the user may switch between the two modes simply by opening and closing the suction port 866.

FIGS. 12A and 12B show an alternative embodiment of a connecting device 860' that includes another switching mechanism, i.e., using a toggle switch 870' to selectively open and close a valve at the suction port 866' to either direct active suction through the suction port 866' (with the switch 870' closed, as shown in FIG. 12A) or provide passive deflation through the passive one-way valve 868' (with the switch 870' opened, as shown in FIG. 12B).

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.

While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

We claim:

1. A method for ultrasound imaging within a lung, comprising:

introducing an isolation device into an airway of a lung;

expanding an expandable member on the isolation device to isolate a region of the lung distal to the expandable member;

introducing an ultrasound conducting fluid into the isolated region; and

acquiring one or more ultrasound images of the isolated region,

2. The method of claim 1 , further comprising, before introducing the ultrasound conducting fluid:

introducing a blood-absorbable gas into the isolated region, thereby causing alveolar sacs in the isolated region to absorb the gas and collapse; and

applying at least one of passive deflation and active suction to the isolated region to maintain the alveolar sacs collapsed,

wherein the ultrasound conducting fluid is introduced into the isolated region with the alveolar sacs collapsed.

3. The method of claim 2, wherein the blood-absorbable gas comprises at least one of oxygen, hydrogen, and helium.

4. The method of claim 1 , wherein the ultrasound conducting fluid comprises a biocompatible liquid.

5. The method of claim 1 , wherein the ultrasound conducting fluid comprises water or saline.

6. The method of claim 1 , wherein acquiring one or more ultrasound images of the isolated region comprises introducing an ultrasound imaging device through the isolation device into the isolated region.

7. The method of claim 1 , wherein acquiring one or more ultrasound images of the isolated region comprises:

introducing an ultrasound imaging device into the airway adjacent the isolation device; and

advancing the ultrasound imaging device through a channel in the expandable member into the isolated region. 8. The method of claim 1 , further comprising performing a biopsy on tissue adjacent the isolated region.

9. The method of claim 1 , further comprising introducing one or more instruments into the isolated region to perform a procedure within or adjacent the isolated region.

10. The method of claim 9, wherein introducing one or more instruments comprises introducing an instrument through a lumen of the isolation device into the isolated region.

11. The method of claim 9, wherein introducing one or more instruments comprises:

introducing an instrument into the airway adjacent the isolation device; and advancing the instrument through a channel in the expandable member into the isolated region. 2. The method of claim 9, wherein introducing one or more instruments comprises:

introducing an instrument into the isolated region under ultrasound image guidance; and

treating tissue adjacent the isolated region.

13. The method of claim 1 , further comprising treating tissue adjacent the isolated region, and wherein acquiring one or more ultrasound images of the isolated comprises using the ultrasound images to monitor or assess treatment of the tissue.

14. The method of claim 1 , wherein acquiring one or more ultrasound images of the isolated region comprises using the ultrasound images to localize a lesion adjacent the isolated region, the method further comprising surgically removing the lesion.

15. The method of claim 1 , wherein the isolation device comprises a sheath carried on a bronchoscope, and wherein introducing the isolation device comprises:

introducing a distal end of the bronchoscope and sheath together into the airway of the lung; and

removing the bronchoscope, thereby leaving the sheath within the airway.

16. The method of claim 15, wherein the sheath comprises an inner tubular member slidable relative to an outer tubular member, and wherein introducing the isolation device further comprises, after removing the bronchoscope, advancing the inner tubular member distally beyond the expandable member to access a site within the isolated region.

17. The method of claim 1 , wherein the isolation device comprises a sheath and wherein introducing the isolation device comprises:

introducing a distal end of the bronchoscope into the airway of the lung;

introducing the sheath through a working channel of the bronchoscope in a collapsed condition;

deploying the sheath from the working channel such that the sheath expands to an enlarged condition; and

removing the bronchoscope, thereby leaving the sheath within the airway in the enlarged condition.

18. A method for isolating a region of an airway within a lung, comprising: introducing a distal end of a bronchoscope into an airway within a lung, the bronchoscope carrying an expandable member in a contracted condition on the distal end; expanding the expandable member within the airway to engage a wall of the airway and isolate a region distally beyond the expandable member;

advancing the bronchoscope with the expandable expanded and engaging the wall of the airway, thereby directing the distal end into a distal airway within the lung; and

introducing one or more instruments from a working channel of the bronchoscope into the distal airway to perform a procedure.

19. The method of claim 18, wherein introducing one or more instruments comprises introducing an imaging device into the distal airway through the working channel and imaging tissue adjacent the distal airway.

20. The method of claim 18, wherein introducing one or more instruments comprises introducing a treatment device into the distal airway to treat tissue adjacent the distal airway.

21. A method for performing a procedure within a lung, comprising:

introducing an isolation device into an airway of a lung;

acquiring one or more ultrasound images of the isolated region; and

performing a procedure on tissue adjacent the isolated region.

