Endoscope valve devices, systems, and methods

Abstract

A valve shaft for a valve assembly of a medical device. The valve shaft is movable between a closed position in which the valve assembly is in a closed configuration and does not cause the fluid source to be in fluid communication with the patient, and an open position in which the valve assembly is in an open configuration and causes the fluid source to be in fluid communication with the patient. The valve shaft is formed from a valve shaft proximal member formed from a first material and a valve shaft distal member formed from a second material. The first material is more rigid than the second material such that the valve shaft proximal member may have a hard stop feature that limits axial and / or rotational movement of the valve shaft. The second material is capable of forming a seal between the valve shaft distal component and another component of the valve assembly.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 436,758, filed on January 3, 2023, the entire disclosure of which is hereby incorporated by reference herein for all purposes. Technical Field

[0002] The present disclosure generally relates to devices (including but not limited to components and assemblies), systems and methods for controlling the flow of materials through valves. In particular, the present disclosure relates to devices, systems and methods for controlling the flow of materials through valve assemblies that can be used in medical devices such as endoscopes. Background Art

[0003] Various endoscopes are known in the art for use during various medical procedures. Endoscopes typically have an insertion tube with a working channel through which substances (e.g., fluids such as gases or liquids) or devices, instruments, or tools can be introduced, or substances can be removed or aspirated. Thus, endoscopes typically also include a control handle with various actuators, connectors, etc. configured to control the endoscope (e.g., navigation of the endoscope) and / or materials, substances, devices, systems, instruments, tools, etc. delivered through the working channel. For example, the actuators, connectors, etc. can be engaged to supply fluid to the anatomical site (e.g., for irrigation) and / or apply suction to the anatomical site (e.g., to extract material therefrom) through the insertion tube. A fluid supply source and / or a vacuum source can be fluidically coupled to the insertion tube of the endoscope via the endoscope's control handle. To control the flow of substances through the endoscope, the fluid source and / or suction pump / vacuum source are fluidically coupled to the endoscope handle and the insertion tube via a valve assembly. A valve assembly typically includes a valve well and a valve shaft movable within the valve well between a closed position and an open position. In the closed position, the valve assembly is in a closed configuration; in the open position, the valve assembly is in an open configuration. In the closed configuration, the valve assembly blocks fluid communication between a fluid source / suction source and the insertion tube of an endoscope. When the valve assembly is moved to the open configuration (typically by pressing against a handle), fluid communication is established between the fluid source / suction source and the working channel of the endoscope to supply fluid and / or apply suction / negative pressure to the insertion tube of the endoscope. Proper sealing of the ports, channels, lumens, etc. associated with such valve assemblies is important. However, seals that provide sealing interference also create significant resistance, which can affect the operation of the valve shaft as it (typically repeatedly) moves within the valve well. Furthermore, if a sealing material is overmolded onto a portion of the valve shaft, such overmolding may result in a reduction in the cross-sectional dimensions of the valve shaft, thereby reducing the inner diameter of the suction channel through the valve shaft. Furthermore, endoscope valve assemblies are typically biased to the closed configuration because the suction source continuously applies suction to the valve assembly. If the valve shaft is made of a single compliant material, such material may experience creep / relaxation in the packaged / at-rest state due to the preload force exerted thereon to maintain the suction valve assembly in the closed configuration. There remains a need for improvements in endoscopic valves, such as suction valves and their associated seals. Summary of the Invention

[0004] This summary is intended to introduce in simplified form some concepts that are further described in detail in the detailed description below. This summary is not intended to necessarily identify the key features or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter. Those skilled in the art will understand that the various aspects and features of this disclosure can be used alone in some cases, or in other cases can be used in combination with other aspects and features of the disclosure, whether or not described in this summary. The inclusion or exclusion of elements, components, etc. in this summary is not intended to limit the scope of the claimed subject matter.

[0005] According to various principles of the present disclosure, a valve shaft for a valve assembly of a medical device is formed according to various principles of the present disclosure. The valve shaft has a valve shaft proximal component formed from a first material and a valve shaft distal component formed from 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, into which the valve shaft extends. The valve shaft is movable within the valve well passage along an actuation axis between a closed position and an open position. When the valve shaft is in the closed position, the valve assembly is in a closed configuration. When the valve shaft is in the open position, the valve assembly is in an open configuration.

[0006] In some embodiments, the distal valve shaft component is formed of foam; and the proximal valve shaft component has a distal extension configured to extend into the distal valve shaft component. Optionally, 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 prevent the proximal valve shaft component from separating from the distal valve shaft component.

[0007] Optionally, the valve shaft proximal component and the valve shaft distal component are fixed together by at least one of the following means: insert molding, overmolding, snap fit, interference fit, welding, bonding or adhering.

[0008] Optionally, the outer diameter of the valve shaft distal component is larger than the inner diameter of a valve well of the valve assembly into which the valve shaft will extend.

[0009] In some embodiments, the valve well includes a valve well suction source port configured to be in fluid communication with a suction source. When the valve shaft is in the closed position, the valve assembly does not apply suction; and when the valve shaft is in the open position, the valve assembly can apply suction.

[0010] In some embodiments, the valve shaft distal component defines a valve shaft suction passage therethrough, the passage extending along the actuation axis and in fluid communication with the valve well suction source port; the valve shaft further defines a valve shaft suction application port extending transverse to the actuation axis; when the valve shaft is in a closed position, the valve shaft distal component seals fluid communication between the valve well suction application port and the valve well suction source port; and when the valve shaft is in an open position, the valve shaft suction application port is in fluid communication with the valve well suction application port, such that the valve well suction application port is in fluid communication with the valve well suction source port via the valve shaft suction passage. In some embodiments, the valve shaft suction passage 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 therearound and radially outwardly therefrom to seal against the valve well passage. Optionally, the one or more circumferential sealing elements are spaced axially from one another along the actuation axis. Optionally, the valve assembly defines a drain passage that is in fluid communication with the valve shaft suction passage and the valve well suction source port when the valve shaft is in the closed position, and is sealed from fluid communication with the valve shaft suction passage and the valve well suction source port by at least one of the circumferential sealing elements when the valve shaft is in the open position.

[0011] Optionally, the valve assembly includes a valve cap coupled to the valve well; the valve shaft is axially movable relative to the valve cap between a closed position and an open position; and the valve shaft proximal component includes one or more hard 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 relative to the valve cap and axially movable relative thereto.

[0012] According to various principles of the present disclosure, a valve shaft for a valve assembly is configured to move between a closed configuration and an open configuration by moving the valve shaft between the closed position and the open position, respectively, and the valve shaft includes a valve shaft proximal component formed of a first material; and a valve shaft distal component formed of a second material. The first material is more rigid than the second material; and the second material is formed of a sealing material capable of sealing a suction path or a discharge path through the valve assembly.

[0013] In some embodiments, the distal valve shaft component is formed of foam; and the proximal valve shaft component has a distal extension configured to extend into the distal valve shaft component. Optionally, 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 prevent the proximal valve shaft component from separating from the distal valve shaft component.

