Devices, systems and methods for medical cleaning valves

Abstract

A medical cleaning valve (or cleaning valve) can be configured to provide a cleaning function to the air and water channels of an endoscope. One or more embodiments described herein may include a cleaning valve having features and / or components that are easy to distinguish from a surgical valve. In some embodiments, the valve can be made of a limited number of parts and materials to limit its cost. For example, multiple seals can be formed as a single component, such as via overmolding. In another example, a wiper seal can be used to accommodate larger manufacturing tolerances. In yet another example, the valve can have a single elastomeric component or spring cap that can combine the functions of multiple components (e.g., a protective cover, a spring, a spring housing, and a rod cap).

Description

[0001] Related Applications

[0002] This application claims the benefit of priority under 35 USC §119 to U.S. Provisional Application No. 62 / 844,465, filed on May 7, 2019, entitled “MEDICAL CLEAN VALVE,” the entire contents of which are incorporated herein by reference.

[0003] This application claims the benefit of priority under 35 USC §119 to U.S. Provisional Patent Application No. 62 / 923,197, filed on October 18, 2019, entitled “DEVICES, SYSTEMS, METHODS, AND DESIGNS FOR MEDICAL CLEAN VALVES,” the entire contents of which are incorporated herein by reference.

[0004] This application claims the benefit of priority under 35 USC §119 to U.S. Provisional Patent Application No. 63 / 002,759, filed on March 30, 2020, entitled “DEVICES, SYSTEMS, AND METHODS FOR MEDICAL CLEAN VALVES,” the entire contents of which are incorporated herein by reference. Technical Field

[0005] The present invention generally relates to valves for medical devices. In particular, the present invention relates to clean valves for medical devices. Background Art

[0006] Endoscopes include functions for delivering fluids (including air and water) to the surgical site and for suctioning the surgical site. Tubing for delivering fluids and / or suction extends from the handle of the endoscope, through the shaft of the endoscope and to the distal tip of the endoscope. During surgery, body fluids, tissues, or other materials may accumulate in the tubing. In order to help reprocess reusable endoscopes between surgeries, pretreatment is performed in the endoscope kit. For example, after the endoscope is removed from the patient, water or other fluids are flushed through the tubing to remove debris from the air / water and / or suction tubing. One option for completing this pretreatment is a reusable cleaning valve. This cleaning valve may include multiple components, including a valve stem (usually made of metal), multiple seals, a spring, a spring housing, a protective cover, and / or a stem cap. After the scope is removed from the patient and the surgical valve is removed from the valve barrel, the cleaning valve can be inserted into the air / water valve barrel (i.e., valve well) of the endoscope. The operator can then press the button of the cleaning valve for a predetermined amount of time (e.g., 30 seconds) to flush the air and / or water channels of the endoscope before further reprocessing the endoscope. A reusable cleaning valve must clean itself between uses, which increases reprocessing costs. An important aspect of a cleaning valve is that it is not confused with a surgical valve during surgery when the scope is inserted into a patient, and is not inadvertently used in place of the surgical valve. In view of all of the above considerations, the improvements of the present invention may be useful. Summary of the invention

[0007] In one aspect, the present invention relates to a valve for a medical device, comprising an interface member for a cleaning valve. The interface member may include a proximal end having a proximal surface, a distal end, one or more indicators, a first connector portion, and a second connector portion. The one or more indicators may distinguish an interface member for a cleaning valve from another interface member for a surgical valve. The first connector portion may be configured to couple with a valve stem of a cleaning valve, and the second connector portion may be configured to couple with a valve well for a cleaning valve. The one or more indicators may include a first indicator, which includes first and second raised surfaces on a proximal surface of the interface member. In many embodiments, the first raised surface surrounds the second raised surface. In many such embodiments, the first raised surface includes an exclamation mark and the second raised surface includes a geometric shape surrounding the exclamation mark. In other such embodiments, the geometric shape surrounding the exclamation mark includes a circle, a triangle, a square, a diamond, or a hexagon. In various embodiments, the first and second raised surfaces have a texture different from the proximal surface. In various such embodiments, the texture of the first or second raised surface includes a plurality of small protrusions, including one or more of a cone, a rod, a ridge, a ring, and a ridge. In some embodiments, the interface member includes a sticky surface. In some such embodiments, the first and second raised surfaces include a viscous material. In one or more embodiments, the interface member includes a spring portion between the first connector portion and the second connector portion. In many embodiments, the interface member is configured to be coupled to the valve stem via an interference fit. In various embodiments, the proximal surface and the first or second raised surface include different colors. Several embodiments include a second indicator that extends laterally from the interface member between the proximal and distal ends of the interface member. In several such embodiments, the second indicator includes a label. In another such embodiment, the label is integrally attached to the interface member. In some such embodiments, the second indicator includes a plurality of raised surfaces to convey that the interface member is used for cleaning.

[0008] In another aspect, the present invention relates to a cleaning valve for a medical device, comprising a valve stem, a plurality of seals, an interface member, and an indicator. The valve stem may include a proximal end, a distal end, one or more orifices, and a cavity in fluid communication with the one or more orifices. A plurality of seals may be positioned between the proximal and distal ends of the valve stem. At least one of the plurality of seals may be overmolded onto the valve stem. The interface member may be coupled to the proximal end of the valve stem. The indicator may distinguish between a cleaning valve and a surgical valve. In some embodiments, at least one seal comprises a first, second, and third seal. In various embodiments, at least one seal surrounds a first orifice in one or more orifices. In various such embodiments, the first orifice comprises a radial hole in the valve stem. In one or more embodiments, at least one seal blocks a second orifice in one or more orifices. In one or more such embodiments, the distal end of the valve stem comprises a second orifice. In many embodiments, the indicator is removably disposed around the valve stem and prevents the valve stem from being inserted into the valve well when disposed around the valve stem. In some embodiments, the indicator is removably inserted into the orifice of the valve stem and prevents the valve stem from being inserted into the valve well when inserted into the orifice of the valve stem.

[0009] In yet another aspect, the present invention relates to a valve for a medical device, comprising a valve stem, an interface member, and a first indicator. The interface member may include a proximal end having a proximal surface and a first connector portion and a second connector portion, the first connector portion being connectable to the valve stem. The first indicator may include one or more raised surfaces on the proximal surface of the interface member. In many embodiments, the one or more raised surfaces include numbers, symbols, geometric shapes, or a combination thereof. In some embodiments, the interface member includes a spring portion. In some such embodiments, the spring portion of the interface member includes an annular wall having a first portion, a second portion distal to the first portion, and a third portion distal to the second portion. In other such embodiments, the thickness of the annular wall at the second portion is less than the thickness at the first portion and the third portion. In other such embodiments, in response to a force applied to the proximal surface, the annular wall may expand radially outward at the second portion. In various embodiments, the second connector portion is disposed at the distal end of the interface member so that the second connector portion is separated from the valve stem. In various such embodiments, the second connector portion may be removably attached to the valve well of the endoscope. In one or more embodiments, in the attached form, the valve stem and the interface member are movable between a first form and a second form so that the valve stem is movable in the valve well of the endoscope. Several embodiments include one or more seals disposed along the valve stem. In many embodiments, the first connector portion of the interface member is configured to be coupled to the valve stem via an interference fit. In some embodiments, the proximal surface and one or more raised surfaces include different colors, textures, or materials, or a combination thereof. Various embodiments may include a second indicator extending laterally from the interface member. In various such embodiments, the second indicator includes a label. In some such embodiments, the label is integrally attached to the interface member. In other such embodiments, the label is removably attached to the interface member.

[0010] In yet another aspect, the present invention relates to a manufacturing method. The method may include forming a valve stem, the valve stem including a proximal end, a distal end, one or more orifices and a cavity in fluid communication with the one or more orifices. The method may include overmolding one or more seals onto the valve stem. The method may include connecting an interface member to the proximal end of the valve stem. The method may include removably coupling an indicator to the valve stem, which, when coupled to the valve stem, prevents the valve stem from being inserted into the valve well. In various embodiments, the method includes blocking at least one of the one or more orifices via overmolding one or more seals onto the valve stem. In many embodiments, the method includes forming an interface member from a viscous material and forming the valve stem from a non-viscous material. In several embodiments, the method includes forming a second indicator in the proximal end of the interface member.

[0011] In yet another aspect, the present invention is directed to a medical valve comprising an inner member and an outer member, the outer member comprising an annular wall having an inner surface defining a chamber configured to receive the inner member. The annular wall may have a first portion, a second portion distal to the first portion, and a third portion distal to the second portion. The thickness of the annular wall at the second portion may be less than the thickness at the first portion and the third portion.

[0012] Alternatively or additionally to the above features, any of the exemplary medical valves disclosed herein may have any of the following features. The outer member may be a single integral structure formed of a single material. The outer member may have a first form and a second form. In the second form, the outer member may have a shorter length along the longitudinal axis of the valve than in the first form. In the second form, the annular wall may protrude radially outward at a second portion of the annular wall. The outer member may be coupled to the inner member. The proximal end of the outer member may be coupled to the proximal end of the inner member, and the distal end of the outer member may be detachable from the inner member. The outer member may be releasably attached to the valve barrel of the endoscope. The inner member may be a valve stem. In the attached form, the medical valve may be movable between the first form and the second form so that the valve stem may be movable in the valve barrel. The inner member may be a single integral structure formed of a single material. The inner member may include a plurality of seals configured to form a slidable interference fit with the wall of the endoscope valve barrel so as to prevent fluid from passing between each of the plurality of seals and the wall of the endoscope valve barrel. The inner surface may taper from the first portion to the second portion and from the third portion to the second portion. The valve may consist of an inner member; an outer member; three distal seals; a proximal seal; and a one-way seal. The inner member may be a first single unitary structure formed of a single material. The outer member may be a second single unitary structure formed of a single material. The radially outer surface of the inner member may include a first hole and a second hole. The inner member may include a cavity extending along the longitudinal axis of the valve. The cavity may be in fluid communication with the first hole and the second hole. The first hole may be between the proximal seal and the one-way seal. The second hole may be between the first of the three distal seals and the second of the three distal seals. The first hole may be located at the proximal end of the cavity. The second hole may be located at the distal end of the cavity. The one-way seal may be proximal to the three distal seals.

[0013] In yet another aspect, the present invention relates to a medical valve comprising: an inner member; and an outer member defining a chamber for receiving the inner member. A proximal portion of the outer member can be coupled to the inner member. A distal portion of the outer member can be releasably attached to an endoscope valve barrel. The outer member can be a single unitary structure formed of a single material. In response to applying a force to an end of the outer member, the outer member can be transformed from a first configuration to a second configuration that is radially expanded relative to the first configuration.

[0014] Alternatively or additionally to the above features, any of the exemplary medical valves disclosed herein may have any of the following features. The internal member may be a valve stem. In the attached form, the medical valve may be movable between a first form and a second form so that the valve stem may be movable in the valve barrel. The external member may include an annular wall having a first portion distal to the proximal portion, a second portion distal to the first portion, and a third portion distal to the second portion. The third portion may be proximal to the distal portion. The thickness of the second portion may be less than the thickness of both the first portion and the third portion. The internal member may be a single integral structure formed from a single material. The internal member may include a plurality of seals configured to form a slidable interference fit with the wall of the endoscope valve barrel so that fluid does not pass between each of the plurality of seals and the wall of the endoscope valve barrel. The external member may be biased to the first form.

[0015] In yet another aspect, the present invention relates to a medical valve comprising: an inner member formed as a valve stem; a plurality of seals disposed along the valve stem; and an outer member comprising an annular wall having an inner surface defining a chamber configured to receive the inner member. The annular wall may have portions of different thicknesses such that the annular wall may bend at a predetermined position when the outer member is converted from an uncompressed configuration to a compressed configuration. The outer member may be biased toward the uncompressed configuration.

[0016] Alternatively or additionally to the above features, any of the exemplary medical valves disclosed herein may have any of the following features. The annular wall may have a first portion, a second portion distal to the first portion, and a third portion distal to the second portion. The distance between the inner surface and the outer surface may be smaller at the second portion than at both the first portion and the third portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings which are schematic and are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is generally represented by a single numeral. For clarity, not every component is labeled in every figure, and not every component of every embodiment is shown without necessary description for one skilled in the art to understand the present invention. In the drawings:

[0018] Figures 1A to 1H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view are respectively shown of an exemplary embodiment of a medical clean valve assembly according to the present invention described herein.

[0019] Figures 2A to 2HA first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view are respectively shown of an exemplary embodiment of a medical clean valve assembly according to the present invention described herein.

[0020] Figures 3A to 3H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view are respectively shown of an exemplary embodiment of a medical clean valve assembly according to the present invention described herein.

[0021] Figures 4A to 4H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view are respectively shown of an exemplary embodiment of a medical clean valve assembly according to the present invention described herein.

[0022] Figures 5A to 5H A first perspective view, a left side view, a front view, a rear view, a right side view, a top view, a bottom view, and a second perspective view are respectively shown of an exemplary embodiment of a medical clean valve assembly according to the present invention described herein.

[0023] Figures 6A to 6H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view are respectively shown of an exemplary embodiment of a medical clean valve assembly according to the present invention described herein.

[0024] Figures 7A to 7H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view are respectively shown of an exemplary embodiment of a medical clean valve assembly according to the present invention described herein.

