Medical valves

Abstract

A valve for an endoscope may include a distal valve stem member having a first lumen extending from a proximal opening at a proximal-most end of the proximal valve stem member to a distal opening at a distal-most end of the proximal valve stem member. The distal valve stem member may have a second lumen having a proximal opening at a proximal-most end of the distal valve stem member. The proximal-most end of the distal valve stem member may be received within the distal opening of the first lumen. The distal valve stem is movable relative to the proximal valve stem.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 854,689, filed May 30, 2019, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to valves for medical devices, particularly endoscopes. Background Art

[0004] Endoscopes include functions for delivering fluids (including air and water) and for suctioning the surgical site. Tubes for delivering fluids and / or suction extend from the endoscope's handle through its sheath to the distal tip of the endoscope. A combined air / water valve can be used to deliver air or water during surgery. During surgery, body fluids, tissue, or other material may enter the tubes or accumulate therein, leading to blockage. To facilitate post-processing of reusable endoscopes between surgeries, pre-conditioning is implemented in endoscopy kits. 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 and / or suction tubes. One option for accomplishing this pre-processing is a reusable purge valve. When using reusable air / water and purge valves, these valves must undergo post-processing between surgeries. Therefore, there is a need for valves that can deliver air / water and perform cleaning functions. Summary of the Invention

[0005] A valve for use in an endoscope may include a proximal valve stem member having a first lumen extending from a proximal opening at a proximal-most end of the proximal valve stem member to a distal opening at a distal-most end of the proximal valve stem member. The distal valve stem member may have a second lumen with a proximal opening at the proximal-most end of the distal valve stem member. The proximal-most end of the distal valve stem member may be received within the distal opening of the first lumen. The distal valve stem is movable relative to the proximal valve stem.

[0006] Additionally or alternatively, any embodiment of the valve described herein may include one or more of the following features. The proximal valve stem member may include a membrane within the first lumen, the membrane forming a fluid-tight barrier between the proximal opening and the proximal opening. In a first configuration, the proximal-most end of the distal valve stem member may be distal to the initial position of the membrane, such that the first lumen is not in fluid communication with the second lumen. In a second configuration, the membrane may be pierced and the proximal-most end of the distal valve stem member may be proximal to the initial position of the membrane, such that the first lumen is in fluid communication with the second lumen. The distal valve stem member may have a shoulder, which in the second configuration is contacted by the distal-most end of the proximal valve stem member. The proximal valve stem member may include a first hole formed through a wall of the proximal valve stem member. The first hole may be in fluid communication with the first lumen. The proximal valve stem member may include a second hole formed through a wall of the proximal valve stem member, wherein the second hole is in fluid communication with the first lumen. The second lumen may be sealed at its distal-most end. The distal valve stem member may have a third aperture formed through a wall of the distal valve stem member. The third aperture may be in fluid communication with the second lumen. The proximal valve stem member may include a button configured to be contacted by an operator's finger. The proximal surface of the button may be at the proximal-most end of the proximal valve stem member. The proximal valve stem member may include at least one tab on the distal surface of the button. At least one seal may be disposed on an outer surface of the distal valve stem member. At least two O-ring seals may be disposed on the outer surface of the distal valve stem member. At least one O-ring seal may be disposed on the outer surface of the proximal valve stem member. A one-way seal may be disposed on the outer surface of the proximal valve stem member. The proximal-most end of the distal valve stem may be tapered.

[0007] In another example, a valve for use in an endoscope may include a proximal valve stem member having a first lumen extending from a proximal opening at the proximal-most end of the proximal valve stem member to a distal opening at the distal-most end of the proximal valve stem member. A membrane within the first lumen may form a fluid-tight barrier between the proximal opening and the distal opening. The distal valve stem member may be received within the distal opening of the first lumen. In a first configuration, the proximal-most end of the distal valve stem member may be distal to the initial position of the membrane. In a second configuration, the membrane may be pierced and the proximal-most end of the distal valve stem member may be proximal to the initial position of the membrane. The distal valve stem member may have a second lumen with a proximal opening at the proximal-most end of the distal valve stem member. In the first configuration, the first lumen and the second lumen are not in fluid communication. In the second configuration, the first lumen and the second lumen may be in fluid communication.

[0008] Additionally or alternatively, any example of a valve described herein can include one or more of the following features. The second lumen can be closed at its distal-most end. The distal valve stem member can have a hole formed through a wall of the distal valve stem member. The hole can be in fluid communication with the second lumen. The proximal valve stem member can include a first hole and a second hole formed through a wall of the proximal valve stem member. Each of the first hole and the second hole can be in fluid communication with the first lumen.

[0009] A method of delivering air and water may include delivering air to an air channel of a medical device via a valve in a first configuration; converting the valve from the first configuration to a second configuration to deliver water to a water channel of the medical device; and converting the valve from the second configuration to a third configuration to deliver water to the air channel of the medical device.

[0010] Any method described herein may include one or more of the following features or steps. The valve may be converted to a first configuration by covering a proximal aperture of the valve. Converting the valve to a second configuration may include partially depressing the valve. Converting the valve to a third configuration may include fully depressing the valve. The valve may include a proximal valve stem member having a first lumen extending from a proximal opening at a proximal-most end of the proximal valve stem member to a distal opening at a distal-most end of the proximal valve stem member. A membrane within the first lumen may form a fluid-tight barrier between the proximal opening and the distal opening. The distal valve stem member may be received within the distal opening of the first lumen. In the first and second configurations, the proximal-most end of the distal valve stem member is distal to the initial position of the membrane. Converting from the second configuration to the third configuration may include piercing the membrane and moving the proximal-most end of the distal valve stem to a position proximal to the initial position of the membrane.

[0011] It will be understood that the foregoing summary and the following detailed description are exemplary and explanatory only and are not intended to limit the invention as claimed. As used herein, the words "comprises," "comprising," or any other variations thereof are intended to encompass a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements includes not only those elements but may also include other elements not expressly listed or unique to such process, method, article, or apparatus. The word "exemplary" is used in the sense of "exemplary" rather than "ideal." As used herein, the term "proximal" refers to a direction closer to a surface (e.g., a button) contacted by an operator to operate a valve, and the word "proximal" refers to a direction away from a surface (e.g., a button) used to operate a valve. Although endoscopes are mentioned herein, reference to endoscopes or endoscopic examinations should not be construed 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0013] Figure 1A-1C A cross-sectional view of a first exemplary valve is shown.

[0014] Figure 2A-2C A cross-sectional view of a second exemplary valve is shown.

[0015] Figure 3A-3B and Figure 4A-4B An exemplary seal for a second exemplary valve is shown.

[0016] Figures 5A-5C A cross-sectional view of a third exemplary valve is shown. DETAILED DESCRIPTION

[0017] The valve can be configured to deliver air and water during surgery and to direct fluid to clean the air and water channels of the endoscope after surgery. In various embodiments, the valve can be a single-use valve and thus discarded after only one surgery and after surgery, although in other embodiments the valve can be reusable. The valve can have up to four or more configurations. In a first configuration, the valve cannot deliver air or water to the channels in the endoscope sheath. In a second configuration, the valve can deliver air only to the sheath's air channel. In a third configuration, the valve can deliver water only to the sheath's water channel. In a fourth configuration, the valve can deliver water only to both the air and water channels, thereby performing a pre-treatment cleansing of the air and water channels.

[0018] Figure 1A-1C A cross-sectional view of an exemplary valve 10 is shown in a valve cartridge 12. The valve cartridge 12 may have a surface 14 that defines a cavity into which the valve 10 may be inserted. The valve cartridge 12 may include connections to passageways for air or water to flow in or out of a medical device, such as an endoscope. For example, the valve cartridge 12 may have an air inlet 16 and an air outlet 18. The valve cartridge 12 may also have a water inlet 20 and a water outlet 22. From proximal to distal, the outlets may be in the following order: air outlet 18, air inlet 16, water outlet 22, and water inlet 20.

