Title: Tray Holder

This application claims priority to U.S. Provisional Patent Application Ser. No. 63/286,054 filed on December 5, 2021 and incorporated by reference herein in entirety.

FIELD OF THE INVENTION

[0001] The present invention relates to a tray holder. Moreover, the present invention is of a tray holder for an autoclave.

BACKGROUND OF THE INVENTION

[0002] Instruments such as surgical, medical, veterinary and dental tools are typically sterilized before use. A common sterilizer used is an autoclave, which employs steam sterilization. The items to be sterilized may be placed in containers or suitably wrapped in order to maintain their sterile state when in storage. The wrapped or unwrapped instruments are then placed on trays, which may be inserted into corresponding rails for the trays in the sterilization chamber to hold the tray and its contents in place. A sterilization cycle is run. Excessive condensation may be produced when the steam contacts the cold surfaces of the chamber and the items to be sterilized. The wrapped and unwrapped items must be completely dry, or they will not remain sterile. As such a drying stage must be included, but this is found to be time consuming and may take up to about an hour. This delay is problematic when quick reuse of the instruments is needed and when there is a need to sterilize a large number of instruments daily using the sterilizer. [0003] It would therefore be desirable to have an autoclave system which provides a faster sterilization cycle. It would be beneficial to have an autoclave system configured to dry the items being sterilized more quickly. It would also be advantageous if the faster drying could be realized without using more power. It would be further desirable if a method of using the system resulted in less condensation on the surfaces of the items being sterilized and the chamber for speedier drying. The present invention provides such a system and method of use thereof.

SUMMARY

[0004] The invention may have several aspects. One aspect is a tray holder for an autoclave. The tray holder may include a hollow conductive body defining an interior cavity, the shape of the external surface of the conductive body conforming to the shape of the internal surface of an autoclave chamber. The tray holder may include at least one tray support guide. The at least one tray support guide may be attached to the conductive body so that the at least one tray support guide is capable of receiving and holding a sterilization tray in a horizontal position in the hollow cavity. The tray holder may include a mechanism for reversibly shifting the hollow conductive body from a first arrangement with an interior hollow of a first size to a second arrangement with an interior hollow of a second size.

[0005] In various embodiments of the tray holder the first arrangement of a first size may provide optimal contact of the external surface of the tray holder with the internal surfaces of the autoclave chamber, and wherein the first size is larger than the second size. The tray holder may be shaped and sized for uniform contact between the external surface of the conductive body with the internal surface of the autoclave chamber. The at least one tray support guide may feature a pair of corresponding conductive tray support guides, which protrude into the cavity of the conductive body. Each of the at least one pair of corresponding conductive tray support guides may be positioned spaced apart in the same horizontal line, the distance between each support guide of a pair of support guides corresponding to about the length of an autoclave tray and wherein the at least one pair of corresponding tray supports may be positioned so that in the configuration of the tray holder with the first size, different pairs of a plurality of pairs of support guides are vertically spaced apart in a stack. The conductive body may have a thickness of from about 1 mm to about 4 mm. The at least one tray support may have a width of greater than about 10 mm. The conductive body may be made from a conductive material including at least one of aluminum, copper, magnesium and alloys thereof. The mechanism may include a spring. The conductive body may include a flexible material, which is configured with the properties of a spring. The conductive body may include a flexible material and the spring may be a rounded spring clip featuring a handle for manually bending the flexible conductive body to compress or extend the interior hollow. The hollow conductive body may be box shaped and the mechanism may feature a plurality of expandable walls with retractable extensions and a means for releasing the retractable extension in an expandable wall to form the first arrangement with an extended wall length and an interior hollow of the first size and for retracting the extension in the expandable wall to form the second arrangement with the non-extended wall length and an interior hollow of the second size. The mechanism may feature the conductive body, the conductive body including a material with a high thermal coefficient of expansion for expansion of the diameter of the conductive body on application of heat. The mechanism may further feature the thermal expansion properties of the conductive body, the conductive body including a material with a high thermal coefficient of expansion for expansion of the diameter of the conductive body on application of heat. The tray holder may be attached to the internal surface of the conductive body. The at least one tray support guide may be detachable from the tray holder.

[0006] In various embodiments of the tray holder the conductive body may feature a tubular body having a proximal end and a distal end defining a slit that allows the tubular body to be shifted from the first arrangement to the second arrangement by the mechanism. The conductive body, in cross-section perpendicular to the proximal to distal longitudinal direction may have a C-shape configuration. The width of the slit may be reduced by the mechanism. In the first arrangement the first size of the diameter of the interior hollow may be from about 280 mm to about 285 mm and in the second arrangement the second size of the diameter of the interior hollow may be from about 255 mm to about 273 mm. The mechanism may include a spring with two handles, the two handles attached to the proximal end of the conductive body and wherein each handle is attached to a different side of the slit.

[0007] In various embodiments of the tray holder, the tray holder may be a sterilization cart tray holder featuring at least one transport means for moving the sterilization cart tray holder. The conductive body may have a box shape, the box shape comprising closed side walls. The conductive body may include a plurality of walls. The mechanism may feature a plurality of expandable walls with retractable extensions and a means for releasing the retractable extension in an expandable wall to form the first arrangement with an extended wall length and an interior hollow of the first size and for retracting the extension in the expandable wall to form the second arrangement with the non-extended wall length and an interior hollow of the second size.

[0008] A further aspect is a sterilization system. The sterilization system may include an autoclave and a tray holder. The autoclave may feature at least one heating source and a sterilization chamber. The tray holder may feature a hollow conductive body defining an interior cavity, the shape of the external surface of the conductive body conforming to the shape of the internal surface of the sterilization chamber. The tray holder may feature at least one conductive tray support guide. The at least one conductive tray support guide may be attached to the conductive body so that the at least one conductive tray support guide is capable of receiving and holding a sterilization tray in a horizontal position in the hollow cavity. The tray holder may feature a mechanism for reversibly shifting the hollow conductive body from a first arrangement with an interior hollow of a first size to a second arrangement with an interior hollow of a second size. The at least one heating source may be external to and in contact with the external surface of the sterilization chamber and wherein the external surface of the tray holder conductive body may be configured in at least one arrangement to be in contact with the internal surface of the sterilization chamber. Heat from the heat source may heat the external and internal surfaces of the sterilization chamber and the heat may be conducted to the tray holder and wherein the heat conducted to the tray holder may be conducted to a tray held in the tray holder for heating the tray and items placed on the tray. The tray holder may be configured for drying items placed on the tray. The autoclave may be configured to dry items placed on the tray in less than about fifteen minutes. The sterilization system may include at least one sterilization tray and the at least one conductive tray support guide may feature at least one pair of corresponding conductive tray support guides for holding the at least one sterilization tray. The conductive body may include a material with a high thermal coefficient of expansion and the sterilization chamber may include a material with a relatively low thermal coefficient of expansion for expansion of the diameter of the conductive body on application of heat.

[0009] In various embodiments of the sterilization system the first size may provide optimal contact of the external surface of the tray holder with the internal surfaces of the sterilization chamber, and wherein the first size may be larger than the second size. The at least one conductive tray support guide may include a pair of corresponding conductive support guides which protrude into the cavity of the conductive body. The at least one tray support guide may be attached to the internal surface of the conductive body. The tray holder may be removable from the autoclave.

[0010] In various embodiments of the sterilization system the conductive body may feature a tubular body having a proximal end and a distal end defining a slit that allows the tubular body to be shifted from the first arrangement to the second arrangement by the mechanism and wherein the conductive body in cross-section perpendicular to the proximal to distal longitudinal direction may have a C-shape configuration. The tray holder may include at least one handle, and wherein a force applied to the at least one handle may narrow the slit to compress the diameter of the interior cavity from the first size of the first arrangement to the second smaller size of the second arrangement for releasing the tray holder from the attachment to the sterilization chamber for removal of the tray holder from the sterilization chamber.

[0011] In various embodiment of the sterilization system the tray holder may be a sterilization cart tray holder and the conductive body may feature a box shaped body featuring closed side walls. The conductive body may include a plurality of walls and wherein the mechanism may feature a plurality of expandable walls with retractable extensions and a means for releasing the retractable extension in an expandable wall to form the first arrangement with an extended wall length and an interior hollow of the first size and for retracting the extension in the expandable wall to form the second arrangement with the non-extended wall length and an interior hollow of the second size.

[0012] An additional aspect is an autoclave. The autoclave may include at least one heating source, a sterilization chamber and a tray holder. The tray holder may feature a hollow conductive body defining an interior cavity, the shape of the external surface of the conductive body conforming to the shape of the internal surface of the sterilization chamber. The tray holder may feature at least one conductive tray support guide capable of receiving and holding a sterilization tray in a horizontal position in the hollow cavity, the at least one tray support guide attached to the internal surface of the conductive body. The tray holder may feature a mechanism for reversibly shifting the hollow conductive body from a first arrangement with an interior hollow of a first size to a second arrangement with an interior hollow of a second size. The at least one heat source may be external to and in contact with the external surface of the sterilization chamber and the internal surface of the sterilization chamber may be in contact with the external surface of the conductive body.

