Process monitoring device

Abstract

The invention relates to a process monitoring device. In particular, the present disclosure relates to an article for detecting a disinfectant via visual feedback. The article has a first substrate having a first major surface and opposing ends. The article also includes a process indicator disposed on at least a portion of the first major surface. The process indicator reacts with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, o-phthalaldehyde, hydrogen peroxide, peroxyacetic acid, and compositions thereof. The process indicator may be formed from a synthetic amine-containing polymer derived from polyaziridine (PEI). The article may have a flow channel formed from a portion of the process indicator and extending between the opposing ends. The present disclosure also relates to kits containing the articles and methods of using the articles during disinfection. The article is used to diagnose problems in an automatic endoscopic reprocessor (AER).

Description

[0001] This invention patent application is a divisional application of the invention patent application with international application number PCT / US2017 / 065009, international application date December 7, 2017, application number 201780076129.2 entering the Chinese national phase, and invention name “Process Monitoring Device”. Technical Field

[0002] The present disclosure relates to process monitoring devices. Specifically, the present disclosure relates to an article for detecting a disinfectant via visual feedback. The present disclosure also relates to a kit containing the article and a method of using the article in a disinfection process. The article is used to diagnose problems in an automated endoscope reprocessor (AER). Background Art

[0003] The present disclosure relates to methods and articles for disinfecting medical devices using liquid disinfectants. Reusable medical devices or articles that contact mucous membranes are commonly used in the medical field. Examples of such devices include reusable flexible endoscopes, endotracheal tubes, anesthesia breathing circuits, and respiratory therapy equipment. When inserted into the body, these medical devices may be severely contaminated with patient biological materials and microorganisms (including potential pathogens). Careful reprocessing of medical devices is critical to reducing the risk of cross contamination between patients and possible pathogen transmission.

[0004] According to the Spaulding classification of medical devices, flexible endoscopes are rated as semi-critical, thus requiring decontamination of these devices by high-level disinfection. Therefore, frequent visual inspection of both endoscopes and reusable accessories is recommended during use and reprocessing, including before, during, and after use, as well as after cleaning and prior to high-level disinfection. However, vision-based verification methods have severe limitations when applied to flexible endoscopes because the complex, narrow lumens in these devices cannot be directly visually inspected.

[0005] Automated endoscope reprocessors (AERs) are used to clean and disinfect flexible endoscopes to mitigate the transmission of pathogenic organisms and disease between patients who are undergoing endoscopic procedures. To disinfect the AER, a liquid disinfectant is typically recirculated through the AER for a specified period of time. Typically, the only information available to the user is parameter information provided by the AER device itself, which primarily consists of time and temperature information. The AER does not typically monitor chemically related parameters that could establish the effectiveness of the disinfection cycle. The AER also does not typically provide feedback on how the disinfectant flows out of the medical device.

[0006] Some solutions provide various process indicators for use with the AER, however, the process indicators do not necessarily provide details about the flow of liquid sterilant that can be used to diagnose AER problems. Summary of the invention

[0007] Aspects of the present disclosure are directed to articles that provide visual feedback of how disinfectant is flowing from a medical device.

[0008] In particular, aspects of the present disclosure relate to articles for detecting disinfectants. The article may have a first substrate. The first substrate may have a first major surface and opposing ends. The article may also have a process indicator. The process indicator is disposed on at least a portion of the first major surface. The process indicator reacts with at least one liquid disinfectant selected from glutaraldehyde, o-phthalaldehyde, hydrogen peroxide, and peracetic acid. The article may have a flow channel formed by a portion of the process indicator and extending between the opposing ends.

[0009] The present disclosure may be directed to kits containing articles and methods of using the articles in a sterilization process. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1A is a front cross-sectional view of an article having a first substrate and a flow channel extending longitudinally therethrough.

[0011] Figure 1B yes Figure 1A A front perspective view of a product.

[0012] Figure 1C yes Figure 1A-1B Side view of the product.

[0013] Figure 2A is a front cross-sectional view of an article having a second substrate and a flow channel extending longitudinally therethrough.

[0014] Figure 2B yes Figure 2A A front perspective view of a product.

[0015] Figure 3 is a front cross-sectional view of an article having a mechanical attachment.

[0016] Figure 4A is a front perspective view of an article having multiple flow channels.

[0017] Figure 4B yes Figure 4A A side sectional view of a cross section of an article in FIG.

[0018] Figure 5 is a front perspective view of any of the articles of FIGS. 2-4 with a funnel arrangement.

[0019] Figure 6 is a front view of any one of the articles of FIGS. 1-4 .

[0020] Figure 7is a front-side perspective view of an article having a spacing element.

[0021] Figure 8 is a front-side perspective view of an article having a spacing element and a funnel arrangement.

[0022] Fig. 9 is a front perspective view of the disinfection system.

[0023] Fig.10 is a front view of the installation guide. DETAILED DESCRIPTION

[0024] Aspects of the present disclosure relate to a flow channel formed by at least a portion of a process indicator.

[0025] Before explaining any embodiment of the present disclosure in detail, it should be understood that the present invention is not limited to the construction details and component arrangements mentioned in the following description or shown in the following drawings in its application. The present invention can have other embodiments and can be practiced or implemented in a variety of ways. Moreover, it should be understood that the words and terms used herein are for illustrative purposes and should not be considered as restrictive. The use of "including", "comprising" or "having" and its variations herein is intended to cover the items listed thereafter and their equivalents and additional items. Unless otherwise specified or limited, the terms "support" and "connection" and their variations are used in a broad sense and cover both direct and indirect support and connection. In addition, "connection" and "connection" are not limited to physical or mechanical connections or connections. It should be understood that other embodiments can be adopted and structural changes or logical changes can be made without departing from the scope of the present disclosure. In addition, terms such as "front", "rear", "top", "bottom", etc. are only used to describe elements when the elements are related to each other, but are by no means intended to describe the specific orientation of the device, indicate or imply the necessary or required orientation of the device, or specify how the present invention described herein will be used, installed, displayed or positioned when used.

[0026] In the present disclosure, components of the embodiments of FIGS. 1-10 may be similarly numbered, although disclosed as separate embodiments, unless otherwise indicated.

[0027] Figures 1A-1C An exemplary embodiment of an article 100 is shown. The article 100 may perform a sterilization indication of a sterilization process. The article 100 may have a substrate 110 and a process indicator 120 that further defines a flow channel 142 extending longitudinally thereto.

[0028] The process indicator 120 can be disposed (e.g., as a film or coating) on ​​the substrate 110. The process indicator 120 can be applied to the substrate by a suitable method as described herein, including, for example, spin coating, dip coating, spray coating, brush coating, roller coating, gravure coating, curtain coating, knife coating, and slot coating.

[0029] Preferably, the substrate 110 is selected to be non-reactive with the disinfectant. For example, the substrate may be porous or impermeable, and / or opaque or transparent, but preferably transparent. Examples of suitable substrates include paper, metal, glass and / or plastic / polymer sheets, films, membranes, fabrics (e.g., nonwoven fabrics or woven fabrics), and combinations thereof.

[0030] Suitable polymeric materials include, but are not limited to, polyolefins, poly(isoprene), poly(butadiene), polyurethanes, silicones, polystyrenes, fluorinated polymers, chlorinated polymers, polyesters, polyamides, acrylates, polyimides, polyethers, poly(ether sulfones), poly(sulfones), polyphenylene ethers, poly(vinyl acetate), copolymers of vinyl acetate, poly(phosphazenes), poly(vinyl esters), poly(vinyl ethers), poly(vinyl alcohols), and poly(carbonates).

[0031] Suitable polyolefins include, but are not limited to, polyethylene terephthalate, poly(ethylene), poly(propylene), poly(1-butene), copolymers of ethylene and propylene, α-olefin copolymers (such as copolymers of 1-butene, 1-hexene, 1-octene, and 1-decene), poly(ethylene-co-1-butene), and poly(ethylene-co-1-butene-co-1-hexene).

[0032] Suitable fluorinated polymers include, but are not limited to, poly(vinyl fluoride), poly(vinylidene fluoride), copolymers of vinylidene fluoride such as poly(vinylidene fluoride-co-hexafluoropropylene), and copolymers of chlorotrifluoroethylene such as poly(ethylene-co-chlorotrifluoroethylene).

[0033] Suitable polyamides include, but are not limited to, poly(imino(1-oxyhexamethylene)), poly(imidoadipimidohexamethylene), poly(imidoadipimidodecamethylene), and polycaprolactam. Suitable polyimides include, but are not limited to, poly(pyromellitimide). Suitable poly(ethersulfones) include, but are not limited to, poly(diphenyl ether sulfone) and poly(diphenyl sulfone-co-oxidized diphenylene sulfone). Suitable copolymers of vinyl acetate include, but are not limited to, poly(ethylene-co-vinyl acetate) and those copolymers in which at least some of the acetate groups have been hydrolyzed to provide a variety of poly(vinyl alcohol). In some embodiments, cellulose paper may be used alone or in combination with films or thin films of the aforementioned polymeric materials. The selection of substrate 110 may be influenced by process indicator 120 and is further described herein.

[0034] In some embodiments, process indicator 120 may form a layer. The layer may be continuous across the surface of substrate 110 and may have a uniform thickness. In other embodiments, process indicator 120 forms one or more non-uniform deposits. Generally, the type, thickness, or uniformity of process indicator 120 is not particularly important. It is preferred that sufficient process indicator material be present to enable easy and accurate observation of the reaction of the process indicator composition and the disinfectant.

[0035] The process indicator 120 can be any disinfectant-specific composition that reacts (directly or indirectly) with at least one liquid disinfectant selected from glutaraldehyde, o-phthalaldehyde, hydrogen peroxide, and peracetic acid. Some examples include sodium sulfite, ammonium chloride, ammonium bromide, ammonium bicarbonate, or ammonium acetate to indicate the presence of glutaraldehyde. Compositions with aldehyde-reactive groups for indicating the presence of o-phthalaldehyde (such as the synthetic amine-containing compounds described herein) and various compositions for indicating the presence of hydrogen peroxide or peracetic acid are provided in, for example, U.S. Pat. No. 7,481,975, U.S. Pat. No. 7,670,552, and U.S. Pat. No. 6,566,090.

