Endoscope valve devices, systems, and methods

By designing a simplified valve shaft structure and a movement mechanism in opposite directions, the problem of large seal drag in endoscope valve assemblies is solved, achieving more efficient fluid control and operational convenience.

CN120751972APending Publication Date: 2025-10-03BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
CN202380094295.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-12-16
Filing Date
2023-12-15
Publication Date
2025-10-03

AI Technical Summary

Technical Problem

During operation, the seals of existing endoscope valve assemblies generate a large drag force, which affects the convenience and efficiency of valve shaft switching operations.

Method used

A valve assembly is designed in which a valve shaft can be switched within a valve well. The valve assembly is switched between closed and open positions by moving a user engagement element and the valve shaft in opposite directions, combined with a biasing assembly and a connecting rod assembly. The structure of the valve shaft is simplified and its length is reduced to facilitate sealing and fluid control.

Benefits of technology

It improves the operating convenience of the valve assembly and the accuracy of fluid control, reduces the friction of the valve shaft during switching, and enhances the user experience.

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Abstract

The invention discloses a valve assembly with a valve shaft that is switchable within a valve well from a closed position that blocks fluid communication between ports in the valve well to an open position that permits fluid communication between such ports. The open position may be proximal to the closed position. The length of the valve shaft is selected to block access to one of the ports of the valve well only when in the closed position, and thus may be shorter than existing valve shafts. The valve shaft is along a distal end of an actuatable member of the valve assembly, and a user engagement element may be disposed along the proximal end of the actuatable member. The user engagement element may move toward the valve shaft to move the valve shaft from the closed position to the open position.
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Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 433,063, filed on December 16, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

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

[0003] Various devices having valve assemblies are known in the art for use during various medical procedures. For example, during a medical procedure, materials may be supplied to an anatomical site (e.g., fluids may be supplied, such as for irrigation), and / or aspirated from an anatomical site (e.g., fluids or biological materials may be withdrawn from an anatomical site). A valve assembly may be used to control the flow of such materials. An endoscope is a common medical device used to introduce or remove substances relative to an anatomical site and, therefore, typically includes a valve assembly. An endoscope typically has an insertion tube having a working channel through which substances (e.g., fluids, such as gases or liquids), devices, instruments, or tools may be introduced, or substances may be removed or aspirated. To control the flow of substances through the endoscope, a fluid source and / or a suction pump / vacuum source are fluidically coupled to the endoscope handle and the insertion tube via a valve assembly. The valve assembly typically has a valve well and a valve shaft that is switchable within the valve well between a closed position and an open position, wherein the valve assembly is in a closed / closed configuration and an open position, wherein the valve assembly is in an open / open configuration. In the closed configuration, the valve assembly blocks fluid communication between the fluid source / suction source and the insertion tube of the endoscope. When the valve assembly is transitioned to the open configuration (typically by depression of a handle), fluid communication is established between the fluid source / suction source and the working channel of the endoscope to supply fluid to the insertion tube of the endoscope and / or to apply suction pressure / negative pressure thereto. Proper sealing of the ports, channels, cavities, etc. associated with such a valve assembly is important. However, seals that provide sealing interference may also generate significant drag forces that may affect the operation of the valve shaft as it switches (typically repeatedly) within the valve well. There remains a need for improvements to endoscopic valves, such as suction valves, and their arrangement and operation. Summary of the Invention

[0004] This disclosure is provided to introduce a series of concepts in a simplified form, which will be further described in the following detailed description. This disclosure 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. It will be understood by those skilled in the art that various aspects and features of the present invention may be advantageously used alone in some cases, or in other cases in combination with other aspects and features of the present invention, whether or not described in this disclosure. The inclusion or exclusion of elements, components, etc. in this disclosure is not intended to limit the scope of the claimed subject matter.

[0005] According to various principles of the present invention, an actuable member of a valve assembly for a medical device is formed. The valve assembly may include a valve well having a proximal end and a distal end and defining a valve well passage extending therebetween and along an actuation axis. The valve shaft has an actuable member having a proximal end and a distal end, the actuable member extending through the valve well passage and being switchable therein between a first position and a second position along the actuation axis. The actuable member includes a user engagement element along its proximal end and a shaft along its distal end that is movable relative to the user engagement element. Distal movement of the user engagement element toward the distal end of the valve well causes proximal movement of the valve shaft toward the proximal end of the valve well.

[0006] Optionally, the biasing assembly couples the user engagement element and the valve shaft. Optionally, the biasing assembly is configured to transition between an extended configuration and a retracted configuration, wherein the user engagement element and the valve shaft are spaced apart from each other by a first distance, and in the retracted configuration, the user engagement element and the valve shaft are spaced apart from each other by a second distance that is less than the first distance. Optionally, the biasing assembly includes one or more links configured to transition between an extended configuration and a retracted configuration, wherein the user engagement element and the valve shaft are spaced apart from each other by a first distance, and in the retracted configuration, the user engagement element and the valve shaft are spaced apart from each other by a second distance that is less than the first distance. Optionally, the biasing assembly includes a link assembly comprising a plurality of links pivotally coupled together between the user engagement element and the valve shaft. In some embodiments, the plurality of links includes a proximal link having a proximal end and a distal end, and a distal link having a proximal end and a distal end, wherein the proximal end of the proximal link is coupled to the user engagement element, the distal end of the distal link is coupled to the valve shaft, and the distal end of the proximal link and the proximal end of the distal link are pivotally coupled relative to each other. Optionally, a guide path positioned relative to the link assembly guides a portion of one or more links to move the links between an extended configuration and a compressed configuration. Optionally, the distal end of the proximal link and the proximal end of the distal link are guided relative to the guide path to move along a guide axis transverse to the actuation axis to transition the link assembly between an expanded configuration and a compressed configuration.

[0007] In some embodiments, a linkage assembly couples the user engagement element and the valve shaft, the linkage assembly comprising at least one linkage having a proximal end coupled to the user engagement element and a distal end coupled to the valve shaft. Optionally, the at least one linkage is formed from an elastic material; and distal movement of the user engagement element toward the distal end of the valve well causes the at least one linkage to flex and shift the valve shaft toward the proximal end of the valve well. Optionally, a guide path is positioned relative to the linkage assembly to guide a portion of the at least one linkage between a neutral position relative to the valve assembly and a laterally outward position relative to the valve assembly laterally away from an actuation axis to facilitate flexing the at least one linkage into a collapsed configuration.

[0008] Optionally, the user engagement element is biased away from the distal end of the valve well.

[0009] In some aspects, the axially extending port is in fluid communication with the valve well passage along the actuation axis; the transversely extending port is in fluid communication with the valve well passage in a direction transverse to the actuation axis; and distal movement of the user engagement element switches the valve shaft from a position in which fluid is blocked from communicating between the axially extending port and the transversely extending port via the valve well passage to a position in which fluid is allowed to communicate between the axially extending port and the transversely extending port via the valve well passage.

[0010] According to various further principles of the present invention, an actuatable member of a valve assembly for a medical device having a valve shaft is formed, the valve shaft being extendable within a valve well passage between a closed position and an open position, in which the valve shaft blocks fluid from communicating between an axially extending port and a laterally extending port via the valve well passage, and in the open position, the valve shaft moves out of the flow path between the axially extending port and the laterally extending port via the valve well passage to allow fluid communication therebetween.