[0013] A still further aspect is a method of sterilizing an item with steam. The method may include placing at least one item to be sterilized in the sterilization system of the present invention, wherein the item is placed on a tray held in the tray holder. The method may include heating the autoclave, providing steam to the heated autoclave for sterilization of the at least one item and drying the at least one item.

[0014] In various embodiments of the method, the method may include prior to the placing at least one item on the tray, inserting the tray holder into the sterilization chamber and inserting a tray into the tray holder so that the tray is received and held by the conductive tray support guides of the tray holder. The tray holder may include at least one handle and inserting the tray holder into the sterilization chamber may include applying a force to the at least one handle which compresses the diameter of the interior cavity from the first size of the first arrangement to the second smaller size of the second arrangement for placing the tray holder in the sterilization chamber and releasing the force applied to the at least one handle for returning the hollow conductive body to the first arrangement with the diameter of the interior cavity of the larger first size for contacting the external surface of the body of the tray holder with the internal surface of the sterilization chamber for attachment to the sterilization chamber. The method may further feature after drying the at least one item removing the tray holder from the sterilization chamber. Removing may include applying a force to the at least one handle which compresses the diameter of the interior cavity from the first size of the first arrangement to the second smaller size of the second arrangement for detaching the tray holder and moving the tray holder out of the sterilization chamber and releasing the force applied to the at least one handle for returning the hollow conductive body to the first arrangement with the diameter of the interior cavity of the larger first size. Heating the autoclave may include activating the heating source to heat the external and internal surfaces of the sterilization chamber and conducting the heat from the sterilization chamber to the tray holder. Conducting the heat may include raising the temperature of the hollow tray holder body, the tray holder body featuring a material with a high coefficient of expansion, thermally expanding the diameter of the tray holder and tighter contacting of the external surface of the thermally expanded tray holder conductive body with the internal surface of the sterilization chamber. The drying may include heating with the heating source the external and internal surfaces of the sterilization chamber and conducting the heat from the surface of the sterilization chamber to the tray holder. The drying stage my take less than about fifteen minutes. The at least one item may be wrapped.

[0015] In various embodiments of the method, the tray holder may be a sterilization cart tray holder and the conductive body may feature a box shaped body featuring closed, conductive side walls. The mechanism may include a plurality of expandable walls with retractable extensions and a means for releasing the retractable extension in an expandable wall to form the first arrangement with an extended wall length and an interior hollow of the first size and for retracting the extension in the expandable wall to form the second arrangement with the nonextended wall length and an interior hollow of the second size. The method may include inserting the sterilization cart tray holder into the sterilization chamber. Inserting may include inserting the sterilization cart tray holder in the arrangement with the non-extended wall length and the interior hollow of the smaller second size and applying a force to the means for releasing the retractable extension to form the first arrangement with an extended wall length and the interior hollow of the first larger size. The method may include removing the sterilization cart tray holder from the sterilization chamber after the drying. Removing may feature applying a force to the means for releasing the retractable extensions to retract the extensions and form the sterilization cart tray holder body in the arrangement with the nonextended wall length and the interior hollow of the smaller second size and removing the sterilization cart tray holder in the arrangement with the non-extended wall length and the interior hollow of the smaller second size.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The various features of the invention will best be appreciated by simultaneous reference to the description which follows and the accompanying drawings, which are not drawn to scale and in which: [0017] FIGs la, lb and 1c show schematic perspective views of exemplary tray holders according to aspects of the present invention;

[0018] FIGs 2a and 2b show schematic views of two states of an exemplary tray holder according to an aspect of the present invention;

[0019] FIGs 3a, 3b and 3c show schematic views of states of an exemplary tray holder according to an aspect of the present invention;

[0020] FIGs 4a-4g show schematic views of exemplary mechanisms for changing at least one dimension of the tray holder according to an aspect of the present invention;

[0021] FIGs 5a and 5b show schematic views of exemplary tray holders with tray supports according to aspects of the present invention;

[0022] FIGs 6a and 6b show schematic views of exemplary add-on tray supports according to an aspect of the present invention;

[0023] FIG. 6c shows a schematic view of an exemplary tray holder featuring exemplary add-on tray supports according to an aspect of the present invention;

[0024] FIG. 6d shows a schematic view of an exemplary body of a tray holder for accommodating an exemplary add-on tray support according to an aspect of the present invention;

[0025] FIG. 6e shows a schematic view of an exemplary tray holder according to an aspect of the present invention;

[0026] FIG. 7 shows a schematic view of an exemplary sterilization cart tray holder according to an aspect of the present invention;

[0027] FIG. 8 shows a schematic view of an exemplary autoclave and tray holder system according to an aspect of the present invention;

[0028] FIG. 9 shows a schematic view of an exemplary autoclave and sterilization cart tray holder according to an aspect of the present invention; [0029] FIG. 10 shows a schematic view of an exemplary autoclave with a fixedly attached tray holder system according to an aspect of the present invention;

[0030] FIGs I la and 11b show schematic side views of exemplary arrangements of conductive surfaces of the system without and with trays respectively according to an aspect of the present invention;

[0031] FIG. 12 shows a flow chart of an exemplary method of using a tray holder according to an aspect of the present invention;

[0032] FIG. 13 shows a flow chart of an exemplary method of using a sterilization cart tray holder according to an aspect of the present invention;

[0033] FIG. 14 shows a flow chart of an exemplary method of production of an exemplary tray holder according to an aspect of the present invention; and

[0034] FIG. 15 shows a flow chart of an exemplary method of production of an exemplary sterilization cart tray holder according to an aspect of the present invention.

DETAILED DESCRIPTION

[0035] In one aspect the present invention is of a tray holder device. The tray holder device is configured for use in an autoclave. In a further aspect, the present invention provides a sterilization system featuring an autoclave with a tray holder. In a still further aspect, the present invention provides a method of sterilizing using an autoclave system which employs the tray holder of the present invention.

[0036] The tray holder and autoclave system and method of use thereof of the present invention have many advantages. The system provides a shortened sterilization process for a faster sterilization cycle time, which allows more instruments to be sterilized daily. The shortened cycle time results in a reduction in energy consumption per cycle. The system is configured for faster drying of items sterilized using the system. The system may reduce the drying time of sterilization methods using autoclaves by up to about eighty percent. The tray holder is designed so that heat is conducted to it from the sterilization chamber surface. Moreover, the heated tray holder conducts heat to the attached trays and items placed on the trays. As such conduction is used to transfer by contact heat to the load. The tray holder is removable for optimal cleaning of it and the autoclave chamber. The tray holder can be configured as a sterilization cart tray holder for faster drying of the sterilization cart contents. The method of sterilization using the system of the present invention results in less wet surfaces, due to heating of the autoclave chamber, tray holder and items being sterilized before steam is applied. Pre sterilization heating may be done during the vacuum pulse stage of the cycle and since the heat is conducted to the solid conductive material of the tray holder and trays, the energy is not evacuated during the vacuum pulsing, as it is stored in the tray holder, trays and items to be sterilized, warming them. The direct contact of the surfaces of the autoclave chamber with the conductive tray holder and the contact of the conductive tray holder with the conductive trays ensures conduction of heat to all these surfaces. When steam is introduced, the steam contacting the hot surfaces produces less condensation than if the steam was applied prior to the heating stage and the steam would touch the cold surfaces. A further benefit is that the preheating may reduce the energy needed to heat the steam for providing a sufficient sterilization temperature of the items being sterilized, thus saving heating time and energy.

[0037] As used herein the term ‘sterilization chamber’ may include, but is not limited to a compartment or suitable cavity where sterilization may be carried out.

[0038] As used herein the term ‘sterilization device’ may include, but is not limited to a sterilizer, which features a sterilization chamber or any suitable cavity for placement of an item to be sterilized. The sterilizer may provide the sterilization chamber or suitable cavity with sterilization conditions, materials, and other means for facilitating a sterilization process and sterilization of items in the sterilization chamber. [0039] As used herein the term ‘sterilization’ may include, but is not limited to elimination, killing, removal or deactivation of biological agents, such as, but not limited to microorganisms, pathogens, bacteria, viruses, fungi, spore forms and prions from a specified region. Sterilization may be performed using a sterilization process and may run for longer than is required to provide a sterility assurance level. The term may include a process providing a sterility assurance level of at least 10’ ⁶ .

[0040] As used herein the term ‘disinfection’ may include, but is not limited to a process to destroy microorganisms on a specified region. The term includes a method, which is less effective than sterilization at killing microorganisms and may not kill all microorganisms on a specified area, such as resistant bacterial spores.

[0041] As used herein the term ‘sterilization cycle’ may include, but is not limited to at least one stage of a sterilization procedure. The sterilization cycle may include all the stages of the sterilization procedure or only at least one stage.

