MXPA98006874A - Multip compartment sterilization system - Google Patents

Abstract

The present invention relates to: An apparatus for sterilizing a medical device includes a multi-chamber compartment having at least one first rigid chamber and a second rigid chamber therein, each of the first and second chamber being adapted to serve independently as a sterilization chamber and can be operated independently, the apparatus also has a removable interface between the first and second chambers, the interface can have an opening to receive a lumen device in such a way that the first and second chambers are put in fluid communication through the lumen, a source of sterilant is also included in the apparatus, this source is adapted to supply the sterilizer in the first and / or second chambers, sealed containers with a permeable membrane can be used in the apparatus. gas, but impermeable to microorganisms so that the sterility of the devices in the container is maintains after completing a sterilization cycle

Description

STERILIZATION SYSTEM OF MULTIPLE COMPARTMENTS BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The invention relates to systems used for chemical sterilization of medical devices and very particularly to systems having multiple chambers that are used for chemical sterilization of medical devices.

DESCRIPTION OF THE RELATED TECHNIQUE Medical instruments have traditionally been sterilized using either heat »- as supplied by means of steam» or a chemical compound »in a gas or vapor state. It has been shown that sterilization using hydrogen peroxide vapor has some advantages over other chemical sterilization processes. The combination of hydrogen peroxide with a plasma provides certain additional advantages "as described in the patent of E.U.A. No. 4 »643» S7ß, issued on February 17, 1987 to Jacobs and others »patent of E.U.A. No. 4 »75S» 88Z > issued on July 12, 1988 also to Jacobs et al. "describes the use of hydrogen peroxide vapor» generated from an aqueous solution of hydrogen peroxide »as a precursor to the reactive species generated by a plasma generator. The combination of hydrogen peroxide vapor diffusing into close proximity to the article to be sterilized and the plasma acts to sterilize the articles and remove the residual hydrogen peroxide. However, effective sterilization of articles having narrow and long lumens is very difficult to achieve because the methods depend on the diffusion of steaming vapor into close proximity to the article before sterilization can be achieved. Thus, it has been found that these methods require a high concentration of sterilizer, a prolonged exposure time and / or high temperatures when using narrow and long lumens. For example »lumens over 27 cm and / or having an internal diameter of less than 0.3 cm have been particularly difficult to sterilize. Therefore »the sterilization of articles containing narrow and long lumens present a special challenge. The patent of E.U.A. No. 4,744,951 to Cummings et al. "Discloses a two-chamber system that provides hydrogen peroxide in the form of steam for use in sterilization processes. The ester is initially vaporized in one chamber and then applied to the object to be sanitized in another individual stellate chamber producing a vapor of concentrated hydrogen peroxide which is relatively more effective. The sterilization processes are designed to provide concentrated hydrogen peroxide vapor to interior surfaces of articles having a tortuous or narrow path. However, sterilization procedures are ineffective for rapidly sterilizing lumen devices since they depend on the diffusion of hydrogen peroxide to the lumen to effect sterilization. The patent of E.U.A. No. 4,797,285 to Hatanaka et al. Describes a two-chamber sterilization and filling system consisting of a single sterilization chamber adjacent to a germ chamber which is used to dry and fill sterilized containers. The patent of E.U.A. No. 4 »8S3» 6BT of Schott et al. Discloses a sterilization system consisting of a liquid hydrogen peroxide vaporization chamber and a housing for sterilization. The housing may also include containers in which sterile hydrogen peroxide vapor does not contact the interior of the containers. This system is designed to control the exposure to hydrogen peroxide vapor. The system is not designed to sterilize a device with lumen. The patent of E.U.A. No. 4, 952, 370 of Cu mings et al. Discloses a sterilization process in which the aqueous hydrogen peroxide vapor first condenses on the article to be sterilized and then a vacuum source is applied to the chamber of sterilization. sterilization to evaporate water and hydrogen peroxide from the article. This method is suitable for sterilizing surfaces; however, it is not effective in the rapid sterilization of devices with lumen, since it depends too much on the diffusion of hydrogen peroxide vapor to the lumen to effect sterilization. The patents of E.U.A. Nos. 4 »937» 046, 5 »118» 471 and »227,132 of Anderson and others describe» each »a sterilization system using ethylene oxide gas for sanitation purposes. The gas is initially in a small housing and then slowly enters a second housing where the objects to be sterilized are located. A medium is then introduced into the second housing to flush the sterilizing gas to a third housing containing the second housing. An exhaust system then expels the sterilizing gas and air from the third housing. These systems also have the drawback of relying on the diffusion of the sterilizing vapor to effect sterilization and therefore are not suitable for rapidly sterilizing devices with lumen. The patent of E.U.A. No. 5,132,444 to Schoegner describes a chemical sterilizing system for sterilizing articles by vaporizing a chemical sterilant in a sterilizing chamber. The pre-evacuation of the sterilization chamber increases the sterilization activity. The sterilizer is injected into the sterilizing chamber from a second prefilled chamber. This system is also based on the diffusion of sterilizing steam to effect sterilization and is also not suitable for rapidly sterilizing devices with lumen. The patent of E.U.A. No. 5,2GG »275 by Faddis, describes a sterilization system for disinfecting instruments. The sterilization system contains a first sterilization chamber and a second secondary safety chamber. The secondary safety chamber provides detection and ventilation to a destruction chamber of any sterilization agent that is released from the primary sterilization chamber. This system, as in other systems, is also based on the diffusion of sterilizing steam to effect sterilization and is also not suitable for rapidly sterilizing devices with lumen. In the patents of E.U.A. Nos. 5,492,672 and 5'556 »S07 by Childers et al. Are a method and apparatus for sterilizing narrow lumens. This method and apparatus uses a sterilizing vapor of multiple components and requires successive alternating periods of sterilizing steam flow and discontinuance of said flow. A complex apparatus is used to achieve the method. Further »the method and apparatus of 'S72 and' 607 require maintaining the pressure in the sterilization chamber at a predetermined subatmospheric pressure. In the patent of E.U.A. No. 5,527, 508 of Chders et al., Describes a method for increasing the penetration of chemical vapor sterilants under a low vapor pressure into openings and openings of complex objects. The method repeatedly introduces air or an inert gas into the closed sterilization chamber in an amount effective to raise the pressure to a subatmospheric pressure to propel the diffused sterilizing vapor into the article in order to achieve sterilization. The Childers inventions of the '508, TS72 and' S07 patents are similar in that all three require repeated pulsations of sterilizing steam flow and maintenance of the pressure of the sterilization chamber at a predetermined subatmospheric pressure. In the patent of E.U.A. No. 5,534,221 to Hi 11 ebrenner et al., Describes a device and method for sterilizing and storing an endoscope or other medical device with lumen. The device includes a sealable cartridge in which the endoscope or other medical device is placed. The cartridge has an inlet port for receiving a sterilizing agent through a connector, an outlet port for ejecting the sterilizing agent when a vacuum is applied thereto through a connector »and passage valves in the ports inlet and outlet to open the ports when the connectors are attached to the ports and to seal them when the connectors are removed from the ports in such a way that after the endoscope has been sterilized, it remains sterilized inside the cartridge until it is opened. The method of the invention of '221 involves placing the medical device inside the cartridge and coupling the device to either the inlet or outlet port of the cartridge. The cartridge is then placed in an outer container in the form of an oven or heating chamber where the temperature is properly maintained. Connections are made to open the inlet and outlet ports in the cartridge such that the sterilizing agent can be introduced through a first port to bathe the exterior of the medical instrument or other object, such as an endoscope "while the end of the hollow object, such as the endoscope, is coupled to the outlet port where an external vacuum is supplied to the cartridge to pull the sterilization agent into the cartridge and through the interior passages of the endoscope. When the sterilization is completed, the heating chamber is opened and the sterilization cartridge is simply removed from the chamber by decoupling the inlet and outlet ports from their respective sources. An airtight seal is maintained and the object remains in the sterilized interior of the cartridge until it is opened or until the device is going to be used. Therefore »the invention of '221 refers to providing a means by which a sterilized medical device can be retained within a cartridge in which it was sterilized until it is ready to be used» thus avoiding any contamination by exposure to the atmosphere or by handling before use. Further »in some cases of the invention of '221, wherein the lumen of the device to be sterilized is connected to the exit port, particularly where the device has narrow and long lumens» the time to expel the sterilizing agent through of the lumen and out of the cartridge can be desirably long. Also »in the case where the device with lumen is very flexible» crushing of the lumen can occur, thus making it slower or avoiding the vapor leak or damaging the lumen. The patents of E.U.A. Nos. 5,445,792 and 5,508,009 to RicKloff et al. Each describe a sterilization system essentially equivalent to the system described in '221 of Hillebrenner. The patent of E.U.A. No. 5, 43,801 of Langford teaches a portable piece / sterilization apparatus and a method for external / external sterilization of medical / dental instruments. The appliance avoids the use of heat, pressure, severe agitation or corrosive chemical compounds that could damage delicate equipment. This invention uses ozone gas or ozone solution as a sterilizer. It does not include the use of sterilizing steam or vaporization of a sterilizing solution in steam, and is not suitable for operations under vacuum since flexible bags or containers are used. Considering the above »in the prior art there is no simple, safe and effective method of sterilizing small lumens. Therefore »there remains a need for a simple and effective method of steam sterilization of articles with narrow and long lumens as well as larger and shorter lumens. In addition, there is also a need for a simple and effective sterilization system with cameras operating independently.

