Article, system, and method for indication of treatment

An article, a system, and a method for indication of treatment are provided. The article comprises a first body, a second body, and a treatment indicator. The first body comprises a first axis, a cavity, a first port, and a second port. The cavity is positioned within the first body and configured to receive the second body. The second body comprises a second axis, a chamber, a third port, and a fourth port. The article is configured to move between a first configuration and a second configuration. In the first configuration, the first port is aligned with the third port to form a fluid pathway to the chamber, and the second port is aligned with the fourth port to form a fluid pathway to the chamber. In the second configuration, the first port is misaligned with the third port, and the second port is misaligned with the fourth port.

FIELD

The present disclosure relates to an article, a system, and a method for indication of treatment.

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 is 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 the ultimate use on a patient can prevent the risk of cross contamination and the spread of disease.

SUMMARY

The present disclosure provides an article for indication of treatment. The article comprises a first body, a second body, and a treatment indicator. The first body comprises a first axis, a cavity, a first port, and a second port. The cavity is positioned within the first body and configured to receive the second body. The second port is offset from the first port relative to the first axis. The second body comprises a second axis, a chamber, a third port, and a fourth port. The chamber is positioned within the second body and configured to receive a fluid. The fourth port is offset from the third port relative to the second axis. The article is configured to move between a first configuration and a second configuration. In the first configuration, the first port is aligned with the third port to form a fluid pathway to the chamber, and the second port is aligned with the fourth port to form a fluid pathway to the chamber. In the second configuration, the first port is misaligned with the third port, and the second port is misaligned with the fourth port. The treatment indicator is positioned within the chamber.

The present disclosure also provides a system comprising an article for indication of a treatment and a detector. The article comprises a first body, a second body, and a treatment indicator. The first body comprises a first axis, a cavity, a first port, and a second port. The cavity is positioned within the first body and configured to receive the second body. The second port is offset from the first port relative to the first axis. The second body comprises a second axis, a chamber, a third port, a fourth port, and a transparent section. The chamber is positioned within the second body and configured to receive a fluid. The fourth port is offset from the third port relative to the second axis. The transparent section is configured to transmit electromagnetic radiation through the chamber. The article is configured to move between a first configuration and a second configuration. In the first configuration, the first port is aligned with the third port to form a fluid pathway to the chamber, and the second port is aligned with the fourth port to form a fluid pathway to the chamber. In the second configuration, the first port is misaligned with the third port, and the second port is misaligned with the fourth port. The treatment indicator is positioned within the chamber. The detector is configured to measure an electromagnetic property of fluid within the chamber via the transparent section of the second body.

The present disclosure also provides a system comprising an apparatus for treatment and an article for indication of treatment. The apparatus for treatment comprises a treatment basin and a vessel. The treatment basin is configured to receive a device to be treated. The vessel is positioned separate from the treatment basin and is in fluid communication with the treatment basin. The vessel is suitable to receive the article for indication of treatment and to provide a treatment agent to the article. The article comprises a first body, a second body, and a treatment indicator. The first body comprises a first axis, a cavity, a first port, and a second port. The cavity is positioned within the first body and configured to receive the second body. The second port is offset from the first port relative to the first axis. The second body comprises a second axis, a chamber, a third port, and a fourth port. The chamber is positioned within the second body and configured to receive a fluid. The fourth port is offset from the third port relative to the second axis. The article is configured to move between a first configuration and a second configuration. In the first configuration, the first port is aligned with the third port to form a fluid pathway to the chamber, and the second port is aligned with the fourth port to form a fluid pathway to the chamber. In the second configuration, the first port is misaligned with the third port, and the second port is misaligned with the fourth port. The treatment indicator is positioned within the chamber.

In a further example, the present disclosure also provides an article for indication of treatment. The article comprises a first body, a second body, a treatment indicator, and a reservoir. The first body comprises a first axis, a cavity, a first port, and a second port. The cavity is positioned within the first body and configured to receive the second body. The second port is offset from the first port relative to the first axis. The second body comprises a second axis, a chamber, a third port, a fourth port, and a transparent section. The chamber is positioned within the second body and configured to receive a fluid. The fourth port is offset from the third port relative to the second axis. The transparent section is configured to transmit electromagnetic radiation through the chamber. The article is configured to move between a first configuration and a second configuration. In the first configuration, the first port is aligned with the third port to form a fluid pathway to the chamber, and the second port is aligned with the fourth port to form a fluid pathway to the chamber. In the second configuration, the first port is misaligned with the third port, and the second port is misaligned with the fourth port. The treatment indicator is positioned within the chamber and comprises biological material. The reservoir is positioned within the chamber and comprises a seal configured to retain growth media separate from the treatment indicator. The seal is configured to break responsive to the second configuration of the article. Breaking of the seal is suitable to introduce the growth media to the treatment indicator.

