How to sterilize an endoscope

Abstract

A method for sterilizing an article includes receiving the article in a sterilization chamber. The method also includes applying a vacuum to a first pressure less than 100 Torr. The method also includes introducing a sterilant into the sterilization chamber. The method also includes maintaining the first pressure in the sterilization chamber for a first period of time. The method also includes venting the sterilization chamber to a second pressure less than 100 Torr. The method also includes maintaining the second pressure. The method also includes venting the sterilization chamber to a third pressure. The method also includes maintaining the third pressure. The method also includes venting the sterilization chamber to atmospheric pressure. The method further includes, between the venting step and the maintaining step, applying a vacuum to a fourth pressure less than 100 Torr, introducing additional sterilant, and maintaining the fourth pressure.

Description

Content of disclosure

[0001] [Priority] This application is a continuation-in-part of U.S. patent application Ser. No. 15 / 198,670, entitled "Apparatus and Method for Sterilizing Endoscope," filed June 30, 2016, now published as U.S. Patent No. 10,314,929, on June 11, 2019, which is a continuation-in-part of U.S. patent application Ser. No. 16 / 225,035, entitled "Apparatus and Method for Sterilizing Endoscope," filed December 19, 2018, now published as U.S. Patent Application Publication No. 2019 / 0224356, on July 25, 2019, which is a continuation-in-part of U.S. patent application Ser. No. 16 / 225,035, entitled "Method for Sterilizing Endoscope," filed December 19, 2018, now published as U.S. Patent Application Publication No. 2019 / 0224356, on July 25, 2019, which is a continuation-in-part of U.S. patent application Ser. This application claims the benefit of U.S. patent application Ser. No. 16 / 843,366, entitled "A Novel Endoscope," filed April 8, 2020, which now published as U.S. Patent Application Publication No. 2020 / 0230279 on July 23, 2020, the disclosures of which are incorporated herein by reference.

[0002] 〔background〕 Reusable medical devices, such as certain surgical instruments, endoscopes, etc., may be sterilized before reuse to minimize the possibility of a contaminated device being used on a patient and thereby causing an infection to the patient. A variety of sterilization techniques may be used, such as steam, hydrogen peroxide, peracetic acid, and vapor phase sterilization, with or without gas plasma and ethylene oxide (EtO). Each of these methods may depend in part on the rate of diffusion of a sterilizing fluid (e.g., gas) onto or into the medical device being sterilized.

[0003] Prior to sterilization, medical devices may be packaged in containers or pouches with semi-permeable barriers that allow the penetration of sterilizing fluids, sometimes called sterilants, but prevent the ingress of contaminating microorganisms, particularly after sterilization and until the package is opened by medical personnel. For a sterilization cycle to be effective, contaminating microorganisms within the package must be killed, as microorganisms that survive the sterilization cycle may grow and recontaminate the medical device. Sterilant dispersion may be particularly problematic for medical devices that have dispersion-restricted spaces within them, as these may reduce the likelihood that the sterilization cycle will be effective. For example, some endoscopes have one or more long, narrow lumens, and the sterilant must be dispersed within the lumen at a sufficient concentration for a sufficient time to achieve a successful sterilization cycle.

[0004] Sterilization of medical devices can be performed by an automated sterilization system, such as the STERRAD® System by Advanced Sterilization Products of Irvine, California. Examples of automated sterilization systems include U.S. Pat. No. 6,939,519, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma," issued on Sep. 6, 2005, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 6,852,279, entitled "Sterilization with Temperature-Controlled Diffusion Path," issued on Feb. 8, 2005, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 6,852,277, entitled "Sterilization System Employing a Switching Module Adapter to Pulsate the Low Frequency Power Applied to a Plasma," issued on Feb. 8, 2005, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 6,447,719, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma," issued on Sep. 10, 2002, the disclosure of which is incorporated herein by reference; and U.S. Pat. No. 6,447,719, entitled "System and Method for Sterilization of Low Frequency Plasma," issued on Sep. 10, 2002, the disclosure of which is incorporated herein by reference. This disclosure is described in U.S. Provisional Patent Application No. 62 / 316,722, filed April 1, 2016, entitled "Polyester-Based Polymeric Polymers for Sterilizing Medical Devices."

[0005] Some sterilization systems can sterilize medical devices using vaporized chemical sterilants or gases, such as hydrogen peroxide, peracetic acid, ozone, chlorine dioxide, nitrogen dioxide, etc. Examples of such systems are described in U.S. Patent No. 6,365,102, entitled "Method of Enhanced Sterilization with Improved Material Compatibility," issued April 2, 2002, the disclosures of which are incorporated herein by reference, and U.S. Patent No. 6,325,972, entitled "Apparatus and Process for Concentrating a Liquid Sterilant and Sterilizing Articles Therewith," issued December 4, 2001, the disclosures of which are incorporated herein by reference. Some such systems provide a hydrogen peroxide / gas plasma sterilization system that includes a vacuum chamber, a plasma source, and a high concentration of hydrogen peroxide for sterilization. Some such systems may have difficulty sterilizing the lumens of some medical devices when their length exceeds a certain value; or the processing time of such systems may still not be fast enough for some applications. Thus, some medical devices, such as long and / or narrow flexible endoscopes, may not be completely sterilized with these systems due to the sterilant vapor not reaching the inside of the channels sufficiently. Thus, such medical devices may only be disinfected, not sterilized. Sterilization systems using ethylene oxide may have relatively long processing times (e.g., longer than 24 hours), which may be undesirable in some cases.

[0006] Due to operator error, a medical device may be returned to service that is mistakenly believed to be decontaminated. Confirming that a sterilization cycle was effective may help medical personnel avoid using contaminated medical devices on patients. Sterilized medical devices may not be checked for contaminating microorganisms themselves, as such activity may introduce other contaminating microorganisms to the medical device, thereby recontaminating the medical device. Thus, an indirect check may be performed using a sterilization indicator. A sterilization indicator is a device that may be placed alongside or in close proximity to a medical device undergoing a sterilization cycle, the sterilization indicator undergoing the same sterilization cycle as the medical device. For example, a biological indicator having a predetermined amount of microorganisms may be placed in a sterilization chamber alongside the medical device and undergo a sterilization cycle. After the cycle is completed, the microorganisms in the biological indicator may be cultured to determine whether any of the microorganisms survive the cycle. The presence or absence of viable microorganisms in the biological indicator indicates whether the sterilization cycle was effective.

[0007] Although various systems and methods have been made and used for surgical instrument sterilization, it is believed that no one prior to the inventors has created or used the technology as described herein.

[0008] The invention will be better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [Brief description of the drawings]

[0009] [Figure 1] 1 depicts a schematic diagram of an exemplary medical device sterilization cabinet. [Diagram 2] 2 depicts a high-level flowchart of an exemplary series of steps that the sterilization cabinet of the system of FIG. 1 may perform to sterilize medical devices. [Diagram 3] 3 depicts a flow chart of an exemplary sequence of steps that may be performed as part of a first exemplary sterilization cycle within the sequence of steps of FIG. 2. [Figure 4] 4 depicts a graph showing a first exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of the first exemplary sterilization cycle of FIG. 3. [Diagram 5] 3 depicts a flow chart of an exemplary alternative sequence of steps that may be performed as part of a first exemplary alternative sterilization cycle within the sequence of steps of FIG. 2. [Figure 6] 7 depicts a graph showing a second exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of the first exemplary alternative sterilization cycle of FIG. 5. [Figure 7] 13 depicts a graph showing a third exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a second exemplary alternative sterilization cycle. [Figure 8] 13 depicts a graph showing a fourth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a third exemplary alternative sterilization cycle. [Figure 9] 13 depicts a graph showing a fifth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a fourth exemplary alternative sterilization cycle. [Figure 10] 13 depicts a graph showing a sixth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a fifth exemplary alternative sterilization cycle. [Figure 11] FIG. 11 depicts a graph showing a seventh exemplary plot of pressure in the sterilization chamber of the sterilization cabinet of FIG. 1 over time overlaid on an exemplary plot of hydrogen peroxide concentration in the sterilization chamber of the sterilization cabinet of FIG. 1 over time during execution of a sixth exemplary alternative sterilization cycle. [Figure 12] 13 depicts a graph showing an eighth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a seventh exemplary alternative sterilization cycle. [Figure 13] 13 depicts a graph showing a ninth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of an eighth exemplary alternative sterilization cycle. [Figure 14] 10 depicts a graph showing a tenth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a ninth exemplary alternative sterilization cycle. [Figure 15] 10 depicts a graph showing an eleventh exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a tenth exemplary alternative sterilization cycle. [Figure 16] 13 depicts a graph showing a twelfth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of an eleventh exemplary sterilization cycle. [Figure 17] 13 depicts a graph showing a thirteenth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during the performance of the twelfth exemplary sterilization cycle. [Figure 18] 13 depicts a graph showing a fourteenth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of the thirteenth exemplary alternative sterilization cycle. [Figure 19] 10 depicts a graph showing a fifteenth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of the fourteenth exemplary alternative sterilization cycle. [Figure 20] 1 depicts a graph showing a sixteenth exemplary plot of pressure within the sterilization chamber of the sterilization cabinet of FIG. 1 over time during performance of a fifteenth exemplary alternative sterilization cycle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The following description of a specific example of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description. The following description is, by way of example, one of the best modes contemplated for implementing the technology. As will be appreciated, the technology described herein is capable of other distinct and obvious aspects that do not depart from the technology. Thus, the drawings and description should be regarded as illustrative in nature, and not as restrictive.

[0011] It is further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Thus, the teachings, expressions, embodiments, examples, etc. described below should not be viewed in isolation with respect to each other. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0012] I. Overview of an Exemplary Sterilization System FIG. 1 depicts an exemplary sterilization cabinet (150) operable to sterilize medical devices, such as endoscopes. The sterilization cabinet (150) of this example includes a sterilization chamber (152) configured to receive one or more medical devices for sterilization. Although not shown, the sterilization cabinet (150) also includes a door that opens and closes the sterilization chamber (152) in response to actuation of a kick plate. An operator may thereby open and close the sterilization chamber (152) in a hands-free manner. Of course, any other suitable features may be used to provide selective access to the sterilization chamber. The sterilization cabinet (150) also includes a sterilization module (156) operable to dispense a sterilant into the sterilization chamber (152) to sterilize the medical devices contained therein. In this example, the sterilization module (156) is configured to receive a replaceable sterilant cartridge (158) containing a quantity of sterilant. By way of example only, each sterilant cartridge (158) may contain enough sterilant to perform five sterilization procedures.

[0013] The sterilization cabinet (150) of this example further includes a touch screen display (160). The touch screen display (160) is operable to render a variety of user interface display screens, such as those described in U.S. Provisional Patent Application No. 62 / 316,722, the disclosure of which is incorporated herein by reference. Of course, the touch screen display (160) may display a variety of other screens. The touch screen display (160) is further configured to receive user input in the form of a user contacting the touch screen display (160) in accordance with conventional touch screen technology. Additionally or alternatively, the sterilization cabinet (150) may include a variety of other types of user input features, including, but not limited to, buttons, keypads, keyboards, mice, trackballs, and the like.

[0014] The sterilization cabinet (150) of this example further includes a processor (162), which is in communication with the sterilization module (156) and with the touchscreen display (160). The processor (162) is operable to execute control algorithms to drive the sterilization module (156) according to user input. The processor (162) executes instructions to display various screens on the touchscreen display (160); and is further operable to process instructions received from a user via the touchscreen display (160) (and / or via other user input features). The processor (162) is also in communication with various other components of the sterilization cabinet (150) and is operable to drive those components and / or process input and / or other data from those components. A variety of suitable components and configurations that may be used to form the processor (162) will be apparent to those of skill in the art in view of the teachings herein.

[0015] The sterilization cabinet (150) of this embodiment further includes an identification tag reader (166), which is operable to read the identification tag of the biological indicator as described herein. By way of example only, the identification tag reader (166) may include an optical reader operable to read the optical identification tag (e.g., barcode, QR code, etc.) of the biological indicator. Additionally or alternatively, the identification tag reader (166) may include an RFID reader operable to read the RFID identification tag (e.g., barcode, QR code, etc.) of the biological indicator. Various suitable components and configurations that may be used to form the identification tag reader (166) will be apparent to those of skill in the art in view of the teachings herein. Data received through the identification tag reader (166) is processed through the processor (162).

[0016] The sterilization cabinet (150) of this example further includes a memory (168) operable to store control logic and instructions that, when executed by the processor (162), drive components such as the sterilization module (156), the touch screen display (160), the communications module (154), and the identification tag reader (166). The memory (168) may also be used to store results related to sterilization cycle set-up, performance of the load adjustment cycle, performance of the sterilization cycle, and / or various other types of information. The various suitable forms that the memory (168) may take, as well as the various ways in which the memory (168) may be used, will be apparent to those of skill in the art in view of the teachings herein.

[0017] The sterilization cabinet (150) of this example further includes a printer (170), which is operable to print information, such as results regarding the sterilization cycle setup, performance of the load adjustment cycle, performance of the sterilization cycle, and / or various other types of information. By way of example only, the printer (170) may include a thermal printer, although of course any other suitable type of printer may be used. The various suitable forms that the printer (170) may take, as well as the various ways in which the printer (170) may be used, will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that the printer (170) is merely optional and may be omitted in some versions.