BRIEF DESCRIPTION OF THE INVENTION One aspect of the present invention relates to a multi-compartment sterilization apparatus for sterilizing a medical device. The apparatus comprises a multi-chamber compartment having at least a first rigid chamber and a second rigid chamber, an interface that can be opened and closed between the first and second chambers and a source of sterilizer adapted to provide the sterilizer. in the first and / or second chambers "wherein each of the first and second chambers can be operated independently as a sterilization chamber. The apparatus may further comprise a flow path between the first and second chambers. Preferably, the interface is removable. In a modality »the interface can be opened and closed because it is removable. The apparatus may further comprise a gas sterilizing and gas permeable container impermeable to microorganisms, either in the first or in the second chamber, and the device to be sterilized is placed inside the container. The container serves to maintain the sterility of the device after sterilization. The device to be sterilized can be placed either in the first chamber or in the second chamber. In one embodiment, each of the first and second cameras provides an environment restricted to diffusion. In another embodiment, the first chamber and the second chamber have a first and a second door sellab! is, respectively, and the second sealable door is smaller than the first door and is located within the first door. In one embodiment the interface has at least one opening, wherein the device to be sterilized comprises a lumen and the lumen of the device is placed through the opening such that the lumen is partially located in each of the first and second cameras. The opening may form a gas-tight seal around the lumen or may form a loose fit seal around the lumen allowing the sterilant to flow out of the lumen through the opening or may form an airtight seal around the lumen in the lumen. The seal consists of a material permeable to gases and / or liquids. An opening without a lumen can be provided at the interface. In one mode »the flow path is inside the multi-chamber compartment. Preferably »the flow path allows flow in both directions. The flow path is preferably through a lumen device. In another mode, the flow path is outside the multi-chamber compartment, allowing flow in both directions. The apparatus may also comprise a second flow path in addition to the first flow path. In a »mode the second flow path is outside the multi-chamber compartment and the first flow path is at the interface. In another embodiment, the first flow path is within the multi-chamber compartment and the second flow path is outside the multi-chamber compartment. The source of sterilant is preferably selected from the group consisting of an injector, a device that passes the flow of liquid from one side to another, a reservoir of liquid or solid or aerosol spray device. The esterifier source is preferably placed at a site selected from the group consisting of: the first chamber; the second chamber »a container placed in the multi-chamber sterilization compartment; a housing placed inside the multi-chamber sterilization compartment. In one embodiment, the housing is connected to one of the first and second chambers, or to the first and second chambers. In another embodiment, the housing is connected to the container. The source of sterilizer can be a reservoir of liquids. The sterilant can include a liquid »a solid or condensed vapor. The liquid ester is preferably comprised of hydrogen peroxide or peracetic acid. The sterilant can be a solid complex of hydrogen peroxide. The hydrogen peroxide complex preferably comprises a complex of urea peroxide or a complex of sodium pyrophosphate peroxide or a similar complex. In one embodiment, the sterilizer is condensed vapor comprising hydrogen peroxide or peracetic acid vapor. The flow system can comprise a vacuum pump to apply vacuum, a pump to circulate the sterilizer »or pressurization induced by heat. The apparatus may also comprise at least one additional interface. The apparatus may further comprise a heater for vaporizing the ester. The apparatus may also comprise a plasma generator for exposing to a plasma the device to be sterilized. The plasma generator can be located in a separate container and the apparatus can further comprise a flow system for flowing said plasma into the multi-chamber compartment. In one embodiment, the opening in the interface is provided with an iris diaphragm. In another mode »the opening is defined by two plates. The plates have compressible material at the edges or on surfaces adjacent to the opening "and at least one of the plates is movable. In yet another embodiment, the opening is equipped with inflatable material so that when this material is inflated, the opening is reduced to contain and seal a device to be sterilized. Another aspect of the present invention relates to a method for sterilizing a medical device. The method for sterilizing the interior and exterior of a lumen device comprises: a) placing the device sn in a multi-chamber compartment having a first chamber, a second chamber and an interface with at least one opening, such that the lumen is partially in the first chamber and partially in the second chamber through the interface; b) introducing a sterilant from a source of sterilizer into the multi-chamber compartment; and c) creating a flow of sterilant between the first chamber and the second chamber through the lumen. Prior to the laying step, the device can be placed in a sterile vapor permeable container impervious to microorganisms, the container maintains the sterility of the device after sterilization. A device without a lumen can be sterilized in either the first or second chamber. The placement step may also include the steps of removing the interface; Replace the interface with a different interface to accommodate a different lumen. In one embodiment, one or both of the first and second chambers is an environment restricted to diffusion. The sizes of the first and second camarse are different. The method may further comprise placing the lumen in the opening such that the lumen is partially located in each of the first and second chambers. The opening can form a gas-tight seal around the lumen or can form a loose fitting seal around the lumen allowing the sterilant to flow out of the lumen through the opening, or it can form an airtight seal around the lumen. the seal being made of a material permeable to gases and / or liquids. The interface can have an opening without a lumen. The flow path can be inside the multi-chamber compartment allowing flow in both directions. In addition to the flow path, the method can comprise flowing sterilant through a second flow path. In one embodiment, the first flow path is within the multi-chamber compartment and the second flow path is outside the multi-chamber compartment. The source of sterilant can be placed in a site selected from the group consisting of: the first chamber; the second camera; a container in which the container is placed in the multiple chamber sterilization compartment; a housing positioned outside the multi-chamber sterilization compartment, wherein the housing can be connected to one of the first and second chambers, or to the first and second chambers, or to the container. In one embodiment, the source of sterilant can be liquid reservoir. The sterilant may include a liquid, a solid or condensed vapor. In one embodiment, the sterilant is a liquid comprising hydrogen peroxide or peracetic acid. In another embodiment, the sterilant is a solid complex of hydrogen peroxide. The solid may comprise a complex of urea peroxide or a complex of sodium pyrophosphate peroxide or a similar complex. In another embodiment, the sterilant is condensed vapor, the method further comprising condensing steaming vapor. Preferably, the condensed vapor is hydrogen peroxide or peracetic acid vapor. A flow system comprising a vacuum pump, a pump for circulating sterilizer or heat-induced pressurization can be used to achieve the flow path. The method may further comprise the step of exposing the device to a plasma. The plasma can be generated in a separate container and the method further comprises the step of flowing the plasma from the container to the first or second sterilization chamber. The method may further comprise heating the device to be sterilized before step (b). The device to be heated can be heated with an applied electric field. Preferably, the device is heated to a pressure below atmospheric pressure. Steps (b) and (c) can be repeated one or more times. Step (a) may further comprise the steps of: opening the opening in 1 to interface; inserting the device through the opening such that the device is partly in the first chamber and partly in the second chamber; and then closing the opening in such a way that a seal is formed around the device. Step (a) may also comprise placing the device through the opening equipped with an iris diaphragm that can seal around the device; or place the device through the opening defined by two plates, the plates have compressible material at the edges or on the surfaces of the plates adjacent to the opening, at least one of the plates is movable so that the plates can be taken one to another to contain and seal 1S around the device; or place the device through the opening equipped with inflatable material so that when this material is inflated the opening is reduced to contain and seal around the device. In one embodiment, step (a) comprises positioning the device through an opening equipped with an expandable material, and expanding the expandable material with compressible material, and compressing the compressible material to seal around the device. In a preferred embodiment, the device with lumen to be sterilized is an endoscope. In another fashion, the lumen has at least two ends and the lumen crosses the interface through the opening between the ends. Another aspect of the present invention relates to a method for sterilizing a medical device. The method comprises the steps of: a) placing the device in a multi-chamber compartment having a first rigid chamber, a second rigid chamber and a removable interface between the first and second chambers; b) adjusting the interface so that a device too large to fit in the first or second chamber can be sterilized in a larger chamber formed by the first and second chambers; and c) introducing a sterilizer from a source of sterilant into the multi-chamber compartment. Prior to the placement step, the device is placed in a vapor permeable, sterile container impermeable to microorganisms. The container maintains the sterility of the device after sterilization.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic diagram of one embodiment of the apparatus of the present invention showing two separate chambers with a sealable interface; Figure 1A is a schematic diagram of one embodiment of the apparatus of the present invention showing the interface, doors and two cameras; Fig. 2 is a schematic diagram of one embodiment of the apparatus of the present invention showing two chambers separated by an intterface and in fluid communication through a lumen device; Figure 3 is a schematic diagram of one embodiment of the apparatus of the present invention showing a camera positioned within another chamber; Figure 4 is a schematic diagram of one embodiment of the apparatus of the present invention showing a camera within another chamber with the lumen connecting the two chambers; Figure 5 is a schematic diagram of one embodiment of the apparatus of the present invention showing two chambers containing containers; Figure 6 is a schematic diagram of one embodiment of the apparatus of the present invention showing two chambers containing containers and which are connected through a lumen; Figure SA is a cross-sectional view of the system of Figure S. Figure 7 is a schematic diagram of one embodiment of the apparatus of the present invention showing a container in separate chambers with an interface.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY The multi-compartment sterilization apparatus of the present invention is suitable for the sterilization of devices without lumen and with lumen. According to one aspect of the present invention, the multi-compartment sterilization apparatus comprises at least two chambers separated by a sealable and removable interface. Each of the chambers can be operated independently and can serve as a sterilization chamber. In a sterilization method using the apparatus of the present invention, the interface can be adjusted for different situations. For example, if the device to be sterilized is too large to fit in either of the two chambers, the interface can be removed so that more space is available to accommodate the device. If the device is not so large, it can be sterilized in one of the two cameras while other devices can be prepared to be sterilized in the other chamber. According to another aspect of the present invention, the multi-compartment sterilization apparatus comprises a sterilization system with a multi-chamber compartment having at least one rigid first chamber and a second rigid chamber with an interface that can be opening and closing between the first and second chambers »a flow path between the first and second chambers» and a source of sterilant adapted to provide the sterilant in the first and / or second chambers. The flow path can be a lumen of the device to be sterilized, so that the sterilant can flow directly through the lumen to sterilize the interior of the lumen device. Different sterilization methods and technologies can be used in connection with the sterilization system of the present invention. Several modalities of these methods are described below.