The present disclosure also provides a method for indication of treatment. The method comprises introducing an article for treatment into an apparatus for treatment. The article comprises a first body, a second body, a treatment indicator, and a reservoir. The first body comprises a first axis, a cavity, a first port, and a second port. The cavity is positioned within the first body and configured to receive the second body. The second port is offset from the first port relative to the first axis. The second body comprises a second axis, a chamber, a third port, a fourth port, and a transparent section. The chamber is positioned within the second body and configured to receive a fluid. The fourth port is offset from the third port relative to the second axis. The transparent section is configured to transmit electromagnetic radiation through the chamber. The article is configured to move between a first configuration and a second configuration. In the first configuration, the first port is aligned with the third port to form a fluid pathway to the chamber, and the second port is aligned with the fourth port to form a fluid pathway to the chamber. In the second configuration, the first port is misaligned with the third port, and the second port is misaligned with the fourth port. The treatment indicator is positioned within the chamber and comprises biological material. The reservoir is positioned within the chamber and comprises a seal configured to retain growth media separate from the treatment indicator. The seal is configured to break responsive to the second configuration of the article. Breaking of the seal is suitable to introduce the growth media to the treatment indicator. A treatment solution is introduced into the chamber of the article in the first configuration. The treatment solution is removed from the chamber. The article is changed from the first configuration to the second configuration to contact the treatment indicator with the growth media. An electromagnetic property of at least one of the growth media and treatment indicator is measured.

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.

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

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.

Also, any numerical range recited herein includes all sub-ranges subsumed within the recited range. For example, a range of “1 to 10” 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. All such ranges are inherently described in this specification such that amending to expressly recite any such sub-ranges would comply with the requirements of 35 U.S.C. § 112 and 35 U.S.C. § 132(a).

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 archaeon, 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.

Ensuring that a treatment process is properly performed on a device can support prevention of cross-contamination and the spread of disease. Testing a device, such as a medical device (e.g., an endoscope), directly may not be practical due to cost and/or time constraints. Thus, the present disclosure provides an article, a method, and a system for indication of treatment that can be employed to determine the effectiveness of a treatment process to which the device was subjected.

FIGS. 1A-Band2A-B illustrate one example of an article100for indication of treatment according to the present disclosure. The article100can comprise a first body102and a second body104. The first body102may comprise a cavity108positioned therein and configured to receive at least a portion of the second body104. The cavity108may be any size and shape that allows for cooperative engagement with the second body104. The first body102may cooperatively engage the second body104in a partially or fully sealed orientation. As illustrated, the first body102may be a sleeve-like I-shaped member, and the second body104may comprise a generally rectangular chamber116that can be received into the cavity108of the first body102. An axis106extends through the first body102from a first end102ato a second end102band illustrates one longitudinal orientation by which the second body104may engage the first body102. The second end102bcan be oppositely disposed from the first end102a.

The first body102can comprise at least two ports110and112. Each port110,112can be a bore through the first body102. The ports110and112can be suitable to receive fluid and transport fluid therethrough. Port112can be offset from port110relative to axis106, as illustrated. For example, port112can be more proximal to the second end102bof the first body102than port110. Port112can be adjacent to the second end102b. Port112can also be radially offset from port110relative to axis106.

The second body104can be positioned within the cavity108of the first body102. The second body104can comprise an axis114. The second body104can further comprise a chamber116configured to receive a fluid. Axis114can extend from a first end104aof the second body104to a second end104bof the second body104. Axis114can be the same as axis106. The second end104bof the second body104can be oppositely disposed from the first end104a. When the first body102and the second body104are engaged, the first end102aof the first body102can be adjacent to the first end104aof the second body104and the second end102bof the first body102can be adjacent to the second end104bof the second body104.

