Treatment Indicator, A Method Of Production Thereof, And A Method Of Use Thereof

FIELD

The present disclosure relates to a treatment indicator, a method of producing a treatment indicator, and a method of use thereof.

BACKGROUND

Various medical devices are used in numerous procedures in the medical field. These devices are as varied as the procedures themselves. After a medical device, such as an endoscope, is used, the medical device can be treated (e.g., cleaned, disinfected, and/or sterilized) in order to prepare the medical device for its next use. Ensuring the medical device is properly treated prior to its subsequent use on a patient can prevent the risk of cross contamination and the spread of disease.

SUMMARY

The present disclosure provides a treatment indicator. The treatment indicator comprises a first body comprising a biological material, a fluid porous body in fluid communication with the first body in a fluid path, and a cleaning test soil disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path.

The present disclosure provides a method for indicating a level of treatment in a treatment apparatus. The method comprises introducing a treatment indicator into the treatment apparatus. The treatment indicator comprises a first body comprising a biological material, a fluid porous body in fluid communication with the first body in a fluid path, and a cleaning test soil disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path. The treatment indicator is subjected to a cleaning process and at least one of a disinfection process and a sterilization process. A quantity of active biological material in the first body is measured following the cleaning process and the at least one of the disinfection process and the sterilization process.

The present disclosure provides a method for preparing a treatment indicator. The method comprises forming a first body comprising a biological material and forming a fluid porous body comprising a cleaning test soil. The fluid porous body is in fluid communication with the first body in a fluid path, and the cleaning test soil is disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path.

It is understood that the inventions described in this specification are not limited to the examples summarized in this Summary. Various other examples are described and exemplified herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the examples, and the manner of attaining them, will become more apparent and the examples will be better understood by reference to the following description of examples taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a schematic view of a treatment indicator according to the present disclosure;

FIG. 2A is a schematic view of the treatment indicator of FIG. 1 in a first configuration;

FIG. 2B is a schematic view of the treatment indicator of FIG. 1 in a second configuration;

FIG. 2C is a schematic view of the treatment indicator of FIG. 1 in a third configuration; and

FIG. 3 is a perspective view of a system comprising a treatment apparatus and a treatment indicator according to the present disclosure.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate certain examples, in one form, and such exemplifications are not to be construed as limiting the scope of the examples in any manner.

DETAILED DESCRIPTION

Certain examples of the present disclosure will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. Various examples are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting examples and that the scope of the various examples of the present disclosure is defined solely by the claims.

Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

Reference throughout the specification to “various examples,” “some examples,” “one example,” “an example,” or the like, means that a particular feature, structure, or characteristic described in connection with the example is included in at least one example. Thus, appearances of the phrases “in various examples,” “in some examples,” “in one example”, “in an example,” or the like, in places throughout the specification are not necessarily all referring to the same example. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one example or two or more examples. Thus, the particular features, structures, or characteristics illustrated or described in connection with one example may be combined, in whole or in part, with the features, structures, or characteristics of one other example or two or more examples without limitation. Such modifications and variations are intended to be included within the scope of the present disclosure.

In the present disclosure, unless otherwise indicated, all numerical parameters are to be understood as being prefaced and modified in all instances by the term “about”, in which the numerical parameters possess the inherent variability characteristic of the underlying measurement techniques used to determine the numerical value of the parameter. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter described herein should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Also, any numerical range recited herein includes all sub-ranges subsumed within the recited range. For example, a range of “1 to 1 0” includes all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10. Any maximum numerical limitation recited in this specification is intended to include all lower numerical limitations subsumed therein and any minimum numerical limitation recited in this specification is intended to include all higher numerical limitations subsumed therein. Accordingly, Applicant reserves the right to amend this specification, including the claims, to expressly recite any sub-range subsumed within the ranges expressly recited.

The grammatical articles “a”, “an”, and “the”, as used herein, are intended to include “at least one” or “one or more”, unless otherwise indicated, even if “at least one” or “one or more” is expressly used in certain instances. Thus, the articles are used herein to refer to one or more than one (i.e., to “at least one”) of the grammatical objects of the article. Further, the use of a singular noun includes the plural, and the use of a plural noun includes the singular, unless the context of the usage requires otherwise.

A device such as a medical device (e.g., and endoscope) can undergo a treatment process to prevent cross-contamination and the spread of disease. As used herein, a “treatment process” may be a cleaning process, a disinfecting process, a sterilization process, the like, and combinations thereof. A treatment process may be either manual, automated, or some combination thereof, and may utilize a treatment agent. As used herein, a “treatment agent” can comprise at least one of a cleaning agent, a disinfectant, and a sterilant. As used herein a “cleaning process” means a treatment process employing a cleaning agent that removes and/or eliminates debris such as, for example, a dirt, a dust, a particle, an oil, a protein, a carbohydrate, and the like. As used herein, a “cleaning agent” means a type of treatment agent that removes and/or eliminates debris during a cleaning process such as, for example, a surfactant and/or a detergent.