[0018] The sterilization cabinet (150) of this example further includes a vacuum source (180) and a vent valve (182). The vacuum source (180) is in fluid communication with the sterilization chamber (152) and in communication with the processor (162). As such, the processor (162) is operable to selectively activate the vacuum source (180) according to one or more control algorithms. When the vacuum source (180) is activated, the vacuum source (180) is operable to reduce pressure within the sterilization chamber (152), as described in further detail below. The vent valve (182) is also in fluid communication with the sterilization chamber (152). Additionally, the vent valve (182) is in communication with the processor (162), which is operable to selectively activate the vent valve (182) according to one or more control algorithms. When the vent valve (182) is activated, the vent valve (182) is operable to vent the sterilization chamber (152) to atmosphere, as described in further detail below. A variety of suitable components that may be used to provide the vacuum source (180) and vent valve (182) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0019] In addition to the foregoing, the sterilization cabinet (150) may be constructed and operable in accordance with at least some of the teachings of U.S. Pat. No. 6,939,519, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,852,279, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,852,277, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,447,719, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,365,102, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,325,972, the disclosures of which are incorporated herein by reference; and / or U.S. Provisional Patent Application No. 62 / 316,722, the disclosures of which are incorporated herein by reference.

[0020] II. Overview of Exemplary Sterilization Methods 2 depicts a high-level flow chart of an exemplary series of steps that a sterilization cabinet (150) may execute to sterilize used medical devices, such as an endoscope. The sterilization cabinet (150) may be configured to perform one or more sterilization cycles, with different sterilization cycles being suitable for different types and quantities of medical devices. Thus, as a first step, the sterilization cabinet (150) may display one or more available sterilization cycles via the touch screen display (160) and then receive a sterilization cycle selection from a user (block 200).

[0021] The sterilization cabinet (150) may also display instructions indicating whether a biological indicator should be used with the selected sterilization cycle and receive a biological indicator identification (block 202). Such biological indicator identification (block 202) may be provided via an identification tag reader (166), via a touch screen display (160), or otherwise. The biological indicator may be placed inside the sterilization chamber (152) of the sterilization cabinet (150) before the sterilization cycle begins and may remain in the sterilization chamber during the sterilization cycle. Thus, a user may identify a particular biological indicator (block 202) before the biological indicator is placed in the sterilization chamber. The biological indicator may contain a microorganism that is responsive to a particular sterilization cycle. Once the sterilization cycle is completed, the biological indicator may be tested for that microorganism to provide a measure of the effectiveness of the sterilization cycle. Although a biological indicator is not necessarily required for all sterilization cycles, a biological indicator may be required based on hospital regulations or local ordinances.

[0022] The selection of a sterilization cycle (block 200) and the identification of the biological indicators (block 202) may dictate one or more requirements for the configuration and placement of the medical devices within the sterilization chamber (152). Thus, to provide for preparation of a sterilization cycle (204), once a sterilization cycle has been selected (block 200) and the biological indicators have been identified (block 202), the sterilization cabinet (150) may provide an indication via the touch screen display (160) of the proper placement of the medical devices. This indication may serve as a visual guide to the user's placement of the medical devices (and possibly the biological indicators) within the sterilization chamber (152) of the sterilization cabinet (150) based on the sterilization cycle selection (block 200). The door of the sterilization chamber (152) may be opened to allow the user to place the medical devices (and possibly the biological indicators) within the sterilization chamber (152) as directed.

[0023] Once the user has placed the medical device within the sterilization chamber (152) based on these instructions, the user may press a start button or other button to indicate that placement of the medical device is complete. In some versions, the sterilization cabinet (150) is configured to automatically verify proper medical device placement. By way of example only, the sterilization cabinet (150) may verify proper medical device placement within the sterilization chamber (152) using photo sensors, imaging devices, weight sensors, and / or other components. However, it should be understood that some versions of the sterilization cabinet (150) may lack the ability to automatically verify proper placement of the medical device within the sterilization chamber (152).

[0024] If the medical device placement is authorized and / or the user has otherwise completed preparation for the cycle (block 204), the sterilization cabinet (150) may initiate a load adjustment process (block 206). The load adjustment process (block 206) prepares the sterilization chamber (152) and the medical devices therein for optimal sterilization during a sterilization cycle. Adjustment may include controlling and optimizing one or more characteristics of the sterilization chamber (152). For example, during load adjustment, the sterilization cabinet (150) may continuously monitor the moisture level within the sterilization chamber (152) and reduce the moisture level by, for example, circulating and dehumidifying air within the sterilization chamber (152), creating a vacuum within the sterilization chamber (152), heating the sterilization chamber (152), and / or other methods of dehumidifying the sealed chamber. This may continue until the sterilization cabinet (150) determines that an acceptable moisture level has been reached.

[0025] As part of the load conditioning cycle (block 206), the sterilization cabinet (150) may also continuously sense the temperature inside the sterilization chamber (152) and heat the sterilization chamber (152), for example, by convection of heated air, conduction through the interior surfaces of the sterilization chamber (152), and / or using other techniques. This may continue until the sterilization cabinet (150) determines that an acceptable internal temperature has been reached. Various conditioning actions, for example, temperature or humidity control, may be performed in parallel or sequentially. It should also be appreciated that the load conditioning cycle (block 206) may verify that the sterilization chamber is sealed; verify the contents of the sterilization chamber; check physical characteristics of the contents of the sterilization chamber, such as the volume of the contents, the weight of the contents, or other characteristics; and / or perform one or more conditioning steps, which may include chemical, plasma, or other types of treatments to reduce moisture, increase temperature, and / or otherwise prepare the medical devices in the sterilization chamber (152) for the sterilization cycle (block 208).

[0026] While one or more adjustment actions have been performed as part of the load adjustment cycle (block 206), the sterilization cabinet (150) may display information via the touch screen display (160) to the user indicating the amount of time until the sterilization cycle (block 208) may begin to run. Once all load adjustment criteria have been successfully met, the load adjustment cycle (block 206) is complete and the sterilization cycle (block 208) may then be run. It should therefore be understood that the sterilization cabinet (150) is configured such that the sterilization cycle (block 208) does not actually begin until the load adjustment cycle (block 206) is complete. It should also be understood that the load adjustment cycle (block 206) may be omitted or modified in some versions of the operation of the sterilization cabinet (150).

[0027] As previously mentioned, the sterilization cabinet (150) may automatically and immediately begin performing a sterilization cycle (block 208) after the load adjustment (block 206) is completed. The sterilization cycle (block 208) may include exposing the medical devices in the sterilization chamber to autoclaved sterilant gas, further heat treatment, chemical treatment, plasma treatment, vacuum treatment, and / or other types of sterilization treatment. During the performance of the sterilization cycle (block 208), the sterilization cabinet (150) may display information via the touch screen display (160), such as the time remaining in the sterilization cycle (block 208), the current stage of the sterilization cycle (block 208) (e.g., plasma, vacuum, injection, heat, chemical treatment), and / or other information.

[0028] In some versions, the sterilization cycle (block 208) includes the exemplary substeps shown in FIG. 3. Specifically, the cycle may begin by applying a vacuum within the sterilization chamber (152) (block 310). To provide such vacuum, the processor (162) may activate the vacuum source (180) according to a control algorithm. The processor (162) then determines whether a sufficient pressure level has been reached within the sterilization chamber (152) (block 312). By way of example only, the processor (162) may monitor data from one or more pressure sensors within the sterilization chamber (152) as part of the decision step (block 312). Alternatively, the processor (162) may simply activate the vacuum source (180) for a predetermined period of time and assume that the appropriate pressure has been reached within the sterilization chamber (152) based on the time the vacuum source (180) was activated. Other suitable methods by which the processor (162) may determine (block 312) whether a sufficient pressure level has been reached inside the sterilization chamber (152) will be apparent to those of ordinary skill in the art in view of the teachings herein. The vacuum source (180) remains activated until the appropriate pressure level has been reached inside the sterilization chamber (152).

[0029] Once the sterilization chamber (152) has reached an appropriate pressure level (e.g., about 0.2 Torr to about 10 Torr), the processor (162) then activates the sterilization module (156) to apply a sterilant into the sterilization chamber (152) (block 314). This stage of the process may be referred to as the "transition phase." By way of example only, the sterilant may include vapor of an oxidizing agent, such as hydrogen peroxide, a peroxyacid (e.g., peracetic acid, performic acid, etc.), ozone, or mixtures thereof. Additionally, the sterilant may include chlorine dioxide. Various other suitable forms that the sterilant may take are described herein, although other forms will be apparent to those of skill in the art in view of the teachings herein. It should also be appreciated that in some versions, the sterilant may be applied in various ways (block 314) based on the user's selection of the cycle (block 200), as previously described. Once the sterilant has been applied to the sterilization chamber (152) (block 314), the processor (162) monitors the time (block 316) to determine whether a sufficient predetermined time has elapsed. By way of example only, this predetermined time may be anywhere from a few seconds to a few minutes. Until the predetermined time has elapsed, the sterilization chamber (152) remains sealed at the predetermined pressure level discussed above, allowing the applied sterilant to act on the medical devices contained within the sterilization chamber (152).

[0030] After a predetermined time has elapsed, the processor (162) activates the vent valve (182) (block 318) to vent the sterilization chamber (152) to atmosphere. In some versions, the sterilization chamber (152) is allowed to reach atmospheric pressure, while in other versions, the sterilization chamber (152) only reaches reduced pressure. The venting stage of the process may be referred to as the "diffusion phase." In this embodiment, the sterilization cycle is then completed after completion of the diffusion phase (block 320). In some other cases, vacuum is again applied to the sterilization chamber (152) after completion of the diffusion phase; then plasma is applied to the sterilization chamber (152). It should be understood that the entire sterilization cycle shown in FIG. 3 (including the previously mentioned variants, where vacuum and then sterilization are applied) may be repeated one or more times after being completed once. In other words, the medical device may remain in the sterilization chamber (152) and undergo two or more iterations of the entire cycle shown in FIG. 3 (including the previously mentioned variants, where vacuum and then sterilization are applied). The number of iterations may vary based on cycle selection (block 200), which may be dictated by the particular type of medical device being sterilized in the sterilization chamber (152).

[0031] FIG. 4 depicts an exemplary plot (400) showing the pressure inside the sterilization chamber (152) during a sterilization cycle (block 208) as depicted in FIG. 3 and as described above. As can be seen, the pressure level drops significantly and abruptly when the vacuum source (180) is activated to apply a vacuum to the sterilization chamber (152) (block 310). The pressure level then remains substantially constant while the sterilant is applied (block 314) and for a predetermined time thereafter (block 316). The pressure level then rises significantly and abruptly when the vent valve (182) is activated to vent the sterilization chamber (152) to atmosphere (block 318). Thus, broadly speaking, the plot (400) illustrates how the pressure inside the sterilization chamber (152) simply switches between a single relatively high level (i.e., atmospheric pressure) and a single relatively low level (i.e., a vacuum state). An exemplary alternative sterilization cycle is described in further detail below with reference to FIGS.

[0032] Upon completion of the sterilization cycle (block 208), the sterilization cabinet (150) may cycle (block 210) the results of the sterilization cycle (block 208). For example, if the sterilization cycle (block 208) is cancelled or unable to be completed due to an error or due to a user action, the sterilization cabinet (150) may remain sealed and may display a sterilization cycle cancelled message via the touch screen display (160); and various details regarding the sterilization cycle, such as date, time, configuration, elapsed time, sterilization cycle operator, the stage at which the sterilization cycle failed, and other information that may be used to identify why the sterilization cycle. Upon successful completion of the sterilization cycle (block 208), the sterilization cabinet (150) may display a notification via the touch screen display (160) indicating successful completion of the sterilization cycle (block 208). Additionally, the sterilization cabinet (150) may display information such as a sterilization cycle identifier, sterilization cycle type, start time, duration, operator, and other information (666).

[0033] In addition to the foregoing, the sterilization cabinet (150) may be configured to perform a sterilization process in accordance with at least some of the teachings of U.S. Pat. No. 6,939,519, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,852,279, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,852,277, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,447,719, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,365,102, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,325,972, the disclosures of which are incorporated herein by reference; and / or U.S. Provisional Patent Application No. 62 / 316,722, the disclosures of which are incorporated herein by reference.

[0034] III. Additional Exemplary Alternative Sterilization Cycles Exemplary methods of sterilizing articles are described in detail below with reference to Figures 5-20. Although the methods associated with Figures 5-20 are described in the context of sterilizing medical devices, and in particular endoscopes, it should be understood that the teachings herein may be readily applied in the context of sterilizing a variety of other types of articles. The teachings are not limited to endoscopes or other medical devices. Other suitable articles that may be sterilized in accordance with the teachings herein will be apparent to those skilled in the art.

[0035] According to an exemplary embodiment, the endoscope may be 1 m to 4 m long and may include an internal lumen having a diameter of 0.5 mm to 6 mm. However, endoscopes of other sizes are envisioned. Prior to receiving the endoscope within the sterilization chamber, a liquid sterilant may be applied to one or more interior spaces within the endoscope. Alternatively, or in addition to applying a sterilant to one or more interior spaces within the endoscope, a sterilant may be applied to the exterior of the endoscope.

[0036] Any suitable sterilant may be used in the exemplary methods associated with FIGS. 5-20. By way of example only, the sterilant may include vapor of an oxidizing agent, such as hydrogen peroxide, a peroxyacid (e.g., peracetic acid, performic acid, etc.), ozone, or a mixture thereof. According to an exemplary embodiment, the sterilant may include one or more of hydrogen peroxide, peracetic acid, chlorine dioxide, or nitrogen dioxide. Various other suitable forms that the sterilant may take are described herein, although other forms will be apparent to those of skill in the art in view of the teachings herein. The same or different sterilants may be used in successive sterilant introductions. As previously mentioned, the pressure level remains substantially constant while the sterilant is applied. For example, the pressure inside the sterilization chamber (152) may rise to around about 5 torr to about 10 torr as the sterilant is introduced. As used herein, "substantially constant" is intended to include this increase in pressure of about 5 Torr to about 10 Torr since there is logically a small increase in pressure as the sterilant is added as shown in Figures 5 and 7-20.

