Endoscopic valve devices, systems, and methods

Abstract

A valve shaft for a valve assembly of a medical device is disclosed. The valve shaft is movable between an off position, in which the valve assembly is in an off configuration and does not place a fluid source in fluid communication with a patient, and an on position, in which the valve assembly is in an on configuration and places the fluid source in fluid communication with the patient. The valve shaft is formed of a proximal valve shaft component formed of a first material and a distal valve shaft component formed of a second material. The first material is stiffer than the second material such that the proximal valve shaft component can have a force stop feature that limits axial and / or rotational movement of the valve shaft. The second material is capable of forming a seal between the distal valve shaft component and another component of the valve assembly.

Description

[Technical Field]

[0001] The present disclosure relates generally to devices, systems, and methods (including, but not limited to, components and assemblies) for controlling the flow of material through a valve. In particular, the present disclosure relates to devices, systems, and methods for controlling the flow of material through a valve assembly usable in a medical device, such as an endoscope. [Background technology]

[0002] Various endoscopes for use during various medical procedures are known in the art. Endoscopes typically have an insertion tube with a working channel through which a substance (e.g., a fluid, such as a gas or liquid), device, instrument, or tool can be introduced or through which a substance can be removed or aspirated. Therefore, endoscopes also typically include a control handle with various actuators, connections, etc. configured to control the endoscope (e.g., to navigate the endoscope) and / or to control materials, substances, devices, systems, instruments, tools, etc. delivered through the working channel. For example, the actuators, connections, etc. may be involved in supplying fluid (e.g., for irrigation) to an anatomical site and / or applying suction (e.g., to withdraw material from the site) to an anatomical site through the insertion tube. A fluid supply and / or a vacuum source can be fluidly coupled to the endoscope's insertion tube via the endoscope's control handle. A fluid source and / or a suction pump / vacuum source is fluidly coupled to the endoscope handle and insertion tube via a valve assembly to control the flow of substances through the endoscope. A valve assembly typically includes a valve well and a valve shaft that is movable within the valve well between an off position, in which the valve assembly is in an off / closed configuration, and an on position, in which the valve assembly is in an on / open configuration. In the off configuration, the valve assembly blocks fluid communication between a fluid / suction source and the insertion tube of the endoscope. When the valve assembly is moved to the on configuration (typically by being depressed relative to a handle), fluid communication is established between the fluid / suction source and the working channel of the endoscope, thereby providing fluid and / or applying suction / negative pressure to the insertion tube of the endoscope. Proper sealing of ports, channels, lumens, etc. associated with such valve assemblies is important. However, seals that provide sealing interference can also create significant drag that can affect the movement of the valve shaft as it is moved, often repeatedly, within the valve well.Furthermore, if a sealing material is overmolded onto a portion of the valve shaft, such overmolding can result in a reduction in the cross-sectional dimension of the valve shaft, thereby reducing the inner diameter of the suction channel through the valve shaft. Furthermore, the valve assembly of an endoscope is typically biased to an off configuration when a suction source continuously applies suction to the valve assembly. If the valve shaft is made of a single flexible material, such material can experience creep / relaxation due to the preload force applied to maintain the suction valve assembly in the closed, off configuration in the packaged / rest state. Improvements to endoscopic valves, such as suction valves and seals associated with suction valves, remain needed. Summary of the Invention

[0003] This Summary is provided to introduce, in a simplified form, a selection of concepts that are described in more detail below in the Detailed Description. This Summary is not intended to necessarily identify key or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that each of the various aspects and features of the present disclosure, whether described in this Summary or not, can be advantageously used separately in some instances, or in combination with other aspects and features of the present disclosure in other instances. Neither the inclusion or exclusion of an element, component, or the like in this Summary is intended to limit the scope of the claimed subject matter.

[0004] In accordance with various principles of the present disclosure, a valve shaft for a valve assembly of a medical device is formed in accordance with various principles of the present disclosure. The valve shaft has a proximal valve shaft component formed of a first material and a distal valve shaft component formed of a second material. The first material is more rigid than the second material, and the second material is configured to seal a port defined in a valve well of the valve assembly, through which the valve shaft extends. The valve shaft is movable within the valve well channel along an actuation axis between an off position and an on position. When the valve shaft is in the off position, the valve assembly is in an off configuration. When the valve shaft is in the on position, the valve assembly is in an on configuration.

[0005] In some embodiments, the valve shaft distal component is formed of foam, and the valve shaft proximal component has a distal extension configured to extend into the valve shaft distal component. Optionally, the distal extension of the valve shaft proximal component includes one or more barbs engaging within the proximal end of the valve shaft distal component to resist separation of the valve shaft proximal component from the valve shaft distal component.

[0006] Optionally, the proximal valve shaft component and the distal valve shaft component are secured together by at least one of insert molding, overmolding, snap fitting, interference fitting, welding, bonding, or adhesive.

[0007] Optionally, the valve shaft distal component has an outer diameter greater than an inner diameter of a valve well channel of the valve assembly into which the valve shaft extends.

[0008] In some embodiments, the valve well includes a valve well suction source port configured to be in fluid communication with a suction source, such that when the valve shaft is in the off position, no suction is applied by the valve assembly, and when the valve shaft is in the on position, suction can be applied by the valve assembly.

[0009] In some embodiments, the valve shaft distal component defines a valve shaft suction channel extending through the valve shaft distal component along the actuation axis, the valve shaft suction channel in fluid communication with the valve well suction source port, and the valve shaft further defines a valve shaft suction application port extending transversely to the actuation axis, such that when the valve shaft is in the off position, the valve shaft distal component seals the valve well suction application port from fluid communication with the valve well suction source port, and when the valve shaft is in the on position, the valve shaft suction application port is in fluid communication with the valve well suction application port, thereby fluidly connecting the valve well suction application port to the valve well suction source port via the valve shaft suction channel. In some embodiments, the valve shaft suction channel and the valve shaft suction application port are defined in the valve shaft distal component distal to the distal end of the valve shaft proximal component. In some embodiments, the valve shaft distal component includes one or more circumferential sealing elements extending circumferentially around and radially outward from the valve shaft distal component to seal against the valve well channel. Optionally, the one or more circumferential sealing elements are axially spaced apart from one another along the actuation axis. Optionally, the valve assembly defines a bleed passage in fluid communication with the valve shaft suction channel and the valve well suction source port when the valve shaft is in the off position, and sealed from fluid communication with the valve shaft suction channel and the valve well suction source port by at least one of the circumferential sealing elements when the valve shaft is in the on position.

[0010] Optionally, the valve assembly has a valve cap coupled to the valve well, the valve shaft being axially movable relative to the valve cap between an off position and an on position, and the valve shaft proximal component including one or more force stop features that engage the valve cap to limit axial and / or rotational movement of the valve shaft relative to the valve cap. Optionally, the valve cap is rotationally fixed relative to the valve well, and the valve shaft is rotationally fixed and axially movable relative to the valve cap.

