Patent Description:
Surgical procedures of the respiratory system may include, for example, removal of a mass or growth (e.g., pulmonary nodule) located within a lung, among others. These procedures may involve accessing a bronchus within the lung of a patient. Accessory devices for performing such procedures may include limited control or maneuverability, especially within small and tortuous bronchioles. Further, interfaces of such devices may provide limited articulating capabilities for maneuvering the device through the bronchiole, thereby requiring use of additional devices or multiple hands to manipulate said device.

<CIT> discloses a surgical apparatus that includes a body, an ultrasonic transducer, a shaft, an acoustic waveguide, an articulation section, an end effector, and a restricting member. The ultrasonic transducer is operable to convert electrical power into ultrasonic vibrations. The shaft couples the end effector and the body together. The acoustic waveguide is coupled with the transducer. The articulation section is operable to flex to thereby deflect the end effector from a longitudinal axis defined by the shaft. The restricting member is operable to restrict lateral deflection of the end effector. The restricting member is further operable to cooperate with a translating member to rigidize the articulation section when the end effector is aligned with the longitudinal axis. Such rigidization includes removing any "play" or other small movement that might otherwise be provided by the articulation section due to manufacturing tolerances and/or looseness between parts.

<CIT> discloses a medical device that includes an articulating shaft with a pair of slat assemblies. By moving an articulator, the slat assemblies are configured to concurrently push while the other pulls in order to bend the articulating shaft. The articulating shaft includes a series of alternating pins and pivot members. Each pin defines an aperture that collectively forms a passageway for receiving an actuator or a tube. The pair of slat assemblies extend generally parallel to each other on opposite sides of the pins. A method for articulating a shaft of a medical device is also provided.

<CIT> discloses a device for laparoscopic surgery comprising a surgical instrument having an elongated shaft that is at least partially bendable with a surgical tool coupled to a distal end of the elongated shaft and a handle coupled to a proximal end of the elongated shaft to manipulate the surgical tool and a bendable elongated guide coupled to the handle to support the surgical instrument.

The invention is defined by independent claim <NUM>, while further embodiments are disclosed by the dependent claims.

Aspects of the disclosure relate to, among other things, systems devices, and methods for treating a target treatment site using an articulating device providing enhanced degree of maneuverability, among other aspects.

Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

According to an example, a medical device includes a handle, an actuator movably coupled to the handle, a shaft extending distally from the handle, and a sheath including a distal end disposed within the shaft and a proximal end disposed within the handle. The sheath includes a plurality of branches secured to one another at the distal end and separated from one another at the proximal end. The actuator is coupled to each of the plurality of branches at the proximal end of the sheath, and the actuator is configured to move each of the plurality of branches relative to one another to articulate the shaft in a plurality of directions.

Any of the medical devices described herein may include any of the following features. The actuator includes a ball joint at least partially disposed within the handle. The plurality of branches are disposed about the ball joint in an annular array. The ball joint includes an opening that is configured to receive one or more devices. The plurality of branches form a closed lumen along the distal end of the sheath and an open lumen at the proximal end of the sheath. The closed lumen is completely surrounded along a first length of the sheath by the plurality of branches, and the open lumen is not completely surrounded along a second length of the sheath by the plurality of branches. The open lumen and the closed lumen are aligned with the opening in the ball joint, such that the sheath is configured to receive the one or more devices extending through the ball joint into the open and closed lumens. The plurality of branches are secured to an interior surface of the shaft at the distal end of the sheath. The plurality of branches are secured to a flexible tube disposed within the shaft along the distal end of the sheath. The plurality of branches are movable relative to one another at the proximal end of the sheath. The plurality of branches translate and rotate relative to the handle. The handle includes a first channel and a second channel that has a cross-sectional profile that is smaller than the first channel. The proximal end of the sheath and at least a portion of the actuator is received within the first channel. A proximal portion of each of the plurality of branches is disposed within and spaced apart from one another in the first channel. The proximal portion of each of the plurality of branches is configured to flex radially within the first channel in response to movement of the actuator relative to the first channel. A distal portion of each of the plurality of branches is received within the second channel. The distal portion of each of the plurality of branches is configured to translate within the second channel in response to movement of the actuator relative to the first channel. Further including a cutting tool positioned on a distal end of the shaft.

According to another example, a medical device includes a handle, an actuator rotatably coupled to the handle, a shaft extending distally from the handle, and a sheath including a plurality of branches. The plurality of branches are secured to the actuator at a proximal end and to the shaft at a distal end. The plurality of branches are movable relative to one another at the proximal end and immovable relative to one another at the distal end. The actuator is configured to articulate the shaft by rotating relative to the handle and translating at least one of the plurality of branches relative to the remaining plurality of branches.