[0042] As used herein the term ‘steam sterilization cycle’ may include a plurality of stages, such as air removal, heating, sterilization, steam removal and drying. The air removal stage may include removing the air by methods, such as, but not limited to gravity, positive steam pulses and negative steam pulses with vacuum. The heating stage of the steam sterilization may include applying steam or water that is converted into steam for heating the load to the sterilization temperature. The sterilization stage may feature maintaining the temperature for a period of time approved for providing sterilization by use of steam or heated water. Removal of steam may be achieved by opening of a valve. The drying stage may include at least one of evacuating the steam, providing air, providing nitrogen and a vacuum.

[0043] As used herein the terms ‘first’ and ‘second’ in conjunction to the term ‘arrangement’ are used to differentiate between two different arrangements with different sizes. The larger arrangement may be referred to as the first arrangement when the narrower arrangement is referred to as the second arrangement. The larger arrangement can also be referred to as the second arrangement when the narrower arrangement is referred to as the first arrangement. [0044] As used herein the term ‘connection’ may include, but is not limited to direct and indirect attachment.

[0045] As used herein the terms ‘a’ and ‘an’ may mean ‘one’ or ‘more than one’.

[0046] As used herein the terms ‘comprising’, ‘including’, ‘containing’, ‘featuring’, ‘having’ and any forms of the terms thereof are inclusive and open ended and do not exclude additional elements or method steps, which are not recited.

[0047] The principles and operation of a tray holder and an autoclave tray holder system, as well as methods of use thereof according to the present invention may be better understood with reference to the figures. The figures show non-limiting aspects of the present invention.

[0048] The Tray Holder

[0049] The present invention provides a tray holder. The tray holder of the present invention may include a conductive body, at least one tray support for holding an inserted tray and a mechanism for shifting the body from a first arrangement to a second arrangement.

[0050] Figure la shows a schematic view of an exemplary tray holder 10 of the present invention. The tray holder 10 includes a body 12. The body 12 may be configured in any suitable shape. The body 12, such as but not limited to the external surface/s of the body may be configured into a similar shape as the internal surface/s of a sterilization chamber of an autoclave. The tray holder body may be shaped and sized for uniform contact between the external surface of the body with the internal surface of an autoclave chamber. Non limiting examples include a body 12 which is square, rectangular and round to be used respectively with a square, rectangular and round sterilization chamber.

[0051] The body 12 may be made as one complete part, which may feature for example side walls and a base. In some embodiments, the body 12 may be made from a plurality of connectable sections. Figure lb shows an example of a body featuring a plurality of connected sections. Figure lb, shows the body 12, which may include at least one section 13 about the base 15 of the body 12. The at least one section 13 may exhibit greater flexibility than the other sections of the body, which enables manipulation at these flexible sections 13 of the shape of the body 12 for easier placement of the tray holder 10 in an autoclave. As shown in the example of Figure lb, the body 12 may include two sections 13 about the base 15, which have greater flexibility than the side walls 17 of the body. The greater flexibility may be provided by the material from which these flexible sections 13 are manufactured and/or by a component such as a spring. In some embodiments, at least part of the base 15 of the tray holder 10 may be constructed as a separate part from the sides 17 of the tray holder for easier and cheaper production of the tray holder as shown schematically in Figure 1c. The separate constructed base 15 may then be connected by suitable connection means to the sides 17 of the body 12 of the tray holder 10 to form the complete body. The separate sides 17 and base 15 of the body 12 may be fixedly connected or may be detachable.

[0052] In some embodiments, the body 12 may be formed into a rounded tubular shape as shown in Figure la. The configuration may be a closed complete tubular configuration or a partially formed tubular configuration with an opening. The body may be shaped into a hollow configuration, whereby the body 12 surrounds a cavity 14. The body may have a proximal end 16 and a distal end 18. The proximal end 16 may be defined as the end of the body which when placed in an autoclave will be positioned in closer proximity to the opening, such as the door of the sterilization chamber and the distal end 18 may be defined as the body end which will be positioned in closer proximity to the back wall of an autoclave sterilization chamber. In some embodiments, such as shown schematically in Figure la, the body 12 may be a tubular body with a slit 20 defined extending from the proximal end 16 to the distal end 18 that allows the tubular body 12 to be shifted form a first arrangement to a second arrangement. The conductive body 12 in cross-section perpendicular to the proximal to distal longitudinal direction may have a C-shape configuration, such as shown in Figure 1 a. The longitudinal gap 22 defined by the slit 20 of the elongated C shaped rounded hollow tubular design may be disposed between the extremities 24 of the length of material forming the elongated C shape of the body 12 of the tray holder. The curve 26 of the body 12 may conform to the curve of a sterilization chamber. The body 12 of the tray holder may be made from any suitable material. The material may be flexible. A flexible material may be sufficiently rigid for holding the trays and load. The body 12 is made from a conductive material for conduction of heat. Non limiting examples of suitable conductive materials include aluminum, magnesium, copper and alloys thereof.

[0053] The body 12 may have any suitable dimensions for fitting into an autoclave chamber and contacting the internal surfaces of the autoclave chamber. The body 12 may include an external surface 28 and an internal surface 30. The body 12 may be designed so that substantially all its external surface/s 28 touch the internal surfaces of the autoclave chamber. In some embodiments, the body 12 may be designed so that at least one wall 28 contacts the internal surfaces of the autoclave chamber. The body 12 may be configured into at least two arrangements with different sizes of the tray holder body and/or the cavity formed by the body. In one embodiment when the body 12 is in a first arrangement, the hollow conductive body may have an interior hollow 14 of a first size, such that the tray holder body may have a first size. The body 12 may be shifted to a second arrangement in which the interior hollow 14 may have a second size such that the tray holder body may have a second size. The first size and the second size may feature a change in at least one dimension. The at least one dimension may be any suitable dimension such as but not limited to the diameter or length. In some embodiments, in one arrangement the size of the at least one dimension such as the diameter 32 (for a rounded shape) or length 36 (for a box shape) of the body 12, may be slightly larger than the corresponding dimension of the autoclave chamber in order to fit tightly against the walls of the sterilization chamber when inserted therein. Figure 2a and Figure 2b show the non-limiting example of a tubular body with a C-shape configuration in cross-section perpendicular to the proximal to distal direction. Figures 2a and 2b show respectively a first arrangement, the configuration with a diameter 32 of the interior hollow with a first size 34a and a second arrangement, the configuration with a diameter 32 of the interior hollow with a second size 34b. In such an example, the first sized diameter 34a may be equal to or larger than the diameter of an autoclave chamber for providing optimal contact of the external surface of the tray holder with the internal surfaces of the autoclave chamber. The optimal contact is necessary for optimal heat conduction from the surfaces of the autoclave chamber to the tray holder. The body 12 may be adapted to a configuration with a second sized diameter 34b wherein the second size 34b of the diameter may be smaller than the first size 34a of the diameter. The configuration of the body 12 with the second size may be narrower than the first sized configuration. A narrower or smaller configuration of the tray holder body may be conducive for insertion or removal of a tray holder from the sterilization chamber of an autoclave. The narrower body may not engage with the walls of the chamber facilitating movement of the body 12 for correct placement or removal of the tray holder body 12. The size of the tray holder and the tray holder body is related to the size of the sterilization chamber in which it is to be used. The narrower and wider body may respectively have any suitable sizes for insertion or removal from and fitting with contact in a sterilization chamber. The depth of the tray holder may be sized as close as possible to the depth of the sterilization chamber. In one non-limiting example the first size of the diameter may be from about 280 mm to about 285 mm and the second narrower size of the diameter may be from about 255 mm to about 273 mm. In one nonlimiting example the length of the conductive body elongated C shaped tube may be from about 350 mm to about 420 mm. In one non-limiting example the conductive body may have a thickness of from about 1 mm to about 4 mm. Figure 3a and Figure 3b show respectively the non-limiting example of a rectangular shaped tray holder body 12 in an arrangement, which is configured with a length 36 of the internal cavity of a size 38a and another arrangement, which is configured with a length 36 of the internal cavity of a size 38b. In this non limiting example, the body 12 may be shifted from the arrangement with a length 38a, which is smaller than the length of a square sterilization chamber to a body with the arrangement with a length 38b, which is a little wider or about the same size as the length of the square sterilization chamber into which it is, or will be placed. The length 38b, which is slightly wider than the chamber results in a tight fit with optimal contact for conductivity. As with the tubular tray holder body, a configuration of the box shaped tray holder body with a smaller length or diameter may be conducive for releasing a tray holder from being held firmly in the autoclave and for facile removal of the tray holder from the autoclave. A configuration with a smaller length or diameter may also be suitable for inserting the tray holder into an autoclave chamber. The box shaped tray holder body 12 may have a length 36, a depth 40 and a height 42. The cavity 14 of the box shaped tray holder body may have substantially the same dimensions as the box shaped tray holder body. The size of the depth 40 and the height 42 of the box shaped tray holder body may remain unchanged when the length of the tray holder body is changed.