[0011] In accordance with various principles of the present disclosure, a valve shaft for a valve assembly is configured to be transitioned between an off configuration and an on configuration by transitioning the valve shaft between an off position and an on position, respectively, the valve shaft including a proximal valve shaft component formed of a first material and a distal valve shaft component formed of a second material, the first material being more rigid than the second material, the second material being formed of a sealing material capable of sealing a suction path or a bleed path through the valve assembly.

[0012] In some embodiments, the valve shaft distal component is formed of foam, and the valve shaft proximal component has a distal extension configured to extend into the valve shaft distal component. Optionally, the distal extension of the valve shaft proximal component includes one or more barbs engaging within the proximal end of the valve shaft distal component to resist separation of the valve shaft proximal component from the valve shaft distal component.

[0013] Optionally, the proximal valve shaft component and the distal valve shaft component are secured together by one of insert molding, overmolding, a snap fit, an interference fit, welding, bonding, or adhesive.

[0014] In some aspects, in accordance with various principles of the present disclosure, an endoscope is formed having a control handle including a valve assembly, a connector cord configured to fluidly couple the control handle to a fluid source, and an insertion tube coupled to the control handle and configured to be fluidly coupled to the fluid source via the control handle. The valve assembly includes a valve shaft movable relative to the control handle between an off position and an on position along an actuation axis. When the valve shaft is in the off position, the valve shaft seals the insertion tube from fluid communication with the fluid source. When the valve shaft is in the on position, the insertion tube is in fluid communication with the fluid source via the valve assembly. The valve shaft has a proximal valve shaft component formed of a first material and a distal valve shaft component formed of a second material. The second material is capable of forming a seal with one or more components of the valve assembly, and the first material is more rigid than the second material.

[0015] Optionally, the valve shaft proximal component includes one or more force stop features that engage another component of the valve assembly to limit axial and / or rotational movement of the valve shaft relative to a port in a valve well of the valve assembly.

[0016] Optionally, the valve assembly defines a bleed passage that is in fluid communication with the fluid source when the valve shaft is in the off position and is sealed from fluid communication with the fluid source by a valve shaft distal component when the valve shaft is in the on position.

[0017] According to various principles of the present disclosure, a method of forming a valve shaft for a valve assembly for a medical device includes forming a valve shaft proximal component of a first material and forming a valve shaft distal component of a second material, the second material being less stiff than the first material, the second material extending distally away from the proximal valve shaft component and capable of forming a seal with one or more components of the valve assembly.

[0018] Optionally, the method further comprises forming the proximal valve shaft component and the distal valve shaft component separately and then bonding them together. Optionally, the method further comprises molding the proximal end of the valve shaft distal component onto and distally beyond the distal end of the valve shaft proximal component.

[0019] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that or any other embodiment.

[0020] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures therein may be altered. For example, devices may be enlarged so that details can be discerned, but are also intended to be reduced in size, e.g., in relation to fitting within the working channel of a delivery catheter or endoscope. In the drawings, identical, nearly identical, or equivalent elements are typically designated with the same reference numeral, and similar elements are typically designated with similar reference numerals that differ by hundreds, with redundant description omitted. For purposes of clarity and simplicity, not every element is labeled in every figure, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the present disclosure.

[0021] The detailed description will be better understood in conjunction with the following accompanying drawings, in which like reference numerals represent like elements and in which: [Brief explanation of the drawings]

[0022] [Figure 1] 1 shows a perspective view of an example of an embodiment of an endoscope having one or more valves formed in accordance with aspects of the present disclosure. [Figure 2] 2 illustrates a perspective view of an example of an embodiment of a valve assembly formed in accordance with various principles of the present disclosure for an endoscope, such as that shown in FIG. 1, in an off configuration. [Figure 3] 2 shows a perspective view of an example of an embodiment of a valve assembly formed in accordance with various principles of the present disclosure for an endoscope, such as that shown in FIG. 1, in an on configuration. [Figure 4] 4 shows a perspective view of an example of an embodiment of a valve shaft formed in accordance with various principles of the present disclosure for a valve assembly such as that shown in FIGS. 2 and 3. FIG. [Figure 5] 4 shows a perspective view of an example of an embodiment of a valve shaft formed in accordance with various principles of the present disclosure for a valve assembly such as that shown in FIGS. 2 and 3. FIG. [Figure 6A] 1 illustrates a cross-sectional view of an example of an embodiment of a valve assembly, such as along line IIA-IIA of the valve assembly as shown in FIG. 2, in an off or closed configuration. [Figure 6B] 1B illustrates a cross-sectional view of an example of an embodiment of a valve assembly, such as along line IIB-IIB of the valve assembly as shown in FIG. 3, in an on or open configuration. [Figure 7A] 1 illustrates a cross-sectional view of an example of an embodiment of a valve assembly, such as along line IIA-IIA of the valve assembly as shown in FIG. 2, in an off or closed configuration. [Figure 7B] 1B illustrates a cross-sectional view of an example of an embodiment of a valve assembly, such as along line IIB-IIB of the valve assembly as shown in FIG. 3, in an on or open configuration. [Figure 8A] FIG. 4 is a bottom perspective view of a cap portion of the valve assembly as shown in FIG. 2 or 3. [Figure 8B] FIG. 4 is a top perspective view of a valve well of a valve assembly such as that shown in FIG. 2 or 3. DETAILED DESCRIPTION OF THE INVENTION

[0023] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the present disclosure is not limited to the particular embodiments described, as such may vary. All devices, systems, and methods discussed herein are examples of devices, systems, and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided by way of illustration and is merely an example, not the only way, to implement these principles. Therefore, references to elements, structures, or features in the drawings should be understood as references to example embodiments of the present disclosure, and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. Those skilled in the art will, upon reading this disclosure, suggest other examples of ways to implement the disclosed principles. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield yet a further embodiment. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0024] It will be understood that the present disclosure has been described in various levels of detail in this application. In certain instances, details that are not necessary for understanding the present disclosure or that would make it difficult for those skilled in the art to appreciate other details may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0025] As used herein, "proximal" refers to the direction or location closest to the user (e.g., a medical professional, or clinician, or technician, or surgeon, or physician, etc.; such terms are used interchangeably herein without limitation and include an automated controller system or other manner) and / or closest to the delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery); and "distal" refers to the direction or location furthest from the user and / or closest to the delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, nor does it necessarily maintain a fixed configuration when the element bends or curves; and "axial" generally refers to along the longitudinal axis. It will be understood, however, that references to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and / or longitudinal movement along the longitudinal or central axis of the referenced element. "Center" means at least generally intersecting the center point and / or being generally equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line that at least generally intersects the center point of the opening and extends longitudinally along the length of the opening, for example, when the opening comprises a tubular element, channel, cavity, or hole. As used herein, "channel" or "hole" or "passage" is not limited to a circular cross-section. As used herein, a "free end" of an element is a terminal end beyond which such element does not extend. It will be understood that terms such as at, on, adjacent to, or along, etc., may be used interchangeably herein without limitation unless otherwise stated, and are intended to indicate a general relative spatial relationship rather than a precisely defined location.

[0026] Various medical devices include valve assemblies for regulating or controlling the delivery of fluids (irrigation) or the suction of fluids (aspiration) to an anatomical site. While the present disclosure describes suction valves, it will be understood that the principles of the present disclosure need not be so limited.