[0037] Additional sterilant may be introduced into the sterilization chamber (152) while simultaneously venting the sterilization chamber (152) to increase the pressure inside the sterilization chamber (152). The plasma may be applied in any of the exemplary manners associated with FIGS. 5-20. In applying the plasma, a vacuum may first be applied to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152). For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. Once the vacuum is applied, a plasma may then be applied to the sterilization chamber (152). In one example, the plasma may be applied at less than about 3 Torr, and in another example, the plasma may be applied at a pressure of about 0.15 Torr to about 2 Torr. The sterilization chamber (152) may be vented to a pressure between 10 Torr and atmospheric pressure (ATM) after applying additional plasma to the sterilization chamber (152). Multiple venting, staged or otherwise, may be used in any of the exemplary methods of Figures 5-20. The upper dashed horizontal lines in Figures 7-10 and 12-20 represent atmospheric pressure (ATM) and the lower dashed horizontal lines in Figures 7-10 and 12-20 represent a lower pressure, shown as 100 Torr. Alternatively, other lower pressures (e.g., 50 Torr) are also envisioned. A break is shown between the upper and lower dashed horizontal lines in Figures 7-10 and 12-20.

[0038] One or more of the steps may be automatically controlled in any of the exemplary methods associated with FIGS. 5-20. For example, the steps may be automatically controlled using a controller including a processor and memory. A notification indicating successful completion of sterilization may be displayed using the touch screen display. The notification may include at least one of the type, start time, or duration of the sterilization cycle. A sterilization cancellation message may be displayed using the touch screen display. For example, at least one of the elapsed time, the sterilization operator, or the step at which the sterilization failed may be displayed using the touch screen display. The moisture level inside the sterilization chamber (152) may be monitored while decreasing the moisture level inside the sterilization chamber (152) until a predetermined moisture level is reached.

[0039] A. First Exemplary Alternative Sterilization Cycle As previously mentioned, some versions of the sterilization cabinet (150) may have difficulty effectively sterilizing some articles, including medical devices such as flexible endoscopes, that have relatively long and narrow lumens. For example, some conventional sterilization cabinets are capable of sterilizing lumens that are less than or equal to about 875 mm and have a lumen diameter of about 1 mm or more. It may therefore be desirable to provide a modified sterilization cycle (block 208) that further facilitates effective sterilization of medical devices having one or more relatively long and narrow lumens. A merely illustrative example of such a modified sterilization cycle is described in further detail below. By way of example only, a medical device having one or more relatively long and narrow lumens may include a gastrointestinal endoscope that is about 1 m long to about 3 m long and has a lumen diameter of about 0.5 mm to about 2.0 mm. Nevertheless, it should be understood that the process described below may be performed on an endoscope having a length of at least about 500 mm or at least about 800 mm and a lumen diameter of less than about 6.0 mm.

[0040] FIG. 5 illustrates an exemplary alternative sequence of substeps that may be performed to provide a sterilization cycle (block 208) of the sterilization cabinet (150). Specifically, the cycle illustrated in FIG. 5 may begin with a vacuum being applied to the interior of the sterilization chamber (152) (block 510). To provide such vacuum, the processor (162) may activate the vacuum source (180) in accordance with a control algorithm. The processor (162) then determines whether a sufficient pressure level has been reached inside the sterilization chamber (152) (block 512). By way of example only, the processor (162) may monitor data from one or more pressure sensors inside the sterilization chamber (152) as part of the decision step (block 512). Alternatively, the processor (162) may simply activate the vacuum source (180) for a predetermined period of time and assume that the appropriate pressure has been reached inside the sterilization chamber (152) based on the time the vacuum source (180) was activated. The processor (162) may determine (block 512) whether a sufficient pressure level has been reached inside the sterilization chamber (152); other suitable methods will be apparent to those of ordinary skill in the art in view of the teachings herein. The vacuum source (180) remains activated until the appropriate pressure level has been reached inside the sterilization chamber (152).

[0041] Once the sterilization chamber (152) reaches an appropriate pressure level (e.g., about 0.2 Torr to about 10 Torr), the processor (162) then activates the sterilization module (156) to apply a sterilant into the sterilization chamber (152) (block 514). It should also be appreciated that in some versions, the sterilant may be applied in various ways (block 514) based on the user's selection of a cycle (block 200) as previously described. Once the sterilant has been applied to the sterilization chamber (152) (block 514), the processor (162) monitors the time (block 516) to determine whether a sufficient predetermined time has elapsed. By way of example only, this predetermined time may be anywhere from a few seconds to a few minutes. Until the predetermined time has elapsed, the sterilization chamber (152) remains sealed at the previously described predetermined pressure level, and the applied sterilant acts on the medical devices contained within the sterilization chamber (152). This stage of the process may be referred to as the "transition phase."

[0042] After the predetermined time has elapsed, the processor (162) activates the vent valve (182) (block 518) to vent the sterilization chamber (152) to atmosphere. Once the sterilization chamber (152) has been vented to atmosphere (block 518), the processor (162) monitors the time (block 520) to determine whether a sufficient predetermined venting (block 518) time has elapsed. The sterilization chamber (152) remains vented until the predetermined venting (block 518) time has elapsed. After the predetermined venting (block 518) time has elapsed, the processor (162) determines whether the sterilization cycle is complete (block 522). Examples of how this determination (block 522) may be made are described in more detail below. It should be understood that in this embodiment, the predetermined venting (block 518) time may be very short. By way of example only, the predetermined venting (block 518) time may be approximately 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, or any other suitable time.

[0043] If the processor (162) determines (block 522) that the sterilization cycle is complete, then the sterilization cycle is in fact complete (block 528). However, if the processor (162) determines (block 522) that the sterilization cycle is not yet complete, then the processor (162) closes the vent valve (182) and seals the sterilization chamber (152) at a pressure level that is still below atmospheric pressure (block 524). As previously mentioned, the venting (block 518) time is very short in this embodiment, and the act of sealing (block 524) can occur shortly after the venting (block 518) is initiated, assuming the determinations (blocks 520, 522) confirm that sealing (block 524) is appropriate.

[0044] The sterilization chamber (152) remains sealed (block 524) for a period of time. Specifically, once the sterilization chamber (152) is sealed (block 524), the processor (162) monitors the time (block 526) to determine whether a sufficient predetermined sealing (block 524) time has elapsed. The sterilization chamber (152) remains sealed until the predetermined sealing (block 524) time has elapsed. After the predetermined sealing (block 524) time has elapsed, the processor (162) again activates (block 518) the vent valve (182) to vent the sterilization chamber (152) to atmosphere. By way of example only, the predetermined sealing time may be between about 5 seconds and 5 minutes, or, more specifically, between about 10 seconds and about 2 minutes, or, even more specifically, between about 20 seconds and about 2 minutes.

[0045] At this point, the process continues through the steps previously described (blocks 518, 520, 522, 524, 526) to provide a series of venting (block 518) and sealing (block 524) of the sterilization chamber (152) to incrementally increase the pressure within the sterilization chamber (152) until the sterilization chamber (152) reaches atmospheric pressure or some predetermined reduced pressure. Again, each venting (block 518) step is very short in this embodiment, and the pressure in the sterilization chamber (152) is maintained at a level below atmospheric pressure during the sealing (block 524) action (e.g., for a period of time on the order of a few seconds or minutes). By way of example only, each step of venting (block 518) may result in a respective increase in pressure inside the sterilization chamber (152) by about 10 torr to about 100 torr, or more specifically, by about 10 torr to about 30 torr, until the final step of venting (block 518) is reached. Other suitable incremental pressure increase values ​​will be apparent to those of skill in the art in view of the teachings herein. Once the sterilization cabinet (150) has reached the end of the process, the vent valve (182) remains open, maintaining the sterilization chamber (152) at atmospheric pressure. The final venting step (block 518) of the process may be referred to as the "diffusion phase."

[0046] In some versions, the vent time (block 520) and / or the seal time (block 526) may vary. For example, the vent time (block 520) and / or the seal time (block 526) may vary based on cycle selection (block 200), which may be influenced by the particular type of medical device being sterilized in the sterilization chamber (152). Additionally or alternatively, the vent time (block 520) and / or seal time (block 526) may vary based on where in the process the sterilization cycle is (i.e., which vent (block 518) iteration and / or which seal (block 524) iteration). Various suitable ways in which the vent time (block 520) and / or seal time (block 526) may vary, as well as various reasons why such times may vary, will be apparent to one of ordinary skill in the art in view of the teachings herein.

[0047] Figure 6 shows an exemplary plot (600) illustrating the pressure inside the sterilization chamber (152) during a sterilization cycle (block 208) as depicted in Figure 5 and as previously described. As can be seen, the pressure level drops significantly and suddenly when the vacuum source (180) is activated to apply a vacuum to the sterilization chamber (152) (block 510). The pressure level then remains substantially constant while the sterilant is applied (block 514) and for a predetermined time thereafter (block 516). The pressure level then rises slightly when the vent valve (182) is activated to vent the sterilization chamber (152) to atmosphere (block 518), but remains at a subatmospheric level once the sterilization chamber (152) is sealed (block 524). The pressure level then rises slightly again when the vent valve (182) is again activated to vent the sterilization chamber (152) to atmosphere (block 518), but remains at a sub-atmospheric level when the sterilization chamber (152) is again sealed (block 524).

[0048] In the embodiment shown in Figure 6, the cycle involves four iterations of short venting (block 518), followed by four iterations of sealing (block 524), before finally venting completely to atmosphere (block 518). Thus, broadly speaking, plot (600) illustrates how the pressure inside the sterilization chamber (152) is gradually increased from a substantial vacuum to atmospheric pressure. Although Figure 6 illustrates four iterations of short venting (602, 606, 610, 614) and short sealing (604, 608, 612, 616) followed by a vent to atmosphere (618), other processes may use any other suitable number of iterations of short venting and short sealing. Optionally, atmospheric pressure may be maintained for a period of time before proceeding with another cycle (application of vacuum is illustrated in Figure 5). By way of example only, the variant may provide anywhere from 2 repeats of short venting and short sealing to 100 repeats of short venting and short sealing, or, more specifically, from 2 repeats of short venting and short sealing to 10 repeats of short venting and short sealing, or, even more specifically, from 3 repeats of short venting and short sealing to 7 repeats of short venting and short sealing.

[0049] In some cases, the process illustrated in Figures 5-6 may more effectively sterilize some medical devices as compared to sterilization of the same medical devices using the process illustrated in Figures 3-4. Specifically, without being limited to theory, staged venting of the sterilization chamber (152) may agitate the contents of the sterilization chamber (152), which may help drive the sterilant into the lumen and / or other interior spaces within the medical device. Additionally, again without being limited to theory, staged venting of the sterilization chamber (152) associated with the process illustrated in Figures 5-6 may provide convective mass transfer of sterilant vapor molecules inside the lumen and / or other interior spaces within the medical device as compared to simple diffusive mass transfer of the vapor associated with the process illustrated in Figures 3-4. Thus, when sterilization cabinet (150) performs the process shown in Figures 5-6, sterilization cabinet (150) is able to sterilize the same type of gastrointestinal endoscope as compared to sterilization cabinet (150) performing the process shown in Figures 3-4, which is unable to sterilize the long and narrow lumen of a relatively long gastrointestinal endoscope (e.g., having a length of up to about 3 m and a lumen having a diameter of up to about 1 mm).

[0050] It should also be understood that the entire cycle shown in Figures 5-6 may be repeated one or more times once completed. In other words, the medical device may remain within the sterilization chamber (152) and undergo two or more iterations of the entire cycle shown in Figures 5-6. The number of iterations may vary based on the cycle selection (block 200), which may be influenced by the specific type of medical device being sterilized within the sterilization chamber (152). This is also true for any of the exemplary methods shown in the plots (700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000) of Figures 7-20.

[0051] By way of example only, an endoscope having a 3 m long lumen may be placed into the sterilization chamber (152). A vacuum may be applied (block 510) to achieve a pressure level of about 4.5 Torr within the sterilization chamber (152). A sterilant (e.g., about 1 mL of hydrogen peroxide vapor at a concentration of 59%) may then be applied (block 514) to provide a transition phase lasting about 30 seconds. The sterilization chamber (152) may then be briefly vented (block 518) to achieve a pressure level of about 13.7 Torr, and the sterilization chamber (152) may then be sealed (block 524). The sterilization chamber (152) may be held at about 13.7 Torr for about 150 seconds. The sterilization chamber (152) may then be briefly vented again (block 518) to achieve a pressure level of about 4.01 kPa (about 30.1 Torr), and then the sterilization chamber (152) may be resealed (block 524). The sterilization chamber (152) may be held at about 4.01 kPa (about 30.1 Torr) for about 200 seconds. The sterilization chamber (152) may then be briefly vented again (block 518) to achieve a pressure level of about 6.28 kPa (about 47.1 Torr), and then the sterilization chamber (152) may be resealed (block 524). The sterilization chamber (152) may be held at about 6.28 kPa (about 47.1 Torr) for about 190 seconds. The sterilization chamber (152) may then be briefly vented again (block 518) to achieve a pressure level of about 760 Torr (i.e., atmospheric pressure), thereby providing a diffusion phase. Of course, the foregoing is merely one illustrative example.

[0052] As previously mentioned, in some variations, additional sterilant is introduced into the sterilization chamber (152) during one or more of the staged venting (block 518) actions before the final step of venting (block 518) is reached. This is also true for any of the exemplary methods shown in the plots (700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000) of Figures 7-20.

[0053] As previously mentioned, in some variations, a pre-plasma may be applied in the sterilization cycle (block 208) to heat the medical devices contained within the sterilization chamber (152). By way of example only, the plasma may be applied between the application of the vacuum (block 510) and the application of the sterilant (block 514). Additionally or alternatively, a post-plasma may be applied at the end of the sterilization cycle (block 208) to break down any residual sterilant that may be adsorbed to the surfaces of the medical devices contained within the sterilization chamber (152). It should be understood that a vacuum must first be applied to the sterilization chamber (152) before applying the post-plasma. This is true for any of the exemplary methods shown in the plots (700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000) of Figures 7-20.