A disinfecting process and a sterilization process can remove and/or eliminate a bioburden from a device. A bioburden may be, for example, a bacterium (e.g., mycobacterium, bacterial spores), an archaean, a eukaryote, a virus, a fungus, and/or other forms of biological agents. Bacterial spores (e.g., endospores) are a form of bacteria which are dormant and highly resistive to physical and chemical degradation. As used herein, a “disinfecting process” means a treatment process that substantially removes a bioburden except for bacterial spores. As used herein, “substantially remove” means that at least 99% of the bioburden has been removed from the device such as, for example, at least 99.9% of the bioburden, at least 99.99% of the bioburden, at least 99.999% of the bioburden, or at least 99.9999% of the bioburden has been removed from the device. As used herein, a “sterilization process” means a treatment process which substantially removes a bioburden including bacterial spores. The sterilization process may include, for example, the addition of heat, freezing, a sterilant, irradiation, pressure, and combinations thereof. The sterilant may comprise a chemical capable of sterilization. The disinfection process may include, for example, the addition of heat, a disinfectant, irradiation, pressure, and combinations thereof. The disinfectant may comprise a chemical capable of disinfection.

A treatment process can comprise bulk removal and/or elimination of debris from the device (e.g., cleaning) and a secondary step of removal and/or elimination of bioburden (e.g., disinfection, sterilization) from the device after the cleaning. Ensuring the device is effectively cleaned, disinfected, and/or sterilized prior to the ultimate use on a patient can prevent the risk of cross contamination and the spread of disease. When a substantial removal of bioburden is desired, disinfection and/or sterilization may be employed in the treatment process. Thus, a treatment indicator is provided herein which can determine whether the device was effectively disinfected and/or sterilized utilizing a single indicator. The treatment indicator can provide a single result for the effectiveness of the disinfection process and/or sterilization process. The treatment indicator can provide a single result for the effectiveness of the cleaning process and at least one of a disinfection process and a sterilization process which can avoid difficulties encountered when interpreting results from multiple sources. Additionally, the present disclosure provides a method for indicating a level of treatment in a treatment apparatus, and a method of preparing a treatment indicator.

FIG. 1 illustrates a treatment indicator 100 of the present disclosure which can comprise a first body 102 and a fluid porous body 106. The first body 102 can comprise a biological material 104. The biological material 104 can be disposed on, in, and/or adhered to a surface of the first body 102. The biological material 104 can be disposed at least partially within the first body 102 (e.g., embedded on, in, or over the interstitial spaces (not shown) of the first body 102). The biological material 104 can be disposed at a single location or at a plurality of locations on/in the first body 102, such as in one layer or two or more layers, and the like. Accordingly, it is contemplated that the positioning of the biological material 104 with respect to the first body 102 may be at various suitable locations, orientations, and configurations. The biological material 104 can be deposited over at least a portion of a surface of the first body 102 in any suitable manner, such as in the manner described in greater detail herein.

The biological material 104 can comprise, for example, a bacterial spore. The bacterial spore can comprise at least one of a Bacillus bacterium (e.g., Bacillus subtilis) and a Geobacillus bacterium (e.g., Geobacillus stearothermophilus). The biological material can be removed and/or eliminated (e.g., degraded) responsive to at least one of a disinfectant and a sterilant. The level of removal and/or elimination of the biological material can be dependent on the type of disinfectant and/or sterilant used, the contact time between the disinfectant and/or sterilant and the biological material, the temperature of the disinfectant and/or sterilant, and the activity of the disinfectant and/or sterilant.

The biological material can multiply (e.g., reproduce) responsive to contact with a growth media. Whether or not the biological material has been removed and/or eliminated by a treatment process can provide an indication of the effectiveness of the treatment process. For example, a sterilant can degrade the biological material on the first body 102 such that biological material is substantially removed from the treatment indicator 100. Therefore, upon contacting the first body 102 with growth media if the biological material has not been substantially removed and/or eliminated (e.g., survived), the biological material can multiply and therefore can indicate that the treatment process was not effective. If the biological material has been substantially removed and/or eliminated by the treatment (e.g., not survived), the biological material may not multiply and therefore can indicate that the treatment process was effective.

The first body 102 can take any form suitable to support the biological material 104. For example, the first body 102 can be at least one of a solid sheet, a perforated sheet, an amorphous support (e.g., a cotton ball), a membrane, and a filter. The first body 102 can comprise a fluid porous material and/or fluid non-porous material, and can comprise, for example, at least one of paper, fiber, cardboard, fabric, metal or metal alloy, a polymer (e.g., plastic), a ceramic, and a glass.

The fluid porous body 106 can comprise interstitial spaces 110 and can be in fluid communication with the first body 102 via a fluid path 108. The fluid path 108 refers to one or more pathways that are either direct or indirect through all or a portion of the fluid porous body 106. The interstitial spaces 110 can be cavities (e.g., pores) within the fluid porous body 106. The interstitial spaces 110 can extend from a first surface 114a of the fluid porous body 106, through the fluid porous body 106 to a second surface 114b of the fluid porous body 106. The interstitial spaces 110 can have any size or cross-sectional configuration through all or part of the fluid porous body 106. For example, the interstitial spaces 110 can be arranged in uniform, varied, and/or random orientations. The first surface 114a and the second surface 114b of the fluid porous body 106 can be in any suitable orientation. For example, the first surface 114a can be disposed opposite the second surface 114b, as illustrated, such that fluid enters the first surface 114a, flows through the fluid porous body 106, and exits the fluid porous body 106 through the second surface 114b.