[0036] In some embodiments, the reaction of the composition with the liquid disinfectant produces a visual indication of the presence of the liquid disinfectant. The composition may also indicate the concentration strength of the disinfectant in the liquid.

[0037] The process indicator 120 may be formed from a synthetic amine-containing polymer, such as described in U.S. Patent Application 62 / 332,243 filed May 5, 2016 (Attorney Docket No. 78258US002) and U.S. Patent Application 62 / 332,255 filed May 5, 2016 (Attorney Docket No. 78340US002), which are incorporated herein by reference in their entirety.

[0038] In at least one embodiment, the process indicator 120 relies at least in part on the reaction of aldehydes in the disinfectant with one or more synthetic amine-containing compounds. In some exemplary embodiments, the synthetic amine-containing compound comprises at least one synthetic amine-containing polymer. In some preferred embodiments, the synthetic amine-containing polymer is derived from polyethylenimine (PEI).

[0039] PEI is available in a variety of forms, such as linear, branched and dendritic. Linear PEI can be represented by the following formula I:

[0040] (I)

[0041] Wherein --- indicates continuous linear polyethyleneimine derived units or H. Linear PEI can be obtained by post-modification of other polymers such as poly (2-oxazoline) or N-substituted aziridine. Linear PEI is commercially available and / or can be prepared according to known methods.

[0042] An exemplary branched PEI segment can be represented by the following Formula II:

[0043] (II)

[0044] Wherein --- indicates continuous linear and / or branched polyethyleneimine derived units or H. Since branching is usually more or less random, branched PEI usually contains many compounds of this general type as a mixture. Branched PEI can be synthesized by ring-opening polymerization of aziridine. Branched PEI is commercially available and / or can be prepared according to known methods.

[0045] Dendritic PEI is a special case of branched PEI. An exemplary (4th generation) dendritic PEI is represented by the following formula III:

[0046] (III)

[0047] In this case, the PEI contains only primary and tertiary amino groups.Dendritic PEIs are commercially available and / or can be prepared according to known methods.

[0048] For the purposes of this patent application, the term "polyethylenimine" also includes ethoxylated polyethylenimines, which can be formed by reacting some or all (preferably less than 50%, less than 30%, or even less than 10%) of the primary amino groups with one or more ethylene oxide molecules. As used herein, the term "polyethylenimine" also includes protonated forms.

[0049] In one embodiment, the process indicator comprises, consists essentially of, or even consists of at least one branched PEI. In the case where such an embodiment can be effective as an indicator, the branched PEI may tend to be immersed in the disinfectant. For this reason, it may be desirable to reduce the leaching rate of the PEI. If glutaraldehyde is used in the disinfectant, this embodiment may be useful because glutaraldehyde (which is a dialdehyde) can achieve cross-linking of the branched PEI when the branched PEI reacts with the primary amino groups.

[0050] In another embodiment, leaching is reduced or eliminated by electron beam grafting of branched PEI to the first substrate 110 (branched PEI is arranged thereon). In one method, substrate 110 contacts PEI and is exposed to electron beam radiation sufficient to cause grafting. Electron beam generators are commercially available from a variety of sources, including ESI "ELECTROCURE" EB SYSTEM from Energy Sciences, Inc. (Wilmington, Mass.) in Wilmington, Massachusetts and BROADBEAM EB PROCESSOR from PCT Engineered Systems, LLC (Davenport, Iowa) in Davenport, Iowa. For any designated piece of equipment and irradiation sample position, the delivery of the release can be measured according to ASTM E-1275, which is named "Practice for Use ofa Radiochromic Film Dosimetry System". Various dose rates can be obtained by changing the extractor grid voltage, beam diameter and / or the distance to the source. An exemplary electron beam dose may be about 5 kilograys (kGy) to about 100 kGy at an accelerating voltage of 150 to 400 keV, preferably 250 to 350 keV. Electron beam grafting may also be achieved by methods such as those described in, for example, U.S. Pat. No. 8,551,894 (Seshadri et al.), in which amine-reactive ligands (e.g., bromine atoms or acryloxy groups) are grafted onto substrate 110, and the resulting functionalized substrate is then contacted with PEI to produce a chemical reaction that binds PEI to substrate 110. Additional details on electron beam grafting of PEI to substrate 110 may be found in U.S. Patent Application Publication No. 2007 / 0154703 (Boden et al.). Suitable substrates are preferably porous, but this is not required.

[0051] Leaching may also be reduced by washing the PEI coating (eg, 120) and substrate 110 during manufacturing so that the PEI coated substrate 110 is free of extraneous PEI that may leach into the AER disinfectant or rinse solution.

[0052] The molecular weight of PEI can be customized according to specific application requirements. In some embodiments, the number average molecular weight (M) of PEI is w ) is at least 500 g / mol, at least 1500 g / mol, at least 2000 g / mol, at least 5000 g / mol, at least 15000 g / mol, at least 30000 g / mol, at least 60000 g / mol, or at least 100000 g / mol.

[0053] Exemplary substrates for electron beam grafting include porous films, porous nonwoven webs, paper materials and porous fibers. In some embodiments, polyethylenimine is crosslinked (using chemical crosslinking agents) before reacting with amine-reactive hydrolyzable organosilanes. Suitable crosslinking agents have multiple (e.g., 2, 3, 4 or 5) amine-reactive groups that form covalent bonds with amino groups. Preferably, the crosslinking agent has two amine-reactive groups. Usually, crosslinking is affected by simply combining PEI and a crosslinking agent under relatively high dilution conditions (favoring intramolecular crosslinking) to minimize the gelation caused by interchain crosslinking. The determination of suitable conditions is within the capabilities of those of ordinary skill in the art.

[0054] Examples of suitable cross-linking agents may include a cross-linking agent represented by the formula

[0055] R 3 -ZR 3

[0056] R 3 represents an amine-reactive group containing 1 to 12 carbon atoms. Preferably, R 3 Contains 1 to 8 carbon atoms, more preferably 1 to 6 carbon atoms, and even more preferably 1 to 3 carbon atoms.

[0057] Exemplary amine reactive groups R 3 Including isocyanate group (-N=C=O), ethylene oxide group ( ), glycidoxyl group ( ), acryloyl group ( ), acryloyloxy group ( ), an alkoxycarbonyl group having 2 to 5 carbon atoms (e.g., an ethoxycarbonyl group ( ) or a methoxycarbonyl group ( )), vinylsulfonyl group ( ), cyclic anhydride groups (e.g., ), alkyl carbamate groups (e.g. ), haloalkyl groups (e.g., BrCH2- or ClCH2-), and acrylamido groups (i.e., ).

[0058] Z represents a divalent organic group containing 1 to 8 carbon atoms. In some embodiments, Z further contains 1 to 6 heteroatoms selected from O, N and S.

[0059] Suitable divalent organic groups Z include, for example: alkylene groups having 1 to 8 carbon atoms, more preferably 1 to 6 carbon atoms, more preferably 1 to 4 carbon atoms, and even more preferably 1 to 3 carbon atoms; alkyleneoxyalkylene groups having 1 to 8 carbon atoms, more preferably 1 to 6 carbon atoms, more preferably 1 to 4 carbon atoms; di(alkylene)amino groups having 1 to 8 carbon atoms, more preferably 1 to 6 carbon atoms, more preferably 1 to 4 carbon atoms; alkylenethioalkylene groups having 1 to 8 carbon atoms, more preferably 1 to 6 carbon atoms, more preferably 1 to 4 carbon atoms.

[0060] Specific examples of the group Z include methylene, ethylene, 1,2- and 1,3-propylene, butylene, isobutylene, hexylene, octylene, ethylcyclohexane-4,2'-diyl, ethyleneoxyethylene, ethyleneaminoethylene, ethyleneoxypropylene, ethylenethioethylene, and ethylene(methyl)aminoethylene. Among them, ethylene and 1,3-propylene are particularly preferred.

[0061] Suitable crosslinking agents for PEI include, for example, multifunctional compounds such as: halogenated alcohols (e.g., epichlorohydrin); multifunctional acrylates (e.g., 1,6-hexanediol diacrylate, ethylene glycol diacrylate, diethylene glycol diacrylate, triethylene glycol diacrylate, tetraethylene glycol diacrylate, ethoxylated trimethylolpropane triacrylate, trimethylolpropane triacrylate, glycerol triacrylate, dipentaerythritol hexaacrylate); dialdehydes (e.g. , alkyl, aryl or alkaryl dialdehydes such as acetaldehyde, malondialdehyde, propanedialdehyde, succinaldehyde, glutaraldehyde, adipaldehyde, 2-hydroxy-adipaldehyde, phthalaldehyde, 1,4-phthalaldehyde, 4,4-(ethylenedioxy)-dibenzaldehyde and 2,6-naphthalenedialdehyde); diepoxides (e.g., aliphatic, alicyclic and glycidyl ether diepoxides such as, for example, vinylcyclohexene dioxide, 3,4-epoxycyclohexylmethyl 3,4-epoxycyclohexanecarboxylate , 3,4-epoxy-6-methylcyclohexylmethyl 3,4-epoxy-6-methylcyclohexanecarboxylate, bis(3,4-epoxy-6-methylcyclohexylmethyl) adipate, dipentene dioxide, diglycidyl ether of bisphenol A, diglycidyl ether of bisphenol F, 1,4-butanediol diglycidyl ether); diesters (e.g., diethyl adipate, dimethyl fumarate, diethyl sebacate, and dimethyl maleate); divinyl sulfone; multifunctional acrylamide (e.g., piperazine diacrylamide, diacrylamide, N,N-methylene diacrylamide and N,N'-(ethane-1,2-diyl) diacrylamide); polyisocyanates (e.g., hexamethylene diisocyanate, methylene diisocyanate) and polyaziridine compounds (e.g., tris-(1-aziridine) phosphine oxide), carbodiimides (e.g., 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide) and N-hydroxysuccinimide. Additional crosslinking agents are known in the art and are available to those skilled in the art.

[0062] Preferably, an amount of cross-linking agent is used which results in reaction with 1% to 10%, more preferably 3% to 8%, of the available primary nitrogen atoms in the PEI.