[0054] As previously mentioned, the sterilant is applied in vapor form within the sterilization chamber (152) (block 514). By way of example only, the sterilization module (156) may include a combination of an evaporator and a condenser. The evaporator may include a chamber that receives a sterilant solution of a particular concentration (e.g., a liquid hydrogen peroxide solution nominally at about 59% concentration, or at about 58% to about 59.6% concentration); the sterilant solution changes phase from liquid to vapor. The condenser may provide condensation of the sterilant solution vapor, whereby the concentration of the sterilant solution may be increased (e.g., from about 59% nominally to anywhere from about 83% nominally to about 95% nominally) by removal of water vapor. Alternatively, any other suitable methods and components may be used to apply the sterilant in vapor form within the sterilization chamber (152). In either case, to supplement the application of the sterilant in vapor form, the sterilant may be applied (in liquid form) inside lumens and / or other interior spaces within the medical device and / or to the exterior of the medical device before the medical device is placed into the sterilization chamber (152). In such versions, the sterilant evaporates while the vacuum is applied (block 510) and even after the vacuum is applied (block 510); the sterilant can be more concentrated in areas of the medical device with less penetration, thereby further promoting effective sterilization.

[0055] By way of example only, the process depicted in FIG. 5 may be carried out at a temperature where the walls of the sterilization chamber (152) are from about 30° C. to about 56° C., or, more specifically, from about 47° C. to about 56° C., or, even more specifically, about 50° C.; and the temperature of the medical devices within the sterilization chamber (152) is from about 5-10° C. to about 40-55° C.

[0056] C. Second Exemplary Alternative Sterilization Cycle Figure 7 depicts a graph showing a third exemplary plot (700) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during performance of a second exemplary alternative sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 7 may be performed on an endoscope or any other type of article.

[0057] In step (702), the method illustrated in plot (700) includes receiving an endoscope into a sterilization chamber. In step (704), the method illustrated in plot (700) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the chamber or gases introduced during venting. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (706), the method illustrated in plot (700) includes introducing a sterilant into the sterilization chamber (152). Any suitable sterilant may be used.

[0058] In step (708), the method illustrated in plot (700) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time. In step (710), the method illustrated in plot (700) includes venting the sterilization chamber (152) to raise the pressure inside the sterilization chamber (152) to a second pressure, which is higher than the first pressure, but the second pressure is still less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the chamber or the gases introduced during venting. For example, in some cases, the second pressure may be between about 5 Torr and 30 Torr higher than the first pressure, and in some cases, the second pressure may be between about 10 Torr and 15 Torr higher than the first pressure. The second pressure is independent of the temperature of the sterilization chamber (152). In step (712), the method illustrated in plot (700) includes maintaining the second pressure in the sterilization chamber (152) for a second period of time. The second period of time may be shorter or longer than the first period of time. Additional steps may be added prior to, during, and after the method illustrated in plot (700) is completed. For example, the variations can include one or more steps before or after the vacuum step (704), or one or more steps before or after the aeration steps (710, 714, 718).

[0059] D. Third Exemplary Alternative Sterilization Cycle Figure 8 depicts a graph showing a fourth exemplary plot (800) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during performance of a third exemplary alternative sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 8 may be performed on an endoscope or any other type of article.

[0060] For example, the article may include an endoscope. In step (802), the method illustrated in plot (800) includes receiving the endoscope within a sterilization chamber. In step (804), the method illustrated in plot (800) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is desirably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the chamber or gases introduced during venting. The vacuum may be applied until the pressure in the sterilization chamber (152) is well below 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (806), the method illustrated in plot (800) includes introducing a sterilant into sterilization chamber (152). In step (808), the method illustrated in plot (800) includes maintaining a first pressure in sterilization chamber (152) for a first period of time.

[0061] In step (810), the method illustrated in plot (800) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a second pressure. The second pressure is higher than the first pressure, but the second pressure is still less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, in some cases, the second pressure can be about 5 Torr to about 30 Torr higher than the first pressure, and in some cases, the second pressure can be about 10 Torr to about 15 Torr higher than the first pressure. In step (812), the method illustrated in plot (800) includes maintaining a second pressure in the sterilization chamber (152) for a second period of time, which may be shorter or longer than the first period of time.

[0062] In step (814), the method illustrated in plot (800) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a third pressure. The third pressure is less than 100 Torr. For example, in some cases, the third pressure can be about 5 Torr to about 30 Torr greater than the second pressure, and in some cases, the third pressure can be about 10 Torr to about 15 Torr greater than the second pressure. In step (816), the method illustrated in plot (800) includes maintaining the third pressure in the sterilization chamber (152) for a third time period. The third time period can be shorter or longer than any one of the first or second time periods.

[0063] In step (818), the method illustrated in plot (800) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, in some cases, the fourth pressure may be about 5 Torr to about 30 Torr higher than the third pressure, and in some cases, the fourth pressure may be about 10 Torr to about 15 Torr higher than the third pressure. The pressure difference between the first venting and the second venting in steps (814, 818) may be the same or different. In step (820), the method illustrated in plot (800) includes maintaining a fourth pressure in the sterilization chamber (152) for a fourth time period, which may be shorter or longer than any one of the first, second, or third time periods.

[0064] In step (822), the method illustrated in plot (800) includes venting the sterilization chamber (152) to increase the pressure within the sterilization chamber (152) to a fifth pressure. The fifth pressure is less than 100 Torr. For example, in some cases, the fifth pressure can be about 5 Torr to about 30 Torr greater than the fourth pressure, and in some cases, the fifth pressure can be about 10 Torr to about 15 Torr greater than the fourth pressure. In step (824), the method illustrated in plot (800) includes maintaining the fifth pressure in the sterilization chamber (152) for a fifth time period. In some versions, one or more of the steps (808, 812, 816, 820, 824) may have a duration in the range of about 30 seconds to about 300 seconds.

[0065] In step 826, the method illustrated in plot 800 includes venting the sterilization chamber 152 to raise the pressure within the sterilization chamber 152 to a sixth pressure, shown as atmospheres (ATM). Although not shown, in some cases the sixth pressure can be about 5 torr to about 30 torr greater than the fifth pressure, and in some cases the sixth pressure can be about 10 torr to about 15 torr greater than the fifth pressure.

[0066] The method steps (802, 804, 806, 808, 810, 812, 814, 816, 818, 820, 822, 824, 826) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, the introduction of air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (800) is completed. For example, the variations can include one or more steps before or after the vacuum step (804) or one or more steps before or after the aeration steps (810, 814, 818, 822, 826).

[0067] E. Fourth Exemplary Alternative Sterilization Cycle Figure 9 depicts a graph showing a fifth exemplary plot (900) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during performance of a fourth exemplary alternative sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 9 may be performed on an endoscope or any other type of article.

[0068] In step (902), the method illustrated in plot (900) includes receiving an endoscope into a sterilization chamber. In step (904), the method illustrated in plot (900) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, a vacuum may be applied to the chamber to reduce the pressure to between about 0 Torr and about 5 Torr. In step (906), the method illustrated in plot (900) includes introducing a sterilant into the sterilization chamber (152). In step (908), the method illustrated in plot (900) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0069] In step (910), the method illustrated in plot (900) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a second pressure. The second pressure is higher than the first pressure, but still less than 100 Torr. For example, in some cases the second pressure can be about 5 Torr to about 30 Torr higher than the first pressure, and in some cases the second pressure can be about 10 Torr to about 15 Torr higher than the first pressure. In step (912), the method illustrated in plot (900) includes maintaining the second pressure in the sterilization chamber (152) for a second period of time. The second period of time can be shorter or longer than the first period of time.

[0070] In step (914), the method illustrated in plot (900) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a third pressure. The third pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (916), the method illustrated in plot (900) includes introducing a sterilant into the sterilization chamber (152). In step (918), the method illustrated in plot (900) includes maintaining the third pressure within the sterilization chamber (152) for a third time period. The third time period may be less than or greater than any one of the first or second time periods.

[0071] In step (920), the method illustrated in plot (900) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. For example, in some cases, the fourth pressure can be about 5 Torr to about 30 Torr higher than the third pressure, and in some cases, the fourth pressure can be about 10 Torr to about 15 Torr higher than the third pressure. The fourth pressure can be higher or lower than the second pressure. In step (922), the method illustrated in plot (900) includes maintaining the fourth pressure in the sterilization chamber (152) for a fourth time period. The fourth time period can be shorter or longer than any one of the first, second, or third time periods. In some versions, one or more of the steps (908, 912, 918, 922) may have a duration in the range of about 30 seconds to about 300 seconds.

[0072] In step 924, the method illustrated in plot 900 includes venting the sterilization chamber 152 to raise the pressure within the sterilization chamber 152 to a fifth pressure, shown as atmospheres (ATM). Although not shown, in some cases the fifth pressure can be about 5 torr to about 30 torr higher than the fourth pressure, and in some cases the fifth pressure can be about 10 torr to about 15 torr higher than the fourth pressure.

[0073] The method steps (902, 904, 906, 908, 910, 912, 914, 916, 918, 920, 922, 924) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, the introduction of air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (900) is completed. For example, the variations can include one or more steps before or after the vacuum step (904) or one or more steps before or after the aeration steps (910, 920, 924).

[0074] F. Fifth Exemplary Alternative Sterilization Cycle Figure 10 depicts a graph showing a sixth exemplary plot (1000) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of a fifth exemplary alternative sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 10 may be performed on an endoscope or any other type of article.

[0075] In step (1002), the method illustrated in plot (1000) includes receiving an endoscope into a sterilization chamber. In step (1004), the method illustrated in plot (1000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1006), the method illustrated in plot (1000) includes introducing a sterilant into the sterilization chamber (152). In step (1008), the method illustrated in plot (1000) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0076] In step (1010), the method illustrated in plot (1000) includes venting the sterilization chamber (152) to raise the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is higher than the first pressure, but still less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, in some cases, the second pressure may be between about 10 Torr and 100 Torr higher than the first pressure, and in some cases, the second pressure may be between about 10 Torr and 30 Torr higher than the first pressure. In step (1012), the method illustrated in plot (1000) includes maintaining a second pressure in the sterilization chamber (152) for a second period of time, which may be shorter or longer than the first period of time.

[0077] In step (1014), the method illustrated in plot (1000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a third pressure. The third pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1016), the method illustrated in plot (1000) includes introducing additional sterilant into the sterilization chamber (152). The same or a different sterilant may be used as in step (1006). In step (1018), the method illustrated in plot (1000) includes maintaining the third pressure within the sterilization chamber (152) for a third time period. The third time period may be shorter or longer than the first or second time periods.

[0078] In step (1020), the method illustrated in plot (1000) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is higher than the third pressure but still less than 100 Torr. For example, in some cases, the fourth pressure can be about 5 Torr to about 30 Torr higher than the third pressure, and in some cases, the fourth pressure can be about 10 Torr to about 15 Torr higher than the third pressure. The fourth pressure can be higher or lower than the second pressure illustrated in step (1012). In step (1022), the method illustrated in plot (1000) includes maintaining the fourth pressure within the sterilization chamber (152) for a fourth time period. The fourth period of time may be shorter or longer than any one of the first, second, or third periods.

[0079] In step (1024), the method illustrated in plot (1000) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fifth pressure. For example, in some cases, the fifth pressure can be about 5 Torr to about 30 Torr higher than the fourth pressure, and in some cases, the fifth pressure can be about 10 Torr to about 15 Torr higher than the fourth pressure. In step (1026), the method illustrated in plot (1000) includes maintaining the fifth pressure in the sterilization chamber (152) for a fifth time period. The fifth time period can be shorter or longer than any one of the first, second, third, or fourth time periods. In some versions, one or more of the steps (1008, 1012, 1018, 1022, 1026) may have a duration in the range from about 30 seconds to about 300 seconds.

[0080] In step 1028, the method illustrated in plot 1000 includes venting the sterilization chamber 152 to raise the pressure within the sterilization chamber 152 to a sixth pressure, shown as atmospheres (ATM). Although not shown, in some cases the sixth pressure can be about 5 torr to about 30 torr greater than the fifth pressure, and in some cases the sixth pressure can be about 10 torr to about 15 torr greater than the fifth pressure.

[0081] The method steps (1002, 1004, 1006, 1008, 1010, 1012, 1014, 1016, 1018, 1020, 1022, 1024, 1026, 1028) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to cause convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (1000) is completed. For example, the variants can include one or more steps before or after the vacuum step (1004), or one or more steps before or after the venting steps (1010, 1020, 1024, 1028).

[0082] G. Sixth Exemplary Alternative Sterilization Cycle FIG. 11 depicts a graph showing a seventh exemplary plot (1100) of pressure in the sterilization chamber (152) of the sterilization cabinet (150) of FIG. 1 over time superimposed on a graph showing hydrogen peroxide concentration in the sterilization chamber (152) of the sterilization cabinet (150) of FIG. 1 over time during the performance of a sixth exemplary sterilization cycle. FIG. 11 includes both a solid line (1102) showing the pressure in the sterilization chamber (152) measured with respect to time in seconds, and a dashed line (1104) showing the H2O2 concentration in the sterilization chamber (152) measured with respect to time in seconds. These two plots are superimposed on one another with respect to time shown on the horizontal axis. As previously mentioned, the sterilization cycle method associated with FIG. 11 may be performed on an endoscope or any other type of article.