[0025] Figure 8 Shown is a perspective view of a first exemplary valve according to the invention described herein.

[0026] Fig. 9 and 10 The invention described herein is shown Figure 8 A cross-sectional view of a first exemplary valve.

[0027] Fig.11 and 12 Shown is a cross-sectional view of a second exemplary valve according to the inventions described herein.

[0028] Fig.13 and 14 Shown is a cross-sectional view of a third exemplary valve according to the inventions described herein.

[0029] Fig.15 Various aspects of an exemplary cleaning valve assembly according to the invention described herein are shown.

[0030] Fig.16 Various aspects of exemplary interface components according to the invention described herein are shown.

[0031] Fig.17 Various aspects of an exemplary valve stem according to the invention described herein are shown.

[0032] Fig.18 Various aspects of an exemplary one-way seal according to the invention described herein are shown.

[0033] Fig.19 Various aspects of an exemplary valve stem assembly according to the invention described herein are shown.

[0034] Fig. 20 Various aspects of an exemplary valve stem according to the invention described herein are shown.

[0035] Fig.21A and 21B Various aspects of exemplary seals according to the invention described herein are shown.

[0036] Fig.22A and 22B Various aspects of exemplary seals according to the invention described herein are shown.

[0037] Fig.23 Various aspects of an exemplary valve stem according to the invention described herein are shown. DETAILED DESCRIPTION

[0038] A medical cleaning valve (or cleaning valve) can be configured to provide a cleaning function to the air and water channels of an endoscope. In a first form, the cleaning valve can provide a continuous supply of air to both the air and water channels in the handle and shaft of the endoscope, and through an air / water nozzle at the distal end of the endoscope. In a second form, the cleaning valve can supply water to the air channels in the handle and shaft of the endoscope, and through an air nozzle at the distal end of the endoscope. Oftentimes, the cleaning valve can have an appearance similar to a surgical valve. However, using a cleaning valve instead of a surgical valve may result in fluid flow through an incorrect endoscope channel, for example, liquid is delivered through the air channel. Therefore, one or more embodiments described herein may include a cleaning valve having features and / or components that facilitate distinguishing it from a surgical valve. In at least some embodiments, the cleaning valve (or valve) may be suitable for single use and therefore disposable. Therefore, the valve can be made of a limited number of parts and materials, for example, to limit its cost so that it can be economically disposable. For example, multiple seals can be formed as a single component, such as via overmolding. In another example, a wiper seal can be used to accommodate greater manufacturing tolerances. In yet another example, the valve can have a single elastomeric component or spring cap that can combine and simplify the functions of multiple components (e.g., a boot, spring, spring housing, and stem cap).

[0039] It is understood that the disclosure included herein is exemplary and illustrative only, not restrictive. As used herein, the terms "include", "comprise" or any other variation thereof are intended to cover non-exclusive contents, so that a process, method, article or device including a list of elements includes not only those elements, but may include other elements that are not explicitly listed or are not inherent to such a process, method, article or device. The term "exemplary" is used in the sense of "example" rather than "exemplary". As used herein, the term "proximal" refers to the direction closer to the surface (e.g., interface member, user interface, button) used by the operator to operate the valve, and the term "distal" refers to the direction away from the surface (e.g., button) used by the operator to operate the valve. Although an endoscope is cited in this article, the reference to an endoscope or endoscopic examination should not be interpreted as limiting the possible applications of the disclosed aspects. For example, the disclosed aspects can be used with a duodenoscope, a bronchoscope, a ureteroscope, a colonoscope, a catheter, a diagnostic or therapeutic tool or device, or other types of medical devices.

[0040] Reference is now made to the accompanying drawings, in which the same reference numerals are used throughout to refer to the same elements. In the following description, for the purpose of explanation, many specific details are set forth to provide a thorough understanding thereof. However, it is apparent that novel embodiments can be practiced without these specific details. In other cases, well-known structures and devices are shown in block diagram form to facilitate description thereof. It is intended to cover all modifications, equivalents, and substitutes that fall within the scope of the claims.

[0041] Figures 1A to 7H Various aspects and / or components of a cleaning valve assembly (or cleaning valve) according to the present invention described herein are shown. More specifically, Figures 1A to 1H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view of the cleaning valve assembly 102 are respectively shown; Figures 2A to 2H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view of the cleaning valve assembly 202 are respectively shown; Figures 3A to 3H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view of a cleaning valve assembly 302 are respectively shown; Figures 4A to 4H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view of a cleaning valve assembly 402 are respectively shown; Figures 5A to 5H A first perspective view, a left side view, a front view, a rear view, a right side view, a top view, a bottom view, and a second perspective view of a cleaning valve assembly 502 are respectively shown; Figures 6A to 6H A first perspective view, a front view, a rear view, a right side view, a left side view, a top view, a bottom view, and a second perspective view of a cleaning valve assembly 602 are shown, respectively; and Figures 7A to 7H A first stereogram, a front view, a rear view, a right view, a left view, a top view, a bottom view, and a second stereogram of a cleaning valve assembly 702 are shown, respectively. One or more of the cleaning valves disclosed herein may include features and / or components that facilitate distinction from a surgical valve (i.e., a valve used in an operation performed on a patient). In addition, the features and / or components described herein may be used in any combination to distinguish from a surgical valve. For example, the feel and / or look may be different from a surgical valve, including differences in shape, color, material, and other visual and / or tactile indicators. In another example, additional components, such as indicators, may be included to distinguish from a surgical valve. The embodiments are not limited to this context.

[0042] The feel of the valve may be important for the user to identify the valve as something that is adjusted for use in surgery or whether the valve is something that feels essentially different from what they are used to. Often, different valves (air and water valves and suction valves) are designed to look or feel basically similar. This can be done so that the physician cannot explain the tactile differences between the different available valves. However, this may cause confusion between the cleaning valve and the surgical valve, which may lead to unfavorable results. Therefore, the embodiments described herein can have a feeling that is essentially different from the surgical valve for the user, so as to minimize potential incorrect use, for example, to make it clear to the user whether the operation was started with a cleaning valve instead of a surgical air / water valve in the air / water valve well. In various embodiments, the interface member or user interface portion of the valve (e.g., a button or spring cap) can be made of essentially different materials. For example, a soft, sticky and / or flexible material such as a silicone elastomer or a thermoplastic elastomer (TPE) can form a soft and / or sticky user interface surface of a valve that interacts with a user (e.g., a user's finger / hand). In such an example, this soft, sticky and / or flexible feel can distinguish the cleaning valve from the rigid molded plastic valve button of the surgical valve. In various embodiments, the soft, sticky and / or flexible feel can be applied to selective components of the cleaning valve. For example, a first raised surface can be sticky, a second raised surface can have a rough texture, and another surface can be smooth.

[0043] In many embodiments, features may be added to the user interface of the valve to differentiate the feel of the valve when compared to a surgical valve. Surgical valves typically have a smooth, flat, circular user interface surface that interacts with the user when the valve is pressed. However, one or more embodiments described herein may have a user interface surface that feels substantially different when the valve is pressed. For example, the user interface surface may include a plurality of small protrusions from the surface in the form of cones, rods, bumps, rings, ridges, or any other three-dimensional textured surface that can cause the user to notice that they are not pressing a smooth surface.

[0044] In several embodiments, an interface member or user interface (e.g., a button or spring cap) can be shaped to differentiate the feel of a cleaning valve when compared to a surgical valve. For example, the user interface can include a geometric shape to interact with the user that has distinct corners that can be felt during pressing the user interface, such as a circle, triangle, square, diamond, hexagon, or any other shape that would have a different or distinct edge when compared to a circle. These shapes, when pressed, may feel substantially different than a round button used on a surgical valve with a smooth radius on the edge of the valve.

[0045] In some embodiments, the size of the user interface (e.g., a button or spring cap) can be designed to facilitate differentiation from a surgical valve. Many surgical valves have a diameter of about half an inch on the user interface surface (e.g., the proximal side of the button). However, making the size of the user interface surface that the user presses much larger or smaller can allow the user to notice the size difference of the surface that he presses, further distinguishing the cleaning valve from the surgical valve. The size difference can include one or more of the surface area of ​​the user interface surface that is pressed, and the height of the surface located above the endoscope handle when inserted into the air / water well. For example, a much shorter or much taller surface may require the user to move their hands / fingers in a way that they are not accustomed to in order to operate the valve, thereby making them notice again the fact that this is not a typical surgical valve. In order to achieve optimal differentiation, the valve can include any combination of the above-mentioned features and / or technologies to distinguish the look and / or feel of the cleaning valve from the surgical valve.

[0046] In several embodiments, the look or appearance of the cleansing valve can be used to differentiate the feel of the valve when compared to a surgical valve. Many surgical valves are primarily an all-black button with a cylindrical collar that snaps onto the valve well and a cylindrical button with a flat button surface. By significantly changing the appearance of the cleansing valve from the surgical valve, the user may better notice the cleansing valve when the user sees the cleansing valve inserted into the air / water valve well of the endoscope handle. The appearance of the cleansing valve can be differentiated by including one or more of the following.

[0047] In some embodiments, the color selection of one or more components of the cleaning valve can be used to distinguish the appearance of the cleaning valve when compared to the surgical valve. In many embodiments, the color can be selected to provide a contrast with the black endoscope handle and / or a black surgical valve that blends in with the endoscope handle. For example, using one or more bright or neon colors such as yellow, orange, red, and pink on one or more components of the cleaning valve assembly can be used to visually distinguish the valve. In another example, a transparent or "natural" silicone elastomer color or TPE color can be used. When looking at the valve in the endoscope handle, this transparent color can leave a translucent appearance that can be clearly noticed. In some embodiments, a reflective or shiny surface can be used.

[0048] Differentiating Valves by Feel Valves can also be differentiated by look. For example, changing the shape of a valve user interface (e.g., a button or spring cap) from a circle to some other geometric shape would allow for visual differentiation in addition to feel differentiation, especially when combined with significantly different colors / patterns as described above. Making the interface a triangle, square, diamond, hexagon, or any other shape with sharp edges can provide visual and tactile differentiation of the valve from a round surgical valve.

[0049] Typically, the air / water and suction surgical valves used (whether disposable or reusable versions) can have the same combination of button surfaces to be pressed that slide inside the collar assembly attached to the mirror. By changing this configuration so that there are no longer the same two components with the same type of interaction, it can also help to distinguish the cleaning valve from the surgical valve. In various embodiments, the way the switch button assembly and the collar assembly interact can be used to distinguish the valve. For example, the button can be a skirt that slides over the outside of the collar assembly. In such an example, this may significantly change the overall shape of the user interface compared to the button of the surgical valve. In some embodiments, the interaction of the shape and components can be changed to completely eliminate the separate button and collar assembly, such as by having a single seamless spring cap connected to the valve well and the top of the valve stem that completely closes the entire valve from the outside. This, together with soft flexible materials and / or different colors, can significantly distinguish the valve from the surgical valve.

[0050] In several embodiments, some type of indicator (e.g., a warning) may be included in or on the valve. For example, including a warning on the valve to distinguish a cleaning valve from a surgical valve may include pad printing or laser etching the warning onto a user interface (e.g., a spring cap or button) or an exposed surface of the cleaning valve during use. Alternatively or in addition, a warning label may be embossed on the side of the user interface (e.g., a spring cap or button), thereby providing a warning that protrudes from the side of the valve and can be felt and clearly visible during use. This may be located on the side of the valve, or on the top surface, forcing the user to feel the warning when they press the valve. In Figure 1A Alternatively or additionally, the warning label may be molded into the interface member and integrally attached as part of the assembly, such as Figure 2A and 3A In some embodiments, the label may be removably attached to the interface member. It should be understood that the text and / or symbols may vary (as long as it helps to distinguish it from the surgical valve) without departing from the scope of the present invention.

[0051] In addition or alternatively to the cap color change, the color of one or more other components can be changed to distinguish from the surgical valve. For example, the valve stem color can be significantly different from the surgical valve stem. In some embodiments, the seal color can be a bright color (e.g., yellow) on the stem, or any other color combination that draws the user's attention to the fact that the valve is for cleaning. Similarly, the color or pattern of the valve stem itself can be significantly different from the surgical valve, which may be the natural color of stainless steel. In various embodiments, a combination of a natural color elastomeric spring cap with a natural color seal and a yellow stem can be used, but any different combination, such as a yellow stem and seal, a blue seal and a yellow stem, a pink stem and a yellow seal, etc., can also be used. Additionally, the cap can have a raised feature molded therein, such as circumferentially around its base, and / or circumferentially with pad printing, which carries text indicating a warning or some type of instructions for use. In many embodiments, the user may be able to read the warning on the cap without actually having a separate warning label attached, because it will be directly printed or visible as part of the cap itself.

[0052] In many embodiments, there may be an additional component that slides over or is removably attached to the sealing end of the valve stem in a package that has a shape that prevents the valve from being inserted into the valve well of an endoscope without first removing the additional component. See e.g. Figures 4A to 7H In many embodiments, a portion of the assembly can be inserted through a radial hole, aperture, or hole in the valve stem. See, e.g. Figures 4A to 4H In various embodiments, the assembly can be clamped to the valve stem. See, e.g. Figures 5A to 5H In some embodiments, the assembly may be hollow, having an inner diameter large enough to slide over the end of the valve stem, and an outer diameter large enough so that it has an interference fit with the valve well on the endoscope so that it cannot be inserted. See, e.g. Figures 6A to 7H .