[0019] The valve 10 may include a valve stem 24. The valve stem 24 may include a proximal member 26 and a distal member 28. The various portions of the valve stem 24, including the proximal member 26 and the distal member 28, may be made of metal (e.g., stainless steel, titanium, aluminum, etc.), a polymer (e.g., polycarbonate, acrylonitrile butadiene styrene (ABS), high-density polyethylene (HDPE), nylon, polyether ether ketone (PEEK), thermoplastics, plastics, etc.), or any other suitable material. The proximal member 26 and the distal member 28 may be made of the same material or different materials. The proximal member 26 and / or the distal member 28 may be formed of a single, continuous piece of material.

[0020] The proximal member 26 can include a button 32. The button 32 can be formed as a continuous structure with the rest of the proximal member 26, or the button 32 can be a separate structure attached to the rest of the proximal member 26. The button 32 can have an outer circumference that is wider than the proximal opening of the valve cylinder 12, such that when the button 32 is pressed, the button 32 cannot pass through the proximal opening of the valve cylinder 12.

[0021] The proximal member 26 can have a proximal lumen 40. The proximal member 26 can have a generally annular shape about the lumen 40. The proximal lumen 40 can have a proximal-most opening 41 on the proximal-most end of the proximal member 26. For example, the proximal lumen 40 can open on the proximal-most side of the button 32. The proximal opening 41 is shown in phantom to indicate that (as discussed below) the proximal opening 41 can be covered by an operator (e.g., by the operator's index finger or thumb).

[0022] like Figure 1A and Figure 1B As shown in FIG, the membrane 42 may extend completely across the proximal lumen 40 toward the distal end 44 of the proximal lumen 40, or alternatively, the membrane 42 may be located at the distal-most end of the proximal lumen 40. The membrane 42 may be composed of a thin material. Figure 1B-1C Various aspects of membrane 42 are discussed in greater detail.

[0023] The proximal aperture 46 can be formed in the wall of the proximal member 26 and extend completely therethrough and can fluidly connect the proximal lumen 40 to an area external to the proximal member 26. Figure 1A-1C 26 , one proximal aperture 46 is shown, but any number of proximal apertures may be used. One or more air apertures 48 may also be formed in the wall of the proximal member 26 and extend completely through the wall and may fluidly connect the proximal lumen 40 to an area external to the proximal member 26. Although only one air aperture 48 is shown, any suitable number of apertures may be used.

[0024] The distal member 28 may include a neck 50 at the proximal end of the distal member 28. The neck 50 may have an outer diameter that is smaller than the diameter of the lumen 40. The neck 50 may terminate distally at a shoulder 52. The neck 50 may have a proximal tapered portion 54. A distal lumen 60 may extend through the distal member 28 (including the neck 50). The distal lumen 60 may be open on the proximal side of the distal member 28 (e.g., at the proximal end 62 of the neck 50) and may be closed on the proximal side of the distal member 28. The diameter of the distal lumen 60 may be smaller than the diameter of the proximal lumen 40. The tapered portion 54 may taper from an initial outer diameter (at the proximal end) until its outer diameter is approximately the same as the diameter of the distal lumen 60. The proximal end of the tapered portion 54 may form a sufficiently sharp annular ring to penetrate, puncture, or remove the membrane 42 with sufficient force. Portions of the membrane 42 severed by the tapered portion 54 may be flushed away by fluid flowing through the valve 10 (the flushing process is discussed in more detail below) or may remain within the valve 10. The distal aperture 64 may be formed in the wall of the distal member 28 and extend completely through the wall of the distal member 28 and may fluidly connect the distal lumen 60 to an area external to the distal member 28. Although Figure 1A-1C One distal aperture 64 is shown in FIG. 1 , but any number of distal apertures may be used.

[0025] The neck 50 may be slidably received within the proximal lumen 40 such that the distal lumen 60 is in fluid communication with the proximal lumen 40. The proximal lumen 40 and / or the neck 50 may have features (e.g., notches, protrusions, tabs, etc.) (not shown) that retain the neck 50 within the lumen 40 and prevent the proximal-most end 62 of the neck 50 from exiting the distal-most end 44 of the proximal lumen 40.

[0026] The valve stem 30 may be equipped with one or more seals. For example, in the proximal-to-proximal direction, the valve stem 30 may include a first seal 72, a second seal 74, a third seal 76, and a fourth seal 78. The seals 72, 74, 76, and 78 may be, for example, O-rings. The seals 72, 74, 76, and 78 may be made of an elastic material. The valve stem 30 may also include a one-way seal 82, which may be made of the same or different material (e.g., an elastic material) as the seals 72, 74, 76, and 78. The one-way seal 82 may allow fluid or other substances to pass through the one-way seal 82 proximally, but due to its flexibility and arrangement relative to its contact structure, it does not allow fluid or other substances to pass through the one-way seal 82 proximally. The first seal 72 and the second seal 74 may be disposed on the proximal member 26. The third seal 76 and the fourth seal 78 may be disposed on the distal member 28. The one-way seal 82 can be disposed on the proximal member 26 between the second seal 74 and the third seal 76. Alternatively, the seals 72, 74, 76, 78 and the one-way seal 82 can be disposed on other portions of the valve stem 30 or in a different order. The proximal aperture 46 can be disposed between the first seal 72 and the second seal 74. The distal aperture 64 can be disposed between the third seal 76 and the fourth seal 78.

[0027] Seals 72, 74, 76, and 78 can be configured to form a slidable interference fit between seals 72, 74, 76, and 78 and surface 14. Thus, valve stem 30 can move relative to surface 14, but fluid (e.g., water and air) cannot move between seals 72, 74, 76, and 78 and surface 14. Thus, seals 72, 74, 76, and 78 prevent fluid external to valve 10 from moving past seals 72, 74, 76, and 78 in either a proximal or distal direction.

[0028] The inner diameter of the one-way seal 82 can be designed to have a slight interference fit between the outer surface of the proximal member 26 and the inner diameter of the one-way seal 82 to form a tight seal. The outer diameter of the one-way seal 82 can be designed to form a slight interference fit with a portion of the surface 14. The thin flap (flap) of the one-way seal 82 can extend radially outward from the proximal member 26 at an angle that intersects the longitudinal axis of the proximal member 26. For example, the thin flap can extend at an angle between 10 degrees and 80 degrees relative to the longitudinal axis of the proximal member 26. The flap of the one-way seal 82 can be expandable (open, unfold) so that when a fluid (e.g., water or air) moves in a proximal direction toward the one-way seal 82, the positive pressure will cause the flap to expand, thereby maintaining a seal between the one-way seal 82 and the surface 14. Fluid moving proximally toward the one-way seal 82 will also create a positive pressure, but this positive pressure will generate a force perpendicular to the longitudinal axis of the proximal member 26 to radially compress the flaps of the one-way seal 82. Thus, fluid (e.g., air or water) is permitted to move proximally between the one-way seal 82 and the surface 14, past the one-way seal 82.

[0029] Figure 1A The valve 10 is shown in a first configuration and / or a second configuration.In the first configuration of the valve 10, neither air nor water is delivered to any outlet of the valve 10 and will be exhausted to the atmosphere through the proximal-most opening 41 .