[0014] Optionally, the valve shaft proximal component and the valve shaft distal component are fixed together by one of the following means: insert molding, over molding, snap fit, interference fit, welding, bonding or adhering.

[0015] In some aspects, an endoscope is formed according to various principles of the present disclosure and includes a control handle including a valve assembly; a connecting cord configured to fluidically couple the control handle to a fluid source; and an insertion tube coupled to the control handle and configured to fluidically couple to the fluid source via the control handle. The valve assembly includes a valve shaft movable along an actuation axis relative to the control handle between a closed position and an open position. When the valve shaft is in the closed position, the valve shaft seals fluid communication between the insertion tube and the fluid source. When the valve shaft is in the open position, the insertion tube is in fluid communication with the fluid source via the valve assembly. The valve shaft includes a proximal valve shaft component formed from a first material and a distal valve shaft component formed from 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.

[0016] Optionally, the valve shaft proximal component includes one or more hard stop features that engage another component of the valve assembly to limit axial and / or rotational movement of the valve shaft relative to the port in the valve well.

[0017] Optionally, the valve assembly defines a vent passage in fluid communication with the fluid source when the valve shaft is in the closed position, and seals fluid communication with the fluid source through the valve shaft distal member when the valve shaft is in the open position.

[0018] According to various principles of the present disclosure, a method for forming a valve shaft for a valve assembly of a medical instrument includes forming a proximal valve shaft component from a first material; and forming a distal valve shaft component extending distally from the proximal valve shaft component, the distal valve shaft component being made of a second material that is capable of forming a seal with one or more components of the valve assembly and is less rigid than the first material.

[0019] Optionally, the method further comprises forming the valve shaft proximal component and the valve shaft distal component separately and then coupling them together.

[0020] Optionally, the method further comprises overmolding the proximal end of the valve shaft distal component over and distally beyond the distal end of the valve shaft proximal component.

[0021] These and other features and advantages of the present disclosure will be readily apparent from the following detailed description, with the scope of the claimed invention being set forth in the appended claims. Although the following disclosure is presented in the form of aspects or embodiments, it should be understood that each aspect may be claimed independently or in combination with aspects and features of that embodiment or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] 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, orders, and relative sizes reflected in the drawings may vary. For example, the device may be enlarged so that details can be discerned, but is intended to be scaled down relative to, for example, a working channel suitable for a delivery catheter or endoscope. In the drawings, identical or nearly identical or equivalent elements are generally represented by the same reference numerals, and similar elements are generally designated by similar reference numerals that differ by 100, omitting redundant descriptions. For the sake of clarity and brevity, not every element in each of the drawings is labeled, and not every element of each embodiment is shown, and a person of ordinary skill in the art will be able to understand the present disclosure without the need for such illustrations.

[0023] The detailed description will be better understood when read in conjunction with the accompanying drawings, in which like reference numerals represent like elements, as follows:

[0024] Figure 1 A perspective view of an example embodiment of an endoscope having one or more valves formed in accordance with aspects of the present disclosure is shown.

[0025] Figure 2 A perspective view illustrating an example embodiment of a valve assembly formed according to various principles of the present disclosure, such as for example Figure 1 Endoscope shown in closed configuration.

[0026] Figure 3 A perspective view illustrating an example embodiment of a valve assembly formed according to various principles of the present disclosure, such as for example Figure 1 Endoscope shown in open configuration.

[0027] Figure 4 The invention is shown as follows: Figure 2 and Figure 3 A perspective view of an example embodiment of a valve shaft of a valve assembly is shown.

[0028] Figure 5 The invention is shown as follows: Figure 2 and Figure 3 A perspective view of an example embodiment of a valve shaft of a valve assembly is shown.

[0029] Figure 6A A cross-sectional view of an example embodiment of a valve assembly is shown, for example, along Figure 2 The valve assembly is shown along line IIA-IIA, with the valve assembly in a closed configuration.

[0030] Figure 6B A cross-sectional view of an example embodiment of a valve assembly is shown, for example, along Figure 3 The valve assembly is shown along line IIB-IIB, with the valve assembly in an open configuration.

[0031] Figure 7A A cross-sectional view of an example embodiment of a valve assembly is shown, for example, along Figure 2 The valve assembly is shown along line IIA-IIA, with the valve assembly in a closed configuration.

[0032] Figure 7B A cross-sectional view of an example embodiment of a valve assembly is shown, for example, along Figure 3 The valve assembly is shown along line IIB-IIB, with the valve assembly in an open configuration.

[0033] Figure 8A Yes Figure 2 or Figure 3 A bottom perspective view of the cover portion of the valve assembly is shown.

[0034] Figure 8B Yes Figure 2 or Figure 3 A top perspective view of the valve well of the valve assembly is shown. DETAILED DESCRIPTION

[0035] The following detailed description should be read in conjunction with the accompanying drawings, which depict illustrative embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described, as these may vary. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example embodiment is provided by way of explanation and is not the only way to implement these principles, but rather merely an example. Therefore, references to elements, structures, or features in the accompanying drawings must be understood as references to examples of embodiments of the present disclosure and should not be construed as limiting the present disclosure to the specific elements, structures, or features shown. After reading this disclosure, one of ordinary skill in the art will recognize 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 may be made to the present disclosure without departing from the scope or spirit of the present subject matter. For example, features shown or described as part of one embodiment can be used in conjunction with another embodiment to produce yet another embodiment. Therefore, it is intended that the present subject matter encompass such modifications and variations as fall within the scope of the appended claims and their equivalents.

[0036] It should be understood that the present disclosure is described in this application with varying degrees of detail. In some cases, details that are not necessary for a person of ordinary skill in the art to understand the present disclosure, or details that make other details difficult to understand, may be omitted. The terms used herein are only used to describe specific embodiments and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood to have the meanings commonly understood by a person of ordinary skill in the art to which the present disclosure belongs. Under the guidance of the present disclosure, all devices and / or methods disclosed and claimed herein can be manufactured and performed without difficulty.

[0037] As used herein, "proximal" refers to the direction or position closest to a user (a medical professional or clinician or technician or operator or physician, etc., these terms are used interchangeably herein without limitation, including automated controller systems or others), such as when the device is being used (e.g., when the device is introduced into a patient, or during implantation, positioning, or delivery), and / or closest to a delivery device, and "distal" refers to the direction or position farthest from a user, such as when the device is being used (e.g., when the device is introduced into a patient, or during implantation, positioning, or delivery), and / or closest to a delivery device. "Longitudinal" refers to extending along the longer or larger dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, although not necessarily straight and not necessarily in a fixed configuration if the element is bent or flexed, and "axial" generally refers to along the longitudinal axis. However, it should be understood that references to axial or longitudinal movement of the above-described systems or elements thereof are not necessarily strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Center" means at least approximately bisecting a center point and / or approximately equidistant from a periphery or boundary, and "central axis" means, with respect to an opening, a line that at least approximately bisects the center point of the opening and, when the opening comprises, for example, a tubular element, a channel, a cavity, or a hole, extends longitudinally along the length of the opening. As used herein, a "channel" or "hole" or "channel" is not limited to a circular cross-section. As used herein, a "free end" of an element refers to a terminal end beyond which the element does not extend. It should be understood that, unless otherwise specified, terms such as at or on or adjacent to or along an end are used interchangeably herein without limitation and are intended to indicate general relative spatial relationships rather than precisely defined positions.

