Devices, systems and methods for medical cleaning of valves

Abstract

A medical purge valve (or purge valve) may be configured to provide a purge function to fluid (e.g., air and water) channels of an endoscope. Many embodiments described herein may include purge valves (or valves) that are suitable for single use and thus may be disposable. Thus, the valve may be made from a limited number of parts and materials, for example, to limit its cost and / or manufacturing complexity. For example, a plurality of seals may be integrally formed with the stem. In another example, the valve may have an interface member that may merge and simplify the functionality of several components, such as by connecting a valve stem to a valve well, sealing an opening to an internal cavity in the valve stem, and / or biasing the valve stem to a position relative to the valve well.

Description

(Division of 202080028917.6) Related Applications

[0001] Pursuant to Section 119 of Title 35 of the United States Code, this application claims priority to U.S. Provisional Patent Application No. 62 / 844,465, filed on May 7, 2019, entitled “Medical Flushing Valve,” the entire contents of which are incorporated herein by reference.

[0002] Pursuant to Section 119 of Title 35 of the United States Code, this application claims priority to U.S. Provisional Patent Application No. 62 / 923,197, filed on October 18, 2019, entitled “DEVICES, SYSTEMS, METHODS, AND DESIGNS FOR MEDICAL PURGE VALVES,” the entire contents of which are incorporated herein by reference.

[0003] Pursuant to Section 119 of Title 35 of the United States Code, this application claims priority to U.S. Provisional Patent Application No. 63 / 002,759, filed on March 30, 2020, entitled “DEVICES, SYSTEMS, AND METHODS FOR MEDICAL PURGE VALVES,” the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present disclosure generally relates to valves for medical devices. In particular, the disclosure relates to purge valves for medical devices. Background Art

[0005] Endoscopes include functions for delivering fluids (including air and water) and for suctioning at the surgical site. The conduit for delivering fluids and / or suction extends from the handle of the endoscope through the shaft of the endoscope to the distal tip of the endoscope. During surgery, body fluids, tissues, or other materials may accumulate in the conduit. In order to facilitate the reprocessing of reusable endoscopes between surgeries, pretreatment is performed in the endoscope set. For example, water or other fluids are flushed through the conduit after the endoscope is removed from the patient, thereby removing debris from the air / water and / or suction conduits. To achieve this purpose, a purge valve can be inserted into the air / water valve cylinder of the endoscope after the endoscope is removed from the patient and the surgical valve is removed from the valve cylinder. The operator can then press the button of the purge valve for a predetermined amount of time (e.g., 30 seconds) to flush the air and / or water channels of the endoscope with air and / or flush the air channels with water before further reprocessing of the endoscope. One option for achieving this preprocessing is a reusable purge valve. Such a reusable purge valve may include several components, including a valve stem (often made of metal), some seals, springs, spring sleeves, shields, and / or interface members (e.g., a valve stem cap or button). Many components in a reusable purge valve may be removable and / or replaceable components, for example, to facilitate maintenance on the reusable purge valve. However, the replaceability of the purge valve components may increase the cost and complexity of the purge valve. For example, manufacturing many independent components and assembling them together may significantly increase both the cost and complexity of the purge valve. In addition, the reusable purge valve itself must be cleaned between uses, which may increase reprocessing costs. Taking all of the above factors into account, improvements disclosed herein may be useful. Summary of the invention

[0006] In one aspect, the present disclosure relates to a valve for a medical device, the valve comprising a valve stem and one or more seals. The valve stem may include a proximal end, a distal end, one or more orifices, and an inner cavity in fluid communication with at least one of the one or more orifices. One or more seals may be located between the proximal end and the distal end of the valve stem. The valve stem and the one or more seals may constitute an integral structure. In many embodiments, the valve stem and the one or more seals may include a first material. In many such embodiments, the first material may include a polymer. In some embodiments, the proximal end of the valve stem may include an orifice in the one or more orifices. In some such embodiments, the valve stem is configured to be coupled to an interface member. In several embodiments, the valve may include an interface member, and the interface member may be configured to seal the orifice when the valve stem is coupled to the interface member. In various embodiments, the interface member may be configured to surround at least one of the one or more seals when the valve stem is coupled to the interface member. In some embodiments, the one or more orifices may include a first orifice and a second orifice located between the proximal end and the distal end of the valve stem. In some such embodiments, the one or more seals may include a first seal and a second seal located between the first orifice and the second orifice. In other embodiments, one or more seals may include a third seal located distally of the first and second orifices. In one or more embodiments, one or more seals may include a seal comprising a first portion having a first thickness and a second portion having a second thickness thinner than the first thickness. In one or more such embodiments, the first thickness is greater than 0.015 inches and the second thickness is less than 0.015 inches. In other embodiments, the first thickness of the seal transitions to the second thickness of the seal at an angle between 25 degrees and 45 degrees. In some embodiments, the second portion may extend radially outwardly beyond the first portion by at least 0.01 inches. In many such embodiments, the second portion is configured to form an interference fit with the valve well. In one or more embodiments, each seal of the one or more seals may be configured to form an interference fit with the valve well.

[0007] In another aspect, the present disclosure relates to a method of manufacturing. The method may include forming a valve stem as an integral structure, the valve stem including a proximal end, a distal end, one or more seals, one or more orifices, and an inner cavity in fluid communication with at least one of the one or more orifices. In various embodiments, the method may include sealing at least one of the one or more orifices with an interface member. In some embodiments, the method may include removing the molded core pin from the inner cavity through an orifice in the one or more orifices, wherein the orifice is included in the proximal end of the valve stem. In various embodiments, the method may include forming a valve stem with a closed distal end. In one or more embodiments, the method may include forming the valve stem from a polymer material. In several embodiments, the method may include forming at least one of the one or more seals, wherein the first portion has a first thickness and the second portion has a second thickness, wherein the second portion is a radially outward portion of the first portion and the second thickness is thinner than the first thickness.

[0008] In yet another aspect, the present disclosure relates to a valve for medical devices, the valve comprising an interface member, a valve stem, and two or more seals. The interface member can be removably connected to the valve stem. The valve stem may include a proximal end, a distal end, two or more orifices, and an inner cavity that is fluidly connected to the first orifice and the second orifice in the two or more orifices. The first orifice may be located close to the distal end of the valve stem. At the proximal end of the valve stem, the inner cavity may be blocked by the interface member. The two or more seals may include a first seal and a second seal, wherein the first seal is located between the proximal end of the valve stem and the second orifice and the second seal is located between the second orifice and the distal end of the valve stem. In many embodiments, the distal end of the valve stem is closed, and the inner cavity terminates at or terminates distally beyond the first orifice and in front of the closed distal end. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Non-limiting embodiments of the present disclosure are described below by way of example and with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In each of the drawings, each identical or nearly identical illustrated component is generally represented by a single numeral. For clarity, not every component is labeled in each of the drawings, nor is every component of each embodiment shown, where an illustration is not necessary to allow a person skilled in the art to understand the present disclosure. In each of the drawings:

[0010] Figure 1A A front view of an exemplary purge valve according to the disclosure described herein is shown.

[0011] Figure 1B A cross-sectional view of an exemplary purge valve according to the disclosure described herein is shown.

[0012] Figure 2AA cross-sectional view of an exemplary purge valve and valve well in a first configuration is shown according to the disclosure described herein.

[0013] Figure 2B A cross-sectional view of an exemplary purge valve and valve well in a second configuration is shown according to the disclosure described herein.

[0014] Figure 3A-3C Various aspects of an exemplary integral valve stem according to the disclosure described herein are shown.

[0015] Figure 4A-4C Various aspects of exemplary interface components according to the disclosure described herein are shown.

[0016] Figure 5A-5C Various aspects of an exemplary valve stem according to the disclosure described herein are shown.

[0017] Figure 6A-6H Various aspects of an example valve stem assembly according to the disclosure described herein are shown.

[0018] Figure 7A-7G Exemplary indicators according to the disclosure described herein are shown. DETAILED DESCRIPTION

[0019] A medical purge valve (or purge valve) may be configured to provide a purge function to a fluid (e.g., air and water) channel of an endoscope. In a first configuration, the purge valve may provide air (or carbon dioxide) to both the air and water channels in the handle and shaft of the endoscope and a continuous feed through an air / water nozzle at the distal end of the endoscope. In a second configuration, the purge valve may feed water into the air channels in the handle and shaft of the endoscope and through an air nozzle at the distal end of the endoscope. Many embodiments described herein may include a purge valve (or valve) that is suitable for single use and is therefore disposable. Thus, the valve may be made of a limited number of parts and materials, for example to limit its cost and / or manufacturing complexity. For example, a plurality of seals may be integrally formed with the valve stem. In another example, the valve may have an interface member (e.g., a cap) that combines and simplifies the functions of several components, for example, by connecting the valve stem to a valve well, sealing the opening to the lumen in the valve stem, and / or offsetting the valve stem to a position relative to the valve well. In yet another example, the valve stem may be formed with a closed distal end (see, e.g. Figure 1BAchieving the disposable nature of the purge valve in an economically feasible manner can result in safer purge valves that can minimize or prevent the spread of infection by eliminating or reducing the chance of bacteria being inadvertently introduced into a patient (e.g., due to improper cleaning of a reusable purge valve). Additionally, eliminating the need to reprocess the purge valve between uses can reduce or eliminate the personnel, validation processes, processing equipment, time, and / or funds required for reprocessing.

[0020] It is understood that the disclosure included herein is exemplary and is only illustrative and not restrictive. As used herein, the terms "comprise", "comprising" or any other variant thereof are intended to cover non-exclusive inclusion, so that a step, method, article or device that includes a series of elements includes not only these elements, but also may include other elements that are not explicitly listed or unique to such steps, methods, articles or devices. The term "exemplary" is used in the sense of "exemplary" rather than "ideal". As used herein, the term "proximal" means the direction closer to the surface (e.g., button) used by the operator to operate the valve, and the term "distal" means the direction away from the surface (e.g., button) used by the operator to operate the valve. Although endoscopes are mentioned herein, reference to endoscopes or endoscopic examinations should not be understood to limit the possible applications of the disclosed aspects. For example, the disclosed aspects may be applicable to duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices.

