WO2018136274A1

WO2018136274A1 - Disposable valve for an endoscope having a lubricant and/or antimicrobial

Info

Publication number: WO2018136274A1
Application number: PCT/US2018/013127
Authority: WO
Inventors: John Schreiner; David C. Hemink
Original assignee: Medivators Inc.
Priority date: 2017-01-20
Filing date: 2018-01-10
Publication date: 2018-07-26

Abstract

A disposable valve assembly configured for use with an endoscope is disclosed. The disposable valve assembly may include a stem comprised of thermoplastic material, a spring stanchion configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion, a spring configured to contact that spring stanchion and the stem and a lubricant disposed on the stem, the spring stanchion and/or the spring. The disposable valve assembly may also include an antimicrobial agent disposed in the lubricant, or in the thermoplastic material and/or can be coated thereon. A method for manufacturing the disposable valve assemblies for use with an endoscope may include several steps.

Description

DISPOSABLE VALVE FOR AN ENDOSCOPE HAVING

A LUBRICANT AND/OR ANTIMICROBIAL

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Serial No.

62/448,758 filed January 20, 2017. This application is incorporated herein by reference, in its entirety.

BACKGROUND

[0002] Health care organizations are continually under pressure to find ways to lower or limit health care costs. One such opportunity for health care organizations to reduce costs is by recycling materials and supplies, in particular, by recovering single use medical devices (SUDs) that can be cleaned and sterilized for reuse.

[0003] Typically, medical devices fall into two categories. The first category is reusable devices, which are sold as reusable and can be cleaned and sterilized for reuse by a health care organization, such as a hospital. Reusable, manufacturer designated multiple-use medical devices are sold with the expectation the medical devices can and will be processed for reuse by hospitals or surgery centers. Such medical devices are sold once and are typically cleaned and resterilized many times for use on multiple patients. These medical devices are collected after use by hospital or surgery center personnel and are cleaned, resterilized in an autoclave or by exposure to ethylene oxide or other appropriate sterilant, repackaged as necessary, and then reused.

[0004] The second category involves reprocessable devices, which are designated by the manufacturer for single use only; these medical devices can be reused only if properly reprocessed.

[0005] Among medical devices, endoscopes are well-known in the art and are commonly used for numerous medical procedures. A control section of an endoscope may include a suction cylinder, air/water cylinder, biopsy channels, and the like. Valves may be inserted into these cylinders or channels to control various functions of the endoscope.

[0006] After each use, an endoscope will undergo cleaning, disinfection, sterilization, and the like to prevent the spread of disease, germs, bacteria, illness, and the like. Many components of an endoscope may be reusable, including valves which regulate the flow through the endoscope, and which must also be cleaned, disinfected, and/or sterilized between uses.

[0007] Unfortunately, there is usually a great expense associated with maintaining a high level of disinfection of the equipment and the reusable valves. Reusable endoscope valves must be carefully tracked together with the corresponding endoscope during cleaning and reprocessing procedures to identify breaches in reprocessing of the endoscope and its corresponding valves, which reduces the risk of cross-contamination among patients when endoscopes and their corresponding valves are reused.

[0008] Reusable valves may be assembled from the combination of several metal, plastic, and/or rubber components. As such, there are significant costs associated with the

manufacturing of reusable valves for use with endoscopes.

[0009] Disposable valves eliminate the need for cleaning, disinfection, and sterilization of reusable valves, thereby eliminating the cost of repeated cleaning, disinfection, and

sterilization. Disposable valves also eliminate the need to track valves to a specific endoscope model and serial number and provide the highest level of infection prevention to the patient, through the use of new and disposable valves. Additionally, disposable valves do not require expensive materials to be utilized to manufacture the valves, thereby eliminating the high cost of manufacturing valves from expensive materials.

[0010] Thus, there is a need to develop new disposable valves for use with endoscopes and methods that reduce or eliminate cross contamination and the need for repeated cleaning, disinfection, and sterilization and reduce or eliminate the risk of infecting the patient. In particular, there is a need for new valves that have the ability of preventing or substantially eliminating the growth of bacteria, fungi and the like during the endoscopic procedure.

SUMMARY

[0011] New disposable endoscope valves and methods are provided that reduce or eliminate the risk of contaminating the endoscope and reduce or eliminate the risk of infecting the patient. New disposable endoscope valves and methods are provided that allow the disposable valve to function better by providing an improved seal using a lubricant that allows a more uniform fit in the valve chamber or channel and better suction, and/or flow of air and water. Various embodiments provide disposable valve assemblies configured for use with an endoscope and are discussed herein, including manufacturing processes for the same. The new disposable endoscope valves, in addition to the lubricant or as an alternative to the lubricant, can have an antimicrobial agent disposed in the lubricant or coated on the disposable valve, or the antimicrobial can be made with the disposable valve and be integral with it.

[0012] In some embodiments, a disposable valve assembly is provided and may include a stem comprising a first opening disposed along a longitudinal axis of the stem. The stem comprises, consists essentially of, or consists of thermoplastic material. The valve assembly also includes a spring stanchion, the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion. The valve assembly may also include a spring configured to contact the spring stanchion and the stem and a lubricant disposed on the stem, spring stanchion and/or the spring. In some embodiments, (i) the lubricant comprises an antimicrobial agent; (ii) the thermoplastic material comprises an antimicrobial agent; and/or (iii) the thermoplastic material has an antimicrobial agent coated thereon.

[0013] In certain embodiments, a disposable valve assembly configured for use with an endoscope is provided, wherein the disposable valve assembly comprises: a stem comprising a first opening disposed along a longitudinal axis of the stem, the stem comprising thermoplastic material; a spring stanchion, the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and an antimicrobial agent disposed on the stem, spring stanchion and/or the spring. In other embodiments, the disposable valve having the antimicrobial agent disposed on the stem, spring stanchion and/or the spring also comprises (i) a lubricant disposed on the stem, spring stanchion and/or the spring; or (ii) the lubricant disposed on the stem, spring stanchion and/or the spring, comprises the antimicrobial agent.

[0014] In certain embodiments, this disclosure provides a disposable suction valve assembly comprising: a stem comprising thermoplastic material, the stem comprising a first opening disposed along a longitudinal axis of the stem, and a second opening disposed transverse to the first opening, the first and second openings for allowing passage of air and/or fluid; a spring stanchion comprising at least one recess and/or projection configured to attach to the stem, the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and a lubricant disposed on the stem, spring stanchion and/or the spring or the thermoplastic material comprises an antimicrobial agent and the lubricant, in other embodiments, comprises an antimicrobial agent.

[0015] In other embodiments, this disclosure provides a disposable suction valve assembly comprising: a stem comprising thermoplastic material, the stem comprising a first opening disposed along a longitudinal axis of the stem, and a second opening disposed transverse to the first opening, the second opening intersecting with the first opening for allowing passage of air and/or fluid; a spring stanchion comprising at least one recess and/or projection configured to attach to the stem, the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and a lubricant disposed on the stem, spring stanchion and/or the spring or the thermoplastic material comprises an antimicrobial agent and the lubricant, in other embodiments, comprises an antimicrobial agent.

[0016] In various embodiments, this disclosure provides a disposable air/water valve assembly comprising: a main stem comprising thermoplastic material, the main stem having a proximal end, the main stem comprising a plurality of ridges and grooves disposed

circumferentially about the main stem, the plurality of ridges and grooves being monolithic with the main stem and the main stem comprising a first opening disposed at the proximal end and running along a longitudinal axis of the main stem, and a second opening disposed transverse to the first opening, the first and second openings for allowing passage of air and/or fluid through at least a portion of the main stem, and a lubricant disposed on the stem, spring stanchion and/or the spring or the thermoplastic material comprises an antimicrobial agent and, in other embodiments, the lubricant comprises an antimicrobial agent.

[0017] In various embodiments, this disclosure provides a disposable air/water valve assembly comprising: a main stem comprising thermoplastic material, the main stem having a proximal end, the main stem comprising a plurality of ridges and grooves disposed

circumferentially about the main stem, the plurality of ridges and grooves being monolithic with the main stem and the main stem comprising an opening disposed at the proximal end and running along a longitudinal axis of the main stem, the opening for allowing passage of air and/or fluid through at least a portion of the main stem, and a lubricant disposed on the stem, spring stanchion and/or the spring or the thermoplastic material comprises an antimicrobial agent and, in other embodiments, the lubricant comprises an antimicrobial agent.

[0018] In some embodiments, a method is provided for manufacturing a disposable valve assembly for use with an endoscope and may include several steps. A stem is precision molded optionally in the presence of an antimicrobial agent, then placed in a mold for over-molding seals onto the stem. Prior to the next steps, the retaining ring and button cap are molded. The boot is over-molded onto the retaining ring. The back end of the stem is placed through the center of the retaining ring/boot and resilient member (e.g., spring, rubber, elastic, etc.). The button cap is then placed on and secured to the stem. A lubricant may be applied onto the stem, spring and/or spring stanchion.

[0019] In some embodiments, a spring stanchion is molded; a bottom end of the stem is placed through the center of a spring; a bottom end of the stem is placed through a stem opening in the spring stanchion; and a lubricant is applied onto the stem, spring, and/or spring stanchion and the lubricant, in other embodiments, includes an antimicrobial agent.

[0020] In other embodiments, a method for manufacturing a disposable valve configured for use with an endoscope is provided, the method comprising: molding a main stem optionally in the presence of an antimicrobial; overmolding at least one seal onto the main stem; molding a retaining ring; molding a button cap; placing a back end of the stem through the center of the retaining ring and a resilient member; and placing the button cap on the stem; and securing the button cap to the main stem; placing a lubricant onto the valve; and applying a lubricant onto the main stem, resilient member, and/or retaining ring and in some embodiments, the lubricant comprises an antimicrobial agent.

[0021] Additional features and advantages of various embodiments will be set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practice of various embodiments. The objectives and other advantages of various embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the description and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In part, other aspects, features, benefits and advantages of the embodiments will be apparent with regard to the following description, appended claims and accompanying drawings where:

[0023] FIG. 1 illustrates an isometric view of an embodiment of a disposable air/water valve;

[0024] FIG. 2 illustrates an exploded view of an embodiment of a disposable air/water valve;

[0025] FIG. 3 illustrates an enlarged view of an embodiment of a disposable air/water valve stem suitable for use in Olympus® endoscopes;

[0026] FIG. 4 illustrates a top view of an embodiment of a retaining ring that is a component of the disposable air/water valve for use in Olympus® endoscopes;

[0027] FIG. 5A illustrates an enlarged view of an embodiment of a stem of a disposable air/water valve for use in Pentax® endoscopes;

[0028] FIG. 5B illustrates a perspective view of an embodiment of a retaining ring for use in Pentax® endoscopes;

[0029] FIG. 5C illustrates a perspective view of another embodiment of a retaining ring for use in Pentax® endoscopes;

[0030] FIG. 5D illustrates an exploded view of an embodiment of a disposable air/water valve suitable for use in Pentax® endoscopes;

[0031] FIGS. 6A, 6B and 6C illustrate the general operation of an air/water valve in an endoscope;

[0032] FIGS. 7A and 7B illustrate the general operation of a disposable air/water valve in an endoscope;

[0033] FIG. 8 illustrates an embodiment of a manufacturing process for a disposable air/water valve including placement of the lubricant on the valve;

[0034] FIG. 9A illustrates an isometric view of an embodiment of a disposable suction valve suitable for use in Olympus® endoscopes;

[0035] FIG. 9B illustrates a side view of an embodiment of a disposable suction valve suitable for use in Olympus® endoscopes; [0036] FIG. 9C illustrates an exploded view of an embodiment of a disposable suction valve suitable for use with Pentax® endoscopes;

[0037] FIG. 9D illustrates a perspective enlarged view of an embodiment of a disposabl suction valve suitable for use with Pentax® endoscopes;

[0038] FIG. 10 illustrates a side view and a cross sectional view of an embodiment of a stem, which is a component of a disposable suction valve;

[0039] FIG. 11 illustrates a side view and a cross sectional view of an embodiment of a stem rotated about 90 degrees, which is a component of a disposable suction valve;

[0040] FIG. 12A illustrates an embodiment of alternative implementation of a stem, which is a component of a disposable suction valve;

[0041] FIG. 12B illustrates an embodiment of another implementation of a stem, which a component of a disposable suction valve;

[0042] FIG. 12C illustrates an embodiment of another implementation of a stem, which a component of a disposable suction valve;

[0043] FIG. 12D illustrate a cross sectional view of an embodiment of a stem;

[0044] FIG. 12E illustrate a bottom view of an embodiment of a stem;

[0045] FIG. 13 illustrates a top view of an embodiment of a spring cup or stanchion cup, which is a component of a disposable suction valve;

[0046] FIG. 14 illustrates a cross sectional view of an embodiment of a spring cup or stanchion cup, which is a component of a disposable suction valve;

[0047] FIG. 14A illustrates a cross sectional view of an embodiment of alternative implementation of a spring cup or stanchion cup;

[0048] FIG. 14B illustrates a top view of an embodiment of alternative implementation of a spring cup or stanchion cup;

[0049] FIG. 14C illustrates a cross sectional view of an embodiment of alternative implementation of a spring cup or stanchion cup;

[0050] FIG. 14D illustrates a top view of an embodiment of alternative implementation of a spring cup or stanchion cup;

[0051] FIG. 14E illustrates a cross sectional view of an embodiment of alternative implementation of a spring cup or stanchion cup; [0052] FIG. 15 illustrates an isometric view of an embodiment of a boot, which is a component of a disposable suction valve;

[0053] FIG. 15A illustrates an isometric view of an embodiment of a boot, which is a component of a disposable suction valve;

[0054] FIG. 15B illustrates a perspective view of an embodiment of a retaining ring, which is a component of a disposable suction valve;

[0055] FIG. 16 illustrates a cross sectional view of an embodiment of a disposable suction valve;

[0056] FIGS. 17A and 17B illustrate embodiments of the general operation of a disposable suction valve in a medical instrument, such as for example, an endoscope;

[0057] FIG. 18 illustrates a flow chart of an embodiment of a manufacturing process for a disposable suction valve, including placement of a lubricant on the valve;

[0058] FIG. 19A illustrates an enlarged perspective view of an embodiment of a disposable biopsy valve;

[0059] FIG. 19B illustrates an enlarged bottom view of an embodiment of a disposable biopsy valve; and

[0060] FIG. 20 illustrates a schematic of parts of an endoscope.