[0053] In various embodiments, the component can be a molded component made of a brightly colored material to further draw attention to it. In many embodiments, it must be removed from the valve before the valve can be inserted into the endoscope. This can ensure that the user must complete additional steps before being able to insert the cleaning valve into the endoscope, further calling attention to the fact that the valve is not a surgical valve. The component can also be a clip-on component that clamps onto the valve stem from the side, which can again cause interference with the valve well if the user attempts to insert the valve before it is removed. Clip labels or labels that slide over the end of the valve stem (i.e., cylindrical labels) can also have a molded label that breaks away from the side with embossed or pad printed letters. See, e.g. Fig. 6AIn some embodiments, this wording may also act as a warning label, not only informing the user of the intended "cleaning" use, but also requiring the user to remove the warning prior to inserting the valve well, thereby forcing the user to focus on it for a period of time before attempting to insert the valve into the scope.

[0054] Specific reference Figure 1A , the cleaning valve assembly 102 (or cleaning valve 102) can include an interface member 104 having a first indicator 108, a valve stem 106, a proximal end 145, and a distal end 155. In various embodiments, the cleaning valve assembly 102 or one or more of its components can be the same or similar to other cleaning valve assemblies or one or more of their components described herein. For example, the cleaning valve assembly 102 can be similar to Fig.15 145 and the distal end 155. The cleaning valve assembly 1502 of the present invention is the same or similar. It should be understood that the orientation of other cleaning valves and / or cleaning valve assemblies described herein will be consistent with the orientation of the cleaning valve 102 relative to the proximal end 145 and the distal end 155. The interface member 104 may include a proximal surface 111-1 and a radial surface 111-2. The proximal surface 111-1 of the interface member 104 may include an indicator 108, which includes raised surfaces 112-1, 112-2. More generally, the indicators described herein may include one or more raised surfaces having various features (e.g., texture, color, viscosity, etc.) configured to distinguish a cleaning valve from a surgical valve.

[0055] In the indicator 108, the raised surface 112-2 can surround the raised surface 112-1. In one or more embodiments, the raised surface 112-1 can be a symbol and the raised surface 112-2 can be a geometric shape surrounding the symbol, such as a triangle, square, diamond, hexagon, or similar shape. For example, the raised surface 112-1 can be an exclamation point and the raised surface 112-2 can be a triangle surrounding the exclamation point. In various embodiments, one or more of the proximal surface 111-1, the radial surface 111-2, and the raised surface 112 can include one or more textures to distinguish the cleaning valve 102 from the surgical valve. For example, the proximal surface 111-1 and the radial surface 111-2 can be smooth, while the raised surface 112-1 has a texture including a plurality of cones and the raised surface 112-2 has a texture including a plurality of protrusions. Additionally or alternatively, one or more of the surfaces can include a viscous material. For example, the raised surface 112 may be adhesive while the proximal and radial surfaces 111 - 1 , 111 - 2 have non-adhesive surfaces.

[0056] Specific reference Figure 2A, the cleaning valve assembly 202 (or cleaning valve 202) can include an interface member 204 having an indicator 208 and a valve stem 206. In various embodiments, the cleaning valve assembly 202 or one or more of its components can be the same or similar to other cleaning valve assemblies or one or more of their components described herein. For example, the cleaning valve assembly 202 can be similar to Figure 8 The valve 10 of the embodiment of the present invention is the same or similar to that of the embodiment of the present invention. Although not labeled, the interface member 204 may also include a proximal surface and a radial surface similar to the interface member 104. The indicator 208 may include a label 210 having raised surfaces 212-1, 212-2. The indicator 208 may be integrally attached to the interface member 204 (e.g., molded together with it). In many embodiments, the indicator 208 extends laterally from the interface member 204 between the distal end and the proximal end of the interface member 204. For example, in the illustrated embodiment, the indicator 208 extends laterally from the interface member 204 immediately adjacent to the junction of the proximal surface and the radial surface. In some embodiments, the indicator and / or label may extend horizontally, proximally, distally, or at any angle in between from the proximal surface and / or radial surface of the interface member.

[0057] Specific reference Figure 3A , the cleaning valve assembly 302 (or cleaning valve 302) can include an interface member 304 having an indicator 308 and a valve stem 306. In various embodiments, the cleaning valve assembly 302 or one or more of its components can be the same or similar to other cleaning valve assemblies or one or more of their components described herein. For example, the valve stem 306 can be similar to Fig.19 The interface member 304 may be the same or similar to the valve stem 1906 of the interface member 104. Although not labeled, the interface member 304 may also include a proximal surface and a radial surface similar to the interface member 104. The interface member 304 may include an indicator 308, which includes a label 310 having a plurality of raised surfaces (e.g., each letter may be considered a separate raised surface). The indicator 308 may be integrally attached to the interface member 304 (e.g., molded therewith). In many embodiments, the indicator 308 extends laterally from the interface member 304 between the distal end and the proximal end of the interface member 304. For example, in the illustrated embodiment, the indicator 308 extends laterally from the interface member 304 at the junction of the proximal surface and the radial surface.

[0058] Specific reference Figure 4A and 4B , the cleaning valve assembly 402 (or cleaning valve 402) can include an interface member 404 having a first indicator 408-1, a valve stem 406, and a second indicator 408-2. In various embodiments, the cleaning valve assembly 402 or one or more of its components can be the same or similar to other cleaning valve assemblies or one or more of their components described herein. For example, the interface member 404 can be similar to Figure 1AThe interface member 104 is the same or similar to the interface member 104. As mentioned previously, the cleaning valve assembly 402 can include a first indicator 408-1 and a second indicator 408-2. The first indicator 408-1 can be Figure 1A The second indicator 408-2 may include a label 410 having multiple raised surfaces (e.g., each letter may be considered a separate raised surface) and a clip 414. In many embodiments, the clip 414 is inserted through a radial hole, orifice, or hole in the valve stem. In many such embodiments, the second indicator 408-2 may prevent the cleaning valve 402 from being inserted into the valve well without removing the indicator 408-2. The clip 414 may include two arms that may be deflected inwardly to allow insertion through the orifice. Once the clip 414 is inserted through the orifice, the arms may be deflected back outwardly to hold the clip 414 in place (see, e.g., Figure 4B ).

[0059] Specific reference Figure 5A and 5B , the cleaning valve assembly 502 (or cleaning valve 502) can include an interface member 504 having a first indicator 508-1, a valve stem 506, and a second indicator 508-2. In various embodiments, the cleaning valve assembly 502 or one or more of its components can be the same or similar to other cleaning valve assemblies or one or more of their components described herein. For example, the cleaning valve assembly 502 can be similar to Fig.11 As previously mentioned, the cleaning valve assembly 502 may include a first indicator 508-1 and a second indicator 508-2. The first indicator 508-1 may be the same as or similar to the valve 100 of FIG. Figure 1A The second indicator 508-2 may include a label 510 having a plurality of raised surfaces (e.g., each letter may be considered a separate raised surface) and a clip 514. In many embodiments, the clip 514 is coupled around a portion of the valve stem 514. In many such embodiments, the second indicator 508-2 may prevent the cleaning valve 502 from being inserted into the valve well without removing the indicator 508-2. The clip 514 may include two arms that may be deflected outward to allow coupling around a portion of the valve stem 514. Once the clip 514 is coupled around the valve stem 514, the arms may be deflected back inward to keep the clip 514 coupled to the valve stem 514 (see, e.g., Figure 5B 514-1, 514-2).

[0060] Specific reference Fig. 6A, the cleaning valve assembly 602 (or cleaning valve 602) can include an interface member 604 having a first indicator 608-1, a valve stem 606, and a second indicator 608-2. In various embodiments, the cleaning valve assembly 602 or one or more of its components can be the same or similar to other cleaning valve assemblies or one or more of their components described herein. For example, the valve stem 606 can be connected to Fig.15 As previously mentioned, the cleaning valve assembly 602 can include a first indicator 608-1 and a second indicator 608-2. The first indicator 608-1 can be the same as or similar to the valve stem 1506 of FIG. Figure 1A The second indicator 608-2 may be the same as the indicator 108. The second indicator 608-2 may include a barrel 616 and a label 610 having a plurality of raised surfaces (eg, each letter may be considered a separate raised surface).

[0061] In many embodiments, the barrel 616 can slide on a portion of the valve stem 606. In many such embodiments, the second indicator 608-2 can prevent the cleaning valve 602 from being inserted into the valve well without removing the indicator 608-2. The barrel 616 can have an inner diameter that is substantially the same as the maximum outer diameter of the distal portion of the valve stem 606. In some embodiments, there may be a slight interference fit between the barrel 616 and the valve stem 606. For example, a slight interference fit can prevent the barrel 616 from sliding off the valve stem 606 without external force. In various embodiments, the label 610 can be integrally formed with the barrel 616. In the illustrated embodiment, the label 610 extends radially from the barrel 616 along the entire length of the barrel 616. In some embodiments, the indicator and / or label can extend horizontally, proximally, distally, or at any angle in between from any portion of the barrel 616. For example, the label 610 can extend distally from the distal end of the barrel 616.

[0062] Specific reference Fig. 7A , the cleaning valve assembly 702 (or cleaning valve 702) can include an interface member 704 having a first indicator 708-1, a valve stem 706, and a second indicator 708-2. In various embodiments, the cleaning valve assembly 702 or one or more of its components can be the same or similar to other cleaning valve assemblies or one or more of their components described herein. For example, the cleaning valve assembly 702 can be similar to Fig.15 The cleaning valve assembly 1502 is the same or similar to the cleaning valve assembly 1502. As mentioned previously, the cleaning valve assembly 702 may include a first indicator 708-1 and a second indicator 708-2. The first indicator 708-1 may be Figure 1AThe second indicator 708-2 may include a barrel 716 having a plurality of raised surfaces (e.g., each letter may be considered a separate raised surface). In many embodiments, the barrel 716 may slide over a portion of the valve stem 706. In many such embodiments, the second indicator 708-2 may prevent the cleaning valve 702 from being inserted into the valve well without removing the indicator 708-2. The barrel 716 may have an inner diameter that is substantially the same as the maximum outer diameter of the distal portion of the valve stem 706. In some embodiments, there may be a slight interference fit between the barrel 716 and the valve stem 706. For example, a slight interference fit may prevent the barrel 716 from sliding off the valve stem 706 without an external force.

[0063] Figures 8 to 14 Exemplary medical cleaning valves, assemblies and systems according to the present invention described herein are shown. In many embodiments, Figures 1A to 7H One or more components of the medical clean valve assembly may be different in structure, function and / or appearance from those related to Figures 8 to 14 One or more of the above-mentioned features for distinguishing surgical valves may be incorporated into Figures 8 to 14 The embodiments are not limited in this context.

[0064] Figure 8 A perspective view of an exemplary cleaning valve 10 (or cleaning valve assembly 10 ) is shown. Fig. 9 shows a cross-sectional view of the valve 10 in a first configuration, and Fig.10 A cross-sectional view of the valve 10 is shown in a second configuration. Fig. 9 and Fig.10 A valve 10 is shown inserted into an endoscope valve barrel (i.e., a valve well) in an endoscope handle. The valve 10 can have a proximal end 12 and a distal end 14. An inner cylindrical member 16 can extend from the proximal end 12 to the distal end 14. An outer cylindrical member 18 can be disposed around the inner cylindrical member 16 at the proximal end 12. In the illustrated embodiment, one or more portions of the outer cylindrical member 18 and the inner cylindrical member 16 can form an interface member. For example, the proximal end 12 of the inner cylindrical member 16 can include a first portion of the interface member, and the outer cylindrical member 18 can include a second portion of the interface member. In addition, in some embodiments, the distal end of the inner cylindrical member 16 can include one or more indicators. In many embodiments, the inner cylindrical member 16 can include and / or be referred to as a valve stem.

[0065] The inner cylindrical member 16 can be, for example, a valve stem. The inner cylindrical member 16 can be a single integral structure formed by a single continuous piece of material, and can be made of metal (e.g., stainless steel, titanium, aluminum, alloys, etc.), polymers (e.g., polycarbonate, acrylonitrile butadiene styrene (ABS), high-density polyethylene (HDPE), nylon, polyetheretherketone (PEEK), thermoplastics, plastics, etc.), or any other suitable material. Depending on the material used, the inner cylindrical member 16 can be machined, injection molded, extruded (via, for example, 3D printing), or otherwise formed. The inner cylindrical member 16 can be formed of a transparent thermoplastic so that certain portions of the interior of the inner cylindrical member 16 are visible through the outer wall of the inner cylindrical member.

[0066] The inner cylindrical member 16 can have a first lumen 22 extending at least partially through the inner cylindrical member 16 along the central longitudinal axis (see, e.g., Fig. 9 and 10 ). Alternatively, the first cavity 22 can extend through another longitudinal axis of the inner cylindrical member 16 (e.g., the first cavity 22 can be eccentric). The space between the outer surface of the inner cylindrical member 16 and the surface defining the first cavity 22 can be solid, and the first cavity 22 can be a hole formed in the inner cylindrical member 16. In another example, the space between the outer surface of the inner cylindrical member 16 and the surface defining the first cavity 22 can be hollow. In this case, the first cavity 22 can be formed by a longitudinal tube within the inner cylindrical member 16.