[0030] In the second configuration, air is delivered to the air channel of the endoscope, but water is not delivered to any channel. The first configuration and the second configuration may differ only in that the proximal opening 41 at the proximal end of the proximal lumen 40 remains open in the first configuration and is closed in the second configuration (e.g., by the operator's thumb or index finger). In the first and second configurations, the button 32 is not depressed. The valve 10 may include features such as tactile feedback features (not shown) to indicate that the valve 10 is properly positioned within the valve barrel 12. For example, the valve 10 may include ridges, bumps, or other protrusions on the outer surface of the proximal member 26. The proximal end 62 of the distal lumen 60 (and neck 50) may be distal to the membrane 42 so that the proximal lumen 40 is not in fluid communication with the distal lumen 60.

[0031] In the first and second configurations, the water inlet 20 can be distal to the fourth seal 78. The water outlet 22 can be between the third seal 76 and the fourth seal 78. Thus, water from the water inlet 20 does not move proximally to the fourth seal 78. The water outlet 22 is surrounded by the third seal 76 and the fourth seal 78, and therefore fluid (air and water) cannot move longitudinally along the surface 14 of the barrel 12 to the water outlet 22. And because the membrane 42 is in place, the distal lumen 60 is not in fluid communication with the proximal lumen 40. Therefore, fluid does not exit the outlet 22.

[0032] In a first configuration (eg, when the proximal-most opening 41 is uncovered and neither air nor water is being delivered), as shown in FIG. Figure 1A As shown by the dashed arrows in FIG, air can enter from the air inlet 16, proximally pass through the one-way seal 82, and then flow around the circumference of the proximal member 26 of the valve stem 24 to the air hole 48. The air will enter the air hole 48 rather than exit the air outlet 18 because the proximal-most opening 41 to the atmosphere provides the path of least resistance. The air can then be discharged proximally from the proximal-most opening 41. Any air attempting to exit the hole 46 will be trapped between the first and second seals 72, 74, and thus will be discharged from the proximal-most opening 41. The air will not travel distally past the third seal 76 and therefore will not exit the water outlet 22. The air inlet 16 may be proximal to the third seal 76 but distal to the one-way seal 82. While air entering from the air inlet 16 may travel distally past the one-way seal 82 toward the air outlet 18, the path of least resistance will be used for the air to be discharged from the proximal-most opening 41, and therefore, the air will not exit the air outlet 18. Thus, in the first configuration, neither air nor water is conveyed.

[0033] In the same Figure 1A In the second configuration shown in FIG, the proximal most opening 41 can be covered by, for example, the operator's thumb or index finger. The proximal most opening 41 can also be covered in the third and fourth configurations described below. In addition, the second configuration can be identical to the first configuration, for example, all of the structures of the valve 10 are in the same position relative to each other and the barrel 12. Because air will no longer be discharged from the proximal most opening 41 (as shown in FIG, 2 ), the proximal most opening 41 can be covered by, for example, the operator's thumb or index finger. Figure 1A 82). Thus, air entering from the air inlet 16 can pass proximally through the one-way seal 82. Consequently, air entering from the air inlet 16 can pass through the air outlet 18 to be delivered to the air passageway of the endoscope. Air from the air inlet 16 will not flow proximally through the second seal 74 and, therefore, will not enter the proximal aperture 46. When the proximal-most opening 41 is covered, air entering the aperture 48 cannot exit from the proximal-most opening 41. Thus, in the second configuration, the valve 10 will deliver air to the air passageway of the endoscope.

[0034] Figure 1BThe valve 10 is shown in a third configuration, in which water is delivered to the water channel of the endoscope but air is not delivered to any endoscope channel. In order to switch from the second configuration to the third configuration, the button 32 can be partially pressed. For example, the button 32 can be pressed until the flexible structure on the distal surface of the button 32 contacts the proximal outer surface of the tube 12. For example, the tab 94 can contact the outer surface of the tube 12. The contact of a feature (structure) such as the tab 94 can cause tactile feedback to the operator to indicate that the valve 10 is in the third configuration. The tab 94 is merely exemplary and any suitable feature can be used. For example, an annular flap / flange, an expanded inflatable feature, a frangible part, or other features can be used. The tab 94 can be made of the same material as the button 32 or of a different material.

[0035] In the conversion from the second configuration to the third configuration, as a result of the button 32 being pressed, both the proximal member 26 and the distal member 28 can be translated distally relative to the tube 12. The membrane 42 can have sufficient elasticity so that the force acting on the button 32 in order to convert the valve 10 from the second configuration to the third configuration does not cause the most proximal end of the neck 50 to break through the membrane 42. Therefore, the membrane 42 can remain intact in the third configuration, and the force acting on the neck 50 by the membrane 42 can cause the distal member 28 to translate distally together with the proximal member 26. The distal member 28 (and the proximal member 26) can translate distally until the distal member 28 rests on the distal surface of the tube 12, or until the tab 94 contacts the proximal upper surface of the tube 12. In addition or alternatively, the friction between the outer surface of the neck 50 and the inner surface of the proximal lumen 40 can cause the distal member 28 to move in unison with the proximal member 26.

[0036] In the third configuration, the fourth seal 78 may be distal to the water inlet 20. The third seal 76 may be distal to the water outlet 22. Thus, as indicated by the solid arrow, water from the water inlet 20 cannot move proximally past the fourth seal 78, but can move through the water outlet 22 and through the endoscope's water channel. Although water can move through the distal aperture 64, it cannot move proximally past the membrane 42, which may be sufficiently resilient to prevent proximal movement. Therefore, water cannot enter the proximal lumen 40. Water also cannot move proximally past the third seal 76. The one-way seal 82 may be distal to the air inlet 16, preventing air from entering the air aperture 48 without passing through it. The second seal 74 may be proximal to the air inlet 16. Therefore, air from the air inlet 16 cannot move through the air aperture 48 or past the seal 74 into the proximal lumen 40 and, therefore, will not exit the air outlet 18. Also, because the operator's index finger or thumb still covers the proximal-most opening 41, air cannot enter the air hole 48 and be exhausted from the proximal-most opening 41. As a result, in the third configuration, the only fluid flowing to the endoscope sheath is water through the water channel.

[0037] The valve 10 can be switched from the third configuration back to the first / second configuration. For example, the valve 10 can include a spring (not shown) or other feature that biases the valve 10 toward the first configuration. Alternatively, the valve 10 can be switched from the third configuration (or the first / second configuration) to the fourth configuration.

[0038] As shown in Figure 1C , the fourth configuration facilitates the flushing of water from the water inlet 20 through the water outlet 22 and the air outlet 18. The fourth configuration can be referred to as the cleaning configuration of the valve 10. In order to move from the third configuration to the fourth configuration, the button 32 can be pressed until the tab 94 is collapsed against the surface of the tube 12. Compared with switching to the third configuration, switching the valve 10 to the fourth configuration requires significantly more force. When the button 32 is partially pressed in the third configuration, the button 32 can be fully pressed in the fourth configuration. In the fourth configuration, the tab 94 can break (for example, by breaking the proximal end of the tab 94) or bend and straighten, thereby being parallel to the proximal surface of the button 32 and / or the proximal surface of the endoscope barrel 12. In order to bend or break the tab 94, a minimum amount of force is required.

[0039] Because the distal member 28 is already resting against the distal surface of the barrel 12 in the third configuration, the distal member 28 does not translate distally along with the proximal member 26 when the button 32 is fully depressed. Distal translation of the proximal member 26 relative to the distal member 28 causes the proximal tapered portion 54 to pierce the membrane 42 and thereby fluidically connect the distal lumen 60 to the proximal lumen 40. In the fourth configuration, the proximal tapered portion 54 of the distal member 28 may be proximal to the initial position of the membrane 42. Thus, as shown by the solid arrows, in the fourth configuration of the valve 10, water may flow from the water inlet 20 and out of the water outlet 22, as in the third configuration of the valve 10. However, unlike the third configuration, the fourth configuration also allows water to travel into the distal hole 64, through the distal lumen 60, into the proximal lumen 40, and out of the proximal hole 46, so that water can flow between the valve stem 30 and the surface of the valve cylinder 12 to the air outlet 18. Because the air hole 48 can be covered by the neck 50 in the fourth configuration, water does not pass through the air hole 48.

