Reuse prevention mechanism for single-use valves for medical devices - Patent Application 20070122997

Abstract

To provide cleaning valves (or valves) that are single-use devices (SUDs).SOLUTION: Valves (or valve assemblies) for medical devices, such as endoscopes, disclosed may be configured to transition from a first state to a second state in response to utilization of the valve, e.g., to control fluid flow through a valve well. The transition from the first state to the second state may prevent reuse of valves of the present disclosure. For instance, a lumen between first and second orifices in a valve stem may be blocked or disconnected.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to valves for medical devices. In particular, the present disclosure relates to irrigation valves for medical devices. [Background technology]

[0002] Endoscopes include features for delivering fluids and suction at the site of a procedure. Tubes for delivering fluids and / or aspirants extend from the handle of the endoscope, through the shaft of the endoscope, and to the distal tip of the endoscope. During a procedure, bodily fluids, tissue, or other materials may accumulate in the tubes. To aid in the reprocessing of reusable endoscopes between procedures, endoscope sets are pre-processed. For example, after the endoscope is removed from the patient, water or other fluids are flushed through the tubes to remove debris from the air / water and / or suction tubes. A flush valve may be inserted into the endoscope's air / water valve cylinder (i.e., valve well) after the endoscope is removed from the patient and the procedure valve is removed from the valve cylinder. The operator may then depress the flush valve button for a predetermined time to flush the endoscope's air and / or water channels before further reprocessing of the endoscope. An important aspect of single-use valves is that they cannot be inadvertently reused. Another important aspect of the irrigation valve is that it is not confused with, and inadvertently used in place of, the procedure valve during a procedure in which an endoscope is inserted into a patient's body. It is with all of the above considerations in mind that the improvements of the present disclosure may be useful. Summary of the Invention

[0003] In one aspect, the present disclosure relates to a valve assembly for controlling fluid flow through a valve well. The valve assembly may include an interface member and a valve stem to which the interface member is removably connectable. The valve stem may include a proximal portion, a distal portion, two or more orifices, and a lumen communicating with a first orifice and a second orifice of the two or more orifices. The valve assembly may be configured to transition from a first state to a second state in response to use of the valve assembly to control fluid flow through the valve well. The second state of the valve assembly may prevent use of the valve assembly to control fluid flow through the valve well.

[0004] In some embodiments, communication between the first orifice and the second orifice through the lumen is blocked in the second state. In various embodiments, the lumen includes a transition deposit comprising a material configured to expand and fill a portion of the lumen upon exposure to a liquid. In many embodiments, the proximal and distal portions of the valve stem separate to transition from the first state to the second state. In some embodiments, in the first state, the proximal and distal portions of the valve stem are coupled by a retaining linkage and a separation linkage, and in the second state, the proximal and distal portions of the valve stem are coupled by the retention linkage but not the separation linkage. In some such embodiments, the separation linkage or retention linkage is disposed within the lumen. In some such embodiments, the separation linkage or retention linkage is disposed external to the lumen. In various such embodiments, the separation linkage comprises a loop disposed at a distal end of the proximal portion of the valve stem or at a proximal end of the distal portion of the valve stem. In several embodiments, using the valve assembly to control fluid flow through the valve well includes one or more of inserting a valve stem into the valve well, controlling fluid flow through the valve well, and removing the valve stem from the valve well. In some embodiments, in a first state, a proximal portion of the valve stem is secured relative to a distal portion of the valve stem by a shaped frangible portion, and in a second state, the proximal portion of the valve stem is slidably coupled to the distal portion of the valve stem. In some such embodiments, using the valve assembly to control fluid flow through the valve well transitions the valve assembly from the first state to the second state by breaking the shaped frangible portion. In various embodiments, the proximal portion of the valve stem is secured relative to the distal portion of the valve stem by a transition deposit in the first state, and the proximal portion of the valve stem is slidably coupled to the distal portion of the valve stem in the second state. In various such embodiments, exposing the transition deposit to liquid from using the valve assembly to control fluid flow through the valve well dissolves the transition deposit and transitions the valve assembly from the first state to the second state.Many embodiments include a plurality of radial legs having a plurality of first ends and a plurality of second ends, the plurality of first ends pivotally coupled to the valve stem, and in many such embodiments, in a first state, the plurality of second ends are held close to the valve stem by a hat slidably coupled to the valve stem, and in a second state, the plurality of second ends are released by the hat.