[0038] Various medical devices include valve assemblies to regulate or control fluid delivery (irrigation) or fluid aspiration (suction, inhalation) relative to an anatomical site. Although the present disclosure describes a suction valve, it should be understood that the principles of the present disclosure are not necessarily limited thereto.

[0039] A suction valve assembly of a medical device is arranged to apply suction from a suction source to an anatomical site through a flexible tubular element that is 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 creates a vacuum that is applied to the anatomical site through the flexible tubular element. In a closed configuration of the valve assembly, fluid communication between the suction source and the flexible tubular element is severed or blocked so that suction is not applied to the anatomical site, and the valve can be considered to be in a closed configuration. In an open configuration of the valve assembly, the suction source is fluidly coupled to the flexible tubular element, for example to draw the anatomical site, and the valve can be considered to be in an open configuration.

[0040] The valve assembly of a medical device can be mounted on a control handle and typically includes an actuatable member movable relative to the control handle to move the valve assembly between a closed configuration and an open configuration. The actuatable member can include a valve shaft and a user engagement element that are movable relative to a valve well formed in the control handle or formed and 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 connect or disconnect the suction source to the fluid of the flexible tubular element of the device to apply suction to the anatomical site or not. Various control handles have different port and flow path arrangements that connect or disconnect the suction source to the fluid of the flexible tubular element to be directed to the anatomical site. Thus, various hole arrangements in the valve shaft can align or misalign the port leading to the suction source and the port leading to the flexible tubular element (directed toward the patient) with each other.

[0041] For convenience, and without any intention to limit, reference is made herein to a valve assembly for a suction valve of an endoscope. The flexible tubular element of an endoscope is referred to herein as an insertion tube and is generally positionable within a patient's body, such as within an organ, body cavity / channel, cavity, etc. (reference is made herein to any or other such anatomical site without any intention to limit). The insertion tube defines one or more lumens passing therethrough, which are configured for materials, instruments, tools, devices, etc. to reach the anatomical site through a working channel. For example, the lumens may include a suction lumen, a flushing lumen, a working channel, and a visualization lumen (e.g., for light guides, optical fibers, camera elements, etc.). The present disclosure describes a valve assembly that can be used in a control handle having a suction source port fluidically connected to the suction source port of a valve well, a suction source port of a valve shaft, and an axially extending suction channel extending through the valve shaft. More specifically, the axially extending suction channel extends approximately parallel to the actuation motion direction of the actuable member of the valve assembly, and therefore approximately parallel to the longitudinal axis of the valve shaft. The valve shaft has a suction application port extending transversely to the actuation motion direction of the valve shaft. When the endoscope is in use, the suction application port of the valve shaft is selectively moved into or out of fluid communication with the suction application port in the valve well of the valve assembly to selectively apply suction to the anatomical part. More specifically, when the valve assembly is in a closed configuration, the valve shaft is in a closed position and the valve shaft blocks fluid communication with the suction application port. When the valve assembly is in an open configuration, the valve shaft connects the suction application port to the suction channel and the suction source port fluid passing through the valve shaft. The suction application port is fluidly connected to a suction application device (such as a suction lumen or working channel of an insertion tube of an endoscope) to apply suction to the anatomical part. Typically, the actuatable member of the valve assembly is biased to a closed configuration, for example by a biasing element, so that suction is applied only when the medical professional intends to apply suction (for example, by pressing the actuatable member).

[0042] It will be appreciated that a close tolerance fit between the valve shaft and the valve well is typically required to create and maintain a good seal around its ports. According to various principles of the present disclosure, the valve shaft is formed by a proximal component and a distal component that are generally connected axially together. 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. In addition, a biasing force is applied to the proximal component of the valve shaft to maintain the valve shaft in a desired position, typically a closed position. The distal component of the valve shaft moves within the valve well of the valve assembly between a closed position and an open position, wherein the closed position closes / seals the valve well suction application port and the open position opens / is fluidically connected to the valve shaft suction application port and a suction application channel passing through the valve shaft to allow 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 by a sealing material (such as a gasket material (e.g., foam, rubber, etc.)) that is capable of forming a seal with the valve well suction application port. Furthermore, according to various principles of the present disclosure, the proximal component of the valve shaft is formed of a material sufficiently rigid to resist creep or other deformation that may be caused by the biasing force applied thereto. Thus, the proximal component is more rigid than the distal component. The proximal and distal components of the valve shaft can be formed separately and connected together, for example, by a mechanical interference fit or adhesive bonding. The proximal and distal components of the valve shaft can be molded together, for example, by insert molding.

[0043] Various embodiments of valve devices (including but not limited to components and assemblies), systems, and methods will now be described with reference to the examples illustrated in the accompanying drawings. References throughout this specification to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that, in accordance with the principles of the present disclosure, one or more specific features, structures, concepts, and / or characteristics may be included in connection with that embodiment. However, such references do not necessarily imply that all embodiments include a particular feature, structure, concept, and / or characteristic, or that one embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations. It should be understood that one or more features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more features, structures, concepts, and / or characteristics of any other embodiment provided herein. In other words, any features, structures, concepts, and / or characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Furthermore, references to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., throughout the specification do not necessarily refer to the same embodiment, nor do separate or alternative embodiments necessarily exclude other embodiments. It should also be understood that the various features, structures, concepts and / or characteristics of the disclosed embodiments are independent and separate from each other and can be used alone or in various combinations with each other to create alternative embodiments, which are considered to be part of this disclosure. Therefore, the present disclosure is not limited to the embodiments specifically described herein, as describing all the numerous possible combinations and sub-combinations of features, structures, concepts and / or characteristics would be overly cumbersome, and the disclosed embodiment examples 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 one of ordinary skill in the art can readily determine the standard deviation and appropriate range of acceptable deviations, which are covered by this disclosure and any claims related thereto. The following description is for illustrative embodiment examples only and is not intended to limit the broader aspects of the present disclosure.

[0044] In the accompanying drawings, it should be understood that common features are identified by common reference numerals, and for the sake of brevity and convenience, and without limitation, the description of common features is generally not repeated. For the sake of clarity, not all components with the same reference numerals are numbered. It should be understood that in the following description, similar elements or components in the various illustrated embodiments are generally designated by the same reference numerals differing by 100, and redundant descriptions are generally omitted for the sake of brevity. In addition, certain features in one embodiment may be used in different embodiments and are not necessarily individually labeled when appearing in different embodiments.

[0045] Turning now to the drawings, an embodiment of a valve assembly 100 formed in accordance with various principles of the present disclosure is illustrated in FIG. Figure 1 1000. It should be understood that the endoscope 1000 is an example of an embodiment to which the principles of the present disclosure may be applied, and that the various principles of the present disclosure are applicable to other medical instruments for controlling the flow of fluid relative thereto, the details of which are not critical to the present disclosure. Furthermore, although reference is made to a suction valve, it should be understood that the disclosed principles and embodiments are applicable to other valves, such as a fluid supply / flushing valve.