Any of the medical devices described herein may include any of the following features. The actuator includes a ball joint at least partially disposed within the handle, and the plurality of branches are disposed about the ball joint in an annular array. The ball joint includes an opening that is configured to receive one or more devices. The plurality of branches form a closed lumen along the distal end of the sheath and an open lumen at the proximal end of the sheath. The closed lumen is completely surrounded along a first length of the sheath by the plurality of branches, and the open lumen is not completely surrounded along a second length of the sheath by the plurality of branches. The open lumen and the closed lumen are aligned with the opening in the ball joint, such that the sheath is configured to receive the one or more devices extending through the ball joint into the open and closed lumens. The handle includes a first channel and a second channel that has a smaller diameter than the first channel. A proximal portion of each of the plurality of branches is configured to flex radially within the first channel in response to movement of the actuator relative to the first channel. A distal portion of each of the plurality of branches is configured to translate within the second channel in response to movement of the actuator relative to the first channel.

According to a further example, a medical device includes a handle, a shaft extending distally from the handle, an end effector at a distal end of the shaft, and an actuator secured to the shaft. The actuator is configured to provide omnidirectional movement of the distal end of the shaft. The medical device includes a sheath disposed within the shaft and defining a lumen that receives the end effector. A proximal end of the sheath is attached to the actuator and a distal end of the sheath is attached to the shaft. The sheath is bifurcated into at least a first branch and a second branch, and the actuator is configured to move the first branch relative to the second branch at the proximal end of the sheath to articulate the distal end of the shaft and deflect the end effector.

Access to a bronchus (e.g., a bronchiole) within a patient to remove a target object has been proposed. In such procedures, the target object may be a mass or growth, such as a pulmonary nodule, located within a bronchus. The bronchus may include one or more bronchioles defining a passageway with a relatively small diameter. An ancillary device capable of removing the target object may be placed through the bronchiole via a medical instrument (e.g., a bronchoscope) capable of maneuvering through the bronchus to access the target treatment site. Ancillary devices, medical instruments, and systems suited for traversing the bronchus are limited, however.

Examples of the disclosure include systems, devices, and methods for manipulating materials and/or objects (e.g., pulmonary nodule) at a target treatment site within a subject (e.g., patient) with enhanced degree of maneuverability. In examples, accessing a patient's lung includes endoluminal placement of an end effector, e.g., a jaw assembly, needle assembly, cautery knife, or other like tool into the target treatment site. Placement of the end effector may be via a catheter, scope (endoscope, bronchoscope, colonoscope, etc.), tube, or sheath, inserted into an anatomical passageway via a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and the placement can be in any portion of the respiratory tract, including the throat. Placement also can be in other organs or body lumens, including any portion of the gastrointestinal tract, urologic tract, etc. This disclosure is not limited to any particular medical procedure or treatment site within a body.

Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a patient. By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the subject. 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 necessarily 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. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of a stated value.

Examples of the disclosure may relate to devices and methods for performing various medical procedures and/or treating portions of the respiratory tract, and/or any other suitable patient anatomy (collectively referred to herein as a "target treatment site"). As mentioned above, this disclosure is not limited to any specific medical device or method, and aspects of the disclosure may be used in connection with any suitable medical tool and/or medical method, at any suitable site within the body. Various examples described herein include single-use or disposable medical devices.

<FIG> shows an exemplary medical device <NUM> in accordance with an example of this disclosure. Medical device <NUM> may include a handle <NUM>, an actuator <NUM>, and a shaft <NUM>. Handle <NUM> may include a proximal body <NUM> and a distal body <NUM>, with proximal body <NUM> defining an interface for manually grasping handle <NUM>. In the example, handle <NUM> may further include a connection port <NUM> (e.g., an electrical connection) for coupling one or more devices to medical device <NUM>. For example, a cable coupled to an ancillary device may be coupled to handle <NUM> at connection port <NUM>. Distal body <NUM> may extend distally from proximal body <NUM>, and shaft <NUM> may extend distally from distal body <NUM>.

In the example, shaft <NUM> may be at least partially received in handle <NUM>, such as within distal body <NUM>. Handle <NUM> may include a distal end <NUM> extending distally from distal body <NUM>, and including a strain relief configured to maintain shaft <NUM> outwardly from distal body <NUM> in a distal direction, and relieve strain at the interface of shaft <NUM> and distal body <NUM>. Shaft <NUM> may include a proximal shaft segment <NUM> and a distal articulation joint <NUM> that extends distally from proximal shaft segment <NUM>. In the example, proximal shaft segment <NUM> may form a unitary component with distal articulation joint <NUM>. In other examples, distal articulation joint <NUM> may be attached to a distal end of proximal shaft segment <NUM>. Shaft <NUM> may further include an opening <NUM> at a distal end of distal articulation joint <NUM>. As described in further detail herein, one or more devices received through a lumen of shaft <NUM> may be extended distally from distal articulation joint <NUM> via opening <NUM>.