[0011] Optionally, the user engagement element is coupled to the valve shaft and is movable distally to switch the valve shaft from a valve shaft closed position to a valve shaft open position. Optionally, the valve assembly includes an assembly coupling the user engagement element and the valve shaft. In some cases, the biasing assembly includes one or more links configured to transition between an extended configuration and a retracted configuration, wherein in the extended configuration, the user engagement element and the valve shaft are spaced apart from each other by a first distance, and in the retracted configuration, the user engagement element and the valve shaft are spaced apart from each other by a second distance less than the first distance. Optionally, the valve assembly includes a guide path positioned relative to the linkage assembly to guide a portion of one or more links to enable the links to move between the extended configuration and the retracted configuration.

[0012] In some aspects, when the valve shaft is in the closed position, the valve shaft is positioned to block the flow path between the axially extending port and the laterally extending port; and when the valve shaft is in the open position, the valve shaft is positioned proximal to the laterally extending port and outside of the flow path between the axially extending port and the laterally extending port.

[0013] A valve shaft and / or valve assembly formed in accordance with one or more of the various principles of the present invention may be operably associated with a control handle of an endoscope.

[0014] These and other features and advantages of the present invention will become apparent from the following detailed description, and the scope of the invention as claimed is set forth in the appended claims. Although the following disclosure is presented in terms of various aspects or embodiments, it should be understood that individual aspects may be claimed alone or in combination with various aspects and features of that or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Non-limiting embodiments of the present invention 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 in the drawings may vary. For example, the device may be enlarged so that details are discernible, but is intended to be reduced with respect to, for example, fitting within a delivery catheter or working channel of an endoscope. In the drawings, identical or nearly identical or equivalent elements are generally indicated by the same reference characters, and similar elements are generally indicated by similar reference numerals with a ' added at the end, with redundant description omitted. For clarity and simplicity, not every element is labeled in every figure, nor is every element of each embodiment shown necessary to allow a person of ordinary skill in the art to understand the invention.

[0016] The detailed description will be better understood with reference to the accompanying drawings, in which like reference characters represent like elements, as follows:

[0017] Figure 1 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 invention is shown.

[0018] Figure 2A It shows that it can be set in Figure 1 An example of an embodiment of a valve assembly in an endoscope is shown along Figure 1 In a cross-sectional view taken along line II of FIG, the valve assembly is shown in a closed or closed configuration.

[0019] Figure 2B Shows something like Figure 2A , but with the valve assembly in an open or actuated configuration.

[0020] Figure 3A Shows such as Figure 2A , but also showing an example of an embodiment of a biasing assembly.

[0021] Figure 3B Shows such as Figure 2B , but also showing an example of an embodiment of a biasing assembly.

[0022] Figure 4A Shows such as Figure 2A , but also shows another example of an embodiment of a biasing assembly.

[0023] Figure 4B Shows such as Figure 2B , but also shows another example of an embodiment of a biasing assembly.

[0024] Figure 5A Shows such as Figure 2A , but also shows another example of an embodiment of a biasing assembly.

[0025] Figure 5B Shows such as Figure 2B , but also shows another example of an embodiment of a biasing assembly.

[0026] Figure 6A It shows that it can be set in Figure 1 Another example of an embodiment of a valve assembly in an endoscope is shown along Figure 1 In a cross-sectional view taken along line II of FIG, the valve assembly is shown in a closed or closed configuration.

[0027] Figure 6B Shows something like Figure 6A , but with the valve assembly in an open or actuated configuration.

[0028] Figure 7A It shows that it can be set in Figure 1 Another example of an embodiment of a valve assembly in an endoscope is shown along Figure 1 In a cross-sectional view taken along line II of FIG, the valve assembly is shown in a closed or closed configuration.

[0029] Figure 7B Shows something like Figure 7A , but with the valve assembly in an open or actuated configuration. DETAILED DESCRIPTION

[0030] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that the present invention is not limited to the specific embodiments described and is therefore subject to variation. 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 invention. Each example of the 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 invention and should not be construed as limiting the present invention to the specific elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the present subject matter. For example, features illustrated and described as part of one embodiment can be used with another embodiment to produce a further embodiment. Therefore, the present subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0031] It should be understood that the present invention is described in various levels of detail in this application. In some cases, details that are not necessary for a person of ordinary skill in the art to understand the present invention or that make other details difficult to perceive may have been omitted. The terms used herein are used only to describe specific embodiments and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise specified, the technical terms used herein are to be understood as commonly understood by a person of ordinary skill in the art to which the present invention belongs. According to the present invention, all devices and / or methods disclosed and claimed herein can be made and performed without undue experimentation.

[0032] 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., such terms are used interchangeably herein and are not intended to be limiting, and include 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" means extending along the longer or larger dimension of an element. "Longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends, and "axial" generally refers to along the longitudinal axis. However, it should be understood that references to axial or longitudinal movement with respect to 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 generally bisecting a center point and / or being generally equidistant from a periphery or boundary, and "central axis" means a line, relative to an opening, that at least generally bisects the center point of an opening, which extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a passage, a cavity or a hole. As used herein, a "cavity" or "passageway" or "hole" or "passageway" is not limited to a circular cross-section. As used herein, the "free end" of an element is the terminal end beyond which such element does not extend. It should be understood that unless otherwise stated, terms such as, at or on or near or along an end are used interchangeably herein, are not intended to be limiting, unless otherwise stated, and are intended to indicate generally relative spatial relationships, rather than to limit precisely defined positions. Finally, reference to "at" a position or location is intended to include at and / or near such position or location (e.g., along it, adjacent it, etc.).

[0033] Various medical devices include valve assemblies for regulating or controlling fluid delivery (irrigation) or fluid aspiration (suction) relative to an anatomical site.While the present invention describes an aspiration valve, it should be understood that the principles of the present invention need not be so limited.

[0034] A suction valve assembly of a medical device is arranged to apply suction from a suction source to an anatomical site, such as via 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, although the invention need not be limited in this respect. The suction source can be a pump or other mechanism that creates a vacuum to be applied to the anatomical site via the flexible tubular element, although the invention is not limited in this respect. In the 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 the open configuration of the valve assembly, the suction source is fluidly coupled to the flexible tubular element, such as to suction the anatomical site, and the valve can be considered to be in an open configuration.

[0035] The valve assembly of a medical device can be mounted relative to a control handle and typically includes a valve well and an actuable member that can move relative to the valve well to transition the valve assembly between a closed configuration and an open configuration. The valve well is formed in the control handle or formed and positioned within the control handle. The actuable member can include a user engagement element and a valve shaft. The valve shaft can move along an actuation axis within a valve well channel extending through the valve well. Various valve assemblies have different arrangements of ports and flow paths, such as providing and disabling fluid communication between a fluid source, such as a suction source, and an anatomical site via a flexible tubular element. For example, in some valve assemblies, a suction source is fluidically coupled to a suction source port in the valve well that extends approximately transversely to the actuation axis of the valve shaft. In such a valve assembly, the flexible tubular element is typically fluidically coupled to a suction application port in the valve well that is approximately axially aligned with the actuation axis of the valve shaft. In other valve assemblies, the suction source is fluidly coupled to a suction source port in the valve well that is generally axially aligned with the actuation axis of the valve shaft. In such valve assemblies, a flexible tubular element is typically fluidly coupled to a suction application port in the valve well that extends generally transverse to the actuation axis of the valve shaft. In both valve assemblies, the flexible tubular element extends from a control handle to an anatomical site within the patient's body for applying suction. The principles of the present invention can be applied to either configuration of valve assemblies.

