Sample port system for automated endoscope reprocessor

Abstract

A system may include a reprocessing chamber configured to receive a fluid. A system may include a pump fluidly connected to the reprocessing chamber, the pump configured to circulate the fluid. A system may include a plurality of valves configured to regulate circulation of the fluid within the system. A system may include a sampling port system fluidly connected to the reprocessing chamber, the sampling port system comprising: a main body for receipt of the fluid, a sampling port valve system actuatable for regulation of fluid flow into the main body, a closure actuatable fluidly sealing the main body, one or more sensors configured therein for monitoring the sampling port system and providing sensor feedback to a controller.

Description

SAMPLE PORT SYSTEM FOR AUTOMATED ENDOSCOPE REPROCESSORCLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority to U.S. Provisional Application Serial No. 63 / 680,791, filed August 8, 2024, which is incorporated by reference herein in its entirety.BACKGROUND

[0002] Medical devices designed to come into contact with the body of a patient during treatment and or diagnosis require, before being re-used on a new patient, to be “reprocessed”, so that the device can be used without concern for patient safety, infection and death resulting from remaining body fluids, body wastes, viruses, bacteria, or combinations thereof.

[0003] A variety of methods and systems can be used for disinfection or sterilization of medical, pharmaceutical, dental, or mortuary devices, and the like. For example, endoscopes can be disinfected through the use of endoscope reprocessing systems, which may be automated. Such automated endoscope reprocessing systems can use various sterilant or disinfectant solutions.SUMMARY OF THE DISCLOSURE

[0004] In some aspects, the techniques described herein relate to an automated endoscope reprocessor (AER) system including: a reprocessing chamber configured to receive a fluid; a pump fluidly connected to the reprocessing chamber, the pump configured to circulate the fluid; a plurality of valves configured to regulate circulation of the fluid within the system; a sampling port system fluidly connected to the reprocessing chamber, the sampling port system including: a main body for receipt of the fluid; a sampling port valve system actuatable for regulation of fluid flow into the main body; a closure actuatable fluidly sealing the main body; one or more sensors configured therein for monitoring the sampling port system and providing sensor feedback to a controller.

[0005] In some aspects, the techniques described herein relate to a Minimum Required Concentration (MRC) sampling system for an automated endoscope reprocessor(AER) system, the MRC sampling system including: an MRC main body configured to receive a test strip for conducting MRC testing; an MRC circuit valve configured as a 3 -way valve, configured to regulate flow from a dosing chamber and a reprocessing chamber to the MRC main body; an MRC dosing valve configured as a 3 -way valve, configured to regulate flow from the MRC circuit valve to the MRC main body and from the MRC main body to a pump; a cap for fluidly sealing the main body; and one or more sensors configured therein for monitoring the sampling port system and providing sensor feedback to a controller.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0007] FIG. 1 A depict a perspective view of an AER system in an example.

[0008] FIG. IB depicts a schematic view of an AER system in an example.

[0009] FIG. 2 illustrates an AER system with an MRC sampling port system in an example.

[0010] FIG. 3 depicts a close up view of an MRC sampling port system in an example.

[0011] FIGS. 4A-4D depict a cap for a sampling port system in an example.

[0012] FIGS. 5 A to 5B depict example methods of using that a sampling port system in an example.

[0013] FIG. 6 depicts a controller that may be used with any of the method or system discussed herein.DETAILED DESCRIPTION

[0014] The present disclosure describes, among other things, a sampling port system for use with an automated endoscope reprocessing (AER) system. The sampling port system can be used to allow or detect the Minimum Required Concentration of a sterilant, such as peracetic acid (PAA). In some cases, the sampling port can be used to take a sample from rinse water.

[0015] The AER system discussed herein integrates the MRC sampling port system to allow for detection of a minimum required concentration (MRC) of a sterilant such as peracetic acid (PAA), such as with a test strip, or for taking a sample of rinse water from the last cycle of the AER system. The system can include several components in an MRC sampling port system, including a circuit valve and a dosing valve, in addition to a check valve, fluidly connected to an MRC main body. The integrated MRC sampling port system can help enhance the functionality of an AER system by allowing for MRC testing and water sampling without contaminating the internal environment of the AER system itself during a cycle. In some examples, the MRC sampling port system can be integrated into existing AER systems. Moreover, the MRC sampling port system can include beneficial features like a closure or cap configuration that signals open or closed status, allowing real-time monitoring, accuracy, and safety during such sampling.

[0016] The proposed MRC sampling port system for integration with an AER system can help address several technical problems and challenges previously found with such AER systems and associated sampling. Chiefly, other methods of sampling for MRC and testing rinse water would allow for contamination of the internal environment of the AER system. Previous methods and systems lacked the ability to perform such sampling without entering the main AER system basin, risking exposure to the user and contamination of the basin. For example, previous methods could use a mechanical valve under the basin, filled with solution and / or test strips. Other previous methods performed sampling directly in the chamber. Here, the new MRC sampling port system can accommodate test strips or collection of rinse water without even entering or opening the main basin of the AER system. This prevents disruption of the sterilization cycle.

