Devices for treatment of body lumens

A medical device may comprise a handle portion; an insertion portion having a proximal end portion at the handle portion, wherein the insertion portion includes a lumen therein and a distal end having a distal opening in communication with the lumen; and a member disposed within the lumen, the member having a distal end portion with an imaging device. The member may be configured to transition between a first configuration and a second configuration. In the first configuration, the imaging device may face distally, and, in the second configuration, the imaging device may face proximally. Extending the distal end portion of the member distally past the distal opening may cause the member to transition from the first configuration to the second configuration.

TECHNICAL FIELD

The present disclosure relates generally to devices and methods for diagnosing and/or treating tissue using, for example, endoscopes, bronchoscopes, and ureteroscopes. More specifically, aspects of the present disclosure pertain to devices and methods for positioning and/or visualizing medical devices within body lumens of a subject.

BACKGROUND

Endoscopic, bronchoscopic, or ureteroscopic techniques may be used for diagnosing, treating, and/or monitoring conditions by advancing tools and other devices through body lumens. However, it may be difficult to perform procedures in certain body lumens due to a narrow diameter of the lumen. For example, it may be difficult to obtain a biopsy or to treat a nodule or lesion in the periphery of the lungs, due to an inability to visualize the periphery lumen using traditional endoscopes. Typical therapeutic and diagnostic endoscopes may be limited in how many generations of the bronchi they are able to navigate due to their relatively large outer diameter of approximately 6 mm or greater. Many current procedures for obtaining a biopsy of a nodule or lesion in the fifth or higher generation of the bronchi tend to be done blind because of the lack of an optics system compatible with biopsy devices and small enough to provide visualization of peripheral airways. A lack of visualization may lead to (a) low yields and/or (b) increased procedure time resulting from a user's needing to spend additional time to ensure that a tool is positioned in the correct location.

SUMMARY

Examples of the present disclosure relate to, among other things, devices and methods for positioning and/or visualizing medical devices within body lumens of a subject. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

A medical device may comprise a handle portion; an insertion portion having a proximal end portion at the handle portion, wherein the insertion portion includes a lumen therein and a distal end having a distal opening in communication with the lumen; and a member disposed within the lumen, the member having a distal end portion with an imaging device. The member may be configured to transition between a first configuration and a second configuration. In the first configuration, the imaging device may face distally, and, in the second configuration, the imaging device may face proximally. Extending the distal end portion of the member distally past the distal opening may cause the member to transition from the first configuration to the second configuration.

Any medical device described herein may include one or more of the features described below. The member may include a flat shaft having a cross sectional width greater than a thickness and having at least one substantially planar outer surface. The shaft may be ribbon shaped. The imaging device may be disposed on a side surface of the member. On the first configuration, the distal end portion of the member may form approximately a right angle relative to a more proximal portion of the member. In the second configuration, the distal end portion of the member may form a curl shape. The member may be configured to transition between the first configuration and the second configuration by moving the member longitudinally relative to the lumen. A proximal portion of the member may be coupled to a hub. The hub may be configured to effect longitudinal movement of the member relative to the lumen as the hub translates relative to the handle portion. The lumen may be in communication with a first proximal opening in the handle portion and with a second proximal opening in the handle portion. A tool may be insertable into at least one of the first and second opening. A first proximal lumen and a second proximal lumen may join to form the lumen. The member may rest against a side surface of the lumen so that a tool may be disposed in the lumen along with the member. In the first configuration, a side surface of the lumen may engage a surface of the member. The member may transition from the first configuration to the second configuration due to a shape memory of the member. The insertion portion may further comprise a second lumen.

A method of treatment may comprise: advancing an insertion portion of a medical device in a body lumen of a subject; visualizing the body lumen using an imaging device of a member, wherein the member is disposed in a lumen of the insertion portion, and wherein the imaging device faces distally out of a distal opening of the lumen; moving the member longitudinally relative to the lumen, causing the imaging device to be located distally of the distal opening of the lumen and to face proximally; after moving the member, visualizing the body lumen using the imaging device; inserting a tool into the lumen of the insertion portion; and performing a procedure using the tool.

Any method described herein may include one or more of the features or steps described below. Moving the member may include sliding a hub at a proximal portion of the member, relative to a handle portion of the medical device. The member may include a flat shaft having a cross sectional width greater than a thickness and having at least one substantially planar outer surface. The shaft may be ribbon shaped. After moving the member, a distal end portion of the member may form a curl shape. A second tool may be inserted into a second lumen of the member.