[0061] It is to be understood that the figures are not drawn to scale. Further, the relation between objects in a figure may not be to scale, and may in fact have a reverse relationship as to size. The figures are intended to bring understanding and clarity to the structure of each object shown, and thus, some features may be exaggerated in order to illustrate a specific feature of a structure.

DETAILED DESCRIPTION

[0062] For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities of ingredients, percentages or proportions of materials, reaction conditions, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0063] For the purposes of this disclosure, the phrase "effective amount" or

"therapeutically effective amount" is defined as a dosage sufficient to induce a microbicidal or microbistatic effect upon the microbes contacted by the composition on a surface.

[0064] Notwithstanding the numerical ranges and parameters set forth herein, the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a range of " 1 to 10" includes any and all subranges between (and including) the minimum value of 1 and the maximum value of 10, that is, any and all subranges having a minimum value of equal to or greater than 1 and a maximum value of equal to or less than 10, e.g. , 5.5 to 10.

[0065] Reference will now be made in detail to certain embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the illustrated embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover all alternatives, modifications, and equivalents that may be included within the invention as defined by the appended claims.

[0066] It is noted that, as used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless expressly and unequivocally limited to one referent. Thus, for example, reference to "a seal" includes one, two, three or more seals.

[0067] We refer now to the drawings wherein depicted elements are not necessarily shown to scale and wherein like or similar elements are designated by the same reference numeral through the several views.

[0068] Referring to the drawings in general, it will be understood that the illustrations are for the purpose of describing particular embodiments of the disclosure and are not intended to be limiting thereto. [0069] While most of the terms used herein will be recognizable to those of ordinary skill in the art, it should be understood that when not explicitly defined, terms should be interpreted as adopting a meaning presently accepted by those of ordinary skill in the art.

Disposable Valve Assembly for Use with an Endoscope

[0070] New disposable endoscope valves and methods are provided that reduce or eliminate the risk of contaminating the endoscope and reduce or eliminate the risk of infecting the patient. New disposable endoscope valves and methods are provided that allow the disposable valve to function better by providing an improved seal using a lubricant that allows a more uniform fit in the valve chamber or channel and better suction and/or flow of air and water. Various embodiments of disposable valve assemblies configured for use with endoscopes are discussed herein, including manufacturing processes for the same. The new disposable endoscope valves, in addition to the lubricant or as an alternative to the lubricant, can have an antimicrobial agent disposed in the lubricant or coated on the disposable valve or the

antimicrobial can be made with the disposable valve and be integral with it.

[0071] In certain embodiments, the present disclosure provides a disposable valve assembly configured for use with an endoscope comprising: a stem comprising a first opening disposed along a longitudinal axis of the stem; a spring stanchion; the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and a lubricant disposed on at least one of the stem, spring stanchion or the spring. In other embodiments, the disposable valve assembly configured for use with an endoscope does not contain a lubricant and instead, it contains an antimicrobial agent disposed in at least one of the stem, spring stanchion or the spring. In other embodiments, the valve assembly, which contains a lubricant, can further comprise an antimicrobial agent in (i) a molding of the valve assembly, (ii) a coating disposed in at least one of the stem, spring stanchion or the spring of the valve assembly, or (iii) the lubricant or a combination thereof.

[0072] In various embodiments, in the disposable valve assemblies described in this disclosure (i) the lubricant can comprise a silicone-based grease, a non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant, silane, or a combination thereof. In various embodiments, the antimicrobial agent comprises minocycline, gendine, genlenol, genlosan, genfoctol, aminoglycosides, beta lactams, quinolones, fluoroquinolones, macrolides,

sulfonamides, sulfamethaxozoles, tetracyclines, streptogramins, oxazolidinones (linezolid), clindamycins, lincomycins, rifamycins, glycopeptides, polymyxins, lipopeptide antibiotics, pharmacologically acceptable sodium salts, pharmacologically acceptable calcium salts, pharmacologically acceptable potassium salts, and lipid formulations.

[0073] In other embodiments, the disposable valve assembly described in this disclosure further comprises a boot configured to be attached to the spring stanchion and the stem, the boot configured to contact the stem when the stem is moved in a downward position; a stem insert disposed in the first opening of the stem, the stem insert configured to prevent air passage out of the first opening, wherein the lubricant disposed on at least one of the stem, the spring stanchion, the spring, the stem insert or the boot, wherein the boot comprises a ledge configured to receive a button head portion of the stem to provide an air tight seal when the top portion of the stem contacts the ledge of the boot. In yet other embodiments, the stem further comprises a second opening, the second opening disposed transverse to the first opening, the first and second openings for allowing passage of air and/or fluid, wherein the opening in the spring stanchion is disposed in a center of the spring stanchion and the spring stanchion comprises a ledge to receive a first end of the spring and the stem comprises a ledge to receive the second end of the spring.

[0074] In certain embodiments, (i) the stem has a proximal end, the stem further comprising a plurality of ridges and grooves disposed circumferentially about the stem, the plurality of ridges and grooves being monolithic with the stem, a plurality of seals disposing in the grooves of the stem and the stem comprising a first opening disposed at the proximal end and running along a longitudinal axis of the stem; a retainer ring contacting and disposed around the stem; a button head or button cap contacting the proximal end of the stem and a resilient member contacting the retainer ring and the button head or button cap, wherein application of a downward force to the button head or button cap causes the stem to move in a downward position; (ii) the retaining ring, a boot, and/or a button cap are attached to the proximal end of the stem and a resilient member contacts the retaining ring, boot and/or button cap, wherein movement of the resilient member in a downward direction moves the stem in a downward position; (iii) the retaining ring comprises a diaphragm and portion that contacts the resilient member, the retaining ring disposed in the center of the stem, the resilient member comprising a spring that contacts the retaining ring and the button cap and the button cap is disposed at the proximal end of the stem.

[0075] In other aspects, (i) the spring stanchion further comprises at least one recess and/or projection configured to attach to the stem, wherein the at least one recess and/or projection of the spring stanchion comprises a tab and the stem is configured to slidably receive the tab and the stem being movable in a downward position on application of a downward pressing force; (ii) wherein the at least one recess and/or projection of the spring stanchion comprises a cutout configured to lock the stem to the spring stanchion; and (iii) the lubricant is disposed on the tab.

[0076] In certain embodiments, in the disposable antimicrobial valve assembly described in this disclosure, (i) the stem comprises a plurality of points at one end, and a top portion or a button head at an opposite end configured to be contacted by a finger; (ii) the stem comprises a projection comprising a sealing member to assure a proper seal within a suction port of a medical device; (iii) the stem comprises an O-ring attached thereto to assure a proper seal within a suction port of the endoscope; and (iv) wherein the stem, and spring stanchion comprise thermoplastic material. In other embodiments, (i) the stem has a diameter that is concentric to the diameter of the boot to provide an airtight seal within a suction port of an endoscope; (ii) wherein the first opening of the stem contacts the second opening of the stem, and when the stem is pressed in a downward direction, the second opening aligns with a suction channel of the endoscope and allows passage of air and/or fluid to a suction connection.

[0077] In yet other embodiments, in the disposable valve assembly described in this disclosure (i) the stem comprises a thermoplastic material, and a second opening disposed transverse to the first opening, the first and second openings intersecting with each other and configured to allow passage of air and/or fluid through at least through a portion of the stem and the first and second openings intersect with each other; and (ii) the button cap comprises a vent running into the first opening of the stem.

Disposable Air/Water Valve

[0078] Referring to FIG. 1 and FIG. 2, FIG. 1 is an isometric view of an illustrative implementation of a disposable air/water valve 100, and FIG. 2 is an exploded view of an illustrative embodiment of a disposable air/water valve 100 of FIG. 1. Disposable air/water valve 100 has nine components, all positioned along longitudinal axis A namely main stem 101, seals 112, 110, 108, 106, retaining ring 200, boot 104, resilient member (e.g., spring, rubber, elastic, etc.) 125, and button cap 102. Stem 101 is monolithic (e.g., a single piece) having grooves 134, 136, 138, 140, ridges 124, 126, 128 and 130 that are molded as part of the stem and proximal end 133 positioned about opening end 132. The disposable air/water valve 100 also contains aligners 114, 116 and 118. Boot 104 contains a recess 120. Stem 101 further contains a transverse hole 122. These ridges and/or grooves can be rigid or they can be flexible. In the embodiments shown due to the ridges and/or grooves the main stem has a varied diameter, where the diameter is greater by the ridges and the diameter is smaller by the grooves. This

configuration allows seals to be inserted into the grooves.

[0079] Unlike the non-disposable air/water valves that are not monolithic as many of the ridges and/or grooves are molded separately and contain different material than the stem, which often comprises metal, the monolithic stem (one piece) of the disposable air/water valve comprises a plurality of ridges and grooves that are the same material as the stem. In some embodiments, the seals 106, 108, 110, or 112 can be set into the grooves of the stem.

[0080] One or more components of the device of the current application (e.g., seals 106,

108, 110, 112, stem 101, retaining ring 200, boot 104, resilient member (e.g., spring, rubber, elastic, etc.) 125, and button cap 102 can be made from a suitable material such as for example, thermoplastic material. Suitable materials include, but are not limited to, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, silicone, or the like or combinations thereof. FIG. 1 also illustrates lubricant 1000 which may be disposed on valve 100, at least on stem 101. The lubricant can also be disposed on the retaining ring or spring stanchion 200 and spring 125. In some embodiments, lubricant 1000 also contains an antimicrobial agent. In some embodiments, disposable air/water valve 100 can contain the antimicrobial as part of the stem, spring stanchion, seal, and/or spring. The antimicrobial can be a coating on the components or homogenously disposed in the material that the stem, spring stanchion, seal, and/or spring is made from. In some embodiments, the air/water valve shown in FIG. 1, does not include a transverse hole 122. [0081] FIG. 3 is an enlarged view of an illustrative implementation of stem 101. Stem

101 is precision molded in one piece for accuracy and rigidity. Stem 101 may be color coded to identify the product as an air/water valve. Color coding of stem 101 allows the air/water valve to be easily identified. Further, the color coding also identifies disposable air/water valve as a disposable valve. Stem 101 provides several seal retaining regions or grooves 134, 136, 138, 140 for keeping seals 106, 108, 110, 112 (FIG. 2) in desired positions on stem 101. Stem 101 also contains a proximal end 133 positioned about opening end 132. At proximal end 133, stem 101 contains a first opening 142. Ridges 124, 126, 128 and 130, like the retaining regions or grooves, are molded as part of the stem. Seals 106, 108, 110, 112 of FIG. 2 may be over-molded to stem 101 or appropriately secured to the stem 101. Over-molding the seals on the stem avoids the need to slide the seals onto stem 101, which could tear or damage the seals during assembly. Operation of an air/water valve in an endoscope is discussed in further detail below.

[0082] Retaining ring 200 (of FIG. 2) provides an outer ring 202 and a diaphragm 204, as shown in FIG. 4, with a cutout opening 206 for receiving proximal end 133 of stem 101. A diaphragm 204 as used herein is a partition. While cutout opening 206 is shaped as a larger diameter circle with three semi-circular cutouts (one shown as 208) along the radius of the larger diameter circle, it should be recognized that any other suitably shaped cutout opening 206 may be utilized (e.g. square, triangle, etc.). Proximal end 133 of stem 101 may be placed through retaining ring 101 and resilient member (e.g., spring, rubber, elastic, etc.) 125 and secured to button cap 102 (of FIG. 2).

[0083] The outer diameter of proximal end 133 of stem 101 is smaller than a hollow center bore of button cap 102, thereby allowing proximal end 133 of stem 101 to be inserted into the center bore of button cap 102. Proximal end 133 may protrude slightly from button cap 102 to provide an operator with tactile confirmation that the vent hole is sealed with the finger. Stem 101 may be secured to button cap 102 using ultrasonic welding, a suitable adhesive, mechanical attachment (e.g. threading or the like) or any suitable attachment method.

[0084] In another implementation of the disposable air/water valve 100, stem 101 and button cap 102 may be molded as a single piece.

[0085] Seals 106, 108, 110, 112 are molded on stem 101. Then stem 101 is inserted through the center of retaining ring 200. Above seal retaining region 134 (of FIG. 3), stem 101 may be modified to provide grooves or the like in another implementation. Retaining ring 200 of FIG. 2 may be modified to provide a larger diameter cutout opening 206 to allow the bottom of stem 101 to pass through the opening 206. Further, retaining ring 200 of FIG. 2 may provide protrusions that fit into the grooves to secure retaining ring 200 to the combined stem and button cap 102. Boot 104 may be over-molded around retaining ring 200.

[0086] In other implementations, boot 104 may be molded separately from retaining ring

200 and placed on the retaining ring 200 during assembly. Stem 101 may be color coded or color matched by forming stem 101 from a colored material, painting, or the like. The color coding of disposable air/water valve 100 is easily visible when the valve is out of an endoscope, thereby making air/water valve 100 easy to identify as an air/water valve and a disposable valve. Further, the color coding eliminates the need for separate color components necessary to produce an air/water valve. Because stem 101 is inserted into the center bore of button cap 102, the color coding of stem 101 is also visible from the top of button cap 102 or when disposable air/water valve 100 is placed in the air/water cylinder of the endoscope.

[0087] The outside diameter of the top end of button cap 102 is larger than the diameter of resilient member (e.g., spring, rubber, elastic, etc.) 125, which resumes its original shape or position after being compressed, and the inside diameter of cutout opening 206 in diaphragm 204 is smaller than the diameter of resilient member (e.g., spring, rubber, elastic, etc.) 125 to retain resilient member (e.g., spring, rubber, elastic, etc.) 125 between retaining ring 200 and button cap 102.

