Fixing mechanism for an endoscope device

Abstract

The medical device may include a sheath configured to be inserted into a body lumen of a patient. A distal end of the sheath may include an elevator for changing the orientation of the medical device. The handle may include an actuator. The actuator may be operably coupled to the elevator. Actuation of the actuator may cause movement of the elevator. In at least one configuration of the handle, the engagement portion may protrude from a surface of the handle body toward the actuator. A force applied by a user to at least one of the actuator or the engagement portion may transition the handle between (a) a first configuration in which the engagement portion acts on the actuator to restrict movement of the actuator relative to the engagement portion, and (b) a second configuration in which the actuator is movable relative to the engagement portion.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to devices and methods for suppressing movement of components of a medical device. In embodiments, the present disclosure relates to a device for fixing components of a duodenoscope handle.

Background Art

[0002] A duodenoscope may be grasped by an operator and may include a handle portion that may include control elements for functions such as steering, suction, water, air, light, and imaging. A duodenoscope may also include a portion that may be inserted into a subject. For example, a duodenoscope may include a shaft suitable for insertion into a subject. Such an insertion portion may include one or more lumens. The lumens of the insertable portion of the duodenoscope may support functions such as conveying air, water, suction, electricity, data, light, and / or an image. Tools may also be inserted through the working channel of the shaft. For example, a tool may be inserted through a port in or near the handle of the duodenoscope into the working channel.

[0003] The distal tip of a duodenoscope may include an elevator for changing the orientation of a tool protruding from the distal end of the working channel. The elevator may be controlled via a control mechanism of the handle such as a lever.

Summary of the Invention

[0004] Each of the aspects disclosed herein may include one or more of the features described in relation to any of the other disclosed aspects. The medical device may comprise a sheath configured to be inserted into a body lumen of a patient. The distal end of the sheath may include an elevator for changing the orientation of the medical device. The handle may have a handle body. The handle may include an actuator. The actuator may be operably coupled to the elevator. Actuation of the actuator may cause movement of the elevator. The actuator may be configured to be contacted by a user. In at least one form of the handle, the engagement portion may project from the surface of the handle body toward the actuator. By a force applied by the user to at least one of the actuator or the engagement portion, the handle may be transitioned between (a) a first form in which the engagement portion acts on the actuator to inhibit movement of the actuator relative to the engagement portion and (b) a second form in which the actuator is movable relative to the engagement portion.

[0005] Any of the medical devices disclosed in this specification may include any of the following features. The actuator may include a lever. The actuator may include a protrusion extending radially inwardly towards the surface of the handle body. The protrusion may have a wedge shape. The engagement portion may have a hook. In a first configuration, the protrusion may engage with the hook. The hook may be movable to shift the handle from a first configuration to a second configuration. The hook may include a first portion projecting radially outwardly from the handle body at least in the first configuration of the handle and a second portion projecting radially outwardly from the handle body at least in the first configuration of the handle. The first portion may be configured to engage with the protrusion in the first configuration of the handle. The second portion may be configured to be pushed radially inwardly by a user to shift the handle from the first configuration to the second configuration. The engagement portion may include a shape memory material. The handle may further include a button configured to apply a force to the second portion. The handle may be configured to shift from the second configuration to the first configuration by moving the protrusion from a first side of the first portion to a second side of the first portion. The second side may be opposite to the first side. The engagement portion may include a plurality of teeth. The handle may be shifted from the first configuration to the second configuration by moving a first portion of the actuator relative to a second portion of the actuator. The engagement portion may apply a frictional force to the actuator to inhibit movement of the actuator in the first configuration. The engagement portion may include a body and a spring disposed in a cavity of the handle body. The actuator may include a wall. In the first configuration, a first portion of the wall may have a first angle relative to the surface of the handle body. In the second configuration, the first portion of the wall may have a second angle relative to the surface of the handle body. The second angle may be different from the first angle. The actuator may be movable in a first direction and a second direction to move an elevator. To shift the handle from the first configuration to the second configuration, the actuator may be moved in a third direction substantially perpendicular to each of the first direction and the second direction.

[0006] In another example, the medical device may comprise a sheath configured to be inserted into a body lumen of a patient. The distal end of the sheath includes an elevator for changing the orientation of the medical device. The handle may have a handle body. The handle may include an actuator. The actuator may be operably coupled to the elevator. Actuation of the actuator may cause movement of the elevator. The actuator may be configured to be contacted by a user. In at least one form of the handle, the engagement portion may project from the surface of the handle body toward the actuator. The interaction between the engagement portion and the actuator may be configured to fix the actuator and thereby inhibit movement of the elevator. Pressing a button on at least one of (a) the surface of the handle body or (b) the actuator may be configured to release the actuator and thereby permit movement of the elevator.

[0007] Any of the medical devices described herein may have any of the following features. The actuator may include a lever. The actuator may include a projection extending radially inwardly toward the surface of the handle body. The engagement portion may have a hook. The projection may engage the hook to fix the elevator. The button may move the hook to release the elevator.

[0008] For example, the method may include contacting an actuator, applying a force to the actuator to move the actuator from a first position to a second position, thereby (a) raising an elevator at a distal tip of a duodenoscope from a lowered configuration to a raised configuration, and (b) causing the actuator to encounter an engagement portion on a surface of a handle body of the duodenoscope, and stopping contact with the actuator. After stopping contact with the actuator, the elevator may be held in the raised configuration. The force may be applied to the actuator or the engagement portion. The elevator may be moved from the second position to the first position, thereby lowering the elevator from the raised configuration to the lowered configuration.