[0021] Reference is now made to the accompanying drawings, in which similar reference numerals are used to refer to similar elements in all the accompanying drawings. In the following description, for the purpose of explanation, many specific details are stated to provide a detailed understanding thereof. However, it is apparent that these novel embodiments can be implemented without these specific details. In other cases, well-known structures and devices are shown in the form of block diagrams for the convenience of their description. It is intended to encompass all modifications, equivalents, and substitutes within the scope of the claims.

[0022] Figure 1A and Figure 1B Various aspects of an exemplary purge valve 102 according to the present disclosure described herein are shown. More specifically, Figure 1A A front view of the purge valve 102 is shown having a proximal end 145 and a distal end 155, and Figure 1B 1 shows a cross-sectional view of a purge valve 102 having a proximal end 145 and a distal end 155. In general, the purge valve 102 may include an interface member 104, an integral valve stem 106, and a one-way seal 108. Figure 1A , a wireframe version of the interface member 104 is shown. Figure 1A As shown in , the integral valve stem 106 may extend along a longitudinal axis and may include seal seating members 110-1, 110-2 (i.e., seating members 110), seals 112-1, 112-2, 112-3, 112-4 (i.e., seals 112), centering surfaces 114-1, 114-2, 114-3, 114-4 (i.e., centering surfaces 114), and fixing flanges 116-1, 116-2 (i.e., fixing flanges 116) arranged along the longitudinal axis of the integral valve stem 106. Figure 1B As shown in , the interface member 104 may include a spring portion 118, stem grooves 120-1, 120-2 (ie, stem grooves 120), a stem plug 122, a well groove 124, a protrusion 125, and a retaining member 126. Figure 1B As shown in , the integral valve stem 106 may include an inner cavity 128 with orifices 130-1, 130-2, 130-3 (i.e., orifice 130), wherein orifice 130-1 is open along the longitudinal axis and orifices 130-2, 130-3 extend generally perpendicularly relative to the longitudinal axis of the integral valve stem 106. In one or more embodiments described herein, the cleaning valve 102 can be used for cleaning / reprocessing of endoscopes and / or related equipment, such as at the end of a procedure. The embodiments are not limited to this context.

[0023] In many embodiments, the purge valve 102 can be inserted into a valve well of an endoscope (e.g., Figure 2A and Figure 2B In many such embodiments, the interface member 104 can be pressed to cause the fluid to rush out and clean the various parts of the valve well and the various components connected to the valve well fluid. Many embodiments described herein may include an integral valve stem (e.g., an integral valve stem 106) formed during manufacturing using a molded core pin that can be removed through the orifice 130-1 at the proximal end 145 of the integral valve stem. In many such embodiments, the orifice 130-1 is blocked by the valve stem plug 122 when the interface member 104 is assembled. In various embodiments, the valve stem 106 can be formed with a closed distal end 155 (e.g., no orifice on the distal end). In this way and other ways, the construction and assembly of the cleaning valve 102 can be simplified, for example by minimizing the number of independent parts required to make the cleaning valve and minimizing the assembly steps for the cleaning valve. Additionally or alternatively, the various embodiments described herein may apply techniques to integrally form one or more components (e.g., the seal 112) of the purge valve 102 with the integral valve stem 106 (e.g., from the same materials and / or at the same time), such as to minimize the number of separate parts required to manufacture the purge valve and to minimize the assembly steps used to purge the valve.

[0024] In many embodiments, one or more components of the integral valve stem 106, such as one or more of the seating member 110, the seal 112, the centering surface 114, the retaining flange 116, the inner cavity 128, and the orifice 130, can be integrally formed as a unitary structure. In other words, in several embodiments, the integral valve stem 106 can include a valve stem and one or more other components formed as a unitary structure. For example, during manufacturing, the inner cavity 128 can be formed with a molded core pin (or core pin). In such an example, the molded core pin can be used as a support and / or manipulation member when forming other components of the integral valve stem 106. In addition, the molded core pin can be removed through the orifice 130-1. In another example, the integral valve stem 106 can include a valve stem having one or more seals (e.g., the seal 112) and / or a flange (e.g., the centering surface 114 or the retaining flange 116) formed as a unitary structure.

[0025] Thus, in many of the embodiments described herein, the use of the term "integral valve stem" may include a valve stem that is integrally formed with at least one seal and / or at least one flange, regardless of whether other seals and / or flanges are integrally formed with the valve stem (see, e.g., Figure 5A ). However, one or more of the valve stem formation and valve assembly features described herein (e.g., a valve stem formed using a molded core pin that can be removed through an orifice at the proximal end of the valve stem and then plugged with a valve stem plug of an interface member) can be applied to a valve stem that is not a unitary valve stem (e.g., a valve stem assembled from two pieces), or to a valve stem that is partially unitary (e.g., a first portion of the valve stem is integrally formed with one or more seals and / or flanges, and one or more seals and / or flanges for a second portion of the valve stem are not integrally formed with the second portion of the valve stem). In one embodiment, only the valve stem itself may be integrally formed. Thus, in some embodiments, the unitary valve stem may not be integrally formed with any seals and / or flanges.

[0026] Additionally or alternatively, in some embodiments, one or more aspects of the interface member 104 and / or the one-way seal 108 can be formed as part of the integral valve stem 106. In one or more embodiments, different materials can be used during the formation of the integral valve stem 106. In various embodiments, some components of the purge valve 102 can be assembled, overmolded, and / or formed through other processing of the integral valve stem 106. For example, one or more seals 112 can be overmolded and / or assembled to the integral valve stem 106. In this case, one or more seals 112 can be independently formed from another material and then assembled to the integral valve stem 106, or can be overmolded directly to the integral valve stem 106.

[0027] exist Figure 1A and Figure 1BIn the illustrated embodiment of the present invention, the seat member 110, the seal 112, the centering surface 114, the fixing flange 116, the inner cavity 128, and the orifice 130 are each integrally formed as part of the integral valve stem 106. The seat member 110 may include circumferential protrusions that define grooves between them. When assembled, the seat members 110-1, 110-2 may be at least partially embedded in the valve stem grooves 120 of the interface member 104, respectively. In addition, the protrusions 125 of the interface member 104 may be at least partially embedded in the grooves defined between the seat members 110 of the valve stem. Therefore, in some embodiments, the interface member 104 and the integral valve stem 106 can be attached together by snap fit. In some such embodiments, the snap fit can be a snap interference fit. It is understood that the proximal end of the valve stem and the interface member may have any interlocking or mating features (e.g., protrusions, grooves, etc.) for attachment.

[0028] Similarly, the valve well recess 124 and the retaining member 126 of the interface member 104 can be used to engage the valve well via a corresponding circumferential protrusion (e.g., at Figure 2A The connection flange 236 of the valve well 232 in the middle of the cleaning valve 102 connects the cleaning valve 102 to the valve well. The connection between the interface members 104 of the cleaning valve 102 can be a snap fit and / or a snap interference fit. The fixed flange 116 of the integral valve stem 106 may include circumferential protrusions that define a groove between them for receiving the one-way seal 108. As should be understood, many techniques for attaching the interface member 104 to the integral valve stem 106, attaching the one-way seal 108 to the integral valve stem 106, and / or attaching the cleaning valve 102 to the valve well can be applied without departing from the scope of the present disclosure. In many embodiments, the interface member 104 may include a cap. In some embodiments, instead of or in addition to one or more of the centering surfaces 114, one or more of the fixed flanges 116 may provide a centering surface.

[0029] like Figure 1BAs shown in , the one-way seal 108 may include an inner core 107 and an outer edge 109. In various embodiments, the one-way seal 108 may include one or more features to prevent the outer edge 109 from reversing during use. For example, the one-way seal 108 may include one or more ridges connecting the outer edge 109 to the inner core 107. In another example, one or more ribs may be attached to the outer edge 109. In some examples, one or more ribs and / or ridges may be attached to an outer edge with a uniform thickness. In yet another example, the thickness of the outer edge 109 may be varied. In various embodiments, the height of one or more ridges and / or ribs may be a portion of the height of the inner core 107 and / or outer edge 109. For example, one or more ridges and / or ribs may be the same height or half the height of the inner core 107 and / or outer edge 109. In many embodiments, the ribs and / or ridges may be aligned with the longitudinal (and / or radial) axis of the valve stem 106. In one or more embodiments, the ribs and / or ridges can be angled relative to the longitudinal (and / or radial) axis of the valve stem 106. In various embodiments, one or more ribs and / or ridges can be arranged around the circumference of the inner core 107. For example, one or more ribs and / or ridges can be equally spaced (or unequally spaced) around the circumference of the inner core 107.

[0030] In various embodiments, the spring portion 118 of the interface member 104 can be used to facilitate the conversion of the purge valve 102 from the first configuration to the second configuration when installed in the valve well. For example, the first configuration can be a standby state and the second configuration can be a flushing state. In some embodiments, the spring portion 118 can bias the purge valve to one of the first configuration and the second configuration. For example, the spring portion 118 can bias the purge valve 102 to the standby state, and the purge valve 102 can be converted to the flushing state by pressing the interface member 104 toward the distal end 155. This aspect and other aspects of different configurations of the purge valve 102 will be described in more detail below, such as according to Figure 2A and Figure 2B .

[0031] The centering surface 114 of the integral valve stem 106 may include circumferential protrusions that are used to align the purge valve 102 with the valve well of the endoscope (e.g., Figure 2AIn some embodiments, the centering surfaces 114 may be sized to fit with a slight clearance of the inner diameter of the valve well. In various embodiments, the centering surfaces 114 may ensure that one or more of the components (e.g., seals) are aligned for proper function. For example, the centering surfaces 114-3, 114-4 may ensure that the seals 112-3, 112-4 are properly aligned to form a seal with the valve well. In several embodiments, one or more of the centering surfaces 114 may include one or more features (e.g., angled transitions or rounded edges) to guide the purge valve 102 to align with the valve well.