[0067] The first lumen 22 can be open to the exterior of the inner cylindrical member 16 at the proximal end of the first lumen 22 via one or more proximal apertures 24. For example, the first lumen 22 can be fluidly connected to the proximal apertures 24 via a second proximal lumen (not shown) that can be transverse to the first lumen 22. For example, the second lumen can be perpendicular to the first lumen 22 (extending to Fig. 9 The first lumen 22 may open to an outer region of the inner cylindrical member 16 via one or more distal apertures 26 at the distal end of the first lumen 22. The first lumen 22 may be fluidly connected to the distal apertures 26 via a third distal lumen (not shown) that may be transverse to the first lumen 22. For example, the third distal lumen may be perpendicular to the first lumen 22 (extending to Fig. 9 In some embodiments described herein, the hole can be used interchangeably with the orifice. In addition, in one or more embodiments described herein, the inner cylindrical member can be used interchangeably with the valve stem. Thus, for example, the hole of the inner cylindrical member can be equivalent to the orifice of the valve stem.

[0068] The inner cylindrical member 16 may be provided with a first distal seal 32, a second distal seal 34, and a third distal seal 36. The distal seals 32, 34, 36 may be made of an elastomeric material. The distal seals 32, 34, 36 may be identical to one another and may be, for example, an O-ring. In some embodiments, the distal seal may be formed as a disc so that the edge of the disc seal may contact the valve well and conform to it to form a seal. The disc or "wiper" seal may accommodate greater manufacturing tolerances. The distal seals 32, 34, 36 may be provided in a circumferential, annular groove or recess on the inner cylindrical member 16 along the central longitudinal axis and spaced apart by a distance "D". The distance "D" between each of the distal seals 32, 34, 36 may be the same, however, the distance may be different and / or may be separated from one another for any distance for sealing the valve 10. The outer surfaces of the distal seals 32, 34, 36 can be configured to have certain dimensions and / or the seals 32, 34, and 36 can be made of materials and / or have characteristics (such as, appropriate hardness values) so that when the valve 10 is inserted into the endoscope valve barrel 39, the distal seals 32, 34, 36 are in contact with the inner wall 38 of the endoscope valve barrel 39 (see, for example, Fig. 9 and 10 ) have an interference fit. The interference fit can be loose enough so that the inner cylindrical member 16 can slideably move relative to the wall 38 in response to the application of force (e.g., a user inserting / removing the endoscope valve barrel 39), but tight enough so that the valve 10 remains stationary in the endoscope valve barrel 39 and fluid cannot flow longitudinally between the radially outermost surfaces of the seals 32, 34, 36 and the wall 38. The third distal seal 36 can be disposed proximal to the distal end 14 of the valve 10 and distal to the distal aperture 26. The second distal seal 34 can be proximal to the third distal seal 36 and proximal to the distal aperture 26. The first distal seal 32 can be proximal to the second distal seal 34, but still distal to the proximal aperture 24.

[0069] refer to Fig. 9 and 10 , a proximal seal 42 may also be disposed on the inner cylindrical member 16. The proximal seal 42 may have any of the characteristics of the distal seals 32, 34, 36. For example, the proximal seal 42 may be an elastomeric O-ring and may be disposed in an annular circumferential groove or recess of the inner cylindrical member 16. The size and / or material of the outer surface of the proximal seal 42 may be configured such that when the valve 10 is inserted into the endoscope valve barrel 39, the proximal seal 42 has an interference fit with the wall 38 (see Fig. 9 and 10). The interference fit can be loose enough so that the inner cylindrical member 16 can slidably move relative to the endoscope valve barrel wall 38 in response to the application of force (e.g., insertion / removal of the endoscope valve barrel 39 by a user); but tight enough so that the valve 10 remains stationary in the endoscope valve barrel 39 and fluid cannot flow longitudinally between the radially outermost surface of the seal 42 and the wall 38. Due to the wider diameter of the inner cylindrical member 16 at the location of the proximal seal 42, the proximal seal 42 can have a larger inner diameter than the distal seals 32, 34, 36. Due to the wider space defined by the wall 38 at the location of the seal 42 compared to the space defined by the wall 38 at the location of the seals 32, 34, 36, the proximal seal 42 can have a larger outer diameter than the distal seals 32, 34, 36.

[0070] The inner cylindrical member 16 can also be equipped with a one-way seal 62, which can be arranged between the first distal seal 32 and the proximal seal 42. The one-way seal 62 can be formed of an elastic material and can be annular, having an inner surface and an outer surface. The one-way seal 62 can be stretchable so that the central opening of the one-way seal 62 can be expanded to be fitted on the inner cylindrical member 16. The one-way seal 62 can be arranged in a groove or recess of the inner cylindrical member 16. The size of the inner surface of the one-way seal 62 can be arranged so that there is a slight interference between the outer surface of the inner cylindrical member 16 and the inner surface of the one-way seal 62, so that a tight seal is formed. The size of the outer diameter of the one-way seal 62 can be arranged to form a slight interference fit with the wall 38. The thin flap 63 of the one-way seal 62 can extend radially outward from the inner cylindrical member 16 at an angle transverse to the longitudinal axis of the inner cylindrical member 16. For example, the thin flaps can extend at an angle between 10 and 80 degrees relative to the longitudinal axis of the inner cylindrical member 16. The flaps of the one-way seal 62 can be expandable so that when a fluid (e.g., water or air) moves in a distal direction, the positive pressure will expand the flaps, thereby maintaining the seal between the one-way seal 62 and the wall 38. The fluid moving proximally will also create a positive pressure, but the positive pressure will generate a force orthogonal to the longitudinal axis of the inner cylindrical member 16 to radially compress the flaps of the one-way seal 62 toward the inner cylindrical member 16. Thus, the fluid (e.g., air or water) is allowed to move proximally between the one-way seal 62 and the wall 38 past the one-way seal 62.

[0071] The proximal aperture 24 may be disposed between the one-way seal 62 and the proximal seal 42. The distal aperture 26 may be disposed between the third distal seal 36 and the second distal seal 34.

[0072] Return to reference Figure 8, an outer cylindrical member 18 (e.g., a spring cap) can be coupled to a portion of the inner cylindrical member 16 on the proximal end 12 of the valve 10. The outer cylindrical member 18 can be formed of an elastomeric material, such as, for example, silicone rubber, polyurethane rubber, natural rubber, nitrile rubber, butyl rubber, any combination thereof, and / or any material that exhibits appropriate material properties, including elongation / recovery properties. The outer cylindrical member 18 can be a single unitary structure formed from a single continuous piece of material and can be, for example, molded, extruded, or otherwise formed. The outer cylindrical member 18 can be a cap.

[0073] In particular Fig. 9 and 10 As shown, the outer cylindrical member 18 can have an inner chamber 72, which can extend from a proximal portion 74 of the outer cylindrical member 18 to a distal portion 76. The inner chamber 72 can be open on the distal portion 76 (e.g., there is an annular gap between the distal end of the outer cylindrical member 18 and the inner cylindrical member 16) and closed on the proximal portion 74 (e.g., the proximal end of the outer cylindrical member 18 is closed around the proximal end of the member 16). An annular wall 82 of the outer cylindrical member 18 can extend from the radial outer surface of the outer cylindrical member 18 to the radial inner surface of the outer cylindrical member 18. The radial inner surface of the outer cylindrical member 18 can define the inner chamber 72. The inner chamber 72 can be sized to receive the proximal portion 84 of the inner cylindrical member 16. The surfaces defining the inner chamber 72, the radial inner surface of the outer cylindrical member 18, and the radial inner surface of the inner portion of the annular wall 82 can be discussed interchangeably herein and can refer to the same or similar structures.

[0074] The outer cylindrical member 18 and the inner cylindrical member 16 can have corresponding features for coupling the outer surface of the proximal portion 84 of the outer cylindrical member 18 with the surface defining the inner chamber 72. For example, the outer surface of the proximal portion 84 of the inner cylindrical member 16 can have one or more annular notches or channels 86, and the inner surface of the proximal portion 74 of the outer cylindrical member 18 can have one or more corresponding annular protrusions 88 that mate with the notches 86 on the inner cylindrical member 16. When the inner cylindrical member 16 is inserted into the outer cylindrical member 18, the notches 86 of the inner cylindrical member 16 can mate with the protrusions 88 of the outer cylindrical member 18 to retain the inner cylindrical member 16 within the inner chamber 72 of the outer cylindrical member 18. Additionally or alternatively, the inner cylindrical member 16 can have protrusions and the outer cylinder can have one or more notches or channels that can achieve the same mating functions described above. Alternatively, other features (e.g., lugs, notches, etc.) may be used to fixedly attach the proximal end of the inner cylindrical member 16 and the outer cylindrical member 18. In various embodiments, the annular protrusion 88 or any alternative structure for the annular protrusion 88 may include or be referred to as a first connector portion.

[0075] The proximal portion 74 of the outer cylindrical member 18 may have features that complement the shape of the endoscope valve barrel 39. For example, Fig. 9 and 10 As shown, the outer cylindrical member 18 can have a feature 79, such as an annular recess or channel, to releasably receive a portion of the endoscope valve barrel 39 and secure the outer cylindrical member 18 relative to the endoscope valve barrel 39. Any alternative structure can be used for feature 79, including grooves, protrusions, lips, edges, lugs, slots, etc. In some embodiments, feature 79 or any alternative structure for feature 79 can include or be referred to as a second connector portion.

[0076] The thickness of the wall 82 may vary longitudinally along the proximal outer cylindrical member 18. The thickness of the wall 82 may be the distance between the outer surface of the outer cylindrical member 18 and the inner surface of the outer cylindrical member 18. The first portion 90 and the third portion 91 may have a relatively thick wall 82. In other words, the distance between the outer surface and the inner surface of the inner cylindrical member 18 may be relatively large at the first portion 90 and the third portion 91. The outer cylindrical member 18 may have a relatively thin portion of the wall 82 at the second portion 92 (e.g., the middle section) of the outer cylindrical member 18 between the first portion 90 and the third portion 91. Each of the first portion 90, the second portion 92, and the third portion 91 may be between the protrusion 88 and the feature 79. For example, the first portion 90 may be distal to the protrusion 88, the second portion 92 may be distal to the first portion 90, the third portion 91 may be distal to the second portion 92, and the feature 79 may be distal to the third portion 91. In various embodiments, the first portion 90, the second portion 92, and the third portion 91 can be collectively referred to as a spring portion. In many embodiments, the annular wall 82 can expand radially outward at the second portion in response to a force applied to the proximal surface.

[0077] At any longitudinal position along the wall 82, its thickness may be constant, or its thickness may vary. The inner surface of the outer cylindrical member 18 may taper radially outward from the first portion 90 to the second portion 92 and from the third portion 91 to the second portion 92. The thickness of the wall 82 of the outer cylindrical member 18 may also taper between the first portion 90 and the second portion 92 and between the third portion 91 and the second portion 92. As described below with respect to Fig.10 As discussed in further detail, the tapered profile of the wall 82 may facilitate radially outward displacement of the wall 82 about the second portion 92 when an axial force is applied to the proximal portion 84 .

[0078] Fig. 9The valve 10 is shown in a first configuration, wherein air is flushed through the water channel and the air channel of the endoscope. When the valve 10 is first inserted into the endoscope, it may be in the first configuration. As discussed in further detail below, the valve 10 may return to the first configuration after operating in the second configuration so as to flush water out of the air and water channels of the endoscope. In the first configuration, the outer cylindrical member 18 may be in an uncompressed (e.g., relaxed) state. The outer cylindrical member 18 may be biased to the uncompressed state of the first configuration of the valve 10. In the first configuration, the third distal seal 36 may be positioned proximal to the water inlet A of the endoscope valve barrel 39 and also distal to the water outlet B of the endoscope valve barrel 39. The second distal seal 34 may be proximal to the water outlet B but distal to the air inlet C. The first distal seal 32 may also be distal to the air inlet C. The one-way seal 62 may be proximal to the air inlet C and distal to the air outlet D.

[0079] Thus, in the first configuration, water from the water inlet A may not move proximally past the third distal seal 36 and thus may not move to the water outlet B. Due to the first distal seal 32, air from the air inlet C may not move distally along the outer surface of the inner cylindrical member 16. However, air from the air inlet C may move proximally past the one-way seal 62. The air may thus pass into the air outlet D and may also enter the proximal hole 24. The air that has passed into the proximal hole 24 may pass distally through the first cavity 22 and out of the distal hole 26. Because the distal hole 26 is located between the third distal seal 36 and the second distal seal 34, the air leaving the distal hole 26 may not move proximally or distally along the outer surface of the inner cylindrical member 16. However, the air leaving the distal hole 26 may leave the water outlet B.

