The present invention relates to a sterilizer. Moreover, the present invention is of a sterilizer that is configured to provide more than one class of sterilization cycle.
Sterilization is carried out routinely in many industries and on diverse items, such as those related to the medical and food industries. Items to be sterilized can be placed in the sterilization chamber of a sterilization device and a sterilization cycle can be run using a suitable sterilization medium, such as for example steam and heat.
Sterilization cycles in steam sterilizers can be classified based on the performance of the cycle as Class B, Class N and Class S. These cycles differ in the way in which air is removed, the types of load they can sterilize and whether the items can be wrapped during sterilization. All three types remove air from the sterilization chamber, however the methods to attain this are different. Class N sterilizers use passive air removal from the sterilizer. Class S sterilizers use active air removal by for example steam pulsing and Class B sterilizers use active air removal by for example using a vacuum pump. Class N sterilization cycles are suitable for unwrapped solid items, whilst Class B is used for wrapped or unwrapped solid or hollow items. Class S sterilization cycles are suitable only for the types of load specified by the sterilizer manufacturer. Although Class B has the widest range of applications, it is typically more expensive and may take longer than a Class S sterilization cycle.
The guidelines regarding which type of sterilization cycle should be used for which type of item differ by country. In America, Class S sterilization is within the recommended guidelines for certain end uses and this type of sterilizer is typically used in for example tabletop sterilizers in dentistry and medical clinics. However, in view of the possibility that government guidelines may change, and/or a potential future need by a user for optimal sterilization on a wider variety of type of object, there may be a widespread need to replace Class N sterilizers with Class S or Class B sterilizers and Class S sterilizers with Class B sterilizers. Currently, a Class N or a Class S sterilizer may meet the needs of a user. The user may like to continue to use a machine that he is familiar with, as well as it typically being cheaper for him to run than a higher class sterilizer, such as a Class B sterilizer. As such the user may want to switch to a Class B sterilizer only when, or if it is necessary. Such a user may be averse to the expense of having to replace the Class N or Class S sterilizer at this future time with a costly Class B sterilizer.
It would therefore be desirable to have a sterilizer which provides more than one class of sterilization. It would be useful to have a Class N or Class S sterilization device and wherein the same sterilizer can be adapted to provide Class B sterilization. It would further be advantageous to have a Class N or Class S sterilizer, which could be easily configured to provide Class B sterilization. It would be beneficial if the upgrade is significantly cheaper than replacing the Class N sterilizer or Class S sterilizer with a Class B sterilizer. It would be further environmentally desirable to provide an upgradable sterilizer, obviating the need to discard a redundant Class N or Class S sterilizer. The present invention provides such a system, device and method of use thereof.
The invention may have several aspects. One aspect is a sterilization device. The sterilization device may include a sterilization chamber for accommodating at least one item for sterilization. The sterilization device may include a power means for powering the device. The sterilization device may include a means for providing a sterilization medium for sterilizing the at least one item. The sterilization device may include a plurality of sterilization cycle programs. The plurality of sterilization cycle programs may include at least one S class sterilization cycle program and at least one B class sterilization cycle program. The at least one S class sterilization programs may be for sterilization of at least one item as defined by the manufacturer of the sterilization device. The at least one B class sterilization programs may be for sterilization of items for which Class S may be sufficient, in addition to items for which Class S is not adequate for sterilization, such as but not limited to at least one of a solid product, a porous product, a lumen device, a single-wrapped product, a multiple-layer product and a non-wrapped product. In a first state the sterilization device provides sterilization using the at least one S class sterilization cycle program and the at least one B class sterilization cycle program is locked and unavailable for use by a user. The sterilization device may include a second state wherein the sterilization device provides the at least one B Class sterilization cycle program unlocked and available for use by a user. The sterilization medium may include steam for steam sterilization. The sterilization chamber may include at least one inlet for steam. The sterilization chamber may include at least one valve configured for connection to a vacuum system.
In various embodiments of the sterilization device the at least one locked B class sterilization cycle program is configured to be unlocked with a code. The code may be provided separately from the sterilization device. The device may include a keyboard for inputting the code. The code may be inputted remotely.
