Patent Description:
The proper sterilization of reusable articles for medical use is a critical consideration in preventing transmission of diseases between patients. Sterilization techniques for such articles include those involving high temperature, such as steam and dry heat, chemical sterilants such as ethylene oxide gas and hydrogen peroxide vapour, and irradiation, to name a few. Suitability of any one or more of these techniques for sterilization of an article depends on many factors including, but not limited to, the configuration of the article to be sterilized such as its shape and size, its suitability for liquid immersion, and its material composition.

For medical use articles which include a tubular structure having an internal lumen, sterilization throughout the entire length of the lumen can present difficulties. This can be especially pertinent for articles with relatively long and narrow lumen, and for articles with a plurality of lumen. Endoscopes are one example of such articles where diffusion of sterilant through the entire length of the lumen can present a challenge.

Endoscopes are medical devices which include one or more tubes which can be inserted into a body cavity of a patient, the tube having an internal lumen allowing for various functions such as light transmission for viewing purposes, sample collection from the body cavity, and/or substance delivery to the body cavity. Endoscopes can be of flexible, rigid and semi-flexible form, and include but are not limited to bronchoscopes, colonoscopes, intubation scopes, duodenoscopes, gastroscopes, and sigmoidoscopes. The endoscope tubes may be as long as <NUM> metres and have internal lumen diameters as narrow as <NUM> diameter. Multi-lumen endoscopes may have up to <NUM> lumens. As such, some endoscopes have long and narrow lumen(s) that are difficult to sterilize using known techniques.

Many endoscopes are heat-sensitive articles and so do not lend themselves to sterilization techniques involving high temperatures. Ethylene gas oxide based techniques involve toxic, carcinogen and flammable products, and require lengthy sterilization cycles and so are not ideal. Liquid chemical techniques have a number of disadvantages including a requirement to rinse the chemical residues which can compromise the sterility, and unsuitability for non-immersible endoscope designs. Hydrogen peroxide leaves no toxic residues and can be used for heat and moisture sensitive items but, in the past, has had limited success in sterilizing articles having relatively long and narrow lumen and in sterilizing articles with multi-lumen, particularly those with more than <NUM> lumen.

Furthermore, in certain sterilization techniques, a portion of the article to be sterilized may require a connection to the sterilization apparatus or support within the sterilization apparatus. This can result in occluded connection points between the article and the sterilization apparatus leaving unsterilized areas on the article.

The incomplete sterilization of an article such as an endoscope can be fatal. Reported cases of patient infection with antimicrobial resistant bacteria have been attributed to incomplete sterilization of duodenoscopes. This led to a U. Food and Drug Administration Safety Communication in <NUM> (http://www. gov/MedicalDevices/Safety/AlertsandNotices/ucm454766. htm) recommending supplemental measures to consider when reprocessing duodensoscopes. These measures included the use of sterilizing techniques using a chemical sterilant after cleaning and high level disinfection, as well as microbiological culturing involving sampling duodenoscope lumens and the distal end of the duodenoscope and culturing those samples to identify any bacterial contamination that may be present on the duodenoscope after reprocessing. However, verifying the sterility of each article is expensive and slow, with the article in question requiring quarantine until the test results are obtained.

Therefore, there is a need for an apparatus and a method for sterilizing an article, such as an article with a lumen, e.g. an endoscope, that would reduce, minimize or alleviate one or more of the problems associated with current sterilization methods and apparatus.

It is an object of the present to ameliorate at least some of the inconveniences present in the prior art.

According to an aspect of the present technology, there is provided an apparatus for sterilization of an article, as described in the appended claims.

In certain embodiments of any of the preceding or foregoing aspects, the apparatus further comprises at least one or more of the pump, the sterilant source, and a vaporizer for vaporizing the sterilant.

In certain embodiments of any of the preceding or foregoing aspects, the chamber connector comprises a valve which is configurable between an open and a closed position for fluidly connecting and isolating the first and second chambers. The article connector can be connectable to the second chamber by the chamber connector, or in another manner.

In certain embodiments of any of the preceding or foregoing aspects, the apparatus further comprises a by-pass conduit to fluidly connect the first chamber to the second chamber, separate from the chamber connector, and to selectively allow fluid flow from the second chamber to the first chamber.

In certain embodiments of any of the preceding or foregoing aspects, the inlet is configurable to selectively supply air to the first chamber. The first chamber can further comprise an auxiliary inlet for allowing fluid, such as air, to flow into the first chamber. This can increase the pressure in the first chamber.

In certain embodiments of any of the preceding or foregoing aspects, there is no direct connection from the second chamber to the pump. The fluid path to and from the second chamber may extend only through the first chamber which is connectable to the pump.

In certain embodiments of any of the preceding or foregoing aspects, the container for housing the article, has a container outlet through which the article connector is fluidly connectable to the second chamber, and a container inlet arranged to allow ingress of a sterilant. The container can comprise a box having walls and a lid; and the container inlet can comprise a porous area in at least one of the walls and the lid arranged to allow ingress of the sterilant inside the container and to prevent microbial ingress inside the container. The container further comprises a container connector at the container outlet which is arranged to fluidly connect at least one of the second open end of the article and the article connector, to the chamber connector. The container connector may comprise a valve for preventing fluid communication therethrough when the container connector is disconnected from the chamber connector, or a membrane which is sterilant permeable and microorganism impermeable. In certain embodiments, the container connector comprises an array of container connector ports, each container connector port being fluidly connectable at one end to the article connector and at the other end to the chamber connector.

In certain embodiments of any of the preceding or foregoing aspects, the article comprises a plurality of second open ends, and the apparatus further comprises a plurality of article connectors for connecting at least one of the plurality of second open ends of the article to at least one of the container connector ports. The chamber connector may comprise an array of chamber connector ports, at least one of the chamber connector ports being fluidly connectable to at least one of the container connector port. A conduit may be provided between at least one of the chamber connector ports and a corresponding container connector port. In certain embodiments, at least one of the chamber connector ports has an associated chamber connector valve, the chamber connector valves being separately controllable.

In certain embodiments of any of the preceding or foregoing aspects, the second chamber has a volume which is larger than a volume of the fluid path extending from the first open end of the article, through the lumen of the article and to the chamber connector.

In certain embodiments of any of the preceding or foregoing aspects, the second chamber comprises a plurality of compartments, each one of the plurality of compartments being fluidly connectable to the first chamber through a corresponding one of the chamber connector ports of the chamber connector. At least one of the plurality of compartments may further comprise a by-pass conduit to fluidly connect the first chamber to the at least one of the plurality of compartments of the second chamber. At least one of the plurality of the compartments of the second chamber may have a volume which is larger than a volume of the fluid path extending from the first open end of the article, through the lumen of the article and to the chamber connector.

In certain embodiments of any of the preceding or foregoing aspects, the second chamber comprises a second chamber inlet which is fluidly connectable to a fluid source for supplying fluid to the lumen of the article, which may be through the first or second chamber. The fluid source may be arranged to supply air having a temperature of between about <NUM> and about <NUM>, about <NUM> to about <NUM>, or about <NUM> to about <NUM>.

In certain embodiments of any of the preceding or foregoing aspects, the apparatus further comprises an atmosphere monitoring device for monitoring a parameter of the atmosphere in at least one of the first and second chambers. In certain embodiments, the sterilant is hydrogen peroxide vapour.

In certain embodiments of any of the preceding or foregoing aspects, the second chamber is disposed outside of the first chamber, or at least partially inside the first chamber. The second chamber may be contained within a housing which can be maintained at substantially atmospheric pressure.

In certain embodiments of any of the preceding or foregoing aspects, wherein the article connector comprises a body having a longitudinal axis and an inner surface defining an axially elongate bore extending therethrough, the body having a female portion configured to receive therein the second open end of the article, and a male portion extending from the female portion and configured to be connectable with a portion of the first or second chamber; an annular recessed portion defined in the inner surface of the female portion, the annular recessed portion being axially aligned with the body; at least one annular member which is at least partially receivable in the annular recessed portion; and at least one opening extending through the body to form a fluid communication between the elongate bore and an outer surface of the body.

From a further aspect, there is provided an apparatus for sterilization of an article, the article having a first open end, a second open end and a lumen extending therebetween, the apparatus comprising: a first chamber for receiving the article, the first chamber having an outlet which is fluidly connectable to a pump for adjusting an internal pressure in the first chamber; a sterilant inlet which is fluidly connectable to a sterilant source for supplying sterilant to the first chamber, the sterilant being hydrogen peroxide; and a warm fluid inlet in the first chamber for connection to a fluid source adjusting the temperature of the article in use. In certain embodiments, the fluid source is warm air which is supplied to the first chamber before the article is exposed to the sterilant. In certain embodiments, the first chamber may include an article connector for fluidly connecting the second open end of the article to the warm fluid inlet.

From another aspect, there is provided a kit for retroactively adapting an existing sterilization chamber to the aspects and embodiments of the apparatus described above. In certain embodiments, the existing sterilization chamber is a pressure chamber and the kit comprises a replacement door, wall or panel (hereinafter referred to as 'panel') for the existing sterilization chamber. The panel may comprise any one or more of a second chamber fluidly connectable to a chamber connector, the chamber connector being selectively sealable to fluidly isolate the first and second chambers. The replacement door, wall or panel may also include a by-pass conduit between the existing sterilizaton chamber and the second chamber for further fluidly connecting the first and second chambers separately from the chamber connector. The replacement door, wall or panel may include a fluid connection to a warm air source for warming the lumen of the article.