The second body104can comprise at least two ports118and120that, for example, pair with ports110,112. Each port118,120can be a bore through the second body104. Port118and port120can be suitably configured to receive fluid and transport fluid therethrough. Port120can be offset from port118relative to axis114, as illustrated. For example, port120can be more proximal to the second end104bthan port118. Port120can be adjacent to the second end104b. Port102can also be radially offset from port118relative to axis114.

The ports110,112,118,120can comprise any shape suitably configured to receive and transport fluid. For example, the ports110,112,118,120can comprise at least one of a generally circular, a generally rectangular, and a generally oval cross-sectional shape.

A treatment indicator122can be positioned within the chamber116and can comprise biological material. For example, the biological material can comprise at least one of an archaeon, an eukaryote, a bacterium (e.g., bacterial spore), and a virus. The biological material degrades responsive to contact with at least one of a disinfectant and a sterilant. The level of degradation of the biological material in the treatment process can be dependent on, for example, at least one of 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. The rate and/or amount of growth of the biological material can provide an indication of the effectiveness of a treatment process. For example, a sterilant can degrade the biological material on the treatment indicator122such that the treatment indicator122is substantially free from biological material. Therefore, upon contacting the treatment indicator122with growth media, minimal, if any, biological material can multiply resulting in a reduced rate and/or amount of growth of the biological material compared to a treatment indicator that was not degraded by a sterilant. The reduced rate and/or amount of growth can indicate, for example, whether the treatment process was effective or the degree to which the treatment process was effective.

The growth media (e.g., culture media) can comprise various materials to support the growth of biological material. For example, the growth media can comprise at least one of agar, water, a hormone, a growth factor, blood serum, a vitamin, glucose, glycerol, an ammonium salt, nitrate, and an amino acid. The growth media can be liquid.

The second body104can be moveable (e.g., slidable, rotatable, telescoping, etc.) relative to the first body102, and/or the first body102can be moveable relative to the second body104. For example, the article100can change position between a first configuration, as illustrated inFIG. 2A, and a second configuration, as illustrated inFIG. 2B. The configuration of the article100can enable or limit traversal of fluid into and/or out of the chamber116via, for example, the full or partial blockage of ports110,112,118,120. The fluid can comprise at least one of growth media, a rinse agent (e.g., water, alcohol), and a treatment agent (e.g., a cleaning agent, a disinfectant, a sterilant).

An offset distance from port120to port118relative to axis114can be the same as an offset distance from port112to port110relative to axis106so that there is a pairing between ports110and118, and ports112and120when the second body104is received by first body102. Movement of the first body102and/or second body104can control communication between port110and port118and between port112and port120simultaneously. For example, in the first configuration, port110can be aligned with port118to form a first fluid pathway150to the chamber116, and port112can be aligned with port120to form a second fluid pathway160to the chamber116. When aligned, fluid can flow into the chamber116utilizing ports110,112,116,118. For example, fluid can be introduced into port110and traverse through the first fluid pathway150into the chamber116. Fluid can be introduced into port112and traverse through the second fluid pathway160into the chamber116. While in the chamber116, the fluid can contact the treatment indicator122. In examples where the fluid comprises a disinfectant and/or sterilant, the fluid contact with the treatment indicator122can degrade biological material on the treatment indicator122.

Fluid can flow out of the chamber116utilizing the first pathway150and/or second fluid pathway160. For example, fluid can be introduced into port118from the chamber116and traverse through the first fluid pathway150out of the chamber116. Fluid can be introduced into port120from the chamber116and traverse through the second fluid pathway160out of the chamber116. The first configuration of the article100can be suitable to gravity drain fluid from the chamber116. For example, the article100can be oriented such that fluid in the chamber116flows into port120and traverses through the second fluid pathway160out of the chamber116. The first fluid pathway150can be configured as an inlet, and the second fluid pathway160can be configured as an outlet. Also, for example, the second fluid pathway160can be configured as an inlet, and the first fluid pathway150can be configured as an outlet.

The second configuration of the article100can inhibit and/or prevent communication between port110and port118and between port112and port120. For example, in the second configuration, port110can be misaligned with port118and port112can be misaligned with port120. The misalignment can inhibit or prevent traversal of fluid through the first fluid pathway150and/or second fluid pathway160via, for example, the full or partial blockage of ports110,112,118,120. In the second configuration, fluid remaining within the chamber116may be inhibited or prevented from exiting the chamber116. For example, in the second configuration, the chamber116may be a closed system. Growth media can be in the chamber116while the article100is in the second configuration, and the growth media can contact the treatment indicator122.