[0017] Thus, the described systems and methods provide several advantages, some of which are unexpected. Several technical advantages are achieved with the use of the integrated MRC sampling port system. For example, enhanced safety and accuracy are possible. The system can include a closure, such as a cap, which provides a signal indicating whether the cap is open or closed, which is monitored by logic or a computer program. This feature can ensure that the operations are carried out safely and accurately.

[0018] Moreover, the MRC sampling port system can be integrated with existing AER systems. The MRC sampling port system can be compatible with existing models, making it versatile and easy to adopt without significant modifications to current equipment. For example, the MRC sampling port system can be integrated into existing fluid flow linesof an AER system, and fluidly connected via a series of valves to allow flow of fluid between the AER system proper and the MRC sampling port system. In an example, the MRC sampling port system can be added to existing drain or fill lines of AER models.

[0019] The MRC sampling port system can also have a dual functionality, being used for detection of MRC with a test strip, or for collection of rinse water, depending on the needs of the operator. The MRC sampling port system can also provide automated monitoring using minimum and maximum level sensors that automate the process of solution management within the device, reducing the need for manual monitoring and intervention.

[0020] FIGS. 1A-1B illustrate an example AER system 100 to which a sampling port system could be applied. The AER system 100 can be, for example, a rapid, efficient, and flexible reprocessing system. The AER system 100 can be used for endoscopy units for reprocessing and cleaning of endoscopes in an example, and can be a simple and user- friendly system with a fast cycle time.

[0021] FIG. 1 A depict a perspective view of the AER system 100. FIG. IB depicts a schematic view of the AER system 100. As shown in FIG. IB, the AER system 100 can include a basin or reprocessing chamber 110, a drain basin valve 112, a dosing manifold 113, a main pump 114, a chamber 115, a recirculation valve 116, a channel monitoring manifold 117, a self-disinfection valve 118, a self-disinfection pathway 119, a drain valve 120, a drain 121, and a dosing in chamber valve 122, along the fluid flow pathway 130.

[0022] The fluid flow pathway 130 can run between the reprocessing chamber 110 and other components, circulating fluid within the AER system 100 as desired. Various valves can be situated along the fluid flow pathway 130. In an example, fluid along the fluid flow pathway 130 can be regulated by the main pump 114 in combinations with various valves as described herein. In other examples, additional, different, or alternative valves and / or pumps can be used as desired for movement of fluid through the system 100.

[0023] For example, in the system 100, fluid such as a sterilant and / or detergent can be pumped from the chamber 115 through the chamber valve 122 to the reprocessing chamber 110 for treatment of a medical device therein. The fluid can then be drained through the drain basin valve 112 and the dosing manifold 113, out through the system to the drain 121, the self-disinfection pathway 119, and / or the channel monitoring manifold 117.

[0024] The reprocessing chamber 110 can be a basin or chamber sized and shaped to receive one or more medical instruments or devices, such as an endoscope, for reprocessing.The system 100 can be actuated to provide desired doses (e.g., amounts and timing) of fluid such as a sterilant to the reprocessing chamber 110.

[0025] Such a sterilant can include, for example, liquid chemical solutions suitable for reprocessing medical devices such as flexible endoscopes. Such solutions can include active ingredients such as peracetic acid, hydrogen peroxide, glutaraldehyde, chlorine dioxide, ort / zo-phthaldehyde, hypochlorite acid, hypochlorous acid, chlorine, other approved sterilant components, and combinations thereof. In some examples, sterilant chemistries can include one or more main component and one or more activators, which may be used together or in sequence. Additionally, or alternatively, the system can be configured for receipt, circulation, and dosing of one or more detergents, including but not limited to enzymatic detergents.

[0026] The main pump 114 can be a pump integrated into the system 100 for recirculation, dosing, and draining of one or more fluids, such as a sterilant fluid, around the fluid flow pathway 130. The fluid therein can be directed through the series of valves within the system 100.

[0027] The various valves 112, 116, 118, 120, 122, and any other valves in the system 100 can be any of a variety of valve types suitable for the system, such as automated, manual, or actuated valves, or combinations thereof. In an example, the valves can be a combination of ball valves, butterfly valves, check valves, gate valves, knife gate valves, globe valves, needle valves, pinch valves, plug valves, pressure relief valves, or others as desired. In some cases, the valves can be isolation valves, regulation valves, safety valves, non-return vales, special purpose valves, or combinations thereof. The valves can have connections or ends such as screwed or threaded connections, flanged connections, butt welded connections, socket welded connections, wafer and lug connections, or combinations thereof. As desired, the valves can be made of stainless steel, or polymer materials.