In certain embodiments of any of the preceding or foregoing aspects, the replacement panel comprises an outer compartment for housing a second pressure chamber, the second chamber being fluidly connectable to a chamber connector which is selectively sealable to fluidly isolate the first and second chambers. The replacement panel may be configured such that when the panel is positioned on the existing sterilization chamber, the outer compartment and the second chamber are disposed inside the existing sterilization chamber.

In certain embodiments of any of the preceding or foregoing aspects, a by-pass conduit can be provided between the existing sterilization chamber and the second chamber for further fluidly connecting the first and second chambers separately from the chamber connector. The replacement panel may include a fluid connection to a warm air source for warming the lumen of the article.

In certain embodiments of any of the preceding or foregoing aspects, an article connector is provided for fluidly connecting a second open end of an article to the chamber connector.

In certain embodiments of any of the preceding or foregoing aspects, the container provided to house the article to be sterilized, can be fluidly connectable to the chamber connector through the article connector.

From a further aspect, there is provided a method for sterilization of an article having a first open end, a second open end and a lumen extending therebetween, the method comprising the steps of: a) providing the article in a first chamber of a sterilization apparatus with the first open end of the article in fluid communication with the first chamber; b) forming a fluid path from the first chamber to a second chamber of the sterilization apparatus through the lumen of the article; c) supplying a sterilant to the first chamber; d) creating a pressure difference between an internal pressure of the first chamber and an internal pressure of the second chamber; and e) allowing the sterilant to flow from the first chamber to the second chamber through the lumen of the article. In certain embodiments, the second chamber is selectively sealable to fluidly isolate the first and second chambers.

From a yet further aspect, there is provided a method for sterilization of an article having a first open end, a second open end and a lumen extending therebetween, the method comprising a) providing a first chamber for receiving the article, and a second chamber fluidly connectable to the first chamber and selectively sealable to fluidly isolate the first and second chambers; b) disposing the article in the first chamber with the first open end in fluid communication with the first chamber, and forming a fluid path from the first chamber to the second chamber through the lumen of the article; c) supplying a sterilant to the first chamber; d) creating a pressure difference between an internal pressure of the first chamber and an internal pressure of the second chamber; and e) allowing the sterilant to flow from the first chamber to the second chamber through the lumen of the article.

In certain embodiments of any of the preceding or foregoing aspects, disposing the article in the first chamber further comprises housing the article inside a container and fluidly connecting the second open end of the article to a chamber connector through a container outlet.

In certain embodiments of any of the preceding or foregoing aspects, allowing the sterilant to flow from the first chamber to the second chamber comprises configuring the chamber connector to allow fluid flow from the first chamber to the second chamber.

In certain embodiments of any of the preceding or foregoing aspects, before supplying the sterilant to the first chamber, the method further comprises reducing the internal pressure of one or more of the first and second chambers.

In certain embodiments of any of the preceding or foregoing aspects, reducing the internal pressure of one or more of the first and second chambers comprises evacuating fluid from one or more of the first and second chambers using a pump fluidly connected to the first chamber, and allowing fluid flow from the second chamber to the first chamber through a by-pass conduit between the first and second chambers. The internal pressures of one or more of the first and second chambers can be reduced to about <NUM> Torr or lower than about <NUM> Torr.

In certain embodiments of any of the preceding or foregoing aspects, creating a pressure difference between an internal pressure of the first chamber and an internal pressure of the second chamber comprises supplying the sterilant to the first chamber until the internal pressure in the first chamber is higher than the internal pressure in the second chamber. Other fluid can also be provided to the first chamber to further increase the pressure, such as air. The air and the sterilant can be provided to the first chamber in any order.

In certain embodiments of any of the preceding or foregoing aspects, a valve in the chamber connector is configured in an open position for allowing the sterilant to flow from the first chamber to the second chamber along the fluid path, during supplying the sterilant to the first chamber to create the pressure difference between the first and second chambers. The allowing of the sterilant to flow from the first chamber to the second chamber can happen at the same time as supplying the sterilant to the first chamber.

In certain embodiments of any of the preceding or foregoing aspects, a valve in the chamber connector is configured in a closed position during the supplying of the sterilant to the first chamber. Fluid such as air can be supplied into the first chamber whilst the chamber connector is closed to increase the internal pressure inside the first chamber to a target pressure, or a target pressure difference between the first and second chambers. The target pressure difference may be more than about <NUM> Torr. about <NUM> Torr to about <NUM> Torr, or about <NUM> Torr to about <NUM> Torr, or any other pressure difference for causing the sterilant to flow from the first chamber to the second chamber. The target pressure may be above about <NUM> Torr and below a pressure of condensation of the sterilant. The fluid, such as air, can be supplied into the first chamber through at least one of an inlet and an auxiliary inlet.

In certain embodiments of any of the preceding or foregoing aspects, wherein after the pressure difference has been created, sterilant is allowed to flow from the first chamber to the second chamber along the fluid path by configuring the valve in the chamber connector in an open position.

In certain embodiments of any of the preceding or foregoing aspects, the chamber connector comprises a plurality of valves fluidly connectable to a plurality of lumens of the article, the method further comprising opening the plurality of valves allowing the sterilant to flow from the first chamber to the second chamber through the plurality of lumens. The plurality of valves can be opened at the same time, individually or in batches.

In certain embodiments of any of the preceding or foregoing aspects, the method further comprises step f) maintaining the article in contact with the sterilant for an exposure interval, and (optionally) exhausting the sterilant from the first and second chambers after the exposure interval has lapsed.

In certain embodiments of any of the preceding or foregoing aspects, steps c) to f) are repeated at least once after the exposure interval has lapsed.

In certain embodiments of any of the preceding or foregoing aspects, the method further comprises monitoring a parameter of the atmosphere inside at least one of the first and second chambers. The parameter can be at least one of a pressure, a temperature and a sterilant concentration.

In certain embodiments of any of the preceding or foregoing aspects, the method further comprising, prior to creating the pressure difference between the internal pressure of the first chamber and the internal pressure of the second chamber, supplying air having a temperature of between about <NUM> and about <NUM> into the lumen of the article.

The article connector for connecting an open end of an article to be sterilized to a sterilization apparatus, comprising: a body having a longitudinal axis and an inner surface defining an axially elongate bore extending between two open ends of the body, the body having first and second portions, the first portion being configured to be fluidly connectable to an open end of the article, and the second portion configured to be fluidly connectable to the sterilization apparatus, the elongate bore extending through the first and second portions and fluidly communicable with a lumen of the article to be sterilized in use; at least one recessed portion defined in the first portion of the body and extending circumferentially around the body for receiving at least one annular member for engagement between the first portion of the body and the article open end in use; and at least one opening extending through the body of the first portion to form a fluid path, through the body, between an outside of the article connector which is in contact with a sterilant in use and a mating surface between the open end of the article and the article connector in use. In certain embodiments, the at least one opening extends from an outside surface of the first portion to the elongate bore.

In certain embodiments, the first portion is a female portion and is configured for receiving the open end of the article in use. The at least one opening can extend from an outside surface of the female portion to the elongate bore. In certain embodiments, there are two openings extending from an outside surface of the female portion to the elongate bore, the two openings being spaced circumferentially from one another. The two openings are associated with a single recessed portion and a single annular member. The at least one annular member may comprise two O-rings, one on either side of the at least one opening. The at least one annular member may be configured to protrude from the recessed portion to space the open end of the article from the inner surface of the body. In certain embodiments, the first portion is a male portion and is configured to be received in the article open end in use. The outside surface of the article connector may be external to the open end of the article, in use.

The article connector for connecting an open end of an article to be sterilized to a sterilization apparatus, the article connector comprising: a body having a longitudinal axis and an inner surface defining an axially elongate bore extending between two open ends of the body, the body having a female portion configured to receive therein the open end of the article, and a male portion extending from the female portion and configured to be fluidly connectable to the sterilization apparatus, the elongate bore extending through the female and male portions; an annular recessed portion defined in the inner surface of the female portion extending circumferentially around the body, the annular recessed portion being configured to at least partially receive at least one annular member; and at least one opening extending through the body of the female portion to form a fluid communication between the elongate bore and an outer surface of the body.

The article connector for connecting an open end of an article to be sterilized to a sterilization apparatus, the article connector comprising: a body having a longitudinal axis and an inner surface defining an axially elongate bore extending between two open ends of the body, the body having a first male portion configured to be received in the open end of the article, and a second male portion extending from the first male portion and configured to be fluidly connectable to the sterilization apparatus, the elongate bore extending through the first male portion towards the second male portion; at least one annular recessed portion defined in an outer surface of the first male portion extending circumferentially around the body, the at least one annular recessed portion being configured to at least partially receive at least one annular member in the at least one annular recessed portion; and at least one opening extending through the body of the first male portion to form a fluid communication between a mating surface of the first male portion and the article open end and an outer surface of the first male portion which is not received in the article open end in use.

In certain embodiments of any of the preceding or foregoing aspects, the article connector further comprises the at least one annular member, wherein the at least one annular member is made of a resilient material. The at least one annular member may be a porous material allowing for ingress of sterilant. The at least one annular member may comprise a body defining a matrix of interconnected pores. The at least one annular member may comprise two O-rings, one on either side of the at least one opening.