[0005] In another aspect, the present disclosure relates to a system including a valve well and a valve assembly. The valve well may include a cavity having two or more ports. The valve assembly may be for controlling fluid flow through the valve well. The valve assembly may include a valve stem and an interface member. The valve stem may include a proximal portion, a distal portion, two or more orifices, and a lumen communicating with a first orifice and a second orifice of the two or more orifices. The interface member may be coupled to the valve well and the valve stem. The valve assembly may be configured to transition from a first state to a second state in response to use of the valve assembly to control fluid flow through the valve well. The second state of the valve assembly may prevent use of the valve assembly to control fluid flow through the valve well.

[0006] In some embodiments, using the valve assembly to control fluid flow through the valve well includes one or more of inserting a valve stem into the valve well, controlling fluid flow through the valve well, and removing the valve stem from the valve well. In various embodiments, communication between the first orifice and the second orifice through the lumen is blocked in the second state. In many embodiments, the proximal and distal portions of the valve stem separate to transition from the first state to the second state.

[0007] In yet another aspect, the present disclosure relates to a method, which may include one or more of exposing a valve assembly to a valve well, transitioning the valve assembly from a first state to a second state by exposing the valve assembly to the valve well, wherein the second state of the valve assembly prevents use of the valve assembly to control fluid flow through the valve well. In some embodiments, exposing the valve stem to the valve well includes one or more of inserting the valve stem into the valve well, controlling fluid flow through the valve well with the valve stem, and removing the valve stem from the valve well. [Brief explanation of the drawings]

[0008] Non-limiting embodiments of the present disclosure will now be described, by way of example, with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown will generally be designated by a common reference numeral. For purposes of clarity, not every component will be labeled in every drawing, and not every component of every embodiment will be shown, unless such labeling is necessary to enable those skilled in the art to understand the present disclosure.

[0009] [Figure 1] 1 illustrates an exemplary valve assembly in communication with a valve well, according to one or more embodiments disclosed herein. [Figure 2A-2B] 1 illustrates various aspects of an exemplary valve assembly in communication with a valve well, according to one or more embodiments disclosed herein. [Figure 3A-3B] 1 illustrates various aspects of an exemplary valve assembly in communication with a valve well, according to one or more embodiments disclosed herein. [Figures 4A-4C] 1 illustrates various aspects of an exemplary valve stem portion according to one or more embodiments disclosed herein. [Figures 5A-5C] 1 illustrates various aspects of an exemplary valve stem portion according to one or more embodiments disclosed herein. [Figures 6A-6B]1 illustrates an exemplary valve stem with radial legs according to one or more embodiments disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0010] A medical flushing valve (i.e., a flushing valve) can be configured to provide flushing functionality to the air and water channels of an endoscope. In a first configuration, the flushing valve can provide a continuous supply of air to both the air and water channels in the handle and shaft of the endoscope through an air / water nozzle at the distal end of the endoscope. In a second configuration, the flushing valve can supply water to the air channels in the handle and shaft of the endoscope through an air nozzle at the distal end of the endoscope. The flushing valves (i.e., valves) of the present disclosure are generally single-use devices (SUDs) and are therefore disposable. Reusing SUDs not designed for reprocessing and reuse can result in unnecessary exposure to bacteria. Therefore, many of the valves (i.e., valve assemblies) disclosed herein can be configured to transition from a first state to a second state in response to use of the valve to control fluid flow through the valve well. The transition from the first state to the second state can prevent reuse of one or more of the valves disclosed herein. For example, the lumen between the first and second orifices in the valve stem can be blocked or severed.

[0011] Furthermore, the valve may be fabricated from a limited number of parts and materials, for example, to limit its cost, thereby allowing the valve to be economically disposable. For example, an interface member may seal an orifice to the valve lumen. In yet another example, the valve may have a single elastomeric component or spring cap. In addition, the irrigation valve may have a similar appearance to the procedure valve. However, using the irrigation valve instead of the procedure valve may result in incorrect fluid flow through the endoscope channel, e.g., liquid being delivered through the air channel. Also, using the irrigation valve instead of the procedure valve may result in continuous insufflation of air into the patient, e.g., through both the air and water channels. Accordingly, one or more embodiments disclosed herein may include an irrigation valve with features and / or components that facilitate distinguishing it from a procedure valve.