[0054] In some embodiments, at least one of the configuration with the arrangement of the smaller size internal cavity 14 and the configuration with the arrangement of the larger size internal cavity 14 may be a temporary configuration. The arrangement may be formed by a mechanism for reversibly shifting the hollow conductive body from a first arrangement with an interior hollow of a first size to a second arrangement with an interior hollow of a second size. The mechanism may also shift the hollow conductive body from the second arrangement with the second size to the first arrangement with the first size. The mechanism may change at least one dimension of the conductive body from a first size to a second size or from a second size to a first size. The mechanism may be any suitable mechanism for reversibly changing at least one dimension of the tray holder body 12 and its internal cavity 14. In some embodiments, the mechanism may be designed to apply a force on the body to change the configuration of the body from a first arrangement to a second arrangement. The mechanism may be a manually activated mechanism or an automatically activated mechanism.

[0055] An exemplary mechanism may feature a spring 44. The spring 44 may be connected in any suitable way to the body 12 of the tray holder 10.

[0056] In one embodiment the spring 44 may be connected in any suitable way to two extremities 24 of the tray holder body 12 as shown schematically in Figure 4a. Figure 4a shows schematically one arrangement of a tray holder when no force is applied to the spring 44, such as when the tray holder is outside a sterilization chamber. In such an arrangement, the diameter of the tray holder 10 may be larger than the sterilization chamber into which the tray holder 10 is to be placed. A force can be applied to the tray holder body to contract the spring 44 forming a second configuration with a smaller diameter for insertion of the tray holder 10 into an autoclave. Release of the force facilitates formation of the tray holder 10 with the spring 44 in a more extended configuration as shown schematically in Figure 4b for optimal contact with the internal surfaces/s of a sterilization chamber 214.

[0057] In some embodiments the spring may be supplied by the spring properties of the material of the tray holder 10 as shown schematically in Figure 4c. Figure 4d shows schematically a tray holder 10 constructed from a material with properties of a spring, which is outside an autoclave in a configuration with larger dimensions than the chamber 214 of the autoclave into which it is to be placed. A force can be applied to the tray holder body to contract the dimensions of the tray holder for insertion into an autoclave chamber. Figure 4e shows schematically the tray holder 10 in a configuration after it has been inserted into an autoclave chamber and the force has been released so that the body 12 of the tray holder is pressed against the internal surfaces of the chamber 214 for optimal contact with the surfaces of the chamber 214.

[0058] An exemplary mechanism for reversibly shifting the hollow conductive body into different arrangements is shown schematically in Figure 4f. The mechanism includes a spring. The spring may be any suitable spring, such as, but not limited to a type of rounded spring clip. The spring may include or be applied in any suitable way to a material 52, which is flexible enough to be pliable into a compressed configuration when a force 54 is applied, but with a degree of stiffness compatible for a firm unchanging configuration when no force is applied and is sufficiently rigid to hold a sterilization tray and a load. In some embodiments, the spring may include at least one handle 56 or other suitable element, which can be manipulated, such as but not limited to manually manipulated, to apply a force 54 on the material 52 of the body 12 of the tray holder to compress or extend the interior hollow, which may compress or extend at least one dimension of the body 12. In the non-limiting example shown in figure 4f, the at least one dimension, which is changed by the mechanism, is the diameter of the cavity formed by the curved structure of the body of the tray holder. The at least one handle 56, or other suitable force applying element may be manipulated manually. In one non-limiting example the at least one handle 56, or other suitable force applying element may be electronically controlled. The at least one handle 56 may include a locking mechanism 58, as shown schematically in Figure 4g, which may hold the handles 56 together for maintaining the compressed or expanded configuration of the tray holder. The lock 58 may be released when the other configuration of the tray holder is desired. In some embodiments the other configuration may be the unstressed resting state of the tray holder. The locking component 58 may be any suitable lock, such as but not limited to a clip 58.

[0059] Figure 4f shows schematically the non-limiting example of an elongated C shaped tubular tray holder with a spring mechanism. The spring mechanism may include two handles 56. Each handle 56 may be attached to the corresponding proximal ends of each of the extremities 24 of the open ends of the elongated C shaped flexible tubular conductive body 12. Pressure 54 may be applied to the handles 56, such as squeezing them towards each other, which results in the flexible material of the body of the tray holder compressing to reduce the size of the slit 20, reducing the gap 22 between the two extremities 24 of the elongated C shaped tubular body 12, which results in a reduction of the diameter of the hollow cavity 14 of the tray holder body 12.

[0060] Another non-limiting example of a suitable mechanism, which can be used for elongating and contracting the tray holder body 12 is similar to a cake springform pan opening and closing interlocking clip means. The interlocking clip means (not shown) may be released to provide the wider body and the interlocking clip means may be locked to provide the narrower tray holder body. A tray holder with a cake pan clip means may include a gap, such as in the C shaped tubular tray holder or may be an O shaped tubular holder without a gap.

[0061] An exemplary mechanism for reversibly shifting the hollow conductive body into different arrangements may feature employing the thermal expansion properties of the tray holder and the autoclave. The mechanism may exploit the difference in the coefficient of expansion of the inner positioned tray holder and the externally positioned sterilization chamber. The material the tray holder is constructed from may have a high coefficient of expansion such as for example aluminum or magnesium. The sterilization chamber of the autoclave may be constructed from a material with a low coefficient of expansion such as, but not limited to stainless steel. As a result, when the autoclave is heated, the tray holder may expand and adhere tightly to the inner wall of the autoclave for optimal contact and conductive heat transfer. In some non limiting examples the thermal expansion may cause enlargement of the diameter of the tray holder from about 0.1 mm to about 0.5 mm. In some embodiments, the thermal expansion may not be sufficient for facilitating the contact needed for optimal conduction from the heater to the tray holder. In such embodiments a combination of mechanisms may be used, such as, but not limited to use of a spring as described hereinabove and use of the difference in thermal expansion properties of the materials of the system.

[0062] An alternative mechanism for expanding and contracting the tray holder is shown in Figures 3a, 3b and 3c. The figures show the hollow body 12 of a rectangular box shaped tray holder. The body of the tray holder 12 may include a box frame surrounding a cavity 14, the cavity 14 for accommodating trays in the tray holder. The side walls 70 of the box frame may be fixed in size and may be closed walls. The back wall 72, front wall 74, top wall 76 and bottom wall 78 may be reversibly expandable, such as, but not limited to longitudinally extendable. In some embodiments at least one of the back wall 72, front wall 74, top wall 76 and bottom wall 78 may be open and may be configured by a frame. The mechanism 80 for reversibly shifting the hollow conductive body from a first arrangement with an interior cavity 14 of a first size to a second arrangement with an interior hollow 14 of a second size may change at least one dimension of the body of the tray holder, such as for example the length 36. The mechanism 80 may include a plurality of expandable walls. The expandable walls may include at least one extension 82 of the bottom and top walls of the tray holder, the at least one extension 82 which may in one non-limiting example be held within the frame 84. The at least one extension 82 may be a retractable extension. The expandable walls may include an opening 86, which can be opened by a means for releasing the retractable extension to release the wall extension 82 held within. In some embodiments, the extension 82 may be configured as an extension of the frame. Figure 3c shows schematically the expandable frame and/or walls, with a non-extended length of LI plus L2. The frame 84 can be pulled apart at the opening 86 in any suitable way to open the frame 84 and/or connected walls, releasing the extensions 82 of a length L3, in the expandable walls to provide an expanded length of the frame and/or walls. The expanded length may be LI plus L2 plus L3. The tray holder body 12 may include at least one handle 90 or other suitable means configured for opening the frame and/or walls of the expandable walls and for releasing the extensions 82. The expanded length may be the same length as or slightly longer than the length of a similarly shaped sterilization chamber to contact and tightly fit external walls and/or surfaces of the box shaped tray holder with the internal surfaces of the sterilization chamber. In some embodiments, in one arrangement two walls of the box shaped tray holder are configured to contact the internal surface of the sterilization chamber. The two walls may be the side walls. The mechanism for reversibly changing from a first arrangement to a second arrangement of different sizes of the conductive body and the interior cavity may include a means for retracting the extension to revert to a wall with a length of the smaller size of LI plus L2. The mechanism 80 may be manually, automatically, electronically or mechanically operated.

[0063] The tray holder, sterilization system and methods using the tray holder may use more than one type of mechanism for reversibly shifting the tray holder from a first arrangement to a second arrangement for optimal contact of the tray holder with the sterilization chamber in order to facilitate conduction of heat to the tray holder and the trays and load held in the tray holder.