Still referring to <FIG>, actuator <NUM> may be movably coupled to handle <NUM>. In the example, actuator <NUM> may be positioned along proximal body <NUM>. Actuator <NUM> may include a ball joint <NUM> and a knob <NUM> extending laterally outward from ball joint <NUM>. Ball joint <NUM> may be at least partially received within an opening along a proximal face of proximal body <NUM>. In some examples, ball joint <NUM> may have a shape (e.g., spherical) that corresponds with a shape of the opening on proximal body <NUM>. Actuator <NUM> may further include an opening <NUM> disposed through ball joint <NUM>, and configured to receive one or more devices therethrough. It should be appreciated that opening <NUM> may facilitate access to one or more lumens and/or cavities disposed within handle <NUM>. As described further herein, actuator <NUM> may be configured to articulate distal articulation joint <NUM> in response to moving relative to handle <NUM>.

In some embodiments, medical device <NUM> may further include a guidewire assembly <NUM>, a port assembly <NUM>, and a tool assembly <NUM>. Guidewire assembly <NUM> may include a proximal knob <NUM> and a distal shaft <NUM> extending distally from proximal knob <NUM>. Proximal knob <NUM> may define a grasping feature that facilitates manual manipulation of guidewire assembly <NUM> by a user of medical device <NUM>. For example, rotation and/or translation of proximal knob <NUM> may provide simultaneous rotation and/or translation of distal shaft <NUM>, such as, for example, relative to handle <NUM> and/or shaft <NUM>. Guidewire assembly <NUM> may be sized and/or shaped to extend into handle <NUM> via opening <NUM>, and through a lumen of shaft <NUM>.

Proximal knob <NUM> and distal shaft <NUM> may include a lumen <NUM> (see <FIG>) extending between a proximal end of proximal knob <NUM> and a distal end of distal shaft <NUM>, with proximal knob <NUM> including an opening <NUM> that facilitates access to lumen <NUM>. Guidewire assembly <NUM> may be configured to receive one or more devices through opening <NUM>, such as, for example, port assembly <NUM>, tool assembly <NUM>, and more. As described in detail herein, guidewire assembly <NUM> may facilitate positioning the one or more devices through handle <NUM> and outwardly from shaft <NUM> via opening <NUM>. Distal shaft <NUM>, which may be made of Nitinol or other suitable materials, may transmit torque from the proximal end of medical device <NUM> to the distal end of medical device <NUM>. In other embodiments, guidewire assembly <NUM> may be omitted entirely from medical device <NUM>.

Still referring to <FIG>, port assembly <NUM> may include a proximal knob <NUM> and a distal shaft <NUM>. Proximal knob <NUM> may define a grasping feature that facilitates manual manipulation of port assembly <NUM> by a user of medical device <NUM>. Proximal knob <NUM> may include an attachment mechanism, such as one or more threads (e.g., a luer connector), configured to facilitate connection of port assembly <NUM> to one or more ancillary devices (e.g., a fluid source, a pressure medium source, etc.). Port assembly <NUM> may include an opening <NUM> at proximal knob <NUM> that is configured to receive one or more devices or fluids therein. Distal shaft <NUM> may extend distally from proximal knob <NUM>, and may be sized and shaped to be received within opening <NUM> and/or opening <NUM>. With distal shaft <NUM> received within one of opening <NUM> and/or opening <NUM>, port assembly <NUM> may be effectively coupled to shaft <NUM> via one or more of handle <NUM> and/or guidewire assembly <NUM>.

In some embodiments, port assembly <NUM> may be fixed to guidewire assembly <NUM>. For example, distal shaft <NUM> may be received through opening <NUM> and crimped to proximal knob <NUM> to securely fix port assembly <NUM> to guidewire assembly <NUM>. In other embodiments, port assembly <NUM> may be removably coupled to guidewire assembly <NUM>. Distal shaft <NUM> may terminate within proximal knob <NUM>, and be in fluid communication with a lumen of shaft <NUM> via guidewire assembly <NUM>.

In some embodiments, port assembly <NUM> may be configured to deliver a material (e.g., a therapeutic drug, a contrast medium, a fluid, etc.) to shaft <NUM> from a device coupled to proximal knob <NUM>. In other embodiments, port assembly <NUM> may be configured to extract a material (e.g., a tissue sample, a fluid, etc.) through shaft <NUM> for receipt at the device coupled to proximal knob <NUM> (e.g., a syringe or other device that provides suction). In further embodiments, port assembly <NUM> may be omitted entirely from medical device <NUM>.

Tool assembly <NUM> may include a proximal knob <NUM> and a distal shaft <NUM>. Proximal knob <NUM> may define a grasping feature that facilitates manual manipulation of tool assembly <NUM> by a user of medical device <NUM>. Distal shaft <NUM> may extend distally from proximal knob <NUM>, and may be sized and shaped to be received within opening <NUM>, opening <NUM>, and/or opening <NUM>. Tool assembly <NUM> may further include an end effector <NUM> at a distal end of distal shaft <NUM> (see <FIG>).