[0080] Fig.10 The valve 10 is shown in a second compressed configuration, wherein water is flushed down the air passage. The outer cylindrical member 18 is compressed around the middle section 92. The tapered wall 82 of the outer cylindrical member 18 helps compress the outer cylindrical member 18 to the second configuration. Since the wall 82 is relatively thin at the second portion 92, the second portion 92 can bulge outward. The entire inner cylindrical member 16 is displaced distally by the same amount as the outer cylindrical member 18 is compressed. The distal end 14 of the valve 10 can rest along the distal surface of the endoscope valve barrel 39. The proximal seal 42 can be displaced distally to be positioned proximal to the water outlet D. The one-way seal 62 can be displaced distally relative to the first form, so that since the distal portion of the one-way seal 62 is assembled in the narrowed conical area of ​​the endoscope valve cylinder 39, air from the air inlet C may not move through the one-way seal 62, so that the air will not move proximally through the distal portion of the one-way seal 62 to reach the proximally movable flap portion of the one-way seal 62.

[0081] In the second configuration, the third distal seal 36 can be distal to the water inlet A, and the second distal seal 34 can be proximal to the water inlet A. Thus, water from the water inlet A can enter the third distal seal 36 proximally, but may not move proximally along the outer surface of the inner cylindrical member 16 past the second distal seal 34. However, the water can enter the distal hole 26 and travel through the first lumen 22 and through the proximal hole 24. After the water leaves the proximal hole 24, the water may not travel distally through the one-way seal 62. However, the water may flow out of the air outlet D to flush the air channel of the endoscope.

[0082] After the procedure using the endoscope is completed, the operator can remove the air / water valve used during the procedure from the valve cartridge 39. The operator can then insert the valve 10 into the valve cartridge 39. The distal portion 76 of the outer cylindrical member 18 can be secured to the valve cartridge 39 using protrusions or grooves in the inner surface of the distal portion 76 of the outer cylindrical member. The valve 10 can be in a first configuration of the valve 10 (e.g., Fig. 9 ) is inserted into the valve cylinder 39. The operator can press down on the proximal surface of the outer cylindrical member 18 and / or the proximal surface of the inner cylindrical member 16 (e.g., Figures 8 to 14 The top of the outer cylindrical member 18). Pressing those proximal surfaces distally results in compression of the outer cylindrical member 18, causing the wall 82 of the outer cylindrical member 18 to bulge radially outward (e.g., Fig.10 ). For example, the wall 82 of the outer cylindrical member 18 can bend (e.g., bend, fold, compress, or at least partially collapse like an accordion) at a predetermined location, wherein the second portion 92 bulges radially outward at the thinnest point of the wall 82. The inner cylindrical member 16 can simultaneously move distally relative to the endoscope valve barrel 39. The valve 10 can be maintained in the second compressed state for a predetermined amount of time (e.g., thirty seconds) to flush water through the air channel of the endoscope to remove debris from the air channel. The amount of time required for flushing may depend on the length of tubing in the endoscope that is to be reached at the distal end. Due to the shape memory characteristics or other material characteristics of the outer cylindrical member 18, the valve 10 can be biased to the first state ( Fig. 9 ).

[0083] When the operator releases pressure from the proximal surface of the valve 10, it may return to the first configuration due to the shape memory or other biasing properties of the outer cylindrical member 18. The properties of the outer cylindrical member 18 may make it possible for the valve 10 to not require a separate spring to return to the first configuration. Fig. 9Thus, the functions of the other valves can be performed by only the outer cylindrical member 18. The valve can be maintained in the first configuration for a predetermined duration in order to flush water out of both the air and water channels using air. After completing flushing water through the air channel and flushing air through the air and water channels, the valve 10 can be removed from the endoscope valve barrel 39. The disposable valve 10 can be discarded, or the reusable valve 10 can be reprocessed for subsequent use.

[0084] Fig.11 and 12 An alternative exemplary valve 100 is shown. The valve 100 can have any of the qualities, features, and / or structures of the valve 10 described above. In particular, the valve 100 can have the same outer cylindrical member 18 (e.g., a spring cap) as the valve 10 described above. The valve 100 can have an inner cylindrical member 116, which can have any of the qualities of the inner cylindrical member 16 except as outlined herein. In place of the seals 32, 34, 36, 42, the inner cylindrical member 16 can be molded to achieve the same function of one or more of the seals 32, 34, 36, 42. For example, the inner cylindrical member 116 can have one or more of a proximal circumferential ring 142, a first distal circumferential ring 132, a second distal circumferential ring 134, and a third circumferential ring 136 integrally molded with the member 116. In some embodiments, the first, second, and third distal circumferential rings 132, 134, 136 and the proximal circumferential ring 142 may be referred to as seals 132, 134, 136, 142. The first, second, and third distal circumferential rings 132, 134, 136 may be located on the inner cylindrical member 116 in positions corresponding to the placement of the distal seals 32, 34, 36 on the inner cylindrical member 16. The distal circumferential rings 132, 134, 136 may extend radially from the outer surface of the inner cylindrical member 116 and may be raised annular features. The distal circumferential rings 132, 134, 136 may create a slight interference fit between the outer surface of the inner cylindrical member 116 and the inner wall 38 of the endoscope valve barrel 39, so that a slidable seal is formed at each ring 132, 134, 136. The distal circumferential ring 132 , 134 , 136 may replace all or a subset of the distal seals 32 , 34 , 36 .

[0085] In some embodiments, one or more of the seals 132, 134, 136, 142 and / or seals 32, 34, 36, 42 may be formed as a single, separate component. See, e.g. Figures 21A to 22B In various embodiments, one or more of seals 132, 134, 136, 142 and / or one or more of seals 32, 34, 36, 42 may include a wiper seal that allows for a wider range of diameters with consistent friction for sealing. See, e.g. Fig.19 In many embodiments, one or more of the seals 132, 134, 136, 142 and / or one or more of the seals 32, 34, 36, 42 may be formed via overmolding. See, e.g. Figures 19 to 20 .

[0086] Additionally, instead of the proximal seal 42 of the valve 10, the inner cylindrical member 16 can be molded to achieve the same function of the proximal seal 42. For example, the inner cylindrical member 116 can have a proximal circumferential ring 142. The proximal circumferential ring 142 can be located on the inner cylindrical member 116 in a position corresponding to the placement of the proximal seal 42 on the inner cylindrical member 16. The proximal circumferential ring 142 can extend radially from the outer surface of the inner cylindrical member 116 and can be a raised annular feature. The proximal circumferential ring 142 can create a slight interference fit between the outer surface of the inner cylindrical member 116 and the inner wall 38 of the endoscope valve barrel 39, so that a slidable seal is formed.

[0087] The valve 100 may use any combination of molded seals and elastomeric seals. For example, the inner cylindrical member 116 may have one or more distal circumferential rings 132, 134, 136 and an elastomeric proximal ring. Alternatively, the inner cylindrical member 116 may have a molded proximal circumferential ring 142 and an elastomeric distal seal. Any combination of molded rings and elastomeric seals may be used. The valve 100 may function in the same manner as the valve 10 described above, wherein Fig.11 shows a relaxed state and Fig.12 Shows the compressed state.

[0088] Fig.13 and 14 A first ( Fig.13 ) and the second ( Fig.14 The valve 200 may include a distal member 202, a proximal member 204, and a proximal skirt 206.

[0089] The distal member 202 can be formed of any of the materials described above with respect to the inner cylindrical member 16. The body of the distal member 202 can be a single unitary structure formed of a single continuous material. The distal member 202 can be equipped with a first distal seal 212 and a second distal seal 214, each of which can have any of the characteristics of the above-mentioned distal seals 32, 34, 36 or the proximal seal 42 or the circumferential ring 132, 134, 136, 142. The first and second distal seals 212, 214 can be assembled in annular grooves or recesses on the outer surface of the distal member 202. The first and second distal seals 212, 214 can form a slidable interference fit between the outer surface of the distal member 202 and the inner surface of the valve barrel 139 of the endoscope, so that fluids (e.g., air and water) cannot move between the distal seals 212, 214 and the wall of the endoscope valve barrel 139.

[0090] The distal member 202 can have a distal portion 222 and a proximal portion 224. The distal portion 222 can have a larger outer diameter than the proximal portion 224. The shoulder 226 can form a boundary between the distal portion 222 and the proximal portion 224. Alternatively, there can be a tapered section between the distal portion 222 and the proximal portion 224 or another transition between the distal portion 222 and the proximal portion 224. The distal member 202 can have a first central cavity 232. At least a portion of the first central cavity 232 can extend along the central longitudinal axis of the distal member 202, through the distal portion 222 and the proximal portion 224. The first central cavity 232 can have a proximal opening 236 on the proximal end of the proximal portion 224. The proximal opening 236 of the first central cavity 232 can be surrounded by a lip portion 302 of the proximal portion 224 protruding from the outer surface of the proximal portion 224. The first central lumen 232 may include a bend 238 proximate a distal end 242 of the distal portion 222. The first central lumen 232 may extend from the bend 238 to an outer (lateral) surface of the distal member 202. The distal aperture 240 may fluidly connect an area outside the distal member 202 to the distal end of the first central lumen 232.

[0091] When the valve 200 is positioned within the endoscope valve barrel 139, the distal member 202 can remain fixed during operation of the valve 200. For example, the distal end 242 of the distal member 202 can rest on the distal surface of the endoscope valve barrel 139. The first and second distal seals 212, 214 can both be proximal to the water inlet A. The first distal seal 212 can be proximal to the water outlet B, and the second distal seal 214 can be distal to the water outlet B. Thus, water can be prevented from moving proximally between the outer surface of the distal member 202 and the wall of the endoscope valve barrel 139. Fluids, such as air and water, can be prevented from entering the water outlet B. The distal hole 240 can be aligned with the water inlet A so that water can travel proximally through the first central cavity 232.

[0092] The proximal member 204 can have a proximal finger button 250 and a distal body 260. The body 260 can extend distally from the finger button 250. In some embodiments, the finger button 250 can include an interface member. The body 260 can include a distal flange 262. The proximal member 204 can be a single unitary structure formed from a single continuous material and can be made of any material used to make the distal member 202. The distal flange 262 can be equipped with a body seal 264. The body seal 264 can have any of the qualities of the first distal seal 212 and the second distal seal 214. The first body seal can be fixed to the body 260. The body seal 264 can be disposed on the outer surface of the flange 262. For example, the outer surface of the flange 262 can include a groove or notch, and the body seal 264 is assembled in the groove or notch to fix the body seal 264. The body seal 264 can be configured so that a slidable interference fit is created between the body seal 264 and the inner surface of the endoscope valve barrel 139 when the valve 200 is disposed in the endoscope valve barrel 139. Fluid (e.g., air or water) can be prevented from traveling between the body seal 264 and the inner surface of the endoscope valve barrel.

[0093] The circumferential wall 270 can extend from the distal surface of the finger button 250 around the distal body 260. The outer surface of the wall 270 can be fitted with a wall seal 272. The wall seal 272 can have any of the characteristics of the first distal seal 212, the second distal seal 214, or the body seal 264. The wall seal 272 can be attached to the outer surface of the wall 270. For example, the outer surface of the wall 270 can include a groove or recess in which the wall seal 272 is fitted to fix the wall seal 272. The wall seal 272 can be configured so that a slidable interference fit is created between the wall seal 272 and the inner surface of the endoscope valve barrel 139 when the valve 200 is disposed in the endoscope valve barrel 139. Fluid (e.g., air or water) can be prevented from traveling between the wall seal 272 and the inner surface of the endoscope valve barrel 139.

[0094] The body 260 can have a chamber 280 extending from the distal end of the body 260 to the proximal end of the body 260. The chamber 280 can be open at the distal end 282 of the body 260. The chamber 280 can also be open to an area between the outer surface of the body 260 and the wall 270 via one or more body holes 284. The chamber 280 can receive the proximal portion 224 of the distal member 202. The chamber 280 can be in fluid communication with the first central lumen 232. Thus, the first central lumen 232 can be in fluid communication with one or more body holes 284. The body holes 284 may not be continuous around the entire circumference of the body 260, and therefore Fig.13 and 14 Dashed lines are shown above to show where walls may be present along alternating cross-sections of the valve 200. The cavity seal 286 can be between the inner surface of the body 260 and the outer surface of the proximal portion 224. The cavity seal 286 can create a slidable interference fit between the inner surface of the body 260 and the outer surface of the proximal portion 224 so that fluids (e.g., air and water) cannot pass through the cavity seal 286. The cavity seal 286 can be fixed to, for example, the inner surface of the body 260. For example, the body 260 can include a groove or recess in which the cavity seal 286 can be received. The cavity seal 286 can be axially aligned with the body seal 284. The lip 302 surrounding the proximal opening 236 of the proximal portion 224 can interact with the edge 304 of the chamber 280 so that the lip 302 does not move distally past the edge 304. Lip 302 may have features such that lip 302 may be moved proximally past edge 304 (eg, to allow manufacturing of valve 200), but such that lip 302 may not be moved distally past edge 304 so that valve 200 remains as a unitary piece during processing.

[0095] The valve 200 may also include a skirt 206. The skirt 206 may extend distally from the proximal side of the finger button 250. For example, the finger button 250 may include a groove in which a protrusion of the skirt 206 may be received. The distal end of the skirt 206 may include features for mating the skirt 206 to the valve barrel 139 of the endoscope. For example, the skirt 206 may include a groove for receiving a protrusion of the valve barrel 139 of the endoscope. It should also be understood that the skirt 206 may include a protrusion for receiving a groove of the valve barrel 139, or any other complementary releasable attachment mechanism. Therefore, in some embodiments, the proximal end of the skirt 206 may include or be referred to as a first connector portion, and the distal end of the skirt 206 may include or be referred to as a second connector portion. The skirt 206 may be formed of any suitable material, including the materials described above with respect to the cylindrical member 18. The skirt 206 may have any of the properties or shapes of the cylindrical member 18. The skirt 206 may have accordion-style pleats or may be corrugated. The skirt 206 may be formed of a shape memory material or may be otherwise configured such that the skirt 206 is biased in its longitudinally expanded configuration along the skirt 206. Thus, in some embodiments, the skirt 206 may include a spring portion (e.g., accordion-style pleats).

