Rigid sterilization system for sterilization

Abstract

A rigid sterilization system for use in a sterilization apparatus to sterilize an object that requires sterilization. This system includes a base formed of a material that can withstand being exposed to a sterilizing agent, the base having (i) a support surface with a portion configured to support the object that requires sterilization and (ii) a first sealing surface. The system includes a cover, the cover having a first vent port and a first filter covering the first vent port. The cover is made of a rigid material configured to retain a selected shape. The lower portion of the rigid cover is configured to form a sealed interface with the base. The system includes a continuous seal between the first sealing surface of the base and the cover. The continuous seal forms a continuous sealed interface between the base and the cover.

Description

Technical Field

[0001] The present invention relates to a sterilization system and a sterilization method for sterilizing surgical instruments and the like, and more particularly to a rigid sterilization system for sterilization having a base and a rigid cover and a method of using the same.

Background Art

[0002] The cleaning and sterilization of surgical instruments, laboratory instruments, and medical devices are important in many fields including, but not limited to, scientific research, veterinary medicine, and human medicine. For example, surgical instruments must be provided in a sterilized state for use in surgery. Usually, several procedures are taken to reduce the risk of introducing harmful microorganisms to patients or into scientific research. First, the contamination of the object is removed and pre-rinsed. Next, the object is washed, rinsed, and dried. After thoroughly cleaning the object, it is sterilized. Sterilization refers to any process that eliminates, removes, inactivates, or kills bacteria and other types of living microorganisms. Living microorganisms include infectious pathogens (fungi, bacteria, viruses, or those in the form of spores) present on the surface or contained in compounds such as fluids, drugs, or biological media. Sterilization is carried out by supplying heat, steam, chemicals such as ethylene oxide (EO), irradiation, high pressure, filtration, or a combination thereof. Generally, surgical instruments, laboratory instruments, and medical devices must be sterilized at a high level of aseptic assurance before use on the body. These instruments include, for example, surgical scalpels, hypodermic needles, endoscopes, and implantable medical devices (IMDs) such as artificial pacemakers.

[0003] One widely used method of heat sterilization is the autoclave (sometimes called a converter). In an autoclave, steam heated to usually 121°C to 134°C is used. To achieve a certain level of asepsis, a holding time of at least 15 minutes at 121°C and 100 kPa or at least 3 minutes at 134°C and 100 kPa is required. In the case of instruments packed in liquid and cloth layers, a longer holding time is required because it takes a long time to reach the required temperature.

[0004] As another sterilization method, there is a method of wrapping a tray on which instruments, supplies, medical devices, or such objects are placed with a packaging material, sterilizing the items on the tray, and maintaining the sterility of the items on the tray until the packaging material is opened. Traditionally, instruments that require reprocessing are provided in trays with ventilation holes so that a sterilant can pass through the tray to sterilize the entire surface. In order to maintain sterility even after removal from the sterilization device, the tray is wrapped with a material that protects the inner tray from microorganisms while allowing the sterilant to pass through. Various packaging materials can be used for sterilization. Packaging materials include fabrics made of cotton, blends of cotton and polyester, or blends with synthetic fibers, or non-woven materials made of a material obtained by pressing a plastic polymer, cellulose fiber, or washed paper pulp into a sheet. When wrapping a tray on which instruments, supplies, medical devices, or such objects are placed with a packaging material including but not limited to a wrap, the packaging material may tear or develop holes. In such cases, sterilization must be performed again using a new packaging material. Also, when packaging instruments in this way, the area of the surface to be inspected increases after performing a sterilization cycle in a sterilization device. A single instrument can be sterilized individually in a peel pouch. The peel pouch protects the instrument from contaminants in the environment even after the sterilization process is completed and maintains the sterility of the instrument. However, since a peel pouch cannot sterilize multiple instruments in the same peel pouch, the efficiency is not good. Also, the peel pouch must be placed horizontally in the sterilization device so that air can be easily removed, the sterilant can easily penetrate, and moisture does not accumulate. A peel pouch cannot hold multiple components of an implant together. These components typically need to be placed in separate peel pouches before sterilization by gamma irradiation.

