Biological indicators for liquid chemical disinfection systems

Abstract

Disclosed herein are biological indicators suitable for use in liquid chemical disinfection processes that can be performed by an automated endoscope reprocessor. The biological indicator can include one or more ports for introducing and removing liquid chemical disinfectants therefrom. The biological indicator can include features that can aid in the transfer of the liquid chemical disinfectant, such as a ramp leading to a port opening or a pipette. The system can additionally include a holder having features that facilitate use of the system and the biological indicator.

Description

Technical Field

[0001] The subject matter disclosed herein relates to apparatus and techniques for evaluating the adequacy of liquid chemical sterilization procedures, particularly as applied to endoscope sterilization. Background Art

[0002] Medical devices are typically sterilized prior to use to minimize the possibility of administering a contaminated instrument to a subject, which could result in infection. Various sterilization techniques, such as steam, hydrogen peroxide, and vapor phase sterilization, can be employed with or without the use of gas plasma and ethylene oxide (EtO).

[0003] Some sterilization technologies operate at pressures other than ambient or atmospheric pressure. For example, STERRAD, a division of Advanced Sterilization Products, a division of Ethicon US, LLC, a subsidiary of Johnson & Johnson, ® System、STERRAD ® NX System or STERRAD ® The 100NX System is an example of a sterilization system or sterilizer that vaporizes hydrogen peroxide and operates at low pressure (eg, less than 200 mTorr).

[0004] For various reasons, various elongated medical devices having lumens, such as endoscopes, are difficult to sterilize using steam sterilizers (e.g., vaporized hydrogen peroxide). For example, because the pressure in the lumen decreases as a function of length and diameter from the entrance of the lumen, the pressure drop must be overcome to ensure that the sterilant passes through the entire lumen and reaches all surfaces of the lumen. In addition, the lumen may collect debris or become clogged with fluids such as flushing water.

[0005] Steam-based sterilization procedures often include sterilization indicators, such as biological or chemical indicators, that can provide an indication of the effectiveness of the sterilization cycle. Although such indicators can be positioned close to the endoscope in the sterilization chamber, they can be unreliable for assessing the sterility of the endoscope because the most difficult parts of the endoscope to sterilize are often deep within the lumen of the endoscope. Summary of the Invention

[0006] Disclosed herein is a biological indicator suitable for use in a liquid chemical disinfection process. The biological indicator may include a vial and a cap disposed on top of the vial. A first port (or vial port) may be disposed through the base of the vial, and a second port (or cap port) may be disposed through the cap. An exhaust port may also be disposed through the cap. The cap may additionally include wings extending therefrom.

[0007] A first valve may be provided in the first port, and a second valve may be provided in the second port.In addition, a carrier impregnated with the microorganism may be provided in the vial.

[0008] The first port may include an opening disposed within the vial, and the bottom portion of the vial may include a slope directed toward the opening. In such an embodiment, the carrier may be disposed above the opening and in contact with the slope. Additionally, the carrier may include a gap disposed therethrough.

[0009] A pipette can be connected to a port in the cap. Where a pipette is included, the vial may optionally not include a vial port. Thus, the pipette can include a first end connected to the cap port and a second end disposed proximate the base of the vial.

[0010] The biological indicator can also include an ampoule containing growth medium at least partially disposed within the vial. An insert can be disposed in the vial to contact or support the ampoule. The ampoule can include an irregular cross-sectional shape such that the pipette can be disposed in a recess defined by the irregular cross-sectional shape.

[0011] A liquid chemical disinfection system is also described herein. The system may include a biological indicator having a housing defining an interior and including a first port having a first valve and a second port having a second valve. A divider may be disposed within the interior between the first port and the second port to define two chambers. A carrier impregnated with microorganisms may be disposed in one of the two chambers. The system may also include a source of liquid chemical disinfectant and a first fluid delivery component connected to the source of liquid chemical disinfectant. The system may also include a holder having at least one slot configured to contain the biological indicator and at least a third port connected to the first fluid delivery component. The third port may be located at the base of the slot to mate with the first port. The holder may also include a fourth port disposed at the base of the slot. The fourth port may be positioned to mate with the second port. The holder may also include a window so that the biological indicator is visible through the window when disposed in the slot. The holder may also be connected to a disinfection tray disposed within the disinfection chamber. A manifold may be connected to the disinfection tray so that the holder can be connected to the manifold. Furthermore, the first fluid delivery component may be connected to the manifold so that the manifold can be connected to the third port. The system can also include a second fluid delivery component connected to the manifold and at least partially disposed in the sterilization tray. Thus, the second fluid delivery component can be connected to a lumen of an instrument (e.g., an endoscope) disposed in the sterilization tray. So configured, during a sterilization cycle, the interior of the biological indicator can contain a liquid chemical disinfectant that has previously flowed through the endoscope.