In various embodiments of the sterilization device, the device includes at least one air removal system. The air removal system is configured to provide air removal from the sterilization chamber. The at least one air removal system may feature at least one of a steam pulsing system and a vacuum system. The sterilization chamber may include at least one inlet for at least one of steam and water. The sterilization chamber may include at least one outlet for at least one of air and steam. In an embodiment wherein the air removal system features a steam pulsing system, the steam pulsing system may be connected to the at least one inlet for steam and/or water of the sterilization chamber. The steam pulsing system may include water, which may be stored in a water tank, a water pump and a water heater. In an embodiment wherein the air removal system features a vacuum system, the vacuum system may be connected to the at least one valve of the sterilization chamber.
In various embodiments of the sterilization device, when the device is in a first state, the at least one program for providing B class sterilization is locked and the at least one air removal system is configured to provide air removal from the sterilization chamber sufficient for S class sterilization. The device may provide only S class sterilization.
In various embodiments the device is configured to a second state wherein the at least one program for B class sterilization cycle is unlocked. The at least one air removal system is configured to provide air removal sufficient for producing B class sterilization. The device may provide S class sterilization or B class sterilization. The device may provide only B class sterilization.
In various embodiments the sterilization device may further include at least one controller for controlling the sterilization cycles of the sterilization device. The sterilization device may further include at least one of a means for measuring pressure, a means for measuring temperature and a means for measuring time. The sterilization device may further feature at least one of a means for controlling pressure, a means for controlling temperature and a means for controlling time.
The sterilization device may include at least one control for controlling the steam pulsing system. The sterilization device may include at least one control for controlling the vacuum system.
In various embodiments of the sterilization device, the plurality of sterilization cycle programs may further include at least one N class sterilization cycle. At least one of the at least one S class sterilization cycle program and the at least one B class sterilization cycle program may be in a locked state. In a first state the sterilization device may provide sterilization using the at least one N class sterilization cycle program and the at least one S class sterilization cycle program is locked and unavailable for use by a user and the at least one B class sterilization cycle program is locked and unavailable for use by a user. In a second state, the at least one S class sterilization cycle program may be unlocked and available for use by a user and the sterilization device may provide sterilization using either the at least one N class sterilization cycle program or the at least one S class sterilization cycle program and the at least one B class sterilization cycle program is locked and unavailable for use by a user. In a third state the sterilization device may provide sterilization using either the at least one N class sterilization cycle program or the at least one S class sterilization cycle program or the at least one B class sterilization cycle program. In a fourth state the at last one B class sterilization cycle program may be unlocked and available for use by a user and the sterilization device may provide sterilization using either the at least one N class sterilization cycle program or the at least one B class sterilization cycle program and the at least one S class sterilization cycle program is locked and unavailable for use by a user.
A further aspect is a sterilization system. The sterilization system may include a sterilization device and a code for unlocking at least one B class sterilization cycle of the sterilization device. The sterilization device may include a sterilization chamber for accommodating at least one item for sterilization. The sterilization device may include a means for powering the device. The sterilization device may include a means for providing a sterilization medium for sterilizing the at least one item. The sterilization device may include a plurality of sterilization cycle programs. The plurality of sterilization cycle programs may include at least one S class sterilization cycle program and at least one B class sterilization cycle program. The at least one B class sterilization cycle program may be in a locked state. The sterilization device may provide S class sterilization and is adaptable to unlock and provide B class sterilization.
In various embodiments of the sterilization system, the sterilization device includes at least one controller for controlling the at least one sterilization cycle of the sterilization device. The sterilization device may include at least one of a steam pulsing system and a vacuum system to provide air removal from the sterilization chamber.
A still further aspect is a sterilization system featuring a sterilization device. The device may include a sterilization chamber for accommodating at least one item for sterilization, a means for powering the device, a means for providing a sterilization medium for sterilizing the at least one item and a plurality of sterilization cycle programs. The plurality of sterilization cycle programs may include at least one N class sterilization cycle program, at least one S class sterilization cycle program in a locked state and at least one B class sterilization cycle program in a locked state. The sterilization device may provide N class sterilization and is adaptable to unlock and provide S class sterilization and B class sterilization. The sterilization system may include a code for unlocking the at least one locked S class sterilization cycle and a code for unlocking the at least one locked B class sterilization cycle. The sterilization device may include a passive steam air removal system and at least one of a steam pulsing system and a vacuum system to provide air removal from the sterilization chamber.
An aspect is a method of sterilization. The method features providing a sterilization device of the present invention. The sterilization device may be in a first state, wherein the at least one B class sterilization cycle program is locked. The method includes placing at least one item in the sterilization chamber and running at least one S class sterilization cycle for sterilizing the at least one item.