[0005] Alternatively, there is a method of placing the tray in a sterilization container and using a filter that acts like a wrap that allows the sterilizing agent to pass through but blocks the entry of microorganisms later. This filter also allows the sterilizing agent or its by-products to leak out. Current rigid container systems include a barrel-shaped base with a bottom and sidewalls extending upward from the bottom. This barrel-shaped base is configured to accommodate the tray of the instrument. The problem with rigid containers having a barrel-shaped base is that the sidewalls of the base interfere with access to the instrument. Further, there is a risk of contamination when reaching into the base to access an object contained inside.

[0006] Another method of sterilization is to pass steam through the cabinet. To perform effective sterilization, it is necessary to pass the steam uniformly through the cabinet. Therefore, it is necessary not to overcrowd the cabinet with items and to leave the lids of bottles and containers half-open. During the initial heating of the chamber, it is necessary to remove the residual air. To confirm that the steam has actually penetrated there, it is necessary to place an indicator in the place where the steam is most difficult to reach.

[0007] The filter is usually installed to cover the vent opening to prevent particles and foreign objects from entering the cabinet before, during, or after the sterilization process. After the sterilization process is completed, the filter needs to be removed and inspected by a medical professional to confirm that the integrity of the sterilization process has been maintained. If it is found during the inspection that the filter has not maintained its integrity, it is necessary to repeat the sterilization process using a new filter. SUMMARY OF THE INVENTION

[0008] A first exemplary embodiment of the present disclosure provides a rigid sterilization system for an object that needs to be sterilized in a sterilization apparatus. The rigid sterilization system includes a base having a support surface configured to support the object, and a rigid cover having a body and a lower portion. The body includes a top panel and side panels extending from the top panel, and the top panel and side panels include a rigid material configured to retain a selected shape. The rigid cover and the base define a volume surrounding the object that needs to be sterilized. Further, the system includes a seal interface between the lower portion of the rigid cover and the base, and the seal interface is configured to form a continuous seal between the lower portion of the rigid cover and a first sealing surface.

[0009] The rigid cover may further include a first vent port and a first filter. The first filter covers the first vent port and forms a sealed interface together with the adjacent portion of the rigid cover. In one configuration, the base is a substantially flat surface. In one configuration, the base includes a rack system for holding an object. The base includes, in one configuration, a plurality of sides that form a dependent skirt, and the first seal surface is disposed on the dependent skirt. The gasket is between the lower portion of the rigid cover and the first seal surface. In one configuration, the first seal surface is disposed on a support surface, and the first seal surface further includes a gasket within the first seal surface of the support surface. In one configuration, the gasket is fixed to the lower portion of the rigid cover. In one configuration, the top panel includes a window for viewing the contents within the rigid sterilization system. In one configuration, the base is an operating room back table. The rigid cover is made of thick aluminum in one configuration and a medical grade plastic material in another configuration. In one configuration, the rigid cover is removably fixed to the base by a clamp. In one configuration, a filter covers the vent port. The rigid container system further includes, in one configuration, a gasket surrounding the first filter. The first filter and the gasket form a filter cartridge, and the filter cartridge is removably fixed to the body. The first vent port is disposed on at least one of the top panel or the side panel. In one configuration, the lower portion of the rigid cover is disposed on the first seal surface of the base and forms a sealed interface between the lower portion of the rigid cover and the base. In one configuration, the base further includes a groove for receiving the gasket, and the lower portion of the rigid cover further includes an edge that engages the gasket within the groove to form a peripheral seal between the edge and the base. The base may be further configured to be fixed to a transport cart in one configuration.

[0010] Another exemplary embodiment of the present disclosure provides a rigid sterilization system for an object that needs to be sterilized in a sterilization device. This rigid sterilization system includes a base having a support surface configured to support the object, and a rigid cover having a body and a lower portion. The body includes a top panel and side panels extending from the top panel. The top panel and the side panels include a rigid material configured to retain a selected shape. The rigid cover and the base define a volume surrounding the object that needs to be sterilized. Further, the system includes a seal interface between the lower portion of the rigid cover and the base. This seal interface is configured to form a continuous seal between the lower portion of the rigid cover and a first seal surface. In this configuration, a plurality of bases are provided. Each base includes a rigid cover and a continuous seal between the lower portion of the rigid cover and the first seal surface. A rack with a plurality of shelves is provided. Each of the plurality of shelves is configured to hold one of the plurality of bases with covers after being sterilized in the sterilization device.