A medical device may comprise: a member having a shaft, an imaging device, and an anchor member; a tool having a shaft; and a tether, comprising: a first surface, wherein the first surface is configured so as to slidably engage with the shaft of the member; and a second surface, wherein the second surface is configured so as to engage with the shaft of the tool to secure the tether to the tool as the tether slides relative to the member.

Any medical device described herein may include one or more of the features described below. The member may be configured to transition between a first configuration and a second configuration. In the first configuration, the imaging device may face distally. On the second configuration, the imaging device may face proximally. The first surface may define a first lumen for engaging the shaft of the member, and the second surface may define a second lumen for engaging the shaft of the tool. A surface of the tether may include an opening in communication with at least one of the first and second lumens. The anchor member may include at least one of the following: an inflatable member, a clip, and a coil. A steering mechanism may have a shaft. The second surface may be configured so as to engage with the steering mechanism to secure the tether to the steering mechanism as the tether slides relative to the member.

It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.” The term “endoscope” may be used herein but is not limiting. References to endoscopes may also include other medical devices, including, but not limited to, bronchoscopes and ureteroscopes.

DETAILED DESCRIPTION

The present disclosure is drawn to devices, systems, and/or methods for diagnosing and/or treating tissue using, for example, endoscopes, bronchoscopes, and ureteroscopes. More specifically, aspects of the present disclosure pertain to devices and methods for positioning and/or visualizing tools and/or devices within body lumens of a subject. In particular, in at least some aspects, the devices and methods disclosed herein may provide for visualization of an area of interest in a narrow passageway such as a bronchus. The devices and methods disclosed herein may facilitate advancement of tools to a visualized area of interest. Although respiratory anatomy may be referenced herein, reference to respiratory anatomy should not be construed as limiting possible applications of the disclosed devices and methods. The disclosed devices and methods may be suitable for use in a variety of portions of a subject's body, including, for example, urological organs or the digestive system.

FIGS.1-2depict a medical device10, which may have an insertion portion12and a handle portion14. A proximal end portion of insertion portion12may be connected to a distal portion of handle portion14. Insertion portion12may be disposed distally of handle portion14relative to an operator of device10. Medical device10may be a device, such as an endoscope, ureteroscope, bronchoscope, or other type of scope, catheter, or sheath. Insertion portion12may be inserted into a subject. For example, insertion portion12may be inserted into a body lumen of a subject. Insertion portion12may be an elongate member such as a shaft and may have a longitudinal axis. Insertion portion12may be steerable by any suitable mechanism.

Insertion portion12may have a distal end portion16, including a distal end face18. A lumen20may be within insertion portion12. For example, lumen20may extend from a proximal portion of insertion portion12to distal end portion16of insertion portion12. A longitudinal axis of lumen20may be coaxial with or parallel to a longitudinal axis of insertion portion12. Lumen20may lead to a distally-facing opening22in distal end face18. Lumen20may also include a first proximal portion24, which may extend into handle portion14. Lumen20may also include a second proximal portion26. For example, lumen20may diverge into two proximal portions24and26at a y-shaped or otherwise shaped junction. Proximal portion24may lead to an opening28in handle portion14. Proximal portion26may lead to an opening30in handle portion14. Thus, lumen20may be bifurcated, with two separate access points (opening28and opening30) providing access to lumen20.

Insertion portion12may also optionally include a second lumen40. Second lumen40may lead to a distal opening42in distal end face18. Second lumen40may also lead to an opening44in handle portion14. In addition or in an alternative, second lumen40may lead to openings28and/or30.

A member50may be inserted in lumen20. Member50may have an elongated shape. Member50may extend from proximal portion24of lumen20toward opening22. Member50may be flat or ribbon-shaped. In an alternative, member50may not be flat but may have a first flat surface and a second flat surface. Side surfaces connecting the flat surfaces may be short so that member50is substantially flat. In an alternative, member50may have a circular, polygonal, ovular, or other cross-section. Member50may be made at least partially from nitinol and may be made from a nitinol ribbon. Member50may exhibit shape memory.

Member50may include a distal portion52. Distal portion52of member52may include a camera portion54. Camera portion54may be disposed on a surface of distal portion52of member50. Signal cables may be operative to provide power to camera portion54, provide control signals to camera portion54, and/or retrieve images from camera portion54. Such signal cables may be adhered or otherwise attached to a surface of member50or embedded within member50. For example, signal cables may extend from a proximal portion of member50toward distal portion52of member50. Member50may also include other electronics, such as illumination components. For example, member50may include one or more light emitting diodes (LEDs) such as surface LEDs, printed LEDs, or other suitable devices.