An aspect is an additional method of sterilization. The method features providing a sterilization device of the present invention. The method includes placing at least one item in the sterilization chamber and selecting an S class sterilization cycle or a B class sterilization cycle. The method further includes running the selected class sterilization cycle for sterilizing the at least one item.
A still further aspect is a method of converting a sterilization device for providing S class sterilization into a sterilization device for providing B class sterilization. The method may include providing a sterilization device of the present invention. The sterilization device may be in a first state, wherein the at least one B class sterilization cycle program is locked. The method includes inputting a code for unlocking the at least one B class sterilization cycle program for providing the sterilization device with at least one available B class sterilization cycle program and for converting the sterilization device from a first state wherein the at least one B class sterilization cycle is locked into a second state wherein the at least one B class sterilization cycle program is unlocked.
Another aspect is a further method of sterilization. The method may include providing a sterilization device of the present invention. The sterilization device may be in a first state, wherein the at least one B class sterilization cycle program is locked. The method includes unlocking the at least one B class sterilization cycle program to provide at least one available B class sterilization cycle program. Unlocking may feature inputting a code. The method includes placing at least one item in the sterilization chamber and running at least one B class sterilization cycle for sterilizing the at least one item. The method may include selecting a B class sterilization cycle.
An aspect is a method of sterilization using a sterilization device which features at least one N class sterilization cycle program, at least one S class sterilization cycle program and at least one B class sterilization cycle program. The method may include providing a sterilization device of the present invention, wherein the sterilization device incudes a plurality of sterilization cycle programs, which feature at least one N class sterilization cycle program, at least one S class sterilization cycle program and at least one B class sterilization cycle program. The method includes placing at least one item in the sterilization chamber. The method includes selecting one of an N class sterilization cycle, an S class sterilization cycle or a B class sterilization cycle and running the selected class sterilization cycle to sterilize the at least one item. In various embodiments of the method, at least one of the at least one S class sterilization cycle program and the at least one B class sterilization cycle program are in a locked state. In an embodiment the at least one B class sterilization cycle program is in a locked state. The method may include unlocking the at least one B class sterilization cycle program to provide at least one available B class sterilization cycle program. The method may include running at least one B class sterilization cycle for sterilizing the at least one item.
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:
In one aspect the present invention is of a sterilization device. The sterilization device is configured to provide at least one S class sterilization cycle and at least one B class sterilization cycle. The sterilization device provides S Class sterilization and may be adaptable to provide B class sterilization. In an additional aspect the present invention is of a sterilization device which is configured to provide at least one N class sterilization cycle, at least one S class sterilization cycle and at least one B class sterilization cycle. In a further aspect, the present invention provides a sterilization system featuring a sterilization device and a key for unlocking B class sterilization cycles of the sterilization device. In a further aspect, the present invention provides a method of converting a sterilization device to a B Class sterilization device. Furthermore, the present invention provides a method of sterilization.
The device and system of the present invention have many advantages. The invention ensures that a user is not limited to use of only one class of sterilization from a single sterilizer. The invention provides a user with the option of converting a same S Type sterilizer to a B sterilizer at a future date. The invention provides a user with the option of converting a same N Type sterilizer to an S Type sterilizer and/or a B Type sterilizer. The invention also provides a way of reducing waste caused by throwing out of redundant S Type sterilizers and redundant N Type sterilizers. The invention may also enable a user to choose between S Type and B Type sterilization with a single sterilizer. The invention may also facilitate a user having the choice of using an N Type, S Type or B Type sterilization with a single sterilizer.
As used herein the terms ‘Class’ and ‘Type’ may be used interchangeably.
As used herein the terms ‘locked’ and ‘locked state’ may include, but are not limited to a state where a sterilization program or cycle is configured so that it cannot be used by a user without being unlocked in a suitable way. The unlocking may be by a suitable key.
As used herein the term ‘available’ may include, but is not limited to a state where the cycle is configured such that it can be used and run by a user. The term includes the state where the cycle is not locked.
As used herein the terms ‘adapting’ and ‘adapted’ may include, but are not limited to upgrading and reconfiguring of the sterilizer. The terms may include any suitable method of adapting, such as but not limited to using physical and/or software means.