[0027] The suction valve assembly of the medical device is arranged to apply suction from a suction source to the anatomical site via a flexible tubular element configured and positionable relative to the anatomical site. The medical device can be an endoscope, and the flexible tubular element can be an insertion tube of the endoscope. The suction source can be a pump or other mechanism that generates a vacuum for application to the anatomical site via the flexible tubular element. In the off configuration of the valve assembly, fluid communication between the suction source and the flexible tubular element is blocked or prevented so that suction is not applied to the anatomical site, and the valve can be considered to be in a closed configuration. In the on configuration of the valve assembly, the suction source is fluidly coupled to the flexible tubular element, such as for suctioning the anatomical site, and the valve can be considered to be in an open configuration.

[0028] The valve assembly of the medical device can be attached to a control handle and typically includes an actuatable member movable relative to the control handle to transition the valve assembly between an off configuration and an on configuration. The actuatable member can include a valve shaft and a user-engagement element movable relative to a valve well formed in or positioned within the control handle. Holes can be formed in the valve shaft to form channels that can be selectively aligned with ports in the valve well to selectively place a suction source in and out of fluid communication with the device's flexible tubing to apply or not apply suction to an anatomical site. Various control handles have different arrangements of ports and channels that place a suction source in and out of fluid communication with the flexible tubing that is directed toward the anatomical site. Thus, various arrangements of holes in the valve shaft allow the ports to the suction source and the ports to the flexible tubing (directed toward the patient) to be aligned and out of alignment with each other.

[0029] For convenience, and without intending to be limiting, this specification will refer to a valve assembly for an endoscope suction valve. The flexible tubular element of the endoscope, referred to herein as an insertion tube, is generally positionable within a patient, such as within an organ, body lumen / passageway, or body cavity (any or other such anatomical location is referred to herein, without intending to be limiting). The insertion tube defines one or more lumens therethrough that are configured to pass materials, instruments, tools, devices, etc. through the working channel to the anatomical location. For example, the lumens may include a suction lumen, an irrigation lumen, a working channel, and a visualization lumen (e.g., for a light guide, optical fiber, camera element, etc.). This disclosure describes a valve assembly usable within a control handle having a suction source port that fluidly connects a suction source to a suction source port in a valve well, a suction source port in a valve shaft, and a suction channel extending axially through the valve shaft. More specifically, the axially extending suction channel extends generally parallel to the direction of actuation movement of the actuatable member of the valve assembly, and therefore generally parallel to the longitudinal axis of the valve shaft. The valve shaft has a suction application port extending transversely to the direction of actuation movement of the valve shaft. The suction application port of the valve shaft is selectively moved into and out of fluid communication with a suction application port of a valve well of the valve assembly, which is in fluid communication with a suction application port in the control handle, to selectively apply suction to an anatomical site during use of the endoscope. More specifically, when the valve assembly is in the off configuration, the valve shaft is in an off position in which the valve shaft blocks fluid communication to the suction application port. When the valve assembly is in the on configuration, the valve shaft fluidly connects the suction application port to the suction channel through the valve shaft and to the suction source port. The suction application port is in fluid communication with a suction application device, such as a suction lumen or working channel of an insertion tube of an endoscope, to apply suction to an anatomical site.Typically, the actuatable member of the valve assembly is biased to an off configuration using a biasing element or the like so that suction is applied only when a medical professional intends to apply suction, such as by depressing the actuatable member.

[0030] As can be appreciated, a close-tolerance fit between the valve shaft and the valve well is generally required to create and maintain a good seal around those ports. According to various principles of the present disclosure, the valve shaft is formed of a proximal component and a distal component connected together in a generally axial direction. The proximal component of the valve shaft is configured to be actuated by a user of the valve assembly and typically has a user-engagement element. Furthermore, a biasing force is applied to the proximal component of the valve shaft to hold the valve shaft in a desired position, typically the off position. The distal component of the valve shaft is transitioned within the valve well of the valve assembly between an off position, which closes / seals the valve well suction application port, and an on position, which opens the valve well suction application port and fluidly communicates with the valve shaft suction application port and a suction application channel through the valve shaft, thereby allowing suction from the suction source port to be applied to the suction application port. According to various principles of the present disclosure, the distal component of the valve shaft is formed from a sealing material, such as a gasket material (e.g., foam, rubber, etc.), capable of forming a seal with the valve well suction application port. Furthermore, in accordance with various principles of the present disclosure, the proximal component of the valve shaft is formed from a material that is sufficiently rigid to resist creep or other deformation that might otherwise be caused by a biasing force applied to the proximal component. Therefore, the proximal component is stiffer than the distal component. The proximal and distal components of the valve shaft can be formed separately and coupled together, such as by a mechanical interference fit or bonding. The proximal and distal components of the valve shaft can also be molded together, such as by insert molding.

[0031] Various embodiments of valve devices, systems, and methods (including, but not limited to, components and assemblies) will now be described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more particular features, structures, ideas, and / or characteristics in accordance with the principles of the present disclosure may be included in connection with that embodiment. However, such references do not necessarily imply that all embodiments include that particular feature, structure, idea, and / or characteristic, or that an embodiment includes all features, structures, ideas, and / or characteristics. Some embodiments may include one or more such features, structures, ideas, and / or characteristics in various combinations thereof. It should be understood that one or more of the features, structures, ideas, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, ideas, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, ideas, and / or properties described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Moreover, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. It is further understood that the various features, structures, ideas, and / or properties of the disclosed embodiments are separate and distinct from one another and may be used or presented individually, or may be used or presented in various combinations with one another to create alternative embodiments that are considered part of the present disclosure. Therefore, since it would be unduly burdensome to describe all of the numerous possible combinations and subcombinations of features, structures, ideas, and / or properties, the present disclosure is not limited to only the embodiments specifically described herein, and the example embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure.It should be understood that the various dimensions provided herein are examples, and that one skilled in the art can readily determine the appropriate range of standard deviations and permissible variations therefrom that are encompassed by the present disclosure and any claims associated therewith. The following description is merely an illustrative example of an embodiment and is not intended to limit the broader aspects of the present disclosure.

[0032] It will be understood that in the drawings, common features are identified by common reference elements, and for brevity and convenience, and without intent to be limiting, descriptions of common features generally will not be repeated. For purposes of clarity, not all components having the same reference number are renumbered. It will be understood that in the following description, similar elements or components among various exemplary embodiments are generally designated by the same reference numbers that differ by multiples of 100, and duplicate descriptions are generally omitted for brevity. Furthermore, specific features in one embodiment can be used across various embodiments and are not necessarily individually labeled when appearing in various embodiments.

[0033] Referring now to the drawings, an example of an embodiment of a valve assembly 100 formed in accordance with various principles of the present disclosure is shown in FIG. 1 as provided in an example embodiment of an endoscope 1000. While endoscope 1000 is an example of an embodiment to which the principles of the present disclosure may be applied, it will be understood that the various principles of the present disclosure may also be applied to other medical instruments to control fluid flow associated with those instruments, the details of which are not critical to the present disclosure. Furthermore, although reference is made to a suction valve, it will be understood that the disclosed principles and embodiments may also be applied to other valves, such as fluid delivery / irrigation valves.

