• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
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  • 优先权
    • 专利摘要:

    公开号:DK200700095U1
    申请号:DK200700095U
    申请日:2007-03-16
    公开日:2007-04-13
    发明作者:Busted Tommy
    申请人:Bat Holding Aps；
    IPC主号:
    专利说明:

    DK 2007 00095 U3
    Apparatus for sterilizing an element and removable housing therefor
    This object relates to an apparatus for sterilizing at least one ozone-containing gas element, and a removable housing for such an apparatus.
    The apparatus is particularly suitable for sterilizing elements such as reusable medical equipment, especially heat sensitive equipment such as endoscopes or ultrasonic transducers, but is not limited to use for such heat sensitive equipment, it may also be dental implants, surgical instruments, hearing aids and / or medical devices.
    Sterilization is a process that involves destroying any virus, bacterium, fungus or other microorganism, be it a vegetative or a resting state. Conventional sterile treatment procedures are mainly autoclave processes involving low pressure and high temperature (such as steam appliances with a temperature of about 140 ° C - 300 ° C and a pressure of about 1 atm below normal, or higher temperature dry heaters) or processes involving toxic chemicals (such as ethylene oxide gas, EO).
    Vapor pressure sterilization has been shown to be effective, relatively quick (1-2 hours) and profitable. However, the autoclave process destroys heat sensitive instruments such as arthroscopes, endoscopes and ultrasound transducers which are adversely affected by the heat due to the various materials used, since these materials have different thermal expansion coefficients, which destroy sensitive parts such as lenses, delicate electrical connections and circuits. and ceramic sound emitters.
    Furthermore, due to the low pressure of the process, air bubbles may form in existing thin water and air lines if both ends of the capillary tubes are simultaneously exposed to vacuum, which air bubbles increase the risk of bacterial growth.
    Ethylene oxide sterilization is used to cold sterilize heat sensitive instruments in a process comprising several vacuum cycles and a heat treatment of about 80 ° C in vacuum, a gas treatment for several hours, and a long (two weeks) vent phase in which the gas is to be vented. This complex and time-consuming process, as such, is expensive, and in addition dangerous, since ethylene oxide is carcinogenic, neurotoxic and extremely flammable, and requires venting, containment facilities, burning of the excess gas and fire protection.
    2 DK 2007 00095 U3
    Other existing sterilization processes which are not suitable for such heat sensitive instruments are gamma radiation sterilization since radiation. the effects cause a change in atomic structure, especially in plastic materials, ie. the materials become porous; and plasma sterilization, as a high electric field strength, hydrogen peroxide and vacuum destroy electronic equipment and rubber. In addition, these processes require complex devices and work protection for the operators.
    A more efficient, safer and less expensive sterilization process involves the use of ozone, O3, which is a highly oxidizing agent and which can be easily produced by and transformed back into non-harmful O2, which is a component of ambient air or in medical facilities. is readily available from an oxygen source. The ozone is converted to oxygen by the oxidation reaction, leaving no hazardous residue on the treated equipment. Conventional ozone gas sterilization requires a relatively high concentration of ozone gas to sterilize microorganisms and these high ozone gas concentrations must be combined with critical humidity levels because the ozone activity is rapidly increased at an increased humidity level. In addition, the resistance of the spores to ozone activity varies among the species and species, but the differences become quite small at high humidity levels, which could mean that a high degree of humidity is required for the ozone to be able to penetrate the protective "shell" around such microorganisms. One type, Bacillus Subtilis Var. Niger (ATCC 9372) is particularly resistant and as such can be used as an indicator of the sterilizing effect.
    International Patent Application WO 00/66186 discloses a method and apparatus comprising a chamber which is placed under vacuum during the supply of water vapor and ozone-containing gas, wherein the element to be sterilized is maintained for a predetermined period of time at a humidity of greater than 95%. preferably at the saturation point, at ambient temperature, after which the vacuum is released, which lowers the boiling temperature of the water. The problem here is the relatively large vacuum needed in said process, which causes air bubbles in conduits as mentioned above, and more importantly, requires special equipment to accurately control said humidity, temperature and vacuum, and to maintain such a vacuum, which increases the cost of the apparatus described.
