Apparatus and method for sterilizing an endoscope

Abstract

This invention is entitled "Apparatus and Method for Sterilizing Endoscopes". The invention discloses a method for sterilizing articles such as flexible endoscopes, the method being performed in a sterilization chamber. A vacuum is applied to the sterilization chamber while the articles are contained within it. A sterilizing agent is then introduced into the sterilization chamber. The pressure within the sterilization chamber is gradually increased to provide a gradual transition from a high vacuum state to atmospheric pressure. The articles are thus sterilized.

Description

Background Technology

[0001] Reusable medical devices (such as certain surgical instruments, endoscopes, etc.) can be sterilized before reuse to minimize the possibility of contaminated devices being used on patients, potentially causing infection. Various sterilization techniques, including those containing or without gaseous plasma and ethylene oxide (EtO), such as steam, hydrogen peroxide, peracetic acid, and vapor-phase sterilization, can be employed. Each of these methods may depend to some extent on the diffusion rate of the sterilizing fluid (e.g., gas) on or into the medical device to be sterilized.

[0002] Prior to sterilization, medical devices may be packaged in containers or pouches with a semi-permeable barrier that allows the passage of the sterilizing fluid (sometimes called the sterilizing agent) but prevents the entry of contaminating organisms, especially after sterilization and until medical personnel open the packaging. For an effective sterilization cycle, contaminating organisms within the packaging must be killed, as any organisms surviving the sterilization cycle can multiply and recontaminate the medical device. The diffusion of the sterilizing agent can be particularly problematic for medical devices with diffusion-restricted spaces, as these spaces can reduce the likelihood of an effective sterilization cycle. For example, some endoscopes have one or more long, narrow lumens, and the sterilizing agent must diffuse into these lumens at a sufficient concentration and for a sufficient duration to achieve a successful sterilization cycle.

[0003] Sterilization of medical devices can be performed using automated sterilization systems, such as the STERRAD from Advanced Sterilization Products in Irvine, California. ®Systems. Examples of automated sterilization systems are described in the following patents: U.S. Patent 6,939,519, published September 6, 2005, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma," the disclosure of which is incorporated herein by reference; U.S. Patent 6,852,279, published February 8, 2005, entitled "Sterilization with Temperature-Controlled Diffusion Path," the disclosure of which is incorporated herein by reference; U.S. Patent 6,852,277, published February 8, 2005, entitled "Sterilization System Employing a Switching Module Adapter to Pulsate the Low Frequency Power Applied to a Plasma," the disclosure of which is incorporated herein by reference; and U.S. Patent 6,852,277, published September 10, 2002, entitled "Power System for Sterilization Systems Employing Low Frequency..." U.S. Patent 6,447,719, entitled “Plsma”, the disclosure of which is incorporated herein by reference; and U.S. Provisional Patent Application 62 / 316,722, entitled “System and Method for Sterilizing Medical Devices”, filed April 1, 2016, the disclosure of which is incorporated herein by reference.

[0004] Some sterilization systems use evaporated chemical sterilizing agents or chemical gases such as hydrogen peroxide, peracetic acid, ozone, chlorine dioxide, and nitrogen dioxide to sterilize medical devices. Examples of such systems are described in the following patents: U.S. Patent 6,365,102, published April 2, 2002, entitled "Method of Enhanced Sterilization with Improved Material Compatibility," the disclosure of which is incorporated herein by reference; and U.S. Patent 6,325,972, published December 4, 2001, entitled "Apparatus and Process for Concentrating a Liquid Sterilant and Sterilizing Articles Therewith," the disclosure of which is incorporated herein by reference. Some of these systems provide hydrogen peroxide / gas plasma sterilization systems that include a vacuum chamber and a plasma source, and increased concentrations of hydrogen peroxide for sterilization. If the length of some of these systems exceeds a certain value, they may be difficult to sterilize the lumen of some medical devices; or the processing time of such systems may still be insufficient for some applications. Therefore, because the sterilizing agent vapors are insufficient to reach the interior of the passage, some medical devices, such as long and / or narrow flexible endoscopes, may not be completely sterilized by these systems. Consequently, such medical devices may only be sterilized without actual sterilization. Sterilization systems using ethylene oxide can have relatively long processing times (e.g., longer than 24 hours), which may be undesirable in some cases.

[0005] Operator error can lead to the reuse of medical devices that are mistakenly considered to have been sterilized. Verifying the effectiveness of sterilization cycles helps healthcare personnel avoid using contaminated medical devices on patients. Sterilized medical devices themselves cannot detect contaminating organisms, as such activity can introduce other contaminating organisms into the device, thus re-contaminating it. Therefore, indirect verification can be performed using sterilization indicators. A sterilization indicator is a device that can be placed next to or near a medical device undergoing a sterilization cycle, such that the indicator undergoes the same sterilization cycle as the device. For example, a bioindicator with a predetermined number of microorganisms can be placed in a sterilization chamber next to the medical device and undergo a sterilization cycle. After the cycle is complete, the microorganisms in the bioindicator can be cultured to determine if any microorganisms survived the cycle. The presence or absence of live microorganisms in the bioindicator indicates whether the sterilization cycle was effective.