[0088] When button cap 102 is depressed by an operator, resilient member (e.g., spring, rubber, elastic, etc.) 125 is compressed causing button cap 102 to move towards retaining ring 200. Because stem 101 is secured to button cap 102, it also moves when button cap 102 is depressed, thereby allowing the trumpet-like valve to move into alignment with a desired endoscope port. When the operator releases button cap 102, resilient member (e.g., spring, rubber, elastic, etc.) 126 forces button cap 102 away from retaining ring 200, which causes retaining ring 200 to move along stem 101. However, the cutout opening 206 in diaphragm 204 of retaining ring 200 is smaller than the diameter of stem 101 just above seal retaining region 134, thereby preventing retaining ring 200 from advancing past seal retaining region 134 on stem 101.

[0089] Seals 106, 108, 1 10, 112 are formed from pliable material suitable for creating a seal, such as rubber, polymeric material(s), or a suitable material or a combination of suitable material(s). Boot 104 may also be made from a pliable material for ease of assembly e.g., a material that allows boot 104 to be slid over retaining ring 200. Retaining ring 200, stem 101, and button cap 102 are formed from a suitable material or combination of material(s), such as plastic, polymeric material(s), or the like. However, retaining ring 200, stem 101, and button cap 102 can be formed of a more rigid material than seals 106, 108, 110, 112 and boot 104. It may be preferable to have a more rigid retaining ring 200, stem 101, and button cap 102 because they are subjected to forces exerted by resilient member (e.g., spring, rubber, elastic, etc.) 125, an operator, or the like. The retaining ring 200 is surrounded by outer ring 202.

[0090] In another embodiment, referring to FIGS. 5A and 5B, disposable air/water valve

100a has nine components, namely stem 101a, seals 112a, 110a, 108a, 106a, retaining ring 200a, outer ring 202a, boot 104a, resilient member (e.g., spring, rubber, elastic, etc.) 125a (not shown), and button cap 102a (not shown). Stem 101a is monolithic (e.g., a single piece) having grooves 134a, 136a, 138a, 140a, ridges 124a, 126a, 128a and 130a that are molded as part of the stem and proximal end 133 positioned about opening end 132a. The disposable air/water valve also contains aligners 114, 116 and 118 (not shown). Outer ring 202a is surrounded by boot 104a. As opposed to the air/water valve illustrated in FIGS. 1-4, the air/water valve 100a does not contain a transverse hole. The ridges and/or grooves of stem 101a can be rigid or they can be flexible.

[0091] Unlike the non-disposable air/water valves that are not monolithic as many of the ridges and/or grooves are molded separately and contain different material than the stem, which often comprises metal, the monolithic stem (one piece) of the disposable air/water valve comprises a plurality of ridges and grooves that are the same material as the stem. In some embodiments, the seals 106a, 108a, 110a, or 112a can be set into the grooves of the stem.

[0092] One or more components of the device of the current application (e.g., seals 106a,

108a, 110a, 112a, stem 101a, retaining ring 200a, boot 104a, resilient member (e.g., spring, rubber, elastic, etc.) 125a, and button cap 102a can be made from a suitable material such as for example, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropyl aery 1 amide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, silicone, or the like or combinations thereof. [0093] FIG. 5A is an enlarged isometric view of an illustrative implementation of stem

101a. Stem 101a is precision molded in one piece for accuracy and rigidity. Stem 101a may be color coded to identify the product as an air/water valve. Color coding of stem 101a allows the air/water valve to be easily identified. Further, the color coding also identifies disposable air/water valve as a disposable valve. Stem 101a provides several seal retaining regions or grooves 134a, 136a, 138a, 140a for keeping seals 106a, 108a, 110a, 112a in desired positions on stem 101a, all positioned along longitudinal axis AA. Stem 101a also contains a proximal end 133a positioned about opening end 132a. At proximal end 133a, stem 101a has a first opening 142a. Ridges 124a, 126a, 128a and 130a, like the retaining regions or grooves, are molded as part of the stem. Seals 106a, 108a, 110a, 112a of FIG. 5A may be over-molded to stem 101a or appropriately secured to the stem 101a. Over-molding the seals on the stem avoids the need to slide the seals onto stem 101a, which could tear or damage the seals during assembly. The lubricant 1000 can be disposed on the stem and optionally on the retaining ring or spring stanchion and spring. In some embodiments, lubricant 1000 also contains an antimicrobial agent. In some embodiments, disposable air/water valve can contain the antimicrobial as part of the stem, spring stanchion, seal, and/or spring. The antimicrobial can be a coating on the components or homogenously disposed in the material that the stem, spring stanchion, seal, and/or spring is made from.

[0094] Operation of an air/water valve in an endoscope is discussed in further detail below.

[0095] Retaining ring 200a of FIG. 5 A provides a partition or diaphragm 204a, as shown in FIG. 5B, with a cutout opening 206a for receiving proximal end 133a of stem 101a. While cutout opening 206a is shaped as a larger diameter circle with several peripheral cutouts 206b along the radius of the larger diameter circle, it should be recognized that any other suitably shaped cutout opening may be utilized (e.g. square, triangle etc.). Proximal end 133a of stem 101a may be placed through retaining ring 101a and resilient member 131 of FIG. 5D (e.g., spring, rubber, elastic, etc.) and then it can be secured to button cap 102a (not shown).

[0096] The outer diameter of proximal end 133a of stem 101a is smaller to a hollow center bore of button cap 102a, thereby allowing end 133a of stem 101a to be inserted into the center bore of button cap 102a. Proximal end 133a may protrude slightly from button cap 102a to provide an operator with tactile confirmation that the vent hole is sealed with the finger. Stem 101a may be secured to button cap 102a using ultrasonic welding, a suitable adhesive, mechanical attachment (e.g. threading or the like) or any suitable attachment method.

[0097] In another implementation of the disposable air/water valve 100a, stem 101a and button cap 102a may be molded as a single piece.

[0098] Seals 106a, 108a, 110a, 112a are molded on stem 101. Then stem 101a is inserted through the center of retaining ring 200a. Retaining ring 200a of FIG. 5B may be modified to provide a larger diameter cutout opening 206a to allow the bottom of stem 101a to pass through the opening 206a. Boot 104a may be over-molded around retaining ring 200a.

[0099] In other implementations, boot 104a may be molded separately from retaining ring 200a and placed on the retaining ring 200a during assembly. Stem 101a may be color coded or color matched by forming stem 101a from a colored material, painting, or the like. The color coding of disposable air/water valve 100a is easily visible when the valve is out of an endoscope, thereby making air/water valve 100a easy to identify as an air/water valve and a disposable valve. Further, the color coding eliminates the need for separate color components necessary to produce an air/water valve. Because stem 101a is inserted into the center bore of button cap 102a, the color coding of stem 101a is also visible from the top of button cap 102a or when disposable air/water valve 100a is placed in the air/water cylinder of the endoscope.

[00100] The outside diameter of the top end of button cap 102a is larger than the diameter of resilient member (e.g., spring, rubber, elastic, etc.) 125a, which resumes its original shape or position after being compressed, and the inside diameter of cutout opening 206a in diaphragm 204a is smaller than the diameter of resilient member (e.g., spring, rubber, elastic, etc.) 125a to retain resilient member (e.g., spring, rubber, elastic, etc.) 125a between retaining ring 200a and button cap 102a.

[00101] When button cap 102a is depressed by an operator, resilient member (e.g., spring, rubber, elastic, etc.) 125a is compressed causing button cap 102a to move towards retaining ring 200a. Because stem 101a is secured to button cap 102a, it also moves when button cap 102a is depressed, thereby allowing the trumpet-like valve to move into alignment with a desired endoscope port. When the operator releases button cap 102a, resilient member (e.g., spring, rubber, elastic, etc.) 126a forces button cap 102a away from retaining ring 200a, which causes retaining ring 200a to move along stem 101a. However, the cutout opening 206a in diaphragm 204a of retaining ring 200a is smaller than the diameter of stem 101a just above seal retaining region 134a, thereby preventing retaining ring 200a from advancing past seal retaining region 134a on stem 101a.

[00102] Seals 106, 108, 1 10, 112 are formed from pliable material suitable for creating a seal, such as rubber, polymeric material(s), or a suitable material or a combination of suitable material(s). Boot 104 may also be made from a pliable material for ease of assembly e.g., a material that allows boot 104 to be slid over retaining ring 200. Retaining ring 200, stem 101, and button cap 102 are formed from a suitable material or combination of material(s), such as plastic, polymeric material(s), or the like. However, retaining ring 200, stem 101, and button cap 102 can be formed of a more rigid material than seals 106, 108, 110, 112 and boot 104. It may be preferable to have a more rigid retaining ring 200, stem 101, and button cap 102 because they are subjected to forces exerted by resilient member (e.g., spring, rubber, elastic, etc.) 125, an operator, or the like.

[00103] FIG. 5C is a perspective view of the retaining ring 200a. The retaining ring 200a comprises a top rim 208, an outer ring 210 which provide a surface to hold the boot 104a (not shown). The retaining ring also comprises a cutout opening 206a with several peripheral cutouts 206b around the radius of the cutout opening 206a. It should be recognized that any other suitably shaped cutout opening 206a may be utilized (e.g. square, triangle... etc.). Retaining ring 200a also includes diaphragm(s) 204a positioned among cutout opening 206a and peripheral cutouts 206b. The diaphragms 204a provide partitions to the cutouts and a surface to support spring 125 (FIG. 2). The shapes of the diaphragms 204a can vary depending on the shapes of cutout opening 206a. The shapes of the cutouts and diaphragms affect the laminar flow of the air and the water. In another embodiment, the cutout opening 206a is a circle and the peripheral cutouts 206b are also circles with diaphragms in the shape of an arc.

[00104] FIG. 5D is an exploded view of an embodiment of a disposable air/water valve 100a. The disposable air/water valve 100a provides a button cap 129, a spring 131, a retaining ring 200a and a stem 101a. The retaining ring 200a is disposed around the stem 101a supporting the spring 131. The proximal end of the stem 101a is disposed above the retaining ring 200a engaging the button cap 129.

[00105] FIGS. 6A-C are illustrative implementations of the operation of an air/water valve in an endoscope. Note that the discussion in reference to FIGS. 6A-C is directed toward a generic air/water valve, which can include the Pentax valve 100a discussed in FIGS. 5A and 5B. The discussion merely provides an explanation of how an air/water valve generally operates in an endoscope.

[00106] In FIG. 6A, air/water valve 300 is positioned in the air/water cylinder of an endoscope and is shown in an un-actuated position. The endoscope provides an air channel 302 for air and a water channel 308 for water. Air channel 302 and water channel 308 are connected to water bottle 310. Water channel 308 extends into the fluid contained in water bottle 310. When air/water valve 300 is placed in the air/water cylinder of the endoscope, air/water valve passes through air channel 302 and water channel 308. Air flow (provided by an air pump or the like), shown by the arrows, may flow into water bottle 310 and air channel 302. However, because water bottle 310 is sealed and water channel 308 is blocked by air/water valve 300, air tends to flow down air channel 302 towards air/water valve 300. In the un-actuated position with the air vent uncovered, air/water valve 300 allows air to escape from a vent. For example, with disposable air/water valve 100, air would flow into first opening 142 of stem 101 through the internal bore of stem 101 and out proximal end 133 of the disposable air/water valve 100. Note that disposable air/water valve 100 in FIG. 1 provides several seals 106, 108, 110, 112 that prevent air or water from leaking from air channel 302 or water channel 308. Opening 306 of the air- water valve 300 is not aligned with the water channel and, there is no movement of water away from the water bottle, as the water channel is blocked.

[00107] In FIG. 6B, air/water valve 300 in the air/water cylinder of an endoscope is shown in an un-actuated position with the vent blocked by an operator's finger 304 or the like. Because water bottle 310 is sealed and water channel 308 is blocked by air/water valve 300, air tends to flow down air channel 302 towards air/water valve 300. However, when the air vent of air/water valve 300 is blocked by the operator 304, air flows past air/water valve 300 towards the distal end of an endoscope. This allows the operator to insufflate a body cavity by blocking the air vent of air/water valve 300 without actuating the valve. In FIG. 6B, opening 306 of the air/water valve 300 is shown blocked.

[00108] In FIG. 6C, air/water valve 300 is shown in an actuated position. When air/water valve 300 is actuated the resilient member (e.g., spring, rubber, elastic, etc.) in the valve is compressed and air channel 302 is blocked by the air/water valve 300. However, actuating air/water valve 300 moves opening 306 of the valve into water channel 308, thereby creating a passageway for fluid to pass through air/water valve 300. Because air channel 302 is blocked by operator 304 pressing down on the valve, air flows into water bottle 310. As the air pressure in water bottle 310 increases, fluid is forced from water bottle 310 into water channel 308. By actuating air/water valve 300, the operator causes water to flow towards the distal end of the endoscope for rinsing, irrigation, or the like.

[00109] FIGS. 7A and 7B are illustrative implementations of the operation of a disposable air/water valve 400 in an endoscope. In FIG. 7A, disposable air/water valve 400 is shown in an undepressed or unactuated position. Seals 402, 404, 406 and 408 prevent air from escaping the chamber between seals 404 and 408. Opening 410 allows the air to escape through the central bore of disposable air/water valve 400 as shown. The disposable air/water valve 400 also provides spring 412, cap 414, and stem 416. Spring 412, surrounding a portion of stem 416, is disposed below cap 414. Note that air/water valve 400 is shown without a boot and retaining ring for illustrative purposes only. When an operator places a finger on top of disposable air/water valve 400 to prevent air from escaping, pressure in the chamber between seals 404 and 406 increases.

[00110] If the operator has created a sufficient seal by substantially blocking air flow out of the top of disposable air/water valve 400, the wall of seal 404 collapses to allow air to flow past the seal. Seal 402 prevents air from escaping out through the air/water cylinder of the endoscope. As a result, the air can only escape out through the outlet to the patient.

[00111] Seal 408 prevents water from escaping past disposable air/water valve 400 in the un-actuated position. Seal 408 separates the water inlet from the water outlet. It should be noted that residual water from previously depressing disposable air/water valve 400 may remain between seals 406 and 408. Seal 406 prevents the residual water from escaping further up the air/water cylinder of endoscope.