[0064] The tray holder of the present invention includes at least one tray support 100 capable of receiving and holding a sterilization tray in a horizontal position in the cavity of the tray holder. Exemplary tray holders with tray supports are shown schematically in the figures. Figure la and Figure 5a show different perspectives of an exemplary elongated C shaped tubular tray holder with tray supports 100. Figure 5b shows an exemplary box shaped tubular tray holder with tray supports 100. The at least one support 100 may be at least one pair of corresponding supports 100a, 100b. The at least one pair of corresponding supports 100a, 100b may be attached to the internal surface 30 of the body of the tray holder 12. The supports 100 may be any suitable protruding surfaces, which are attached to and project from the internal surface 30 of the body of the tray holder into at least part of the cavity 14 of the tray holder and which are configured so that they can hold a tray. The supports 100 may be of any suitable dimensions. The dimension of the supports 100 may be chosen for optimal holding of an inserted tray. The dimensions of the supports 100 may be selected for optimal conduction of the heat from the body of the tray holder to the supports and to a tray contacting the supports and held in the tray holder. The supports 100 may have a conductive surface, which is as large as possible for optimal contact with a tray and optimal heat conduction. The supports 100 may feature holes for releasing condensate and better penetration of steam. The length 106 of a support may extend from the proximal end to the distal ends or part thereof of the conductive body of the tray holder. The length 106 may be substantially the same as the depth of the conductive chamber in which the tray holder is to be used. In some embodiments the length 106 of the support may be the length of the tray holder. The length 106 may be at least the same or more than the side of the tray held thereon, such as the width of a tray to be inserted on the support for optimal contact with the entire length of the side of an inserted tray resting on the support. The support may be configured with a thickness which is sufficient for supporting the weight of the load. The width 108 of the support may be at least about 10 mm. A wider conductive support may provide more heat conduction. In one non limiting example the width of a single support may extend from one side of the tray holder to the opposite side, providing a shelf like support. In such a non limiting example the support is not a pair of corresponding supports, but is one shelf like support extending across the entire diameter of the cavity of the tray holder. Each of the pair of corresponding supports 100a, 100b may be attached spaced apart at a distance 102 sufficient to hold the length of a sterilization tray, which is to be supported by the supports. Each of the pair of corresponding supports may be attached in the same horizontal line for facilitating an inserted tray 140 held by each of the pair to lie horizontally in the cavity at about one hundred and eighty degrees as shown schematically in Figure 5a. The supports may also be configured to guide insertion of a tray into the autoclave holder. The supports may be configured to conduct heat from the wall of the tray holder body and are made of a conductive material. Non limiting examples of suitable conductive materials include aluminum and copper.

[0065] The tray holder 10 may have a plurality of pairs of tray supports 100 for insertion of a plurality of trays at the same time. In the non-limiting example shown in Figure la, the tray holder 10 has five pairs of tray supports 100. Each pair 100a, 100b of a plurality of pairs may be attached to the body of the tray holder such that when each tray is placed on a pair of supports, the tray lies horizontally and each tray of a plurality of trays inserted into a respective pair of corresponding supports 100a, 100b are stacked spaced apart. Each pair of supports 100a, 100b may be attached to the internal wall 30 of the tray holder so that the pairs 100a, 100b are in a spaced apart vertical stack. The arrangement of the at least one first size of the tray body and/or the arrangement of the at least one second size of the tray body may feature the spaced apart vertical stack of different pairs of support guides. The distance 104 between adjacent pairs of supports may be configured for sufficient room for items to be placed on the trays for sterilization.

[0066] The tray supports 100 may be integrally formed with the body 12 of the tray holder as shown in Figure la. In an alternative embodiment, the tray supports may be separate components from the tray holder body, which are attachable to the tray body and detachable therefrom. Figures 6a and 6b show schematically different views of a non-limiting example of an add-on 101 featuring at least one tray support 100, the add-on which is attachable to a tray holder 10. The add-on 101 may feature a plurality of tray supports 100 spaced apart on a frame 103. The tray supports 100 may be attached to the frame 103 at any suitable angle. Different angled attachment of the tray supports 100 to the same frame 103 may allow the same frame to be used in any suitable autoclave, but facilitate different distances 105 between adjacent tray supports. Figures 6a and 6b show non-limiting examples of add-ons 101 with different configurations and shapes of tray supports 100. The frame 103 may be configured to suitably attach to the tray holder 10 to provide the tray holder with at least one support for a tray. A plurality of add-ons 101 featuring tray supports 100 may be available with different spacing 105 between adjacent tray supports. The tray support add-on 101 may be selected according to the size and height of a load to be sterilized. Larger spacing between adjacent tray supports 100 of a tray support add-on 101 may be used for taller loads. In some embodiments two tray support add-ons 101 may be attached to the tray holder 10, such as to the body 12 of the tray holder as shown schematically in Figure 6c. One tray support add-on may be attached to one side wall 17 of the tray holder 10 and a second tray support add-on 101 may be attached to the opposing side wall 17 of the tray holder in line with the first tray support add-on to facilitate a tray when placed on the corresponding tray supports 100, to lie at a desired angle, such as at one hundred and eight degrees. The tray support add-ons 101 may be attached to the tray holder 10 by any suitable attachment means 107 which can facilitate providing the frame 103 of the tray support add-on in contact with the body 12 of the tray holder. Non-limiting examples of attachment means 107 include clips, snap fit connections, hooks, slots, recesses and rails. Figure 6d shows the body 12 of the tray holder featuring at least one recess 107a for attaching the tray support add-on, which is sized to accommodate the frame 103 of the add-on tray support 101 so that the add-on is held firmly in the recess of the tray holder 10 and is in contact with the wall 17 of the body of the tray holder for optimal heat conduction from the tray holder to the tray supports. Figure 6c shows the add-on tray support 101 attached to the body 12 of the tray holder. In a method of using the tray holder with a tray support add-on, the tray support add-on may be attached to the tray holder at any suitable time. In some embodiments, the tray support add-on may be attached before insertion of the tray holder into an autoclave. Figure 6e shows a tray holder 10 featuring two tray support add-ons 101 and trays 140 held on the tray support guides 100 of the addons. In the example shown in Figure 6e the add-ons 101 provides tray supports 100 for three trays 140. The tray holder 10 may include a combination of integrally formed tray support guides 100 and add-on tray supports 101. In the non-limiting example of Figure 6e, the tray holder 10 features two integrally formed tray supports 100a on each side wall 17 of the tray holder 10, in addition to the tray supports 100b of the add-ons 101 on which trays 140 are supported.

[0067] In one embodiment (not shown) the add-on tray support may feature only one tray support attached to the frame. Such one tray support add-ons may be attached to the tray holder at any suitable position without the user being hindered by any fixed spacing between adjacent tray holders.

[0068] In one embodiment, the tray holder may be configured as a sterilization cart tray holder as shown schematically in Figure 7. The sterilization cart tray holder 110 may have any suitable shape. In one embodiment, the sterilization cart tray holder has a rectangular box shape. The rectangular box shaped sterilization cart tray holder may be configured for use with a similar box shaped sterilization chamber. The sterilization cart tray holder 110 may include a body 112, which may be a hollow body 112. The sterilization cart tray holder body may include a plurality of walls. The plurality of walls may include side walls 114, a bottom wall 116, a top wall 118, a front wall 120 and a back wall 122. The body 112 of the sterilization cart tray holder 110 may be constructed from a conductive material, similarly to that described for the non cart tray holder hereinabove. The side walls 114 may be closed walls of conductive material. The other walls may be open conductive walls. In some embodiments, at least one of the other walls may be closed walls, or may be walls which can be closed, such as with doors. The open walls may feature a conductive frame 124. The other walls may feature a conductive frame 124 and together with the sides wall may be configured to surround and form a box shaped internal cavity 126. The other walls may be expandable walls. The dimensions of the sterilization cart tray holder 110 may be determined according to its end use and the size of the sterilization chamber in which it is employed. The sterilization cart tray holder may be large and too heavy to be carried by hand. The bottom wall may include on its underside or at any suitable position, transport means such as wheels 128 or equivalent means for moving and transporting the sterilization cart tray holder 110 along a surface.

[0069] The sterilization cart tray holder 110 may include a mechanism 130 for shifting the hollow conductive body from a first arrangement with an interior cavity of a first size to a second arrangement with an interior cavity of a second size. The shifting may change at least one dimension, such as but not limited to the length 134, of the tray holder. The mechanism 130 may be configured for reversible changing of at least one dimension of the body 112 of the sterilization cart tray holder 110, which may result in a reversible change of the dimension of the cavity 126 of the sterilization cart tray holder. The mechanism 130 may include a plurality of expandable walls with extensions 82 as schematically shown and described in Figures 3a, 3b and 3c. The extensions 82 may be retractable extensions. The extensions 82 may be configured as extensions of at least one of the frame 124, or extensions of an entire wall. The mechanism 130 may feature extensions 82 of the frame 124 disposed about the top, bottom, front and back walls. In some embodiments, the extensions 82 may be held in any suitable way, such as, but not limited to within the non-extended frame 124, above the non-extended frame 124 and under the non-extended frame 124. The non-extended frame 124 and/or walls may include a cavity 136 for accommodating the extensions 82. The non-extended frame 124 and/or non-extended walls may include openings 86, the extremities of which can be parted to release the extensions 82. The openings 86 may be opened and closed by any suitable manipulation, which may be manual or automatic. The mechanism 130 may include at least one component 150 for manipulating the extension and contraction of the body 112, such as but not limited to sliding, switching or turning an element connected to the opening 86, for opening and releasing the retractable extension 82. The released extended extensions 82 may be disposed to attach between the extremities of the openings 86 for providing an extension section 92 of a wall and providing the sterilization cart tray holder 110 with an arrangement having a configuration featuring an expanded length as previously described. The expanded length may equal the non-extended length plus the length of the extension. The length of the extended configuration of the sterilization cart tray holder 110 may be the same as, or slightly more than about the length of the sterilization chamber cavity and may provide contact between the conductive side walls 114 of the sterilization cart tray holder 110 and the internal surfaces of the sterilization chamber. The contact may facilitate conduction of heat to the surfaces of the sterilization cart tray holder.