[0083] Steps (1106, 1108, 1110, 1112, 1114) comprise a pre-start sequence. In step (1106), the method illustrated in plot (1100) includes receiving an endoscope within the sterilization chamber. Alternatively, the endoscope may be received within the sterilization chamber (152) in step (1114). For example, in step (1106), a pressure is shown at about 760 Torr, which is equivalent to 1 atmosphere. In step (1108), the method illustrated in plot (1100) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is desirably less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1110), the method illustrated in plot (1100) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time. For example, during at least a portion of step (1110), a plasma may be applied as previously described. The pressure may desirably be less than 5 Torr for the plasma to emit light. In step (1112), the method illustrated in plot (1100) includes venting the sterilization chamber (152) to raise the pressure to a second pressure, illustrated as approximately 200 Torr. However, other pressures are envisioned, including higher pressures, such as atmospheric pressure (not shown). In step (1114), the method illustrated in plot (1100) includes maintaining the pressure in the sterilization chamber (152) for a second period of time. As previously mentioned, the endoscope may be received within sterilization chamber (152) during step (1114) at a pressure of approximately 760 Torr (atmosphere).

[0084] In step (1116), the method illustrated in plot (1100) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a third pressure. The third pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. As shown, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. As shown, beginning at about 383 seconds, a pump is started ("pump down") to create a vacuum. The x-axis represents elapsed time in seconds (S). In step (1118), the method illustrated in plot (1100) includes maintaining the third pressure within the sterilization chamber (152) for a third time period. For example, during at least a portion of step 1118, a plasma may be applied as described above, and a pressure of less than 5 Torr may be desirable for the plasma to emit light.

[0085] In step (1120), the method illustrated in plot (1100) includes introducing a sterilant into the sterilization chamber (152). As shown in FIG. 11, the sterilant is hydrogen peroxide (H2O2). As shown in step (1120a), the H2O2 concentration is increased to about 3 milligrams per liter (mg / L). As shown in step (1120a), the sterilant is introduced from about 728 seconds to about 732 seconds. In step (1122), the method illustrated in plot (1100) includes maintaining a third pressure in the sterilization chamber (152) for a fourth time period, the third pressure remaining substantially constant as previously described during the third time period (before the sterilant is applied) and during the fourth time period (after the sterilant is applied). As shown in step (1122a), the H2O2 concentration is decreased nonlinearly, although other linear and nonlinear decreases in the H2O2 concentration are envisioned. The fourth period of time may be shorter or longer than any one of the first, second, or third periods of time. As shown, the sterilant and the third pressure of about 7 Torr may be held for up to about 840 seconds.

[0086] In step (1124), the method illustrated in plot (1100) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is higher than the third pressure, but still less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, in some cases, the fourth pressure can be about 5 Torr to about 30 Torr higher than the third pressure, and in some cases, the fourth pressure can be about 10 Torr to about 15 Torr higher than the third pressure. As shown, the sterilization chamber (152) may be vented to about 16 Torr for up to 900 seconds. As shown in step (1124a), the H2O2 concentration decreases during the venting. Although not shown, this cycle (minus the optional plasma) may be repeated. In step (1126), the method shown in plot (1100) includes maintaining a fourth pressure in the sterilization chamber (152) for a fifth time period. The fifth time period may be shorter or longer than any one of the first, second, third, or fourth time periods. As shown in step (1126a), the H2O2 concentration decreases nonlinearly, although other linear and nonlinear decreases in H2O2 concentration are envisioned.

[0087] In step (1128), the method illustrated in plot (1100) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fifth pressure. As shown, a vacuum can be applied to the chamber to reduce the pressure to about 0 Torr to about 5 Torr. As shown, a pump down is performed at about 0 Torr from about 900 seconds to about 955 seconds to reduce the pressure within the sterilization chamber (152). As shown in step (1128a), the H2O2 concentration decreases with the application of the vacuum. In step (1130), the method illustrated in plot (1100) includes maintaining the fifth pressure within the sterilization chamber (152) for a sixth time period. The sixth time period can be shorter or longer than any one of the first, second, third, fourth, or fifth time periods.

[0088] In step (1132), the method illustrated in plot (1100) includes introducing additional sterilant into the sterilization chamber (152). The same or a different sterilant may be used as in step (1120). As shown in step (1132a), H2O2 is introduced from about 955 seconds to 1000 seconds, which increases the pressure to about 5 Torr to about 10 Torr. In step (1134), the method illustrated in plot (1100) includes maintaining a fifth pressure in the sterilization chamber (152) for a seventh time period. The sterilant (shown as H2O2) at a pressure of about 10 Torr is held until about 1060 seconds. The seventh time period may be shorter or longer than any one of the first, second, third, fourth, fifth, or sixth time periods. As shown in step (1134a), the H2O2 concentration is decreased non-linearly, although other linear and non-linear decreases in H2O2 concentration are envisioned.

[0089] In step (1136), the method illustrated in plot (1100) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a sixth pressure. The sixth pressure is higher than the fifth pressure, but still less than 100 Torr. Although three staged ventings are illustrated, more or fewer staged ventings are envisioned, as described below. For example, in some cases, the sixth pressure may be about 5 Torr to about 30 Torr higher than the fifth pressure, and in some cases, the sixth pressure may be about 10 Torr to about 15 Torr higher than the fifth pressure. The sixth pressure may be higher or lower than the fourth pressure in step (1126). As shown, the first aeration is to about 20 Torr and is held until 1160 seconds. As shown in step (1136a), the H2O2 concentration decreases during the aeration. In step (1138), the method shown in plot (1100) includes maintaining a sixth pressure in the sterilization chamber (152) for an eighth period of time. The eighth period of time may be shorter or longer than any one of the first, second, third, fourth, fifth, sixth, or seventh periods of time. As shown in step (1138a), the H2O2 concentration decreases non-linearly, although other linear and non-linear decreases in H2O2 concentration are envisioned.

[0090] In step (1140), the method shown in plot (1100) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a seventh pressure. The seventh pressure is higher than the sixth pressure but still less than 100 Torr. For example, in some cases the seventh pressure can be about 5 Torr to about 30 Torr higher than the sixth pressure, and in some cases the seventh pressure can be about 10 Torr to about 15 Torr higher than the sixth pressure. The seventh pressure can be higher or lower than the fourth pressure in step (1126). The second venting is to 30 Torr and held for 1225 seconds. As shown in step 1140a, the H2O2 concentration decreases during aeration. In step 1142, the method shown in plot 1100 includes maintaining a seventh pressure in sterilization chamber 152 for a ninth period of time. The ninth period of time may be shorter or longer than any one of the first, second, third, fourth, fifth, sixth, seventh, or eighth periods of time.

[0091] In step (1144), the method shown in plot (1100) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to an eighth pressure, which may be atmospheric pressure (ATM). The eighth pressure is higher than the seventh pressure, but still less than 100 Torr. For example, in some cases, the eighth pressure may be about 5 Torr to about 30 Torr higher than the seventh pressure, and in some cases, the eighth pressure may be about 10 Torr to about 15 Torr higher than the seventh pressure. As shown, the venting is to atmospheric pressure and is held for 1333 seconds. As shown in step (1144a), the H2O2 concentration decreases during the venting. In step (1146), the method shown in plot (1100) includes maintaining an eighth pressure in the sterilization chamber (152) for a tenth time period. The tenth time period can be shorter or longer than any one of the first, second, third, fourth, fifth, sixth, seventh, eighth, or ninth time periods. In some versions, one or more of steps (1110, 1114, 1118, 1122, 1126, 1130, 1134, 1138, 1142, 1146) can have a duration ranging from about 30 seconds to about 300 seconds.

[0092] The method steps (1106, 1108, 1110, 1112, 1114, 1116, 1118, 1120, 1122, 1124, 1126, 1128, 1130, 1132, 1134, 1136, 1138, 1140, 1142, 1144, 1146) are shown in increasing numerical order with each successive step beginning as the previous step ends, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) causing convective mass transfer and accelerating the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilants into the lumen. Additional steps may be added before, during, and after the method illustrated in plot (1100) is completed. For example, pumping down to 0 Torr and the entire cycle (including steps (1116-1146)) may be repeated. For example, variations may include one or more steps before or after the vacuum steps (1108, 1116, 1128) or one or more steps before or after the venting steps (1124, 1136, 1140, 1144). Further incremental venting may optionally be performed until atmospheric pressure (ATM) is reached within the sterilization chamber (152).

[0093] H. Seventh Exemplary Alternative Sterilization Cycle Figure 12 depicts a graph showing an eighth exemplary plot (1200) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during performance of a seventh exemplary alternative sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 12 may be performed on an endoscope or any other type of article.

[0094] In step (1202), the method illustrated in plot (1200) includes receiving an endoscope into a sterilization chamber. In step (1204), the method illustrated in plot (1200) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1206), the method illustrated in plot (1200) includes introducing a sterilant into the sterilization chamber (152). In step (1208), the method illustrated in plot (1200) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0095] In step (1210), the method illustrated in plot (1200) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a second pressure. The second pressure is higher than the first pressure, but still less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, in some cases, the second pressure can be about 5 Torr to about 30 Torr higher than the first pressure, and in some cases, the second pressure can be about 10 Torr to about 15 Torr higher than the first pressure. In step 1212, the method illustrated in plot 1200 includes maintaining a second pressure in the sterilization chamber 152 for a second period of time, which may be shorter or longer than the first period of time.

[0096] In step (1214), the method illustrated in plot (1200) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a third pressure. For example, in some cases, the third pressure can be about 5 Torr to about 30 Torr higher than the second pressure, and in some cases, the third pressure can be about 10 Torr to about 15 Torr higher than the second pressure. In step (1216), the method illustrated in plot (1200) includes maintaining the third pressure in the sterilization chamber (152) for a third time period. The third time period can be shorter or longer than any one of the first or second time periods.

[0097] In step (1218), the method illustrated in plot (1200) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1220), the method illustrated in plot (1200) includes introducing additional sterilant into the sterilization chamber (152). The same sterilant used in step (1206) or a different sterilant may be used. In step (1222), the method illustrated in plot (1200) includes maintaining the fourth pressure within the sterilization chamber (152) for a fourth time period. The fourth time period may be less than or greater than any one of the first, second, or third time periods. In some versions, one or more of the steps (1208, 1212, 1216, 1222) may have a duration in the range from about 30 seconds to about 300 seconds.

[0098] In step (1224), the method illustrated in plot (1200) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fifth pressure, shown as atmospheric pressure (ATM). Although not shown, in some cases the fifth pressure can be about 5 torr to about 30 torr higher than the fourth pressure, and in some cases the fifth pressure can be about 10 torr to about 15 torr higher than the fourth pressure. Although not shown, venting and maintaining steps can be performed and in some cases can be repeated (e.g., one, two, or more than two times) before reaching atmospheric pressure (ATM).

[0099] The method steps (1202, 1204, 1206, 1208, 1210, 1212, 1214, 1216, 1218, 1220, 1222, 1224) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (1200) is completed. For example, variations can include one or more steps before or after the vacuum step (1204, 1218) or one or more steps before or after the aeration step (1210, 1214, 1224).

[0100] I. Eighth Exemplary Alternative Sterilization Cycle Figure 13 depicts a graph showing a ninth exemplary plot (1300) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of an eighth exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 13 may be performed on an endoscope or any other type of article.

[0101] In step (1302), the method illustrated in plot (1300) includes receiving an endoscope within a sterilization chamber (152). In step (1304), the method illustrated in plot (1300) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1306), the method illustrated in plot (1300) includes introducing a sterilant into the sterilization chamber (152). In step (1308), the method illustrated in plot (1300) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0102] In step (1310), the method illustrated in plot (1300) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the venting step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. The second pressure may be higher or lower than the first pressure. In step (1312), the method illustrated in plot (1300) includes introducing additional sterilant into the sterilization chamber (152). Compared to step (1306), the same or a different sterilant may be used. In step (1314), the method illustrated in plot (1300) includes maintaining a second pressure in the sterilization chamber (152) for a second period of time, which may be shorter or longer than the first period of time.

[0103] In step (1316), the method illustrated in plot (1300) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a third pressure. The third pressure is higher than the second pressure but is still less than 100 Torr. For example, in some cases the third pressure can be about 5 Torr to about 30 Torr higher than the second pressure, and in some cases the third pressure can be about 10 Torr to about 30 Torr higher than the second pressure. In step (1318), the method illustrated in plot (1300) includes maintaining the third pressure in the sterilization chamber (152) for a third time period. The third time period can be shorter or longer than the first or second time periods.

[0104] In step (1320), the method illustrated in plot (1300) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. For example, in some cases, the fourth pressure can be about 5 Torr to about 30 Torr higher than the third pressure, and in some cases, the fourth pressure can be about 10 Torr to about 30 Torr higher than the third pressure. In step (1322), the method illustrated in plot (1300) includes maintaining the fourth pressure in the sterilization chamber (152) for a fourth time period. The fourth time period can be shorter or longer than any one of the first, second, or third time periods. In some versions, one or more of the steps (1308, 1314, 1318, 1322) may have a duration in the range from about 30 seconds to about 300 seconds.

[0105] In step (1324), the method illustrated in plot (1300) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fifth pressure, shown as atmospheric pressure (ATM). Prior to reaching atmospheric pressure (ATM), additional venting and maintaining steps similar to steps (1316, 1318, 1320, 1322) may be performed and in some cases may be repeated (e.g., one, two, or three or more times). Although not shown, in some cases the fifth pressure may be about 5 torr to about 30 torr higher than the fourth pressure, and in some cases the fifth pressure may be about 10 torr to about 15 torr higher than the fourth pressure.

[0106] The method steps (1302, 1304, 1306, 1308, 1310, 1312, 1314, 1316, 1318, 1320, 1322, 1324) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, the introduction of air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (1300) is completed. For example, variations can include one or more steps before or after the vacuum step (1304, 1310) or one or more steps before or after the vent step (1316, 1320, 1324).