Referring now to <FIG>, medical device <NUM> may include a sheath <NUM> having a longitudinal length defined between a proximal end <NUM> and a distal end <NUM>. Sheath <NUM> may include one or more (e.g., a plurality) branches, such as, for example, a first branch 128A, a second branch 128B, a third branch 128C, and a fourth branch 128D. Each of the plurality of branches 128A-128D may extend between proximal end <NUM> and distal end <NUM>, and may collectively define a lumen for receiving one or more devices through sheath <NUM>, such as distal shaft <NUM>. In the example, the plurality of branches 128A-128D may define a closed lumen along a distal portion of sheath <NUM> adjacent to distal end <NUM>, and an open lumen along a proximal portion of sheath <NUM> adjacent to proximal end <NUM>. Stated differently, a lumen of sheath <NUM> may be enclosed within a confined space by the plurality of branches 128A-128D at distal end <NUM>, and not enclosed within a confined space at proximal end <NUM> where space exists between adjacent branches 128A-128D.

The plurality of branches 128A-128D may be separated from one another at proximal end <NUM>, and secured to one another at distal end <NUM>. For example, branches 128A-128D may be secured to one another along a distal portion of sheath <NUM> proximal to distal end <NUM> and distal to proximal end <NUM>. In other examples, branches 128A-128D may be secured to one another at distal end <NUM>. As described further herein, proximal ends <NUM> of each of the plurality of branches 128A-128D may move (e.g., flex, translate, etc.) relative to one another, while distal ends <NUM> of each of the plurality of branches 128A-128D may be fixed relative to one another. Branches 128A-128D may be formed of various suitable materials having at least a minimum rigidity and flexibility, including, for example, a plastic (e.g., high-density polyethylene (HDPE). It should be appreciated that medical device <NUM> may omit the need for, and use of, one or more actuation wires with the use of sheath <NUM>. Accordingly, a diameter of shaft <NUM> may be relatively minimal as shaft <NUM> includes a single lumen in lieu of multiple lumens for receiving each of the one or more actuation wires, as in conventional shafts.

As seen in <FIG>, the plurality of branches 128A-128D may be disposed within handle <NUM> and coupled to actuator <NUM>. In the example, proximal ends <NUM> of the plurality of branches 128A-128D may be coupled to ball joint <NUM> at a plurality of locations, by any suitable method of adhesion (e.g., gluing, welding, etc.). Stated differently, each of the plurality of branches 128A-128D may be secured about a circumference of ball joint <NUM> at different locations. For example, proximal ends <NUM> of the plurality of branches 128A-128D may be disposed in an annular array about ball joint <NUM>. In the example, the plurality of branches 128A-128D may be equally spaced about a circumference of ball joint <NUM> and separated from one another at substantially equidistant angles, e.g., <NUM> degree intervals, from one another. Further, each of the plurality of branches 128A-128D may be equally sized relative to one another (e.g., each branch 128A-128D includes a <NUM> degree segment of a tube, such as sheath <NUM>). In other examples, branches 128A-128D may have varying sizes relative to one another.

Proximal body <NUM> may include a first channel <NUM> and distal body <NUM> may include a second channel <NUM> for receiving portions of the plurality of branches 128A-128D. For example, first channel <NUM> may be sized and shaped to receive proximal ends <NUM> of the plurality of branches 128A-128D, and second channel <NUM> may be sized and shaped to receive at least an intermediate portion of the plurality of branches 128A-128D. Second channel <NUM> may extend through distal body <NUM> and toward distal end <NUM>, such that second channel <NUM> may align with a lumen of shaft <NUM>. In other embodiments, second channel <NUM> may receive at least a portion of shaft <NUM> therein, and particularly proximal shaft <NUM>.

First channel <NUM> may include a relatively greater cross-sectional profile relative to second channel <NUM> to facilitate movement of the plurality of branches 128A-128D within handle <NUM>. First channel <NUM> may be configured to at least partially receive actuator <NUM> therein, and particularly at least a portion of ball joint <NUM>. Ball joint <NUM> may be configured to move (e.g., rotate, pivot, etc.) within first channel <NUM> to cause movement of the plurality of branches 128A-128D within first channel <NUM> and second channel <NUM>.

For example, actuator <NUM> may be configured to move the plurality of branches 128A-128D radially relative to a longitudinal axis of sheath <NUM>, and within one or more of channels <NUM>, <NUM>. Actuator <NUM> may be further configured to translate the plurality of branches 128A-128D longitudinally (e.g., in a proximal and distal direction) within channels <NUM>, <NUM>. Further, actuator <NUM> may be configured to rotate the plurality of branches 128A-128D about the longitudinal axis of sheath <NUM>, and relative to channels <NUM>, <NUM>. It should be understood that actuator <NUM> may be configured to move (e.g., translate, rotate, pivot, etc.) the plurality of branches 128A-128D in response to moving knob <NUM> relative to proximal body <NUM> to cause movement of ball joint <NUM> within first channel <NUM>. It should further be understood that moving proximal ends <NUM> may cause a corresponding movement of distal ends <NUM> within shaft <NUM>. As described in detail herein, distal ends <NUM> may be received within, and secured to, distal articulation joint <NUM>.