[0063] In some embodiments, an increase in the ratio of secondary amines to primary amines results in a different contrast in color or other spectral measurements. For example, the ratio of secondary amines to primary amines in a branched or dendritic PEI can be at least 1:1, at least 3:1, at least 5:1, or even at least 10:1.

[0064] The amount of cross-linking agent used relative to the primary amino groups and / or secondary amino groups is significantly less than the equivalent (or stoichiometric ratio). The amount of cross-linking agent can leave at least a quarter or even at least a half of the NH groups in the polymer unreacted. If desired, excess unreacted PEI can be added to the solution of the partially cross-linked polymerized reaction product to increase the total average frequency of unreacted NH groups.

[0065] In another embodiment, the process indicator comprises, consists essentially of, or consists of at least one cross-linked branched guanylated PEI. The guanylated PEI can be prepared, for example, according to the procedures described in U.S. Patent Application Publication No. 2016 / 0096802 (Boden et al.), using a guanylation agent. As used herein, "guanylation agent" means a compound that reacts with an amino moiety of an amine compound to provide a guanidino-functional compound (e.g., the reaction of the guanylation agent with the amino moiety can form the guanidino moiety in situ by an addition reaction or a displacement reaction).

[0066] Exemplary guanidinating agents include O-alkyl isourea salts, S-alkyl isothiourea salts, carbodiimides, cyanamides, amidine-functional salts, and the like, and combinations thereof. Preferred guanidinating agents include O-alkyl isourea salts, carbodiimides, and combinations thereof. Representative examples of suitable guanidinating agents that can react with amines via a displacement reaction include O-methylisourea sulfate (also known as O-methylisourea hemisulfate), O-methylisourea hydrogen sulfate, O-methylisourea acetate, O-ethylisourea hydrogen sulfate, O-ethylisourea hydrochloride, S-methylisothiourea sulfate (also known as S-methylisothiourea hemisulfate), S-methylisothiourea hydrogen sulfate, S-methylisothiourea acetate, S-ethylisothiourea hydrogen sulfate, S-ethylisothiourea hydrochloride, chloroformamidine hydrochloride, 1-amidino-1,2,4-triazole hydrochloride, 3,5-dimethylpyrazole-1-carboxamidine nitrate, pyrazole-1-carboxamidine hydrochloride, N-amidinopyrazole-1-carboxamidine hydrochloride, and combinations thereof. Representative examples of suitable guanidinating agents that can react with amines via an addition reaction include dicyclohexylcarbodiimide, N-ethyl-N'-(3-dimethylaminopropyl)carbodiimide, diisopropylcarbodiimide, diphenylcarbodiimide, cyanamide, and combinations thereof.

[0067] Preferred guanidinating agents include O-methylisourea sulfate, O-methylisourea hydrogen sulfate, O-methylisourea acetate, O-ethylisourea hydrogen sulfate, O-ethylisourea hydrochloride, dicyclohexylcarbodiimide, N-ethyl-N'-(3-dimethylaminopropyl)carbodiimide, diisopropylcarbodiimide, diphenylcarbodiimide, and combinations thereof. Particularly preferred guanidinating agents include O-methylisourea sulfate, O-methylisourea acetate, diisopropylcarbodiimide, and combinations thereof. Such guanidinating agents are known and can be prepared by known methods. At least some of the guanidinating agents are also commercially available.

[0068] In another embodiment, the process indicator may comprise, consist essentially of, or even consist of a cross-linked silylated branched polyethylenimine. The branched silylated polyethylenimine may be prepared, for example, by reaction of an amine-reactive organosilane coupling agent with at least some of the primary amines present in the branched PEI to obtain the silylated branched PEI. Examples of suitable amine-reactive organosilane coupling agents include compounds represented by the formula:

[0069] RZ-SiY3

[0070] Where R 3 and Z are as previously defined, and each Y independently represents a hydrolyzable group.

[0071] As used herein, the term "hydrolyzable group" indicates a group that can be hydrolyzed, which means that it can react with water to provide a silanol group (Si-OH group), which can further react with a group (e.g., a hydroxyl group) on the surface of the substrate 110. The hydrolysis and condensation reactions can be performed spontaneously and / or in the presence of a hydrolysis / condensation catalyst. Examples of hydrolyzable groups include halogen groups (such as chlorine, bromine, iodine or fluorine), alkoxy groups (-OR', wherein R' represents an alkyl group, the alkyl group preferably contains 1 to 6, more preferably contains 1 to 4 carbon atoms, and can be optionally substituted by one or more halogen atoms), acyloxy groups (-O-(C=O)-R'', wherein R'' is as defined for R'), aryloxy groups (-OR''', wherein R''' represents an aryl moiety, the aryl moiety preferably contains 6 to 12, more preferably contains 6 to 10 carbon atoms, and can be optionally substituted by one or more substituents, the substituents are independently selected from halogen and C1-C4 alkyl groups optionally substituted by one or more halogen atoms). In the above chemical formula, R', R'' and R''' may include a branched structure.

[0072] In some preferred embodiments, Y is each independently selected from methoxy, ethoxy, hydroxy, acetoxy, chlorine and bromine, with methoxy and ethoxy being particularly preferred.

[0073] Examples of suitable amine-reactive organosilane coupling agents include: 3-isocyanatopropyltriethoxysilane; 3-isocyanatopropyltrimethoxysilane; 2-isocyanatoethyltriethoxysilane; 2-isocyanatoethyltrimethoxysilane; 3-acryloxypropyltriethoxysilane; 3-acryloxypropyltrimethoxysilane; 2-acryloxyethyltriethoxysilane; 2-acryloxyethyltrimethoxysilane; 2,3-epoxypropyltrimethoxysilane; 2,3-epoxypropyltriethoxysilane; 3-glycidoxypropyltriethoxysilane; 3-glycidoxypropyltrimethoxysilane; 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane; and 2-(3,4-epoxycyclohexyl)ethyltriethoxysilane.

[0074] Suitable amine-reactive hydrolyzable organosilanes can be purchased from commercial sources (e.g., as silane coupling agents, e.g., from Gelest, Inc., Morrisville, Pennsylvania) and / or can be prepared by known methods. Preferably, the amine-reactive hydrolyzable organosilanes react with primary amino groups, and optionally with secondary and / or tertiary amino groups. Preferably, the amine-reactive hydrolyzable organosilanes react faster with primary amino groups than with secondary and tertiary amino groups (if any).

[0075] In this embodiment, typically, 5% to 70% of the primary amino groups in the PEI, preferably 10% to 40% of the primary amino groups, react with the silane coupling agent. The reaction is typically carried out in an organic solvent, but water may be present if desired. After coating and drying the silane-functionalized PEI on the substrate 110, the hydrolyzable groups hydrolyze and form siloxane crosslinks with other silane groups. This results in a crosslinked PEI disposed on the substrate 110, and depending on the substrate 110, it may be chemically bonded to the substrate 110 (e.g., if the substrate has available hydroxyl groups at its surface; for example, as in the case of cellulose paper). Exemplary substrates may include any substrate described herein.

[0076] In another embodiment, the synthetic amine-containing compound comprises a polyaziridine chemically bonded to silica. This can be achieved, for example, by coating an acidified silica nanoparticle dispersion on a substrate 110 (e.g., a cellulose paper or a substrate as described elsewhere herein), drying to form a silica coating on the substrate. Contacting the silica surface (e.g., by dip coating, spray coating, or spin coating) with an amine-reactive silane coupling agent (e.g., 3-acryloxypropyltrimethoxysilane or 3-isocyanatopropyltriethoxysilane or other coupling agents as described herein) causes the silica on its surface to react and functionalize with the amine-reactive groups.

[0077] Subsequent contacting of the functionalized surface with PEI results in covalent bonding of the PEI to the silica, thereby reducing leaching into the recycled disinfectant. Further details regarding the preparation of acidified silica nanoparticle dispersions and acid-sintered silica coatings prepared therefrom can be found, for example, in U.S. Patent Application Publications 2015 / 0232673 (Jing et al.), 2015 / 0203790 (Strerath et al.), 2015 / 0252196 (Strerath et al.), and 2015 / 0246350 (Sun et al.).

[0078] Polyethylenimine chemically bonded to silica can also be prepared by a multi-step process in which silica particles (e.g., colloidal silica particles) are combined with an amino-functional hydrolyzable silane (e.g., aminopropyltriethoxysilane, aminopropyltrimethoxysilane). The resulting dispersion of amino-functional silica particles is mixed with a second dispersion of silylated branched polyethylenimine (e.g., which can be prepared as discussed above). The resulting mixture is then coated onto substrate 110 and dried.

[0079] If desired, in various embodiments described herein, polyallylamine (PAA) can be substituted or combined with polyaziridine.Polyallylamine can be obtained from commercial sources (eg, Sigma Aldrich Corp.) or prepared according to known methods.

[0080] The molecular weight of PAA can be customized according to specific application requirements. In some embodiments, the number average molecular weight (M) of PAA is w ) is at least 500 g / mol, at least 5000 g / mol, at least 15000 g / mol, at least 30000 g / mol, at least 60000 g / mol, or at least 100000 g / mol.

[0081] The process indicator 120 can be applied using a composition. The composition preferably includes a liquid carrier, which can be organic and / or aqueous, but this is not required. If present, the liquid carrier should generally be selected to minimize the reaction between them and the other components of the composition. Examples of organic carriers include alcohols and ethers. Examples of aqueous liquid carriers include water and water-alcohol mixtures (e.g., water-isopropanol mixtures). If a liquid carrier is present, it is preferred that the other ingredients are dissolved and dispersed therein. Any amount of liquid carrier can be used, and will generally depend on the specific composition and / or intended use.

[0082] Optionally, the composition may also include a polymer binder. In embodiments where a liquid carrier is present, the additional polymer binder is preferably dispersible or soluble in the liquid carrier. Exemplary additional polymer binders include water-soluble polymers such as polyvinyl alcohol, hydroxyethyl cellulose, hydroxypropyl cellulose, and polymer latexes (e.g., polyurethane latex, acrylic latex, and vinyl acetate latex).

