Patent Description:
Technological developments have given users of medical systems, devices, and methods, the ability to conduct increasingly complex procedures on subjects. One challenge in the field of minimally invasive surgeries such as endoscopy, laparoscopy, and thoracoscopy, among other surgical procedures, is associated with providing control of medical devices with respect to an access and manipulation of such devices during a procedure. Placement of such medical devices within a patient may be difficult. Additionally, maintaining a desired position of a device after placement without requiring continued manual control of the device is unreliable. The limitations on medical devices that facilitate access of other devices into a patient for placement may prolong the procedure, limit its effectiveness, and/or cause injury to the patient due to device failure or breakage.

<CIT> relates to an endoscopic treatment device that includes an insertion unit, a manipulation unit provided at a proximal end portion of the insertion unit, and a manipulation unit attachment mechanism attaching the manipulation unit to an insertion port of a channel of an endoscope. The manipulation unit attachment mechanism has a connection slider engaged with the insertion port by sliding in a first direction intersecting an axis of the insertion unit and disengaged from the insertion port by sliding in a second direction intersecting the axis, an insertion-port abutment part moving toward a proximal end by contacting with the insertion port, and a slider abutment part preventing sliding of the connection slider in the first direction when the insertion-port abutment part is located at a distal end side and permitting the sliding of the connection slider in the first direction when the insertion-port abutment part is located at a proximal end side.

<CIT> relates to an endoscopic treatment tool that includes a sheath, a treatment portion capable of protruding and retracting from a distal end of the sheath, a manipulation main body, a slider which advances and retracts in a longitudinal axis direction to cause the treatment portion to protrude and retract from the sheath, a first locking mechanism which locks the slider at a position at which the distal end of the treatment portion is accommodated in the sheath in accordance with a retracting manipulation of the slider, a second locking mechanism provided at further distal side than the first locking mechanism and restricts advance of the slider by being locked to the manipulation main body, a fixing mechanism provided in the second locking mechanism and fixed to the manipulation main body by sliding, and a restricting portion which restricts fixing of the fixing mechanism to the manipulation main body.

<CIT> relates to a handle for a medical device that includes a proximal segment defining a proximal lumen extending therethrough and sized and shaped to receive an endoscopic medical device therein. A medial segment is received within a distal portion of the proximal segment and has an outer diameter smaller than an inner diameter thereof. A medial lumen extends through the proximal segment and is open to the proximal lumen. A distal segment is received within a distal portion of the medial segment and defines a distal lumen extending therethrough open to the medial lumen. The distal segment has an outer diameter smaller than an inner diameter of the medial segment. The medial segment includes a first movement limiting mechanism limiting movement of an endoscopic medical device inserted therethrough along an axis of the distal lumen and a second movement limiting mechanism limiting advancement of an endoscope attached to the distal body portion.

<CIT> relates to a surgical device. The surgical device may include a needle device, an aspiration device, which is attached to or detached from the needle device, for tissue sampling, an injection device, which is attached to or detached from the needle device, for drug injection, and an electrode device, which is attached to or detached from the needle device, for thermal treatment. Therefore, any one of the aspiration device, the injection device, and the electrode device is attached to or detached from the needle device, thereby being capable of performing tissue sampling, drug injection, and thermal treatment. Thus, the time and costs required for tissue sampling, drug injection, and thermal treatment are reduced and foreign substances can be prevented from flowing into a surgical site in advance.

Aspects of the disclosure relate to, among other things, systems, devices, and methods for accessing a target treatment site with a medical apparatus having locking assemblies that facilitate positioning of the apparatus, 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, a sheath extending from the handle, and a tool within the sheath and movable relative to the sheath. The handle includes an inner body and an outer body disposed over the inner body. The outer body is movable relative to the inner body. The handle includes a first actuator secured to the tool. The first actuator has an actuated state permitting movement of the tool relative to the sheath in response to moving the outer body relative to the inner body. The handle includes a second actuator secured to the sheath. The second actuator has an actuated state permitting movement of the sheath relative to the tool in response to moving the second actuator relative to the outer body. An unactuated state of the first actuator and an unactuated state of the second actuator prevents movement of the tool relative to the sheath.

Any of the medical devices described herein may have any of the following features. Longitudinal movement of the second actuator moves the sheath longitudinally relative to the inner body and the outer body. The first actuator inhibits movement of the outer body relative to the inner body when in the unactuated state. The second actuator inhibits movement of the sheath relative to the inner body and the outer body when in the unactuated state. The inner body includes a plurality of teeth extending along an exterior of the inner body. The first actuator includes one or more teeth configured to engage one or more of the plurality of teeth of the inner body when in the unactuated state. Further including a first spring disposed between the first actuator and the outer body, wherein the first spring is configured to bias the first actuator radially outward relative to the outer body and maintain the first actuator in the unactuated state. The first actuator is in the actuated state where the one or more teeth of the first actuator are spaced apart from all of the plurality of teeth of the inner body, when a radially inward force that exceeds a bias of the first spring is applied to the first actuator. The inner body includes a plurality of teeth extending along an exterior of the inner body. The second actuator includes one or more teeth configured to engage one or more of the plurality of teeth of the inner body when in the unactuated state. Further including a second spring disposed between the second actuator and the outer body, wherein the second spring is configured to bias the second actuator radially outward relative to the outer body and maintain the second actuator in the unactuated state. The second actuator is in the actuated state where the one or more teeth of the second actuator are spaced apart from all of the plurality of teeth of the inner body, when a radially inward force that exceeds a bias of the second spring is applied to the second actuator. The first actuator includes one or more first teeth configured to engage one or more of the plurality of teeth of the inner body when in the unactuated state. Further including a first spring disposed between the first actuator and the outer body, wherein the first spring is configured to bias the first actuator radially outward relative to the outer body and maintain the first actuator in the unactuated state. The first actuator is in the actuated state where the one or more teeth of the first actuator are spaced apart from all of the plurality of teeth of the inner body, when a radially inward force that exceeds a bias of the first spring is applied to the first actuator. The handle further includes an active connector configured to communicatively couple the sheath to an electrosurgical generator, and the sheath includes an electrically conductive material, wherein the active connector is coupled to the sheath through the second actuator.