[0012] It will be understood that the disclosure contained herein is exemplary and explanatory only, and not limiting. As used herein, the terms “comprises,” “comprising,” or any other variations thereof are intended to cover a non-exclusive inclusion, whereby a process, method, article, or device comprising a list of elements does not include only those elements, but may also include other elements not expressly listed or inherent to such process, method, article, or device. The term “exemplary” is used to mean “example” rather than “ideal.” As used herein, the term “proximal” refers to a direction closer to a surface (e.g., an interface member, user interface, button) used by an operator to operate the valve, and the term “distal” refers to a direction away from a surface (e.g., a button) used by an operator to operate the valve. With respect to FIGS. 1-6B, “proximal” may refer to a direction toward the top of the drawing sheet, and “distal” may refer to a direction toward the bottom of the drawing sheet. Although endoscopes are referenced herein, references to endoscopes or endoscopy should not be construed as limiting the possible applications of the disclosed embodiments. For example, the disclosed embodiments may be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices. Additionally, although irrigation valves are referenced herein, the reference to irrigation valves should not be construed as limiting the possible applications of the disclosed embodiments. For example, the disclosed embodiments may be used with various medical valves for controlling fluid flow.

[0013] Reference is now made to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it may be apparent that novel embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form to facilitate explanation. The intention is to cover all modifications, equivalents, and alternatives within the scope of the claims.

[0014] FIG. 1 illustrates various aspects of a valve assembly 100 coupled to a valve well 106, in accordance with one or more embodiments of the present disclosure. The valve assembly 100 may include an interface member 102 and a valve stem 104 having an orifice 112-1. More generally, the valve assembly may include an interface member coupled to the valve stem. In various embodiments, the valve assembly 100 may be inserted into and / or coupled to the valve well 106. The valve assembly 100 and the valve well 106 may be oriented relative to a proximal end 105 and a distal end 115. In many embodiments, the interface member 102 may interact to move the valve stem 104 proximally or distally within the valve well 106 to control fluid flow through the valve well 106. For example, the valve assembly 100 may be used to direct water to flush one or more tubes and / or lumens within an endoscopic system. In some embodiments, Figure 1 may include one or more components that are the same as or similar to one or more other components of the present disclosure. Furthermore, one or more components of Figure 1, or aspects thereof, may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0015] 2A and 2B illustrate various aspects of a valve assembly 200 coupled to a valve well 206 in accordance with one or more embodiments of the present disclosure. More specifically, FIG. 2A includes a cross-sectional view of the valve assembly 200 in a first position 216-1, and FIG. 2B includes a cross-sectional view of the valve assembly 200 in a second position 216-2. The valve assembly 200 may include an interface member 200 and a valve stem 204. The interface member 200 may include a resilient portion 214. The valve stem 204 may include a first orifice 212-1 and a second orifice 212-2 coupled by a lumen 220. The valve well 206 may include a cavity 224 having ports 226-1, 226-2, 226-3, and 226-4. In some embodiments, FIGS. 2A and / or 2B may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, valve stem 204 may be the same as or similar to valve stem 104. Additionally, one or more components of Figures 2A and / or 2B, or aspects thereof, may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, transition deposit 222 may be incorporated into valve assembly 100 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0016] In the first configuration 216-1, the valve assembly 200 can be coupled to the valve well 206 without user input. In the second configuration 216-2, the valve assembly 200 can be coupled to the valve well 206 with user input that compresses the resilient portion 214 of the interface member 202 and moves the valve stem 204 distally within the valve well 206. In many embodiments, the second configuration can cause water input through port 226-3, through port 226-1, into an air channel in the handle and shaft of an endoscope (not shown), and through an air nozzle at the distal end of the endoscope.