In certain embodiments of any of the preceding or foregoing aspects, the at least one annular member is configured to protrude from the recessed portion to space the open end of the article from the inner surface of the body. In certain embodiments, the inner surface defines a shoulder from which the open end of the article is spaced when it is received in the body in use. The at least one opening may comprise a pair of openings. The pair of openings may be associated with a single recessed portion and a single annular member.

In certain embodiments of any of the preceding or foregoing aspects, sterilization of long and narrow lumen can be achieved. Multi-lumen sterilization is made possible, which can be simultaneous or sequential. An article having more than two lumen can be sterilized. Simultaneous sterilization of multiple lumens of an article can translate to time savings within the sterilization cycle. Shorter cycle times are advantageous in that bottle necks for patient treatment may be minimized or avoided.

In certain embodiments of any of the preceding or foregoing aspects, a real-time verification of the flow of sterilant through the article during the sterilization cycle can be obtained by monitoring one or more parameters in the first and/or second chamber which could be reflective of a condition at the second open end of the article i.e. blockage or otherwise in the lumen. These parameters can include pressure, rate of pressure change and sterilant concentration.

In certain embodiments of any of the preceding or foregoing aspects, the ability to use hydrogen peroxide as a sterilant to effectively sterilize articles can avoid the disadvantages associated with other sterilants such as ethylene oxide, which is toxic, expensive, not readily available and requires a longer sterilization cycle to flush the toxic by-products (around <NUM>-<NUM> hours). Furthermore, hydrogen peroxide is considered a 'low temperature' sterilization technique and so avoids the disadvantages associated with heated sterilization methods which can damage the article.

The inventors have noted and overcome certain limitations of hydrogen peroxide as a sterilant which include its vulnerability to condense and therefore reduce its fluid velocity, and its ability to decompose which can result in microenvironments within the load which are depleted of sterilizing agents. In certain embodiments of the present method and apparatus, one or more of the pressure difference used to force the hydrogen peroxide vapour through the article lumen, the pre-warming of the lumen before exposure to the sterilant, and repeated rounds of sterilant exposure helps to minimize or reduce the limitations of hydrogen peroxide as a sterilant.

In certain embodiments of the present article connector, the article connector can be used to connect the article to be sterilized with a sterilization chamber. Occlusion of the outer surface of the portion of the article received in the article connector can be minimized or avoided which in turn can reduce the risk of non-sterilized portions of the article.

Embodiments of the present technology each have at least one of the above-mentioned object and/or aspects, but do not necessarily have all of them. It should be understood that some aspects of the present technology that have resulted from attempting to attain the above-mentioned object may not satisfy this object and/or may satisfy other objects not specifically recited herein.

It must be noted that, as used in this specification and the appended claims, the singular form "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

As used herein, the term "about" in the context of a given value or range refers to a value or range that is within <NUM>%, preferably within <NUM>%, and more preferably within <NUM>% of the given value or range.

As used herein, the term "and/or" is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and/or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

As used herein, the term "container" means any type of receptacle or enclosure for receiving the article to be sterilized. The term "container" is used herein to include sealable boxes with at least one port for allowing sterilant ingress, and wrapped trays with openings, such as baskets, which can allow sterilant ingress.

As used herein, the term "sterilant" means any form of gas, vapour or liquid matter that can kill bacteria and other living microorganisms.

Additional and/or alternative features, aspects, and advantages of embodiments of the present technology will become apparent from the following description, the accompanying drawings, and the appended claims.

Broadly, there is provided an apparatus and a method for sterilization of an article, the article having at least one tubular structure defining a lumen extending through the article. For the purpose of the detailed description below, an endoscope will be used as an example of the article to be sterilized. It will be apparent to those skilled in the art that embodiments of the present apparatus and method are also applicable to other articles requiring sterilization, particularly articles having one or more tubular structures with channels or lumen extending therethrough.

The present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The use of "including", "comprising", or "having", "containing", "involving" and variations thereof herein, is meant to encompass the items listed thereafter as well as, optionally, additional items. In the following description, the same numerical references refer to similar elements. The terms 'channel' and 'lumen' are used interchangeably herein.

Referring to <FIG>, there is illustrated an apparatus <NUM> for sterilization of an article <NUM>. The article <NUM> is an endoscope <NUM> having a tail portion <NUM> and a head portion <NUM>. The tail portion <NUM> of the article <NUM> comprises a tube <NUM> which is configured for insertion into a body cavity, for example, having a flexible form and being sized and shaped to be received in the body cavity. Typically, the head portions of endoscopes known in the art comprise a light guide section and a control section. For clarity, in the present description and drawings, only the control section <NUM> of the endoscope <NUM> is illustrated which comprises a head body <NUM> to which various functional assemblies can be attached through openings <NUM> such as optical devices (not shown), air or water sources (not shown) and biopsy instrumentation (not shown). The flexible tube <NUM> and the head body <NUM> define at least one lumen <NUM> therein (shown as dotted lines), the lumen <NUM> extending between a first open end <NUM> and a second open end <NUM> of the article <NUM>. For clarity, a single lumen <NUM> has been illustrated in dotted lines in <FIG>. However, it will be appreciated that other channels through the article <NUM> are possible, such as from the open end <NUM> of the tube to another one of the openings <NUM> of the head body <NUM>. Certain embodiments of the present apparatus <NUM> are suitable for sterilizing articles <NUM> having lumen <NUM> therein of up to about <NUM> in length and of about <NUM> internal diameter, and in certain embodiments for sterilizing articles <NUM> having lumen <NUM> of about <NUM> internal diameter. It will be appreciated that the apparatus <NUM> is also suited for use with other shapes, sizes and configurations of the article <NUM> as well as for articles without lumen.

The apparatus <NUM> broadly comprises a first chamber <NUM> for receiving the article <NUM> therein. The first chamber <NUM> has an outlet <NUM> fluidly connected to a pump <NUM> which is configured to adjust an internal pressure, P1, inside the first chamber <NUM>, and a sterilant inlet <NUM> which is fluidly connected to a sterilant source <NUM> for supplying sterilant into the first chamber <NUM> to sterilize the article <NUM>. The apparatus <NUM> also comprises a second chamber <NUM> which is separate from the first chamber <NUM> and fluidly connected thereto by a chamber connector <NUM> disposed between the first and second chambers <NUM>, <NUM>. The chamber connector <NUM> is configured to allow fluid flow between the first and second chambers <NUM>, <NUM>, and is selectively sealable to fluidly isolate the first and second chambers <NUM>, <NUM> from one another. The chamber connector <NUM> may comprise a valve, or the like.

The second chamber <NUM> has an internal pressure, P2 which can also be adjusted. The internal pressure, P2, is adjustable by lowering the pressure P1 in the first chamber using the pump <NUM> whilst allowing a fluid flow between the first and second chambers <NUM>, <NUM>. In this embodiment, there is no direct connection between the second chamber <NUM> and the pump <NUM>. An article connector <NUM> is provided which is configured to fluidly connect the second open end <NUM> of the article <NUM> to the second chamber <NUM>, whilst the first open end <NUM> of the article <NUM> remains open and unattached and in fluid communication with an atmosphere of the first chamber <NUM>. The article connector <NUM> can be any suitable adaptor-type device configured to fluidly join together two elements. For example, the article adapter can be of a female-male, male-male or female-female connector type. In this embodiment, the article connector <NUM> has one end which is sized and shaped to fluidly connect to the second open end <NUM> of the article <NUM>, and another end which is sized and shaped to fluidly connect to the chamber connector <NUM>. In <FIG>, the article connector <NUM> is illustrated as having an elongate structure but it will be appreciated that the article connector <NUM> can be of any suitable configuration for connecting the second open end <NUM> of the article <NUM> to the chamber connector <NUM>, to thereby connect the article <NUM> to the second chamber <NUM> through the chamber connector <NUM>. A connection to the second chamber <NUM>, separate from the chamber connector <NUM> is also possible (not shown).

In certain embodiments, a plurality (not shown) of article connectors <NUM> is provided for individually connecting a plurality of second open ends <NUM> of the article <NUM> to the second chamber <NUM>. In these embodiments, the chamber connector <NUM> is configured to be fluidly connectable to the plurality of article connectors <NUM>, and the chamber connector <NUM> can fluidly connect each article connector <NUM> separately or together to the second chamber <NUM>. Any number of article connectors <NUM> can be provided, such as but not limited to more than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>.

When the article <NUM> is positioned within the first chamber <NUM> and connected to the article connector <NUM>, a fluid path extends from the first chamber <NUM> to the second chamber <NUM> through the first open end <NUM> of the article <NUM>, the lumen <NUM> of the article <NUM>, the second open end <NUM> of the article <NUM>, the article connector <NUM> and the chamber connector <NUM>. In use, the article <NUM> to be sterilized is connected as described above to form the fluid path through the lumen <NUM> of the article <NUM>. Sterilant from the sterilant source <NUM> is supplied to the first chamber <NUM> and flows from the first chamber <NUM> into the second chamber <NUM> through the first open end <NUM> of the article <NUM>, and flows through the fluid path including the lumen <NUM> to the second chamber <NUM>, thereby sterilizing an inside of the article <NUM>. The sterilant inside the first chamber <NUM> is in contact with an outside of the article <NUM>, for sterilizing an outside of the article <NUM>.