[0006] Although various systems and methods have been developed and used for sterilization of surgical instruments, it is believed that no one had manufactured or used the technology described herein before the inventors. Attached Figure Description

[0007] It is believed that the invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which similar reference numerals denote the same elements, and in the drawings: Figure 1 A schematic diagram of an exemplary medical device sterilization cabinet is shown; Figure 2 A high-level flowchart illustrating an exemplary set of steps is shown. Figure 1 The system's sterilization cabinet can perform these steps to sterilize medical devices; Figure 3 A flowchart illustrating an exemplary set of steps is provided, which can serve as... Figure 2 It is performed as part of a sterilization cycle within the steps of the group; Figure 4 A graph is shown, which illustrates the curve in Figure 3 During the sterilization cycle, as time progresses... Figure 1 An exemplary curve of vacuum pressure in the sterilization chamber of a sterilizer; Figure 5 A flowchart illustrating exemplary alternative group steps is provided, which can be used as... Figure 2 This is performed as part of a sterilization cycle within the steps of the process group; and Figure 6 A graph is shown, which illustrates the curve in Figure 5 During the sterilization cycle, as time progresses... Figure 1 Another exemplary curve of the vacuum pressure in the sterilization chamber of the sterilizer. Detailed Implementation

[0008] The following description of certain examples of the present technology should not be construed as limiting the scope of the present technology. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is given by way of example and is one of the best modes contemplated for implementing the present technology. As will be appreciated, the technology described herein can include other different and obvious aspects without departing from the present invention. Therefore, the accompanying drawings and detailed descriptions should be considered substantially illustrative rather than restrictive.

[0009] It should also be understood that any one or more of the teachings, expressions, embodiments, and examples described herein may be combined with any one or more of the other teachings, expressions, embodiments, and examples described herein. Therefore, the following teachings, expressions, embodiments, and examples should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0010] I. Overview of Exemplary Sterilization Systems Figure 1 An exemplary sterilization cabinet (150) is shown, operable to sterilize medical devices such as endoscopes. This example sterilization cabinet (150) includes a sterilization chamber (152) configured to receive one or more medical devices for sterilization. Although not shown in the figures, the sterilization cabinet (150) also includes a door to the sterilization chamber (152) that opens and closes in response to the actuation of a kick plate. This allows the operator to open and close the sterilization chamber (152) hands-free. 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 sterilizing agent into the sterilization chamber (152) for sterilizing the medical devices contained therein. In this example, the sterilization module (156) is configured to receive a replaceable sterilizing agent cartridge (158) containing a specified amount of sterilizing agent. By way of example only, each sterilizing agent container (158) can hold enough sterilizing agent to perform five sterilization procedures.

[0011] The sterilizer (150) of this example also includes a touchscreen display (160). The touchscreen display (160) is operable to present various user interface displays, such as those described in U.S. Provisional Patent Application 62 / 316,722, the disclosure of which is incorporated herein by reference. Of course, the touchscreen display (160) may also display various other screens. The touchscreen display (160) is further configured to receive user input in the form of user contact with the touchscreen display (160) according to conventional touchscreen technology. In addition or alternatively, the sterilizer (150) may include various other types of user input structures, including but not limited to buttons, keypads, keyboards, mice, trackballs, etc.

[0012] The sterilizer (150) in this example also includes a processor (162) that communicates with a sterilization module (156) and a touchscreen display (160). The processor (162) is operable to execute control algorithms based on user input, thereby driving the sterilization module (156). The processor (162) is further operable to execute instructions to display various screens on the touchscreen display (160); and to process instructions received from the user via the touchscreen display (160) (and / or via other user input structures). The processor (162) also communicates with various other components of the sterilizer (150), thereby being operable to drive those components and / or process input and / or other data from those components. Various suitable components and configurations that can be used to form the processor (162) will be apparent to those skilled in the art from the teachings herein.

[0013] The sterilizer (150) of this example also includes an identification tag reader (166) operable to read identification tags of biometric indicators as described herein. By way of example only, the identification tag reader (166) may include an optical reader operable to read optical identification tags (e.g., barcodes, QR codes, etc.) of biometric indicators. Alternatively, the identification tag reader (166) may include an RFID reader operable to read RFID identification tags (e.g., barcodes, QR codes, etc.) of biometric indicators. Various suitable components and configurations that can be used to form the identification tag reader (166) will be apparent to those skilled in the art from the teachings herein. Data received by the identification tag reader (166) is processed by a processor (162).

[0014] The sterilizer (150) of this example also includes a memory (168) operable to store control logic and instructions, and executed by a processor (162) to drive components such as a sterilization module (156), a touchscreen display (160), a communication module (154), and an identification tag reader (166). The memory (168) can also be used to store results associated with the setup of sterilization cycles, the execution of load conditioning cycles, the execution of sterilization cycles, and / or various other kinds of information. Various suitable forms that the memory (168) can take and various ways in which the memory (168) can be used will be apparent to those skilled in the art in light of the teachings herein.

[0015] The sterilizer (150) in this example also includes a printer (170) operable to print information such as the settings of a sterilization cycle, the execution of a load conditioning cycle, and the results associated with the execution of a sterilization cycle, and / or various other kinds of information. By way of example only, the printer (170) may include a thermal printer, but of course any other suitable type of printer may be used. The various suitable forms in which the printer (170) may take and the various ways in which the printer (170) may be used will be apparent to those skilled in the art in light of the teachings herein. It should also be understood that the printer (170) is only optional and may be omitted in some models.

[0016] The sterilizer (150) in this example also includes a vacuum source (180) and a vent valve (182). The vacuum source (180) is fluidly connected to the sterilization chamber (152) and also connected to a processor (162). Therefore, 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, it is operable to reduce the pressure within the sterilization chamber (152), as will be described in more detail below. The vent valve (182) is also fluidly connected to the sterilization chamber (152). Furthermore, the vent valve (182) is connected to the processor (162) such that the processor (162) is operable to selectively activate the vent valve (182) according to one or more control algorithms. When the vent valve (182) is activated, it is operable to vent the sterilization chamber (152) to atmospheric pressure, as will be described in more detail below. Various suitable components for providing the vacuum source (180) and the vent valve (182) will be apparent to those skilled in the art, taking into account the teachings herein.