[0070] The sterilization cart tray holder 110 may include at least one support 100 capable of receiving and holding a sterilization tray in a horizontal position as described hereinabove and in Figure 5b. The sterilization cart tray holder 110 may include at least one sterilization tray 140. The sterilization cart tray holder 110 may include a plurality of trays 140 for sterilization of items placed on the tray. In one embodiment, the trays 140 may be sized to fit the arrangement with the nonextended configuration of the sterilization cart tray holder 110. The trays 140 may be placed in or on the tray supports 100 before the sterilization cart tray holder 110 is expanded. In such an embodiment, the tray supports 100 may be sufficiently wide to hold the trays 140 after and during extension of the relevant walls of the tray holder 110. The trays 140 may not be in contact with one or both of the side walls 112 of the sterilization cart tray holder 110 in such an expanded configuration. The heat may be conducted from the sterilization chamber walls to the conductive walls and conductive frame of the sterilization cart tray holder which are in contact with the chamber walls. The heat may be conducted from the sterilization cart tray holder conductive walls and frame to the conductive tray supports 100 and from the tray supports 100 to the trays 140 and the load of items held on the trays.

[0071] In some embodiments a sterilization cart tray holder may have a rounded configuration, such as schematically shown in Figure la with a movement means 128, such as but not limited to wheels attached to the underside. A tubular shaped sterilization cart may be suitable for use with a similar shaped sterilization chamber.

[0072] The Autoclave Tray Holder System

[0073] The present invention provides an autoclave tray holder system 200. The system includes an autoclave 210 and a tray holder 212.

[0074] The autoclave 210 may be any suitable autoclave. The autoclave may be an autoclave for steam sterilization. The autoclave may include any known elements needed for steam sterilization, such as, but not limited to a pressure vessel with at least one door, a control system and a vacuum steam to admit steam or generate steam. The autoclave may be for sterilization of any suitable instrument, such as but not limited to medical, surgical and veterinary instruments.

[0075] The autoclave 210 includes a sterilization chamber 214. The sterilization chamber 214 may be of any suitable dimensions and shape. Non limiting examples of the internal shape of an autoclave sterilization chamber include round, square and rectangular. In some embodiments the autoclave 210 may have a rounded sterilization chamber 214, wherein the walls are curved as shown schematically in Figure 8. In some embodiments, the autoclave 210 may have a square sterilization chamber 214 as shown schematically in Figure 9. Figure 9 shows schematically an exemplary rectangular sterilization cart tray holder 110 held in a sterilization chamber 214 according to an aspect of the present invention. The sterilization chamber 214 may be made of any suitable material. The material may be a conductive material. Non limiting examples include aluminum, copper, aluminum alloys, copper alloys and polymers with heat transfer additives. In some embodiments, the sterilization chamber may be made from a material with a low coefficient of expansion, such as, but not limited to stainless steel.

[0076] The autoclave 210 includes a heating device 216. The heating device 216 may include a heat source. The heating device 216 may be configured for optimal heating of the sterilization chamber 214. The heating device 216 may be in contact with the external surface of the sterilization chamber 214 for conduction of heat to the sterilization chamber. The heating device 216 may be configured as a heating jacket. In some embodiments, the heating jacket may surround and may contact the external walls of the sterilization chamber. In some embodiments the heating jacket may not surround and contact the door of the sterilization chamber. The heating device 216 may employ any suitable source of heat. Non-limiting examples include use of steam or hot water flowing in tubes, electrical heaters that use electric power for heating and a double walled mechanism similar to the one used in a thermos flask, where steam flows between the internal wall of the jacket and the external wall of the chamber. In some embodiments, between about 10 percent to about 30 percent of the energy needed to increase the temperature of the load to the sterilization temperature is generated from the conducting heating system.

[0077] The autoclave 210 includes a tray holder 110 of the present invention. In some embodiments, the tray holder may be a sterilization cart tray holder. The tray holder may include a conductive body, at least one support for holding an inserted tray and a mechanism for reversibly shifting the hollow conductive body tray holder from a first arrangement with an interior hollow of a first size to a second arrangement with an interior hollow of a second size. To avoid repetition, the tray holder is substantially as described hereinabove under the heading ‘The Tray Holder’. The tray holder is positioned so that it is in contact and is flush against the interior wall of the sterilization chamber. The external surface of the body of the tray holder, such as, but not limited to side walls and the frame may be in direct contact with the internal wall/s of the sterilization chamber. The tray holder is configured in a similar shape as the sterilization chamber and the tray holder may conform to the curve of the chamber surfaces for optimal contact. The tray holder may have a configuration which is sized for an optimal tight fit against the chamber surface for optimal conduction of heat from the sterilization chamber walls to the tray holder. The tray holder may be sized for fitting against the sterilization chamber wall so that when it adopts this size it cannot move from its position contacting the chamber wall. The tray holder may be removable from the sterilization chamber. [0078] In one embodiment, the tray holder may be fixedly attached to the autoclave so that it is not removable as shown schematically in Figure 10. In such an embodiment, the tray holder 212 may be fixedly attached to the internal wall of the sterilization chamber 214 in any suitable way. Non-limiting examples of suitable attachment means 220 include screws, nails and conductive adhesive. A fixed tray holder 212 may not need a mechanism for shifting the tray holder from a first arrangement with an interior cavity of a first size to a second arrangement with an interior cavity of a second size. A fixed tray holder may include a tray holder body, which is made of a conductive material. The conductive body may be configured in the shape of the sterilization chamber and sized so that its length is at least that of the width or length of a sterilization tray to be held in the tray holder. The length or diameter of the tray holder cavity may be equal to the length or diameter of the cavity of the sterilization chamber. In some embodiments of a fixed tray holder, the tray holder may include a mechanism for changing at least one dimension of the tray holder for facilitating the initial insertion of the tray holder into the sterilization chamber before being fixedly attached to the surface/s of the sterilization chamber. A non-detachable tray holder of the present invention may have improved conductivity compared to the removable tray holder, as a result of optimal contact with the chamber surfaces.

[0079] The autoclave tray holder system may include at least one tray 140. The at least one tray 140 is configured for holding items to be sterilized. The load may rest on the at least one tray 140 so that it touches the at least one tray 140. The at least one tray 140 may be made from any suitable material. The at least one tray 140 may be made from a conductive material. Non limiting examples of suitable materials include aluminum, copper, magnesium and alloys thereof. The at least one tray 140 may be of suitable dimensions to be inserted into a sterilization chamber 214 of an autoclave 210. The at least one tray 140 may be of suitable dimensions to be held in the tray holder 212 of the present invention, such as by the supports of the tray holder. The at least one tray 140 may be of any suitable design. The at least one tray 140 may be made of a solid length of material. In some embodiments the at least one tray 140 may be configured in an open net configuration. A net configuration may provide better steam penetration. [0080] The autoclave and tray holder system is configured for optimal conduction of heat from the heating means to the trays held by the tray holder and the items placed on the trays. Heat from the heating means heat the external and internal surfaces of the sterilization chamber and the heat may be conducted to the tray holder. Heat may be conducted from the tray holder to heat a tray in the tray holder and items placed on the tray. This is achieved by contact between the conductive body of the tray holder and the internal wall/s of the sterilization chamber. The tray holder may be in contact with the sterilization chamber surface/s so that there is no gap between the external surface of the tray holder body and the internal wall of the sterilization chamber. The conductive body of the tray holder is configured to conduct heat to the attached tray supports. Figures I la and 11b show schematic side views of exemplary arrangements of conductive surfaces of the system without and with a tray respectively, according to an aspect of the present invention. In Figure I la it can be seen that the internal surface of the heating means 216 contacts the external conductive surface of the sterilization chamber 214 and that the internal conductive surface of the sterilization chamber 214 contacts the external conductive surface of the tray holder 212. The conductive tray supports 100 are attached to the conductive body of the tray holder 212. Heat can therefore be effectively conducted from the heating means 216 to the tray holder 212. Figure 11b shows schematically sterilization trays 140 made from a conductive material, which are held by the tray holder system. The heat conducted to the tray holder 212 and its supports 100 may then be conducted to the attached trays 140 and to any items 222 held on the trays 140 for sterilization in the sterilization device. The trays 140 and contents 222 supported on the trays 140 may be heated up in this way. Similarly, the tray holder 212 may be configured to conduct heat for drying items placed on a tray 140 held by the tray holder 212. An autoclave of the present invention as herein described may be configured to dry items 222 placed on a tray 140 in less than about fifteen minutes.