[0032] In the illustrated embodiment, the centering surfaces 114-1, 114-2 may have a first diameter and the centering surfaces 114-3, 114-4 may have a second diameter. In such an embodiment, the centering surfaces 114-1, 114-2 may facilitate proper alignment of the purge valve 102 with a valve well of the first diameter, and the centering surfaces 114-3, 114-4 may be used to facilitate proper alignment of the purge valve 102 with the valve well of the second diameter (see, e.g., Figure 2A ). In addition, one or more of the flange 116 and / or the centering surface 114 can be used to facilitate the secondary molding process. For example, the seals 112-3, 112-4 can be formed using a secondary molding process, and the centering surfaces 114-3, 114-4 can be used to maintain flow from the secondary molding process from the proximal side of the centering surface 114-3 and / or the distal side of the centering surface 114-4.

[0033] The seal 112 may include a wiper blade seal geometry. In several embodiments, the wiper blade seal geometry may be used in conjunction with smooth and / or flexible materials, such as polymers (e.g., polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), high-density polyethylene (HDPE), nylon, polyetheretherketone (PEEK), thermoplastics, plastics, etc.). In many embodiments, the seal 112 may include a thin portion or a wiper portion that deforms when introduced into the valve well. In several embodiments, the seal may form a slight interference fit with the valve well. For example, the wiper portion may be deflected proximally while also being compressed radially inwardly so that it can slide into the inner diameter of the valve well and remain in contact with the valve well to prevent fluid from flowing longitudinally through the seal in either direction. In various embodiments, the wiper seal can be used to accommodate larger manufacturing tolerances, such as by allowing a wider range of diameters and consistent friction for sealing.

[0034] This thin wall geometry can allow for the use of a much more rigid material, such as high density polyethylene (HPDE), which can also facilitate the seal being formed from the same material as the integral valve stem. For example, the nominally thicker walls of the inner cavity can provide the integral valve stem with sufficient rigidity and strength during use, while the inner wall of at least a portion of the seal provides the seal with sufficient flexibility. This and other aspects of the integral valve stem 106 are described in detail below, such as with respect to Figure 3A-3C .

[0035] The lumen 128 of the integral valve stem 106 may include a channel that places one or more orifices 130 in fluid communication. In the illustrated embodiment, the lumen 128 places orifices 130-2, 130-3 in fluid communication, and the valve stem plug 122 of the interface member 104 seals the orifice 130-1 and prevents fluid from leaking through the orifice 130-1. The distal end of the lumen 128 may be closed or sealed by a portion of the integral valve stem 106.

[0036] In various embodiments, the orifice 130 may include one or more axial and / or one or more radial holes. For example, the orifice 130-1 may include an axial hole and each of the orifices 130-2, 130-3 may include individual radial through holes spaced around the circumference of the valve stem 106. In other embodiments, for example, a different number of radial through holes may be used, such as two staggered radial through holes for each orifice 130-2, 130-3. As will be described in more detail below, in various embodiments, the orifices 130-2, 130-3 may allow fluid to flow from the outer diameter of the integral valve stem to the inner cavity 128 in the inner diameter.

[0037] Figure 2A and Figure 2B Various configurations of an exemplary purge valve 202 of an endoscope according to the present disclosure described herein are shown along with an exemplary valve well 232. More specifically, Figure 2A A first configuration of the purge valve 202 is shown together with the valve well 232, Figure 2B A second configuration of the purge valve 202 is shown along with the valve well 232. The first configuration may include a standby state (e.g., loaded into the valve well 232, but not depressed by the user) while the second configuration may include a flushing state (e.g., loaded into the valve well 232 and depressed by the user). In many embodiments, Figure 2A and Figure 2B One or more components shown in the drawings may be the same or similar in construction, function, and / or appearance to one or more other components described herein. For example, the purge valve 202 may be the same or similar to the purge valve 102. The embodiments are not limited to this context.

[0038] Figure 2A and Figure 2BIt includes a cleaning valve 202 and a valve well 232. Figure 2A , the purge valve 202 is illustrated with a spring portion 218-A, which may correspond to a first configuration. Figure 2B In FIG. 1 , the purge valve is shown having a spring portion 218-B, which may correspond to the second configuration. Figure 2A and Figure 2B In both, the valve well 232 includes inlets 234-1, 234-2, 234-3, 234-4 (i.e., inlet 234) arranged along the longitudinal axis of the valve well 232 and the connecting flange 236. In various embodiments, inlet 234-1 can be used as an air outlet, inlet 234-2 can be used as an air inlet, inlet 234-3 can be used as a water outlet, and inlet 234-4 can be used as a water inlet in the event that the valve well 232 is used during surgery (e.g., a need to clean / reprocess the purge valve 202 arises during surgery on a patient). As used herein, the inlet does not indicate the direction of flow, so fluid can flow into or out of the inlet. As previously described, the connecting flange 236 may include a circumferential protrusion that facilitates snap-fitting the purge valve 202 to the valve well 232.

[0039] In various embodiments, in a first configuration (e.g., a standby state), the purge valve 202 is loaded into the valve well 232 but is not depressed (e.g., by a user). The interface member may snap and / or engage with the valve well 232 to hold the purge valve 202 in the valve well 232 against positive system pressure. The pump may pump a fluid (e.g., air or CO2) into the inlet 234-2. As in Figure 2A As shown by flow arrow 235A in FIG. 2 , in a first configuration, fluid may flow through purge valve 202 and valve well 232 as follows. The fluid may be transferred proximally through the one-way seal (e.g., due to the pressure of the fluid, the thin wall of the one-way seal, and the orientation of the one-way seal, the seal can be compressed radially inward). The fluid may then flow out of valve well 232 through inlet 234-1 and into the lumen of the integral valve stem through an orifice (e.g., orifice 130-2), down the lumen, and out of the lower orifice (e.g., orifice 130-3) before exiting valve well 232 through inlet 234-3. In addition, in the first configuration, inlet 234-4 is blocked due to the distal-most seal position (e.g., seal 112-4).

[0040] In the second configuration (e.g., flushing state), the valve can be depressed by the user and the inlet 234-2 is blocked, being closed distally by the seal 112-2 and the one-way seal bottoming out distally on the inner diameter of the valve well so that there is no flow. In this configuration, the inlet 232-4 is opened due to the movement of the seal at the distal end, such as Figure 2B234-1 . As shown by flow arrow 235B in the figure, this allows water to flow into the distal valve stem fluid orifice (e.g., orifice 130-3 including four radial holes), flow upward along the inner cavity and out of the proximal fluid orifice (e.g., orifice 130-2) where the water is then forced to flow out of the inlet 234-1. The most proximal wiper seal (e.g., seal 112-1) prevents water from leaving the valve well and is prevented from traveling distally by the one-way seal. It should be understood that although not shown for simplicity, water flows 235A, 235B can travel circumferentially between the interior of the valve well 232 and the exterior of the integral valve stem 106 to enter / exit each of the multiple holes including the orifice. In various embodiments, the one-way seal 1862 can be made of a thermoplastic elastomer (TPE) (such as Versaflex ) In some embodiments, the one-way seal 1862 can be transparent / translucent.

[0041] Figure 3A-3C Various aspects of an example integral valve stem 306 according to the disclosure described herein are shown. Figure 3A A first side view of the integral valve stem 306 is shown. The integral valve stem 306 can include apertures 330-1, 330-2, 330-3, seals 312-1, 312-2, 312-3, 312-4, a proximal end 345, and a distal end 355. Figure 3A Also included is a front view 348 of the proximal end 345 of the integral valve stem 306 . Figure 3B A second side view of the integral valve stem 306 is shown. Figure 3C A cross section 340 of the integral valve stem 306 at the seal 312-4, a cross section 342 of the seal 312-2 (which may be representative of the seals 312-2, 312-3, 312-4), and a cross section 344 of the seal 312-1 are shown. In many embodiments, Figure 3A-3C One or more components shown in the embodiment may be the same or similar in construction, function, and / or appearance to one or more other components described herein. For example, the integral valve stem 306 may be the same or similar to the integral valve stem 106. The embodiments are not limited to this context.

[0042] Reference Figure 3A , the integral valve stem 306 may include a proximal end 345 and a distal end 355 . Figure 3C340 and profiles 342, 344 are shown in FIG. The distance 352 between the section 340 and the proximal end 345 of the integral valve stem 306 may be between 1.25 inches and 2.25 inches. For example, the distance 352 may be 1.77 inches. The diameter between the opposing walls of the lumen may increase from the distal end 355 to the proximal end 345. Thus, the diameter between the opposing walls of the lumen may increase between the proximal end 345 and the distal end 355 at an angle 346 between 0 degrees and 10 degrees. For example, the angle 346 may be 3 degrees. In various embodiments, the increase in diameter from the distal end 355 to the proximal end 345 may facilitate efficient removal of the core pin through the proximal end 345 of the integral valve stem 306.

[0043] In many embodiments, the seal 312 may extend beyond the corresponding bearing surface of the integral valve stem 306. This may result in the seal 312 having a slight interference fit with the interior of the valve well. These slight interference fits may form a wiper blade seal with the interior of the valve well to control the flow of fluid through the valve well while still allowing the integral valve stem 306 to slide up and down in the valve well. In many embodiments, the seal 312-1 may have a first set of dimensions while the seals 312-2, 312-3, 312-4 share a second set of dimensions. For example, the seals 312-2, 312-3, 312-4 may have a first diameter and the seal 312-1 may have a second diameter. In many such embodiments, the second diameter is greater than the first diameter.