[0017] In addition to the foregoing, the sterilizer (150) may be configured and operated in accordance with the teachings of at least some of the following patents: U.S. Patent 6,939,519, the disclosure of which is incorporated herein by reference; U.S. Patent 6,852,279, the disclosure of which is incorporated herein by reference; U.S. Patent 6,852,277, the disclosure of which is incorporated herein by reference; U.S. Patent 6,447,719, the disclosure of which is incorporated herein by reference; U.S. Patent 6,365,102, the disclosure of which is incorporated herein by reference; U.S. Patent 6,325,972, the disclosure of which is incorporated herein by reference; and / or U.S. Provisional Patent Application 62 / 316,722, the disclosure of which is incorporated herein by reference.

[0018] II. Overview of Exemplary Sterilization Processes Figure 2A high-level flowchart of an exemplary set of steps that a sterilizer (150) can perform to sterilize a medical device, such as an endoscope, used in the field. The sterilizer (150) can be configured to perform one or more sterilization cycles, wherein different sterilization cycles are appropriate for different types and numbers of medical devices. Thus, as an initial step, the sterilizer (150) can display one or more available sterilization cycles via a touchscreen display (160) and then receive a sterilization cycle selection from the user (box 200).

[0019] The sterilizer (150) may also display instructions indicating whether a biological indicator should be used with the selected sterilization cycle and receive a biological indicator identifier (box 202). Such a biological indicator identifier (box 202) may be provided via an identification tag reader (166), via a touchscreen display (160), or otherwise. The biological indicator may be placed in the sterilization chamber (152) of the sterilizer (150) before the start of the sterilization cycle and may remain in the sterilization chamber during the sterilization cycle. The user can thus identify a specific biological indicator (box 202) after it is placed in the sterilization chamber. The biological indicator may contain microorganisms responsive to a specific sterilization cycle. After the sterilization cycle is completed, the microorganisms of the biological indicator may be tested to provide a measurement of the effectiveness of the sterilization cycle. A biological indicator may not be required for all sterilization cycles, but may be required based on hospital rules or local regulations.

[0020] The selection of a sterilization cycle (box 200) and the identification of a bioindicator (box 202) may define one or more requirements for the configuration and arrangement of medical devices within the sterilization chamber (152). Therefore, once a sterilization cycle (box 200) has been selected and a bioindicator (box 202) has been identified, the sterilizer (150) may provide a display via a touchscreen display (160) indicating the correct placement of the medical device in order to prepare for the sterilization cycle (204). This display may serve as a visual guide for the user to place the medical device (and possibly the bioindicator) within the sterilization chamber (152) of the sterilizer (150) based on the sterilization cycle selection (box 200). The door of the sterilization chamber (152) may be opened to allow the user to place the medical device (and possibly the bioindicator) within the sterilization chamber (152) as instructed.

[0021] Once the user places the medical device in the sterilization chamber (152) based on these instructions, the user can press the start button or another button indicating that the placement of the medical device is complete. In some models, the sterilizer (150) is configured to automatically verify correct placement of the medical device. By way of example only, the sterilizer (150) may employ light sensors, imaging devices, weight sensors, and / or other components to verify correct placement of the medical device in the sterilization chamber (152). However, it should be understood that some models of sterilizers (150) may lack the ability to automatically verify the correct placement of the medical device in the sterilization chamber (152).

[0022] If the placement of the medical device has been validated and / or the user has otherwise completed cycle preparation (box 204), the sterilizer (150) may initiate a load conditioning process (box 206). The load conditioning process (box 206) prepares the sterilization chamber (152) and the medical device within it for optimal sterilization during the sterilization cycle. Conditioning may include controlling and optimizing one or more characteristics of the sterilization chamber (152). For example, during load conditioning, the sterilizer (150) may continuously monitor the moisture content within the sterilization chamber (152) while reducing the moisture content by, for example, circulating and dehumidifying the air in the sterilization chamber (152), creating a vacuum within the sterilization chamber (152), heating the sterilization chamber (152), and / or other methods used to dehumidify the sealed chamber. This process may continue until the sterilizer (150) determines that an acceptable moisture content has been reached.

[0023] As part of the load conditioning cycle (box 206), the sterilizer (150) may also continuously monitor the temperature within the sterilization chamber (152) while heating the sterilization chamber (152) by, for example, convection of heated air, conduction through the internal surfaces of the sterilization chamber (152), and / or using other techniques. This process may continue until the sterilizer (150) determines that an acceptable internal temperature has been reached. Various conditioning actions, such as controlling temperature or humidity, may be performed in parallel or sequentially. It should also be understood that the load conditioning cycle (box 206) may verify that the sterilization chamber is sealed; verify the contents of the sterilization chamber; examine the physical characteristics of the contents of the sterilization chamber, such as the volume, weight, or other characteristics of the contents; and / or perform one or more conditioning steps that may include chemical treatment, plasma treatment, or other types of treatment to reduce moisture, increase temperature, and / or otherwise prepare the medical device for the sterilization cycle (box 208).

[0024] When one or more conditioning actions (box 206) are performed as part of a load conditioning cycle, the sterilizer (150) may display information via a touchscreen display (160) indicating to the user the duration prior to the start of the sterilization cycle (box 208). Once all load conditioning criteria have been successfully met, the load conditioning cycle (box 206) is complete, and the sterilization cycle (box 208) can then be performed. Therefore, it should be understood that the sterilizer (150) is configured such that the sterilization cycle (box 208) does not actually begin until the load conditioning cycle (box 206) is complete. It should also be understood that in some configurations of sterilizer (150) operation, the load conditioning cycle (box 206) may be omitted or modified.

[0025] As noted above, the sterilizer (150) can automatically begin performing a sterilization cycle (box 208) immediately after load conditioning (box 206) is completed. The sterilization cycle (box 208) may include exposing the medical device in the sterilization chamber to pressurized sterilizing agent gases, further heat treatment, chemical treatment, plasma treatment, vacuum treatment, and / or other types of sterilization procedures. During the execution of the sterilization cycle (box 208), the sterilizer (150) may display information via a touchscreen display (160), such as the remaining duration of the sterilization cycle (box 208), the current stage of the sterilization cycle (box 208) (e.g., plasma, vacuum, injection, heating, chemical treatment), and / or other information.