22. The method of claim 21, wherein performing a procedure comprises introducing an instrument into the isolated region through a lumen of the isolation device.

23. The method of claim 21, wherein performing a procedure comprises:

introducing an instrument into the airway adjacent the isolation device; and advancing the instrument through a channel in the expandable member into the isolated region.

24. The method of claim 21, wherein performing a procedure comprises treating tissue adjacent the isolated region, and wherein acquiring one or more ultrasound images of the isolated region comprises using the ultrasound images to monitor or assess treatment of the tissue.

25. The method of claim 21, wherein acquiring one or more ultrasound images of the isolated region comprises using the ultrasound images to localize a l esion adjacent the isolated region, and wherein performing a procedure comprises surgically removing the lesion.

26. The method of claim 21, further comprising introducing an ultrasound conducting fluid into the isolated region before acquiring the one or more ultrasound images. 27. The method of claim 26, further comprising removing air from the isolated region before acquiring the one or more ultrasound images.

28. A system for ultrasound imaging within a lung of a body, comprising:

a bronchoscope comprising a distal end sized for introduction into an airway of a lung;

an isolation device carried on the bronchoscope and comprising an expandable member expandable between a contracted condition to facilitate introduction into the airway and an enlarged condition to isolate a region of the lung distal to the expandable member; a source of blood- absorbable gas connectable to the isolation device to deliver the gas into the isolated region; and

a source of ultrasound conducting fluid connectable to the isolation device to at least partially fill the isolated region with the fluid.

29. The system of claim 28, further comprising an ultrasound imaging device sized for introduction through a passage of the isolation device into the isolated region.

30. The system of claim 28, further comprising a biopsy device sized for introduction through a passage of the isolation device into the isolated region. 31. The system of claim 28, wherein the isolation device comprises a sheath including a proximal end, a distal end, a lumen extended between the proximal and distal ends of the sheath and communicating with one or more outlets on the distal end distaliy beyond the expandable member. 32. The system of claim 31 , further comprising one or more ports on the proximal end of the sheath that communicate with the lumen, the source of blood- absorbable gas and source of ultrasound conducting fluid connectable to the one or more ports for selectively delivering the gas or fluid through the lumen and out the one or more outlets.

33. The system of claim 32, further comprising a source of vacuum connectable to the one or more ports for selectively applying suction to the isolated region via the lumen and one or more outlets.

34. The system of claim 31 , wherein the sheath is carried on an outer surface of the bronchoscope, the bronchoscope being removable from the sheath to deploy the sheath within an airway.

35. The system of claim 28, further comprising a source of vacuum connectable to the isolation device for selectively applying suction to the isolated region.

36. The system of claim 28, wherein the isolation device comprises a sheath including an inner tubular member slidabiy received within an outer tubular member, the outer tubular member carrying the expandable member on a distal end thereof, the inner tubular member being advanceable distally beyond the expandable member to access a site within the isolated region.

37. The system of claim 28, wherein the isolation device comprises a sleeve slidabiy mounted on an outer surface of the distal end of the bronchoscope and one or more lines extending from the sleeve, the one or more lines comprising an infusion lumen including a port connectable to one or both of the sources.

38. The system of claim 37, wherein the sleeve has a length such that the entire sleeve is introduceable within an airway of a lung, and the one or more lines are substantially longer than the sleeve such that the one or more lines may extend from an airway within which the sleeve is introduced to a location outside the body.

39. The system of claim 37, wherein the sleeve comprises a passage extending between proximal and distal ends of the sleeve, and wherein the distal end of the bronchoscope is positioned through the passage, the sleeve comprising one or more seals for closing the passage to provide a fluid-tight seal when the bronchoscope is removed from the passage and accommodating introducing one or more instruments through the passage.

40. The system of claim 37, wherein the sleeve comprises a passage extending between proximal and distal ends of the sleeve and wherein the distal end of the bronchoscope is positioned through the passage, the sleeve further comprises one or more low-friction elements adjacent the passage to facilitate removal of the bronchoscope from the passage and facilitate introduction of one or more instruments through the passage.

41. The sy stem of claim 40, wherein the one or more low-friction elements comprise one of bearings and miniature conveyor belts mounted to the sleeve adjacent the passage.

42. The system of claim 37, wherein the expandable member comprises a balloon and wherein the one or more lines comprise an inflation lumen comprising a port connectable a source of inflation and communicating with an interior of the balloon for delivering inflation media into the balloon to expand the balloon and remove inflation media from the balloon to collapse the balloon.

43. A system for ultrasound imaging within a lung of a body, comprising:

a bronchoscope comprising a distal end sized for introduction into an airway of a lung and a working channel;

an isolation device comprising an elongate sheath compressible to a collapsed condition for introduction into the working channel and expandable to an expanded condition when deployed within an airway, the isolation device further comprising an expandable member carried on a distal end of the sheath that is expandable between a contracted condition to facilitate introduction into the airway and an enlarged condition to isolate a region of the lung distal to the expandable member;

a source of blood- absorbable gas connectable to the isolation device to deliver the gas into the isolated region; and

The system of claim 43, wherein the sheath is biased to the expanded condition yet is compressible, foldable, or reliable to the collapsed condition.