A proximal portion of member50may be coupled to a hub60. Hub60may be formed of any suitable material, such as the same material comprising member50or a material comprising handle portion14. Hub60may be slidably disposed in a mating cavity62of handle portion28. Hub60may have a clearance fit with mating cavity62. One or more cables70may extend from a proximal portion of hub60and may provide power and/or control signals to camera portion54and/or transmit image data from camera portion54. Cables70may extend through or along hub60and along member50from a proximal portion of member50toward a distal portion52of member50. In addition or in an alternative, cables70may be electrically coupled to other cables which extend through or along hub60and/or along member50.

Sliding hub60relative to handle portion14and insertion portion12may cause movement of member50relative to handle portion14and/or insertion portion12. For example, sliding movement of hub60proximally or distally may cause member50, including distal portion52of member50, to move longitudinally (proximally or distally, respectively) relative to insertion portion12. Hub60may be connected to an actuator for effecting such sliding motion, or a user may effect a sliding motion via hub60alone. Longitudinal movement of member50via, e.g., hub60, may cause member50to transition from a first configuration (FIG.1) to a second configuration (FIG.2). In a first configuration (FIG.1), a distal portion52of member50, including camera portion54, may be located at or near opening22of lumen20. For example, distal portion52and/or camera portion54may be slightly longitudinally proximal to opening22, aligned with opening22, or slightly distal to opening22. In the first configuration, distal portion54may curve upward so that distal portion54forms roughly a right angle with respect to more proximal portions of member50, as shown inFIG.1. In such a configuration, camera portion54may face distally away from distal face18, out of opening22.

In a second configuration (FIG.2), distal portion52of member50, including camera portion54, may be located distally of opening22of lumen20. In the second configuration, distal portion52of member50may be curved upward and backward (in the proximal direction). In either the first or the second configuration, member50may curve smoothly, so that no sharp angles are formed in member50. In an alternative, member50may include angled and/or hinged portions in distal portion52. In the second configuration, camera portion54may face proximally, toward handle14. A proximal orientation of camera portion54may also include other directional components. For example, in addition to facing proximally, camera portion54may also face an upward or downward direction (a direction transverse to the longitudinal axis of member50). For example, inFIG.2., proximally-facing camera portion54also faces upward in a direction transverse to the axis. In the second configuration, member50may roll or curl back on itself by at least 180 degrees with camera portion54mounted on an outward-facing surface of member50near an end of the formed curl.

Member50may be biased to assume the shape of the second configuration or, in other words, member50may be biased so that camera portion54faces proximally. For example, member50may have shape memory. When member50is in the first configuration, the size and shape of lumen20may prevent member50from facing proximally. For example a portion of distal portion52may interact with an interior surface of lumen20and/or opening22. For example, a distal edge of member50may interact with a top surface, a bottom surface, and/or a side surface of lumen20and/or opening20. Movement of hub60, which may be connected to a proximal portion of member50, may cause member50to transition from the first configuration to the second configuration, and from the second configuration to the first configuration. When hub60is moved distally, member50may transition to the second configuration. For example, member50may transition due to removal of engagement of distal end portion52with one or more inner surfaces of lumen20and/or opening22. Member50may transition due to shape memory or other biasing of member50. When hub60is moved proximally, member50may transition to the first configuration. For example, proximal movement of member50may cause member50to partially unwind due to, for example, engagement of distal end portion52with one or more surfaces of lumen20and/or opening22. Hub60may be omitted, and another actuation mechanism may be used to transition member50from the first configuration to the second configuration and from the second configuration to the first configuration.

FIG.3shows a close-up of distal end portion16with member50in the first configuration. Distal end portion52of member50may be oriented so that camera portion54faces distally out of opening22. Distal end portion52may lie in a plane that is transverse to the longitudinal axis of insertion portion12and to the longitudinal axis of a proximal portion of member50. Distal end portion52may lie in a plane that is parallel or substantially parallel to a plane of opening22. As shown inFIG.3, opening42of lumen40may be transverse to distal end face18. For example, opening42may be an elongate opening which is disposed both on a side surface of insertion portion12and on a distal end face18. For example, opening42may open to the side and distally.

FIG.4shows a close-up of distal end portion16in the second configuration. Distal end portion52of member50may be oriented so that camera portion54faces proximally and is extended distally of opening22. Proximally-facing camera portion54may also face to the side, in this case upwardly. As shown inFIGS.2and4, when member50is in the second configuration, member50may occupy only a small portion of lumen20and opening22so that a tool102may be inserted in lumen20along with member50. For example, member50may lie along one side of lumen20such as a bottom side of lumen20. Tool102may be any of a variety of tools for use in a body lumen of a patient. For example, tool102may be a probe such as an ultrasound probe, radio frequency probe, and/or cryogenic probe. Tool102may also be a forceps, a snare, a basket, a tome, a suction device, or any other type of diagnostic or therapeutic tool. The examples above are not exclusive; any type of tool or accessory may be used. The fact that tool102may be inserted into lumen20along with member50may mean that a diameter of insertion portion12may be smaller than conventional scopes because one lumen can be used for both a member50including camera portion54and a tool102. A smaller diameter of insertion portion12may allow use of insertion portion12in narrower body lumens. For example, insertion portion12may be inserted into a subject's lungs, whereas other types of medical devices may be limited as to how far they can extend into a body lumen such as bronchial passages. In addition, because tool102and member50are narrower than insertion portion12, they may reach further into body passages than insertion portion12may reach.