[0009] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. As used herein, the terms "comprise", "comprising", or other variations thereof are intended to non-exclusively include the recited elements, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "diameter" may refer to the width where the element is not circular. The term "distal" refers to the direction away from the operator, and the term "proximal" refers to the direction towards the operator. The term "exemplary" is used in the sense of "example" rather than "ideal". The term "approximately" or similar terms (e.g., "substantially") includes values within + / - 10% of the recited value.

Brief Description of the Drawings

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

Fig. 1A

Fig. 1B

Fig. 2A

Fig. 2B

Fig. 2C

Fig. 3A

Fig. 3B

Fig. 4A

Fig. 4B

Fig. 4C

Fig. 4D

Fig. 5A

Fig. 5B

Fig. 5C

Fig. 6A

Fig. 6B

Mode for Carrying Out the Invention

[0011] After operating the elevator, it may be desirable for the operator to be able to hold the elevator in a desired position without maintaining contact with the control mechanism used to operate the lever. Therefore, there is a need for a fixing mechanism for duodenoscope components such as an elevator. Embodiments of the present disclosure relate to a fixing mechanism that suppresses movement of an elevator control lever when the lever is in one or more predetermined positions. For example, the fixing mechanism may fix the elevator lever so that the elevator is held in an elevated position. After the elevator is fixed, the user may be able to remove their finger from the elevator lever, and the user may freely perform other operations with that finger.

[0012] Figures 1A and 1B show different views of the duodenoscope handle 10. Although the term duodenoscope may be used herein, it will be understood that other devices, including endoscopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, sheaths, catheters, or any other suitable delivery or medical device, may be used in connection with the fixation mechanism of the present disclosure without limitation. As shown by the coordinate systems of FIGS. 1A and 1B, the view of FIG. 1B is rotated compared to the view of FIG. 1A. As shown in FIG. 1A, the handle 10 may include a body 12. An elevator actuator, such as lever 20, may be moved in the direction indicated by the arrow in FIG. 1B to provide control to an elevator at the distal end of the endoscope. Although lever 20 is shown, the scope of the present disclosure may be applied to alternative control mechanisms. For example, a slider, knob, switch, wheel, or other mechanism may be used. Lever 20 may include an arm 24 and a contact portion 26 that may extend radially outward from arm 24 (to the left in FIG. 1A and outside the page in FIG. 1B). Arm 24 may extend into handle 10 and be connected to a wire or other structure (such as a shaft) that extends through the axis of the endoscope and is connected to an elevator at the distal end of the endoscope. By movement of arm 24, the elevator may be raised or lowered.

[0013] Contact portion 26 may extend generally parallel to the surface of body 12. Contact portion 26 may extend generally perpendicular to arm 24. Contact portion 26 may include a top portion or other features to increase friction between contact portion 26 and the user's finger and / or to facilitate gripping.

[0014] The handle 10 may also include a steering assembly 60 that may include a knob and / or lever for articulating the distal end of the endoscope. The umbilicus 62 may extend from the handle 10 and may house cables, cords, wires, and / or conduits for providing signals, powder, air, and / or water to the handle 10 and other parts of the endoscope. The image capture button 68 may permit control of a camera on the distal end of the endoscope for capturing still images. The handle 10 may also have other features such as ports and valves (e.g., for air, water, and / or suction).

[0015] Figures 2A through 6B show various fixation mechanisms. The fixation mechanisms of Figures 2A through 6B may be used with the handle 10 or an alternative handle. The aspects of the fixation mechanisms described herein may be used alone or in combination. Wherever possible, like reference numbers are used herein to indicate similar structures. Unless otherwise described, the handle described below may have any of the features of the handle 10. The drawings show a fixation mechanism for fixing a lever and an elevator in one position, but it will be understood that multiple fixation mechanisms may be used to fix the lever and elevator in various positions. The fixation mechanism is described with respect to the elevator lever and elevator, but it will be understood that the fixation mechanism may alternatively be used with other components (e.g., steering components).

[0016] Figures 2A through 2C show a first exemplary fixing mechanism 100. The fixing mechanism 100 may include an actuator such as a lever 120 having an arm 124 and a contact portion 126. The lever 120, the arm 124, and the contact portion 126 may each have any of the characteristics of lever 20, arm 24, and contact portion 26, respectively. The handle 110 including the body 112 may have any of the characteristics of handle 10 and body 12, respectively. For example, the image capture button 68 may be disposed on the surface of the body 112. The body 112 is shown as being transparent in FIGS. 2A through 2C to show a hook 140 (which may be an engaging portion) described below. It will be understood that other components within the body 112, other than the hook 140, are not shown for clarity of the figure.

[0017] FIG. 2A shows the fixing mechanism 100 in a release configuration, which is a first configuration. The lever 120 is freely movable (subject to other constraints such as stops at the ends of the range of the lever 120). The arrow in FIG. 2A indicates the direction in which the lever 120 is moving to transition the fixing mechanism 100 to a fixed configuration, which is a second configuration shown in FIG. 2B. In FIG. 2B, the lever 120 is not movable in a first direction (generally the left side in FIGS. 2A through 2C). The lever 120 is also not movable in a second direction (generally the right side in FIGS. 2A through 2C) because a stop, or another feature in the arm 124, another portion of the lever 120, and / or the body 112 of the handle 110 inhibits movement of the lever 120 in the second direction beyond the position shown in FIG. 2B.