The fluid porous body 106 can be disposed relative to the first body 102 such that a fluid introduced into the fluid path 108 can traverse through the fluid porous body 106 (e.g., through the interstitial spaces 110) prior to contacting the first body 102. For example, the fluid porous body 106 can be positioned upstream from the first body 102 in the fluid path 108. The fluid path 108 can be the only fluid path to the first body 102. The fluid porous body 106 can surround a surface 116 (e.g., outer surface) of the first body 102. For example, the first body 102 can be positioned within an interior cavity of the fluid porous body 106.

The fluid porous body 106 can take any form suitable that allows fluid to flow therethrough, or be altered such that the interstitial spaces 110 can be made to prevent fluid to the first body 102. For example, the fluid porous body 106 can comprise at least one of paper, fiber, cardboard, fabric, metal or metal alloy, a polymer (e.g., plastic), a ceramic, and a glass. The fluid porous body 106 can comprise any suitable fluid porous structure, such as, for example, at least one of a perforated sheet, an amorphous support (e.g., a cotton ball), a membrane, and a filter. The fluid porous body 106 may, but need not, be formed of the same material throughout its entire thickness, from the first surface 114a through the second surface 114b. It is contemplated that the fluid porous body 106 may have multiple layers or a varied orientation of composite materials that alter the porous properties of the fluid porous body 106 between the first surface 114a and the second surface 114b. For example, one portion of the fluid porous body 106 may have relatively porous properties while another portion of the fluid porous body 106 may have, or may be made to have, limited or no porosity if it is desired to limit fluid flow through the fluid porous body 106 for a period of time, or to inhibit particular materials from passing through the fluid porous body 106.

A cleaning test soil 112 can be disposed in at least a portion of interstitial spaces 110 of the fluid porous body 106 to inhibit or prevent traversal of a fluid through the fluid porous body 106 to the first body 102 via the fluid path 108. The cleaning test soil can be deposited in at least a portion of the interstitial spaces, over at least a portion of the first surface 114a, and/or over at least a portion of the second surface 114b in any suitable manner, such as in the manner described in greater detail herein. The cleaning test soil 112 can be disposed within the interstitial spaces 110 (e.g., embedded, on a wall of the interstitial spaces 110, at an opening of the interstitial spaces 110) of the fluid porous body 106 to partially or entirely occlude the interstitial spaces 110 of the fluid porous body 106. The cleaning test soil 112 can be disposed on at least a portion of the first surface 114a or second surface 114b of the fluid porous body 106. The cleaning test soil 112 can inhibit or prevent traversal of a fluid to the first surface 114a of the fluid porous body 106 and through the fluid porous body 106. When deposited on the second surface 114b the cleaning test soil 112 can inhibit or prevent traversal of a fluid out of the fluid porous body 106 in the orientation illustrated in FIG. 1. The cleaning test soil 112 can be positioned separately from the biological material 104. A fluid porous membrane (not shown in FIG. 1) and/or a void may separate the cleaning test soil 112 and the biological material 104.

The cleaning test soil 112 can be configured for removal from the interstitial spaces 110 of the fluid porous body 106 and/or the first surface 114a responsive to a treatment process. For example, the cleaning test soil 112 can be disposed in the interstitial spaces 110 to inhibit flow through the fluid path 108, but can be removed via the processes and conditions that are part of the treatment process. For example, the cleaning test soil 112 can be removed from the interstitial spaces 110 of the fluid porous body 106 by contact with a fluid (e.g., a fluid used during a cleaning process). The cleaning test soil 112 can be removed from the interstitial spaces by at least one of mechanical removal by a fluid, dissolution into a fluid, and suspension into a fluid. Removal of the cleaning test soil 112 from the interstitial spaces 110 of the fluid porous body 106 responsive to a treatment process (e.g., cleaning process) can enable the traversal of a fluid through the interstitial spaces 110 of the fluid porous body 106 via the fluid path 108. Removal of the cleaning test soil 112 from the interstitial spaces 110 can at least partially increase void volume (e.g., volume within the interstitial spaces that does not comprise cleaning test soil) within an opening or cross-section of the interstitial spaces 110 which can decrease a fluid pressure that is required to drive a fluid through the interstitial spaces 110.

Removal of the cleaning test soil 112 from the interstitial spaces 110 and/or the first surface 114a of the fluid porous body 106 can allow a fluid to flow across, into, and/or through the interstitial spaces 110. After traversal through the interstitial spaces 110 in the fluid porous body 106, the fluid can contact the first body 102 and/or the biological material 104.

The cleaning test soil 112 can comprise debris that a device in need of treatment may comprise. The cleaning test soil 112 can simulate or replicate properties (e.g., physical, chemical) of the debris. For example, the cleaning test soil can simulate or replicate at least one of solubility, viscosity, density, adhesion, and material composition of the debris. The cleaning test soil 112 can comprise various materials that simulate or replicate materials that can accumulate on a medical ice during use on a patient. Thus, subjecting the treatment indicator 100 to a similar or the same treatment process compared to the treatment process to which a device is subjected can indicate whether or not the device was sufficiently treated or treated to an effective level. For example, cleaning test soil removed and/or eliminated from the treatment indicator 100 can indicate that debris was removed and/or eliminated from the device, and substantial removal and/or elimination of biological material can indicate that the bioburden was removed and/or eliminated from the device.