[0026] In some types, the sterilization cycle (box 208) includes the following shown Figure 3 The exemplary sub-steps are described below. Specifically, the cycle may begin by applying a vacuum (box 310) within the sterilization chamber (152). To provide such a vacuum, the processor (162) may activate a vacuum source (180) according to a control algorithm. The processor (162) then determines (box 312) whether a sufficient pressure level has been reached within the sterilization chamber (152). By way of example only, as part of the determination step (box 312), the processor (162) may monitor data from one or more pressure sensors within the sterilization chamber (152). Alternatively, the processor (162) may simply activate the vacuum source (180) for a predetermined period of time and assume that an appropriate pressure has been reached in sterilization (152) based on the duration for which the vacuum source (180) is activated. Other suitable methods by which the processor (162) may determine (box 312) whether a sufficient pressure level has been reached within the sterilization chamber (152) will be apparent to those skilled in the art. The vacuum source (180) will remain active until an appropriate pressure level is reached in the sterilization chamber (152).

[0027] Once the sterilization chamber (152) reaches an appropriate pressure level (e.g., between about 0.2 Torr and about 10 Torr), the processor (162) then activates the sterilization module (156) to apply a sterilizing agent (box 314) into the sterilization chamber (152). This phase of the process may be referred to as the “transfer phase.” By way of example only, the sterilizing agent may include vapors of an oxidizing agent, such as hydrogen peroxide, peroxy acids (e.g., peracetic acid, performic acid, etc.), ozone, or mixtures thereof. Alternatively, the sterilizing agent may include chlorine dioxide. Various other suitable forms of sterilizing agents may be used in light of the teachings herein, which are described herein, and others will be apparent to those skilled in the art. It should also be understood that in some types, the sterilizing agent may be applied in different ways (box 314), as described above, based on the user’s selection of the circulation (box 200). Once the sterilizing agent has been applied (box 314) into the sterilization chamber (152), the processor (162) monitors time (box 316) to determine whether a predetermined duration has elapsed. By way of example only, the predetermined duration can be anywhere from a few seconds to a few minutes. Before the predetermined duration has elapsed, the sterilization chamber (152) remains sealed at the predetermined pressure level described above, wherein the applied sterilizing agent acts on the medical device contained within the sterilization chamber (152).

[0028] After a predetermined duration, the processor (162) activates (box 318) the vent valve (182) to ventilate the sterilization chamber (152) to atmospheric pressure. In some models, the sterilization chamber (152) is allowed to reach atmospheric pressure, while in others, it only reaches sub-atmospheric pressure. This ventilation phase of the process may be referred to as the "diffusion phase." In this example, the sterilization cycle is then completed after the diffusion phase (box 320). In some other cases, after the diffusion phase is completed, a vacuum is applied again to the sterilization chamber (152); and then plasma is applied to the sterilization chamber (152). It should be understood that... Figure 3 The entire sterilization cycle shown (including the changes described above, wherein sterilization is then applied to a subsequent vacuum) can be repeated once or more after completion. In other words, the medical device can remain in the sterilization chamber (152) and undergo... Figure 3 The entire cycle shown is repeated two or more times (including the changes described above, where sterilization is then applied to a subsequent vacuum). The number of iterations may vary based on the cycle selection (box 200), which may be influenced by the specific type of medical device being sterilized in the sterilization chamber (152).

[0029] Figure 4 An exemplary curve (400) is shown, which is illustrated in... Figure 3The pressure within the sterilization chamber (152) during the execution of the sterilization cycle (box 208) shown and described above. It can be seen that when the vacuum source (180) is activated to apply a vacuum (box 310) to the sterilization chamber (152), the pressure level drops significantly and abruptly. Then, during the application of the sterilizing agent (box 314) and for a subsequent predetermined duration (box 316), the pressure level remains substantially constant. Then, when the vent valve (182) is activated (box 318) to vent the sterilization chamber (152) to atmospheric pressure, the pressure level increases significantly and abruptly. Therefore, in general, curve (400) illustrates how the pressure within the sterilization chamber (152) simply switches between a single relatively high level (i.e., atmospheric pressure) and a single relatively low level (i.e., vacuum state). An exemplary alternative sterilization cycle is referenced below. Figures 5-6 To describe in more detail.

[0030] After a sterilization cycle (box 208) is completed, the sterilizer (150) can cycle the result of the sterilization cycle (box 208) (box 210). For example, if the sterilization cycle (box 208) is canceled or cannot be completed due to an error or user action, the sterilizer (150) can remain sealed and can also display a sterilization cycle cancellation message, as well as various details related to the sterilization cycle, such as date, time, configuration, actual time elapsed, sterilization cycle operator, stage of sterilization cycle failure, and other information that can be used to identify why the sterilization cycle was performed, via a touch screen display (160). If the sterilization cycle (box 208) is successfully completed, the sterilizer (150) can display a notification indicating the successful completion of the sterilization cycle (box 208) via a touch screen display (160). In addition, the sterilizer (150) can display information such as sterilization cycle identifier, sterilization cycle type, start time, duration, operator, and other information (666).

[0031] In addition to the foregoing, the sterilizer (150) may be configured to perform sterilization processes in accordance with the teachings of at least some of the following patents: U.S. Patent 6,939,519, the disclosure of which is incorporated herein by reference; U.S. Patent 6,852,279, the disclosure of which is incorporated herein by reference; U.S. Patent 6,852,277, the disclosure of which is incorporated herein by reference; U.S. Patent 6,447,719, the disclosure of which is incorporated herein by reference; U.S. Patent 6,365,102, the disclosure of which is incorporated herein by reference; U.S. Patent 6,325,972, the disclosure of which is incorporated herein by reference; and / or U.S. Provisional Patent Application 62 / 316,722, the disclosure of which is incorporated herein by reference.