[0044] As shown in the front view 348 of the proximal end 345 of the integral valve stem 306, the seal 312-1 can have a diameter 350. The diameter 350 can be between 0.25 inches and 0.75 inches and have a tolerance between 0 inches and 0.01 inches. For example, the diameter 350 can be 0.382 inches and have a tolerance of + / - 0.003 inches. The front view 348 of the proximal end 345 of the integral valve stem 306 also shows the orifice 330-1. In many embodiments, the orifice 330-1 can be blocked by an interface member (e.g., the interface member 104 of the purge valve 102). Referring to Figure 3C As shown in cross section 340, seal 312-4 (which may also be representative of seals 312-2, 312-3) may have a diameter 360. Diameter 360 may be between 0.175 inches and 0.3 inches and have a tolerance between 0 inches and 0.01 inches. For example, diameter 360 may be 0.242 inches and have a tolerance of + / - 0.003 inches. Still referring to Figure 3C , section 344 illustrates various dimensions of seal 112 - 1 and section 342 illustrates various dimensions of seal 312 - 2 (which may also be representative of seals 312 - 3 , 312 - 4 ).

[0045] The profile 342 may include dimensions 362, 364, 366, 368, 370, 372. Dimension 362 may include a thickness close to the outer extent of the seal 312-2. In some embodiments, dimension 362 may be between 0.002 inches and 0.01 inches. For example, dimension 362 may be 0.006 inches. Dimension 364 may include an angle at which the outer portion of the seal 312-2 narrows. In various embodiments, dimension 364 may be between 0 degrees and 10 degrees. For example, dimension 364 may be 2 degrees. Dimension 366 may include the thickness of the inner portion of the seal 312-2. In many embodiments, dimension 366 may be between 0.01 inches and 0.03 inches. For example, dimension 366 may be 0.02 inches. Dimension 368 includes an angle at which the thickness of the inner portion of the seal 312-2 changes to the outer thickness transition. In some embodiments, dimension 368 may be between 15 degrees and 75 degrees. For example, dimension 368 may be 45 degrees. Dimension 370 includes the radius of the outer extension of seal 312-2. In several embodiments, dimension 370 can be between 0.001 inches and 0.006 inches. For example, dimension 370 can be 0.003 inches. Dimension 372 includes the width of the outer portion of seal 312-2. In various embodiments, dimension 372 can be between 0.01 inches and 0.03 inches. For example, dimension 372 can be 0.02 inches.

[0046] The profile 344 may include dimensions 374, 376, 378, 380, 382, ​​384. Dimension 374 may include a thickness close to the outer extent of the seal 312-1. In some embodiments, dimension 374 may be between 0.002 inches and 0.01 inches. For example, dimension 374 may be 0.006 inches. Dimension 376 may include an angle at which the outer portion of the seal 312-1 narrows. In various embodiments, dimension 376 may be between 0 degrees and 10 degrees. For example, dimension 376 may be 2 degrees. Dimension 378 may include a thickness of the inner portion of the seal 312-1. In many embodiments, dimension 378 may be between 0.02 inches and 0.04 inches. For example, dimension 378 may be 0.03 inches. Dimension 380 includes an angle that changes at a transition from the inner portion of the seal 312-1 to the outer portion. In some embodiments, dimension 380 may be between 10 degrees and 70 degrees. For example, dimension 380 may be 35 degrees. Dimension 382 includes the radius of the outer extension of seal 312-1. In several embodiments, dimension 382 can be between 0.001 inches and 0.006 inches. For example, dimension 382 can be 0.003 inches. Dimension 384 includes the width of the outer portion of seal 312-1. In various embodiments, dimension 384 can be between 0.01 inches and 0.03 inches. For example, dimension 384 can be 0.02 inches.

[0047] Refer again Figure 3B , dimension 354 can be the diameter of the distal end 355 of the integral valve stem 306. In various embodiments, dimension 354 can be between 0.15 inches and 0.35 inches. For example, dimension 354 can be 0.231 inches. In such an example and when the diameter of the seals 312-2, 312-3, 312-4 is 0.24 inches, the seals 312-2, 312-3, 312-4 can extend beyond the bearing surface by 0.0045 inches along their circumference. In addition, this extension beyond the bearing surface can facilitate the formation of the aforementioned wiper seal with the valve well.

[0048] Dimension 356 may include the diameter of orifice 330-1 at proximal end 345 of integral valve stem 306. In some embodiments, dimension 356 may be between 0.13 inches and 0.25 inches. For example, dimension 356 may be 0.192 inches. In addition, Figure 3B Reference points AJ may be included. Reference point A may be the distal end 355 of the integral valve stem 306. Reference point B may be the seal 312-4, and the distance between reference points A and B may be between 0.05 and 0.07 inches, such as 0.06 inches. Reference point C may be the center of the orifice 330-3, and the distance between reference points A and C may be between 0.10 and 0.19 inches, such as 0.14 inches. Reference point D may be the seal 312-3, and the distance between reference points A and D may be between 0.20 inches and 0.24 inches, such as 0.22 inches. Reference point E may be the seal 312-2, and the distance between reference points A and E may be between 0.37 and 0.45 inches, such as 0.41 inches. Reference point F may be the center of the orifice 330-2, and the distance between reference points A and F may be between 0.90 and 0.95 inches, such as 0.918 inches. Reference point G may be the seal 312-1 and the distance between reference points A and G may be between 1.11 and 1.21 inches, such as 1.16 inches. Reference point H may be the proximal extent of the seat member (e.g., the seat member 110-2), and the distance between reference points A and H may be between 1.69 and 1.76 inches, such as 1.721 inches. Reference point I may be the distal extent of the seat member (e.g., the seat member 110-1), and the distance between reference points A and I may be between 1.7 and 1.9 inches, such as 1.8 inches. Reference point J may be the proximal end 345 of the integral valve stem 306, and the distance between reference points A and J may be between 1.75 and 1.95 inches, such as 1.851 inches.

[0049] Reference Figure 3CThe cross-sections 342, 344 of the seal can contribute to one or more functions of the seal. In many embodiments, the combination of a relatively thick base and a relatively thin outer edge allows the seal to function in a pressurized system. For example, a thin outer edge of the seal can provide the desired flexibility while resisting deformation in the transition to a thicker base closer to the outer diameter of the valve stem. This can be accomplished so as to maintain appropriate radial opposing forces at the ends of the seal to maintain contact with the wall of the valve well even when the contents (e.g., fluid) being sealed become pressurized.

[0050] As previously described, in various embodiments, the valve stem and the seal built therein can be an integral component. Therefore, one or more seals described herein can eliminate processing steps, the number of materials used, and assembly complexity, thereby reducing the cost of the overall cleaning valve. In some embodiments, a core pin can be used to form the inner cavity of the integral valve stem 306. In addition, the core pin can be used to manipulate (e.g., position and reposition) the integral valve stem 306 during formation. The inner cavity can fluidly connect the orifice to allow a fluid (e.g., liquid or gas) to flow through the inner cavity of the integral valve stem. However, the core pin can leave an orifice (e.g., orifice 330-1) in the integral valve stem for removal of the core pin (e.g., in the proximal end), which needs to be blocked to limit the fluid flow between the radial holes (e.g., orifices 330-2, 330-3) of the valve stem. In various embodiments, this orifice may be blocked with an interface member that may be constructed of silicone, thermoplastic elastomer (TPE), or some other flexible material that may be used to form an interference snap fit over the proximal end of the valve stem.

[0051] A cap, such as one having a conformable material and an interference fit (e.g., interface member 104), once assembled thereto (e.g., using stem plug 122), can act as a seal at the proximal end of the stem. This seal can prevent leakage at the proximal end of the stem during use. Some alternative sealing methods using alternative components can include press-fitting a plug of the same material as the stem into the end of the stem. In various embodiments, the plug can stay in place due to the press-fit, or it can be ultrasonically welded, glued, or any other fastening method applied.

[0052] In some embodiments, the one-way seal can be loaded onto the top of the integral valve stem and embedded in a receiving groove on the valve stem, such as by a snap fit, or the one-way seal (e.g., composed of polysiloxane, thermoplastic elastomer (TPE), or some other flexible material) can be directly overmolded onto the valve stem as a secondary step. In various embodiments, one or more seals 312 can be formed / assembled in the same or similar manner. In some embodiments, one or more magnetic surface treatments can be applied to the integral valve stem 306. For example, one or more surface treatments can be used to clean and / or lubricate the integral valve stem 306. In various embodiments, one or more components can be blocked and / or shielded prior to the surface treatment. For example, the orifice 330 can be blocked prior to the lubrication surface treatment.

[0053] In one or more embodiments described herein, various ranges, tolerances, sizes, and / or ratios thereof may be selected to accommodate specific uses. For example, tighter tolerances may be required for gas valve applications rather than liquid valve applications. In some embodiments, these selections may facilitate and / or optimize one or more functions described herein. For example, accurate dimensions may ensure proper embedding of the valve well. In another example, tolerances may ensure that operating temperature fluctuations may be accommodated. In yet another example, accurate dimensions may ensure proper function of the wiper seal. In yet another example, accurate ratios may ensure efficient flow through the inner cavity. In yet another example, accurate ratios, tolerances, and / or sizes may ensure proper operation of the spring portion (e.g., valve position and / or tactile feedback) of the interface member. Therefore, application of one or more ranges, dimensions, and tolerances (and / or ratios thereof) described herein may provide reliable operation and / or economical production of each component.

[0054] Figure 4A-4C Various aspects of an exemplary interface member 404 according to the disclosure described herein are shown. Figure 4A A perspective view of the interface member 404 is shown. Figure 4B A side view of the interface member 404 is shown. Figure 4C A cross-section 440 of the interface member 404 is shown. In many embodiments, Figure 4A-4COne or more components shown in the embodiment of the present invention may be the same or similar in construction, function, and / or appearance to one or more other components described herein. For example, the interface member 404 may be the same or similar to the interface member 104. Thus, the interface member 404 may include a spring portion (elastic portion) 418, valve stem grooves 420-1, 420-2, a valve stem plug 422, a valve well groove 424, a protrusion 425, a retaining member 426, a proximal end 445, and a distal end 455. In addition, as will be described in more detail below, the interface member 404 may include an indicator 443. The embodiments are not limited to this context.