The article100can change configuration by a variety of methods. For example, article110can be configured to rotate at least one of the first body102around axis106and the second body104around114to change between the first configuration and the second configuration. The article100can be configured to translate at least one of the first body102relative to axis106, and the second body104relative to axis114to change between the first configuration and the second configuration.

The configuration change of the article100can be manual (e.g., activated by an operator) or automatic. For example, the apparatus for treatment can automatically change the configuration of the article100responsive to at least a portion of a treatment process.

The article100can comprise additional components configured for facilitating the configuration change of the article100. For example, the article100can comprise at least one of a spring and a piston. For example where the article100comprises a spring, the spring can be positioned between the first body102and the second body104in order to apply a force to translate at least one of the first body102relative to axis106and the second body104relative to axis114. Similarly, the spring can be positioned in communication with the first body102and/or the second body104in order to apply a force to the first body102and/or second body104to rotate at least one of the first body102around axis106and the second body104around axis114.

The treatment indicator122and/or fluid with the chamber116can comprise an electromagnetic property. The electromagnetic property can be, for example, at least one of absorption, transmittance, scattering, reflectance, and photoluminescence. The electromagnetic property can be measured in order to determine the rate and/or amount of biological material on the treatment indicator122. For example, electromagnetic radiation can be emitted into the chamber116, and electromagnetic radiation can be detected from the chamber116. Based on the emitted and/or detected electromagnetic radiation, the electromagnetic property can be determined. The electromagnetic property can correspond to a rate and/or amount of biological material on the treatment indicator122, and thus the measured electromagnetic property can be used to determine, for example, the rate and/or amount of biological material on the treatment indicator122, whether the treatment process is complete, and the effectiveness of a treatment 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 degree of effectiveness of the treatment process can be determined based on the measured electromagnetic property. If the treatment process is determined to be ineffective based on the measurement of the electromagnetic property, the treatment process may be discontinued, or the treatment process may continue with another treatment indicator until it is later determined that the treatment process is effective, based on a subsequent reading that the electromagnetic property is below a threshold value.

In order to facilitate a measurement of the electromagnetic property, the first body102can comprise an opening140and the second body104can comprise a corresponding transparent section104c. For example, the opening140can be the void space created between the horizontal top/bottom and vertical middle portion of the “I” when the first body102is an I-shaped member, as illustrated. The transparent section104ccan be configured to allow transmission of electromagnetic radiation into and/or through the chamber116. For example, the transparent section104ccan comprise a material that minimally absorbs, or does not absorb, electromagnetic radiation that is emitted through the chamber116. The opening140can be configured to align with the transparent section104cof the second body104when the article100is in a second configuration as illustrated inFIG. 2B. The first body102may be configured with a second transparent section (not shown) in place of the opening140and the second transparent section can be configured to transmit electromagnetic radiation into the transparent section104cthrough the chamber116. The transmission of electromagnetic radiation into and/or through the chamber116can enable measurement of an electromagnetic property of the treatment indicator122and/or fluid within the chamber116.

FIGS. 3A-Cand4A-B illustrate another example of an article300for indication of treatment according to the present disclosure is provided. The article300comprises a first body302and a second body304. The first body302may comprise a cavity308positioned therein and configured to receive at least a portion of the second body304. The cavity308may be any size and shape that allows for cooperative engagement with the second body304. The first body302may cooperatively engage the second body304in a partially or fully sealed orientation. As illustrated, the first body302may be a sleeve-like generally cylindrical-shaped member, and the second body304may comprise a generally cylindrical-shaped chamber316that can be received into the cavity308of the first body302. Axis306extends through the first body302from a first end302ato a second end302band illustrates one longitudinal orientation by which the second body304may engage the first body302. The second end302bcan be oppositely disposed from the first end302a.

The first body302can comprise at least four ports310,312,324, and326. The ports310,312,324,326can be suitably configured to receive fluid and transport fluid. Port312can be offset from port310relative to axis306. Port324can be offset from port326relative to axis306. Port310can be positioned relative to axis306at the same position as port324or offset from port324relative to axis306. Port312can be positioned relative to axis306at the same position as port326or offset from port324relative to axis306.