[0011] A third exemplary embodiment of the present disclosure provides a rigid sterilization system for use in a sterilization device to sterilize an object that requires sterilization. The system includes a base and a cover. The base is formed of a material resistant to exposure to a sterilant and has (i) a support surface having a portion configured to support an object that requires sterilization, and (ii) a first sealing surface. The cover has a first vent port and a first filter covering the first vent port. The cover includes a rigid material configured to retain a selected shape. The lower portion of the rigid cover is configured to form a sealed interface with the base, and a continuous seal is formed between the first sealing surface of the base and the cover. This continuous seal forms a continuous sealed interface between the base and the cover. In one configuration, the support surface of the rigid base is substantially flat. The rigid sterilization system may further include a gasket between the lower portion of the rigid cover and the first sealing surface. The base further includes a plurality of sides forming a dependent skirt, the first sealing surface is disposed on the dependent skirt, and the gasket is disposed between the lower portion of the rigid cover and the dependent skirt. In one configuration, the first sealing surface is disposed on the support surface, and the gasket is disposed on either the first sealing surface or the lower portion of the rigid cover. The base is fixed to a transport cart in one configuration.

[0012] Another exemplary embodiment of the present disclosure provides a rigid sterilization system for use in a sterilization apparatus that sterilizes objects that require sterilization. The system includes a base and a cover. The base is formed of a material adapted to withstand exposure to a sterilizing agent and has (i) a support surface having a portion configured to support an object that requires sterilization and (ii) a first sealing surface. The cover has a first vent port and a first filter that covers the first vent port. The cover is made of a rigid material configured to maintain a selected shape, and the lower portion of the rigid cover forms a sealed interface with the base. The system further includes a continuous seal between the first sealing surface of the base and the cover. The continuous seal forms a continuous sealed interface between the base and the cover. In this configuration, a plurality of bases and racks are provided. Each base has a cover and a continuous seal between the lower portion of the cover and the first sealing surface. The rack has a plurality of shelves, and each shelf is configured to hold one of the plurality of bases having a cover after being sterilized in a sterilization apparatus.

Brief Description of the Drawings

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[0023] It should be noted that the same reference numerals appearing in different figures identify the same components of the present invention. The description of the present invention includes what is currently considered to be the preferred configuration, but it should be understood that the present invention is not limited to such a configuration. Furthermore, the present invention is not limited to the specific methods, materials, and improvements described herein, and it should be understood that the terms used herein are not intended to limit the scope of the present invention. Therefore, the scope of the present invention is determined only by the appended claims.

[0024] The present invention relates to a sterilization system that increases vent to volume ratios during sterilization within a sterilizer for the purpose of sterilizing instruments, medical devices, etc. The term "sterilizer" includes, but is not limited to, a housing or device that defines an interior in which a sterilization system is held and a controlled environment is created for performing desired sterilization. Sterilizers include autoclaves, hot air ovens, ethylene oxide, low temperature steam and formaldehyde, sporicidal chemicals, radiation, chlorine dioxide (CD) gas sterilization, hydrogen peroxide, vaporized hydrogen peroxide, hydrogen peroxide plasma, electron beam, and gas plasma devices.

[0025] By using a base such as a table, a tray with rack components, or a plurality of trays with rack components as a base component, one or more instruments can be placed directly thereon. When using a base such as an operating room back table or tray, it is usually not necessary to transfer the instruments from the container to the back table for use in the operating room. This is because the back table is integrated with the sterilization wrap system, the instruments are already arranged on the table, and can be used as is after sterilization. Furthermore, since there is no base side wall that obstructs the removal of the instruments, the instruments can be easily accessed.