METHOD FOR SUPPLYING A PREDETERMINED AMOUNT OF LIQUID STERILIZER In the present invention, conventional sterilants can be used. Numerous sterile before are available in the art such as ormaldehyde, ethylene oxide, hydrogen peroxide solution and hydrogen peroxide vapor. Although any of these sterilizers can be used in the sterilization apparatus of the present invention, the use of hydrogen peroxide solution and hydrogen peroxide vapor has been shown to have certain advantages over other chemical sterilization processes. Therefore, it is preferred to use hydrogen peroxide solution and hydrogen peroxide vapor as the sterilant in the present invention. In a sterilization process using hydrogen peroxide solution as a sterilizer, the latter can be applied in several different ways. For example, a hydrogen peroxide solution can first be vaporized under vacuum and / or heat in a vacuum chamber, and the device to be sterilized is then exposed to the hydrogen peroxide vapor. Accordingly, in one embodiment of the present invention, an important parameter of the process that is needed to achieve satisfactory sterilization is the amount of liquid hydrogen peroxide that enters the chamber to be vaporized. In this way, it is important that the liquid hydrogen peroxide is supplied to the chamber in dosed quantities. A sterilization apparatus capable of dispensing a predetermined quantity of liquid sterilant can be incorporated into the sterilization system of the present invention. Thus, the sterilization chamber can have a bottom wall with at least one cavity defining a known volume. The cavity is located so that when a liquid sterilant is introduced into the lower surface a known volume of the liquid sterilant fills the cavity and when the liquid ester is drained from the surface the known volume of liquid sterilant remains in the cavity whereby a subsequent sterilization process can be performed on the device on the bottom surface with the known volume of liquid sterilant within the lower surface. The apparatus may also include a heat source and / or a vacuum source to vaporize the liquid sterilant in the cavity and optionally may include a plasma source. The lower surface preferably has at least one perforation for draining the liquid sterilizer from the lower surface. The cavity formed in the lower surface can be curved, flat or angular. In this way, the cavity can be a hemispherical projection extending inwardly. The cavity may also be formed on the lower surface as an inwardly extending rectangular projection having rounded ends. The cavity formed in the lower surface can also be a rectangular box with side walls »defining an opening. Where perforations are provided, they may be arranged adjacent to the cavity, and may have an approximately spherical shape. The projection extending upwards may include a perforation therein, which may be on top of the projection or on one side of the projection. The lower surface may be a sloping surface, a convex or concave surface or a V-shaped surface. The lower surface may be a variety of materials including stainless steels, aluminum, aluminum alloys, liquid crystal polymers, polyesters, polymers of polyolefin or fluorinated polyolefins. If the lower surface is composed of a mixed material, this may include a high thermal conductivity filler. Examples of mixed materials include a metal filled polymer, a ceramic filled polymer and a gas filled polymer. These materials are also suitable for the side walls and doors of the sterilization chamber.