    3 DK 2007 00095 U3
    Accordingly, it is one of the objects of the present invention to provide a method and apparatus for sterilizing an ozone-containing gas element which does not have the aforementioned disadvantages, and which provides a quick, safe and low cost sterilization of such an element.
    This object is achieved by a method and apparatus for sterilizing at least one element with ozone gas, said method comprising providing a housing with a sterilization chamber in which said at least one element is provided, providing said element with a first electrical potential, supplying water mist to said sterilization chamber, electrostatically ionizing an oxygen-containing gas to another electrical potential of an ionization unit, based on said electrostatically ionized oxygen-containing gas to generate ionized ozone gas in an ozone generator, supplying said ionized ozone gas to the sterilization chamber for attracting said ionized ozone surface to said ionized surface. one charged element, and exposing said at least one element to the ionized ozone gas for a predetermined exposure period.
    Thereby, a significant increase in sterilization efficiency is achieved, because the ionized ozone gas is thus able to contact the elements to be sterilized on all available surfaces thereof, both small or complex surfaces, due to the electrical potential difference between a element and the ionized ozone gas. This results in two advantages: First, a smaller amount of ozone gas is needed for an effective sterilization of one or more elements of the sterilization chamber, for example, it is sufficient to use the ambient air to produce the required amount of ozone. Second, there is significant reduction in the required sterilization period, which is important, for example, in a hospital environment where time can be a significant factor.
    Due to the relatively low temperatures and pressures used for effective sterilization in the method and apparatus of manufacture, the sterilized equipment will exhibit a smaller amount of deformation and wear, and the equipment will be ready for use substantially immediately after sterilization. This is particularly advantageous when sterilizing complex medical devices, such as ultrasonic transducers and endoscopes comprising various materials, since the sterilization wear on these instruments has been greatly reduced, resulting in longer shelf life of these often very costly devices, effectively reducing their operating costs. In fact, even other non-medical types of equipment such as recyclable hygiene articles can be effectively sterilized by the present invention, due to the relatively low pressures and temperatures used and the use of ionized ozone gas as the reactive sterilizer.
    It is also a safer and more profitable sterilization since no separate or costly safety precautions are required around or in connection with the sterilizer and because no complicated control systems are needed to monitor and accurately control the time, pressure and temperature. present in the sterilization chamber.
    It is realized upon generation that the housing containing the sterilization chamber can be removed from the apparatus to provide a long-term storage agent for the thus sterilized elements, preferably at the same time maintaining a greater pressure within the chamber than the ambient air.
    The production will be described in more detail in the following description in relation to one embodiment of the apparatus and the removable cassette housing, which is to be considered as an example of the present production, and with reference to the accompanying schematic drawings thereof,
    FIG. 1 is an overview view of the parts of a sterilizer according to one embodiment of the invention, and
    FIG. 2 is a top plan view of the apparatus of FIG. 1 contained in a housing comprising a removably coupled cassette housing.
    In FIG. 1, a general view of a sterilizer according to one embodiment of the invention is shown. In general, the apparatus comprises a housing 1 with a sterilization chamber 12 with a grounded metal grating 2, and a water mist manufacturing plant 3, an ionized ozone manufacturing plant 4 and an outlet gas purification plant 5 for removing the exhaust gases from the sterilization chamber 12.
    5 DK 2007 00095 U3
    The housing 1 comprises a sterilization chamber 12 in which a metal grating 21, during use of the apparatus, is provided with a first electrical potential, preferably a ground potential, which transfers this potential to medical equipment (not shown) disposed on the grating to be sterilized. Said housing 1 is adapted to be opened and closed for the purpose of disposing and removing said medical equipment before and after sterilization.
    The water mist preparation plant 3 comprises a supply 30 of demineralized water connected to a water dosing pump 32 and a fog generator 34, both of which are known in the art to the manufacture of water mist or water mist for an inlet valve 14 leading into the sterilization chamber 12. exact temperature of the water mist is of less importance for the effectiveness of the sterilizer or process of the present invention, but the moisture level may be about 80-100%. As an alternative to water mist, any other electrically conductive mist can be used as a potential carrier.