[0040] The fourth configuration should not be used when the endoscope is inside a patient's body cavity. The valve 10 may include a mechanism to prevent the operator from accidentally switching the valve 10 to the fourth configuration. For example, the tab 94 may provide resistance or other tactile feedback to prevent the button 32 from being pressed past the third configuration. During patient surgery, the operator may also receive tactile feedback from the distal end of the distal member 28 that contacts the distal surface of the valve cylinder 12 in the third configuration, thereby indicating to the operator that the button 32 should not be pressed further when the endoscope is in use. In addition or alternatively, other methods can be used to prevent the valve 10 from accidentally switching to the fourth configuration. For example, a deformable mechanical stopper may provide audible feedback (e.g., a "click"), the valve 10 may need to be rotated before switching to the fourth configuration, and / or a visual indicator may provide feedback to the operator.

[0041] Because the membrane 42 ruptures in the fourth configuration, the valve 10 cannot be reused in any of the first, second, or third configurations. Thus, the valve 10 is a single-use valve, intended for use during only one pre-treatment purge step. Alternatively, after use in one pre-treatment purge, the valve 10 can be used solely as a pre-treatment purge valve 10 and not during patient surgery. Alternatively, the membrane 42 can be a secure, reusable seal that can be reset after use so that the valve 10 can be reused in multiple surgeries.

[0042] To use the valve 10, the operator can insert the valve 10 into the valve barrel 12 of the endoscope before surgery. During surgery, the operator can use the valve 10 in the first, second, and / or third configurations based on the operator's desire to use air or water during surgery. After surgery, the endoscope can be removed from the patient for post-processing. The button 32 can be fully pressed, causing the valve 10 to switch to the fourth configuration. The valve 10 can flush water through the air channel and the water channel for a predetermined amount of time (e.g., 30 seconds). After the flushing is completed, the operator can move the button 32 proximally to terminate the flow of water, or can simply remove the valve 10 from the valve barrel 12. Alternatively, the button 32 can automatically move proximally to terminate the flow of water. The endoscope will undergo further post-processing, and the valve 10 can be disposed of.

[0043] Figure 2A-2C Depicted is another exemplary valve 100 configuration. Although reference is made herein to the same valve cartridge 12, it should be understood that the valve 100 may be used with different valve cartridges. Figure 2A The valve 100 is shown in a first / second configuration, Figure 2B The valve 100 is shown in a third configuration, and Figure 2CThe valve 100 is shown in a fourth configuration. The valve 100 can include a valve stem 102. The valve stem 102 can have a proximal portion 114 and a distal portion 116. The proximal portion 114 of the valve stem 102 can include a button 120, which can be configured to be contacted by an operator's index finger during use of the valve 100. A spring 122 can be disposed in an annular groove within the button 120 and abut a distal-facing surface of the button 120. When the valve 100 is inserted into the barrel 12, the distal surface of the spring 122 can press against the proximal surface of the barrel 12.

[0044] The valve stem 102 can have an air release lumen 128. The air release lumen 128 can extend through the button 120 and have a proximal-most opening 130 on the proximal surface of the button 120. The proximal-most opening 130 is shown in dashed lines to indicate that the proximal-most opening 130 can be covered by an operator (e.g., by the operator's thumb / index finger). The distal end of the air release lumen 128 can open to the outer surface of the valve stem 102 via the air hole 126 so that the air release lumen 128 is in fluid communication with an area outside the valve stem 102. The air release lumen 128 can extend along the longitudinal axis of the valve stem 102, such as the central longitudinal axis of the valve stem 102.

[0045] The valve stem 102 may also have a water cavity 134. The water cavity 134 may extend to the distal end of the valve stem 102 and may have a distal-most opening 135 (see Figure 2C ). The water cavity 134 may have one or more water holes 136. The water holes 136 may be a plurality of openings on the circumferential surface of the valve stem 102. The water cavity 134 may be in fluid communication with an area outside the valve stem 102 via the water holes 136. The water cavity 134 may have a distal portion 140 that is lower than the air hole 126 (on the distal side of the air hole 126) and extends along the central longitudinal axis of the valve stem 102. At a point distal to the farthest end of the air release lumen 128, the water cavity 134 may turn from the central longitudinal axis of the valve stem 102. The proximal portion 142 of the water cavity 134 may extend along a longitudinal axis of the valve stem 102 that is offset from the center. As Figure 2A As shown in FIG, the proximal portion 142 of the water chamber 134 may include multiple branches (e.g., two branches) extending radially outward from the central longitudinal axis of the valve stem 102. Alternatively, the proximal portion 142 of the water chamber 134 may extend annularly around the air release lumen 128. Each branch of the proximal portion 142 of the water chamber 134 may communicate with a separate plurality of apertures 136. Alternatively, the plurality of apertures 136 may extend circumferentially around the proximal portion 142 so that each branch of the proximal portion 142 shares access to a set of apertures 136.

[0046] A collapsible (expandable) seal 160 may form an annular wall of the valve stem 102 and may surround a portion of the distal portion 140 of the water chamber 134. The collapsible seal 160 may be constructed from the same material as the remainder of the valve stem 102 or from a different material. The collapsible seal 160 may be a single, integral structure with the remainder of the valve stem 102. Alternatively, the collapsible seal 160 may comprise a separate or separate structure relative to the remainder of the valve stem 102. In some examples, the material of the remainder of the valve stem 102 (excluding the collapsible seal 160) may be discontinuous at the location of the collapsible seal 160, and the collapsible seal 160 may be bonded to the proximal and distal portions of the valve stem 102 adjacent to the collapsible seal 160. For example, the collapsible seal 160 may be made from a flexible polymer (e.g., a thermoplastic elastomer (TPE)) having suitable properties (e.g., a suitably high durometer value). The foldable seal 160 can be bonded to the respective portions of the distal portion 116 of the valve stem 102 located proximal and distal to the foldable seal 160 using, for example, adhesive or other suitable methods. Alternatively, a thin metal tube can extend through the center of the foldable seal 160, and the foldable seal 160 can be bonded to the thin metal tube. The metal tube and / or the foldable seal 160 can be bonded to the respective portions of the distal portion 116 of the valve stem 102 located proximal and distal to the foldable seal 160. The thin metal tube can have an inner cavity that is in fluid communication with the rest of the water chamber 134. Figure 3A-3B and Figure 4A-4B The exemplary collapsible seal 160 will be described in greater detail. A poppet 170 may extend within the water cavity 134 and may have a proximal end located at the distal inner surface of the distal portion 140 distal to the water cavity 134. The poppet 170 may include a shaft 172 and a tapered plug 174. Additional functionality of the poppet 170 will be described later. The shaft 172 may be fixedly attached to the valve stem 102. When the distal portion 116 of the valve stem 102 is in the first, second, and third configurations, the tapered plug 174 may be abutted against the distal portion 116, thereby forming a seal between the poppet 170 and mating surfaces of the distal portion 116. When the distal portion 116 of the valve stem 102 is in the fourth configuration, the distal portion 116 displaces proximally and moves away from the tapered plug 174. This displacement opens the distal-most opening 135 of the water cavity 134 to the water inlet 20 and the water outlet 22.