[0028] The drain basin valve 112 can be a valve for emptying or draining the reprocessing chamber 110. The drain basin valve 112 can, for example, be a two-way valve that is actuatable to open or close a drain from the reprocessing chamber 110 to the dosing manifold 113. Fluid flowing out of the dosing manifold 113 can be pumped through the pump 114 to the chamber 115, where it can be directed to any of the chamber valve 122 back to the fluid flow pathway 130 and the reprocessing chamber 110, or to the drain 121, the selfdisinfection pathway 119, or the channel monitoring manifold 117, as desired.

[0029] The recirculation valve 116 can be a valve for recirculation and monitoring of that fluid. For example, the recirculation valve 116 can be a 2-way valve that has open and closed configurations. The recirculation valve 116 can regulate fluid flow between the channel monitoring manifold 117 and the chamber 115.

[0030] The self-disinfection valve 118 can be, for example, a two-way valve that can open and close to allow fluid flow to water filters, such as for sanitization. The selfdisinfection valve 118 can connect the fluid flow pathway 130 via the chamber 115 to the self-disinfection pathway 119 area and process.

[0031] The drain valve 120 can be a valve for draining of the AER system 100, such as a two-way valve that can open and close. The drain valve 120 can connect the fluid flow pathway 130 via the chamber 115 to the drain 121 for release of fluid therethrough.

[0032] The chamber valve 122 can be a valve for dosing of a fluid, such as a sterilant fluid, into the reprocessing chamber 110 for treatment of the medical device or other instrument. The chamber valve 122 can connect the chamber 115 to the fluid flow pathway 130 for provision of fluid to the reprocessing chamber 110.

[0033] The example AER system 100 can be used for reprocessing of, for example, flexible endoscopes. The AER system 100 can have a short cycle time, such as up to about 15 minutes, 20 minutes, or 30 minutes.

[0034] FIG. 2 illustrates an AER system 200 with an MRC sampling port system 250. The AER system 200 can contain similar components with similar functions to those described with reference to FIG. IB above, connected in a similar fashion. However, the AER system 200 can additionally include the integrated MRC sampling port system 250.

[0035] As shown in FIG. 2, the AER system 200 can include a basin or reprocessing chamber 210, a drain basin valve 212, a dosing manifold 213, a main pump 214, a chamber 215, a recirculation valve 216, a channel monitoring manifold 217, a self-disinfection valve 218, a self-disinfection route 219, a drain valve 220, a drain 221, and a dosing chamber valve 222. The MRC sampling port system 250 can additionally include an MRC circuit valve 224, an MRC dosing valve 226, an MRC combination check valve and two-way solenoid valve 228, and the MRC body 230. The system 200 can further include a main fluid pathway 225, in addition to MRC sampling port input pathway 232, MRC sampling port output pathway 234, MRC sampling port loop pathway 236, sample port to MRC basin pathway 238, and MRC sampling port overflow pathway 239.

[0036] The MRC sampling port system 250 can be used to sample fluid running through the system AER system 200 and collect samples regarding sterilant amounts therein. The MRC body 230 is an assembly and the main body of the MRC sampling port system 250. At the MRC body 230, a user can insert a test strip to test fluid therein. The MRC sampling port system 250 can be used to provide fluid samples to the MRC body 230 and expose test strip(s) therein. Such test strips can be, for example, flat, paper-like strips of material such as shown in FIGS. 4 A and 4B, that attach to a cap or closure of the MRC body 230. In some cases, at the MRC body 230, water from a system rinse can be collected. The MRC body 230 can be fluidly connected to the rest of the AER system 200 in the MRC sampling port system 250 through the various valves and fluid pathways described herein.

[0037] Here, MRC sampling port system 250 can be connected to the AER system 200 via the various fluid pathways 232, 234, 236, 238, 239. For example, in the AER system 200, fluid can flow into the MRC sampling port system 250 for sampling thereof from the chamber 215 via the MRC sampling port input pathway 232 when the chamber valve 222 is open. Fluid can flow into the MRC body 230 of the MRC sampling port system 250 through the MRC circuit valve 224 and MRC dosing valve 226 as desired when those valves are in the appropriate positions to allow fluid flow for sampling in the MRC body 230.

[0038] In some cases, the valves 224, 226, can be used to route fluid out of the MRC body 230 via the MRC sampling port output pathway 234.

[0039] The MRC circuit valve 224 can be a valve that allows or prohibits fluid flow between the reprocessing chamber 210 and the MRC body 230. The MRC circuit valve 224 can be, for example, an open / close valve for directing fluid flow to go into the MRC sampling port system 250 or bypass the MRC sampling port system 250.

[0040] The MRC dosing valve 226 can be used for tailored dosing in the MRC sampling port system 250. In an example, the MRC dosing valve 226 can be a three-way valve for direction of fluid between the MRC body 230, the reprocessing chamber 210, and other fluid pathways within the AER system 200.