[0096] Specific reference Fig.13 , showing a first configuration of the valve 200. In the first configuration, the skirt 206 can be longitudinally expanded, and the proximal body 260 can be configured such that the body seal 264 and the wall seal 272 are both proximal to the inlet C and the outlet D. The first and second distal seals 212, 214 are in two configurations ( Fig.13 and Fig.14 264). Water also cannot pass proximally through the wall seal 272. Therefore, water from the water inlet A may not leave the endoscope valve barrel 139.

[0097] Specific reference Fig.14, showing a second compressed configuration of the valve 200. In the second configuration, the proximal body 260 moves in a distal direction, thereby compressing the skirt 206. In the second configuration, the body seal 264 is distal to the air outlet D, but proximal to the air inlet C, and the wall seal 272 remains proximal to the air outlet D. The aperture 284 may be aligned with the air outlet D. Air from the air inlet C may not travel proximally through the body seal 264 and therefore may not exit the endoscope valve barrel 139. Water exiting the first central lumen 232 may pass through the body aperture 284 and through the aperture 284 to the air outlet D. Therefore, in the second configuration, water may pass through the air passage of the endoscope.

[0098] After the procedure using the endoscope is completed, the operator can remove the air / water valve used during the procedure from the valve barrel 139 of the endoscope. The operator can then insert the valve 200 into the valve barrel 139. The skirt 206 can be secured to the valve barrel 139 using the mechanism described above. The valve 200 can be inserted into the valve barrel 139 in the first configuration of the valve 200. The operator can press the button 250, thereby pressing the proximal member 204 and switching the valve 200 to the closed configuration. Fig.14 Depressing the button 250 may also cause compression of the skirt 206. The valve 200 may be maintained in the second configuration for a predetermined amount of time (e.g., thirty seconds) to flush water through the air passage of the endoscope, thereby removing debris from the air passage. After flushing water through the air passage, the valve 200 may be disposed of or reprocessed.

[0099] One or more of the above-described features for distinguishing surgical valves may be incorporated into the following Figures 15 to 23 In or with valve designs. For example, Fig.15 and 16 In many embodiments, Figures 1A to 14 One or more components of the medical clean valve assembly may be different in structure, function and / or appearance from those related to Figures 15 to 23 The same or similar to the above. Figures 15 to 17 and 23, dimensions are in inches unless otherwise stated; and Fig.18Dimensions are in millimeters unless otherwise noted. Although dimensions are discussed in inches or millimeters, inches and millimeters can be easily converted based on 1 inch equaling 25.4 millimeters. All dimensions are for illustration only, and other dimensions may be more appropriate for specific applications. In addition, the dimensions described may be approximate values ​​that include tolerances, such as tolerances that allow for plus or minus percentage variation from the value described. Unless otherwise noted, tolerances may be as follows: "X" is ±0.25 millimeters; "XX" is ±0.1 inches or ±0.1 millimeters; "X.XX" is ±0.01 inches or ±0.05 millimeters; "X.XXX" is ±0.05 inches or ±0.01 millimeters; "X.XXXX" is ±0.0005 inches; and angles may be ±2 degrees.

[0100] Figures 15 to 18 Various aspects of an exemplary valve assembly 1502 (or cleaning valve 1502) according to the present invention described herein are shown. In some embodiments, the valve assembly 1502 and / or its components can be combined in form and / or function with one or more other components described herein, such as those described with respect to Figure 8-12 the same or similar. Fig.15 Various views of valve assembly 1502 are shown. In many embodiments, valve assembly 1502 can include or be referred to as a clean valve assembly, a clean valve, a valve, a valve assembly, or the like. Fig.16 Various views of an interface member 1604 for a valve assembly 1502 are shown. Fig.17 Various views of a valve stem 1706 for use with the valve assembly 1502 are shown. Fig.18 Various views of a one-way seal 1862 for use with a valve assembly 1502 are shown. The embodiments are not limited in this context.

[0101] Fig.15A perspective view 1502A, a front view 1502B, and a cross-sectional view 1502C of a cleaning valve assembly 1502 may be included. As shown in the perspective view 1502A, the valve assembly 1502 may include a proximal end 1545 and a distal end 1555. As shown in the front view 1502B, the cleaning valve assembly 1502 may include an interface member 1504, a valve stem 1506, and a one-way seal. Additionally, as shown in cross-section 1502C, the cleaning valve assembly 1502 can include seals 1524-1, 1524-2, 1524-3, 1524-4 (or seals 1524), a proximal seal assembly 1544 (including seals 1524-1), a distal seal assembly 1542 (including seals 1524-2, 1524-3, 1524-4), one or more annular recesses or channels 1586 of the valve stem 1506, a one-way seal 1562, orifices 1520-1, 1520-2 (or orifices 1520), and a cavity 1522 that places orifices 1520 in fluid communication. In some embodiments, orifice 1520-1 can be the same or similar to proximal aperture 24 and / or orifice 1520-2 can be the same or similar to distal aperture 26. As will be described in more detail below, in various embodiments, the valve stem 1506 can include an additional orifice at the distal end that is blocked by a sealing assembly 1542 .

[0102] In various embodiments, the interface member 1504 may include a molded elastomer spring cap. In some embodiments, the valve stem 1506 may include a 6 mm and / or 10 mm overmolded seal. For example, the seal 1524-1 of the sealing assembly 1544 may be a 10 mm overmolded seal, and the seals 1524-2, 1524-3, 1524-4 may be 6 mm overmolded seals. In many embodiments, the one-way seal 1562 may include an air-water valve one-way seal. In various embodiments, one or more annular recesses or channels 1586 of the valve stem 1506 may promote the connection of the interface member 1504 to the valve stem 1506. In various such embodiments, one or more annular recesses or channels 1586 may be the same or similar to the annular recesses or channels 86. Similarly, the valve stem 1506 may include one or more annular recesses or channels to promote the connection of the one-way seal 1562 to the valve stem 1506. It should be understood that additional means may be used to couple the interface member 1504 and / or the one-way seal 1562 to the valve stem 1506 without departing from the scope of the present invention. For example, the valve stem 1506 may include a protrusion instead of a channel. In several embodiments, the valve assembly 1502 may include up to three separate components (e.g., separately manufactured), the valve stem 1506, the interface member 1504, and the one-way seal 1562, thereby reducing manufacturing and assembly time and cost. In several such embodiments, the overmolded components (e.g., the sealing components 1542, 1544) are considered not to be separately manufactured. In some embodiments, the one-way seal 1562 and the valve stem 1506 may be integrally formed or the valve stem 1506 may be overmolded onto the valve stem 1506, thereby reducing the cleaning valve 1502 to a two-piece assembly.

[0103] In various embodiments, the surface finish of the valve assembly 1502 can be 85 micro-inches or smoother, such as 75 micro-inches. For example, the surface finish of the valve assembly 1502 can be 85 micro-inches or smoother, such as 63 micro-inches. In some embodiments, all burrs and sharp edges can be removed. In many embodiments, the inner corner radius can be 0.04 inches or less. For example, the inner corner radius can be only 0.015 inches. In several embodiments, the interface member 1504 can be snap-fitted onto the valve stem 1502 (e.g., via the channel 1586). In some embodiments, the proximal end of the interface member 1504 can be connected to the valve stem 1506 by welding, adhesives, glues, or other known attachment mechanisms. In some embodiments, the one-way seal 1562 can interface with the valve stem 1502 by an interference fit between the inner diameter of the one-way seal 1562 and the outer diameter of the valve stem 1502.

[0104] In one or more embodiments described herein, various ranges, tolerances, sizes and / or ratios thereof can be selected to suit a particular application. For example, a gas valve application may require a tighter tolerance than a liquid valve application. In some embodiments, these selections can facilitate and / or optimize one or more functions described herein. For example, precise dimensions can ensure that the valve well is correctly assembled. In another example, tolerances can ensure that operating temperature fluctuations can be accommodated. In yet another example, precise dimensions can ensure the proper function of the wiper seal. In yet another example, accurate ratios can ensure effective flow through the cavity. In yet another example, accurate ratios, tolerances and / or sizes can ensure the correct operation of the spring portion of the interface member (e.g., both valve position and / or tactile feedback). Therefore, utilizing one or more ranges, sizes and tolerances (and / or ratios thereof) described herein can provide a component with reliable operation and / or economical manufacturing.

[0105] Fig.16 A perspective view 1604A, a front view 1604B, and a cross-sectional view 1604C of the interface member 1604 may be included. In many embodiments, the interface member 1604 may be the same or similar to the interface member 1504. As shown in the perspective view 1604A, the interface member 1604 may include a proximal end 1645 and a distal end 1655. Additionally, as shown in the cross-section 1604C, the interface member 1604 may include a connector portion 1688 (e.g., an annular protrusion) to facilitate coupling with the valve stem; and a connector portion 1679 to facilitate coupling with the valve well. In some embodiments, the connector portion 1688 may be the same or similar to the annular protrusion 88 and / or the connector portion 1679 may be the same or similar to the feature 79.

[0106] In various embodiments, feature 1679 can include a lip and / or a recess configured to couple with a valve well, as shown proximate to the distal end in cross-sectional view 1604C of interface member 1604. Additionally, connector portion 1688 can include a lip and / or a recess configured to couple with valve stem 1506, as shown proximate to the proximal end in cross-sectional view 1604C of interface member 1604 (see also FIG. Fig.15 1502C). In various embodiments, the interface member 1604 may be coupled to the Figures 8 to 12 The outer cylindrical member 18 in is the same or similar.

[0107] In the absence of external input (e.g., in the first form), dimensions (e.g., distance, width, radius, diameter, angle, etc.) are described with respect to the components of this article. Returning to the front view 1604B of the reference interface member 1604, the outer diameter 1601 of the interface member 1604 can be between 0.62 and 0.65 inches, such as 0.634 inches. The outer diameter 1603 of the interface member 1604 can be between 0.61 and 0.64 inches, such as 0.625 inches. The outer diameter 1605 of the interface member 1604 can be between 0.57 and 0.60 inches, such as 0.584 inches. The outer diameter 1607 at the far end of the interface member 1604 can be between 0.63 and 0.66 inches, such as 0.640 inches.

[0108] Additionally, front view 1604B may include reference points AF. Reference point A may be the distal end 1655 of interface member 1604. Reference point B may be at outer diameter 1601 and the distance between reference points A and B may be between 0.14 and 0.18 inches, such as 0.16 inches. Reference point C may be at outer diameter 1603 and the distance between reference points A and C may be between 0.35 and 0.40 inches, such as 0.371 inches. Reference point D may be at outer diameter 1605 and the distance between reference points A and D may be between 0.725 and 0.775 inches, such as 0.748 inches. Reference point E may be the proximal surface of interface member 1604 and the distance between reference points A and E may be between 0.775 and 0.825 inches, such as 0.795 inches. Reference point F may be an indicator of interface member 1604 (see, e.g., Figure 1A In some embodiments, the raised surface included in the indicator can extend proximally from the proximal surface of the interface member 1604 by approximately 0.035 inches.

[0109] Referring back to the cross-sectional view 1604C of the interface member 1604, the inner diameter 1609 of the interface member 1604 proximal to the annular protrusion 1688 and proximal to its distal side can be between 0.34 and 0.36 inches, such as 0.350 inches. The inner diameter 1611 of the interface member 1604 at the annular protrusion 1688 can be between 0.26 and 0.28 inches, such as 0.270 inches. The inner diameter 1619 of the interface member 1604 can be between 0.54 and 0.57 inches, such as 0.551 inches. The inner diameter 1627 of the interface member 1604 can be between 0.45 and 0.47 inches, such as 0.460 inches. The inner diameter 1629 of the interface member 1604 can be between 0.49 and 0.52 inches, such as 0.502 inches. The inner diameter 1631 of the interface member 1604 can be between 0.55 and 0.58 inches, such as 0.562 inches. The angle 1617 of the interface member 1604 can be between 15 and 31 degrees, such as 23 degrees. The angle 1623 of the interface member 1604 can be between 5 and 21 degrees, such as 13 degrees. The angle 1633 of the interface member 1604 can be between 15 and 55 degrees, such as 35 degrees. The radius 1613 of the interface member 1604 can be between 0.04 and 0.06 inches, such as 0.050 inches. The radius 1615 of the interface member 1604 can be between 0.04 and 0.06 inches, such as 0.050 inches. The radius 1621 of the interface member 1604 can be between 0.04 and 0.06 inches, such as 0.050 inches. The radius 1625 of the interface member 1604 can be between 0.04 and 0.06 inches, such as 0.050 inches.