The cleaning test soil 112 can comprise at least one of a protein (and derivatives thereof), a carbohydrate, a nucleic acid, a lipid (e.g., a fat, a wax), a salt (e.g., inorganic salt), and an acid. The inorganic salt can comprise a buffered saline solution. The acid can comprise a bile acid. A protein can be at least one of a blood protein (e.g., hemoglobin, albumin, fibrin, fibrinogen, immunoglobulin), collagen, keratin, casein, and mucin. The level of removal and/or elimination of the cleaning test soil 112 from the interstitial spaces 110 can be dependent on various factors, including the type of treatment agent used, the contact time between the treatment agent and the cleaning test soil 112, the temperature of the treatment agent, and the activity of the treatment agent.

The fluid employed in the desired treatment process can comprise at least one of water, a rinse agent (e.g., water and/or alcohol), a cleaning agent, a disinfectant, and a sterilant. The cleaning agent can comprise at least one of a detergent, a surfactant, and a solvent. The disinfectant can comprise at least one of a quaternary ammonium compound, glutaraldehyde, isopropanol, ethanol, ortho-phthalaldehyde (OP A) (benzene-I,2-dicarbaldehyde), hydrogen peroxide, a phenol, a phenate (e.g., a salt or ester of phenol), and peracetic acid. The sterilant can comprise at least one of hydrogen peroxide, ethylene oxide, nitrogen oxide, ozone, glutaraldehyde, formaldehyde, peracetic acid, chlorine, iodine, and sodium hydroxide.

FIG. 2A illustrates a treatment indicator 200 in a first configuration. The treatment indicator 200 can comprise a housing 220 which can provide mechanical support to the fluid porous body 106 and the first body 102. The housing 220 can enclose a cavity 222 which can comprise the fluid porous body 106 and the first body 102. The housing 220 can comprise a first port 224 and a second port 226. Each port 224, 226 can be a bore through the housing 220. The first port 224 and the second port 226 can be configured to receive fluid and transport fluid throughout the respective port 224, 226. The housing 220 can comprise a single port (not shown), where the single port can be used to both transport the fluid into the cavity 222 and transport the fluid out of the cavity 222. The housing 220 can comprise vent port (not shown) to enable filling and/or emptying of the cavity 222 with fluid through the ports 224, 226 or the single port. For example, the vent port can transport air out of the cavity 222 (e.g., equalize the pressure within the cavity relative to a pressure outside of the cavity 222) as the fluid is introduced into the cavity 222 through the ports 224, 226, or the single port. The vent port can transport air into the cavity 222 as the fluid is removed from the cavity through the ports 224, 226, or the single port.

The housing 220 can be formed of a material suitable to inhibit or prevent fluid traversal between the cavity 222 and an environment external to the cavity 222. The housing 220 can comprise a material such as, for example, at least one of a metal or metal alloy, a polymer (e.g., plastic), a ceramic, and a glass.

The fluid porous body 106 can be positioned within the cavity 222. The fluid porous body 106 can extend radially inward from a surface 234 of the housing 220 and separate the cavity 222 into a first region 222a and a second region 222b. The fluid porous body 106 can engage with the surface 234 to create a seal (e.g., via an adhesive, a friction fit) such that fluid within the first region 222a has to traverse through the fluid path 108 to enter the second region 222b. When the cleaning test soil 112 is present in at least a portion of interstitial spaces 110 of the fluid porous body 106, fluid communication between the first region 222a and the second region 222b can be inhibited or prevented. The first body 102 can be positioned within the second region 222b.

The fluid porous body 106 can extend across less than the entirety of the cavity 222 and can surround a surface 116 of the first body 102. For example, the first body 102 can be positioned within an interior cavity of the fluid porous body 106. At least one of the fluid porous body 106 and the first body 102 can be restrained by a supporting member to prevent movement relative to the housing 220. The fluid porous body 106 and the first body 102 can be positioned in any spatial configuration relative to each other such that fluid traversal to the first body 102 can be limited to the fluid path 108.

The treatment indicator 200 can comprise a sterilant neutralizer 218. The sterilant neutralizer 218 can be in cooperative arrangement with at least one of the first body 102 and the fluid porous body 106. The location of the sterilant neutralizer 218, in relation to the first body 102 and/or the fluid porous body 106 can enable the sterilant neutralizer 218 to contact a fluid in the fluid path 108 and/or neutralize at least a portion of the fluid in the fluid path 108. For example, the sterilant neutralizer 218 can be deposited on the first surface 114a and/or second surface 114b of the fluid porous body 106, on the surface 116 of the first body 102, and/or in at least a portion of the interstitial spaces 110. The sterilant neutralizer 218 can be in contact with or separated from the cleaning test soil 112. The sterilant neutralizer 218 can be incorporated into a coating layer entirely or partially encapsulating the cleaning test soil 112. The sterilant neutralizer 218 can be distributed throughout all or a portion of the cleaning test soil 112. The sterilant neutralizer 218 can be deposited in a layer over the biological material 104.