[0018] The lever 120 may also include a protrusion or catch 130 that extends from the surface of the contact portion 126 facing the surface of the main body 112. The protrusion 130 may extend radially inward from the contact portion 126 toward the surface of the main body 112. The protrusion 130 may have any suitable shape. As shown in FIGS. 2A through 2C, the protrusion 130 may have a triangular or wedge shape. The first side 132 of the protrusion 130 may slope or taper radially outward toward the surface of the main body 112 as it moves in the first direction (left in FIGS. 2A through 2C), or may be tapered. The first side 132 may be straight, or may be slightly curved as shown in FIGS. 2A through 2C. The second side 134 of the protrusion 130 may extend between the end of the first side 132 furthest from the first direction and the radially inner surface of the contact portion 126.

[0019] Most of the hook 140 may be disposed within the main body 112, but a portion of the hook 140 may extend outside of the main body 112 as will be described hereinafter. The hook 140 may extend from a first end 142 (furthest in the first direction) to a second end 144 (furthest in the second direction) inside the main body 112. The shaft 146 may extend from the first end 142 toward the second end 144. A hook-shaped portion 148 may extend laterally from the shaft 146. For example, the hook-shaped portion 148 may extend at an angle of approximately 90 degrees from the shaft 146. The first end 142 may terminate in a barb 147 and may be formed in a shape similar to the end of a fishing hook. In at least some embodiments, as described hereinafter, the first end 142 (and barb 147) may extend radially outward through an opening in the main body 112, such that the first end 142 extends outside of the main body 112.

[0020] The protruding portion 149 of the shaft 146 may be bent to form a generally "U" shape. The protruding portion 149 may extend radially outward from the longitudinal axis of the hook 140. Except for the protruding portion 149, the shaft 146 may be generally straight or may be slightly curved.

[0021] The protruding portion 149 may be aligned with the button 150 on the surface of the main body 112 or may extend into the button 150. The button 150 may have any suitable components. For example, the button 150 may be formed from a flexible material or a rigid material. Since the button 150 may include an elastic component and / or a shape memory component, the button 150 is biased to the non-pushed-in form shown in FIGS. 2A and 2B. For example, the button 150 may include a spring, or the portion of the button 150 that can be contacted by the user may include a shape memory material. The button 150 may have an inner surface configured to fit with the protruding portion 149 and hold the protruding portion 149 via friction. Additionally or alternatively, an adhesive or other mechanism may be used to hold the protruding portion 149 within the button 150.

[0022] The lever 120 can transition between the different forms shown in FIGS. 2A to 2C. In the form of FIG. 2A, the lever 120 may be in a position such that the elevator is in a lowered position or a partially raised position, and the lever 120 is movable in a first direction and / or a second direction (approximately left or right in the drawing respectively) to raise or lower the elevator. In the form of FIG. 2B, the lever 120 may be in a position such that the elevator is in a raised position, and the lever 120 may be fixed, thereby suppressing movement in the first direction. The elevator can thus be suppressed from moving to a lowered position. Alternatively, the fixed position of the lever 120 in FIG. 2B may correspond to other forms of the elevator (lowered or partially raised).

[0023] In the first form shown in FIG. 2A, the button 150 is in a relaxed form, and the lever 120 may be positioned further on the first direction side than the first end 142 of the hook 140 including the return 147. In particular, the second side 134 of the protrusion 130 may be further on the first direction side than the first side 142 of the hook 140. In the first form of FIG. 2A, since the lever 120 is not engaged with the hook 140, it may be freely movable. The lever 120 may be in a released form.

[0024] Since the hook 140 can be positioned within the body 112, the second end 144 is positioned proximally to or in contact with the inner surface of the body 112. The second end 144 may have substantially the same position in each of the configurations of FIGS. 2A through 2C. The protrusion 149 may extend radially outward of the surface of the body 112 into the relaxed button 150. The user can contact the button 150, thereby transmitting a radially inward force to the protrusion 149.

[0025] To transition the lever 120 and the hook 140 from the first configuration of FIG. 2A to the second configuration of FIG. 2B, the lever 120 can be moved in a second direction (approximately to the right from FIGS. 2A to 2C). The first side 132 of the protrusion 130 can slide over the first end 142 of the hook 140, which includes the loop 147. The shape of the first side 132 of the protrusion 130 and the first end 142 of the hook 140, which includes the loop 147, may be complementary such that the first side 132 of the protrusion 130 can slide over the first end 142 of the hook 140. Contact between the first side 132 of the protrusion 130 and the first end 142 of the hook 140 provides tactile feedback to the user and can indicate the position of the lever 120 and / or the elevator controlled by the lever 120.

[0026] As the first side 132 of the protrusion 130 moves through the first end 142 of the hook 140 and in the second direction, the first side 132 can apply a radially inward force to the first end 142, causing the first end 142 to be pushed radially inward. The radially outer angles of the loop 147 and the first side 132 of the protrusion 130 can be substantially parallel or otherwise complementary to facilitate the protrusion 130 sliding through the loop 147. The second end 144 may remain substantially stationary. When the hook 140 is pushed radially inward, the hook 140 can assume a configuration similar to that shown in FIG. 2C, which is described in more detail below. However, compared to the configuration of FIG. 2C, when the protrusion 130 moves through the first end 142 and transitions from the first configuration of FIG. 2A to the second configuration of FIG. 2B, the button 150 may remain unpressed.