    The ionized ozone manufacturing plant 4 comprises a clean air intake assembly 40, comprising an air filter assembly 402, 404 connected to an air intake pump 406, a Teflon filter 408 and a UV / C irradiation unit 410. In order to provide / a clean gas without pollutant substances, the ambient air is taken in through a HEPA filter 401 and an active carbon filter 404. The air intake pump 406 can be any conventional type which provides a suitable amount of air for the production of a continuous or intermittent gas flow. The Teflon filter 408 removes any particle in the airflow. The UV / C radiation unit 410 conventionally irradiates the air flowing through the same to destroy any residual bacterium or microorganism in the air passing through ultraviolet radiation.
    The plant 4 further comprises an air ionization or air charging unit 42 and an ozone generator 44 which, based on filtered ionized intake air, generates ionized ozone-containing gas for supply via the opening of said intake valve 14 into the sterilization chamber 12.
    In the air ioniser 42, the incoming air is ionized or charged by a corona stream, i.e. a high electrostatic charge is provided to the incoming air by a high voltage electrode disposed in the air stream. The electrons are excited by the electrode and transmitted through the air, whereupon the passing air is filled with electrons and thus charged or ionized, where another electrical potential of the order of 80 kV (40 μΑ) is obtained. However, as a side effect ozone should be created during the process, this is not the main purpose of this treatment.
    Then, the ionized air is supplied to the ozone generator 44, which conventionally creates ozone gas by subjecting the ionized air to short wavelength UV or UV / C radiation, about 185 nm. Alternatively, any other conventional ozone production unit may be used. The UV / C radiation induces a photochemical reaction in the oxygen present in the intake air, thus producing a flow of air containing ozone or O 3 gas, ie. a highly reactive gas of molecules consisting of three oxygen atoms in the form of a triangle, each angle being 117 degrees. Since the oxygen-containing gas before ionization was ionized to a relatively high electrical potential, the resulting ozone or O3 gas in the air will be charged with electrons, creating O3.
    Thus, efficiently ionized ozone gas, 03 "~ is produced in a filtered, sterilized, ionized air supply. Such ionized ozone gas, 03" is very aggressive compared to non-ionized ozone gas used by conventional ozone sterilizers at present. The aggressive ΟΓ effectively destroys the bacteria on the medical device, and reduces the need for a high concentration of ozone during sterilization.
    The inlet valve 14 preferably supplies both water mist and ionized ozone-containing air to the sterilization chamber 12 in order to simplify the structure and to facilitate the detachable attachment of the housing, as will be described further below. Alternatively, a combined inlet / outlet valve or two or more separate inlets and / or outlets 14,16 may be provided.
    In the embodiment shown in FIG. 1 and 2, the water mist is passed through the inlet valve 14 and after a predetermined fog exposure period, for example in the order of one minute, it is again ejected through outlet valve 16. Because the water mist is deposited on and effectively covers the available surfaces of the medical equipment which are available for use. present on the metal lattice 21, the first potential created by the metal lattice will be transmitted on substantially all of said surfaces, even non-conductive surfaces, such as, for example, rubber surfaces.
    After the fog has been ejected, air containing ionized ozone gas is supplied to the sterilization chamber via the inlet valve 14. The ionized gas is effectively and substantially instantaneously attracted to the grounded equipment, resulting in a highly effective and very large equipment surface coverage rate for the ionized ozone gas, which results in a substantially improved sterilization effect for the method and apparatus of the invention.
    In addition, since the ozone has been ionized to another electrical potential before it is introduced into the sterilization chamber 12, the ionized ozone gas molecules CV will be attracted essentially solely by the charged surfaces, ie. to the surfaces of the medical device and the metal grating 21, and not to the inner surfaces of the housing 1. This further improves the efficiency of ozone sterilization and it also allows for an additional reduced ozone gas needed to achieve effective sterilization. This provides a further advantage, since most of the ionized ozone gas will be catalytically transformed back into oxygen due to contact with said surfaces, reducing the need for containment and / or conversion of the exhaust gases from the sterilization chamber 1 to reduce the amount of residual aggressive ozone gas. in the exhaust air.