[0017] Additionally, FIGS. 2A and 2B illustrate valve assembly 200 in different states. FIG. 2A illustrates valve assembly 200 in a first state 210-1, and FIG. 2B illustrates valve assembly 200 in a second state 210-2. In first state 210-1, transition deposit 222 may be disposed within lumen 220 in an unexposed state, and in second state 210-2, transition deposit 222 may transition to an exposed state to block water flow through lumen 220. For example, transition deposit 222 may expand upon exposure to a fluid. Thus, the transition material may include a material, such as Porex®, that expands and hardens after exposure to a certain volumetric flow rate of fluid. In other embodiments, the transition deposit may shrink and / or dissolve upon exposure to a fluid (see, e.g., FIGS. 5A-5C). In various embodiments, transition deposit 222 may comprise a cylindrical insert within lumen 220. In some embodiments, the transfer deposit 222 may be a coating, such as by being powder coated onto the surface.

[0018] More generally, one or more components of the valve assemblies disclosed herein may be configured to transition from a first state to a second state in response to use of the valve assembly to control fluid flow through a valve well. The transition from the first state to the second state may prevent reuse of one or more of the valve assemblies disclosed herein. For example, one or more components of the valve assembly may be altered by stretching, transitioning (e.g., chemically) from the first state to the second state, shortening, widening, removal, etc.

[0019] In some embodiments, the volumetric flow rate required for the transition deposit 222 to block the lumen 220 may be correlated to a particular use and / or the length of time the valve assembly 220 is used. For example, properly cleaning (i.e., reprocessing) an endoscope may require running water through the endoscope's air channel for at least 30 seconds, requiring the valve assembly 200 to maintain the second configuration 216-2 for at least 30 seconds. Thus, the transition deposit 222 may be configured to require a volumetric flow rate equal to 30 seconds of flow through the air channel to transition to the second state 210-2. In many embodiments, this technique may simplify or improve cleaning by simply requiring the valve assembly 200 to be depressed until it has fully transitioned to the second state 210-2, instead of requiring a 30-second timer.

[0020] In another example, properly cleaning an endoscope may require flowing a specific volume of water through the endoscope's air channel. In such other examples, the transition deposit 222 may be configured to block the lumen 220 after a specific volume of water has been flowed through the air channel. In this example, cleaning efficiency / reliability may be improved by having the state transition occur directly due to volumetric flow rate, as opposed to time. This may be due to one or more factors, such as variations in flow rate between different endoscopes or variations in pressure or flow rate provided by different processor and / or injector settings. The processor and / or injector setting may comprise a fluid source supplied to the endoscope's valve wells. While FIG. 2B illustrates state 210-2 while the valve assembly 200 is in the second configuration 216-2, it is understood that the transition to the second state 210-2 may occur, at least in part, after the valve assembly 200 has returned to the first configuration 216-1 (e.g., due to the resilient portion 214 comprising a biasing member for returning the valve assembly 200 to the first configuration 216-1 in the absence of an external input).

[0021] Use of a valve assembly (e.g., valve assembly 200) to control fluid flow through a valve well may include one or more of coupling an interface member to the valve well, transitioning the interface member from a first configuration to a second configuration, inserting a distal end of the valve assembly into a proximal end of the valve well, controlling fluid flow through the valve well with valve assembly 100, and removing the valve assembly from the valve well. In many embodiments, use of the valve assembly to control fluid flow through a valve well may cause a transition from a first state to a second state. For example, exposing transition deposit 222 to water while using valve assembly 200 to control fluid flow through valve well 206 (e.g., to flush an air channel) may cause transition deposit 222 to transition from first state 210-1 to second state 210-2.

[0022] In various embodiments, the resilient portion 214 may function as a biasing member. For example, the resilient portion 214 may bias the interface member 202 (and corresponding valve assembly) toward the first position 216-1. In other embodiments, the resilient portion 214 may not include a biasing member. In such other embodiments, a spring may be used as the biasing member. In some embodiments, the walls of the resilient portion 214 may have varying thicknesses and / or other configurations to bias the interface member 202 toward the first position 216-1. In some embodiments, the first position 216-1 may comprise a standby position, and the second position 216-2 may comprise an actuated position.