Referring now to <FIG>, shaft <NUM> is schematically depicted with distal articulation joint <NUM> actuated to a plurality of different positions. With distal ends <NUM> disposed within distal articulation joint <NUM>, the plurality of branches 128A-128D may be configured to move (e.g., deflect) distal articulation joint <NUM> to the plurality of positions in response to branches 128A-128D moving within channels <NUM>, <NUM> and shaft <NUM>. With branches 128A-128D secured to ball joint <NUM>, and ball joint <NUM> rotatably coupled to handle <NUM> with a <NUM> degree range of motion, actuator <NUM> may be configured to move distal articulation joint <NUM> to a plurality of positions corresponding to a movement of ball joint <NUM> relative to a longitudinal axis of shaft <NUM>. Stated differently, a direction of bend of distal articulation joint <NUM> (relative to the longitudinal axis of shaft <NUM>) may correspond to a direction of movement of ball joint <NUM> relative to said axis (which is the same axis as the longitudinal axis of sheath <NUM>). It should be appreciated that each distal end <NUM> may be secured to distal articulation joint <NUM> such that the plurality of branches 128A-128D may include a fixed position relative to shaft <NUM>.

Accordingly, distal articulation joint <NUM> may be caused to articulate in a direction of one of the plurality of branches 128A-128D that is translated proximally when actuator <NUM> is actuated. That is, at least one of the plurality of branches 128A-128D may apply a proximal (e.g., pulling) force onto distal articulation joint <NUM> when the at least one branch 128A-128D is translated proximally relative to shaft <NUM> and channels <NUM>, <NUM>, thereby causing distal articulation joint <NUM> to bend in a direction of the at least one branch 128A-128D. It should be appreciated that the plurality of branches 128A-128D may be further configured to rotate distal articulation joint <NUM> in various direction (e.g., clockwise, counter clockwise, etc.).

Still referring to <FIG>, shaft <NUM> may include a cutting tool <NUM> disposed at a distal end of distal articulation joint <NUM>. Cutting tool <NUM> may be configured to cut one or more objects positioned adjacent to the distal end of distal articulation joint <NUM>, such as, for example, tissue. Cutting tool <NUM> may include various suitable devices, including, for example, a knife, a blade, a sharp edge, a cautery device, and more. In the example, cutting tool <NUM> may include a cautery device having a cylindrical body disposed about a circumference of distal articulation joint <NUM>, and specifically about a distal end of distal articulation joint <NUM>. As described in further detail herein, the cautery device may be configured to receive electrical energy and/or current from a power source (e.g., coupled to handle <NUM> via connection port <NUM>) to cauterize tissue surrounding the cautery device.

Referring now to <FIG>, proximal shaft <NUM> is depicted including an outer layer <NUM> defining a lumen for receiving one or more devices therethrough, such as sheath <NUM>, distal shaft <NUM>, and more. Outer layer <NUM> may be formed of various suitable materials, including, for example, plastic. Outer layer <NUM> may be further formed of a material having a predefined hardness ranging from about <NUM> D (durometer) to about <NUM> D, and particularly <NUM> D to <NUM> D. Sheath <NUM> may be formed of a material (e.g., plastic) having a relatively similar predefined hardness as outer layer <NUM>.

Sheath <NUM> may include four branches 128A-128D that each has substantially equal cross-sectional profiles relative to one another. In other embodiments, the plurality of branches 128A-128D may have varying cross-sectional profiles. Sheath <NUM> may include additional and/or fewer branches than those shown and described herein without departing from a scope of this disclosure. Each of the plurality of branches 128A-128D may be secured to one another (e.g., along corresponding edges that interface with one another) at an intermediate and/or distal portion of sheath <NUM>, such as adjacent to distal ends <NUM>. In other embodiments, as described further herein, the plurality of branches 128A-128D may be secured to one or more other components of medical device <NUM> (e.g., distal articulation shaft <NUM>, distal shaft <NUM>,etc.).

Distal shaft <NUM> may be formed of various suitable materials, including, for example, Nitinol wire. In some embodiments, distal shaft <NUM> may be configured to increase a rigidity of medical device <NUM> along proximal shaft <NUM> when disposed within a lumen of shaft <NUM>. In further embodiments, distal shaft <NUM> may be configured to transmit a torque from proximal ends <NUM> of the plurality of branches 128A-128D to distal ends <NUM> when distal shaft <NUM> is disposed within sheath <NUM>. Distal shaft <NUM> defines lumen <NUM>, which may be sized and shaped to receive one or more devices, such as, for example, distal shaft <NUM>.