    In order to reduce the amount of ionized ozone gas attracted by the grounded grid, the surface area of the grounded part of the grid may preferably be kept as small as possible, e.g. by making the wire of thin wire, and / or with large holes or the like, or providing the grid with insulation on those parts which are not exposed to parts of the elements to be sterilized, e.g. depending on the type of equipment to be sterilized.
    An electrical potential difference must exist between the equipment surfaces with the first potential and the ionized ozone gas with the second potential, but to achieve an effective sterilization effect, the magnitude of this difference is not so important, nor is the sign of the potential difference between the two. Other possible embodiments may include a positive potential on the surfaces, or even positive ionized ozone and a negative or ground potential on the surfaces. The metal grating 21 may be of any type of conductive material, such as surgical stainless steel, other types of stainless steel, iron or copper, and may be of any shape and type, e.g. a plate grating, a tray with edges, a basket or the like. Alternatively, the means for providing the electrical potential to the elements may be one or more metal plates, wires, and / or pins or the like, optionally adapted to specific medical equipment.
    After the ionized ozone gas has been operating for a predetermined exposure period, for example on the order of one minute, the gas is ejected, after which cycles of water mist and ionized ozone gas are repeated a predetermined number of times, e.g. six times and then a fog exposure is performed as the final step, also to catalytically change the remaining ionized ozone back to oxygen again.
    The outlet gas purifier 5 comprises an outlet valve 16, a flow sensor 52, moisture separators 54, a UV / C radiation unit 56, and an output unit comprising a carbon filter 582 and an air outlet pump 584. During and / or after sterilization, the gas or air inside the sterilization chamber 12 is ejected through the outlet valve 16. either by actively opening it, or by keeping it open continuously. The flow sensor 52 records the amount of air flow. The moisture separators 54 remove moisture from the ejected gas and reduce the risk of airborne contamination therein. To ensure that all ozone has been catalytically converted to oxygen and there are no living microorganisms left in the exhaust gas, the exhaust gas flow is transferred to the UV / C radiation unit 56. The exhaust gas is then removed from the apparatus at the exit unit 58, where an air pump 584 extracts the gas. through the carbon filter 58, which removes any residual contamination in the ejected gas, and even prevents external contamination from entering the apparatus when it is shut down.
    Preferably, the water mist is applied over a predetermined mist treatment period and then ejected, and said ionized gas is applied and ejected after said predetermined exposure period, and this is repeated a predetermined number of times. As an alternative to the alternated fog and ionized gas cycle, the ionized ozone gas can be caused to flow through the sterilization chamber after the first fog exposure, either continuously or intermittently. In addition, the ionized ozone gas and the water mist can be supplied at the same time, although this will significantly affect the efficiency of the ozone gas because the ozone gas can then be bound to the water mist in the room inside the sterilization chamber and not to the equipment to be sterilized.
    Each total sterilization period, ie. the total cycles and the final fog step can last from 1 to 120 minutes, preferably from 10 to 20 minutes and more preferably 13 to 15 minutes. Examples of such time periods are one minute at a time, alternating between water mist and ionized ozone gas, optionally with short waiting periods or suction intervals therebetween, in intervals of tens of seconds to decades of gas flow, a total of seven times water mist exposure and six times ionized ozone exposure. The waiting times provide rest periods during which the water mist can be deposited or lie on the equipment to be sterilized, after which or during which periods the remaining water mist in the sterilization chamber is sucked out from there.
    One problem that the applicant has not seen described in the prior art is how the sterilized elements can be enclosed, ie. may be held and / or transported while retaining them in such a sterilized state until the time they are desired to be used. Accordingly, it is recognized in the art that a housing suitable for use with an apparatus according to the art or for carrying out the art of the art can be provided which may contain the elements in a sterilized state until the use of these elements is necessary.
    The apparatus is preferably provided with means for providing a pressure difference between said sterilization chamber and the environment thereof, such that the pressure is higher inside the sterilization chamber than in the air surrounding the housing. This may be provided by shaping the inlet and outlet valves 14, 16 in such a way that there is a minor overpressure present in the sterilization chamber 12 during and / or especially after sterilization to maintain a sterile environment by preventing contamination from coming. through the ambient air.