[0012] In another embodiment, a retainer can be provided on an outer surface of the disinfection system. Such a retainer can also include a display screen. It can also include four or more slots for holding biological indicators. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] While the specification concludes with claims which particularly point out and distinctly claim the subject matter described herein, it is believed the same will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings in which like reference numerals represent the same elements, and wherein:

[0014] Figure 1 depicts a side cross-sectional view of a first biological indicator suitable for use in a liquid chemical disinfection process;

[0015] Figure 2 depicts a side cross-sectional view of a second biological indicator suitable for use in a liquid chemical disinfection process;

[0016] Figure 3 Depicts Figure 2 A top cross-sectional view of a biological indicator;

[0017] Figure 4 depicts a side cross-sectional view of a third biological indicator suitable for use in a liquid chemical disinfection process;

[0018] Figure 5 Schematic diagram depicting a liquid chemical disinfection system in an open configuration, including a Figure 4 Characteristics of biological indicators;

[0019] Figure 6 yes Figure 5 A close-up view of a portion of a device showing alignment with a slot in a holder for receiving a biological indicator Figure 4 biological indicators;

[0020] Figure 7 Is in a closed structure Figure 5 Schematic diagram of a liquid chemical disinfection system;

[0021] Figure 8 is a schematic diagram of another liquid chemical disinfection system including a reading device;

[0022] Figure 9 yes Figure 8 A close-up view of the reading device;

[0023] Figure 10A is a schematic diagram of a fourth biological indicator adjacent to a filling mechanism prior to filling;

[0024] Figure 10Bis a schematic diagram of a fourth biological indicator adjacent to the filling mechanism during filling; and

[0025] Figure 11 A side cross-sectional view of a fourth biological indicator suitable for use in a liquid chemical sterilization process is depicted. DETAILED DESCRIPTION

[0026] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different figures are labeled the same. The drawings, which are not necessarily drawn to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not limitation. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently believed to be the best mode for carrying out the invention.

[0027] As used herein, the terms "about" or "approximately" for any numerical values ​​or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to be used for its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values ​​of ±10% of the stated value, for example, "about 90%" can refer to a range from 81% to 99% of a value. Furthermore, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the present invention in human patients represents a preferred embodiment.

[0028] Automated disinfection equipment and procedures for endoscopes that employ liquid chemical disinfectants, such as hydrogen peroxide or peracetic acid, are being developed to overcome some of the disadvantages associated with using steam chemical disinfectants to disinfect endoscopes. However, as with steam-based processes, developing reliable techniques for assessing whether an endoscope has been sterilized remains a challenge. Furthermore, biological indicators used in steam-based processes are not suitable for use in liquid-based processes because such indicators are designed to remove gaseous, rather than liquid, sterilants. Therefore, it would be advantageous to provide an indicator from which liquids can be easily removed and into which liquids can be easily introduced. Furthermore, indicators for steam-based processes typically require the user to break open an ampoule containing growth medium and transfer the indicator to a device capable of incubating the indicator and detecting changes, such as changes in the color or fluorescence of the growth medium in the indicator. When using liquid chemical disinfectants, precautions should be taken to avoid burns to the user from residual liquid disinfectant remaining on the indicator. Therefore, it would be advantageous to provide a system that can manipulate biological indicators for use with liquid chemical disinfectants without requiring user intervention. Presented herein are devices and methods that can be used to determine whether an endoscope has been sterilized by a sterilization procedure employing a liquid chemical sterilant, which further address these design inputs.