[0110] Additionally, cross-sectional view 1604C may include reference point GN. Reference point G may be the distal end 1655 of interface member 1604. Reference point H may be at inner diameter 1631 and the distance between reference points G and H may be between 0.05 and 0.08 inches, such as 0.063 inches. Reference point I may be at inner diameter 1627 and the distance between reference points G and I may be between 0.09 and 0.13 inches, such as 0.108 inches. Reference point J may be at the distal end of radius 1625 and the distance between reference points G and J may be between 0.13 and 0.18 inches, such as 0.154 inches. Reference point K may be at the proximal end of radius 1615 and the distance between reference points G and K may be between 0.5 and 0.7 inches, such as 0.614 inches. Reference point L may be at the distal end of annular protrusion 1688 and the distance between reference points G and L may be between 0.5 and 0.8 inches, such as 0.635 inches. Reference point M can be proximal to annular protrusion 1688 and the distance between reference points G and M can be between 0.6 and 0.9 inches, such as 0.710 inches. Reference point N can be proximal to the lumen of interface member 1604 and the distance between reference points G and N can be between 0.72 and 0.80 inches, such as 0.760 inches.

[0111] Fig.17 A perspective view 1706A, a side view 1706B, a top view 1706C, a cross-sectional view 1706D, and detail views 1706E, 1706F, 1706G of the valve stem 1706 may be included. In many embodiments, the valve stem 1706 may be the same or similar to the valve stem 1506. As shown in the perspective view 1604A, the interface member 1604 may include a proximal end 1745 and a distal end 1755. The side view 1706B shows the location of the detail views 1706E, 1706F relative to the valve stem 1706. As shown in the cross-sectional view 1706D, in addition to the cavity 1722, the valve stem 1706 may include a chamber 1760. In various embodiments, the chamber 1760 may be created by removing a core forming pin used to make the valve stem 1706. The detail view 1706F shows the location of the detail view 1706G relative to the detail view 1706F. In various embodiments, the valve stem 1706 may include a lip and / or a recess configured to couple with an interface member (see, e.g., Fig.15 Channel 1586).

[0112] Front view 1706B may include reference points AE. Reference point A may be distal end 1755 of valve stem 1706. Reference point E may be at a first seal of valve stem 1706 (see, e.g., seal 1524-1 of valve stem 1506) and the distance between reference points A and E may be between 1.0 and 1.3 inches, such as 1.144 inches. Reference point D may be at a second seal of valve stem 1706 (see, e.g., seal 1524-2 of valve stem 1506) and the distance between reference points A and D may be between 0.35 and 0.46 inches, such as 0.409 inches. Reference point C may be at a third seal of valve stem 1706 (see, e.g., seal 1524-3 of valve stem 1506) and the distance between reference points A and C may be between 0.19 and 0.23 inches, such as 0.210 inches. Reference point B can be at the fourth seal of valve stem 1706 (see, eg, seal 1524 - 4 of valve stem 1506 ) and the distance between reference points A and B can be between 0.03 and 0.08 inches, such as 0.053 inches.

[0113] Fig.17 Detail 1706E can show a portion of the valve stem 1706 including a distal seal assembly (see, e.g., seal assembly 1542 of valve stem 1506). In addition, each of the three seals (see, e.g., seals 1524-2, 1524-3, 1524-4 of valve stem 1506) can share dimensions 1701, 1703, 1705, 1709. The radius 1701 of the radial extent immediately adjacent each of the seals can be between 0.011 and 0.021 inches, such as 0.016 inches. The width 1703 of the radial extent immediately adjacent each of the seals can be between 0.011 and 0.021 inches, such as 0.016 inches with a positive tolerance of 0.003 inches and a negative tolerance of 0.001 inches. The outer diameter 1705 of each of the seals can be between 0.24 and 0.27 inches, such as 0.254 inches. The angle 1709 between the proximal and distal sides of each of the seals can be between 10 and 26 degrees, such as 18 degrees. Additionally, the outer diameter 1707 of the distal seal assembly stem (see, e.g., seal assembly 1542 of stem 1506) between each of the seals can be between 0.15 and 0.17 inches, such as 0.16 inches.

[0114] Fig.17Detail view 1706F can show a portion of the valve stem 1706 including a proximal seal assembly (see, for example, seal assembly 1544 including seal 1524-1 of valve stem 1506). The radius 1713 on the proximal and distal sides of the outer extent of the seal can be between 0.007 and 0.009 inches, such as 0.008 inches. The outer diameter 1711 of the seal can be between 0.39 and 0.42 inches, such as 0.404 inches. The outer diameter 1715 of the seal assembly on either side of the seal can be between 0.26 and 0.29 inches, such as 0.272 inches. Referring to detail view 1706G, the radius 1719 on the proximal and distal sides of the outer extent of the seal can be between 0.007 and 0.009 inches, such as 0.008 inches. The width 1717 of the radial extent immediately adjacent to the seal may be between 0.014 and 0.034 inches, such as 0.024 inches with a positive tolerance of 0.003 inches and a negative tolerance of 0.001 inches. The angle 1723 between the proximal and distal sides of the interior of the seal may be between 8 degrees and 24 degrees, such as 16 degrees. The height 1725 of the interior of the seal may be between 0.04 and 0.06 inches, such as 0.050 inches. The angle 1723 between the proximal and distal sides of the exterior of the seal may be between 3 degrees and 9 degrees, such as 6 degrees. Between 8 degrees and 24 degrees, such as 16 degrees. Thus, the height of the exterior of the seal may be between 0.01 and 0.02 inches, such as 0.016 inches.

[0115] Fig.18 A side view 1862A, a bottom view 1862B, and a cross-sectional view 1862C of the one-way seal 1862 may be included. In many embodiments, the one-way seal 1862 may be Figure 8 The one-way seal 1862 may be the same or similar to the one-way seal 62 of FIG. As shown in the side view 1862A, the one-way seal 1862 may include a proximal end 1845 and a distal end 1855. In various embodiments, the one-way seal 1862 may be made of TPE, such as Versaflex In some embodiments, the one-way seal 1862 can be transparent / translucent. Fig.18The dimensions of the illustrated embodiments may be in millimeters (mm). In embodiments where the one-way seal 1862 is molded, element 1866 may indicate the location of the parting line (i.e., the dividing line separating the core and the cavity halves). In various embodiments, element 1864 in views 1862A, 1862B may indicate that the flash / parting line mismatch on the surface may not exceed 0.1 mm. In addition, the flash on other parting lines (i.e., a thin layer of excess material that flows out of the mold cavity and enters the parting line) may not exceed 0.2 mm. In one or more embodiments, element 1866 may indicate a gate location for introducing material, such as during an injection molding process, to form a one-way valve 1862.

[0116] In addition, the maximum gate mark height as a result of introducing material into the mold can be 0.5mm. Element 1868 can indicate that the chamber identification position is at a maximum of 0.15mm above the surface. For example, the chamber identification position can be at a maximum of 0.13mm above the surface. The chamber identification can be a letter (e.g., A, B, C, etc.). In many embodiments, one or more corners can be sharp fillets, such as a maximum of about 0.15mm. For example, all corners can be sharp fillets, with a maximum of 0.13mm. In many embodiments, one-way seals 1862 must be created using manufacturing techniques that prevent shrinkage marks. For example, sufficient compensation must be provided when cooling the part to limit or prevent local shrinkage in thicker sections. In some embodiments, one-way seals 1862 can be formed separately from the valve stem and subsequently assembled to the valve stem. In other embodiments, one-way seals 1862 can be overmolded or integrally formed with the valve stem.

[0117] Referring back to the side view 1862A, the width 1801 of the one-way seal 1862 can be between 8.2 and 8.5 mm, such as 8.33 mm, with a tolerance of + / - 0.15 mm. The height 1803 of the one-way seal 1862 can be between 3.1 and 3.8 mm, such as 3.46 mm, with a tolerance of + / - 0.2 mm. The angle 1805 between the opposite sides of the upper portion of the one-way seal 1862 can be between 30 degrees and 50 degrees, such as 40.6 degrees. Referring to the bottom view 1862B, the inner diameter 1809 at the distal end of the one-way seal 1862 can be between 4.3 and 5.1 mm, such as 4.7 mm, with a tolerance of + / - 0.15 mm. The outer diameter 1807 of the one-way seal 1862 can be between 9 and 11 mm, such as 9.7 mm, with a tolerance of + / - 0.2 mm. Referring to cross-sectional view 1862C, the flap (see, e.g., Fig. 9The width 1813 of the flap 63) can be between 0.18 and 0.26 mm, such as 0.22 mm, with a tolerance of + / - 0.05 mm. The height 1815 can be between 3.0 and 3.4 mm, such as 3.20 mm, with a tolerance of + / - 0.15 mm. The angle 1811 between the opposing inner side walls of the one-way seal 1862 moving toward the proximal side of the one-way seal 1862 can be between 0 degrees and 6 degrees, such as 2 degrees.

[0118] In various embodiments, the flap of the one-way seal 1862 having the width 1813 (see, eg, cross-sectional view 1862C) can be referred to as an outer edge and the inner wall of the one-way seal 1862 can be referred to as an inner core.

[0119] In various embodiments, the one-way seal 1862 may include one or more features to prevent the outer edge from being inverted during use. For example, the one-way seal 1862 may include one or more bridges connecting the outer edge to the inner core. In another example, one or more ribs may be attached to the outer edge. In some examples, one or more ribs and / or bridges may be attached to the outer edge with a uniform thickness. In yet another example, the thickness of the outer edge may vary. In various embodiments, the height of one or more bridges and / or ribs may be a portion of the height of the inner core and / or outer edge. For example, one or more bridges and / or ribs may be the same height as the height of the inner core and / or outer edge or half of its height. In many embodiments, when mounted on the valve stem, the ribs and / or bridges may be aligned with the longitudinal (and / or radial) axis of the valve stem. In one or more embodiments, when mounted on the valve stem, the ribs and / or bridges may be angled relative to the longitudinal (and / or radial) axis of the valve stem. In various embodiments, one or more ribs and / or bridges may be disposed around the circumference of the inner core. For example, one or more ribs and / or bridges may be equally spaced (or unequally spaced) around the circumference of the inner core.

[0120] Figures 19 to 22B Various aspects of an exemplary valve stem assembly 1906 according to the invention described herein are shown. In some embodiments, the valve stem assembly 1906 and / or its components can be combined in form and / or function with one or more other components described herein, such as Figure 8-14 the same or similar. Fig.19A side view of a valve stem assembly 1906 (or valve stem 1906) having a proximal end 1945 and a distal end 1955 is shown. The valve stem 1906 includes a proximal seal assembly 1944, a distal seal assembly 1942, and a light rod 1940 (or rod 1940). In various embodiments, a rod or light rod can refer to a valve stem lacking one or more components, such as overmolded seals, O-rings, etc. The proximal seal assembly 1944 can include a seal 1924-1, the distal seal assembly 1942 can include seals 1924-2, 1924-3, 1924-4, and the rod 1940 can include orifices 1920-1, 1920-2 (connected via a cavity). In many embodiments, the seal assemblies 1942, 1944 can be overmolded onto the rod 1940.

[0121] Fig. 20 A side view of rod 2040 is shown. In various embodiments, rod 2040 can be the same or similar to rod 1940. Rod 2040 can include a plurality of circumferential protrusions 2046-1, 2046-2, 2046-3, 2046-4, 2046-5, 2046-6, 2046-7, 2046-8, 2046-9 (or protrusions 2046). Protrusions 2046 can include one or more features, such as ridges, lips, protrusions, channels, etc. Additionally, protrusions 2046 can provide one or more functions, such as alignment, coupling, placement, and overmolding support. For example, protrusions 2046-6, 2046-7 can prevent the material used to form seal assembly 1944 from flowing proximally or distally during overmolding. Additionally or alternatively, protrusions 2046-6, 2046-7 can promote centering of rod 2040 within the valve well (e.g., once assembled). In another example, the protrusion 2046-3 can prevent the material used to form the seal assembly 1942 from flowing proximally during overmolding. In addition, the protrusion 2046-2 can prevent the material used to form the seal assembly 1942 from flowing into the cavity via the distal orifice during overmolding. In yet another example, the protrusions 2046-8, 2046-9 and the channels defined therebetween (see, e.g., channel 86) can facilitate the coupling of the rod 2040 to the interface member. In yet another example, a one-way seal can be disposed (or positioned) between the protrusions 2046-4, 2046-5.

[0122] Fig.21A A perspective view of the seal assembly 2142 is shown. Fig. 21BA side view of seal assembly 2142 is shown. In various embodiments, seal assembly 2142 can be the same or similar to seal assembly 1542. Seal assembly 2142 includes seals 2124-2, 2124-3, 2124-4, window 2150, and plug 2148. In some embodiments, window 2150 can be formed by a protrusion (e.g., protrusion 2046-2) during the overmolding process. In many embodiments, plug 2148 can seal at the distal end of the valve stem (see, e.g., Fig.15 An orifice in the distal end of the valve stem assembly 1502 in the cross-sectional view 1502C.

[0123] Fig.22A A perspective view of seal assembly 2244 is shown. Fig. 22B A side view of sealing assembly 2244 is shown. In various embodiments, sealing assembly 2144 can be the same or similar to sealing assembly 1544. In some embodiments, the construction of the seal of a sealing assembly that is molded plastic rather than an O-ring can allow it to be molded with a thickness less than that of an O-ring. In this regard, such a molded seal can be designed with a diameter greater than an O-ring. Considering that a molded seal may be thinner and / or have a larger diameter than an O-ring seal, a performance advantage can be provided to the valve compared to a valve with an O-ring seal. For example, a molded seal having a larger diameter but having flexibility that allows it to slide in a valve well can provide a larger surface area contact and seal against the valve well wall.