[0026] The "operating room back table" or "back table" generally refers to a table used to place surgical instruments in an operating room. The operating room back table may also be referred to as an instrument table or a work table. The back table can be made of stainless steel, plastic, or other rigid materials and can be of any shape and size. Usually, the back table is a rectangular table with legs and / or pedestals. The legs and / or pedestals may or may not be adjustable and / or removable.

[0027] As shown in FIGS. 1 to 9, a rigid sterilization system 100 for an object that needs to be sterilized by a sterilizer includes a rigid cover 106 and a base 102. In one configuration, the base 102 is an operating room back table having a support surface 104 for supporting at least one object 144 (see FIG. 5) that requires sterilization by the sterilizer and legs 148. Objects 144 that require sterilization include, but are not limited to, surgical instruments and appliances, implants, laboratory supplies, medical devices, etc. The base 102 may be removable from the legs 148 or a pedestal (not shown). As shown in FIG. 2, the base 102 may not be provided with legs. In one embodiment, the length of the base 102 is about 24 inches and the width is about 22.5 inches. However, the size of the base may be different. For example, in one configuration, the length of the base is in the range of 12 inches to 36 inches. The base 102 can be of any shape and size to provide the support surface 104. For example, although the base 102 is illustrated as rectangular, it can be circular, oval, square, elliptical, etc., and is not limited thereto. The base 102 of this configuration is rigid and can be a table, sheet, plate, or other rigid support base.

[0028] In one configuration, the base 102 includes sidewalls 112. In another configuration, the base 102 includes a dependent skirt (not shown). Additionally or alternatively, the base 102 includes a flange or sidewall 138 (shown in FIG. 5) along the periphery of the support surface 104, and can hold the object 144 on the support surface 104, particularly when the object may move during transportation. In one configuration, the base 102 is substantially flat. Alternatively or additionally, the base 102 may include an object separator 114 (shown in FIG. 5). The object separator may have, for example, racks, partitions, shelves, or segmented portions for maintaining the object 144 in a particular segmented area of the base 102. The object separator 114 may be fixed to the base 102. "Fixed" means that the object separator 114 is either permanently fixed, integrated, or removably fixed to the base 102. In one configuration, the base 102 supports a tray (not shown). The base 102 may further include additional fasteners (including but not limited to surface fasteners (Velcro), magnets, etc.) for releasably holding the object 144 in place. The base 102 may also include laser outlines of at least some of the objects 144 that identify the preferred positions of the particular objects. Other features for organizing and maintaining the objects 144 on the base 102 are intended to be within the scope of the claimed invention.

[0029] As shown in FIG. 6, in one configuration, the base 102 includes a drainage system 150 for discharging the sterilant and / or liquid condensate generated during the sterilization process. The base 102 may include an inclined surface 152 for guiding the drainage to a predetermined area, as shown, for example, in FIG. 6 or FIG. 7. The inclined surface 152 may be at any inclination and may be straight (angled) or curved. In one configuration, the base 102 includes at least one drainage well (drainage well) having a downward inclined surface 152 arranged to guide the condensate to the drain outlet 154. In one configuration, the diameter of the drain outlet 154 is about 0.5 to 5 inches. In another configuration, the diameter of the drain outlet 154 is about 2 to 3 inches. The discharge port 154 can be of any shape and size that can discharge the condensate or liquid sterilant from the surface of the base 102. The drain outlet may further be provided with a drain check valve and / or at least one filter. The surface 152 may be frustoconical to further guide the sterilant and condensate to the drain outlet 154. Alternatively, the drainage system 150 may include a continuous descending portion that guides the sterilant and / or liquid condensate to a drain well or opening 154 near one side of the base 102. It should be understood that the drain well or opening 154, or multiple drain wells and / or multiple openings 154, can be located anywhere on the support surface 104 of the base if the support surface 104 is configured to allow drainage. In yet another configuration, the drainage system 150 can include an inclined surface or a descending portion even without a drain well or opening 154, thereby guiding the sterilant and / or condensate to the edge of the support surface 104 of the base 102. The drainage system 150 can include one or more filters within the opening. Those skilled in the art should understand that other drainage systems capable of discharging the sterilant and / or condensate from the support surface 104 of the base 102 are possible, and these modifications are intended to be included within the scope of the claims. The base 102 may further include a holder for holding the object 144 above the drainage system 150. The holder may be, for example, a plate having perforations, openings, or wells, or a tray configured to be suspended above the base 102.The holder may be integrated with the base 102 or may be removable from the base 102. As an example, the holder is the object separator 114 shown in FIG. 5. In this technical field, many configurations for holding instruments are known, and in certain embodiments, the instrument is held over a drainage system. It should be understood that these configurations are included in the claims.