[0036] According to various principles of the present invention, a simplified valve shaft is disposed within a valve well of a valve assembly. Valve shafts formed according to various principles of the present invention are generally shorter than prior art valve shafts and do not include holes, suction passages, ports, etc., connecting the valve well's suction source port and suction application port at various locations on the valve shaft relative to the valve well. Instead, the simplified valve shaft of the present invention is sized, shaped, configured, and / or dimensioned to block the transversely extending ports in the valve well only when the valve shaft is in the closed position, thereby placing the valve assembly in a closed or closed configuration. The simplified valve shaft of the present invention can be selectively moved out of a position blocking the transversely extending ports in the valve well to place the valve assembly in an open or open configuration. When the valve shaft is in the closed position, at least a portion of a circumferential surface positioned adjacent to the transversely extending ports is configured to seal fluid communication with the transversely extending ports of the valve well. Optionally, the distal surface of the valve shaft does not include a flow passage therethrough and / or is configured to seal fluid communication with the axially extending ports of the valve well. The simplified valve shaft can be formed from a material that ensures a tight seal relative to the transversely extending ports of the valve well. As can be appreciated, if the valve shaft need only seal a laterally extending port in a valve well, the length of the valve shaft need only be sufficient to seal that port, and therefore need only be sufficiently larger than the diameter of the laterally extending port to seal that port. Typically, the laterally extending port intersects the valve well at an angle such that the port at the intersection can have a generally elliptical cross-sectional shape, and therefore can be generally larger than the passage extending therefrom. For example, the intersection of the laterally extending port and the valve well can define an ellipse having a major axis of approximately 6 mm, while the diameter of the generally circular cross-section of the passage extending therefrom (away from the valve well) can be 4 mm. Therefore, as can be appreciated, the length of a valve sized, shaped, morphologically, and / or dimensioned to seal a laterally extending port is typically significantly shorter than the length of a valve shaft of the prior art for use in a valve assembly.

[0037] As described above, the valve shaft can be considered as part of an actuable member having a user engagement element (e.g., a button, a cap, etc.) for engaging with a user's hand or finger to operate the actuable member. Furthermore, according to various principles of the present invention, movement of the user engagement element causes the valve shaft to move in opposite directions, rather than the movement of the user engagement element causing the valve shaft to move in the same direction, so as to switch the valve assembly from one position to another. More particularly, movement of the user engagement element of the actuable member in a distal direction (toward the valve well) causes the valve shaft to move toward / closer to the proximal direction of the user engagement element. Conversely, movement of the user engagement element of the actuable member in a proximal direction (away from the valve well) causes the valve shaft to move distally away from the user engagement element. This configuration of the actuable member facilitates the valve shaft formed according to various principles of the present invention to move from a position that blocks fluid from communicating between the valve passage in the valve well and the transversely extending port of the valve well (and therefore also with the axially extending port of the valve well) to a position outside the flow path between the transversely extending port and the axially extending port of the valve well, so as to allow unimpeded flow of fluid therebetween. According to various principles of the present invention, a biasing assembly, system, mechanism, etc. (these terms are used interchangeably herein and are not intended to be limiting) can be provided between a user engagement element and a valve shaft to maintain the valve assembly in a closed configuration. A user can actuate (e.g., push, press, apply an actuation force, etc.) the user engagement element to transition the valve assembly to an open configuration. Once the user stops actuating the user engagement element, the biasing assembly can return the valve assembly to the closed configuration by moving the user engagement element and the valve shaft apart.

[0038] For convenience and without limitation, reference is made herein to a valve assembly for an endoscope's suction valve. 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 sites, without limitation). The insertion tube defines one or more lumens therethrough that are configured to allow materials, instruments, tools, devices, etc. to pass through a working channel to reach the anatomical site. For example, the lumens may include a suction lumen, an irrigation lumen, a working channel, and / or a visualization lumen (e.g., for light guides, optical fibers, camera elements, etc.).

[0039] Various embodiments of valve assemblies (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 one or more specific features, structures, concepts, and / or characteristics according to the principles of the present invention may be included in conjunction 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 thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present invention. Furthermore, references throughout this specification to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., do not necessarily refer to the same embodiment, nor are they necessarily separate or alternative embodiments that are mutually exclusive of other embodiments. It should also be understood that the various features, structures, concepts and / or characteristics of the disclosed embodiments are independent and separable from each other and can be used or presented individually or in various combinations with each other to create alternative embodiments that are considered to be part of the present invention. Therefore, the present invention is not limited to the embodiments specifically described herein, as describing all possible combinations and sub-combinations of features, structures, concepts and / or characteristics would be too cumbersome, and the examples of the embodiments disclosed herein are not intended to limit the broader aspects of the present invention. It should be understood that the various dimensions provided herein are examples, and that one of ordinary skill in the art can readily determine the appropriate range of standard deviations and acceptable variations covered by the present invention 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 invention.

[0040] It should be understood that common features in the drawings are identified by common reference elements, and for the sake of brevity and convenience and not intended to be limiting, the description of the common features is generally not repeated. For the sake of clarity, not all parts with the same reference numerals are numbered. In addition, a group of similar elements can be indicated by numbers and letters, and generally only a number can be used to refer to an element or such elements or such elements as a group (excluding the letters associated with each similar element). It should be understood that in the following description, similar elements or parts in the various illustrated embodiments are generally indicated by the same reference numerals followed by ' and / or increased by 100, and for the sake of brevity, redundant descriptions are generally omitted. In addition, certain features in one embodiment can be used across different embodiments and do not need to be individually marked when appearing in different embodiments.

[0041] Turning now to the accompanying drawings, Figure 1 An example of an embodiment of a valve assembly 100 formed according to the various principles of the present invention, as provided in an example of an embodiment of an endoscope 1000, is shown in FIG. It should be understood that endoscope 1000 is an example of an embodiment to which the principles of the present invention may be applied, and that the various principles of the present invention are applicable to other medical devices for controlling fluid flow therewith, the details of which are not critical to the present invention. Furthermore, while reference is made to an aspiration valve, it should be understood that the disclosed principles and embodiments are applicable to other valves, such as a fluid supply / irrigation valve.

[0042] The illustrated example embodiment of the valve assembly 100 is mounted relative 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 cable 1030 extending to a scope connector 1032, with which the endoscope 1000 (and the valve assembly 100) can be fluidically coupled to the suction source 1100. The connector cable 1030 may alternatively be referred to herein as an umbilical cable, an umbilical, a universal cable, etc., without limitation. The scope connector 1032 may also couple the endoscope 1000 to various components, devices, etc., such as a fluid source (for supplying 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. that may be used with the endoscope 1000, via the connector cable 1030. 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 connector cable 1030 has a fluid lumen extending therethrough to fluidically couple the suction source 1100 (e.g., via the scope connector 1032) with the control handle 1010. The fluid lumens through the insertion tube 1020 and connector cable 1030, as well as the distal end of the insertion tube 1020, can be well-known features formed in a manner known to those of ordinary skill in the art and are not shown to eliminate the need for further illustration. Figure 1 The illustration of endoscope 1000 simplifies the drawing by removing details that are not necessary for understanding the present invention.

