Patent Application
20230248218
Various aspects of this disclosure relate generally to devices and methods for actuators of medical devices, and in particular, to actuators for components of duodenoscopes, such as elevator levers.
Duodenoscopes may include a handle and a sheath insertable into a body lumen of a subject. The sheath may terminate in a distal tip portion, which may include features such as optical elements (e.g., camera, lighting), air/water outlets, and working channel openings. An elevator may be disposed at a distal tip and may be actuatable in order to change an orientation of a medical device/tool passed through the working channel. For example, the elevator may be pivotable or otherwise movable.
Elements/actuators in the handle may control the elements of the distal tip. For example, buttons, knobs, levers, etc. may control elements of the distal tip. The elevator may be controlled via a control mechanism in a handle, such as a lever, which may be attached to a control wire that attaches to the elevator. When a mechanism (e.g., a lever) is activated, the wire may move proximally and/or distally, thereby raising and/or lowering the elevator. Activating such a mechanism (e.g., lever/actuator) may require an operator to exert a large amount of force in some configurations, and maintain such force for extended periods of time. Indeed, a variety of procedures may require constant and repetitive operation of the lever throughout the procedure, such as rapidly raising and lowering the elevator or holding the elevator in a desired position. Repetitive activity, static muscle loading, and awkward body movement posture may result in musculoskeletal problems of physicians and other medical personnel. Therefore, it may be desirable to decrease the amount of force required to raise and/or lower the elevator in order to enable an operator to perform a medical procedure more comfortably, accurately, and for longer periods of time.
The devices, and methods of this disclosure may rectify one or more of the deficiencies described above or address other aspects of the art.
Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects. Examples of the disclosure relate to, among other things, devices and methods for actuating an elevator on a distal end. However, it may be understood by those knowledgeable in the art that the mechanisms provided here may be used to articulate, rotate, or otherwise manipulate a distal end of a device other than an elevator.
In one example, a linkage assembly for a medical device may comprise a control lever, a rotatable member rotatable about a first axis, and a plurality of linkages including a first linkage, a second linkage, and a third linkage. The first linkage includes a first end coupled to the rotatable member and a second, opposite end coupled to a first end of the second linkage, and the second linkage includes the first end coupled to the second end of the first linkage and a second, opposite end coupled to a first end of the third linkage, wherein the second linkage is rotatable about a second axis parallel with the first axis. A second end of the third linkage may translate along a third axis, and the second axis is offset from the third axis.
Any example of a linkage assembly described herein may further include a slider having a longitudinal axis. The slider may be coupled to a second end of the third linkage. The linkage assembly may be configured such that the second linkage extends perpendicular to the longitudinal axis of the slider, and the first end of the second linkage is a right-hand end of the second linkage when viewed from above. In a configuration in which the second linkage extends perpendicular to the longitudinal axis of the slider, the first end of the second linkage is a left-hand end of the second linkage when viewed from above. The slider is operatively coupled to a control member extending distally to a distal member. The distal member may be, for example, an elevator of the medical device. Manipulation of the control lever is configured to result in manipulation of the elevator so as to adjust an orientation of a tool extending through the elevator. In some embodiments, at least one of the plurality of linkages is curved. The second linkage pivots about a fixed protrusion extending along the second axis. The second linkage may be eccentrically mounted to the fixed protrusion such that a first length of the second linkage extending from the first end of the second linkage to the fixed protrusion is different than a second length of the second linkage extending from the fixed protrusion to the second end of the second linkage. In any example, the first linkage may be coupled to an intermediary component, wherein the intermediary component is coupled to the rotatable member. In any example, the plurality of linkages are configured in a Z-formation.
In another example, the linkage assembly may include a slider having a longitudinal axis, wherein the slider is connected to a second end of the third linkage, and wherein the fixed protrusion is offset from the longitudinal axis of the slider.
The control lever, rotatable member, and first linkage form a second-class lever assembly, and the first linkage, second linkage, and third linkage form a first-class lever assembly. Additionally or alternatively, in any example, a proximal portion of the control member may further comprise a hypotube.