[0030] As shown in FIGS. 1 - 7, the rigid sterilization system 100 further includes a rigid cover 106 having a body portion 116 and a lower portion 118. The lower portion 118 has a lower edge 130. The rigid cover 106 is composed of a rigid material configured to substantially retain a selected shape. In one embodiment, the rigid cover 106 includes a rigid material configured to substantially retain a selected shape. For example, the rigid cover 106 may be composed of an impact - resistant medical - grade plastic material. Alternatively, the rigid cover 106 may be composed of thick aluminum. In yet another exemplary embodiment, the rigid cover 106 is composed of stainless steel. The base 102 may be composed of the same material as the rigid cover 106. When the rigid cover 106 and the base 102 are sealed, they provide a continuous barrier against bacteria or other types of living microorganisms, including infectious agents (such as fungi, bacteria, viruses, or spore forms). The body portion 116 of the rigid cover 106 is composed of a top panel 120 and side panels 122. The lower portion 118 of the rigid cover 106 is configured to be sealed to the base 102. In one configuration, the seal interface between the lower portion 118 of the rigid cover 106 and the base 102 forms a seal between the lower portion 118 and the base 102. In one configuration, the seal is a continuous seal.

[0031] In an exemplary embodiment, as shown in FIGS. 3 and 8, the base 102 includes sides 112 (sides; side surfaces) that include, for example, a sealing surface. In one configuration, the base 102 includes a dependent skirt (not shown). Either or both of the rigid cover 106 and the sides 112 may include a gasket 134. In one configuration, the gasket 134 is fixed to either or both of the rigid cover 106 and the sides 112. "Fixed" means that the gasket 134 is permanently fixed, integrated, or removably fixed to either or both of the rigid cover 106 or the sides 112. The gasket 134 forms a sealed interface with opposing surfaces such as the lower portion 118 of the rigid cover 106 and / or the base 102 and can maintain its integrity during and after the sterilization cycle. The gasket 134 can be made of any type of material that is substantially rigid and can maintain its integrity during and after the sterilization cycle. Exemplary embodiments of the gasket 134 include polymer-based materials or cellulose-based materials. In other exemplary embodiments, the gasket 134 is flexible, has low rigidity, and may deform or shrink during the sterilization cycle. In another exemplary embodiment, the gasket 134 can be made of any type of material that is flexible, has low rigidity, and can maintain its integrity during and after the sterilization cycle. Examples of materials for the gasket 134 include rubber, closed-cell sponge rubber, silicone, cardboard, plastic, medical-grade light board, or similar materials. The rigid sterilization system 100 may include a hinge or clamp 136. This hinge or clamp 136 releasably fixes and applies pressure between the rigid cover 106 and the base 102 to form an airtight seal. The hinge or clamp 136 may further include a release certification device 138 for detecting whether the sealed seal has been released after sterilization.

[0032] In another exemplary embodiment, as shown in FIG. 4, the base 102 includes a peripheral groove 132 in the support surface 104, and the groove 132 is sized such that the lower edge 130 of the rigid cover 106 engages therewith. As a result, when pressure is applied to the rigid cover 106, a peripheral seal is formed between the lower edge 130 of the rigid cover 106 and the base 102. In one configuration, a gasket is disposed within the groove 132. In another configuration, the gasket is fixed to the lower edge 130 of the rigid cover 106. "Fixed" means that the gasket is permanently fixed, integrated, or removably fixed to the lower edge 130 of the rigid cover. In either configuration, when the lower edge 130 of the rigid cover 106 is inserted into the groove 132, a continuous peripheral seal is formed between the rigid cover 106 and the base 102.