[0029] Figure 1A biological indicator ("BI") 100 for a liquid chemical sterilization process, particularly an automated liquid chemical sterilization process performed by a liquid chemical sterilization apparatus having a chamber in which an instrument, such as a medical device such as an endoscope, can be placed, is shown. BI 100 includes a cap 102, a vial 104, and a carrier 106. Carrier 106 is disposed within vial 104, typically on or near the bottom of vial 104. Cap 102 is disposed on top of vial 104, preferably in a close-fitting relationship such as a friction fit or press fit. For example, cap 102 can have an inner width or inner diameter that is equal to or slightly smaller than the outer width or outer diameter of vial 104. BI 100 also includes at least one port, such as luer ports 108 and 110. As shown, luer port 108 can be integrated into cap 102, while luer port 110 can be integrated through the base of vial 104. Valves (e.g., valve 112 and valve 114) can be incorporated into Luer ports 108 and 110 to help regulate the flow of liquid through the BI (typically flowing in through port 108 and out through port 110) and to prevent accidental removal of liquid therefrom. The valves can further help prevent contaminants from entering the BI 100 after the BI 100 has undergone a sterilization cycle. Valves 112 and 114 can be one-way valves or two-way valves. For example, valve 112 can be a one-way valve, such as a duckbill valve, while valve 114 can be a two-way normally closed check valve that only opens when a force is applied to it by an object inserted from outside the BI. For example, port 112 and valve 114 can be configured as normally closed check valves, such as B. Braun part number 415062, which includes a female Luer port and can open when connected to a male Luer connector. Ports 108 and 110 can additionally extend into the vial 104. For example, port 108 includes a spout or extension 116 that extends deep into vial 104 so that fluid introduced therethrough is forced to flow through carrier 106 while submerging carrier 106. BI 100 may additionally include a vent port, such as port 122 through cap 102, that allows air to escape from the BI when liquid is introduced into the BI. Figure 1 BI 100 is shown in an open or uncompressed configuration. Cap 102 can be depressed relative to vial 104 to place BI 100 in a compressed configuration so that the vent port can become blocked or sealed by the outer wall of vial 104.

[0030] The portion of the port 110 that extends into the vial 104 includes an opening 118. Ideally, the vial 100 does not include any empty space or void below the level of the opening 118, so that when the longitudinal axis of the BI 100 is aligned with the direction of gravity and the valve 114 is open, all of the liquid in the vial 104 can readily flow through the port 110 without any liquid becoming trapped in the vial. Accordingly, a bottom portion 120 of the vial 104 proximate the portion of the port 110 that extends into the vial can be configured with an inclined surface or ramp 121 that points toward the opening 118, so that any liquid disposed on the ramp will flow out of the vial 104 through the opening 118 and the port 104 when the valve 114 is open. In those embodiments that include the ramp 121, the carrier 106 can be positioned somewhat above the opening 118 to prevent it from blocking the opening 118. Additionally, the carrier 106 may include one or more voids or perforations 107 therethrough to facilitate the flow of liquid therethrough and toward the opening 118 so that the liquid can flow out of the BI 100 when the valve 114 is opened.

[0031] The carrier 106 can be in the form of a disc and contain or be impregnated with a source of microorganisms (e.g., spores or active enzymes). The carrier 106 can be disposed in the vial 104. Spores from Bacillus, Geobacillus, and Clostridium species are commonly used to monitor disinfection processes using chemical disinfectants. Therefore, the carrier 106 can be impregnated with spores from Bacillus, Geobacillus, and / or Clostridium species. For example, spores resistant to disinfection processes can include, but are not limited to, at least one of Geobacillus stearothermophilus spores, Bacillus subtilis spores, Bacillus atrophaeus spores, Bacillus megaterium spores, Bacillus coagulans spores, Clostridium sporogenes spores, Bacillus pumilus spores, and combinations thereof.

[0032] The carrier 106 can be absorbent and can be formed from filter paper. Sheet materials such as cloth, non-woven polypropylene, rayon or nylon, and microporous polymeric materials can also be used. Non-absorbent materials are also suitable for use, such as metal (e.g., aluminum or stainless steel), glass (e.g., glass beads or glass fiber), ceramic or plastic. In addition, the carrier 110 can be composed of a combination of the aforementioned materials. In some embodiments, the carrier 110 can have a thickness of approximately 0.1 to 0.5 mm.