[0043] exist Figure 2A and Figure 2B An example of one embodiment of a valve assembly 100 formed according to various principles of the present invention is shown in FIG. Figure 1100). In the illustrated example of the embodiment, the valve assembly 100 includes an actuatable member 110 extending from a proximal end 101 of the valve assembly 100. The distal end 103 of the valve assembly 100 is typically positioned or housed within a control handle or other suitable housing. The actuatable member 110 includes a valve shaft 120 that is movable within the valve assembly 100, and a user engagement element 130 that is accessible to a user (external to any housing within which the valve shaft 120 extends) to engage the user engagement element 130. The valve shaft 120 and the user engagement element 130 are operably coupled via a linkage assembly 140 that transmits movement of the user engagement element 130 to the valve shaft 120, as will be described in further detail below. The valve shaft 120 is actuated by a user engaging the user engaging element 130 (e.g., along the user engaging surface 132) and applying an actuation force thereto (e.g., along the actuation axis A) to actuate the valve shaft 120 in a closed position (e.g., within the valve well 150 of the valve assembly 100). Figure 2A ) and open (open) positions (as shown) Figure 2B ) between the valve well 150 and the valve shaft 120. When the valve shaft 120 is in the closed (closed) position, the valve assembly 100 is in a closed configuration and suction is not applied to a suction applying device that is fluidly coupled to the valve assembly 100 (e.g., an insertion tube of an endoscope). When the valve shaft 120 is in the open (open) position, the valve assembly 100 is in an open configuration and suction can be applied to the suction applying device. The actuatable member 110 can be mounted relative to the valve well 150 via a collar 160, which is coupled to the valve well 150, such as with snap-fit ​​features (such as those known to those of ordinary skill in the art). The collar 160 can also be used to guide the movement of the actuatable member 110 to switch the valve shaft 120 between its closed and open positions, as described in further detail below.

[0044] exist Figure 2A and Figure 2B In the example of the embodiment of the valve assembly 100 shown, the valve shaft 120 is positioned within a passage 152 within a valve well 150 extending along an actuation axis A. The valve well 150 has an axially extending port 154 that allows fluid flow generally axially with respect to the valve well passage 152, and a transversely extending port 156 that allows fluid flow generally transverse to the valve well passage 152. The valve shaft 120 is movable / switched relative to the valve well 150 and within the valve well passage 152 along the actuation axis A. In its closed position, such as Figure 2AAs shown, the valve shaft 120 blocks fluid flow between the axially extending port 154 and the transversely extending port 156 of the valve well 150. Thus, a fluid source in fluid communication with one of the ports 154, 156 is blocked by the valve shaft 120 from fluid communication with the other of the ports 154, 156. Figure 2B As shown, the valve shaft 120 is moved out of a position that blocks fluid communication between the axially extending port 154 and the transversely extending port 156. The valve assembly 100 is thus transitioned to an open configuration in which fluid can be communicated between a fluid source and a fluid application device. For example, the fluid source can be a suction source (e.g., a vacuum pump), and the fluid application device is an insertion tube of an endoscope having a working channel that is in fluid communication with the valve well 150 and in fluid communication with the suction source via the valve well passage 152 to apply suction to a target site in the patient's body.

[0045] As can be appreciated, the valve shaft 120 need not extend the entire length of the valve well passage 152 along the actuation axis A. For example, the length of the valve shaft 120 may be slightly greater than the diameter of the laterally extending port 156 so that when the valve shaft 120 is in the actuation axis A, the valve well passage 152 may extend the entire length of the valve shaft 120 along the actuation axis A. Figure 2A When in the closed position shown, the valve shaft 120 can block fluid communication between the laterally extending port 156 and the valve well passage 152. Therefore, the valve shaft 120 formed according to the various principles of the present invention can have a more limited length than the valve shafts of the prior art and be shorter than the valve shafts of the prior art. Having a substantially different form than the valve shafts of the prior art, the valve shaft 120 formed according to the various principles of the present invention can be considered or referred to as a stopper, a blocker, a plunger, a plug, etc. The valve shaft 120 is formed of a material capable of sealing relative to the walls of the valve well 150 that define the valve well passage 152, and particularly relative to the laterally extending port 156 of the valve well 150. For example, the valve shaft 120 can be formed of an elastomeric material (such as a thermoplastic elastomer) or a metal (e.g., stainless steel), thereby allowing sufficiently tight tolerances to achieve the desired seal. The outer surface of the valve shaft 120 can have a substantially continuous or smooth surface and can be sized, shaped, formed, and / or dimensioned to allow the valve shaft 120 to be shifted along the actuation axis A while also providing sealing relative to the laterally extending ports 156 and the axially extending ports 154. In some embodiments, the valve shaft 120 includes circumferential sealing elements 122a, 122b, which are circumferentially extending, radially projecting sealing elements extending around the circumference of the valve shaft 120, such as Figure 6A and Figure 6B shown.

[0046] According to various principles of the present invention, and as by comparison Figure 2A and Figure 2BThe relative positions of the valve shaft 120 and the user engagement element 130 of the exemplary embodiment of the valve assembly 100 are shown. It will be appreciated that actuation of the actuatable member 110 causes the valve shaft 120 and the user engagement element 130 to move in opposite directions. Specifically, the user engagement element 130 is moved from a neutral proximal position (e.g., Figure 2A ) is moved distally to a more distal position (toward the distal end 103 of the valve assembly 100, as shown Figure 2B As shown) causes the valve shaft 120 to move proximally. Figure 2A and Figure 2B In the example embodiment of the valve assembly 100 shown, when the actuatable member 110 is in a substantially neutral position, the valve assembly 100 is in a closed configuration, wherein the valve shaft 120 is in a position that blocks fluid communication between the axially extending port 154 and the transversely extending port 156. The example actuatable member 110 of the shown embodiment is switched distally to switch the valve assembly 100 to an open configuration, in which the valve shaft 120 moves out of the flow path (via the valve well passage 152) between the axially extending port 154 and the transversely extending port 156. As can be appreciated, the valve shaft 120 must be moved proximally to allow fluid flow between the axially extending port 154 located at the distal end 153 of the valve well 150 and the transversely extending port 156 located proximal to (closer to) the proximal end 153 of the valve well 150. Typically, the actuation direction of the actuatable member 110 is distal, that is, the movement of pressing the user engagement element 130 toward the distal end 103 of the valve assembly 100. Therefore, the actuatable member 110 is configured so that the distal movement of the user engagement element 130 causes the proximal movement of the valve shaft 120 to switch the valve shaft 120 from a closed (or closed) position to an open (or open) position. According to various principles of the present invention, the connecting rod assembly connecting the user engagement element 130 and the valve shaft 120 is configured to achieve the above-mentioned opposite relative movement. In addition, according to various principles of the present invention, the biasing assembly consisting of the connecting rod assembly and the biasing element can be configured to maintain the valve assembly 100 in a closed configuration, wherein the user's active actuation of the user engagement element 130 (that is, the intentional input of the actuation force) causes the valve assembly 100 to transition to an open configuration according to the user's needs.

[0047] exist Figure 2A and Figure 2BIn the illustrated example embodiment of the actuatable member 110, the linkage assembly 140 includes a plurality of links 142a, 142b, 142c, 142d that are pivotally coupled relative to one another and relative to the user engagement element 130 and the valve shaft 120. For example, the proximal ends 141a, 141b of the proximal links 142a, 142b, respectively, are pivotally coupled relative to the user engagement element 130, and the distal ends 143c, 143d of the distal links 142c, 142d, respectively, are pivotally coupled relative to the valve shaft 120. The pivotable connections may employ any suitable configuration known to those of ordinary skill in the art. Examples of pivotable connection embodiments are pivot pins 144 located at the ends of links 142a, 142b pivotally mounted in suitable pivot brackets 134 (which are mounted on the user engagement element 130), and / or pivot pins 144 located at the ends of links 142c, 142d pivotally mounted in suitable pivot brackets 124 (which are mounted on the valve shaft 120). A similar element, such as another pivot pin 144, can guide links 142a, 142b, 142c, 142d relative to the guide path 162, such as by sliding along guide slots 164 formed relative to the guide path 162. However, the present invention is not limited in this respect.