Still with reference to <FIG>, the first chamber <NUM> is fluidly sealable having walls <NUM> and a door (not shown) allowing access inside the first chamber <NUM> when opened, and sealing of the first chamber <NUM> when closed. The first chamber <NUM> is a pressure chamber which can withstand internal pressures of less than or more than atmospheric pressure, and is made of a material or materials capable of handling stresses caused by a variation of the internal pressure P1 inside the first chamber <NUM>. In some embodiments, the first chamber <NUM> is arranged to withstand internal pressure P1 less than atmospheric pressure, such as a vacuum, for example, less than or equal to about <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr, or <NUM> Torr. The first chamber <NUM> is compatible with the sterilant in that it does not degrade upon exposure to the sterilant, and prevents outgassing thereof. The first chamber <NUM> is made of an aluminium alloy, but other suitable materials could be used.

In this embodiment, the sterilant supplied by the sterilant source <NUM> is hydrogen peroxide (H<NUM>O<NUM>), and the sterilant source <NUM> comprises a reservoir of liquid hydrogen peroxide and a vaporizer (not shown in <FIG>) for vaporizing the liquid hydrogen peroxide. As such, the sterilant provided into the first chamber <NUM> is a vapour comprising fine droplets of liquid hydrogen peroxide. In other embodiments, a gaseous or a liquid sterilant could be used, or a combination of any one or more of gaseous, vapour and liquid sterilants. Other suitable sterilants include, but are not limited to ozone, nitrogen oxide, peracetic acid, chlorine dioxide, and ethylene oxide.

The second chamber <NUM> is fluidly sealable having walls <NUM> and which is arranged to withstand an internal pressure which is a vacuum or lower than atmospheric pressure, for example, about less than or equal to about <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr or <NUM> Torr. The second chamber <NUM> is made of a material or materials capable of handling stresses caused by a variation of the internal pressure P2 inside the second chamber <NUM>, as well as exposure to the sterilant. The second chamber <NUM> is made of an aluminium alloy, but other suitable materials could be used.

As illustrated in <FIG>, the second chamber <NUM> is disposed outside of the first chamber <NUM>. However, in certain other embodiments (not shown), the second chamber <NUM> can be disposed at least partially inside the first chamber <NUM>.

The manner in which the sterilant is caused to flow through the fluid path including the article lumen <NUM> broadly comprises a 'pull' system whereby sterilant is pulled through the open first end <NUM> of the article <NUM> by a pressure difference between the first and second chambers <NUM>, <NUM>. A larger internal pressure P1 of the first chamber <NUM> causes sterilant to flow to the second chamber <NUM> which has a lower internal pressure P2 than the first chamber <NUM>.

A sterilization cycle of the apparatus <NUM> typically comprises two half cycles of sterilant exposure. Each half cycle comprises at least one round of sterilant exposure, and in certain embodiments each half cycle comprises two rounds of sterilant exposure. In a first round of sterilant exposure in the first half cycle, the first chamber <NUM> is fluidly sealed other than an open fluid connection between the first and second chambers <NUM>, <NUM>, and the pump <NUM> is operated to evacuate the atmosphere of the first chamber <NUM> and the second chambers <NUM> through the outlet <NUM> thereby reducing the pressures P1 and P2 in the first and second chambers <NUM>, <NUM> respectively. Once the internal pressures P1 and P2 have reached a desired pressure the first and second chambers <NUM>, <NUM> are fluidly isolated by sealing at least the outlet <NUM>, the connector <NUM>. The desired pressures, P1 and P2, are preferably less than atmospheric pressure and as close as possible to a medium vacuum. For example, the pressures P1 and P2 are reduced to about less than or equal to about <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr, <NUM> Torr; or about <NUM> to about <NUM> Torr, or about <NUM> to about <NUM> Torr.

In a first round of sterilant exposure, sterilant from the sterilant source <NUM> is provided into the first chamber <NUM> through the sterilant inlet <NUM>, to increase the pressure P1 in the first chamber <NUM>. The pressure P1 can be further increased by providing air, or any other fluid, into the first chamber <NUM>. Once the pressure P1 in the first chamber <NUM> is greater than the pressure P2 in the second chamber and/or a predetermined pressure difference is reached, the chamber connector <NUM> is opened to allow fluid flow therethrough. The pressure difference causes the sterilant in the first chamber <NUM> to flow into the second chamber <NUM> through the fluid path (from the first open end <NUM> of the article <NUM>, through the lumen <NUM>, the article connector <NUM>, the chamber connector <NUM> and into the second chamber <NUM>) thereby sterilizing the inside of the article <NUM>. The pressure difference (P1-P2) can be any suitable gradient suitable for causing the sterilant to flow from the first chamber <NUM> to the second chamber <NUM>, and can be adapted according to the dimensions of the article <NUM> and the apparatus <NUM> used. In this embodiment, a pressure difference of about <NUM> Torr is used, but any suitable pressure difference suitable for causing sterilant to flow through the fluid path to the second chamber <NUM> according to the article <NUM> to be sterilized can also be used. In certain embodiments, a suitable pressure difference (P1-P2) is within the range of about <NUM> Torr to about <NUM> Torr, or about <NUM> Torr to about <NUM> Torr. Once an equilibrium is reached between the pressures P1 and P2, the second chamber <NUM> is again isolated from the first chamber <NUM> to avoid a backflow from the second chamber <NUM> to the first chamber <NUM>, and this is maintained for a predetermined exposure time (which is considered to run from the moment of equilibrium pressure). In a second round of sterilant exposure, the first and second chambers <NUM>, <NUM> are again evacuated by the pump <NUM> through the outlet <NUM>, the second chamber <NUM> is fluidly sealed, more sterilant is provided into the first chamber <NUM> from the sterilant source <NUM> through the sterilant inlet <NUM> increasing the pressure P1 in the first chamber <NUM>. Once a predetermined pressure difference is reached between P1 and P2, the sterilant is allowed to flow through the fluid path as before. Once an equilibrium is reached between the pressures P1 and P2, the second chamber <NUM> is again isolated from the first chamber <NUM> and this is maintained for a predetermined exposure time. This marks the end of the first half cycle of the sterilization cycle. This first half cycle can be repeated as required. On completion of the entire sterilization cycle, the first chamber <NUM> is returned to atmospheric pressure and the sterilized article <NUM> removed.

The sterilization cycle may also utilize a 'push' system, either alone or in combination with the 'pull' system described above, whereby as the sterilant is being provided into the first chamber <NUM>, the chamber connector <NUM> is configured to allow sterilant flow into the second chamber <NUM>. The sterilization cycle may include two half cycles described above, and more than or less than the two sterilant rounds in each half cycle as described above.

Referring now to <FIG>, a further embodiment of the apparatus <NUM> is illustrated which differs from the apparatus of <FIG> in that a container <NUM> is provided for housing the article <NUM> (<FIG>, <FIG> and <FIG>). The first open end <NUM> of the article <NUM> is free inside the container <NUM> when housed therein. The container <NUM> is positionable within, and removeable from, the first chamber <NUM>. The container <NUM> is arranged to allow ingress of the sterilant into the container <NUM> and to prevent or minimize microbial ingress into the container <NUM>. In certain embodiments, the container <NUM> maintains the sterility of the article <NUM>, once sterilized, during and after its removal from the first chamber <NUM>.

Referring to <FIG>, the container <NUM> is a box <NUM> having lateral walls <NUM> and a base <NUM> defining a container space <NUM> therein, and a lid <NUM> for selectively restricting and allowing access to the container space <NUM>. Closure means, such as latches <NUM>, are provided for securing the lid <NUM> on the box <NUM>. In other embodiments, other closure means may be provided such as clips, clasps, buckles, ties or the like, or the container <NUM> may not include any closure means. In some embodiments, the lid <NUM> is hingedly connected to one of the walls <NUM> and can move between an open and a closed position, although it will be appreciated that the lid <NUM> can be connectable to the box <NUM> in any other way. A gasket (not shown) can be associated with either the lateral walls <NUM> of the box <NUM> or the lid <NUM> to form a sealing engagement between the box <NUM> and the lid <NUM> when the lid <NUM> is in a closed position. The container <NUM> is made of an aluminium alloy and the gasket is made of VITON™. The container <NUM> and the gasket may be made of any other material compatible with the sterilant to prevent degradation when exposed thereto, such as polymers having a low outgassing rate, e.g. polytetrafluoroethylene (PTFE) or polypropylene (PP).

The container <NUM> further includes a container inlet <NUM> arranged to allow ingress of the sterilant inside the container <NUM> when the lid <NUM> is connected to the box <NUM>. The container inlet <NUM> is a porous area in the lid <NUM>. The porous area comprises an aperture <NUM> formed in the lid <NUM>, which aperture <NUM> is covered with a membrane <NUM> which is sterilant permeable and microorganism impermeable. The membrane <NUM> is a sterilization wrap such as KIMGUARD™, SMARTFOLD™, HALYARD™ or any other comparable material. In certain embodiments, the porous area is formed in one or more of the lateral walls <NUM> or base of the box <NUM> instead of in the lid <NUM>. In certain other embodiments, the container inlet <NUM> comprises an array of openings (not shown) defined in the lid <NUM> and/or in the box <NUM>. The size of the porous area, openings and/or the configuration of the membrane <NUM> can be selected so as to allow ingress of the sterilant inside the container <NUM> at a desired rate.