[0034] The illustrated example of one embodiment of the valve assembly 100 is attached to a control handle 1010 of an endoscope 1000 to regulate the flow of material (e.g., fluid) between an insertion tube 1020 of the endoscope 1000 and a suction source 1100. The endoscope 1000 has a connector cord 1030 extending to a scope connector 1032 that can fluidly couple the endoscope 1000 (and the valve assembly 100) with the suction source 1100. The connector cord 1030 may alternatively be referred to herein as an umbilical cord, umbilicus, universal cord, etc., without intending to be limiting. The scope connector 1032 may also couple the endoscope 1000 to various components, devices, etc., via the connector cord 1030, such as a fluid source (for providing air, carbon dioxide, water, saline, or other gases or liquids), electrical connections, light sources, visualization elements (e.g., fiber optics, cameras, etc.), or other components, devices, etc. usable with the endoscope 1000. The insertion tube 1020 has a fluid lumen extending therethrough to a distal end that is positionable (e.g., insertable, navigable, etc.) relative to an anatomical site (e.g., within a patient). Similarly, the connector cord 1030 has a fluid lumen extending therethrough for fluidly coupling the suction source 1100 to the control handle 1010 (e.g., via a scope connector 1032). The fluid lumens through the insertion tube 1020 and connector cord 1030, as well as the distal end of the insertion tube 1020, may be well-known features formed in a manner known to those skilled in the art and are not shown to simplify the drawing by eliminating details in the view of the endoscope 1000 of FIG. 1 that are not necessary to understand the present disclosure.

[0035] An example of an embodiment of a valve assembly 100 formed in accordance with various principles of the present disclosure is shown in FIGS. 2 and 3 separated from an endoscope (such as endoscope 1000 shown in FIG. 1). In the example embodiment shown, valve assembly 100 includes an actuatable member 110 having a valve shaft 120 that is movable relative to a valve well 150 of valve assembly 100. Transition of actuatable member 110 and valve shaft 120 between an off position (as shown in FIG. 2) and an on position (as shown in FIG. 3) transitions valve assembly 100 between an off configuration in which valve assembly 100 does not apply suction to a suction-applying device and an on configuration in which valve assembly 100 can apply suction to a suction-applying device, respectively, as described in more detail below.

[0036] In accordance with various principles of the present disclosure, the valve shaft 120 is formed with a proximal component 130 and a distal component 140, as shown in FIG. 4. An alternative embodiment of a valve shaft 220 formed with a proximal component 230 and a distal component 240 is shown in FIG. 5. Such a configuration of the valve shafts 120, 220 allows for improved sealing capabilities and also provides durable components with reliably alignable valve ports, which are also resistant to deformation, as described in further detail below. It will be understood that the valve shafts 120, 220 shown in FIGS. 4 and 5 can be arranged and operated in substantially the same or similar manner within similar valve assemblies. Accordingly, common elements of the valve shafts 120, 220, such as those having common functions, are designated with the same reference numerals, differing by 100 in value. In general, references and descriptions herein of one of the valve shafts 120, 220 are also applicable to the other of the valve shafts 120, 220, unless expressly indicated otherwise. For simplicity and brevity, and without any intention of limitation, reference may be made only to valve shaft 120, with the understanding that unless expressly indicated otherwise, such description is equally applicable to valve shaft 220. This is for convenience and is not intended to be limiting.

[0037] The valve shaft proximal component 130, 230 is coupled to a user engagement element 112 (e.g., a cap or button) of the actuatable member 110, which is configured to be engaged by a user to transition the actuatable member 110 and the valve shaft 120, 220 between the off and on positions along the actuation axis AA. The user engagement element 112 may be formed separately from and coupled to the proximal end 121, 221 of the valve shaft 120, 220 (e.g., in any of a variety of manners known to those skilled in the art), or alternatively, may be formed integrally with the valve shaft 120, 220. The valve shaft distal component 140, 240 extends into the valve well 150 and is formed of a material capable of sealing the suction path through the valve assembly 100 in the on and off configurations of the valve assembly 100, as described in further detail below.

[0038] The positions of components 130, 140 and components 230, 240, respectively, of an example embodiment of valve shafts 120, 220 relative to the suction source port and suction apply port of an example embodiment of valve assembly 100 are shown in the cross-sectional views of Figures 6A, 6B, 7A, and 7B. In particular, the off and on configurations of an example embodiment of valve assembly 100, and the corresponding off and on positions of actuatable member 110 and its associated valve shafts 120, 220 relative to valve well 150 are shown in Figures 6A, 6B, 7A, and 7B.

[0039] As can be seen with reference to Figures 6A, 6B, 7A, and 7B, the illustrated example of one embodiment of a valve well 150 of a valve assembly 100 includes a valve well suction source port 152 configured to be fluidly coupled with a suction source (such as suction source 1100 as shown in Figure 1) and a valve well suction apply port 154 configured to be fluidly coupled with a suction application device (such as insertion tube 1020 as shown in Figure 1). Valve well suction source port 152 extends generally along actuation axis AA of valve assembly 100, while valve well suction apply port 154 extends transversely to actuation axis AA (and therefore may be considered a lateral port). While the illustrated example of one embodiment of a valve well 150 is formed separately from and inserted into a control handle 1010 of an endoscope 1000 as shown in Figure 1, the disclosure is not limited in this respect. A valve well nut 160 can hold the valve well 150 in place relative to a control handle (such as the control handle 1010 shown in FIG. 1 ), such as in a manner known to those skilled in the art. While an example of an embodiment of a cap 170 is shown coupled to the valve well 150 via the valve well nut 160, the disclosure is not limited to the arrangement shown. The valve shaft 120, 220 extends through a shaft-receiving throughbore 175 defined through a radially inwardly extending limiting shoulder 172 in the cap 170. The cap 170 can provide various features for assembly and use of the valve assembly 100, such as guides for actuation movement of the actuatable member 110, orientation features for the actuatable member 110, a suction bleed passage through the valve assembly 100, and other features, as described in further detail below. In the example of one embodiment shown, the cap 170 is a single-piece element, but the cap 170 can alternatively be formed as a two-piece element without affecting the disclosure.

[0040] The example embodiment of the valve shaft 120, 220 shown in Figures 6A, 6B, 7A, and 7B has a valve shaft suction source port 122, 222 defined in the distal end 123, 223 of the valve shaft 120, 220. The valve shaft suction source port 122, 222 is in fluid communication with a valve shaft suction channel 126, 226 extending generally axially through the valve shaft 120, 220 along the longitudinal axis LA of the valve shaft 120, 220. As can be seen, the valve shaft suction source port 122, 222 remains in fluid communication with the valve well suction source port 152 while the valve shaft 120, 220 is in both the off position and the on position. The valve shaft 120, 220 also includes a valve shaft suction apply port 124, 224 that extends transversely to the longitudinal axis LA of the valve shaft 120, 220 (and therefore may be considered a lateral port) and is in fluid communication with the valve shaft suction channel 126, 226.