[0124] In many embodiments, the seal 2242 can be assembled (or formed) on the distal end of the stem 2040. In many such embodiments, the sealing assembly 2142 can create a seal with the inner cavity of the valve stem (e.g., via the plug 2148). For example, since the valve stem is a single molded component, a cavity extending through the distal top of the valve stem is formed during molding. The distal end of the cavity can be blocked, for example, to prevent fluid from leaking from the distal end during use. In order to block the cavity, the sealing assembly 2142 may include a distal top plug 2148, which extends into the cavity of the valve stem and is at least integral with the overmolded distal disc or "wiper" seal. In one or more embodiments, the sealing assembly 2142 may include multiple seals. For example, the sealing assembly 2142 may include or create three seals with the valve well and one seal with the valve stem. In many embodiments, one or more of the seals may include a wiper seal. In the illustrated embodiment, the sealing assembly 2142 includes a radial opening (e.g., window 2150) aligned with the radial hole in the stem 2040. In some embodiments, the stem 2040 can have one or more features to prevent proximal and / or distal flow of material when overmolding one or more of the seal assemblies 2142 , 2244 .

[0125] Fig.23 Various aspects of the rod 2340 according to the invention described herein are shown. In some embodiments, the rod 2340 and / or its components can be combined in form and / or function with one or more other components described herein, such as with respect to Figure 8-14 For example, rod 2340 may be the same as Figure 8 The rod 2340 may be the same or similar to the inner cylindrical member 16 of the embodiment of the present invention. The rod 2340 may include a proximal end 2345 and a distal end 2355. In various embodiments, the surface finish of the rod 2340 may be approximately 75 micro-inches or smoother. For example, the surface finish of the rod 2340 may be 63 micro-inches or smoother. In some embodiments, all burrs and sharp edges may be removed. In many embodiments, the inner corner radius may be approximately 0.02 inches or less. For example, the inner corner radius may be only 0.015 inches. All dimensions are for illustration only, and other dimensions may be more suitable for specific applications. In addition, the dimensions described may be approximate values ​​that include tolerances, for example, the tolerances allow for positive and negative percentage variations from the described values. The embodiments are not limited to this context.

[0126] Fig.23 A first side view 2340A, a second side view 2340B, a cross-sectional view 2340C, a bottom view 2340D, and a top view 2340E of the rod 2340 may be included. In many embodiments, the rod 2340 may be the same or similar to the rod 2040. In addition, the protrusion 2046 of the rod 2040 may be used to describe a location on the rod 2340. The first side view 2340A may include a reference point AX. The reference point A may be the distal end 2355 of the rod 2340. The reference point B may be proximal to the protrusion 2046-1 and the distance between the reference points A and B may be between 0.02 and 0.03 inches, such as 0.026 inches. The reference point C may be distal to the protrusion 2046-2 and the distance between the reference points A and C may be between 0.05 and 0.07 inches, such as 0.058 inches. Reference point D can be proximal to protrusion 2046-2 and the distance between reference points A and D can be between 0.15 and 0.19 inches, such as 0.171 inches. Reference point E can be proximal to protrusion 2046-3 and the distance between reference points A and E can be between 0.42 and 0.53 inches, such as 0.469 inches. Angle 2303 between a line along the radial direction of rod 2340 and the distal side of protrusion 2046-3 toward the proximal end 2345 of rod 2340 can be between 0 degrees and 9 degrees, such as 3 degrees.

[0127] Reference point F can be distal to protrusion 2046-4 and the distance between reference points A and F can be between 0.58 and 0.65 inches, such as 0.612 inches. Reference point G can be at a step in protrusion 2046-4 and the distance between reference points A and G can be between 0.59 and 0.67 inches, such as 0.630 inches. In many embodiments, the step in protrusion 2046-4 can facilitate positioning and / or coupling of a one-way seal. Reference point H can be proximal to protrusion 2046-4 and the distance between reference points A and H can be between 0.63 and 0.69 inches, such as 0.659 inches. Reference point I can be distal to protrusion 2046-5 and the distance between reference points A and I can be between 0.70 and 0.76 inches, such as 0.731 inches. Reference point J can be at a step in protrusion 2046-5 and the distance between reference points A and J can be between 0.735 and 0.795 inches, such as 0.764 inches. In many embodiments, the step in protrusion 2046-4 can facilitate positioning and / or coupling of a one-way seal. Reference point K can be at a transition of protrusion 2046-4 and the distance between reference points A and K can be between 0.70 and 0.85 inches, such as 0.775 inches. Reference point L can be proximal to protrusion 2046-5 and the distance between reference points A and L can be between 0.75 and 0.85 inches, such as 0.796 inches.

[0128] Reference point M can be distal to protrusion 2046-6 and the distance between reference points A and M can be between 0.9 and 1.1 inches, such as 0.997 inches. Reference point N can be at a first transition in protrusion 2046-6 and the distance between reference points A and N can be between 0.9 and 1.2 inches, such as 1.043 inches. The radius of the fillet at the first transition can be between 0.009 and 0.015 inches, such as 0.012 inches. Reference point O can be at a second transition in protrusion 2046-6 and the distance between reference points A and O can be between 0.9 and 1.2 inches, such as 1.056 inches. Reference point P can be proximal to protrusion 2046-6 and the distance between reference points A and P can be between 0.92 and 1.22 inches, such as 1.066 inches. The angle 2305 between a line along the radial direction of the valve stem 2340 and the proximal side of the protrusion 2046-6 toward the distal end 2355 of the stem 2340 can be between 0 degrees and 9 degrees, such as 3 degrees.

[0129] Reference point Q can be distal to protrusion 2046-7 and the distance between reference points A and Q can be between 1.30 and 1.35 inches, such as 1.321 inches. An angle 2307 between a line along the radial direction of valve stem 2340 and the distal side of protrusion 2046-7 toward proximal end 2345 of stem 2340 can be between 0 and 9 degrees, such as 3 degrees. Reference point R can be at a transition in protrusion 2046-7 and the distance between reference points A and R can be between 1.3 and 1.4 inches, such as 1.349 inches. A fillet radius 2309 at the transition can be between 0.009 and 0.015 inches, such as 0.012 inches. Reference point S can be proximal to protrusion 2046-7 and the distance between reference points A and S can be between 1.31 and 1.43 inches, such as 1.367 inches.

[0130] Reference point T may be distal to protrusion 2046-8 and the distance between reference points A and T may be between 1.60 and 1.67 inches, such as 1.633 inches. Reference point U may be at a transition in protrusion 2046-8 and the distance between reference points A and U may be between 1.61 and 1.72 inches, such as 1.667 inches. The radius of the fillet at the transition may be between 0.009 and 0.015 inches, such as 0.012 inches. Reference point V may be proximal to protrusion 2046-8 and the distance between reference points A and V may be between 1.65 and 1.75 inches, such as 1.697 inches. Reference point W may be distal to protrusion 2046-9 and the distance between reference points A and W may be between 1.73 and 1.85 inches, such as 1.776 inches. Reference point X can be at the distal end of rod 2340 and the distance between reference point A and X can be between 1.78 and 1.90 inches, such as 1.826 inches. Each of protrusions 2046-8, 2046-9 can have an outer diameter 2311 between 0.34 and 0.36 inches, such as 0.348 inches. Additionally, the angle 2301 between the opposing walls of the cavity can be between 0 and 5 degrees, such as 1 degree.

[0131] Referring to the second side view 2340B, the width 2313 of the cavity at the distal end 2355 of the rod 2340 can be between 0.06 and 0.08 inches, such as 0.66 inches. In many embodiments, the plug 2148 can form a slight interference fit with the cavity at the distal end 2355 of the rod 2340 to seal the cavity at the distal end 2355 of the rod 2340. The distance between the distal end of the rod 2340 and the center of the distal orifice can be between 0.10 and 0.13 inches, such as 0.115 inches. The diameter 2328 of the distal orifice can be between 0.07 and 0.09 inches, such as 0.080 inches. The distance between the distal end 2355 of the rod 2340 and the center of the proximal orifice can be between 0.8 and 1.0 inches, such as 0.896 inches. The diameter of the proximal orifice can be between 0.07 and 0.09 inches, such as 0.080 inches. The illustrated embodiment includes distal apertures on both sides of the rod 2340 and proximal apertures on both sides of the rod 2340 .

[0132] The outer diameter 2321 of the rod 2340 can be between 0.09 and 0.13 inches, such as 0.110 inches. The width 2319 of the protrusion 2046-3 can be between 0.02 and 0.03 inches, such as 0.025 inches. The outer diameter 2327 of the proximal step of the protrusion 2046-4 and the outer diameter of the distal step of the protrusion 2046-5 of the one-way seal 1862 can be between 0.18 and 0.22 inches, such as 0.200 inches, with a tolerance of + / - 0.003 inches. The outer diameter 2323 of the rod 2340 between the protrusions 2046-4, 2046-5 can be between 0.12 and 0.14 inches, such as 0.13 inches. The length 2339 of the cavity of the rod 2340 can be between 0.7 and 1.0 inches, for example 0.849 inches. The width 2337 of the cavity at the proximal end 2345 of the rod 2340 may be between 0.12 and 0.14 inches, such as 0.13 inches.

[0133] The outer diameter 2329 of the protrusion 2046-6 can be between 0.36 and 0.39 inches, such as 0.371 inches, with a tolerance of + / - 0.003 inches. The outer diameter 2333 of the protrusion 2046-7 can be between 0.38 and 0.42 inches, such as 0.400 inches. The outer diameter 2331 of the rod 2340 between the protrusions 2046-6, 2046-7 can be between 0.18 and 0.22 inches, such as 0.200 inches. The outer diameter 2335 of the rod 2340 between the protrusions 2046-8, 2046-9 can be between 0.25 and 0.30 inches, such as 0.275 inches.

[0134] Referring to cross-sectional view 2340C, the diameter of protrusion 2046-2 can be between 0.14 and 0.18 inches, such as 0.160 inches. Additionally, the angle 2341 at which protrusion 2046-2 is inclined from the center of the cavity toward each of the distal orifices at the radial extent of protrusion 2046-2 can be between 6 degrees and 14 degrees, such as 10 degrees. Other techniques, features and / or components related to clean valve assemblies that can be used herein are disclosed in U.S. non-provisional patent application entitled “Device, System, and Technology for Medical Clean Valves” with attorney docket number 8150.0717 filed on the same date as this application, the entire contents of which are incorporated herein by reference.

[0135] According to the present invention, all devices and / or methods disclosed and claimed herein can be made and performed without undue experimentation. Although the devices and methods of the present invention have been described in preferred embodiments, it is obvious to those skilled in the art that changes can be made to the devices and / or methods and to the steps or sequences of steps of the methods described herein without departing from the concept, spirit and scope of the present invention.

Claims

1. A cleaning valve, comprising: Valve stem; an interface member including a proximal end having a proximal surface and a first connector portion and a second connector portion, the first connector portion being coupleable to the valve stem; as well as a first indicator comprising at least a first raised surface and a second raised surface on the proximal surface of the interface member; wherein said at least first and second raised surfaces have a texture that provides a tactile distinction of said clean valve from a surgical valve; and Wherein the first raised surface comprises a symbol and the second raised surface comprises a geometric shape surrounding the symbol.

2. The cleaning valve of claim 1, wherein the interface member includes a spring portion.

3. A cleaning valve according to claim 2, wherein the spring portion of the interface member includes an annular wall having a first portion, a second portion distal to the first portion, and a third portion distal to the second portion, and wherein the thickness of the annular wall is smaller at the second portion than at both the first and third portions.

4. The cleaning valve of claim 3, wherein the annular wall is expandable radially outward at the second portion in response to a force applied to the proximal surface.

5. The cleaning valve according to any one of claims 1 to 4, wherein the second connector portion is disposed at a distal end of the interface member such that the second connector portion is separate from the valve stem.

6. The cleaning valve of claim 5, wherein the second connector portion is removably attached to a valve well of an endoscope.

7. The cleaning valve of any one of claims 1 to 4, wherein in the attached configuration, the valve stem and the interface member are movable between a first configuration and a second configuration such that the valve stem is movable within a valve well of an endoscope.

8. The cleaning valve of any one of claims 1 to 4, further comprising one or more seals disposed along the valve stem.

9. The clean valve of any one of claims 1 to 4, wherein the first connector portion of the interface member is configured to couple with the valve stem via an interference fit.

10. A cleaning valve according to any one of claims 1 to 4, comprising a second indicator extending laterally from the interface member. The cleaning valve of claim 10 , wherein the second indicator comprises a label.

12. The clean valve of claim 11, wherein the label is integrally attached to the interface member.

13. The cleaning valve of claim 11, wherein the label is removably attached to the interface member.

14. The cleaning valve of any one of claims 1-4, wherein the symbol is an exclamation point, and the geometric shape is selected from a triangle, a rhombus, or a hexagon.

15. The cleaning valve of any one of claims 1-4, wherein the symbol is an exclamation point and the geometric shape is a square.

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