45. A system for performing a procedure within a lung of a body, comprising: a bronchoscope comprising a distal end sized for introduction into an airway of a lung and a working channel; and

an isolation device compressible to a collapsed condition for introduction into the working channel and expandable to an expanded condition when deployed within an airway- sized to engage a wall of the airway to isolate a region of the lung distal to the expandable member.

46. The system of claim 45, wherein the isolation device comprises a plug sized such that the entire plug is introduceable within the airway.

47. The system of claim 45, wherein the isolation device comprises a passage for receiving one or more instruments therethrough and one or more seals for closing the passage to provide a fluid-tight seal while accommodating introducing one or more instruments through the passage.

48. A device for isolating a region of an airway within a lung, comprising:

a sleeve comprising a proximal end and a distal end and including a passage extending between the proximal and distal ends;

one or more lines extending from the proximal end of sleeve, the one or more lines comprising an infusion lumen including a port connectable a source of fluid and communicating with the passage; and

an expandable member mounted on an outer surface of the sleeve, the expandable member expandable between a contracted condition to facilitate introduction into the airway and an enlarged condition to isolate a region of the lung distal to the expandable member.

49. The device of claim 48, wherein the sleeve has a length such that the entire sleeve is introduceable within an airway of a lung, and the one or more lines are substantially longer than the sleeve such that the one or more lines may extend from an airway within which the sleeve is introduced to a location outside the body.

50. The device of claim 48, wherein the sleeve comprises one or more seals for closing the passage to provide a fluid-tight seal while accommodating introducing one or more instruments through the passage.

51. The device of claim 48, further comprising one or more low-friction elements adjacent the passage to facilitate introduction of one or more instruments through the passage.

52. The device of claim 51, wherein the one or more low-friction elements comprise one of bearings and miniature conveyor belts mounted to the sleeve adjacent the passage.

53. The device of claim 48, wherein the expandable member comprises a balloon and wherein the one or more lines comprise an inflation lumen comprising a port connectable a source of inflation and communicating with an interior of the balloon for delivering inflation media into the balloon to expand the balloon and remove inflation media from the balloon to collapse the balloon

54. A device for isolating a region of an airway within a lung, comprising:

an elongate member comprising a proximal end and a distal end sized for introduction into an airway of a lung; and

a balloon mounted on the distal end and extending only partially around a circumference of the distal end, thereby defining a longitudinal gap between opposite edges of the balloon, the balloon expandable from a contracted condition to an enlarged condition wherein a channel is formed between the edges of the balloon to accommodate receiving one or more instruments therethrough.

55. The device of claim 54, wherein the balloon is formed from elastic material such that, in the enlarged condition, the opposite edges engage one another to provide a fluid-tight seal through the channel, the elastic material deforming to accommodate introducing an instrument through the channel while providing a seal around the instrument.

56. The device of claim 54, further comprising: an inflation lumen extending between the proximal and distal ends of the elongate member and communicating with an interior of the balloon; and

an inflation port on the proximal end connectable to a source of inflation media.

57. A device for isolating a region of an airway within a lung, comprising: an elongate member comprising a proximal end and a distal end sized for introduction into an airway of a lung; and

a balloon mounted on the distal end and extending around a circumference of the distal end and including proximal and distal ends, the balloon comprising a relatively inelastic strip of material extending between the balloon proximal and distal ends and relatively elastic material on either side of the relatively inelastic strip and extending at least partially around the circumference, the balloon expandable from a contracted condition to an enlarged condition wherein the relatively elastic expands more than the inelastic strip to cause the strip to roll and form a channel extending between the balloon proximal and distal ends for receiving one or more instruments therethrough.

58. The device of claim 57, wherein the balloon includes multiple relatively inelastic strips of material extending between the balloon proximal and distal ends and spaced apart circumferentially from one another and relatively elastic material extending circumferentially between the strips such that, when the balloon is expanded to the enlarged condition, the relatively elastic expands more than the strips to cause the strips to roll and form a plurality of channels extending between the balloon proximal and distal ends for receiving one or more instruments therethrough.

59. The device of claim 57, further comprising:

an inflation lumen extending between the proximal and distal ends of the elongate member and communicating with an interior of the balloon; and

60. A device for isolating a region of an airway within a lung, comprising: a bronchoscope comprising a shaft including a proximal end, a distal end sized for introduction into an airway of a lung and terminating in a distal tip, a working channel, and an imaging element for imaging beyond the distal tip; and an expandable member mounted on the distal end and movable from a distal position adjacent the distal tip to a proximal position, the expandable member expandable from a contracted condition to accommodate introduction of the bronchoscope distal end into an airway to an enlarged condition for engaging a wall of the airway to isolate a region distally beyond the balloon.