[0081] Method of Using A Tray Holder [0082] The present invention provides a method of sterilizing an item using a tray holder system of the present invention 300 as shown schematically in Figure 12. The order of the steps is not meant to be limiting and any suitable order may be used. A tray holder of the present invention may be inserted into a sterilization chamber of an autoclave 302. Inserting may include compressing the tray holder from a first arrangement, which may be a resting state into a compressed second configuration 304. The compressed dimensions, which may be smaller than the first state may facilitate more facile insertion of the tray holder through the door of the sterilization chamber and correct positioning of the tray holder in the chamber. The tray holder may include a mechanism for reversibly shifting the hollow conductive body from a first arrangement of a first size to a second arrangement of a second size. The mechanism may change at least one dimension, such as, but not limited to the diameter of the cavity of the body of the tray holder from a first size to a second size. The mechanism may include a means to apply a pressure to the flexible material from which the tray body is constructed. The mechanism may be manually operated or may be automatic. The body may be in a configuration which can be compressed for reversible reduction of at least one dimension by the applied pressure to the body. A handle connected to the flexible body may be configured for applying pressure to the body so that it can bend as required. In one non limiting example the tray body is in an elongated C shaped hollow, open tubular configuration with a longitudinal gap between the proximal and distal extremities of the elongated C shaped tube. At the same proximal end of each extremity a handle is attached. Applying a force to the handles, by for example squeezing them together may reduce the diameter of the cavity formed by the C shaped tubular body. The compressed tray holder may be placed in the sterilization chamber. Insertion may include placing the tray holder so that the tray supports of the tray holder are positioned for receiving trays to rest on the supports so that they are level and horizontal at about one hundred and eighty degrees. The sterilization chamber may include markings for correct placement of the tray holder. The sterilization chamber may include at least one attachment means for positioning the handles and temporarily attaching the handles in the chamber for correct positioning of the tray holder. In one non-limiting embodiment, the handles are positioned so that the handles and the slit are adjacent to the top wall of the sterilization chamber. In some non-limiting embodiments the tray holder may be configured so that the handles and the slit are positioned adjacent to the bottom wall or a side wall of the sterilization chamber. The force may be released. Releasing the compressing force on the tray holder, such as but not limited to releasing a force applied to at least one handle, may restore the tray holder to its former configuration and size which may be a resting expanded configuration with dimensions for a tight fit of the external surfaces of the tray holder body contacting the walls of the sterilization chamber 306. This method of insertion may ensure optimal and uniform contact between the internal walls of the chamber and the external surface of the tray holder body. Trays may be inserted into the tray holder. The trays may be inserted so that they are held by the tray support guide. In one embodiment a tray is supported by a pair of corresponding conductive tray support guides. The trays may be positioned so that they are in contact with the tray supports and may sit on the tray supports of the tray holder. In some embodiments the trays may be inserted into the tray holder before the tray holder is inserted into the sterilization chamber. In such embodiments, the size of the tray holder may be changed by the mechanism while the trays are supported in the tray holder. Items to be sterilized may be wrapped or unwrapped and may be placed on a tray of the tray holder. The door of the chamber may be closed.

[0083] A sterilization cycle may be selected and run 308. Prior to introduction of steam the sterilization chamber may be heated 310. A heat source may be external to the sterilization chamber and may be disposed so that it is in physical contact with the external surface of the sterilization chamber to conduct heat to the sterilization chamber. The heat may be conducted to the tray holder which is in contact with the internal surface of the chamber. Heat from the tray holder body may be conducted to the connected tray supports and the attached trays for heating the trays and the items placed on the trays. The trays may be heated to any suitable temperature. In some embodiments, in the pre sterilization phase the sterilization chamber is heated to from about 120 °C to about 135 °C and by conduction the connected trays may reach about the same temperature. A load placed on the heated tray may be heated to from about 50 °C to about 100 °C. As such in the phase where steam is introduced into the chamber the steam only needs to raise the temperature of the load from the pre sterilization stage load temperature of between about 50 °C to about 100 °C to the sterilization temperature of from about 120 °C to about 135 °C. In a method, which does not use the tray holder of the present invention the same heat may heat the trays to about 20 to 40 °C less. The pre sterilization heating stage may be for any suitable length of time. In some embodiment, the pre sterilization heating is from about two minutes to about ten minutes. Steam may then be introduced for sterilizing the items placed on the trays 312. Stream contacting the previously heated surfaces may produce less condensation than if the surfaces had been unheated. At the end of the sterilization cycle the contents are dried 314. The sterilization chamber is heated to dry the chamber and its contents and the heat is conducted as in the pre sterilization heating 316. However, since the temperature of the load pre sterilization is less than after sterilization, the heat conduction pre sterilization may be greater than in the drying stage. The configuration and good heat conducting materials of the tray holder and its position, which may be in direct contact with the heated sterilization chamber, results in effective conduction of heat to the trays and items sterilized, for drying the items. During the drying, the trays may maintain a temperature of about 10°C less than the sterilization temperature. In some non-limiting examples the sterilization temperature is from about 132°C to about 134°C. In a method, which does not use the tray holder of the present invention the temperature in the drying stage of the instruments being sterilized may be about 20 to 40 °C lower. The effective conduction and the smaller amount of condensation produced by the method of the present invention facilitate a quicker drying time than using methods of the art. In some embodiments the duration of the drying stage may be set according to (a) a fixed time, which may be calculated according to the drying time of a worst case load, or (b) sensing the dryness of the load by sensors, or (c) a combination of (a) and (b) with or without an additional period of time. The sterilized, dry items may be removed and stored before use. [0084] The tray holder may be removed 318. The trays may be removed from the tray holder. In some configurations of the tray holder, such as the tubular tray holder, the trays may be removed before removal of the tray holder from the sterilization chamber. In other configurations, the trays may be removed before or after the tray holder is removed from the sterilization chamber. Removing the tray holder may include compressing the tray holder from its wider expanded state into a compressed configuration 320. The compression may facilitate more facile removal of the tray holder through the door of the sterilization chamber. Compression may be achieved as described above for inserting the tray holder, such as by applying a force to the tray holder and handles, which may be done manually, or automatically. In an embodiment wherein the mechanism incudes at least one handle, a force may be applied to the at least one handle to compress the diameter of the cavity from the wider size to the second compressed size for releasing the tray holder from the attachment to the sterilization chamber for removal of the tray holder from the sterilization chamber. When the tray holder is out of the sterilization chamber, the force may be removed so that the tray holder reverts to its non-compressed state 322. Removal of the force may be done by removing a manual force or may be done automatically.

[0085] The present invention provides a method of sterilizing an item using a tray holder cart system of the present invention 350 as shown schematically in Figure 13. The order of the steps is not meant to be limiting and any suitable order may be used. Trays may be inserted into the cart tray holder such that the trays sit in or on the tray supports attached to the body of the cart tray holder. The trays of the tray holder may be loaded with items for sterilization, which may be wrapped or unwrapped. Wrapping may include placing items in containers, pouches or bags or other suitable holders configured to withstand the conditions of a sterilization cycle. A sterilization cart tray holder of the present invention may be inserted into a sterilization chamber of an autoclave 352. The cart tray holder may be wheeled and lifted in any suitable way into the sterilization chamber. The cart tray holder may be a boxed shaped cart tray holder as described hereinabove. Inserting may include inserting the sterilization cart tray holder in a non-expanded configuration for better fit through the door of the sterilization chamber and correct positioning of the cart tray holder in the chamber 354. In one non-limiting example, wherein the sterilization cart tray holder features retractable extensions, the extensions may be retracted so that the sterilization cart tray holder has an arrangement with a smaller size for insertion into the sterilization chamber. The cart tray holder may include a mechanism for reversibly shifting the hollow conductive body from a first arrangement with an interior cavity of a first size to a second arrangement with an interior cavity of a second size. The mechanism may change at least one dimension of the body of the tray holder and the cavity formed by the body of the tray holder from a first size to a second size. The mechanism may be manually controlled or may be automatic. The control of the mechanism may be connected to the cart tray holder. In one embodiment, the control may be connected to and monitored by the autoclave. The control may be a separate control from that controlling the sterilization cycle. The mechanism may include cart tray holder side extensions which can be manipulated by a means as described hereinabove to extend the length of the cart tray holder. The sterilization cart tray holder may be extended for contacting and firm attachment of the conductive side walls to the corresponding interior surfaces of the sterilization chamber 356. Manipulation may be achieved by application of a suitable force for causing the release of the extensions to form the extended configuration of the sterilization cart tray holder. The cart tray holder with an extended configuration may be placed so that the walls and frame of the body of the cart tray holder are in contact with the internal walls of the sterilization chamber. The expanded configuration may result in the inserted trays, which may be narrower than the expanded diameter of the tray holder, not being in direct contact with one or both of the side walls of the body of the cart tray holder. The width of the tray supports may be sufficiently wide to hold the trays in the expanded configuration of the tray holder. The door of the chamber may be closed 358.

[0086] A sterilization cycle may be selected and run 360. Prior to introduction of steam the sterilization chamber may be heated 362. The system may be heated for any suitable length of time. In some embodiments, the system may be heated for from about two minutes to about ten minutes. The system may be heated to a suitable temperature. The heating may cause thermal expansion of the body of the cart tray holder for tighter contact of the cart tray holder with the sterilization chamber walls and optimal heat conduction between the surfaces. In some embodiments, in the pre steam sterilization stage the system is heated to a temperature of from about 120 °C to about 135 °C and by conduction the connected trays may reach about the same temperature. A load placed on the heated tray may be heated to from about 50 °C to about 100 °C. As such in the phase where steam is introduced into the chamber the steam only needs to raise the temperature of the load from the pre sterilization stage load temperature of between about 50 °C to about 100 °C to the sterilization temperature of from about 125 °C to about 140 °C. In a method, which does not use the tray holder of the present invention the same heat may heat the load to about 20 to 40 °C less.