In another example, a linkage assembly for a medical device may comprise a rotatable member configured to rotate about a first rotational axis, a slider movable along a range of motion extending from a most retracted position of the slider to a maximum advancement of the slider, and a series of elevator linkages rotatably coupled to the rotatable member at a first end of the series and rotatably coupled to the slider on a second end of the series. At least one elevator linkage of the series of elevator linkages is rotatable about a second rotational axis different than the first rotational axis, and movement of the slider along the range of motion results in movement of a distal member coupled to the slider via a control member. A proximal portion of the control member further comprises a hypotube. The distal member is an elevator of the medical device. The second rotational axis may be perpendicular to a longitudinal axis extending longitudinally through the slider.
In another example, a linkage assembly for a medical device may comprise: a rotatable member configured to rotate about a rotation axis, a slider, a plurality of elevator linkages, and an elevator assembly. The plurality of elevator linkages may form a plurality of levers to manipulate the elevator assembly. The plurality of levers include (i) a second-class lever and (ii) a first-class lever connected to the second class lever, and the elevator assembly may be connected to the first-class lever.
It may also be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “diameter” may refer to a width where an element is not circular. The term “distal” refers to a direction away from an operator, and the term “proximal” refers to a direction toward an operator. The term “exemplary” is used in the sense of “example,” rather than “ideal.” The term “approximately,” or like terms (e.g., “substantially”), includes values+/−10% of a stated value.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects this disclosure and together with the description, serve to explain the principles of the disclosure.
Aspects of this disclosure include devices and methods for actuators of medical devices, and in particular to actuators for components of duodenoscopes, such as elevator levers. The ability to manipulate a distal component of a scope, such as an elevator, can, for example, alleviate user discomfort associated with exerting a large amount of force to activate the actuator.
Examples of the disclosure may relate to devices and methods of activating, deactivating, or otherwise manipulating an elevator of a duodenoscope or a portion of a distal end of a device (e.g., a scope). Various examples described herein include a series of first- and second-class levers utilized to reduce the force required to activate or deactivate the elevator. The reduction of force may be related and/or equivalent to a reduction of torque. Reference will now be made in detail to examples of the disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
The lever assemblies described below are described as being used to raise/lower an elevator of a duodenoscope. Although side-facing devices are particularly discussed, the embodiments described herein may also be used with front-facing endoscopes (e.g., endoscopes where a viewing element faces longitudinally forward). Additionally, it will be appreciated that the lever assemblies described herein may have a wider application. For example, the lever assembly may also be used to control other medical device components (e.g., steering or braking components). It will also be appreciated that other devices may include an elevator or any other distal component requiring activation or movement for which these assemblies can be used. Other devices include, but are not limited to, sheaths, catheters, scopes, or any other suitable delivery device or medical device that may include one or more distal components requiring actuation or movement. This may also include non-medical devices, such as borescopes. Thus, the following descriptions and illustrations should be considered illustrative in nature and not limiting the scope of this disclosure.
Insertion portion 108 may include a sheath or shaft 128 and a distal tip 119. Distal tip 119 may include an imaging device (e.g., a camera) and a lighting source (e.g., an LED or an optical fiber) (not shown). Distal tip 119 may be side-facing. That is, the imaging device and lighting source may face radially outward, perpendicularly, approximately perpendicularly, or otherwise transverse to a longitudinal axis of shaft 128 and/or distal tip 119.
Distal tip 119 may also include an elevator 124 for changing an orientation of a tool inserted in a working channel of duodenoscope 101. The mechanisms to activate (e.g., raise) or de-activate (e.g., lower) elevator 124 are to be described in further detail below. Additionally, elevator 124 may alternatively be referred to as a swing stand, pivot stand, raising base, or any suitable other term. Elevator 124 may be pivotable via, e.g., an actuation wire or another control element that extends from handle 106, through shaft 128, to elevator 124.
A distal portion of shaft 128 that is adjacent and/or connected to distal tip 119 may have a steerable section 122. Steerable section 122 may be, for example, an articulation joint. Shaft 128 and steerable section 122 may include a variety of structures that are known or may become known in the art.