[0055] Reference Figure 4A , the interface member may include an indicator 443. In the illustrated embodiment, the indicator 443 includes an exclamation mark enclosed by a triangle, for example in the form of a raised, concave, or embossed surface, or a combination thereof. More generally, the purge valve includes one or more indicators on one or more components. In various embodiments, the indicator (e.g., indicator 443) may serve to convey information through one or more features of the operation or aesthetics of the purge valve. Therefore, one or more of the purge valves disclosed herein may include features and / or components to facilitate distinction from a surgical valve (i.e., a valve for performing surgery in a patient). In addition, the features and / or components described herein may be used in any combination to facilitate distinction from a surgical valve. For example, the feel and / or appearance of the surgical valve may be changed, including differences in shape, color, material, and other visual and / or tactile indicators. In another example, another component (such as an indicator) may be included to facilitate distinction from a surgical valve.

[0056] The feel of the valves can be important in situations where the user will identify the valves as something they are adjusted to be used for surgery, or if the valves are something that feels significantly different from what they are used for. Often, different valves (e.g., both air / water valves, and suction valves) are designed to look and feel significantly similar. This can be accomplished so that the doctor cannot interpret any tactile differences between the different available valves. However, this can lead to confusion between the purge valve and the surgical valve, which can lead to adverse consequences. Therefore, the embodiments described herein can have a feel that is significantly different from the surgical valve for the user, thereby minimizing potential incorrect use, such as making it clear to the user whether the surgery is started from the purge valve in the air / water valve well rather than from the procedure air / water valve. For example, the features of the spring portion 418 of the interface member can provide tactile feedback that is significantly different from the surgical valve.

[0057] In various embodiments, the interface member or user interface portion of the valve (e.g., a button or spring cap) can be made of significantly different materials. For example, a soft, sticky and / or flexible material (such as a silicone elastomer or a thermoplastic elastomer (TPE)) can form a softer and / or stickier user interface or interface member surface of the valve that interacts with the user (e.g., the user's fingers / hands). In such an example, this soft, sticky and / or more flexible feel can distinguish the cleaning valve from the more rigid molded plastic valve button of the surgical valve. In another example, the raised portion of the indicator 443 can have a sticky feel.

[0058] 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 generally smooth, flat, rounded 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 noticeably different when the valve is pressed. For example, the user interface surface may include a plurality of small protrusions protruding from the surface in the form of cones, rods, ridges, rings, ridges, or any other three-dimensional textured surface that may cause the user to notice that they are not pressing on a smooth surface.

[0059] In several embodiments, the shape of the user interface (e.g., a button or spring cap) can be designed to differentiate the feel of the purge valve when compared to a surgical valve. For example, the user interface can include a geometric shape for interacting with the user that has distinct corners that can be felt during depression of the user interface, such as a circle, triangle, square, diamond, hexagon, or any other shape that would have distinct or distinct edges when compared to a circle. When depressed, these shapes can feel distinctly different from the round buttons used on surgical valves with a smooth radius on the valve edge.

[0060] 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. On the user interface surface (e.g., the proximal side of the button), many surgical valves are about half an inch in diameter. However, adjusting the size of the user interface surface pressed by the user to be significantly larger or significantly smaller can allow the user to notice the size difference in the surface they are pressing, thereby further distinguishing the cleaning valve from the surgical valve. This size difference may include one or more surface areas of the user interface surface being pressed, and the height of the surface above the endoscope handle when inserted into the air / water well. For example, a significantly shorter or significantly longer surface may cause the user to move their hands / fingers in a way that they are not used to operate the valve, thereby again drawing other attention to the fact that this is not a typical surgical valve. In order to achieve the best distinction, the valve may include any combination of the above-mentioned features and / or technologies that distinguish the appearance and / or feel of the cleaning valve from the surgical valve.

[0061] In several embodiments, the appearance or look of the purge valve can be used to differentiate the feel of the valve when compared to a surgical valve. Many surgical valves are primarily all black buttons with a cylindrical collar that snaps onto a valve well and a cylindrical button with a flat button surface. By significantly changing the appearance of the purge valve from the surgical valve, users can better focus their attention on the appearance of the purge valve when they see a purge valve inserted into the air / water valve well of an endoscope handle. The appearance of the purge valve can be differentiated by including one or more of the following.

[0062] In some embodiments, the color selection of one or more components of the purge valve can be used to distinguish the appearance of the purge valve when compared to the procedure. In many embodiments, the color can be selected to provide a contrast with a black endoscope handle and / or a black surgical valve combined with an endoscope handle. For example, the use of one or more bright or neon colors (such as yellow, orange, red, and pink) on one or more components of the purge valve assembly can be used to visually distinguish the valve. In another example, a transparent or "natural" polysiloxane elastomer color or thermoplastic elastomer color can be used. This transparent color can leave a translucent appearance that can be clearly noticed when looking at the valve in the endoscope handle. In some embodiments, a reflective or shiny surface can be used.

[0063] Differentiating valves by feel can also differentiate valves by appearance. For example, changing the shape of the valve user interface (e.g., button or spring cap) from a circle to some other geometric shape will allow for visual differentiation in addition to the feel differentiation, especially when combined with the distinctly different colors / patterns described above. Making the interface a triangle shape, a square shape, a diamond shape, a hexagonal shape, or any other shape with sharp corners can provide visual and tactile differentiation of the valve from a round surgical valve.

[0064] Typically, the air / water and suction surgical valves used (whether disposable or reusable variants) may have the same combination of a button surface that is pressed, which slides inside a collar component attached to the field of view. Changing this configuration so that the same two components with the same type of interaction no longer exist can further help distinguish the cleaning valve from the surgical valve. In various embodiments, changing the way the button component interacts with the collar component can be used to distinguish the valve. For example, the button can be a rim that slides over the collar component. In this example, this can significantly change the overall shape of the user interface compared to the button of the surgical valve. In some embodiments, the shape and component interaction can be changed to exclude separate buttons and collar components together, such as by having a single seamless spring cap, both of which are 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 clearly distinguish the valve from the surgical valve.

[0065] In several embodiments, some type of indicator (e.g., a warning) may be included in or on the valve (e.g., valve stem 106). For example, a method of including a warning on the valve for distinguishing a cleaning valve from a surgical valve may include pad printing or laser etching the warning directly onto a user interface (e.g., a spring cap or button) or exposed surface of the cleaning valve during use. Alternatively or in addition, a warning mark may be embossed on the side of the user interface (e.g., a spring cap or button) to provide a warning that protrudes from the side of the valve during use and is felt and clearly visible. This may be on the side of the valve, or on the upper surface so that the user can feel the warning when they press the valve. Alternatively or in addition, the warning mark may be molded into the cap and integrally attached as part of the component. As should be understood, the text and / or symbols may be changed without departing from the scope of the present disclosure (as long as they facilitate distinction from a surgical valve).

[0066] In addition to or in lieu of the cap color, the color of one or more other components may be changed to distinguish it from the surgical valve. For example, the valve stem color may be significantly different from the surgical valve stem. In some embodiments, the seal color may be a bright color (e.g., yellow) on the valve stem, or any other color combination that draws the user's attention to the fact that the valve is for cleaning. In addition, the color or pattern of the valve stem itself may be designed to 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 valve stem may be used, but any different combination may also be used, such as a yellow valve stem with a seal, a blue seal with a yellow valve stem, a pink valve stem with a yellow seal, etc. In addition, the cap may have molded raised features, such as circumferentially near its base, and / or have circumferential pad printing and text or some type of instructions for use that display a warning. In many embodiments, the user is able to read the warning on the cap without actually having to have a separate attached warning mark, because it will be directly printed or visible as part of the cap itself.

[0067] In many embodiments, there may be another component that slides over or is removably attached to the sealed end of the valve stem in the package and has a shape that prevents the valve from being inserted into the valve well of the endoscope without first removing the other components. In many embodiments, a portion of this component can be inserted through the radial hole of the valve stem. In various embodiments, this component can be clamped to the valve stem. In some embodiments, this component can be hollow and have 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 to the extent that it cannot be inserted.

[0068] In various embodiments, this feature can be a molded component made of a brightly colored material to further draw attention to it. In many embodiments, this feature must be removed from the valve before the valve can be inserted into the endoscope. This ensures that the user must complete another step before the cleaning valve can be inserted into the endoscope, thereby further drawing attention to the fact that the valve is not a surgical valve. This feature can also be a clamping feature that clamps onto the valve stem from the outside, thereby again causing interference with the valve well if the user attempts to insert the valve before removing it. The clamping mark or mark that slides over the end of the valve stem can also have a molded mark away from the side with the embossed or pad printed lettering. In some embodiments, the text can also be used as a warning mark, not only informing the user of the intended "cleaning" use, but also requiring the user to remove the warning before inserting into the valve well, thereby forcing their attention to focus on the text for a period of time before attempting to insert the valve into the field of view. As will be discussed in more detail below, Figure 7A-7G Several exemplary indicators are shown, including many of those described above.

[0069] Reference Figure 4C , the cross section 440 of the interface member 404 includes valve stem grooves 420-1, 420-2, a valve stem plug 422, a valve well groove 424, a protrusion 425, and a retaining member 426. Dimensions (e.g., distances, widths, radii, diameters, angles, etc.) are described herein with respect to the various components in the absence of external inputs (e.g., in a first configuration). The diameter 452 of each valve stem groove 420-1, 420-2 may be between 0.3 and 0.4 inches (e.g., 0.348 inches) and have a tolerance of ±0.003. The height 474 of the valve stem groove 420-1 may be between 0.025 inches and 0.075 inches, such as 0.05 inches. The inner diameter 454 of the protrusion 425 may be between 0.22 inches and 0.31 inches (e.g., 0.269 inches) and have a tolerance of ±0.003. The diameter 456 of the proximal portion of the valve stem plug 422 may be between 0.13 and 0.19 inches, such as 0.16 inches. The distal end of the valve stem plug 422 may have a diameter between 0.1 and 0.2 inches, such as 0.132 inches.