According to another example, a medical device includes a sheath, a tool within the sheath and movable relative to the sheath, a handle disposed over the sheath and movable relative to the sheath. The handle including an inner body, an outer body disposed over the inner body and movable relative to the inner body, a first actuator configured to move the tool relative to the sheath and the inner body when in an actuated state, and a second actuator configured to move the sheath relative to the inner body, the outer body, and the tool when in an actuated state. The first actuator and the second actuator engage the inner body when in an unactuated state such that movement of the tool and the sheath are inhibited.

Any of the medical devices described herein may have any of the following features. Further including a plurality of teeth extending along an exterior of the inner body, and one or more teeth extending from the first actuator and configured to engage one or more of the plurality of teeth of the inner body when in the unactuated state. Further including a first spring disposed between the first actuator and the outer body that is configured to bias the first actuator radially outward relative to the outer body to maintain the first actuator in the unactuated state. The first actuator is in the actuated state where the one or more teeth of the first actuator are spaced apart from all of the plurality of teeth of the inner body, when a radially inward force that exceeds a bias of the first spring is applied to the first actuator. Further including one or more teeth extending from the second actuator and configured to engage one or more of the plurality of teeth of the inner body when in the unactuated state. Further including a second spring disposed between the second actuator and the outer body that is configured to bias the second actuator radially outward relative to the outer body to maintain the second actuator in the unactuated state. The second actuator is in the actuated state where the one or more teeth of the second actuator are spaced apart from all of the plurality of teeth of the inner body, when a radially inward force that exceeds a bias of the second spring is applied to the second actuator.

According to another example, a medical instrument includes a sheath and a tool movable within the sheath. The medical instrument includes a medical device including a first actuator, a second actuator, an outer body, and an inner body movable within the outer body. The first actuator is operable to allow movement of the tool relative to the sheath, and the outer body relative to the inner body when in an actuated state. The second actuator is operable to allow movement of the sheath relative to the tool, and relative to the outer body and the inner body when in an actuated state. The first actuator and the second actuator are collectively operable to inhibit movement of the tool relative to the sheath and the sheath relative to the tool and the inner body when in an unactuated state.

Examples of the disclosure include systems, devices, and methods for controlling one or more components of a medical instrument at a target site within the body, where the components generally require manual control or manipulation to access a target site, among other aspects. 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 patient. 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 be used to facilitate control and positioning of tools/devices of a medical instrument at a target treatment site by providing one or more mechanisms and/or assemblies for securing said tools/devices at the target treatment site. For instance, some examples utilize a first actuator and a second actuator on a medical device for selective control and/or manipulation of components of a medical instrument received within the medical device. The medical device may include an inner body that defines a lumen configured to receive the medical instrument therein, and an outer body disposed over the inner body and movable relative to the inner body. The medical instrument may include a sheath and a tool disposed within the sheath. The first actuator may be positioned on the outer body and coupled to the tool of the medical instrument (e.g., an access cannula, a needle, etc.) and the second actuator may be positioned on the outer body and coupled to the sheath of the medical instrument. The first actuator may be configured to move the tool relative to the sheath and the outer body relative to the inner body, and the second actuator may be configured to move the tool relative to the sheath and the second actuator relative to the outer body.

Examples of the disclosure may relate to devices and methods for performing various medical procedures and/or treating portions of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the gastrointestinal tract, and/or any other suitable patient anatomy (collectively referred to herein as a "target treatment site"). The device and related methods may be used laparoscopically or endoscopically, or in any other open or minimally invasive procedure, including thorascopic and ENT procedures. Reference will now be made in detail to examples of the present disclosure described above and illustrated in the accompanying drawings.

<FIG> shows a schematic depiction of an exemplary medical system <NUM>. The medical system <NUM> may include a medical device <NUM> and a medical instrument <NUM>. In the example, the medical device <NUM> has a handle that includes an outer body <NUM> and an inner body <NUM>, with the outer body <NUM> having a longitudinal length that defines a lumen which is sized, shaped, and configured to receive the inner body <NUM>. As described in greater detail herein, the outer body <NUM> is configured to move relative to the inner body <NUM>, and vice versa, the inner body <NUM> is configured to move relative to the outer body <NUM>. The inner body <NUM> of the medical device <NUM> has a longitudinal length that defines a lumen which is sized, shaped, and configured to receive the medical instrument <NUM>.

In the example, the inner body <NUM> includes a rack portion having a plurality of teeth <NUM> extending along an exterior surface of the inner body <NUM>. The plurality of teeth <NUM> extend along a predetermined portion (e.g., longitudinal length) of the inner body <NUM> that corresponds to a range of motion of the outer body <NUM> relative to the inner body <NUM>. Accordingly, it should be understood that the rack portion including the plurality of teeth <NUM> may extend along various other suitable lengths and/or surfaces of the inner body <NUM> than that shown and described herein without departing from a scope of this disclosure, from only a portion of the longitudinal length of the inner body <NUM> up to, and including an entirety of a longitudinal length of the inner body <NUM>. The medical device <NUM> may further include an end cap <NUM>, an active pin or connector <NUM>, and a rotation assembly <NUM> disposed on and/or coupled to the outer body <NUM>. The end cap <NUM> of the medical device <NUM> may be positioned at a proximal end of the outer body <NUM> and is configured to enclose a lumen of the outer body <NUM>.