[0033] During use, the carrier 106 becomes immersed in a growth medium. The growth medium can be introduced or flowed into the BI via port 108. Alternatively, as Figures 2 to 3As reflected, the growth medium can be contained in a frangible ampoule 224 so that the user can break the ampoule, which causes the growth medium to submerge the carrier 106. The growth medium should be capable of promoting the growth of any viable microorganisms or other sources of biological activity disposed on the carrier 106. Preferably, the microorganism is selected to produce an enzyme that interacts with an enzyme substrate of the growth medium to produce a change in a visual characteristic of the growth medium, for example, by causing a color change or a change in fluorescence intensity of the growth medium. Continued growth of the microorganism in the growth medium results in an increase in the concentration of a detectable product in the growth medium. In certain embodiments, the detectable product is a fluorophore. Thus, an increase in the concentration of the detectable product results in an increase in fluorescence. That is, the detectable product can be detected by a change in fluorescence intensity.

[0034] Enzymes and enzyme substrates that can be used to detect the efficacy of a sterilization cycle are identified in the following documents: U.S. Patent No. 5,073,488, entitled "Rapid Method for Determining Efficacy of a Sterilization Cycle and Rapid Read-Out Biological Indicator," issued December 17, 1991, the disclosure of which is incorporated herein by reference; U.S. Patent No. 5,418,167, entitled "Rapid Read-Out Biological Indicator," issued May 23, 1995, the disclosure of which is incorporated herein by reference; U.S. Patent No. 5,223,401, entitled "Rapid Read-Out Sterility Indicator," issued June 29, 1993, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,322,046, entitled "Biological Sterilization Cycle and Rapid Read-Out Biological Indicator," issued December 17, 1991, the disclosure of which is incorporated herein by reference; Indicator”, published on April 26, 2016, the disclosure of which is incorporated herein by reference.

[0035] Suitable enzymes can include hydrolases and / or enzymes derived from spore-forming microorganisms such as Bacillus subtilis. Enzymes from spore-forming microorganisms that can be used in exemplary biological indicators can include β-D-glucosidase, α-D-glucosidase, alkaline phosphatase, acid phosphatase, butyrate esterase, octanoate esterase lipase, myristate lipase, leucine aminopeptidase, valine aminopeptidase, chymotrypsin, phosphohydrolase, α-D-galactosidase, β-D-galactosidase, tyrosine aminopeptidase, phenylalanine aminopeptidase, β-D-glucuronidase, α-L-arabinosidase, N-acetyl-β-glucosaminidase, β-D-cellobiosidase, alanine aminopeptidase, proline aminopeptidase, fatty acid esterase, and combinations thereof.

[0036] In some exemplary methods disclosed herein for determining the efficacy of a disinfection cycle, an enzyme substrate is converted into a detectable product. For example, the enzyme substrate can be characterized by a first emission spectrum (e.g., a first fluorescence emission spectrum), and the detectable product can be characterized by a second emission spectrum (e.g., a second fluorescence emission spectrum).

[0037] In some exemplary methods disclosed herein for determining the efficacy of a disinfection cycle, suitable enzyme substrates for use may include fluorescent enzyme substrates. Useful fluorescent enzyme substrates may be selected from the group consisting of fluorescent 4-methylumbelliferyl derivatives (which can be hydrolyzed to 4-methylumbelliferyl ketone ("4-MU"), derivatives of 7-amido-4-methyl-coumarin, diacetylfluorescein derivatives, fluorescamine, and combinations thereof.

[0038] Exemplary 4-methylumbelliferyl derivatives can be selected from the group consisting of: 4-methylumbelliferyl-2-acetamido-4,6-O-benzylidene-2-deoxy-β-D-glucopyranoside, 4-methylumbelliferyl acetate, 4-methylumbelliferyl-N-acetyl-β-D-galactosamine, 4-methylumbelliferyl-N-acetyl-α-D-glucosamine, 4-methylumbelliferyl-N-acetyl-β-D-glucosamine, 2′-(4-methylumbelliferyl)-α-DN-acetylneuraminic acid, 4-methylumbelliferyl-α-L-arabinofuranoside, 4-methylumbelliferyl-α-L-arabinofuranoside, 4-methylumbelliferyl butyrate. Acid ester, 4-methylumbelliferyl-13-D-cellobioside, methylumbelliferyl-β-DN,N′diacetylchitobioside, 4-methylumbelliferyl alacid, 4-methylumbelliferyl-β-D-fucoside, 4-methylumbelliferyl-α-L-fucoside, 4-methylumbelliferyl β-L-fucoside, 4-methylumbelliferyl α-D-galactoside, 4-methylumbelliferyl β-D-galactoside, 4-methylumbelliferyl α-D-glucoside, 4-methylumbelliferyl β-D-glucoside, 4-methylumbelliferyl (3-D-glucuronide), 4-methylumbelliferyl-P-guanidinobenzoic acid hydrochloride, 4-methylumbelliferyl heptanoic acid, 4-Methylumbelliferyl-α-D-mannopyranoside, 4-methylumbelliferyl-β-D-mannopyranoside, 4-methylumbelliferyl oleate, 4-methylumbelliferyl palmitate, 4-methylumbelliferyl phosphate, 4-methylumbelliferyl propionate, 4-methylumbelliferyl stearate, 4-methylumbelliferyl sulfate, 4-methylumbelliferyl-β-DN,N′,N″-triacetylchitotriose glycoside, 4-methylumbelliferyl-2,3,5-tri-o-benzoyl-α-L-arabinofuranoside, 4-methylumbelliferyl-p-trimethylammonium cinnamic acid chloride, 4-methylumbelliferyl-β-D-xyloside and combinations thereof.

