Patent Description:
Flexible ureteroscopes are often used in the examination of kidneys and are generally incorporated with features to improve accessibility and patient comfort. Flexible ureteroscopes are generally provided with a flexible tip section that is controlled by the physician through manipulation of a lever attached to the handle of the scope. Such manipulation enables the physician to maneuver the tip of the scope to different locations such as, for example, different calyces within the kidney. Ureteroscopes are typically used in conjunction with other devices for the treatment of ailments of the kidney. As an example, urologists often use the LithoVue™ flexible ureteroscope in combination with a basket to pulverize kidney stones and remove the debris from the body. Such procedures require manipulating a lever on the ureteroscope to control the tip of the scope and can be very tiring on the physician's hand and the thumb. Sometimes it is desired to hold the tip of the ureteroscope in a location, (e.g., with the tip directed toward a target stone), while the physician operates other devices to remove the stone. Holding the scope in a specific location/orientation by holding the lever in one place requires holding the lever in one place potentially leading to thumb fatigue. Some ureteroscopes incorporate a locking lever which needs to be actuated using the physician's other hand, adding complexity to the procedure by requiring the physician to perform yet another action to lock the tip of the scope.

The present invention relates to a medical scope device, comprising a sheath extending longitudinally from a proximal end to a distal end and a handle coupled to the proximal end of the sheath. The handle includes a deflection lever coupled thereto, the deflection lever being rotatable proximally and distally along the handle to deflect a distal end of the shaft to which it is operably coupled and a locking mechanism movable between an locked configuration in which the locking mechanism engages an engagement feature on the outer surface of the handle, preventing the deflection lever from rotating and locking the distal end of the shaft in a desired position, and an unlocked configuration in which the locking mechanism releases the engagement feature to allow rotation of the deflection lever and deflection of the distal end of the shaft.

In the medical scope device of the present invention, the deflection lever includes a slot extending therethrough.

In the medical scope device of the present invention, the locking mechanism includes a locking lever including a lever body and a locking tooth, the lever body configured to be positioned within the slot such that the locking tooth engages the engagement mechanism with a portion of the lever body protruding out of the slot when the locking mechanism is in the locked configuration.

In the medical scope device of the present invention, the locking mechanism further includes a spring configured to bias the locking mechanism to the locked configuration, a first end of the spring being coupled to the locking lever and a second end of the spring being coupled to the deflection lever such that depression of the lever body further into the slot causes the lever body to pivot, releasing the locking tooth from the engagement mechanism and moving the locking mechanism to the unlocked configuration.

In an embodiment, the engagement mechanism may be a plurality of indentations, the plurality of indentations configured to receive the locking tooth therein when the locking mechanism is in the locked configuration.

In an embodiment, the deflection lever may be coupled to a first lateral side of the handle.

In an embodiment, the deflection lever may be substantially arced in shape and extends from the first lateral side of the handle toward an opposing second lateral side of the handle.

In an embodiment, the locking lever may be substantially arced in shape.

In an embodiment, the deflection lever may rotate around a rounded proximal corner of the handle.

In an embodiment, the locking lever may include a pivot hole, the biasing spring being coupled to the pivot hole such that, when the lever body is depressed by an external force, the lever body rotates about the pivot hole to release the locking tooth from the plurality of indentations.

In an embodiment, the handle includes a lever assembly actuatable via a single hand of a user to manipulate the shaft. The lever assembly includes the deflection lever and the locking mechanism.

The present disclosure may be further understood with reference to the following description and appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure relates to a medical device and a method of using such a device. In particular, the present disclosure relates to, for example, to devices and methods for passively locking a distal end of a shaft of a scope device. Exemplary embodiments describe a system including a locking mechanism positioned on an endoscope or ureteroscope device, such as the LithoVue™. In these embodiments, the locking mechanism need only be manipulated with a single thumb of the physician. It should be noted that the terms "proximal" and "distal", as used herein, are intended to refer to a direction toward (proximal) and away from (distal) a user of the device (e.g., physician).