[0046] The illustrated example embodiment of the valve assembly 100 is mounted on 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 connection cord 1030 extending to a scope connector 1032, through which the endoscope 1000 (and the valve assembly 100) can be fluidically coupled to the suction source 1100. The connection cord 1030 may alternatively be referred to herein as an umbilical cord, an umbilical cord, a universal cord, etc., without intending to be limiting. The scope connector 1032 may also connect the endoscope 1000 to various components, devices, etc. via the connection cord 1030, such as a fluid source (for supplying air, carbon dioxide, water, saline, or other gases or liquids), an electrical connection, a light source, a visualization element (e.g., fiber optics, a camera, etc.), or other components, devices, etc. that may be used with the endoscope 1000. The insertion tube 1020 has a fluid lumen extending therethrough to a distal end that can be positioned (inserted, navigated, etc.) relative to an anatomical site (e.g., within a patient's body). Similarly, the connecting cord 1030 has a fluid lumen extending therethrough to fluidically couple the suction source 1100 (e.g., via a scope connector 1032) to the control handle 1010. The fluid lumens through the insertion tube 1020 and the connecting cord 1030, as well as the distal end of the insertion tube 1020, can be features known to those of ordinary skill in the art, formed in a known manner, and are not shown in the accompanying drawings for simplicity of illustration. Figure 1 In the illustration of endoscope 1000, details that are not necessary for understanding the present disclosure are omitted.

[0047] An example embodiment of a valve assembly 100 formed according to various principles of the present disclosure is shown in FIG. Figure 2 and Figure 3 As shown in FIG, with an endoscope (such as Figure 1 In the illustrated embodiment, the valve assembly 100 includes an actuable member 110 having a valve shaft 120 that is movable relative to a valve well 150 of the valve assembly 100. The actuable member 110 and the valve shaft 120 are in a closed position (e.g., Figure 2 as shown) and the open position (as Figure 3Movement between the closed configuration (closed state, closed configuration) and the open configuration (open state, open configuration) respectively moves the valve assembly 100 between a closed configuration (closed state, closed configuration), in which the valve assembly 100 does not apply suction to the suction application device, and an open configuration (open state, open configuration), in which the valve assembly 100 can apply suction to the suction application device, as further described in detail below.

[0048] According to various principles of the present disclosure, the valve shaft 120 is formed of a proximal component 130 and a distal component 140, such as Figure 4 An alternative embodiment of the valve shaft 220 formed by the proximal component 230 and the distal component 240 is shown in FIG. Figure 5 This configuration of the valve shaft 120, 220 allows for improved sealing capabilities while also proving to be a durable component with reliably aligned valve ports that also resists deformation, as described in further detail below. It should be understood that Figure 4 and Figure 5 The valve shafts 120 and 220 shown in FIG. 1 and 2 can be arranged and operated in similar valve assemblies in substantially the same or similar manner. Therefore, common elements of the valve shafts 120 and 220 that share common functions are denoted by the same reference numerals, differing by 100. Generally speaking, references and descriptions herein to one of the valve shafts 120 and 220 apply to the other valve shaft 120 and 220 unless expressly stated otherwise. For simplicity and brevity, and without intent to limit, reference may be made only to the valve shaft 120 , with the understanding that such descriptions also apply to the valve shaft 220 unless expressly stated otherwise. This is for convenience only and without intent to limit.

[0049] 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 move the actuatable member 110 and the valve shaft 120, 220 along the actuation axis AA between a closed position and an open position. The user engagement element 112 can be formed and coupled to the proximal ends 121, 221 of the valve shafts 120, 220, respectively (e.g., in any of a variety of ways known to those of ordinary skill in the art), or alternatively, can be integrally formed with the valve shafts 120, 220. The valve shaft distal component 140, 240 extends within the valve well 150 and is formed of a material capable of sealing a suction path through the valve assembly 100 in both the open and closed configurations of the valve assembly 100, as described in further detail below.

[0050] The positions of the components 130, 140 and 230, 240 of the exemplary embodiments of the valve shafts 120, 220, respectively, relative to the suction source port and the suction application port (suction application port) of the exemplary embodiment of the valve assembly 100 are as follows: Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7BSpecifically, the closed and open configurations of an example embodiment of the valve assembly 100, and the corresponding closed and open positions of the actuable member 110 and its associated valve shaft 120, 220 relative to the valve well 150 are shown in FIG. Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7B Shown in.

[0051] refer to Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7B It will be appreciated that the illustrated example embodiment of the valve well 150 of the valve assembly 100 has a valve well configured to engage a suction source such as a Figure 1 The valve well suction source port 152 is fluidly coupled to the suction source 1100 shown, and is configured to be coupled to a suction application device such as a Figure 1 The valve well suction source port 152 extends generally along the actuation axis AA of the valve assembly 100, while the valve well suction application port 154 extends transversely to the actuation axis AA (and thus can be considered a side port). The embodiment example of the valve well 150 shown is similar to that shown in FIG. Figure 1 The control handle 1010 of the endoscope 1000 is shown as being separately formed and inserted therein, although the present disclosure is not limited thereto. The valve well nut 160 can be used to position the valve well 150 relative to the control handle (such as Figure 1 10. The control handle 1010 shown is held in place, for example, in a manner known to those of ordinary skill in the art. An example embodiment of the cover 170 is shown coupled relative to the valve well 150 via a valve well nut 160, however, the present disclosure is not limited to the arrangement shown. The valve shaft 120, 220 extends through a shaft receiving through-hole 175 defined in a radially inwardly extending restricting shoulder 172 within the cover 170. The cover 170 can provide various features for assembly and use of the valve assembly 100, such as guides for the actuation movement of the actuatable member 110, directional features for the actuatable member 110, a suction discharge passage through the valve assembly 100, and other features, as described in further detail below. In the example embodiment shown, the cover 170 is a one-piece element, however, the cover 170 can alternatively be formed as a two-piece element without affecting the present disclosure.

[0052] Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7BThe exemplary embodiment of the valve shaft 120, 220 shown in FIG. 1 defines a valve shaft suction source port 122, 222 at a 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 passage 126, 226 that extends generally axially through the valve shaft 120, 220 along the longitudinal axis LA of the valve shaft 120, 220. It will be appreciated that the valve shaft suction source port 122, 222 remains in fluid communication with the well suction source port 152 when the valve shaft 120, 220 is in both the closed and open positions. The valve shaft 120, 220 also includes a valve shaft suction application port (valve shaft suction application port) 124, 224 (and thus may be considered a side port) that extends transversely to the longitudinal axis LA of the valve shaft 120, 220 and is in fluid communication with the valve shaft suction passage 126, 226.