[00112] In FIG. 7B, disposable air/water valve 400 is depressed in the air/water cylinder of an endoscope. Seals 402 and 404 prevent air from the air output (i.e. air from the patient) from flowing back into the endoscope. Seals 404 and 406 prevent air from the air input from escaping the chamber between seals 404 and 406. It should also be noted that an operator's finger is blocking air flow through the central bore of disposable air/water valve 400. In the depressed position, seal 408 no longer separates the water input and water output. Water from the water input fills the area between seals 406 and 408 and activates the water output to the patient or allows the water to flow out (or be supplied) to the patient. Seal 406 prevents water from escaping up the air/water cylinder of the endoscope.

[00113] Although the air/water valve is designed to be used with an endoscope, it will be understood that other medical instruments can be used with the present air/water valve or assembly. These instruments include, for example, colonoscopes, laparoscopes, bronchoscopes, or any medical instruments with a camera that requires air and/or water use.

[00114] FIG. 8 is a flow chart of a manufacturing process for a disposable air/water valve. The first step SI 00 of the manufacturing process is molding the stem from a suitable material, such as plastic, polymeric material(s), or any other suitable material(s). Molding the stem and using lower cost material(s) creates considerable cost savings when compared to the metal used by reusable air/water valves. Additionally, stem 101 in FIG. 2 is a single piece that does not need to be assembled, like the stem assembly of a reusable air/water valve, thereby reducing assembly cost. For example, stem 101 is monolithic (e.g., a single piece) having grooves 134, 136, 138, 140, and ridges 124, 126 and 128 that are molded as part of the stem. Stem 101 also includes opening end 132. These ridges and/or grooves can be rigid or they can be flexible.

[00115] Unlike the non-disposable air/water valves that are not monolithic as many of the ridges and/or grooves are molded separately and contain different material than the stem, which is metal, the monolithic stem (one piece) comprises a plurality of ridges and grooves that are the same material as the stem.

[00116] Button cap 102 and retaining ring 200 are also molded in steps SI 10 and S120.

Boot 104 may be over-molded on retaining ring 200 in step S130. Further, in other

implementations, boot 104 may be molded separately and simply placed on retaining ring 200 in FIG. 2 during assembly. However, in contrast to stem 101, button cap 102 and retaining ring 200/boot 104 are not required until later in the manufacturing process. As a result, the dotted lines indicate that steps SI 10, SI 20, and SI 30 may occur at various times in the manufacturing process. Because the boot, button cap, and retaining ring are relatively simple when compared to the stem, they may be manufactured using additional manufacturing processes that may not be suitable for stem 101, such as blow molding, over-molding, injection molding, casting, machining, stamping, or any other suitable manufacturing process.

[00117] In some embodiments, once the disposable air/water valve is assembled, in step SI 000, lubricant 1000 can be applied on the stem, spring and/or spring stanchion of the air/water valve assembly. In other aspects, the method of manufacturing of a disposable valve further comprises placing tabs of the spring stanchion into recessed apertures of the stem, and over- molding a boot on the spring stanchion or over-molding a boot onto the spring stanchion, wherein (i) the stem is color coded; (ii) a sealing ledge on the boot creates a seal against a button head of the stem; (iii) the stem provides an O-ring or an alternate sealing device to assure an airtight seal within a suction port; (iv) the stem provides a sealing means to assure an air-tight seal within a suction port or the stem; (v) the stem has a diameter that assures an air-tight seal within a suction port; (vi) the length of the stem is reduced; or (vii) the lubricant comprises an antimicrobial agent.

[00118] Stem 101 may be placed in a mold suitable for over-molding seals 106, 108, 110, 112 of FIG. 2 in step S140. For example, the stem may be placed in a clam-shell like mold and the material utilized to form seals 106, 108, 110, 112 may be injected into the mold. The mold forms the seals 106, 108, 110, 112 of FIG. 2 in seal retaining regions or grooves 140, 138, 136, 134.

[00119] The seals of the current application can be made from rubber, one or more polymeric material(s), or any other suitable material(s). The seals are preferably made from a pliable material to provide a proper seal when disposable air/water valve 100 is in use. As discussed previously regarding steps SI 10, S120, and S130, boot, button cap, and retaining ring can be molded at various stages of the manufacturing process. However, note that each of the components must be made before the step they are specifically needed in. For example, retaining ring 200 of FIG. 2 must be molded before step SI 50 because it is needed in step SI 50 in the manufacturing process. Similarly, button cap 102 of FIG. 2 is needed before proceeding to step SI 60 and boot 104 of FIG. 2 is needed before proceeding to step SI 70.

[00120] In step SI 50, the opening end 132 of FIG. 3 of stem 101 is placed through the opening in the diaphragm of retaining ring 200 and through resilient member (e.g., spring, rubber, elastic, etc.) 126 of FIG. 2. Button cap 102 may then be placed on the proximal end 133 of stem 101 and secured to the stem 101 in step SI 60. For example, the disposable air/water valve 100 may be attached (e.g., adhesive, glue, molding, over molding, curing with UV light, welding, ultrasonically welding, or the like or combinations thereof) to secure button cap 102 and the seals 106, 108, 110, 112 to stem 101. In other implementations, button cap 102 may be secured to stem 101 using any attachment means (e.g., adhesive, glue, molding, over molding, curing with UV light, welding, ultrasonically welding, mechanical attachment, or the like or combinations thereof) to complete the assembly of disposable air/water valve 100.

Disposable Suction Valve

[00121] FIG. 9A is an isometric view of a disposable suction valve 500. FIG. 9B is a side view of an illustrative embodiment of a disposable suction valve 500. While the disposable suction valve 500 shown is suitable for use with Olympus® endoscopes, other embodiments of disposable suction valves may be suitable for use with other types of endoscopes, such as Pentax®, Fujinon®, or the like. As such, the embodiments discussed herein may be modified to accommodate other types and/or brands of endoscopes.

[00122] Disposable suction valve 500 may provide a stem 504, stem insert 502, boot 508, spring cup/stanchion (not shown) and spring 506. One or more components of the disposable suction valve may comprise disposable material, including, but not limited to polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N- isopropyl aery 1 amide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, silicone, or the like or combinations thereof. Stem 504 and stem insert 502 may be formed from a suitable material or combination of material(s), such as plastic, polymeric material(s), or the like. Stem insert 502 may be color coded (e.g. black, red, green, etc.) to indicate the type of valve or that the valve is a suction valve. In other embodiments, stem insert 502 may be omitted or color coding may be provided by another means (e.g. painting).

[00123] Boot 508 may be formed from a suitable material, such as for example, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N- isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), or the like or combinations thereof.

[00124] In one embodiment, boot 508 may be formed from a pliable material for ease of assembly e.g., a material that allows boot 508 to slide over spring stanchion cup (not shown) during assembly and seal off the suction in the circuit. In other embodiments, boot 508 may be over-molded onto the spring stanchion cup. Spring 506 may be formed from a suitable material, such as corrosion resistant metal, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic, or the like or combinations thereof.

[00125] While a spring 506 is shown in Figure 9A, it will be understood that any resilient member (e.g., a member that resumes its original shape or position after being compressed) can be used. A resilient member can include, for example, a spring, plastic, rubber or other elastic member that allows its original shape or position after being compressed. FIG. 9B, a side view of disposable suction valve 500, also illustrates recessed apertures which may be utilized to secure a spring stanchion cup or flange to stem 504.

[00126] The air used for suction in combination with the device can be filtered using an inline air filter assembly having a porous medium to filter air. This filter may be disposed in the air path exterior of it within the suction channel. The porous media can be made of

polyethersulfone, PTFE, PVC, acrylic copolymer, polysulfone, polyvinylidene fluoride, cellulose acetate, cellulose nitrate, mixed esters of cellulose, nylon, polyamide or a combination thereof. The filter can be microporous, and the mean pore size of the media is from about 0.2 micron to about 150 microns. In some embodiments, the filter can have a mean pore size of about 0.22 micron to about 0.8 micron.

[00127] The disposable suction valve of the current application, in some embodiments and as shown in Figure 9A, improves suction, reduces or eliminates leaks and/or fluid going into and out of unwanted areas of the valve or in unwanted areas of the medical instrument. The disposable suction valve of the current application, in some embodiments, reduces or eliminates debris from clogging the valve.

[00128] In some embodiments, as illustrated in FIG. 9A unlike the non-disposable seven- component suction valves in the prior art, the disposable suction valve of the current application, comprises four components: a stem 504, boot 508, spring cup/stanchion (not shown) and spring 506. In some embodiments, unlike the non-disposable seven-component suction valves in the prior art, the disposable suction valve of the current application, comprises five components: a stem 504, boot 508, spring cup/stanchion (not shown), spring 506, and stem insert 502.

[00129] In some embodiments, the difference from the disposable suction valve of the current application and the prior is that in the prior art valve construction, the prior art valve has a stem (with a threaded button head end) plus a metal backing plate (to thread onto stem and offer a secure joint for the plastic button head) and a plastic button head. In the disposable suction valve of the current application, in some embodiments, the stanchion cup is molded and then the boot is overmolded onto this piece. Accordingly, in some embodiments, the stanchion cup is monolithic with the boot (e.g., they are one piece) and therefore, the manufacturing process is simpler. Therefore, the disposable suction valve of the current application can be easier to manufacture and there is less chance of the components malfunctioning when compared to prior art non-disposable seven-component suction valves.

[00130] In contrast, the stem of a re-usable suction valve may be formed from one or more components made of a material that is suitable for repeated cleaning, disinfection, and sterilization, such as stainless steel or the like. While this material allows a re-usable suction valve to be repeatedly cleaned, disinfected, and sterilized for re-use, such material may be costly. It is difficult to properly clean, requires more components, requires additional manufacturing and assembly steps, requires costlier manufacturing processes, and the like. In addition to being costlier to manufacture than a disposable suction valve, a re-usable suction valve also requires equipment and materials that are utilized to repeatedly clean, disinfect, and sterilize the valve.

[00131] FIG. 9A also illustrates lubricant 1000 which may be disposed on valve 500, at least on stem 504, retaining ring or spring stanchion (not shown) and spring 506. In some embodiments, lubricant 1000 also contains an antimicrobial agent.

[00132] FIG. 9C is an exploded view of a disposable suction valve 500a. FIG. 9D is an isometric view of an illustrative embodiment of stem 504a of the disposable suction valve 500a. While the disposable suction valve 500 shown in FIGS. 9A and 9B is suitable for use with Olympus® endoscopes, the disposable suction valve illustrated in FIGS. 9C and 9D is suitable for use with Pentax® endoscopes. As such, the embodiments discussed herein may be modified to accommodate other types and/or brands of endoscopes. In some embodiments, the disposable valves have a plurality of mini-seals (e.g., two, three, four, five, six, seven, eight, nine, ten, eleven, twelve seals, etc.) about the stem either monolithic with the stem or seals that are placed around the stem (e.g., O ring seals, or bands placed about the stem).

[00133] As illustrated in FIGS. 9C and 9D, disposable suction valve 500a contains components found in other valves, for example, stem 504a, stem insert 502a, boot 508a, spring cup/stanchion (not shown), spring 506a and stem cap 526a. Stem 504a of disposable suction valve 500a contains a transverse opening 514a supported by an opening rim 530a and protrusion 532a, however the transverse opening 514a does not contain a through opening hole that extends transversely and completely through the stem. A disposable suction valve having a transverse opening that extends completely through the stem (shown in 514 of FIG. 10) is suitable for use with Olympus® endoscopes.

[00134] Stem 504a is monolithic (e.g., a single piece) containing recesses 510a and 512a and groove 524a positioned between ridges 523a and 523b. Stem 504a also contains an opening 516a passing through stem 504a along axis AA and which can be covered with seal 522a. Boot 508a surrounds a spring stanchion ring also referred to as retaining ring 700a, which engages spring 506a and allows compression of the spring or expansion of the spring 506a by movement of the user' s thumb or finger.

[00135] One or more components of the disposable suction valve 500a may comprise disposable material, including, but not limited to polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, silicone, or the like or combinations thereof. Stem 504a and stem insert 502a may be formed from a suitable material or combination of material(s), such as plastic, polymeric material(s), or the like. Stem insert 502a may be color coded (e.g., black, red, green, etc.) to indicate the type of valve or that the valve is a suction valve. In other embodiments, stem insert 502a may be omitted or color coding may be provided by another means (e.g., painting).

[00136] Boot 508a may be formed from a suitable material, such as for example, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N- isopropyl aery 1 amide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), or the like or combinations thereof.

[00137] In one embodiment, boot 508a may be made from a pliable material for ease of assembly e.g., a material that allows boot 508a to be slid over spring stanchion cup (not shown) during assembly and to seal off the suction in the circuit. In other embodiments, boot 508a may be over-molded onto the spring stanchion cup. Spring 506a may be formed from a suitable material, such as corrosion resistant metal, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic, or the like or combinations thereof.

[00138] While a spring 506a is shown in Figure 9C, it will be understood that any resilient member (e.g., a member that resumes its original shape or position after being compressed) can be used. A resilient member can include, for example, a spring, plastic, rubber or other elastic member that allows its original shape or position after being compressed.

[00139] The air used for suction in combination with the device can be filtered using an inline air filter assembly having a porous medium to filter air. This filter may be disposed in the air path exterior of it within the suction channel. The porous media can be made of

[00140] FIG. 9C also illustrates lubricant 1000 which may be disposed on valve 500a, at least on stem 504a, retaining ring or stanchion spring (not shown) and spring 506a. In some embodiments, lubricant 1000 also contains an antimicrobial agent.

[00141] In contrast, the stem of a re-usable suction valve may be formed from one or more components made of a material that is suitable for repeated cleaning, disinfection, and sterilization, such as stainless steel or the like. While this material allows a re-usable suction valve to be repeatedly cleaned, disinfected, and sterilized for re-use, such material may be costly. It is difficult to properly clean, requires more components, requires additional manufacturing and assembly steps, requires costlier manufacturing processes, and the like. In addition to being costlier to manufacture than a disposable suction valve, a re-usable suction valve also requires equipment and materials that are utilized to repeatedly clean, disinfect, and sterilize the valve.