Referring now to <FIG>, distal articulation joint <NUM> is depicted including an outer layer <NUM> defining a lumen for receiving one or more devices therethrough, such as sheath <NUM>, distal shaft <NUM>, and more. Outer layer <NUM> may be formed of various suitable materials, including, for example, plastic. Outer layer <NUM> may be further formed of a material having a predefined hardness that is relatively less than outer layer <NUM> of proximal shaft <NUM>. For example, outer layer <NUM> may have a predefined hardness ranging from about <NUM> D to about <NUM> D, and particularly <NUM> D to <NUM> D.

In one embodiment, the plurality of branches 128A-128D may be secured to an interior surface of outer layer <NUM>, such as along an intermediate and/or distal portion of sheath <NUM> (e.g., adjacent to distal ends <NUM>). Branches 128A-128D may be secured to outer layer <NUM> in various suitable manners, including, for example, by an adhesive. In this instance, sheath <NUM> may be configured to bend outer layer <NUM> in response to the one or more branches 128A-128D translating relative to shaft <NUM>, when actuator <NUM> is moved proximally and/or distally. Sheath <NUM> may be further configured to rotate shaft <NUM> relative to handle <NUM> in response to the one or more branches 128A-128D rotating relative to shaft <NUM>, when actuator <NUM> is rotated relative to handle <NUM>. Alternatively, shaft <NUM> may be fixed relative to handle <NUM> such that sheath <NUM> may be inhibited from rotating relative to shaft <NUM> when branches 128A-128D are secured to outer layer <NUM>. Further, distal shaft <NUM> may be moved (e.g., translated) relative to sheath <NUM> and shaft <NUM>, and guidewire assembly <NUM> may be removed (e.g., disengaged) from handle <NUM> and shaft <NUM>.

In another embodiment, the plurality of branches 128A-128D may be secured to an exterior surface of distal shaft <NUM> (e.g., along a distal portion) in lieu of, or in addition to, the interior surface of outer layer <NUM>. Branches 128A-128D may be secured to distal shaft <NUM> in various suitable manners, including, for example, by an adhesive. In this instance, sheath <NUM> may be configured to bend the distal shaft <NUM> in response to the one or more branches 128A-128D translating relative to shaft <NUM>. Distal shaft <NUM> may be fixed relative to sheath <NUM> and/or shaft <NUM>, such that guidewire assembly <NUM> may be irremovable from handle <NUM> and shaft <NUM>.

In some embodiments, distal shaft <NUM> may include a distal portion that is flexible, such as relative to a proximal portion of distal shaft <NUM>. For example, a distal portion of distal shaft <NUM> may be formed of various elastic materials, including but not limited to, rubber, plastic elastomers, and the like. In other embodiments, a flexible tube may be coupled (e.g., by an adhesive, ultraviolet curing, etc.) to distal shaft <NUM>, such that the flexible tube may define a distal portion of distal shaft <NUM>. The flexible tube may be formed of a flexible material relative to distal shaft <NUM>, such that the flexible tube may provide a flexibility along the distal portion of distal shaft <NUM>. In this instance, branches 128A-128D may be secured to an exterior surface of the flexible tube, and sheath <NUM> may be configured to bend the flexible tube when the one or more branches 128A-128D translate relative to shaft <NUM>. The distal portion of distal shaft <NUM> may include a marker (e.g., echogenic) configured to facilitate visualization of distal shaft <NUM> with one or more imaging devices (e.g., ultrasound system).

With cutting tool <NUM> including a cautery device, medical device <NUM> may further have a wire extending through the lumen of shaft <NUM>. The wire may be disposed between various layers of proximal shaft <NUM> and distal articulation joint <NUM>, such as, for example, between sheath <NUM> and outer layers <NUM>, <NUM>. The wire may extend through handle <NUM> and be coupled to a power source via connection port <NUM> (see <FIG>).

Referring to <FIG>, a distal end of distal articulation joint <NUM> is depicted with end effector <NUM> extending outward from the lumen of shaft <NUM> through opening <NUM>. In the example, end effector <NUM> may include a pair of jaws <NUM> and a pair of arms <NUM>. A proximal end of the pair of arms <NUM> may be secured to a distal end of distal shaft <NUM>, such as by welding, crimping, an adhesive, etc. A distal end of the pair of arms <NUM> may include the pair of jaws <NUM>, with the pair of arms <NUM> having a predefined curve between the proximal and distal ends. The pair of arms <NUM> may be formed of a deformable material such that arms <NUM> may be configured to deform in response to an application of force thereto, such as, for example, by shaft <NUM>. Suitable materials include Nitinol or other metal alloys.