METHOD BASED ON ENVIRONMENTS RESTRICTED TO DISSEMINATION A method of steam sterilization of hydrogen peroxide to sterilize diffusion-restricted environments can also be used in connection with the present invention. In this embodiment of the present invention, devices (with or without a lumen) to be sterilized are pretreated with a hydrogen peroxide solution and then exposed to pressures less than the vapor pressure of the sterilizer. The interior of the lumen is sterilized taking advantage of environments restricted to diffusion within the lumens. As used here, an area "restricted to" * 23"diffusion" refers to any one or more of the following properties: 1) the area capacity of an article placed within the sterilization system of the present invention to retain 0.17 mg / l or more of a hydrogen peroxide solution after one hour at 40 ° C and 10 torr; 2) having the same or more diffusion restriction as that provided by a single inlet / outlet port of 9 mm or less in internal diameter and 1 cm or more in length; > which has the same or more restriction on diffusion than that provided by a lumen of 27 cm in length and having an internal diameter of 3 mm; 4) the same or more diffusion restriction as that provided by a lumen that has a length ratio with respect to the internal diameter greater than 50; 5) the capacity of an article placed within the sterilization system of the present invention to retain 17% or more of the hydrogen peroxide solution placed therein after one hour at 40 ° C and 10 torr; or S) that is sufficiently restricted to diffusion to completely sterilize a stainless steel blade inside a glass tube 2.2 cm by SO cm having a rubber stopper with a stainless steel outlet tube of 1 mm by 50 cm in a vacuum of 10 torr for one hour at 40 ° C according to the present invention. It is recognized that characteristics (1) and (5) will vary depending on the initial concentration of hydrogen peroxide placed within the article; however, this can easily be determined by one skilled in the art.

In this embodiment of the present invention, a method for sterilizing an interior of a device with an area restricted to diffusion, such as a device having a lumen, is used in connection with the sterilization system. The method includes the steps of contacting the interior of the device with a liquid solution comprising hydrogen peroxide, and exposing the device to negative pressure for a period sufficient to effect complete sterilization. In one embodiment, the liquid solution is peracetic acid. If the exposure step is conducted for 1 hour at 40 ° C and the diffusion-restricted area retains 0.17 mg / l at 40 ° C, and the area restricted to diffusion retains 0.11% or more of hydrogen peroxide placed therein after the exposure step. In some preferred embodiments, the area restricted to diffusion has the same or more restriction to diffusion as that provided by a lumen of 27 cm in length and an internal diameter of 3 mm or has the same or more diffusion restriction than that provided by a lumen having a length ratio with respect to the internal diameter greater than 50. The solution is preferably at a concentration of less than 25% by weight. The contact step can be carried out by means of a method such as injection »static soaking» liquid flow from one side to another or aerosol spray. In a preferred embodiment, the area restricted to diffusion is a lumen of at least 27 cm in length and having an internal diameter of no more than 3 m, most preferably having an internal diameter of not more than 1 mm. The exposure step is preferably carried out for 60 minutes or less, and is preferably carried out at a pressure less than the vapor pressure of the hydrogen peroxide. In this way, the preferred pressure scale under conditions of the present invention is between 0 and 100 torr. In a particularly preferred embodiment, the pressure is about 10 torr and the exposure step is conducted at a temperature of about 23 ° C to about 28 ° C. The exposure step may include the step of heating the article »such as by heating the chamber in which the exposure step occurs. The chamber can be heated to a temperature of about 40 ° C to about 45 ° C. Alternately the solution can be heated, such as at a temperature of about 40 ° C to about 45 ° C. Optionally, the exposure step of the device to a plasma can be conducted during the exposure step of the negative pressure device. In a modality that employs plasma exposure, the method is performed within a first chamber and the plasma is generated in a second chamber, separately. This embodiment also includes the step of flowing the pllas to the first chamber. Advantageously, the contact and / or exposure steps of the method can be repeated one or more times.