The container <NUM> also comprises a container outlet <NUM> (<FIG> and <FIG>), such as an opening extending through one of the lateral walls <NUM> of the container <NUM>. A container connector <NUM> is provided at the container outlet <NUM> for connecting the article connector <NUM> to the chamber connector <NUM>. The container connector <NUM> is configured at one end, on an inside of the container <NUM>, to fluidly connect to the article connector <NUM>, via an article conduit <NUM> (<FIG>). The container connector <NUM> is configured at the other end, on an outside of the container <NUM>, to connect to the chamber connector <NUM> (<FIG>).

The container <NUM> includes a removeable tray or a basket (not shown) on which the article <NUM> can lie.

In certain embodiments, there is also provided a vibration mechanism (not shown) for vibrating any one or more of the tray, basket or article <NUM> to avoid or minimize shadowing.

In some embodiments (not shown), the article connector <NUM> is directly fluidly connected to the container connector <NUM> without the article conduit <NUM>. In some other embodiments (not shown), any one or more of the article connector <NUM>, the article conduit <NUM> and the container connector <NUM> forms an integral unit i.e. the integral unit would connect together the article second open end <NUM> to the chamber connector <NUM>.

As best seen in <FIG>, the container connector <NUM> comprises a plurality of container connector ports <NUM>. Each container connector port <NUM> has one end which is inside the container <NUM>, and another end which is outside of the container <NUM>. On the outside of the container <NUM>, the container connector ports <NUM> are illustrated as extending through a raised portion <NUM> of the lateral wall <NUM> (<FIG>), although it will be appreciated that the raised portion is optional. Although <FIG>, <FIG> and <FIG> illustrate a single article connector <NUM> and a single article conduit <NUM>, the apparatus <NUM> is arranged to accommodate articles <NUM> having a plurality of second open ends <NUM>. When the article <NUM> has a plurality of second open ends <NUM> (and hence a plurality of lumen <NUM>), a plurality of article connectors <NUM> are provided, each second open end <NUM> having an article connector <NUM> attached thereto. At least one of the plurality of the container connector ports <NUM> is fluidly connectable to at least one of the plurality of the article connectors <NUM> through a corresponding article conduit <NUM>. In <FIG> and <FIG>, the plurality of container connector ports <NUM> are arranged in an array (e.g. 5x2) but other configurations are also possible. More or less than the ten container connector ports <NUM> shown are possible.

A container conduit <NUM> is provided to fluidly connect the container connector <NUM> to the chamber connector <NUM>. In certain embodiments, the container connector <NUM> includes a valve (not shown) that prevents fluid communication therethrough when the container conduit <NUM> is disconnected from the container connector <NUM>. This helps to avoid or minimize ingress of microorganisms inside the container <NUM> when the container <NUM> is removed from the first chamber <NUM>. In certain embodiments, the valve is replaced by a membrane (not shown) which is sterilant permeable and microorganism impermeable which can help to maintain sterility within the container <NUM> when the container <NUM> is disconnected from the second chamber <NUM>.

Referring to <FIG>, there is shown the chamber connector <NUM>, when viewed through the first chamber <NUM>, at a sterilant outlet <NUM> of the first chamber <NUM> through one of the first chamber walls <NUM>. The chamber connector <NUM> comprises a plurality of chamber connector ports <NUM> which are arranged in an array. Configurations other than the one illustrated are also possible. At least one of the plurality of the chamber connector ports <NUM> is arranged to engage with at least one of the plurality of the container connector ports <NUM>, through the container conduit <NUM>. Inter-engagement between any one of the chamber connector ports <NUM>, container connector ports <NUM> and container conduits <NUM> can be formed in any manner, such as male-female, male-male or female-female connections. The fluid path extends from the first chamber <NUM> to the second chamber <NUM> through the first open end <NUM> of the article <NUM>, the lumen <NUM> of the article <NUM>, the second open end <NUM> of the article <NUM>, the article connector <NUM>, the article conduit <NUM>, the container connector port <NUM> of the container connector <NUM>, the container conduit <NUM> and the chamber connector port <NUM>.

For an article <NUM> having a plurality of open second ends <NUM>, each open second end <NUM> is connected by its dedicated article connector <NUM> to one of the plurality of container connector ports <NUM> of the container connector <NUM> which in turn is connected to one of the plurality of the chamber connector ports <NUM>, through an associated container conduit <NUM>. In this way, a number of parallel fluid paths are therefore defined, all extending from the open first end <NUM> of the article <NUM> then in parallel, through different second open ends <NUM>, to different article connectors <NUM>, container connector ports <NUM>, and chamber connector ports <NUM>.

In certain embodiments (not shown), the connection between at least one of the plurality of the container connector ports <NUM> and at least one of the plurality of the chamber connector ports <NUM> is direct, and not through the container conduits <NUM>. In these embodiments, the fluid path extends from the first chamber <NUM> to the second chamber <NUM> through the first open end <NUM> of the article <NUM>, the lumen <NUM> of the article <NUM>, the second open end <NUM> of the article <NUM>, the article connector <NUM>, the article conduit <NUM>, the container connector ports <NUM>, and the chamber connector port <NUM>. Such parallel fluid paths are defined when the article <NUM> comprises more than one second open end <NUM>, each of which is connected to its own associated article connector <NUM>, its own associated container connector port <NUM> and its own associated chamber connector port <NUM>.

In embodiments not utilizing a container conduit <NUM>, the container <NUM> can be slid into a connecting position directly with the chamber connector <NUM>. For example, a recessed portion (not shown) may be provided around the chamber connection ports <NUM> on the first chamber wall <NUM> which can receive the raised portion <NUM> of the container connector <NUM>.

As seen in <FIG> and <FIG>, each one of the chamber connector ports <NUM> is in fluid communication with an internal volume of the second chamber <NUM> through a manifold <NUM>, and the fluid flow is controlled by a chamber connector valve <NUM> associated with each chamber connector port <NUM>. To facilitate the 'pull' system mentioned above, the internal volume of the second chamber <NUM> is larger than a volume of the fluid path extending between the first open end <NUM> of the article <NUM>, through the lumen <NUM> of the article <NUM> and through to the chamber connector <NUM>.

Each chamber connector valve <NUM> can be selectively configured to control the flow of fluid between the first and second chambers <NUM>, <NUM> through individual chamber connector ports <NUM>. The chamber connector valves <NUM> can be controlled separately from one another to open or close the fluid path between the first chamber and second chambers <NUM>, <NUM> When such embodiments of the apparatus <NUM> are used to sterilize an article <NUM> having a plurality of lumen <NUM>, sequential sterilization of each lumen <NUM> is possible. Sequential sterilization can also enable the detection of a blockage or a fluid leak in each lumen <NUM>, as well as at any part of the fluid path, by monitoring pressure changes during sterilant flow from the first chamber <NUM> to the second chamber <NUM>. In the case of a lumen blockage or restriction, the increase in the pressure P2 in the second chamber during the sterilant flow from the first chamber <NUM> will be less than expected. An automated system can be provided which will raise an alarm responsive to a lower pressure increase rate relative to a predetermined pressure increase rate or range. The target pressure increase rate can be predetermined based on the make and model of the article <NUM> being sterilized. In the same way, a fluid connection of the article lumen <NUM> to the apparatus <NUM> can be tested by comparing a measured overflow rate with a target flow rate. In other embodiments, the chamber connector valves <NUM> can be operated to provide simultaneous sterilization of the plurality of lumen <NUM> of the article <NUM>.

A by-pass conduit <NUM> (<FIG> and <FIG>) is provided at a by-pass inlet <NUM> of the first chamber <NUM>, the by-pass conduit <NUM> having a by-pass valve <NUM>. The by-pass conduit <NUM> fluidly connects the first and second chambers <NUM>, <NUM>, in a connection which is distinct from the chamber connector <NUM>. When the chamber connector valves <NUM> are closed, the by-pass conduit <NUM> allows evacuation of the second chamber <NUM> through the first chamber <NUM> without having fluid flow through the fluid path running through the chamber connector port <NUM>, the container connector port <NUM>, the article connector <NUM> and the article <NUM>. In certain embodiments, the by-pass conduit <NUM> reduces the time required to reduce the pressure P2 in the second chamber <NUM> and to achieve the required pressure difference between the first and second chambers <NUM>, <NUM>.

As can also be seen in <FIG> and <FIG>, the apparatus <NUM> comprises a number of other valves for controlling fluid movement in and out of the apparatus <NUM>. An outlet valve <NUM> is provided between the pump <NUM> and the outlet <NUM> of the first chamber <NUM> to control the fluid connection between the pump <NUM> and the first chamber <NUM>, the outlet valve <NUM> being configurable between an open and a closed position. A sterilant valve <NUM> is provided at the sterilant inlet <NUM> for controlling a flow of the sterilant from the sterilant source <NUM> into the first chamber <NUM> through a sterilant vaporizer <NUM>. A vent valve <NUM> is provided in an auxiliary inlet <NUM> in the first chamber <NUM> to allow fluid to flow into the first chamber <NUM> to increase the internal pressure P1 in the first chamber <NUM>, and optionally to allow fluid to flow in and out of the first chamber <NUM> to vent the first chamber <NUM>. In some embodiments, the sterilant inlet <NUM> further comprises an air valve <NUM> to supply air to the first chamber <NUM> to adjust the internal pressure P1. A filter (not shown) such as a hepa filter can be provided in either or both of the sterilant inlet <NUM> and the auxiliary inlet <NUM>.