[0032] III. Exemplary alternative sterilization cycle As noted above, some types of sterilizers (150) may have difficulty effectively sterilizing medical devices, such as flexible endoscopes with relatively long, narrow lumens. For example, some conventional sterilizers are capable of sterilizing lumens shorter than or equal to about 875 mm with a lumen diameter of about 1 mm or greater. Therefore, it may be necessary to provide modified sterilization cycles (box 208) that further facilitate the effective sterilization of medical devices with one or more relatively long, narrow lumens. Only exemplary examples of such modified sterilization cycles are described in more detail below. By way of example only, a medical device with one or more relatively long, narrow lumens may include a gastrointestinal endoscope with a length between about 1 m and about 3 m and a lumen diameter between about 0.5 mm and about 2.0 mm. However, it should be understood that the following procedures can also be performed on endoscopes with a length of at least about 500 mm or at least about 800 mm and a lumen diameter less than about 6.0 mm.

[0033] Figure 5 Exemplary alternative sub-steps are shown that can be performed to provide a sterilization cycle for the sterilizer (150) (box 208). Specifically, the cycle may begin by applying a vacuum within the sterilization chamber (152) (box 510). To provide such a vacuum, a processor (162) may activate a vacuum source (180) according to a control algorithm. The processor (162) then determines (box 512) whether a sufficient pressure level has been reached within the sterilization chamber (152). By way of example only, as part of the determination step (box 512), the processor (162) may monitor data from one or more pressure sensors within the sterilization chamber (152). Alternatively, the processor (162) may simply activate the vacuum source (180) for a predetermined period of time and assume that an appropriate pressure has been reached in sterilization (152) based on the duration for which the vacuum source (180) is activated. Other suitable methods by which the processor (162) determines (box 512) whether a sufficient pressure level has been reached within the sterilization chamber (152) will be apparent to those skilled in the art. The vacuum source (180) will remain active until an appropriate pressure level is reached within the sterilization chamber (152).

[0034] Once the sterilization chamber (152) reaches an appropriate pressure level (e.g., between about 0.2 Torr and about 10 Torr), the processor (162) then activates the sterilization module (156) to apply a sterilizing agent (box 514) into the sterilization chamber (152). By way of example only, the sterilizing agent may include vapors of an oxidizing agent, such as hydrogen peroxide, peroxyacids (e.g., peracetic acid, performic acid, etc.), ozone, or mixtures thereof. Alternatively, the sterilizing agent may include chlorine dioxide or nitrogen dioxide. Various other suitable forms of sterilizing agents may be used in light of the teachings herein, and other forms will be apparent to those skilled in the art. It should also be understood that in some configurations, the sterilizing agent may be applied in different ways (box 514), as described above, based on the user's selection of the cycle (box 200). Once the sterilizing agent has been applied (box 514) into the sterilization chamber (152), the processor (162) monitors time (box 516) to determine whether a predetermined duration has elapsed. By way of example only, the predetermined duration can be anywhere from a few seconds to a few minutes. Prior to the predetermined duration, the sterilization chamber (152) remains sealed at the aforementioned predetermined pressure level, during which the applied sterilizing agent acts on the medical device contained within the sterilization chamber (152). This phase of the process may be referred to as the "transfer phase".

[0035] After a predetermined duration, the processor (162) activates (box 518) the vent valve (182) to ventilate the sterilization chamber (152) to atmospheric pressure. While the sterilization chamber (152) is ventilated (box 518) to the atmosphere, the processor (162) monitors time (box 520) to determine if a sufficient predetermined ventilation (box 518) duration has elapsed. The sterilization chamber (152) remains ventilated until the predetermined ventilation (box 518) duration has elapsed. After the predetermined ventilation (box 518) duration has elapsed, the processor (162) determines (box 522) whether the sterilization cycle is complete. An example of how this determination (box 522) can be performed will be described in more detail below. It should be understood that in this example, the predetermined ventilation (box 518) duration may be very short. By way of example only, the predetermined ventilation (box 518) duration may be about one second, two seconds, three seconds, four seconds, five seconds or any other suitable duration.

[0036] If the processor (162) determines (box 522) that the sterilization cycle is complete, then the sterilization cycle is in fact complete (box 528). However, if the processor (162) determines (box 522) that the sterilization cycle is not yet complete, then the processor (162) closes the vent valve (182) to seal (box 524) the sterilization chamber (152) at a pressure level still below atmospheric pressure. As noted above, in this example, the duration of venting (box 518) is very short, such that the sealing (box 524) can occur very quickly after the start of venting (box 518), assuming that the determination (boxes 520, 522) confirms that the seal (box 524) is in good condition.

[0037] The sterilization chamber (152) will remain sealed (box 524) for a certain period of time. Specifically, with the sterilization chamber (152) sealed (box 524), the processor (162) monitors time (box 526) to determine whether a predetermined sealing (box 524) duration has elapsed. The sterilization chamber (152) remains sealed until the predetermined sealing (box 524) duration has elapsed. After the predetermined sealing (box 524) duration has elapsed, the processor (162) reactivates (box 518) the vent valve (182) to ventilate the sterilization chamber (152) to atmospheric pressure. By way of example only, the predetermined sealing duration may be between approximately 5 seconds and 5 minutes, or more specifically between approximately 10 seconds and approximately 2 minutes, or more specifically between approximately 20 seconds and approximately 2 minutes.