[0033] The rigid cover 106 includes a top panel 120 and side panels 122 extending from the top panel, and can form a volume surrounding an object that requires sterilization. In one configuration, the rigid cover 106 surrounds an object that requires sterilization and the side wall 112 of the base 102 including the support surface 104. Thus, the rigid cover 106 has a tabular (barrel-shaped, trough-shaped) structure in which the side panels 122 extend downward from the top panel 120 toward the base 102. In one configuration, the base 102 does not have a tabular structure, but rather includes a flat or substantially flat support surface 142 for receiving the object to be sterilized 144. The base 102 may include a rack system fixed to the base 102 for holding the object 144 to be sterilized. However, since a rack system such as the object separator 114 does not have side walls extending above the object 144, it is easier to access the object 144 when removing the object 144 from the base 102, and the possibility of the object 144 being contaminated can be reduced. The top panel 120 of the rigid sterilization system 100 may include a transparent window for viewing the contents within the rigid sterilization system 100.

[0034] As shown in FIGS. 1-7, the body portion 116 further includes at least one vent port. For example, the top panel 120 and the side panel 122 may each have a vent port 108. Alternatively, the vent port 108 may be disposed on each side panel 122 only, or on the top panel 120 only. In yet another embodiment, the top panel 120 and the side panel 122 may each include a plurality of vent ports 108. In yet another embodiment, the vent port 108 is disposed on one, two, or three side panels 120. The filter 124 covers each vent port 108 and forms a sealed interface with the body portion 116. The filter 124 can be removably fixed to the rigid cover 106 using a clamp or a hinge. In another exemplary embodiment, the rigid cover 106 has a vent area (ventilation area) including a windowed grid, holes, gaps, or other grids. This vent area allows the passage of sterilizing steam.

[0035] The filter 124 may include a gasket 126 surrounding the filter 124. The filter 124 and the gasket 126 form a filter cartridge. In a further configuration, the filter cartridge may include a gasket 126 between two filters 124. In another configuration, the filter cartridge may include a gasket 126 fixed to a double layer of the filter 124. In yet another configuration, one or two filters are fixed between two gaskets 126. "Fixed" means that the gasket is permanently fixed, integrated, or removably fixed to the filter. "Filter" means a material that is porous enough to allow a sterilizing agent such as steam to pass through, yet has enough elasticity so as not to tear or break during the sterilization cycle or during insertion / tightening into the filter holder. In another embodiment, the "filter" is porous and has low elasticity, so there is a possibility that the filter may break or tear during use in the sterilization cycle or while being used with the filter holder.

[0036] In one configuration, as shown in FIG. 9, the base 10 includes a locking mechanism for releasably locking the base to a pedestal, legs, or transport cart 192. The transport cart 192 is composed of a frame 252, a push handle 254, and wheels 256. When the transport cart 192 is used as a table in the back room of the surgery, the transport cart 192 may optionally not include the push handle 254 or the locking mechanism. The transport cart 192 is strong enough to maintain its shape even under a significant load and can be made of a durable material that can be sterilized. Ideally, the transport cart 192 is composed of steel or aluminum alloy, or a combination thereof. It should be understood that the transport cart 192 is merely an exemplary embodiment of the transport cart 192. In one configuration, the base 102 includes legs 148 that connect to the transport cart 192. In another configuration, the base 102 is received by the transport cart 192 by the legs 148. FIG. 9 shows the configuration of FIG. 3 (the rigid cover 106 surrounds the base 102) fixed to the transport cart 192, but alternatively, the rigid sterilization system shown in FIG. 4 can also be attached to the transport cart 192. "Fixed" means that the base 102 is permanently fixed to, integrated with, or removably fixed to the transport cart 192.