[0041] The actuatable member 110, along with its associated valve shaft 120, 220, is movable along an actuation axis AA to transition the valve shaft suction apply port 124, 224 into and out of fluid communication with the laterally extending valve well suction apply port 154. When the actuatable member 110 is in the off position, the valve shaft 120 is in the off position and the valve assembly 100 is in an off configuration in which the valve shaft suction apply port 124 is out of alignment and not in fluid communication with the valve well suction apply port 154. Thus, the valve shaft suction channels 126, 226 (and the suction source fluidly coupled thereto) are not in fluid communication with the valve well suction apply port 154. Therefore, the valve assembly 100 is in the off configuration and does not apply suction. When actuable member 110 is actuated to move valve assembly 100 to the on configuration, valve shafts 120, 220 are transitioned to the on position to align valve shaft suction apply ports 124, 224 with valve well suction apply ports 154. Valve well suction apply ports 154 are thereby placed in fluid communication with valve shaft suction apply ports 124, 224, and therefore with valve shaft suction channels 126, 226 and valve well suction source ports 152 and the suction source. Valve assembly 100 is therefore in the on configuration and capable of applying suction along suction path S.

[0042] Typically, when a valve assembly 100 as described herein is configured for use with an endoscope 1000, the suction source coupled to the valve assembly 100 operates continuously. However, it is generally desirable to limit the suction applied by the valve assembly 100 when suction is desired and to limit, and preferably eliminate, suction to the valve well suction application port 154 when suction is not desired. For example, in certain endoscopic procedures, it is desirable to maintain an insufflated anatomical site to improve visualization of the treatment target site and / or to irrigate the target site, such as by supplying fluid to the target site. Suction may be limited to reducing the supply of fluid and / or removing other material (e.g., biological material) from the target site in certain cases. In such cases, the neutral position of the actuatable member 110 and valve shaft 120, 220 is typically the off position. In the example embodiment shown in Figures 6A, 6B, 7A, and 7B, a biasing element 114 is provided to bias the actuatable member 110 and the valve shaft 120, 220 toward such a position. The biasing element 114 may be a coil spring or other element capable of holding the elements apart but allowing such elements to selectively move together when a force is applied to at least one of the elements and / or the biasing element. In the example embodiment shown in Figures 6A, 6B, 7A, and 7B, the biasing element 114 may be positioned between an underside of the user engagement element 112 and a radially inwardly extending spring support 174 of the cap 170 to bias the actuatable member 110 toward the neutral, off configuration (biasing the user engagement element 112 proximally, away from the cap 170 and the valve well 150), such as in a manner known to those skilled in the art. In the illustrated embodiment, the actuatable member 110 of the valve assembly 100 is moved distally from a neutral position in which the valve assembly 100 is in an off configuration, thereby transitioning the valve assembly 100 to an on configuration.For example, the user engagement element 112 may be transitioned distally from a position proximal to the proximal end 101 of the valve assembly 100 toward the distal end 103 of the valve assembly 100. However, the principles of the present disclosure may be applied to other arrangements as well.

[0043] In accordance with various principles of the present disclosure, the valve shaft 120, 220 has a valve shaft distal component 140, 240 formed from a material that provides sealing of the valve well suction apply port 154 against the valve shaft suction channel 126, 226 of the valve shaft 120, 220 when the actuatable member 110 and valve shaft 120, 220 are in the off configuration, as shown in Figures 6A and 7A. Thus, a valve shaft 120, 220 formed in accordance with various principles of the present disclosure can provide improved sealing of the valve well suction apply port 154 when the valve assembly 100 is in the off configuration.

[0044] In one example embodiment of the valve shaft 120 shown in FIG. 4 , the valve shaft distal component 140 is formed from a compressible material capable of forming a seal with and around the valve well suction application port 154 when the valve shaft 120 is in the off position (as shown in FIG. 6A ). The seal created by the material of the valve shaft distal component 140 should be capable of blocking suction to the valve well suction application port 154 when the valve assembly 100 is in the off configuration. The valve shaft distal component 140 can be formed from a compressible closed-cell foam (e.g., a closed-cell plastic or rubber foam material) to achieve such a seal. Furthermore, the outer diameter of the valve shaft distal component 140 can be oversized relative to the inner diameter of the valve well channel 156 defined within the valve well 150 through which the valve shaft 120 transitions axially between the off and on positions of the valve shaft 120. Such relative diameters of the valve shaft distal component 140 and the valve well channel 156 balance the competing demands of sealing and shaft movement, allowing the valve shaft distal component 140 to move relative to the valve well channel 156 while also compressing against the valve well channel 156 to create the desired seal against the valve well suction apply port 154. Material selection can also facilitate the desired sealing and movement of the valve shaft distal component 140 relative to the valve well channel 156, with plastic foam typically providing the desired properties. Furthermore, the increased diameter of the valve shaft distal component 140 compensates for the negative pressure in the valve shaft suction channel 126 applied by the suction source (via the valve well suction source port 152 and the valve shaft suction source port 122), resisting collapse of the valve shaft distal component 140 that might otherwise result from that negative pressure.The valve shaft suction channel 126 can be extruded during the manufacture of the valve shaft distal component 140 and / or can be machined from a solid cylinder of material forming the valve shaft distal component 140. It will be appreciated that an extruded valve shaft suction channel 126 can provide smoother walls, thereby creating less turbulence and reducing the likelihood of aspirated material becoming trapped within the walls of the valve shaft distal component 140. The valve shaft suction apply port 124 can be formed by stamping the valve shaft distal component 140, such as transversely to the valve shaft suction channel 126. The outer surface of the valve shaft distal component 140 can have a relatively smooth surface to create low drag when the valve shaft distal component 140 transitions between its off and on positions, which may occur multiple times during use of the valve assembly 100.

[0045] The valve shaft proximal component 130 may include a distal extension 132 configured to securely engage the valve shaft distal component 140 to secure the components 130, 140 together to form the valve shaft 120. For example, as can be understood with reference to FIGS. 6A and 6B and shown in phantom in FIG. 2, the distal extension 132 may include one or more barbs that fit within the valve shaft distal component 140, such as within the valve shaft suction channel 126. The distal extension 132 is sized, shaped, configured, and / or dimensioned to engage and resist separation from the valve shaft distal component 140, as can be understood by one skilled in the art. As can be understood, the configuration of the distal extension 132 that engages the valve shaft distal component 140 need not extend continuously around the circumference of the valve shaft proximal component 130. For example, discrete barbs arranged around the circumference of the proximal valve shaft component 130 may be sufficient to resist relative movement between the proximal valve shaft component 130 and the distal valve shaft component 140 .