The second body304can comprise an axis314. Axis314can extend from a first end304aof the second body304to a second end304bof the second body304. The second end304bcan be oppositely disposed from the first end304a. The second body can further comprise a chamber316configured to receive a fluid.

The second body304can comprise at least four ports318,320,328, and port330that, for example, pair with ports310,312,324,326, respectively. The ports318,320,328,330can be suitably configured to receive fluid and transport fluid. Port320can be offset from port318relative to axis314. Port328can be offset from port330relative to axis314. Port318can be positioned relative to axis314at the same position as port328or offset from port328relative to axis314. Port320can be positioned relative to axis314at the same position as port330or offset from port330relative to axis314. A distance port320is offset from port318relative to axis314can be the same as a distance port312is offset from port310relative to axis306so that there is a pairing between ports310and318, and ports312and320when the second body304is received by first body302. A distance port330is offset from port328relative to axis314can be the same as a distance port326is offset from port324relative to axis306so that there is a pairing between ports324and328, and ports326and330when the second body304is received by first body302.

The treatment indicator122can be positioned within the chamber316. The second body304can comprise a shape configured to be received by the cavity308of the first body302. For example, the second body304can be positioned within the cavity308of the first body302. The second body304can be moveable with respect to the first body302and/or the first body302can be moveable with respect to the second body304. For example, as illustrated inFIG. 4A, the article300can be configured in a first configuration. In the first configuration, port310can be aligned with port318to form a first fluid pathway350to the chamber316; port312can be aligned with port320to form a second fluid pathway360to the chamber316; port324can be aligned with port328to form a third fluid pathway370to the chamber316; and port326can be aligned with port330to form a fourth fluid pathway380to the chamber316.

The article300can be configured to move between the first configuration inFIG. 4Aand a second configuration as illustrated inFIG. 4B. In the second configuration, port310can be misaligned with port318; port312can be misaligned with port320; port324can be misaligned with port328; and port326can be misaligned with port330. The misalignment can inhibit or prevent traversal of fluid through at least one of the first fluid pathway350, the second fluid pathway360, the third fluid pathway370, and the fourth fluid pathway380via, for example, the full or partial blockage of ports310,312,318,320,324,326,328,330. For example, in the second configuration of the article300, the chamber316can be a closed system and fluid within the chamber316can be inhibited or prevented from exiting the chamber316.

The article300can comprise a reservoir332configured to retain growth media. The reservoir332can be positioned within the chamber316, and the reservoir332can comprise a seal334configured to retain growth media separate from the treatment indicator122. The seal334can comprise at least one of a film, a membrane, a wall, and a vial. The seal334can comprise various materials, such as, for example, metallic materials, polymeric materials (e.g., plastic), ceramic materials, and glass materials.

The reservoir332can be configured to introduce the growth media to the treatment indicator122upon degradation of the seal334. For example, in the first configuration of the article300(FIG. 4A), the seal334of the reservoir332may be configured to retain the growth media. In the second configuration of the article300(FIG. 4B), the seal334of the reservoir332can be configured to break and to introduce the growth media to the treatment indicator122. For example, the seal334can be pierced, punctured, snapped, and/or torn.

As illustrated inFIGS. 4A-B, the reservoir332can be integral to the second body304and the article300can comprise a seal disruption member336comprising a first end336aand a second end336b. The first end336can be any shape or configuration that assists in breaking the seal334, such as, for example, one or more fork tangs, as illustrated, to pierce the seal334in one or more locations. In the first configuration of the article300, the seal334can be positioned a distance, d1, from the second end336bof the seal disruption member336. When changing the article300from the first configuration to the second configuration, the first end336aof the seal disruption member336can engage the second end304bof the second body304and prevent movement of the seal disruption member336relative to axis314towards the second end304bof the second body304. During the configuration change of the article300from the first configuration to the second configuration, the distance between the seal334and the second end304bof the body304can decrease, thereby allowing the first end336aof the seal disruption member336to break the seal334and release growth media from the reservoir332. The growth media can traverse into the chamber316and be introduced to and contact the treatment indicator122. In the second configuration of the article300, the seal334can be positioned a distance, d2, from the second end336bof the seal disruption member336.