As shown in <FIG>, a scope device <NUM> according to an exemplary embodiment of the present embodiment comprises, in an exemplary embodiment, a handle <NUM> which, during use, remains outside a living body and a shaft <NUM> configured to be inserted through a target lumen to a target site within the body. As shown in <FIG>, the scope device <NUM> may comprise any scope configured for use in minimally invasive procedures, such as a ureteroscope, for example, under the brand name LithoVue™ or Next Generation LithoVue™, an endoscope, a hysteroscope, a bronchoscope, a cystoscope, or any similar device. The handle <NUM> includes a distal portion <NUM>, an intermediate portion <NUM> and a proximal portion <NUM>. As shown in <FIG>, the curvature of the handle <NUM> defines the proximal portion <NUM>. A distal end of the distal portion <NUM> is connected to a proximal end of the shaft <NUM>, which extends distally therefrom to a shaft distal end <NUM>. The distal end <NUM> of the shaft <NUM> may be steered through movement of a deflection lever mechanism <NUM> at the proximal portion <NUM> of the handle <NUM>.

The proximal portion <NUM> of the handle <NUM> may be sized and shaped to provide a form-fitting shape to be ergonomically held by a user's hand. The deflection lever mechanism <NUM>, as shown in <FIG>, may be coupled to one lateral side of the handle <NUM>. For example, the deflection lever mechanism <NUM> may be positioned on a rounded corner portion of the proximal portion <NUM>. Then, when the handle <NUM> is held by a user, the user's thumb may manipulate the deflection lever mechanism <NUM> by subjecting a force, either proximally or distally, to cause rotational movement along the rounded corner portion of the proximal portion <NUM> of the handle <NUM>. The deflection lever mechanism <NUM> includes a deflection lever <NUM> and a locking mechanism <NUM> comprising a locking lever <NUM>, a serrated section <NUM> of the proximal portion <NUM> of the handle <NUM>, and a biasing spring <NUM> (shown in greater detail in <FIG>).

The deflection lever <NUM>, as shown in <FIG>, is a rotatable lever rotatably coupled to a first lateral side <NUM> of the handle <NUM>. The deflection lever <NUM> extends from the first lateral side <NUM> of the handle <NUM> over the proximal portion <NUM> toward a free end <NUM> at a second lateral side <NUM> of the handle <NUM>. As noted above, the deflection lever <NUM> is rotatable proximally and distally along the rounded corner portion of the proximal portion <NUM> to steer the distal end <NUM> of the shaft <NUM> as desired. The deflection lever <NUM> may include gripping features <NUM> such as ridges or cutouts <NUM> to help the user's thumb manipulate the lever <NUM> as desired. The deflection lever <NUM> includes a slot <NUM> extending therethrough from the first lateral side <NUM> to the free end <NUM> of the deflection lever <NUM> and is configured to receive the locking lever <NUM> and the biasing spring <NUM> therein, as will be described in further detail below. In an exemplary embodiment, shown in <FIG>, the deflection lever <NUM> may be substantially rounded or arc-shaped from the first lateral side <NUM> to the free end <NUM>, following the contour of the outer surface of the proximal portion <NUM>. This arced contour of the deflection lever <NUM> allows for easier gripability and maneuverability by the user when in use.

The locking lever <NUM>, as better shown in <FIG>, includes a lever body <NUM>, a pivot hole <NUM> and a locking tooth locking tooth <NUM>. The lever body <NUM> is substantially flat and is sized and shaped to be inserted into the slot <NUM> of the deflection lever <NUM>. Similar to the deflection lever <NUM>, the lever body <NUM> may be substantially rounded or arc-shaped from a first lateral end <NUM> to a second lateral end <NUM> to follow the contour of the outer surface of the proximal portion <NUM> of the handle <NUM>. This arced shape of the lever body <NUM> allows for smoother maneuverability over the outer surface of the handle <NUM>. As can be seen in <FIG>, the arced shape of the lever body <NUM> is substantially similar to the arced shape of the deflection lever <NUM>.