METHODS OF STERILIZATION IN ENVIRONMENTS NOT RESTRICTED TO DISSEMINATION The present invention can also be used to sterilize devices with lumens without relying on a diffusion-restricted environment. The inventors have discovered that similar sterilization results can be created to those created in environments restricted to diffusion by controlling the evacuation speed of the chamber in which the articles to be sterilized are placed. Thus »in one embodiment of the present invention» a method for sterilizing a device can be used in combination with the sterilization system of the present invention. The method comprises the steps of contacting the device with liquid sterilant outside or inside the sterilization chamber at a first pressure; place the device in the camera before or after the contact step; and reducing the pressure of the chamber to a second pressure below the vapor pressure of the liquid sterilant in which at least a portion of the decrease in pressure below the vapor pressure of the liquid sterilant occurs at a pressure of descending pumping of less than 0.8 liters per second »calculated based on the time required to evacuate the chamber from atmospheric pressure to 20 torr when the chamber is empty and dry» that is, when the chamber has sterilization articles or a visible amount of liquid inside it. According to one aspect of the preferred embodiment, at least the decrease in pressure below approximately twice the vapor pressure of the liquid sterilant occurs at a downstream pumping speed of less than O.8 liters per second. According to another aspect of this embodiment, the decrease in pressure below approximately four times the vapor pressure of the liquid sterilant occurs at a descending pumping rate of less than 0.8 liters per second. Preferably, the downstream pumping speed is 0.6 liters per second or less; very preferred, 0.4 liters per second or less; and most preferably still 0.2 liters per second or less. Advantageously, the first pressure is atmospheric pressure. Preferably, the liquid sterilizer is hydrogen peroxide. In another aspect, the device is a medical instrument that has a lumen. The present invention can also use a method for sterilizing a device comprising the steps of: a) contacting the device with liquid sterilant outside or inside a sterilization chamber at a first pressure; b) placing the device in the chamber before or after the contact step; c) pumping the chamber down to a second pressure that is less than the first pressure at a first speed; and d) pumping the chamber downwardly to a third pressure that is less than the second pressure "wherein at least a portion of the pumping downstream of the third pressure is at a second speed that is less than the first speed. The pumping speed either above and / or below the second pressure can be constant or varibale. In some embodiments, the downward pumping speed either above and / or below the second pressure is reduced as steps. Preferably, the second pressure is greater than or equal to about the vapor pressure of the liquid ester; most preferably, the second pressure is greater than or equal to about twice the vapor pressure of the liquid sterilant; most preferably, the second pressure is greater than or equal to about four times the vapor pressure of the liquid sterilant. Advantageously »the downward pumping speed in step d) is 0.8 li / second or less; very advantageously from O.S liters / second or less; very advantageously still 0.4 liters / second or less; and very advantageously still 0.2 liters / second or less »calculated based on the time required to evacuate the atmospheric pressure chamber to 20 torr under empty and dry conditions. Preferably, the liquid ester is liquid hydrogen peroxide. In another aspect of this embodiment, the device is a medical instrument that has a lumen. Preferably the downward pumping of step c) reduces the pressure to less than about three times, very preferably to less than about twice the vapor pressure of the liquid sterilizer. Another suitable method includes contacting the article with liquid sterilizer either inside or outside the sterilization chamber "placing the device in the chamber either before or after the contact passage" and reducing the pressure of the chamber while regulating the descending pumping rate to control the vaporization rate of the sterilant in said chamber. In any of the methods described above, the contact step may comprise the application of liquid or condensed vapor. These methods described above may further comprise reevarying the chamber to remove residual sterilant. Furthermore, these previously described methods may also comprise exposing the device to plasma to remove residual sterilant or to increase the sterilization efficiency. The contact step in these methods can be by direct or indirect contact. As indicated below, indirect contact involves the introduction of sterilant into the chamber without direct contact of the article to be sterilized. In another embodiment, a two-step descending pumping sterilization process can be used in connection with the sterilization system of the present invention. The method comprises the steps of: contacting a device with a liquid sterilizer outside or inside a sterilization chamber »placing the device in the chamber before or after the contact passage» bringing the pressure of the chamber to a first scale of pressure at which the liquid sterilant is vaporized from the area not restricted to diffusion to sterilize the area not restricted to diffusion bring the pressure of the chamber to a second pressure scale at which the liquid sterilizer is vaporized from the area restricted to diffusion to sterilize the area restricted to diffusion »where the minimum pressure at 1 to the second pressure scale is less than the maximum pressure at the first pressure scale. Preferably »the first pressure scale is from 20 to 760 torr, most preferably» the first pressure scale is from 20 to 50 torr; most preferably still, the first pressure scale is 40-90 torr. Advantageously, the second pressure scale is 1-30 torr; very advantageously »the second pressure scale is 5-10 torr. In one aspect of this preferred embodiment, the device includes the environment restricted to diffusion. Preferably, the device is a medical instrument with a lumen having an interior surface and an exterior surface. Advantageously, the sterilant is hydrogen peroxide. According to another aspect of this preferred embodiment, the chamber is at a fixation temperature and wherein the first pressure is greater than the vapor pressure of the sterilant at the fixation temperature. Preferably, the pressure of the chamber is kept constant at the first pressure for a period sufficient to sterilize the area not restricted to diffusion. Advantageously, the pressure of the chamber is kept constant at the second pressure for a sufficient time to sterilize the area restricted to diffusion. The chamber pressure may be allowed to increase after reaching the first or second pressure scale as a result of vaporization of the sterilant within the chamber. At the same time, the pressure of the chamber is reduced after reaching the first or second pressure by pumping said chamber at a slower speed than that used to reduce the pressure between the first and second pressure scales. Preferably "the contact step is with liquid or condensed vapor. The method may also include the steps of: bringing the pressure to a third pressure lower than the second pressure to remove residual sterilant and / or exposing the device to plasma to remove residual sterilant or increase the sterilization efficiency.