Further, the medical instrument <NUM> of the medical system <NUM> may include a catheter having a sheath <NUM>, a cannula <NUM>, and a needle <NUM>. The cannula <NUM> may be disposed within a lumen of the sheath <NUM>, and the needle <NUM> may be disposed within a lumen of the cannula <NUM>, and may extend at least partially outward from the tip <NUM> of the cannula <NUM>. Although the needle <NUM> is described herein, it should be understood that the exemplary medical instrument <NUM> of this disclosure may be a tool having any end effector, including but not limited to a grasper, a snare, forceps, scissors, and the like. In the example, a position, orientation, and/or configuration of the needle <NUM> relative to the cannula <NUM> is fixed such that a distal end of the needle <NUM> is maintained at an extended position relative to the tip <NUM> of the cannula <NUM>. The sheath <NUM> includes a tip <NUM> and has a longitudinal length defined by the distance between the tip <NUM> and a proximal end of the sheath <NUM> (not shown). The cannula <NUM> of the medical instrument <NUM> includes a tip <NUM> and has a longitudinal length defined by the distance between the tip <NUM> and a proximal end of the cannula <NUM> (not shown). As described in greater detail herein, one or more components of the medical device <NUM> may be configured and operable to position the medical instrument <NUM> relative to a target treatment site within a patient (e.g., patient anatomy). For example, the medical instrument <NUM> may be operable to puncture a target treatment site with the needle <NUM>, when the needle <NUM> is extended distally of the tip <NUM>, or may be able to perform a medical procedure with a desired end effector.

Still referring to <FIG>, in some examples, the medical instrument <NUM> may be operable to facilitate access of one or more tools and/or devices to a target treatment site with the cannula <NUM>, including and/or in addition to the needle <NUM>. In this instance, upon removal of the needle <NUM> from a lumen of the cannula <NUM>, one or more additional tools and/or devices may be received through a lumen of the cannula <NUM> and extended outwardly and distally therefrom via the tip <NUM> of the cannula <NUM>. Further, in some examples, the medical instrument <NUM> may be operable to electrosurgically dilate a target treatment site with the sheath <NUM>. In this instance, the sheath <NUM> includes an electrosurgical sheath and the tip <NUM> includes an electrosurgical tip. It should be understood that, in other examples, the medical instrument <NUM> may include various other suitable tools, configurations, hypotubes and/or components than those shown and described herein. By way of illustrative example, in some examples the medical instrument <NUM> may include an electrosurgical end (e.g., cystotome needle) that omits the tip <NUM>, such as, for example, for delivering a stent during a procedure. In other examples the medical instrument <NUM> omits components configured for electrical activation.

As seen in <FIG>, the outer body <NUM> of the medical device <NUM> may include one or more slots <NUM> disposed through the outer body <NUM>. In this instance, a lumen of the outer body <NUM> may be accessible via the one or more slots <NUM>. In the example, the outer body <NUM> includes a pair of slots <NUM> formed along a longitudinal length of the outer body <NUM> and positioned along opposing sides of the outer body <NUM>, such as, for example, along a top surface and a bottom surface of the outer body <NUM>. As described in greater detail below, the one or more slots <NUM> of the outer body <NUM> are configured to slidably receive one or more components of the medical device <NUM> therein, such as, for example, a second actuator <NUM>.

In the example, the inner body <NUM> of the medical device <NUM> may further include one or more slots <NUM> disposed through the inner body <NUM>. In this instance, a lumen of the inner body <NUM> may be accessible via the one or more slots <NUM>. In the example, the inner body <NUM> includes a pair of slots <NUM> formed along a longitudinal length of the inner body <NUM> and positioned along opposing sides of the inner body <NUM>, such as, for example, along a top surface and a bottom surface of the inner body <NUM>. As described in greater detail below, the one or more slots <NUM> of the inner body <NUM> are configured to slidably receive one or more components of the medical device <NUM> therein, such as, for example, a first actuator <NUM> and/or the second actuator <NUM>. As shown, the one or more slots <NUM> of the outer body <NUM> are radially aligned with the one or more slots <NUM> of the inner body <NUM>, however, it should be understood that in other examples the slots <NUM> may be radially offset relative to the slots <NUM>.

Referring now to <FIG>, the end cap <NUM> may include one or more snap features <NUM> disposed along an exterior of the end cap <NUM> for coupling the end cap <NUM> to the outer body <NUM>. In the example, the one or more snap features <NUM> are configured to engage and snap into an aperture <NUM> formed on a distal end of the outer body <NUM>. The active pin <NUM> of the medical device <NUM> may be coupled to the end cap <NUM>, and the active pin <NUM> is operable to establish electrical communication with the medical instrument <NUM> disposed within a lumen of the inner body <NUM>. For example, the active pin <NUM> may include a connector <NUM> extending from the active pin <NUM> that is configured to be received within the end cap <NUM> and operable to communicatively couple the active pin <NUM> to one or more components of the medical instrument <NUM>, such as, for example, the electrosurgical sheath <NUM>. In this instance, the active pin <NUM> is operable to establish electrosurgical connection between the electrosurgical sheath <NUM> of the medical instrument <NUM> and an ancillary device, such as, for example, an electrosurgical generator, a power source, a controller, or the like (not shown) operable to generate high frequency electric or RF current.

Still referring to <FIG>, the rotation assembly <NUM> of the medical device <NUM> may be coupled to the end cap <NUM> at a proximal end of the end cap <NUM> opposite of the outer body <NUM>. For instance, the rotation assembly <NUM> may include a coupling feature <NUM> that is received within the end cap <NUM> for securing the rotation assembly <NUM> thereto. In this instance, with the rotation assembly <NUM> coupled to the end cap <NUM>, and the end cap <NUM> coupled to the outer body <NUM> via the snap feature <NUM>, it should be appreciated that the end cap <NUM> and the rotation assembly <NUM> may move simultaneously with the outer body <NUM>. In the example, at least a portion of the rotation assembly <NUM> extends outwardly and proximally from the end cap <NUM> to facilitate access of the rotation assembly <NUM> to a user of the medical system <NUM>. The coupling feature <NUM> of the rotation assembly <NUM> is further configured to engage a proximal end of the medical instrument <NUM> disposed within a lumen of the inner body <NUM> when the coupling feature <NUM> is received within the end cap <NUM>. The rotation assembly <NUM> engages and is coupled to the cannula <NUM> of the medical instrument <NUM> within the inner body <NUM>.