It is contemplated that the air valve <NUM> and the vent valve <NUM> can be used alone or in combination to adjust the pressure P1 of the first chamber <NUM>. Accordingly, the air valve <NUM> and the vent valve <NUM> may be provided with different sensitivities of fluid flow such that, for example, the vent valve <NUM> can provide a coarse control of the flow of fluid into the first chamber <NUM>, and the air valve <NUM> can provide a finer control of the fluid flow into the first chamber <NUM>.

When the vent valve <NUM> and the air valve <NUM> are closed, the pump <NUM> can be operated, through the outlet valve <NUM> when it is in the open position, to reduce the internal pressure P1 of the first chamber <NUM>. Opening the by-pass valve <NUM> will also allow reduction of the internal pressure P2 of the second chamber <NUM>. When the desired pressure P1 is reached, the outlet valve <NUM> and the by-pass valve <NUM> can be closed to maintain the pressure P1 in the first chamber <NUM> and the pressure P2 in the second chamber <NUM>. A pressure differential can be created between the first and second chambers <NUM>, <NUM> by at least one of: allowing sterilant to flow into the first chamber <NUM> through the sterilant inlet <NUM>, allowing air to flow into the first chamber <NUM> through one or both of the sterilant inlet <NUM> and the auxiliary inlet <NUM>. The chamber connector valve(s) <NUM> can then be opened which causes sterilant to flow into the container <NUM> and in through the first open end <NUM> of the article <NUM> and follow the fluid path (shown as arrows in <FIG>), namely through lumen <NUM>, through the second open end <NUM>, through the article connector <NUM>, through the container connector <NUM> (if there is a container connector <NUM>), through the chamber connector conduit <NUM>.

A first atmosphere monitoring device <NUM> is fluidly connected to the first chamber <NUM> through a first instrumentation inlet <NUM> for monitoring a parameter of the atmosphere inside the first chamber <NUM>, and a second atmosphere monitoring device <NUM> is fluidly connected to the second chamber <NUM> through a second instrumentation inlet <NUM> for monitoring a parameter of the atmosphere inside the second chamber <NUM>. The first and/or second monitoring devices <NUM>, <NUM> can monitor one or a combination of different parameters, such as, but not limited to, pressure, temperature and sterilant concentration. In some embodiments, only one atmosphere monitoring device is fluidly connected to either one or the other of the first and second chambers <NUM>, <NUM>. By monitoring a pressure in the second chamber <NUM>, for example, a blockage in the fluid path can be detected which can be indicative of an incomplete sterilization. Monitoring a sterilant concentration in the second chamber <NUM>, for example, may provide an indication of sterilization efficacy.

The second chamber <NUM> further comprises a second chamber inlet <NUM> (<FIG>) and inlet valve <NUM> through which warmed fluid can be provided. In this embodiment, the fluid is air and the second chamber inlet <NUM> is fluidly connectable to an air source <NUM> arranged to supply air to the second chamber <NUM> having a temperature of between about <NUM> and about <NUM>, about <NUM> to about <NUM>, or about <NUM> to about <NUM>. The air source <NUM> can provide air having any suitable temperature to allow an atmosphere inside the article lumen <NUM> to warm up to between a room temperature and up to a temperature which does not adversely affect the stability of the article <NUM>, such as about <NUM> in the case of endoscopes. The provision of a warmed fluid to the second chamber <NUM> and through the fluid path, particularly before sterilant flows through the fluid path, can minimize or reduce condensation of the sterilant within the article <NUM> including the lumen <NUM>, in certain embodiments.

It is to be noted that the present technology extends to the provision of warmed fluid, such as air, to the lumen of an article to be sterilized by H<NUM>O<NUM> in an apparatus which differs from the apparatus <NUM> described herein. For example, an apparatus comprising a first chamber for receiving the article, the first chamber having an outlet which is fluidly connectable to a pump for adjusting an internal pressure in the first chamber; a sterilant inlet which is fluidly connectable to a sterilant source for supplying sterilant to the first chamber, the sterilant being hydrogen peroxide; and a warm fluid inlet in the first chamber for connection to a fluid source adjusting the temperature of the article in use. In certain embodiments, the fluid source is warm air which is supplied to the first chamber before the article is exposed to the sterilant. In certain embodiments, the first chamber may include an article connector for fluidly connecting the second open end of the article to the warm fluid inlet.

Referring now to <FIG>, an alternative embodiment of the apparatus <NUM> is shown. The apparatus of <FIG> differs from that of <FIG> in that the second chamber <NUM> comprises a plurality of compartments <NUM> in communication with the manifold <NUM>. Although eight compartments <NUM> are shown, any number of compartments <NUM> may be provided in the second chamber <NUM>. Each compartment <NUM> is in fluid communication with a corresponding chamber connector valve <NUM> through the manifold <NUM>. Alternatively, each chamber connector valve <NUM> could be connected to a number of different compartments <NUM>. Each compartment <NUM> is also fluidly connected to the by-pass conduit <NUM> by its corresponding by-pass valve <NUM>. In this embodiment, each compartment <NUM> has a volume which is larger than the volume of a fluid path between the first open end <NUM> of the article <NUM> through an individual lumen <NUM> of the article <NUM> through to the chamber connector valve <NUM>. Instead of a single atmospheric measurement device <NUM>, a plurality of atmospheric measurement devices (not shown) could be fluidly connected to each compartment <NUM> to measure parameters within each compartment <NUM>, or the atmospheric pressure device <NUM> could be selectively fluidly connected to each compartment <NUM>. Although the second chamber inlet <NUM>, second chamber inlet valve <NUM> and the air source <NUM> are not shown in <FIG>, they may also be included in the apparatus <NUM> of this embodiment. As in the embodiments of <FIG>, the lumen <NUM> can be warmed before exposure to the sterilant to avoid sterilant condensation by providing warm air into the second chamber <NUM> and allowing the warm air to flow into the lumen <NUM> through the chamber connector valves <NUM>.

Referring now to <FIG>, an alternative embodiment of the apparatus <NUM> is shown. The apparatus of <FIG> differs from that of <FIG> in that the pump <NUM> is additionally fluidly connected to the second chamber <NUM> through a second chamber outlet <NUM> including an outlet valve <NUM> to selectively control the flow of fluid from the second chamber <NUM> towards the pump <NUM>. Unlike the embodiments of <FIG>, in the embodiment of <FIG>, a direct connection is provided between the pump <NUM> and the second chamber <NUM> allowing evacuating of the second chamber <NUM> directly and not through the first chamber <NUM>. A by-pass connector and valve is not required in this embodiment and the first and second chambers <NUM>, <NUM> can be evacuated at the same time or at different times. In this embodiment, when the outlet valve <NUM> is open to allow evacuation of the second chamber <NUM>, the fluid connection of the second chamber <NUM> to the first chamber <NUM> is closed i.e. the chamber connector valves <NUM> are closed. Once the first and second chambers <NUM>, <NUM> are evacuated to the desired pressure, sterilant is provided into the first chamber <NUM> and once the desired pressure difference (P1-P2) is achieved, the chamber connector valve(s) <NUM> are opened and the sterilant is pulled into the open first end <NUM> of the article <NUM> and flows through the fluid path to sterilize the article <NUM>. As before, the lumen <NUM> can be warmed before exposure to the sterilant to avoid sterilant condensation by allowing warm air to flow into the second chamber <NUM> through the inlet <NUM> and into the lumen <NUM> through the chamber connector valves <NUM>.

Referring now to <FIG>, an alternative embodiment of the apparatus <NUM> of <FIG> is shown, in which the second chamber <NUM> comprises a plurality of compartments <NUM> fluidly connectable to the manifold <NUM> (as also shown in the embodiment of <FIG>). However, instead of eight compartments <NUM>, the second chamber <NUM> of <FIG> comprises four compartments <NUM>, each compartment <NUM> being connected to an associated chamber connector valve <NUM>. Each compartment <NUM> has an associated second chamber outlet <NUM> and outlet valve <NUM> to fluidly connect each compartment <NUM> to the pump <NUM>. In this configuration, each compartment <NUM> can be evacuated individually and/or simultaneously. This can be performed at the same time as the first chamber <NUM> evacuation by the pump <NUM>. Although not shown, each compartment <NUM> can also be provided with its own inlet (not shown) for supplying warmed fluid to the second chamber <NUM> and then into the article <NUM> through the fluid path to warm the article <NUM> before sterilization for minimizing or reducing condensation within the article <NUM>. Alternatively, the inlet for supplying warm air can be provided into the manifold <NUM>.

In <FIG>, the apparatus <NUM> differs from the apparatus of <FIG> and <FIG> in that the second chamber <NUM> is disposed inside the first chamber <NUM>. Together with the manifold <NUM>, chamber connector ports <NUM>, by-pass conduit <NUM> and by-pass valve <NUM> and monitoring device <NUM>, the second chamber <NUM> is contained within a sealable outer compartment <NUM>, which can maintain an atmospheric pressure within, and which has an outlet <NUM> through the first chamber wall <NUM>. The chamber connector ports <NUM> fluidly connect with the manifold <NUM> through the outer compartment <NUM>.

In <FIG>, the apparatus <NUM> differs from that of <FIG> in that the second chamber <NUM> is directly connected to the pump <NUM> through the outlet <NUM>.