As also shown inFIG.4, another tool104may be inserted into lumen40and may extend out of opening44. Tool104may include any of the tools described in connection with tool102. Tool104may exit opening40at an angle transverse to a longitudinal axis of insertion portion12. Alternatively, tool104may exit opening40parallel to a longitudinal axis of insertion portion12.

FIG.5depicts medical device10in a body lumen. The body lumen shown inFIG.5is a bronchial lumen; however, device10may be used in any body lumen. Device10may optionally be used in conjunction with an introduction device150. Introduction device150may be a scope, such as an endoscope, ureteroscope, bronchoscope, duodenoscope, or any other type of scope, catheter, or sheath. Introduction device150may have a larger diameter than device10. Introduction device150may include a lumen152. Lumen152may be sized so as to allow passage of medical device10through lumen152. Introduction device150may also include other lumens154,156through which other devices may be passed. Introduction device150may be advanced to a certain portion of a body lumen. Introduction device150may reach a point in a body lumen where device150is too large in diameter to pass further into the body lumen. Insertion portion12may be further advanced into the lumen. The small diameter of insertion portion12may facilitate advancing insertion portion12into a further and/or narrower portion of a body lumen than other scopes could reach. For example, as described above with regard toFIG.4, because tool102and member50may occupy the same lumen20, an outer diameter of insertion portion12may be smaller than if two separate lumens were required for tool102and member50.

When a distal end portion16of device10is proximal of an area of interest, member50may be advanced into the second configuration, as shown inFIG.5. In the second configuration, camera portion54may be directed toward an area of interest in a body lumen. For example, as shown inFIG.5, an area of interest may be located between a distal face18of insertion portion12and distal portion52of member50. Camera portion54may, for example, capture images of a side surface of a body lumen and/or of a central portion of a body lumen, proximal to a location of camera portion54. Tool102may be deployed toward the area of interest. Tool104(FIG.4) may also be deployed toward the area of interest. Tools102and/or104may be used to perform therapeutic and/or diagnostic procedures on an area of interest in a body lumen.

FIG.6shows another embodiment according to the present disclosure, which may be used in conjunction with or in an alternative to the aspects described above with regard toFIGS.1-5. As shown inFIG.6, a distal portion of a medical device200may include an insertion portion210. Insertion portion210may have any of the qualities of insertion portion12or introduction device150, described above. Insertion portion210may include a camera212to provide imaging of a body lumen of a subject. Insertion portion210may also include other features, such as illumination features (not shown). Insertion portion212may include a lumen214. Lumen214may have any of the qualities of, for example, lumen152.

A member220may be inserted through lumen214and may extend out of an opening at a distal end of lumen214and on a distal face of insertion portion212. Member220may have any of the qualities of member50, described above. In an alternative, member220may have differing qualities from member50. For example, member220may have a round cross-section. Member220may include a shaft222, which may extend from a proximal end (not shown) of insertion portion210, through insertion portion210, and out an end of insertion portion210. Member220may be steerable (see, e.g.,FIGS.11A-11C, discussed in further detail below). For example, one or more steering mechanisms may be disposed within an inside lumen of member220or on an external surface of member220. Member220may have a distal portion224. Distal portion224may include an atraumatic tip. For example, an atraumatic tip may be formed from a soft durometer material, such as silicone, polyurethane, soft durometer pebax, or any other suitable material.