In the example, the rotation assembly <NUM> is configured to move (e.g., rotate) relative to the end cap <NUM>, the outer body <NUM>, and the inner body <NUM>. Accordingly, with the rotation assembly <NUM> coupled to the medical instrument <NUM> via the coupling feature <NUM>, the rotation assembly <NUM> is operable to move (e.g., rotate) the cannula <NUM> of the medical instrument <NUM> relative to the medical device <NUM>. For example, the rotation assembly <NUM> rotates the medical instrument <NUM> within lumens of the outer body <NUM> and the inner body <NUM>. As described above, with the needle <NUM> disposed within the cannula <NUM>, it should be appreciated that the rotation assembly <NUM> is operable to move (e.g., rotate or actuate) the needle <NUM> with the cannula <NUM>, together, relative to the outer body <NUM> and the inner body <NUM>. In some examples, the rotation assembly <NUM> may include a rotatable knob, wheel, and/or various other suitable actuators for rotating the cannula <NUM> of the medical instrument <NUM> relative to the medical device <NUM>. It should be appreciated that, in other examples, the rotation assembly <NUM> may engage other and/or additional components of the medical instrument <NUM> than those shown and described herein.

Although not shown, it should be appreciated that the rotation assembly <NUM> includes a lumen extending through the rotation assembly <NUM> and the coupling feature <NUM>. The lumen of the rotation assembly <NUM> may be sized, shaped, and configured to receive one or more tools and/or devices of the medical instrument <NUM> therethrough, such as, for example, the needle <NUM>. In the example, with the rotation assembly <NUM> coupled to the cannula <NUM>, it should be understood that a lumen of the rotation assembly <NUM> may be aligned with, coupled to, and/or in communication with a lumen of the cannula <NUM>. Accordingly, the rotation assembly <NUM> may be configured and operable to facilitate access to a lumen of the cannula <NUM>, to the tip <NUM> of the cannula <NUM>. As seen in <FIG>, a proximal end of the needle <NUM> is received through the rotation assembly <NUM> and a sharp distal end of the needle <NUM> may be positioned adjacent to the tip <NUM> of the cannula <NUM>. In some examples, the needle <NUM> may be removed from a lumen of the cannula <NUM> by extracting the needle <NUM> proximally through a lumen of the rotation assembly <NUM>.

Referring back to <FIG>, the medical device <NUM> may further include the first actuator <NUM> and the second actuator <NUM> positioned on the outer body <NUM>. In the example, the first actuator <NUM> and the second actuator <NUM> are disposed over the outer body <NUM> and are movable relative to one another. As described in further detail herein, the first actuator <NUM> is secured and/or coupled to the outer body <NUM> and is configured to move the outer body <NUM> relative to the inner body <NUM> in response to actuation of the first actuator <NUM>. In the example, the first actuator <NUM> is integral with the outer body <NUM> such that the first actuator <NUM> forms a unitary structure with the outer body <NUM>. However, it should be appreciated that a unitary structure of the first actuator <NUM> and the outer body <NUM> may not be required in other examples. Further, the second actuator <NUM> is secured and/or coupled to the inner body <NUM> and is configured to move the inner body <NUM> relative to the outer body <NUM> in response to actuation of the second actuator <NUM>. For instance, the second actuator <NUM> may be coupled to the inner body <NUM> through the outer body <NUM>, such as, for example, via one or more of the pair of slots <NUM> formed on the outer body <NUM>.

The medical device <NUM> further includes a distal housing <NUM> positioned at a distal end of the inner body <NUM> opposite of the outer body <NUM>. The distal housing <NUM> of the medical device <NUM> defines a lumen that is sized, shaped, and configured to receive one or more components of the medical device <NUM> therethrough, such as, for example, at least a portion of the inner body <NUM>, the medical instrument <NUM>, and the like. The distal housing <NUM> of the medical device <NUM> may further include a housing tip <NUM> and a screw (fastener) <NUM>. In the example, the housing tip <NUM> includes an opening that is sized and shaped to facilitate an exit of the medical instrument <NUM> from a lumen of the distal housing <NUM> and/or a lumen of the inner body <NUM>. The screw <NUM> is configured to engage an exterior surface of the inner body <NUM> (i.e., a portion of which is disposed within a lumen of the distal housing <NUM>) to securely couple the inner body <NUM> to the distal housing <NUM>. In this instance, the screw <NUM> is movable (e.g., rotatable) relative to the distal housing <NUM> to selectively engage and/or disengage the inner body <NUM> received therein. It should be appreciated that various other suitable fastening elements, clamps, pins, and the like are also contemplated without departing from a scope of this disclosure.

Referring now to <FIG>, a schematic of the first actuator <NUM> is depicted with the outer body <NUM> and the inner body <NUM> disposed within the first actuator <NUM>. The first actuator <NUM> of the medical device <NUM> is positioned at a distal end <NUM> of the outer body <NUM>. In the example, a body of the first actuator <NUM> may include a top housing <NUM> and a bottom housing <NUM> coupled to one another with the outer body <NUM> and the inner body <NUM> disposed therebetween. Further, the top housing <NUM> and the bottom housing <NUM> are positioned relative to the outer body <NUM> such that at least a portion of the housings <NUM>, <NUM> are disposed over the distal end <NUM> of the outer body <NUM>. The first actuator <NUM> may further include a button top <NUM> received within the top housing <NUM> and a button bottom <NUM> received within the bottom housing <NUM>. It should be understood that the button top <NUM> and the button bottom <NUM> of the first actuator <NUM> may be a unitary structure, such as, for example, a ring disposed about the outer body <NUM> such that the buttons <NUM>, <NUM> are integral with one another. In other examples, the button top <NUM> and the button bottom <NUM> may be coupled to one another thereby forming an assembly, such that movement of the button top <NUM> and/or the button bottom <NUM> provides for a corresponding movement of the opposing button <NUM>, <NUM>.