[0053] The actuatable member 110 and its associated valve shaft 120, 220 are movable along the actuation axis AA to place the valve shaft suction application port 124, 224 in fluid communication or disconnection with the laterally extending valve well suction application port 154. When the actuatable member 110 is in the closed position, the valve shaft 120 is in the closed position, and the valve assembly 100 is in a closed configuration, wherein the valve shaft suction application port 124 is not aligned with and is not in fluid communication with the valve well suction application port 154. Thus, the valve shaft suction passage 126, 226 (and the suction source fluidly coupled thereto) is not in fluid communication with the valve well suction application port 154. Thus, the valve assembly 100 is in the closed configuration and no suction is applied. When the actuatable member 110 is actuated to move the valve assembly 100 to the open configuration, the valve shaft 120, 220 is moved to the open position to align the valve shaft suction application port 124, 224 with the valve well suction application port 154. The valve well suction application port 154 is thereby in fluid communication with the valve shaft suction application ports 124, 224 and hence with the valve shaft suction passages 126, 226 and the valve well suction source port 152 and the suction source.

[0054] Typically, when a valve assembly 100, such as that described herein, is configured for use with an endoscope 1000, a suction source coupled to the valve assembly 100 is operated continuously. However, it is typically desirable to limit the suction applied by the valve assembly 100 to situations in which suction is required, and to limit and preferably eliminate suction to the valve well suction application port 154 when suction is not required. For example, in certain endoscopic procedures, it is desirable to keep the anatomical site inflated (inflated) to improve visualization of the surgical target site, and / or to flush the target site, such as by supplying fluid to the target site. The suction may be limited to reducing the supplied fluid in certain circumstances, and / or to remove other matter (e.g., biological matter) from the target site. In such circumstances, the neutral position of the actuatable member 110 and the valve shaft 120, 220 is typically the closed position. In Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7B In the example embodiment shown in FIG, a biasing element 114 is provided to bias the actuatable member 110 and the valve shaft 120, 220 into 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 element and / or the biasing element. Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7B In the example embodiment shown in FIG, a biasing element 114 can be positioned between the underside of the user engagement element 112 and the radially inwardly extending spring support 174 of the cover 170 to bias the actuatable member 110 to a neutral closed configuration (the user engagement element 112 is biased proximally away from the cover 170 and the valve well 150), for example in a manner known to those of ordinary skill in the art. In the example embodiment shown, the actuatable member 110 of the valve assembly 100 is moved distally from a neutral position in which the valve assembly 100 is in a closed configuration to move the valve assembly 100 to an open configuration. For example, the user engagement element 112 can be moved distally from a proximal position of 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 also be applied to other arrangements.

[0055] According to various principles of the present disclosure, the valve shaft 120, 220 has a valve shaft distal component 140, 240, which is configured to be movable when the actuatable member 110 and the valve shaft 120, 220 are in a state such as Figure 6A 、 Figure 7A The closed configuration shown is formed of material that seals the well suction application port 154 relative to the valve shaft suction passage 126, 226. Thus, the valve shaft 120, 220 formed according to various principles of the present disclosure can provide an improved seal against the well suction application port 154 when the valve assembly 100 is in the closed configuration.

[0056] exist Figure 4 In the embodiment example of the valve shaft 120 shown in FIG, the valve shaft distal component 140 is composed of a valve shaft that can be opened when the valve shaft 120 is in the closed position (such as Figure 6A The valve shaft distal member 140 is formed of a compressible material that forms a seal with and around the valve well suction application port 154 when the valve assembly 100 is in the closed configuration (as shown). The seal created by the material of the valve shaft distal member 140 should be capable of shutting off suction to the valve well suction application port 154 when the valve assembly 100 is in the closed configuration. The valve shaft distal member 140 can be formed of a compressible closed-cell foam (e.g., a closed-cell plastic or rubber foam material) to achieve this seal. In addition, the outer diameter of the valve shaft distal member 140 can interfere with the inner diameter of a valve well passage 156 defined in the valve well 150 (through which the valve shaft 120 axially moves between its closed and open positions). This relative diameter of the valve shaft distal member 140 and the valve well passage 156 balances the competing demands of sealing and shaft movement and allows the valve shaft distal member 140 to move relative to and against the valve well passage 156 to create the desired seal with respect to the valve well suction application port 154. The material selection can also facilitate the desired sealing and movability of the valve shaft distal member 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 member 140 compensates for the negative pressure applied by the suction source (via the valve well suction source port 152 and the valve shaft suction source port 122) within the valve shaft suction channel 126 and resists potential collapse of the valve shaft distal member 140 due to the negative pressure within it. The valve shaft suction channel 126 can be produced by extrusion during manufacture of the valve shaft distal member 140 and / or can be cut from a solid cylinder of material forming the valve shaft distal member 140. It will be appreciated that the valve shaft suction channel 126 formed by extrusion can provide smoother walls, generate less turbulence, and reduce the likelihood of aspirated material becoming trapped within the walls of the valve shaft distal member 140. The valve shaft suction application port (valve shaft suction application port) 124 can be formed by die-cutting the valve shaft distal member 140, such as by cutting transversely to the valve shaft suction channel 126. The outer surface of the valve shaft distal member 140 can have a relatively smooth surface to provide low resistance when the valve shaft distal member 140 moves between its closed position and its open position, which may occur multiple times during use of the valve assembly 100.

[0057] 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, referring to Figure 6A and Figure 6B Combined with Figure 4As shown in dashed lines in FIG, the distal extension 132 may include one or more barbs that are assembled within the valve shaft distal component 140 (e.g., within the valve shaft suction channel 126). The size, shape, configuration, and / or dimensions of the distal extension 132 are designed to engage with the valve shaft distal component 140 to prevent the two from separating, as will be readily understood by those of ordinary skill in the art. It will be understood that the configuration of the distal extension 132 that engages with the valve shaft distal component 140 does not need to extend continuously around the circumference of the valve shaft proximal component 130. For example, discrete barbs arranged around the circumference of the valve shaft proximal component 130 may be sufficient to resist relative movement of the valve shaft proximal component 130 and the valve shaft distal component 140.

[0058] exist Figure 5 In the embodiment example of the valve shaft 220 shown, the valve shaft distal component 240 is made of a compliant material. Figure 7A ) when the valve shaft distal portion 240 is in the closed configuration, the material is capable of forming a seal with and around the valve well suction application port 154. The seal formed by the material of the valve shaft distal portion 240 should be capable of shutting off the suction to the valve well suction application port 154 when the valve assembly 100 is in the closed configuration. In some embodiments, the valve shaft distal portion 240 includes one or more circumferential sealing elements 242a, 242b, 242c that extend around its circumference and project radially outward. The circumferential sealing elements 242a, 242b, 242c can be positioned relative to the valve well suction application port 154 to maintain a proper seal relative thereto. For example, when the valve shaft 220 is in Figure 7A In the closed configuration shown, the intermediate circumferential sealing element 242b forms a seal proximal to the valve well suction application port 154, and the distal circumferential sealing element 242c forms a seal distal to the valve well suction application port 154, thereby reliably sealing the valve well suction application port 154 from the suction source. Figure 7B In the open configuration shown, the intermediate circumferential sealing element 242b can form a seal distal to the valve well suction application port 154, and the proximal circumferential sealing element 242a can form a seal proximal to the valve well suction application port 154, thereby reliably sealing the valve well suction application port 154 relative to the valve shaft suction passage 126 and the suction source, thereby eliminating suction leakage. The valve shaft distal component 240 can be made of materials such as, but not limited to, rubber, thermoplastic elastomer ("TPE"), silicone, etc.