The sterilant neutralizer 218 can be a secondary stage to the cleaning test soil 112 that can inhibit or prevent a false indication of an effective treatment process by neutralizing a first portion of disinfectant and/or sterilant that traverses into the fluid path 108. The sterilant neutralizer 218 can comprise a chemical substance that can inhibit the sterilizing efficacy and/or disinfecting efficacy of the fluid. Thus, the sterilant neutralizer 218 may need to be removed prior to removing and/or eliminating the biological material 104. For example, the sterilant neutralizer 218 can comprise a disinfectant neutralizer, such as, sodium thiosulfate and/or catalase. The sterilant neutralizer 218 can increase the stringency (e.g., exactness) of the treatment indicator 200 when determining whether or not the treatment process was effective. For example, if the test soil 112 is not removed from the interstitial spaces 110, the sterilant neutralizer may also not be removed, and therefore the sterilant neutralizer can partially or completely neutralize sterilant that may enter the cavity 222, and therefore the sterilant may not substantially remove and/or eliminate the biological material 104. The biological material 104 can then multiply responsive to contact with growth media which can indicate the treatment process was not effective.

The cavity 222 can comprise a reservoir 228 comprising a seal 232 configured to retain growth media separate from the biological material 104. The seal 232 can comprise at least one of a film, a membrane, a wall, and a vial. The seal 232 can comprise various materials, such as, for example, at least one of a metal or metal alloy, a polymer (e.g., plastic), a ceramic, and a glass. The reservoir 228 can store the growth media within the treatment indicator 200 until it may be desired to determine if the biological material 104 is active.

The reservoir 228 can be configured to introduce the growth media to the cavity 222 upon degradation of the seal 232. For example, the seal 232 can be broken (e.g., cut, pierced, snapped). The seal 232 of the reservoir 228 can be configured to be broken to introduce the growth media to the biological material 104 by, such as, for example, an application of a mechanical force to the seal 232. The seal 232 can, for example, comprise a glass vial and the glass vial can be broken.

The growth media can be any media suitable for multiplication (e.g., reproduction) and/or germination (e.g., germination of a bacterial spore) of the biological material 104. The growth media can comprise at least one of water, macronutrients (e.g., a carbon source, a nitrogen source, a sulfur source, a phosphorous source, and the like), micronutrients (e.g. vitamins, co-factors, metal ions, and the like), a pH adjusting agent, blood, blood serum or plasma, a hormone, a growth factor, live host cells to support viral replication, and an enzymatic substrate for detection of biological material 104. The growth media can be a liquid.

FIG. 2B illustrates the treatment indicator 200 in a second configuration. In the second configuration, fluid 230 has been introduced into the first region 222a of cavity 222 through port 224 and/or port 226. The fluid 230 can be in contact with the fluid porous body 106 (e.g., in contact with the cleaning test soil 112). For example, the fluid 230 can contact the cleaning test soil 112, if present, on the first surface 114a of the fluid porous body 106 and/or within the interstitial spaces 110. In the second configuration, the cleaning test soil 112 can act to inhibit or prevent the fluid 230 from passing through the fluid porous body 106. The cleaning test soil 112 can be configured for removal from the interstitial spaces 110 of the fluid porous body 106 responsive to the treatment process including exposure to the fluid for a predetermined period.

FIG. 2C illustrates the treatment indicator 200 in a third configuration. In the third configuration, the fluid 230 has removed at least a portion of the cleaning test soil 112 and thereby enabled traversal of the fluid 230 through the interstitial spaces 110 of the fluid porous body 106. After the fluid 230 traverses through the interstitial spaces 110, the fluid 230 can contact and remove and/or eliminate the sterilant neutralizer 218 of FIG. 2B and contact the first body 102 and the biological material 104. The fluid 230 can contact the sterilant neutralizer 218 of FIG. 2B before proceeding to contact the first body 102 and the biological material 104.

FIG. 3 illustrates a system 300 comprising a treatment apparatus 340 and the treatment indicator 200. As illustrated, the treatment apparatus 340 can comprise a chamber 342 including a treatment basin 344 in fluid communication with a reservoir 346. The treatment basin 344 can be configured to receive a device 348 to be treated. The chamber 342 can be configured to perform a treatment process on the device 348 in the treatment basin 344. The chamber 342 can comprise at least one of a heater (e.g., heating element), a pump, a wash arm, a spray nozzle, a tube, and other features known to one of ordinary skill in the art. The chamber 342 can be at least one of a cleaning chamber, a disinfection chamber, and a sterilization chamber. The device 348 can comprise a medical device, such as, for example, an endoscope. The treatment apparatus 340 can comprise an endoscope re-processor (e.g., an automated endoscope re-processor).

The treatment apparatus 340 can comprise a lid 352. The lid 352 can be positioned to cover the treatment basin 344. The lid 352 can be positioned in a first configuration and a second configuration. The first configuration can enable access to the treatment basin 344 for loading and/or unloading of the device 348. The second configuration can limit access to the treatment basin 344 and can inhibit excess fluid from leaving the treatment basin 344. For example, in the second configuration, the lid 352 may be positioned in a sealable arrangement with the treatment basin 344 to inhibit access to the treatment basin 344 while the device 348 is being treated.