[0023] In some embodiments, the interface member 202 may couple with the valve well. In some such embodiments, the interface member 202 may apply a force against the valve well 206 to bias the interface member in the first configuration 216-1. In many embodiments, the second configuration 216-2 may allow fluid to flow through the valve well 206. Alternatively, the interface member 202 (and the remainder of the valve assembly) may be coupled to the valve well 206 in the first configuration 216-1 without fluid flowing through the valve well 206. In many embodiments, the interface member 202 may be moved distally to transition from the first configuration 216-1 to the second configuration 216-2. Furthermore, distal movement of the interface member 202 moves the valve stem 204 distally within the valve well 206. In some embodiments, the interface member may include one or more portions. For example, an operator's finger may interact with a first portion of the interface member, and a second portion of the interface member may couple with the valve well.

[0024] 3A and 3B illustrate various aspects of valve assemblies 300A, 300B coupled with a valve well 306 in accordance with one or more embodiments of the present disclosure. FIG. 3A includes the valve assembly 300A and the valve well 306. The valve assembly 300A may include an interface member 302 and a valve stem 304. The valve stem 304 may include a first stem portion 328-1 and a second stem portion 328-2 connected by retaining linkages 330-1, 330-2. The valve assembly 300B may be the same as or similar to the valve assembly 300A. In FIG. 3B, the valve assembly 300B may include a contact surface 334 and isolation linkages 332-1, 332-2 in addition to the components of the valve assembly 300A. Although not labeled, in some embodiments, the valve assembly 300A may include the contact surface 334. In various embodiments, first and second stem portions 328-1, 328-2 may be movable relative to one another, such as by extending or retracting, to transition from a first state to a second state. In some embodiments, FIGS. 3A and / or 3B may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, valve stem 304 may be the same as or similar to valve stem 204. Furthermore, one or more components, or aspects thereof, of FIGS. 3A and / or 3B may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, retaining linkages 330-1, 330-2 may be incorporated into valve assembly 100 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0025] In many embodiments, the first and second stem portions 328-1, 328-2 may be able to move relative to one another, such as by telescoping, to transition from a first state to a second state. For example, the junction between the first and second stem portions 328 may include one or more weakened portions (e.g., thin-walled portions, perforations, transition deposits, insufficient filling, or weakening after molding) via molding, additive manufacturing, subtractive manufacturing, and / or powder coating, etc. In some such cases, the weakened portions may allow the stem portions 328 to move relative to one another, such as during removal from the valve well or during transition from an actuated configuration (e.g., the second configuration) back to a standby configuration (e.g., the first configuration). In some embodiments, the retaining linkages 330-1, 330-2 may keep the first and second stem portions 328 coupled in the second state. In some such embodiments, the retaining linkage 330 may prevent the stem portion 328-2 from remaining within the valve well 306 when the valve assembly is removed. Frictional forces corresponding to the radial seals 350-1, 350-2, 350-3 on the valve stem 304 contacting the valve well cavity may cause the first and second stem portions 328 to separate during removal from the valve well.

[0026] In one or more embodiments disclosed herein, the first and second stem portions 328 may have interlocking loops (e.g., breakaway linkages) that engage with one another. When pressed together (e.g., in an actuated configuration), the loops may press against a solid surface of the opposing component (e.g., contact surface 334, contact surface 434). A perforated breaking point included in one or more of the loops may enable the proximal portion to separate when pulled away from the distal portion during removal. The proximal and distal stem portions may be connected by a retention linkage to retain the distal stem portion during removal and prevent it from being left behind in the valve well.

[0027] The separation linkages 332-1, 332-2 in FIG. 3B may comprise loops that break and / or are severed in the second state. For example, one or more of the separation linkages 332 may break when the valve assembly 300B is removed from the valve well 306. In various embodiments, the separation linkage 332-1 of the stem portion 328-1 may press against the contact surface 334 of the stem portion 328-2 when the interface member is depressed to transition the valve assembly 300B from the standby position to the actuated position. In the embodiment shown, the separation linkage 332 may be disposed within the lumen of the valve stem, and the retention linkage 330 may be disposed external to the valve stem. However, the valve assembly may include one or more retention linkages and / or one or more separation linkages coupling the stem portion 328 via various locations without departing from the scope of the present disclosure. In various embodiments, the linkage may include or be referred to as a leash. In some embodiments, the linkage may comprise a polymer and / or a metal (e.g., Nitinol). In some embodiments, the linkage may be integrally molded with the valve stem.