[0059] The separately formed valve shaft distal component 240 can be fixed to the valve shaft proximal component 230 by insert molding, overmolding, snap fit, interference fit, welding, bonding, adhering or other means (mechanical and / or chemical fixation by any acceptable means known to those of ordinary skill in the art). The connection between the valve shaft distal component 240 and the valve shaft proximal component 230 should be sufficiently strong to ensure that the components 240, 230 do not rotate relative to each other, thereby achieving repeatable and accurate alignment of the valve shaft suction application port 224 in the valve shaft distal component 240 with the valve well suction application port 154. For example, the valve shaft proximal component 230 may include a distal extension 232 (such as Figure 5 ), the extension is inserted into the proximal end 241 of the valve shaft distal component 240, or the proximal end 241 of the valve shaft distal component 240 can be molded on (e.g., overmolded onto) the extension. The distal extension 232 of the valve shaft proximal component 230 can be shaped (scalloped, knurled, or otherwise formed with at least one non-circular area) to form a mechanical interlock with the valve shaft distal component 240 to prevent relative rotation between the valve shaft proximal component 230 and the valve shaft distal component 240, particularly during use.

[0060] Advantageously, as described above, the proximal valve shaft portion 130, 230 of the respective valve shaft 120, 220 is made of a different material than the distal valve shaft portion 140, 240. In some aspects, the material of the proximal valve shaft portion 130, 230 can be a relatively rigid material that does not flex significantly during normal use or even at rest, compared to the more compliant sealing material of the distal valve shaft portion 140, 240. The material of the proximal valve shaft portion 130, 230 can be selected to withstand various axial forces acting on the valve shaft 120, 220, such as during use and / or in a packaged / rest state (e.g., a preload force applied by the biasing element 114). Furthermore, forming the valve shaft proximal component 130, 230 from a material that is more rigid than the material of the valve shaft distal component 140, 240 enables the valve shaft proximal component 130, 230 to withstand various hard stops as the actuatable member 110 and / or valve shaft 120, 220 moves to maintain alignment of the valve shaft suction application port 124 with the valve well suction application port 154. Additionally or alternatively, the material of the valve shaft proximal component 130, 230 may be selected to resist creep that may occur over time (e.g., over a shelf life that may be two years or more) under the constant load of the biasing element 114.

[0061] As described above, the actuatable member 110, and therefore the valve shaft 120, 220, can be biased to a neutral position by the biasing element 114 located between the user engagement element 112 of the actuatable member 110 and the radially inwardly extending spring support 174 of the cover 170. Because the user engagement element 112 is connected to the proximal end 121, 221 of the valve shaft 120, 220, the biasing force of the biasing element 114 also applies a biasing force to the valve shaft 120, 220. The biasing element 114 is typically a preloaded compression spring that applies a continuous and constant biasing force to the actuatable member 110 when the device with the valve assembly 100 is packaged (before use) and even when in the neutral rest position during use. For example, the biasing element 114 can have a preload of approximately 5 Newtons, and the shelf life of the device with the valve assembly 100 can be approximately two (2) years. This continuous and constant force may cause a valve shaft made of a less rigid material than the material selected for the valve shaft 120, 220 to stretch or otherwise exhibit creep, which may result in misalignment of the valve shaft suction application port 124 from the valve well suction application port 154 when the valve shaft 120, 220 moves from the neutral closed position to the open position. As will be appreciated by one of ordinary skill in the art, forming the valve shaft proximal portion 130, 230 from a material that is more rigid than the material of the valve shaft distal portion 140, 240 imparts to the valve shaft proximal portion 130, 230 a greater resistance to deformation than the valve shaft distal portion 140, 240, while also providing a stronger sealing capability to the valve shaft distal portion 140, 240 than the material of the valve shaft proximal portion 130, 230 would otherwise provide. The valve shaft proximal component 130 , 230 may be formed from a rigid plastic (eg, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), blends thereof, etc.) or metal, in contrast to the compliant material of the valve shaft distal component 140 , 240 .

[0062] It will be appreciated that in order to maintain a reliable seal between the valve shaft suction application port 124 and the valve well suction application port 154, not only are the sealing ability and deformation / stretch resistance of the joint material important, but the axial and rotational alignment of the ports 124, 154 are also important and must be strictly controlled. According to the various principles of the present disclosure, forming the valve shaft proximal component 130, 230 from a material that is more rigid than the material of the valve shaft distal component 140, 240 can form a hard stop structure that can strictly control the axial travel of the valve shaft 120, 220 along the actuation axis AA and the rotation of the valve shaft 120, 220 about the actuation axis AA.

[0063] Various features and / or structures may be provided on the actuatable member 110 to provide hard stops that limit axial movement of the actuatable member 110 (and thereby limit axial movement of the valve shafts 120, 220) to maintain precise axial alignment of the valve shaft suction application ports 124, 224 with the valve well suction application ports 154. For example, the actuatable member 110 may include one or more hard stop features that interact with one or more corresponding hard stop features on the cover 170. Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7B In the illustrated embodiment of the cap 170, the radially inwardly extending limiting shoulder 172 of the cap 170 not only defines a shaft receiving through-hole 175 through which the valve shaft 120 extends, but also forms a proximal limiting stop for the proximal travel of the valve shaft 120, 220. Figure 4 In the illustrated example embodiment of the valve shaft 120, the valve shaft proximal member 130 has a valve shaft proximal limit stop 134 in the form of a radially outwardly extending flange or shoulder. Figure 6A It will be appreciated that the proximal surface of the valve shaft proximal limit stop 134 abuts the distal surface of the cover proximal limit stop formed by the radially inwardly extending limit shoulder 172 of the cover 170, which defines a shaft receiving through-hole 175 through which the valve shaft 120 extends. It will be appreciated that forming the valve shaft proximal component 130 from a material that is more rigid 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, which biasing force presses the valve shaft proximal limit stop 134 against the radially inwardly extending limit shoulder 172 to maintain the valve shaft 120 in the closed position. Figure 5 In the illustrated embodiment of the valve shaft 220, the distal extension 232 of the valve shaft proximal component 230 imparts rigidity to the valve shaft distal component 140, which abuts the distal surface of the radially inwardly extending limiting shoulder 172 of the cap 170, as shown. Figure 7A This interaction provides a more secure hard stop for proximal travel of the valve shaft 220 than would be achievable if the valve shaft 220 were formed entirely of the material forming the valve shaft distal component 240 .