The top housing <NUM> of the first actuator <NUM> includes a recess <NUM> for receiving the button top <NUM> such that the button top <NUM> extends at least partially outward from the top housing <NUM>. In this instance, the button top <NUM> is partially exposed at the recess <NUM> to facilitate access to the button top <NUM> for actuation by a user of the medical device <NUM>. The button bottom <NUM> of the first actuator <NUM> is disposed within the bottom housing <NUM> such that the button bottom <NUM> is entirely enclosed therein. In other examples, the button bottom <NUM> may extend at least partially outward from the bottom housing <NUM> to thereby expose the button bottom <NUM> therefrom. As described above, the button top <NUM> and the button bottom <NUM> of the first actuator <NUM> form a unitary structure such that the button bottom <NUM> is configured to move simultaneously with the button top <NUM>. Accordingly, a manual depression of the button top <NUM> (e.g., toward the outer body <NUM>) may provide a simultaneous depression and/or movement of the button bottom <NUM> (e.g., away from the outer body <NUM>) when actuating the first actuator <NUM>.

Still referring to <FIG>, the first actuator <NUM> may further include a biasing mechanism <NUM>. In the example, the biasing mechanism <NUM> includes a spring disposed in the top housing <NUM>, for example, the biasing mechanism <NUM> is positioned between the button top <NUM> and an exterior surface of the outer body <NUM>. More specifically, an exterior of the outer body <NUM> includes a cavity <NUM> adjacent to the distal end <NUM> of the outer body <NUM> that is sized and shaped to receive the biasing mechanism <NUM> therein. In other examples, the biasing mechanism <NUM> may include various other suitable devices than those shown and described herein without departing from a scope of this disclosure. With the biasing mechanism <NUM> disposed underneath the button top <NUM>, it should be understood that, in a resting state, the biasing mechanism <NUM> is configured to apply a radially outward force against the button top <NUM> (e.g., away from the outer body <NUM>). Accordingly, the button top <NUM> is biased to an extended position (i.e., an unactuated state) by the biasing mechanism <NUM>, as shown in <FIG>. As described in greater detail herein, a depression of the first actuator <NUM> may be provided in response to applying a radially-inward directed force onto the button top <NUM> that exceeds a radially-outward force generated by the biasing mechanism <NUM>.

Referring now to <FIG>, the button bottom <NUM> of the first actuator <NUM> may include one or more teeth <NUM> extending outwardly therefrom and toward the rack portion of the inner body <NUM>. For example, with the first actuator <NUM> disposed and/or extending at least partially over the distal end <NUM> of the outer body <NUM>, the one or more teeth <NUM> of the button bottom <NUM> may be configured to engage at least some of the plurality of teeth <NUM> (i.e. the rack portion) of the inner body <NUM> that are positioned adjacent to the distal end <NUM>. In the example, the button bottom <NUM> of the first actuator <NUM> includes a pair of teeth <NUM>, however, it should be understood that in other examples the button bottom <NUM> may include additional and/or fewer teeth <NUM>. Since the button top <NUM> and the button bottom <NUM> are connected to one another, it should be appreciated that the biasing mechanism <NUM> is configured to bias the button bottom <NUM> and the one or more teeth <NUM> located thereon to a locked position.

As described in greater detail herein, the first actuator <NUM> is configured such that the teeth <NUM> of the button bottom <NUM> engage the plurality of teeth <NUM> of the inner body <NUM> when the first actuator <NUM> is in an unactuated and resting state (i.e., an undepressed position), as shown in <FIG>. In this instance, with the teeth <NUM> of the first actuator <NUM> engaged (interlocked) with one or more of the plurality of teeth <NUM> of the inner body <NUM>, a position of the outer body <NUM> (which the first actuator <NUM> is secured to) is fixed longitudinally relative to the inner body <NUM>. Accordingly, it should be appreciated that actuation of the first actuator <NUM> (i.e., manual depression of the button top <NUM>) may allow the teeth <NUM> of the button bottom <NUM> to move radially away from and disengage the plurality of teeth <NUM> of the inner body <NUM>. In this instance, with the first actuator <NUM> disengaged from the inner body <NUM>, the first actuator <NUM> may move (e.g., translate) the outer body <NUM> relative to the inner body <NUM>. Upon release of the radially-inward directed force on the button top <NUM> of the first actuator <NUM>, the biasing mechanism <NUM> urges the button bottom <NUM> back to a locked position with the one or more teeth <NUM> engaged with at least some of the plurality of teeth <NUM> on the inner body <NUM>.

Referring now to <FIG>, a schematic of the second actuator <NUM> is depicted with portions of the outer body <NUM> and the inner body <NUM> disposed within the second actuator <NUM>. In the example, a body of the second actuator <NUM> may include a top housing <NUM> and a bottom housing <NUM> coupled to one another with portion of the outer body <NUM> and the inner body <NUM> disposed therebetween. The second actuator <NUM> may further include a button top <NUM> received within the top housing <NUM> and a button bottom <NUM> received within the bottom housing <NUM>. It should be understood that the button top <NUM> and the button bottom <NUM> of the second actuator <NUM> may be a unitary structure, such as, for example, a ring disposed about the outer body <NUM>, such that the buttons <NUM>, <NUM> are integral with one another. In other examples, the button top <NUM> and the button bottom <NUM> may be coupled to one another thereby forming an assembly, such that movement of the button top <NUM> and/or the button bottom <NUM> provides for a corresponding movement of the opposing button <NUM>, <NUM>.

The top housing <NUM> of the second actuator <NUM> includes a recess <NUM> for receiving the button top <NUM>, such that the button top <NUM> extends at least partially outward from the top housing <NUM>. In this instance, the button top <NUM> is partially exposed at the recess <NUM> to facilitate access to the button top <NUM> for actuation by a user of the medical device <NUM>. The button bottom <NUM> of the second actuator <NUM> is disposed within the bottom housing <NUM> such that the button bottom <NUM> is enclosed entirely therein. In other examples, the button bottom <NUM> may extend at least partially outward from the bottom housing <NUM> to thereby expose the button bottom <NUM> therefrom. As described above, the button top <NUM> and the button bottom <NUM> of the second actuator <NUM> form a unitary structure such that the button bottom <NUM> is configured to move simultaneously with the button top <NUM>. Accordingly, a manual depression of the button top <NUM> (e.g., toward the outer body <NUM>) may provide a simultaneous depression and/or movement of the button bottom <NUM> (e.g., away from the outer body <NUM>) when actuating the second actuator <NUM>.