[0107] J. Ninth Exemplary Alternative Sterilization Cycle Figure 14 depicts a graph showing a tenth exemplary plot (1400) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of a ninth exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 14 may be performed on an endoscope or any other type of article.

[0108] In step (1402), the method illustrated in plot (1400) includes receiving an endoscope within a sterilization chamber (152). In step (1404), the method illustrated in plot (1400) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1406), the method illustrated in plot (1400) includes introducing a sterilant into the sterilization chamber (152). In step (1408), the method illustrated in plot (1400) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0109] In step (1410), the method illustrated in plot (1400) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the venting step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. In step (1412), the method illustrated in plot (1400) includes introducing additional sterilant into the sterilization chamber (152). As compared to step (1406), the same or a different sterilant may be used. In step (1414), the method illustrated in plot (1400) includes maintaining a second pressure in the sterilization chamber (152) for a second period of time, which may be shorter or longer than the first period of time.

[0110] In step (1416), the method illustrated in plot (1400) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a third pressure. The third pressure is higher than the second pressure but is still less than 100 Torr. For example, in some cases the third pressure can be about 5 Torr to about 30 Torr higher than the second pressure, and in some cases the third pressure can be about 10 Torr to about 15 Torr higher than the second pressure. In step (1418), the method illustrated in plot (1400) includes maintaining the third pressure in the sterilization chamber (152) for a third time period. The third time period can be shorter or longer than the second time period.

[0111] In step (1420), the method illustrated in plot (1400) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. The fourth pressure may be higher or lower than the first and second pressures. In step (1422), the method illustrated in plot (1400) includes introducing a sterilant into the sterilization chamber (152). As compared to steps (1406) or (1412), the same or a different sterilant may be used. In step (1424), the method illustrated in plot (1400) includes maintaining the fourth pressure within the sterilization chamber (152) for a fourth time period. The fourth period of time may be shorter or longer than the first, second, or third period of time.

[0112] In step (1426), the method illustrated in plot (1400) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fifth pressure. For example, in some cases, the fifth pressure can be about 5 Torr to about 30 Torr higher than the fourth pressure, and in some cases, the fifth pressure can be about 10 Torr to about 15 Torr higher than the fourth pressure. In step (1428), the method illustrated in plot (1400) includes maintaining the fifth pressure in the sterilization chamber (152) for a fifth period of time. In some versions, one or more of steps (1408, 1414, 1418, 1424, 1428) can have a duration ranging from about 30 seconds to about 300 seconds.

[0113] In step (1430), the method illustrated in plot (1400) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a sixth pressure, shown as atmospheres (ATM). Although not shown, the venting step (1426) and maintaining step (1428) may be repeated (e.g., one, two, or three or more times). Although not shown, in some cases, the sixth pressure may be about 5 torr to about 30 torr higher than the fifth pressure, and in some cases, the sixth pressure may be about 10 torr to about 15 torr higher than the fifth pressure.

[0114] The method steps (1402, 1404, 1406, 1408, 1410, 1412, 1414, 1416, 1418, 1420, 1422, 1424, 1426, 1428, 1430) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (1400) is completed. For example, the variations can include one or more steps before or after the vacuum step (1404, 1410, 1420) or one or more steps before or after the vent step (1416, 1426, 1430).

[0115] K. Tenth Exemplary Alternative Sterilization Cycle Figure 15 depicts a graph showing an eleventh exemplary plot (1500) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of a tenth exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 15 may be performed on an endoscope or any other type of article.

[0116] In step (1502), the method illustrated in plot (1500) includes receiving an endoscope within a sterilization chamber (152). In step (1504), the method illustrated in plot (1500) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the aeration step. For example, a vacuum may be applied to the chamber to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1506), the method illustrated in plot (1500) includes introducing a sterilant into the sterilization chamber (152). In step (1508), the method illustrated in plot (1500) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0117] In step (1510), the method illustrated in plot (1500) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the venting step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1512), the method illustrated in plot (1500) includes introducing additional sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1506). In step (1514), the method illustrated in plot (1500) includes maintaining a second pressure in the sterilization chamber (152) for a second period of time, which may be shorter or longer than the first period of time.

[0118] In step (1516), the method illustrated in plot (1500) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a third pressure. The third pressure is higher than the second pressure but is still less than 100 Torr. For example, in some cases the third pressure can be about 5 Torr to about 30 Torr higher than the second pressure, and in some cases the third pressure can be about 10 Torr to about 15 Torr higher than the second pressure. In step (1518), the method illustrated in plot (1500) includes maintaining the third pressure in the sterilization chamber (152) for a third time period. The third time period can be shorter or longer than the first or second time periods.

[0119] In step (1520), the method illustrated in plot (1500) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to between about 0 Torr and about 5 Torr. In step (1522), the method illustrated in plot (1500) includes introducing a sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1506) or (1512). In step (1524), the method illustrated in plot (1500) includes maintaining the fourth pressure within the sterilization chamber (152) for a fourth time period. The fourth period of time may be shorter or longer than any one of the first, second, or third periods.

[0120] In step (1526), ​​the method illustrated in plot (1500) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fifth pressure. For example, in some cases, the fifth pressure can be about 5 Torr to about 30 Torr higher than the fourth pressure, and in some cases, the fifth pressure can be about 10 Torr to about 15 Torr higher than the fourth pressure. In step (1528), the method illustrated in plot (1500) includes maintaining the fifth pressure in the sterilization chamber (152) for a fifth time period. The fifth time period can be shorter or longer than any one of the first, second, third, or fourth time periods.

[0121] In step (1530), the method illustrated in plot (1500) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a sixth pressure. The sixth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1532), the method illustrated in plot (1500) includes introducing additional sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1506), (1512), or (1522). In step (1534), the method illustrated in plot (1500) includes maintaining the sixth pressure within the sterilization chamber (152) for a sixth time period. The sixth period of time may be shorter or longer than any one of the first, second, third, fourth, or fifth periods of time. In some versions, one or more of the steps (1508, 1514, 1518, 1524, 1528, 1534) may have a duration in the range of about 30 seconds to about 300 seconds.

[0122] In step (1536), the method illustrated in plot (1500) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a seventh pressure, shown as atmospheric pressure (ATM). Although not shown, additional venting and maintaining steps similar to steps (1526, 1528) may be performed before reaching atmospheric pressure (ATM), and in some cases may be repeated (e.g., one, two, or three or more times). Although not shown, in some cases, the seventh pressure may be about 5 torr to about 30 torr higher than the sixth pressure, and in some cases, the seventh pressure may be about 10 torr to about 15 torr higher than the sixth pressure.

[0123] The method steps (1502, 1504, 1506, 1508, 1510, 1512, 1514, 1516, 1518, 1520, 1522, 1524, 1526, 1528, 1530, 1532, 1534, 1536) are shown in increasing numerical order with each successive step beginning as the previous step ends, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilants into the lumen. Additional steps may be added before, during, and after the method illustrated in plot (1500) is completed. For example, the variants may include one or more steps before or after the vacuum steps (1504, 1510, 1520, 1530) or one or more steps before or after the vent steps (1516, 1526, 1536).

[0124] L. Eleventh Exemplary Alternative Sterilization Cycle Figure 16 depicts a graph showing a twelfth exemplary plot (1600) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of an eleventh exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 16 may be performed on an endoscope or any other type of article.

[0125] At step (1602), the method illustrated in plot (1600) includes receiving an endoscope within a sterilization chamber (152). At step (1604), the method illustrated in plot (1600) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. At step (1606), the method illustrated in plot (1600) includes introducing a sterilant into the sterilization chamber (152). In step (1608), the method illustrated in plot (1600) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0126] In step (1610), the method illustrated in plot (1600) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the venting step. The second pressure may be higher or lower than the first pressure. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. In step (1612), the method illustrated in plot (1600) includes introducing a sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1606). In step 1614, the method illustrated in plot 1600 includes maintaining a second pressure in the sterilization chamber 152 for a second period of time, which may be shorter or longer than the first period of time.

[0127] In step 1616, the method illustrated in plot 1600 includes applying a vacuum to the sterilization chamber 152 to reduce the pressure within the sterilization chamber 152 to a third pressure. For example, a vacuum may be applied to the sterilization chamber 152 to reduce the pressure to between about 0 Torr and about 5 Torr.

[0128] In step (1618), the method illustrated in plot (1600) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is higher than the third pressure but still less than 100 Torr. For example, in some cases, the fourth pressure can be about 10 Torr to 100 Torr higher than the third pressure, and in some cases, the fourth pressure can be about 10 Torr to 30 Torr higher than the third pressure. In step (1620), the method illustrated in plot (1600) includes maintaining the fourth pressure in the sterilization chamber (152) for a third time period. The third time period can be shorter or longer than any one of the first or second time periods.

[0129] In step (1622), the method illustrated in plot (1600) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fifth pressure. For example, in some cases, the fifth pressure can be about 10 torr to 100 torr greater than the fourth pressure, and in some cases, the fifth pressure can be about 10 torr to 30 torr greater than the fourth pressure. In step (1624), the method illustrated in plot (1600) includes maintaining the fifth pressure in the sterilization chamber (152) for a fourth time period. The fourth time period can be shorter or longer than any one of the first, second, or third time periods. In some versions, one or more of the steps (1608, 1614, 1620, 1624) may have a duration in the range from about 30 seconds to about 300 seconds.

[0130] In step (1626), the method illustrated in plot (1600) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a sixth pressure, shown as atmospheric pressure (ATM). Although not shown, in some cases the sixth pressure may be about 5 torr to about 30 torr higher than the fifth pressure, and in some cases the sixth pressure may be about 10 torr to about 15 torr higher than the fifth pressure. Additional venting and maintaining steps similar to steps (1618, 1620, 1622, 1624) may be performed and in some cases may be repeated (e.g., one, two, or more than two times) before atmospheric pressure (ATM) is reached.

[0131] The method steps (1602, 1604, 1606, 1608, 1610, 1612, 1614, 1616, 1618, 1620, 1622, 1624, 1626) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (1600) is completed. For example, variations can include one or more steps before or after the vacuum step (1604, 1610, 1616) or one or more steps before or after the vent step (1618, 1622, 1626).

[0132] M. Twelfth Exemplary Alternative Sterilization Cycle Figure 17 depicts a graph showing a thirteenth exemplary plot (1700) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of the twelfth exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 17 may be performed on an endoscope or any other type of article.

[0133] At step (1702), the method illustrated in plot (1700) includes receiving an endoscope within a sterilization chamber (152). At step (1704), the method illustrated in plot (1700) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. At step (1706), the method illustrated in plot (1700) includes introducing a sterilant into the sterilization chamber (152). In step (1708), the method illustrated in plot (1700) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0134] In step (1710), the method illustrated in plot (1700) includes venting the sterilization chamber (152) to raise the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is higher than the first pressure, but still less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, in some cases, the second pressure can be between about 10 Torr and 100 Torr higher than the first pressure, and in some cases, the second pressure can be between about 10 Torr and 30 Torr higher than the first pressure. In step 1712, the method illustrated in plot 1700 includes maintaining a second pressure in the sterilization chamber 152 for a second period of time, which may be shorter or longer than the first period of time.

[0135] In step (1714), the method illustrated in plot (1700) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a third pressure. The third pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. The third pressure may be greater than or less than the first pressure. In step (1716), the method illustrated in plot (1700) includes introducing additional sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1706). In step (1718), the method illustrated in plot (1700) includes maintaining the third pressure within the sterilization chamber (152) for a third time period. The third time period may be less than or greater than the second time period.

[0136] In step (1720), the method illustrated in plot (1700) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fourth pressure. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. The fourth pressure may be higher or lower than any one of the first, second, or third pressures.

[0137] In step (1722), the method illustrated in plot (1700) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fifth pressure. The fifth pressure is higher than the fourth pressure but still less than 100 Torr. For example, in some cases the fifth pressure can be about 10 Torr to 100 Torr higher than the fourth pressure, and in some cases the fifth pressure can be about 10 Torr to 30 Torr higher than the fourth pressure. In step (1724), the method illustrated in plot (1700) includes maintaining the fifth pressure in the sterilization chamber (152) for a fourth time period. The fourth time period can be shorter or longer than the second or third time periods. In some versions, one or more of the steps (1708, 1712, 1718, 1724) may have a duration in the range from about 30 seconds to about 300 seconds.

[0138] In step (1726), the method illustrated in plot (1700) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a sixth pressure, shown as atmospheric pressure (ATM). Although not shown, additional venting and maintaining steps similar to steps (1724, 1726) may be performed and in some cases may be repeated (e.g., one, two, or three or more times) before reaching atmospheric pressure (ATM). Although not shown, in some cases the sixth pressure may be about 5 torr to about 30 torr higher than the fifth pressure, and in some cases the sixth pressure may be about 10 torr to about 15 torr higher than the fifth pressure.

[0139] The method steps (1702, 1704, 1706, 1708, 1710, 1712, 1714, 1716, 1718, 1720, 1722, 1724, 1726) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to cause convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (1700) is completed. For example, the variations can include one or more steps before or after the vacuum step (1704, 1714, 1720) or one or more steps before or after the vent step (1710, 1722, 1726).

[0140] N. Thirteenth Exemplary Alternative Sterilization Cycle Figure 18 depicts a graph showing a fourteenth exemplary plot (1800) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of the thirteenth exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 18 may be performed on an endoscope or any other type of article.

[0141] In step (1802), the method illustrated in plot (1800) includes receiving an endoscope within a sterilization chamber (152). In step (1804), the method illustrated in plot (1800) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1806), the method illustrated in plot (1800) includes introducing a sterilant into the sterilization chamber (152). In step (1808), the method illustrated in plot (1800) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0142] In step (1810), the method illustrated in plot (1800) includes venting the sterilization chamber (152) to raise the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is higher than the first pressure, but still less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gases introduced during the venting step. For example, in some cases, the second pressure can be between about 10 Torr and 100 Torr higher than the first pressure, and in some cases, the second pressure can be between about 10 Torr and 30 Torr higher than the first pressure.