[0048] exist Figure 2A and Figure 2B In the example embodiment of the actuatable member 110 shown, the ends of the links that are not pivotally coupled to the valve shaft 120 or the user engagement element 130 are guided by the guide paths 162. More specifically, the distal ends 143a, 143b of the proximal links 142a, 142b and the proximal ends 141c, 141d of the distal links 142c, 142d, respectively, are guided by the guide paths 162. Figure 2A and Figure 2B In the example of the embodiment shown, the guide path 162 is mounted relative to the collar 160. The links 142a, 142b, 142c, 142d can be considered to be coupled relative to each other and movable relative to each other via the guide path 162. When the actuatable member 110 is toggled distally relative to the collar 160, the skirt 136 extending distally from the user engagement surface 132 of the user engagement element 130 can extend circumferentially around the link assembly 140, as well as around the collar 160 and the guide path 162 mounted thereto.

[0049] When the actuatable member 110 is toggled distally, the ends 143a, 143b, 141c, 141d of the links 142a, 142b, 142c, 142d are guided along the guide axis G (which is along the guide path 162), which is away from a rest position along the mid-region of the actuatable member 110 (e.g., spaced a distance inwardly from the skirt 136 of the user engagement element 130, as shown in FIG. Figure 2A ) and in a lateral / radially outward direction to be closer to the ends 161, 163 of the guide path 162 (as shown) Figure 2B ). The actuation axis A is located in a mid-region along the valve assembly 100, such as along its central axis, and the guide axis G extends transversely to the actuation axis A. Thus, the connecting rod assembly 140 is extended from its extended configuration (extended closer to the actuation axis A than the ends 161, 163 of the guide axis G, as shown). Figure 2A As shown) moves to a retracted configuration (extending to the ends 161, 163 closer to the guide axis G than the actuation axis A, as shown Figure 2B ). It should be understood that references to the collapsed, folded, compressed, etc. configurations may be made interchangeably herein and are not intended to be limiting. When the configuration of the linkage assembly 140 transitions from the extended configuration to the collapsed configuration, the valve shaft 120 is moved closer to the user engagement element 130 and out of the fluid communication path between the axially extending port 154 and the laterally extending port 156 of the valve well 150.

[0050] In some cases, it is desirable that the valve assembly 100 be in a closed configuration when in a neutral position (when no actuating force is applied to the actuatable member 110). Such situations include when the valve assembly 100 (such as described herein) is configured for use with an endoscope 1000 and is coupled to a continuously operating suction source. It is generally desirable to limit the suction applied by the valve assembly 100 to situations in which suction is required, and to limit and preferably eliminate the suction force on the valve well suction application port 154 when suction is not required. For example, in certain endoscopic procedures, it is desirable to maintain insufflation of the anatomical site to improve visualization of the target site of the procedure, and / or to irrigate the target site, such as by supplying fluid to the target site. Suction can be limited to reduce the supplied fluid in certain situations, and / or to remove other materials (e.g., biological materials) from the target site. In this case, the valve assembly 100 can be biased to a neutral closed configuration such that the actuatable member 110 (including the valve shaft 120 and the linkage assembly 140) returns to the closed configuration upon removal of the actuation force applied to move the valve assembly 100 to the actuated open configuration.

[0051] exist Figure 2A and Figure 2B In the example embodiment shown, a biasing element may be provided to return the linkage assembly 140 from the retracted configuration to the neutral extended configuration. The present invention encompasses various configurations of the biasing element and its arrangement relative to the linkage assembly 140, and in some aspects, the combination of the biasing element and the linkage assembly is considered a biasing assembly, system, mechanism, etc. An example embodiment of this configuration is shown in FIG. Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5Aand Figure 5B , wherein the biasing element is positioned relative to the linkage assembly 140 to bias the linkage assembly 140 (and therefore the valve assembly 100) from an actuated configuration (such as Figure 3B 、 Figure 4B and Figure 5B as shown) back to a neutral state (such as Figure 3A 、 Figure 4A and Figure 5A As shown). The biasing element may be a tension spring or a compression spring. It will be appreciated that Figure 2A and Figure 2B The components of the exemplary embodiment of the valve assembly 100 shown in FIG. Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A and Figure 5B Elements of the valve assemblies 100', 100", 100'" shown in FIG are denoted by the same reference numerals and, for the sake of brevity and without limitation, reference is made to the description thereof provided above. Additionally, although the biasing element is Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A and Figure 5B The examples of various embodiments shown may vary and may affect the relative positions of the links 142a, 142b, 142c, 142d, but Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A and Figure 5B The connecting rod assembly 140 in the example of the embodiment shown may also be similar in other respects and is therefore referenced with the same reference numerals and reference is made to the description thereof provided above, without limitation. Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A and Figure 5B Slight differences in the arrangement of the ends of the center links 142a, 142b, 142c, 142d are shown and do not affect the operation of the linkage assembly 140 or the general principles of the invention described herein.

[0052] exist Figure 3A and Figure 3BIn the example of an embodiment of the valve assembly 100' shown, a biasing element in the form of a tension spring 146' extending along the guide axis G is provided in relation to the linkage assembly 140. One end 145' of the spring 146' is coupled to the ends 143a, 141c of the linkages 142b, 142d, which ends 143a, 141c move towards the end 161 of the guide path 162 when the actuatable member 110 is switched to its open position. The other end 147' of the spring 146' is coupled to the ends 143b, 141d of the linkages 142b, 142d, which ends 143b, 141d move towards the end 163 of the guide path 162 (opposite the end 161) when the actuatable member 110 is switched to the open position. When the user engagement element 130 is switched distally to cause the valve assembly to be opened, the user engagement element 130 is engaged. Figure 3A The form changes to Figure 3B , tension is applied to spring 146'. This tension in spring 146' causes linkage assembly 140 to return to its original position once actuation force is no longer applied to actuatable member 110 (in a distal direction toward distal end 103 of valve assembly 100'). Figure 3A The form shown.

[0053] exist Figure 4A and Figure 4B In the example of an embodiment of the valve assembly 100″ shown, a biasing element in the form of a pair of compression springs 146a″, 146b′ extending along the guide axis G is provided in relation to the connecting rod assembly 140. One end 145a″ of the spring 146a″ is coupled to the ends 143a, 141c of the connecting rods 142a, 142c, and when the actuatable member 110 is switched to its open position, the ends 143a, 141c move toward the end 161 of the guide path 162. The other end 147a″ of the spring 146a″ is coupled to the end 161 of the guide path 162. Similarly, one end 145b″ of the spring 146b″ is coupled to the ends 143b, 141d of the connecting rods 142b, 142d, and when the actuatable member 110 is switched to the open position, the ends 143b, 141d move toward the end 163 of the guide path 162 (opposite the end 161). The other end 147b" of the spring 146b" is coupled to the end 163 of the guide path 162. When the user engages the element 130 distally to cause the valve assembly 100" to Figure 4A The form changes to Figure 4B When the valve assembly 100 is in the closed position, springs 146a", 146b" are compressed. The potential energy generated by the compressed springs 146a", 146b" allows the springs 146a", 146b" to return the linkage assembly 140 to the closed position once the springs 146a", 146b" are no longer applying an actuating force to the actuatable member 110 (in a distal direction toward the distal end 103 of the valve assembly 100). Figure 4A The form shown.

[0054] exist Figure 5A and Figure 5B In the example of an embodiment of the valve assembly 100'' shown, a biasing element in the form of a compression spring 146'' extending along the actuation axis A is provided in relation to the linkage assembly 140. The proximal end 145'' of the spring 146'' is coupled to the proximal ends 141a, 141b of the proximal links 142a, 142b (which are coupled to the user engagement element 130). The distal end 147'' of the spring 146'' is coupled to the distal ends 143c, 143d of the distal links 142c, 142d (which are coupled to the valve shaft 120). When the user engagement element 130 is switched distally to cause the valve assembly 100'' to be disengaged from the distal end, the spring 145'' is coupled to the proximal ends 141a, 141b of the proximal links 142a, 142b (which are coupled to the user engagement element 130). Figure 5A The form changes to Figure 5B ' is compressed. The potential energy generated by the compressed spring 146' allows the spring 146' to return the linkage assembly 140 to the closed position once it no longer applies an actuating force to the actuatable member 110 (in a distal direction toward the distal end 103 of the valve assembly 100'). Figure 5A The form shown.