METHOD THAT INVOLVES DIRECT FLOW THROUGH A LUMEN OF DEVICES THAT ARE TO BE STERILIZED In accordance with the present invention, a sterilization apparatus is provided which can more efficiently sterilize devices with narrow and long lumens by flowing a sterilant, either in a liquid phase or in a vapor phase, directly through the lumens of devices with lumen that have to be sterilized. The flow of a sterilant (solution or vapor) through a lumen of a medical device is accomplished by a pressure drop between two ends of the lumen. The pressure drop can be generated by applying either a vacuum or a high pressure at one end. By generating a forced flow through a pressure differential other than that based on diffusion, the sterilization rate increases significantly and less time is needed for a sterilization cycle. It is clear from the above discussion that the two ends of the lumen need to be exposed to a pressure difference. This is achieved in the present invention by placing a sealable interface between the two chambers. An opening is provided at the interface and the lumen device to be sterilized is placed within the opening such that the lumen serves as a flow path between the two chambers. The opening can be constructed in several ways. One way to achieve this is with a camera shutter approach that reads an iris diaphragm, such as a precision iris diaphragm from Ed und Scientific. An optional spring can be used to ensure closure of the shutter. Another way to achieve an acceptable opening is to employ two plates "where the area between the two plates has a compressible material" such as a rubber material. The lumen device can be placed between the two plates and the two plates can be moved together to form a seal impervious to gases and vapor around the lumen device. Optically »a porous material such as sponge or air permeable material can be used as the compressible material. In this case »some sterilant can flow between the compressible material and the lumen device. However, most of the sterilizer flows through the lumen device. Yet another acceptable interface is a horizontal hole or opening for one or more lumen devices, said hole or opening being inflatable with gas or liquid so that when inflating the inflatable material in the opening or opening the lumen devices are contained and sealed. Yet another option is to place compressible material on top of an inflatable material to facilitate sealing around the dis to facilitate sealing around the lumen device. The movement to close and open the aperture such as the plate and the iris diaphragm can be controlled mechanically or electronically with any conventional mechanism. It is sealed to a different degree between the opening and the lumen device depending on the desired purpose. For example, the opening may form a gas-tight seal around the lumen device so that nothing can flow out of the lumen device through the opening; or can form a loose fitting seal around the lumen device allowing the sterilant to flow out of the lumen device through the opening whereby the exterior of the lumen device adjacent to the opening can be sterilized; or it can form a tight fit with a porous material, such as a gas and / or liquid permeable membrane around the lumen device so that the gas and ester can pass and meanwhile the porous material helps contain the lumen device . The interface can be made openable, lockable and removable. A flow path between different chambers can also be provided outside the sterilization system. In order to promote sterilization efficiency, all the sterilizing apparatuses of the present invention can be equipped with a heater, vacuum and / or a plasma. The present invention is also described in connection with the following drawings. In the following Figures, the same numbers refer to equal parts in all the drawings. Referring to Figure 1, the sterilization apparatus comprises a first chamber 2 and a second chamber 4. The two chambers are separated by a sealable and removable interface 6 so that the two chambers can be operated independently "i.e. Different articles can be simultaneously sterilized in the two chambers, or one chamber is operated for sterilization while the other is not in operation. A housing 10 for receiving a source of sterilant 12 is connected to each of the chambers 4 and 2 through a valve 14a and a valve 14b, respectively. Two housings 10 are shown in Figure 1. However, these two housings 10 can be combined into one. The housing 10 can be made of materials similar to those of the walls of the chambers 2 and 4. The sterilant source 12 can be connected to the IO housing or directly to the chambers 2 and 4. There are various forms for forms for controlling the amount of sterilant that enters chamber 2 or 4 if said control is desired. For example, the valves 14a and 14b can be a metering valve and the amount of the sterilizer flowing from the housing 10 to the chambers 2 and 4 is metered and controlled by the valve 14a or 14b; the housing IO is equipped with a volume reader so that the volume of the sterilant in the housing 10 can be read; or cavities containing sterilant (not shown) can be provided in the chambers to control the amount of liquid sterilant. The sterilant source 12 can also be connected directly to the chambers 2 and / or 4. The chambers 2 and 4 are equipped with a vacuum pump 16 to generate vacuum within these chambers during the sterilization process. Valve 15a and valve 15b are provided by connecting vacuum pump 16 to chamber 4 and 2, respectively. They are controlled in a dependent manner. Chambers 2 and 4 can also be equipped with a pump 18 to calculate the sterilant between the two chambers. The chambers 2 and 4 can be of any desired shape, but a regular shape as cylindrical or rectangular would facilitate accommodating the interface 6. FIG. IA shows more details of the chambers 2 and 4 with interface and doors. As shown in the Figure »the cameras 2 and 4 can be equipped with doors 8a, 8b» 9a and 9b »respectively. A camera does not necessarily have more than one door. There is a frame lia and a guide piece 11b between the two chambers. The interface 6a or & t > it is secured between the two chambers through the frame Ia and the guide piece 11b by sliding the interface into the space 13 defined by the frame Ia and the guide part 11b. If necessary, the interface 6a or 6b can be secured to the frame Ia by any conventional means, such as screws or screeners. A sealing 0 ring (not shown) can be provided around the frame lia to generate a good seal between the two chambers. The interface 6a has an opening 7 adapted to receive a lumen device. The opening 7 may have different shape and size to accommodate different types of lumen devices. Under different situation, you can choose a different interface. The opening 7 is controllable. In one embodiment, the opening has a shutter structure that is electrically controlled. By changing the size of the opening, a different degree of seal can be achieved between the opening and the lumen device contained by the opening. Figure 2 shows a sterilization apparatus capable of generating a flow of sterilant through a lumen to be sterilized. As shown in Figure 2, the apparatus comprises a first chamber 2 and a second chamber 4. The two chambers are separated by an open and closable interface 6a The interface 6a has an opening 7. A lumen device 40 with a lumen 42 is positioned through the opening 7 such that one end of the lumen 42 is in the chamber 2 and the other end in the chamber 4. At least during a part of the sterilization procedure to sterilize the interior of the lumen 42, the opening 7 is gas tightly sealed around the lumen device 40 whereby the sterilizing fluid flows through the lumen 42 under a pressure drop between the two chambers 2 and 4. Although a liquid sterilant can be used in In the apparatus, sterilizing steam is preferred The sterilizing vapor may be generated by any suitable method known in the art or by the method described in the copending application mentioned above. In general, the usual way to generate vapors in a sterilization system is the use of heating and / or vacuum. In the present invention, both heating and vacuum can be used to generate steaming vapor. In order to generate a flow of sterile fluid through the lumen 42, there must be a pressure difference between the two ends of the lumen 42. One way to generate said pressure gradient is to pressurize one end of the lumen 42. But it is more it is convenient to apply vacuum to one end of lumen 42 with vacuum pump 16 »especially when sterilizing steam is used. The two chambers can operate either under vacuum or under pressure to approximately 4 atmospheres. The temperature of the two chambers can be controlled independently through a conventional heating device (not shown). The operating temperature of the chambers is adjusted so as not to damage the device to be sterilized. It is usually below 80 ° C, most preferably 20 to 55 ° C. The vacuum pump 16 is used to generate vacuum either in the chamber 2 or in the chamber 4 through the valve 15b and 15a. The pump 18 is used to circulate sterilant between the chamber 2 and the chamber 4. If necessary, the vacuum pump 16 and the air pump 13 can be operated simultaneously or sequentially. In addition to the lumen device 40, a plurality of devices can be sterilized in a chamber 2 and 4. In this embodiment, the devices to be sterilized can be treated again or they can be untreated with liquid sterilizer. . Because the sterilant is circulated through the lumen 42, the interior of the lumen device 40 is mainly sterilized by the flow of sterilizer therethrough. This circulation of sterilant provides efficient sterilization of interior of lumen 42, especially when hydrogen peroxide vapor is circulated through lumen 42. Gates for the two chambers can be provided at any convenient sites, for example, as shown. in Figure IA, the sterilant can be supplied from the housing 10, or directly from the source of sterilizer 12. The source of sterilizer 12 can be in the form of injection, static soaking, flow of liquid from one side to the other, or spray of spray. The liquid sterilizer can also be placed over the cavities (not shown) on the inner surface of the chambers and is vaporized during the sterilization by applying vacuum and / or heat. All the features and functions of the apparatus shown in Figure 1 and described above are applicable to the apparatus shown in the Figure. Figure 3 shows a top view of the two chambers in another embodiment of the present invention. The apparatus comprises elements similar to those shown in Figure 2 but are configured differently. The chamber 4 is now located inside the chamber 2. The chambers 2 and 4 are connected separately to a vacuum pump 16, housing IO and pump 18 as shown in Figure 3. The pump 18 is not usually necessary when there is no flow of sterilant between the two chambers. The two cameras can operate independently. One of the advantages of the arrangement is that devices with longer length such as device 44 can be accommodated between the space between chamber 2 and chamber 4. Chambers 2 and 4 share the upper surface and the lower surface, and are equipped with two doors sel lab! is. The chamber 2 has a large door on the upper surface and the chamber 4 has a smaller door on the upper surface. The smallest door is inside the largest door »but the two doors can be operated independently. Figure 4 shows an apparatus of the present invention similar to that shown in Figure 3. The difference between the two modes shown in Figure 3 and Figure 4 is that in the apparatus of Figure 4 the camera 2 and the camera 4 are in fluid communication through a lumen device 40. Therefore, this apparatus has all the advantages possessed by the apparatus of Figure 3. Furthermore it can be used to effectively sterilize devices with narrow and long lumens. In this case, a removable interface 6a with an opening 7 is provided to accommodate the lumen device 40. The interface 6a can be installed in a manner similar to that described and shown in Figure la. The valves 19a and 19b can be provided between the pump 18 and the chambers. Figure 5 demonstrates the use of a container 20 in chambers 2 and 4. For certain devices, sterility needs to be maintained after sterilization. A sterile vapor permeable container impervious to microorganisms is generally used to achieve the goal of keeping microorganisms away from sterilized devices after they have been sterilized. As shown in Figure 5, a container 20 is placed in either the chamber 2 or the chamber 4 or both. The remainder of the system is the same as that of the apparatus shown in Figure 1. The container is provided with a membrane (not shown) that is permeable to sterile steam and impermeable to microorganisms and can be located in any convenient position on the wall of the container 20. The vapor permeable and waterproof micro-vapor impermeable membrane can be made of any conventional material known in the art such as TYVEK ™ non-woven polyethylene fabric, non-woven polypropylene such as SPUNQUARD ™ or material Similary. During the sterilization procedure, the sterilizing vapor generated from a liquid sterilant in chamber 2 or 4 enters the container 20 through the membrane and sterilizes the device placed inside the container 20. The devices to be sterilized can also be re-treated with sterilant liquid and then the liquid sterilizer contained or absorbed by the devices is vaporized under vacuum applied through the vacuum pump 16. Another option is to provide the liquid sterilizer container 20 before the sterilization process is started, then to close a sealable door of the container 20 and apply vacuum to the container 20 to vaporize the liquid sterilant contained in the container 20. When the sterilization cycle has been completed, the container is removed from the chamber. Due to the characteristic impermeable to microorganisms, the container 20 can maintain the sterility of the device inside the container 20. This greatly reduces the likelihood of recontamination during the handling of the sterilized device. Figure 6 shows a sterilization apparatus similar to that of Figure 5. In the apparatus shown in Figure 6, a container 22 for a lumen device 40 is placed through the opening 7b at the interface 6c. The opening 7b is sealed around the exterior of the container 22, for example, by an O-ring or other similar material mounted in the opening 7b. The container 22 also has an interface 22a with an opening 22b as shown in Figure 6A. The opening 22b is also sealed around the outer surface of the lumen device 40 whereby no gas or vapor can flow between them when the seal is in a gas-tight seal state. When desired, the seal between the outer surface of the lumen device 40 and the opening 22b of the interface 22a of the container 22 can be released so that the outer surface of the lumen device 40 adjacent the seal is sterilized. A gas permeable but sterilizing vapor permeable membrane to microorganisms 24 is provided to both portions of the container 22 in the chamber 2 and 4. The membrane 24 can be placed in any convenient position on the container 22, such as at both ends of the container 22. Through the membranes 24 and the lumen 42 of the device with lumen 40 »the chamber 2 and the chamber 4 are placed in fluid communication. By applying vacuum to any chamber with the vacuum pump 16, a pressure difference can be established and a flow of sterilant is generated between the two chambers. The container 22 serves to maintain the sterility of device with lumen 40 placed therein after sterilization. Figure 7 shows a sterilization apparatus comprising a container 26. The container 26 is divided by an interface 6d. In the same way as the interface Sa described in Figure 2, the interface 6d is sealable and has an opening 7c. The container 26 is accessible to the source of sterilant 12 or housing 10. The space between the inner surface of the chambers 2 and 4 and the outer surface of the container 26 is sealed in a gas-tight manner so that sterilizing air or steam can not flow through the space of camera 2 to camera 4 or vice versa. In the embodiment shown in Figure 7, the sealing of the space between the inner surface of the chambers 2 and 4 and the outer surface of the container 26 is provided at approximately the same location where the interface 6d separates the container 26 into two portions. The two portions of the container 26 separated by the interface 6d are in fluid communication through the lumen 42. The opening 7c is sealed around the outer surface of the device with lumen 40 of 1 in the same manner as described in the section for the Apparatus shown in Figure 2. A gas permeable, sterilizing, gas permeable membrane, but impermeable to microorganisms, is provided in both portions of container 26. In this way, a pressure difference can be generated between the two chambers and between the two portions of the container 26 by means of a vacuum pump 16 and / or a pump 18. The pressure difference between the two container portions 26 forces the sterilizing fluid to flow through the lumen 42, and both the interior and the exterior of the lumen device 40 and other devices that are inside the container 26 are efficiently sterilized. The sterility of the devices in the container 26 is maintained after sterilization. The present invention is described based on drawings and different modalities. It is obvious to one skilled in the art that various modifications can be made without departing from the spirit and scope of the present invention.