The chamber 342 can comprise a vessel 350 positioned separate from the treatment basin 344. The vessel 350 can comprise a cavity suitable to receive the treatment indicator 200. The vessel 350 can be configured to subject the treatment indicator 200 to a similar or the same treatment process as the treatment process that can be performed on the device 348 in the treatment basin 344. For example, the vessel 350 can subject the treatment indicator 200 to similar or the same treatment process parameters (e.g., temperature, pressure, fluid, duration) as the device is subjected to in the treatment basin 344. The vessel 350 can be in fluid communication with at least one of the treatment basin 344 and the reservoir 346 which can provide a fluid to the vessel 350. The level of treatment of the treatment indicator 200 can correlate to the level of treatment of the device 348.

The treatment process can comprise a single fluid or a plurality of different fluids. The vessel 350 can be configured to introduce fluid into the treatment indicator 200 and remove fluid from the treatment indicator 200. The treatment indicator 200 can be removed from the vessel 350 and fluid can be removed from the treatment indicator 200 while outside of the vessel 350.

FIGS. 2C and 3 illustrate a method for indicating a level of treatment in the treatment apparatus 340. The method can comprise introducing a treatment indicator 100, 200 into the treatment apparatus 340. The device 348 can be introduced into the treatment basin 344 of the treatment apparatus 340. The treatment indicator 100, 200 can be positioned in the treatment basin 344 with the device 348 or separate from the device 348 in the vessel 350 of the treatment apparatus 340. A lid 352 can be positioned to cover the treatment basin 344.

The treatment indicator 100, 200 can be subjected to a cleaning process and at least one of a disinfection process and a sterilization process. Fluid can be introduced to the device 348 and to the cavity 222 of the treatment indicator 200. The fluid can contact the fluid porous body 106 of the treatment indicator 100, 200. Responsive to contact and if active (e.g., not neutralized by sterilant neutralizer) the fluid can remove and/or eliminate cleaning test soil 112 and/or biological material 104 of the treatment indicator 100, 200. During the treatment process, a single fluid or a plurality of different fluids can contact and/or act on the treatment indicator 100, 200 and the device 348. For example, a first fluid can remove and/or eliminate the cleaning test soil 112 (e.g., a cleaning process) and if present, the sterilization neutralizer, and a second fluid can remove and/or eliminate the biological material 104 (e.g., at least one of a disinfection process and a sterilization process). After conclusion of the cleaning process and at least one of the disinfection process and the sterilization process, any remaining fluid in the treatment indicator 100, 200 can be removed.

A quantity of active biological material in the first body 102 can be measured following the cleaning process and the at least one of the disinfection process and the sterilization process. As used herein “active biological material” means biological material that has not been removed and/or eliminated by a treatment process. For example, active biological material within the treatment indicator after the conclusion of the treatment process can be biological material that is capable of multiplying and/or germinating.

The treatment indicator 100, 200 can be used to determine the level of treatment that the device 348 in the treatment apparatus 340 was subjected to. For example, the quantity of active biological material remaining in the treatment indicator (e.g., on/in the first body of the treatment indicator) after the treatment process can be dependent on the efficacy of a cleaning process and at least one of a disinfection process and a sterilization process.

The treatment indicator 100, 200 can be incubated with growth media. For example, following the cleaning process and at least one of the disinfection process and sterilization process, the seal 232 of the treatment indicator 100, 200 can be broken and growth media can contact the first body 102 and active biological material in the first body 102. The seal 232 can be broken manually or automatically. Breaking the seal 232 can cause release of the growth media from the reservoir 228. The growth media can provide nutrients and/or a biologically-compatible environment to the active biological material. The active biological material can multiply and/or germinate responsive to contact with the growth media. Incubation can occur for a time and at a temperature that are suitable for multiplication and/or germination of the active biological material. For example, growth and/or germination of the active biological material can create an enzymatic reaction with a substrate in the growth media and biological expression of a protein from a gene encoding a photoluminescent protein. A product of the enzymatic reaction and/or the protein can be photoluminescent. Incubation can occur within or outside of an apparatus for treatment according to the present disclosure. In various examples, there may not be active biological material present in the first body (e.g., complete elimination of the biological material during at least one of the disinfection process and sterilization process).

Measuring a quantity of the active biological material can comprise measuring the electromagnetic property of at least one of the active biological material and the growth media. For example, the electromagnetic property can be at least one of absorption, transmittance, scattering, reflectance, and photoluminescence. The electromagnetic property can be measured in order to determine the rate of growth and/or amount of biological material in the treatment indicator 100, 200. For example, electromagnetic radiation can be emitted into the treatment indicator 100, 200, and electromagnetic radiation can be detected from the treatment indicator 100, 200. Based on the emitted and/or detected electromagnetic radiation, the electromagnetic property can be determined. The electromagnetic property can correspond to a rate of growth and/or amount of biological material on the treatment indicator 100, 200, and thus the measured electromagnetic property can be used to determine the rate and/or amount of biological material on the treatment indicator 100, 200 and the level of effectiveness of a treatment process (e.g., cleaning process and at least one of the disinfection process and sterilization process). If the electromagnetic property is below a threshold value, the treatment process can be determined to be effective. If the electromagnetic property is at least the threshold value, the treatment process can be determined to be ineffective. A level of effectiveness of the treatment process can be determined based on the measured electromagnetic property.