[0027] After the entire protrusion 130 has moved beyond the first end 142 (such that the protrusion 130 is on the opposite side of the first end 142 from that in the first configuration of FIG. 2A as shown in FIG. 2B), the first end 142 (including the return 147) can extend radially outward of the surface of the body 112 toward the protrusion 130 so that the first end 142 can return to its original position, and the hook 140 can be biased. After returning to the biased position, the hook 140 can have the same shape as that in the first configuration of FIG. 2A.

[0028] In the configuration of FIG. 2B, the first end 142 of the hook 140 including the return 147 can extend radially outward beyond the radially innermost end of the second side 134 of the protrusion 130. The first end 142 of the hook 140 can prevent the protrusion 130, and accordingly the lever 120, from moving in the first direction (the left side of the drawing). A force in the first direction (from a user or another type of force) on the lever 120 can bring the second side 134 of the protrusion 130 into contact with the hook-shaped portion 148 of the hook 140 including the first end 142 and / or the return 147. The force applied to the protrusion 130 by the hook 140 can be substantially in the second direction and can prevent movement in the first direction. For example, as shown from FIG. 2A to FIG. 2C, the hook-shaped portion 148 and the second side 134 can be substantially parallel to each other.

[0029] To release the lever 120 (and thereby allow movement of the elevator controlled by the lever 120), the button 150 can be pushed by the user as shown in the third configuration of FIG. 2C. The button 150 can apply a radially inward force to the protruding portion 149, thereby causing at least a portion of the hook 140 to move radially inward. Alternatively, the button 150 may be omitted and the user may directly push the protruding portion 149 or another portion of the hook 140. Since the hook 140 may be connected to a spring or have shape memory characteristics, the hook 140 is biased to the configurations of FIGS. 2B and 2C. For example, the hook 140 may be made of nitinol or another material (such as metal or plastic). As a further alternative, other suitable mechanisms may be used to push a portion of the hook 140 (including the second end 144) radially inward. The hook 140 may have any suitable shape to effect the transition of the first end 142 between the positions of FIGS. 2A and 2B and the position of FIG. 2C.

[0030] When the button 150 is pushed and the protruding portion 149 is pushed radially inward, the second end 144 of the hook 140 is pushed against the inner surface of the body 112, so that a rotational movement is transmitted to the first end 142, moving the first end 142 radially inward to the position shown in FIG. 2C. The hook 140 may have suitable flexibility or rigidity to effect the radially inward movement of the first end 142 of the hook 140. Alternatively or additionally, pushing the protruding portion 149 radially inward results in the radially inward movement of the hook 140, and all portions of the hook 140, including the first end 142, can be moved radially inward.

[0031] The first end 142 can be at approximately the same height as the body 112 or radially inward of the surface of the body 112. The first end 142 may not intersect the protrusion 130 radially in the third configuration of FIG. 2C. Therefore, the hook 140 may not inhibit the movement of the lever 120 in the first direction. Alternatively, the first end 142 may be shaped such that the first end 142 and the protrusion 130 intersect each other radially, but the protrusion 130 can slide over the first end 142 when pushed radially in as in FIG. 2C. For example, the return 147 may have an inclined surface-like shape to allow such sliding.

[0032] While depressing the button 150, the user may move the release lever 120 in the first direction. After the second end 134 of the protrusion 130 is located further in the first direction than the first end 142 (e.g., clear of the first end 142), the user may release the button 150 and continue to move the lever 130 in the first direction.

[0033] During use, the operator can position the distal end of the duodenoscope at a desired location. The tool can pass through the sheath of the duodenoscope until it protrudes from the distal end of the duodenoscope. The fixing mechanism 100 can be in the form of FIG. 2A. The user can then move the lever 120 in a second direction to raise the elevator of the duodenoscope. The user can move the lever 120 until the fixing mechanism automatically transitions to the form of FIG. 2B. The user may not be required to press the button 150 to transition the fixing mechanism to the second form. Instead, due to the shape and characteristics of the hook 140 and the protrusion 130, once the protrusion 130 crosses the first end 142 of the hook 140, automatic fixation can be facilitated. The hook 140 may bend radially inward when the protrusion 130 crosses the first end 142 of the hook 140. The hook 140 can engage the protrusion 130 to fix the lever 120 when the elevator is in the raised position. The operator may freely remove their finger from the lever 120 while the lever 120 is fixed. When the user desires to lower the elevator, the user presses the button 150 to move the first end 142 of the hook 140 radially inward, allowing the protrusion 130 to cross the outside of the first end 142 of the hook 140 so that the lever 120 is moved in a first direction.

[0034] The parameters of the fixing mechanism 100 can be changed to adjust the amount of force required to fix and / or release the lever 120. For example, the size and shape of the first end 142 (including the return 147) of the hook 140 and the protrusion 130 can be changed to adjust the interaction between those components, the amount of force required to move the lever 120 to the fixed position, and the amount of fixing force provided. The aspect of the protruding portion 149 and / or the button 150 can also be changed to adjust the amount of release force required to release the lever 120.