[0055] It should be understood that the present invention need not be limited to the illustrated and described configurations of the biasing element and / or linkage assembly, or to the illustrated and described configurations of the biasing element in relation to the linkage assembly. For example, instead of a biasing assembly having a biasing element with a linkage assembly (and separate from the linkage assembly), the biasing assembly of the actuable member of a valve assembly formed according to various principles of the present invention can have a linkage assembly that is itself made of a resilient, elastic, springy, or the like material (e.g., spring steel, music wire, nitinol wire, etc.) that returns the actuable member to a neutral position. Thus, the biasing assembly can be considered to be formed by a linkage assembly that also serves as the biasing element of the biasing assembly. For example, the linkage assembly can include one or more linkages, each having a first end coupled (e.g., pivotally) to a user engagement element and a second end coupled (e.g., pivotally) to a valve shaft, and each linkage being capable of biasing the user engagement element and the valve shaft apart. Additionally or alternatively, instead of two or more connecting rods extending between the user engagement element of the actuatable member and the valve shaft, wherein the intermediate end is guided along a guide path, such as in Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A and Figure 5B In the example of the embodiment shown, a single link may extend between the user engagement element and the valve shaft, wherein a proximal end of the single link is coupled to the user engagement element and a distal end of the single link is coupled to the valve shaft. One or more such single links may be provided.

[0056] Figure 6A and Figure 6B An example of an embodiment of a valve assembly 200 is shown in FIG, which has a linkage assembly 240 that includes a pair of individual links (i.e., a first link and a second link together forming a pair of links that form a linkage assembly), each link having a proximal end coupled to a user engagement element of an actuatable member and a distal end coupled to a valve shaft of the actuatable member. It should be understood that Figure 2A and Figure 2B The components of the exemplary embodiment of the valve assembly 100 shown in FIG. Figure 6A and Figure 6B Elements of the valve assembly 200 shown in FIG are denoted by like reference numerals, and for the sake of brevity and without intent to be limiting, reference is made to the description thereof provided above. Figure 6A and Figure 6B In the example of the embodiment of the valve assembly 200 shown, a pair of links 242a, 242b are provided between the user engagement element 130 and the valve shaft 120, each link 242a, 242b having a respective proximal end 241a, 241b coupled to the user engagement element 130 and a distal end 243a, 243b coupled to the valve shaft 120. The intermediate regions 245a, 245b of the respective links 242a, 242b engage with and are guided by the guide path 162. The ends 241a, 241b, 243a, 243b of the links 242a, 242b can be pivotally coupled to the user engagement element 130 and the valve shaft 120, respectively. Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A and Figure 5B As with the example of the embodiment shown, the pivotable connection can be of any suitable configuration known to those of ordinary skill in the art. An example of an embodiment of a pivotable connection is a pivot pin 244 located at the end 241a, 241b, 243a, 243b of a connecting rod 242a, 242b that is pivotally mounted in a suitable pivot bracket 134, 124 (which is mounted on the user engagement element 130 and the valve shaft 120). However, the present invention is not limited in this respect. Similarly, the intermediate region 245a, 245b of the respective connecting rod 242a, 242b can include an element, such as a pivot pin 244 that guides relative to the guide slot 164 (which is formed relative to the guide path 162).

[0057] when Figure 6A and Figure 6B When the user engagement element 130 of the example embodiment of the valve assembly 200 is switched distally, the links 242a, 242b are moved from a generally elongated extended configuration (e.g., Figure 6A ) to a compressed form (as shown Figure 6B). For example, the links 242a, 242b flex from an extended configuration to a compressed configuration. In embodiments where the links 242a, 242b include guide pins (e.g., pivot pin 144), the guide path 162 can guide movement of the intermediate regions 245a, 245b of the respective links 242a, 242b along the guide axis G and laterally away from the actuation axis A. This compression of the links 242a, 242b pulls the valve shaft 120 proximally as the user engagement element 130 moves distally. Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A and Figure 5B As with the examples of the above-described embodiments shown, proximal movement of the valve shaft 120 allows fluid communication between the axially extending port 154 and the transversely extending port 156 of the valve well 150, thereby transitioning the valve assembly 200 to the open configuration. The elasticity, resiliency, spring force, etc., of the links 242a, 242b can bias the user engagement element 130 proximally upon withdrawal of the actuating force thereto (in a distal direction toward the distal end 103 of the valve assembly 200), thereby returning the actuatable member 110 to the closed position and returning the valve assembly 200 to the open configuration. Figure 6A Closed pattern shown.

[0058] Instead of forming a generally linear biasing member and / or link (such as in Figure 6A and Figure 6B In the example of the embodiment shown, a biasing member that uses and / or applies a torsional force can be used to bias the user engagement element 130 relative to the valve shaft 120 of a valve assembly formed according to various principles of the present invention. For example, Figure 7A and Figure 7B The example embodiment of the valve assembly 300 shown has a biasing assembly 340 that includes a biasing structure configured and adapted to perform substantially as a torsion spring (e.g., storing and subsequently releasing nonlinear rotational rather than linear energy). Similar to the valve assemblies 100, 100', 100", 100'", 200 described above, the biasing assembly 340 maintains the user engagement element 130 and the valve shaft 120 spaced apart from each other to maintain the valve assembly 300 in a closed, closed configuration. Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A 、 Figure 5B 、 Figure 6A and Figure 6BAs with the examples of the above-described embodiments shown, application of an actuating force to the user engagement element 130 effects proximal movement of the valve shaft 120, which permits fluid communication between the axially extending port 154 and the transversely extending port 156 of the valve well 150, thereby transitioning the valve assembly 200 into the open configuration. Once the actuating force is no longer applied to the user engagement element 130, the biasing assembly 340 (specifically, the force stored therein / by it) returns the user engagement element 130 and the valve shaft 120 to a spaced-apart configuration, thereby transitioning the valve assembly 300 from the open configuration back into the closed configuration. The closed configuration and the opened configuration of the valve assembly 300 may be substantially similar to the closed configuration and the opened configuration of the valve assemblies 100, 100', 100", 100'", 200 described above, and for the sake of brevity, and not intended to be limiting, reference will be made to the above description of the valve assembly 300 applicable thereto. Figure 7A and Figure 7B The valve assembly 300 is shown in FIG. Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B 、 Figure 4A 、 Figure 4B 、 Figure 5A 、 Figure 5B 、 Figure 6A and Figure 6B The components of the exemplary embodiment of the valve assembly 100 shown in FIG. Figure 7A and Figure 7B Elements of the valve assembly 300 shown in FIG. 3 are denoted with the same reference numerals and / or reference numerals increased by a multiple of 100, and for the sake of brevity and without intending to be limiting, reference is made to the description thereof provided above.

[0059] exist Figure 7A and Figure 7B In the illustrated example of an embodiment of a biasing element 340, the biasing assembly 340 includes one or more biasing assembly units 340a, 340b, each having a proximal arm or link 342a, 342b and a distal arm or link 342c, 342d, with the links 342a, 342b, 342c, 342d coupled to a rotational element 346. It should be understood that terms such as arm or link may be used interchangeably herein with reference to the links 342a, 342b, 342c, 342d and are not intended to be limiting. It should also be understood that the rotational element 346 may be a wheel, hub, or the like, around which the links 342a, 342b, 342c, 342d may be wound to store rotational / torsional energy in the biasing assembly 340. The biasing assembly 340 may be formed from a metal, such as stainless steel, spring steel, nitinol (or other shape memory material / alloy), or a plastic.