[0039] In certain embodiments, the fluorescent response can be based on a naturally occurring α-glucosidase found in the spore coat of Bacillus stearothermophilus, which contains the enzyme and is believed to be important in the germination of Bacillus stearothermophilus. α-glucosidase can be used to hydrolyze the bond between glucose and the 4-methylumbelliferyl moiety of 4-methylumbelliferyl-α-D-glucopyranoside (α-MUG). α-MUG is not fluorescent. However, after partial hydrolysis and separation, the 4-methylumbelliferyl (4-MU) product is fluorescent. When excited by an external energy source (such as a light source emitting light with a wavelength between about 360 and 370 nanometers), 4-MU fluoresces. When so excited, 4-MU emits light with a wavelength between about 440 and 460 nanometers. In certain embodiments, the light source emits light with a wavelength of about 365 nanometers, and 4-MU emits light with a wavelength of 450 nanometers. The fluorescence of 4-MU depends on the pH value. For example, when excited by light of a wavelength of 365 nanometers, the intensity of emitted light is highest at a pH of 10.3. The intensity decreases with pH until a pH of about 7. Below this pH, the intensity becomes negligible.

[0040] Cap 102 and vial 104 can be made of any suitable material, preferably a hard and inert plastic, such as polycarbonate. Ideally, at least vial 104 is transparent to facilitate monitoring of detectable changes in the color or fluorescence of the growth medium.

[0041] Figure 2 BI 200 is reflected and includes a cap 202, a vial 204, and a carrier 206 preferably disposed within the vial 204 at or near the base of the vial 104. BI 200 also includes an ampoule 224 that is at least partially disposed within the vial 104 and in contact with an insert 226. The ampoule 224 can contain a growth medium, such as those described above, for example, α-MUG. The insert 226 and the cap 202 can also include features such as stress concentrators that can help rupture the ampoule 224, such as when the cap 202 is pressed down along the vial 204, for example, as explained in co-pending U.S. patent application Nos. 15 / 057,768 and 15 / 397,018, the disclosures of which are incorporated herein by reference in their entireties. Additionally, the cap 202 can include one or more wings 228 extending therefrom, which can assist a user in providing a compressive force between the cap 202 and the vial 204. As Figure 3 As shown, Figure 3 2 is a cross-sectional top view of the BI 200. The ampoule 224 may be provided with an irregular shape, such as a jagged circle defining a notch to provide a space in which the pipette 216 is disposed.

[0042] The port 208 can be integrated into the cap 202 and pass through the cap 202. The port 208 can also include an extension, such as a pipette 216, which can include a first end connected (e.g., coupled) to the port 208 so that any liquid introduced through the port 208 exits the pipette 216 inside the vial 204 and is removed from the cap 202 to a certain extent. As shown, the pipette 216 includes a second end disposed near the base of the vial 204. Thus, liquid can be introduced into and removed from the BI 200 via a single port. Preferably, the sufficient space between the base of the vial 204 and the second end of the pipette 216 should be large enough so that when the cap 202 is depressed, the second end of the pipette 216 should contact or nearly contact the carrier 206. In addition, by including the pipette 216, the inclusion of the ampoule 224 in the BI 200 is optional. That is, the ampoule 224 may not be included in the BI 200 to allow the growth medium to be introduced into the BI via the port 208 and the pipette 216. In another embodiment not shown, the tube may be integrated into the side wall of the vial 204, extending from a position between the cap 202 and the carrier 206 to a position near the carrier 206. The second end of the pipette 216 may be disposed within the tube so that when the cap 202 is depressed relative to the vial 204, the second end of the pipette 216 may move toward the carrier 206 within the tube. Thus, the pipette 216 and the tube are provided to have a telescopic relationship. A seal, such as a gasket, may be provided between the two to ensure that the fit between the pipette 216 and the tube is fluid-tight. Thus, the fluid can be delivered to and removed from the vial 204 through the channel defined by the pipette 216 and the tube integrated into the wall of the vial 204.