Claims (17)

NOVELTY OF THE INVENTION CLAIMS

1. An apparatus for sterilizing a medical device comprising: a) a multi-chamber compartment having at least one rigid first chamber and a second rigid chamber, wherein each of the first and second chambers serve as a sterilization chamber and can be operated independently; b) an interface that can be opened and closed between the first and second chambers, and c) a source of sterilant adapted to supply the sterilant in 1 to the first and / or second chambers

2. The apparatus according to claim 1 characterized also because it comprises a flow path between the first and second chambers, and a flow system for flowing the sterilant through the flow path.

3. The apparatus according to claim 1, further characterized in that the interface can be opened and closed by being removable.

4. The apparatus according to claim 1, further characterized in that the interface is a removable solid plate.

5. The apparatus according to claim 1, further characterized in that the device is placed in a vapor permeable, sterilizing, gas-tight container impermeable to microorganisms, said container maintaining the sterility of the device after sterilization and wherein the container is Place inside the multi-chamber compartment.

6. The apparatus according to claim 1, further characterized in that the device is placed either in the first chamber or in the second chamber.

7. The apparatus according to claim 1, further characterized in that each of the first and second chambers provides an environment restricted to diffusion.

8. The apparatus in accordance with the claim

1, further characterized in that the first chamber and the second chamber have first and second sealable doors, respectively, wherein the second sealable door is smaller than the first door and is located inside the first door.

9. The apparatus in accordance with the claim

2, further characterized in that the interface has at least one opening that can be opened and closed.

10. The apparatus in accordance with the claim

9, further characterized in that the device comprises a lumen and in that the lumen of the device is placed through the opening such that the lumen is partially located in each of the first and second chambers.

11. The apparatus according to claim 10 »further characterized in that the opening forms a gas-tight seal around the lumen.

12. The apparatus in accordance with the rei indication

10f further characterized in that the opening forms a loose fitting seal around the lumen and allows the sterilant to flow out of the lumen through the opening.

13. The apparatus according to claim 10, further characterized in that the opening forms a sealing seal around the lumen, said seal consisting of a material permeable to gases and / or liquids.

14. The apparatus according to claim 1, characterized in that it comprises an opening without a lumen in said interface.

15. The apparatus in accordance with the claim

2, further characterized in that the flow path is within the multi-chamber compartment.

16. The apparatus according to claim 15 »further characterized in that the flow path allows flow in both directions.

17. The apparatus according to claim 16, further characterized in that the flow path is through a device with lumen. IB.- The apparatus according to claim 2, further characterized in that the flow path is outside the multi-chamber compartment.

19. - The apparatus in accordance with the rei indication 18, further characterized in that the flow path allows flow in both directions. 20. The apparatus according to claim 2, further characterized in that said flow path is a first flow path, said apparatus further comprising a second flow path. 21. The apparatus according to claim 20 »further characterized in that the second flow path is outside the multi-chamber compartment. 22. The apparatus according to the re-indication 20, further characterized in that the first flow path is in the interface. 23. The apparatus according to claim 20 »further characterized in that the first flow path is within the multi-chamber compartment and the second flow path is outside the multi-chamber compartment. 24. The apparatus according to claim 1 characterized in that the source of sterilant is selected from the group consisting of an injector, a device that passes the flow of liquid from one side to another, a reservoir of liquid or solid or aerosol spray device. 25.- The device in accordance with the claim

1, further characterized in that the sterilizing source is placed at a site selected from the group consisting of: the first chamber; the second camera; a container wherein said container is placed in the multi-chamber sterilization compartment; a housing positioned within the multi-chamber sterilization compartment, wherein said housing is connected to one of the first and second chambers, or to the first and second chambers. 26. The apparatus according to claim 25, further characterized in that the housing is connected to the container. 27. The apparatus according to claim 25, further characterized in that the sterilizer source is a liquid reservoir. 28. The apparatus according to claim 1, further characterized in that the sterilant comprises a liquid »a solid or condensed vapor. 29. The apparatus according to claim 28, further characterized in that said liquid comprises hydrogen peroxide or peracetic acid. 30.- The device in accordance with the rei indication

28, further characterized in that the sterilant is a solid complex of hydrogen peroxide. 31.- The device in accordance with the claim

30, further characterized in that the hydrogen peroxide complex comprises a complex of urea peroxide or a complex of sodium pyrophosphate peroxide or a simi 1 ar complex. 32. The apparatus according to claim 28 »further characterized in that the sterilant is condensed vapor comprising hydrogen peroxide or peracetic acid vapor. 33.- The apparatus according to claim 2, further characterized in that the flow system comprises a vacuum pump for applying vacuum, a pump for circulating the sterilizer »or pressurization induced by heat. 34. The apparatus according to claim 1, further characterized in that it comprises at least one additional interface. 35. The apparatus according to claim 1, further characterized in that it comprises a heater for vaporizing the sterilant. 36. The apparatus according to claim 1, further characterized in that it comprises a plasma generator for exposing the device to a plasma. 37. The apparatus according to claim 36, further characterized in that the plasma generator is located in a separate container and the apparatus further comprises a flow system for flowing said plasma into the multi-chamber compartment. 38.- The apparatus according to claim 9, further characterized in that the opening in the interface is provided with an iris diaphragm.