[0047] The valve stem 102 may also be equipped with multiple seals. For example, the valve stem 102 may include a first seal 180, a second seal 182, and a third seal 184. Seals 180, 182, and 184 may be disposed in a groove in the valve stem 102. Seals 180, 182, and 184 may have any of the characteristics of seals 72, 74, 76, or 78 described above. Seals 180, 182, and 184 may have a slidable interference fit with the surface 14 of the valve cylinder 12, such that fluid (e.g., air, water) cannot migrate proximally or distally between the seals 180, 182, or 184 and the surface 14 of the valve cylinder 12. The first seal 180 may be disposed proximal to the water port 136. The second seal 182 may be disposed distal to the water port 136 and proximal to the air port 126. The third seal 184 may be disposed distal to the air port 126 and the foldable seal 160. The valve stem 102 may also have a one-way seal 186, which may have any of the properties of the one-way seal 82. The one-way seal 186 may allow fluids (e.g., air and water) to move proximally past the one-way seal 82 but not distally past the one-way seal 186.

[0048] The valve stem 102 may also include a plurality of coarse threads 190. The coarse threads 190 are Figure 2A-2C The threads 190 are shown in dashed lines because they may be on the circumferential outer surface of the valve stem 102. The coarse thread 190 may include alternating notches and projections.

[0049] Figure 2A The valve 100 is shown in a first configuration and / or a second configuration. In the first configuration and the second configuration, the button 120 is not depressed and the spring 122 can be in a relaxed, extended state. The spring 122 can be biased to Figure 2A The first and second seals 180 and 182 may be proximal to the air outlet 18. A one-way seal 186 may be between the air outlet 18 and the air inlet 16. The foldable seal 160 may be between the air inlet 16 and the water outlet 22. The third seal 184 may be proximal to the water inlet 20 and distal to the water outlet 22. The poppet valve 170 may be closed (with the plug 174 closing the opening 135) so that fluid cannot enter the distal-most opening 135 of the water chamber 134.

[0050] In the first configuration, the proximal-most opening 130 can be left uncovered. Water from the water inlet 20 cannot migrate proximally past the third seal 184. Water from the water inlet 20 also cannot enter the water chamber 134 because the poppet valve 170 is closed. Therefore, water cannot escape and enter the endoscope's channel. As indicated by the dashed arrows, air from the air inlet 16 will be drawn into the air hole 126, passing through the air release lumen 128 and out of the proximal-most opening 130. Air will be drawn into the air hole 126 rather than proximally through the one-way seal 186 because the air hole 126 and the proximal-most opening 130 provide a path of least resistance, as there is no resistance to air escaping and flowing into the atmosphere. Therefore, when the proximal-most opening 130 is uncovered, air entering from the air inlet 16 does not have sufficient pressure to bypass the flexible seal 186.

[0051] In the second configuration, air can be delivered to the patient's body cavity during surgery. In the second configuration, the proximal most opening 130 can be covered by, for example, the operator's thumb or index finger. The proximal most opening 130 can also be covered in the third and fourth configurations described below. Therefore, as shown by the solid arrows, air will be prevented from leaving the proximal most opening 130. On the contrary, the air from the air inlet 16 will pass through the one-way seal 186 to the proximal side and flow out from the air outlet 18. The air will not pass through the second seal 182 to the proximal side and therefore will not leave from the proximal opening of the tube 12.

[0052] To shift valve 100 to the third configuration, button 120 can be depressed distally, compressing spring 122 and moving valve stem 102 distally. In the third configuration, poppet 170 remains closed (plug 174 covers opening 135). Shaft 172 of poppet 170 can be fixedly attached to valve stem 102 at its proximal end. Collapsible seal 160 can be sufficiently rigid in the axial / longitudinal direction to permit movement of valve stem 102 as a whole (including distal portion 116 of valve stem 102). First seal 180 is proximal to air outlet 18, while second seal 182 is distal to air outlet 18. Third seal 184 can be distal to water inlet 20, one-way seal 186 can be distal to air inlet 16 and proximal to water outlet 22, and collapsible seal 160 can be proximal to water outlet 22. Thus, as indicated by the solid arrows, water can enter the water inlet 20 and exit the water outlet 22 because there is no seal between the water inlet 20 and the water outlet 22. However, water cannot move proximally past the foldable seal 160. Air from the air inlet 16 cannot move proximally past the second seal 182 or past the one-way seal 186 into the air hole 126. Thus, even though the proximal-most opening 130 can be covered by the operator's index finger or thumb, air cannot exit the air outlet 18. Air also cannot exit the water outlet 22 because it cannot travel distally from the air inlet 16 past the one-way seal 186.

[0053] The valve 100 can be switched back to the first or second configuration by releasing the pressure on the button 120. The spring 122 can be biased toward the extended state of the first configuration. Thus, when the button 120 is released, the button 120 can move distally to the position of the first / second configuration.

[0054] To convert the valve 100 to the fourth configuration, the button 120 (and the valve stem 102) can be rotated counterclockwise, which engages the coarse threads 190 and causes the distal portion 116 of the valve stem 102 to be pulled upward. The coarse threads 190 can act (e.g., via an internal mechanism) to pull the distal portion 116 of the valve stem 102 upward. The upward movement of the distal portion 116 causes the foldable seal 160 to collapse. The collapse of the foldable seal 160 causes the poppet 170 to open (disengage from the opening 135). In an alternative embodiment, rotating the button 120 can open a valve that diverts air pressure from the air inlet 16 to the distal-most chamber in the valve 100, distal to the poppet 170 and the distal portion 116 of the valve stem 102. This action drives the distal portion 116 of the valve stem 102 proximally, compressing the foldable seal 160 and opening the water passage 134 to the water inlet 20. Instead of the poppet valve 170, a porous elastomer seal may be used. When the porous elastomer is loosened (e.g., Figure 2A and Figure 2B In configurations 1-3 of FIG, the pores are closed and fluid does not pass through the porous seal. When the seal is stretched, as in Figure 2C In the fourth configuration, the pores will be open and fluid (such as water) can pass through the porous elastomeric seal.

[0055] In the fourth configuration, the third seal 184 may be aligned with the water inlet 20. The foldable seal 160 may be retained proximal to the water outlet 22. The one-way seal 186 may be retained distal to the air inlet 16, and the second seal 182 may be retained distal to the air outlet 18. The first seal 180 may be proximal to the air outlet 18. Thus, as indicated by the solid arrow, water from the water inlet 20 may move distally toward the distal-most opening 135 of the water cavity 134. Because the poppet valve 170 is open, water may enter the water cavity 134 and travel proximally through the water cavity 134 and through the water hole 136. The water may then move between the outer circumference of the valve stem 102 and the surface of the valve cylinder 12 and out of the air outlet 18. The water may also move proximally to the proximal side of the water inlet 20 and to the water outlet 22. Thus, in the fourth configuration, water may flush the air and water channels of the endoscope.

[0056] The folding of the foldable seal 160 may be an irreversible process. Thus, after the foldable seal 160 is transformed to the fourth configuration, it cannot be transformed back to the first, second, or third configurations.

[0057] To utilize the valve 100, prior to surgery, the operator can insert the valve 100 into the valve barrel 12 of the endoscope. During surgery, the operator can use the valve 100 in the first, second, and / or third configurations, based on the operator's desire to use air or water during surgery. After surgery, after the endoscope is removed from the patient for post-processing, the button 120 can be rotated to convert the valve 100 to the fourth configuration. The valve 100 can flush water through the air and water channels for a predetermined amount of time (e.g., 30 seconds). After the flushing is complete, the operator can cut off the air and water supply to terminate the flow of air and water, or can simply remove the valve 100 from the valve barrel 12. The endoscope will then undergo further processing, and the valve 100 can be disposed of.