[0028] In many embodiments, one or more components and / or features disclosed herein can be used to distinguish the flush valve from the treatment valve. For example, retaining linkages 330-1, 330-2 can distinguish valve assembly 300 from treatment valve assemblies. In another example, interface member 302 can include one or more distinguishing features, such as a raised surface, color, and warning label.

[0029] 4A-4C illustrate various aspects of valve stem portions 428-1, 428-2 of a valve stem 404 according to one or more embodiments of the present disclosure. FIGS. 4A-4C illustrate alternative embodiments of a valve stem having first and second stem portions 428-1, 428-2, a retaining linkage 430, and isolation linkages 432-1, 432-2. In the illustrated embodiment, isolation linkage 432-2 is attached to the proximal end of stem portion 428-2 and includes arm 436. In some embodiments, arm 436 may be pivoted and / or biased to a particular position by a biasing member (e.g., a spring). Isolation linkage 432-1 is attached to the distal end of stem portion 428-1, including contact surface 434. In some embodiments, FIGS. 4A-4C may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, stem portions 428-1, 428-2 can be the same as or similar to stem portions 328-1, 328-2. Furthermore, one or more components, or aspects thereof, of Figures 4A-4C may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, isolation linkages 432-1, 432-2 may be incorporated into valve stem 304 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0030] 4A-4C show a first stem portion 428-1 having a strong, unperforated loop, similar to a carabiner, except that the arm 436 can be biased to an open state rather than a closed position, and a second stem portion 428-2 having a spring-loaded gate (i.e., arm 436) loop (e.g., breakaway linkage 432-2). More specifically, FIG. 4A shows the valve stem 404 in a first state 410-1, which may correspond to a standby configuration; FIG. 4B shows the valve stem 404 in a transition state, which may correspond to an actuated configuration; and FIG. 4C shows the valve stem 404 in a second state 410-2, which may occur when the valve stem 404 is removed from the valve well after the transition state. In the transition state, the contact surface 434 can push against the proximal end of the breakaway linkage 432-2, pushing the second stem portion 428-2 distally within the valve well. Additionally, the distal end of separation linkage 432-1 can pass through arm 436 (e.g., by pushing it open), allowing arm 436 to reclose. When the valve stem is removed, reclosed arm 436 causes separation linkage 432 to separate.

[0031] 5A-5C illustrate various aspects of valve stem portions 528-1, 528-2 according to one or more embodiments of the present disclosure. Valve stem 504 may include stem portions 528-1, 528-2 and retaining linkages 530-1, 530-2. FIG. 5A illustrates valve stem 504 in a first state 510-1, including transition deposit 522. FIGS. 5B and 5C illustrate valve stem 504 in a second state 510-2. In some embodiments, FIGS. 5A-5C may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, stem portions 528-1, 528-2 may be the same as or similar to stem portions 328-1, 328-2. Additionally, one or more components, or aspects thereof, of FIGS. 5A-5C may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, stem portions 328-1, 328-2 may be incorporated into valve stem 104 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0032] In the first state 510-1, the transition deposit 522 may lock the stem portions 528-1, 528-2 in a compressed position relative to one another. However, in the second state 510-2, the transition deposit 522 may be absent, and the stem portions 528 may be in an extended position relative to one another. Thus, in the absence of the transition deposit 522, the stem portions 528 may move relative to one another, such as by expanding and contracting. In many embodiments, the transition deposit 522 may behave in an opposite manner to the transition deposit 222, such as by dissolving when exposed to a fluid.

[0033] In many embodiments, the extended position may expose one or more radial openings 533, preventing reuse of the valve stem 504. In some embodiments, the valve stem 504 may include one or more features for locking the stem portions 528 in the extended state. For example, a transition deposit similar to the transition deposit 222 may be used to lock the stem portions 528 in the extended state. In other embodiments, the stem portions 528 may be free to move relative to each other in the second state 510-2. In various embodiments, controlling fluid flow through the valve well dissolves (or at least weakens) the transition deposit 522, allowing the valve stem to transition to state 510-2 when the valve stem is removed from the valve well. In some embodiments, the transition deposit 522 may comprise an adhesive, such as polyvinyl acetate.