[0041] In some cases, the valves 224, 226, can be used to route fluid back through the MRC body 230 via the MRC sampling port loop pathway 236. For example, during sampling, movement of fluid within the MRC body 230 can allow for effective monitoring of sterilant levels therein, such as via test strip or rinse cycle, as discussed in more detail below.

[0042] In some instances, overflow fluid can leave the MRC body 230 through the MRC sampling port overflow pathway 239 pathway. For example, where too much fluid ispresent in the MRC body 230, a portion of the fluid can be let out the MRC sampling port overflow pathway 239. Such fluid levels can be detected and monitored by one or more sensors.

[0043] In some cases, sampling fluid can be routed out the MRC sampling port output pathway 234, or can be routed to the MRC basin pathway 238 for use in the sterilization process. For example, when the sampling process in the MRC sampling port system 250 is completed, the fluid can be emptied of the MRC body 230.

[0044] If the fluid is routed out of the MRC body 230 through the MRC sampling port output pathway 234, it can be routed to the MRC combination check valve and two-way solenoid valve 228. The MRC combination check valve and two-way solenoid valve 228 can be, for example, a check valve that prevents liquid from the basin and / or dosing manifold from returning to the line of the MRC.

[0045] The use of the various valves 224, 226, 228, with the MRC sampling port system 250 can help regulate the flow of fluid in and out of the MRC body 230 to allow for sampling in the AER system 200 when desired, and bypass the MRC sampling port system 250 when desired. In this way, the use of the MRC sampling port system 250 can be turned off or on as needed, and not affect the use of the AER system 200 overall. The various valves 224, 226, 228, can allow for fluid-tight use of the MRC sampling port system 250 within the system 200.

[0046] FIG. 3 depicts a close up view of an example MRC sampling port system 300. The MRC sampling port system 300 can include an MRC sampling port body 310 with an MRC circuit valve 312, an MRC dosing valve 314, MRC sensors 316, an MRC overflow outlet 318, lock indicators 320, and a cap 400.

[0047] The MRC sampling port body 310 can be similar to the sampling port body described above, and can include a chamber size and shaped for sampling of fluid in an AER system. The MRC sampling port body 310 can be the central component where a test strip for the MRC test is placed or where a last rinse water can be collected. This dual functionality can allow for either testing or sampling.

[0048] The MRC sampling port body 310 can, for example, be sized and shaped for receipt of a test strip for sampling fluid in such a system. In some cases, the MRC sampling port body 310 can be sized and shaped for receipt of a portion of fluid during a rinse cycle. The MRC sampling port body 310 can be fluidly connected to the overall AER system, to allow for flow of fluid from the AER system into and through the 310. In some cases, one ormore sensors can be present inside the MRC sampling port body 310 to detect a level of a sterilant. In some cases, a holder for a test strip can be present.

[0049] The MRC circuit valve 312 and the MRC dosing valve 314 allow for regulation of fluid flow into the MRC sampling port body 310 for sampling. The MRC circuit valve 312 and the MRC dosing valve 314 allow for additional control within the system. The MRC circuit valve 312 can be, for example, a 3-way valve that is normally open in the path from to the basin of the AER system and normally closed in the path to the MRC main body 310. The MRC dosing valve 314 can be, for example, a 3-way valve that is normally closed in both paths: from MRC circuit valve 312 to the MRC main body 310 for loading, and from the MRC main body 310 to the pump for draining the solution.

[0050] The MRC sampling port system 300 can additionally be connected to a check valve that prevents liquid from flowing from the basin of the AER system and / or the dosing manifold to the MRC sampling port system 300, ensuring directional flow and preventing backflow.

[0051] The MRC sensors 316 can be level sensors within the MRC sampling port body 310. For example, the MRC sensors 316 can include a minimum level sensor and a maximum level sensor. The minimum level sensor can monitor the level of the solution to ensure it does not fall below a certain point during operation, while the maximum level sensors can ensure that the solution does not exceed a certain level during loading, preventing overflow and potential errors. These sensors can be in communication with a controller or computer as desired. Such a controller or computer can additionally monitor things such as the cap secure, a test strip, and other components of the MRC sampling port system 300 as discussed below.

[0052] The MRC overflow outlet 318 can be a fluid pathway connection to the MRC sampling port body 310 to allow outflow of fluid when too high a volume of fluid is reached in the MRC sampling port body 310, such as indicated by the MRC sensors 316. The lock indicators 320, meanwhile, can indicate whether the cap 400 is properly secured for sampling an operation.

[0053] A closure mechanism, such as a cap, can be used to help regulate the system. The cap 400, examples of which are shown in FIGS. 4A-4D, can be used to secure the MRC sampling port body 310 and ensure a fluid-tight MRC sampling port system 300 for sampling or collection of rinse water. One or more sensors, such as the lock indicators 320, can beintegrated with the cap 400 to allow for monitoring of the state of the cap: open or fully closed.