[0070] The valve stem plug 422 can be converted from the first diameter to the second diameter at an angle 466 between 10 degrees and 25 degrees (e.g., 14 degrees). The outer corner 478 can have a radius between 0.0025 inches and 0.0075 inches (e.g., 0.005 inches). The height 472 of the valve stem plug 422 can be between 0.05 inches and 0.13 inches, such as 0.085 inches. The corner 458 between the valve stem groove 420-1 and the valve stem plug 422 can have a radius between 0.005 inches and 0.015 inches (e.g., 0.01 inches). The corner 462 between the valve stem groove 420-1 and the protrusion 425 can have an inclined or beveled edge. For example, the corner 462 can have a chamfer of 0.01 inches plus 45 degrees. One or more edges, bends, walls, and / or corners (inside or outside) described herein may include bevels, chamfers, radii, and / or fillets having selected characteristics, for example based on whether the corner is for flexion, reception, and / or fixation.

[0071] The height 484 of the proximal range from the distal end of the interface member 404 to the valve stem groove 420-1 can be between 0.72 inches and 0.80 inches, such as 0.76 inches. The height 482 of the proximal range from the distal end of the interface member 404 to the valve stem groove 420-1 can be between 0.68 inches and 0.74 inches, such as 0.71 inches. The height 480 of the proximal range from the distal end of the interface member 404 to the valve stem groove 420-2 can be between 0.60 inches and 0.67 inches, 0.635 inches. The radial deflection 468 of the proximal portion of the spring portion 418 can be between 14 degrees and 36 degrees, such as 24 degrees. The radial deflection 470 of the distal portion of the spring portion 418 can be between 5 degrees and 21 degrees, such as 13 degrees. The radius 476 between the proximal portion and the distal portion of the spring portion 418 at the transition can be between 0.02 inches and 0.1 inches, such as 0.05 inches.

[0072] The diameter 492 of the well recess 424 may be between 0.51 and 0.63 inches, such as 0.562 inches. The height 486 from the distal end of the interface member 404 to the proximal extent of the well recess 424 may be between 0.09 and 0.12 inches, such as 0.108 inches. The height 482 from the distal end of the interface member 404 to the distal extent of the well recess 424 may be between 0.057 inches and 0.069 inches, such as 0.063 inches. The inner diameter 490 of the retaining member 426 may be between 0.48 inches and 0.52 inches, such as 0.502 inches. Figure 4B and Figure 4C Alternatively, one or more other embodiments described herein may be described in accordance with the American Society of Mechanical Engineers Y14.5M-2009 standard. The material of the interface member 404 may include one or more of Wacker silicone rubber, liquid polysiloxane, rubber (e.g., having a hardness (durometers) between 25 and 75, such as 50). In many embodiments, the inner corner radius may be a maximum of 0.15 inches. In various embodiments, the outer surface may have an SPI-d1 finish. Unless otherwise specified, the circular radius may be 0.005 inches.

[0073] Figure 5A-5C Various aspects of an example valve stem 506 according to the disclosure described herein are shown. Figure 5A A perspective view of a valve stem 506 is shown. The valve stem 506 may include a proximal end 545, a distal end 555, seating members 510-1, 510-2, centering surfaces 514-1, 514-2, 514-3, retaining flanges 516-1, 516-2, 516-3, 516-4, 516-5, and apertures 530-1, 530-2, 530-3. The aperture 530-1 may include a notch 541. Figure 5BA first side view of the valve stem 506 is shown having an internal cavity 528 and a retaining flange 516 - 6 . Figure 5C A second side view of the valve stem 506, a cross section 540 of the valve stem 506 at the orifice 530-3, and a top view of the proximal end 545 of the valve stem 506 are shown. In many embodiments, Figure 5A-5C One or more components shown in the figure may be the same or similar in construction, function, and / or appearance to one or more other components described herein. For example, the seat component 510 may be the same or similar to the seat component 110. The embodiments are not limited to this context.

[0074] In many embodiments, one or more components of the integral valve stem 506 (such as one or more of the seating member 510, the centering surface 514, the fixing flange 516, the inner cavity 528, and the orifice 530) can be integrally formed as a unitary structure. In various embodiments, the various components of the valve stem 506 can play a variety of roles. For example, the fixing flange 516-2 can also be a centering surface. In another example, the seating member 510-2 can also be a fixing flange. In some embodiments, the various components of the valve stem can be adjacent to and / or in contact with other components. For example, the fixing flange 516-4 and the centering surface 514-2 are in contact with the valve stem 506. In addition, the centering surface 514-1 may include a mirrored fixing flange. In this example, the two fixing flanges can prevent the fixing flange 516-4 from flowing distally and the other fixing flanges from flowing proximally during the secondary molding process.

[0075] More generally, the valve stem 506 may include a plurality of features that support a secondary molding process, such as ridges, lips, protrusions, grooves, etc. For example, the orifice 530-3 may include a raised lip that prevents flow into the interior cavity of the valve stem 506 during the secondary molding process. Additionally or alternatively, the seating member 510, the centering surface 514, the retaining flange 516, and one or more of the orifices 530-1, 530-2 may support a secondary molding process. For example, the notch 541 may maintain alignment of the valve stem 506 on the core molding pin. In various embodiments, the notch 541 may facilitate alignment of an interface member connected to the valve stem 506. In some embodiments, the valve stem 506 may be referred to as a stem or bare stem, while Fig. 6A The stem assembly 605 is referred to as a stem. In various embodiments, a stem or bare stem may be referred to as a stem lacking one or more components, such as overmolded seals, O-rings, etc. As will be discussed in more detail below, an overmolding process may be used to form one or more seals along the stem 506 (see, e.g., Figure 6B and Figure 6C ).

[0076] Figure 5BAngles 552, 554, 556, 558, 560, 562, 564, 566, 568, dimension 570, and reference point AS may be included. Angle 552 may be the angle at which the walls of the distal portion of the lumen 528 diverge in the proximal direction. Angle 568 may be the angle at which the walls of the proximal portion of the lumen 528 converge in the distal direction. In various embodiments, angles 552, 568 may be between 0 and 10 degrees. For example, angle 552 may be 1 degree and angle 568 may be 2 degrees. However, the angle at which the walls of the lumen 528 diverge may be within a range between 0 and 90 degrees. For example, at the transition between the proximal portion and the distal portion of the lumen 528 (close to reference point G), the walls may converge at an angle of 45 degrees. In one or more embodiments, angles 552, 568 may facilitate efficient and reliable removal of the forming core pin. In various embodiments, dimension 570 can be between 0.25 and 0.4 inches (eg, 0.348 inches) and have a tolerance of ±0.003. In one or more embodiments, element 572 can indicate a gate location for introducing material (eg, during an injection molding step) to form valve stem 506.

[0077] Angle 554 can be the slope of the distal side of the fixing flange 516-3 in the radial direction. In various embodiments, angle 554 can be between 0 and 15 degrees. For example, angle 554 can be 3 degrees. Angle 556 can be the angle between the proximal side of the centering surface 514-3 and the distal side of the fixing flange 516-2 in the radial direction. In various embodiments, angle 556 can be between 0 and 20 degrees. For example, angle 556 can be 4 degrees. Angle 558 can be the angle between the proximal side of the fixing flange 516-2 and the distal side of the fixing flange 516-1 in the radial direction. In various embodiments, angle 558 can be between 0 and 20 degrees. For example, angle 558 can be 4 degrees. Angle 560 can be the angle between the walls of the orifice 530-2 in the radial direction. In various embodiments, angle 560 can be between 0 and 10 degrees. For example, angle 560 can be 2 degrees.

[0078] Angle 562 can be an angle between the proximal side of the fixing flange 516-4 and the distal side of the fixing flange 516-6 in the radial direction. In various embodiments, angle 562 can be between 0 and 20 degrees. For example, angle 562 can be 4 degrees. Similarly, angle 564 can be an angle between the proximal side of the centering surface 514-2 and the distal side of the centering surface 514-1 in the radial direction. In various embodiments, angle 564 can be between 0 and 20 degrees. For example, angle 564 can be 4 degrees. Angle 566 can be an angle between the proximal side of the seat member 510-2 and the distal side of the seat member 510-1 in the radial direction. In various embodiments, angle 566 can be between 0 and 10 degrees. For example, angle 566 can be 2 degrees. In some embodiments, negative angles can be used between features, for example, to maintain, connect, guide and / or receive another component.

[0079] also, Figure 5B Reference point AS may be included. Reference point A may be the distal end 555 of the valve stem 506. Reference point B may be proximal to the retaining flange 516-3, and the distance between reference points A and B may be between 0.02 and 0.04 inches, such as 0.027 inches. Reference point C may be distal to the orifice 530-3, and the distance between reference points A and C may be between 0.05 and 0.07 inches, such as 0.06 inches. Reference point D may be proximal to the orifice 530-3, and the distance between reference points A and D may be between 0.176 and 0.196 inches, such as 0.186 inches.

[0080] Reference point E can be proximal to centering surface 514-3, and the distance between reference points A and E can be between 0.47 and 0.50 inches, such as 0.482 inches. Reference point F can be distal to fixing flange 516-2, and the distance between reference points A and F can be between 0.58 and 0.65 inches, such as 0.616 inches. Reference point G can be proximal to fixing flange 516-2, and the distance between reference points A and G can be between 0.60 and 0.68 inches, such as 0.639 inches. Reference point H can be distal to fixing flange 516-1, and the distance between reference points A and H can be between 0.74 and 0.79 inches, such as 0.764 inches. Reference point I can be proximal to fixing flange 516-1, and the distance between reference points A and I can be between 0.75 and 0.85 inches, such as 0.792 inches.

[0081] Reference point J may be distal to centering surface 514-2, and the distance between reference points A and J may be between 0.90 and 1.10 inches, such as 1.002 inches. Reference point K may be proximal to centering surface 514-2, and the distance between reference points A and K may be between 0.96 and 1.16 inches, such as 1.060 inches. Reference point L may be proximal to fixing flange 516-4, and the distance between reference points A and L may be between 0.98 and 1.18 inches, such as 1.089 inches. Reference point M may be distal to fixing flange 516-6, and the distance between reference points A and M may be between 1.19 and 1.39 inches, such as 1.298 inches. Reference point N may be distal to centering surface 514-1, and the distance between reference points A and N may be between 1.22 and 1.42 inches, such as 1.327 inches.