[0058] Figure 3A and Figure 3B An exemplary first collapsible seal 200 is shown that may be suitable for use with valve 100. Collapsible seal 200 may be made of a flexible material, such as an elastomeric material or a flexible polymer, such as a thermoplastic elastomer (TPE). Figure 3A The foldable seal 200 is shown in a first closed configuration. Figure 3B The foldable seal 200 is shown in a second open configuration. Figure 3A In the closed configuration, the annular walls 202 of the foldable seal 200 protrude inwardly into the central cavity 204 of the foldable seal 200. Contact between the annular walls 202 in the central cavity 204 prevents fluid (eg, water) from passing through the central cavity 204.

[0059] By inflating the valve 200 with a fluid (such as water or air), the foldable seal 200 can be converted to an open configuration. Air can be input from the air inlet 16 and actuated by applying a twisting or pushing motion on the proximal end of the valve of the foldable seal 200. In the second configuration, the walls 202 of the foldable seal 200 expand so that the inner surfaces of the walls 202 can separate from each other and open the central cavity 204 to the fluid (such as water). The circumferential outer surface of the wall 202 can have a feature 206 (e.g., a protrusion) that causes the wall 202 to engage with the inner surface of the barrel 12 and prevent fluid from flowing proximally past the outer surface of the foldable seal 200.

[0060] Figure 4A and Figure 4B Another exemplary collapsible seal 300 is shown. The collapsible seal 300 may be constructed of a rigid or semi-rigid material, such as plastic or metal. The collapsible seal 300 may have a plurality of longitudinal grooves 302 formed about a circumferential surface of the collapsible seal 300. The longitudinal grooves 302 may be covered with a material, such as an elastomer (not shown), to render them impermeable to fluids, such as water and air. Figure 4A In the first configuration of the collapsible seal 300 shown in FIG. 3 , the outer surface of the collapsible seal 300 , including the groove 302 , may be relatively parallel to the longitudinal axis of the collapsible seal 300 .

[0061] exist Figure 4B In the invention, for example, a valve 100 is used to switch the valve 100 to Figure 2C The above-described mechanism of the fourth configuration converts the foldable seal 300 to the second configuration. In the second configuration, the annular wall of the foldable seal 300 bulges outward due to the flexibility imparted by the groove 302. The circumferential outer surface of the wall of the foldable seal 300 can contact the wall of the valve cylinder 12, thereby preventing fluid (such as water) from passing proximally outside the foldable seal 300. However, fluid (such as water) can travel proximally through the proximal opening of the foldable seal 300 and through the central cavity of the foldable seal 300.

[0062] Figures 5A-5CA cross-sectional view of an exemplary valve 500 in a valve cartridge 12 is shown. The valve 500 may have a valve stem 524. The valve stem 524 may have a proximal member 526 and a distal member 528. The portions of the valve stem 524, including the proximal member 526 and the distal member 528, may be made of metal (e.g., stainless steel, titanium, aluminum, etc.), polymer (e.g., polycarbonate, acrylonitrile-butadiene-styrene (ABS), high-density polyethylene (HDPE), nylon, polyetheretherketone (PEEK), thermoplastics, plastics, etc.), or any other suitable material. The proximal member 526 and the distal member 528 may be made of the same material or different materials. The proximal member 526 and / or the distal member 528 may be made of a single continuous material.

[0063] The proximal member 526 can include a button 532. The button 532 can be formed as a continuous structure with the rest of the proximal member 526, or the button 532 can be a separate structure attached to the rest of the proximal member 526. The button 532 can have an outer circumference that is wider than the proximal opening of the valve cylinder 12, such that when the button 532 is depressed, the button 532 cannot pass through the proximal opening of the valve cylinder 12.

[0064] The proximal member 526 can have a proximal lumen 540. The proximal member 526 can have a generally annular shape around the lumen 540. The proximal lumen 540 can have a proximal-most opening 541 on the proximal-most end of the proximal member 526. For example, the proximal lumen 540 can open on the proximal-most side of the button 532. The proximal opening 541 is shown in dashed lines to indicate that the proximal opening 541 can be covered by an operator (e.g., by the operator's index finger or thumb) as described below.

[0065] like Figure 5A and Figure 5B As shown in FIG, the membrane 542 can extend completely across the proximal lumen 540 toward the distal end 544 of the proximal lumen 540. For example, the membrane 542 can be a small distance away from the distal-most end of the proximal lumen 540. Alternatively, the membrane 542 can be at the distal-most end of the proximal lumen 540. The membrane 542 can be made of a thin material. Figure 5B-5C Various aspects of membrane 542 are discussed in greater detail.

[0066] The proximal aperture 546 can be formed in and extend completely through the wall of the proximal member 526 and can fluidly connect the proximal lumen 540 to an area external to the proximal member 526. Figures 5A-5C546, but any number of proximal holes may be used. One or more air holes 548 may also be formed in the wall of the proximal member 526 and extend completely through the wall of the proximal member 526 and may fluidly connect the proximal lumen 540 to an area external to the proximal member 526. Although only one air hole 548 is shown, any suitable number of holes may be used.

[0067] The distal member 528 may include a neck 550 at the proximal end of the distal member 528. The neck 550 may have an outer diameter that is smaller than the diameter of the lumen 540. The neck 550 may terminate distally at a shoulder 552. The neck 550 may have a proximal tapered portion 554. A distal lumen 560 may extend through the distal member 528 (including the neck 550). The distal lumen 560 may be open at the proximal side of the distal member 528 (e.g., at the proximal end 562 of the neck 550) and may be closed at the distal-most side of the distal member 528. The diameter of the distal lumen 560 may be smaller than the diameter of the proximal lumen 540. The tapered portion 554 may taper from an initial outer diameter (at the proximal end) until its outer diameter is approximately the same as the diameter of the distal lumen 560. The proximal end of the tapered portion 554 can form a sufficiently sharp annular ring to penetrate, puncture, or remove the membrane 542 with sufficient force. Portions of the membrane 542 severed by the tapered portion 554 can be flushed away by fluid flowing through the valve 510 (further details of the flushing process are discussed below) or can remain within the valve 510. The distal aperture 564 can be formed in the wall of the distal member 528 and extend completely through the wall of the distal member 528 and can fluidly connect the distal lumen 560 to an area outside the distal member 528. Although Figures 5A-5C One distal hole 564 is shown in FIG, but any number of distal holes may be used.

[0068] The neck 550 may be slidably received within the proximal lumen 540 such that the distal lumen 60 is in fluid communication with the proximal lumen 540. The proximal lumen 540 and / or the neck 550 may have features (e.g., notches, protrusions, tabs, etc.) (not shown) that retain the neck 550 within the lumen 540 and prevent the proximal-most end 562 of the neck 550 from exiting the distal-most end 544 of the proximal lumen 540.

[0069] The valve stem 530 may be equipped with one or more seals. For example, the valve stem 530 may include a first seal 572, a second seal 574, a third seal 576, and a fourth seal 578 in a proximal-to-distal direction. The seals 572, 574, 576, and 578 may be, for example, O-rings. The seals 572, 574, 576, and 578 may be made of an elastomeric material. The valve stem 530 may also include a one-way seal 582, which may be made of the same or different material (e.g., an elastomeric material) as the seals 572, 574, 576, and 578. Due to its flexibility and arrangement relative to the structure it contacts, the one-way seal 582 may allow fluid or other substances to pass proximally through the one-way seal 582 but not allow fluid or other substances to pass distally through the one-way seal 582. The first seal 572 and the second seal 574 may be disposed on the proximal member 526. The third and fourth seals 576, 578 can be disposed on the distal member 528. The one-way seal 582 can be disposed on the proximal member 526 between the second and third seals 574, 576. Alternatively, the seals 572, 574, 576, 578, and the one-way seal 582 can be disposed on alternative portions of the valve stem 530 or in a different order. The proximal aperture 546 can be disposed between the first and second seals 572, 574. The distal aperture 564 can be disposed between the third and fourth seals 576, 578.