[00142] FIG. 10 and FIG. 11 show cross sectional views of illustrative embodiments of stem 504 rotated 90 degrees. FIG. 10 and FIG. 11 also show stem 504 in a side view along longitudinal axis AA. Stem 504 is a single molded component of disposable suction valve 500. Stem 504 provides openings 514 and 516 passing through the stem. Fluid may pass horizontally through one side of opening 514, the second opening of stem 504, and vertically through opening 516, the first opening of stem 504. The stem 504 is symmetrical for ease of use. Openings 514 and 516 may allow air or fluid to pass through the instrument channel of an endoscope when a suction valve is actuated. Recessed apertures 510 and 512 illustrated in Figure 9B may be utilized to secure a spring stanchion cup or flange to stem 504. In some embodiments of stem 504, the stem diameter may be precisely controlled to assure an air tight or nearly air tight seal within the suction cylinder/port of an endoscope.

[00143] FIG. 12A is an illustrative embodiment of alternative implementation of a stem

504b. Stem 504b has a reduced stem length and includes points 520a and 520b. Suction valves may become clogged due to debris from the body that "plugs" the vertical and horizontal passages of the suction valve stem. By reducing or eliminating, in essence, the "tube" portion of the stem below the opening in the stem, this clogging condition can be drastically reduced or eliminated. Points 520a and 520b minimize the contact between stem 504b and the interior of the suction cylinder of the endoscope, thereby reducing or eliminating the chances of debris clogging in the stem 504b jamming in the endoscope. Points 520a and 520b are positioned at a distal end of stem 504b.

[00144] By reducing the stem length suction efficiency is improved and the potential for suction valve clogging is reduced or eliminated. In some embodiments, the shorter stem allows the user to press less on the valve in a downward direction to align an opening with the suction channel (not shown). In this way, debris and/or fluid is prevented from clogging the suction channels as the distance to align the suction channel with the opening is shorter. In some embodiments, the stem length is reduced by 10%, 20%, 30%, 40%, 50%, or 60% compared to stems that are full length (e.g., full length stems can be 0.95 of an inch).

[00145] FIG. 12B is an illustrative embodiment of another implementation of a stem 504c.

Stem 504c may include an O-ring 518 or any other suitable alternative sealing method, which may be over-molded on stem 504c or placed on stem 504c during assembly. O-ring 518 may seal suction cylinder to prevent air and/or fluids from escaping through suction valve 500. O- ring 518 may also include, in some embodiments, mold design considerations that provide a substantially or perfectly cylindrical stem and/or fully concentric configuration in order to provide an air tight seal in the endoscope port.

[00146] It will be understood that the seal can be any member suitable for sealing a portion of the stem. The seal can be permanently attached to the stem such as, for example, by over-molding so that is a raised member. In some embodiments, the seal can be removably attached to the stem, such as for example, by sliding it on the stem. Like other components of the suction valve, the seal can comprise polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, silicone or the like or combinations thereof.

[00147] FIG. 12C and 12D are illustrative embodiments of another implementation of a stem 504. FIG. 12C shows a side view of stem 504 with a longitudinal axis A. Stem may include a stem cap 526, a protruding slot 540, and a transverse opening 514 to a passage. Stem further comprises a stem insert 502 and a recess region 510. Protruding slot 540 is disposes about stem cap 526 and will match the tab on a spring stanchion to provide an additional seal as the stem moves slidably downward or upward relative to the endoscope. The stem insert extends longitudinally in the stem cap 526. The stem is made from thermoplastic material and can be molded to the desired shape and size.

[00148] FIG. 12E is another top view of a stem 504 for a disposable valve. FIG. 12E shows a surface of the stem cap 526, a protruding slot 540 extending out and around the stem, and a passage 516 for air.

[00149] Referring to FIG. 13 and FIG. 14, FIG. 13 is top view of an illustrative embodiment of a spring stanchion cup 600. FIG. 14 is a cross section view of an illustrative embodiment of spring stanchion cup 600. Spring stanchion cup 600 includes outer ring 608, stem cutout opening 602, extension(s) 610, tab(s) 604, and diaphragm or partition 606. Outer ring 608 shown in FIGS. 13 and 14 provides a generally cylindrical ring body for spring stanchion cup 600. Stem opening 602 provides an opening for receiving stem 504. Extension(s) 610 extend up from diaphragm 606 of spring stanchion cup 600. Extension(s) 610 extend a predetermined distance from diaphragm or partition 606 and work in conjunction with recessed apertures 510 and 512 of FIGS. 9B and 10 to limit how far stem 504 travels when the disposable suction valve 500 is actuated or released. Tab(s) 604 may protrude from the top of extension(s) 610 towards stem cutout opening 602. When disposable suction valve 500 is assembled, a spring is placed between stem 504 and diaphragm or partition 606 of spring stanchion cup 600. Tab(s) 604 of spring stanchion cup 600 are placed into recessed apertures 510, 512 of stem 504, thereby securing spring stanchion cup 600 to stem 504. Spring 506 maintains disposable suction valve 500 in an un-actuated position, unless an operator depresses disposable suction valve 500. In some embodiments, spring stanchion cup 600 may have one or more, recesses, such as for example, cut outs 616 that can be any shape (circular, square, triangle, etc.) to allow for bonding to a boot, such as for example, boot 104 shown in FIG. 1 and FIG. 2.

[00150] While a spring stanchion cup 600 is shown in Figures 13 and 14, it will be understood that any flange can be used to hold a portion of the resilient member (e.g., spring, rubber, etc.) in position that allows the resilient member to return to its original shape or position after being compressed.

[00151] In some embodiments, spring stanchion cup 600 the cutouts 616 are configured to allow for bonding to an over molded boot in a subsequent over molding operation. In some embodiments, the cutouts 616 are configured to mate with corresponding projections, recesses or cutouts of the stem and/or boot to lock the spring stanchion cup 600 to the stem and/or boot. In this way the components are attached to each other. In some embodiments, the boot 508 (FIGS. 9A, 9B) creates the seal and, among other things, enhances suction as compared to prior art suction valves by about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, or 60% or more, depending on composition of the bodily fluid suctioned. For example, bodily fluid (e.g., waste, blood, etc.) having a low viscosity like water can be suctioned more than about 12% with the current disposable suction valve while higher viscosity bodily fluids that are thicker can be suctioned more than about 40% with the current disposable suction valve.

[00152] In some embodiments, the concentricity of the stem is used to optimize suction.

Therefore, manufacturing methodology that enhances concentricity of the stem can provide optimum suction capability.

[00153] FIGS. 14A-E illustrate various embodiments of spring stanchion cup 600 that receives the spring or resilient member (not shown) in the disposable air/water valve and/or the disposable suction valve suitable for use with a Pentax, or Olympus endoscope. Spring stanchion has an opening 602 and an outer ring 608. In some embodiments, the spring stanchion further comprises an extension 610, a tab 604, a bottom of the extension 612, and a diaphragm 606. Outer ring 608 has a tip 614 that ensures a boot can be put around the outer ring tightly. The bottom of the spring stanchion has various features and texture including cutouts 620 in different shapes and holes.

[00154] FIG. 15 is an isometric view of an embodiment of a boot 704 with a sealing ledge 702 on a spring stanchion 700. Lubricant 1000 can be applied to the spring stanchion. FIG 15 illustrates an isometric view of another embodiment of a boot 704 with a sealing ledge 702 on a spring stanchion 700 with lubricant 1000.

[00155] FIG. 15B is a perspective view of the retaining ring or stanchion ring 700a. The stanchion ring 700a comprises a top rim 708, an outer ring 710 which provide a surface to hold the boot 704 (not shown). The stanchion ring also comprises a cutout opening 706a with several peripheral cutouts 706b around the radius of the cutout opening 706a. It should be recognized that any other suitably shaped cutout opening 706a may be utilized (e.g. square, triangle... etc.). Stanchion ring 700a also includes diaphragm(s) 704a positioned among cutout opening 706a and peripheral cutouts 706b. The diaphragm(s) 704a provide partitions to the cutouts and a surface to support spring 506 (FIG. 9C). The shapes of the diaphragms 704a can vary depending on the shapes of cutout opening 706. The shapes of the cutouts and diaphragms affect the laminar flow of the air and the water. In another embodiment, the cutout opening 706a is a circle and the peripheral cutouts 206b are also circles with diaphragms in the shape of an arc.

[00156] FIG. 16 shows a cross sectional view and side view of an illustrative embodiment of an assembled disposable suction valve 800. Stem 802 extends through spring 804 and spring stanchion cup 808. Boot 806 is over-molded or placed over spring stanchion cup 808. Boot 806 provides a sealing ledge 702 (FIG. 15 A) that seals off the suction port in the endoscope. For example, the top of stem 504 engages sealing ledge 702 when disposable suction valve 500 is depressed. In an illustrative embodiment shown in FIG. 15, boot 704 provides a sealing ledge 702 that seals off the suction port in the endoscope. Note that sealing ledge 702 may be placed at any suitable position on boot 704. Further, sealing ledge 702 may alternatively be disposed on spring stanchion cup 808 shown in FIG. 16. For example, a sealing ledge on the boot or spring stanchion cup may create a seal against stem 802, suction cylinder, a portion of the endoscope, or the like. Referring to FIG. 16, tabs 812 of spring stanchion cup 808 reside in recessed apertures 810 of stem 802. Recessed apertures 810 allow the restricted movement of stem 802 up and down on spring stanchion cup 808. The recessed apertures 810, in some embodiments, can be disposed on all or a portion of the stem 802. In some embodiments, the recessed apertures 810 can be disposed on all or a portion of opposed surfaces of the stem 802.

[00157] FIG. 16 also illustrates lubricant 1000 which may be disposed on valve 800, at least on stem 802, retaining ring or stanchion spring (not shown) and spring 804. In some embodiments, lubricant 1000 also contains an antimicrobial agent. [00158] As shown in FIG. 16, spring 804 maintains stem 802 in its upper position, but recessed apertures 810 and tabs 812 prevent stem 802 from being separated from spring stanchion cup 808. When disposable suction valve 800 is actuated, spring 804 is compressed and stem 802 moves further down into spring stanchion cup 808. Recessed apertures 810 limit how far down stem 802 may travel because tabs 812 will eventually come in contact with the top part of stem 802. In some embodiment, the top part of stem 802 can also be referred to as a button head or button cap.

[00159] FIGS. 17A and 17B are illustrative embodiments of the general operation of a disposable suction valve 900 in an endoscope. Disposable suction valve 900 may be placed into the suction cylinder of an endoscope. The suction channel 908 of the endoscope is linked to the instrument channel 906 and leads to the distal end of an endoscope or leads toward the patient. The endoscope may be connected to a suction pump or the like to create negative pressure in the suction channel when a suction valve is actuated. In an un-actuated position shown in FIG. 17A, opening 902 is out of position with suction channel 908, thereby preventing the suction pump from creating negative pressure in the suction channel 908. Suction valve 900 has not created a seal against sealing ledge 904 in an un-actuated position, which may allow air to enter through suction cylinder/port of the endoscope through suction valve 900.

[00160] For example, disposable suction valve 900 when spring 804 is not compressed, shown in an un-actuated position in FIG. 16, may allow air to enter through suction valve 900. Note that stem 802 does not create a seal against spring stanchion cup 808, and stem 802 does not create a seal against the cylinder wall of the suction cylinder of the endoscope in the non- actuated position. When an operator actuates disposable suction valve 900 (e.g. depressing stem 802 and compressing spring 804), opening 902 moves into position with the suction channel 908 from the distal end of the endoscope or from the patient as shown in FIG. 17B. Further, disposable suction valve 900 creates a seal between the stem 802 and sealing ledge 904 when actuated.

[00161] By aligning opening 902 with the suction pathway from the patient and sealing the suction cylinder of the endoscope, the negative pressure created by a suction pump or the like cause flow from the distal end of the endoscope towards the suction connection as shown in FIG. 17B. As a result, air and/or fluid may be suctioned from the distal end of the endoscope when disposable suction valve 900 is in an actuated position. When the operator releases the suction valve, spring 804 causes disposable suction valve 900 to return to the un-actuated position shown in FIG 17 A.

[00162] This procedure of aligning opening 902 with the suction pathway from the patient and sealing the suction cylinder of the endoscope, and the negative pressure created by a suction pump or the like causing flow from the distal end of the endoscope towards the suction connection as shown in FIG. 17B, can be accomplished with various suction valves and/or components, for example, those described in FIGS. 9A-15. As a result, air and/or fluid may be suctioned from the distal end of the endoscope when disposable suction valve 900 is in an actuated position. When the operator releases the stem 802 of the suction valve 900, spring 804 causes disposable suction valve 900 to return to the un-actuated position shown in FIG 17A.

[00163] Although the suction valve is designed to be used with an endoscope, it will be understood that other medical instruments can be used with the present suction valve or assembly. These instruments include, for example, colonoscopes, laparoscopes, bronchoscopes, or any medical instrument with a camera that requires suctioning.

[00164] In some embodiments, there is a method for manufacturing a disposable suction valve comprising: molding a stem; molding a flange for a resilient member; placing a bottom end of the stem through the center of the resilient member; placing the bottom end of the stem through a stem opening in the flange for the resilient member; and placing tabs of the flange for the resilient member into recessed apertures of the stem.

[00165] In some embodiments, there is a disposable suction valve wherein the stanchion or flange is monolithic with the boot (e.g., they are one piece).

[00166] In some embodiments, there is a suction valve assembly comprising: a stem comprising a first opening disposed along a longitudinal axis of the stem, and a second opening disposed transverse to the first opening, the first and second openings for allowing passage of air and/or fluid; a flange for supporting a resilient member comprising at least one recess and/or projection configured to attach to the stem; the flange comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the flange; and the resilient member configured to contact the flange and the stem.