[0035] Figures 3A and 3B show an alternative fixing mechanism 200. The fixing mechanism 200 may use a ratchet mechanism. The fixing mechanism 200 may include an actuator such as a lever 220 that may include a contact portion 226. The lever 220 and the contact portion 226 may each have any of the properties of the levers 20, 120 and the contact portions 26, 226. The protrusion 230 may extend radially inward from the surface of the contact portion 226 toward the surface of the main body 212. The main body 212 may have any of the characteristics of the main bodies 12, 112. The protrusion 230 may have a feature similar to a detent and may bend with respect to the surface of the contact portion 226.

[0036] The main body 212 may have, for example, serrated teeth 240 formed on its surface. The teeth 240 may form an engaging portion. The teeth 240 may be oriented in a second direction (the right side in FIGS. 3A and 3B) that may be the direction in which the lever 220 is moved to raise the elevator controlled by the lever 220. The teeth 240 may be formed integrally with the main body 212 from the same material as the main body 212, or may be formed from one or more separate pieces fixed to the main body 212. The teeth 240 may extend along all or part of the main body 212 along which the lever 220 is movable therealong, or may protrude from the main body 212. For example, the teeth 240 may be arranged along the range where the fixing of the lever 220 is desired.

[0037] The protrusion 230 and the teeth 240 may have complementary shapes such that when the lever 220 is moved at least in the second direction (the right side in FIGS. 3A and 3B), the radially inner tip of the protrusion 230 engages the teeth 240 and the protrusion 230 may bend radially inward as it moves over the teeth 240. Engagement of the protrusion 230 with the teeth 240 may provide the user with tactile or audible feedback that the lever 220 (and thus the elevator controlled thereby) is within a certain range of movement. For example, engagement of the protrusion 230 with the teeth 240 may indicate to the user that the elevator has been raised to a particular angle.

[0038] The lever 220 may have a pivotable portion 222. The pivotable portion 222 may be pivotable with respect to the remaining portion of the lever 220 (e.g., the arm of the lever 220). A hinge may be disposed between the pivotable portion 222 and the remaining portion of the lever 220. The pivotable portion 222 may be biased into the configuration of FIG. 3A where the radially inner surface of the contact portion 226 is substantially parallel to the surface of the body 212. The biasing may be caused via a spring at the hinge of the lever 220 or via the shape memory characteristics of the lever 220. The user may use a finger to pivot or switch the pivotable portion 222 in the direction indicated by the arrow in FIG. 3B. By pivoting the pivotable portion 222, the protrusion 230 may be moved radially away from the surfaces of the body 212 and the teeth 240.

[0039] During use, the operator may position the distal end of the duodenoscope at a desired location. The tool may pass through the sheath of the duodenoscope until it protrudes from the distal end of the duodenoscope. The user may then move the lever 220 in a second direction while the pivotable portion 222 is in the configuration of FIG. 3A to raise the elevator of the duodenoscope. The user may move the lever 220 until the protrusion 230 engages the teeth 240. After the protrusion 230 engages the teeth 240, the lever 220 may be movable in the second direction (so long as another feature such as a stop does not prevent movement beyond a desired range). However, engagement of the protrusion 230 with the teeth 240 may inhibit movement of the lever 220 in a first direction. Engagement between the teeth 240 and the protrusion 230 may cause the lever 220 to be fixed in a particular position (e.g., the position where the elevator is raised or another desired position). The operator may freely remove a finger from the lever 220 while the lever 220 is thus fixed. When the user desires to move the lever 220 in a first direction (e.g., to lower the elevator), the user may pivot the pivotable portion 222 into the configuration shown in FIG. 3B. By pivoting the pivotable portion 222, the lever protrusion 230 is separated from the teeth 240, thereby releasing the fixation of the lever 220 and allowing the lever 220 to be moved in the first direction (e.g., to lower the elevator).

[0040] The fixing mechanism 200 may include a plurality of segments having teeth 240 for providing a plurality of fixing locations for the lever 120 and corresponding fixed positions for the elevator controlled by the lever 120. The flat segments without teeth 240 may interrupt the plurality of segments having teeth 240.

[0041] FIGS. 4A and 4B show cross-sectional views of another exemplary fixing mechanism 300. The fixing mechanism 300 may include an actuator such as a lever 320 that can control the movement of the elevator at the distal end of the duodenoscope. The lever 320 may have any of the characteristics of the upper levers 20, 120, 220. The lever 320 may have a contact surface 326, an arm 360, and a rotatable portion 362 that is rotatable about an axis A. The rotatable portion 362 may be washer-shaped and may be disposed outside or inside the body 312. The arm 360 may extend radially outward from the rotatable portion 362 and may terminate at the contact portion 326. The arm 360 may be narrower than the rotatable portion 362. The contact portion 326 may protrude outward with respect to the longitudinal axis of the arm 360. The lever 320 may have alternative forms including those described above with respect to the levers 20, 120, 220.

[0042] The stop 340 may be disposed on the surface of the handle body 312 and may form an engaging portion. The body 312 may have any of the characteristics of the upper bodies 12, 112, 212. The stop 340 may protrude radially outward from the surface of the handle body 312. The stop 340 may be formed in a shape and size such that it acts on the radially inner surface of the lever 320. As shown in FIG. 4A, the stop 340 may have a cross-sectional shape that is part of a circle or an ellipse. The stop 340 may be disposed on one side of the arm 360 or may include a channel formed therein to allow passage of the arm 360 therethrough.