[0034] The retaining linkages 530-1, 530-2 may include corresponding features that prevent separation when the stem portion 528 is removed from the valve well. For example, the retaining linkage 530 may include a collar and / or a ledge. In another example, the retaining linkage 530-1 may include a channel and the retaining linkage 530-2 may include a protrusion that moves within the channel.

[0035] 6A and 6B illustrate a valve stem 604 with radial legs 640 according to one or more embodiments of the present disclosure. The valve stem 604 may further include a hat 642. FIG. 6A may illustrate the valve stem 604 in a first state 610-1, in which the hat 642 holds one or more radial legs 640 adjacent to the valve stem 604. FIG. 6B may illustrate the valve stem 604 in a second state 610-2, in which the radial legs 640 are released by the hat 642. In some embodiments, FIGS. 6A and / or 6B may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, the valve stem 604 may be the same as or similar to the valve stem 104. Furthermore, one or more components, or aspects thereof, of FIGS. 6A and / or 6B may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, radial legs 640 may be incorporated into valve assembly 200 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0036] In various embodiments, the valve stem 604 can include one or more radial legs 640 having first ends coupled to the valve stem 604. A hat 642 can hold second ends of the radial legs 640 proximate the shaft of the valve stem 604 until the valve stem is depressed. In various embodiments, the hat 642 can include one or more of a cylindrical cuff, a containment tray / box / guard, or the like. In many embodiments, the radial legs 640 are in a shortened configuration when held by the hat 642. For example, the radial legs can include a bent or arcuate portion in state 610-1. In some such examples, the bent or arcuate portion can cause the radial legs 640 to radially expand and extend proximally when released by the hat. In some embodiments, a biasing member, such as a spring, can be used to cause the radial legs 640 to radially expand and extend proximally.

[0037] In the second state 610-2, the legs may extend and lock against the hat 642, or the like, thereby lengthening and disabling the valve stem 604 to control fluid flow through the valve well. For example, the radial legs 640 may lock to the valve stem 604, and the hat 642 may be slidably coupled to the valve stem 604. Thus, when the valve stem 604 is pushed distally (e.g., to transition to the actuated configuration), the second ends of the radial legs 640 may move distally enough to no longer be retained by the hat 640. When the radial legs 640 are no longer retained by the hat 642, the radial legs 640 may lengthen. When the valve stem 604 moves proximally (e.g., to transition back to the parked configuration), the radial legs 640 may lock against the hat 642 in the lengthened position, increasing the overall length of the valve stem 604.

[0038] This application is related to U.S. patent application Ser. No. 16 / 868,325, filed May 6, 2020, entitled "Devices, Systems, Methods, and Designs for Medical Cleaning Valves," which is incorporated by reference in its entirety for all purposes.

[0039] This application is related to U.S. Patent Application No. 16 / 868,329, entitled "Devices, Systems, and Methods for Medical Cleaning Valves," filed May 6, 2020, and incorporated by reference in its entirety for all purposes.

[0040] All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of the present disclosure have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that variations can be applied to the devices and / or methods, and to the steps or sequence of steps of the methods, disclosed herein without departing from the concept, spirit, and scope of the present disclosure.

Claims

1. 1. A valve assembly for controlling fluid flow through a valve well, comprising: An interface member; a valve stem to which the interface member is removably connectable; the valve stem includes a proximal portion, a distal portion, one or more weakened portions between the proximal portion and the distal portion, two or more orifices, and a lumen communicating with first and second orifices of the two or more orifices; the valve assembly is configured to transition from a first state to a second state in response to use of the valve assembly to control fluid flow through a valve well; the one or more weakened portions or one or more linkages between the proximal and distal portions of the valve stem allow the proximal and distal portions of the valve stem to move longitudinally relative to one another to transition from the first state to the second state, which transition prevents the valve assembly from being reused to control a fluid.

2. A valve assembly as described in claim 1, wherein the lumen includes a transition deposit comprising a material configured to expand when exposed to a liquid to fill a portion of the lumen, and in the second state, the expanded transition deposit blocks communication between the first and second orifices through the lumen.