[0046] In one example embodiment of the valve shaft 220 shown in FIG. 5 , the valve shaft distal component 240 is formed from a flexible material capable of forming a seal with and around the valve well suction application port 154 when the valve shaft 220 is in the off position (as shown in FIG. 7A ). The seal created by the material of the valve shaft distal component 240 should be capable of blocking suction to the valve well suction application port 154 when the valve assembly 100 is in the off configuration. In some embodiments, the valve shaft distal component 240 includes one or more circumferential sealing elements 242 a, 242 b, 242 c extending circumferentially around and radially outward from the valve shaft distal component 240. The circumferential sealing elements 242 a, 242 b, 242 c can be positioned relative to the valve well suction application port 154 to maintain a proper seal against the valve well suction application port 154. 7A, when the valve shaft 220 is in the off configuration, the intermediate circumferential sealing element 242b can create a seal proximal to the valve well suction application port 154, and the distal circumferential sealing element 242c can create a seal distal to the valve well suction application port 154, thereby securely sealing the valve well suction application port 154 from the suction source. As shown in FIG. 7B, when the valve shaft 220 is in the on configuration, the intermediate circumferential sealing element 242b can create a seal distal to the valve well suction application port 154, and the proximal circumferential sealing element 242c can create a seal proximal to the valve well suction application port 154, thereby securely sealing the valve well suction application port 154 from the valve shaft suction channel 126 and the suction source, thereby eliminating suction leakage. The valve shaft distal component 240 can be formed from materials such as, but not limited to, rubber, thermoplastic elastomer ("TPE"), silicone, and the like.

[0047] The separately formed valve shaft distal component 240 can be insert molded, overmolded, snap-fit, interference fit, welded, bonded, adhesively, or otherwise secured (mechanically and / or chemically in any acceptable manner known to those skilled in the art) to the valve shaft proximal component 230. The coupling of the valve shaft distal component 240 to the valve shaft proximal component 230 should be sufficiently secure so that the components 240, 230 do not rotate relative to one another, thereby allowing for repeatable and precise alignment of the valve shaft suction apply port 224 in the valve shaft distal component 240 with the valve well suction apply port 154. For example, the valve shaft proximal component 230 can include a distal extension 232 (shown in phantom in FIG. 5 ) that can be inserted into or form (e.g., insert molded onto) the proximal end 241 of the valve shaft distal component 240. The distal extension 232 of the proximal valve shaft component 230 can be shaped (e.g., wavy, knurled, or otherwise shaped to have at least a non-circular region) to provide a mechanical interlock with the distal valve shaft component 240, particularly to prevent relative rotation between the proximal valve shaft component 230 and the distal valve shaft component 240 during use.

[0048] Advantageously, as mentioned above, the valve shaft proximal component 130, 230 of each of the valve shafts 120, 220 is formed from a different material than the material of the valve shaft distal component 140, 240. In some embodiments, the material of the valve shaft proximal component 130, 230 can be a relatively inflexible material that does not flex in any discernible manner during normal use or even while at rest, compared to the more flexible sealing material of the valve shaft distal component 140, 240. The material of the valve shaft proximal component 130, 230 can be selected to withstand various axial forces acting on the valve shaft 120, 220 during use and / or in packaged / rest states, etc. (e.g., preload forces applied to the valve shaft 120, 220 by the biasing element 114). Furthermore, forming the valve shaft proximal component 130, 230 from a material that is stiffer than the material of the valve shaft distal component 140, 240 allows the valve shaft proximal component 130, 230 to withstand various hard stops to the movement of the actuatable member 110 and / or valve shaft 120, 220 and maintain alignment between the valve shaft suction apply port 124 and the valve well suction apply port 154. Additionally, or alternatively, the material of the valve shaft proximal component 130, 230 can be selected to resist creep that may occur over time (such as over the course of a shelf life, which may be two years or even more) under the constant load of the biasing element 114.

[0049] As described above, the actuatable member 110, and therefore the valve shaft 120, 220, can be biased toward a neutral position by a biasing element 114 positioned between the user-engagement element 112 of the actuatable member 110 and the radially inward-extending spring support 174 of the cap 170. Because the user-engagement element 112 is coupled to the proximal ends 121, 221 of the valve shafts 120, 220, the biasing force of the biasing element 114 also applies a biasing force to the valve shafts 120, 220. The biasing element 114 is typically a preloaded compression spring that exerts a continuous, constant biasing force on the actuatable member 110 in a neutral, resting position while the device including the valve assembly 100 is packaged (prior to use) and even during use. For example, the biasing element 114 may have a preload of approximately 5 Newtons, and the shelf life of a device including the valve assembly 100 may be approximately two years. Such continuous and constant forces can cause a valve shaft formed of a material less stiff than the material selected for the valve shaft 120, 220 to stretch or otherwise exhibit creep, which can cause misalignment of the valve shaft suction apply port 124 and the valve well suction apply port 154 when the valve shaft 120, 220 is transitioned from the neutral off position to the on position. As can be appreciated by one skilled in the art, forming the valve shaft proximal component 130, 230 from a material more stiff than the material of the valve shaft distal component 140, 240 provides the valve shaft proximal component 130, 230 with a greater ability to resist deformation than that provided by the valve shaft distal component 140, 240, while providing the valve shaft distal component 140, 240 with a greater sealing ability than can be provided by the material of the valve shaft proximal component 130, 230.The proximal valve shaft components 130, 230 may be formed from a hard plastic (e.g., acrylonitrile butadiene styrenes (ABS), polycarbonates (PC), blends thereof, etc.) or metal, in contrast to the flexible material of the distal valve shaft components 140, 240.

[0050] As can be appreciated, not only the sealing ability of the mating materials, resistance to deformation / stretching, but also the axial and rotational alignment of the ports 124, 154 are important and must be tightly controlled to maintain a reliable seal between the valve shaft suction apply port 124 and the valve well suction apply port 154. In accordance with various principles of the present disclosure, forming the valve shaft proximal components 130, 230 from a material that is stiffer than the material of the valve shaft distal components 140, 240 allows for the formation of a structure that allows for tightly controlled positive stops to the axial movement of the valve shaft 120, 220 along the actuation axis AA, as well as the rotation of the valve shaft 120, 220 about the actuation axis AA.

[0051] Various features and / or structures can be provided on the actuatable member 110 to provide positive stops that limit the axial movement of the actuatable member 110, and therefore the valve shafts 120, 220, to maintain precise axial alignment of the valve shaft suction apply ports 124, 224 and the valve well suction apply ports 154. For example, the actuatable member 110 can include one or more positive stop features that interact with one or more corresponding positive stop features on the cap 170. In the example embodiment of the cap 170 shown in FIGS. 6A, 6B, 7A, and 7B, a radially inwardly extending limit shoulder 172 of the cap 170 not only defines the shaft-receiving throughbore 175 through which the valve shaft 120 extends, but also forms a proximal limit stop for proximal movement of the valve shafts 120, 220. In one example embodiment of the valve shaft 120 shown in FIG. 4 , the valve shaft proximal component 130 has a valve shaft proximal limit stop 134 in the form of a radially outwardly extending flange or shoulder. As can be seen with reference to FIG. 6A , the proximal surface of the valve shaft proximal limit stop 134 abuts a distal surface of the cap proximal limit stop formed by a radially inwardly extending limit shoulder 172 of the cap 170, which defines a shaft-receiving throughbore 175 through which the valve shaft 120 extends. As can be seen, forming the valve shaft proximal component 130 from a material that is stiffer than the material of the valve shaft distal component 140 enables the valve shaft 120 to withstand the biasing force of the biasing element 114 pressing the valve shaft proximal limit stop 134 against the radially inwardly extending limit shoulder 172 to hold the valve shaft 120 in the off position. In one example embodiment of the valve shaft 220 shown in FIG. 5, the distal extension 232 of the proximal valve shaft component 230 provides stiffness to the distal valve shaft component 140, which abuts the distal surface of the radially inwardly extending limiting shoulder 172 of the cap 170, as shown in FIG. 7A.Such interaction provides a stronger stop to proximal movement of the valve shaft 220 than would be achieved by the valve shaft 220 being formed entirely from the material forming the valve shaft distal component 240.