Distal portion224may include a camera portion226and/or an illumination portion. Camera portion226may be disposed in a lumen of distal portion224or on an exterior surface of distal portion224. Distal portion224may be formed at least partially of transparent material. Camera portion226may incorporate an illumination mechanism. Camera portion226may include components such as lenses and imagers. Camera portion226may be mounted at an angle between 0 degrees and 70 degrees relative to a longitudinal axis of member220. If camera portion226is mounted at an angle of 0 degrees, an end face of camera portion226(which, in one example, may include a planar surface of a cover, lens, or the like) may lie flat against the longitudinal axis of member220, or may lie parallel to the longitudinal axis of member220, such that the end face may face a sideways direction. The end face may, for example, face a direction perpendicular to the longitudinal axis of member220. If camera portion226is angled with respect to the longitudinal axis of member220, its end face may face either proximally (see, e.g.,FIGS.8A and8B) or distally (see, e.g.,FIGS.9A,10A, and10B). The end face may, for example, face a direction transverse to, but not perpendicular to, the longitudinal axis of member220. An angle of tilt may be measured between the end face of camera portion226and the longitudinal axis of member220. Camera portion226may be at least partially proximally facing so that camera portion226may view an area proximal of camera portion226. Camera portion226may also face in a lateral, or side, direction relative to member220. In an alternative, camera portion226may face distally so that camera portion226may view an area distal to camera portion226. Distal portion224may also include an anchor member228. Anchor member228may be used to secure distal portion224in a body lumen of a subject at a location of interest. While anchor member228is shown being located distally of camera portion226inFIG.6, other configurations are also available. For example, camera portion226may be located distally of anchor member228.

A tether240may engage with shaft222of member220.FIGS.7A-7C, discussed in further detail below, show potential configurations of tether240. Tether240may be slidable or otherwise longitudinally movable with respect to member220. For example, tether240may slide along shaft222of member220. Tether240may have a smaller cross-section than a cross-section of lumen214, so that tether240can fit within lumen214. Tether240may be capable of sliding proximally to a proximal portion of insertion member210and distally out of an opening of lumen214. Tether240may be prevented from sliding distally past distal portion224of member220. For example, distal portion224may be wide enough that tether240may not move past distal portion224.

A tool250may also be inserted through lumen214and may extend out of an opening on a distal face of insertion portion212. Tool250may include a shaft252. Tether240may also engage with shaft252of tool250. One or more surfaces of tether240may have an interference fit with one or more surfaces of tool250. Movement of tether240longitudinally with respect to member220therefore may result in longitudinal movement of tool250with respect to member220. Tool250may also have an atraumatic tip at a distal portion254. An atraumatic tip of tool250may have any of the qualities of an atraumatic tip of member210, discussed above. An atraumatic tip or other feature of tool250may prevent tether240from moving off of a distal end of tool250, so that tool250may be stationary relative to tether240.

FIGS.7A-7Cdepict different exemplary cross-sectional configurations of tethers. As shown inFIG.7A, an exterior surface260of tether240may have a circular cross-section. Such a circular cross-section is merely exemplary. Tether240may have any suitable cross-sectional shape. Tether240may have a lumen262formed therein. A shaft222of member220may be slidably disposed within lumen262. Lumen262and shaft222may be sized and shaped so as to allow for translational sliding of tether240along shaft222of member220while tether240is coupled to shaft252of tool250. For example, lumen262and shaft222may be sized and shaped so that there is a clearance fit between lumen262and shaft222. While lumen262and shaft222are shown inFIG.7Aas having circular cross-sections, lumen262and shaft222may have any suitable shape and size. For example, shaft222may be keyed to lumen262. Shaft222and/or lumen262may have an ovular, polygonal, or other shape. For example, shaft222and/or lumen262may have a hexagonal or star shape. Alternatively, member220may have any of the properties of member50, described with regard toFIGS.1-5above, and tether240may be configured to work in conjunction with such a member. For example, shaft222may have a substantially flat shape (width substantially greater than thickness), and lumen262may have a corresponding substantially flat rectangular shape.

Tether240may also have another lumen264formed therein. Shaft252of tool250may be disposed within lumen264. Shaft252and lumen264may be sized and shaped so as to have an interference fit or a slight interference fit with one another. The interference fit or slight interference fit may serve as a locking and/or mating mechanism between shaft262and lumen264, securing the two together during translational movement relative to shaft222. While lumen264and shaft252are shown inFIG.7Aas having a circular cross-section, lumen264and shaft252may have any suitable shape and size. For example, shaft252may be keyed to lumen264. Shaft252and/or lumen264may have an ovular, polygonal, or other shape. One or both of shaft252and/or lumen264may additionally or alternatively have anchoring mechanisms which may prevent or limit translational movement between shaft252and lumen264. When tether240moves longitudinally with respect to member220, tool250may also move longitudinally with respect to member220. While lumen262is shown as having a smaller cross-sectional diameter than lumen264, lumen262may be larger than lumen264, or lumens262and264may be the same size. WhileFIGS.7A-7Cdepict shaft222as having a smaller diameter than shaft252, shaft222may be the same size as shaft252or may be larger than shaft222.