As seen in <FIG>, the pair of arms <NUM> may be deformed to a linear, compact configuration (e.g., parallel to a longitudinal axis of shaft <NUM>) when a distal end of distal shaft <NUM> is disposed within the lumen of distal articulation joint <NUM>. In this instance, distal articulation joint <NUM> and/or distal shaft <NUM> may apply a radially inward force onto the pair of arms <NUM> while end effector <NUM> is substantially disposed within distal articulation joint <NUM>. As seen in <FIG>, the pair of arms <NUM> may be deformed to an expanded configuration (e.g., transverse to a longitudinal axis of shaft <NUM>) when the distal end of distal shaft <NUM> is extended distally from the lumen of distal articulation joint <NUM> via opening <NUM>. It should be appreciated that end effector <NUM> may move (e.g., translate, rotate, etc.) relative to shaft <NUM> in response to movement of proximal knob <NUM>.

Each of the pair of jaws <NUM> may include a plurality of teeth positioned along an interior surface of jaws <NUM>. It should be understood that end effector <NUM> may include various suitable configurations, including, but not limited to, one or more clamps, shears, forceps, scissors, suturing devices, lighting devices, imaging systems, grasper assemblies, and various other suitable tools and/or devices. Accordingly, end effector <NUM> shown and described herein is merely exemplary such that medical device <NUM> may include various other end effectors without departing from a scope of this disclosure.

According to an exemplary method of using medical device <NUM>, a medical instrument (e.g., a bronchoscope, an endoscope, etc.) may be initially navigated through the body of a subject to position a distal end of the medical instrument at a treatment site (e.g., a bronchi). Medical device <NUM> may be received within the medical instrument, and shaft <NUM> may extend outwardly from the distal end of the medical instrument. In this instance, distal articulation joint <NUM> may be positioned within the subject and at the treatment site while handle <NUM> is positioned external from the subject at a proximal end of the medical instrument. It should be appreciated that end effector <NUM> may be maintained within shaft <NUM> during delivery of medical device <NUM> through the medical instrument. Further, cutting tool <NUM> may be used to facilitate access of distal articulation joint <NUM> to the treatment site.

Referring to <FIG>, actuator <NUM> may be actuated (e.g., rotated, pivoted, etc.) to articulate distal articulation joint <NUM> to at least one of a plurality of positions, to direct medical device <NUM> from the treatment site (e.g., the bronchi) to a target area within the treatment site (e.g., a bronchiole branch). By way of illustrative example, knob <NUM> may be pulled proximally to move ball joint <NUM> in a proximal direction, thereby pulling at least first branch 128A proximally and pushing second branch 128B distally (see <FIG>).

Referring to <FIG>, first branch 128A may flex radially within handle <NUM>, such as toward a top interior surface of first channel <NUM>, and second branch 128B may flex radially within first channel <NUM> in a similar direction as first branch 128A. Further, first branch 128A may translate proximally within second channel <NUM>, and second branch 128B may translate distally within second channel <NUM>. In this instance, distal articulation joint <NUM> may bend in a direction that corresponds to (e.g., is the same as) a relative position of first branch 128A relative to the remaining branches 128B-128D. Stated differently, distal articulation joint <NUM> may bend in a direction that is opposite of a relative position of second branch 128B relative to the remaining branches 128A-128D.

It should be appreciated that the target area may define a bodily space within the subject that includes a size, shape, and/or configuration that the medical instrument is incapable of accessing. Upon positioning the distal end of distal articulation joint <NUM> toward the target area, cutting tool <NUM> may be actuated to sever an object targeted for removal (e.g., a cancerous mass) from the surrounding target area. For example, cutting tool <NUM> may be actuated to cauterize tissue adjacent to the cancerous mass to separate the mass from the subject's body. Further, guidewire assembly <NUM> may be received through handle <NUM> via opening <NUM>. In embodiments where distal shaft <NUM> is not fixed to sheath <NUM>, it should be appreciated that movement of proximal knob <NUM> (e.g., translation, rotation, etc.) proximal to handle <NUM> may provide simultaneous movement of distal shaft <NUM> relative to distal articulation joint <NUM>. Distal shaft <NUM> may be extended distally from shaft <NUM> at opening <NUM> and positioned adjacent to the target object.

Still referring to <FIG>, port assembly <NUM> may be coupled to guidewire assembly <NUM> via opening <NUM> to perform one or more functions, including delivery of a substance to the target area or aspiration of the target area. Further, tool assembly <NUM> may be coupled to port assembly <NUM> to move distal shaft <NUM> through handle <NUM> and shaft <NUM>. In other examples, port assembly <NUM> may be decoupled from guidewire assembly <NUM> such that tool assembly <NUM> may be directly coupled to guidewire assembly <NUM>. It should be appreciated that movement of proximal knob <NUM> (e.g., translation, rotation, etc.) proximal to handle <NUM> may provide simultaneous movement of distal shaft <NUM> relative to distal articulation joint <NUM>.