[0087] A heating means may be external to the sterilization chamber and may be disposed so that it is in physical contact with the external surface of the sterilization chamber to conduct heat to the sterilization chamber. The heat may be conducted to the cart tray holder which is in contact with the internal surface of the chamber. Heat from the tray holder may be conducted to the connected tray supports and the attached trays for heating the trays and the items placed on the trays. Steam may then be introduced for sterilizing the items placed on the shelves 364. Stream contacting the previously heated surfaces may produce less condensation than if the surfaces had been unheated. At the end of the sterilization cycle the contents are dried 366. The sterilization chamber is heated to dry the chamber and its contents and the heat is conducted in a similar way as in the pre sterilization heating 368. Since the temperature of the load pre sterilization is less than after sterilization, the heat conduction pre sterilization may be greater than in the drying stage. The configuration and materials of the cart tray holder and its positioning to be in direct contact with the heated sterilization chamber, results in effective conduction of heat to the trays and items sterilized, for drying the items. The effective conduction and the smaller amount of condensation produced by the method of the present invention facilitate a quicker drying time than using methods of the art. In some embodiments, the drying time may be about fifteen minutes, compared to about thirty minutes when using an autoclave without the conductive tray holder of the present invention. In some embodiments the duration of the drying stage may be set according to (a) a fixed time, which may be calculated according to the drying time of a worst case load, or (b) sensing the dryness of the load by sensors, or (c) a combination of (a) and (b) with or without an additional period of time. The cart tray holder and the sterilized, dry items held on its shelves may be removed from the sterilization chamber 370.

[0088] Removing the tray holder may include compressing the tray holder from its arrangement in an extended state into the non-extended configuration. The compression may facilitate more facile removal of the cart tray holder through the door of the sterilization chamber. Compression may be achieved as described above for inserting the sterilization cart tray holder, such as, but not limited to by manipulating the cart tray holder to retract the extensions and close the openings in the extended walls to return to the non-extended dimensions 372. Manipulating may include applying a force to the means for releasing the extensions which may retract the extensions and form the configuration of the sterilization cart tray holder body with non-extended walls. The sterilization cart tray holder may be removed in the configuration with the extensions retracted and the walls not extended. The compression and extension may be done manually or automatically. The cart tray holder may be removed and transported manually or electronically. The removal may be controlled remotely.

[0089] The method of the present invention uses conduction of heat from the heat source via the tray holder to the trays and the load on the trays. Good conduction is achieved by employing good heat conducting materials in the tray holder and the trays. Good conduction also results from using a heat source configured in such a way as to provide a large contact area with the sterilization chamber. Conduction is also optimized by ensuring good contact between each adjacent surface, such as between the heat source and the sterilization chamber, between the sterilization chamber and the body of the tray holder, between the tray holder supports and the trays and between the trays with the load. Improved heat transfer also results from using tray supports and trays with a large cross-sectional area and thickness.

[0090] Production Of A Tray Holder

[0091] The present invention provides a method of production of a tray holder 400 as shown schematically in Figure 14. A length of a material which is suitably conductive and has flexible spring like properties is provided. Non limiting examples of suitable materials include aluminum and copper. The metal may be formed into a configuration that wraps around a central cavity to produce the body of the tray holder 402. In some embodiments the conductive material is formed into an elongated C shaped tubular configuration. The width of the gap produced by the slit, which extends from the proximal end to the distal end of the elongated C shaped tubular configuration may be determined to allow for sufficient compression of the elongated C shaped tube for easy insertion into a sterilization chamber. The width of the gap may also be determined so that the diameter of the central cavity of the non-compressed arrangement is the same or slightly more than the diameter of the sterilization chamber into which the tray holder will be placed. In some embodiments, the mechanism to reversibly shift the tray holder from a first arrangement with a first size to a second arrangement with a second size includes a component to assist in applying a force to the tray holder spring body. In such embodiments, handles or other suitable means which can be manipulated to compress or expand the flexible tray holder body may be attached to the tray holder body 404. The handles may be attached to any suitable position of the tray holder body. In one embodiment, wherein the body is in an elongated C shaped tubular configuration, two handles may be attached and each of two handles may be attached to the same end, such as the proximal end of a different extremity of the elongated C tubular body.

[0092] Tray supports may be attached to the internal surface of the body of the tray holder 406. The tray supports may feature a pair of corresponding supports for supporting one tray. A plurality of tray supports may be attached to the internal surface of the tray holder. The tray support may be constructed from a length of conductive material which is formed into a bracket or a ledge or any suitable shape for supporting a tray and attached so that it protrudes into the central cavity of the tray holder. A tray support may be attached to extend from the proximal end to the distal end of the body of the tray holder. A pair of corresponding supports may be attached spaced apart and in the same horizontal line so that a shelf resting on them will be level 408. The distance between each support of the pair is equivalent to about the diameter of the cavity. The length of the support may correspond to the length from the proximal end to the distal end of the tray holder and may be sufficiently long to hold the corresponding side of a tray inserted into the tray holder. The dimensions of the tray supports may be determined for stable holding of a tray and for efficient conduction of heat from the tray holder to the held tray and the items placed on the tray for sterilization.

[0093] The present invention provides a method of production of a sterilization cart tray holder 450 as shown schematically in Figure 15. A length of a material which is suitably conductive and flexible is provided. Non limiting examples of suitable materials include aluminum and copper. The metal may be formed into a box configuration that wraps around a central cavity to produce the body of the tray holder 452. In some embodiments, the side walls may be closed side walls and the other walls may feature a frame. The size of the box is determined for holding sterilization trays and for an easy fit through the door of a sterilization chamber. The frame of the box shaped body may be hollow with a central opening along each wall. In some embodiment, the closed side walls may not have a central opening. Extensions of the frame may be attached in the hollow of the central openings 454. The extensions are sized so that the extended cart tray holder will have the same as or slightly wider dimensions than the interior of a sterilization chamber and so that the walls of the cart tray holder will contact the interior surfaces of a sterilization chamber in which it is placed. A mechanism is also attached for manipulating the extensions to retract and release them for a contracted or extended configuration of the cart tray holder. [0094] Tray supports may be attached to side walls so that they protrude from the internal surface of the body of the tray holder into the cavity 456. The tray supports may feature a pair of corresponding supports for supporting one tray. A plurality of tray supports may be attached to the internal surface of the tray holder. The tray support may be constructed from a length of conductive material which may be formed into a bracket or a ledge or any suitable shape for supporting a tray and attached so that it protrudes into the central cavity of the tray holder. A tray support may be attached to extend from the front side to the back side of the body of the tray holder. A pair of corresponding supports may be attached spaced apart and in the same horizontal line so that a shelf resting on them will be level 458. The dimensions of the tray supports may be determined for stable holding of a tray in both the expanded and contracted arrangements and for efficient conduction of heat from the tray holder to the held tray and the items placed on the tray for sterilization. Wheels are attached to the underside of the cart tray holder body for easy transport of the sterilization cart tray holder.

[0095] Reference is made to the following example, which together with the above descriptions illustrates the invention in a non-limiting fashion.

[0096] Example 1

[0097] Surgical instruments were sterilized using steam sterilization in an autoclave. An elongated C shaped tubular tray holder of the present invention was provided. Handles of the tray holder were squeezed by the user in order to bend the body of the tray holder and contract the diameter of the internal cavity of the tray holder. The contracted tray holder had an arrangement with a narrower configuration for easier insertion through the door of the sterilization chamber. The compressed tray holder was inserted into the sterilization chamber. The squeezing force was removed and the tray holder reverted to its arrangement with a wider configuration. The wider configuration was sufficiently large so that the walls of the tray holder contacted the internal surfaces of the sterilization chamber. Shelves were inserted into the tray holder and the trays were loaded with surgical instruments. The sterilization chamber was heated. The heat resulted in thermal expansion of the aluminum tray holder for an even tighter fit of the tray holder with the sterilization chamber surfaces. The heat was conducted to the trays and items placed thereon from the surfaces of the sterilization chamber, which were in contact with the conductive tray holder. Steam was applied to the heated sterilization chamber for sterilization of the items on the trays. At the end of the sterilization cycle the items were dried by applying heat. The heat was conducted to the trays and the items placed thereon for drying the sterilized items. The drying took fifteen minutes.

[0098] One skilled in the art can appreciate from the foregoing description that the broad systems, devices, and techniques of the aspects of the present invention can be implemented in a variety of forms. Therefore, while the aspects of this invention have been described in connection with particular examples thereof, the true scope of the aspects of the invention should not be so limited since other modifications will become apparent to the skilled practitioner upon a study of the specification, and following claims.