As used herein the term ‘distribution system’ may include, but is not limited to any suitable means for providing a material from a first location to a second location. The term includes providing a material from one part of a system to another part of a system.
As used herein the term ‘sterilization chamber’ may include, but is not limited to a compartment where sterilization may be carried out.
As used herein the term ‘connection’ may include, but is not limited to direct and indirect attachment.
As used herein the term ‘inlet’ may include, but is not limited to a means of entry. The term may include any suitable means of entry, such as, but not limited to vents, ducts, pipes, flues and openings.
As used herein the term ‘outlet’ may include, but is not limited to a means of exit. The term may include an opening or passage configured for letting something out. The term may include vents, pipes, ducts and exits for expelling something.
As used herein the term ‘channel’ may include, but is not limited to a passage or a structure, which provides a passage or pathway for a material, such as a gas, vapor or liquid to flow along. The term may include a channel made from a material resistant to the material it is carrying. The term may include a channel for a separated passage of a material.
As used herein the term ‘sterilization device’ may include, but is not limited to a sterilizer, which features a sterilization chamber. The sterilizer may provide the sterilization chamber with sterilization conditions, materials, and other means for facilitating a sterilization process and sterilization of items in the sterilization chamber.
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.
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.
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.
As used herein the terms ‘a’ and ‘an’ may mean ‘one’ or ‘more than one’.
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 methods steps, which are not recited.
The principles and operation of a system and device, such as a sterilizer, 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.
The Sterilization Device
In one aspect, the sterilizer features a plurality of states. In a first state, the sterilizer is provided wherein the B Class sterilization cycles are unavailable for use by a user and the user can only use the sterilizer in this first state for S Class sterilization. In this first state, the B Class sterilization cycle programs are in a dormant or locked state. The sterilizer 10 may be adapted to a second state wherein the B Class sterilization cycles are available for use.
The sterilization device 10 may feature a sterilization chamber 12. The sterilization chamber 12 may be any suitable sterilization chamber and may be constructed from any suitable material, such as, but not limited to stainless steel or polycarbonate. The sterilization chamber 12 may be of any suitable size and shape for sterilizing at least one item.
The sterilizer 10 may include at least one system for providing sterilization conditions to the sterilization chamber 12. The at least one system for providing sterilization conditions to the sterilization chamber may include a heating device 16 for providing heat to the sterilization chamber 12. The heating device may be any suitable heating device. One non-limiting example of a suitable heating device is an electrical jacket heater for heating the sterilization chamber. The heating device 16 may be configured so that it surrounds the sterilization chamber 12 or may be positioned in any other suitable way so that it provides uniform heat to the sterilization chamber. The heating device may provide heat of a temperature greater than about 100° C. In some embodiments, the heating device may provide a temperature of greater than about 120° C.
The at least one system for providing sterilization conditions to the sterilization chamber may include a means 18 for providing steam 20 to the sterilization chamber 12. The means 18 for providing steam 20 to the sterilization chamber may be positioned externally from the sterilization chamber 12. As shown schematically in
In an alternative example, which is not shown in
As shown schematically in
In an alternative embodiment, shown schematically in
As shown schematically in
The control 60 may include different programs 76 of sterilization cycle. The programs may be provided as part of a menu 78. The programs 76 may be preset and/or may be programmable.
In some embodiments, the locked sterilization class may be unlocked once and may then remain unlocked. In one embodiment, the at least one B Class sterilization cycles 76b may be relockable. In one non-limiting example, the unlocking of the at least one B Class sterilization cycle 76b may be for a specific time duration after which the B Class sterilization cycles relock 76b. Alternatively, the at least one B Class sterilization cycle 76b may be locked remotely. Such a relockable sterilizer may be suitable for a subscription payment scheme for use of the B Class Sterilization cycles. In one embodiment, the at least one B Class sterilization cycle once unlocked may be made unavailable. Unavailability of B Class sterilization may result from a selection choice in a sterilization cycle menu, such as but not limited to selecting an S Class sterilization menu.