Still referring to <FIG>, the second actuator <NUM> may further include a biasing mechanism <NUM>. In the example, the biasing mechanism <NUM> includes a spring disposed in the top housing <NUM>, for example, the biasing mechanism <NUM> is positioned between the button top <NUM> and a retainer <NUM> of the second actuator <NUM>. In other examples, the biasing mechanism <NUM> may include various other suitable devices than those shown and described herein without departing from a scope of this disclosure. With the biasing mechanism <NUM> disposed underneath the button top <NUM>, it should be understood that the biasing mechanism <NUM> is configured to apply a radially-outward force against the button top <NUM> (e.g., away from the outer body <NUM>). Accordingly, the button top <NUM> is biased to an extended position such that a manual depression of the second actuator <NUM> may be provided in response to applying a radially-inward force onto the button top <NUM> (e.g., in a direction A) that exceeds the radially-outward force generated by the biasing mechanism <NUM>. As described further herein, depression of the second actuator <NUM> provides for a disengagement of the button bottom <NUM> with the inner body <NUM>.

The retainer <NUM> is at least partially disposed within the top housing <NUM> of the second actuator <NUM> and is positioned between the button top <NUM> and the outer body <NUM>. The retainer <NUM> is configured to receive the biasing mechanism <NUM> along a top surface of the retainer <NUM> and includes one or more engagement features <NUM> positioned along a bottom surface of the retainer <NUM>. The one or more engagement features <NUM> may include protrusions that extend outwardly from a bottom surface of the retainer <NUM>. In the example, the engagement features <NUM> of the retainer <NUM> are received in a lumen of the inner body <NUM> via the slot <NUM> formed along a top surface of the outer body <NUM> and the slot <NUM> formed along a top surface of the inner body <NUM> (see <FIG>). It should be appreciated that the slots <NUM>, <NUM> of the outer body <NUM> and the inner body <NUM> may overlap the radially-aligned, and/or be positioned coincident to one another such that the engagement features <NUM> of the retainer <NUM> extend through a respective pair of slots <NUM>, <NUM> and into a lumen of the inner body <NUM>.

Still referring to <FIG>, the second actuator <NUM> may further include a sled <NUM> disposed within a lumen of the inner body <NUM>. In the example, the sled <NUM> includes one or more apertures <NUM> formed along a top surface of the sled <NUM>. A size, shape, and quantity of the apertures <NUM> may correspond to the one or more engagement features <NUM> (e.g., protrusions) of the retainer <NUM>. Accordingly, the retainer <NUM> is configured to couple the button top <NUM> to the sled <NUM> via receipt of the engagement features <NUM> within the apertures <NUM>. In the example, the sled <NUM> is disposed about and secured to the medical instrument <NUM>, for example, the sheath <NUM>. For example, the sled <NUM> may be attached to the sheath <NUM> of the medical instrument <NUM> by an adhesive such that the sled <NUM> is fixed relative to the medical instrument <NUM>. In this instance, the medical instrument <NUM> is movable relative to a lumen of the inner body <NUM> in response to movement of the sled <NUM>, such as, for example, via movement of the second actuator <NUM>. It should be understood that, in other examples, the sled <NUM> may be attached to the sheath <NUM> of the medical instrument <NUM> by various other devices and/or mechanisms suitable for fixing the sled <NUM> to the medical instrument <NUM>.

Referring now to <FIG>, the button bottom <NUM> of the second actuator <NUM> may include one or more teeth <NUM> extending outwardly therefrom and toward the rack portion of the inner body <NUM>. For example, with the second actuator <NUM> disposed and/or extending over the outer body <NUM>, the one or more teeth <NUM> of the button bottom <NUM> may be configured to engage at least some of the plurality of teeth <NUM> (i.e. the rack portion) of the inner body <NUM> through the slot <NUM> formed along a bottom surface of the outer body <NUM>. In the example, the button bottom <NUM> of the second actuator <NUM> includes a pair of teeth <NUM>, however, it should be understood that in other examples the button bottom <NUM> may include additional and/or fewer teeth <NUM>. Since the button top <NUM> and the button bottom <NUM> are connected to one another, it should be appreciated that the biasing mechanism <NUM> is configured to bias the button bottom <NUM> and the one or more teeth <NUM> located thereon to a locked position.

As described in greater detail herein, the second actuator <NUM> is configured such that the teeth <NUM> of the button bottom <NUM> are engaged with the plurality of teeth <NUM> of the inner body <NUM> when the second actuator <NUM> is in an unactuated and resting state (i.e., an undepressed position). In this instance, with the teeth <NUM> of the second actuator <NUM> engaged (interlocked) with one or more of the plurality of teeth <NUM> of the inner body <NUM>, a position of the inner body <NUM> is fixed longitudinally relative to the outer body <NUM> and the sheath <NUM>. Accordingly, it should be appreciated that actuation of the second actuator <NUM> (i.e., manual depression of the button top <NUM> in a direction A) may allow the teeth <NUM> of the button bottom <NUM> to move radially away from and disengage the plurality of teeth <NUM> of the inner body <NUM>. In this instance, with the second actuator <NUM> disengaged from the inner body <NUM>, the second actuator <NUM> may move (e.g., translate) the sheath <NUM> of the medical instrument relative to the outer body <NUM>, the inner body <NUM>, and/or the cannula <NUM>. Upon release of the radially-inward directed force on the button top <NUM> of the second actuator <NUM>, the biasing mechanism <NUM> urges the button bottom <NUM> back to a locked position with the one or more teeth <NUM> engaged with at least some of the plurality of teeth <NUM> on the inner body <NUM>.