Handle 106 may have one or more actuators/control mechanisms 112, 114. Control mechanisms 112, 114 may enable deflection/steering of steerable section 122 and thereby, distal tip 119. For example, control mechanisms (e.g., knobs) 112, 114 may control movement of distal tip 119 in left, right, up, and/or down directions. That is, a first control mechanism 112 may control deflection of distal tip 119 along a first plane (e.g., up, down); while a second control mechanism 114 may control deflection of distal tip 119 along a second plane (e.g., left, right). The second plane may be orthogonal, perpendicular, and/or transverse to the first plane. Handle 106 may further include one or more locking mechanisms 109, 110 (e.g., knobs or levers) for securing a position of control mechanisms 112, 114. When engaged or actuated, locking mechanism(s) 109, 110 may prevent manipulation (e.g., rotation) of control mechanisms 112, 114 thereby preventing deflection/steering of steerable section 122 or distal tip 119 in at least one of an up, down, left, or right direction. Further, handle 106 may include an elevator control lever 107 (interchangeably referred to herein as “control lever”, “lever,” or “elevator lever”). Manipulation of elevator control lever 107 may result in movement of elevator 124. For example, manipulation of elevator control lever 107 may raise and/or lower elevator 124, as will be described further herein. Further, a port 103 may allow passage of a tool into a working channel of duodenoscope 101 through shaft 128 to distal tip 119.
In use, an operator may insert insertion portion 108 into a body lumen of a subject and navigate distal tip 119 to a procedure site in the body lumen. The operator may insert a tool (not shown) into port 103, and pass the tool through a working channel of shaft 128 toward distal tip 119. The tool may exit the working channel at distal tip 119. The user may use elevator lever 107 to raise elevator 124 and angle the tool toward a desired location (e.g., a papilla of the pancreatico-biliary tract). Once so positioned, the user may use the tool to perform a medical procedure.
As previously described, distal tip 119 may include elevator 124, which may be used for changing an orientation of a tool (not pictured) inserted in a working channel (not pictured) of duodenoscope 101. Elevator 124 may alternatively be referred to as a swing stand, pivot stand, raising base, or any suitable other term. Elevator 124 may be pivotable about pivot point 25 via, e.g., control wire 20 or another control element that extends from a proximal portion of the elevator assembly 10 within handle 106 of
The previously described assembly can be categorized as a series of first-class levers (e.g., levers having the fulcrum between the force and the load). A first lever in the series is depicted within box A (referred to as first lever A) and a second lever is depicted within box B of
While the combination of two first-class levers provides a significant mechanical advantage to activate or de-activate elevator 124, the remaining figures demonstrate improvements to further increase the mechanical advantage associated with rotating lever 107 about axis 19.
Referring to
A distal portion of first elevator linkage 140a may be rotatably coupled to a second elevator linkage 140b by means of a second lever connector 130b. This connection may be accomplished through the same or similar means described above with respect to first lever connector 130a. However, second elevator linkage 140b pivots about a protrusion 145 extending from a proximal portion of a slider track 175. Protrusion 145 may be offset from the center longitudinal axis 21 of the slider track 175, forming a third axis. The center longitudinal axis 21 may extend through a center of slider track 175 and parallel to a center axis of the handle. Slider track 175 may be a separable component relative to handle 106, or it may be molded as a portion of handle 106. Slider track 175 may further comprise track 17, described above, and may be a variety of shapes and sizes. Protrusion 145 may extend partially or completely through second elevator linkage 140b. To maximize the mechanical advantage of this configuration, protrusion 145 may be configured to be at approximately two-thirds of a length of the second elevator linkage 140b. For example, for an elevator linkage 140b approximately 25 mm in length, second elevator linkage 140b may pivot about the protrusion 145 at approximately 14.5 mm from a proximal end of second elevator linkage 140b. The remaining third, or 10.5 mm, of the length of second elevator linkage 140b may extend past the protrusion 145 and may be rotatably coupled to a proximal end of a third elevator linkage 140c via a third lever connector 130c. Second elevator linkage 140b may be rotatably coupled to protrusion 145 by, for example, a snap-fit, a clip, or other means commonly known in the art. In other words, second elevator linkage 140b may be eccentrically mounted to the protrusion 145. In one configuration, second elevator linkage 140b may extend perpendicular to the longitudinal axis of the slider, the first end of the second linkage is a right-hand end of the second linkage when viewed from above. A distal end of third elevator linkage 140c may be pivotally coupled to a slider 16 via a fourth lever connector 130d. The fourth lever connector 130d may translate along the third axis offset from the second axis.