In some embodiments, a secondary guidewire may be received within opening <NUM> and extended through shaft <NUM>. A distal portion of the secondary guidewire may be extended distally from distal shaft <NUM>, such that the secondary guidewire is positioned adjacent to the target object. A proximal portion of the secondary guidewire may be secured to the medical instrument, thereby fixing a position of the secondary guidewire relative to handle <NUM> and shaft <NUM>. In this instance, proximal knob <NUM> may be translated proximally, thereby retracting distal shaft <NUM> from the target area and out of medical device <NUM>. Tool assembly <NUM> may be coupled directly to the secondary guidewire with distal shaft <NUM> received within a lumen of the secondary guidewire or riding (e.g., translating) over the secondary guidewire.

Referring to <FIG>, proximal knob <NUM> may be translated distally toward handle <NUM> to extend end effector <NUM> distally from distal articulation joint <NUM>. End effector <NUM> may be maintained in a closed configuration as the pair of arms <NUM> are positioned substantially within a lumen of distal articulation joint <NUM>. Further translation of proximal knob <NUM> toward handle <NUM> may provide distal extension of end effector <NUM> from opening <NUM>. As seen in <FIG>, the pair of arms <NUM> may bow radially outwardly when arms <NUM> are positioned substantially external from distal articulation joint <NUM>. It should be appreciated that the pair of arms <NUM> are biased to a predefined shape where arms <NUM> are positioned away from one another. Accordingly, end effector <NUM> may be configured to automatically transition to an open configuration (<FIG>) when a radial force applied against arms <NUM> (e.g., from an interior surface of distal articulation joint <NUM>) is removed.

Referring to <FIG>, the pair of jaws <NUM> may move radially outward relative to one another in response to a distal translation of distal shaft <NUM> from opening <NUM>. With end effector <NUM> in the open configuration, the pair of jaws <NUM> may be positioned adjacent to the target object and returned to the closed configuration to grasp the target object. In some embodiments, end effector <NUM> may be transitioned to the closed configuration in response to moving distal articulation joint <NUM> distally relative to distal shaft <NUM>, thereby abutting a distal end of distal articulation joint <NUM> against arms <NUM>. As the pair of arms <NUM> are received with distal articulation joint <NUM>, end effector <NUM> is transitioned to the closed configuration (<FIG>) such that the pair of jaws <NUM> move toward one another and grasp the target object positioned therebetween.

In other embodiments, end effector <NUM> may be transitioned to the closed configuration in response to moving proximal knob <NUM> proximally relative to distal articulation joint <NUM>, thereby abutting arms <NUM> against a distal end of distal articulation joint <NUM>. The pair of jaws <NUM> may be retracted into a lumen of distal articulation joint <NUM>, thereby extracting the target object from the target area and into medical device <NUM>. It should be appreciated that retracting end effector <NUM> into shaft <NUM> may further detach the target object from the target area. For example, cutting tool <NUM> may include a blade positioned about opening <NUM> and along a distal edge of distal articulation joint <NUM>. In this instance, medical device <NUM> may be configured to cut the mass from the surrounding tissue in response to the pair of jaws <NUM> pulling the mass through distal articulation joint <NUM> and cutting tool <NUM> abutting against the mass.

In an embodiment, shaft <NUM> may be retracted proximally relative to the subject and the medical instrument, to remove the target object from the subject's body. In another embodiment, proximal knob <NUM> may be translated proximally relative to handle <NUM> to retract distal shaft <NUM> from shaft <NUM>. In this instance, the target object is removed from the subject and distal articulation joint <NUM> is maintained at the target area. Upon removal of tool assembly <NUM> from handle <NUM>, port assembly <NUM> may be recoupled to perform one or more functions, including delivery of a substance to the target area or aspiration of the target area.

Each of the aforementioned systems, devices, assemblies, and methods may be used to access and/or manipulate target tissue with enhanced degree of maneuverability. By providing a medical device with an intuitive handle interface capable of controlling an actuation and articulation of an end effector with a single hand, a user may utilize another hand to control other devices and/or tools during a procedure for treating the target site. In this instance, a user may reduce overall procedure time, increase efficiency of procedures, and/or avoid unnecessary harm to a subject's body caused by limited control of the other tools/devices.

Claim 1:
A medical device (<NUM>), comprising:
a handle (<NUM>);
an actuator (<NUM>) movably coupled to the handle (<NUM>);
a shaft (<NUM>) extending distally from the handle (<NUM>); and
a sheath (<NUM>) including a distal end disposed within the shaft (<NUM>) and a proximal end disposed within the handle (<NUM>), wherein the sheath (<NUM>) includes a plurality of branches (128A-D) secured to one another at the distal end and separated from one another at the proximal end, wherein the plurality of branches (128A-D) form a closed lumen along the distal end of the sheath (<NUM>) and an open lumen at the proximal end of the sheath (<NUM>);
wherein the actuator (<NUM>) is coupled to each of the plurality of branches (128A-D) at the proximal end of the sheath (<NUM>), and the actuator (<NUM>) is configured to move each of the plurality of branches (128A-D) relative to one another to articulate the shaft (<NUM>) in a plurality of directions.