[0064] exist Figure 6A 、 Figure 6B 、 Figure 7A and Figure 7B In the illustrated example embodiment of the cap 170, 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 the proximal travel of the actuatable member 110 (and thus the proximal travel of the valve shaft 120, 220). For example, the distal surface of the user engagement element 112 may abut the proximal surface of the radially inwardly extending spring support 174. Figure 6B and Figure 7B In the illustrated example embodiment of the actuatable member 110, the user engagement element 112 has a circumferential skirt 116 that can extend distally to engage a radially inwardly extending spring support 174, thereby forming a hard stop for distal axial movement of the actuatable member 110. Additionally or alternatively, the user engagement element 112 can have a cylindrical neck 118 that extends around and engages the proximal end 121, 221 of the valve shaft 120, 220. The distal end of the cylindrical neck 118 can engage a radially inwardly extending limit shoulder 172 of the cap 170, which acts as a hard stop for distal axial movement of the valve shaft 120 through a shaft-receiving through-hole 175 in the radially inwardly extending limit shoulder 172. Additionally or alternatively, distal movement of the valve shaft 120, 220 can be limited by the physical height of the biasing element 114 (when the biasing element 114 bottoms out), thereby helping to ensure axial alignment of the valve shaft suction source port 122, 222 with the valve well suction source port 152. It will be appreciated that forming the valve shaft proximal component 130, 230 from a material that is more rigid than the material of the valve shaft distal component 140, 240 enables the user engagement element 112 to be more securely secured to the proximal end 111, 211 of the valve shaft 120, 220 to withstand impacts from the circumferential skirt 116 and the radially inwardly extending spring support 174 and / or the circumferential neck 118 and the radially inwardly extending limit shoulder 172 and / or forces of the biasing element 114 relative to the user engagement element 112.

[0065] Additionally or alternatively, various features and / or structures may be provided on the valve shaft proximal component 130, 230 to provide a hard stop that limits rotational movement of the actuatable member 110, thereby maintaining precise rotational alignment of the valve shaft suction application port 124, 224 with the valve well suction application port 154. For example, the valve shaft proximal component 130, 230 may have a non-circular cross-sectional shape, and the shaft receiving throughbore 175 in the cover 170 (through which the valve shaft proximal component 130, 230 extends) may have a corresponding non-circular cross-sectional shape such that rotation of the valve shaft 120, 220 relative to the cover 170 is inhibited, and preferably prevented. Figure 4 and Figure 5 In the illustrated example embodiment, the valve shaft proximal portion 130, 230 may include one or more flat surfaces 136, 236, respectively. Figure 8A In the illustrated embodiment of the cap 170, the shaft receiving through-hole 175 defined in the radially inwardly extending limiting shoulder 172 of the cap 170 has a corresponding cross-sectional shape to receive the valve shaft proximal component 130, 230 therethrough, thereby rotationally fixing the valve shaft proximal component 130, 230 (and thus the valve shaft 120, 220) relative to the cap 170 (fixing it so that it cannot rotate relative to each other). In addition, the cap 170 in the illustrated embodiment is configured to be rotationally fixed relative to the valve well 150. Figure 8A and Figure 8B In the illustrated embodiment, the cap 170 includes one or more axially extending projections 178 that engage corresponding seats 158 in the valve well 150 to rotationally secure the cap 170 relative to the valve well 150. It should be understood that the illustrated engagement features are examples, and that other engagement features between the valve shaft 120, 220, the cap 170, and the valve well 150 are within the scope and spirit of the present disclosure, which is not limited thereto. Providing a relatively rigid proximal valve shaft component 130, 230 allows the valve shaft 120, 220 to be rotationally secured relative to the cap 170. Because the cap 170 is generally rigid, the rotational securing of the cap 170 relative to the valve well 150 allows the valve shaft 120, 220, which is rotationally secured relative to the cap 170, to also be rotationally secured relative to the valve well 150. Furthermore, the rotational securing of the valve shaft 120, 220 results in the rotational securing of the valve shaft suction application port 124, 224 relative to the valve well suction application port 154.

[0066] As described above, in some cases, the suction source may remain open during use of the valve assembly 100 to which it is fluidly coupled, with movement of the actuatable member 110 controlling whether the suction source is in fluid communication with the suction application device coupled to the valve assembly 100. It will be appreciated that it may be desirable to vent or release the vacuum pressure generated within the valve assembly 100 from the suction source (via the valve well suction source port 152) when the valve assembly 100 is in the closed configuration. As in the illustrated embodiment example, rotational fixation of the valve shaft 120, 220 relative to the cover 170 facilitates venting or releasing the suction source. For example, the cover 170 may be provided with an exhaust passage 176 in fluid communication with the valve shaft suction passage 126, 226 to define an exhaust path B for exhausting ambient air to the suction source, as shown. Figure 8A 、 Figure 6A and Figure 7A As shown. When the valve shaft 120, 220 is in Figure 6A and Figure 7A In the closed position shown, ambient air can enter the cover exhaust passage 176 through the proximal end 101 of the valve assembly 100 and enter the valve shaft suction passage 126, 226 through the valve shaft suction application port 124, 224 to exhaust the suction source through the valve shaft suction source port 122, 222 and the valve well suction source port 152. Once the valve shaft 120, 220 is in the open position, the valve shaft distal member 140, 240 seals the valve shaft suction application port 124, 224 from the exhaust passage 176 to allow suction to be applied to the valve well suction application port 154 without leakage to the exterior of the valve assembly 100. The seal formed by the material of the valve shaft distal member 140 should be able to withstand the full force of the valve assembly 100 when the valve assembly 100 is in the open position. Figure 6B The open configuration shown shuts off suction to the valve well suction application port 154. Figure 7BAs shown, a proximal circumferential sealing element 242a on the valve shaft distal component 240 can seal the suction path S from the exhaust passage 176 in the cap 170 and the ambient air.

[0067] In addition to those discussed above, various other benefits of the valve shaft and associated sealing member, and various aspects, features, components, and structures of valve assemblies and endoscopes such as those described above may be appreciated by those of ordinary skill in the art.

[0068] It will be understood by those skilled in the art that this discussion describes only illustrative implementation examples and is not intended to limit the broader aspects of the present disclosure. It will be understood that the principles of the present disclosure can be applied to various medical devices, instruments, tools, and the like, such as, but not limited to, various medical devices, instruments, tools, and the like, for accessing and applying suction and / or irrigation to anatomical sites, including, for example, endoscopes, gastroscopes, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like, with integrated features for suction and / or irrigation of anatomical sites. Furthermore, the principles of the present disclosure can be applied to reusable or disposable devices, instruments, tools, and the like.

[0069] All devices and methods discussed herein are examples of devices and / or methods that may be implemented according to one or more principles of the present disclosure. These examples are not the only ways to implement these principles, but 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 accompanying drawings must be understood as references to examples of embodiments of the present disclosure and should not be construed as limiting the present disclosure to the specific elements, structures, or features shown. After reading this disclosure, one of ordinary skill in the art will recognize other examples of ways to implement the disclosed principles. For example, the various elements and components of the valve assemblies described herein may be directly or indirectly coupled or engaged with each other, regardless of how such connections are depicted in the accompanying drawings. It will be apparent to one of ordinary skill in the art that variations may be made to the disclosed devices, systems, and / or methods, and / or the order of the steps of the methods described herein, without departing from the concept, spirit, and scope of the present disclosure. It should be understood that various features described with respect to one embodiment may generally be applicable to another embodiment, whether or not expressly stated otherwise. The various features described below may be used alone or in any combination. Therefore, the present disclosure is not limited to the specific embodiments described herein, and all alternatives and modifications apparent to one skilled in the art are considered to be within the spirit, scope, and concept of the present disclosure, as defined by the appended claims.