    Preferably, the inlet valve and outlet valve 16 can be individually adjustable and controllable to provide said pressure difference, and / or said water metering pump 32, said air intake pump 406 and said air outlet pump 584 are individually adjustable and controllable. Said control / control is preferably carried out by control means, such as a processor or the like, which are also included in the apparatus.
    10 DK 2007 00095 U3 In fig. 2 is a top perspective view of a compact and self-contained apparatus according to the present invention, in which all the constituent parts shown in FIG. 1 may preferably be contained in a housing 70 which is provided with wheels for easy transport of the apparatus. Thus, the only external supply needed is an electrical supply unit, e.g. an electrical receiver, in which case the apparatus is provided with a high voltage generator for supplying e.g. The UV radiation units and the ionizer. The water may also be supplied from an apparatus external supply of demineralized water, but is preferably supplied from a water supply located within the cabinet 70.
    The front of housing 70 is provided with a control panel 72 from which an operator is able to control from start to finish of the sterilization process or set parameters such as selecting preset sterilization programs, controlling and monitoring temperature, pressure, exhaust gas flow, ozone gas, and / or other functions to be regulated and controlled, and preferably electronically record the sterilization process inside the sterilization chamber inside the housing 1.
    Alternatively, no panel is provided and the attachment of the cassette housing 1 to the cabinet 70 automatically starts a preset sterilization program which ends after a predetermined period of time, and then a minor overpressure is provided in the sterilization chamber; then it can be opened using an opening handle 18 provided on the upper portion of the cassette housing. Monitoring parameters from the sterilization process may be provided visually, for example on a screen or with indicator light.
    The housing 1 is a cassette housing with a sterilization chamber for receiving at least one element, wherein the sterilization chamber comprises means for providing said element with a first electrical potential, the cassette housing comprising an inlet valve 14 for supplying water mist and for supplying ionized ozone gas and an outlet valve 16 for exhausting the gases. Further, the cassette housing includes fasteners which allow the housing to be detachably coupled to the apparatus. In addition, the cassette housing may comprise pressure means for providing a pressure difference between said sterilization chamber and the environment such that the pressure is higher within the sterilization chamber, as described above.
    11 DK 2007 00095 U3 In fig. 2, the housing 1 is provided as a cassette housing or "trunk" with an upper portion 1a and a lower portion 1b interconnected by hinges (not shown) on one side thereof. Said cassette housing is removably coupled to housing 70 via fasteners comprising the inlet and outlet valves 14, 16 which allow the housing to be removably coupled to the apparatus. The cassette housing is provided with transport handles 19 on both sides of it for transporting the cassette housing itself away from the apparatus and for holding the elements or medical equipment on the horizontally arranged metal grille, either for storage or to be used on site or another place in the medical facility.
    According to "Premarket Notifications [510 (k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers," published by U.S. Federal Drug Administration 12001, the type may be Bacillus Subtilis var. Niger is used as a biological indicator so that users can be provided with information on the effectiveness of the sterilization process. During testing with an apparatus according to the invention as shown in FIG. 1 and 2, which performed a method of manufacture on medical equipment provided with a known amount of said bacterial type, the sterilization efficiency was found to be very high, and at least comparable to the most effective EO and vacuum sterilization devices available on the market today. .
    The generation may be carried out in other ways within the scope of the protection as defined by the appended claims, for example, the housing may be provided in another manner, e.g. a cylindrical bucket with a lid, a resealable plastic bag, or the like; the housing may or may not be present; the housing may be removably coupled or not; The oxygen may as an alternative be provided as an oxygen supply container.
    权利要求:
    Claims (22)
    [1]
    An apparatus for sterilizing at least one element with ozone gas, comprising a housing with a sterilization chamber for receiving said at least one element, supply means for supplying water mist to said sterilization chamber, said apparatus being further characterized in that it further comprises potential means for providing said an element having a first electric potential, means for supplying an electrostatic ionized ozone gas to said sterilization chamber, comprising a supply of oxygen-containing gas which is connected to a gas ionization unit for providing said gas with a second electrical potential connected to an ozone generator connected to said sterilization chamber.