In <FIG>, the apparatus <NUM> differs from the apparatus <NUM> of <FIG> in that the outer compartment <NUM> is directly fluidly connectable to the container <NUM>. In this embodiment, the container connector ports <NUM> and the chamber connector ports <NUM> are integrated (and labelled as <NUM>/<NUM> in <FIG>) in that a single connector is provided which can connect the article second open end <NUM> to the second chamber <NUM>. There is no container conduit <NUM>. The article connector <NUM> connects the second open end <NUM> of the article <NUM> to the article conduit <NUM> which is directly connectable to the connector port <NUM>/<NUM>.

<FIG> shows an alternative embodiment to that of <FIG>. In the apparatus <NUM> of <FIG>, the second chamber <NUM> is directly connected to the pump <NUM>.

In further alternative embodiments (not shown), the second chamber <NUM> may have multiple compartments <NUM> as previously illustrated in <FIG> and <FIG>.

For any one of the embodiments of the present apparatus <NUM>, a kit (not shown) may be provided for retroactively converting an existing sterilization chamber into embodiments of the present apparatus <NUM>. The kit may comprise a replacement door or wall for the existing sterilization chamber, the door or wall including any one or more of the features shown in the present drawings and described herein, including but not limited to the chamber connector <NUM>, chamber connector ports <NUM>, chamber connector valves <NUM>, second chamber <NUM>, atmosphere monitoring device <NUM>, by-pass inlet <NUM>, by-pass conduit <NUM> and by-pass valve <NUM>, warm air source <NUM>, warm air inlet <NUM>, container <NUM>, article connector <NUM>, container connectors <NUM>, container connector ports <NUM>, article conduit <NUM> and outer compartment <NUM>.

A method <NUM> for sterilization of the article <NUM> having the first open end <NUM>, the second open end <NUM> and the lumen <NUM> extending therebetween will now be described with reference to <FIG>. The method <NUM> can be operated, but is not limited to, using any one of the embodiments of the apparatus <NUM> as described herein or as illustrated in <FIG>.

In a step <NUM>, the method <NUM> comprises disposing the article <NUM> in a first chamber <NUM> of the sterilization apparatus <NUM> with the first open end <NUM> in fluid communication with the first chamber <NUM>.

In a step <NUM>, the method <NUM> comprises forming a fluid path from the first chamber <NUM> to a second chamber <NUM> of the sterilization apparatus <NUM> through the lumen <NUM> of the article <NUM>. In other words, in step <NUM>, the method <NUM> comprises forming a direct fluid path from the first open end <NUM> of the article <NUM>, through the lumen <NUM> of the article <NUM> and the second open end <NUM> to the second chamber <NUM> through the chamber connector <NUM>. The second chamber <NUM> is selectively sealable to fluidly isolate the first and second chambers <NUM>, <NUM>.

In a step <NUM>, the method <NUM> comprises supplying sterilant to the first chamber <NUM>.

In a step <NUM>, the method <NUM> comprises creating a pressure difference between the internal pressure P1 of the first chamber <NUM> and an internal pressure P2 of the second chamber <NUM>.

In a step <NUM>, the method <NUM> comprises allowing the sterilant to flow from the first chamber <NUM> to the second chamber <NUM> through the lumen <NUM> of the article <NUM>.

The method <NUM> will now be described in more detail. In step <NUM>, disposing the article <NUM> in the first chamber <NUM> further comprises housing the article <NUM> inside a container <NUM>.

In step <NUM>, forming the fluid path comprises fluidly connecting the second open end <NUM> of the article <NUM> to the second chamber <NUM>, for example via any one or more of the article connector <NUM>, container connector <NUM> and chamber connector <NUM>.

Before step <NUM>, the internal pressure of one or more of the first and second chambers <NUM>, <NUM> is reduced to less than <NUM> Torr or lower, such as between <NUM> Torr and <NUM> Torr. This can be performed using the pump <NUM> through the outlet <NUM>. The second chamber <NUM> is evacuated through the first chamber <NUM> through the chamber connector <NUM> (as illustrated in <FIG>), or through the by-pass conduit <NUM> (as illustrated in <FIG>).

Before step <NUM>, warm air can be supplied into the second chamber <NUM>, having a temperature of between about <NUM> and about <NUM>, about <NUM> to about <NUM>, or about <NUM> to about <NUM>, such as through the second chamber inlet <NUM>.

In step <NUM>, creating the pressure difference between the internal pressure P1 of the first chamber <NUM> and the internal pressure P2 of the second chamber <NUM> comprises supplying the sterilant to the first chamber <NUM> until the internal pressure P1 in the first chamber <NUM> is higher than the internal pressure P2 in the second chamber <NUM>. In this respect, sterilant is allowed to flow from the first chamber <NUM> to the second chamber <NUM> along the fluid path, for example by configuring the chamber connector valve <NUM> in an open position. This can happen at the same time as supplying the sterilant to the first chamber <NUM>. Alternatively, the pressure P1 in the first chamber <NUM> can be allowed to build up by configuring the chamber connector valve <NUM> in a closed position during the supplying of the sterilant to the first chamber <NUM>. The pressure difference between P1 and P2 can be further increased by supplying air into the first chamber <NUM>, such as through the sterilant inlet <NUM> or the auxiliary inlet <NUM> of any one of <FIG>. In one embodiment, air is supplied firstly through the auxiliary inlet <NUM>, then through the sterilant inlet <NUM>. The internal pressure P1 can be increased until a target pressure difference (P1-P2) is reached, such as more than about <NUM> Torr, about <NUM> Torr to about <NUM> Torr, or about <NUM> Torr to about <NUM> Torr, or any other pressure difference for causing the sterilant to flow from the first chamber <NUM> to the second chamber <NUM>.

In step <NUM>, the chamber connector valve <NUM> is configured in an open position to allow the sterilant to flow from the first chamber <NUM> to the second chamber <NUM>. When there are a plurality of chamber connector ports <NUM> each having its associated chamber connector valve <NUM> (as illustrated in <FIG>), and each of the chamber connector ports <NUM> being fluidly connected to each one of a plurality of lumen <NUM> of the article <NUM>, the chamber connector valves <NUM> are configured in an open position to allow the sterilant to flow from the first chamber <NUM> to the second chamber <NUM> through the plurality of lumen <NUM>. The chamber connector valves <NUM> can be opened at the same time, individually or in batches. The chamber connector valves <NUM> close after reaching an equilibrium in pressure. The article <NUM> is then maintained in contact with the sterilant for an exposure interval. After the exposure interval has lapsed, during which time the article is exposed to the sterilant, the first and second chambers <NUM>, <NUM> are exhausted once more, such as through the outlet <NUM> by the pump <NUM>. In this embodiment, steps <NUM> to <NUM> are then repeated to complete a first half-cycle, but a single exposure or more than <NUM> exposures may also be possible. A full sterilization cycle comprises two such half-cycles. At the end of the full sterilization cycle, the container <NUM> is disconnected from the first chamber <NUM>. This can help to ensure sterility. Alternatively, the container outlet <NUM> can comprise one or more valves (not shown) automatically closing after the sterilization cycle is completed and prior to the opening of the first chamber <NUM>. The closing of the one or more valves may be triggered by a pressure change or by a command. The sterilization cycle may be at least partially automated.

A parameter of the atmosphere in the first or the second chamber <NUM>, <NUM> can be monitored at any time throughout the method <NUM>. For example, in one embodiment, various parameters of the atmosphere in the second chamber <NUM> are monitored using the atmosphere monitoring device <NUM> as the sterilant is flowing through the article lumen <NUM> into the second chamber <NUM>. These parameters include a pressure, which can indicate a blockage in the lumen <NUM> and/or a sterilant concentration to provide an indication of the efficacy of the sterilization process. On detection of a reduced pressure or a reduced concentration of the sterilant below a pre-set value, the method if it is automated may stop automatically, or an alarm be raised.

Certain embodiments of the technology are illustrated by the following nonlimiting example.

An embodiment of the apparatus <NUM> according to <FIG> and <FIG> was used to sterilize an article <NUM> comprising a tube made of PTFE of <NUM> length having a lumen <NUM> extending therethrough with an internal diameter of approximately <NUM>. The article <NUM> was placed in the container <NUM> which was a tray wrapped in a sterile wrap made of polypropylene and having pores which allowed ingress of sterilant (see Example <NUM> below). One end of the tube was connected to the container <NUM> using the article connector <NUM>, and the article connector <NUM> was connected to the second chamber <NUM>. Sterility was assessed in one location (the most challenging site) at the end of the <NUM> tube next to the second chamber <NUM>, by placing a biological indicator consisting of <NUM>×<NUM><NUM> Bacillus Stearothermophilus spores inoculated on a stainless steel wire inside the lumen <NUM>. The sterilization cycle of <FIG>, in which steps <NUM> to <NUM> were repeated two times (equivalent to one half-cycle), was applied to the apparatus <NUM> using H<NUM>O<NUM> vapour as the sterilant. At the end of the sterilization cycle, the stainless steel wire was retrieved from the lumen <NUM> of the tube and cultured in growth medium for <NUM> days, and the spore viability was assessed by an indication of turbidity by visual evaluation. The test was repeated <NUM> times. A positive control comprised an inoculated stainless steel wire in a lumen which was not sterilized. A negative control comprised a sterile uninoculated stainless steel wire incubated in growth medium. A growth media sterility control was also performed. The results (average of <NUM> repeats) are shown in Table <NUM>.