According to an exemplary method of using the medical system <NUM>, the medical system <NUM> may be utilized in various endoscopic procedures to treat a target site (e.g., patient anatomy). Initially, the medical instrument <NUM> may be received within the medical device <NUM> with at least a distal portion of the sheath <NUM> extending distally from the distal housing <NUM>. The tip <NUM> of the cannula <NUM> may be disposed within the sheath <NUM> of the medical instrument <NUM> by positioning the first actuator <NUM> at and/or near a proximal portion of the inner body <NUM>, as shown in <FIG>. Further, the sheath <NUM> of the medical instrument <NUM> may be disposed over the tip <NUM> of the cannula <NUM> by positioning the second actuator <NUM> at and/or near the distal end <NUM> of the outer body <NUM>, as shown in <FIG>. In this instance, with the needle <NUM> received within a lumen of the cannula <NUM> and extending at least partially outward therefrom via the tip <NUM>, the tip <NUM> of the sheath <NUM> may enclose a distal tip of the needle <NUM> therein.

Upon positioning the medical system <NUM> at and/or near a target site, a user of the medical system <NUM> may actuate one or more components of the medical system <NUM> to utilize the components of the medical instrument <NUM> (e.g., the sheath <NUM>, the cannula <NUM> and/or the needle <NUM>) at the target site. In examples where the sheath <NUM> includes an electrosurgical sheath and the tip <NUM> includes an electrosurgical tip, the sheath <NUM> and/or the tip <NUM> may be operable to electrosurgically dilate and/or ablate the target site in response to actuation of an ancillary device (e.g., an electrosurgical generator) coupled to the medical instrument <NUM> via the active pin <NUM>.

By way of further example, a user may actuate the second actuator <NUM> by applying a radially-inward force (e.g., transverse to a longitudinal length of the outer body <NUM>) onto the button top <NUM> to depress the biasing mechanism <NUM> and disengage the teeth <NUM> of the button bottom <NUM> from the plurality of teeth <NUM> of the inner body <NUM>. It should be appreciated that the radially-inward force should be greater than an opposing, radially-outward biasing force applied against the button top <NUM> of the second actuator <NUM> by the biasing mechanism <NUM>. In this instance, with the second actuator <NUM> disengaged from the inner body <NUM>, a user may move the second actuator <NUM> relative to the outer body <NUM> by applying a slidable force (e.g., parallel to a longitudinal length of the outer body <NUM>) onto the second actuator <NUM>.

With the sled <NUM> secured to the sheath <NUM> of the medical instrument <NUM> and the second actuator <NUM> secured to the sled <NUM> via the retainer <NUM> (see <FIG>), movement of the second actuator <NUM> provides a simultaneous movement of the sheath <NUM> relative to the outer body <NUM>, the inner body <NUM>, and the cannula <NUM>. Accordingly, movement of the second actuator <NUM> from the distal end <NUM> of the outer body <NUM> (see <FIG>) toward a proximal portion of the outer body <NUM> (e.g., adjacent to the end cap <NUM>) provides a retraction of the sheath <NUM> into a lumen of the outer body <NUM>, exposing the cannula <NUM> and the needle <NUM>. In this instance, the tip <NUM> of the sheath <NUM> may be positioned proximally relative to a distal tip of the needle <NUM> and the tip <NUM> of the cannula <NUM> for use at the target site during a procedure (see <FIG>).

A user may lock the second actuator <NUM> by releasing the button top <NUM> to thereby fix a position of the second actuator <NUM> relative to the outer body <NUM>, and in result a position of the sheath <NUM> and the tip <NUM> relative to the cannula <NUM> and the needle <NUM>. For example, removing the radially-inward force from the button top <NUM> allows the biasing force of the biasing mechanism <NUM> to supersede, thereby returning the second actuator <NUM> to an unactuated state wherein the teeth <NUM> of the button bottom <NUM> engage at least some of the plurality of teeth <NUM> of the inner body <NUM>. Accordingly, a position of the second actuator <NUM> relative to the outer body <NUM>, and a position of the sheath <NUM> relative to the cannula <NUM> and the needle <NUM>, remains fixed without requiring continued actuation (e.g., depression) of the second actuator <NUM> by a user. With a distal tip of the needle <NUM> exposed from within the sheath <NUM>, a user may direct the needle <NUM> toward a target treatment site to puncture the target site with the distal tip of the needle <NUM>.

With the target site dilated, ablated, and/or punctured by the medical instrument <NUM>, a user may further actuate the medical system <NUM> to utilize one or more other components of the medical device <NUM> and/or the medical instrument <NUM> at the target site. By way of illustrative example, a user may actuate the first actuator <NUM> by applying a radially-inward force (e.g., transverse to a longitudinal length of the outer body <NUM>) onto the button top <NUM> to depress the biasing mechanism <NUM> and disengage the teeth <NUM> of the button bottom <NUM> from the plurality of teeth <NUM> of the inner body <NUM>. It should be appreciated that the radially-inward force should be greater than an opposing biasing force applied against the button top <NUM> of the first actuator <NUM> by the biasing mechanism <NUM>.

In this instance, with the first actuator <NUM> disengaged from the inner body <NUM>, a user may move the outer body <NUM> relative to the inner body <NUM> by applying a slidable force (e.g., parallel to a longitudinal length of the outer body <NUM>) onto the first actuator <NUM>. With the rotation assembly <NUM> secured to the cannula <NUM> of the medical instrument <NUM> and the outer body <NUM> secured to the rotation assembly <NUM>, movement of the first actuator <NUM> provides a simultaneous movement of the rotation assembly <NUM> and the cannula <NUM> relative to the sheath <NUM>. Accordingly, actuation of the first actuator <NUM> allows for the tip <NUM> of the cannula <NUM> to move relative to the tip <NUM> of the sheath <NUM>, and/or relative to the target site. In this instance, the tip <NUM> of the cannula <NUM> may be extended distally relative to the tip <NUM> of the sheath <NUM> by translating the first actuator <NUM> distally along the inner body <NUM> to position a distal tip of the needle <NUM> at another location at the target site to puncture the target site, for example. Additionally and/or alternatively, the needle <NUM> may be removed from a lumen of the cannula <NUM> and replaced with one or more other tools/devices via a lumen of the rotation assembly <NUM>.