[0060] The links 342a, 342b, 342c, 342d are coupled to the user engagement element 130 and the valve shaft 120, as well as to the rotation element 346. In some aspects, the links 342a, 342b, 342c, 342d can be considered to link the user engagement element 130 and the valve shaft 120 of the valve assembly 300. In some aspects, the proximal ends 341a, 341b of the proximal links 342a, 342b, respectively, are pivotally coupled with respect to the user engagement element 130, and the distal ends 343c, 343d of the distal links 342c, 342d, respectively, are pivotally coupled with respect to the valve shaft 120. The pivotable connections can employ any suitable configuration known to those of ordinary skill in the art. Examples of embodiments of pivotable connections are pivot pins 344 located at the ends of links 342a, 342b pivotally mounted in suitable pivot brackets 134 (which are mounted on the user engagement element 130), and / or pivot pins 344 located at the ends of links 342c, 342d pivotally mounted in suitable pivot brackets 124 (which are mounted on the valve shaft 120). However, the present invention is not limited in this respect. In some aspects, the distal ends 343a, 343b of the proximal links 342a, 342b and the proximal ends 341c, 341d of the distal links 342c, 342d are respectively coupled with respect to corresponding rotational elements 346 so as to wrap around the rotational elements 346 when the user engagement element 130 and the valve shaft 120 move closer to / toward each other, as described in further detail below. In some aspects, the connection of the links 342a, 342b, 342c, 342d to the rotational element 346 can allow the links 342a, 342b, 342c, 342d to pivot less than the degree of pivoting produced by the pivoting about the pivot pin described above, and thus, rather than about the pivot pin, a more fixed but flexible / non-rigid connection that still allows pivoting.

[0061] The rotational element 346 can be rotatably mounted relative to the valve assembly 300 (e.g., via a pin 344, a shaft, etc.) such that upon application of an actuation force to the user engagement element 130, the links 342a, 342b, 342c, 342d are moved closer to / toward each other and caused to wrap around the rotational element 344, thereby rotating the rotational element 346 about the rotation axis R and bringing the user engagement element 130 and the valve shaft 120 together to transition the valve assembly 300 to the open configuration. As can be appreciated, the wrapping of the links 342a, 342b, 342c, 342d around the rotational element 346 stores rotational (torsion spring) energy in the links 342a, 342b, 342c, 342d. When the actuation force is removed from the user engagement element 130, the force stored in the links 342a, 342b, 342c, 342d causes the rotational element 344 to rotate in the opposite direction, wherein the links 342a, 342b, 342c, 342d expand or straighten to move the user engagement element 130 and the valve shaft 120 apart to transition the valve assembly 300 to a closed, closed configuration.

[0062] In some aspects, to facilitate the application of a torsional force by the rotating element 346, the ends 341a, 341b, 343c of the links 342a, 342b, 342c, 342d coupled to the user engagement element 130 and the valve shaft 120 are mounted on substantially diametrically opposed sides, offset from the rotational axis R of the rotating element 346. As can be appreciated, such a position maximizes the moment arm of the links 342a, 342b, 342c, 342d relative to the rotating element 346. The greater the distance from the pivotal connection of the links 342a, 342b, 342c, 342d to the user engagement element 130 and the valve shaft 120 to the rotational axis R, the greater the moment arm that results in the rotating element 346 rotating and the links 342a, 342b, 342c, 342d wrapping around it. However, it should be appreciated that this distance may be limited by the dimensions of the space within the valve assembly 300, such as the inner diameter of the passageway 152 within the valve well 150. Alternatively or additionally, the ends 343a, 343b, 341c, 341d of the connecting rods 342a, 342b, 342c, 342d, respectively coupled to the corresponding rotating element 346, can be attached tangentially to the outer periphery of the rotating element 346. In other words, the connecting rods 342a, 342b, 342c, 342d can be considered as flat, ribbon-like spring arms whose ends are tangentially coupled to and coupled to the rotating element 346. This configuration can facilitate the connecting rods 342a, 342b, 342c, 342d wrapping around the rotating element 346 and storing torsional force therein. As can be appreciated, the width of the connecting rods 342a, 342b, 342c, 342d can be determined based on the space within the valve assembly 300, such as the inner diameter of the passage 152 within the valve well 150. Alternatively or additionally, it will be appreciated that the diameter of the rotating element 346 can affect the amount of energy stored by the biasing assembly 340 and / or the ease with which the valve assembly 300 transitions between the open and closed configurations. While a larger diameter rotating element 346 will generally provide a better mechanical advantage, like other components of the biasing assembly 340, the size of the rotating element 346 may be limited by the space within the valve assembly 300, such as the inner diameter of the passageway 152 within the valve well 150 and / or the internal distance between the user engagement element 130 and the valve shaft 120.

[0063] In the case where the valve assembly described herein is fluidly coupled to a suction source that is continuously open during use of the valve assembly, it may be necessary to discharge or release the vacuum pressure generated by the suction source within the valve assembly when the valve assembly is in a closed configuration. According to various principles of the present invention, one or more bleed passages can be defined in the valve assembly to release / exhaust ambient air to the suction source. As will be appreciated, the position and configuration of such bleed passages will depend on the position of the valve shaft relative to the valve well port that is fluidly connected to the suction source. For example, if the suction source is fluidly coupled to a laterally extending port of the valve well, a bleed passage can be formed along the proximal end of the valve shaft to fluidly connect the laterally extending port to the ambient air when the valve shaft is in the closed position. The longitudinal extent of such a bleed passage may be limited so that when the valve shaft is in the open position, the flow path between the laterally extending port and the axially extending port is sealed from the influence of ambient air, so that suction applied from the laterally extending port to the axially extending port is not lost to the environment. If an axially extending port of the valve well is fluidly coupled to a suction source, a bleed passage defined relative to the valve shaft and the valve well may extend axially relative to the valve shaft when the valve shaft is in the closed position, but be blocked when the valve shaft is switched to the open position. For example, a bleed passage may extend axially through the valve shaft 120. When the valve shaft 120 moves upward, such a passage may then be blocked by features on the bottom of the guide path 162 to shut off the bleed passage when a suction source is in fluid communication with the suction application port.

[0064] In addition to those discussed above, one of ordinary skill in the art will appreciate various further benefits of various aspects, features, components and structures of the valve shaft and associated sealing member, as well as the valve assembly and endoscope, such as described above.

[0065] It will be understood by those skilled in the art that this discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the invention. It will be understood that the principles of the present invention 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 an anatomical site and applying suction and / or lavage thereto, including, for example, endoscopes, gastroscopes, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like, which have integrated features for suctioning and / or lavaging an anatomical site. Furthermore, the principles of the present invention can be applied to reusable or disposable devices, instruments, tools, and the like.

[0066] All devices and methods discussed herein are examples of devices and / or methods implemented according to one or more principles of the present invention. 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 invention. Therefore, references to elements, structures, or features in the accompanying drawings must be understood as references to examples of embodiments of the present invention and should not be construed as limiting the present invention to the specific elements, structures, or features shown. A person of ordinary skill in the art will recognize other examples of ways to implement the disclosed principles upon reading this disclosure. For example, the various elements and components of the valve assemblies described herein may be directly or indirectly coupled or engaged to one another, regardless of how these connections are depicted in the accompanying drawings. It should be apparent to a person of ordinary skill in the art that variations may be applied to the disclosed devices, systems, and / or methods and / or the series of steps described herein without departing from the concept, spirit, and scope of the present invention. It should be understood that various features described with respect to one embodiment may typically be applied to another embodiment, whether or not explicitly stated. The various features described below may be used alone or in any combination thereof. Therefore, the present invention is not limited to the specific embodiments described herein, and all alternatives and modifications apparent to those skilled in the art are considered to be within the spirit, scope and concept of the present invention as defined by the appended claims.