[0054] The cap 400 can have an associated electrical signal. The cap 400 can be designed with a metal component that closes an electrical circuit, signaling to the controller or computer whether it is safely closed. This feature can help ensure that the system is secure and that the cycle can only start when the cap 400 is fully closed.

[0055] The MRC sampling port system 300 can additionally include optional features such as a loading and draining function. Here, the MRC sampling port system 300 can include specific operational steps for loading activated solution into the main body and draining it after the cycle, controlled by the sequential operation of valves and the pump.

[0056] In another example, the MRC sampling port system 300 can include one or more operational features for test strips and / or rinse water sampling. For example, the MRC sampling port system 300 can allow for insertion of a test strip into the MRC main body for MRC testing or for collecting rinse water, depending on the configuration used.

[0057] These components and features of the MRC sampling port system 300 collectively enhance the functionality of an AER by allowing for precise control and monitoring of the sampling and testing processes, thereby improving safety, accuracy, and compliance with medical standards.

[0058] FIGS. 4 A, 4B, 4C, 4D depict examples of a cap 400 for a sampling port system, and FIGS. 5A to 5B depict example methods of using that cap. FIGS. 4A-5B will be discussed together. FIG. 5A depicts a flow chart of a method of using an example MRC sample port system in the configuration of an MRC port, while FIG. 5B depicts a flow chart of a method of using an example MRC sample port system in the configuration of a sample port.

[0059] When using the MRC sample port system for MRC detection as outlined in FIG. 5 A, a test strip can be used. FIG. 4A and FIG. 4B depict an example cap 400 with a test strip 410 attached thereto. The test strip 410 can be attached to the cap 400, such as by aligning the test strip and pushing in the direction of the arrow in FIG. 4A. In the cap 400, there can be a spring that keeps the test strip in position to prevent accidental release during a cycle of the AER system. Extraction of the test strip can be done by operating a force to remove it.

[0060] In the method 500A of FIG. 5 A, the test strip 410 can be attached to the cap 400 (box 510). Then, the cap can be connected to the MRC sampling port main body (box520). FIGS. 4C and 4D depict the cap 400 up close. Connection of the cap 400 to the MRC sampling port main body is depicted in FIG. 4C. The cap 400 can be configured so that connection of the cap 400 with the MRC sampling port main body is possible when the cap 400 is matched with the label “OPEN” on the MRC sampling port main body.

[0061] Subsequently, the cap 400 can be closed to the MRC sampling port main body (box 530). Closing the cap 400 is depicted in FIG. 4D. Here, it is possible to rotate the cap 400 until it is aligned with the written label “CLOSED” on the MRC sampling port main body. In correspondence of the lateral pin, there can be a lock system to avoid the cap moving during operation of the AER system. For example, a lateral pin 420 can be used to secure the cap 400.

[0062] In addition, the cap 400 can close an electrical circuit that indicates to a controller or computer that the cap 400 is safely closed. For example, the pin 420 can connect with electrical cables when in the secured position, and close a circuit. Such a closure can provide a signal to the controller or computer. For example, only if the signal indicates the closure can a cycle on the AER system be started. Conversely, if the cap 400 is not secure, an error signal can be sent to the user, the cycle can be aborted, or both. Similarly, if the AER system is not properly locked, another safety mechanism can be engaged.

[0063] Next, the MRC function can proceed within the AER cycle (box 540). Here, the reprocessing cycle can be run on the AER system with the integrated MRC sampling port system. This can include loading activated solution into the MRC sampling port main body (block 542) and draining solution from the MRC sampling port main body (block 544).

[0064] At block 542, the activated solution can be loaded into the MRC sampling port main body by opening the drain basin valve, activating the pump, and opening the dosing chamber valve to allow the fluid to flow towards the MRC sampling port system. At the MRC sampling port system, the MRC circuit valve and MRC dosing valve can be opened to allow flow of the fluid into the MRC main body to fill the basin until the maximum level sensor indicates a maximum fluid level has been reached. At this point, the valves can be closed to prevent overfill of the MRC sampling port main body.

[0065] At block 544, the solution can be drained from the MRC sampling port main body. Here, the drain valve can be opened, the pump can be activated, and the way from the MRC circuit valve and MRC dosing valve can be actuated to allow draining of the solution. This can be drained until the minimum level sensor indicates the fluid has been drained, at which point the valves can be closed.

[0066] At block 550, after the end of the AER cycle, the test strip can be removed and read via manual (human-controlled) or automated technologies. Thus, the MRC sampling port system can be used for sampling of AER system fluid via a test strip for verifying an MRC.