[0070] Seals 572, 574, 576, and 578 can be configured to form a slidable interference fit between seals 572, 574, 576, and 578 and surface 14. Thus, valve stem 530 can move relative to surface 14, but fluid (e.g., water and air) cannot move between seals 572, 574, 576, and 578 and surface 14. Thus, seals 572, 574, 556, and 578 prevent fluid external to valve 510 from moving past seals 572, 574, 576, and 578 in a proximal or proximal direction.

[0071] The inner diameter of the one-way seal 582 can be designed to provide a slight interference fit between the outer surface of the proximal member 526 and the inner diameter of the one-way seal 582 to form a tight seal. The outer diameter of the one-way seal 582 can be designed to form a slight interference fit with a portion of the surface 14. The thin flap of the one-way seal 582 can extend radially outward from the proximal member 526 at an angle that intersects the longitudinal axis of the proximal member 526. For example, the thin flap can extend at an angle between 10 degrees and 80 degrees relative to the longitudinal axis of the proximal member 526. The flap of the one-way seal 582 can be expandable (open) so that when a fluid (e.g., water or air) moves in a distal direction toward the one-way seal 582, the positive pressure will cause the flap to expand, thereby maintaining a seal between the one-way seal 582 and the surface 14. Fluid moving proximally toward the one-way seal 582 will also create a positive pressure, but this positive pressure will generate a force perpendicular to the longitudinal axis of the proximal member 526 to radially compress the flap of the one-way seal 582. Thus, fluid (e.g., air or water) is permitted to move proximally between the one-way seal 582 and the surface 14, past the one-way seal 582. However, the one-way seal 582 of the valve 510 can be positioned distal to the air hole 548, and the one-way seal 582 of the valve 510 can be positioned proximal to the air hole 548.

[0072] Figure 5A The valve 510 is shown in a first configuration and / or a second configuration. In the first configuration of the valve 510, neither air nor water is delivered to any outlet of the valve 510 and will be exhausted to the atmosphere through the proximal-most opening 541 .

[0073] In the second configuration, air is delivered to the air channel of the endoscope, but water is not delivered to any channel. The first configuration and the second configuration may differ only in that the proximal-most opening 541 at the proximal-most end of the proximal lumen 540 is open in the first configuration and blocked (e.g., by an operator's thumb or index finger) in the second configuration. In both the first and second configurations, the button 532 cannot be pushed downward. The valve 510 may include features such as tactile feedback features (not shown) to indicate that the valve 510 is properly positioned within the valve barrel 12. For example, the valve 510 may include a ridge, bump, or other protrusion on the outer surface of the proximal member 526. The proximal-most end 562 of the distal lumen 560 (and the neck 550) may be proximal to the membrane 542, such that the proximal lumen 540 is not in fluid communication with the distal lumen 560.

[0074] In the first and second configurations, the water inlet 20 can be distal to the fourth seal 578. The water outlet 22 can be between the third seal 76 and the fourth seal 579. Therefore, water from the water inlet 20 does not move to the proximal side of the fourth seal 578. The water outlet 22 is surrounded by the third seal 76 and the fourth seal 578, and therefore fluid (air and water) cannot move longitudinally along the surface 14 of the barrel 12 to the water outlet 22. Because the membrane 542 is in place, the distal lumen 560 is not in fluid communication with the proximal lumen 540. Therefore, no fluid can leave the water outlet 22.

[0075] In the first configuration (eg, when the proximal-most opening 541 is uncovered and air and water are not being delivered), as indicated by Figure 5A As shown by the dashed arrows in FIG, air can enter from the air inlet 16 and then flow around the circumference of the proximal member 526 of the valve stem 524 to the air hole 548. The air will enter the air hole 548 rather than exit the air outlet 18 because the proximal-most opening 541, which vents to atmosphere, provides the path of least resistance. The air can then be discharged from the proximal-most opening 541. Any air attempting to exit the hole 546 will be trapped between the first seal 572 and the second seal 574, and thus will be discharged from the proximal-most opening 541. The air will not travel distally past the third seal 576 and therefore will not exit the water outlet 522. The air inlet 16 may be proximal to the third seal 576 but distal to the one-way seal 582. Air entering from the air inlet 16 will not travel proximally past the one-way seal 582 toward the air outlet 18 because the path of least resistance will be provided for the air to vent from the proximal-most opening 541 and therefore will not exit the air outlet 18. Thus, between the first configurations, neither air nor water is transported.

[0076] In the same Figure 5A In the second configuration shown in FIG, the proximal most opening 541 can be covered, for example, by the operator's thumb or index finger. The proximal most opening 541 can also be covered in the third and fourth configurations described below. In addition, the second configuration can be identical to the first configuration, for example, all of the structures of the valve 510 are in the same position relative to each other and the barrel 12. Because air can no longer be exhausted from the proximal most opening 541, as shown in FIG. Figure 1A As shown by the solid arrow in FIG, air entering from the air inlet 16 can travel proximally past the one-way seal 582. Thus, air entering from the air inlet 16 can pass through the air outlet 18 to be delivered to the air channel of the endoscope. Air from the air inlet 16 does not pass proximally past the second seal 574 and, therefore, does not enter the proximal aperture 546. When the proximal-most opening 541 is covered, air entering the aperture 548 cannot exit the proximal-most opening 541. Thus, in the second configuration, the valve 510 delivers air to the air channel of the endoscope.

[0077] Figure 5B The valve 510 is shown in a third configuration, in which water is delivered to the water channel of the endoscope but air is not delivered to any endoscope channel. To switch from the second configuration to the third configuration, the button 532 can be partially pressed. For example, the button 532 can be pressed until the flexible structure on the distal surface of the button 532 contacts the proximal outer surface of the barrel 12. For example, the tab 594 can contact the outer surface of the barrel 12. The contact of a feature (such as the tab 594) can cause tactile feedback to the operator to indicate that the valve 510 is in the third configuration. The tab 594 is merely exemplary, and any suitable feature can be used. For example, an annular flap / flange, an expanded inflatable feature, a frangible member, or other features can be used. The tab 594 can be made of the same material as the button 532 or a different material.

[0078] In the conversion from the second configuration to the third configuration, both the proximal member 526 and the distal member 528 can be translated proximally relative to the barrel 512, resulting in the button 532 being pressed downward. The membrane 542 can have sufficient elasticity so that the force acting on the button 532 to convert the valve 510 from the second configuration to the third configuration will not cause the most proximal end of the neck 550 to break through the membrane 542. Therefore, the membrane 542 can remain intact in the third configuration, and the force acting on the neck 550 by the membrane 542 can cause the distal member 528 to translate distally along with the proximal member 526. The distal member 528 (and the proximal member 526) can translate distally until the distal member 528 abuts against the distal surface of the barrel 12, or until the tab 594 contacts the proximal upper surface of the barrel 12. Additionally or alternatively, friction between the outer surface of the neck 50 and the inner surface of the proximal lumen 540 may cause the distal member 528 to move in unison with the proximal member 526 .