[0143] In step (1812), the method illustrated in plot (1800) includes maintaining a second pressure in the sterilization chamber (152) for a second time period. The second time period can be shorter or longer than the first time period. In step (1814), the method illustrated in plot (1800) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a third pressure. For example, in some cases, the third pressure can be about 10 torr to about 100 torr higher than the second pressure, and in some cases, the third pressure can be about 10 torr to about 30 torr higher than the second pressure. In step (1816), the method illustrated in plot (1800) includes maintaining a third pressure in the sterilization chamber (152) for a third time period. The third period of time may be shorter or longer in duration than any one of the first or second periods of time.

[0144] In step (1818), the method illustrated in plot (1800) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fourth pressure. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. The fourth pressure is less than the third pressure. In step (1820), the method illustrated in plot (1800) includes introducing a sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1806). In step (1822), the method illustrated in plot (1800) includes maintaining the fourth pressure in the sterilization chamber (152) for a fourth time period. The fourth time period may be less than or greater than any one of the first, second, or third time periods. In some versions, one or more of the steps (1808, 1812, 1816, 1822) may have a duration in the range from about 30 seconds to about 300 seconds.

[0145] In step (1824), the method illustrated in plot (1800) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fifth pressure. The fifth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1826), the method illustrated in plot (1800) includes venting the sterilization chamber (152) to increase the pressure within the sterilization chamber (152) to a sixth pressure, shown as atmospheres (ATM). Although not shown, in some cases the sixth pressure can be about 5 Torr to about 30 Torr higher than the fifth pressure, and in some cases the sixth pressure can be about 10 Torr to about 15 Torr higher than the fifth pressure. Although not shown, additional venting and maintaining steps similar to steps (1814, 1816) can be performed and in some cases repeated (e.g., one, two, or more than two times) before reaching atmospheric pressure (ATM).

[0146] The method steps (1802, 1804, 1806, 1808, 1810, 1812, 1814, 1816, 1818, 1820, 1822, 1824, 1826) are shown in increasing numerical order with each successive step beginning as the previous step is completed, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to cause convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added prior to, during, and after the method illustrated in plot (1800) is completed. For example, the variations can include one or more steps before or after the vacuum step (1804, 1818, 1824) or one or more steps before or after the aeration step (1810, 1814, 1826).

[0147] O. Fourteenth Exemplary Alternative Sterilization Cycle Figure 19 depicts a graph showing a fifteenth exemplary plot (1900) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of a fourteenth exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 19 may be performed on an endoscope or any other type of article.

[0148] In step (1902), the method illustrated in plot (1900) includes receiving an endoscope within a sterilization chamber (152). In step (1904), the method illustrated in plot (1900) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1906), the method illustrated in plot (1900) includes introducing a sterilant into the sterilization chamber (152). In step (1908), the method illustrated in plot (1900) includes maintaining a first pressure in the sterilization chamber (152) for a first period of time.

[0149] In step (1910), the method illustrated in plot (1900) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the venting step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. In step (1912), the method illustrated in plot (1900) includes introducing a sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1906). In step (1914), the method illustrated in plot (1900) includes maintaining a second pressure in the sterilization chamber (152) for a second period of time, which may be shorter or longer than the first period of time.

[0150] In step (1916), the method illustrated in plot (1900) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a third pressure. The third pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr.

[0151] In step (1918), the method illustrated in plot (1900) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is higher than the third pressure but still less than 100 Torr. For example, in some cases the fourth pressure can be about 5 Torr to about 30 Torr higher than the third pressure, and in some cases the fourth pressure can be about 10 Torr to about 30 Torr higher than the third pressure. In step (1920), the method illustrated in plot (1900) includes maintaining the fourth pressure in the sterilization chamber (152) for a third time period. The third time period can be shorter or longer than any one of the first or second time periods.

[0152] In step (1922), the method illustrated in plot (1900) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fifth pressure. The fifth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (1924), the method illustrated in plot (1900) includes introducing a sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (1906) or step (1912). In step (1926), the method illustrated in plot (1900) includes maintaining the fifth pressure within the sterilization chamber (152) for a fourth time period. The fourth time period may be shorter or longer than any one of the first, second, or third time periods.

[0153] In step (1928), the method illustrated in plot (1900) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a sixth pressure. The sixth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. The sixth pressure is less than the fifth pressure.

[0154] In step (1930), the method illustrated in plot (1900) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a seventh pressure. The seventh pressure can be less than 100 Torr. For example, in some cases, the seventh pressure can be about 5 Torr to about 30 Torr greater than the sixth pressure, and in some cases, the seventh pressure can be about 10 Torr to about 30 Torr greater than the sixth pressure. In step (1932), the method illustrated in plot (1900) includes maintaining the seventh pressure in the sterilization chamber (152) for a fifth time period. The fifth time period can be less than or greater than any one of the first, second, third, or fourth time periods. In some versions, one or more of the steps (1908, 1914, 1920, 1926, 1932) may have a duration in the range from about 30 seconds to about 300 seconds.

[0155] In step (1934), the method shown in plot (1900) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to an eighth pressure, shown as atmospheric pressure (ATM). Although not shown, in some cases the eighth pressure may be about 5 torr to about 30 torr higher than the seventh pressure, and in some cases the eighth pressure may be about 10 torr to about 15 torr higher than the seventh pressure. Although not shown, additional venting and maintaining steps similar to steps (1930, 1932) may be performed and in some cases may be repeated (e.g., one, two, or more than two times) before atmospheric pressure (ATM) is reached.

[0156] The method steps (1902, 1904, 1906, 1908, 1910, 1912, 1914, 1916, 1918, 1920, 1922, 1924, 1926, 1928, 1930, 1932, 1934, 1936, 1934) are shown in increasing numerical order with each successive step beginning as the previous step ends, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) causing convective mass transfer and accelerating the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added before, during, and after the method shown in plot (1900) is completed. For example, the variants may include one or more steps before or after the vacuum steps (1904, 1910, 1916, 1922, 1928) or one or more steps before or after the vent steps (1918, 1930, 1934).

[0157] P. 15 Exemplary Alternative Sterilization Cycles Figure 20 depicts a graph showing a sixteenth exemplary plot (2000) of pressure within the sterilization chamber (152) of the sterilization cabinet (150) of Figure 1 over time during the performance of a fifteenth exemplary sterilization cycle. As previously discussed, the sterilization cycle method associated with Figure 20 may be performed on an endoscope or any other type of article.

[0158] In step (2002), the method illustrated in plot (2000) includes receiving an endoscope within a sterilization chamber (152). In step (2004), the method illustrated in plot (2000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a first pressure. The first pressure is preferably less than 100 Torr. At or below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the aeration step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (2006), the method illustrated in plot (2000) includes introducing a sterilant into the sterilization chamber (152). In step 2008, the method shown in plot 2000 includes maintaining a first pressure for a first period of time in the sterilization chamber 152. The second pressure may be higher or lower than the first pressure.

[0159] In step (2010), the method illustrated in plot (2000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure inside the sterilization chamber (152) to a second pressure. The second pressure is less than 100 Torr. Again, below 100 Torr, condensation is prevented without the need to heat the sterilization chamber (152) or the gas introduced during the venting step. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (2012), the method illustrated in plot (2000) includes introducing a sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (2006). In step (2014), the method shown in plot (2000) includes maintaining a second pressure in the sterilization chamber (152) for a second period of time, which may be shorter or longer than the first period of time.

[0160] In step (2016), the method shown in plot (2000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a third pressure. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. The third pressure may be higher or lower than the first or second pressure.

[0161] In step (2018), the method illustrated in plot (2000) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a fourth pressure. The fourth pressure is higher than the third pressure, but still less than 100 Torr. For example, in some cases, the fourth pressure can be about 5 Torr to about 30 Torr higher than the third pressure, and in some cases, the fourth pressure can be about 10 Torr to about 15 Torr higher than the third pressure. In step (2020), the method illustrated in plot (2000) includes maintaining the fourth pressure in the sterilization chamber (152) for a third time period. The fourth time period can be shorter or longer than any one of the first, second, or third time periods.

[0162] In step (2022), the method illustrated in plot (2000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a fifth pressure. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to about 0 Torr to about 5 Torr. As shown, the fifth pressure is less than the fourth pressure. The fifth pressure may be less than the first, second, or third pressure. In step (2024), the method illustrated in plot (2000) includes introducing additional sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (2006) or step (2012). In step (2026), the method illustrated in plot (2000) includes maintaining the fifth pressure within the sterilization chamber (152) for a fourth period of time. The fourth period of time may be shorter or longer than any one of the first, second, or third periods.

[0163] In step (2028), the method illustrated in plot (2000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a sixth pressure. The sixth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr.

[0164] In step (2030), the method illustrated in plot (2000) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a seventh pressure. The seventh pressure is greater than the sixth pressure. As illustrated, the seventh pressure is also greater than any one of the first, second, third, fourth, fifth, or sixth pressures. The seventh pressure may be less than 100 Torr. In step (2032), the method illustrated in plot (2000) includes maintaining the seventh pressure in the sterilization chamber (152) for a fifth time period. The fifth time period may be less than or greater than any one of the first, second, third, or fourth time periods.

[0165] In step (2034), the method illustrated in plot (2000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to an eighth pressure. The eighth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr. In step (2036), the method illustrated in plot (2000) includes introducing a sterilant into the sterilization chamber (152). The sterilant may be the same or different than the sterilant introduced in step (2006), step (2012), or step (2024). In step (2038), the method illustrated in plot (2000) includes maintaining the eighth pressure within the sterilization chamber (152) for a sixth time period. The sixth period of time may be shorter or longer than any one of the first, second, third, fourth, or fifth periods of time. In some versions, one or more of the steps (2008, 2014, 2020, 2026, 2032, 2038) may have a duration in the range from about 30 seconds to about 300 seconds.

[0166] In step (2040), the method illustrated in plot (2000) includes applying a vacuum to the sterilization chamber (152) to reduce the pressure within the sterilization chamber (152) to a ninth pressure. The ninth pressure is less than 100 Torr. For example, a vacuum may be applied to the sterilization chamber (152) to reduce the pressure to between about 0 Torr and about 5 Torr.

[0167] In step (2042), the method shown in plot (2000) includes venting the sterilization chamber (152) to raise the pressure within the sterilization chamber (152) to a tenth pressure, shown as atmospheric pressure (ATM). Although not shown, in some cases the tenth pressure may be about 5 torr to about 30 torr higher than the ninth pressure, and in some cases the tenth pressure may be about 10 torr to about 15 torr higher than the ninth pressure. Although not shown, additional venting and maintaining steps similar to steps (2030, 2032) may be performed and in some cases may be repeated (e.g., one, two, or more than two times) before atmospheric pressure (ATM) is reached.

[0168] The method steps (2002, 2004, 2006, 2008, 2010, 2012, 2014, 2016, 2018, 2020, 2022, 2024, 2026, 2028, 2030, 2032, 2034, 2036) are shown in increasing numerical order with each successive step beginning as the previous step ends, although variations are envisioned. The pulses may create agitation within the sterilization chamber (154) to induce convective mass transfer and accelerate the diffusion of the sterilant (e.g., hydrogen peroxide) into the lumen of the medical device (e.g., endoscope). Conversely, introducing air into the sterilization chamber (154) may increase resistance to the diffusion of sterilant into the lumen. Additional steps may be added before, during, and after the method shown in plot (2000) is completed. For example, the variants may include one or more steps before or after the vacuum steps (2004, 2010, 2016, 2022, 2028, 2034, 2040) or one or more steps before or after the vent steps (1210, 1214, 1224).

[0169] V. Exemplary Combinations The following examples relate to various non-exhaustive methods in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or in a subsequent application of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Thus, none of the aspects or features mentioned below should be considered critical unless later expressly indicated as such by the inventor or the inventor's successor in interest. If any claim including additional features other than those mentioned below is presented in this application or in a subsequent application related to this application, those additional features shall not be considered added for patentability reasons.

[0170] Example 1 1. A method of sterilizing an article, comprising: (a) receiving the article in a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce a pressure within the sterilization chamber to a first pressure, the first pressure being less than 100 Torr; (c) introducing a sterilant into the sterilization chamber; (d) maintaining the first pressure within the sterilization chamber for a first period of time; (e) venting the sterilization chamber to raise the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 100 Torr; (f) maintaining the second pressure within the sterilization chamber for a second period of time; and (g). (a) venting the sterilization chamber to increase the pressure within the sterilization chamber to a third pressure; (b) maintaining the third pressure within the sterilization chamber for a third period of time; and (c) venting the sterilization chamber to increase the pressure within the sterilization chamber to atmospheric pressure, the method further comprising, between at least one of steps (d) and (e), (f) and (g), or (h) and (i), (A) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fourth pressure less than 100 Torr; (B) introducing additional sterilant into the sterilization chamber; and (C) maintaining the pressure in the sterilization chamber for a fourth period of time.

[0171] Example 2 The method of example 1, further comprising repeating substeps (A)-(C) at least one between steps (d) and (e), between (f) and (g), or between (h) and (i).

[0172] Example 3 The method according to any one or more of Examples 1 to 2, wherein sub-steps (A) to (C) are carried out between steps (d) and (e).

[0173] Example 4 The method according to any one or more of Examples 1 to 3, wherein sub-steps (A) to (C) are carried out between steps (f) and (g).

[0174] Example 5 The method according to any one or more of Examples 1 to 4, wherein sub-steps (A) to (C) are carried out between steps (h) and (i).

[0175] Example 6 The method according to any one or more of Examples 1 to 2, wherein sub-steps (A) to (C) are carried out between steps (d) and (e) and between steps (f) and (g).