[00167] FIG. 18 illustrates a flow chart of a manufacturing process for a disposable suction valve. In contrast to disposable suction valves, a re-usable suction valve may include metal components that are suitable for repeated cleaning, disinfection, and sterilization. These metal components may require costlier manufacturing and more complicated assembly than the components of a disposable suction valve. For example, metal components may be

manufactured by precision machining/grinding, threading, stamping, machine pressing, or the like. Further, during assembly, the metal components may need to be welded together, glued using an adhesive, or the like. These steps may complicate manufacturing and increase cost.

[00168] A disposable suction valve provides a low-cost manufacturing and simplified assembly process, thereby significantly reducing the cost of the suction valve. The low-cost materials, manufacturing processes, and assembly process of disposable suction valves provides an alternative to utilizing costly re-usable suction valve. Further, disposable suction valves allow the number of components to be reduced.

[00169] In step S10, a stem is molded using a suitable molding process, such as injection molding or the like. In step S20, a spring stanchion cup is molded using a suitable thermoplastic processing techniques, such as, for example, injection molding, rotational molding, or the like, extrusion techniques (for example, extrusion, co-extrusion, multi-layer extrusion, and so forth) and casting.

[00170] The stem and spring stanchion cup are formed from a suitable material such as for example, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropyl aery 1 amide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, silicone, or the like or combinations thereof. The stem and spring stanchion cup may be formed from a rigid material that is capable of withstanding forces exerted on a suction valve by an operator.

[00171] In another embodiment of the manufacturing process, the stem and spring stanchion may be formed by ultrasonically welding molded pieces. A boot may be molded or assembled onto spring stanchion cup in step S30. The boot may be injection molded, over molded on the spring stanchion cup, or molded using any suitable molding process. When the boot is molded separately, the boot may also be assembled on the spring stanchion cup during step S30. The boot is formed from a suitable material or combination of material(s), such as rubber, plastic, polymeric material(s), or the like. In steps S40 and S50, the bottom of the stem is placed through the center of a spring and the stem opening in the spring stanchion cup. Next, spring stanchion cup tabs are placed into recess apertures of the stem in step S60 to complete the assembly of the disposable suction valve.

[00172] In other embodiments, once the valve assembly 500 or 800 are manufactured, in step SI 000 a lubricant 1000 can be placed onto the valve by applying lubricant 1000 onto the main stem, resilient member, and/or retaining ring. In certain aspects, the lubricant comprises an antimicrobial agent, wherein (i) the main stem is color coded and the resilient member is a spring; (ii) the button cap is ultrasonically welded or otherwise attached to the stem; or (iii) the button cap centers the resilient member. In other aspects, the method of manufacturing the disposable valve assembly further comprises the step of placing the retaining ring in a second mold, wherein a boot is over-molded onto the retaining ring.

Disposable Biopsy Valve

[00173] In another embodiment, a disposable biopsy valve 1100 can be used with an endoscope. FIG. 19A is a perspective view of biopsy valve 1100 for use with an endoscope where lid 1102 is in an open position. FIG. 19B is a bottom view of the biopsy valve 1100 with lid 1102 in a closed position. Referring to FIGS. 19A and 19B, biopsy valve 1100 is tethered to body 1120 through a connector 1108. The body 1120 has a through hole or opening 11 18 defined by a top outer rim 1114, a top inner rim 1116 and a base bottom 1122. Opening 1118 is configured to receive an inner seal 1110 of the lid 1102 in order to form a seal between the body 1120 of the biopsy valve and lid 1102. The lid 1102 contains a depression aperture 1104 disposed into a protrusion diaphragm 1106. The bottom view of biopsy valve 1100 shown in FIG. 19B illustrates opening 1118 as viewed from the bottom where valve 1100 is connected to the endoscope. From the bottom view, opening 1118 is defined by a bottom inner rim 1126, a bottom outer rim 1128 and the base 1122.

[00174] One or more components of the biopsy valve 1100 of the current application can be made from a suitable material such as, for example, polyurethane, polyurea, polyether(amide), PEB A, thermoplastic or thermoset elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, silicone, or the like or combinations thereof. Once the biopsy valve has been assembled, a small amount of lubricant 1000 can be applied by hand or machine spraying and/or coating. Lubricant 1000 may or may not include an antimicrobial agent. In some embodiments, the antimicrobial agent can be included with the material suitable for manufacturing the biopsy valve as described above.

[00175] FIG. 19A also illustrates lubricant 1000 which may be disposed on valve 1100. In some embodiments, lubricant 1000 also contains an antimicrobial agent.

[00176] In one embodiment, there is a disposable valve assembly configured for use in a biopsy port of an endoscope, the disposable valve assembly comprising: a body having an opening at a proximal end of the body and an opening at a distal end of the body; a lid configured to cover the opening at the proximal end of the body; a connector contacting the body for connecting the body to the lid; and a lubricant disposed on the body, the lid and/or the connector, wherein the disposable valve assembly is made from thermoplastic material and (i) a lubricant is disposed on the body, lid and/or connector or (ii) the thermoplastic material comprises an antimicrobial agent.

[00177] FIG. 20 is a schematic of parts of an endoscope 1200. In one application, endoscope 1200 includes a supply plug 1210 (not shown), an umbilical cord 1220, a control head 1230, an insertion tube (shaft) 1240, and a bending section 1250. The supply plug 1210 is located at one end of the umbilical cord 1220 and includes a plurality of connectors 1211 (not shown). The connectors 1211 are configured to connect the endoscope 1200 to a plurality of external elements, including, but not limited to a light guide, an air supply, a water bottle and suction, and an air vent. The umbilical cord 1220 connects the supply plug 1210 to the control head 1230, which is attached to the other end of the umbilical cord 1220. The control head 1230 is provided between the umbilical cord 1220 and the insertion tube 1240. The control head 1230 includes a plurality of controls for air insufflation, irrigation, and suction. The control head 1230 may also include mechanisms for steering the bending section 1250 located at a distal end of the endoscope 1200. The insertion tube 1240 has a distal bending section 1250 whose tip houses terminal ends of an illuminating end of a light guide, air and water jets, a common port (i.e., a combined suction and biopsy port), and a distal lens or video chip.

[00178] A fiberoptic endoscope has an eyepiece, while a video endoscope has remote control buttons for a video control unit. In a fiberoptic endoscope, light is conducted from the distal lens in the bending section 1250 to the eyepiece by bundles of optical glass fibers. In a video endoscope, the image is captured with the video chip in the bending section 1250, transmitted electronically, and displayed on a monitor. [00179] The biopsy port 1260 is located at an intersection of the insertion tube 1240 and the control head 1230. The biopsy port 1260 is configured for passing sampling and/or operative instruments down the insertion tube 1240 and the bending section 1250 to an internal site to be examined or surgically manipulated. In operation, in one embodiment, the biopsy port 1260 is covered by the biopsy valve 1261 shown in FIGS. 19A and 19B illustrated as biopsy valve 1100.

[00180] Referring further to FIG. 20, the biopsy port 1260 meets the suction port 1270 to form a common port 1280 that passes down the insertion tube 40 and terminates at a distal end of the bending section 1250. Suction is controlled by a suction valve 1231 on the control head 1230. The suction valve 1231 has two positions: a neutral position and a suction position. When the suction valve 1231 is not activated, it automatically assumes a neutral position and blocks suction within the suction port 1270 and common port 1280. When the endoscopist depresses the suction valve 1231, the suction port 1270 is opened, creating a negative pressure that draws air or fluid into the terminal end of the common port 1280 (located in the bending section 1250).

[00181] It will be recognized by one of ordinary skill in the art that numerous steps in the manufacturing process may be optional or may be performed in a different sequence than specifically shown. The scope of the manufacturing process is not limited to the particular sequence and steps discussed herein, except as expressly recited in the claims.

[00182] All the valves described in this disclosure are disposable, but may be sterilizable before single use. In various embodiments, one or more components of these valves are sterilized by radiation in a terminal sterilization step in the final packaging. Terminal sterilization of a product provides greater assurance of sterility than from processes such as an aseptic process, which require individual product components to be sterilized separately and the final package assembled in a sterile environment.

[00183] Typically, in various embodiments, gamma radiation is used in the terminal sterilization step, which involves utilizing ionizing energy from gamma rays that penetrate deeply into the device. Gamma rays are highly effective in killing microorganisms; they leave no residues nor have sufficient energy to impart radioactivity to the device. Gamma rays can be employed when the device is in the package and gamma sterilization does not require high pressures or vacuum conditions; thus, package seals and other components are not stressed. In addition, gamma radiation eliminates the need for permeable packaging materials. [00184] In various embodiments, electron beam (e-beam) radiation may be used to sterilize one or more components of the device. E-beam radiation comprises a form of ionizing energy, which is generally characterized by low penetration and high-dose rates. E-beam irradiation is similar to gamma processing in that it alters various chemical and molecular bonds on contact, including the reproductive cells of microorganisms. Beams produced for e-beam sterilization are concentrated, highly-charged streams of electrons generated by the acceleration and conversion of electricity.

[00185] Other methods may also be used to sterilize one or more components of the device, including, but not limited to, gas sterilization, such as, for example, with ethylene oxide or steam sterilization.

[00186] In various embodiments, a kit is provided that may include additional parts along with each valve described in this disclosure combined together to be used with the respective valve. For example, the kit may include the air/water, suction or biopsy valve device in a first compartment. The second compartment may include a canister holding the air/water, suction or biopsy valve and any other instruments needed for the procedure. A third compartment may include a lubricant with or without an antimicrobial agent, gloves, drapes, wound dressings and other procedural supplies for maintaining sterility, as well as an instruction booklet. A fourth compartment may include additional cannulas and/or needles. A fifth compartment may include an agent for radiographic imaging. Each device may be separately packaged in a plastic pouch that is radiation sterilized. A cover of the kit may include illustrations of the use of the device and a clear plastic cover may be placed over the compartments to maintain sterility.

Lubricants

[00187] Oftentimes, disposable valve assemblies for use with an endoscope develop leaks between the endoscope valve ports and the valve because the fit is not sufficiently tight.

Lubricants covering a disposable valve assembly and, in particular, the portion of the valve assembly that sits on an endoscope port can prevent air or water leaks and provide a tight fit. In some embodiments, useful lubricants that can be used with the disposable valve assemblies discussed in this disclosure comprise silicone based lubricants, non-silicone based lubricants and/or a combination thereof. [00188] In some embodiments, lubricant 1000 comprises an oil lubricant. The oil lubricant can be polydimethyl siloxane, polytrifluoropropylmethyl siloxane, or a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane. The viscosity of the oil lubricant can be from about 20 cp to about 1,000,000 cp. In some embodiments, a solvent is added to the oil lubricant with very high viscosity to facilitate application of the antimicrobial lubricant onto the disposable valve assemblies for use with an endoscope described in this disclosure.

[00189] For example, silicone based lubricants comprise Dow Corning ®4 electrical insulating compound, Dow Corning® 360 medical fluid, Dow Corning® 245 fluid or 345 fluid. Other silicone based lubricants can include other components, for example, diisopropyl adipate, purcellin oil, glycerol tribehenate, silicone oil, a surfactant, sorbitan monooleate, and sorbitan trioleate.

[00190] A suitable lubricant is a silicone oil or a mixture thereof having a molecular weight of about 20,000 to 60,000, preferably about 35,000 to 45,000. In certain embodiments, lubricants are polydialkylsiloxanes of general structure I:

wherein each of R and R' may be independently a lower alkyl of 1 to 20 carbon atoms, preferably 1 to 8 carbon atoms, or may be joined into a silicone containing ring of 5 to 8 carbon atoms, and n may be an integer from 1 to 2000, in some embodiments, 1 to 800. In other embodiments, the lubricants of structure I have viscosities of from about 10 to 1,000,000, in yet other embodiments, about 100 to 20,000 centistokes. In one embodiment, the lubricant is Dow Corning DC-360® silicone oil of 12,500 centistokes viscosity.

[00191] In other embodiments, another useful formulation of the silicone oil solution for the disposable valve assemblies described in this disclosure uses approximately 1500 to 3500 grams, preferably between about 2000 to 2,500 grams, of volatile solvent methylsiloxane (available as Dow Corning® OS- 10) in combination with approximately 150 to 400 grams, preferably between about 200 to 300 grams, of a not as volatile solvent solution that contains about 30% polydimethylsiloxane copolymers dispersed in xylene (sold under the trade name MED-4162 by the NuSil Technology Company). The OS- 10 solvent and the MED-4162 solvent solution are combined by a spinning or mixing process using any one of a number of

conventional mixing machines known in the field. For this formulation, the spinning or mixing process continues for a given time period, for example from a minimum of 10 minutes to about 30 minutes. In one particular practice of this formulation, an acceptable silicone oil solution was made by spinning or mixing about 2,262 grams of OS-10 with about 250 grams of MED-4162 for approximately 10 minutes.

[00192] In some embodiments, the disposable valve assemblies described in this disclosure may be dipped into a solvent solution of chlorhexidine and a silicone lubricant whereby a layer of chlorhexidine and lubricant is applied to the surface of the article. An effective coating of chlorhexidine may be obtained when the solvent solution contains from about 0.02 to 5%, in other embodiments, from about 0.1 to 3.0% of chlorhexidine and from about 0.1 to about 8%, or in yet other embodiments, from about 1% to 4% (w/v) of silicone.

[00193] In other embodiments, non-silicone based lubricants include, without limitation, a water soluble lubricant, an insoluble lubricant, a viscous gel lubricant, a solid lubricant or a combination thereof. Water soluble lubricants include, without limitation, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, and derivatives thereof.

[00194] In some embodiments, lubricant 1000 comprises at least one of a water soluble lubricant, an insoluble lubricant, a viscous gel lubricant, a solid lubricant and a shapeable lubricant.

[00195] Lubricant 1000 with or without an antimicrobial agent may be applied to outer surface of disposable valve assemblies 100, 500, 1100 as illustrated in FIGS. 1, 9A and 19A by dipping, brushing, spraying, or any other compatible techniques known to one of skill in the art.

[00196] In some embodiments, the layer of lubricant 1000 on the disposable valve assemblies described in this disclosure is uniform and can, for example, have a thickness of from about one micrometer to about five micrometers.