[0082] Reference point O may be proximal to centering surface 514-1, and the distance between reference point A and O may be between 1.29 and 1.49 inches, such as 1.392 inches. Reference point P may be distal to seating member 510-2, and the distance between reference point A and P may be between 1.53 and 1.73 inches, such as 1.635 inches. Reference point Q may be proximal to seating member 510-2, and the distance between reference point A and Q may be between 1.59 and 1.79 inches, such as 1.699 inches. Reference point R may be distal to seating member 510-1, and the distance between reference point A and R may be between 1.67 and 1.87 inches, such as 1.777 inches. Reference point S may be the proximal end 545 of valve stem 506, and the distance between reference point A and S may be between 1.72 and 1.92 inches, such as 1.828 inches.

[0083] Figure 5C A second side view of the valve stem 506, a cross section 540 of the valve stem 506 at the orifice 530-3, and a top view of the proximal end 545 of the valve stem 506 are shown. The distance 574 between the cross section 540 and the distal end 555 of the valve stem 506 can be between 0.05 inches and 0.23 inches. For example, the distance 352 can be 1.77 inches. The outer diameter 580 of the valve stem 506 can be between 0.05 inches and 0.23 inches. For example, the outer diameter 580 can be 1.77 inches. The width 578 of the centering surface 514-3 can be between 0.01 inches and 0.058 inches. For example, the width 578 can be 0.029 inches. The outer diameter 571 of the centering surface 514-3 can be between 0.1 inches and 0.31 inches. For example, the outer diameter 571 can be 0.227 inches. The outer diameter 573 of the valve stem 506 may be between 0.05 inches and 0.27 inches. For example, the outer diameter 580 may be 0.13 inches.

[0084] The diameter 575 of the orifice 530-2 may be between 0.05 inches and 0.22 inches, such as 0.83 inches. The distance 576 from the distal end of the valve stem 506 to the center of the orifice 530-2 may be between 0.7 inches and 0.12 inches, such as 0.896 inches. The outer diameter 577 of the centering surface 514-2 may be between 0.3 inches and 0.42 inches (such as 0.371 inches) and have a tolerance of + / - 0.003 inches. The diameter 579 of the valve stem 506 may be between 0.17 and 0.23 inches, such as 0.2 inches. The outer diameter 581 of the centering surface 514-1 may be between 0.35 inches and 0.44 inches, such as 0.4 inches.

[0085] The diameter 583 of the valve stem 506 between the seating members 510 can be between 0.22 inches and 0.33 inches (e.g., 0.275 inches) and have a tolerance of + / - 0.003 inches. The length 582 of the valve stem 506 from the distal end 555 to the proximal end 545 can be between 1.5 inches and 2 inches, such as 1.793 inches. The diameter of the orifice 530-1 can be between 0.125 inches and 0.165 inches (e.g., 0.151 inches) and have a tolerance of + / - 0.003 inches. Referring to the cross section 540, the outer width 586 of the orifice 530-3 can be between 0.0266 inches and 0.226 inches, such as 0.126 inches. The angle 588 between the inner wall of the inner cavity 528 and / or the orifice 530-3 can be between 0 degrees and 10 degrees, such as 2 degrees.

[0086] Figure 6A-6H Various aspects of an example valve stem assembly 605 according to the disclosure described herein are shown. Fig. 6A A perspective view of a valve stem assembly 605 is shown. The valve stem assembly 605 may include a proximal end 645, a distal end 655, and seal assemblies 607-1, 607-2. The seal assembly 607-1 may include a seal 612-1 and the seal assembly 607-2 may include seals 612-2, 612-3, 612-4. In one or more embodiments described herein, the seal assembly 607 may be overmolded onto the valve stem 506. Figure 6B and Figure 6C A sealing assembly 607 - 1 and a sealing assembly 607 - 2 with an opening 631 are shown respectively. Fig.6D A first side view of the valve stem assembly 605 and a top view of the proximal end of the valve stem assembly 605 are shown. Fig. 6E A cross section 540 of the valve stem assembly 605 is shown. Fig. 6F Details of the seal assembly 607-1 are shown, and Figure 6G Details of seal 612-1 of seal assembly 607-1 are shown. Figure 6H Details of the seal assembly 607-2 are shown. In many embodiments, Figure 6A-6HOne or more components shown in the figure may be the same or similar in construction, function, and / or appearance to one or more other components described herein. For example, the one-way valve 108 may be applicable to the valve stem assembly 605, such as between the fixed flanges 516-1, 516-2. The embodiments are not limited to this context.

[0087] Reference Figure 6B In one or more embodiments, the sealing assembly 607-1 can be overmolded on the valve stem 506 between the retaining flanges 516-4, 516-6. Figure 6C In one or more embodiments, the sealing assembly 607-2 can be overmolded on the valve stem 506 around the distal end 555 and up to the distal side of the fixed flange 516-5. In the illustrated embodiment, the sealing assembly 607-2 includes an opening 631. The opening 631 can facilitate the flow of fluid into and out of the inner cavity 528 through the orifice 530-3. In some embodiments, the opening 631 can be referred to as a window. As previously described, the lip surrounds the orifice 530-3. In many embodiments, the lip surrounding the orifice 530-3 can cause the opening 631 to form the sealing assembly 607-2 during the overmolding process. In addition, the lip can prevent the fluid from the overmolding process from flowing through the orifice 530-3 and entering the inner cavity 528.

[0088] In some embodiments, the seals of the sealing assembly 607 are constructed of molded plastic rather than O-rings, which can allow them to be molded to have a thickness less than an O-ring. Therefore, such molded seals can be designed to have a diameter greater than an O-ring. Assuming that the molded seals are thinner and / or have a diameter greater than an O-ring seal, this can provide performance benefits to the valve compared to valves with O-ring seals. For example, molded seals with larger diameters but flexibility (which allows them to slide in the valve well) can provide more surface area contact and sealing against the valve well wall.

[0089] Fig.6D A side view of the valve stem assembly 605 with a proximal end 645 and a distal end 655 is shown, as well as a front view 642 of the proximal end 645 of the valve stem assembly 605. Fig.6D , a side view of the valve stem assembly 605 includes the seal assembly 607 and details 644, 646 are identified (see Fig. 6F and Figure 6H ). In the front view 642 of the proximal end 645, the cross section 640 is identified. In addition, Fig.6DReference points AE may be included. Reference point A may be the distal end 555 of the valve stem assembly 605. Reference point B may be at the seal 612-4, and the distance between reference points A and B may be between 0.043 inches and 0.063 inches, such as 0.053 inches. Reference point C may be at the seal 612-3, and the distance between reference points A and C may be between 0.13 inches and 0.33 inches, such as 0.234 inches. Reference point D may be at the seal 612-2, and the distance between reference points A and D may be between 0.30 and 0.50 inches, such as 0.409 inches. Reference point E may be at the seal 612-1, and the distance between reference points A and E may be between 1.04 inches and 1.24 inches, such as 1.144 inches.

[0090] exist Fig. 6E , a cross section 640 of a valve stem assembly 605 is illustrated having a valve stem 506 and a sealing assembly 607. The valve stem 506 includes an inner cavity 528 and an orifice 530. As shown, a sealing assembly 607-1 can be formed between the retaining flanges 516-4, 516-6, and the sealing assembly 607-1 can be formed to enclose the distal end 555 of the valve stem 506 and extend to the retaining flange 516-5. In one or more embodiments, the valve stem assembly 605 may include a one-way seal located between the retaining flanges 516-1, 516-2 (see, e.g., Figure 1A and Figure 1B In some embodiments, the one-way seal 108 can be overmolded. In other embodiments, the one-way seal can be loaded onto the valve stem 506, for example, after overmolding one or more sealing components 607.

[0091] Fig. 6F Detail 644 of seal assembly 607-1 is shown. In detail 644 of seal assembly 607-1, detail 648 of seal 612-1 is identified (see Figure 6G ). Fig. 6F , seal 612-1 may have an outer diameter between 0.35 inches and 0.45 inches (e.g., 0.404 inches). In many embodiments, the outer diameter of seal 612-1 on the proximal and / or distal sides may have a radius 654. In several embodiments, circular radius 654 is between 0.001 and 0.018 inches, such as 0.008 inches. The outer diameter 656 of seal assembly 607-1 may be between 0.23 inches and 0.31 inches, such as 0.272 inches. For example, on both sides of seal 512-1, the outer diameter of seal assembly 607-1 may be 0.27 inches.

[0092] Reference Figure 6GDetail 648 of seal 612-1 may include a width 660 between 0.14 inches and 0.34 inches (e.g., 0.24 inches) and have a positive tolerance of 0.003 inches and a negative tolerance of 0.001 inches. In many embodiments, the proximal edge and distal edge of seal 612-1 may have a radius 654. In several embodiments, radius 654 is between 0.001 and 0.018 inches, such as 0.008 inches. Angles 664, 666 may be slopes in the radial direction of the proximal and distal sides of seal 612-1. For example, seal 612-1 may converge at an angle 664 between 3 degrees and 10 degrees (e.g., 5.5 degrees) in the radial direction approaching the radial extent of the seal. In addition or alternatively, seal 612-1 may converge at an angle 666 between 9 degrees and 23 degrees (e.g., 16 degrees) in the radial direction approaching the valve stem 506. In many embodiments, the portion of the seal 612 - 1 having the angle 666 may transition from the outer diameter 656 to the portion of the seal 612 - 1 at the angle 664 by approximately 0.05 inches.