[0083] Suitable polymer binders include film-forming polymer binders, which can be provided, for example, as latex. In some preferred embodiments, the latex is added to the composition before the composition is deposited on the substrate 110. Suitable film-forming polymers include acrylics (e.g., polybutyl acrylate and polymethyl methacrylate), ethylene-vinyl acetate copolymers (and partially or completely hydrolyzed forms thereof, polyvinyl alcohol, polyurethane, polyamide, polyvinyl chloride, polystyrene, polyester, polycarbonate, natural and synthetic rubbers, and combinations thereof. The film-forming polymer binder can be self-crosslinkable.

[0084] If present, the film-forming polymeric binder is preferably present in an amount up to 50 wt%, more preferably 1 to 30 wt%, and more preferably 5 to 25 wt%, based on the combined total weight of the film-forming polymeric binder and the synthetic amine-containing compound.

[0085] The composition may also optionally contain various additives such as thickeners, fillers, fragrances, antioxidants, UV stabilizers and surfactants.

[0086] Compositions according to the present disclosure can generally be prepared by simply mixing the various components in a container, optionally with heating or cooling.

[0087] Compositions according to the present disclosure can be used, for example, in a method of preparing an article 100 by coating at least a portion of a first major surface 110A of a substrate 110 with the composition, and then hydrolyzing at least some of the hydrolyzable groups to form covalent crosslinks (e.g., with Si-O-Si units) between PEI chains and / or the substrate. Hydrolysis can occur spontaneously upon drying or standing. In some cases, optional heating may be advantageous.

[0088] Various configurations of article 100 are possible. Figure 1A, article 100 is shown as having a circular cross-section. The width of article 100 may be provided by a diameter, which is measured end-to-end along transverse axis Dx. Substrate 110 may have a first major surface 110A and a second major surface 110B. Process indicator 120 may be disposed on at least a portion of first major surface 110A, thereby forming channel 142 therein. In some embodiments, process indicator 120 is disposed on the entire first major surface 110A, which may include the entire circumference of a portion of article 100. In some embodiments, process indicator 120 is disposed along longitudinal axis D L (like Figure 1B ) is arranged on the entire length of the first substrate and a portion of the circumference of the article 100.

[0089] The second major surface 110B can form the exterior of the article 100 and can be exposed to the environment of the sterilization system.

[0090] The first substrate 110 may have a Figure 1B and 1C End 113 and end 115 are shown. As discussed herein, first substrate 110 can have process indicators 120 disposed thereon on all or a portion of surface 110A. Flow channel 142 can be established between end 113 and end 115 from at least a portion of process indicator 120.

[0091] The flow channel 142 may be defined by the process indicator 120 and / or at least a portion of the first substrate 110 (e.g., an exposed portion of the substrate 110 or a portion in which the process indicator 120 is defined). For example, when the process indicator 120 partially covers the first substrate 110, the flow channel 142 may be partially defined by the first substrate 110 and the process indicator 120.

[0092] The flow channel 142 may have one or more walls. In an embodiment of the present invention, the flow channel 142 is shown as having a single wall formed by a portion of the process indicator 120. The flow channel 142 may have a specific width x (measured along the transverse axis) and a specific height y (measured along the transverse axis perpendicular to the transverse D). x In article 100, flow channel 142 may be measured by an inner diameter (ie, x).

[0093] The flow channel 142 may be along the longitudinal axis D L For example, the flow channel 142 may extend in the longitudinal direction and be perpendicular to the transverse axis D x The distance from end 113 to end 115 along the longitudinal axis is l (eg Figure 1C as shown).

[0094] Although various configurations of the flow channel 142 are possible, the width x of the flow channel is generally no greater than its length l. The flow channel 142 may also be cut and shaped according to the desired length. For example, the distance l between the ends 113, 115 may be no greater than 4 inches, no greater than 3 inches, no greater than 2 inches, no greater than 1 inch. In at least one embodiment, the width x of the flow channel 142 may be no greater than 0.5 inches, no greater than 0.375 inches, no greater than 0.25 inches, or no greater than 0.125 inches.

[0095] The disinfectant may flow through the flow channel 142 from the end 113 to the end 115. The end 113 may have a first area, and through the end 115 may have a second area (each area is defined by the flow channel). In some embodiments, the first area is larger than the second area so as to generate back pressure with the flow of the disinfectant. The back pressure may cause the process indicator 120 to react to the presence of the disinfectant more easily than in the absence of the back pressure.

[0096] Back pressure can be achieved using a variety of techniques. In some embodiments, end 115 can be sealed. For example, article 100 can be a sock-like structure that fits adjacent to or even around the endoscope tip.

[0097] Figure 1C Membrane 112 and membrane 114 are shown covering at least a portion of end 113 and end 115, respectively. The thin film may cover an area defined by the first region, the second region, or both. Membrane 112 and membrane 114 may be optional. For example, the absence of membrane 112 and the presence of membrane 114 may create back pressure. Membrane 112 may also have a larger pore size than membrane 114 so as to create back pressure when the disinfectant flows through end 113.

[0098] The article 100 may also include an adhesive 150 disposed on the second major surface 110B of the first substrate 110. The adhesive 150 may be disposed so that the article 100 adheres to a surface, such as a surface located on an automated endoscope reprocessor (AER). The adhesive 150 may be planar, having an attachment surface. In some embodiments, the adhesive 150 may be a pressure sensitive adhesive.

[0099] Figure 2A An article 200 using two substrates is shown. The article 200 may have a first substrate 210 with a first major surface 210A and a second major surface 210B. The first substrate 210 may be similar to Figures 1A-1C The first substrate 110 in the embodiment of the present invention.

[0100] The article 200 can also have a process indicator 220 disposed on at least a portion of the first major surface 210A. The process indicator 220 can have a first major surface 220A.

[0101] The first substrate 210 may also have at least one surface. The first substrate 210 may have a longitudinal surface (eg, 233 or 235) and a transverse surface. The longitudinal surface (eg, 233 or 235) may be formed along a longitudinal axis D on one side of the article 200. L For example, the longitudinal surface can also be defined by the orientation of the flow channel 242. The length of the longitudinal surface (e.g., 233 or 235) can also be defined by the length l of the first substrate 210. The length of the first substrate 210 is the distance between the first transverse surface and the second transverse surface. The transverse surface is defined by the transverse axis D x Oriented face definition.

[0102] The article 200 may also have a polymer film 260 disposed on the second major surface 210B. The polymer film 260 may form a protective layer for the article 200. In some embodiments, the polymer film extends over the first substrate and the process indicator 220 along a longitudinal face (e.g., 233 or 235). The polymer film 260 may be any elastic polymer. In some embodiments, the polymer film may be a polyethylene terephthalate (PET) film. Although the thickness may vary depending on the desired durability, the thickness of the PET film may be less than ten thousandths of an inch. An adhesive may optionally be disposed between the second major surface 210B and the polymer film 260 to secure the polymer film 260 to the second major surface 210B.

[0103] The article 200 may have a second substrate 230 with a first major surface 230A and a second major surface 230B. The second substrate 230 may be used to form a flow channel 242 with the first major surface 210A. Specifically, the first major surface 230A may form a flow channel 242 with the first major surface 220A. The second substrate 230 may be positioned so that the process indicator 220 may be sandwiched between the first substrate 210 and the second substrate 230. The second substrate 230 may be attached to the surface by an adhesive 250.

[0104] To form the flow channel 242, the second substrate 230 may be attached to the first substrate 210 and / or the process indicator 220 at a location adjacent to the longitudinal face (e.g., 233 or 235). For example, the second substrate 230 may be attached to an edge of the first substrate 210. The second substrate 230 may also contact at least a portion of the process indicator 220 during attachment to the first substrate 210. Preferably, the second substrate 230 is attached to the first substrate 210 via a longitudinal edge region (described herein) of the first substrate. The longitudinal edge region may be an area of ​​attachment. The longitudinal edge region may be a place where an attachment point may be formed with the second substrate 230 while still forming the flow channel 242. The flow channel width x may be measured based on the distance b, while the longitudinal edge region may be defined by the distance a.

[0105] The attachment may bond at least some layers of the article 200 (as shown in the adhesive 232 that bonds the second substrate 230 to the process indicator 220). The attachment is shown as a distance a, which is the distance from the longitudinal faces 233, 235 to the innermost portion of the attachment. In some embodiments, a is no greater than 80%, no greater than 60%, no greater than 50%, no greater than 40%, no greater than 30%, no greater than 20% of b. In some embodiments, a is no greater than 30%, no greater than 20%, no greater than 10%, no greater than 5% of the distance a+b.

[0106] The attachment may be mechanical, adhesive or bonding. If a narrower flow channel 242 is desired, the attachment may be made away from the longitudinal face (increasing distance a, decreasing distance b).

[0107] Figure 3 Shown with Figure 2A-2B 300 is constructed similarly to article 200, except that article 300 includes mechanical attachments 309 and 311. Attachment 309 is attached at a location further inward (relative to article 200) from longitudinal face 335 (within the longitudinal edge portion). Distance a' may be greater than distance a in article 200, which reduces the flow channel width 342 defined by distance b'. Distance a remains unchanged compared to article 200. The two mechanical attachments penetrate the layers (first substrate 310, process indicator 320, and second substrate 330). The mechanical attachments are drawn as rivets.

[0108] Back to Figure 2B , flow channel 242 can be formed between ends 213 and 215 of article 200. Article 200 shows flow channel 242 having at least two walls, one wall formed by major surface 220A and another wall formed by major surface 230A. Adhesive 232 can also form side walls of flow channel 242.

[0109] The article 200 may have features that promote the flow of the disinfectant through the flow channel 242. For example, portions of the first major surface 210A and the first major surface 230A may be made hydrophobic or hydrophilic to draw the disinfectant into the process indicator 220. For example, the first major surface 230A may be hydrophobic and the first major surface 210A may be hydrophilic.