[0067] FIG. 5B depicts the use of an MRC sampling port for collecting of last rinse water. Here, no test strip is connected. Instead, the cap is connected (block 560) and closed (block 565), and the circuit completed, indicating to the system to proceed.

[0068] Then, at block 570, the last rinse water is loaded into the MRC sampling port main body. Here, the drain basin valve is opened and the pump is activated. The dosing chamber valve is also opened. This allows the fluid to flow towards the MRC sampling port system. At the MRC sampling port system, the MRC circuit valve and MRC dosing valve can be opened to allow flow of the fluid into the MRC main body to fill the basin until the maximum level sensor indicates a maximum fluid level has been reached. At this point, the valves can be closed to prevent overfill of the MRC sampling port main body.

[0069] The AER system cycle can then be run to completion. Then, at block 580, the user can unlock the cap by rotating it to “OPENED”, and collect the water, such as by syringe. The cap can then be closed by the user. Finally, at block 590, the AER system can be run to drain solution to eliminate residual.

[0070] FIG. 6 is a block diagram of a typical, general-purpose computer 600 that may be programmed into a special purpose computer suitable for implementing one or more embodiments of the manifest record generating program disclosed herein. The manifest record generating program described above may be implemented on any general-purpose processing component, such as a computer with sufficient processing power, memory resources, and communications throughput capability to handle the necessary workload placed upon it. The computer 600 includes a processor 602 (which may be referred to as a central processor unit or CPU) that is in communication with memory devices including secondary storage 604, read only memory (ROM) 606, random access memory (RAM) 608, input / output (I / O) devices 610, and network connectivity devices 612. The processor 602 may be implemented as one or more CPU chips or may be part of one or more application specific integrated circuits (ASICs).

[0071] The secondary storage 604 is typically comprised of one or more disk drives or tape drives and is used for non-volatile storage of data and as an over-flow data storage device if RAM 608 is not large enough to hold all working data. Secondary storage 604 maybe used to store programs that are loaded into RAM 608 when such programs are selected for execution. The ROM 606 is used to store instructions and perhaps data that are read during program execution. ROM 606 is a non-volatile memory device that typically has a small memory capacity relative to the larger memory capacity of secondary storage 604. The RAM 608 is used to store volatile data and perhaps to store instructions. Access to both ROM 606 and RAM 608 is typically faster than to secondary storage 604.

[0072] The devices described herein may be configured to include computer-readable non-transitory media storing computer readable instructions and one or more processors coupled to the memory, and when executing the computer readable instructions configure the computer 600 to perform method steps and operations described above with reference to FIG. 3 to FIG. 6. The computer-readable non-transitory media includes all types of computer readable media, including magnetic storage media, optical storage media, flash media and solid-state storage media.

[0073] It should be further understood that software including one or more computerexecutable instructions that facilitate processing, and operations as described above with reference to any one or all of steps of the disclosure may be installed in and sold with one or more servers and / or one or more routers and / or one or more devices within consumer and / or producer domains consistent with the disclosure. Alternatively, the software may be obtained and loaded into one or more servers and / or one or more routers and / or one or more devices within consumer and / or producer domains consistent with the disclosure, including obtaining the software through physical medium or distribution system, including, for example, from a server owned by the software creator or from a server not owned but used by the software creator. The software may be stored on a server for distribution over the Internet, for example.

[0074] Also, it will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly andencompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled", and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0075] The components of the illustrative devices, systems and methods employed in accordance with the illustrated embodiments may be implemented, at least in part, in digital electronic circuitry, analog electronic circuitry, or in computer hardware, firmware, software, or in combinations of them. These components may be implemented, for example, as a computing program product such as a computing program, program code or computer instructions tangibly embodied in an information carrier, or in a machine-readable storage device, for execution by, or to control the operation of, data processing apparatus such as a programmable processor, a computer, or multiple computers.

[0076] A computing program may be written in any form of programming language, including compiled or interpreted languages, and it may be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computing program may be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by a communication network. Also, functional programs, codes, and code segments for accomplishing the techniques described herein may be easily construed as within the scope of the present disclosure by programmers skilled in the art. Method steps associated with the illustrative embodiments may be performed by one or more programmable processors executing a computing program, code or instructions to perform functions (e.g., by operating on input data and / or generating an output). Method steps may also be performed by, and apparatus may be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit), for example.

[0077] The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general-purpose processor, a digital signal processor (DSP), an ASIC, a FPGA or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general- purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may alsobe implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0078] Processors suitable for the execution of a computing program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random-access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. Information carriers suitable for embodying computing program instructions and data include all forms of non-volatile memory, including by way of example, semiconductor memory devices, e.g., electrically programmable read-only memory or ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory devices, and data storage disks (e.g., magnetic disks, internal hard disks, or removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks). The processor and the memory may be supplemented by or incorporated in special purpose logic circuitry.