[00197] In various embodiments, lubricant 1000 generally comprises an antimicrobial or biocidal agent effective against various forms and strains of bacteria which may cause infection within a patient. The terms "biocidal agent" or "biocide," as used herein refer to an agent that destroys, inhibits and/or prevents the propagation, growth, colonization and multiplication of unwanted organisms. The term "organism" includes, but is not limited to, microorganisms, bacteria, undulating bacteria, spirochetes, spores, spore-forming organisms, gram-negative organisms, gram- positive organisms, yeasts, fungi, molds, viruses, aerobic organisms, anaerobic organisms and mycobacteria. Specific examples of such organisms include the fungi Aspergillus niger, Aspergillus flavus, Rhizopus nigricans, Cladosprorium herbarium, Epidermophyton floccosum, Trichophyton mentagrophytes, Histoplasma capsulatum, and the like; bacteria such as Pseudomanas aeruginosa, Escherichia coli, Proteus vulgaris, Staphylococcus aureus, Staphylococcus epidermis, Streptococcus faecalis, Klebsiella, Enterobacter aewgenes, Proteus mirabilis, other gram-negative bacteria and other gram-positive bacteria, mycobactin and the like; and yeast such as Saccharomcyces cerevisiae, Candida albicans, and the like. Additionally, spores of microorganisms, viruses and the like are organisms within the scope of the present disclosure.

[00198] Antimicrobial or biocide agents suitable for use in the present invention include, but are not limited to phenol, quaternary ammonium, guanidine, taurolidine,

parachlorometaxylenol, silver sulfadiazine, silver oxide, silver nitrate, pyridinium, benzalkonium chloride, cetrimide, benethonium chloride, cetylpyridinium chloride, dequalinium acetate, dequalinium chloride, and chloroxylenol. Further, in some embodiments lubricant 1000 comprises a microbial agent selected from chlorhexidine base, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine hydrochloride, chlorhexidine dihydrochloride,

dibromopropamidine, halogenated diphenylalkanes, carbanilide, salicylanilide,

tetrachlorosalicylanilide, trichlorocarbanilide, and mixtures thereof. Still further, in some embodiments lubricant 1000 comprises a microbial agent selected from chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chloroxylenol, dequalinium chloride, benzethonium chloride, benzalkonium chloride, and combinations thereof. The antimicrobial agent can be solid particles that are insoluble in the lubricant or in liquid form. The antimicrobial agent is well mixed within a lubricant prior to application to the disposable valve assembly.

[00199] In some embodiments, lubricant 1000 comprises one or more antimicrobial agents in an amount from about 0.01, 0.015, 0.020, 0.025, 0.030, 0.035, 0.040, 0.045, 0.050, 0.055, 0.060, 0.065, 0.070, 0.075, 0.080, 0.085, 0.090, 0.095, 0.10, 0.15, 0.20, 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5% (w/v) to about 10.0% (w/v) of lubricant 1000. In other embodiments, lubricant 1000 comprises one or more antimicrobial agents in an amount from about 0.001, 0.0015, 0.0020, 0.0025, 0.0030, 0.0035, 0.0040, 0.0045, 0.0050, 0.0055, 0.0060, 0.0065, 0.0070, 0.0075, 0.0080, 0.0085, 0.0090, 0.0095, 0.010, 0.015, 0.020, 0.025, 0.030, 0.035, 0.040, 0.045, 0.050, 0.055, 0.060, 0.065, 0.070, 0.075, 0.080, 0.085, 0.090, 0.095, 0.10, 0.15, 0.20, 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5% (w/v) to about 5.0% (w/v) of lubricant 1000. Further, in some embodiments lubricant 1000 comprises one or more antimicrobial agents in an amount from about 0.01% to about 10.0% (w/v).

[00200] In some embodiments, lubricant 1000 further comprises one or more fugitive solvents, such as tetrahydrofuran (TUF), methylethylketone (MEK) and hexane solvents. In some embodiments, lubricant 1000 comprises a fugitive solvent in an amount about equal to 70%) (w/v) of lubricant 1000. In other embodiments, lubricant 1000 comprises two or more fugitive solvents.

[00201] In other embodiments, lubricant 1000 comprises one or more alcohol components.

Suitable alcohol components generally include a lower alcohol having between one and six carbons (Ci-C₆). In some embodiments, lubricant 1000 comprises an alcohol component selected from the group consisting of ethyl alcohol, isopropanol, propanol, and butanol. In other embodiments, lubricant 1000 comprises two or more lower alcohol components, for example a mixture of isopropyl alcohol and ethyl alcohol in a ratio of about 1 : 10 to about 1 : 1. Further, in some embodiments lubricant 1000 comprises a mixture of more than two alcohol components.

[00202] In some embodiments, lubricant 1000 comprises an alcohol component in an amount about equal to 40%> (w/v) of lubricant 1000. In other embodiments, lubricant 1000 comprises an alcohol component in an amount from about 20%>, 25%>, 30%>, 35%>, 40%>, 45%>, 50%, 55%, 60%, 65% 70%, 75%, 80%, 85%, 90% (w/v) to about 95% (w/v). In yet other embodiments, antimicrobial lubricant 1000 further comprises a lubricant, such as silicone oil.

[00203] In various embodiments, non-silicone lubricants useful to cover the valves described in this disclosure include hydrophilic polymer coatings, Teflon (PTFE) lubricants and coatings, thermoplastic coatings, cyanoacrylate coatings, Parylene coatings, plasma surface treatments, cornstarch powder coatings liquid soaps, Astroglide lubricants, mineral oil, glycerin, alcohol, saline, Krytox lubricants, molybdenum disulfide lubricants and graphite. Antimicrobial Agents

[00204] It has been unexpectedly found that the application of lubricant containing an antimicrobial agent to the surface or a portion of the disposable valve assemblies for use with an endoscope described in this disclosure can prevent or substantially eliminate the growth of harmful bacteria, fungi and the like present or growing in the colon or any other body part accessible during an endoscopic procedure. In particular, activating the lens-rinsing function can distribute the antimicrobial agent by itself or contained in a lubricant along the endoscope channel, along the lens and has the ability of destroying harmful bacteria and/or fungi that may form in the endoscope channel, the lens and other ancillary components of the endoscope, for example the disposable valve assemblies.

[00205] Referring to the disposable valve assemblies described in this disclosure, an antimicrobial agent by itself or with a lubricant can be applied to any component of the disposable valve assembly. For example, it can be part of the material of the disposable valve, or applied to the disposable valve assembly by hand or machine spraying or coating. In particular, the antimicrobial agent can be applied to the stem, the spring stanchion and/or the spring.

[00206] In various embodiments, the antimicrobial agent useful for this disclosure comprises, essentially consists of or consists of an antibiotic, an antiviral agent, an antifungal agent, an antiseptic, a disinfectant or combination thereof. In some embodiments of this disclosure the lubricant comprises an antimicrobial agent. In other embodiments, the

thermoplastic material comprises the antimicrobial agent and in yet other embodiments, the thermoplastic material has an antimicrobial agent coated thereon. In various embodiments, the antimicrobial agent is an antibacterial agent. While any antibacterial agent may be used with lubricants, the thermoplastic material or coatings covering the thermoplastic material, some non- limiting exemplary antibacterial agent(s) include those classified as aminoglycosides, beta lactams, quinolones or fluoroquinolones, macrolides, sulfonamides, sulfamethaxozoles, tetracyclines, streptogramins, oxazolidinones (such as linezolid), clindamycins, lincomycins, rifamycins, glycopeptides, polymyxins, lipopeptide antibiotics, as well as pharmacologically acceptable sodium salts, pharmacologically acceptable calcium salts, pharmacologically acceptable potassium salts, lipid formulations, derivatives and/or analogs of the above.

[00207] Each of these classes of antibacterial agents have different mechanisms of action and are represented by several antibiotics a discussion of which is presented below. However, the skilled artisan will recognize that the invention is in no way limited to the agents set forth here and that these agents are described merely as examples.

[00208] The aminoglycosides are bactericidal antibiotics that bind to the 30S ribosome and inhibit bacterial protein synthesis. They are typically active against aerobic gram-negative bacilli and staphylococci. Exemplary aminoglycosides that may be used in some specific aspects of the invention include amikacin, kanamycin, gentamicin, tobramycin, or netilmicin.

[00209] Beta lactams are a class of antibacterials that inhibit bacterial cell wall synthesis. A majority of the clinically useful beta-lactams belong to either the penicillin group (penam) or cephalosporin (cephem) groups. The beta-lactams also include the carbapenems (e.g., imipenem), and monobactams (e.g., aztreonam). Inhibitors of beta-lactamase such as clavulanic acid and its derivatives are also included in this category.

[00210] Non-limiting examples of the penicillin group of antibiotics that may be used in the solutions of the present invention include amoxicillin, ampicillin, benzathine penicillin G, carbenicillin, cloxacillin, dicloxacillin, piperacillin, or ticarcillin. Examples of cephalosporins include ceftiofur, ceftiofur sodium, cefazolin, cefaclor, ceftibuten, ceftizoxime, cefoperazone, cefuroxime, cefprozil, ceftazidime, cefotaxime, cefadroxil, cephalexin, cefamandole, cefepime, cefdinir, cefriaxone, cefixime, cefpodoximeproxetil, cephapirin, cefoxitin, cefotetan. Other examples of beta lactams include mipenem or meropenem which are extremely active parenteral antibiotics with a spectrum against almost all gram-positive and gram-negative organisms, both aerobic and anaerobic and to which Enterococci, B. fragilis, and P. aeruginosa are particularly susceptible.

[00211] Examples of beta lactamase inhibitors include clavulanate, sulbactam, or tazobactam. In some aspects of the present invention, the antibacterial solutions may comprise a combination of at least one beta lactam and at least one beta lactamase inhibitor.

[00212] Macrolide antibiotics are another class of bacteriostatic agents that bind to the 50S subunit of ribosomes and inhibit bacterial protein synthesis. These drugs are active against aerobic and anaerobic gram-positive cocci, with the exception of enterococci, and against gram- negative anaerobes. Exemplary macrolides include erythromycin, azithromycin, clarithromycin.

[00213] Quinolones and fluoroquinolones typically function by their ability to inhibit the activity of DNA gyrase. Examples include nalidixic acid, cinoxacin, trovafloxacin, ofloxacin, levofloxacin, grepafloxacin, trovafloxacin, sparfloxacin, norfloxacin, ciprofloxacin, moxifloxacin and gatifloxacin.

[00214] Sulfonamides are synthetic bacteriostatic antibiotics with a wide spectrum against most gram-positive and many gram-negative organisms. These drugs inhibit multiplication of bacteria by acting as competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle. Examples include mafenide, sulfisoxazole, sulfamethoxazole, and sulfadiazine.

[00215] The tetracycline group of antibiotics include tetracycline derivatives such as tigecycline, minocycline, doxycycline or demeclocycline and analogs such as

anhydrotetracycline, chlorotetracycline, or epioxytetracycline. The present inventors have previously shown that minocycline has a higher penetration of the microbial biofilm layer than vancomycin and that EDTA is unique in effectively preventing and dissolving polysaccharide- rich microbial glycocalyx.

[00216] The streptogramin class of antibacterial agents is exemplified by quinupristin, dalfopristin or the combination of two streptogramins. Drugs of the rifamycin class typically inhibit DNA-dependent RNA polymerase, leading to suppression of RNA synthesis and have a very broad spectrum of activity against most gram-positive and gram-negative bacteria including Pseudomonas aeruginosa and Mycobacterium species. An exemplary rifamycin is rifampicin.

[00217] Other antibacterial drugs are glycopeptides such as vancomycin, teicoplanin and derivatives thereof. Yet other antibacterial drugs are the polymyxins which are exemplified by colistin.

[00218] In addition to these several other antibacterial agents such as prestinomycin, chloramphenicol, trimethoprim, fusidic acid, metronidazole, bacitracin, spectinomycin, nitrofurantion, daptomycin or other leptopeptides, oritavancin, dalbavancin, ramoplamin, ketolide etc. may be used in preparing the compositions described herein. Of these,

metronidazole is active only against protozoa, such as Giardia lamblia, Entamoeba histolytica and Trichomonas vaginalis, and strictly anaerobic bacteria. Spectinomycin, is a bacteriostatic antibiotic that binds to the 30S subunit of the ribosome, thus inhibiting bacterial protein synthesis and nitrofurantoin is used orally for the treatment or prophylaxis of UTI as it is active against Escherichia coli, Klebsiella-Enterobacter species, staphylococci, and enterococci.

[00219] In other embodiments, the antimicrobial agent is an antifungal agent. Some exemplary classes of antifungal agents include imidazoles or triazoles such as clotrimazole, miconazole, ketoconazole, econazole, butoconazole, omoconazole, oxiconazole, terconazole, itraconazole, fluconazole, voriconazole, posaconazole, ravuconazole or flutrimazole; the polyene antifungals such as amphotericin B, liposomal amphoterecin B, natamycin, nystatin and nystatin lipid formulation; the cell wall active cyclic lipopeptide antifungals, including the echinocandins such as caspofungin, micafungin, anidulfungin, cilofungin; LY121019; LY303366; the allylamine group of antifungals such as terbinafine. Yet other non-limiting examples of antifungal agents include naftifine, tolnaftate, mediocidin, candicidin, trichomycin, hamycin, aurefungin, ascosin, ayfattin, azacolutin, trichomycin, levorin, heptamycin, candimycin, griseofulvin, BF-796, MTCH 24, BTG-137586, pradimicins (MNS 18184), benanomicin;

ambisome; nikkomycin Z; flucytosine, or perimycin.

[00220] In still other embodiments of the invention, the antimicrobial agent is an antiviral agent. Non-limiting examples of antiviral agents include cidofovir, amantadine, rimantadine, acyclovir, gancyclovir, pencyclovir, famciclovir, foscarnet, ribavirin, or valcyclovir. In some embodiments the antimicrobial agent is an innate immune peptide or proteins. Some exemplary classes of innate peptides or proteins are transferrins, lactoferrins, defensins, phospholipases, lysozyme, cathelicidins, serprocidins, bactericidal permeability increasing proteins, amphipathic alpha helical peptides, and other synthetic antimicrobial proteins.