[0079] In the third configuration, the fourth seal 578 may be distal to the water inlet 20. The third seal 576 may be proximal to the water outlet 22. Thus, as indicated by the solid arrow, water from the water inlet 20 cannot move distally past the fourth seal 578, but can move past the water outlet 22 and through the endoscope's water channel. Although water can move through the proximal aperture 564, it cannot move proximally past the membrane 542, which may be sufficiently resilient to prevent proximal movement. Therefore, water cannot enter the proximal lumen 540. Water also cannot move proximally past the third seal 576. The one-way seal 582 may be distal to the air inlet 16, preventing air from passing through and into the air aperture 548. The second seal 574 may be proximal to the air inlet 16. Therefore, air from the air inlet 16 cannot move into the proximal lumen 540 through the air aperture 548 or past the seal 574, and therefore does not exit the air outlet 18. As a result, in the third configuration, the only fluid flowing to the endoscope sheath is water through the water channel.

[0080] The valve 510 can be switched back from the third configuration to the first / second configuration. For example, the valve 510 can have a spring (not shown) or other feature that biases the valve 510 to the first configuration. Alternatively, the valve 510 can be switched from the third configuration (or the first / second configuration) to the fourth configuration.

[0081] like Figure 5C , the fourth configuration helps to flush water from the water inlet 20 through the water outlet 22 and the air outlet 18. The fourth configuration can be referred to as the cleaning configuration of valve 510. In order to move to the fourth configuration from the third configuration, the button 532 can be pressed until the tab 594 is folded to the surface of the abutment tube 12. Compared with being converted to the third configuration, it is necessary to have a significantly larger force for valve 510 to be converted to the fourth configuration. In the third configuration, the button 532 is partially pressed, and in the fourth configuration, the button 532 can be fully pressed. In the fourth configuration, the tab 594 can break (for example, by breaking apart at the proximal end of the tab 594) or bend and flatten, thereby being parallel to the proximal surface of the button 532 and / or the proximal surface of the endoscope barrel 12. In order to make the tab 594 bend or break, a certain minimum amount of force can be needed.

[0082] In the 3rd configuration, distal member 528 rests on the distal surface of tube 12, so when button 532 is fully pressed, distal member 528 can not translate toward the proximal side together with proximal member 526. Proximal member 526 can cause proximal taper 554 to pierce film 542 and thus distal lumen 560 is connected with proximal lumen 540 fluidly relative to distal member 528 toward the proximal side. In the 4th configuration, the proximal taper 554 of distal member 528 can be on the proximal side of film 542 initial position. Therefore, as shown by the solid arrow, in the 4th configuration of valve 510, water can advance from water inlet 20 and flow out from water outlet 22, as in the 3rd configuration of valve 510. However, unlike the third configuration, the fourth configuration also allows water to travel into the distal hole 564, through the distal lumen 560, into the proximal lumen 540, and out of the proximal hole 546, so that water can flow between the valve stem 530 and the surface of the barrel 12 to the air outlet 18. Because the air hole 548 can be covered by the neck 550 in the fourth configuration, water cannot pass through the air hole 548.

[0083] The fourth configuration should not be used when the endoscope is inside a patient's body cavity. The valve 510 may include a mechanism to prevent the operator from accidentally switching the valve 510 to the fourth configuration. For example, the tab 594 may provide resistance or other tactile feedback against pressing the button 532 downward past the third configuration. The operator may also receive tactile feedback from the distal end of the distal member 528 in contact with the distal surface of the valve cylinder 12 in the third configuration, thereby indicating to the operator that the button 532 should not be pressed further during the use of the endoscope during patient surgery. In addition or alternatively, other methods may be used to prevent the valve 510 from accidentally switching to the fourth configuration. For example, a deformable mechanical stopper may provide audible feedback (e.g., a "click"), the valve 510 may need to be rotated before switching to the fourth configuration, and / or a visual indicator may provide feedback to the operator.

[0084] Because the membrane 542 ruptures in the fourth configuration, the valve 510 cannot be reused in any of the first, second, or third configurations. Thus, the valve 510 is a single-use valve that is used during only one pre-treatment purge step. Alternatively, after use in one pre-treatment purge, the valve 510 can be used solely as a pre-treatment purge valve 510 and not during patient surgery. Alternatively, the membrane 542 can be a secure, reusable seal that can be reset after use so that the valve 510 can be reused for multiple surgeries.

[0085] To use valve 510, the operator can insert valve 510 into the valve barrel 12 of the endoscope before surgery. During surgery, the operator can use valve 510 in the first, second, and / or third configurations based on the operator's desire to use air or water during surgery. After surgery, the endoscope can be removed from the patient for post-processing. Button 532 can be fully depressed to switch valve 510 to the fourth configuration. Valve 510 can flush water through the air and water channels for a predetermined amount of time (e.g., 30 seconds). After flushing is complete, the operator can move button 532 proximally to terminate the flow of water or can simply remove valve 510 from valve barrel 12. Alternatively, button 532 can automatically move proximally to terminate the flow of water. The endoscope will undergo further post-processing, and valve 510 can be set.

[0086] Although the principles of the present disclosure are described herein with reference to illustrative examples for specific applications, it should be understood that the present disclosure is not limited to these examples. Those skilled in the art and having access to the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents fall within the scope of the examples described herein. Therefore, the present invention is not to be considered as being limited by the foregoing description.

Claims

1. A valve for use in an endoscope, the valve comprising: a proximal valve stem member having a first lumen extending from a proximal opening at a proximal-most end of the proximal valve stem member to a distal opening at a distal-most end of the proximal valve stem member, wherein a membrane within the first lumen forms a fluid-tight barrier between the proximal opening and the distal opening; as well as a distal stem member having a second lumen with a proximal opening at a proximal-most end of the distal stem member; wherein a proximal-most end of the distal valve stem member is received within a distal opening of the first lumen, and wherein the distal valve stem member is movable relative to the proximal valve stem member, wherein in a first configuration, a proximal-most end of the distal valve stem member is distal to an initial position of the membrane such that the first lumen is not in fluid communication with the second lumen; and Wherein in a second configuration, the membrane is pierced and the proximal-most end of the distal valve stem member is proximal to an initial position of the membrane such that the first lumen is in fluid communication with the second lumen.

2. The valve of claim 1, wherein the distal stem member has a shoulder that, in the second configuration, contacts the distal-most end of the proximal stem member.

3. The valve of any one of the preceding claims, wherein the proximal stem member includes a first aperture formed through a wall of the proximal stem member, and wherein the first aperture is in fluid communication with the first lumen.

4. The valve of claim 3, wherein the proximal stem member includes a second aperture formed through a wall of the proximal stem member, and wherein the second aperture is in fluid communication with the first lumen.

5. The valve of any one of the preceding claims 1-2, wherein the second lumen is closed at a distal-most end of the second lumen.

6. The valve of claim 5, wherein the distal stem member has a third aperture formed through a wall of the distal stem member, and wherein the third aperture is in fluid communication with the second lumen.

7. The valve of claim 1 , wherein the proximal stem member comprises a button configured to be contacted by an operator's finger.

8. The valve of claim 7, wherein the proximal surface of the button is at the proximal-most end of the proximal valve stem member.

9. The valve stem of claim 7 or claim 8, wherein the proximal valve stem member comprises at least one tab on a distal surface of the button.

10. The valve of any one of the preceding claims 1-2, wherein at least one seal is provided on an outer surface of the distal stem member.

11. The valve of any one of the preceding claims 1-2, wherein there are at least two O-ring seals provided on an outer surface of the distal stem member.

12. The valve of any one of the preceding claims 1-2, wherein at least one O-ring seal is provided on an outer surface of the proximal stem member.

13. The valve of any one of the preceding claims 1-2, wherein a one-way seal is provided on an outer surface of the proximal stem member.

14. The valve of any one of the preceding claims 1-2, wherein the proximal-most end of the proximal valve stem is tapered.

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