[0079] Those of skill in the art understand that information and signals may be represented using any of a variety of different technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0080] Those of skill in the art further appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not beinterpreted as causing a departure from the scope of the disclosure. A software module may reside in random access memory (RAM), flash memory, ROM, EPROM, EEPROM, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such the processor may read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. In other words, the processor and the storage medium may reside in an integrated circuit or be implemented as discrete components.

[0081] As used herein, “machine-readable medium” means a device able to store instructions and data temporarily or permanently and may include, but is not limited to, random-access memory (RAM), read-only memory (ROM), buffer memory, flash memory, optical media, magnetic media, cache memory, other types of storage (e.g., Erasable Programmable Read-Only Memory (EEPROM)), and / or any suitable combination thereof. The term “machine-readable medium” should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, or associated caches and servers) able to store processor instructions. The term “machine-readable medium” shall also be taken to include any medium, or combination of multiple media, that is capable of storing instructions for execution by one or more processors, such that the instructions, when executed by one or more processors cause the one or more processors to perform any one or more of the methodologies described herein. Accordingly, a “machine-readable medium” refers to a single storage apparatus or device, as well as “cloud-based” storage systems or storage networks that include multiple storage apparatus or devices. The term “machine- readable medium” as used herein excludes signals per se.Various Notes & Examples

[0082] In some aspects, the techniques described herein relate to an automated endoscope reprocessing (AER) system including: a reprocessing chamber configured to receive a fluid; a pump fluidly connected to the reprocessing chamber, the pump configured to circulate the fluid; a plurality of valves configured to regulate circulation of the fluid within the system; a sampling port system fluidly connected to the reprocessing chamber, the sampling port system including: a main body to receive a portion of the fluid; a sampling port valve system actuatable to regulate fluid flow into the main body; a closure actuatable between a closed state and an open state; one or more sensors adapted to monitor the sampling port system and provide sensor measurements to a controller.

[0083] In some aspects, the techniques described herein relate to a system, wherein when the closure is in the closed state, an electrical signal is provided to the controller.

[0084] In some aspects, the techniques described herein relate to a system, wherein, if the closure is in the open state, an electrical signal is not provided to the controller.

[0085] In some aspects, the techniques described herein relate to a system, wherein, if the closure is in the open state, the controller is configured to provide an error message, and if the closure is in the closed state, the controller is configured to provide an indication to proceed.

[0086] In some aspects, the techniques described herein relate to a system, wherein the closure is a cap actuatable to complete an electrical circuit when in the closed state.

[0087] In some aspects, the techniques described herein relate to a system, wherein the main body contains one or more spring mechanisms configured to receive a test strip for minimum required concentration (MRC) testing.

[0088] In some aspects, the techniques described herein relate to a system, wherein the main body is configured to collect rinse water from a final cycle of the AER system.

[0089] In some aspects, the techniques described herein relate to a system, wherein the one or more sensors include a maximum level sensor and a minimum level sensor.

[0090] In some aspects, the techniques described herein relate to a system, wherein the system is configured to perform a cycle that includes loading a solution into the main body until detected by the maximum level sensor and subsequently draining the solution when detected by the minimum level sensor.

[0091] In some aspects, the techniques described herein relate to a system, wherein the plurality of valves include: a drain basin valve configured to control the flow from thebasin to the pump; a self-disinfection valve configured to control the flow to water filters for sanitization; a drain valve configured to control drainage of the system; and a dosing inchamber valve configured to control the dosing of solution into the basin.

[0092] In some aspects, the techniques described herein relate to a system, wherein the sampling port valve system includes a fluid circuit valve that allows flow from the dosing in-chamber valve to the reprocessing chamber and prevents flow from the dosing chamber valve to the main body.

[0093] In some aspects, the techniques described herein relate to a system, wherein the sampling port valve system includes a dosing valve that controls flow from the circuit valve to the main body and from the main body to the pump.

[0094] In some aspects, the techniques described herein relate to a system, wherein the sampling port valve system includes at least one three-way valve.

[0095] In some aspects, the techniques described herein relate to a system, further including a check valve positioned to prevent backflow from the reprocessing chamber to the sampling port system.

[0096] In some aspects, the techniques described herein relate to a system, wherein the sampling port system is fluidly integrated with the AER system.

[0097] In some aspects, the techniques described herein relate to a Minimum Required Concentration (MRC) sampling system for an automated endoscope re-processor (AER) system, the MRC sampling system including: an MRC main body configured to receive a test strip; an MRC circuit valve configured as a 3 -way valve, configured to regulate flow from a dosing chamber and a reprocessing chamber to the MRC main body; an MRC dosing valve configured as a 3 -way valve, configured to regulate flow from the MRC circuit valve to the MRC main body and from the MRC main body to a pump; a cap for fluidly sealing the main body; and one or more sensors configured therein for monitoring the MRC sampling system and providing sensor data to a controller.