[0052] 6A, 6B, 7A, and 7B, the radially inwardly extending spring support 174 of the cap 170 not only provides distal support for the biasing element 114, but also forms a distal limit stop for proximal movement of the actuatable member 110, and therefore the valve shaft 120, 220. For example, a distal surface of the user engagement element 112 may abut a proximal surface of the radially inwardly extending spring support 174. In the example embodiment of the actuatable member 110 shown in FIGS. 6B and 7B, the user engagement element 112 has a circumferential skirt 116 that extends distally to engage the radially inwardly extending spring support 174, which may form a positive stop for distal axial movement of the actuatable member 110. Additionally or alternatively, the user engagement element 112 may have a cylindrical neck 118 extending around and engaging the proximal end 121, 221 of the valve shaft 120, 220. The distal end of the cylindrical neck 118 may engage a radially inwardly extending limiting shoulder 172 of the cap 170 as a positive stop against distal axial movement of the valve shaft 120 through the shaft-receiving throughbore 175 therein. Additionally or alternatively, distal movement of the valve shaft 120, 220 may be limited by the solid height of the biasing element 114 (when the biasing element 114 bottoms out), thus helping to ensure axial alignment of the valve shaft suction source port 122, 222 with the valve well suction source port 152. As can be appreciated, forming the valve shaft proximal component 130, 230 from a material that is stiffer than the material of the valve shaft distal component 140, 240 allows for a more rigid fixation between the user engagement element 112 and the proximal end 111, 211 of the valve shaft 120, 220 to withstand forces from collision between the circumferential skirt 116 and the radially inwardly extending spring support 174, and / or collision between the circumferential neck 118 and the radially inwardly extending limiting shoulder 172, and / or collision of the biasing element 114 against the user engagement element 112.

[0053] Additionally or alternatively, various features and / or structures can be provided on the valve shaft proximal component 130, 230 to provide positive stops that limit rotational movement of the actuatable member 110 to maintain precise rotational alignment between the valve shaft suction apply port 124, 224 and the valve well suction apply port 154. For example, the valve shaft proximal component 130, 230 can have a non-circular cross-sectional shape, and the shaft-receiving through-hole 175 in the cap 170 (through which the valve shaft proximal component 130, 230 extends) can have a corresponding non-circular cross-sectional shape such that rotation of the valve shaft 120, 220 relative to the cap 170 is inhibited, and preferably prevented. In one example embodiment shown in FIGS. 2 and 3 , the valve shaft proximal component 130, 230 can include one or more flats 136, 236, respectively. Also, in the example embodiment of the cap 170 shown in Figure 8, the shaft-receiving throughbore 175 defined through the radially inwardly extending limiting shoulder 172 of the cap 170 has a corresponding cross-sectional shape for receiving the valve shaft proximal component 130, 230 therein to rotationally secure the valve shaft proximal component 130, 230, and therefore the valve shaft 120, 220, relative to the cap 170. Furthermore, the cap 170 in the example embodiment shown is configured to be rotationally secured relative to the valve well 150. In the example embodiment shown in Figures 8A and 8B, the cap 170 has one or more axially extending protrusions 178 that engage corresponding seats 158 in the valve well 150 to rotationally secure the cap 170 relative to the valve well 150. It will be understood that the illustrated engagement features are examples and that other configurations of engagement features between the valve shaft 120, 220, cap 170, and valve well 150 are within the scope and spirit of the present disclosure, which is not intended to be limited in this respect. Providing a relatively rigid valve shaft proximal component 130, 230 allows for rotational fixation of the valve shaft 120, 220 relative to the cap 170.Because the cap 170 is typically rigid, rotational fixation of the cap 170 relative to the valve well 150 allows the valve shaft 120, 220, which is rotationally fixed relative to the cap 170, to also be rotationally fixed to the valve well 150. The rotational fixation of the valve shaft 120, 220 also results in the rotational fixation of the valve shaft suction apply port 124, 224 relative to the valve well suction apply port 154.

[0054] As mentioned above, in some instances, the suction source may remain on during use of the valve assembly 100 that is fluidly coupled to the suction source, with the transition of the actuatable member 110 controlling whether the suction source is in fluid communication with the suction-applying device coupled to the valve assembly 100. As can be appreciated, when the valve assembly 100 is in the off configuration, it may be desirable to vent or bleed the vacuum pressure generated within the valve assembly 100 from the suction source (via the valve well suction source port 152). Rotationally securing the valve shaft 120, 220 to the cap 170, as in the illustrated embodiment, facilitates bleeding or venting the suction source. For example, the cap 170 may be provided with a bleed passage 176 in fluid communication with the valve shaft suction channel 126, 226 to define a bleed path B for bleeding ambient air into the suction source, as shown in FIGS. 8A, 6A, and 7A. When the valve shafts 120, 220 are in the off position shown in Figures 6A and 7A, ambient air can enter the cap bleed passage 176 through the proximal end 101 of the valve assembly 100 and flow into the valve shaft suction channel 126, 226 through the valve shaft suction apply port 124, 224, thereby allowing suction to be bled to the suction source via the valve shaft suction source port 122, 222 and the valve well suction source port 152. When the valve shafts 120, 220 are in the on position, the valve shaft distal component 140, 240 seals the valve shaft suction apply port 124, 224 from the bleed passage 176, thereby allowing suction to be applied to the valve well suction apply port 154 without bleed air external to the valve assembly 100. The seal created by the material of the valve shaft distal component 140 should be capable of blocking suction to the valve well suction apply port 154 when the valve assembly 100 is in the on configuration as shown in Figure 6B. As shown in FIG. 7B, a proximal circumferential sealing element 242a on the valve shaft distal component 240 can seal the suction path S from the bleed passage 176 within the cap 170 and from the ambient air.

[0055] In addition to those discussed above, various additional advantages of the various aspects, features, components, and structures of the valve shaft and associated sealing elements, as well as the valve assembly and endoscope, as described above, can be appreciated by those skilled in the art.

[0056] Those skilled in the art will appreciate that this discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the present disclosure. It will be appreciated that the principles of the present disclosure may be applied to a variety of medical devices, instruments, tools, etc., such as, but not limited to, various medical devices, instruments, tools for accessing and applying suction and / or irrigation to anatomical sites, including, for example, endoscopes, gastroscopes, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc., with integrated features for suction and / or irrigation of anatomical sites. Furthermore, the principles of the present disclosure may be applied to reusable or disposable devices, instruments, tools, etc.