[0093] Figure 6H Detail 646 of seal assembly 607-2 with seals 612-2, 612-3, 612-4 is shown. Figure 6H As shown in , seals 612-2, 612-3, 612-4 may each have an outer diameter between 0.19 inches and 0.31 inches (such as 0.254 inches). Each seal 612-2, 612-3, 612-4 may include a width 676 between 0.06 inches and 0.26 inches (such as 0.16 inches), and have a positive tolerance of 0.003 inches and a negative tolerance of 0.001 inches. In many embodiments, the proximal and distal edges of each seal 612-2, 612-3, 612-4 may have a radius 670. In several embodiments, the radius 654 is between 0.006 inches and 0.026 inches, such as 0.016 inches. Angle 674 may be between the slopes in the radial direction of the proximal and distal sides of each seal 612-2, 612-3, 612-4. For example, each seal 612-2, 612-3, 612-4 may converge at an angle 674 between 13 and 22 degrees (e.g., 17.9 degrees) in the radial direction. In many embodiments, the seal assembly 607-2 may have an outer diameter 680 between 0.06 inches and 0.26 inches (e.g., 0.16 inches) on the straight portions of the proximal and distal sides of one or more seals 612-2, 612-3, 612-4. In addition, the proximal and distal sides of the seals 612-2, 612-3, 612-4 may have a radius between 0.001 inches and 0.015 inches (e.g., 0.005 inches) at the transition toward and / or away from the outer diameter 680.

[0094] The size and / or composition of one or more components of the valve stem assembly 605 can contribute to one or more functions of the seal. In various embodiments, the sealing function of the seal can be adjusted by changing the size and / or composition of the valve stem assembly. In many embodiments, the combination of a relatively thick base and a relatively thin outer edge allows the seal to function in a pressurized system. For example, the thin outer edge of the seal can provide the desired flexibility while the transition to the thicker base closer to the outer diameter of the valve stem prevents deformation. This is done to maintain an appropriate radial reaction force at the end of the seal to maintain contact with the valve well wall even when the contents (e.g., fluid) against which the seal is sealed are pressurized.

[0095] As previously described, in various embodiments, the valve stem 506 may include one or more integral aspects. For example, the retaining flange 516 may be integrally formed with the valve stem 506. In addition, the interface member may also serve to seal the orifice in the valve stem. In some such embodiments, an inner cavity may be left when the core forming pin is removed through the orifice. Therefore, one or more components described herein may eliminate processing steps, the number of materials used, and assembly complexity, thereby reducing the cost of the overall cleaning valve. In some embodiments, a core pin may be used to form the inner cavity of the valve stem 506. In addition, during formation, the core pin may be used to manipulate (e.g., position and reposition) the valve stem 506. The inner cavity may be fluidly connected to the orifice to allow a fluid (e.g., liquid or gas) to flow through the inner cavity of the valve stem. However, the core pin may leave an orifice (e.g., orifice 530-1) in the valve stem for removal of the core pin (e.g., in the proximal end), which needs to be blocked to limit fluid flow between the radial orifices (e.g., orifices 530-2, 530-3) of the valve stem. In various embodiments, this orifice can be blocked using an interface component (e.g., a stem plug 122, 422) that can be formed from silicone, a thermoplastic elastomer (TPE), or some other flexible material that can be used to form an interference fit over the proximal end of the stem.

[0096] A cap, such as one having a conformable material and an interference fit (e.g., interface member 104, 404), once assembled on stem assembly 605 (e.g., using stem plug 422) can act as a seal at the proximal end of stem assembly 605. This seal can prevent leakage at the proximal end of the stem during use. Some alternative sealing methods using alternative components can include press-fitting a plug of the same material as the stem onto the end of the stem. In various embodiments, the plug can be left in place due to the press fit, or it can be ultrasonically welded, glued, or any other fastening method can be used.

[0097] In some embodiments, the one-way seal can be loaded above the integral valve stem and embedded in a receiving well on the valve stem of a snap-fit, or the one-way seal can be overmolded directly onto the valve stem (e.g., from silicone, thermoplastic elastomer (TPE), or some other flexible material) as a secondary step. In various embodiments, one or more seals 612 can be formed / assembled in the same or similar manner. In some embodiments, one or more surface treatments can be applied to the valve stem 506. For example, one or more surface treatments can be used to clean and / or lubricate the valve stem 506, such as prior to the overmolding process. In various embodiments, one or more components can be blocked and / or shielded prior to the surface treatment. For example, the orifice 530 can be blocked prior to the lubrication surface treatment.

[0098] All dimensions are illustrative only, and other dimensions may be more suitable for a particular application. In addition, the dimensions described may be approximate values ​​including tolerances, for example, tolerances allow for addition or subtraction of variations from the described values ​​(e.g., + / - percentages, + / - lengths, and / or + / - angles). Although many dimensions are described in inches, inches can be easily converted to millimeters (mm) based on 1 inch being equal to 25.4 mm. Unless otherwise specified, tolerances may be as follows: "X" is ±0.25 mm; "XX" is ±0.1 inch or ±0.1 mm; "X.XX" is ±0.01 inch or ±0.05 mm; "X.XXX" is ±0.05 inch or ±0.01 mm; "X.XXXX" is ±0.0005 inch; and angles may be ±2 degrees. In various embodiments, Figure 5B , Figure 5C , Figure 6D-Figure 6E It can be described according to the American Society of Mechanical Engineers Y14.5M-2009 standard. In various embodiments, the valve stem 506 can be composed of polycarbonate and the sealing assembly 607 can be composed of a thermoplastic elastomer. For example, the valve stem 506 can be formed in a first batch of polycarbonate and the sealing assembly 607 can be formed in a second batch of thermoplastic elastomer.

[0099] Figure 7A-7G Exemplary indicators for a purge valve assembly (or purge valve) according to the present disclosure described herein are shown. One or more purge valves disclosed herein may include features and / or components to facilitate distinction from a surgical valve (i.e., a valve used for surgery performed on a patient). In addition, the features and / or components described herein may be used in any combination to facilitate distinction from a surgical valve. For example, the feel and / or appearance of a surgical valve may be changed, including differences in shape, color, material, and other visual and / or tactile indicators. In another example, another component (such as an indicator) may be included to facilitate distinction from a surgical valve. The embodiments are not limited to this context.

[0100] In several embodiments, some type of indicator (e.g., a warning) may be included in or on the valve. For example, a method of including a warning on the valve to distinguish a cleaning valve from a surgical valve may include pad printing or laser etching the warning directly onto a user interface (e.g., a spring cap or button) or exposed surface of the cleaning valve during use. In many embodiments, the indicators described herein may include one or more raised surfaces having various features (e.g., texture, color, etc.) configured to distinguish a cleaning valve from a surgical valve. Alternatively or in addition, a warning mark may be embossed onto the side of the user interface (e.g., a spring cap or button) to provide a warning that protrudes and is felt from the side of the valve and is clearly seen during use. This may be located on the side of the valve or on the upper surface so that the user feels the warning when they press the valve. An example of this situation can be seen in Fig. 7A Alternatively or in addition, the warning symbol may be molded into the cap and integrally attached as part of the component, such as in Figure 7B and Figure 7C As will be appreciated, the text and / or symbols may be changed (so long as they facilitate distinction from surgical valves) without departing from the scope of the present disclosure.

[0101] In many embodiments, there may be another component that slides over or is removably attached to the sealing end of the valve stem in the package and has a shape that prevents the valve from being inserted into the valve well of an endoscope without first removing the other component. See, e.g. Figure 7D-7G In many embodiments, a portion of this component can be inserted through a radial hole, orifice, or aperture in the valve stem. See, e.g. Fig.7D In various embodiments, this component may be clamped to the valve stem. See, e.g. Fig. 7E In some embodiments, this component may be hollow and have an inner diameter large enough to slide over the end of the valve stem and an outer diameter large enough that it has an interference fit with the valve well in view so that it cannot be inserted. See e.g. Figure 7F and Figure 7G , related technologies, features, and / or components of other cleaning valve assemblies that can be used in this application are disclosed in the U.S. non-provisional patent application with attorney case number 8150.0669 and titled "DEVICES, SYSTEMS, AND METHODS FOR MEDICAL PURGE VALVES AND INDICATORS" filed on the same date as this application, the entire contents of which are incorporated herein by reference.

[0102] In light of the present disclosure, all devices and / or methods disclosed and claimed herein can be made and implemented without undue experimentation. Although the devices and methods of the present disclosure have been described using preferred embodiments, it is apparent to those skilled in the art that changes can be made in the devices and / or methods and in the steps or in the order of the steps of the methods described herein without departing from the concept, spirit and scope of the disclosure.

Claims

1. A valve for a medical device, comprising: a valve stem having a proximal end, a distal end, one or more orifices, and an inner cavity in fluid communication with at least one of the one or more orifices, the valve stem being configured to be inserted into the valve well; one or more seals located between the proximal end and the distal end of the valve stem; as well as An interface member is configured to be coupled to the valve stem, and the interface member is further configured to be directly coupled to the valve well. 2 . The valve of claim 1 , wherein the interface member comprises a valve well groove configured to couple with a corresponding protrusion of the valve well.

3. The valve according to claim 2, wherein the corresponding protrusion of the valve well is a circumferential protrusion.

4. The valve according to claim 2, wherein the corresponding protrusion of the valve well is a flange.

5. The valve according to claim 2, wherein the valve well groove is configured to couple with a corresponding protrusion of the valve well by a snap fit.

6. The valve according to claim 2, wherein the valve well groove is configured to couple with a corresponding protrusion of the valve well by a snap interference fit.

7. The valve of claim 1, wherein the interface member is formed of a flexible material.

8. The valve of claim 7, wherein the interface member is formed of silicone or a thermoplastic elastomer.

9. The valve of claim 1, wherein the interface member has a durometer hardness of 25 to 75.

10. A manufacturing method comprising: forming a valve stem comprising a proximal end, a distal end, one or more seals between the proximal and distal ends of the valve stem, a plurality of orifices, and an inner cavity in fluid communication with at least one of the plurality of orifices; and An interface member is coupled to the valve stem, wherein the interface member is configured to couple directly to a valve well.

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