However, the lever body <NUM> is positioned within the slot <NUM> so that it protrudes past a top surface (i.e., a surface opposing a surface facing the outer surface of the handle <NUM>) of the deflection lever <NUM> when in a resting, or normal, state, shown in <FIG>. As will be described in further detail below, this positioning of the locking lever <NUM> provides space between a bottom surface of the locking lever <NUM> (i.e., a surface facing the outer surface of the handle <NUM>) and the outer surface of the handle <NUM> such that the lever <NUM> may be depressed (i.e., pivoted about the pivot hole <NUM>), as shown in <FIG>, to release the locking lever <NUM> from the serrated section <NUM> of the handle <NUM>. Furthermore, when the locking lever <NUM> is depressed, releasing the locking tooth <NUM> from the serrated section <NUM>, the user's thumb is in contact with both the locking lever <NUM> and the deflection lever <NUM>, enabling the levers <NUM>, <NUM> to be moved, or rotated, together.

The lever body <NUM> of the locking lever <NUM> includes the pivot hole <NUM> extending therethrough from a substantially planar proximal surface <NUM> thereof to a substantially planar distal surface <NUM> thereof. A pin (not shown) extends across the slot <NUM> of the deflection lever <NUM> and through the pivot hole <NUM> to pivotally couple the lever body <NUM> to the deflection lever <NUM>. Thus, when the locking lever <NUM> is depressed to move the locking lever from an engaged state, in which the locking tooth <NUM> engages an indentation <NUM> in the serrated section <NUM> (locking deflection lever mechanism <NUM> in place), to a released state, in which the locking tooth <NUM> is rotated out of the indentation <NUM> to be released from the serrated section <NUM> of the handle <NUM>, the locking lever <NUM> pivots about an axis of the pivot hole <NUM>. While the locking lever <NUM> is depressed and in the released state, the deflection lever mechanism <NUM> may be rotated to change a steering angle of the distal end <NUM> of the shaft <NUM>.

In particular, the locking tooth <NUM> extends from the lever body <NUM> toward the first lateral side <NUM> of the proximal portion <NUM> of the handle <NUM> to engage the serrated section <NUM> of the handle <NUM>. When in an engaged state, the locking tooth <NUM> engages one of the indentations <NUM> of the serrated section <NUM> to lock the locking lever <NUM> in position, thereby locking the deflection lever <NUM> and the distal end <NUM> of the shaft <NUM> in a desired position. Depression of the lever body <NUM> by the user, however, causes the lever body <NUM> to rotate about the pivot hole <NUM>, moving the locking tooth <NUM> out of the serrated section <NUM>, unlocking the deflection lever <NUM> until the lever body <NUM> is released.

The lever body <NUM> may be biased toward the engaged configuration via the biasing spring <NUM> which, in this embodiment, is an extension spring. It will be understood by those skilled in the art, however, that the biasing spring <NUM> may be any type of spring member such as, for example, a torsion spring, or even a molded part of the locking mechanism <NUM>. The biasing spring <NUM> may extend from a first end <NUM> to a second end <NUM> and is configured so that in a normal, or un-extended, state, the biasing spring <NUM> engages the locking tooth <NUM> with the serrated section <NUM>. The first end <NUM> is passed through an opening <NUM> extending into the first lateral side <NUM> of the lever body <NUM> to form a loop thereabout while the second end <NUM> is passed through a connection hole <NUM> in the deflection lever <NUM> to form a loop thereabout. It will be understood, however, that the biasing spring <NUM> maybe coupled to the lever body <NUM> and the deflection lever <NUM> in any suitable manner such that the locking tooth <NUM> engages the serrated section <NUM> when the spring is in its normal state.