[0038] At this point, the process continues to the steps described above (boxes 518, 520, 522, 524, 526), ​​such that the process provides a series of venting (box 518) and sealing (box 524) of the sterilization chamber (152), thereby allowing the pressure within the sterilization chamber (152) to increase gradually until the sterilization chamber (152) reaches atmospheric pressure or a predetermined sub-atmospheric pressure. Again, in this example, each step of venting (box 518) is very brief, such that the pressure in the sterilization chamber (152) remains below atmospheric pressure during the sealing (box 524) process (e.g., for a duration between a few seconds and a few minutes). By way of example only, each step of venting (box 518) may cause the pressure within the sterilization chamber (152) to increase accordingly by about 10 to about 100 tors, or more specifically, about 10 to about 30 tors, before reaching the final step of venting (box 518). Other suitable values ​​for gradual pressure increases will be apparent to those skilled in the art in light of the teachings herein. Once the sterilizer (150) reaches the end of the process, the vent valve (182) remains open to keep the sterilization chamber (152) at atmospheric pressure. The final venting step of the process (box 518) may be referred to as the "diffusion phase".

[0039] In some configurations, the ventilation duration (box 520) and / or sealing duration (box 526) may be varied. For example, the ventilation duration (box 520) and / or sealing duration (box 526) may vary based on cycle selection (box 200), which may be influenced by the specific type of medical device being sterilized in the sterilization chamber (152). Alternatively or additionally, the ventilation duration (box 520) and / or sealing duration (box 526) may vary based on where the sterilization cycle occurs during the process (i.e., which ventilation (box 518) iteration and / or which sealing (box 524) iteration). The ability to vary the ventilation duration (box 520) and / or sealing duration (box 526), ​​and various suitable ways in which such durations may be varied based on various bases, will be apparent to those skilled in the art in light of the teachings herein.

[0040] Figure 6 An exemplary curve (600) is shown, which illustrates the curve as shown in the example curve (600). Figure 5 The pressure within the sterilization chamber (152) during the execution of the sterilization cycle (box 208) shown and described above. It can be seen that when the vacuum source (180) is activated to apply a vacuum (box 510) to the sterilization chamber (152), the pressure level drops significantly and abruptly. Then, during the application of the sterilizing agent (box 514) and for a subsequent predetermined duration (box 516), the pressure level remains substantially constant. The pressure level then increases slightly when the vent valve (182) is activated (box 518) to vent the sterilization chamber (152) to atmospheric pressure, but remains below atmospheric pressure when the sterilization chamber (152) is sealed (box 524). The pressure level then increases slightly again when the vent valve (182) is reactivated (box 518) to vent the sterilization chamber (152) to atmospheric pressure, but remains below atmospheric pressure again when the sterilization chamber (152) is sealed again (box 524).

[0041] exist Figure 6 In the example shown, the cycle provides four iterations of brief ventilation (box 518), followed by four iterations of sealing (box 524), and finally, complete ventilation to the atmosphere (box 518). Therefore, in general, curve (600) shows how the pressure within the sterilization chamber (152) increases progressively from a essentially vacuum state to atmospheric pressure. Although Figure 6The diagram illustrates four iterations of brief ventilation and brief sealing, but other processes may employ any other suitable number of iterations of brief ventilation and brief sealing. As an example only, variations may be provided between two and 100 iterations of brief ventilation and brief sealing, or more specifically between two and ten iterations of brief ventilation and brief sealing, or more specifically between three and seven iterations of brief ventilation and brief sealing.

[0042] In some cases, with use Figures 3-4 Compared to the sterilization of the same medical device, the process shown is... Figures 5-6 The process illustrated provides more effective sterilization for some medical devices. Specifically, and without theoretical limitations, progressive aeration of the sterilization chamber (152) provides agitation of the contents of the sterilization chamber (152), which can help drive the sterilizing agent into the lumen and / or other internal spaces within the medical device. Furthermore, and also without theoretical limitations, in conjunction with... Figures 3-4 Compared to the simple diffusive mass transfer of vapors associated with the process shown, the sterilization chamber (152) exhibits... Figures 5-6 The stepwise ventilation associated with the illustrated process can provide convective mass transfer of sterilizing agent vapor molecules within the lumen and / or other internal spaces of the medical device. Therefore, in conjunction with the execution Figures 3-4 Compared to the sterilizer (150) shown in the process (which is unable to sterilize the long, narrow lumens of the same type of gastrointestinal endoscope), when the sterilizer (150) performs... Figures 5-6 During the process shown, the sterilizer (150) can sterilize relatively long gastrointestinal endoscopes (e.g., with a length of up to about 3 m and a lumen diameter of up to about 1 mm).

[0043] It should also be understood that Figures 5-6 The entire cycle shown can be repeated once or multiple times after completion. In other words, the medical device can be kept in the sterilization chamber (152) and undergo... Figures 5-6 The entire loop shown undergoes two or more iterations. The number of iterations may vary based on the loop selection (box 200), which may be influenced by the specific type of medical device being sterilized in the sterilization chamber (152).

[0044] By way of example only, an endoscope with a 3-meter-long lumen can be placed in a sterilization chamber (152). A vacuum (box 510) can be applied to achieve a pressure level of approximately 4.5 Torr in the sterilization chamber (152). A sterilizing agent (e.g., approximately 1 mL of 59% hydrogen peroxide vapor) (box 514) can then be applied to provide a transfer phase lasting approximately 30 seconds. The sterilization chamber (152) can then be briefly ventilated (box 518) to achieve a pressure level of approximately 13.7 Torr, and the sterilization chamber (152) can then be sealed (box 524). The sterilization chamber (152) can be maintained at approximately 13.7 Torr for approximately 150 seconds. The sterilization chamber (152) can then be briefly ventilated again (box 518) to achieve a pressure level of approximately 30.1 Torr, and the sterilization chamber (152) can then be sealed again (box 524). The sterilization chamber (152) can be held at approximately 30.1 Torr for approximately 200 seconds. The sterilization chamber (152) can then be briefly ventilated again (box 518) to achieve a pressure level of approximately 47.1 Torr, and the sterilization chamber (152) can then be resealed (box 524). The sterilization chamber (152) can be held at approximately 47.1 Torr for approximately 190 seconds. The sterilization chamber (152) can then be briefly ventilated again (box 518) to achieve a pressure level of approximately 760 Torr (i.e., atmospheric pressure), thereby providing the diffusion phase. Of course, the foregoing is merely an exemplary example.