[0110] The article 200 may also include a spacer element 240. The spacer element 240 maintains the flow channel 242 by maintaining an opening for the sterilant to flow through the flow channel 242 (thereby preventing the flow channel 242 from collapsing). The spacer element 240 may be a mechanical device that is integrated or separate from either substrate. Figure 2A, the spacer element 240 is shown as a rigid tube inserted into the flow channel 242. In some embodiments, the spacer element forms at least a portion of the flow channel 242. The spacer element 240 can generally be sandwiched between the process indicator 220 and the second substrate 230. If present, the height of the flow channel 242 can be defined by the spacer element 240.

[0111] The spacer element 240 can be formed of a variety of materials. For example, the spacer element 240 can be a tube, which also has one or more openings formed by the body of the tube. In other examples, the spacer element 240 can also be a sponge or a nonwoven polymer or foam.

[0112] As discussed herein, the spacing elements 240 may also be integrated with the second substrate 230 .

[0113] Figure 4A-4B The article 400 is shown with the spacing elements 440 integrated into the second substrate 430. In some embodiments, the second substrate 430 can be a microreplicated surface such that the process indicators 420 form at least one flow channel with the first major surface 430A.

[0114] like Figure 4B As shown, the spacing element 440 can be a plurality of members. At least two of the members 434 and 438 can be elevated relative to the other members 436. At least one of the members (e.g., 434) extends through at least a portion of the length of the second substrate 430 along the longitudinal axis and is non-planar to the second substrate 430. In some embodiments, the member 434 extends the entire length of the second substrate.

[0115] The surface of member 434 is substantially flat and positioned to form an angle α with the major surface 430A of the second substrate 430. Angle α may be 1 to 179 degrees so as to maintain the structural integrity of the flow channel. Preferably, angle α is about 90 degrees. The height h of member 434 may define the height of flow channel 442. In some embodiments, the height may be at least 0.01 mm, at least 0.1 mm, or at least 0.5 mm.

[0116] The height h' of member 436 may be less than the height h. In some embodiments, member 436 is optional and does not contribute to the height of the flow channel. However, additional sterilant flow management may be affected by member 436. Member 436 may also extend at least a portion of the length of second substrate 430 and be non-planar to second substrate 430. In some embodiments, member 436 is perpendicular to second substrate 430.

[0117] The flow channel width may be provided by x, which includes the distance between members 434 and 438. The members may be defined by the spacing between the members. For example, the distance from members 436 and 438 may be at least 0.2 mm.

[0118] In some implementations, member 438 may also have a portion that extends away from member 438 and parallel to second substrate 430 .

[0119] Figure 5 An article 500 is shown having a funnel device 570. The article 500 can have a first substrate 510 and a process indicator 520 disposed thereon. The process indicator 520 can be at least partially disposed on a second substrate 530, thereby forming a channel as described herein.

[0120] The funnel device 570 can be configured to direct the flow of disinfectant into the end 513 of one or more flow channels. For example, the first end 572 can receive the flow of disinfectant and direct it toward the end 513. The funnel device 570 can have a sufficient height to fit on the first substrate 510. The funnel device 570 can have a width X 1 The first end 572 has a width X 2 In at least one embodiment, the width X 1 At least X 2 The funnel device 570 may also have a length L. The length L may be modified depending on the desired degree of disinfectant flow.

[0121] exist Figure 6 , the area of ​​the second substrate 630 may be larger than the first substrate 610. Not shown is a process indicator. The width and length of the article 600 may affect the pressure required for the AER. Generally speaking, the ratio of the length to the width (e.g., length L and width x) of the process indicator portion is no greater than 2:1, no greater than 3:1, and no greater than 4:1.

[0122] exist Figure 72 , an endoscope 790 is assembled into an article 701 of the present disclosure using a spacer element 740. The spacer element 740 may be generally u-shaped to substantially conform to the endoscope 790 and be inserted into the article 701 (which is similar to the article 200 in FIG. 2 ). The spacer element 740 may contact the second substrate 730. The spacer element 740 may be positioned between the second substrate 730 and the process indicator 720. The process indicator 720 may be deposited on a portion of the substrate 710. As shown, the process indicator 720 is shown in a cross-sectional view of the substrate 710 and is intended to be positioned in the interior of the article 701. A disinfectant may flow through the endoscope 790 and into the flow channel formed by the process indicator 720 and the second substrate. The disinfectant may contact the process indicator 720, which may provide a visual indication of disinfection.

[0123] exist Figure 8 In the embodiment, the endoscope 790 is positioned to rest on the spacer element 740. Outflow from the endoscope 790 can be concentrated into the funnel device 770. There can be a separation distance d between the tip of the endoscope 790 and the funnel device 770. The disinfectant can flow from the endoscope 790 and into the funnel device 770. The funnel device 770 can concentrate the flow of the disinfectant through the flow channel, such as Figure 7 As described in.

[0124] Fig. 9 A perspective view of a disinfection device 900 is shown. The disinfection device 900 includes a pool 997 in which disinfection is performed. The disinfection device 900 may include a disinfectant port 999 in which a medical device (e.g., an endoscope) 990 is attached. The medical device 990 may be positioned within the pool 997. When the disinfectant flows through the disinfection port 999 and the medical device 990, an outflow 998 is generated at the end of the medical device 990. The outflow 998 is collected in the pool 997. The article 901 is positioned within the pool 997 so that the article 901 can provide an indication of the outflow 998. The article 901 may be similar to the articles from Figures 1-8.

[0125] The article 901 may be arranged along the longitudinal axis D L Oriented at a specific standoff distance d from the effluent 998. For example, the article 901 can be positioned such that the standoff distance d between the effluent 998 and the flow channel of the medical device is no greater than 3 inches, no greater than 2 inches, no greater than 1 inch, or no greater than 0.5 inches.

[0126] The article 901 can be positioned so that at least a portion of the flow channel is oriented toward the outflow. For example, a majority of the flow channel can be oriented toward the outflow 998.

[0127] The disinfectant may contain aldehydes known to be used to disinfect medical devices, such as, for example, formaldehyde and dialdehydes (e.g., flutaraldehyde, glutaraldehyde, or o-phthalaldehyde), and combinations thereof. The disinfectant may include the aldehyde in a liquid carrier, such as, for example, water, an organic solvent (e.g., propylene glycol), or a mixture thereof. The appropriate dilution level may depend on industry and / or regulatory standards. When the concentration of the aldehyde in the disinfectant is sufficient, the reaction of the aldehyde with the synthetic amine-containing compound produces a product that may have an easily observable change in color and / or other spectral properties (e.g., dielectric constant).

[0128] Examples of suitable medical articles 990 for practicing the present disclosure include, for example, graspers (e.g., forceps), clamps, occluders, retractors, traction devices, positioners, stereotactic devices, mechanical cutters, (e.g., surgical scalpels, lancets, files, trocars, drills, rongeurs, reamers, ridge reamers, bone scrapers, scissors, broaches), dilators, specula, sealing devices (e.g., surgical staplers), needles (e.g., for irrigation or injection), tips (e.g., for irrigation or aspiration), tubes (e.g., for irrigation or aspiration), tools (e.g., hip impactors, screwdrivers, spreaders, hammers, spreader holders, probes, carriers, applicators, cutting laser guides, rulers, calipers, drill keys), powered devices (e.g., dermatomes, ultrasonic tissue disruptors, cryo-microtomes, drills), and lumen-bearing devices. Lumen-bearing devices have at least one internal conduit through which a disinfectant can be introduced. Examples of lumen-bearing devices include endoscopes, such as, for example, arthroscopy, laparoscopes, thoracoscopes, cystoscopes, rhinoscopes, bronchoscopes, colonoscopes, choledochoscopes, echoendoscopes, enteroscopes, esophagoscopes, gastroscopes, laryngoscopes, rhinolaryngoscopes, sigmoidoscopes, and duodenoscopes.

[0129] The endoscope may have at least one internal conduit, and the disinfectant may be recirculated through the at least one internal conduit.

[0130] When the article 901 is positioned within a portion of the effluent 998, the process indicator of the article 901 may contact the disinfectant. There may be predetermined disinfectant exposure criteria for contacting the disinfectant with the medical device 990. Generally, the predetermined disinfectant exposure criteria correspond to industry-recognized standards for disinfecting the medical device 990. The predetermined disinfectant exposure criteria may correspond to industry and / or government standards and / or guidelines or protocols for disinfecting medical devices, or a specific disinfection procedure of a medical device manufacturer. Examples include ANSI / AAMI ST91:2015, “Flexible and semi-rigid endoscopic processing in health care facilities,” American National Standards Institute, Washington, DC, and “Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes,” Society of Gastroenterology Nurses and Associates, Inc. (SGNA), Chicago, Illinois, 2015.

[0131] The disinfection device 900 can be arranged in parallel. For example, the disinfectant is recirculated through the medical device 990 and the product 901 by a pump. The disinfectant can be transferred through the tubing so that the product 901 flows in parallel with the medical device 990.

[0132] After the sterilization cycle is complete, the user can observe (e.g., visually or instrumentally) the article 901 to determine whether a predetermined sterilant exposure (e.g., minimum effective concentration (MEC), time, and / or temperature) has been achieved. If not, the process can be continued or restarted. Examples of instrumental methods for observing process indicators include human eye observation, reflectance spectroscopy, transmission spectroscopy, fluorescence spectroscopy, phosphorescence spectroscopy, and capacitance. Such methods are well known in the art, and corresponding commercially available equipment can be used.

[0133] If the article 901 is observed to indicate inadequate disinfection (i.e., fails) relative to the predetermined disinfectant exposure criteria, further processing is typically performed until the article 901 indicates adequate disinfection (i.e., passes) relative to the predetermined disinfectant exposure criteria, or the medical device 990 can be optionally re-cleaned and the entire process repeated. If the article 901 is observed to indicate adequate disinfection (i.e., passes) relative to the predetermined disinfectant exposure criteria, the disinfection / cleaning process can be stopped.

[0134] A user may observe the article 901 spectroscopically (e.g., by reflection, transmission, and / or fluorescence spectroscopy) and obtain therefrom at least one parameter predictive of a predetermined sterilant exposure criterion (e.g., reflectance, transmittance, and / or fluorescence at one or more wavelengths). For example, observation may be made at one or more wavelengths, which may optionally be compared to a reference wavelength. The parameter to be monitored may be any parameter directly or indirectly related to the amount of reaction product of an aldehyde in the sterilant and a process indicator formed. Exemplary parameters may include visible color (or color change), optical reflectance at one or more wavelengths, capacitance, and fluorescence at one or more wavelengths. The parameters may be obtained continuously or periodically.