FIG.7Bdepicts an alternative exemplary configuration of a tether denoted240′. As shown inFIG.7B, tether240′ may have an outer surface270and lumens272,274. Surface270may include side openings276,278in communication with lumens272,274. Openings276,278may extend from a proximal portion of tether240′ to a distal portion of tether240′. Openings276,278may be parallel to a longitudinal axis of tether240′. Openings276,278may be disposed approximately 180 degrees apart from one another. Alternatively, openings276,278may be disposed at a smaller angle from one another. Opening276may have a width which is smaller than a diameter of shaft222of member220. Opening278may have a width that is smaller than a diameter of shaft252of tool250.

Shaft222of member220may be slidably disposed in lumen272. Lumen272may have any of the properties of lumen252, described above with regard toFIG.7A. Tether240may have lip portions280at either side of opening276. Lip portions280may be deformable so that shaft222may be pressed and/or snapped into lumen272via opening276. Shaft252of tool250may be disposed within lumen274. Lumen274may have any of the properties of lumen264, described above with regard toFIG.7A. Tether240may have lip portions282at either side of opening278. Lip portions282may be deformable so that shaft252may be pressed and/or snapped into lumen274via opening278. As described with regard toFIG.7A, when tether240moves longitudinally with respect to member220, tool250may also move longitudinally with respect to member220. In an alternative, a tether may contain one lumen with an opening (for example, such as lumens272and274) and one lumen without an opening (for example, such as lumens262and264).

FIG.7Cdepicts a further exemplary configuration of a tether240″. As shown inFIG.7C, tether240″ may have a protruding surface280that is configured to engage with a broken lumen surface282of shaft252of tool250. Shaft surface282and tether surface280may be sized and shaped so as to have an interference fit with one another so as to lock and/or mate to one another, securing the two together as tether240″ translates relative to member220. Tether surface280may be pressed and/or snapped into a lumen defined by shaft surface282. Shaft252may include surface282at only a distal portion254of tool250, or shaft252may include surface282along a greater portion of a length of shaft252, such as an entirety or a majority of shaft252. While shaft surface282and tether surface280are shown inFIG.7Cas being rounded, shaft surface282and tether surface280may have any suitable shape and size. For example, shaft surface282may be keyed tether surface280. Shaft surface282and/or tether surface280may have an ovular, polygonal, teardrop, or other shape. For example, shaft surface282and/or tether surface280may have a hexagonal, a triangular, or a star shape. One or both of shaft surface282and/or tether surface280may additionally or alternatively have anchoring mechanisms which may prevent or limit translational movement between shaft surface282and tether surface280.

Tether240″ may also have a lumen284. Lumen284may have any of the properties of lumens262and/or272, described above with regard toFIGS.7A-7B. A surface of tether240″ may include an opening286that is in communication with lumen284. In an alternative, tether240″ may lack such opening286and lumen284may be similar to lumen262, described above. Tether240may have lip portions288at either side of opening286. Lip portions288may be deformable so that shaft222may be pressed and/or snapped into lumen284via opening286. As described with regard toFIGS.7A-7B, when tether240″ moves longitudinally with respect to member220, tool250may also move longitudinally with respect to member220.

FIGS.8A and8Bshow exemplary distal portion224of member220. Distal portion224may include a surface302defining a space that may contain camera portion226. Surface302may be transparent. In an alternative, camera portion226may be disposed on any outer surface of shaft222. Camera portion226may be connected to a cable304which may provide power and/or control signals to camera portion226and/or transmit images obtained by camera portion226. Cable304may be disposed in a lumen306of member220.

Anchor228may include an expandable member310.FIG.8Ashows expandable member310in a collapsed configuration, andFIG.8Bshows expandable member310in an expanded configuration. Expandable member310may be an inflatable member such as a balloon. The wall of shaft222of member220may include openings312,314therethrough. Openings312and314may be in communication with an interior of expandable member310and with lumen306. Air, fluid, or another medium may be passed through lumen306and through openings312and314in order to expand expandable member310. When expandable member310is in an expanded configuration (FIG.8B), expandable member310may engage with walls of a body lumen, such as the body lumen shown inFIG.6. Engagement of expandable member310with walls of a body lumen may serve to anchor member220in place so that member220may not be longitudinally movable when expandable member310is in an expanded configuration.

Expandable member310may have a variety of shapes and sizes. A longitudinal length of expandable member (along a longitudinal axis of member220) as well as a radial width of expandable member (extending orthogonally from member220) may be any suitable amount. For example, expandable member310may have a circular cross section having a diameter of approximately 4-5 mm. In an alternative, expandable member310may have a hexagonal cross section having a greatest width dimension of approximately 10 mm. Alternatively, expandable member310may have any other cross-sectional geometry and any diameter or cross-sectional size that is effective in anchoring member220to a body lumen in an expanded configuration. For example, a diameter or cross-sectional size of expandable member310may be approximately 2 mm-5 mm or 2 mm-6 mm. Expandable member310may be a non-compliant balloon formed of a semi-rigid material such as PEBAX, PET, or any other suitable material. Alternatively, expandable member310may be a compliant balloon formed of a soft durometer material such as silicone, polyurethane, or any other suitable material.