In may be understood, however, that the aforementioned measurements are for demonstrative purposes only. Alternative measurements may be utilized to accomplish the desired configuration and/or an improved mechanical advantage of the subassembly.
As shown in
A first lever in the series is depicted within box C (referred to as first lever C) and a second lever in the series is depicted within box D (referred to as second lever D). First lever C is arranged as a second-class lever. For example, first elevator linkage 140a (e.g., the load of first lever C) is between axis 19 (e.g., the fulcrum of first lever C) and lever 107 (e.g., point of force application of first lever C). In other words, the load of first lever C is between the point at which force is applied and the fulcrum. When a force is applied to lever 107, first elevator linkage 140a (e.g., the load) is translated relative to axis 19 (e.g., the fulcrum). A distal portion of first elevator linkage 140a subsequently applies force on second lever D in the series. Second lever D is arranged as a first-class lever. When first elevator linkage 140a is translated, second elevator linkage 140b pivots about protrusion 145 (e.g., the fulcrum). In other words, first elevator linkage 140a applies the force necessary to translate the remaining components on an opposite side of second elevator linkage 140b (e.g., the load) about protrusion 145 (e.g., the fulcrum). That is, the fulcrum of the second lever D is between the point at which force is applied and the location of the load. The combination of these levers (e.g., a second class lever (first lever C) followed by a first class lever (second lever D)) requires less force to activate or de-activate elevator 124 of the distal tip 119.
The measurements of elevator linkages 140a, 140b, 140c may differ slightly, as well, in order to maximize the mechanical advantage of the subassembly or fit within a handle. For example, a distance extending from a surface of lever 107 (e.g., where the user would apply force) to axis 19 may be about 33 mm. The proximal portion of elevator linkage 140a may be rotatably fixed about 13 mm from axis 19 and between lever 107. Additionally, the length of elevator linkage 140a may be about 32 mm, the length of second elevator linkage 140b may be about 25 mm in length, and third elevator linkage 140c may be about 24 mm in length. In this configuration, second elevator linkage 140b may extend perpendicular to the longitudinal axis of the slider, the first end of the second linkage is a left-hand end of the second linkage when viewed from above. The aforementioned exemplary lengths may accomplish a mechanical advantage of 2.5 within box C and a mechanical advantage of 1.4 within box D. It may also be understood that other lengths for the elevator lever 107 and one or more of the elevator linkages 140a, 140b, 140c may be utilized to accomplish a desired mechanical advantage or configuration or be otherwise manipulated to fit within a handle of a medical device.
Similarly to the method described above with respect to the embodiment of
The measurements of elevator linkages 240a, 240b, 240c may differ slightly, as well, in order to maximize the mechanical advantage of the subassembly or accomplish a desired configuration. While the measurements associated with lever 107 relative to axis 19 and a proximal portion of first elevator linkage 240a relative to axis 19 may be similar to the measurements described above with respect to the embodiment depicted in
In the arrangements discussed above with respect to
One advantage of the disclosed embodiments includes the reduction of forces, or torque, on the system. For example, the force, or torque, necessary to manipulate a variety of tools may be reduced approximately 0.1-50% as a result of the arrangements discussed above with respect to
While principles of this disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, and substitution of equivalents all fall within the scope of the examples described herein. Accordingly, the invention is not to be considered as limited by the foregoing description.
This application claims the benefit of priority under 35 U.S.C. § 119 from U.S. Provisional Application No. 63/307,785, filed Feb. 8, 2022, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63307785 | Feb 2022 | US |