[0067] The above discussion has broad applicability and has been presented for purposes of illustration and description, and is not intended to limit the invention 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 invention. In particular, it will be apparent to those skilled in the art that the principles of the invention may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from its concept, spirit, scope, or characteristics. For example, to simplify the invention, various features of the invention may be combined together in one or more aspects, embodiments, or forms. However, it should be understood that various features of certain aspects, embodiments, or forms of the invention may be combined in alternative aspects, embodiments, or forms. Although the invention is presented in the form of embodiments, it should be understood that the various individual features of the subject matter need not all be present in order to achieve at least some of the desired properties and / or benefits of the subject matter or such individual features. Those skilled in the art will understand that the invention may be used with numerous modifications or variations to the structures, arrangements, proportions, materials, components, and other features used in the practice of the invention, which modifications or variations are particularly suitable for specific environments and operational requirements without departing from the principles, spirit, or scope of the invention. For example, an element shown as being integrally formed may be composed of multiple parts or elements that are shown as being integrally formed, the operation of an element may be reversed or otherwise varied, and the size or dimensions of an element may vary. Similarly, although operations or actions or procedures are described in a particular order, this should not be understood as requiring such a particular order or that all operations or actions or procedures must be performed to achieve the desired result. Additionally, other embodiments are also within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve the desired result. Therefore, the presently disclosed embodiments 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 preceding description or the specific embodiments or arrangements described or shown herein. In view of the foregoing, individual features of any embodiment may be used and may be claimed alone or in combination with 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 preceding description.

[0068] In the description above and in the claims below, 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 conjunctions and non-conjunctions in operation. The terms "one", "an", "the", "first", "second", etc. do not exclude a plurality. For example, the terms "one" or "an" entity as used herein refer to one or more of the entities. Therefore, the terms "one" (or "an"), "one or more", and "at least one" are used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally adopted in the sense of including "and / or" unless the content clearly indicates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected, unless the context clearly indicates otherwise, and the conjunction "or" includes one or other of the structures, components, features, etc. so connected, individually and in any combination and quantity, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, up, down, upward, downward, 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 invention and / or to distinguish areas of associated elements from one another and do not limit the associated elements, particularly the position, orientation, or use of the present invention. Unless otherwise indicated, connection references (e.g., attach, couple, connect, join, and combine) are to be interpreted broadly and may include intermediate members between a collection of elements and relative movement between elements. In this regard, connection references do not necessarily imply 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 imply importance or priority, but are used to distinguish one feature from another.

[0069] The following claims are hereby incorporated by this reference into the detailed description, with each claim standing on its own as a separate embodiment of the invention. In the claims, the terms "comprises," "comprising," "includes," and "including" do not exclude the presence of other elements, parts, features, groups, regions, integers, steps, operations, etc. Additionally, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not mean that a combination of features is not feasible and / or advantageous. Furthermore, singular references do not exclude the plural. Reference signs in the claims are provided merely as an example of clarification and should not be construed as limiting the scope of the claims in any way.

Claims

1. An actuatable member for a valve assembly of a medical device, the actuatable member having a proximal end and a distal end and comprising: a user engagement element along the proximal end of the actuatable member; as well as a shaft along the distal end of the actuatable member and movable relative to the user engagement element; in: The actuatable member is extendable through a valve well passage of a valve well of the medical valve assembly and is switchable between a first position and a second position along an actuation axis relative to the valve well passage; as well as Distal movement of the actuatable member toward the distal end of the valve well causes the valve shaft to move toward the user engagement element. 2 . The actuatable member of claim 1 , further comprising a biasing assembly coupling the user engagement element and the valve shaft.

3. An actuatable member according to claim 2, wherein the biasing assembly is configured to switch between an extended form and a retracted form, wherein in the extended form, the user engagement element and the valve shaft are spaced apart from each other by a first distance, and in the retracted form, the user engagement element and the valve shaft are spaced apart from each other by a second distance that is less than the first distance.

4. The actuatable member according to any one of claims 2 to 3, wherein the biasing assembly comprises a linkage assembly including a plurality of linkages pivotably coupled together between the user engagement element and the valve shaft.

5. The actuatable member of claim 4, wherein the plurality of links comprises: a proximal link having a proximal end and a distal end; as well as a distal link having a proximal end and a distal end; in: the proximal end of the proximal link coupled to the user engagement element; The distal end of the distal link is coupled to the valve shaft; and The distal end of the proximal link and the proximal end of the distal link are pivotally coupled relative to each other.

6. The actuatable member of any one of claims 3 to 5, further comprising a guide path positioned relative to the linkage assembly to guide a portion of the one or more linkages to move the linkages between the extended and compressed configurations.

7. An actuatable member according to claim 6, wherein the distal end of the proximal link and the proximal end of the distal link are guided relative to the guide path so as to move along a guide axis transverse to the actuation axis so that the link assembly switches between the expanded form and the contracted form.

8. The actuatable member of claim 3, wherein the biasing assembly comprises at least one link having a proximal end coupled to the user engagement element and a distal end coupled to the valve shaft.

9. The actuatable member according to claim 8, wherein: The at least one link is formed of an elastic material; and Distal movement of the user engagement element toward the distal end of the valve well causes the at least one link to flex and translate the valve shaft toward the proximal end of the valve well.

10. An actuatable member according to any one of claims 1 to 5, 8 or 9, wherein the biasing assembly includes a linkage assembly having two or more linkage arms and a rotating element, and the linkage arms are wrapped around the rotating element when the user engagement element and the valve shaft are moved toward each other.

11. An actuatable member according to any one of claims 1 to 9, wherein the user engagement element is biased away from the distal end of the valve well.

12. An actuatable member according to any one of claims 1 to 11, wherein: an axially extending port in fluid communication with the valve well passage along the actuation axis; a transversely extending port in fluid communication with the valve well passage in a direction transverse to the actuation axis; as well as Distal movement of the user engagement element switches the valve shaft from a position that blocks fluid communication between the axially extending port and the laterally extending port via the valve well passage to a position that allows fluid communication between the axially extending port and the laterally extending port via the valve well passage.

13. An actuatable member for a medical valve assembly, the actuatable member having a proximal end and a distal end and comprising: A valve shaft is extendable along an actuation axis within a valve well passage of a medical valve assembly between a closed position in which the valve shaft blocks fluid communication between an axially extending port and a transversely extending port in the valve well, and an open position in which the valve shaft moves out of the flow path between the axially extending port and the transversely extending port to allow fluid communication therebetween.

14. The actuatable member of claim 13, wherein: When the valve shaft is in the closed position, the valve shaft is positioned to block a flow path between the axially extending port and the transversely extending port; and When the valve shaft is in the open position, the valve shaft is positioned proximal to the transversely extending port and outside of the flow path between the axially extending port and the transversely extending port.

15. The actuatable member of claim 14, further comprising: a biasing assembly comprising one or more linkages coupling the user engagement element and the valve shaft; The linkage assembly is configured to switch between an extended configuration and a retracted configuration, wherein the extended configuration comprises a first distance between the user engagement element and the valve shaft, and wherein the retracted configuration comprises a second distance between the user engagement element and the valve shaft that is less than the first distance.