[0043] The lever 320 can move freely while it is not aligned with the stop portion 340 and / or does not engage with the stop portion 340. When a part of the lever 320, such as the inner surface of the contact portion 326, is aligned with and / or engages with the outer surface of the stop portion 340, the lever 320 contacts the stop portion 340 and can provide a frictional force between the lever 320 and the stop portion 340.

[0044] The frictional force between the lever 320 and the stop portion 340 may depend on the characteristics of the lever 320 and / or the stop portion 340. For example, the materials used to form the surfaces of the lever 320 and the stop portion 340 can affect the frictional force between them. The surface treatments of the lever 320 and the stop portion 340 can also affect the frictional force between the lever 320 and the stop portion 340. For example, the roughness of the lever 320 and / or the stop portion 340 can increase the frictional force between the lever 320 and the stop portion 340. The stop portion 340 (or the surface of the lever 320) may include a flexible material and / or a compressible material (such as rubber) to increase the frictional force between the lever 320 and the stop portion 340.

[0045] The frictional force between the lever 320 and the stop portion 340 can be adjusted to allow the user to manually move the lever 320 beyond the stop portion 340 while causing a fixing effect between the lever 320 and the stop portion 340 due to the frictional force. The desired frictional force may depend on the characteristics of the duodenoscope (e.g., the force applied to the elevator of the duodenoscope by the tension on the axis of the duodenoscope), user characteristics, type of treatment, or other factors. The frictional force between the lever 320 and the stop portion 340 may be established during manufacturing or may be adjusted by the user.

[0046] Figures 3A and 3B show one stop portion 340, but a plurality of stop portions 340 may be used. For example, the stop portion 340 may be installed at a position corresponding to a default form of the elevator (fully raised, fully lowered, partially raised, etc.). The stop portion 340 may be installed at both ends of the travel path of the lever 320 (within the range where the lever 320 can travel in both directions), or between the ends of the travel path of the lever 320.

[0047] During use, the user can freely adjust the lever 320 when a part of the lever 320 is not engaged with the stop portion 340. When the surface of the lever 320 (for example, the surface of the contact portion 326) contacts the stop portion 340, the lever 320 can be fixed by the frictional force between the lever 320 and the stop portion 340. The user may freely remove their finger from the elevator while the lever 320 is fixed in this way. The user can release the fixation of the lever 320 by applying a sufficient force to overcome the frictional force between the stop portion 340 and the lever 320.

[0048] Figures 4C and 4D show another exemplary fixing mechanism 300'. The fixing mechanism 300' may function in the same manner as the fixing mechanism 300. The fixing mechanism 300' may have the characteristics of the fixing mechanism 300 except as specified herein.

[0049] The fixing mechanism 300 may include a stop portion 340 on the outer surface of the main body 312, but the stop portion 340' may be disposed inside the main body 312. The stop portion 340' may be fixed to any suitable structure within the main body 312.

[0050] The rotating part 362' can also be disposed within the main body 312. The rotating part 362' can have any of the characteristics of the rotating part 362, except that the surface of the rotating part 362' can be shaped such that it sometimes engages the stop part 340' and at other times does not engage the stop part 340'. For example, as shown in FIG. 4D, the rotating part 362' can have a portion where the radial size changes. As shown in FIG. 4D, the rotating part 362' can have a notch portion 364, i.e., a recess, such that a corresponding portion of the rotating part 362' has a smaller radius than the remaining portion of the rotating part 362'. When the notch portion 364 aligns with the stop part 340' (FIG. 4C), the lever 320 can be freely movable. When the notch portion 364 does not align with the stop part 340', the rotating part 362' engages the stop part 340' and can provide a frictional force that serves as a brake as described above. As shown in FIGS. 4C and 4D, since the notch 364 can form a small subset of the outer periphery of the rotating part 362', most of the rotating part 362' is configured to engage the stop part 340'. Alternatively, the notch 364 can occupy a greater proportion of the outer periphery of the rotating part 362'. The rotating part 362' can include a plurality of notch portions 364 that do not engage the stop part 340' and a plurality of portions that engage the stop part 340'.

[0051] The principles regarding the above-described fixing mechanism 300 include those related to the adjustment of the frictional force between the rotatable part 362' and the stop part 340', and are also applicable to the fixing mechanism 300'. During use, in the first configuration of FIG. 4C, the stop part 340' can align with the notch 364 and the lever 320 can be freely movable. Both directions of the notch 364 are surfaces of the rotatable part 362 that can engage the stop part 340'. When the lever 320 is rotated such that the notch 364 no longer aligns with the stop part 340' (FIG. 4D), the stop part 340' can engage the surface of the rotatable part 362' to provide a frictional force that fixes the lever 320. To release the fixation of the lever 320, the user can apply a force to the lever 320 to overcome the frictional force.

[0052] Figures 5A through 5C show another exemplary fixing mechanism 500. The fixing mechanism 500 may include an actuator such as a lever 520 that may have any of the features of levers 20, 120, 220, 320. The lever 520 may include an actuation assembly 580 that moves the lever 520 between a first configuration (Figs. 5A and 5B) and a second configuration (Fig. 5C). The actuation assembly 580 may include a button 582. The button 582 may pass through the center or other portion of the lever 520, or extend across the lever 520.