39. - The apparatus in accordance with the rei indication

9, further characterized in that the opening is defined by two plates with compressible material at the edges or on surfaces adjacent to the opening, and at least one of the plates is movable. 40.- The apparatus according to claim 9, further characterized in that the opening is equipped with inflatable material so that when this material is inflated, the opening is reduced to contain and seal a device. 41.- A method for sterilizing the interior and exterior of a device with lumen comprising: a) placing the device in a multi-chamber compartment having a first chamber, a second chamber and an interface with at least one opening, such that the lumen is partially in the first chamber and partially in the second chamber through the interface; b) introducing a sterilant from a source of sterilant into the multi-chamber compartment; and c) creating a sterilizing flow between the first chamber and the second chamber through the lumen. 42.- The method of compliance with the claim

41 »further characterized in that before the laying step, the device is placed in a sterilizing vapor permeable container impervious to microorganisms» the container maintaining the sterility of the device after sterilization. 43. The method according to claim 41, further characterized in that a device without a lumen is being sterilized in either the first or second chamber. 44. The method according to claim 41, further characterized in that the placement step can also include the steps of removing the interface; Replace the interface with a different interface to accommodate a different lumen. 45.- The method according to the rei indication 41, further characterized in that one or both of the first and second chambers is an environment restricted to diffusion. 46.- The method according to claim 41, further characterized in that the sizes of the first and second cams are different. 47.-The method of compliance with the claim

41, further characterized in that the opening forms a gas tight seal around the lumen. 48.- The method of compliance with the claim

41, further characterized in that the opening forms a loose fitting seal around the lumen and allows the ester to flow out of the lumen through the opening. 49. The method according to claim 41, further characterized in that the opening forms a sealing seal around the lumen, said seal consisting of a material permeable to gases and / or liquids.

50. - The method according to claim 41 »further characterized in that said interface has an opening without a lumen. 51.- The method of compliance with the re vication 41, further characterized in that the flow path is within the multi-chamber compartment. 52. The method according to claim 41, further characterized in that the flow path allows flow in both directions. 53.- The method of compliance with the claim

41, further characterized in that said flow path is a first flow path which comprises flowing sterilizer through a second flow path. 54. The method according to claim 53, further characterized in that the first flow path is within the multi-chamber compartment and the second flow path is outside the multiple-chamber compartment. The method according to claim 41, further characterized in that the source of sterilant is located at a site selected from the group consisting of the first chamber; the second camera; a container wherein said container is placed in the sterilization chamber of multiple chambers; a housing positioned within the multi-chamber sterilization compartment, wherein said housing is connected to one of the first and second chambers, or to the first and second chambers. 56.- The method according to claim 55, further characterized in that the housing is connected to the container. 57.- The method of compliance with the rei indication

55, further characterized in that the source of sterilant is a liquid reservoir. 58. The method according to claim 41, further characterized in that the sterilant comprises a liquid, a solid or condensed vapor. 59. The method according to the rei indication 58, further characterized in that said sterilant is a liquid comprising hydrogen peroxide or peracetic acid. 60.- The method according to claim 58, further characterized in that the sterilant is a solid complex of hydrogen peroxide. 61.- The method according to claim 60, further characterized in that said solid comprises a complex of urea peroxide or a complex of sodium pyrophosphate peroxide. 62. The method according to claim 58, further characterized in that the ester is condensed steam, said method also comprising condensed steam vapor. 63.- The method of compliance with the claim

62, further characterized in that said condensed vapor is hydrogen peroxide or peracetic acid vapor. 64.- The method of compliance with the claim

41, further characterized in that the flow system comprises a vacuum pump, a pump for circulating the sterilant, or heat-induced pressurization is used to achieve the next step. 65.- The method according to claim 41, further characterized in that it comprises the step of exposing the device to a plasma. 66.- The method of compliance with the claim

65 f further characterized in that said plasma is generated in a separate container and said method further comprises the step of flowing said plasma from the container to the first or second sterilization chamber. 67.- The method of compliance with the claim

41 »further characterized in that it comprises heating the device to be sterilized before step (b). 68.- The method according to claim 67, further characterized in that the device to be heated can be heated with an applied electric field. 69. The method according to claim 67, further characterized in that the device is heated to a pressure below atmospheric pressure. 70. The method according to claim 41 further characterized because steps (b) and (c) can be repeated one or more times.

71. - The method according to claim 41, further characterized in that step (a) further comprises the steps of: opening the opening in the interface; inserting the device through the opening such that the device is partially in the first chamber and partly in the second chamber; and then closing the opening in such a way that a seal is formed around the device. 72. The method according to claim 41, further characterized in that step (a) comprises placing the device through the opening equipped with an iris diaphragm that can seal around the device 73. The method of compliance with claim 41, further characterized in that step (a) comprises positioning the device through the opening equipped with expandable material. The method according to claim 73, further characterized in that step (a) comprises expanding the expandable material with expandable material to seal around the device. 75.- The method of compliance with the claim

41, further characterized in that step (a) comprises positioning the device through the opening equipped with compliant material. The method according to claim 75, further characterized in that step (a) comprises compressing the compressible material to seal around the device.

77. - The method according to claim 41, further characterized in that step (a) comprises placing the device through the opening defined by two plates, the plates having compressible material on the edges or on the surfaces of the plates adjacent to the opening »at least one of the plates is movable so that the plates can be led towards each other to contain and seal around the device. 78.- The method of compliance with the claim

10 41 »further characterized in that step (a) comprises positioning the device through the opening equipped with inflatable material so that when this material is inflated, the opening is reduced to contain and seal around the device. 79. The method according to claim 15 41 »further characterized in that the device with lumen is an endoscope. rf BO.- The method according to claim 41, further characterized in that the lumen has at least two ends and the lumen passes through the interface through the opening between the ends. 81.- A method for sterilizing a medical device, comprising the steps of: a) placing the device in a multi-chamber compartment having a first rigid chamber, a second rigid chamber and a removable interface between the first and second chamber; b) adjusting the interface so that a device too large to fit in the first or second chamber can be sterilized in a larger chamber formed by the first and second chambers; and c) introducing a sterilizer from a sterilizing source into the multi-chamber compartment. 82.- The method according to claim 81, further characterized in that, before the placement step, the device is placed in a sterile vapor permeable container impervious to microorganisms, said container maintaining the sterility of the device after the steri 1 ization.