[0037] The transport cart 192 may further include a sled (not shown) with wheels. This sled slides along the guide rails of the transport cart 192 when the sled and the base 102 are loaded into the sterilization device 10. The transport cart 192 has sufficient rigidity to hold the weight of the base 102 and the sled, or other similar sterilization devices. In one configuration, the base 102 is releasably locked to the sled via a locking mechanism. The locking mechanism provides means for removably fixing the base 102 to the transport cart 192. In an exemplary embodiment of the locking mechanism, any means that can firmly fix the base to the moving cart 192 (e.g., the sled of the moving cart 192) is included, whereby the base 102 moves only when the transport cart 192 moves. Further, the sled is releasably locked to the transport cart 192 via a locking mechanism. The locking mechanism provides means for removably fixing the sled to the transport cart 192. In an exemplary embodiment of the locking mechanism, any means that can firmly fix the sled to the transport cart 192 such that the sled moves only when the transport cart 192 moves is included. The transport cart 192 may further include a locking mechanism 262 for releasably locking the transport cart 192 to the sterilization device 10. Thus, when the sled and / or the base 102 are loaded into the sterilization device 10, the transport cart 192 can be locked to the sterilization device 10, and unwanted movement of the transport cart 192 can be prevented during the transfer of the load from the transport cart 192 to the sterilization device 10. Exemplary embodiments of the locking mechanism include clamps, latches, slots, bolts, screws, etc. In another configuration, the base 102 is fixed to the transport cart 192. For example, in one configuration, the base 102 is integrated with and permanently fixed to the transport cart 192.

[0038] The push handle 254 of the transport cart 192 provides a means for the user to more easily push or pull the transport cart 192. The push handle 254 may be provided on the opposite side of the transport cart 192. Each push handle 254 extends across the width of the transport cart 192. It should be understood that embodiments of the push handle 254 include examples where the push handle 254 is arranged on all sides of the transport cart 192 and examples where it is arranged on only one side, and that various shapes can be adopted.

[0039] One of the advantages of directly loading the base 102, such as a back table in the operating room, onto the transport cart 192 and then placing it in the sterilization device 10 is that once the sterilization cycle is completed, the base 102 (table) can be reloaded onto the transport cart 192 and directly moved to the operating room for reuse. Since the instruments and other objects are already arranged on the tray before sterilization, they can be used without any further processing or arrangement. In another configuration, the base 102 and the transport cart 192 are loaded together into the floor-loading type sterilization device 10. In this configuration, the transport cart 192, the base 102, and the instruments included in the base are sterilized by the floor-loading type sterilization device 10. This prevents the base 102 from being separated from the transport cart 192 during sterilization or transportation.

[0040] As shown in FIG. 10, the rigid sterilization system 100 can include a plurality of bases 102 disposed in a rack system 160. One embodiment of the rack system 160 includes a plurality of shelves 162 for accommodating the bases 102, or the bases 102 covered and sealed with a rigid cover 106. The rack system 160 includes side walls 164 and a door 166, and when the door is in the open position, the plurality of bases 102 are loaded onto the plurality of shelves. In one configuration, the shelves 162 are removable. In another configuration, the shelves are extendable to facilitate accommodating the bases 102. Typically, after the bases 102 sealed with the rigid cover 106 are sterilized in a sterilization device, the plurality of bases 102 (each base 102 is provided with a rigid cover 106 that surrounds and seals the base) are inserted into the rack system 160 and placed on the shelves 162. In this way, after processing the bases in a sterilization device, a large number of bases can be stored in the rack system 160. In one embodiment, the rack system 160 includes wheels 168, enabling the rack system 160 holding the plurality of processed bases 102 to be transported to an operating room.

[0041] The present invention contemplates that many changes and modifications are possible. Accordingly, while the presently preferred forms of the apparatus and method have been shown and described and some variations and alternatives have been discussed, it will be readily understood by those skilled in the art that various additional changes and modifications can be made without departing from the scope of the invention as defined and differentiated by the claims.

Claims

1. A rigid sterilization system for an object that requires sterilization in a sterilization device, comprising: a base having a support surface configured to support the object to be sterilized, and a rigid cover having a body and a lower part, wherein the body has a top panel and side panels extending from the top panel, the top panel and the side panels comprising a rigid material configured to retain a selected shape, and the rigid cover and the base define a volume surrounding the object to be sterilized, further comprising a seal interface between the lower part of the rigid cover and the base, the seal interface being configured to form a continuous seal between the lower part of the rigid cover and a first sealing surface, the rigid sterilization system.