FIGS.9A-9Bshow another exemplary distal portion224′ of member220′.FIG.9Ashows a side view of distal portion224′, andFIG.9Bshows a top view of distal portion224′ rotated 90 degrees relative toFIG.9A. Distal portion224′ may include a surface320, which along with surface324of member220′, defines a lumen that may contain camera portion226and a cable326. Surface320may project radially outward to form a surface322near camera portion226. Surfaces320and/or322may be transparent. In addition or in an alternative, camera portion226may be disposed on a surface of shaft222(such as surface324). Camera portion226may be connected to cable326, which may provide power and/or control signals to camera portion226and/or transmit images from camera portion226. Surface320may extend proximally from distal portion224′ so that cable326passes through a lumen defined by surface320instead of a central lumen (such as lumen333) of member220′. In an alternative, cable326may pass through lumen333.

Anchor228′ may include a clipping mechanism330. Clipping mechanism330may include a control member332. Control member332may be slidably disposed in a lumen333of shaft222so that control member332and other portions of clipping mechanism330may move longitudinally relative to shaft222. A distal portion of control member332may be fixed to a proximal portion of a pair of jaws334. Jaws334may include curved end portions336. End portions336may curve toward one another. Jaws334may be moved laterally relative to one another so that they may be opened and closed. Jaws334may be biased toward an open configuration. For example, a shape of jaws334may be such that jaws334are biased in an open configuration and/or jaws334may be made of material having shape memory. In a first configuration, control member332and jaws334may be disposed within a lumen of shaft222. In the first configuration, jaws334may be in a closed position resulting from pressure exerted by walls of lumen333on jaws334. In a closed position, tips336of jaws334may contact one another, may be near to one another, or may overlap one another. Control member332may be slid longitudinally relative to shaft222so that jaws334extend completely through a distal opening338of lumen333in a second configuration. After clipping mechanism330is moved into the second configuration, jaws334may be in an open position due to the bias of jaws334and the absence of pressure from the walls of lumen333. In an open configuration, there may be a gap (or a relatively larger gap) between tips336.

In order to achieve an anchoring function such as via clamping jaws334, control member332may be retracted into a third configuration so that a proximal end of jaws334is within lumen333. The pressure of the walls of lumen333and/or opening338on the proximal ends of jaws334may cause tips336of jaws334to move toward one another. Body tissue that is between tips336of jaws334when the clipping mechanism330is transitioned to the third configuration may be pinched by tips336and/or other portions of jaws334in the third configuration. Closing jaws334around tissue may result in anchoring of clipping mechanism330and member220to the tissue. Jaws334may angle away from a longitudinal axis of lumen333so that tips336extend past an exterior surface of shaft220, toward a side surface of a body lumen, as shown inFIG.9A. Jaws334may each diverge from the longitudinal axis of lumen333so that jaws334are substantially parallel to one another. Angling of jaws334away from the longitudinal axis of lumen333may facilitate engagement of jaws334with tissue on a size surface of the body lumen.

FIGS.10A-10Bdepict another exemplary distal portion224″ of member220″. The example ofFIGS.10A and10Bmay be similar to the example ofFIGS.9A and9B, except with respect to the features described below. Anchor228″ may include an auger member340. Auger member340may have an elongated control member342disposed within lumen333of shaft222. Control member342may be rotatable relative to shaft222. A distal portion of control member342may be attached to a coil344. Coil344may be a corkscrew-type coil that may have one, two, four, or any other suitable number of coils. A distal end of coil344may include a pointed tip346that may be sharp. Control member342may be longitudinally movable relative in lumen333relative to shaft222so that coil344may be retracted into lumen333and extended out of opening338in lumen333. Coil344may be made of a wire and may be made from, for example, stainless steel, elgiloy and other cobalt-containing alloys, nitinol, titanium, platinum or any other suitable material that may be formed into a coil shape and may have requisite stiffness to maintain the shape and to move through a tissue of a subject.