[0053] In FIGS. 5A and 5B, the button 582 is shown in the depressed position. FIG. 5C shows the button 582 in a non-actuated neutral position where the button 582 is not depressed. A spring 592 is disposed about the axis 584 of the button 582 to bias the button 582 toward the non-depressed position of FIG. 5C. A mechanism other than the spring 592, such as a shape memory material, may be used to bias the button 582 to the configuration of FIG. 5C.

[0054] Wall portions 586 and 588 may at least partially extend around the axis 584 and the spring 592. For example, the wall portions 586 and 588 may be part of a structure (such as a tube) that completely surrounds the axis 584. Alternatively, the wall portions 586 and 588 may be separate pieces that only partially surround the axis 584. The wall portions 586 and 588 may be straight or curved.

[0055] The wall portion 588 may include a movable portion 590. In the actuated configurations of FIGS. 5A and 5B, when the button 582 is depressed or actuated, the movable portion 590 may form an inclined edge. The movable portion 590 may form a portion of the wall portion 588 radially inward (towards the surface of the body 512 which may have any of the characteristics of the bodies 12, 112, 212, 312). In the actuated configurations (FIGS. 5A and 5B), the movable portion 590 may be angled towards the wall portion 586 relative to the remainder of the wall portion 588. In the configuration of FIG. 5C where the button 582 is in the neutral unactuated position, the wall portion 588 including the movable portion 590 may be substantially straight, and the movable portion 590 may be substantially parallel or coaxial with the remainder of the non - movable portion of the wall portion 588. In the straight configuration of the wall portion 588, the movable portion 590, and the entirety of the wall portion 588, may be substantially parallel to the wall portion 586. The straight wall portion 588 and the wall portion 586 may be substantially perpendicular to the surface of the body 512. In the configuration of FIG. 5C, the wall portion 588 and the wall portion 586 may have radially inner ends that are close to or in contact with the surface of the body 512. To actuate the movable portion 590 to transition the wall portion 588 from the substantially straight configuration of FIG. 5C to the angled configurations of FIGS. 5A and 5B, the button 582 may be operatively coupled to the movable portion 590.

[0056] The surface of the body 512 may include a cavity 594. The cavity 594 may have any suitable shape. For example, the cavity 594 may have a square side or a circular cross - section. The cavity 594 may be positioned at a location corresponding to the location of the lever 520 when the elevator is in the raised position. A body 596 may be movably disposed within the cavity 594 and may be coupled to a spring 598 or other biasing mechanism. The body 596 may form an engaging portion. The body 596 may, for example, include ball bearings. The body 596 may be biased in the configurations of FIGS. 5A and 5C, and at least a portion of the body 596 extends radially outward of the surface of the body 512.

[0057] When the lever 520 is not aligned with the cavity 594 (as shown in FIG. 5A), the lever 520 is freely movable and can raise or lower the elevator. When the user moves the lever 520 to operate the elevator, the user can depress the button 582 to cause the movable part 590 to assume the angled configurations of FIGS. 5A and 5B. When the movable part 590 is in the angled configuration as shown in FIG. 5B, the radially inner edge of the movable part 590 can move over the body 596 and apply a radially inward force to the body 596 to push the body 596 into the cavity 594. The elevator may be in the raised position when the lever 520 is in the configuration of FIG. 5B.

[0058] When the elevator is raised (or in another fixable position corresponding to the position of the lever 520 in the configurations of FIGS. 5B and 5C), the user may release the lever 520 and the button 582. When the button 582 is released, the movable part 590 can transition to the configuration shown in FIG. 5C where the movable part 590 is substantially straight with respect to the remaining portion of the wall part 588. The movable part 590 can swing away from the wall part 586 to transition to the configuration of FIG. 5C. Since the movable part 590 may no longer apply a force to the body 596, the spring 598 may assume a neutral configuration and the body 596 may move radially outward to the configuration of FIG. 5C. The body 596 can be disposed radially outside the radially inner ends of the wall parts 586 and 588. In the configuration of FIG. 5C, the body 596 can prevent the body 596 from moving in either a first direction (to the left from FIG. 5A to FIG. 5C) or a second direction (to the right from FIG. 5A to FIG. 5C). Due to the characteristics of the body 596 and the spring 598 (e.g., the mass or volume of the body 596 or the stiffness of the spring 598), a sufficient restoring force can be caused in the body 596 to prevent the lever 520 from moving in the configuration of FIG. 5C. Thus, in the configuration of FIG. 5C, the lever 520 can be in a fixed configuration.

[0059] To release the fixing of the lever 520, the button 582 can be depressed to shift the lever 520 to the configuration of FIG. 5B. The movable part 590 can apply a radially inward force to the body 594 to push the body 596 into the cavity 594, thereby allowing the lever 520 to move in the first and second directions.

[0060] FIGS. 5A through 5C show the movable part of the wall portion 588 and do not show the movable part of the wall portion 586, but it will be understood that the wall portion 586 may also include a movable part that can transition between a configuration angled toward the wall portion 588 and a configuration where the movable part is substantially straight with respect to the remainder of the wall portion 586. Such additional movable parts can facilitate the use of multiple fixed positions via the multiple cavities 594 having the body 596 therein.