A user may lock the first actuator <NUM> by releasing the button top <NUM> to thereby fix a position of the outer body <NUM> relative to the inner body <NUM>, and a position of the cannula <NUM> relative to the sheath <NUM>. For example, removing the radially-inward force from the button top <NUM> allows the biasing force of the biasing mechanism <NUM> to supersede, thereby returning the first actuator <NUM> to an unactuated state (see <FIG>) wherein the teeth <NUM> of the button bottom <NUM> engage at least some of the plurality of teeth <NUM> of the inner body <NUM>. Accordingly, a position of the outer body <NUM> relative to the inner body <NUM>, and the cannula <NUM> relative to the sheath <NUM> of the medical instrument <NUM>, remains longitudinally fixed without requiring continued actuation (e.g., depression) of the first actuator <NUM> by a user.

Upon puncturing a target site with the cannula <NUM> and the needle <NUM>, a user may actuate the first actuator <NUM> and/or the second actuator <NUM> to redispose the cannula <NUM> and the needle <NUM> within a lumen of the sheath <NUM>. For instance, the first actuator <NUM> may be actuated, as described in detail above, and moved proximally relative to the inner body <NUM> to retract the cannula <NUM> and the needle <NUM> into the sheath <NUM>. Alternatively, the second actuator <NUM> may be actuated, as described above, and moved distally relative to the outer body <NUM> to extend the tip <NUM> of the sheath <NUM> over the cannula <NUM> and the needle <NUM>. In such instances, with the cannula <NUM> and the needle <NUM> fully disposed within a lumen of the sheath <NUM>, a user may utilize the sheath <NUM> during a procedure. Further actuation of the medical system <NUM> may be performed by a user during a procedure to utilize components of the medical device <NUM> and/or the medical instrument <NUM> at the target site, such as, for example, actuating the first actuator <NUM> and/or the second actuator <NUM> in accordance with the steps described above. It should be understood that the steps described herein, and the sequence in which they are presented, are merely illustrative such that additional and/or fewer steps may be included without departing from a scope of this disclosure.

<FIG> shows a schematic depiction of an exemplary medical system <NUM> in accordance with an example of this disclosure. Except as otherwise described below, it should be understood that the medical system <NUM> may be configured and operable like the medical system <NUM> shown and described above such that like reference numerals are used to identify like components. Accordingly, it should be appreciated that the medical system <NUM> functions similar to the medical system <NUM> except for the differences explicitly noted herein.

For example, the medical system <NUM> may include a medical device <NUM> and the medical instrument <NUM> at least partially disposed within the inner body <NUM> of the medical device <NUM>. The outer body <NUM> of the medical device <NUM> may include the first actuator <NUM> and a second actuator <NUM> disposed along an exterior of the outer body <NUM>. In the example, the second actuator <NUM> is substantially similar to the second actuator <NUM> of the medical system <NUM> shown and described above except for the second actuator <NUM> including an active pin (connector) <NUM> extending outwardly therefrom.

Referring now to <FIG>, a bottom housing <NUM> of the second actuator <NUM> includes a port <NUM> that is sized and shaped in accordance with the active pin <NUM> such that the bottom housing <NUM> is configured to receive the active pin <NUM> through the port <NUM>. It should be understood that the active pin <NUM> of the medical device <NUM> is configured and operable similar to the active pin <NUM> of the medical device <NUM> shown and described above. In this instance, the active pin <NUM> of the medical device <NUM> is received in a lumen of the inner body <NUM>, and coupled to the medical instrument <NUM> disposed therein, via the second actuator <NUM>. A connector <NUM> of the active pin <NUM> is received within the bottom housing <NUM> of the second actuator <NUM> through the port <NUM>, rather than in the end cap <NUM> as shown and described above with respect to the medical device <NUM> of the medical system <NUM>.

Accordingly, it should be appreciated that the active pin <NUM> of the medical device <NUM> is operable to move relative to the outer body <NUM> in response to a movement of the second actuator <NUM> relative to the outer body <NUM>. In this instance, the active pin <NUM> remains adjacent to the sheath <NUM> of the medical instrument <NUM> during use of the medical system <NUM> in a procedure, such as, for example, when the sheath <NUM> is moved relative to the outer body <NUM>, the inner body <NUM>, and the like.

Each of the aforementioned devices, assemblies, and methods may be used to facilitate access to a target treatment site and provide enhanced control of ancillary tools/devices for use at the target treatment site. By providing a medical device with a pair of actuators capable of controlling and automatically locking a plurality of tools/devices of a medical instrument coupled to the medical device, a user may interact with a target treatment site using the various tools/devices of the medical instrument during a procedure without requiring continued manual control of the medical device. In this instance, a user may reduce overall procedure time, increase efficiency of procedures, and/or avoid unnecessary harm to a patient's body caused by limited control of the ancillary tools/devices.

It will be apparent to those skilled in the art that various modifications and variations may be made in the disclosed devices and methods without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as exemplary only.

Claim 1:
A medical device (<NUM>), comprising:
a handle;
a sheath (<NUM>) extending from the handle; and
a tool (<NUM>) within the sheath and movable relative to the sheath;
wherein the handle includes:
an inner body (<NUM>);
an outer body (<NUM>) disposed over the inner body, wherein the outer body is movable relative to the inner body;
a first actuator (<NUM>) coupled to the outer body, wherein the first actuator has an actuated state permitting movement of the tool relative to the sheath in response to moving the outer body relative to the inner body;
a second actuator (<NUM>, <NUM>) coupled to the inner body, wherein the second actuator has an actuated state permitting longitudinal movement of the sheath relative to the tool in response to longitudinally moving the second actuator relative to the inner body and the outer body;
wherein an unactuated state of the first actuator and an unactuated state of the second actuator prevents movement of the tool relative to the sheath.