The reservoir332may not be integral to the second body304and may be a separate entity within the chamber316. For example, the reservoir332may be a third body positioned within the chamber316. The seal334can be a wall of the reservoir332, which can be broken by changing the article300from the first configuration to the second configuration and/or another physical force. For example, seal334can be deformed causing the seal334to break and release the growth media into the chamber316. The reservoir332can comprise a seal334of a glass vial, and deformation of the glass vial breaks the glass vial and releases the growth media into the chamber316.

The reservoir332may be positioned outside of the article300and in communication with at least one of the ports,310,312,324,326. The growth media can be released from the reservoir332into the chamber316while the article300is in the first configuration, and then the article300can be positioned in the second configuration. It is contemplated that growth media can be injected into the chamber316with an injection device, such as, for example, a syringe.

The article300can comprise a keyway338positioned on an end of the second body304, such as, for example, the second end304b. The keyway338can be configured to facilitate alignment of the article300with an apparatus for treatment and/or a detector.

In order to facilitate a measurement of the electromagnetic property, the first body302can comprise an opening340and the second body304can comprise a corresponding transparent section304c. The transparent section304ccan be configured to allow transmission of electromagnetic radiation into and/or through the chamber316. For example, the transparent section304ccan comprise a material that minimally absorbs, or does not absorb, electromagnetic radiation that is emitted through the chamber316. The opening340can be configured to align with the transparent section304cof the second body304when the article300is in a second configuration as illustrated inFIG. 4B. The first body302may be configured with a second transparent section (not shown) in place of the opening340and the second transparent section can be configured to transmit electromagnetic radiation into the transparent section304cthrough the chamber316. The transmission of electromagnetic radiation into and/or through the chamber316can enable measurement of an electromagnetic property of the treatment indicator122within the chamber316and/or fluid within the chamber316.

As illustrated inFIG. 5, the article300for indication of treatment can be introduced to a detector542. The detector542can be configured to measure an electromagnetic property of fluid within the chamber316via the transparent section304cof the second body304. The detector542can comprise an electromagnetic radiation source542asuitable to emit electromagnetic radiation544ainto the chamber316and an electromagnetic radiation detector542bsuitable to receive and measure electromagnetic radiation544b. The electromagnetic radiation544aemitted by the electromagnetic radiation source542acan comprise a wavelength in a wavelength range of 100 nm to 1000 nm, and the electromagnetic radiation544breceived and measured by the electromagnetic radiation detector542bcan comprise a wavelength in a wavelength range of 100 nm to 1000 nm.

In examples where the electromagnetic property of the fluid comprises fluorescence, the electromagnetic radiation544acan enter the chamber316and interact with the fluid within the chamber316. The interaction can produce fluorescence as electromagnetic radiation544b, which can be measured by electromagnetic radiation detector542b. In examples where the electromagnetic property of the fluid comprises absorbance, the electromagnetic radiation544acan enter the chamber316, and at least part of the electromagnetic radiation544acan be absorbed by the fluid within the chamber316. The remaining portion of electromagnetic radiation544bcan leave the chamber316as electromagnetic radiation544b, which can be measured by electromagnetic radiation detector542b.

FIG. 6illustrates a system600comprising an apparatus646for treatment and the article300for indication of treatment. As illustrated, the apparatus646can comprise a chamber648including a treatment basin650in fluid communication with a reservoir656. The treatment basin650can be configured to receive a device652to be treated. The chamber648can be suitably configured to perform a treatment process on the device652in the treatment basin650. The chamber648can 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 chamber648can be at least one of a cleaning chamber, a disinfection chamber, and a sterilization chamber. The device652can be, for example, a medical device such as, for example, an endoscope. The apparatus646can comprise an endoscope re-processor (e.g., an automated endoscope re-processor).

The chamber648can comprise a vessel654positioned separate from the treatment basin650. The vessel654can be in fluid communication with at least one of the treatment basin650and the reservoir656. The vessel654can comprise a cavity suitable to receive the article300for indication of treatment. The vessel654can be configured to provide a fluid to the article300, such as, for example, growth media, a rinse agent, and a treatment agent. The vessel654can subject the article300to the same treatment process that the device652is subjected to in the basin650such that the article300can accurately represent the degree to which the device652is treated.