[0061] FIGS. 6A and 6B show another exemplary fixing mechanism 600. The fixing mechanism 600 may include an actuator such as a lever 620 (having any of the features of levers 20, 120, 220, 320, 520) and a body 612 (having any of the features of bodies 12, 112, 212, 312, 512). The lever 520 is movable in a first and a second direction (up and down in FIGS. 6A and 6B) about a pivot point and can raise or lower the elevator.

[0062] The body 612 may include features 640 formed on its surface. For example, the features 640 can include protrusions, channels, notches, and / or other structures. The lever 620 may have complementary structures (not shown) on its radially inner surface. For example, the lever 620 can include a protrusion configured to engage the channel of the feature 640 or a recess configured to engage the protrusion of the feature 640. FIG. 6A shows one feature 640, but it will be understood that multiple features may be disposed on the surface of the body 612.

[0063] In the configuration of FIG. 6A, the lever 620 is movable in a first direction and a second direction and can operate the elevator. The lever 620 may also be movable in a third direction (the left side in FIGS. 6A and 6B) that is substantially perpendicular to the first and second directions. When the lever 620 is aligned with the feature 640 and the lever 620 is moved in the third direction to the configuration shown in FIG. 6B, the lever 620 can engage the feature 640 and hold the lever 620 in a position along the first / second direction in which the feature 640 is disposed. The feature 640 thus serves to fix the lever 620 and can suppress the rotation of the lever 620 and thereby the movement of the elevator controlled thereby. To release the fixing of the lever 620, the lever 620 can be moved in a fourth direction (right side).

[0064] The feature 640 can be present at a position on the surface 612 where fixing of the elevator is desired. For example, the feature 640 can be disposed at a position along the first / second direction corresponding to the position of the lever 620 when the elevator is in the raised configuration, the lowered configuration, or a partially raised configuration.

[0065] Although the principles of the present disclosure have been described herein with reference to illustrative examples for specific applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art will recognize that further modifications, applications, and substitutions of equivalents are all within the scope of the examples described herein. Accordingly, the present invention is not to be regarded as limited by the foregoing description.

Claims

1. A sheath configured to be inserted into a body lumen of a patient, the distal end of the sheath including an elevator for changing the orientation of a medical device, the sheath, and A medical device comprising a handle having a handle body, the handle Including a protrusion extending radially inwardly toward the surface of the handle body, an actuator operably coupled to the elevator, movement of the elevator being caused by actuation of the actuator, the actuator being configured to be contacted by a user, the actuator, and In at least one form of the handle, an engagement portion protruding from the surface of the handle body toward the actuator, the engagement portion including a hook. By a force applied by the user to at least one of the actuator or the engagement portion, (a) a first form in which the engagement portion acts on the actuator to suppress movement of the actuator relative to the engagement portion, and (b) a second form in which the actuator is movable relative to the engagement portion, the handle is transitioned between the two forms. The hook includes a first portion protruding radially outward from the handle body at least in the first form of the handle, and a second portion protruding radially outward from the handle body at least in the first form of the handle, the first portion being configured to engage the protrusion in the first form of the handle, the second portion being configured to be pushed radially inward by the user to transition the handle from the first form to the second form, the medical device.

2. The medical device according to claim 1, wherein the actuator includes a lever.

3. The medical device according to claim 1 or 2, wherein the protrusion has a wedge shape.

4. The medical device according to claim 1 or 2, wherein the engagement portion includes a shape memory material.

5. The medical device according to claim 1, wherein the handle further includes a button configured to apply a force to the second portion.

6. The medical device according to claim 1, wherein the handle is configured to be transitioned from the second form to the first form by moving the protrusion from a first side of the first portion to a second side of the first portion opposite the first side.

7. The engagement portion includes a plurality of teeth, the medical device according to claim 5 or 6.

8. The handle is shifted from the first form to the second form by moving a first portion of the actuator relative to a second portion of the actuator, the medical device according to claim 1.

9. The engagement portion applies a frictional force to the actuator to suppress movement of the actuator to the first form, the medical device according to claim 1.

10. The engagement portion includes a body and a spring disposed in a cavity of the handle body, the medical device according to claim 1.

11. A sheath configured to be inserted into a body lumen of a patient, wherein a distal end of the sheath includes an elevator for changing an orientation of a medical device, a sheath, and A medical device comprising a handle having a handle body, wherein the handle An actuator operably coupled to the elevator, wherein movement of the elevator is caused by actuation of the actuator, and the actuator is configured to be contacted by a user, an actuator, and In at least one form of the handle, an engagement portion protruding from a surface of the handle body toward the actuator, the engagement portion including a body and a spring disposed in a cavity of the handle body, and By a force applied by the user to at least one of the actuator or the engagement portion, (a) a first form in which the engagement portion acts on the actuator to suppress movement of the actuator relative to the engagement portion, and (b) the actuator is movable relative to the engagement portion, the handle is shifted between a second form, The actuator includes a wall, in the first form, a first portion of the wall has a first angle with respect to a surface of the handle body, in the second form, the first portion of the wall has a second angle with respect to the surface of the handle body, and the second angle is different from the first angle, a medical device.

12. The actuator is movable in a first direction and a second direction to cause movement of the elevator, and to transition the handle from the first configuration to the second configuration, the actuator is moved in a third direction that is substantially perpendicular to each of the first direction and the second direction, the medical device according to claim 11.

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