    [2]
    Apparatus according to claim 1, wherein said supply means is adapted to deliver water mist to said sterilization chamber for a predetermined water mist treatment period and said supply means is adapted to deliver said ionized ozone gas to said sterilization chamber for a predetermined exposure period.
    [3]
    Apparatus according to claim 2, wherein said predetermined exposure time and said fog treatment time are on the order of between 30 seconds and 15 minutes, preferably 1 minute to 5 minutes, and most preferably about 1 minute.
    [4]
    Apparatus according to claim 3 or 4, wherein said exposure period may be provided continuously, intermittently, or as a one-time exposure.
    [5]
    Apparatus according to any one of claims 1 to 4, wherein said water mist supply means and said supply means are arranged to supply said water mist and said ionized ozone gas respectively to said ionization chamber respectively. 13 DK 2007 00095 U3
    [6]
    Apparatus according to any one of claims 2 to 5, further arranged to comprise a rest period after said predetermined fog treatment period, said rest period lasting in the range of tens of seconds to decades of seconds.
    [7]
    Apparatus according to any one of claims 2 to 6, which is adapted to complete the sterilization process with a water mist supply during said predetermined mist mist treatment period.
    [8]
    Apparatus according to any one of the preceding claims, wherein said first and second electrical potentials are ground potentials respectively and a substantially large negative potentials.
    [9]
    Apparatus according to any one of the preceding claims, wherein said potential means comprises a metal grating.
    [10]
    Apparatus according to claim 9, wherein said metal grating can be of any shape and type, e.g. a plate grating, a tray with edges, a basket or the like.
    [11]
    Apparatus according to any one of the preceding claims, wherein said potential means comprises one or more metal plates, wires, and / or pins or the like, optionally adapted to specific elements.
    [12]
    Apparatus according to any one of the preceding claims, wherein said housing further comprises an inlet valve for said ionized ozone gas and said water mist, and an outlet valve for the exhaust gases.
    12 DK 2007 00095 U3
    [13]
    Apparatus according to any one of the preceding claims, wherein said supply of oxygen-containing gas is the ambient air surrounding the apparatus.
    [14]
    Apparatus according to any one of the preceding claims, further comprising fasteners which enable said housing to be detachably coupled to said apparatus.
    [15]
    The apparatus of claim 14, wherein said fasteners comprise said inlet and outlet valves. DK 2007 00095 U3 14
    [16]
    Apparatus according to any one of the preceding claims, wherein said one element is a complex medical device such as an ultrasonic transducer.
    [17]
    Apparatus according to any one of the preceding claims, wherein said housing and chamber are adapted to accommodate a pressure difference with respect to the ambient atmosphere, such that the pressure is higher within the sterilization chamber.
    [18]
    The housing of an apparatus according to any one of claims 1 to 17, wherein the housing is a cassette housing with a sterilization chamber for receiving at least one element to be sterilized, wherein the sterilization chamber comprises the potential means for providing said element with a first electrical potential. , wherein the casing housing comprises inlet means for supplying water mist and for the supply of ionized ozone gas and exhaust gases for exhausting the gases, and further comprises fasteners which allow the housing to be detachably coupled to the apparatus.
    [19]
    The housing of claim 18, wherein the inlet means and outlet means are an inlet / outlet valve or an inlet and outlet valve.
    [20]
    The housing of claim 18 or 19, wherein said fasteners comprise said inlet / outlet valve or said inlet and outlet valves.
    [21]
    A housing according to any one of claims 18 to 20, which is provided with pressure means for providing a pressure difference between said sterilization chamber and the surroundings, such that the pressure is higher within the sterilization chamber.
    [22]
    The housing of any one of claims 18 to 21, wherein said at least one element is a complex medical device such as an ultrasonic transducer.
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    同族专利:
    公开号 | 公开日
    DK200700095U3|2007-05-25|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    2011-08-26| UBP| Utility model lapsed|
    优先权:
    申请号 | 申请日 | 专利标题
    DK200700095U|DK200700095U3|2007-03-16|2007-03-16|Apparatus for sterilizing an element and removable housing therefor|DK200700095U| DK200700095U3|2007-03-16|2007-03-16|Apparatus for sterilizing an element and removable housing therefor|
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