[0043] Biological indicators used in steam-based sterilization processes do not require features related to fluid management, such as the ports, pipettes, and valves described above, because steam can be easily introduced into and removed from the interior of the biological indicator by pressurizing and depressurizing the vacuum chamber in which the biological indicator and the instrument are located during the process. This feature is essential for biological indicators used in liquid-based chemical sterilization processes, at least because the disinfectant (e.g., peracetic acid or hydrogen peroxide) must be introduced into and removed from the biological indicator. In addition, when a neutralizer (e.g., sodium metabisulfite or sodium bisulfite) is used to neutralize any disinfectant remaining in the biological indicator, the neutralizer must be introduced into and removed from the biological indicator. Furthermore, in those embodiments where the biological indicator does not include an ampoule containing growth medium, the growth medium must also be introduced into the biological indicator. This fluid management step can be facilitated by a biological indicator designed to interface with a liquid chemical disinfection system that may also include an integrated incubator and reader similar to the reader for the commercially available STERRAD VELOCITY™ system manufactured by Applicant (ASP Part No. 43220).

[0044] Figure 4 , BI 300. BI 300 includes a housing 304 defining an interior 337, a first port 308 including a valve 312, a second port 310 including a valve 314, and a carrier holder 330 containing a carrier 306. A divider 332 can be disposed between ports 308 and 310, extending into interior 337 to define two chambers: chamber 338 and chamber 340. As shown, carrier 306 is disposed in chamber 340. Ports 308 and 310 can function as inlet and outlet ports, or both. For example, disinfectant can be introduced into chamber 338 and then into chamber 340 before being removed through port 310. However, to minimize the amount of growth medium introduced, growth medium can be introduced into and removed from chamber 340 via port 310, filling only chamber 340 and leaving port 308 unused for the flow of growth medium. The BI 300 may additionally include a handle 334 , which may also include a serrated portion 336 to help a user grip the BI 300 .

[0045] Figures 5 to 7 300 can be used in conjunction with a liquid chemical disinfection system 10. The system 10 includes a disinfection tray or basket 12 configured to be disposed in a vertical position within a disinfection chamber 14 ( Figure 7 ), or arranged in a horizontal position outside the disinfection chamber 10 ( Figure 5). The tray 12 can be manipulated between an inner vertical position and an outer horizontal position via an articulated arm 16. The articulated arm can be hollow so that it can direct a liquid, such as a disinfectant, neutralizer, or growth medium, through a fluid delivery component (e.g., a common tube or multiple tubes, each designated for a liquid). The articulated arm cooperates with the basket 12 and the manifold 13. Additional fluid delivery components (e.g., tubes 24) extend out of the manifold 13 and into the basket 12 so that at least a portion of at least one of the tubes 24 (but preferably both tubes 24) is disposed in the basket 12. A connecting adapter 15 can help secure the manifold 13 to the basket 12 and provide only the disinfectant to the endoscope via the tubes 24. The tubes 24 can be connected to the lumens of the instruments to be sterilized disposed in the basket 12 and inside the chamber 14. For example, the tubes 24 can be connected to various ports, tubes, or other components of the endoscope ( Figure 7 ) so that the disinfectant can flow through the lumen of the endoscope during the disinfection process. In this way, a certain volume of disinfectant that flows through the endoscope can be introduced into the BI 300.