3. The valve further comprises a pair of separation linkages, one of which is disposed at the proximal portion of the valve stem and the other of which is disposed at the distal portion, the pair of separation linkages being detachable from each other; In the first state, the proximal and distal portions of the valve stem are coupled by a retaining linkage and the connected separation linkage, respectively, and in the second state, the proximal and distal portions of the valve stem are not coupled by the disconnected separation linkages but are coupled by the retaining linkages; 3. The valve assembly of claim 1 or claim 2, wherein the retaining linkage prevents the distal portion from remaining within the valve well when the valve assembly is removed from the valve well.

4. The valve assembly of claim 3 , wherein the separation linkage pair or the retaining linkage is disposed within the lumen.

5. 5. A valve assembly according to claim 3 or claim 4, wherein the separation linkage pair or the retaining linkage is disposed external to the lumen.

6. 6. A valve assembly according to claim 3, wherein the pair of separation linkages comprises a loop disposed at the distal end of the proximal portion of the valve stem or at the proximal end of the distal portion of the valve stem.

7. A valve assembly as described in any one of claims 1 to 6, wherein the valve assembly is configured to be inserted into a valve well, and using the valve assembly to control fluid flow through the valve well includes one or more of inserting the valve stem into the valve well, controlling fluid flow through the valve well, and removing the valve stem from the valve well.

8. 8. The valve assembly of claim 1, wherein in the first state, the proximal portion of the valve stem is fixed relative to the distal portion of the valve stem by the one or more weakened portions, and in the second state, the proximal portion of the valve stem is slidably coupled to the distal portion of the valve stem.

9. 9. The valve assembly of claim 8, wherein using the valve assembly to control fluid flow through the valve well causes the valve assembly to transition from the first state to the second state by rupturing the one or more weakened portions.

10. 10. The valve assembly of claim 1, wherein in the first state, the proximal portion of the valve stem is fixed relative to the distal portion of the valve stem by a transition deposit, and in the second state, the proximal portion of the valve stem is slidably coupled to the distal portion of the valve stem.

11. A valve assembly as described in claim 10, wherein the transition deposit is a dissolvable transition deposit, and when the dissolvable transition deposit is exposed to liquid by using the valve assembly to control fluid flow through the valve well, the dissolvable transition deposit dissolves and the valve assembly transitions from the first state to the second state.

12. A valve stem further comprising a hat slidably connected to the valve stem, and a plurality of radial legs having a plurality of proximal ends and a plurality of proximal ends, the plurality of proximal ends being pivotally coupled to the valve stem; 12. The valve assembly of claim 1, wherein the hat is configured to hold the distal ends of the radial legs in the first state, thereby placing the radial legs in a shortened, bent or curved position, and to release the distal ends of the radial legs in the second state, thereby placing the radial legs in an extended, bent or curved position.

13. 1. A valve assembly for controlling fluid flow through a valve well, comprising: An interface member; a valve stem to which the interface member is removably connectable, the valve stem including a proximal portion, a distal portion, two or more orifices, and a lumen communicating with first and second orifices of the two or more orifices; a plurality of radial legs, each radial leg having a proximal end pivotally connected to the valve stem and a distal end; a hat slidably coupled to the valve stem; the valve assembly is configured to transition from a first state to a second state in response to using the valve assembly to control fluid flow through a valve well; the hat is configured to hold the distal ends of the plurality of radial legs in the first state, thereby causing the plurality of radial legs to assume a shortened position with bend or curvature, and to release the distal ends of the plurality of radial legs in the second state, thereby causing the plurality of radial legs to assume an extended position with the bend or curvature relaxed or eliminated, a valve assembly, wherein the overall length of the valve stem increases when the plurality of radial legs transition from the contracted configuration in the first state to the extended configuration in the second state, thereby preventing reuse of the valve assembly to control fluid flow through a valve well.

14. A valve assembly as described in any one of claims 1 to 3, wherein when the valve assembly transitions from the first state to the second state, one or more components of the valve assembly are configured to be altered by lengthening, shortening, widening, removing, or chemically altered to prevent reuse of the valve assembly to control fluid flow through the valve well.

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