The serrated section <NUM> longitudinally extends along the outer surface of the proximal portion <NUM> of the handle <NUM>. Specifically, the serrated section <NUM> extends along the proximal rounded edge or corner portion of the handle <NUM> adjacent to the deflection lever <NUM> along a track followed by the locking tooth <NUM> as the levers <NUM>, <NUM> are moved proximally and distally, as shown in <FIG>. The serrated section <NUM> includes a plurality of indentations connection hole <NUM> that are longitudinally spaced along the serrated section <NUM>. Each of the indentations <NUM> is sized and shaped to receive the locking tooth <NUM> therein to lock the deflection lever <NUM> in a position corresponding to the indentation within which the locking tooth is received. It is noted that although the embodiments of the figures describe a serrated section <NUM> on the handle <NUM> configured to engage the locking tooth <NUM>, the handle may include any type of engagement feature such as, for example, a rough area on the handle <NUM> formed through, for example, a knurling finished surface.

An exemplary method of use of the scope device <NUM> includes inserting the distal end <NUM> of the shaft <NUM> into a target lumen and advancing the shaft <NUM> therethrough to a target cavity within, for example, the kidney. During insertion, the distal end <NUM> may be locked in a substantially straight position. Once the shaft <NUM> has been positioned within the kidney as desired, the user may depress the locking lever <NUM> with his thumb such that the locking tooth <NUM> is rotated out of the serrated section <NUM>. The levers <NUM>, <NUM> may then be moved proximally and distally by the user's thumb as desired. This proximal/distal movement allows the user to deflect the distal end <NUM> of the shaft <NUM> to a preferred orientation within the target cavity. Once the distal end <NUM> is in the preferred orientation, the user may release his thumb from the levers <NUM>, <NUM>, causing the locking tooth <NUM> to rotate into a corresponding one of the indentations <NUM>, locking the distal end <NUM> in position. At any point, the user may change the position of the distal end <NUM> by repeating the described method. Said method does not form part of the claimed subject-matter.

Claim 1:
A medical scope device (<NUM>), comprising:
a sheath extending longitudinally from a proximal end to a distal end; and
a handle (<NUM>) coupled to the proximal end of the sheath, the handle (<NUM>) including:
a deflection lever (<NUM>) coupled thereto, the deflection lever (<NUM>) being rotatable proximally and distally along the handle (<NUM>) to deflect a distal end of the shaft to which it is operably coupled; and
a locking mechanism (<NUM>) movable between a locked configuration in which the locking mechanism (<NUM>) engages an engagement feature on the outer surface of the handle (<NUM>), preventing the deflection lever (<NUM>) from rotating and locking the distal end of the shaft in a desired position, and an unlocked configuration in which the locking mechanism (<NUM>) releases the engagement feature to allow rotation of the deflection lever (<NUM>) and deflection of the distal end of the shaft,
wherein the locking mechanism (<NUM>) includes a locking lever (<NUM>) including a lever body and a locking tooth (<NUM>), the lever body (<NUM>) configured to be positioned within a slot (<NUM>) extending through the deflection lever (<NUM>) such that the locking tooth (<NUM>) engages an engagement mechanism (<NUM>, <NUM>) with a first portion of the lever body (<NUM>) protruding out of the slot (<NUM>) when the locking mechanism (<NUM>) is in the locked configuration, wherein the locking mechanism (<NUM>) further includes a spring (<NUM>) configured to bias the locking mechanism (<NUM>) to the locked configuration, a first end (<NUM>) of the spring (<NUM>) being coupled to the locking lever (<NUM>) and a second end (<NUM>) of the spring (<NUM>) being coupled to the deflection lever (<NUM>) such that depression of the lever body (<NUM>) further into the slot (<NUM>) causes the lever body (<NUM>) to pivot, pivoting the first portion of the lever body (<NUM>) into the slot (<NUM>) and releasing the locking tooth (<NUM>) from the engagement mechanism (<NUM>, <NUM>), thereby moving the locking mechanism (<NUM>) to the unlocked configuration.