[0046] A holder 18 including a slot 20 in which a BI 300 may be disposed is attached to the tray manifold 13. That is, the slot 20 is configured to contain a biological indicator. The holder 18 also includes a window 22 through which the BI 300 may be read by a reading device 26 ( Figure 7 ) to assess a detectable change in the color or fluorescence of the growth medium in the BI 300. The reading device can be at least partially disposed within or outside of chamber 14, but adjacent to chamber 14, but still within the disinfection system. At least one port (e.g., two ports (ports 30 and 32)) can be disposed at the base of slot 20 and can mate with ports 308 and 310, respectively, of the BI 300. Thus, liquid can be delivered (e.g., under pressure generated by a pump) from a liquid source within system 10 (e.g., a source of liquid chemical disinfectant or a source of neutralizer) through articulated arm 16, manifold 13, holder 18, and to BI 300 via port 308 or 310. Liquid can also be removed from BI 300 in the opposite direction. In further embodiments, holder 18 further includes a heating element that can be used to incubate BI 300 at a temperature between approximately 50°C and approximately 60°C (e.g., approximately 57°C), for example, when the growth medium is contained in chamber 340 of BI 300.

[0047] like Figure 7 As shown, when the tray 12 is positioned in a vertical position inside the chamber 14, the window 22 on the holder 18 is aligned with the reading device 26 of the liquid chemical sterilization system 10, so that the BI 300 can be interrogated during the cycle to assess the sterility of the BI 300 and any other devices within the chamber 14, for example, to determine whether the sterilization cycle can be concluded.

[0048] Figure 8 A top-loading liquid chemical disinfection system 50 is shown that incorporates an external holder 52 configured to contain at least one BI 400, such as four BIs 400. The holder 52 may include a heating element for incubating the BIs 400, fluid connections for introducing and removing liquids such as disinfectants, neutralizers, and growth media from the BIs 400, and light emitters and detectors capable of interrogating changes in color or fluorescence intensity of the BIs 400. The holder 52 may also include a user interface such as a screen 54, which may be a touch screen capable of accepting input from a user. Figure 9 As shown, the BI 400 can be inserted into and removed from the holder 52. The BI 400 may include a handle 434 that fits into the slot 56, leaving a small space 58 between the handle 434 and the holder 52, which may facilitate removal of the BI 400 therefrom. Because multiple BIs 400 can be placed into the holder 52, these multiple BIs can each be interrogated to provide an indication of the sterility of a single sterilization cycle. In this way, the BIs can be compared to each other as controls to confirm that they provide similar results. In this way, when one or more BIs provide an indication of sterility that is different from one or more of the other BIs, the system can remind the user through the screen 54 to perform further analysis or subject the instrument to another sterilization cycle.

[0049] Figure 10A and Figure 10B , a technique for delivering liquid to a BI 500 is reflected in FIG. BI 500 includes a port 508 and a base 505. Filling mechanism 60 includes a reservoir 62 for liquid, an opening 64, and an arm 66. BI 500 can be moved downward, causing base 505 to contact arm 66, causing filling mechanism 60 to rotate. As BI 500 moves further downward, opening 64 rotates onto port 508 as arm 66 rotates out of contact with base 505. Further downward movement of BI 500 continues the rotation of mechanism 500 due to the force applied to it by port 508. When port 508 drops below a portion of reservoir 62, liquid can flow out of opening 64, through port 508, and into BI 500.

[0050] Figure 11BI 600 is shown, which includes a cap 602, a vial 604, a carrier 606, and an insert 626. The cap 602 includes a spout or extension 616 that extends deep into the vial 604 so that fluid introduced therethrough is forced to flow through the carrier 606 while submerging the carrier 606. The extension can extend through the insert 626, which in this embodiment can help maintain the position of the carrier 606 at the base of the vial 604, particularly during shipping. As shown, the BI 600 does not include growth medium provided in an ampoule. In addition, the BI 600 includes a single port 608 integrated into the cap 602. Thus, the port 608 can be used to introduce liquid into and remove liquid from the vial 604. The BI 600 can be provided in an open or uncompressed configuration, similar to Figure 1 622. The cap 602 is configured such that gas (e.g., air or sterilant) can flow into or out of the vial 604 through the vent 622. For example, when a liquid chemical sterilant is introduced into the vial 604 via the spout 616, air within the vial 604 can be exhausted from the BI 600 through the vent 622. Additionally, in the open or uncompressed configuration, the bottom surface of the spout 616 is slightly offset from the carrier 606 to allow fluid to be easily introduced into the vial 604 through the spout 616. Figure 11 600 is shown in a compressed configuration, wherein the vent port 622 is partially blocked by the vial 604, and wherein the bottom surface of the spout 616 is positioned adjacent to or in contact with the carrier 606. Because the vent port 622 is blocked, airflow therethrough is restricted, which minimizes the possibility of contaminants entering the vial 604 after sterilization. Typically, the BI 600 is sterilized in an open or uncompressed configuration. After sterilization, the cap 602 can be depressed relative to the vial 604, placing the BI 600 in a compressed configuration for further analysis.