Auger member340may be transitioned from a first configuration to a second configuration. In a first configuration (FIG.10A), coil344may be navigated to a target site within a lumen of a subject. Coil344then may rest against a wall360of a body lumen without engaging the tissue of the wall360. Auger340may be transitioned to a second configuration (FIG.10B) by rotating control member342about its own axis. Rotation of control member342may cause rotation of coil344. Pointed tip346of coil344may pierce a tissue surface of a wall360of the body lumen. Continued rotation of control member342may cause pointed tip346to pass through tissue before exiting into the body lumen again. Coil344may continue to pierce and/or pass through the tissue with continued rotation of control member342. Engagement of coil344with the tissue may cause member220″ to be fixed in a desired location in the body lumen.

FIGS.11A-11Cdepict exemplary steering mechanisms. As shown inFIG.11A, member220(like member220inFIG.6) may be navigated to a desired location by a steering member400. Steering member400may be coupled to tether240(like tether240inFIG.6). For example, shaft402of steering member400may be inserted into a lumen of tether240. An end cap portion404of steering member400may restrain steering member400so that it remains coupled with tether240. Steering member400may have an interference fit with a lumen of tether240. Steering member400may have any of the properties of tool252, described above, including those described with regard toFIGS.7A-7C. Tether240may also have any of the properties described above, including those described with regard toFIGS.7A-7C. Steering member400may also have a steering mechanism410that may be disposed inside of steering member400(e.g., in a lumen of shaft402) or outside of shaft402.FIG.11Adepicts an exemplary embodiment wherein steering mechanism410is disposed within a lumen of shaft402for a portion of a length of shaft402and is disposed outside of shaft402at another portion of a length of shaft402. Steering mechanism410may exit shaft402via a hole near the distal end of shaft402. Steering mechanism410may be, for example, a wire or a cable or any other suitable mechanism. Member220may also be slidably secured to tether240, using any of the methods or mechanisms described above.

After steering member400and member220are coupled to tether240, steering member400, member220, and tether240may be advanced through a lumen214of an insertion portion210. Interaction between tether240and distal portion224of member220(e.g., the distal end of tether240abutting the proximal end of an enlarged portion of distal portion224) may cause member220to be advanced along with tether240and steering member400. Steering member400, member220, and tether240may extend out of a distal opening of lumen214and advanced distally of insertion portion210. A relatively smaller size of tether240, steering member400, and member220may allow those components to reach narrower body lumens, such as bronchial lumens, than could be reached by insertion portion210.

Steering mechanism410may extend proximally through a lumen214of insertion portion210to a control device. Actuation of steering mechanism410may cause bending of a distal portion of steering member400, as shown inFIG.11B. For example, actuation of steering mechanism410may cause a shortening of steering mechanism410. After steering member400is used to position member220in a desired location of a subject's body lumen, member220may be anchored using anchor member228. Steering member400and tether240may then be retracted through lumen214so that an operator may detach steering member400from tether240. A tool250may then be secured to tether240and advanced through lumen214of insertion portion210. Member220may act as a guidewire for tether240and tool250. Tether240may ride along shaft222of member220so that tool250can be transported to a location of interest, proximate to distal portion224of member220. Tool250may then be used to conduct a variety of diagnostic or treatment procedures on a subject. Tool250may eventually be retracted through lumen214and replaced by another tool250, using the method described above. The above process may be repeated any number of times. At the end of a procedure, anchor portion228may be disengaged so that member220is no longer secured to a body lumen of a subject. Member220may then be retracted through lumen214.

FIG.11Cshows an exemplary alternative configuration wherein member220includes a steering mechanism450such as a steering wire or cable or any other suitable mechanism. Steering mechanism450may have any of the properties of steering mechanism410, described above. Steering mechanism450may be disposed inside of member220(e.g., in a lumen of shaft222) or outside of shaft222.FIG.11Cdepicts an exemplary embodiment wherein steering mechanism450is disposed within a lumen of shaft222for a portion of a length of shaft222and is disposed outside of shaft222at another portion of a length of shaft402. Actuation of steering mechanism450may cause bending of a distal portion of member220, as shown inFIG.11C. For example, actuation of steering mechanism450cause a shortening of steering mechanism450.

In use, member220may be advanced toward a desired location of a subject's body lumen. Steering mechanism450may aid in such positioning. Member220may then be anchored using anchor member228. A tool250may then be secured to tether240. Tether240may be secured to member220if it is not already secured to member220. Tool250and tether240may then be advanced through lumen214of insertion portion210. Member220may act as a guidewire for tether240and tool250. Tether240may ride along shaft222of member220so that tool250can be transported to a location of interest, proximate to distal portion224of member220. Tool250may then be used to conduct a variety of diagnostic or treatment procedures on a subject. Tool250may eventually be retracted through lumen214and replaced by another tool250, using the method described above. The above process may be repeated any number of times. At the end of a procedure, anchor portion228may be disengaged so that member220is no longer secured to a body lumen of a subject. Member220may then be retracted through lumen214.

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