[0135] In addition, it can be determined whether a predetermined disinfectant exposure criterion has been reached. This step generally involves comparing the observed parameter with the value of the parameter corresponding to the predetermined disinfectant exposure criterion, and then determining that the predetermined disinfectant exposure criterion has been reached. If not, the process continues until the predetermined disinfectant exposure criterion is met, or the entire cycle is repeated.

[0136] Fig.10 A mounting guide 1096 is shown that can be used with the article 1001. The mounting guide 1096 can consistently position the article 1001 relative to the medical device 1090. In some embodiments, the mounting guide can be an instrument protector designed to protect the medical device 1090 (e.g., an endoscope) from impact. In other embodiments, the mounting guide 1096 can provide limited or no protection to the medical device 1090. The mounting guide 1096 can be made of a rigid material that is preferably antimicrobial and structurally resistant to disinfectant conditions. Exemplary materials include polymers, paper, or even ceramics. The mounting guide 1096 can have one or more fixing components (e.g., 1094, 1095). The fixing components (e.g., 1094, 1095) can fix the medical device 1090 to the mounting guide 1096 and can be rubber, polymer, or even metal clips.

[0137] like Fig.10As shown, the fixing components (e.g., 1094, 1095) are vertical slits formed by the body of the mounting guide 1096. The fixing component 1095 can fix the top end of the medical device 1090. The fixing component 1095 can be formed by a first vertical slit and a second vertical slit on the mounting guide 1095, thereby allowing the medical device 1090 to pass through the slits. Likewise, the fixing component 1094 can also prevent the movement of the medical device 1090 and can be formed similarly to the fixing component 1095.

[0138] The mounting guide 1096 may also have one or more marking areas 1092, 1093 for placing the medical article 1001 as described above. The marking area 1092 may provide a visual indication of how to position the medical device 1090. The marking area 1093 may provide a visual indication of how to position the article 1001 described herein. The positioning defined by the marking area 1092 may maintain a specific separation distance d of the disinfectant effluent 1098.

[0139] List of Exemplary Implementations

[0140] Embodiment 1. An article comprising:

[0141] a first substrate having a first major surface and opposite ends; and

[0142] a process indicator disposed on at least a portion of the first major surface;

[0143] Wherein a flow channel is formed by a portion of the process indicator and extends between opposite ends.

[0144] Embodiment 1a. The article of any of the preceding embodiments, wherein the fluid transported through the flow channel contacts the process indicator.

[0145] Embodiment 1b. The article of any of the preceding embodiments, wherein the first wall of the flow channel is formed by a portion of the process indicator.

[0146] Embodiment 1c. The article of any of the preceding embodiments, further comprising a second substrate having a first major surface, wherein the flow channel is also formed by a portion of the first major surface of the second substrate.

[0147] Embodiment 1d. The article of any of the preceding embodiments, wherein the second wall of the flow channel is formed by a portion of the first major surface of the second substrate.

[0148] Embodiment 1e. The article of any of the preceding embodiments, wherein the opposing ends include a first end and a second end, wherein the flow channel defines a fluid path for the disinfectant from the first end to the second end.

[0149] Embodiment 1f. The article according to any of the preceding embodiments, wherein the process indicator is chemically reacted with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, o-phthalaldehyde, hydrogen peroxide, and peracetic acid.

[0150] Embodiment 2. The article according to any of the preceding embodiments, wherein the process indicator is sandwiched between the first substrate and the second substrate.

[0151] Embodiment 3. An article according to any of the preceding embodiments, wherein the first substrate has at least one side.

[0152] Embodiment 4. The article of any of the preceding embodiments, wherein the second substrate is coupled to at least a portion of the process indicator.

[0153] Embodiment 5. The article of any of the preceding embodiments, wherein the second substrate is secured to at least a portion of the first substrate.

[0154] Embodiment 6. An article according to any of the preceding embodiments, wherein the first substrate has at least a first longitudinal side.

[0155] Embodiment 7. The article of any of the preceding embodiments, wherein the first longitudinal face is parallel to the flow channel.

[0156] Embodiment 8. The article of any of the preceding embodiments, wherein the first longitudinal side is defined by a length of the first substrate along the longitudinal axis.

[0157] Embodiment 9. The article of any of the preceding embodiments, wherein the second substrate is secured to at least a portion of the first substrate at least through an area defined by the first longitudinal side of the first substrate.

[0158] Embodiment 9a. An article according to any of the preceding embodiments, wherein the region is further defined by a distance that is no greater than 30% of the width of the first substrate.

[0159] Embodiment 9b. The article of any of the preceding embodiments, wherein the flow channels are defined by regions.

[0160] Embodiment 10. The article of any of the preceding embodiments, wherein the first substrate has at least a first lateral surface.

[0161] Embodiment 11. The article of any of the preceding embodiments, wherein the second substrate is not secured to the first substrate via the first lateral face.

[0162] Embodiment 12. The article of any of the preceding embodiments, wherein the process indicator is disposed over the entire surface of the first substrate.

[0163] Embodiment 13. The article of any of the preceding embodiments, wherein the first substrate is a laminated paper.

[0164] Embodiment 14. The article of any of the preceding embodiments, wherein the first substrate is a polymer.

[0165] Embodiment 15. The article according to any of the preceding embodiments, wherein the first substrate is a polyethylene terephthalate (PET) film.

[0166] Embodiment 16. The article of any of the preceding embodiments, wherein the PET film has a thickness of no greater than ten thousandths of an inch.

[0167] Embodiment 17. An article according to any of the preceding embodiments, wherein the first substrate has at least a first longitudinal side and a second longitudinal side.

[0168] Embodiment 18. The article of any of the preceding embodiments, wherein the second substrate is secured to at least a portion of the first substrate at least through the second longitudinal face of the first substrate.

[0169] Embodiment 19. An article according to any of the preceding embodiments, wherein the first major surface of the second substrate is hydrophobic.

[0170] Embodiment 20. The article of any of the preceding embodiments, wherein the first major surface of the second substrate is hydrophilic.

[0171] Embodiment 21. An article according to any of the preceding embodiments, wherein the first major surface of the first substrate is hydrophobic.

[0172] Embodiment 22. An article according to any of the preceding embodiments, wherein the first major surface of the first substrate is hydrophilic.

[0173] Embodiment 23. The article of any of the preceding embodiments, further comprising a spacing element.

[0174] Embodiment 23a. The article of any of the preceding embodiments, wherein the spacing element is sandwiched between the process indicator and the second substrate.

[0175] Embodiment 23b. The article of any of the preceding embodiments, wherein a spacing element is disposed in at least a portion of the flow channel.

[0176] Embodiment 24. The article of any of the preceding embodiments, wherein the spacer element is a nonwoven article.

[0177] Embodiment 24a. The article of any of the preceding embodiments, wherein the spacer element is a sponge.

[0178] Embodiment 25. The article of any of the preceding embodiments, wherein the spacer element is a tube.

[0179] Embodiment 26. The article of any of the preceding embodiments, wherein the tube has a plurality of openings formed by the body of the tube.

[0180] Embodiment 27. An article according to any of the preceding embodiments, wherein the spacing element is integrated with the second substrate.

[0181] Embodiment 28. An article according to any of the preceding embodiments, wherein the spacing element includes a first member that extends at least a portion of the length of the second substrate and is non-planar to the second substrate.

[0182] Embodiment 29. The article of any of the preceding embodiments, wherein the first member is positioned at an angle of approximately 90 degrees relative to the second substrate.

[0183] Embodiment 30. An article according to any of the preceding embodiments, wherein the first member includes a portion extending away from the first member and parallel to the second substrate.

[0184] Embodiment 31. An article according to any of the preceding embodiments, wherein the first member extends the entire length of the second substrate.

[0185] Embodiment 32. An article according to any of the preceding embodiments, wherein the spacing element includes a second member that extends at least a portion of the length of the second substrate and is non-planar to the second substrate.

[0186] Embodiment 33. An article according to any of the preceding embodiments, wherein the spacing element comprises a plurality of members.

[0187] Embodiment 34. The article of any of the preceding embodiments, wherein the second substrate is a microreplicated surface.

[0188] Embodiment 35. The article of any of the preceding embodiments, wherein the height of the first member is at least 0.01 mm.

[0189] Embodiment 36. The article of any of the preceding embodiments, wherein the plurality of members includes a second member, wherein the first member is spaced apart from the second member by at least 0.05 millimeters.

[0190] Embodiment 37. The article of any of the preceding embodiments, wherein the face of the first member is straight and is positioned to form an angle of no more than 45 degrees with the face of the second substrate.

[0191] Embodiment 38. An article according to any of the preceding embodiments, wherein the distance between the opposing ends is no greater than 4 inches.

[0192] Embodiment 39. An article according to any of the preceding embodiments, wherein the distance between the opposing ends is no greater than 3 inches.

[0193] Embodiment 40. The article of any of the preceding embodiments, wherein the distance between the opposing ends is no greater than 2 inches.

[0194] Embodiment 41. The article of any of the preceding embodiments, wherein the distance between the opposing ends is no greater than 0.5 inches.

[0195] Embodiment 42. The article of any of the preceding embodiments, wherein the distance between the opposing ends is no greater than 0.375 inches.

[0196] Embodiment 43. The article of any of the preceding embodiments, wherein the distance between the opposing ends is no greater than 0.25 inches.

[0197] Embodiment 44. The article of any of the preceding embodiments, wherein the distance between the opposing ends is no greater than 0.125 inches.

[0198] Embodiment 44a. An article according to any of the preceding embodiments, wherein the ratio of the length to the width of the first substrate is no greater than 5:1.

[0199] Embodiment 44b. An article according to any of the preceding embodiments, wherein the ratio of the length to the width of the first substrate is no greater than 4:1.

[0200] Embodiment 44c. An article according to any of the preceding embodiments, wherein the ratio of the length to the width of the first substrate is no greater than 3:1.