The electromagnetic property can be measured after removal of the treatment indicator 100, 200 from the apparatus 340 for treatment via a spectrophotometer or a similar device. The electromagnetic property can be measured at a wavelength of 100 nm or greater such as, for example, 200 nm or greater, 400 nm or greater, or 500 nm or greater. The electromagnetic property can be measured at a wavelength of 1000 nm or less such as, for example, 800 nm or less, 700 nm or less, or 600 nm or less. The electromagnetic property can be measured at a wavelength of 100 nm to 1000 nm such as, for example, 200 nm to 800 nm, 400 nm to 700 nm, or 500 nm to 600 nm.

A method of preparing a treatment indicator 100, 200 according to the present disclosure is also provided. The method can comprise forming the first body 102 and the fluid porous body 106. Forming can comprise at least one of plastic injection molding, polymer extrusion, machining, and additive manufacturing. The fluid porous body 102 and first body 106 can be formed by the same method or different methods.

Cleaning test soil 112 can be disposed in at least a portion of interstitial spaces 110 of the fluid porous body 106 to inhibit or prevent traversal of a fluid through the fluid porous body 106 to the first body 102 via the fluid path 108. The cleaning test soil 112 can be deposited on/in the interstitial spaces 110 of the fluid porous body 106 as a liquid solution and allowed to dry on/in the interstitial spaces 110. Deposition of the cleaning test soil 112 as a liquid solution can comprise at least one of spraying the liquid solution onto the fluid porous body 106, flowing the liquid solution over the fluid porous body 106, and submerging the fluid porous body 106 in the liquid solution. The deposition of the cleaning test soil 112 can occlude at least a portion of the interstitial spaces 110 of the fluid porous body 106 with the cleaning test soil 112. The cleaning test soil 112 can comprise a single component or a plurality of components. The cleaning test soil 112 can be deposited as a mixture of the plurality of components or components of the cleaning test soil 112 can be deposited in succession.

Biological material 104 can be deposited on/in the first body 102 as a liquid solution and allowed to dry on the first body 102. Deposition of the biological material 104 as a liquid can comprise spraying the liquid solution onto the first body 102, flowing the liquid solution over the first body 102, and submerging the first body 102 in the liquid solution. The biological material 104 can be deposited as a dry component. The deposition of the biological material 104 can adhere the biological material 104 to the first body 102. The biological material 104 can comprise a single component or a plurality of components. The biological material 104 can be deposited as a mixture of the plurality of components or components of the biological material 104 can be deposited in succession.

The fluid porous body 106 can be positioned relative to the first body 102 in the fluid path 108. For example, the fluid porous body 106 and the first body 102 can be positioned in and operatively coupled to the housing 220. A seal can be created by engaging the fluid porous body 106 with a surface of the housing 220 (e.g., via an adhesive, friction fit) such that a fluid has to traverse through the fluid porous body 106 to contact the first body 102.

The fluid porous body 106 can be positioned to surround the surface 116 of the first body 102. For example, the first body 102 can be positioned within an interior cavity of the fluid porous body 106. A supporting member can be positioned to restrain at least one of the fluid porous body 106 and the first body 102 from moving relative to the housing.

Various examples of the present disclosure include, but are not limited to, the examples listed in the following numbered clauses.

1. A treatment indicator comprising: a first body comprising a biological material; a fluid porous body in fluid communication with the first body in a fluid path; and a cleaning test soil disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path.

2. The treatment indicator of clause 1, wherein the cleaning test soil is disposed in at least a portion of the interstitial spaces of the fluid porous body to prevent traversal of a fluid through the fluid porous body to the first body via the fluid path.

3. The treatment indicator of any one of clauses 1-2, wherein the cleaning test soil is configured for removal from the interstitial spaces of the fluid porous body responsive to a cleaning process.

4. The treatment indicator of clause 3, wherein removal of the cleaning test soil from the interstitial spaces of the fluid porous body responsive to a cleaning process enables traversal of a fluid through the fluid porous body to the first body.

5. The treatment indicator of any one of clauses 1-4, wherein the cleaning test soil is positioned separate from the biological material.

6. The treatment indicator of any one of clauses 1-5, wherein the cleaning test soil comprises at least one of a protein (and derivatives thereof), a carbohydrate, a nucleic acid, a lipid, a salt, and an acid.

7. The treatment indicator of any one of clauses 1-6, wherein the cleaning test soil comprises at least one protein selected from the group consisting of a blood protein, collagen, keratin, casein, and mucin.

8. The treatment indicator of any one of clauses 1-7, further comprising a sterilant neutralizer in cooperative arrangement with at least one of the first body and the fluid porous body.

9. The treatment indicator of any one of clauses 1-8, wherein the biological material comprises a bacterial spore.

10. The treatment indicator of any one of clauses 1-9, further comprising: a housing comprising: a cavity, wherein the first body, the fluid porous body, and the cleaning test soil are positioned within the cavity; a first port; and a second port, the first port and second port in fluid engagement with the cavity.