[0045] In some variations, additional sterilizing agent is introduced into the sterilization chamber (152) during one or more periods of the progressive ventilation (box 518) action, prior to the final step of ventilation (box 518) being reached.

[0046] In some variations, pre-plasma may be applied during the sterilization cycle (box 208) to heat the medical device contained in the sterilization chamber (152). By way of example only, plasma may be applied between the application of vacuum (box 510) and the application of sterilizing agent (box 514). Alternatively, post-plasma may be applied at the end of the sterilization cycle (box 208) to degrade any residual sterilizing agent that may have been adsorbed onto the surface of the medical device contained in the sterilization chamber (152). It should be understood that a vacuum must first be applied to the sterilization chamber (152) before the application of post-plasma.

[0047] As noted above, the sterilizing agent is applied in vapor form (box 514) within the sterilization chamber (152). 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 sterilizing agent solution of a specific concentration (e.g., a liquid hydrogen peroxide solution with a concentration of about 59% nominal, or between about 58% and about 59.6%); wherein the sterilizing agent solution changes phase from liquid to vapor. The condenser provides condensation of the sterilizing agent solution vapor and thus increases the concentration of the sterilizing agent solution (e.g., from about 59% nominal to somewhere between about 83% nominal and about 95% nominal) by removing water vapor. Alternatively, any other suitable method and components may be used to apply the sterilizing agent in vapor form within the sterilization chamber (152). In any case, to supplement the application of the sterilizing agent in vapor form, the sterilizing agent may also be applied (in liquid form) into the lumen and / or other internal spaces within the medical device and / or outside the medical device, after which the medical device is placed in the sterilization chamber (152). In this type, the sterilizing agent may evaporate during and even after the application of vacuum (box 510); and a higher concentration of sterilizing agent is provided to areas of the medical device with a smaller penetration range, thereby further promoting effective sterilization.

[0048] To give just one example, Figure 5 The process shown can be carried out at a temperature between about 30°C and about 56°C, or more specifically between about 47°C and about 56°C, or even more specifically at about 50°C, on the walls of the sterilization chamber (152); and the temperature of the medical device in the sterilization chamber (152) is between about 5°C-10°C and about 40°C-55°C.

[0049] While the foregoing examples have been described in the context of sterilizing medical devices, particularly endoscopes, it should be understood that the teachings herein can also be readily applied to the sterilization of various other types of articles. The teachings are not limited to endoscopes or other medical devices. Other suitable articles that can be sterilized according to the teachings herein will be apparent to those skilled in the art.

[0050] IV. Exemplary Combinations The following embodiments relate to various incomplete ways in which the teachings herein can be combined or applied. It should be understood that the following embodiments are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following embodiments are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that certain variations may omit certain features mentioned in the following embodiments. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim provided in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0051] Example 1 A method for sterilizing an article, the method comprising: (a) receiving the article in a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce the pressure inside the sterilization chamber to a first pressure, wherein the first pressure is less than atmospheric pressure; (c) introducing a sterilizing agent into the sterilization chamber; (d) maintaining the first pressure in the sterilization chamber for a first time period; (e) ventilating the sterilization chamber to increase the pressure inside the sterilization chamber to a second pressure, wherein the second pressure is less than atmospheric pressure; (f) maintaining the second pressure in the sterilization chamber for a second time period; (g) ventilating the sterilization chamber to increase the pressure inside the sterilization chamber to a third pressure; and (h) maintaining the third pressure in the sterilization chamber for a third time period.

[0052] Example 2 According to the method of Example 1, the article includes a medical device.

[0053] Example 3 According to the method described in Example 2, the medical device includes an endoscope.

[0054] Example 4 According to the method described in Example 3, the endoscope defines a lumen.

[0055] Example 5 According to the method described in Example 4, the length of the lumen is at least 800 mm and the inner diameter is less than 6 mm.

[0056] Example 6 According to any one or more of the methods described in Examples 1 to 5, the second time period is longer than the first time period.

[0057] Example 7 According to any one or more of the methods described in Examples 1 to 6, the first time period is between about 5 seconds and about 5 minutes.

[0058] Example 8 According to any one or more of the methods described in Examples 1 to 7, the first time period is between about 20 seconds and about 2 minutes.

[0059] Example 9 According to any one or more of the methods described in Examples 1 to 8, the second pressure is between about 10 Torr greater than the first pressure and about 100 Torr greater than the first pressure.

[0060] Example 10 According to any one or more of the methods described in Examples 1 to 9, the second pressure is between about 10 Torr greater than the first pressure and about 30 Torr greater than the first pressure.

[0061] Example 11 According to any one or more of the methods described in Examples 1 to 10, the third pressure is between about 10 Torr greater than the second pressure and about 100 Torr greater than the second pressure.

[0062] Example 12 The method according to any one or more of Examples 1 to 11, wherein the third pressure is about 760 Torr.

[0063] Example 13 The method according to any one or more of Examples 1 to 12 further includes applying plasma to the sterilization chamber.

[0064] Example 14 According to the method of Example 13, the act of applying plasma includes applying plasma to the sterilization chamber between the act of applying vacuum to the sterilization chamber and the act of introducing sterilizing agent into the sterilization chamber.

[0065] Example 15 According to any one or more of the methods in Examples 13 to 14, the act of applying plasma includes: (i) evacuating the sterilization chamber after maintaining a third pressure in the sterilization chamber; and (ii) then applying plasma.

[0066] Example 16 The method according to any one or more of Examples 1 to 15 further includes introducing additional sterilizing agent into the sterilization chamber during the act of ventilating the sterilization chamber to increase the pressure inside the sterilization chamber to a second pressure.