The present disclosure provides a method for indication of treatment. The method comprises introducing the article300for indication of treatment according to the present disclosure into an apparatus646for treatment. The article300for indication of treatment can be introduced into a treatment basin650of the apparatus646or a vessel positioned separate from the treatment basin. A device652to be treated can be introduced into the treatment basin650of the apparatus646.

The device652and article300can be subjected to a treatment process. The treatment process can comprise introducing a treatment solution to the device652. Concomitantly, the treatment solution can be introduced to a chamber of the article for indication of treatment according to the present disclosure. The treatment solution can contact a treatment indicator122in the article, as provided here. Responsive to contact and if active, the treatment solution can reduce and/or eliminate biological material on the treatment indicator122. The treatment solution can be removed from the chamber of the article300responsive to removal of the treatment solution from the device652. The article300for indication of treatment according to the present disclosure can be used to measure the effectiveness of the treatment process. The article300for indication of treatment according to the present disclosure can be removed from the apparatus646for treatment or left in the apparatus646for treatment.

The article300can be changed from the first configuration to the second configuration, as set forth herein, and can introduce and contact the treatment indicator122with the growth media. The growth media can be incubated with the treatment indicator in order to determine the effectiveness of the treatment process. An electromagnetic property of at least one of the growth media and treatment indicator can be measured.

Although various examples have been described herein, many modifications, variations, substitutions, changes, and equivalents to those examples may be implemented and will occur to those skilled in the art. Also, where materials are disclosed for certain components, other materials may be used. It is therefore to be understood that the foregoing description and the appended claims are intended to cover all such modifications and variations as falling within the scope of the disclosed examples. The following claims are intended to cover all such modification and variations.