[0057] All devices and methods discussed herein are examples of devices and / or methods implemented in accordance with one or more principles of the present disclosure. These examples are not the only ways of implementing these principles; they are merely examples and are not intended to limit the broader aspects of the present disclosure. Therefore, references to elements, structures, or features in the drawings should be understood as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. Those skilled in the art will likely recall other examples of ways of implementing the disclosed principles upon reading this disclosure. For example, the various elements and components of the valve assemblies described herein can be directly or indirectly coupled or engaged with one another, regardless of how such connections are shown in the drawings. Those skilled in the art will appreciate that variations can be applied to the disclosed devices, systems, and / or methods and / or to the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. It will be understood that various features described with respect to one embodiment can typically be applied to other embodiments, whether or not explicitly stated. The various features described hereinafter can be used alone or in any combination thereof. Therefore, the present invention is not limited to only the embodiments specifically described herein, and all substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

[0058] The foregoing discussion has broad applicability and is presented for purposes of illustration and description, and is not intended to limit the disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the disclosure have been grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of particular aspects, embodiments, or configurations of the disclosure can be combined into alternative aspects, embodiments, or configurations. While the disclosure is presented in terms of embodiments, it should be understood that various individual features of the subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the subject matter or such individual features. Those skilled in the art will recognize that the present disclosure can be used with many modifications specifically adapted to particular environments and operating requirements, or with modifications to the structure, arrangement, proportions, materials, components, and other modifications used in practicing the disclosure, without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed can be composed of multiple pieces, or elements shown as multiple pieces can be formed integrally, operations of elements can be reversed or otherwise changed, and elements can be sized or dimensioned differently. Similarly, although operations, actions, or steps are described in a particular order, this should not be construed as requiring such a particular order, or as requiring all operations, actions, or steps to be performed, to achieve desirable results. Moreover, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the foregoing description or to the specific embodiments or arrangements described or illustrated herein. In view of the above, it is to be understood that individual features of any embodiment can be used and claimed separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0059] In the foregoing description and in the claims that follow, it will be understood that the terms "at least one," "one or more," and "and / or," as used herein, are open-ended expressions that operate both conjunctively and disjunctively. The terms "a," "an," "the," "first," "second," etc., do not exclude a plurality. For example, the terms "a" or "an" entity, as used herein, refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so connected, alone as well as in any combination and number, unless the context clearly dictates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader in understanding this disclosure and / or serve to distinguish regions of associated elements from one another and do not limit the associated elements, particularly with respect to position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and connected) should be interpreted broadly and may include intermediate members between groups of elements and relative movement between the elements, unless otherwise indicated. Thus, connection references do not necessarily imply that two elements are directly connected and in fixed relationship to each other.Distinguishing references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0060] The following claims are incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms "comprises," "comprising," "includes," and "including" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Furthermore, although individual features may be included in different claims, these features may, in some cases, be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. Furthermore, reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. a valve shaft configured to transition within a valve well channel of a valve assembly of a medical device along an actuation axis between an off position in which the valve assembly is in an off configuration and an on position in which the valve assembly is in an on configuration; a valve shaft proximal component having a proximal end and a distal end and formed of a first material; a valve shaft distal component having a proximal end and a distal end and formed of a second material; Equipped with the first material being stiffer than the second material; the second material is configured to seal a port defined in the valve well; the valve shaft distal component extends distally beyond the valve shaft proximal component; Valve shaft.

2. the valve shaft distal component is formed of foam; the proximal valve shaft component having a distal extension configured to extend into the proximal end of the distal valve shaft component; The valve shaft according to claim 1 .

3. 3. The valve shaft of claim 2, wherein the distal extension of the proximal valve shaft component includes one or more barbs that engage within the proximal end of the distal valve shaft component to resist separation of the proximal valve shaft component from the distal valve shaft component.

4. 4. The valve shaft of claim 1, wherein the proximal valve shaft component and the distal valve shaft component are secured together by at least one of insert molding, overmolding, snap-fitting, interference fitting, welding, bonding, or adhesive.

5. 5. A valve shaft according to any one of claims 1 to 4, wherein the valve shaft distal component has an outer diameter greater than an inner diameter of the valve well channel of the valve assembly, into which the valve shaft extends.

6. the valve shaft distal component defines a valve shaft suction channel extending through the valve shaft distal component along the actuation axis, the valve shaft suction channel in fluid communication with a valve well suction source port at a distal end of the valve well channel; the valve shaft further defines a valve shaft suction apply port extending transversely to the actuation axis and in fluid communication with the valve shaft suction channel; when the valve shaft is in the off position, the valve shaft distal component seals a valve well suction apply port from fluid communication with the valve well suction source port; when the valve shaft is in the on position, the valve shaft suction apply port is in fluid communication with the valve well suction apply port, thereby fluidly connecting the valve well suction apply port to the valve well suction source port via the valve shaft suction channel; The valve shaft according to claim 5.

7. The valve shaft of claim 6 , wherein the valve shaft suction channel and the valve shaft suction apply port are defined in the valve shaft distal component distal to the distal end of the valve shaft proximal component.

8. 7. The valve shaft of claim 6, wherein the valve shaft distal component includes one or more circumferential sealing elements extending circumferentially around and radially outward from the valve shaft distal component to seal against the valve well channel.

9. The valve shaft of claim 8 , wherein the one or more circumferential sealing elements are axially spaced apart from one another along the actuation axis.

10. 10. The valve shaft of claim 8 or 9, wherein when the valve shaft is in the off position, the valve shaft suction channel is in fluid communication with a bleed passage in the valve assembly and with the valve well suction source port, and when the valve shaft is in the on position, the valve shaft is sealed from fluid communication with the valve shaft suction channel and the valve well suction source port by at least one of the circumferential sealing elements.

11. the valve shaft is axially movable between the off position and the on position relative to a valve cap configured to be coupled to a valve well of the valve assembly; the valve shaft proximal component includes one or more force stop features that engage the valve cap to limit axial and / or rotational movement of the valve shaft relative to the valve cap; A valve shaft according to any one of claims 1 to 10.

12. the valve cap is configured to be rotationally secured to the valve well; the valve shaft is rotationally fixed relative to the valve cap and axially movable relative to the valve cap; The valve shaft of claim 11.

13. a valve shaft for a valve assembly configured to be transitioned between an off configuration and an on configuration by transitioning the valve shaft between an off position and an on position, respectively; a valve shaft proximal component formed of a first material; a valve shaft distal component formed from a second material; and Equipped with the first material being stiffer than the second material; the second material is formed of a sealing material capable of sealing the suction path through the valve assembly; at least a portion of the valve shaft distal component is formed exclusively of the second material; Valve shaft.

14. the valve shaft distal component is formed of foam; the valve shaft proximal component having a distal extension configured to extend into the valve shaft distal component; 14. The valve shaft of claim 13.

15. 1. A method of forming a valve shaft for a valve assembly for a medical device, comprising: forming a valve shaft proximal component of a first material; forming a valve shaft distal component of a second material less rigid than the first material, the second material extending distally away from the valve shaft proximal component and capable of forming a seal with one or more components of the valve assembly; A method comprising:

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