2. The rigid sterilization system according to claim 1, wherein the rigid cover further comprises a first vent port and a first filter forming an interface sealed with an adjacent part of the rigid cover covering the first vent port.

3. The rigid sterilization system according to claim 1, wherein the base is a substantially flat surface.

4. The rigid sterilization system according to claim 1, wherein the base includes a rack system for holding the object.

5. The rigid sterilization system according to claim 1, wherein the base includes a plurality of sides, and the first sealing surface is disposed on the plurality of sides.

6. The rigid sterilization system according to claim 4, further comprising a gasket between the lower part of the rigid cover and the first sealing surface.

7. The rigid sterilization system according to claim 1, wherein the first sealing surface is disposed on the support surface, and the first sealing surface further comprises a gasket within the first sealing surface of the support surface.

8. The rigid sterilization system according to claim 1, further comprising a gasket fixed to the lower part of the rigid cover.

9. The rigid sterilization system according to claim 1, wherein the top panel includes a window for viewing the contents within the rigid sterilization system.

10. The rigid sterilization system according to claim 1, wherein the base is a back table in an operating room.

11. The rigid sterilization system according to claim 1, wherein the rigid cover is selected from the group consisting of thick aluminum and a medical grade plastic material.

12. The rigid sterilization system according to claim 1, further comprising a clamp for releasably fixing the rigid cover to the base.

13. The filter covering the vent opening further comprises a gasket surrounding the first filter, the first filter and the gasket form a filter cartridge, and the filter cartridge is removably fixed to the main body. The rigid sterilization system according to claim 1.

14. The rigid sterilization system according to claim 7, wherein the first vent opening is disposed in at least one of the top panel or the side panel.

15. The rigid sterilization system according to claim 1, wherein a lower portion of the rigid cover is disposed on the first sealing surface of the base, and a sealed interface is formed between the lower portion of the rigid cover and the base.

16. The base further comprises a groove for accommodating a gasket, the lower portion of the rigid cover further comprises an edge, and the edge engages with the gasket in the groove, thereby forming a peripheral seal between the edge and the base. The rigid sterilization system according to claim 1.

17. Furthermore, it comprises a plurality of bases and a rack having a plurality of shelves, Each base has the rigid cover and the continuous seal between the lower portion of the rigid cover and the first sealing surface, The rigid sterilization system according to claim 1, wherein each of the plurality of shelves is configured to hold one of the plurality of bases having the cover after sterilization in the sterilization device.

18. The rigid sterilization system according to claim 1, wherein the base is configured to be fixed to a transport cart.

19. A rigid sterilization system for use in a sterilization device to sterilize an object requiring sterilization, Formed of a material adapted to withstand exposure to a sterilizing agent, having a support surface having a portion configured to support an object requiring sterilization, and (ii) a base having a first sealing surface, A cover including a rigid material configured to maintain a selected shape, having a body portion and a lower portion, the body portion including a first vent opening and a first filter covering the first vent opening, and the lower portion being configured to form a sealed interface with the base. A continuous seal interface between the first seal surface of the base and the cover, which forms a continuous seal between the base and the cover. A rigid sterilization system comprising the same. **Claim 20** The rigid sterilization system according to claim 19, wherein the support surface of the rigid base is substantially flat. **Claim 21** The rigid sterilization system according to claim 19, further comprising a gasket between the lower part of the rigid cover and the first seal surface. **Claim 22** The rigid sterilization system according to claim 21, wherein the base further comprises a plurality of side portions, the first seal surface is disposed on the plurality of side portions, and the gasket is between the lower part of the rigid cover and the plurality of side portions. **Claim 23** The rigid sterilization system according to claim 21, wherein the first seal surface is disposed on the support surface, and the gasket is disposed on one of the first seal surface and the lower part of the rigid cover. **Claim 24** Furthermore, it comprises a plurality of bases and a rack having a plurality of shelves. Each base has the cover and the continuous seal between the lower part of the cover and the first seal surface. The rigid sterilization system according to claim 19, wherein each of the plurality of shelves is configured to hold one of the plurality of bases having the cover after sterilization in a sterilization device. **Claim 25** The rigid sterilization system according to claim 19, wherein the base is configured to be fixed to a transport cart.

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