Various examples according to the present disclosure include, but are not limited to, the examples listed in the following numbered clauses.1. An article for indication of treatment comprising a first body comprising: a first axis; a cavity positioned within the first body and configured to receive a second body; and a first port and a second port, the second port offset from the first port relative to the first axis. The second body comprising: a second axis; a chamber positioned within the second body and configured to receive a fluid; and a third port and a fourth port, the fourth port offset from the third port relative to the second axis. Wherein the article is configured to move between a first configuration and a second configuration. Wherein in the first configuration the first port is aligned with the third port to form a fluid pathway to the chamber and the second port is aligned with the fourth port to form a fluid pathway to the chamber. Wherein in the second configuration the first port is misaligned with the third port and the second port is misaligned with the fourth port. A treatment indicator is positioned within the chamber.2. The article of clause 1, further comprising a reservoir positioned within the chamber, the reservoir comprising a seal configured to retain growth media separate from the treatment indicator.3. The article of clause 2, wherein the seal is configured to break responsive to the second configuration of the article, the breaking of the seal suitable to introduce the growth media to the treatment indicator.4. The article of any one of clause 2-3, wherein the seal comprises at least one of a film, a membrane, a wall, and a vial.5. The article of any one of clauses 1-4, wherein the treatment indicator comprises biological material.6. The article of clause 5, wherein the biological material comprises at least one of an archaeon, an eukaryote, a bacterium, and a virus.7. The article of clause 6, wherein the biological material comprises a bacterial spore.8. The article of any one of clauses 5-7, wherein the biological material degrades responsive to at least one of a disinfectant and a sterilant.9. The article of any one of clauses 1-8, wherein the first configuration of the article is suitable to gravity drain fluid from the chamber.10. The article of any one of clauses 1-9, wherein the article is configured to rotate at least one of the first body around the first axis and the second body around the second axis to change between the first and second configuration.11. The article of any one of clauses 1-10, wherein the article is configured to translate at least one of the first body relative to the first axis and the second body relative to the second axis to change between the first and second configuration.12. The article of any one of clauses 1-11, further comprising a keyway positioned on an end of the second body.13. The article of any one of clauses 1-12, wherein the second body comprises a transparent section configured to transmit electromagnetic radiation through the chamber.14. The article of clause 13, further comprising an opening in the first body, the opening configured to align with the transparent section of the second body when the article is in the second configuration.15. The article of any one of clauses 1-14, further comprising at least one of a spring and a piston configured to move the article between the first configuration and the second configuration.16. A system comprising: an article for indication of a treatment comprising a first body comprising: a first axis; a cavity positioned within the first body and configured to receive a second body; and a first port and a second port, the second port offset from the first port relative to the first axis. The second body comprising: a second axis; a chamber positioned within the second body and configured to receive a fluid; a third port and a fourth port, the fourth port offset from the third port relative to the second axis; and a transparent section configured to transmit electromagnetic radiation through the chamber. Wherein the article is configured to move between a first configuration and a second configuration. Wherein in the first configuration the first port is aligned with the third port to form a fluid pathway to the chamber and the second port is aligned with the fourth port to form a fluid pathway to the chamber. Wherein in the second configuration the first port is misaligned with the third port and the second port is misaligned with the fourth port. A treatment indicator is positioned within the chamber. A detector is configured to measure an electromagnetic property of fluid within the chamber via the transparent section of the second body.17. The system of clause 16, wherein the electromagnetic property is at least one of absorption, transmittance, scattering, reflectance, and photoluminescence.18. The system of any one of clauses 16-17, wherein the electromagnetic property is measured in a wavelength range of 100 nm to 1000 nm.19. A system comprising an apparatus for treatment, the apparatus for treatment comprising: a treatment basin configured to receive a device to be treated; and a vessel positioned separate from the treatment basin. The vessel is in fluid communication with the treatment basin and suitable to receive an article for indication of treatment. The vessel is configured to provide a treatment agent to the article. Wherein the article comprises a first body comprising: a first axis; a cavity positioned within the first body and configured to receive a second body; and a first port and a second port, the second port offset from the first port relative to the first axis. The second body comprising: a second axis; a chamber positioned within the second body and configured to receive a fluid; and a third port and a fourth port, the fourth port offset from the third port relative to the second axis. Wherein the article is configured to move between a first configuration and a second configuration. Wherein in the first configuration the first port is aligned with the third port to form a fluid pathway to the chamber and the second port is aligned with the fourth port to form a fluid pathway to the chamber. Wherein in the second configuration the first port is misaligned with the third port and the second port is misaligned with the fourth port. A treatment indicator is positioned within the chamber.20. An article for indication of treatment comprising a first body comprising: a first axis; a cavity positioned within the first body and configured to receive a second body; and a first port and a second port, the second port offset from the first port relative to the first axis. The second body comprising: a second axis; a chamber positioned within the second body and configured to receive a fluid; a transparent section configured to transport electromagnetic radiation through the chamber; and a third port and a fourth port, the fourth port offset from the third port relative to the second axis. Wherein the article is configured to move between a first configuration and a second configuration. Wherein in the first configuration the first port is aligned with the third port to form a fluid pathway to the chamber and the second port is aligned with the fourth port to form a fluid pathway to the chamber. Wherein in the second configuration the first port is misaligned with the third port and the second port is misaligned with the fourth port. A treatment indicator is positioned within the chamber and comprising biological material. A reservoir is positioned within the chamber. The reservoir comprising a seal configured to retain growth media separate from the treatment indicator. The seal is configured to break responsive to the second configuration of the article. The breaking of the seal suitable to introduce the growth media to the treatment indicator.21. A method for indication of treatment, the method comprising: introducing the article of clause 20 into an apparatus for treatment; introducing a treatment solution into the chamber of the article in the first configuration; removing the treatment solution from the chamber; changing the article from the first configuration to the second configuration to contact the treatment indicator with the growth media; and measuring an electromagnetic property of at least one of the growth media and treatment indicator.22. The method of clause 21, further comprising incubating the growth media with the treatment indicator.23. The method of any one of clauses 21-22, wherein the biological material comprises at least one of an archaeon, an eukaryote, a bacterium, and a virus.24. The method of clause 23, wherein the biological material comprises bacterial spores.25. The method of any one of clauses 21-24, further comprising: introducing a device to be treated into a treatment basin of the apparatus for treatment; and introducing the article into a vessel positioned separate from the treatment basin.26. The method of any one of clauses 21-25, wherein the electromagnetic property is at least one of absorption, transmittance, scattering, reflectance, and photoluminescence.27. The method of any one of clauses 21-26, wherein the electromagnetic property is measured at a wavelength in a range of 100 nm to 1000 nm.28. The method of any one of clauses 21-27, wherein changing the article from the first configuration to the second configuration is manual or automatic.

Numerous benefits have been described which result from employing the concepts described herein. The foregoing description of the one or more examples has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more examples were chosen and described in order to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize the various examples and with various modifications as are suited to the particular use contemplated. It is intended that the claims submitted herewith define the overall scope.

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.