Claims

1. A biological indicator comprising: a vial comprising a first port disposed through a base of the vial; a cap disposed on a top of the vial, the cap including a second port; a first valve disposed in the first port; a second valve disposed in the second port; and a carrier, which is disposed in the vial and impregnated with a microorganism, wherein the second port comprises an extension portion, the extension portion extending into the vial to guide the incoming fluid to flow through the carrier, The first port includes an opening disposed inside the vial, and the vial includes a bottom portion having a slope directed toward the opening. 2 . The biological indicator of claim 1 , further comprising a vent port disposed through the cap.

3. The biological indicator according to claim 1, wherein The carrier is disposed above the opening and in contact with the slope.

4. The biological indicator according to claim 3, wherein The carrier includes a void disposed therethrough.

5. The biological indicator of claim 1, further comprising an ampoule containing growth medium disposed at least partially within the vial.

6. A biological indicator comprising: a vial having a base; a cap disposed on a top of the vial, the cap including a port; a pipette having a first end connected to the port and a second end disposed proximate the base of the vial; and A carrier is disposed in the vial and impregnated with microorganisms. The biological indicator of claim 6 , further comprising wings extending from the cap.

8. The biological indicator of claim 6, further comprising an ampoule at least partially disposed within the vial.

9. The biological indicator of claim 8, further comprising an insert in contact with the ampoule.

10. The biological indicator according to claim 9, wherein The ampoule comprises an irregular cross-sectional shape.

11. The biological indicator according to claim 10, wherein The pipette is disposed in a recess defined by the irregular cross-sectional shape.

12. A liquid chemical disinfection system comprising: Biological indicators, including a housing defining an interior and including a first port having a first valve and a second port having a second valve, a divider disposed within the interior between the first port and the second port, defining two chambers, and a carrier disposed in one of the two chambers and impregnated with microorganisms; Source of liquid chemical disinfectant; a first fluid delivery component connected to a source of said liquid chemical disinfectant; and A retainer comprising at least one slot configured to contain the biological indicator, and At least one third port is connected to the first fluid delivery component and is positioned at the base of the slot to mate with the first port.

13. The liquid chemical disinfection system according to claim 12, wherein: The retainer includes a fourth port disposed at the base of the slot, the fourth port positioned to mate with the second port.

14. The liquid chemical disinfection system according to claim 12, wherein: The retainer includes a window.

15. The liquid chemical disinfection system according to claim 14, wherein: The holder is connected to a sterilization tray disposed inside the sterilization chamber.

16. The liquid chemical disinfection system according to claim 15, wherein: A manifold is connected to the sterilization tray, and the holder is connected to the manifold.

17. The liquid chemical disinfection system according to claim 16, wherein: The first fluid delivery component is connected to the manifold, and the manifold is connected to the third port.

18. The liquid chemical sterilization system of claim 17, further comprising a second fluid delivery component connected to the manifold and at least partially disposed in the sterilization tray.

19. The liquid chemical disinfection system according to claim 18, wherein: The second fluid delivery component is connected to a lumen of an instrument disposed in the sterilization tray.

20. The liquid chemical disinfection system of claim 19, wherein: The instrument includes an endoscope.

21. The liquid chemical disinfection system of claim 20, wherein: The interior of the biological indicator contains a liquid chemical disinfectant that has previously flowed through the endoscope.

22. The liquid chemical disinfection system of claim 21, wherein: A volume of liquid chemical disinfectant that has previously flowed through the endoscope is disposed within the interior of the biological indicator.

23. The liquid chemical disinfection system of claim 13, wherein: The retainer is disposed on an outer surface of the disinfection system.

24. The liquid chemical disinfection system of claim 23, wherein: The holder includes a screen.

25. The liquid chemical disinfection system of claim 24, wherein: The retainer includes four slots.

26. The liquid chemical disinfection system of claim 25, wherein: Each slot contains a different biological indicator.

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