[0176] Example 7 The method of Example 1, wherein sub-steps (A)-(C) are performed between steps (d) and (e), between steps (f) and (g), and between steps (h) and (i).

[0177] Example 8 The method of any one or more of Examples 1 to 7, further comprising repeating steps (g) and (h) at least one time.

[0178] Example 9 The method of any one or more of Examples 1 to 8, further comprising applying a plasma to the sterilization chamber between steps (b) and (c).

[0179] Example 10 The method of any one or more of Examples 1 to 9, further comprising applying a vacuum and introducing additional sterilant into the sterilization chamber during at least one of steps (e), (g), or (i) after applying the vacuum.

[0180] Example 11 The method of any one or more of Examples 1 to 10, wherein the first, second, third, and fourth pressures are each less than 13.33 kPa (100 Torr).

[0181] Example 12 1. A method of sterilizing an article, comprising: (a) receiving the article within a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce a pressure within the sterilization chamber to a first pressure, the first pressure being less than 100 Torr; (c) introducing a sterilant into the sterilization chamber; (d) maintaining the first pressure within the sterilization chamber for a first period of time; (e) venting the sterilization chamber to increase the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 100 Torr; (f) maintaining the second pressure within the sterilization chamber for a second period of time; and (g) venting the sterilization chamber to increase the pressure within the sterilization chamber to a third pressure. (c) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fourth pressure, the fourth pressure being less than 100 Torr; (d) introducing additional sterilant into the sterilization chamber; (e) maintaining the fourth pressure within the sterilization chamber for a fourth period of time; and (f) venting the sterilization chamber to increase the pressure within the sterilization chamber to atmospheric pressure, the method further comprising, between at least one of steps (d) and (e), (f) and (g), or (h) and (i), (A) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fourth pressure, the fourth pressure being less than 100 Torr; (B) introducing additional sterilant into the sterilization chamber; (C) maintaining the fourth pressure in the sterilization chamber for a fourth period of time; and (D) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fifth pressure, the fifth pressure being less than 100 Torr.

[0182] Example 13 The method of example 12, further comprising repeating substeps (A)-(D) at least one between steps (d) and (e), between (f) and (g), or between (h) and (i).

[0183] Example 14 The method of any one or more of Examples 12 to 13, wherein sub-steps (A) to (D) are performed between steps (d) and (e).

[0184] Example 15 The method of any one or more of Examples 12 to 14, wherein sub-steps (A) to (D) are performed between steps (f) and (g).

[0185] Example 16 The method of any one or more of Examples 12 to 15, wherein sub-steps (A) to (D) are performed between steps (h) and (i).

[0186] Example 17 The method of any one or more of Examples 12 to 13, wherein sub-steps (A) to (D) are performed between steps (d) and (e) and between steps (f) and (g).

[0187] Example 18 The method of any one or more of Examples 12 to 13, wherein sub-steps (A) to (D) are performed between steps (d) and (e), between steps (f) and (g), and between steps (h) and (i).

[0188] Example 19 The method of any one or more of Examples 12 to 18, further comprising repeating steps (g) and (h) at least one time.

[0189] Example 20 The method of any one or more of Examples 12 to 19, further comprising applying a plasma to the sterilization chamber between steps (b) and (c).

[0190] Example 21 The method of any one or more of Examples 12 to 20, wherein the first, second, third, fourth, and fifth pressures are each less than 13.33 kPa (100 Torr).

[0191] Example 22 1. A method of sterilizing an endoscope comprising: (a) receiving an endoscope in a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce a pressure within the sterilization chamber to a first pressure, the first pressure being less than 10 Torr; (c) introducing a sterilant into the sterilization chamber without heating the sterilant prior to introducing the sterilant into the sterilization chamber or heating the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first period of time; (e) venting the sterilization chamber to increase the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 30 Torr; and (f) applying a vacuum or venting to atmospheric pressure and then applying a vacuum.

[0192] V.Other It should be understood that all or part of a patent, publication, or other disclosure material that is said to be incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosure material set forth in this disclosure. Thus, to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material or part thereof that is said to be incorporated herein by reference but that contradicts existing definitions, descriptions, or other disclosure material set forth herein is incorporated only to the extent that no conflict occurs between the incorporated material and the existing disclosure material.

[0193] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Although some of such possible modifications have been mentioned, other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, shapes, materials, dimensions, ratios, steps, etc. described above are illustrative and not required. Therefore, it is understood that the scope of the present invention should be considered in terms of the following claims and is not limited to the details of structure and operation shown and described in the specification and drawings.

[0194] [Embodiment] (1) A method for sterilizing an article, comprising the steps of: (a) receiving the article into a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce pressure within the sterilization chamber to a first pressure, the first pressure being less than 100 Torr; (c) introducing a sterilant into the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first period of time; (e) venting the sterilization chamber to raise the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 100 Torr; (f) maintaining the second pressure in the sterilization chamber for a second period of time; (g) venting the sterilization chamber to increase the pressure within the sterilization chamber to a third pressure; (h) maintaining the third pressure in the sterilization chamber for a third period of time; (i) venting the sterilization chamber to increase the pressure within the sterilization chamber to atmospheric pressure; Including, The method further comprises at least one of steps (d) and (e), (f) and (g), or (h) and (i), comprising: (A) applying a vacuum to the sterilization chamber to reduce pressure within the sterilization chamber to a fourth pressure, the fourth pressure being less than 100 Torr; (B) introducing additional sterilant into the sterilization chamber; (C) maintaining the fourth pressure in the sterilization chamber for a fourth period of time; The method further comprising: (2) The method of embodiment 1, further comprising repeating substeps (A)-(C) at least one between steps (d) and (e), between steps (f) and (g), or between steps (h) and (i). (3) The method of embodiment 1, wherein substeps (A) to (C) are performed between steps (d) and (e). (4) The method of embodiment 1, wherein substeps (A) to (C) are performed between steps (f) and (g). (5) The method of embodiment 1, wherein substeps (A) to (C) are performed between steps (h) and (i).

[0195] (6) The method of embodiment 1, wherein substeps (A) to (C) are performed between steps (d) and (e) and between steps (f) and (g). (7) The method of embodiment 1, wherein substeps (A) to (C) are performed between steps (d) and (e), between steps (f) and (g), and between steps (h) and (i). (8) The method of embodiment 1, further comprising repeating steps (g) and (h) at least once. (9) The method of embodiment 1, further comprising applying a plasma to the sterilization chamber between steps (b) and (c). (10) The method of embodiment 1, wherein the first pressure, the second pressure, the third pressure, and the fourth pressure are each less than 13.33 kPa (100 Torr).

[0196] (11) A method for sterilizing an article, comprising the steps of: (a) receiving the article into a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce pressure within the sterilization chamber to a first pressure, the first pressure being less than 100 Torr; (c) introducing a sterilant into the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first period of time; (e) venting the sterilization chamber to raise the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 100 Torr; (f) maintaining the second pressure in the sterilization chamber for a second period of time; (g) venting the sterilization chamber to increase the pressure within the sterilization chamber to a third pressure; (h) maintaining the third pressure in the sterilization chamber for a third period of time; (i) venting the sterilization chamber to increase the pressure within the sterilization chamber to atmospheric pressure; Including, The method further comprises at least one of steps (d) and (e), (f) and (g), or (h) and (i), comprising: (A) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fourth pressure, the fourth pressure being less than 100 Torr; (B) introducing additional sterilant into the sterilization chamber; (C) maintaining the fourth pressure in the sterilization chamber for a fourth period of time; (D) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fifth pressure, the fifth pressure being less than 100 Torr; The method further comprising: (12) The method of embodiment 11, further comprising repeating substeps (A)-(D) at least one between steps (d) and (e), between steps (f) and (g), or between steps (h) and (i). (13) The method of embodiment 11, wherein substeps (A) to (D) are performed between steps (d) and (e). (14) The method of embodiment 11, wherein substeps (A) to (D) are performed between steps (f) and (g). (15) The method of embodiment 11, wherein substeps (A) to (D) are performed between steps (h) and (i).

[0197] (16) The method of embodiment 11, wherein substeps (A) to (D) are performed between steps (d) and (e) and between steps (f) and (g). (17) The method of embodiment 11, wherein substeps (A) to (D) are performed between steps (d) and (e), between steps (f) and (g), and between steps (h) and (i). (18) The method of embodiment 11, further comprising repeating steps (g) and (h) at least once. 19. The method of claim 11, further comprising applying a plasma to the sterilization chamber between steps (b) and (c). 20. The method of claim 11, wherein the first pressure, the second pressure, the third pressure, the fourth pressure, and the fifth pressure are each less than 13.33 kPa (100 Torr).

[0198] (21) A method for sterilizing an endoscope, comprising the steps of: (a) receiving the endoscope within a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce pressure within the sterilization chamber to a first pressure, the first pressure being less than 10 Torr; (c) introducing the sterilant into the sterilization chamber without heating the sterilant or heating the sterilization chamber prior to introducing the sterilant into the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first period of time; (e) venting the sterilization chamber to raise the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 4.00 kPa (30 Torr); (f) applying a vacuum or venting to atmospheric pressure and then applying said vacuum; A method comprising:

Claims

1. 1. A method for sterilizing an article, comprising the steps of: (a) receiving the article into a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce pressure within the sterilization chamber to a first pressure, the first pressure being less than 100 Torr; (c) introducing a sterilant into the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first period of time; (e) venting the sterilization chamber to raise the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 100 Torr; (f) maintaining the second pressure in the sterilization chamber for a second period of time; (g) venting the sterilization chamber to increase the pressure within the sterilization chamber to a third pressure; (h) maintaining the third pressure in the sterilization chamber for a third period of time; (i) venting the sterilization chamber to increase the pressure within the sterilization chamber to atmospheric pressure; Including, The method may further comprise, at least one of between steps (d) and (e) or between steps (f) and (g), (A) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fourth pressure, the fourth pressure being less than 100 Torr; (B) introducing additional sterilant into the sterilization chamber; and (C) maintaining the fourth pressure in the sterilization chamber for a fourth period of time; The method further comprising:

2. 2. The method of claim 1, further comprising repeating substeps (A)-(C) at least one of between steps (d) and (e) or between steps (f) and (g).

3. The method of claim 1 , wherein sub-steps (A)-(C) are performed between steps (d) and (e).

4. The method of claim 1 , wherein sub-steps (A)-(C) are performed between steps (f) and (g).

5. 2. The method of claim 1, further comprising performing sub-steps (A)-(C) between steps (h) and (i).

6. 2. The method of claim 1, wherein sub-steps (A)-(C) are performed between steps (d) and (e) and between steps (f) and (g).

7. 2. The method of claim 1 , wherein sub-steps (A)-(C) are performed between steps (d) and (e), between steps (f) and (g), and between steps (h) and (i).

8. 10. The method of claim 1, further comprising repeating steps (g) and (h) at least one time.

9. 10. The method of claim 1, further comprising applying a plasma to the sterilization chamber between steps (b) and (c).

10. 2. The method of claim 1, wherein the first pressure, the second pressure, the third pressure, and the fourth pressure are each less than 100 Torr.

11. 1. A method for sterilizing an article, comprising the steps of: (a) receiving the article into a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce pressure within the sterilization chamber to a first pressure, the first pressure being less than 100 Torr; (c) introducing a sterilant into the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first period of time; (e) venting the sterilization chamber to raise the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 100 Torr; (f) maintaining the second pressure in the sterilization chamber for a second period of time; (g) venting the sterilization chamber to increase the pressure within the sterilization chamber to a third pressure; (h) maintaining the third pressure in the sterilization chamber for a third period of time; (i) venting the sterilization chamber to increase the pressure within the sterilization chamber to atmospheric pressure; Including, The method further comprises, at least one of between steps (d) and (e) or between steps (f) and (g), (A) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fourth pressure, the fourth pressure being less than 100 Torr; (B) introducing additional sterilant into the sterilization chamber; and (C) maintaining the fourth pressure in the sterilization chamber for a fourth period of time; (D) applying a vacuum to the sterilization chamber to reduce the pressure within the sterilization chamber to a fifth pressure, the fifth pressure being less than 100 Torr; The method further comprising:

12. 12. The method of claim 11, further comprising repeating sub-steps (A)-(D) at least one of between steps (d) and (e), or between steps (f) and (g).

13. The method of claim 11 , wherein sub-steps (A)-(D) are performed between steps (d) and (e).

14. The method of claim 11 , wherein sub-steps (A)-(D) are performed between steps (f) and (g).

15. 12. The method of claim 11, further comprising performing sub-steps (A)-(D) between steps (h) and (i).

16. The method of claim 11, wherein sub-steps (A)-(D) are performed between steps (d) and (e) and between steps (f) and (g).

17. 12. The method of claim 11, wherein sub-steps (A)-(D) are performed between steps (d) and (e), between steps (f) and (g), and between steps (h) and (i).

18. 12. The method of claim 11, further comprising repeating steps (g) and (h) at least one time.

19. 12. The method of claim 11, further comprising applying a plasma to the sterilization chamber between steps (b) and (c).

20. 12. The method of claim 11, wherein the first pressure, the second pressure, the third pressure, the fourth pressure, and the fifth pressure are each less than 13.33 kPa (100 Torr).

21. 1. A method for sterilizing an endoscope, comprising the steps of: (a) receiving the endoscope within a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce pressure within the sterilization chamber to a first pressure, the first pressure being less than 10 Torr; (c) introducing a sterilant into the sterilization chamber without heating the sterilant or heating the sterilization chamber prior to introducing the sterilant into the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first period of time; (e) venting the sterilization chamber to raise the pressure within the sterilization chamber to a second pressure, the second pressure being higher than the first pressure but still less than 30 Torr; (f) applying a vacuum or venting to atmospheric pressure and then applying said vacuum; A method comprising:

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