[0098] In some aspects, the techniques described herein relate to a system, further including a check valve positioned to prevent backflow to the MRC main body.

[0099] In some aspects, the techniques described herein relate to a system, wherein the cap includes an electrical signal mechanism that indicates whether the cap is open or closed.

[0100] In some aspects, the techniques described herein relate to a system, further including a control system configured to monitor and control the operation of the MRCcircuit valve, the MRC dosing valve, and the pump based on signals from minimum and maximum level sensors located within the MRC main body.

[0101] In some aspects, the techniques described herein relate to a system, wherein the system is configured to load a solution into the MRC main body until a maximum level sensor detects a predetermined fluid level, maintain the solution within the MRC main body for a predetermined testing period, and subsequently drain the solution from the MRC main body until a minimum level sensor detects the fluid level has been sufficiently reduced.

[0102] Each of these non-limiting examples can stand on its own or can be combined in various permutations or combinations with one or more of the other examples.

[0103] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0104] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0105] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc.are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0106] Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine- readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or nonvolatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0107] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMSWhat is claimed is:

1. An automated endoscope reprocessing (AER) system comprising: a reprocessing chamber configured to receive a fluid; a pump fluidly connected to the reprocessing chamber, the pump configured to circulate the fluid; a plurality of valves configured to regulate circulation of the fluid within the system; a sampling port system fluidly connected to the reprocessing chamber, the sampling port system comprising: a main body to receive a portion of the fluid; a sampling port valve system actuatable to regulate fluid flow into the main body; a closure actuatable between a closed state and an open state; one or more sensors adapted to monitor the sampling port system and provide sensor measurements to a controller.

2. The system of claim 1, wherein when the closure is in the closed state, an electrical signal is provided to the controller.

3. The system of claim 2, wherein, if the closure is in the open state, an electrical signal is not provided to the controller.

4. The system of claim 3, wherein, if the closure is in the open state, the controller is configured to provide an error message, and if the closure is in the closed state, the controller is configured to provide an indication to proceed.

5. The system of claim 1, wherein the closure is a cap actuatable to complete an electrical circuit when in the closed state.

6. The system of claim 1, wherein the main body contains one or more spring mechanisms configured to receive a test strip for minimum required concentration (MRC) testing.

7. The system of claim 1, wherein the main body is configured to collect rinse water from a final cycle of the AER system.

8. The system of claim 1, wherein the one or more sensors include a maximum level sensor and a minimum level sensor.

9. The system of claim 8, wherein the system is configured to perform a cycle that includes loading a solution into the main body until detected by the maximum level sensor and subsequently draining the solution when detected by the minimum level sensor.

10. The system of claim 1, wherein the plurality of valves comprise: a drain basin valve configured to control the flow from the basin to the pump; a self-disinfection valve configured to control the flow to water filters for sanitization; a drain valve configured to control drainage of the system; and a dosing in-chamber valve configured to control the dosing of solution into the basin.

11. The system of claim 10, wherein the sampling port valve system comprises a fluid circuit valve that allows flow from the dosing in-chamber valve to the reprocessing chamber and prevents flow from the dosing chamber valve to the main body.

12. The system of claim 11, wherein the sampling port valve system comprises a dosing valve that controls flow from the circuit valve to the main body and from the main body to the pump.

13. The system of claim 1, wherein the sampling port valve system comprises at least one three-way valve.

14. The system of claim 1, further comprising a check valve positioned to prevent backflow from the reprocessing chamber to the sampling port system.

15. The system of claim 1, wherein the sampling port system is fluidly integrated with the AER system.

16. A Minimum Required Concentration (MRC) sampling system for an automated endoscope reprocessor (AER) system, the MRC sampling system comprising: an MRC main body configured to receive a test strip; an MRC circuit valve configured as a 3 -way valve, configured to regulate flow from a dosing chamber and a reprocessing chamber to the MRC main body; an MRC dosing valve configured as a 3 -way valve, configured to regulate flow from the MRC circuit valve to the MRC main body and from the MRC main body to a pump; a cap for fluidly sealing the main body; and one or more sensors configured therein for monitoring the MRC sampling system and providing sensor data to a controller.

17. The system of claim 16, further comprising a check valve positioned to prevent backflow to the MRC main body.

18. The system of claim 16, wherein the cap includes an electrical signal mechanism that indicates whether the cap is open or closed.

19. The system of claim 16, further comprising a control system configured to monitor and control the operation of the MRC circuit valve, the MRC dosing valve, and the pump based on signals from minimum and maximum level sensors located within the MRC main body.

20. The system of claim 16, wherein the system is configured to load a solution into the MRC main body until a maximum level sensor detects a predetermined fluid level, maintain the solution within the MRC main body for a predetermined testingperiod, and subsequently drain the solution from the MRC main body until a minimum level sensor detects the fluid level has been sufficiently reduced.

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