[00221] In other embodiments of the invention, the antimicrobial agent is an antiseptic agent. Several antiseptic agents are known in the art and these include a taurinamide derivative, a phenol, a quaternary ammonium surfactant, a chlorine-containing agent, a quinaldinium, a lactone, a dye, a thiosemicarbazone, a quinone, a carbamate, urea, salicylamide, carbanilide, a guanide, an amidine, an imidazoline biocide, acetic acid, benzoic acid, sorbic acid, propionic acid, boric acid, dehydroacetic acid, sulfurous acid, vanillic acid, esters of p-hydroxybenzoic acid, isopropanol, propylene glycol, benzyl alcohol, chlorobutanol, phenylethyl alcohol, 2- bromo-2-nitropropan-l,3-diol, formaldehyde, glutaraldehyde, calcium hypochlorite, potassium hypochlorite, sodium hypochlorite, iodine (in various solvents), povidone-iodine,

hexamethylenetetramine, noxythiolin, l-(3-choroallyl)-3,5,7-triazo 1-azoniaadamantane chloride, taurolidine, taurultam, N(5-nitro-2-furfurylidene)-l-amino-hydantoin, 5-nitro-2- furaldehyde semicarbazone, 3,4,4'-trichlorocarbanilide, 3,4',5-tribromosalicylanilide, 3- trifluoromethyl-4,4'-dichlorocarbanilide, 8-hydroxyquinoline, l-cyclopropyl-6-fluoro-l,4- dihydro-4-oxo-7-(l-piperazinyl)-3-quinolinecarboxylic acid, l,4-dihydro-l-ethyl-6-fluoro-4-oxo- 7-(l-piperazinyl)-3-quinolinecarboxylic acid, hydrogen peroxide, peracetic acid, phenol, sodium oxychlorosene, parachlorometaxylenol, 2,4,4'-trichloro-2'-hydroxydiphenol, thymol,

chlorhexidine, benzalkonium chloride, cetylpyridinium chloride, silver sulfadiazine, or silver nitrate. In some embodiments, a useful antiseptic that can be used with the disposable valve assemblies configured for use with an endoscope include silver halides, for example, silver iodide and silver chloride colloidal compositions. In some embodiments, some antiseptics contain silver in the presence of protein. For example, some mild silver protein antiseptics contain from about 19% to about 23% silver weight by weight. In some embodiments,

Argyrol®, a mild protein antiseptic containing 30% silver weight by weight can be used with the disposable valve assemblies described in this disclosure. Other strong silver protein antiseptics contain from about 7.5% to about 8.5% silver weight by weight.

[00222] In some embodiments, a composition that includes an antiseptic agent may be applied to the surface by any method known to those of ordinary skill in the art. For example, if the surface is a surface of a disposable valve assembly as described in this disclosure, the disposable valve assembly may be immersed in the composition, or the composition may be painted or sprayed onto the device. In some embodiments, the coating composition may include a dye. The self-impregnating property of the dyes such as, for example, the triarylmethane dyes, removes the need for another binding agent.

[00223] For example, in one embodiment, one method of coating the disposable valve assembly first requires application or absorption of a layer of surfactant, such as

tridodecylmethyl ammonium chloride (TDMAC) followed by the antibiotic coating layer, to the surface of the disposable valve assembly. Another method used to coat surfaces of the disposable valve assembly with antibiotics involves first coating the selected surfaces with benzalkonium chloride followed by ionic bonding of the antibiotic composition (Solomon and Sherertz, 1987; U.S. Pat. No. 4,442,133). Other methods of coating surfaces of medical devices with antibiotics are taught in U.S. Pat. No. 4,895,566 (a medical device substrate carrying a negatively charged group having a pH of less than 6 and a cationic antibiotic bound to the negatively charged group); U.S. Pat. No. 4,917,686 (antibiotics are dissolved in a swelling agent which is absorbed into the matrix of the surface material of the medical device); U.S. Pat. No. 4, 107,121 (constructing the medical device with ionogenic hydrogels, which thereafter absorb or ionically bind antibiotics); U.S. Pat. No. 5,013,306 (laminating an antibiotic to a polymeric surface layer of a medical device); and U.S. Pat. No. 4,952,419 (applying a film of silicone oil to the surface of an implant and then contacting the silicone film bearing surface with antibiotic powders).

[00224] In certain embodiments, antiseptic derivative compounds with broad-spectrum antiseptic activity against bacteria and fungi including nosocomial and multidrug-resistant varieties may be used to impregnate, bind, coat, adhere and/or attach to various device surfaces without the assistance of impregnating vehicles such as tridodecylmethylammonium chloride (TDM AC).

[00225] In some embodiments, one example of a broad-spectrum antiseptic is a composition that includes a combination of gentian violet and chlorhexidine ("Gendine").

Gentian violet, on its own, is a good impregnating triarylmethane dye. However, after impregnating the surfaces of various polymers, including polyvinylchloride, gentian violet on its own has no activity against Pseudomonas aeruginosa, which is the second most common cause of nosocomial pneumonia and the third most common cause of nosocomial urinary tract infections. Compositions with antiseptic properties that are specifically contemplated for use in this application include, but are not limited to Gendine, Genlenol and Genfoctol.

[00226] In some embodiments, the antimicrobial agent that can be used with the disposable valve assemblies described in this disclosure are present in an amount from at least 0.01% (w/v) to about 5.0%.

[00227] The above antimicrobials can be delivered in solvents. Non-limiting examples of a solvent as used herein may be an aqueous solvent or a nonaqueous solvent. In particular embodiments, the solvent is inert in that it has no ability to alter or modify the chemical structure of the antimicrobial agent. Nonlimiting examples of solvents include water, methylene chloride, alcohols (such as methanol and ethanol), ketones (such as acetone, methylethylketone), esters (such as tetrahydrofuran), aldehydes (such as formaldehyde), acetonitrile, acetic acid, methylene chloride, chloroform, butyl acetate, or a combination thereof. In some embodiments, the solvent is a dipolar aprotic solvent, such as dimethylsulfoxide or Ν,Ν-dimethylformamide. The solvent may also be a protic solvent or an aprotic solvent.

[00228] Implementations described herein are included to demonstrate particular aspects of the present disclosure. It should be appreciated by those of skill in the art that the

implementations described herein merely represent exemplary implementation of the disclosure. Those of ordinary skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific implementations described and still obtain a like or similar result without departing from the spirit and scope of the present disclosure. From the foregoing description, one of ordinary skill in the art can easily ascertain the essential characteristics of this disclosure, and without departing from the spirit and scope thereof, can make various changes and modifications to adapt the disclosure to various usages and conditions. The implementations described hereinabove are meant to be illustrative only and should not be taken as limiting of the scope of the disclosure, which is defined in the following claims.

[00229] From the foregoing description, one of ordinary skill in the art can easily ascertain the essential characteristics of this disclosure, and without departing from the spirit and scope thereof, can make various changes and modifications to adapt the disclosure to various usages and conditions. The implementations described hereinabove are meant to be illustrative only and should not be taken as limiting of the scope of the disclosure, which is defined in the following claims.

Claims

WHAT IS CLAIMED IS:

1. A disposable valve assembly configured for use with an endoscope, the disposable valve assembly comprising: a stem comprising a first opening disposed along a longitudinal axis of the stem, the stem comprising a thermoplastic material; a spring stanchion; the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and a lubricant disposed on the stem, spring stanchion and/or the spring.

2. A disposable valve assembly according to claim 1, wherein (i) the lubricant comprises an antimicrobial agent; (ii) the thermoplastic material comprises an antimicrobial agent; and/or (iii) the thermoplastic material has an antimicrobial agent coated thereon.

3. A disposable valve assembly of claim 2, wherein (i) the lubricant comprises silicone- based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.

4. A disposable valve assembly configured for use with an endoscope, the disposable valve assembly comprising: a stem comprising a first opening disposed along a longitudinal axis of the stem, the stem comprising a thermoplastic material; a spring stanchion; the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and an antimicrobial agent disposed on the stem, spring stanchion and/or the spring.

5. A disposable valve assembly according to claim 4, wherein (i) the disposable valve assembly comprises a lubricant disposed on the stem, spring stanchion and/or the spring; or (ii) the disposable valve assembly comprises a lubricant disposed on the stem, spring stanchion and/or the spring, the lubricant comprising an antimicrobial agent.

6. A disposable valve assembly of claim 5, wherein (i) the lubricant comprises silicone- based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.

7. A disposable suction valve assembly comprising: a stem comprising a thermoplastic material, the stem comprising a first opening disposed along a longitudinal axis of the stem, and a second opening disposed transverse to the first opening, the first and second openings configured for allowing passage of air and/or fluid; a spring stanchion comprising at least one recess and/or projection configured to attach to the stem; the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and a lubricant disposed on the stem, spring stanchion and/or the spring or the thermoplastic material comprises an antimicrobial.

8. A disposable suction valve assembly according to claim 7, wherein the lubricant comprises an antimicrobial agent.

9. A disposable valve assembly of claim 8, wherein (i) the lubricant comprises a silicone- based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.

10. A disposable suction valve assembly comprising: a stem comprising a thermoplastic material, the stem comprising a first opening disposed along a longitudinal axis of the stem, and a second opening disposed transverse to the first opening, the second opening intersecting with the first opening for allowing passage of air and/or fluid; a spring stanchion comprising at least one recess and/or projection configured to attach to the stem; the spring stanchion comprising an opening configured to receive the stem and allow movement of the stem in an upward and downward position relative to the spring stanchion; a spring configured to contact the spring stanchion and the stem; and a lubricant disposed on the stem, spring stanchion and/or the spring or the thermoplastic material comprises an antimicrobial agent.

11. A disposable suction valve assembly according to claim 10, wherein the lubricant comprises an antimicrobial agent.

12. A disposable valve assembly of claim 10, wherein (i) the lubricant comprises a silicone- based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.

13. A disposable air/water valve assembly comprising: a main stem comprising thermoplastic material, the main stem having a proximal end, the main stem comprising a plurality of ridges and grooves disposed circumferentially about the main stem, the plurality of ridges and grooves being monolithic with the main stem and the main stem comprising a first opening disposed at the proximal end and running along a longitudinal axis of the main stem, and a second opening disposed transverse to the first opening, the first and second openings for allowing passage of air and/or fluid through at least a portion of the main stem; a retaining ring disposed adjacent to the main stem and configured to engage a spring; and (i) a lubricant disposed on the main stem, the retaining ring and/or the spring or (ii) the thermoplastic material comprises an antimicrobial.

14. A disposable air/water valve assembly according to claim 13, wherein the lubricant comprising an antimicrobial agent.

15. A disposable air/water valve assembly of claim 14, wherein (i) the lubricant comprises a silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.

16. A disposable air/water valve assembly comprising: a main stem comprising thermoplastic material, the main stem having a proximal end, the main stem comprising a plurality of ridges and grooves disposed circumferentially about the main stem, the plurality of ridges and grooves being monolithic with the main stem and the main stem comprising an opening disposed at the proximal end and running along a longitudinal axis of the main stem, the opening for allowing passage of air and/or fluid through at least a portion of the main stem, and (i) a lubricant disposed on the stem, retaining ring and/or the spring or (ii) the thermoplastic material comprises an antimicrobial agent.

17. A disposable air/water valve assembly according to claim 16, wherein the lubricant comprises an antimicrobial agent.

18. A disposable air/water valve assembly of claim 17, wherein (i) the lubricant comprises silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.

19. A method for manufacturing a disposable valve configured for use with an endoscope, the method comprising: molding a stem optionally in the presence of an antimicrobial; molding a spring stanchion; placing a bottom end of the stem through a center of a spring; placing the bottom end of the stem through a stem opening in the spring stanchion; and applying a lubricant onto the stem, spring, and/or spring stanchion.

20. A method of claim 19, further comprising placing tabs of the spring stanchion into recessed apertures of the stem, and over-molding a boot on the spring stanchion or over-molding a boot onto the spring stanchion.

21. A method of claim 20, wherein (i) the stem is color coded or (ii) a sealing ledge on the boot creates a seal against a button head of the stem; (iii) the stem provides an O-ring or an alternate sealing device to assure an air-tight seal within a suction port or (iv) the stem provides a sealing means to assure an air-tight seal within a suction port or the stem; (v) the stem has a diameter that assures an air-tight seal within a suction port; (vi) the length of the stem is reduced or (vii) the lubricant comprises an antimicrobial agent.

22. A method for manufacturing a disposable valve configured for use with an endoscope, the method comprising: molding a main stem optionally in the presence of an antimicrobial; overmolding at least one seal onto the main stem; molding a retaining ring; molding a button cap; placing a back end of the stem through a center of the retaining ring and a resilient member; and placing the button cap on the stem; and securing the button cap to the main stem; placing a lubricant onto the valve; and applying a lubricant onto the main stem, resilient member, and/or retaining ring.

23. A method according to claim 22, wherein the lubricant comprises an antimicrobial agent.

24. A method of claim 22, wherein (i) the main stem is color coded and the resilient member is a spring; (ii) the button cap is ultrasonically welded or otherwise attached to the stem; or (iii) the button cap centers the resilient member.

25. A method of claim 22, further comprising the step of placing the retaining ring in a second mold, wherein a boot is over-molded onto the retaining ring.

26. A disposable valve assembly configured for use in a biopsy port of an endoscope, the disposable valve assembly comprising: a body having an opening at a proximal end of the body and an opening at a distal end of the body; a lid configured to cover the opening at the proximal end of the body; a connector contacting the body for connecting the body to the lid; and a lubricant disposed on the body, the lid and/or the connector, wherein the disposable valve assembly is made from thermoplastic material and (i) a lubricant is disposed on the body, lid and/or connector where the lubricant may optionally be antimicrobial or (ii) the thermoplastic material comprises an antimicrobial agent.

27. A disposable valve assembly of claims 1-18 and 26, wherein the disposable valve assembly is suitable for use with an endoscope.

28. A method for manufacturing a disposable valve according to claims 19-25, wherein the disposable valve is used in an endoscope to perform an endoscopy.