The controller 60 may include means for controlling the sterilization cycles of the sterilization device. The controller may include a heating control 80 for controlling the temperature provided to the chamber. The device may include at least one thermometer 82 for measuring the temperature. The controller may include a control 84 for controlling the production of steam. The controller may include a means for controlling pulsing of steam 86 provided to the incubation chamber. The controller may control the water pump to control pulsing of steam, which may be by controlling the pump control 27. The controller may include a means for controlling pressure 88. The controller may include a pressure measuring device 90. The controller may include a means for controlling the time of a sterilization cycle 92. The controller may include a means for opening and closing steam inlets 94 for allowing steam into the incubation chamber. The controller may include a means for controlling operation and parameters of a vacuum system, such as a vacuum pump 96. The controller may include means for closing and opening steam and air outlets of the sterilization chamber.
The sterilizer may include a power supply 100 and electrical connections for powering the sterilization device 10 and its components. The power supply 100 may be any suitable power supply that supplies power. The sterilizer may include a safety valve 102.
The sterilizer may be constructed from materials suitable for Class S sterilization conditions and suitable for Class B sterilization conditions.
In one non-limiting embodiment, the sterilizer of the present invention may be configured to provide three classes of sterilization cycle, Class N, Class S and Class B. In such an embodiment, the three class sterilizer may have four states. In a first state, sterilization cycles/s of Class N may be available to a user. The sterilization cycles of Class S and Class B may be locked in any suitable way as described herein for Class B, such as with a lock, which can be opened with a suitable key. In one non-limiting example a different key may unlock each of the locked classes. In a second state, Class S sterilization cycle/s may be unlocked providing a user with unlocked and available sterilization cycles of Class N and Class S. In a third state, Class S and Class B sterilization cycles may be unlocked to provide a user with unlocked and available sterilization cycles of Class N, Class S and Class B. In a fourth state, Class B sterilization cycles may be unlocked providing a user with unlocked and available Class N and Class B sterilization cycles. In one non-limiting embodiment, the three class sterilizer may be provided with Class N, Class S and Class B sterilization cycles, which are available to a user on selection of the desired class of sterilization.
The three class sterilizer may feature substantially the same components as the two class S and B sterilizer 10 described hereinabove. To avoid repetition the components of the sterilizer 10 which provide Class S and Class B sterilization will not be described again. In the three class sterilizer, Class N sterilization may be provided by gravity displacement of air using steam. Referring to
The sterilizer of the present invention may be suitable for a variety of sterilization applications. Non limiting examples include sterilization of instruments used in medical clinics and all types of dental clinic.
Sterilization System
The present invention provides a sterilization system as shown schematically in
In one non-limiting embodiment, the system may include a sterilization device configured to provide Class N, Class S and Class B sterilization, wherein at least one of the Class S and Class B sterilization cycles are locked. The system may include two keys 110, a first key for unlocking Class S sterilization cycles and a second key for unlocking Class B sterilization cycles. The key for unlocking Class B sterilization cycles may work as described for the key for unlocking Class B sterilization cycles in a Class S and Class B sterilizer. Use of the key for unlocking Class S sterilization cycles may facilitate physical connection and/or commands to the sterilization chamber of any necessary opening or activation of means or conditions for active air removal sufficient for Class S sterilization.
Method of Converting a Sterilizer to a B Class Sterilizer
The present invention provides a method of converting a convertible Class S sterilizer of the present invention to a Class B sterilizer.
Method of Sterilization
The present invention provides a method of sterilizing at least one item as shown schematically in the flow chart of
In an alternative embodiment, the present invention provides a method of sterilizing at least one item as shown schematically in the flow chart of
In a further embodiment, the present invention provides a method of sterilizing at least one item as shown schematically in the flow chart of
Reference is made to the following example, which together with the above descriptions illustrates the invention in a non-limiting fashion.
A dentist purchases a sterilizer of the present invention which provides S Class sterilization and is upgradeable to provide B Class sterilization. She uses the standard mode of the sterilizer for sterilizing dental equipment specified as being suitable for S Class sterilization. The dentist expands her practice and some equipment of her associate cannot be sterilized by S Class sterilization. She does not want to buy a B Class sterilizer. Instead, the dentist buys the code for converting the S Class sterilizer of the present invention to a sterilizer that can provide B Class sterilization. She inputs the code and the B Class sterilization programs are unlocked and available to use. She has upgraded the sterilizer, which can now sufficiently sterilize all the equipment of her clinic.
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.
This application claims priority to U.S. Provisional Patent Application Ser. No. 62/964,690 filed on Jan. 23, 2020 and incorporated by reference herein in entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/050322 | 1/17/2021 | WO |
Number | Date | Country | |
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62964690 | Jan 2020 | US |