[0067] Example 17 The method according to any one or more of Examples 1 to 16 further includes applying a sterilizing agent to one or more internal spaces within the article before receiving the article in a sterilization chamber.

[0068] Example 18 The method according to any one or more of Examples 1 to 17, wherein the sterilizing agent is selected from hydrogen peroxide, peroxy acid, ozone, or mixtures thereof.

[0069] Example 19 A method for sterilizing an article, the method comprising: (a) receiving the article in a sterilization chamber; (b) applying a vacuum to the sterilization chamber to reduce the pressure inside the sterilization chamber to below atmospheric pressure; (c) introducing a sterilizing agent into the sterilization chamber; (d) ventilating the sterilization chamber to increase the pressure inside the sterilization chamber without reaching atmospheric pressure; (e) maintaining the increasing pressure in the sterilization chamber for a certain period of time; (f) repeating steps (d) to (e) at least once; and (g) ventilating the sterilization chamber to increase the pressure inside the sterilization chamber to atmospheric pressure.

[0070] Example 20 An apparatus comprising: (a) a sterilization chamber configured to receive a medical device; (b) a vacuum source fluidly connected to the sterilization chamber; (c) a sterilizing agent application module fluidly connected to the sterilization chamber; (d) a vent valve fluidly connected to the sterilization chamber, wherein the vent valve is further fluidly connected to the atmosphere, such that the vent valve is operable to selectively open and close a ventilation path between the sterilization chamber and the atmosphere; and (e) a control module connected to the vacuum source, wherein the control module is further connected to the sterilizing agent application module, wherein the control module is further connected to the vent valve, wherein the control module includes control logic configured to execute a sterilization algorithm, such that the control logic is configured to: (i) activate the vacuum source to apply a vacuum to the sterilization chamber, (ii) activate the sterilizing agent application module to apply a sterilizing agent to the sterilization chamber, and (iii) selectively activate the vent valve to provide a gradual increase in pressure within the sterilization chamber toward atmospheric pressure.

[0071] V. Miscellaneous It should be understood that any patent, publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with the definitions, statements, or other public materials set forth in this disclosure. Therefore, and to the extent necessary, the disclosure expressly set forth herein substitutes for any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with existing definitions, statements, or other public materials stated herein is incorporated only to the extent that it does not conflict with existing public materials.

[0072] Various embodiments of the invention have been shown and described, and further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such potential modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not claimed. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus comprising: (a) A sterilization chamber, wherein the sterilization chamber is configured to receive a medical device; (b) A vacuum source, said vacuum source being fluidly connected to said sterilization chamber; (c) A sterilizing agent application module, wherein the sterilizing agent application module is fluidly connected to the sterilization chamber; (d) A vent valve, said vent valve being fluidly connected to the sterilization chamber; and (e) A control module connected to the vacuum source, the sterilizing agent application module, and the vent valve, wherein the control module is configured to: (i) Activate the vacuum source to apply a vacuum to the sterilization chamber. (ii) Activate the sterilizing agent application module to apply sterilizing agent to the sterilization chamber, and (iii) Selectively activate the vent valve to provide a gradual increase in pressure within the sterilization chamber to drive the sterilizing agent into the medical device.

2. A system comprising: The device according to claim 1; and The medical device.

3. The system according to claim 2, wherein, The medical device is an endoscope.

4. The system according to claim 2, wherein, The medical device consists of multiple endoscopes.

5. The apparatus of claim 1, further comprising opening and closing the door of the sterilization chamber in response to the actuation of the kick plate.

6. The device according to claim 1, wherein, The sterilizing agent application module is configured to receive a replaceable sterilizing agent cartridge containing at least a portion of the sterilizing agent.

7. The device of claim 1, further comprising a touchscreen display configured to receive user input.

8. The device according to claim 7, wherein, The touchscreen display can be operated to present various user interface displays.

9. The device according to claim 7, wherein, The control module communicates with the sterilizing agent application module and the touch screen display and is operable to execute a control algorithm based on the user input to drive the sterilizing agent application module.

10. The device of claim 1, further comprising an identification tag reader operable to read identification tags of biometric indicators.

11. The device according to claim 10, wherein, The identification tag reader includes an optical reader capable of operating to read optical identification tags for biometric indicators.

12. The device according to claim 10, wherein, The identification tag reader includes an RFID reader capable of operating to read RFID identification tags for biometric indicators.

13. The device according to claim 10, wherein, The control module processes the data received through the identification tag reader.

14. The device of claim 10, further comprising a memory operable to store control logic and instructions executed by the control module to drive components such as the sterilizing agent application module and the identification label reader.

15. The device according to claim 14, wherein, The memory is used to store results associated with the setting of the sterilization cycle, the execution of the load conditioning cycle, and / or the execution of the sterilization cycle.

16. The device of claim 1 further includes an output device operable to print information, such as results associated with the setting of a sterilization cycle, the execution of a load conditioning cycle, and / or the execution of a sterilization cycle.

17. The device according to claim 16, wherein, The output device is a printer.

18. An apparatus comprising: (a) Sterilization room; (b) A vacuum source, which is in fluid communication with the sterilization chamber and is configured to apply a vacuum to the sterilization chamber; (c) A module having a sterilizing agent, the module being fluidly connected to the sterilization chamber to allow the application of the sterilizing agent to the sterilization chamber; as well as (d) A vent valve fluidly connected to the sterilization chamber and to the atmosphere outside the sterilization chamber, the vent valve being operable to selectively open and close the ventilation path between the sterilization chamber and the atmosphere to provide a gradual increase in pressure within the sterilization chamber during the application of a sterilizing agent to the sterilization chamber.

19. A system comprising: The device according to claim 18; and Medical devices.

20. The system according to claim 19, wherein, The medical device is an endoscope or multiple endoscopes.

Images