The results showed that the apparatus and the method effectively sterilized the article when compared to a positive and a negative control.

An article connector <NUM> will now be described with reference to <FIG>. The article connector <NUM> can be used with any other sterilization apparatus or system requiring a removeable fluid connection between an end of an article to be sterilized and the sterilization apparatus or a portion of a sterilization apparatus. The article connector <NUM> can be considered as a type of adaptor for fluidly connecting an article to be sterilized to a sterilization apparatus or a portion of a sterilization apparatus. For example, the article connector <NUM> can be used with the apparatus <NUM> and the method <NUM> as illustrated in any one of <FIG>, as the article connector <NUM>, but its use is not limited as such.

Referring initially to <FIG>, the article connector <NUM> is fluidly and removably connectable to an article <NUM> to be sterilized. The article <NUM> is an endoscope <NUM> having a tail portion <NUM> (shown partially in <FIG>) and a head portion <NUM>, but can be any other article requiring sterilization. The tail portion <NUM> of the article <NUM> comprises a tube (not shown) which is configured for insertion into a body cavity, for example, having a flexible form and being sized and shaped to be received in the body cavity. The head portion <NUM> comprises a head body <NUM> to which various functional assemblies can be attached through openings such as optical devices (not shown), air or water sources (not shown) and biopsy instrumentation (not shown). The flexible tube and the head body <NUM> define at least one lumen <NUM> therein (<FIG>), the lumen <NUM> extending between a first open end <NUM> and a second open end <NUM> of the article <NUM>.

As best seen in <FIG> and <FIG>, the article connector <NUM> has a body <NUM> with a bore <NUM> defined therein by an inner surface <NUM> of the body <NUM>, the bore <NUM> extending between a first end <NUM> and a second end <NUM> of the article connector <NUM>, the first and second ends <NUM>, <NUM> being open. The article connector <NUM> and the bore <NUM> have a longitudinal axis <NUM>.

The body <NUM> comprises a female portion <NUM> at the first end <NUM> and a male portion <NUM> at the second end <NUM>, aligned along the longitudinal axis <NUM>. The elongate bore <NUM> extends through the female and male portions <NUM>, <NUM>. The female portion <NUM> of the body <NUM> is configured to receive therein the second open end <NUM> of the article <NUM>. The male portion <NUM> extends from the female portion <NUM> and is configured to be connected to the sterilization apparatus, such as the article conduit <NUM> of <FIG>. A distal tip <NUM> of the male portion <NUM> is flanged on an outer surface <NUM> of the body <NUM>. This configuration may assist in retention of the male portion <NUM> of the article connector <NUM> in a corresponding opening (not shown) of the sterilization apparatus to which it is to be fluidly connected. The female and male portions <NUM>, <NUM> are substantially cylindrical, with the female portion <NUM> having an outer diameter <NUM> which is larger than an outer diameter <NUM> of the male portion <NUM>. An inner diameter <NUM> of the bore <NUM> is also larger in the female portion <NUM> than in the male portion <NUM> of the body <NUM>. Inside the body <NUM>, at the junction of the female and male portions <NUM>, <NUM>, the inner surface <NUM> defines a transverse shoulder <NUM> from which the second open end <NUM> of the article <NUM> is spaced when received in the body <NUM>, in use.

A plurality of openings <NUM> are defined in the body <NUM>, each opening <NUM> extending through the body <NUM> between the inner and outer surfaces <NUM>, <NUM> to form a fluid communication between the bore <NUM> and the outer surface <NUM> of the body <NUM>. The openings <NUM> are spaced circumferentially around the body <NUM>. In <FIG>, there are three openings <NUM> visible (with one of the openings being partially visible). However, it will be appreciated that more or less than three openings <NUM> extending through the body <NUM> may be provided. In <FIG>, the cross-section through the body <NUM> is taken along the line A-A shown in <FIG>.

In the female portion <NUM>, the inner surface <NUM> has two recessed portions <NUM>, which are annular and extend circumferentially about the body <NUM> and axially aligned with the body <NUM>. The two recessed portions <NUM> are axially spaced apart from one another. Each recessed portion <NUM> is channel-like and configured to at least partially receive an annular member <NUM>. Instead of the two recessed portions <NUM>, the article connector <NUM> may have one annular recessed portion <NUM> or more than two annular recessed portions <NUM> (not shown).

Each annular member <NUM> is made of a resilient material and is sized and shaped to allow contact between an outer surface <NUM> (<FIG>) of the article second open end <NUM> when the article second open end <NUM> is received in the female portion <NUM>. This can aid in retention and/or alignment of the article second open end <NUM> in the bore <NUM> of the female portion <NUM> in use. The annular member <NUM> may be made of a non-porous compatible material, such as VITON™. The annular member <NUM> may have an interconnected porous structure allowing for ingress of sterilant, and can be made of any open cell material such as porous silicon, porous PTFE, synthetic rubber such as VITON™, or any other compatible material.

Each corresponding annular member <NUM> and recessed portion <NUM> is configured so that at least a portion of the annular member <NUM> protrudes out of the recessed portion <NUM> in use, i.e. when the article second open end <NUM> is in position in the female portion <NUM>, at least a portion of the annular member <NUM> protrudes out of the recessed portion <NUM> and spaces the outer surface <NUM> of the article second open end <NUM> from the inner surface <NUM> of the body <NUM>. In use, this configuration can provide a continuous fluid path around the second open end <NUM> of the article <NUM> received in the female portion <NUM>. The continuous fluid path is defined by a space between the outer surface <NUM> of the article second open end <NUM> and the inner surface <NUM> of the female portion <NUM> of the body <NUM>, and a fluid path through the interconnecting pores through at least a portion of the annular member <NUM>.

In use, when the article connector <NUM> is fluidly connected to the article second open end <NUM>, a sterilant such as hydrogen peroxide can be caused to flow through the lumen <NUM> of the article <NUM> and through the bore <NUM> of the article connector <NUM>. As the sterilant flows through the bore <NUM> of the article connector <NUM> as well as being present around the outside of the article <NUM>, the outer surface <NUM> of the article second open end <NUM> is also sterilized. Therefore, according to certain embodiments of the article connector <NUM>, occluded areas of the article <NUM> which are received within the article connector <NUM> which the sterilant cannot contact are minimized or avoided.

<FIG> shows an alternative embodiment of the annular member <NUM> of <FIG>, wherein the annular member <NUM> has lateral sides <NUM> which are sealed which can force fluid flow (indicated by the arrows) through the unsealed sides <NUM> to contact the outer surface <NUM> of the article second open end <NUM>.

<FIG> show another embodiment of the article connector <NUM>, which differs from the article connector <NUM> of <FIG> in that a pair of openings <NUM> is provided extending through the body <NUM> instead of a single opening <NUM>. Instead of a recessed portion <NUM> which is associated with a single one of the openings <NUM>, in this embodiment, the single annular recessed portion <NUM> is associated with the pair of openings <NUM>. A single annular member <NUM> is provided in the recessed portion <NUM> and is in fluid communication with the pair of openings <NUM>. This configuration can be better suited for smaller article connectors <NUM> in which the use of two separate annular members <NUM> such as o-rings or disks may not be possible. As with the embodiment of <FIG>, the annular members can be porous.

<FIG> show another embodiment of the article connector <NUM>, which differs from the article connector <NUM> of <FIG> in that the female portion <NUM> of <FIG> is a male portion <NUM> in <FIG> and is arranged to be inserted inside the article lumen <NUM>. The recessed portion <NUM> and the annular members <NUM> are located on the outer surface <NUM> of the article connector <NUM>, allowing insertion inside the article second open end <NUM>. A single annular recessed portion <NUM> and annular member <NUM> may be provided instead of the two shown. The openings <NUM> extend from the outer surface <NUM> of the male portion <NUM> through the body <NUM> and extend to a portion of the article connector <NUM> which will be in contact with the sterilant in use. The openings <NUM> are positioned between the recessed portions <NUM> and arranged to allow ingress of the sterilant to a mating surface between the annular members <NUM>, thus exposing the mating surface to sterilant when in use. As before, the annular members <NUM> can be porous.

Claim 1:
An apparatus (<NUM>) for sterilization of an article, the article having a first end (<NUM>), a second end (<NUM>) and a lumen (<NUM>) extending between the first end and the second end, the apparatus comprising:
a first chamber (<NUM>) having:
an outlet (<NUM>) configured to be fluidly connected to a pump (<NUM>) for adjusting an internal pressure in the first chamber; and
an inlet (<NUM>) configured to be fluidly connected to a sterilant source (<NUM>) for supplying sterilant to the first chamber;
a container (<NUM>) configured to house the article, the container being sized and shaped to be receivable in the first chamber, the container having:
a container inlet (<NUM>) arranged to allow ingress of the sterilant from the first chamber, and
a container outlet (<NUM>) comprising a container connector port (<NUM>), the container connector port being configured to fluidly connect to the lumen at the second end of the article when the article is housed in the container;
a second chamber (<NUM>) configured to be fluidly connected to the container outlet when the container is received in the first chamber, the second chamber comprising a chamber connector port (<NUM>) configured to fluidly connect to the container connector port to form a fluid path extending from the first chamber to the second chamber through the lumen of the article when the article is housed in the container and the container is received in the first chamber; and
a valve (<NUM>) between the second chamber and the container outlet, the valve being configurable between an open position and a closed position for fluidly connecting and isolating the first and second chambers respectively.