11. The treatment indicator of clause 10, further comprising a reservoir positioned within the cavity, the reservoir comprising a seal configured to retain growth media separate from the biological material.

12. The treatment indicator of any one of clauses 1-11, wherein the fluid porous body surrounds an outer surface of the first body.

13. The treatment indicator of any one of clauses 1-12, wherein the fluid porous body is positioned upstream from the first body in a fluid path.

14. A method for indicating a level of treatment in a treatment apparatus, the method comprising: introducing a treatment indicator into the treatment apparatus. The treatment indicator comprises: a first body comprising a biological material; a fluid porous in fluid communication with the first body in a fluid path; and a cleaning test soil disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path. The method further comprises: subjecting the treatment indicator to a cleaning process and at least one of a disinfection process and a sterilization process; and measuring a quantity of active biological material in the first body following the cleaning process and the at least one of the disinfection process and the sterilization process.

15. The method of clause 14, further comprising incubating the treatment indicator with growth media.

16. The method of any one of clauses 14-15, wherein measuring the quantity of active biological material in the first body comprises measuring an electromagnetic property of at least one of the growth media and the active biological material.

17. The method of any one of clauses 14-16, wherein the electromagnetic property is at least one of absorption, transmittance, scattering, reflectance, and photoluminescence.

18. The method of any one of clauses 14-17, wherein the electromagnetic property is measured at a wavelength in a range of 100 nm to 1000 nm.

19. The method of any one of clauses 14-18, further comprising: introducing a device to be treated into a treatment basin of the apparatus for treatment; and introducing the treatment indicator into a vessel.

20. The method of clause 19, wherein the vessel is positioned separate from the treatment basin.

21. A method of preparing a treatment indicator, the method comprising: forming a first body comprising a biological material; and forming a fluid porous body comprising a cleaning test soil, the fluid porous body in fluid communication with the first body in a fluid path, the cleaning test soil disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path.

22. The method of clause 21, wherein the cleaning test soil is positioned separate from the biological material.

23. The method of any one of clauses 21-22, wherein the cleaning test soil comprises at least one of a protein (and derivatives thereof), a carbohydrate, a nucleic acid, a lipid, a salt, and an acid.

24. The method of any one of clauses 21-23, wherein the cleaning test soil comprises at least one protein selected from the group consisting of a blood protein, collagen, keratin, casein, and mucin.

25. The method of any one of clauses 21-24, further comprising positioning a sterilant neutralizer in cooperative arrangement with at least one of the first body and the fluid porous body.

26. The method of any one of clauses 21-25, wherein the biological material comprises a bacterial spore.

The herein described subject matter sometimes illustrates different components contained within, or connected with, other different components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures may be implemented that achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as “associated with” each other such that the desired functionality is achieved irrespective of architectures or intermedial components. Likewise, any two components so associated can also be viewed as being “operably connected” or “operably coupled” to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “operably couplable” to each other to achieve the desired functionality. Specific examples of operably couplable include, but are not limited to, physically mateable and/or physically interacting components, and/or wirelessly interactable, and/or wirelessly interacting components, and/or logically interacting, and/or logically interactable components.

One skilled in the art will recognize that the herein described components (e.g., operations), devices, objects, and the discussion accompanying them are used as examples for the sake of conceptual clarity and that various configuration modifications are contemplated. Consequently, as used herein, the specific exemplars set forth and the accompanying discussion are intended to be representative of their more general classes. In general, use of any specific exemplar is intended to be representative of its class, and the non-inclusion of specific components (e.g., operations), devices, and objects should not be taken limiting.

With respect to the appended claims, those skilled in the art will appreciate that recited operations therein may generally be performed in any order. Also, although various operational flows are presented in a sequence(s), it should be understood that the various operations may be performed in other orders than those which are illustrated, or may be performed concurrently. Examples of such alternate orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplemental, simultaneous, reverse, or other variant orderings, unless context dictates otherwise. Furthermore, terms like “responsive to,” “related to,” or other past-tense adjectives are generally not intended to exclude such variants, unless context dictates otherwise.

One skilled in the art will recognize that the herein described components, devices, operations/actions, and objects, and the discussion accompanying them, are used as examples for the sake of conceptual clarity and that various configuration modifications are contemplated. Consequently, as used herein, the specific examples set forth and the accompanying discussion are intended to be representative of their more general classes. In general, use of any specific exemplar is intended to be representative of its class, and the non-inclusion of specific components, devices, operations/actions, and objects should not be taken limiting. While the present disclosure provides descriptions of various specific examples for the purpose of illustrating various examples of the present disclosure and/or its potential applications, it is understood that variations and modifications will occur to those skilled in the art. Accordingly, the invention or inventions described herein should be understood to be at least as broad as they are claimed and not as more narrowly defined by particular illustrative examples provided herein.

	Number	Date	Country
	62786075	Dec 2018	US
	62785971	Dec 2018	US

	Number	Date	Country
Parent	16673026	Nov 2019	US
Child	18388226		US

Treatment Indicator, A Method Of Production Thereof, And A Method Of Use Thereof

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