[0201] Embodiment 44d. An article according to any of the preceding embodiments, wherein the ratio of the length to the width of the first substrate is no greater than 2:1.

[0202] Embodiment 45. The article of any of the preceding embodiments, further comprising a funnel device positioned adjacent to the flow channel.

[0203] Embodiment 46. The article of any of the preceding embodiments, wherein the funnel is further positioned to direct the disinfectant into the flow channel.

[0204] Embodiment 47. The article of any one of the preceding embodiments, wherein the composition further comprises an aqueous liquid carrier in which the compound is dispersed or dissolved.

[0205] Embodiment 48a. The article of any one of the preceding embodiments, wherein the process indicator is selected from the group consisting of sodium sulfite, ammonium chloride, ammonium bromide, ammonium bicarbonate, ammonium acetate, and combinations thereof.

[0206] Embodiment 48b. An article according to any of the preceding embodiments, wherein the process indicator comprises a synthetic amine-containing compound disposed on at least a portion of the first major surface, wherein the synthetic amine-containing compound comprises at least one of a primary amino group or a secondary amino group.

[0207] Embodiment 48c. The article of any of the preceding embodiments, wherein the synthetic amine-containing compound comprises a synthetic amine-containing polymer.

[0208] Embodiment 48d. The article according to any of the preceding embodiments, wherein the synthetic amine-containing polymer comprises at least one of:

[0209] i) branched polyethylenimine;

[0210] ii) branched polyethylenimine that has been electron beam grafted onto a substrate;

[0211] iii) cross-linked branched polyethylenimine;

[0212] iv) cross-linked branched guanidinium polyethylenimine; or

[0213] v) Cross-linked branched silylated polyaziridine.

[0214] Embodiment 49. The article of any of the preceding embodiments, wherein the cross-linked branched silylated polyethylenimine comprises a cross-linked reaction product of polyethylenimine and a compound containing at least two amine-reactive groups.

[0215] Embodiment 49a. The article according to any of the preceding embodiments, wherein the compound is at least one amine-reactive organosilane coupling agent represented by the formula:

[0216] R 3 –Z–SiY3

[0217] in:

[0218] R 3 represents an amine-reactive group containing 1 to 12 carbon atoms;

[0219] Z represents a divalent organic group containing 1 to 8 carbon atoms; and

[0220] Each Y independently represents a hydrolyzable group.

[0221] Embodiment 49b. The article of any one of the preceding embodiments, further comprising an aqueous liquid carrier in which the compound is dispersed or dissolved.

[0222] Embodiment 49c. The article according to any one of the preceding embodiments, wherein R 3 Having 1 to 3 carbon atoms.

[0223] Embodiment 49d. The article according to any one of the preceding embodiments, wherein R 3 Selected from

[0224] isocyanate group, oxiranyl group, glycidoxy group, acryloxy group, ethoxycarbonyl group, methoxycarbonyl group, vinylsulfonyl group and acrylamide group.

[0225] Embodiment 49e. The article according to any of the preceding embodiments, wherein Z further contains 1 to 6 heteroatoms selected from O, N and S.

[0226] Embodiment 49f. The article of any one of the preceding embodiments, wherein Z comprises an alkylene group containing 1 to 3 carbon atoms.

[0227] Embodiment 49g. The article of any of the preceding embodiments, wherein each Y is independently selected from methoxy, ethoxy, hydroxy, acetoxy, chloro, and bromo.

[0228] Embodiment 49h. An article according to any of the preceding embodiments, wherein the at least one amine-reactive hydrolyzable organosilane is selected from 3-isocyanatopropyltriethoxysilane, 3-isocyanatopropyltrimethoxysilane, 2-isocyanatoethyltriethoxysilane, 2-isocyanatoethyltrimethoxysilane, 3-acryloxypropyltriethoxysilane, 3-acryloxypropyltrimethoxysilane, 2-acryloxyethyltriethoxysilane, 2-acryloxyethyltrimethoxysilane, 2,3-epoxypropyltrimethoxysilane, 2,3-epoxypropyltriethoxysilane, 3-glycidoxypropyltriethoxysilane and 3-glycidoxypropyltrimethoxysilane.

[0229] Embodiment 49i. An article according to any of the preceding embodiments, further comprising a polymeric binder material.

[0230] Embodiment 50. The article according to any of the preceding embodiments, wherein the synthetic amine-containing polymer comprises an amine-functional polysiloxane.

[0231] Embodiment 51. The article of any of the preceding embodiments, wherein the synthetic amine-containing compound comprises polyaziridine chemically bonded to silica.

[0232] Embodiment 52. An article according to any of the preceding embodiments, wherein the first substrate includes a second major surface.

[0233] Embodiment 53. The article of any of the preceding embodiments, further comprising a polymer film disposed on the second major surface of the first surface.

[0234] Embodiment 54. The article according to any of the preceding embodiments, wherein the polymer film is a PET film.

[0235] Embodiment 55. The article of any of the preceding embodiments, wherein the PET film has a thickness of no greater than ten thousandths of an inch.

[0236] Embodiment 56. The article of any of the preceding embodiments, further comprising an adhesive disposed between the second major surface of the first surface and the polymeric film.

[0237] Embodiment 57. An article according to any of the preceding embodiments, wherein the second substrate comprises a second major surface, and the article further comprises an adhesive disposed on the second major surface of the second surface.

[0238] Embodiment 58. The article of any of the preceding embodiments, wherein the adhesive is a pressure sensitive adhesive.

[0239] Embodiment 59. A kit comprising:

[0240] The article according to any of the preceding embodiments.

[0241] Embodiment 60. The kit according to any one of the preceding embodiments, further comprising:

[0242] Release liner;

[0243] Cutting device.

[0244] Embodiment 61. The kit according to any one of the preceding embodiments, further comprising:

[0245] Install the guide.

[0246] Embodiment 61a. A kit according to any of the preceding embodiments, wherein the mounting guide has one or more slots for positioning the medical device.

[0247] Embodiment 62. The kit of any of the preceding embodiments, wherein the mounting guide is configured to position the medical device such that outflow of disinfectant from the medical device has a standoff distance of no greater than 2 inches.

[0248] Embodiment 63. A kit according to any of the preceding embodiments, wherein the spacing distances are marked on the mounting guide.

[0249] Embodiment 63. A method comprising:

[0250] positioning the medical device within the sterilization device, wherein an effluent is generated when a sterilant flows through the sterilization device;

[0251] positioning an article according to any of the preceding embodiments within a portion of the effluent; and

[0252] A disinfectant is contacted with the process indicator, wherein a predetermined disinfectant exposure criterion exists for contacting the disinfectant with the medical device.

[0253] Embodiment 64. The method according to any one of the preceding embodiments, further comprising:

[0254] spectrally observing the process indicator and deriving therefrom at least one parameter predictable of a predetermined sterilant exposure criterion; and

[0255] Determine that predetermined disinfectant exposure criteria have been achieved.

[0256] Embodiment 65. The method according to any of the preceding embodiments, wherein the disinfectant comprises at least one dialdehyde.

[0257] Embodiment 66. The method of any one of the preceding embodiments, wherein the disinfectant comprises at least one of flutalaldehyde or o-phthalaldehyde.

[0258] Embodiment 67. The method of any of the preceding embodiments, wherein the predetermined disinfectant exposure criteria corresponds to an industry-recognized standard for disinfecting medical devices.

[0259] Embodiment 68. The method of any of the preceding embodiments, wherein the medical device comprises an endoscope having at least one internal conduit, and wherein the disinfectant is recirculated through the at least one internal conduit.

[0260] Embodiment 69. A method according to any of the preceding embodiments, wherein at least one parameter includes optical reflectivity.

[0261] Embodiment 70. A method according to any of the preceding embodiments, wherein at least one parameter includes visible color.

[0262] Embodiment 71. A method according to any of the preceding embodiments, wherein at least one process parameter indicator is obtained continuously.

[0263] Embodiment 72. The method according to any of the preceding embodiments, wherein positioning the article comprises:

[0264] The article is positioned such that at least a portion of the flow channel is oriented toward the outflow.

[0265] Embodiment 73. The method according to any of the preceding embodiments, wherein positioning the article comprises:

[0266] The article is positioned so that a majority of the flow channels are oriented toward the outflow.

[0267] Embodiment 74. The method according to any of the preceding embodiments, wherein positioning the article comprises:

[0268] The article is positioned such that the effluent and flow channels of the medical device are separated by no more than 3 inches.

[0269] Embodiment 75. A method according to any of the preceding embodiments, wherein the separation distance between the effluent and the flow channel of the medical device is no greater than 2 inches.

[0270] Embodiment 76. A method according to any of the preceding embodiments, wherein the separation distance between the effluent and the flow channel of the medical device is no greater than 1 inch.

[0271] Embodiment 77. The method according to any of the preceding embodiments, further comprising contacting the medical device with a mounting guide, wherein positioning the article comprises positioning the article on the mounting guide.

[0272] Example

[0273] Sample preparation (EX1-EX2) :

[0274] Example 1 (EX1)

[0275] The substrate material was prepared by laminating an approximately 2.5 mil thick polyester / ionomer film (commercially available under the trade name SURLYN from EI du Pont de Nemours and Company (Wilmington, DE)) to one side of Whatman 410 grade filter paper (approximately 7.3 mils thick). Branched polyethylenimine (molecular weight 60,000 g / mol, 50 wt % aqueous solution, available from Thermo Fisher Scientific, Waltham, Massachusetts) was diluted to 10 wt % with added distilled water. The solution was coated onto the paper side of the substrate material using reverse gravure printing as described in Example PI4 of U.S. Patent Application 62 / 332,243 filed May 5, 2016 (Attorney Docket No. 78258US002). The coated substrate was then dried at 100° C. for 5 minutes to form a polyethyleneamine chemical indicator (PEI CI) and cut into units of 5 cm×1 cm size.