[0070] The foregoing discussion has a wide range of applications and is presented for the purposes of illustration and description and is not intended to limit the present disclosure to the forms disclosed herein. It should be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and together with other elements, materials, and components without departing from its concept, spirit, scope, or characteristics. For example, to simplify the present disclosure, various features of the present disclosure are combined in one or more aspects, embodiments, or configurations. However, it should be understood that various features of certain aspects, embodiments, or configurations of the present disclosure may be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented in the form of embodiments, it should be understood that the various individual features of the present subject matter do not necessarily need to be present to achieve at least some of the desired characteristics and / or benefits of the present subject matter, or such individual features. Those skilled in the art will understand that the present disclosure may be used in the practice of the present disclosure through many modifications or modifications of structure, arrangement, proportion, material, components, and other means, which are particularly suitable for specific environments and operational requirements without departing from the principles, spirit, or scope of the present disclosure. For example, an element shown as being integrally formed may be composed of multiple parts, or an element shown as being multiple parts may be integrally formed, the operation of an element may be reversed or otherwise changed, and the size or dimensions of an element may be changed. Similarly, although operations, actions, or procedures are described in a particular order, this should not be understood as requiring such a particular order, or requiring that all operations, actions, or procedures be performed to achieve the desired result. In addition, other embodiments are within the scope of the appended claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve the desired result. Therefore, the embodiments disclosed herein should be considered in all respects to be illustrative and not restrictive, and the scope of the subject matter claimed is indicated by the appended claims, and is not limited to the foregoing description or the specific embodiments or arrangements described or shown herein. In view of the foregoing, the individual features of any embodiment may be used and may be claimed alone or in combination with the features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims, and is not limited to the foregoing description.

[0071] In the foregoing description and the claims that follow, the following will be understood. As used herein, the phrases "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "one," "an," "the," "first," "second," etc. do not exclude pluralities. For example, as used herein, the term "one" entity refers to one or more of that entity. Thus, the terms "one" (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 that includes "and / or," unless the content clearly indicates otherwise. As used herein, the conjunction "and" includes each structure, component, feature, etc. so connected, unless the context clearly indicates otherwise, and the conjunction "or" includes one or another structure, component, feature, etc. so connected, individually and in any combination and quantity, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, upper, lower, up, down, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used for identification purposes only to assist the reader in understanding the present disclosure and / or to distinguish regions of related elements and do not limit the position, orientation, or use of the related elements, particularly with respect to the present disclosure. Connection references (e.g., attach, couple, connect, join, and connect) should be interpreted broadly and may include intermediate members between a collection of elements and relative movement between elements, unless otherwise indicated. Thus, a connection reference does not necessarily mean that two elements are directly connected and in a fixed relationship to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to indicate importance or priority, but are used to distinguish one feature from another.

[0072] The following claims are hereby incorporated into this detailed description by reference, 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, or the like. Furthermore, although individual features may be included in different claims, these features may be advantageously combined, and the inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. Furthermore, singular references do not exclude plural references. Reference signs in the claims are provided merely as an illustrative example and shall not be construed as limiting the scope of the claims in any way.

Claims

1. A valve shaft configured to move along an actuation axis within a valve well of a valve assembly of a medical device between a closed position and an open position, wherein the valve assembly is in a closed state in the closed position and in an open state in the open position, the valve shaft comprising: a valve shaft proximal member having a proximal end and a distal end and made of a first material; and a valve shaft distal member having a proximal end and a distal end and made of a second material; in: the first material being more rigid than the second material; The second material is used to seal a port defined in the valve well; and The valve shaft distal component extends distally beyond the valve shaft proximal component.

2. The valve shaft according to claim 1, wherein: The valve shaft distal component is made of foam; and The valve shaft proximal component has a distal extension configured to extend into a proximal end of the valve shaft distal component.

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

4. The valve shaft according to any one of claims 1 to 3, wherein the valve shaft proximal component and the valve shaft distal component are fixed together by at least one of the following means: insert molding, overmolding, snap fit, interference fit, welding, bonding or adhesion. 5 . The valve shaft according to claim 1 , wherein an outer diameter of the valve shaft distal component is larger than an inner diameter of the valve well channel into which the valve shaft is to extend in the valve assembly.

6. The valve shaft according to claim 5, wherein: The valve shaft distal component defines a valve shaft suction passage therethrough extending along the actuation axis and in fluid communication with a valve well suction source port at a distal end of the valve well passage; The valve shaft further defines a valve shaft suction application port extending transverse to the actuation axis and in fluid communication with the valve shaft suction passage; When the valve shaft is in the closed position, the valve shaft distal component seals the valve well suction application port to disconnect fluid communication with the valve well suction source port; and When the valve shaft is in the open position, the valve shaft suction application port is in fluid communication with the valve well suction application port, so that the valve well suction application port is in fluid communication with the valve well suction source port through the valve shaft suction channel. 7 . The valve shaft according to claim 6 , wherein the valve shaft suction passage and the valve shaft suction application port are defined in the valve shaft distal component and are located distal to the distal end of the valve shaft proximal component.

8. The valve shaft according to claim 6, wherein the valve shaft distal component comprises one or more circumferential sealing elements extending around the circumference thereof and extending radially outward therefrom for forming a seal with the valve well channel.

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

10. The valve shaft according to any one of claims 8-9, wherein when the valve shaft is in a closed position, the valve shaft suction channel is fluidically connected to the exhaust channel in the valve assembly and the valve well suction source port; and when the valve shaft is in an open position, the fluid connection between the valve shaft and the valve shaft suction channel and the valve well suction source port is sealed and disconnected by at least one of the circumferential sealing elements.

11. The valve shaft according to any one of claims 1 to 10, wherein: The valve shaft is axially movable relative to a valve cover between a closed position and an open position, the valve cover being configured to connect to a valve well of the valve assembly; and The valve shaft proximal component includes one or more hard stop structures that engage the valve cover to limit axial and / or rotational movement of the valve shaft relative to the valve cover.

12. The valve shaft according to claim 11, wherein: The valve cover is configured to be rotationally fixed relative to the valve well; and The valve shaft is rotationally fixed relative to the valve cover but is axially movable relative thereto.

13. A valve shaft for a valve assembly, the valve assembly being configured to be in a closed state and an open state by moving the valve shaft between a closed position and an open position, respectively, the valve shaft comprising: a valve shaft proximal component formed from a first material; and a valve shaft distal component formed from a second material; in: the first material being more rigid than the second material; The second material is a sealing material capable of sealing a suction path through the valve assembly; and At least a portion of the valve shaft distal component is made solely of the second material.

14. The valve shaft according to claim 13, wherein: The valve shaft distal component is made of foam; and The valve shaft proximal component has a distal extension configured to extend into the valve shaft distal component.

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

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