[0276] The PEI CI was adhered to the adhesive side of an adhesive-coated 10-mil polyester terephthalate (PET) top film (the adhesive was 2 mil thick and commercially available from 3M Company with 300 LSE transfer adhesive), with the PET film side of the PEICI facing the adhesive and the Whatman paper side of the PEI coating facing away from the adhesive. The PET film was commercially available from 3M Company as Model Series 990 Polyester Film 9901000, which has a hydrophilic treated side and an opposite untreated hydrophobic side. The PEICI was then sandwiched between the bottom layer of a 3M condensation management film (purchased from 3M Company, St. Paul, MN) and the adhesive-coated 10-mil PET top film, such that the PEI coated side faced the micro-replicated surface of the condensation management film, which was a micro-replicated moisture management band. In this configuration, a series of channels were formed longitudinally between the PEI CI strips and the micro-replicated surface.

[0277] Example 2 (EX2)

[0278] Example 1 (EX1) was repeated with the following differences. A branched polyethylenimine (abbreviated as bPEI, MW 60,000 g / mol, 50 wt% aqueous solution) was mixed with 30 wt% of a polyurethane dispersion (obtained as model # CS 8057, Incorez Copolymer Ltd., United Kingdom) and distilled water to form a coating formulation with a bPEI:polyurethane dispersion weight ratio of 1:1. The polyurethane / polyethylenimine (PU / PEI) composition was coated directly onto a 10 mil PET film, rather than onto the paper side of the laminated paper.

[0279] Test Method :

[0280] An endoscope (Olympus PCF Type S from Olympus Corporation (Japan)) was placed in a bath of an AER (commercially available as Model DSD-201 from Medivators Inc. (Minneapolis, MN)). A standard AER cycle was run without a detergent wash stage using 0.35% OPA as the disinfectant. The flow rate of the disinfectant out of the endoscope was approximately 800 ml / min. The exemplary article was placed in the direct flow path of the endoscope for one cycle. The color definitions are recorded in Table 1.

[0281] Table 1

[0282]

[0283] Sample preparation (EX3-EX5) :

[0284] Example 3 (EX3)

[0285] Example 1 (EX1) was repeated with the following differences. The process indicator of the PU / PEI composition was sandwiched between the top and bottom layers of a 10 mil PET film so that the PU / PEI coated side of the PU / PEI CI faced the hydrophilic treated side of the bottom of the PET film (3M Series 900 Polyester Film 9901000). In this configuration, a single channel with the width of the PU / PEI CI was formed longitudinally between the PU / PEI CI strip and the hydrophilic treated surface of the PET bottom film. The PET bottom film was adhered to the entire length (along the edges) of the article using 3M 300 LSE transfer adhesive, with no direct adhesive between the PU / PEI CI and the bottom PET film. A channel was formed between the PET bottom film and the PEI CI. The adhesive used to adhere the label sample to the wall of the AER pool can be purchased from 3M Company as VHB transfer adhesive.

[0286] Example 4 (EX4)

[0287] The sample was prepared identically to EX3, except that the PU / PEI CI faced the untreated hydrophobic side of the bottom PET film. In this configuration, a single channel with the width of the PU / PEI CI was formed longitudinally between the PEI CI strip and the untreated hydrophobic surface of the PET bottom film.

[0288] Example 5 (EX5)

[0289] The samples were prepared identically to CE1, except that the PEI indicator was used instead of the PU / PEI indicator.

[0290] Test Method :

[0291] An endoscope (Olympus PCF Type S from Olympus Corporation, Japan) was placed in a bath of an AER (commercially available as Model DSD-201 from Medivator, Minneapolis, Minnesota). A standard AER cycle was run without a detergent wash stage using 0.35% OPA as the disinfectant. The flow rate of the disinfectant out of the endoscope was approximately 800 ml / min. The exemplary article was placed in the direct flow path of the endoscope for one cycle. The color definitions are recorded and ranked in Table 2 (where 1 is the most defined color).

[0292] Table 2

[0293]

[0294] Sample preparation (EX6-EX10) :

[0295] Example 6 (EX6)—Same as EX4 above, but with the following differences. Figure 6, the width x of the chemical indicator strip is held constant at 0.5 in. The distances s and t are 1 in. The distances v and u are zero. The length l of the strip is 2 in.

[0296] Example 7 (EX7)—A sample was prepared identically to that in EX6, except that the length l was 2.5 inches.

[0297] Example 8 (EX8)—A sample was prepared identically to that in EX6, except that the length l was 3 inches.

[0298] Example 9 (EX9)—A sample was prepared identically to that in EX6, except that the length l was 3.5 inches.

[0299] Example 10 (EX10)—A sample was prepared identically to that in EX6, except that the length l was 4 inches.

[0300] Test Method :

[0301] An endoscope (Olympus PCF Type S from Olympus Corporation of Japan) was placed in a bath of AER (commercially available as Model DSD-201 from Medivator, Minneapolis, Minnesota). A standard AER cycle was run using 0.35% OPA as the disinfectant. The flow rate of the disinfectant leaving the endoscope was approximately 800 ml / min. An exemplary article was placed in the direct flow path of the endoscope for one cycle with a standoff distance of 1 inch from the flow channel of the article to the endoscope tip. The cycle did not include a 15 minute detergent wash phase. The color definitions were recorded and ranked in Table 3.

[0302] Table 3

[0303]

[0304] Sample preparation (EX11-EX14) :

[0305] Example 11 (EX11)—Same as EX4 above, but with the following differences. Figure 6 , the length l of the chemical indicator strip x is held constant at 2 inches. The distances s and t are equal but vary relative to the total width. The distances v and u are zero. The width of the strip is 0.5 inches.

[0306] Example 12 (EX12) - A sample was prepared identically to EX11, except that the width x was 0.375 inches.

[0307] Example 13 (EX13) - A sample was prepared identically to EX11, except that the width x was 0.25 inches.

[0308] Example 14 (EX14) - A sample was prepared identically to EX11, except that the width x was 0.125 inches.

[0309] Test Method :

[0310] The endoscope (Olympus PCF Type S from Olympus Corporation, Japan) was placed in a bath of AER (commercially available as Model DSD-201 from Medivator, Minneapolis, Minnesota). A standard AER cycle was run using 0.35% OPA as the disinfectant. The flow rate of disinfectant leaving the endoscope was approximately 800 ml / min. Fig. 9 , the exemplary article was placed in the direct flow path of the endoscope for one cycle, where the standoff distance d from the flow channel of the article to the endoscope tip was 1 inch. The cycle did not include a 15 minute detergent wash phase. The color definitions were recorded and ranked in Table 4.

[0311] Table 4

[0312]

[0313] Sample preparation (EX15-EX18) :

[0314] Example 15 (EX15) - Indicator strips were prepared identically to EX11. The spacing was 1 inch.

[0315] Example 16 (EX16) - Indicator strips were prepared identically to EX11. The spacing was 1.5 inches.

[0316] Example 17 (EX17) - Indicator strips were prepared identically to EX11. The spacing was 2 inches.

[0317] Example 18 (EX18) - Indicator strips were prepared the same as in EX1. The spacing was 3 inches.

[0318] Test Method :

[0319] The endoscope (Olympus PCF Type S from Olympus Corporation, Japan) was placed in a bath of AER (commercially available as Model DSD-201 from Medivator, Minneapolis, Minnesota). A standard AER cycle was run using 0.35% OPA as the disinfectant. The flow rate of disinfectant leaving the endoscope was approximately 800 ml / min. Fig. 9, the exemplary article was placed in a direct flow path for one cycle, where the standoff distance d from the flow channel of the article to the endoscope tip varied between 1 inch and 3 inches. The cycle did not include a 15 minute detergent wash phase. The color definitions are recorded in Table 5.

[0320] Table 5

[0321]

Claims

1. A product, comprising: a first substrate having a first major surface and opposing ends, wherein the opposing ends include a first end and a second end; and a process indicator and a polymer binder disposed in the form of a coating or film over the entire surface area of ​​the first major surface, wherein the process indicator is reactive with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, o-phthalaldehyde, hydrogen peroxide, peracetic acid, and combinations thereof; a flow passage formed by a portion of the process indicator, the flow passage extending between the opposed ends, wherein the flow channel defines a fluid path for said at least one disinfectant from said first end portion through said second end portion; and A second substrate having a first major surface, wherein the flow channel is also formed by a portion of the first major surface of the second substrate, wherein the second substrate is a microreplicated surface. 2 . The article of claim 1 , wherein the first wall of the flow channel is formed by a portion of the process indicator. 3 . The article of claim 1 , wherein a second wall of the flow channel is formed by a portion of the first major surface of the second substrate.

4. The article of claim 1, wherein the process indicator is sandwiched between the first substrate and the second substrate.

5. The article of claim 1, further comprising a spacer element, wherein the spacer element is sandwiched between the process indicator and the second substrate.

6. The article of claim 1 , wherein the first substrate has at least a first longitudinal surface, wherein the second substrate is secured to at least a portion of the first substrate at least via an area defined by the first longitudinal surface of the first substrate, wherein the area is further defined by a distance no greater than 30% of a width of the first substrate.

7. The article of claim 1, wherein the first substrate is a polyethylene terephthalate (PET) film.

8. The article of claim 7, wherein the PET film has a thickness no greater than ten thousandths of an inch.

9. A kit, comprising: The product according to claim 1; A mounting guide, wherein the mounting guide has one or more fixation devices for positioning a medical device.

10. The kit of claim 9, further comprising: Release liner; Cutting device.

11. The kit of claim 10, wherein the mounting guide is configured to position the medical device such that outflow of disinfectant from the medical device has a standoff distance of no greater than 2 inches.

12. A method comprising: positioning the medical device within a sterilization device, wherein an effluent is generated when a disinfectant flows through the sterilization device; positioning the article of claim 1 within a portion of the effluent; and The disinfectant is contacted with the process indicator, wherein a predetermined disinfectant exposure criterion exists for contacting the disinfectant with the medical device.

13. The method according to claim 12, further comprising: spectrally observing the process indicator and deriving therefrom at least one parameter predictive of the predetermined disinfectant exposure criterion; as well as A determination is made that the predetermined disinfectant exposure criterion has been met.

14. The article of claim 1, wherein the process indicator comprises a synthetic amine-containing compound disposed on at least a portion of the first major surface, wherein the synthetic amine-containing compound comprises at least one of a primary amino group or a secondary amino group.

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